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Mindray BeneHeart D3 Operator's Manual

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BeneHeart D3

Defibrillator/Monitor

Operator’s Manual

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Summary of Contents for Mindray BeneHeart D3

  • Page 1
    BeneHeart D3 Defibrillator/Monitor Operator’s Manual…
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    © 2010 — 2013 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2013-09.
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    Mindray is strictly forbidden. are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.
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    Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
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    Mindray’s obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
  • Page 7
    Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product.
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    FOR YOUR NOTES…

  • Page 9: Table Of Contents

    Contents 1 Safety……………………………… 1-1 1.1 Safety Information………………………………..1-1 1.1.1 Dangers ………………………………….1-2 1.1.2 Warnings …………………………………..1-2 1.1.3 Cautions ………………………………….1-3 1.1.4 Notes ………………………………….1-3 1.2 Equipment Symbols………………………………..1-4 2 The Basics …………………………….2-1 2.1 Overview……………………………………2-1 2.2 Intended Use ………………………………….2-1 2.2.1 AED……………………………………2-2 2.2.2 Manual Defibrillation…………………………….2-2 2.2.3 Noninvasive Pacing ……………………………….2-2 2.2.4 ECG……………………………………2-2 2.2.5 Resp ……………………………………2-2 2.2.6 SpO…

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    4 Managing Patients…………………………. 4-1 4.1 Overview ……………………………………4-1 4.2 Editing Patient Information …………………………….. 4-1 5 Alarms…………………………….. 5-1 5.1 Alarm Categories ………………………………… 5-1 5.2 Alarm Levels ………………………………….5-2 5.3 Alarm Indicators………………………………….. 5-2 5.3.1 Alarm Lamps ………………………………..5-2 5.3.2 Audible Alarms ………………………………. 5-3 5.3.3 Alarm Message ……………………………….
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    6.7.4 Changing Arrhythmia Threshold Settings ……………………..6-10 6.7.5 Initiating Arrhythmia Relearning Manually……………………..6-11 6.7.6 Automatic Arrhythmia Relearn…………………………6-11 6.8 Calibrating ECG…………………………………. 6-11 7 AED ………………………………7-1 7.1 Overview……………………………………7-1 7.2 Safety……………………………………..7-1 7.3 AED View……………………………………7-2 7.4 AED Procedure………………………………….7-3 7.5 Shock Advised………………………………….7-4 7.6 No Shock Advised (NSA)………………………………7-4 7.7 CPR ……………………………………..7-5 7.7.1 CPR Metronome ………………………………7-5 7.8 AED Sound Recording………………………………..7-6…
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    10.4.2 Changing Resp Wave Settings…………………………10-3 11 Monitoring PR …………………………..11-1 11.1 Overview ……………………………………11-1 11.2 Adjusting Pulse Tone Volume ……………………………..11-1 12 Monitoring SpO …………………………12-1 12.1 Introduction………………………………….12-1 12.2 Safety……………………………………12-2 12.3 Identifying SpO Modules…………………………….12-2 12.4 SpO Monitoring Procedure…………………………….12-2 12.5 Changing SpO Settings ……………………………….12-3 12.5.1 Setting SpO Sensitivity …………………………..12-3 12.5.2 Monitoring SpO…
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    16 Review …………………………….16-1 16.1 Reviewing Events ………………………………..16-1 16.2 Reviewing Tabular Trends…………………………….16-2 17 Data Management…………………………17-1 17.1 Introduction ………………………………….17-1 17.2 Reviewing Patient Events …………………………….17-2 17.3 Exporting Data ………………………………..17-2 18 Recording …………………………… 18-1 18.1 Using a Recorder………………………………..18-1 18.2 Recording Types………………………………..
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    20.2 Installing the Batteries ………………………………20-2 20.3 Battery Alarms………………………………….20-2 20.3.1 No Battery Alarm……………………………….20-2 20.3.2 Low Battery Alarm …………………………….20-2 20.3.3 Battery Aged Alarm…………………………….20-3 20.3.4 Battery Error Alarm…………………………….20-3 20.4 Checking the Batteries………………………………20-3 20.5 Charging batteries………………………………..20-3 20.6 Storing Batteries………………………………..20-4 20.7 Recycling the Batteries………………………………20-4 21 Care and Cleaning…………………………21-1 21.1 General Points ………………………………….21-1 21.2 Cleaning …………………………………….21-2 21.3 Disinfecting ………………………………….21-2…
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    A.7 Alarm Specifications………………………………..A-10 A.8 Data Management Specifications …………………………..A-11 A.9 Environmental Specifications …………………………….A-11 B EMC………………………………B-1 C BeneHeart Defibrillator Shift Checklist ……………………C-1 D Alarm Messages …………………………..D-1 D.1 Physiological Alarm Messages …………………………….D-1 D.2 Technical Alarm Messages ………………………………D-2 E Electrical Safety Inspection……………………….E-1 E.1 Power Cord Plug…………………………………..E-1 E.2 Device Enclosure and Accessories…………………………..E-1 E.3 Device Labelling…………………………………..E-2…
  • Page 16
    FOR YOUR NOTES…

  • Page 17: Safety

    Safety 1.1 Safety Information DANGER Indicates an imminent hazard that, if not avoided, will result in death or serious injury. WARNING Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. CAUTION Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

  • Page 18: Dangers

    1.1.1 Dangers DANGER The equipment delivers up to 360 J of electrical energy. Unless properly used as described in these Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to operate this defibrillator unless thoroughly familiar with these operating instructions and the function of all controls, indicators, connectors, and accessories.

  • Page 19: Cautions

    For the treatment of patients with implantable pacemakers, place therapy pads or paddles away from internal pacemaker generator if possible to help prevent damage to the pacemaker. To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement or strangulation by patients or personnel.

  • Page 20: Equipment Symbols

    1.2 Equipment Symbols Caution (Attention, consult Status indicator accompanying documents) Alternating current Battery indicator Audio paused Alarm off Audio off Alarm paused Marker Lead select Gain select Event summary NIBP start/stop key Graphical recorder Menu Unlocking Network connector Shock button USB connector Input/Output Equipotentiality…

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    Fragile Right side up Keep dry Maximum stacks Manufacturer Date of manufacture General symbol for recovery/recyclable Electrostatic sensitive devices Mark of conformity to European Medical Device Directive 93/42/EEC Authorised representative in the European community DEFIBRILLATION-PROOF TYPE CF APPLIED PART DEFIBRILLATION-PROOF TYPE BF APPLIED PART Dispose of in accordance to your country’s requirements…
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    FOR YOUR NOTES…

  • Page 23: The Basics

    The Basics 2.1 Overview The BeneHeart (hereinafter called the equipment) is a lightweight and portable defibrillator/monitor. It provides four operating modes: Monitor, Manual Defib, AED and Pacer. In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing multiple physiological parameters and waveforms including ECG, pulse oximetry (SpO ), respiration (Resp), and non-invasive blood pressure (NIBP).

  • Page 24: Aed

    2.2.1 AED The AED mode is to be used only on cardio arrest patients who are at least 8 years. The patients must be: Unresponsive Not breathing or not breathing normally 2.2.2 Manual Defibrillation Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive.

  • Page 25: Main Unit

    2.3 Main Unit 2.3.1 Front View External paddle Handle Alarm lamp Area 1 Area 3 Microphone Area 2 Speaker…

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    Area 1 Display screen AC power indicator Illuminated: when AC mains is connected. Off: when AC mains is not connected. Battery indicator Yellow: when the battery is being charged. Green: when the battery is fully charged or the equipment is run on battery. Off: when no battery is installed or battery fails.
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    Area 2 Lead Select button Press this button to select the lead of the first ECG waveform. Gain select button Press this button to select the size of the first ECG waveform. NIBP button (for equipments configured with NIBP function) Press this button to start or stop NIBP measurements.
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    Area 3 Mode Select knob Rotate this knob to select the operating mode or turn the equipment off. Energy Select button In Manual Defib mode, press this button to select energy level. Charge button Press this button to charge the defibrillator. Shock button Press this button to deliver a shock to the patient.
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    Recorder Start/Stop Key Press this key to start a recording or stop the current recording. Indicator Illuminated: when the recorder works correctly. Flashes: when an error occurred to the recorder, or the recorder runs out of paper. Paper outlet Recorder door Latch…

  • Page 30: Side View

    2.3.2 Side View Therapy port Therapy port is used to connect paddles cable or pads cable. Recorder ECG: ECG cable connector : SpO sensor connector NIBP: NIBP cuff connector…

  • Page 31: Rear View

    2.3.3 Rear View Hook Battery Equipotential grounding terminal When the defibrillator/monitor and other devices are to be used together, their equipotential grounding terminals should be connected together to eliminate the potential difference between them. External power input It connects an AC power cord or a DC/AC adapter to run the equipment respectively on the external AC mains or DC power supply.

  • Page 32: External Paddles

    2.3.4 External Paddles Sternum paddle Apex paddle Shock button Energy Select button Shock indicator Charge button Shock button 2-10…

  • Page 33: Display Views

    2.4 Display Views A typical screen in Manual Defib Mode is shown below. Patient Information area This area shows patient name, patient category, paced status, and current date and time. : indicates that the patient has an implanted pacemaker. Alarm status symbols indicates alarms are paused;…

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    Waveform area This area shows measurement waveforms. The waveform label is displayed at the upper left corner of the waveform. Parameter area This area shows measurement parameters. Each measurement module has a parameter block and the parameter name is displayed at the upper left corner. Manual Defib information area This area shows the selected defibrillation energy, shock counter as well as prompt related to manual defibrillation.

  • Page 35: Basic Operations And Settings

    Basic Operations and Settings 3.1 Installation WARNING The equipment shall be installed by personnel authorized by the manufacturer. The software copyright of the equipment is solely owned by the the manufacturer. No organization or individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.

  • Page 36: Environmental Requirements

    3.1.2 Environmental Requirements The operating environment of the equipment must meet the requirements specified in this manual. The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances. If the equipment is installed in a cabinet, sufficient space in front and behind shall be left for convenient operation, maintenance and repair.

  • Page 37: Disconnecting From Power

    3.2.3 Disconnecting from Power To disconnect the equipment from the AC power source, follow this procedure: Confirm that the patient monitoring or therapy is completed. Disconnect the patient cables and sensors from the patient. Make sure to save or clear the patient data as required. Turn the Mode Select Knob to Off.

  • Page 38: Adjusting The Screen Brightness

    You can also set system time by selecting [Configuration >>]→[View Config]→[General Setup >>]. However, you cannot select date format and time format in this case. After the completion of setting system time, exit the configuration mode, and then the system will restart. 3.4.2 Adjusting the Screen Brightness Press the Main Menu button on the front panel, and then select [Others >>].

  • Page 39: Managing Patients

    Managing Patients 4.1 Overview Patient information management function enables you to edit and manage information of the current patient. 4.2 Editing Patient Information You can edit patient information in Monitor, Manual Defib and Pacer mode. To edit patient information, Press the Main Menu button on the front panel, and then select [Patient Demographics >>] and then make changes as desired.

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    FOR YOUR NOTES…

  • Page 41: Alarms

    Alarms Alarms, triggered by a vital sign that appears abnormal or by technical problems of the equipment, are indicated to the user by visual and audible alarm indications. WARNING A potential hazard exists if different alarm presets are used for the same or similar device in any single area, e.g.

  • Page 42: Alarm Levels

    5.2 Alarm Levels By severity, alarms can be classified into three categories: high level alarms, medium level alarms and low level alarms. Physiological alarms Technical alarms High level Indicate that your patient is in a life Indicate a severe device malfunction or an improper operation, threatening situation, such as Asystole, which could make it possible that the equipment cannot detect Vfib/Vtac and so forth, and an…

  • Page 43: Audible Alarms

    5.3.2 Audible Alarms The equipment uses different alarm tone patterns to match the alarm level: High level alarms triple+double+triple+double beeps. Medium level alarms triple beeps. Low level alarms single beep. 5.3.3 Alarm Message When an alarm occurs, the alarm message will appear in the technical or physiological alarm area. For physiological alarms, the asterisk symbols (*) before the alarm message match the alarm level as follows: High level alarms Medium level alarms…

  • Page 44: Alarm Tone Configuration

    5.4 Alarm Tone Configuration 5.4.1 Changing the Alarm Volume → Alm Volume >>]. Press the Main Menu button on the front panel, and then select [Alarm Setup >>] [ Set [Alm Volume] to an appropriate level: If [Audio Off] is enabled, alarm volume can be set to a value between 0 and 10, in which 0 means audio off and 10 the maximum volume level.

  • Page 45: Setting Alarm Properties For All Parameters

    5.5.1 Setting Alarm Properties for All Parameters → Para. Alarm >>] to enter the Para. Alarm setup menu, where you can In the main menu, select [Alarm Setup >>] [ review and set alarm limits, alarm switches, alarm level and alarm recordings for all parameters. When a parameter alarm is switched on, the equipment gives alarm indications in accordance with the preset alarm level and stores related waveforms and parameter values.

  • Page 46: Adjusting Alarm Limits Automatically

    5.5.2 Adjusting Alarm Limits Automatically The defibrillator/monitor can automatically adjust the patient’s alarm limits according to the measured vital signs. When [Auto Limits] is selected, the equipment automatically calculates alarm limits based on the latest measured parameter values. To enable auto alarm limits, press the Main Menu button on the equipment’s front panel, and then select [Alarm Setup →…

  • Page 47: Pausing Alarms

    5.6 Pausing Alarms You can temporarily disable alarm indicators by pressing the hardkey on the equipment’s front. When alarms are paused: For physiological alarms, no alarm indication is shown. New physiological alarm will not be presented. The remaining alarm pause time is displayed in the physiological alarm area. For technical alarms, alarm sounds are paused, but alarm lamps and alarm messages remain presented.

  • Page 48: Pausing Alarm Sounds

    5.8 Pausing Alarm Sounds You can press the [Audio Pause] softkey to pause alarm tones. In this case, the symbol will be displayed in the sound symbol area indicating all system sounds are silenced temporarily. In the audio paused status, all alarm indicators except audible alarm tones works properly.

  • Page 49: Latching Alarms

    5.11 Latching Alarms The latching setting for physiological alarms defines how alarm indicators behave when you do not acknowledge them. If an alarm is latched, alarm indications remain presented even though alarm conditions end, except that: The parameter reading and violated alarm limit stop flashing. The time when the alarm is last triggered is displayed behind the alarm message.

  • Page 50: When An Alarm Occurs

    5.13 When an Alarm Occurs When an alarm occurs, observe the following steps and take proper actions: Check the patient’s condition. Confirm the alarming parameter or alarm category. Identify the alarm source. Take proper action to eliminate the alarm condition. Make sure the alarm condition is corrected.

  • Page 51: Monitoring Ecg

    Monitoring ECG 6.1 Overview The electrocardiogram (ECG) measures the electrical activity of the heart and displays it as waveforms and numerics. The equipment enables ECG monitoring through 3-, 5- lead ECG sets, external paddles and multifunction electrode pads. If both ECG sets and paddles/pads are connected, the configured ECG waveforms are displayed in the waveform area. 6.2 Safety WARNING Periodically inspect the electrode application site to ensure skin quality.

  • Page 52: Monitoring View

    6.3 Monitoring View You can access Monitor mode by switching the Mode Select knob to the Monitor position. When operating in Monitor mode, the equipment displays up to two ECG waveforms, the heart rate reading, other available parameter values and active alarm settings.

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    5-Lead Placement The following is a typical AHA electrode placement for a 5-lead ECG set: RA placement: directly below the clavicle and near the right shoulder. LA placement: directly below the clavicle and near the left shoulder. RL placement: on the right lower abdomen. LL placement: on the left lower abdomen.

  • Page 54: Ecg Monitoring With Paddles/Pads

    6.4.2 ECG Monitoring with Paddles/Pads Prepare the patient’s skin. Apply the paddles/pads to the patient. If multifunction electrode pads are used, apply pads according to the instructions for use indicated on pads package. Use anterior-lateral placement. If external paddles are used, remove the paddle set from the paddle tray by grasping the handles and pulling them straight up.

  • Page 55: Checking Paced Status

    6.4.3 Checking Paced Status It is important to set the paced status correctly when you start monitoring ECG. The paced symbol is displayed in the patient information area when the [Paced] is set to [Yes]. The pace pulse markers “︱” are shown on the ECG wave when the patient has a paced signal.

  • Page 56: Changing Ecg Settings

    6.6 Changing ECG Settings 6.6.1 Changing Lead Settings 6.6.1.1 Selecting Lead Type Select the ECG parameter area to enter the [ECG Setup] menu. Select [Lead Set] and toggle between [3-lead] and [5-lead]. You can also set lead type in the configuration mode: →…

  • Page 57: Changing Ecg Wave Settings

    6.6.2 Changing ECG Wave Settings You can select the ECG parameter area to enter the [ECG Setup] menu to set ECG cascade and wave speed. You can also select the hot keys above the ECG waveform to change ECG lead, size and filter. You can press the Lead Select button on the equipment’s front panel or use the Navigation knob to select the lead hot key above the first ECG waveform to select a lead.

  • Page 58: Adjusting Heartbeat Volume

    6.6.4 Adjusting Heartbeat Volume In the case that ECG alarm is switched on, or both ECG alarm and PR alarm are switched off, heartbeat tone is issued. To adjust the heartbeat volume, → QRS Volume], or Select the ECG parameter window to enter the [ECG Setup] menu, and then select [Others >>] [ →…

  • Page 59: Switching Arrhythmia Analysis On And Off

    Arrhythmia event Description Category Bigeminy A dominant rhythm of N, V,N, V, N, V. Trigeminy A dominant rhythm of N, N, V,N, N, V, N, N, V. R ON T R on T detected in normal heartbeats. Missed Beats* No beat detected for 1.75x average R-R interval for HR <120, or No beat for 1 second with HR >120 (for non-paced patients only), or No beat detected for more than the set pause threshold.

  • Page 60: Changing Arrhythmia Alarm Settings

    6.7.3 Changing Arrhythmia Alarm Settings To change arrhythmia alarm settings, select the ECG parameter area to enter the [ECG Setup] menu, and then select [Arrhythmia >>]→[Arrh. Alarm] menu, where you can set alarm switch, alarm level and alarm record switch for all the arrhythmia events..

  • Page 61: Initiating Arrhythmia Relearning Manually

    6.7.5 Initiating Arrhythmia Relearning Manually Normally arrhythmia relearning allows the equipment to learn new ECG patterns to correct arrhythmia alarms and heart rate value. We suggest you to manually initiate arrhythmia relearning when you suspect the result of arrhythmia analysis. To initiate relearning manually, select the ECG parameter window to enter the [ECG Setup] menu, select [Arrhythmia →…

  • Page 62
    FOR YOUR NOTES 6-12…

  • Page 63: Aed

    7.1 Overview This chapter describes how to operate the equipment in AED Mode. While operating in AED Mode, the equipment analyses the patient’s ECG waveforms and guides you through the defibrillation process. The equipment starts analyzing the patient’s heart rhythm immediately after entering AED mode. When a shockable rhythm is detected, the equipment gives a prompt and automatically starts charging.

  • Page 64: Aed View

    WARNING During defibrillation, air pockets between the skin and multifunction electrode pads can cause patient skin burns. To help prevent air pockets, make sure defibrillation pads are completely adhered to the skin. Do not use dried-out pads. In AED mode, this equipment is not designed to administer energy at pediatric joule settings. The American Heart Association recommends AEDs be used only on patients who are more than eight years old.

  • Page 65: Aed Procedure

    7.4 AED Procedure Confirm that the patient is unresponsive, not breathing or not breathing normally. Then: Remove clothing from the patient’s chest. Wipe moisture from the patient’s chest and, if necessary, clip or shave excessive chest hair. Apply multifunction electrode pads to the patient as directed on the pads package. Use anterior-lateral placement. Connect the pads with pads cable, and then plug the pads cable in the equipment’s therapy port.

  • Page 66: Shock Advised

    overcome to deliver an effective discharge of energy. The degree of impedance differs from patient to patient and is affected by several factors including the presence of chest hair, moisture, and lotions or powders on the skin. If the “Impedance too high. Shock not delivered” message appears, make sure that the patient’s skin has been washed and dried and that any chest hair has been clipped.

  • Page 67: Cpr

    7.7 CPR If [Initial CPR Time] is not configured as Off, the system enters initial CPR if AED mode is entered. You can set [Initial CPR Time] to an appropriate time or switch it off through configuration management. After the shock series, ECG analysis pauses and the equipment enters the CPR status. Analysis resumes at the completion of the pause period or when you press the [Resume Analyzing] soft key in CPR status.

  • Page 68: Aed Sound Recording

    Warning The CPR metronome sounds do not indicate information regarding the patient’s condition. Because patient status can change in a short time, the patient should be assessed at all times. Do not perform CPR on a patient who is responsive or is breathing normally. NOTE CPR metronome and its volume is affected by the settings of [Voice Prompt] and [Voice Volume] in the AED Setup menu.

  • Page 69: Manual Defibrillation

    Manual Defibrillation 8.1 Overview This chapter explains how to prepare for and perform asynchronous defibrillation and synchronous cardioversion using multifunction electrode pads and external paddles. In Manual Defib Mode, you must assess the ECG waveforms, decide if defibrillation or cardioversion is indicated, select appropriate energy setting, charge the equipment, and deliver the shock.

  • Page 70
    WARNING During synchronous cardioversion, if monitoring patient’s ECG through external paddles, artifact introduced by paddle movement may resemble an R-wave and trigger a defibrillation shock. Do not use conductive liquid. Use only conductive gel specified by the equipment manufacturer. If external paddles are used for defibrillation, apply the paddles tightly and evenly to the patient’s chest to ensure good skin contact.

  • Page 71: Manual Defibrillation View

    8.3 Manual Defibrillation View A typical screen in Manual Defib Mode is shown below. In the enlarged ECG area, an ECG waveform and related parameters are displayed. In the middle of the screen, defibrillation mode, synchronous icon, prompt message, selected energy, contact impedance indicator, and a shock counter are displayed.

  • Page 72
    WARNING Hold only the insulating parts of the paddle handles to avoid shock hazard during charging or shock delivery. Turn the Mode Select knob to Manual Defib. You can access manual therapy directly, by confirmation or by password, which can be defined through configuration management.

  • Page 73: Using Pediatric Paddles

    NOTE Defibrillation is always performed through paddles or pads. However, during defibrillation you may choose to monitor the ECG using an alternate ECG source (3- or 5-lead monitoring electrodes). If an alternate ECG source is connected, any available lead may be displayed. When external paddles are used, the Shock button on the equipment’s front panel is disabled.

  • Page 74: Synchronized Cardioversion

    NOTE When internal paddles are used for defibrillation, the energy selection is automatically limited to 50 joules because of possible cardiac damage from higher energies. Sterilize the internal paddles before each use. Otherwise, severe infection may result. Clean the internal paddles after each use. 8.5 Synchronized Cardioversion Synchronized Cardioversion allows you to synchronize delivery of the defibrillator shock with the R-wave of the ECG.

  • Page 75: Performing Synchronized Cardioversion

    8.5.1 Performing Synchronized Cardioversion Connect the therapy cable and apply the multifunction electrode pads or external paddles to the patient. If ECG set is used for ECG monitoring, connect the ECG trunk cable and apply the ECG electrodes to the patient, referring to 6 Monitoring ECG.

  • Page 76: Remote Synchronized Cardioversion

    8.6 Remote Synchronized Cardioversion The equipment can be configured to receive an ECG source from a remote patient monitor (such as a bedside patient monitor) to perform synchronized cardioversion. To do so, the remote patient monitor shall have a sync out connector and shall be connected to the defibrillator/monitor’s multifunctional connector with a synchronous cable.

  • Page 77: Contact Impedance Indicator

    NOTE During remote synchronous defibrillation, the local defibrillator/monitor does not display the ECG waveform. To view the patient’s ECG, check the remote monitor. When you use an remote monitor as the ECG source, a biomedical technician must verify that the remote monitor and the defibrillator/monitor combination will deliver a synchronized shock within 60 ms of the peak of the R-wave.

  • Page 78
    FOR YOUR NOTES 8-10…

  • Page 79: Noninvasive Pacing

    Noninvasive Pacing 9.1 Overview In pacer mode, the patient’s ECG is monitored through ECG lead set and pace pulses are delivered through multifunction electrode pads. The pads cannot be used to monitoring ECG rhythm and deliver pacing current at the same time. A white pacing marker is shown on the ECG waveform each time a pacer pulse is delivered to the patient.

  • Page 80: Pacing View

    CAUTION Use of Pacer mode may be password protected. Make sure the operator knows and remembers the password as defined in Configuration. Failure to enter correct password will prevent the delivery of pacing therapy. For treatment of patients with implanted devices such as permanent pacemakers or cardioverter-defibrillators, consult a physician and the instructions for use provided by the device’s manufacturer Prolonged noninvasive pacing may cause patient skin irritation and burns.

  • Page 81: Demand Mode Versus Fixed Mode

    9.4 Demand Mode versus Fixed Mode The equipment can deliver paced pulses in either demand or fixed mode. In demand mode, the pacer only delivers paced pulses when the patient’s heart rate is lower than the selected pacing rate. In fixed mode, the pacer delivers paced pulses at the selected rate. During pacing, you can change pacer mode.

  • Page 82: Demand Mode Pacing

    9.5.1 Demand Mode Pacing To pace in demand mode: Turn the Mode Select knob to the Pacer position. Thus the pacing function is enabled in demand mode automatically. ECG waveform of Lead II is displayed in the waveform area by default. You can access manual therapy directly, by confirmation or by password, which can be defined through configuration management.

  • Page 83: Fixed Mode Pacing

    Verify the presence of a peripheral pulse. You can temporarily withhold pacing pulse and observe the patient’s underlying rhythm by pressing and holding the [4:1] soft key. This causes pacing pulse to be delivered at 1/4 of the defined pacer rate. To resume pacing at set rate, release this key.

  • Page 84
    WARNING Use care when handling the multifunction electrode pads on the patient to avoid shock hazard during pacing. If you are using the pacing function with battery power and the Low Battery alarm is presented, connect the equipment to external power or install a fully charged battery. CAUTION The monitoring or pacing function may be unstable in the presence of ESU or other electronic devices.

  • Page 85: Monitoring Resp

    Monitoring Resp 10.1 Overview Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is calculated from these impedance changes, and a respiration waveform appears on the equipment screen. 10.2 Safety WARNING When monitoring the patient’s respiration, do not use ESU-proof ECG cables.

  • Page 86: Placing Resp Electrodes

    10.4 Placing Resp Electrodes As the skin is a poor conductor of electricity, preparing the skin is necessary for a good Respiration signal. You can refer to the ECG section for how to prepare the skin. As the Respiration measurement adopts the standard ECG electrode placement, you can use different ECG cables (3-lead or 5-lead).

  • Page 87: Optimizing Lead Placement For Resp

    10.4.1 Optimizing Lead Placement for Resp If you want to measure Resp and you are already measuring ECG, you may need to optimize the placement of the two electrodes between which Resp will be measured. Repositioning ECG electrodes from standard positions results in changes in the ECG waveform and may influence ST and arrhythmia interpretation.

  • Page 88
    FOR YOUR NOTES 10-4…

  • Page 89: Monitoring Pr

    Monitoring PR 11.1 Overview The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart. You can display a pulse from SpO . The displayed pulse numeric is color-coded to match SpO parameter. PR unit PR alarm high limit PR value PR alarm low limit…

  • Page 90
    FOR YOUR NOTES 11-2…

  • Page 91: Monitoring Spo

    Monitoring SpO 12.1 Introduction monitoring is a non-invasive technique used to measure the amount of oxygenated haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the probe passes through the tissue and is converted into electrical signals by the photodetector in the probe. The SpO module processes the electrical signal and displays a waveform and digital values for SpO and pulse rate.

  • Page 92: Safety

    Change the application site every four hours. For neonates or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently. 12.3 Identifying SpO Modules The equipment can be configured with any of the following SpO modules. Mindray SpO module; Masimo SpO module; Nellcor SpO module.

  • Page 93: Changing Spo Settings

    12.5.1 Setting SpO Sensitivity For Mindray SpO module, you can set [Sensitivity] to [High], [Med] or [Low] from the [SpO2 Setup] menu. For Masimo module, you can set [Sensitivity] to [Normal] or [High], in which [Normal] is equivalent to [Med].

  • Page 94: Sat-Seconds Alarm Management

    12.5.4 Sat-Seconds Alarm Management With traditional alarm management, high and low alarm limits are set for monitoring oxygen saturation. During monitoring, as soon as an alarm limit is violated, an audible alarm immediately sounds. When the patient’s SpO value fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarm can be distracting. The Sat-Seconds feature is available with the Nellcor SpO module to decrease the likelihood of false alarms caused by motion artifacts.

  • Page 95: Changing The Speed Of The Pleth Wave

    12.5.5 Changing the Speed of the Pleth Wave In the [SpO2 Setup] menu, select [Sweep] and then select the appropriate setting. The faster the wave sweeps, the wider the wave is. 12.6 SpO Desat Alarm The defibrillator/monitor provides an SpO Desat alarm.

  • Page 96: Masimo Information

    Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 Drop of arterial blood flow to immeaurable level caused by shock, anemia, low temperature or vasoconstrictor. 12.9 Masimo Information Masimo Patents This device may be covered by one or more of the following US patents and foreign equivalents: 5,758,644, 6,011,986, 6,699,194, 7,215,986, 7,254,433, 7,530,955.

  • Page 97: Nibp

    NIBP 13.1 Introduction Automatic non-invasive blood pressure monitoring uses the oscillometric method of measurement. It is intended for adult, pediatric and neonatal patients. To understand how this method works, we’ll compare it to the auscultative method. With auscultation, the clinician listens to the blood pressure and determines the systolic and diastolic pressures. The mean pressure can then be calculated with reference to these pressures as long as the arterial pressure curve is normal.

  • Page 98: Measurement Limitations

    Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. If you doubt the NIBP readings, determines the patient’s vital signs by alternative means and then verify that the equipment is working correctly.

  • Page 99: Starting And Stopping Nibp Measurements

    Warning Continuous CUFF pressure due to connection tubing kinking may cause blood flow interference and resulting harmful injury to the patient. 13.5.2 Starting and Stopping NIBP Measurements You can start and stop NIBP measurements by using the hardkey on the equipment’s front panel. 13.5.3 Correcting the Measurement The cuffed limb should be at the same level as the patient’s heart.

  • Page 100: Understanding The Nibp Numerics

    13.6 Understanding the NIBP Numerics The NIBP display shows numerics only as below. Your display may be configured to look slightly different. Measurement mode Pressure unit: mmHg or kPa NIBP alarm high limit NIBP alarm low limit Time of last measurement Systolic pressure Diastolic pressure Mean pressure at the completion of measurement, or cuff pressure during the measurement…

  • Page 101: Marking Events

    Marking Events During patient monitoring or therapy, some events may exert effects on the patient and as a result change related waveforms and parameter values. To help analysing the waveforms or numerics at that time, you can mark these events. Before marking an event, you can define events A to H, for example, define event D as injecting Atropine.

  • Page 102
    FOR YOUR NOTES 14-2…

  • Page 103: Freezing Waveforms

    Freezing Waveforms During patient monitoring, the freeze feature allows you to freeze the currently displayed waveforms on the screen so that you can have a close examination of the patient’s status. Besides, you can select any frozen waveform for recording. Waveforms can be frozen only in the Monitor Mode.

  • Page 104: Unfreezing Waveforms

    15.3 Unfreezing Waveforms To unfreeze the frozen waveforms, you can either: Press the [Unfreeze] soft key, or Select [Exit] to return to the Main screen, or Perform any other action that causes the screen to be readjusted or opens a menu, such as plugging in or out a module, pressing the [Lead Select] or [Main Menu] button, etc.

  • Page 105: Review

    Review 16.1 Reviewing Events The equipment can automatically record and save patient events. You can review patient events following this procedure: To review events, you can: In the Monitor, Manual Defib or Pacer mode, press the Main Menu button on the front panel, and then select [Review>>]→[Review Events >>] to enter the [Review Events] menu, or In the Monitor mode, repeatedly press the [Trends] soft key to enter the [Review Events] menu.

  • Page 106: Reviewing Tabular Trends

    16.2 Reviewing Tabular Trends In the Monitor, Manual Defib o Pacer mode, press the Main Menu button on the front panel; select [Review>>]→[Trends>>] or, if you are operating in the Monitor mode, select the [Trends] soft key to enter the tabular trends menu, as shown below: 16-2…

  • Page 107: Data Management

    Data Management 17.1 Introduction The data management function enables you to: Edit patient information; Review patient events; and Export patient data to USB memory. To access data management, press the Main Menu button on the front panel to enter the Main Menu, and then select →…

  • Page 108: Reviewing Patient Events

    17.2 Reviewing Patient Events To view patient events, select a patient in the Archives Main screen, and then press the navigation knob to confirm the selection. In this case, you can select the [Return] soft key to return to the Archives Main screen. To edit patient information, select the [Patient Info] button and change the patient information as desired.

  • Page 109: Recording

    Recording 18.1 Using a Recorder The thermal recorder records patient information, measurement numerics and up to three waveforms. 18.2 Recording Types By the way recordings are triggered, they can be classified into the following categories: Manually-triggered realtime waveform recordings. Event-triggered recordings. Alarm recordings triggered by an alarm limit violation or an arrhythmia event.

  • Page 110: Setting The Recorder

    Automatic recordings will be triggered in the following conditions: If both [Alarm] and [Alm Rec] for a measurement are switched on, an alarm recording will be triggered automatically as an alarm occurs. When related event is triggered. To manually stop a recording, you can press the hardkey again.

  • Page 111: Changing The Recording Speed

    18.4.4 Changing the Recording Speed Enter the [Record Setup] menu. Select [Paper Speed] and toggle among [6.25 mm/s], [12.5 mm/s], [25 mm/s] and [50 mm/s]. This setting is for all recordings containing waveforms. 18.4.5 Switching Gridlines On or Off Enter the [Record Setup] menu. Select [Gridlines] and toggle between [On] and [Off].

  • Page 112: Removing Paper Jam

    18.6 Removing Paper Jam If the recorder works incorrectly or produces unusual sounds, check if there is a paper jam first. If a paper jam is detected, follow this procedure to remove it: Open the recorder door. Take out the paper and tear off the draped part. Reload the paper and close the recorder door.

  • Page 113: Configuration Management

    Configuration Management 19.1 Introduction Configurations management enables you to customize you equipment to best meet your needs. With this function, you can: Change system configuration; Record system configuration; Restore the factory default configuration. After the system configurations have been changed, the equipment restarts and new configuration settings take effect immediately.

  • Page 114: General Setup Menu

    Enter the required password and then select [OK] to enter the Configuration Main menu as shown below: Selecting [Factory Config] and confirming the selection restores all the current settings to factory default settings: Selecting [Record] records the settings of all system configurations. Selecting [Exit] pops up a dialog box as shown below: WARNING Never connect the equipment with the patient while performing configuration management.

  • Page 115: Manual Defib Setup Menu

    Menu Item Options/Range Default Remark Year 2007 to 2099 2007 Month 01 to 12 01 to 31 System 24 h: 00 to 23 24 h: 00 Time Hour 12 h: 12AM to 11PM 12 h: 12AM Minute 00 to 59 Second 00 to 59 19.3.2 Manual Defib Setup Menu…

  • Page 116: Pacer Setup Menu

    Menu Item Options/Range Default Remark Voice Prompts On, Off Voice Volume High, Med, Low High Voice Prompt Interval Off, 30s, 60s, 90s, 120s, 150s, 180s Voice Recording On, Off 19.3.4 Pacer Setup Menu Menu Item Options/Range Default Pacer Rate 40 to 170 ppm 70 ppm Pacer Output 0 to 200 mA…

  • Page 117
    Menu Item Options/Range Default Remark Arrhythmia On, Off ARR Alarm On, Off ARR Alm Lev PVCs/min High, Med, Low R ON T VT>2 Couplet Vent. Rhythm Bigeminy Trigeminy Tachy Brady Missed Beat Multif. PVCs Nonsus. Vtac Pause Irr. Rhythim Asystole Delay 3 to 10 V-Tach Rate 100 to 200…

  • Page 118: Resp Setup Menu

    Desat Limit to (High-1) Desat 50 to (High-1) Averaging Masimo SpO 2-4s, 4-6s, 8s, 10s, 12s, 14s, 16s For Masimo SpO module only. Mindray SpO High, Med, Low Different options are available to Sensitivity match the SpO module used. Masimo SpO Normal, Maximum…

  • Page 119: Nibp Setup Menu

    Menu Item Options/Range Default Remark PR Low 25 to (High-2) This setting is linked with the [QRS QRS Volume 0 to 10 Volume] setting in the [ECG Setup] menu 19.3.9 NIBP Setup Menu Menu Item Options/Range Default Remark Manual, 1 min, 2 min, 2.5 min, 3 min, 5 Interval min, 10 min, 15 min, 20 min, 30 min, 1 h, Manual…

  • Page 120: Alarm Setup Menu

    19.3.10 Alarm Setup Menu Menu Item Options/Range Default Alarm Pause Time 1, 2, 3, 5, 10, 15 min, Permanent 2 min Audio Off Enabled, Disabled Disabled 0 to 10 (If Audio Off is enabled), Alarm Volume 1 to 10 (If Audio Off is disabled) Reminder Tone On, Off Reminder Volume…

  • Page 121: Mark Event Setup Menu

    19.3.12 Mark Event Setup Menu Menu Item Options/Range Default Remark Event A Generic Generic Unchangeable Event B Adrenalin Adrenalin, Lidocaine, Atropine, Nitroglycerin, Event names that have been Event C Lidocaine Morphine, Intubation, IV Access, Adenosine, selected by previous events will Event D Atropine Amiodarone, Vasopressin, Isoprenaline,…

  • Page 122: User Test Setup Menu

    19.3.15 User Test Setup Menu Menu Item Options/Range Default User Test Prompt On, Off 12h time format: 12:00 AM ~ 05:00 AM 03:00 AM Auto Test Time 24h time format: 00:00 ~ 05:00 03:00 19.3.16 Others Menu Menu Item Options/Range Default Brightness 1 to 10…

  • Page 123: Battery

    Battery 20.1 Introduction The equipment is designed to operate on battery power when external power supply is not available. The battery is charged whenever the equipment is connected to AC mains or the DC power supply through an external DC/AC adapter, regardless of whether or not the equipment is currently turned on.

  • Page 124: Installing The Batteries

    20.2 Installing the Batteries To install the batteries: Align a battery with the battery compartment. Insert the battery, and press until you hear it click into the place. To replace a battery, press the latch on the battery and push the battery to the right until you remove it. Insert a new battery into the battery compartment.

  • Page 125: Battery Aged Alarm

    20.3.3 Battery Aged Alarm If the battery runtime is significantly shorter than the specification, a low level technological alarm “Battery Aged” will be presented. We recommend you to contact our company and replace it with a new one. 20.3.4 Battery Error Alarm In the situation that the battery has a failure, a high level technological alarm “Battery Err”…

  • Page 126: Storing Batteries

    20.6 Storing Batteries When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If batteries are stored for an extended period of time, they should be placed in a cool place with a partial charge of 40% to 60% capacity (3 LEDs illuminated).

  • Page 127: Care And Cleaning

    Care and Cleaning Use only the substances approved by the equipment manufacturer and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damages caused by unapproved cleaning and disinfection substances or methods. We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For the method to control infection, consult your hospital’s infection control officer or epidemiologist.

  • Page 128: Cleaning

    21.2 Cleaning Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of dust and sand in your place, the equipment should be cleaned more frequently. Before cleaning the equipment, consult your hospital’s regulations for cleaning the equipment.

  • Page 129: Maintenance And Testing

    Maintenance and Testing WARNING Failure for the responsible individual, hospital or institution employing this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. The safety checks or maintenance involving any disassembly of the equipment should be performed by professional servicing personnel.

  • Page 130: Maintenance And Testing Schedule

    22.2 Maintenance and Testing Schedule The following tests, except recorder check and user test, shall be carried out by the service personnel only. Contact your service personnel if any maintenance is required. Make sure to clean and disinfect the equipment before any test and maintenance.

  • Page 131: Shift Check

    Check the display of technical alarm area, prompt area and battery status indicator on the upper right corner of the main screen to judge whether the equipment runs normally. 22.3.2 Shift Check In order to ensure your defibrillator/monitor is ready when needed, we recommended you to inspect your equipment and complete a check list at the change of every shift.

  • Page 132: User Test

    22.3.4 User Test WARNING Do not perform user test when a patient is connected to the equipment. User test covers the following items: Routine Test, Energy delivery test, and Controls test. NOTE Before user test or after each use, thoroughly clean the paddles and properly place them in the paddle tray. User test passes only when paddles properly contact the metal parts of the paddle tray.

  • Page 133
    22.3.4.2 Routine Test Routine Test covers the following items: Batteries, Mainboard, Defib/Pacer function, and Monitor function If any of above items fails, the red status indicator will flash. If mainboard, Defib/Pacer function, or monitor function fails, a low level technical alarm “Last User Test Failed” will be displayed in the technical alarm area when the equipment is restarted.

  • Page 134: Recorder Inspection

    22.3.4.5 Test Summaries The results of User Test are automatically saved as summaries. You can select the [History] button from the User Test Main menu to review the test summaries. The equipment can store up to 300 historical test summaries which are listed in the sequence of time, with the latest on the top.

  • Page 135: Ecg Cable Test

    22.3.6 ECG Cable Test It is recommended to perform ECG cable test once a year. Test tool: ECG simulator Follow this procedure to perform ECG cable test: Turn the Mode Select knob to “Monitor”. Connect the ECG cable to the defibrillator and the electrodes to the simulator. Turn on the simulator and select a normal ECG rhythm.

  • Page 136
    Press the “Disarm” soft key to discharge the energy internally. Verify that a prompt “Charge Removed” appears on the screen and the charge done tone stops. Verify that the value measured by the analyzer is 0J or blank. 10. Enter the Configuration Main menu, select [Manual Therapy Setup] and set [Time to Auto Disarm] to [60s]. 11.

  • Page 137: Pacing Test

    22.3.8 Pacing Test Test tools: defibrillator/pacer analyzer Run the equipment on fully charged battery. Move the Mode Select knob to Pacer. Select Fixed mode.. Connect the pads cable to the equipment and properly place the pads on the defibrillator/pacer analyzer. Set the analyzer to Pacing Measurement mode.

  • Page 138
    22.3.9.3 NIBP Accuracy Test The NIBP accuracy test is required at least once every two years or whenever you doubt the NIBP reading. Tools required: T-shape connector Tubing Balloon pump Metal Vessel, volume 500±25 ml Calibrated manometer for reference, accuracy superior to 1 mmHg Follow this procedure to perform the accuracy test: Connect the equipment as shown below.
  • Page 139
    22.3.9.4 NIBP Leakage Test The NIBP leakage test checks the integrity of the system and of the valve. It is required at least once every two years or whenever you doubt the NIBP reading. Tools required: An adult cuff An air tubing A correct sized cylinder Follow this procedure to perform the leakage test: Set the patient category to [Adu].

  • Page 140: Nibp Overpressure Protection Test

    22.3.9.6 Formatting Storage Card You can format the storage card if data in the card is useless, or if the card has a failure. To format the storage card, select → Format] through the Installation Mode Main menu. Then a dialog box pops up as shown below: [Format Data Card] If storage card is formatted successfully, a prompt “Formatting is completed!”…

  • Page 141: Accessories

    Accessories WARNING Use accessories specified in this chapter. Using other accessories may cause damage to the equipment or not meet the claimed specifications. Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

  • Page 142
    Lead Sets 3-Electrode Lead Sets Type Compatible with Model Applicable patient Remark EL6302A 0010-30-42725 Adult, pediatric EL6304A 0010-30-42732 Long EL6306A Neonate 0010-30-42897 EL6308A Pediatric 0010-30-42899 Clip EL6301A 0010-30-42726 Adult, pediatric EL6303A 0010-30-42731 Long EL6305A Neonate 0010-30-42896 EL6307A Pediatric 0010-30-42898 EL6302B Adult, pediatric 0010-30-42733 EL6308B…

  • Page 143: Spo 2 Accessories

    23.2 SpO Accessories Extension Cables Module type Applicable patient Remark Mindray SpO module 0010-20-42710 040-000332-00 8 pins, purple connector Adult, pediatric, neonate Masimo SpO module 0010-30-42738 7 pins, white connector Nellcor SpO module 0010-20-42712 Sensors Mindray SpO module Type Model…

  • Page 144
    9000-10-07308 OXI-A/N Adult, neonate 9000-10-07336 Wavelength of Mindray 518B, 512E, 512F, 512G and 512H SpO sensors: red light 660 nm, infrared light 905 nm. Wavelength of Masimo SpO sensors: red light: 660 nm, infrared light: 940 nm. Wavelength of Nellcor SpO sensors: red light: 660 nm, infrared light: 890 nm.

  • Page 145: Nibp Accessories

    23.3 NIBP Accessories Tubing Type Applicable patient Adult, pediatric 6200-30-09688 Reusable Neonate 6200-30-11560 Cuff Applicable Limb Circumference Bladder Type Model Applied site patient (cm) Width (cm) CM1201 Infant 10 to 19 0010-30-12157 CM1202 Pediatric 18 to 26 12.2 0010-30-12158 Upper arm CM1203 Adult 24 to 35…

  • Page 146: Miscellaneous

    23.5 Miscellaneous Description Model Rechargeable lithium ion battery LI24I001A 022-000047-00 Test load MR6901 0651-20-77032 Test load MR6905 040-000413-00 Synchronous defibrillation input cable 009-001404-00 Grounding cable UL1015/14AWG 1000-21-00122 DC/AC adapter 0010-30-12471 Patient data management software kit 0651-30-77145 Carrying case and shield cover 115-018610-00 D3 back pouch 115-008708-00…

  • Page 147: A Specifications

    Specifications A.1 General Specifications Class I, equipment energized from an external and internal electrical power source. Type of protection against If you suspect the integrity of the external protective earthing or the protective earthing electrical shock wire, you should run the equipment on internal electrical power supply (battery). Type BF defibrillation proof for external defibrillation.

  • Page 148: Defibrillator Specifications

    Audio Indicator Gives alarm tones (45 to 85 dB), key tones, QRS tones; Speaker Supports PITCH TONE and multi-level tone modulation; Alarm tones comply with IEC60601-1-8. Multifunctional connector Standard Meets the requirements of EN60601-1 for short-circuit protection and leakage current Output impedance Typically 50Ω…

  • Page 149
    360 J defibrillation waveform into impedance of 25Ω, 50Ω, 75Ω, 100Ω, 125Ω, 150Ω, 175Ω Time (MS) Selected energy accuracy Impedance 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω Accuracy Energy ±2J ±2J ±2J ±2J ±2J ±2J ±2J ±2J ±2J 10 J ±2J 15 J ±15%…
  • Page 150
    Charge time (Note: at 20 °C of ambient temperature) Manual Defib From initiation of From initial power From initial power on to Charge time rhythm analysis to on to charge done charge done charge done 200J 360J 200J 360J 200J 360J 200J 360J…

  • Page 151: Pacer Specifications

    A.3 Pacer Specifications Pacing mode Demand, fixed Monophasic square wave pulse Output waveform pulse width 20 ms Accuracy: ±5% 40ppm to 170ppm Pacing rate Accuracy: ±1.5% Resolution: 5 ppm 0mA to 200mA, Pacing output Accuracy: ±5% or ±5mA, whichever is greater Resolution: 5mA 200 to 300 ms (depending on pacing rate) Refractory period…

  • Page 152
    Neonate 15 to 350 bpm HR measurement range Pediatric 15 to 350 bpm Adult 15 to 300 bpm HR accuracy ±1% or ±1bpm, which ever is greater HR resolution 1 bpm Measuring electrode: <0.1 μA Lead-off detection current Drive electrode: <1 μA Baseline recovery time <5 s (after defibrillation, in monitor mode and therapy mode) When the test is performed based on part 4.1.2.1 c) of ANSI/AAMI EC 13-2002,…
  • Page 153
    Difference input impedance >2.5 MΩ Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s Mindray SpO Module *Measurement accuracy verification: The SpO accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a CO-oximeter.
  • Page 154
    Measurement range 20 to 254 bpm ±3 bpm (measured without motion) Accuracy ±5 bpm (measured with motion) Masimo SpO Module Measurement range 1 to 100% Resolution 70 to 100%: ±2% (measured without motion in adult/pediatric mode) 70 to 100%: ±3% (measured without motion in neonate mode) Accuracy 70 to 100%: ±3% (measured with motion)

  • Page 155: Power Supply Specifications

    NIBP Standards Meet standards of EN60601-2-30/IEC60601-2-30, EN1060-1, EN1060-3, EN1060-4 and SP10 Technique Oscillometry Mode of operation Manual, Auto and STAT Static pressure measurement 0kPa to 40.0kPa (0mmHg to 300mmHg) range Static pressure measurement ±0.4kPa (±3mmHg) accuracy 120s for adult and pediatric patients Maximum measurement time 90s for neonatal patients Adult…

  • Page 156: Recorder Specifications

    Battery 14.8V/3Ah, smart lithium ion battery, rechargeable and free of maintenance, one battery Battery type can be configured Less than 2 hours to 80% and less than 3 hours to 100% with equipment power off; Charge time Less than 3.5 hours to 80% and less than 4.5 hours to 100% with equipment power on. New fully charged battery Testing condition Without recording, typical ECG…

  • Page 157: Data Management Specifications

    A.8 Data Management Specifications Data Storage Internal CF card, 1G Bytes Marking Events 16 types of events, user customized Event recording Up to 1000 events for each patient. Waveform storage Up to 24 hours of consecutive ECG waveform Voice recording Max.

  • Page 158
    Vibration Complies with requirements of 21.102, ISO9919. Bump Complies with the requirements of 6.3.4.2, EN1789. Peak acceleration: 15g Duration: 6ms Number of impacts: 1000 Impact direction: vertical impacts are applied when the equipment under test is placed at normal operating position. Free fall Complies with the requirements of 6.3.4.3, EN1789.
  • Page 159
    The equipment meets the requirements of IEC 60601-1-2. NOTE Use of accessories, transducers, and cables other than those specified may result in increased emission and/or decreased electromagnetic immunity of the defibrillator/monitor. The equipment or its components should not be used adjacent to or stacked with other devices. If adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used.
  • Page 160
    Guidance and Declaration — Electromagnetic Immunity The equipment is suitable for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment — guidance…
  • Page 161
    Guidance and Declaration — Electromagnetic Immunity The equipment is suitable for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. IEC 60601 Immunity test Test level Compliance level Electromagnetic environment — guidance…
  • Page 162
    a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. b Compliance level in the ISM frequency bands between 150 kHz to 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that portable/ mobile communication equipment could cause interference if it is inadvertently brought into patient areas.

  • Page 163: C Beneheart Defibrillator Shift Checklist

    BeneHeart Defibrillator Shift Checklist Inspect the defibrillator/monitor at the change of every shift. Place a “√” in the “Pass/Fail” box as you check the item , or place a “-” if not applicable. Describe the problem if there is any abnormity. Equipment Name: Serial Number: Department:…

  • Page 164
    Perform this test only when automatic selftest is not performed using pads cable or when selftest fails. Perform this test only when automatic selftest is not performed using paddles or when selftest fails. NOTE Remember to disconnect the test load when the test is finished. Otherwise, delay could happen in patient treatment.

  • Page 165: D Alarm Messages

    Alarm Messages This chapter lists only the most important physiological and technical alarm messages. Some messages appearing on your equipment may not be included. In this chapter: The “I” column indicates how indications of technological alarms are cleared after the hardkey or [Audio Pause] softkey is pressed: “A”…

  • Page 166: Technical Alarm Messages

    Measurement Alarm Message Cause and solution Nonsus. Vtac Pause Irr. Rhythm The pacer appears abnormal. Check the pacer. Resp Resp Apnea The respiration signal was so weak that the equipment cannot perform respiration analysis. Check the patient’s condition and the Resp connections. SpO2 SpO2 Desat The SpO…

  • Page 167
    Measurement Alarm Message Cause and solution SpO2 Too Much Light There is too much light on the SpO sensor. Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light. SpO2 Low Signal The SpO signal is too low or too weak.
  • Page 168
    Measurement Alarm Message Cause and solution Keyboard Comm Err An error occurred to the keypad board, or there is a problem with the communications between the keypad board and the host. Restart the equipment. Therapy Module Comm Err An error occurred to the therapy module, or there is a problem with the communications between the therapy module and the host.
  • Page 169
    Measurement Alarm Message Cause and solution Monitoring Monitor Module Selftest Err An error occurred during MPM module power-on self test. module Contact your service personnel. Monitor Module Reset Err MPM module reset abnormally. In this case, the MPM module restores to default configuration. You can ignore this problem.
  • Page 170
    FOR YOUR NOTES…

  • Page 171: E Electrical Safety Inspection

    Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations. All tests can be performed by using commercially available safety analyzer test equipment.

  • Page 172: Device Labelling

    E.3 Device Labelling Check the labels provided by the manufacturer or the healthcare facilities are present and legible. Main unit label Integrated warning labels E.4 Protective Earth Resistance Plug the probes of the analyzer into the device’s protective earth terminal and protective earth terminal of the AC power cord.

  • Page 173: Patient Leakage Current

    E.6 Patient Leakage Current Patient leakage currents are measured between a selected applied part and mains earth. All measurements have a true RMS only The following outlet conditions apply when performing the Patient Leakage Current test. normal polarity (Normal Condition) reverse polarity (Normal Condition) normal polarity with open neutral (Single Fault Condition) reverse polarity with open neutral (Single Fault Condition)

  • Page 174: Patient Auxiliary Current

    E.8 Patient Auxiliary Current Patient Auxiliary currents are measured between any selected Applied Part connector and the remaining Applied Part connector s. All measurements may have a true RMS only response. The following outlet conditions apply when performing the Patient Auxiliary Current test. normal polarity (Normal Condition) reverse polarity (Normal Condition) normal polarity with open neutral (Single Fault Condition)

  • Page 175: F Symbols And Abbreviations

    Symbols and Abbreviations F.1 Units μA microampere μV microvolt ampere ampere hour beat per minute bit per second ºC centigrade cubic centimeter centimeter decibel dyne second ºF fahrenheit gram gigahertz gutta hour hertz inch Joule kilo kilogram kilopascal litre pound meter Milliampere hour mega byte…

  • Page 176: Symbols

    mmHg millimeters of mercury millisecond millivolt milliwatt MΩ megaohm nanometer breaths per minute second volt volt ampere Ω watt F.2 Symbols negative, minus – percent per; divide; or plus equal to < less than > greater than ≤ less than or equal to ≥…

  • Page 177
    arterial left foot augmented lead left arm augmented lead right arm augmented lead awRR airway respiratory rate brachial aterial pressure bispectral index blood pressure BPSK binary phase shift keying body surface area blood temperature BTPS body temperature and pressure, saturated C.I.
  • Page 178
    ethylene oxide EtO2 end-tidal oxygen femoral arterial pressure Federal Communication Commission Food and Drug Administration FEV1.0% first second forced expiratory volume ratio fraction of inspired FiCO2 fraction of inspired carbon oxygen FiN2O fraction of inspired nitrous oxide FiO2 fraction of inspired oxygen FPGA field programmable gate array flow-volume…
  • Page 179
    MetHb methemoglobin magnetic resonance imaging expiratory minute volume inspiratory minute volume not applied neonate NIBP noninvasive blood pressure negative inspiratory pressure oxygen O2CI oxygen consumption index oxygen extraction ratio operating room oxyCRG oxygen cardio-respirogram pulmonary artery airway pressure PAWP pulmonary artery wedge pressure photodetector pediatric PEEP…
  • Page 180
    sevoflurane self-maintenance stroke index satellite module rack SpO2 arterial oxygen saturation from pulse oximetry signal quality index suppression ratio systolic time ratio systemic vascular resistance SVRI systemic vascular resistance index Sync synchronization systolic pressure Taxil axillary temperature temperature difference Temp temperature thoracic fluid content thoracic fluid index…

  • Page 181: G Device Tracking

    In order to provide high quality product and perform better service, we are going to track our product. Please contact us with the device tracking information when you have received your defibrillator/monitor: Please fill the information in the next page, cut the table and fax it to +86 755 26582934. You can also email your information to service@mindray.com.

  • Page 182
    FOR YOUR NOTES…
  • Page 186
    P/N: 046-001653-00 (6.0)

Источник

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    I

    Intellectual Property Statement

    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter
    called

    Mindray) owns the intellectual property rights to this product
    and this manual. This manual

    may refer to information protected by copyrights or patents and
    does not convey any license

    under the patent rights of Mindray, nor the rights of others.
    Mindray does not assume any

    liability arising out of any infringements of patents or other
    rights of third parties.

    , , and are the registered trademarks or

    trademarks owned by Mindray in China and other countries.

    Revision History

    This manual has a revision number. This revision number changes
    whenever the manual is

    updated due to software or technical specification change.
    Contents of this manual are subject

    to change without prior notice.

      Version number 7.0

      Release time: May 2011

    © 2009-2011 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    All rights reserved.

    Company Contact

    Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co.,
    Ltd.

    E-mail Address: [email protected]

    Tel: +86 755 26582479, +86 755 26582888

    Fax: +86 755 26582934, +86 755 26582500

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    II

    Preface

    Manual Purpose

    This manual provides detailed information about the assembling,
    dissembling, testing and

    troubleshooting of the equipment to support effective
    troubleshooting and repair. It is not

    intended to be a comprehensive, in-depth explanation of the
    product architecture or technical

    implementation. Observance of the manual is a prerequisite for
    proper equipment

    maintenance and prevents equipment damage and personnel
    injury.

    Intended Audience

    This manual is for biomedical engineers, authorized technicians
    or service representatives

    responsible for troubleshooting, repairing and maintaining the
    defibrillator/ monitors

    Passwords

    Passwords may be required to access different modes. The
    passwords are listed below:

      Installation mode: 888888

    Service mode: 332888

      Configuration mode: 315666

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    1

    Contents

    1
    Safety…………………………………………………………………………………………………………………
    1-1 

    1.1 Safety Information
    …………………………………………………………………………………………….
    1-1

    1.1.1 Dangers
    ………………………………………………………………………………………………..
    1-2

    1.1.2
    Warnings……………………………………………………………………………………………….
    1-2

    1.1.3 Cautions
    ……………………………………………………………………………………………….
    1-2

    1.1.4 Notes
    ……………………………………………………………………………………………………
    1-3

    1.2 Equipment Symbols
    …………………………………………………………………………………………..
    1-3

    2 Theory of Operation
    …………………………………………………………………………………………..
    2-1 

    2.1 The Basics
    ………………………………………………………………………………………………………..
    2-1

    2.1.1
    Overview………………………………………………………………………………………………
    2-1

    2.1.2 Main
    Functions………………………………………………………………………………………
    2-1

    2.2 Components
    ……………………………………………………………………………………………………..
    2-2

    2.3 Main Unit
    …………………………………………………………………………………………………………
    2-2

    2.4 Front Housing
    Assembly…………………………………………………………………………………….
    2-4

    2.5 Paddle Tray
    ………………………………………………………………………………………………………
    2-6

    2.6 Rear Housing
    Assembly……………………………………………………………………………………..
    2-6

    2.6.1 Power
    System………………………………………………………………………………………..
    2-6

    2.6.2 Main Control System
    ……………………………………………………………………………..
    2-7

    2.6.3 Therapy
    System……………………………………………………………………………………..
    2-7

    2.6.4 Parameter Measurement System
    ………………………………………………………………
    2-7

    2.7 External Device
    Connectors………………………………………………………………………………..
    2-8

    3 Unpacking and Installation
    …………………………………………………………………………………
    3-1 

    3.1 Unpacking the
    Equipment…………………………………………………………………………………..
    3-1

    3.2 Preparation for
    Installation………………………………………………………………………………….
    3-2

    3.2.1 Preparation for Installation
    Site………………………………………………………………..
    3-2

    3.2.2 Electrical Requirements
    ………………………………………………………………………….
    3-3

    3.3 Vehicle Mount Kit Installation
    …………………………………………………………………………….
    3-3

    3.4 Installing Hook Kit or Conductive Gel Container
    Kit…………………………………………….. 3-3

    3.5 Preparation for Power
    On……………………………………………………………………………………
    3-3

    3.6 User
    Test…………………………………………………………………………………………………………..
    3-4

    4 Testing and
    Maintenance…………………………………………………………………………………….
    4-1 

    4.1
    Introduction………………………………………………………………………………………………………
    4-1

    4.1.1 Test Report
    ……………………………………………………………………………………………
    4-2

    4.1.2 Preventative Maintenance
    ……………………………………………………………………….
    4-2

    4.1.3 Recommended
    Frequency……………………………………………………………………….
    4-3

    4.2 Preventative Maintenance Procedures
    ………………………………………………………………….
    4-4

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    2

    4.2.1 Visual Test
    …………………………………………………………………………………………….
    4-4

    4.2.2 NIBP
    Tests…………………………………………………………………………………………….
    4-4

    4.2.3 CO2 Module
    Tests…………………………………………………………………………………..
    4-7

    4.2.4 Preventative maintenance test
    report…………………………………………………………
    4-8

    4.3 Power On Test
    …………………………………………………………………………………………………..
    4-9

    4.4 User
    Test…………………………………………………………………………………………………………
    4-10

    4.5 Password for Installation Mode
    ………………………………………………………………………….4-11

    4.6 Module Performance
    Tests…………………………………………………………………………………4-11

    4.6.1 Manual Defibrillation Test
    ……………………………………………………………………..4-11

    4.6.2 Pacing Test
    ………………………………………………………………………………………….
    4-13

    4.6.3 ECG Test
    …………………………………………………………………………………………….
    4-14

    4.6.4 Resp Test
    …………………………………………………………………………………………….
    4-15

    4.6.5 IBP
    Tests……………………………………………………………………………………………..
    4-15

    4.6.6
    SpO2 Test…………………………………………………………………………………………….
    4-17

    4.6.7 Temp Test
    ……………………………………………………………………………………………
    4-17

    4.7 Analogue Output
    Test……………………………………………………………………………………….
    4-18

    4.8 Electrical Safety Tests
    ………………………………………………………………………………………
    4-18

    4.9 Recorder
    Check……………………………………………………………………………………………….
    4-18

    4.10 Factory Service
    ……………………………………………………………………………………………..
    4-18

    4.10.1 Password for Service
    Mode………………………………………………………………….
    4-18

    4.10.2 Accessing Service Mode Menu
    …………………………………………………………….
    4-19

    4.10.3 Calibrating
    NIBP………………………………………………………………………………..
    4-19

    4.10.4 Calibrating/Zeroing
    Impedance…………………………………………………………….
    4-19

    4.10.5 Device Information
    …………………………………………………………………………….
    4-21

    4.10.6 Checking Failure
    Code………………………………………………………………………..
    4-21

    4.10.7 Inputting Serial
    Number………………………………………………………………………
    4-22

    4.10.8 Paddle Open Circuit
    Display………………………………………………………………..
    4-22

    4.10.9 Selecting Recorder Type
    ……………………………………………………………………..
    4-22

    5 Hardware and Software
    Upgrade………………………………………………………………………..
    5-1 

    5.1 Hardware Upgrade
    …………………………………………………………………………………………….
    5-1

    5.1.1 Upgrading MPM module
    ………………………………………………………………………..
    5-1

    5.1.2 MPM Module upgrade procedure
    …………………………………………………………….
    5-5

    5.1.3 Upgrade the Therapy
    Module…………………………………………………………………..
    5-7

    5.1.4 Upgrade the Equipment with CO2
    Module………………………………………………..
    5-8

    5.1.5 Upgrade the Recorder
    …………………………………………………………………………..
    5-10

    5.2 Software Upgrade through a
    PC…………………………………………………………………………
    5-10

    5.2.1 Installing Mindray Patient Monitor Software Upgrade
    Tool………………………..5-11

    5.2.2 Software Upgrade Procedure
    …………………………………………………………………
    5-13

    5.3 Software Upgrade through a USB Memory
    …………………………………………………………
    5-14

    5.3.1
    Precautions………………………………………………………………………………………….
    5-14

    5.3.2 Software Upgrade Procedure
    …………………………………………………………………
    5-14

    6
    Troubleshooting………………………………………………………………………………………………….
    6-1 

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    3

    6.1
    Overview………………………………………………………………………………………………………….
    6-1

    6.2 Part Replacement
    ………………………………………………………………………………………………
    6-1

    6.3 Checking Defibrillator/Monitor
    Status………………………………………………………………….
    6-1

    6.4 Checking Device
    Information……………………………………………………………………………..
    6-2

    6.5 Checking Technical
    Alarm………………………………………………………………………………….
    6-2

    6.6 Troubleshooting
    Guide……………………………………………………………………………………….
    6-3

    6.6.1 Defibrillation
    Problems…………………………………………………………………………..
    6-3

    6.6.2 Pacing
    Problems…………………………………………………………………………………….
    6-5

    6.6.3 Power On/Off
    Problems………………………………………………………………………….
    6-5

    6.6.4 Display Problems
    …………………………………………………………………………………..
    6-6

    6.6.5 Alarm
    Problems……………………………………………………………………………………..
    6-7

    6.6.6 Button and Knob Problems
    ……………………………………………………………………..
    6-8

    6.6.7 Recorder
    Problems…………………………………………………………………………………
    6-9

    6.6.8 Output Interface Problems
    ………………………………………………………………………
    6-9

    6.6.9 CF Card
    Problems………………………………………………………………………………..
    6-10

    6.6.10 Wireless Transmission Module Problems
    ……………………………………………… 6-10

    6.6.11 Power Supply Problems
    ……………………………………………………………………….6-11

    6.6.12 Software Upgrade
    Problems…………………………………………………………………
    6-12

    6.7 Technical Alarm
    Messages………………………………………………………………………………..
    6-12

    6.8 Error Codes
    …………………………………………………………………………………………………….
    6-13

    6.8.1 Therapy Module Error
    Codes…………………………………………………………………
    6-13

    6.8.2 Power Module Error
    Codes……………………………………………………………………
    6-14

    6.8.3 Main Control Error
    Codes……………………………………………………………………..
    6-15

    6.8.4 MPM Error Codes
    ………………………………………………………………………………..
    6-15

    7 Disassembly and Repair
    ……………………………………………………………………………………..
    7-1 

    7.1 Tools Required
    ………………………………………………………………………………………………….
    7-1

    7.2 Preparations for
    Disassembly………………………………………………………………………………
    7-2

    7.3 Disassembling the Main
    Unit………………………………………………………………………………
    7-3

    7.3.1 Removing Hook
    Mount…………………………………………………………………………..
    7-3

    7.3.2 Removing Paddle
    Tray……………………………………………………………………………
    7-4

    7.3.3 Separating the Housing
    …………………………………………………………………………..
    7-5

    7.3.4 Removing the Measurement Module Panel
    ………………………………………………. 7-6

    7.3.5 Removing the Power Supply Assembly
    …………………………………………………….
    7-8

    7.3.6 Discharging the
    Capacitor……………………………………………………………………….
    7-9

    7.3.7 Removing the Therapy Module High-voltage
    Board………………………………… 7-10

    7.3.8 Disassembling the MPM
    Module…………………………………………………………….7-11

    7.3.9 Removing the CO2 Module
    …………………………………………………………………..
    7-12

    7.3.10 Removing the CPU board
    Assembly……………………………………………………..
    7-12

    7.3.11 Removing the Therapy Port
    Assembly…………………………………………………..
    7-13

    7.3.12 Checking Waterproof Material on the Rear Housing
    ………………………………. 7-14

    7.4 Disassembling the Front Housing
    Assembly………………………………………………………..
    7-15

    7.4.1 Removing the Keypad
    board………………………………………………………………….
    7-15

    7.4.2 Removing Display
    Assembly…………………………………………………………………
    7-17

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    4

    7.4.3 Removing the Speaker
    ………………………………………………………………………….
    7-20

    7.4.4 Removing the Indicating Lamp Board and Alarm Lamp Board
    …………………. 7-20

    7.4.5 Removing the Mode Select Knob
    …………………………………………………………..
    7-21

    7.4.6 Removing the Rotary Encoder
    ……………………………………………………………….
    7-22

    7.4.7 Removing the
    Recorder…………………………………………………………………………
    7-22

    7.5 Disassembling the MPM
    Module……………………………………………………………………….
    7-23

    7.5.1 Removing the Fan
    ………………………………………………………………………………..
    7-23

    7.5.2 Removing the SpO2 board
    …………………………………………………………………….
    7-24

    7.5.3 Removing the MPM Module Analog Board
    ……………………………………………. 7-25

    7.5.4 Removing the MPM Module Digital
    Board…………………………………………….. 7-26

    7.5.5 Removing the NIBP
    Module………………………………………………………………….
    7-27

    7.6 Disassembling the Power Supply Assembly
    ………………………………………………………..
    7-28

    7.6.1 Removing the AC/DC board
    ………………………………………………………………….
    7-28

    7.6.2 Removing the Power Supply Sheet Metal and the Grounding
    Terminal………. 7-29

    7.7 Disassembling the CO2 Module
    ………………………………………………………………………..
    7-30

    7.7.1 Disassembling the Microstream CO2 Module
    …………………………………………. 7-30

    7.7.2 Disassembling Mindray CO2
    Module……………………………………………………..
    7-31

    7.8 Disassembling the Measurement Module Panel
    Assembly……………………………………. 7-32

    7.8.1 Disassembling the Measurement Module Panel with Mindray
    CO2 Module.. 7-32

    7.8.2 Disassembling the Measurement Module Panel with
    Microstream CO2 Module

    …………………………………………………………………………………………………………………..
    7-33

    7.8.3 Disassembling the Measurement Module Panel without CO2
    Module ……….. 7-33

    7.9 Disassembling the
    Recorder………………………………………………………………………………
    7-34

    7.9.1 Disassembling the TR6F
    Recorder………………………………………………………….
    7-34

    7.9.2 Disassembling the TR8A Recorder
    …………………………………………………………
    7-35

    7.10 Disassembling the External
    Paddle…………………………………………………………………..
    7-37

    7.10.1 Disassembling the Adult
    Paddle……………………………………………………………
    7-37

    7.10.2 Disassembling the Apex Pediatric
    Paddle………………………………………………
    7-37

    7.10.3 Disassembling the Sternum Pediatric
    Paddle…………………………………………. 7-38

    8 Parts
    ………………………………………………………………………………………………………………….
    8-1 

    8.1
    Introduction………………………………………………………………………………………………………
    8-1

    8.2 Main Unit
    …………………………………………………………………………………………………………
    8-2

    8.2.1 Exploded View
    ………………………………………………………………………………………
    8-2

    8.2.2 Parts List
    ………………………………………………………………………………………………
    8-2

    8.3 Front Housing
    Assembly…………………………………………………………………………………….
    8-4

    8.3.1 Exploded View
    ………………………………………………………………………………………
    8-4

    8.3.2 Parts List
    ………………………………………………………………………………………………
    8-4

    8.4 Rear Housing
    Assembly……………………………………………………………………………………..
    8-8

    8.4.1 Exploded View
    ………………………………………………………………………………………
    8-8

    8.4.2 Parts List
    ………………………………………………………………………………………………
    8-8

    8.5 Rear
    Housing…………………………………………………………………………………………………..
    8-10

    8.5.1 Exploded View
    …………………………………………………………………………………….
    8-10

    8.5.2 Parts List
    ……………………………………………………………………………………………..8-11

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    5

    8.6 Measurement Module Panel
    Assembly……………………………………………………………….
    8-12

    8.6.1 Exploded View
    …………………………………………………………………………………….
    8-12

    8.6.2 Parts List
    …………………………………………………………………………………………….
    8-12

    8.7 Power Supply Assembly
    …………………………………………………………………………………..
    8-14

    8.7.1 Exploded View
    …………………………………………………………………………………….
    8-14

    8.7.2 Parts List
    …………………………………………………………………………………………….
    8-15

    8.8 MPM
    Module………………………………………………………………………………………………….
    8-16

    8.8.1 Exploded View
    …………………………………………………………………………………….
    8-16

    8.8.2 Parts List
    …………………………………………………………………………………………….
    8-17

    8.9 Capacitor Assembly
    …………………………………………………………………………………………
    8-18

    8.9.1 Exploded View
    …………………………………………………………………………………….
    8-18

    8.9.2 Parts List
    …………………………………………………………………………………………….
    8-18

    8.10 Sidestream CO2 Module Kit
    ……………………………………………………………………………
    8-19

    8.10.1 Exploded View
    …………………………………………………………………………………..
    8-19

    8.10.2 Parts List
    …………………………………………………………………………………………..
    8-19

    8.11 Microstream CO2 Module Kit
    …………………………………………………………………………
    8-20

    8.11.1 Exploded View
    …………………………………………………………………………………..
    8-20

    8.11.2 Parts
    List……………………………………………………………………………………………
    8-20

    8.12 Paddle Tray
    Assembly…………………………………………………………………………………….
    8-21

    8.12.1 Exploded View
    …………………………………………………………………………………..
    8-21

    8.12.2 Parts List
    …………………………………………………………………………………………..
    8-21

    8.13 External Paddle
    ……………………………………………………………………………………………..
    8-22

    8.13.1 Exploded View
    …………………………………………………………………………………..
    8-22

    8.13.2 Parts List
    …………………………………………………………………………………………..
    8-22

    8.14 Sternum Pediatric Paddle Kit
    …………………………………………………………………………..
    8-23

    8.14.1 Exploded View
    …………………………………………………………………………………..
    8-23

    8.14.2 Parts List
    …………………………………………………………………………………………..
    8-23

    8.15 Sternum Adult Paddle Kit
    ……………………………………………………………………………….
    8-24

    8.15.1 Exploded View
    …………………………………………………………………………………..
    8-24

    8.15.2 Parts List
    …………………………………………………………………………………………..
    8-24

    8.16 Apex Pediatric Paddle Kit
    ……………………………………………………………………………….
    8-25

    8.16.1 Exploded View
    …………………………………………………………………………………..
    8-25

    8.16.2 Parts List
    …………………………………………………………………………………………..
    8-25

    8.17 Apex Adult Paddle Kit
    ……………………………………………………………………………………
    8-26

    8.17.1 Exploded View
    …………………………………………………………………………………..
    8-26

    8.17.2 Parts List
    …………………………………………………………………………………………..
    8-26

    8.18 External Paddle Cable
    …………………………………………………………………………………….
    8-27

    8.18.1 Exploded View
    …………………………………………………………………………………..
    8-27

    8.18.2 Parts List
    …………………………………………………………………………………………..
    8-27

    8.19 Hook Mount
    ………………………………………………………………………………………………….
    8-28

    8.19.1 Exploded View
    …………………………………………………………………………………..
    8-28

    8.19.2 Parts List
    …………………………………………………………………………………………..
    8-28

    8.20 Replacement
    Parts………………………………………………………………………………………….
    8-29

    8.20.1 Main Unit
    ………………………………………………………………………………………….
    8-29

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    8.20.2 Connecting Cables
    ……………………………………………………………………………..
    8-32

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    1-1

    1 Safety

    1.1 Safety Information

    DANGER

      Indicates an imminent hazard that, if not avoided, will
    result in death, serious

    personal injury or property damage.

    WARNING

      Indicates a potential hazard or unsafe maintenance
    practice that, if not avoided,

    could result in death, serious personal injury, product /
    property damage.

    CAUTION

      Indicates a potential hazard or unsafe maintenance
    practice that, if not avoided,

    could result in minor personal injury or product/property
    damage

    NOTE

      Provides application tips or other useful information to
    ensure that you can better

    service your product.

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    1-2

    1.1.1 Dangers

    WARNING

      Do not open the equipment cases to avoid shock hazard.
    All servicing and future

    upgrades must be carried out by the personnel trained and
    authorized by our

    company only.

    1.1.2 Warnings

    WARNING

      To avoid high voltage shock, disconnect the
    defibrillator/monitor from AC adapter

    and remove the batteries before disassembly.

      The equipment must be connected to a properly installed
    power socket with

    protective earth contacts only. If the installation does not
    provide a protective

    earth conductor, do not use this socket and operate the
    equipment on rechargeable

    batteries.

      When disposing of the packaging material, be sure to
    observe the applicable waste

    control regulations and keep it out of children’s reach.

    1.1.3 Cautions

    CAUTION

      Make sure that no electromagnetic radiation interferes
    with the performance of the

    equipment when preparing to carry out performance tests. Mobile
    phone, X-ray

    equipment or MRI devices are a possible source of interference
    as they may emit

    higher levels of electromagnetic radiation.

      Before connecting the equipment to the power line, check
    that the voltage and

    frequency ratings of the power line are the same as those
    indicated on the

    equipment’s label or in this manual.

      Protect the equipment from damage caused by drop, impact,
    strong vibration or

    other mechanical force during servicing.

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    1-3

    1.1.4 Notes

    NOTE

      Refer to Operation Manual for detailed operation and
    other information.

    1.2 Equipment Symbols

    Attention: Please read thismanual carefully before

    servicing.

    Equipotential terminal

    Danger: High-voltage Service indicator

    Alternating current(AC) Network connector

    Battery Video output

    USB connector Analog input/out

    ESD warning symbol for Electrostatic sensitive devices.

    Type CF applied part. Defibrillator-proof protection against
    electric shock.

    Type BF applied part. Defibrillator-proof protection against
    electric shock.

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    2-1

    2 Theory of Operation

    2.1 The Basics

    2.1.1 Overview

    BeneHeart D6 defibrillator/monitor (hereinafter called the
    equipment) provides four

    operating modes: Manual Defib, AED, Pacer, and Monitor. The
    equipment is for use in

    hospital and pre-hospital settings. It adopts the most advanced
    biphasic defibrillation

    technology and can deliver up to 360J of defibrillation
    energy.

    BeneHeart D6 has an 8.4″ LCD display.

    2.1.2 Main Functions

    The equipment has the following main functions:

      Manual Defib Mode

    In Manual Defib Mode, the operator analyzes the patient’s ECG,
    and, if appropriate, follows

    this procedure:

    1 Select the Manual Defib mode, adjust the energy level if
    necessary

    2 Charge; and

    3 Deliver the shock.

    Defibrillation may be performed through external paddles or
    multifunction electrode pads. In

    Manual Defib Mode, you can also perform synchronized
    cardioversion.

      AED Mode

    In AED mode, the equipment automatically analyzes the patient’s
    ECG rhythm and

    indicates whether or not a shockable rhythm is detected. Voice
    prompts provide

    easy-to-follow instructions and patient information to guide you
    through the

    defibrillation process. Messages and flashing buttons are also
    presented to reinforce the

    voice prompts.

      Pacer Mode

    The Pacer Mode offers non-invasive transcutaneous pacing
    therapy. Pace pulses are

    delivered through multifunction electrode pads using a
    monophasic square waveform.

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    2-2

      Monitor Mode

    In Monitor Mode, the equipment is intended for monitoring,
    displaying, reviewing,

    storing and printing multiple physiological parameters and
    waveforms including ECG,

     pulse oximetry (SpO2), temperature (Temp), non-invasive
    blood pressure (NIBP),

    invasive blood pressure (IBP) and carbon dioxide (CO2).

    2.2 Components

    The equipment consists of a main unit, accessories and PC
    software.

    The main unit is the core of the equipment. It provides:

    Overall system control;

      System power supply;

      Display;

      Defibrillation and pacing;

      AED ;

      Man-mahcine interface;

      Audible and visible alarms;

    Multiple parameter measurements;

      External connectors and communication; and

      Recording, printing and data storage.

    2.3 Main Unit

    The main unit is composed of the front housing assembly, rear
    housing assembly and the

     paddle tray assembly. External paddles are rested in the
    paddle tray.

      The front housing assembly mainly consists of LCD, keypad
    board, recorder, speaker,

    microphone, Mode Select knob, navigation knob, backlight
    inverter, alarm lamp board,

    indicating lamp board, front housing and front housing sheet
    metal, etc.

      The rear housing assembly consists of CPU board, therapy
    module, high voltage

    capacitors, MPM module, CO2 module, power management board,
    wireless network

    adapter, fan, measurement module panel, therapy port, and rear
    housing, etc.

      The paddle tray is for holding the external paddles.

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    The main unit consists of the following subsystem:

      Input subsystem: Its input includes keypad board,
    microphone, Mode Select knob,

    navigation knob, and paddle handle controls.

    Output subsystem: includes display screen, alarm lamp board,
    recorder, and speaker

      Processing and communication subsystem: includes CPU
    board, therapy module, MPM

    module, and CO2 module.

      Power management subsystem: includes batteries, AC/DC
    board and power

    management board.

      External device connection subsystem: includes USB
    connector, network connector,

    VGA connector and multifunction connector for analog output and
    synchronous input.

    System Structure

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    System Signal Flow

    2.4 Front Housing Assembly

    The front housing assembly consists of display assembly
    (including the backlight inverter), a

    keypad board, a recorder, a speaker, a microphone, a Mode Select
    knob, a navigation knob,

    an alarm lamp board, an indicating lamp board, a front housing
    and front housing sheet metal,

    etc.

    Navigation Knob

    You can rotate the knob clockwise or counterclockwise and then
    press it to confirm a

    selection. The knob is connected to the keypad board.

    Mode Select Knob

    A 8-position encoder is used to select the operating mode
    (Monitor, Manual Defib, AED and

    Pacer) and power-off. The unused positions are mechanically
    disabled.

    Recorder

    The recorder receives data from the CPU board and then sends the
    data to a thermal head for

     printing. The recorder front panel has a key for starting/
    stopping the recorder and a green

    indicator which is lit when working normally. The recorder is
    connected to the keypad board

    which board provides connection for the TR6F recorder. The block
    diagram and functional

    modules of the recorder are shown as below.

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    Module Description

    Power Interface Introduces DC power supply from the CPU
    board.

    Recorder Power Module Adjusts input voltage to run each
    module.

    Recorder CPUCoordinates module communication, controls and
    processes module

    status.

    Keypad board InterfaceServes as the data communication channel
    between the keypad board

    and the recorder CPU.

    Motor Drive CircuitReceives control signals sent by the recorder
    CPU to drive the step

    motor.

    Keypad and Indicator

    Interface

    Sends keypad commands to CPU and receives CPU commands to

    control the indicator.

    FPC InterfaceSends print head information to CPU and receives
    CPU commands to

    control the print head.

    Speaker

    The speaker emits alarm tones, key-stroke tone, heart beats and
    PR sound. It supports the

    functions of PITCH TONE and the multi-level volume. The speaker
    is connected to the

    keypad board.

    Microphone

    It provides the function of voice recording.

     Alarm Lamp Board

    The keypad board interfaces with the alarm lamp board. The alarm
    lamp transmits signals to

    drive the green and yellow alarm lamp.

    Indicating Lamp Board

    The keypad board interfaces with the indicating lamp board. On
    the equipment’s front panel,

    there are 3 indicators: AC power indicator, battery indicator
    and service indicator, each has an

    icon aside.

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    2.5 Paddle Tray

    The paddle tray is used to hold paddles. It has a 50 Ω test
    load inside. When the equipment

    runs self tests, test current will pass through the test
    load.

    2.6 Rear Housing Assembly

    Rear housing assembly consists of the CPU board, the therapy
    module, high voltage

    capacitors, a MPM module, a CO2 module, a power management
    board, a fan, a rear housing,

    a measurement module panel, and a therapy port, etc.

    2.6.1 Power System

    The power system consists of the following items:

      AC/DC board: The AC mains is the input, and the outputs
    is 18VDC.

      Battery: 14.8V, 4500mAh.

      Power Management Board

    It is intended for power transform and battery charge control.
    The system outputs four

    types of power supply: 18V (when AC mains is used) or 14.8V
    (when a battery is used),

    12V, 5V, and 3.3V.

    The priority of system power supply is rated in the order of AC
    mains, Battery 1 and

    Battery 2. That is to say, when AC is not available, Battery 1
    will be used; if Battery 1 is

    defective or depleted, Battery 2 will be used.

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    2.6.2 Main Control System

    The CPU board is connected with the power management board with
    stacking connectors, as

    shown below.

    The main control module mainly consists of the CPU and FPGA. CPU
    is used to provide

    least required internal storage, program memory, large capacity
    non-volatile storage, and the

    watch dog. It connects EEPROM and other peripheral ICs such as
    Ethernet PHY chip. FPGA

     performs the main functions of display and audio. Besides,
    it has the function of adapting

    interfaces from CPU to MPM module, the keypad board and the
    recorder. CPU controls

    FPGA via Flexbus.

    2.6.3 Therapy System

    The therapy system provides the functions of defibrillation,
    pacing and AED analysis. The

    therapy module is an unseparated assembly.

    The therapy module adopts DSP+MCU framework. MCU is responsible
    for therapy control

    while DSP for ECG and impedance detection, AED algorithm,
    monitoring algorithm, pacing

    algorithm, auxiliary therapy control, etc.

    2.6.4 Parameter Measurement System

    MPM modules and the CO2 module are used to provide
    parameter monitoring. However,

    ECG monitoring can also be implemented by the therapy module.
    .

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    2.7 External Device Connectors

    1. Hook

    2. Battery 2

    3. Battery 1

    4. External power input: It connects an AC power cord or a DC/AC
    adapter to run the

    equipment respectively on the external AC mains or DC power
    supply.

    5. Equipotential grounding terminal: When the
    defibrillator/monitor and other devices are

    to be used together, their equipotential grounding terminals
    should be connected

    together to eliminate the potential difference between them.

    6. USB connector: It connects the USB memory for data export.
    Data stored in the internal

    CF card can be transferred to the USB memory and then export to
    a PC via the data

    management software.

    7. Network connector: It is a standard RJ45 connector, through
    which software can be

    upgraded.

    8. Multifunctional connector: provides ECG analog output and
    defibrillation

    synchronization input.

    9. VGA connector: connects an external VGA display.

    1

    2

    4

    3

    6

    7

    8

    9

    5

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    3-1

    3 Unpacking and InstallationThis chapter provides information
    you need to install a defibrillator/monitor ready for use.

    3.1 Unpacking the Equipment

    Open the package and take out the packing list. Check that all
    the articles included in the

     packing list are available and the quantity and
    specification are correct.

      All the optional parts purchased by the customer shall
    also be checked.

     Notify the supplier if provided components are not correct
    as compared to the packing

    list.

      In case of damage during transportation, keep the packing
    material and notify the

    supplier immediately.

      Keep the packing material till new equipment is
    accepted.

    The following pictures show the defibrillator/monitor and
    accessory packing.

    Main unit packing

    Accessory packing

    Main unitAccessory packing

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    3.2 Preparation for Installation

    3.2.1 Preparation for Installation Site

    1. Ensure that the site meets all safety, environmental and
    power requirements

    2. Check that required power sockets are available.

    3. Check that a network connector is available if the
    defibrillator/monitor needs to be

    connected to network.

    WARNING

      Only power cables provided with the system may be used.
    For reasons of safety,

    power (mains) extension cables or adapters shall not be
    used.

    Environmental Requirements

    WARNING

      To avoid explosion hazard, do not use the equipment in
    the presence of flammable

    anaesthetics, vapours or liquids.

    CAUTION

      The environment where the defibrillator/monitor will be
    used should be reasonably

    free from vibration, dust and corrosive substances. If these
    conditions are not met,

    the accuracy of the system may be affected and damage may
    occur.

    The environmental specification is as follows:

    Operating Temperature

    0 to 45℃  (without CO2 module)

    5 to 35℃  (with sidestream CO2 module)

    0 to 40ºC (with microstream CO2 module)

    Operating humidity 15% to 95%, (non-condensing)

    Operating altitude -381m to +4575 m (-1250 ft to 15000 ft, or
    106.2kPa to 57kPa)

    Storage temperature -30 to 70℃ 

    Storage humidity 10% to 95%, (non-condensing)

    Storage altitude -381m to +4575 m (-1250 ft to 15000 ft, or
    106.2kPa to 57kPa)

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    3.2.2 Electrical Requirements

    Check cables and power cords. Make sure that: 

    1. All system cables, power cords and power plugs are not
    damaged, and pins are not loose.Otherwise, remove it from use.

    2. The insulation of patient cables and leadwires is not
    damaged, and connectors are not

    loose.

    WARNING

      Only power sockets with protective grounding can be
    used.

    The electrical specification is as follows:

    Line voltage: 100 to 240VAC

    Current: 1.8 to 0.8 A

    Frequency: 50/60Hz

    3.3 Vehicle Mount Kit Installation

    Refer to BeneHeart D6/D5 Vehicle Mount Kit Instructions for
    Use for the detailed

    information on how to install the equipment on the vehicle mount
    kit.

    3.4 Installing Hook Kit or Conductive Gel Container Kit

    Refer to Hook Kit and Conductive Gel Container Kit
    Installation Guide to install the hook

    kit or conductive gel container kit.

    3.5 Preparation for Power On

    Before connecting the power cord to the defibrillator/monitor’s
    power input, check that

      The mains voltage meets the requirement.

      3-wire power cord is used. The power socket should be
    3-wire also. This ensures that the

    defibrillator/monitor is properly grounded. Do not use 2-wire
    power cord or socket.

      The equipotential grounding terminals should be connected
    together when the

    defibrillator/monitor and other devices are to be used
    together.

      The defibrillator/monitor is not placed under the
    infusion bag or placed where their

    might be liquid spillage. This protects the
    defibrillator/monitor from liquid ingress.

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    4Testing and Maintenance

    4.1 Introduction

    To ensure the equipment always functions normally, qualified
    service personnel should

     perform regular inspection, maintenance and test. This
    chapter provides a checklist of the

    testing procedures for the equipment with recommended test
    equipment and frequency. The

    service personnel should perform the testing and maintenance
    procedures as required and use

    appropriate test equipment.

    The testing procedures provided in this chapter are intended to
    verify that the equipment

    meets the performance specifications. If the equipment or a
    module fails to perform as

    specified in any test, repairs or replacement must be done to
    correct the problem. If the

     problem persists, contact our Customer Service
    Department.

    CAUTION

      All tests should be performed by qualified service
    personnel only.

      Care should be taken to change the settings in
    [Installation Mode] and [Service

    Mode] menus to avoid loss of data.

      Before testing, service personnel should acquaint
    themselves with the test tools and

    make sure that test tools and cables are applicable.

      When testing monitoring parameters, move the Mode Select
    knob to Monitor to

    access the Monitor Mode.

      When performing therapy function tests, move the Mode
    Select knob to

    corresponding mode.

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    4.1.1 Test Report

    After completing the tests, service personnel are required to
    record test results and report

    them to Mindray Customer Service Department.

    See the

    Test Report at the end of this chapter.

    4.1.2 Preventative Maintenance

    Below are preventative maintenance tests which need to be
    performed on the

    defibrillator/monitor. See the following sections for detailed
    maintenance procedures.

      Visual inspection

       NIBP test and calibration

      Microsteam and Sidestram CO2 test and calibration.

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    4-3

    4.1.3 Recommended Frequency

    Test itemAfter

    repair

    Function

    suspected

    6

    months

    12

    months

    24

    months

    Visual inspection × 

    Power-on Test × 

    User test × 

    Recorder check × 

    Charge/

    discharge

    Energy disarming

    Manual

    defibrillation

    tests Synchronous

    defibrillation

    Pacing test

    ×  ×  × 

    Performance test ×  ×  × ECG

    Module calibration ×  × 

    Resp Performance test ×  ×  × 

    SpO2 Performance test ×  ×  × 

    Temp Performance test ×  ×  × 

    Accuracy test

    Leakage test NIBP

    Module calibration

    ×  ×  × 

    Performance testIBP

    Pressure calibration

    Leakage test ×  ×  × CO2 

    Module calibration ×  ×  × 

     NIBP overpressure protection test ×  × 
    × 

    Analog out test × 

    Earth leakage current

    Patient leakage

    current

    Electrical

    safety tests as

     per

    IEC60601-1 Patient auxiliary

    current

    ×  × 

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    4-5

    4. Compare the value of manometer with the value displayed on
    the equipment’s screen.

    The difference should be no greater than 3 mmHg.

    5. Raise the pressure in the metal vessel to 50 mmHg with the
    balloon pump. Repeat steps

    3 and 4.

    6. Raise the pressure in the metal vessel to 200 mmHg with the
    balloon pump. Repeat steps

    3 and 4.

    Note

      You can replace the balloon pump and manometer with a
    blood pressure simulator

    to form a test system.

    NIBP Leakage Test

    Tools required:

      An adult cuff

      An air tubing

      A correct sized cylinder

    To perform the leakage test:

    1. Connect the cuff to the equipment’s NIBP connector.

    2. Wrap the cuff around the cylinder as shown below.

    3. Press the Main menu button on the equipment’s front panel.
    Select [Others>>]→ 

    [Installation Mode>>]→ enter the required
    password→[Maintain NIBP]→ [Start 

    Leakage Test].

    After about 20 seconds, the equipment automatically deflates.
    This means the leakage test

    finishes.

    When the accuracy test is completed, the result will be
    displayed. If the message [NIBP

    Pneumatic Leak ] is displayed, it indicates that the NIBP
    airway may have leakages. Check

    the tubing and connections for leakages, and then perform a
    leakage test again.

    Defibrillator/monitor 

    Connector for 

      NIBP cuf 

    Tubing

    Cylinder 

    Cuff

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    Calibrating NIBP

    Tools required:

      T-shape connector

      Tubing

      Balloon pump

      Metal Vessel, volume 500±25 ml

      Calibrated manometer, accuracy higher than 1 mmHg

    1. Connect the equipment as shown below

    2. Before inflation, the reading of the manometer should be 0.
    If not, disconnect the

    airway and reconnect it until the readings is 0

    3. Press the Main menu button on the equipment’s front panel.
    Select [Others>>]→ 

    [Service Mode>>]→ enter the required
    password→[Calibrate NIBP].

    4. Calibrate pressure. To do so, set the calibration value to
    150 mmHg and adjust the pump

    output pressure to 150 mmHg. After the system is stable, click
    the [Calibrate] button to

    start calibration.

    5. Calibrate overpressure. To do so,

      set [Patient Cat.] to [Adu/Ped] and adjust pump output
    pressure to 330 mmHg.

    Click the [Calibrate] button and start calibration. Or

      set [Patient Cat.] to [Neo] and adjust pump output
    pressure to 165 mmHg. Click

    the [Calibrate] button and start calibration.

    All the calibration results will be displayed in the
    [Calibrating NIBP] screen. If the

    calibration fails, please check the connections and then perform
    a calibration again.

    Defibrillator/monitor

    Connector for

     NIBP cuff

    Manometer 

    Tubing

    Balloon pumpMetal vessel

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    4-7

    4.2.3 CO2 Module Tests

    Leakage Check

    1. Access the [CO2 Setup] menu and set [Operating
    Mode] to [Measure].Wait for  CO2 

    warm-up. 

    2. Block the CO2 module gas inlet completely. This will
    cause different reactions from the

    Sidestream and Microstream CO2 modules.

      Sidestream: Check that alarm message [CO2 Filter Line
    Err] is displayed on the

    screen in 3s. Block the gas inlet for another 30s, if the alarm
    message does not

    disappear, the module does not leak.

      Microstream CO2 module: [CO2
    Purging…] is displayed in 3s. Block the gas
    inlet

    for another 30s, if the alarm message [CO2 Tubing Err] appears,
    the module does

    not leak.

    Module Calibration

    Test tools

      Gas cylinder, with 6% of CO2 and balance gas N2.

      T-shape connector

      Tubing

    For sidestream CO2 module, zeroing is required before
    calibration. Enter [CO2 Setup] menu

    and select [Zero] to perform zeroing.

    To calibrate the CO2 module, follow this procedure:

    1. Make sure that the CO2 module has been warmed up or
    started up.

    2. Connect the gas cylinder with the tubing using a T-shape
    connector as shown below.

    Check the airway and make sure there are no leaks.

    Defibrillator 

    /monitor

    Gas cylinder 

    To the air

    Gas valveTubing

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    4-8

    3. Vent the tubing to the CO2 by opening the gas valve.

    4. Access the [Maintain CO2] menu. To do so, Press the Main Menu
    button on the

    equipment’s front panel. Select [Others>>]→[Installation
    Mode>>]→enter the

    required password→ [Maintain CO2].

    5. In the [Maintain CO2] menu, select a CO2 value equal to the
    vented CO2 

    concentration.

    6. In the [Calibrate CO2] menu, the measured
    CO2 concentration is displayed. Wait till

    the measured CO2 concentration becomes stable; select
    [Calibrate] to start CO2 

    calibrate.

    The message [Calibration Completed!] is displayed after a
    successful calibration. If the

    calibration failed, the prompt [Calibration Failed!] will be
    displayed. In this case, perform

    another calibration.

    4.2.4 Preventative maintenance test report

    Customer name

    Customer address

    Servicing person

    Servicing company

    Equipment under test

    (EUT)

    Model of EUT

    SN of EUT

    Hardware version

    Software version

    Test equipment Model/No. Effective date of calibration

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    4-9

    Test items Test records Test results

    (Pass/Failed)

    Visual inspection

    The case, display screen, buttons, knob, SMR, modules, power

    cord, wall-mount bracket and accessories have no obvious
    signs

    of damage.

    The external connecting cables are not frayed and the
    connector

     pins are not loose and bent.

    The external connectors are not loose or their pins are not
    bent.

    The safety labels and data plate are clearly legible.

    NIBP test

    The difference is within ±3 mm when 0, 50 or 200 mmHg is set

    for NIBP accuracy test.

    There is no leakage with NIBP, or the manual leakage test
    result

    does not exceed 6mmHg/min.

    Sidestream CO2 test

    Block the gas inlet of the module or watertrap. The
    sidestream

    CO2 flowrate is slower than 10ml/min and an alarm of CO2

    Filterline Err is given. It indicates that there is no
    leakage.

    The displayed CO2 value is within 6±0.05％.

    Microstream CO2 test

    Block the gas inlet of the module or watertrap. An alarm of
    CO2

    Filterline Err is given. It indicates that there is no
    leakage.

    The displayed CO2 value is within 6±0.05％.

    4.3 Power On TestThis test is to verify that the defibrillator/
    monitor can power on normally. The test is passed if the

    defibrillator/ monitor starts up by following this
    procedure:

    1. Place the external paddles on paddle tray, insert the battery
    (install both if two batteries

    are configured) in the battery compartment, and then connect the
    equipment with AC

    mains. In this case, both the AC indicator and battery indicator
    shall light.

    2. Turn the Mode Select knob to Monitor. Check that the
    equipment passes the self test and

    is turned on properly.

    3. Check the display of technical alarm area, prompt area and
    battery status indicator on

    the upper right corner of the main screen to judge whether the
    equipment runs normally.

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    4.4 User Test

    Follow this procedure to perform user test:

    1. If you use external paddles, place them on the paddle tray;
    if you use a pads cable,connect it to the 50 Ω test load.

    2. Insert the battery (2 if configured) into the equipment.
    Connect the AC mains if no

     battery is available.

    3. Select the Main Menu button on the equipment’s front panel.
    In the Main Menu, select

    [User Test>>]. Then a prompt “Enter user test?” pops up.
    Select “Yes” to enter the User

    Test screen.

    4. Check the test items you want to perform and select [Start]
    to start user test

    The test results indicate the condition of the system. If any
    item fails, the service indicator

    flashes.

    If you cannot pass User Test or the message “Connect paddles
    cable, and place paddles in

     paddle tray” is shown when paddle cable is connected and
    paddles are placed in paddle tray,

    check paddles status.

    Select the Monitor mode. Press and hold the [Event] hardkey, and
    then press the [Lead

    Select] hardkey on the front panel, the following screen
    appears.

    Observe the reading of “Lead Stat”:

      0 x 382: Paddles are properly placed in paddle tray.

      0 x 182: The travel switch indicating paddle status may
    fail, but impedance is correct.

      0 x 102 :Paddles are not properly placed in paddle tray
    and the impedance value is not

    correct.

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    4.5 Password for Installation Mode

    Accessing installation mode is password protected. The required
    password is set to 888888

     before the equipment leaves the factory.

    4.6 Module Performance Tests

    4.6.1 Manual Defibrillation Test

    Test tools:

      Defibrillator/pacer analyzer

    Charge/Discharge

    1. Remove the batteries and connect the equipment with AC mains.
    Turn the Mode Select

    knob to Manual Defib.

    2. Connect the external paddles to the equipment and place the
    paddles on the

    defibrillator/pacer analyzer.

    3. Enter the Configuration-Main screen. From the Record Setup
    menu set [Shock Event]

    to [On] so that shock events can be recorded automatically if
    happened.

    4. Set the analyzer to Energy Measurement mode. In this case,
    the energy value should be

    displayed as 0 or blank.

    5. Select the energy level to 1J.

    6. Charge/discharge the equipment to verify the energies
    measured by the analyzer meet

    the following accuracy:

    Selected Energy (J) Measured Value (J)

    1 0 to 3

    100 85 to 115

    360 306 to 414

    7．  Set the energy to 100J and 360J respectively. Repeat
    Step 6.

    8. Disconnect the equipment from the AC mains. Run the equipment
    on fully charged

     battery. Move the Mode Select knob to Manual Defib. Repeat
    Steps 5 to 7.

    9. Use multifunctional electrode pads. Repeat Step 5 to Step
    7.

    10. Verify that the equipment records the shock events
    automatically and correctly.

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    7. When charging finishes, press and hold the “Shock” button to
    deliver a shock.

    8. Verify that synchronous discharge succeeds and the delivery
    energy measured by the

    analyzer is 10J±2J.

    9. Verify that the delay time of synchronous defibrillation
    measured by the analyzer is less

    than 60ms.

    10. Verify that the synchronous discharge mark appears on the R
    wave.

    11. Verify that the prompt messages are correct during
    testing.

    12. Select lead II as ECG source and perform charging. Repeat
    steps 7 to 11.

    13. Use multifunctional electrode pads. Repeat steps 2 to
    12.

    4.6.2 Pacing Test

    Test tools:

      Defibrillator/pacer analyzer

    1. Run the equipment on fully charged battery. Move the Mode
    Select knob to Pacer. Set

    [Pacer Mode] to [Fixed].

    2. Connect the pads cable to the equipment and properly place
    the pads on the

    defibrillator/pacer analyzer.

    3. Set the analyzer to Pacing Measurement mode. Use test load of
    50Ω.

    4. On the equipment, set [Pacer rate] to [70ppm] and [Pacer
    Output] to [30mA].

    5. Press the [Start Pacing] soft key. Verify that the pacer rate
    measured by the analyzer is

    70 ppm±1ppm and the pacer output measured is 30 mA±5mA.

    6. Press the “Stop Pacing” soft key, and then set [Pacer rate]
    to [170ppm] and [Pacer

    Output] to [200mA].

    7. Press the [Start Pacing] soft key. Verify that the pacer rate
    measured by the analyzer is

    170 ppm±2ppm, and the measured current is 200 mA±10mA.

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    4.6.3 ECG Test

    Performance Test

    Test tools

      ECG simulator

    1. Connect the simulator to the equipment’s ECG connector.

    2. Configure the simulator as HR=80 bmp.

    3. The displayed HR should not exceed 80±1 bmp;

    ECG Calibration

    1. Select the ECG parameter area to enter the [ECG Setup]
    menu.

    2. Select [Others>>]→[Calibrate]. A waveform signals
    appear on the screen and the

    message [ECG Calibrating] is displayed in the prompt information
    area in the lower

    left corner of the screen.

    3. Compare the amplitude of the waveform with the wave scale.
    The difference should be

    within 5%. If needed, you can also print out the waveform and
    the wave scale.

    4. After ECG calibration is completed, select [Stop
    Calibrating].

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    Pressure Calibration

    Tools required:

      Standard sphygmomanometer

      Balloon pump

      Tubing

      T-shape connector

    To perform a calibration:

    1. Connect the 3-way stopcock, the sphygmomanometer and the
    balloon pump through a

    T-shape connector, as shown below.

    2. Zero the transducer. Then open the stopcock to the
    sphygmomanometer.3. Press the Main menu button on the equipment’s
    front panel. Select [Others>>]→ 

    [Installation Mode>>]→ enter the required
    password→[Maintain IBP]. Then

    configure IBP calibration value.

    4. Inflate using the balloon pump until the reading of
    sphygmomanometer approximates

    the preset calibration value.

    5. Adjust the calibration value in the [Maintain IBP] menu until
    it is equal to the reading

    of sphygmomanometer

    6. Select the [Calibrate] button to start a calibration

    7. The message [Calibration Completed!] is displayed after a
    successful calibration. If

    the calibration failed, the prompt [Calibration Failed!] will be
    displayed.

    Sphygmomanometer

    T-shape connector 

    3-way stopcock 

    Pressure transducer 

    Pressure adapter cable

    IBP Module

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    4.6.6 SpO2 Test

    Test tool

    Patient simulator.

    1. Connect the patient simulator to the equipment’s SpO2
    connector  .

    2. Select the model and manufacturer of the SpO2 module under
    test. Configure the

     parameter as SpO2 96% and PR 80 bmp.

    3. The displayed SpO2 and PR values should be within the ranges
    listed below

    SpO2 (%) PR (bmp)

    Mindray 96% ±2% 80±3

    Masimo 96% ±2% 80±3

    MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I,

    MAX-FAST96% ±2%

    OxiCliq A, OxiCliq N, OxiCliq P, OxiCliq I 96% ±2.5%

    D-YS, DS-100A, OXI-A/N, OXI-P/I 96% ±3%

     Nellcor

    MAX-R, D-YSE, D-YSPD 96% ±3.5%

    80±3

    4.6.7 Temp Test

    Test tools

      Resistance box

    1. Connect the two pins of any Temp connector on equipment to
    the two ends of the

    resistance box using 2 wires.

    2. Set the resistance box to 1354.9Ω (corresponding
    temperature is 37 ). The displayed℃

    value on the equipment should not exceed 37±0.2 .℃

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    4.7 Analogue Output Test

    Test tool:

    Oscillograph

    1. Connect the patient simulator to the equipment under test
    using an ECG or IBP cable.

    2. Connect the oscillograph to the equipment’s multifunctional
    connector.

    3. Verify that the waveforms displayed on the oscillograph is
    identical with those

    displayed on the defibrillator/ monitor.

    4.8 Electr ical Safety Tests

    See A Electrical Safety Inspection for electrical
    safety tests..

    4.9 Recorder Check

    Tools required:

       None.

    1. Print ECG waveforms. The recorder should print correctly and
    the printout should be

    clear.

    2. Simulate some recorder problems, such as out of paper, paper
    jam, etc. the defibrillator/

    monitor should give corresponding prompt messages. After the
    problem is removed, the

    recorder should be able to work correctly.

    3. Switch automatic alarm recording for each parameter ON and
    then set each parameter’s

    limit outside set alarm limits. Corresponding alarm recordings
    should be triggered when

     parameter alarms occur.

    4.10 Factory Service

    4.10.1 Password for Service Mode

    Accessing service mode is password protected. The required
    password is set to 332888

     before the equipment leaves the factory.

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    4.10.2 Accessing Service Mode Menu

    To access the factory service menu, Press the Main menu button
    on the equipment’s front

     panel. Select [Others>>]→ [Service
    Mode>>]→ enter the required passwords. The Service

    Mode-Main menu is shown below.

    4.10.3 Calibrating NIBP

    Refer to 4.2.2 NIBP Tests for calibrating NIBP.

    4.10.4 Calibrating/Zeroing Impedance

     Normally impedance calibration and zeroing is unnecessary.
    However, you can perform

    impedance checking after replacing the therapy module.

    1. If not pre-connected, connect the pads cable to the
    equipment.

    2. Connect a test load of 300 ohms to the pads cable.

    3. Start the equipment and select the Monitor mode. Press and
    hold the [Event] hardkey,

    and then press the [Lead Select] hardkey on the front panel, the
    following screen

    appears.

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    4. Verify that the reading of “RT Imped” is between
    3000±450.

    NOTE

      If 300 ohms test load is not available, you can use a 50
    ohms test load to perform

    impedance checking. In this case, Verify that the reading of “RT
    Imped” is

    between 500±75.

    If the reading of “RT Imped” is not correct, perform impedance
    calibration/zeroing.

    1. Press the Main menu button on the equipment’s front panel.
    Select [Others>>]→ [Service Mode>>]→ enter
    the required passwords→[Calibrate/Zero Impedance] to

    enter the Calibrate/Zero Impedance screen.

    2. Connect a test load of 0 ohm to the pads cable; then select
    “Zero”. A message “Zero

    Completed” shall be shown. If the message “Zero Failed” is
    displayed, check the

    connection of pads cable.

    3. Connect a test load of 100 ohms to the pads cable; then
    select “Calibrate”. A message

    “Calibration Completed” shall be shown. If the message
    “Calibration Failed” is

    displayed, check the connection of pads cable.

    Replace the therapy module if impedance calibration/zeroing
    fails.

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    4.10.5 Device Information

    Press the Main menu button on the equipment’s front panel.
    Select [Others>>]→ [Service

    Mode>>]→ enter the required passwords→ [Device
    Information]. In the Device

    Information list, you can view the device information such as
    software version, system status,

    and etc, as shown below.

    In the Device Information screen, you can select [Export] to
    export error codes and shock

    delivery data to a USB flash memory.

    4.10.6 Checking Failure Code

    Press the Main Menu button on the equipment’s front panel.
    Select [Others>>]→ [Service

    Mode>>]→ enter the required passwords→ [Failure
    Code] to check error codes. This helps

    the service personnel to identify failures.

    Refer to 6.8 Error Codes for the description of each error
    code.

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    4.10.7 Inputt ing Serial Number

    Press the Main Menu button on the equipment’s front panel.
    Select [Others>>]→ [Service

    Mode>>]→ enter the required passwords→ [Input
    Serial Number] to input the equipment’s

    serial number.

    After inputting the serial number, you can view it by accessing
    Installation Mode and select

    [Version].

    4.10.8 Paddle Open Circuit Display

    This [Paddle Open Circuit Display] switch is for testing only.
    In normal operation, it should

     be set to [Off ]].

    4.10.9 Selecting Recorder Type

    BeneHeart D6 defibrillator/monitor can be configured with a 50
    mm recorder or an 80 mm

    recorder. You can choose the recorder type in the service mode
    by selecting [ Recorder Type]

    and toggle between [50 mm Recorder] and [80 mm Recorder].

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    Test Report

    Customer name

    Customer address

    Servicing person

    Servicing company

    Equipment under test

    (EUT)

    Model of EUT

    SN of EUT

    Hardware version

    Software version

    Test equipment Model/No. Effective date of calibration

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    Test items Test recordsTest results

    (Pass/Failed)

    Visual inspection

    The case, display screen, buttons, knob, modules, power cord,
    and

    accessories have no obvious signs of damage.

    The external connecting cables are not frayed and the connector
    pins

    are not loose and bent.

    The external connectors are not loose or their pins are not
    bent.

    The safety labels and data plate are clearly legible.

    Power-on test

    The power-on test is passed. The power indicator and alarm
    system

    work correctly and the equipment start up properly.

    Performance test

    Manual Defibrillation Test

    When running on AC mains and external paddles are used, the

    equipment can be properly charged and discharged; the energy

    delivered meets accuracy requirement, and shock information
    is

    correctly recorded. 

    When running on fully charged battery and external paddles are
    used,

    the equipment can be properly charged and discharged; the
    energydelivered meets accuracy requirement, and shock information
    is

    correctly recorded. 

    When running on AC mains and multifuncational electrode pads
    are

    used, the equipment can be properly charged and discharged;
    the

    energy delivered meets accuracy requirement, and shock
    information

    is correctly recorded. 

    When running on fully charged battery and multifuncational

    electrode pads are used, the equipment can be properly charged
    and

    discharged; the energy delivered meets accuracy requirement,
    and

    shock information is correctly recorded. 

    When external paddles are used, charge tone is correctly issued
    when

    the equipment is being charged. The prompt «Charged Removed»
    is

    shown on the screen and charge done tone stops when the
    Disarm 

    hotkey is pressed. The equipment does not discharge
    externally.

    When [Time to Auto Disarm] is set to [60s], the prompt
    «Charged

    Removed» is shown on the screen and the charge done tone
    stops

    after 60 seconds at the completion of charging. The equipment
    does

    not discharge externally. 

    When pads are used, the charge tone is correctly issued when
    theequipment is being charged. The prompt «Charged Removed» is

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    Test items Test recordsTest results

    (Pass/Failed)

    not exceed 6mmHg/min.

    Temp test

    The value displayed for each Temp channel of the monitor is
    within

    37±0.1ºC.

    IBP test

    The static pressure value displayed for each IBP channel is
    within

    200±2 mmHg.

    The ART and LV waves for each IBP channel are displayed
    correctly.

    Sidestream CO2 test

    Block the gas inlet of the module or watertrap. The sidestream
    CO2flowrate is slower than 10ml/min and an alarm of CO2 Filterline
    Err

    is given. It indicates that there is no leakage.

    The displayed CO2 value is within 6±0.05％.

    Miscrostream CO2 test

    Block the gas inlet of the module or watertrap. An alarm of
    CO2

    Filterline Err is given. It indicates that there is no
    leakage.

    The displayed CO2 value is within 6±0.05％ 

    Analog output performance test

    The waves displayed on the oscillograph are identical with
    those

    displayed on the monitor.

    SpO2 test

    The displayed SpO2 and PR values should be within the
    specified

    ranges.

    Electrical safety tests

    Refer to Appendix A Electrical Safety Inspection. All the
    electrical

    safety tests should be passed.

    Recorder check

    The recorder can print ECG waves correctly and the printout is
    clear.

    Set the recorder to some problems such as out of paper, paper
    jam,

    etc. the equipment gives corresponding prompt messages. After
    the

     problem is removed, the recorder is able to work
    correctly.

    Automatic alarm recording for each parameter functions
    correctly

    when parameter alarms occur.

    Tested by: _________________________ Date:
    ________________________

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    5-1

    5 Hardware and Software Upgrade

    5.1 Hardware Upgrade

    After upgrade the hardware, please upgrade corresponding
    software.

    5.1.1 Upgrading MPM module

    Upgrading MPM module configured with 3/5-lead ECG only

    You can upgrade MPM module from 3/5-lead ECG only to any of the
    following

    configuration:

    PN Description of upgrade package Configuration after
    upgrade

    801-0651-00117-00 Low cost MPM subassembly 12-Lead

    ECG upgrade package

    12-lead ECG

    801-0651-00118-00 12-Lead ECG/Mindray SpO2upgrade

     package

    12-lead ECG/Mindray SpO2

    801-0651-00049-00 NIBP upgrade package 3/5-lead ECG/NIBP

    801-0651-00050-00 Mindray SpO2 upgrade package 3/5-lead
    ECG/Mindray SpO2

    801-0651-00051-00 Masimo SpO2 upgrade package 3/5-lead
    ECG/Masimo SpO2

    801-0651-00052-00 Nellcor SpO2 upgrade package 3/5-lead
    ECG/Nellcor SpO2

    801-0651-00053-00 Mindray SpO2/NIBP/TEMP upgrade

     package

    3/5-lead ECG/Mindray SpO2

    /NIBP/TEMP

    801-0651-00056-00 Mindray SpO2/NIBP/IBP/TEMP

    upgrade package

    3/5-lead ECG/Mindray SpO2

    /NIBP/IBP/TEMP

    801-0651-00059-00 Masimo SpO2/NIBP/TEMP upgrade

     package

    3/5-lead ECG/Masimo SpO2

    /NIBP/TEMP

    801-0651-00060-00 NellcorSpO2/NIBP/TEMP upgrade

     package

    3/5-lead ECG /Nellcor SpO2

    /NIBP/TEMP

    801-0651-00061-00 Masimo SpO2/NIBP/IBP/TEMP upgrade

     package

    3/5-lead ECG/Masimo SpO2

    /NIBP/IBP/TEMP

    801-0651-00062-00 NellcorSpO2/NIBP/IBP/TEM upgrade

     package

    3/5-lead ECG/Nellcor SpO2

    /NIBP/IBP/TEMP

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    Upgrading MPM module configured with 3/5-leadECG/NIBP

    You can upgrade MPM module from 3/5-lead ECG/NIBP to any of the
    following

    configuration:

    PN Description of upgrade package Configuration after
    upgrade

    801-0651-00053-00 Mindray SpO2/NIBP/TEMP upgrade

     package

    3/5-lead ECG/Mindray SpO2

    /NIBP/TEMP

    801-0651-00056-00 Mindray SpO2/NIBP/IBP/TEMP upgrade

     package

    3/5-lead ECG/Mindray SpO2

    /NIBP/IBP/TEMP

    801-0651-00059-00 Masimo SpO2/NIBP/TEMP upgrade

     package

    3/5-lead ECG/Masimo SpO2

    /NIBP/TEMP

    801-0651-00061-00 Masimo SpO2/NIBP/IBP/TEMP upgrade

     package

    3/5-lead ECG/Masimo

    SpO2/NIBP/IBP/TEMP

    801-0651-00060-00 NellcorSpO2/NIBP/TEMP upgrade

     package

    3/5-lead ECG/Nellcor

    SpO2/NIBP/TEMP

    801-0651-00062-00 NellcorSpO2/NIBP/IBP/TEMP upgrade

     package

    3/5-lead ECG/Nellcor

    SpO2/NIBP/IBP/TEMP

    801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG

    Upgrading MPM module configured wi th 3/5-lead ECG/Mindray
    SpO2

    You can upgrade MPM module from 3/5-lead ECG/Mindray SpO2 to any
    of the following

    configuration:

    PN Description of upgrade package Configuration after
    upgrade

    801-0651-00118-00 12-lead ECG/Mindray SpO2upgrade

     package

    12-lead ECG

    801-0651-00053-00 Mindray SpO2/NIBP/TEMP upgrade

     package

    3/5-lead ECG/Mindray

    SpO2/NIBP/TEMP

    801-0651-00056-00 Mindray SpO2/NIBP/IBP/TEMP upgrade

     package

    3/5-lead ECG/Mindray

    SpO2/NIBP/IBP/TEMP

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    Upgrading MPM module configured with 3/5-lead ECG/Mindray

    SpO2/NIBP/TEMP

    You can upgrade MPM module from 3/5-lead ECG/Mindray
    SpO2/NIBP/TEM to any of the

    following configuration:

    PN Description of upgrade package Configuration after
    upgrade

    801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG

    801-0651-00081-00 IBP upgrade package 3/5-lead ECG/Mindray

    SpO2/NIBP/IBP/TEMP

    Upgrading MPM module configured with 3/5-lead ECG/ Nellcor

    SpO2/NIBP/TEMP

    You can upgrade MPM module from 3/5-lead ECG/ Nellcor
    SpO2/NIBP/TEMP to any of the

    following configuration:

    PN Description of upgrade

    package

    Configuration after upgrade

    801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG

    801-0651-00081-00 IBP upgrade package 3/5-lead ECG/Nellcor

    SpO2/NIBP/IBP/TEMP

    Upgrading MPM module configured with 3/5-lead ECG/ Mindray

    SpO2/NIBP/IBP/TEMP

    You can upgrade MPM module from 3/5-lead ECG/ Mindray
    SpO2/NIBP/IBP/TEMP to any

    of the following configuration:

    PN Description of upgrade package Configuration after

    upgrade

    801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG

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    Upgrading MPM module configured with 3/5-lead ECG/ Masimo

    SpO2/NIBP/IBP/TEMP

    You can upgrade MPM module from 3/5-lead ECG/ Masimo
    SpO2/NIBP/IBP/TEMP to any

    of the following configuration:

    PN Description of upgrade package Configuration after
    upgrade

    801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG

    Upgrading MPM module configured with 3/5-lead ECG/Nellcor

    SpO2/NIBP/IBP/TEMP

    You can upgrade MPM module from 3/5-lead ECG/ Nellcor
    SpO2/NIBP/IBP/TEMP to anyof the following configuration:

    PN Description of upgrade package Configuration after
    upgrade

    801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG

    5.1.2 MPM Module upgrade procedure

    1. Remove the MPM module assembly and parameter panel assembly
    as described in 7.3.8

     Disassembling the MPM Module.

    2. Replace the old parameter panel assembly and MPM module
    assembly with those in the

    upgrade package.

    3. Remove the watertrap receptacle unit, or microstream CO2
    connector assembly, or CO2

     panel as described in 7.8 Disassembling the Measurement
    Module Panel Assembly.

    4. Reassemble the watertrap receptacle unit, or microstream CO2
    connector assembly, or

    CO2 panel on the replacement parameter panel assembly in the
    upgrade package.

    NOTE

      If you need to upgrade 3/5-lead ECG to 12-lead ECG,
    insert the 12-lead ECG

    board into the MPM module. Make sure that the 12-lead ECG board
    should be in

    correct direction. Then fix the clip in place.

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    5. Reassemble the equipment.

    6. Stick correct parameter panel overlay on the parameter panel
    according to theconfiguration you upgrade.

      If the upgrade MPM module is equipped with Masimo SpO2,
    you need to stick a

    Masimo label on the lower left corner of the front housing and a
    No Implied

    License label below the parameter panel, as indicated in the
    following pictures.

      If the upgraded MPM module is equipped with Nellcor SpO2,
    you need to stick a

     Nellcor label at the lower left corner of the front
    housing, as indicated in the

    following pictures.

    7. Perform the tests as described in 4.6 Module Performance
    Tests.

    Masimo label No Implied License label

     Nellcor label

    12-lead ECG board

    Clip 1Cli 2

    Clip here in place Clip here in place

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    5-7

    5.1.3 Upgrade the Therapy Module

    You can use 801-0652-00039-00 pacer function upgrade kit to
    upgrade the therapy module so

    that equipment has pacing function. After upgrading the therapy
    module, choose Mode label

    (with pacing function) with the language you need.

    Follow this procedure to upgrade the therapy module:

    1. Remove therapy module as described in 7.3.7 Removing the
    Therapy Module

     High-voltage Board . Be noted that you need not to
    remove the parameter panel

    assembly and MPM module assembly.

    2. Take off the Mode Select knob. Peel off the Mode label.

    3. Replace the old therapy module with the one configured with
    pacing function in the

    upgrade package.

    4. Replace the old Mode Select knob and Mode label with those in
    the upgrade package.

    5. Reassemble the equipment.

    6. After upgrade the therapy module, perform the tests described
    in 4.6 Module

     Performance Tests.

    Mode Select knob

    Mode label

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    5-8

    5.1.4 Upgrade the Equipment with CO2 Module

    You can use the following CO2 upgrade package to upgrade the
    equipment so as to have a

    CO2 monitoring function.

    PN Description of upgrade package

    801-0651-00079-00 M02B CO2 upgrade package (for adult/pediatric)
    (FRU)

    801-0651-00082-00 M02B CO2 upgrade package (for neonate)
    (FRU)

    801-0651-00080-00 Microstream CO2 upgrade package (for neonate)
    (FRU)

    Follow this procedure to upgrade the equipment:

    1. Remove the parameter module panel assembly as described in
    7.3.4 Removing the

     Measurement Module Panel .

    2. Remove the left capacitor sheet metal as described in 7.3.9
    Removing the CO2 Module.

    3. Install the required M02B CO2 module or microstream CO2
    module on the left

    capacitor sheet metal.

    Mindray CO2 module Microstream CO2 module

    4. Apply the CO2 insulating sheet on the MPM module mounting
    plate. Be careful to align

    the edge of insulating plate with the edge of the metal plate
    when stick the insulating

     plate to the metal sheet. Do not stick the screw holes on
    the metal sheet. Then bent the

    insulating plate properly to avoid being cut by the insulating
    plate during later assembly

     process.

    Make sure that the part number of

    connecting cable for the microstream

    CO2 connector fixing plate should

     be 0651-20-77166.

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    5-9

    5. Peel off the overlay on the parameter module panel and
    install the connector fixing part

    of the microstream CO2 module or the watertrap receptacle kit
    and the gas outlet of the

    Mindray CO2 module on the parameter module panel. Choose an
    appropriate overlayfrom the upgrade package and apply it on the
    parameter module panel.

    6. Install the left capacitor metal sheet with CO2 module in the
    machine.

    7. Reassemble the machine. Route the gas pipes to avoid blocking
    them.

    8. Perform the tests as described in 4.2.3 CO2 Module
    Tests.

    Gas outlet

    Mindray CO2

    watertrap kit

    Microstream CO2

    connector fixing part

    CO2

    insulating plate

    Align the edge of

    insulating plate with the

    edge of the metal plate

    Bent here

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    5.2.1 Installing Mindray Patient Monitor Software Upgrade
    Tool

    1. Find the installation program and double click it to
    start

    installation.

    2. Select installation language.

Источник

BeneHeart D3

Defibrillator/Monitor

Service Manual

Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties.

,

,

and

are the registered trademarks or

trademarks owned by Mindray in China and other countries.

Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. „

Version number

2.0

„

Release time:

March 2011

© 2010 — 2011 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

E-mail Address:

[email protected]

Tel:

+86 755 26582479, +86 755 26582888

Fax:

+86 755 26582934, +86 755 26582500

I

Preface Manual Purpose This manual provides detailed information about the assembling, dissembling, testing and troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive, in-depth explanation of the product architecture or technical implementation. Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment damage and personnel injury.

Intended Audience This manual is for biomedical engineers, authorized technicians or service representatives responsible for troubleshooting, repairing and maintaining the defibrillator/ monitors

Passwords Passwords may be required to access different modes. The passwords are listed below: „

Installation mode:

888888

„

Service mode:

332888

„

Configuration mode:

315666

II

Contents 1 Safety ………………………………………………………………………………………………………………… 1-1  1.1 Safety Information ……………………………………………………………………………………………. 1-1  1.1.1 Dangers ……………………………………………………………………………………………….. 1-2  1.1.2 Warnings ……………………………………………………………………………………………… 1-2  1.1.3 Cautions ………………………………………………………………………………………………. 1-2  1.1.4 Notes …………………………………………………………………………………………………… 1-3  1.2 Equipment Symbols ………………………………………………………………………………………….. 1-3  2 Theory of Operation ………………………………………………………………………………………….. 2-1  2.1 The Basics ……………………………………………………………………………………………………….. 2-1  2.1.1 Overview ……………………………………………………………………………………………… 2-1  2.1.2 Main Functions …………………………………………………………………………………….. 2-1  2.2 Components …………………………………………………………………………………………………….. 2-2  2.3 Main Unit ………………………………………………………………………………………………………… 2-2  2.4 Front Housing Assembly ……………………………………………………………………………………. 2-4  2.5 Paddle Tray ……………………………………………………………………………………………………… 2-5  2.6 Rear Housing Assembly …………………………………………………………………………………….. 2-5  2.6.1 Power System ……………………………………………………………………………………….. 2-5  2.6.2 Main Control System …………………………………………………………………………….. 2-6  2.6.3 Therapy System …………………………………………………………………………………….. 2-6  2.6.4 Parameter Measurement System ……………………………………………………………… 2-7  2.7 External Device Connectors ……………………………………………………………………………….. 2-8  3 Unpacking and Installation ………………………………………………………………………………… 3-1  3.1 Unpacking the Equipment ………………………………………………………………………………….. 3-1  3.2 Preparation for Installation …………………………………………………………………………………. 3-2  3.2.1 Preparation for Installation Site……………………………………………………………….. 3-2  3.2.2 Electrical Requirements …………………………………………………………………………. 3-3  3.3 Preparation for Power On…………………………………………………………………………………… 3-3  3.4 User Test …………………………………………………………………………………………………………. 3-4  4 Testing and Maintenance ……………………………………………………………………………………. 4-1  4.1 Introduction ……………………………………………………………………………………………………… 4-1  4.1.1 Test Report …………………………………………………………………………………………… 4-2  4.1.2 Recommended Frequency ………………………………………………………………………. 4-2  4.2 Preventive maintenance …………………………………………………………………………………….. 4-3  4.2.1 Visual Test ……………………………………………………………………………………………. 4-3  4.3 Power On Test ………………………………………………………………………………………………….. 4-3  4.4 User Test …………………………………………………………………………………………………………. 4-3  1

4.5 Password for Installation Mode ………………………………………………………………………….. 4-4  4.6 Module Performance Tests …………………………………………………………………………………. 4-5  4.6.1 Manual Defibrillation Test ……………………………………………………………………… 4-5  4.6.2 Pacing Test …………………………………………………………………………………………… 4-7  4.6.3 ECG Test ……………………………………………………………………………………………… 4-8  4.6.4 Resp Test ……………………………………………………………………………………………… 4-9  4.6.5 SpO2 Test ……………………………………………………………………………………………… 4-9  4.7 Electrical Safety Tests ……………………………………………………………………………………….. 4-9  4.8 Recorder Check ………………………………………………………………………………………………. 4-10  4.9 Factory Service ………………………………………………………………………………………………. 4-10  4.9.1 Password for Service Mode ………………………………………………………………….. 4-10  4.9.2 Accessing Service Mode Menu ……………………………………………………………… 4-10  4.9.3 Calibrating/Zeroing Impedance……………………………………………………………….4-11  4.9.4 Device Information ……………………………………………………………………………… 4-12  4.9.5 Checking Failure Code …………………………………………………………………………. 4-12  4.9.6 Inputting Serial Number ……………………………………………………………………….. 4-13  4.9.7 Paddle Open Circuit Display …………………………………………………………………. 4-13  5 Hardware and Software Upgrade ……………………………………………………………………….. 5-1  5.1 Hardware Upgrade ……………………………………………………………………………………………. 5-1  5.1.1 Upgrade MPM module from ECG only to ECG plus SPO2 ………………………… 5-1  5.1.2 Upgrade the Therapy Module …………………………………………………………………. 5-2  5.2 Software Upgrade through a PC …………………………………………………………………………. 5-3  5.2.1 Installing Mindray Patient Monitor Software Upgrade Tool………………………… 5-4  5.2.2 Software Upgrade Procedure ………………………………………………………………….. 5-6  5.3 Software Upgrade through a USB Memory ………………………………………………………….. 5-7  5.3.1 Precautions …………………………………………………………………………………………… 5-7  5.3.2 Software Upgrade Procedure ………………………………………………………………….. 5-7  6 Troubleshooting …………………………………………………………………………………………………. 6-1  6.1 Overview …………………………………………………………………………………………………………. 6-1  6.2 Part Replacement ……………………………………………………………………………………………… 6-1  6.3 Checking Defibrillator/Monitor Status…………………………………………………………………. 6-1  6.4 Checking Device Information …………………………………………………………………………….. 6-2  6.5 Checking Technical Alarm …………………………………………………………………………………. 6-2  6.6 Troubleshooting Guide ………………………………………………………………………………………. 6-3  6.6.1 Defibrillation Problems ………………………………………………………………………….. 6-3  6.6.2 Pacing Problems ……………………………………………………………………………………. 6-5  6.6.3 Power On/Off Problems …………………………………………………………………………. 6-5  6.6.4 Display Problems ………………………………………………………………………………….. 6-6  6.6.5 Alarm Problems…………………………………………………………………………………….. 6-7  6.6.6 Button and Knob Problems …………………………………………………………………….. 6-8  6.6.7 Recorder Problems ………………………………………………………………………………… 6-9  6.6.8 Output Interface Problems ……………………………………………………………………… 6-9  2

6.6.9 CF Card Problems ……………………………………………………………………………….. 6-10  6.6.10 Power Supply Problems ……………………………………………………………………… 6-10  6.6.11 Software Upgrade Problems ………………………………………………………………….6-11  6.7 Technical Alarm Messages ……………………………………………………………………………….. 6-12  6.8 Error Codes ……………………………………………………………………………………………………. 6-15  6.8.1 Therapy Module Error Codes ………………………………………………………………… 6-15  6.8.2 Power Module Error Codes …………………………………………………………………… 6-17  6.8.3 Main Control Error Codes …………………………………………………………………….. 6-17  6.8.4 MPM Error Codes ……………………………………………………………………………….. 6-18  7 Disassembly and Repair …………………………………………………………………………………….. 7-1  7.1 Tools Required …………………………………………………………………………………………………. 7-1  7.2 Preparations for Disassembly ……………………………………………………………………………… 7-2  7.3 Disassembling the Main Unit ……………………………………………………………………………… 7-3  7.3.1 Removing Hook Mount (if configured) ……………………………………………………. 7-3  7.3.2 Removing Paddle Tray …………………………………………………………………………… 7-4  7.3.3 Separating the Housing ………………………………………………………………………….. 7-5  7.3.4 Discharging the Capacitor ………………………………………………………………………. 7-6  7.3.5 Disassembling the MPM Module Assembly ……………………………………………… 7-7  7.3.6 Removing the Parameter Panel Assembly…………………………………………………. 7-8  7.3.7 Removing the Therapy Module……………………………………………………………….. 7-9  7.3.8 Disassembling the Power Base Assembly ……………………………………………….. 7-10  7.3.9 Disassembling the AC/DC Power Supply Board ……………………………………….7-11  7.3.10 Disconnecting the Therapy Port Cable ………………………………………………….. 7-12  7.3.11 Removing the Main Board Assembly……………………………………………………. 7-13  7.3.12 Checking Waterproof Strips before Reassembling ………………………………….. 7-14  7.4 Disassembling the Front Housing Assembly ………………………………………………………. 7-15  7.4.1 Removing the Keypad Board ………………………………………………………………… 7-16  7.4.2 Removing Display Assembly ………………………………………………………………… 7-17  7.4.3 Removing the Alarm Lamp Board and Assistant Keypad Board ………………… 7-18  7.4.4 Removing the Speaker …………………………………………………………………………. 7-18  7.4.5 Removing the Mode Select Knob ………………………………………………………….. 7-19  7.4.6 Removing the Encoder …………………………………………………………………………. 7-19  7.4.7 Checking Waterproof Material on the Front Housing ……………………………….. 7-20  7.5 Removing the Recorder …………………………………………………………………………………… 7-20  7.6 Disassembling the Recorder ……………………………………………………………………………… 7-21  8 Parts …………………………………………………………………………………………………………………. 8-1  8.1 Introduction ……………………………………………………………………………………………………… 8-1  8.2 Main Unit ………………………………………………………………………………………………………… 8-2  8.2.1 Exploded View ……………………………………………………………………………………… 8-2  8.2.2 Parts List ……………………………………………………………………………………………… 8-2  8.3 Front Housing Assembly (115-007249-00) …………………………………………………………… 8-5  8.3.1 Exploded View ……………………………………………………………………………………… 8-5  3

8.3.2 Parts List ……………………………………………………………………………………………… 8-5  8.4 Rear Cover Assembly (115-007255-00)……………………………………………………………….. 8-8  8.4.1 Exploded View ……………………………………………………………………………………… 8-8  8.4.2 Parts List ……………………………………………………………………………………………… 8-8  8.5 Power Base Assembly（115-007253-00）…………………………………………………………… 8-9  8.5.1 Exploded View ……………………………………………………………………………………… 8-9  8.5.2 Parts List ……………………………………………………………………………………………… 8-9  8.6 Main Board Assembly (115-007254-00) …………………………………………………………….. 8-10  8.6.1 Exploded View ……………………………………………………………………………………. 8-10  8.6.2 Parts List ……………………………………………………………………………………………. 8-10  8.7 Treatment Board Subassembly (115-007913-00)…………………………………………………..8-11  8.7.1 Exploded View ……………………………………………………………………………………..8-11  8.7.2 Parts List ……………………………………………………………………………………………..8-11  8.8 Parameter Panel Assembly (115-007258-00) ………………………………………………………. 8-12  8.8.1 Exploded View ……………………………………………………………………………………. 8-12  8.8.2 Parts List ……………………………………………………………………………………………. 8-12  8.9 MPM Assembly (ECG + masimo SpO2) (115-007264-00)…………………………………………….. 8-13  8.9.1 Exploded View ……………………………………………………………………………………. 8-13  8.9.2 Parts List ……………………………………………………………………………………………. 8-13  8.10 Capacitor Assembly (801-0651-00040-00) …………………………………………………….. 8-14  8.10.1 Exploded View ………………………………………………………………………………….. 8-14  8.10.2 Parts List ………………………………………………………………………………………….. 8-14  8.11 Paddle Tray Assembly ……………………………………………………………………………………. 8-15  8.11.1 Exploded View ………………………………………………………………………………….. 8-15  8.11.2 Parts List…………………………………………………………………………………………… 8-15  8.12 External Paddles Assembly (0651-30-76937) ……………………………………………………. 8-16  8.12.1 Exploded View ………………………………………………………………………………….. 8-16  8.12.2 Parts List ………………………………………………………………………………………….. 8-16  8.13 Pediatric Sternum Paddle Kit (0651-30-76920) …………………………………………………. 8-17  8.13.1 Exploded View ………………………………………………………………………………….. 8-17  8.13.2 Parts List ………………………………………………………………………………………….. 8-17  8.14 Adult Sternum Paddle Kit (0651-30-76922) ……………………………………………………… 8-18  8.14.1 Exploded View ………………………………………………………………………………….. 8-18  8.14.2 Parts List ………………………………………………………………………………………….. 8-18  8.15 Pediatric Apex Paddle Kit (0651-30-76921) ……………………………………………………… 8-19  8.15.1 Exploded View ………………………………………………………………………………….. 8-19  8.15.2 Parts List ………………………………………………………………………………………….. 8-19  8.16 Adult Apex Paddle Kit (0651-30-76923) ………………………………………………………….. 8-20  8.16.1 Exploded View ………………………………………………………………………………….. 8-20  8.16.2 Parts List ………………………………………………………………………………………….. 8-20  8.17 External Paddle Cable (0651-20-76827) …………………………………………………………… 8-21  8.17.1 Exploded View ………………………………………………………………………………….. 8-21  8.17.2 Parts List ………………………………………………………………………………………….. 8-21  8.18 Pothook Assembly (0651-30-76864) ……………………………………………………………….. 8-22  4

8.18.1 Exploded View ………………………………………………………………………………….. 8-22  8.18.2 Parts List ………………………………………………………………………………………….. 8-22  8.19 Replacement Parts …………………………………………………………………………………………. 8-22  8.19.1 Main Unit …………………………………………………………………………………………. 8-23  8.19.2 Connecting Cables …………………………………………………………………………….. 8-24  A Electrical Safety Inspection …………………………………………………………………………………… 1 

5

FOR YOUR NOTES

6

1 Safety 1.1 Safety Information

DANGER z

Indicates an imminent hazard that, if not avoided, will result in death, serious personal injury or property damage.

WARNING z

Indicates a potential hazard or unsafe maintenance practice that, if not avoided, could result in death, serious personal injury, product / property damage.

CAUTION z

Indicates a potential hazard or unsafe maintenance practice that, if not avoided, could result in minor personal injury or product/property damage

NOTE z

Provides application tips or other useful information to ensure that you can better service your product.

1-1

1.1.1 Dangers

WARNING z

Do not open the equipment cases to avoid shock hazard. All servicing and future upgrades must be carried out by the personnel trained and authorized by our company only.

1.1.2 Warnings

WARNING z

To avoid high voltage shock, disconnect the defibrillator/monitor from AC adapter and remove the batteries before disassembly.

z

The equipment must be connected to a properly installed power socket with protective earth contacts only. If the installation does not provide a protective earth conductor, do not use this socket and operate the equipment on rechargeable batteries.

z

When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.

1.1.3 Cautions

CAUTION z

Make sure that no electromagnetic radiation interferes with the performance of the equipment when preparing to carry out performance tests. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

z

Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual.

z

Protect the equipment from damage caused by drop, impact, strong vibration or other mechanical force during servicing.

1-2

1.1.4 Notes NOTE z

Refer to Operation Manual for detailed operation and other information.

1.2 Equipment Symbols Attention: Please read this manual carefully before servicing.

Equipotential terminal

Danger: High-voltage

Status indicator

Alternating current(AC)

Network connector

Battery

USB connector

ESD warning symbol for Electrostatic sensitive devices.

Type CF applied part. Defibrillator-proof protection against electric shock.

Type BF applied part. Defibrillator-proof protection against electric shock.

1-3

FOR YOUR NOTES

1-4

2 Theory of Operation 2.1 The Basics 2.1.1 Overview The BeneHeart D3 defibrillator/monitor (hereinafter called the equipment) provides four operating modes: Manual Defib, AED, Pacer, and Monitor. The equipment is for use in hospital and pre-hospital settings. It adopts the most advanced biphasic defibrillation technology and can deliver up to 360J of defibrillation energy. The equipment has an 7.0 inch color TFT LCD display with LED Backlight.

2.1.2 Main Functions The equipment has the following main functions: „

Manual Defib Mode

In Manual Defib Mode, the operator analyzes the patient’s ECG, and, if appropriate, follows this procedure: 1

Select the Manual Defib mode, adjust the energy level if necessary

2

Charge; and

3

Deliver the shock.

Defibrillation may be performed through external paddles or multifunction electrode pads. In Manual Defib Mode, you can also perform synchronized cardioversion. „

AED Mode In AED mode, the equipment automatically analyzes the patient’s ECG rhythm and indicates whether or not a shockable rhythm is detected. Voice prompts provide easy-to-follow instructions and patient information to guide you through the defibrillation process. Messages and flashing buttons are also presented to reinforce the voice prompts.

„

Pacer Mode The Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through multifunction electrode pads using a monophasic square waveform. 2-1

„

Monitor Mode In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing multiple physiological parameters and waveforms including ECG and pulse oximetry (SpO2),

2.2 Components The equipment consists of a main unit, accessories and PC software. The main unit is the core of the equipment. It provides: „

Overall system control;

„

System power supply;

„

Display;

„

Defibrillation and pacing;

„

AED ;

„

Man-mahcine interface;

„

Audible and visible alarms;

„

Multiple parameter measurements;

„

External connectors and communication; and

„

Recording, printing and data storage.

2.3 Main Unit The main unit is composed of the front housing assembly, rear housing assembly and the paddle tray assembly. External paddles are rested in the paddle tray. „

The front housing assembly mainly consists of LCD, keypad board, speaker, microphone, Mode Select knob, navigation knob, alarm lamp board, front housing and front housing sheet metal, etc.

„

The rear housing assembly consists of CPU board, therapy module, high voltage capacitors, MPM module, power management board, fan, measurement module panel, therapy port, recorder and rear housing, etc.

„

The paddle tray is for holding the external paddles.

2-2

The main unit consists of the following subsystem: „

Input subsystem: Its input includes keypad board, microphone, Mode Select knob, navigation knob, and paddle handle controls.

„

Output subsystem: includes display screen, alarm lamp board, recorder, and speaker

„

Processing and communication subsystem: includes CPU board, therapy module, MPM module and power manager board.

„

Power management subsystem: includes batteries, AC/DC board and power management board.

„

External device connection subsystem: includes USB connector, network connector, and multifunction connector for synchronous input.

System Structure

Paddle Tray assembly

Paddle tray

Front housing assembly

B12 mode select knob

W2

B14 speaker

W3

W1

50 discharge resistance

Paddle on-position detection

W9

W4

B13 navigation knob LCD & inverter

W5 Kaypad board

W6 W7

B15 microphone

Status indicator

W12

W8 Main control board

Rear housing assembly

Battery

C3

C1

Therapy module

W14

Power management board

C2

W13

W15

C4

High-voltage capacitor Therapy port Fan ECG connector

MPM Recorder

W11

RJ45

W10

USB

SPO2 connector

I/O, extended

18V/GND AC/DC module

External components Socket connector

External paddle

Connecting cable

2-3

System Signal Flow

2.4 Front Housing Assembly The front housing assembly consists of display assembly, a keypad board, a speaker, a microphone, a Mode Select knob, a navigation knob, an alarm lamp board, a front housing and front housing sheet metal, etc.

Navigation Knob You can rotate the knob clockwise or counterclockwise and then press it to confirm a selection. The knob is connected to the keypad board.

Mode Select Knob A 8-position encoder is used to select the operating mode (Monitor, Manual Defib, AED and Pacer) and power-off. The unused positions are mechanically disabled.

Speaker The speaker emits alarm tones, key-stroke tone, heart beats and PR sound. It supports the functions of PITCH TONE and the multi-level volume. The speaker is connected to the keypad board.

Microphone It provides the function of voice recording. 2-4

Alarm Lamp Board The keypad board interfaces with the alarm lamp board. The alarm lamp transmits signals to drive the green and yellow alarm lamp.

2.5 Paddle Tray The paddle tray is used to hold paddles. It has a 50 ohm test load and position detective switch inside. When the equipment runs self tests, test current will pass through the test load.

2.6 Rear Housing Assembly Rear housing assembly consists of the CPU board, the therapy module, high voltage capacitors, a MPM module, a power management board, a fan, a rear housing, a measurement module panel, and a therapy port, etc.

2.6.1 Power System

1.

AC/DC board It has AC mains as an input and outputs 18VDC.

2.

Battery Its rated voltage is 14.8V, 3000mAh.

3.

Power Management Board It is responsible for power transform and battery charge control. The system has four power supplies: 18V (when AC mains is used) or 14.8V (when batteries are used), 12V, 5V, and 3.3V. The priority of system power supply is AC mains, Battery. That is to say, when AC is not available, Battery is used. 2-5

2.6.2 Main Control System The CPU board is connected with the power management board with stacking connectors, as shown below.

The main control module mainly consists of the CPU and FPGA. CPU is used to provide least required internal storage, program memory, large capacity non-volatile storage, and the watch dog. It connects EEPROM and other peripheral ICs such as Ethernet PHY chip. FPGA performs the main functions of display and audio. Besides, it has the function of adapting interfaces from CPU to MPM module, the keypad board and the recorder. CPU controls FPGA via Flexbus.

2.6.3 Therapy System The therapy system provides the functions of defibrillation, pacing and AED analysis. Therapy module is undetachable.

The therapy module adopts DSP+MCU framework. MCU is responsible for therapy control while DSP for ECG and impedance detection, AED algorithm, monitoring algorithm, pacing algorithm, auxiliary therapy control, etc.

2-6

Recorder The recorder receives data from the CPU board and then sends the data to a thermal head for printing. The recorder front panel has a key for starting/ stopping the recorder and a green indicator which is lit when working normally. The recorder is connected to the keypad board which board provides connection for the TR6F recorder. The block diagram and functional modules of the recorder are shown as below.

Module

Description

Power Interface

Introduces DC power supply from the CPU board.

Recorder Power Module

Adjusts input voltage to run each module.

Recorder CPU

Coordinates module communication, controls and processes module status.

Keypad board Interface

Serves as the data communication channel between the keypad board and the recorder CPU.

Motor Drive Circuit

Receives control signals sent by the recorder CPU to drive the step motor.

Keypad and Indicator Interface

Sends keypad commands to CPU and receives CPU commands to control the indicator.

FPC Interface

Sends print head information to CPU and receives CPU commands to control the print head.

2.6.4 Parameter Measurement System MPM module is used to provide parameter monitoring. However, ECG monitoring can also be implemented by the therapy module. .

2-7

2.7 External Device Connectors 6

1

2

7 8

3 9

5

4

1.

Paddle Tray

2.

Hook mount

3.

Battery

4.

External power input: It connects an AC power cord or a DC/AC adapter to run the equipment respectively on the external AC mains or DC power supply.

5.

Equipotential grounding terminal: When the defibrillator/monitor and other devices are to be used together, their equipotential grounding terminals should be connected together to eliminate the potential difference between them.

6.

Handle

7.

Multifunctional connector: defibrillation synchronization input.

8.

USB connector: It connects the USB memory for data export. Data stored in the internal CF card can be transferred to the USB memory and then export to a PC via the data management software.

9.

Network connector: It is a standard RJ45 connector, through which software can be upgraded.

2-8

3 Unpacking and Installation This chapter provides information you need to install a defibrillator/monitor ready for use.

3.1 Unpacking the Equipment Open the package and take out the packing list. Check that all the articles included in the packing list are available and the quantity and specification are correct. „

All the optional parts purchased by the customer shall also be checked.

„

Notify the supplier if provided components are not correct as compared to the packing list.

„

In case of damage during transportation, keep the packing material and notify the supplier immediately.

„

Keep the packing material till new equipment is accepted.

The following pictures show the defibrillator/monitor and accessory packing.

Main unit packing

Accessory packing

3-1

3.2 Preparation for Installation 3.2.1 Preparation for Installation Site 1.

Ensure that the site meets all safety, environmental and power requirements

2.

Check that required power sockets are available.

3.

Check that a network connector is available if the defibrillator/monitor needs to be connected to network.

WARNING z

Only power cables provided with the system may be used. For reasons of safety, power (mains) extension cables or adapters shall not be used.

Environmental Requirements

WARNING z

To avoid explosion hazard, do not use the equipment in the presence of flammable anaesthetics, vapours or liquids.

CAUTION z

The environment where the defibrillator/monitor will be used should be reasonably free from vibration, dust and corrosive substances. If these conditions are not met, the accuracy of the system may be affected and damage may occur.

The environmental specification is as follows: Operating Temperature

0 to 45℃

Operating humidity

15% to 95%, (non-condensing)

Operating altitude

-381m to +4575 m (-1250 ft to 15000 ft, or 106.2kPa to 57kPa)

Storage temperature

-30 to 70℃

Storage humidity

10% to 95%, (non-condensing)

Storage altitude

-381m to +4575 m (-1250 ft to 15000 ft, or 106.2kPa to 57kPa)

3-2

3.2.2 Electrical Requirements Check cables and power cords. Make sure that: 1. All system cables, power cords and power plugs are not damaged, and pins are not loose. Otherwise, remove it from use. 2.

The insulation of patient cables and leadwires is not damaged, and connectors are not loose.

WARNING z

Only power sockets with protective grounding can be used.

The electrical specification is as follows: Line voltage: 100 to 240VAC Current: 1.8 to 0.8 A Frequency: 50/60Hz

3.3 Preparation for Power On Before connecting the power cord to the defibrillator/monitor’s power input, check that „

The mains voltage meets the requirement.

„

3-wire power cord is used. The power socket should be 3-wire also. This ensures that the defibrillator/monitor is properly grounded. Do not use 2-wire power cord or socket.

„

The equipotential grounding terminals should be connected together when the defibrillator/monitor and other devices are to be used together.

„

The defibrillator/monitor is not placed under the infusion bag or placed where their might be liquid spillage. This protects the defibrillator/monitor from liquid ingress.

3-3

3.4 User Test A user test shall be performed after the defibrillator/monitor is installed. Follow this procedure: 1.

Connect AC mains or install the battery.

2.

Connect the external paddles. If pads are used, connect the test load.

3.

Select the Main Menu button on the equipment’s front panel and select [User Test >>]. Select all test items and press [Start] to perform user test.

NOTE z

Install the battery and properly place the external paddles in the paddle tray or connect the pads cable and 50 Ω test load. Otherwise the User Test will fail.

Refer to BeneHeart D3 Operating Manual for the detailed information on user test.

3-4

4 Testing and Maintenance 4.1 Introduction To ensure the equipment always functions normally, qualified service personnel should perform regular inspection, maintenance and test. This chapter provides a checklist of the testing procedures for the equipment with recommended test equipment and frequency. The service personnel should perform the testing and maintenance procedures as required and use appropriate test equipment. The testing procedures provided in this chapter are intended to verify that the equipment meets the performance specifications. If the equipment or a module fails to perform as specified in any test, repairs or replacement must be done to correct the problem. If the problem persists, contact our Customer Service Department.

CAUTION z

All tests should be performed by qualified service personnel only.

z

Care should be taken to change the settings in [Installation Mode] and [Service Mode] menus to avoid loss of data.

z

Before testing, service personnel should acquaint themselves with the test tools and make sure that test tools and cables are applicable.

z

When testing monitoring parameters, move the Mode Select knob to Monitor to access the Monitor Mode.

z

When performing therapy function tests, move the Mode Select knob to corresponding mode.

4-1

4.1.1 Test Report After completing the tests, service personnel are required to record test results in this table and report them to Mindray Customer Service Department. See the Test Report at the end of this chapter.

4.1.2 Recommended Frequency Test item

After repair

Function suspected

6 months

Visual inspection

×

Power-on Test

×

User test

×

Recorder check

×

×

×

×

Performance test

×

×

Module calibration

×

×

Resp

Performance test

×

×

×

SpO2

Performance test

×

×

×

Manual defibrillation tests

12 months

24 months

Charge/ discharge Energy disarming Synchronous defibrillation

Pacing test ECG

Electrical safety tests as per IEC60601-1

×

Earth leakage current Patient leakage current

×

×

Patient auxiliary current

4-2

4.2 Preventive maintenance 4.2.1 Visual Test Inspect the equipment for obvious signs of damage. The test is passed if the equipment has no obvious signs of damage. Follow these guidelines when inspecting the equipment: „

Carefully inspect the housing, the display screen and the buttons for physical damage.

„

Inspect accessories for signs of damage.

„

Inspect all external connections for loose connectors, bent pins or frayed cables.

„

Inspect all connectors on the equipment for loose connectors or bent pins.

„

Make sure that safety labels and data plates on the equipment are clearly legible.

4.3 Power On Test This test is to verify that the defibrillator/ monitor can power on normally. The test is passed if the defibrillator/ monitor starts up by following this procedure: 1.

Place the external paddles on paddle tray, insert the battery in the battery compartment, and then connect the equipment with AC mains. In this case, both the AC indicator and battery indicator shall light.

2.

Turn the Mode Select knob to Monitor. Check that the equipment passes the self test and is turned on properly.

3.

Check the display of technical alarm area, prompt area and battery status indicator on the upper right corner of the main screen to judge whether the equipment runs normally.

4.4 User Test Follow this procedure to perform user test: 1.

If you use external paddles, place them on the paddle tray; if you use a pads cable, connect it to the test load.

2.

Insert the battery into the equipment. Connect the AC mains if no battery is available.

3.

Select the Main Menu button on the equipment’s front panel. In the Main Menu, select [User Test>>]. Then a prompt “Enter user test?” pops up. Select “Yes” to enter the User Test screen.

4.

Check the test items you want to perform and select [Start] to start user test

The test results indicate the condition of the system. If any item fails, the Red Cross status indicator flashes. 4-3

If you cannot pass User Test or the message “Connect paddles cable, and place paddles in paddle tray” is shown when paddle cable is connected and paddles are placed in paddle tray, check paddles status. Select the Monitor mode. Press and hold the [Event] hardkey, and then press the [Lead Select] hardkey on the front panel, the following screen appears.

Observe the reading of “Lead Stat”: „

0 x 382: Paddles are properly placed in paddle tray.

„

0 x 182: The travel switch indicating paddle status may fail, but impedance is correct.

„

0 x 102 :Paddles are not properly placed in paddle tray and the impedance value is not correct.

4.5 Password for Installation Mode Accessing installation mode is password protected. The required password is set to 888888 before the equipment leaves the factory.

4-4

4.6 Module Performance Tests 4.6.1 Manual Defibrillation Test Test tools: „

Defibrillator/pacer analyzer

Charge/Discharge 1.

Remove the batteries and connect the equipment with AC mains. Turn the Mode Select knob to Manual Defib.

2.

Connect the external paddles to the equipment and place the paddles on the defibrillator/pacer analyzer.

3.

Enter the Configuration-Main screen. From the Record Setup menu set [Shock Event] to [On] so that shock events can be recorded automatically if happened.

4.

Set the analyzer to Energy Measurement mode. In this case, the energy value should be displayed as 0 or blank.

5.

Select the energy level to 1J.

6.

Charge/discharge the equipment to verify the energies measured by the analyzer meet the following accuracy: Selected Energy (J)

Measured Value (J)

1

0 to 3

100

85 to 115

360

306 to 414

7． Set the energy to 100J and 360J respectively. Repeat step 6. 8.

Disconnect the equipment from the AC mains. Run the equipment on fully charged battery. Move the Mode Select knob to Manual Defib. Repeat steps 5 to 7.

9.

Use multifunctional electrode pads. Repeat steps 5 to 7.

10. Verify that the equipment records the shock events automatically and correctly.

4-5

Energy Disarming 1.

Run the equipment on fully charged battery. Move the Mode Select knob to Manual Defib.

2.

Connect the external paddles to the equipment and place the paddles on the defibrillator/pacer analyzer.

3.

Set the analyzer to Energy Measurement mode. In this case, the energy value should be displayed as 0 or blank.

4.

Select the energy level to 360J.

5.

Charge the equipment.

6.

Verify that the charge tone is issued during charging.

7.

Press the “Disarm” soft key to discharge the energy internally.

8.

Verify that a prompt “Charge Removed” appears and the charge done tone stops.

9.

Verify that the value measured by the analyzer is 0J or blank.

10. Enter the Configuration-Main menu, select [Manual Therapy Setup] and set [Time to Auto Disarm] to [60s]. 11. Exit “Configuration Management”. The equipment restarts automatically. 12. Set the analyzer to Energy Measurement mode. In this case, the energy value should be displayed as 0 or blank. 13. Select the energy level to 360J. 14. Charge the equipment. Count time after charging is completed.. Verify that the prompt “Shock Removed” appears on the equipment and the energy measured by the analyzer is 0J or blank after 60 seconds. 15. Use multifunctional electrode pads. Repeat steps 3 to 14.

Synchronous Defibrillation 1.

Connect the external paddles and ECG cable to the equipment. Place the paddles ECG electrodes on the defibrillator/pacer analyzer.

2.

Set the analyzer to Measurement Mode and output normal sinus rhythms, e.g. amplitude value 1mV and HR 60bpm.

3.

Enter Configuration Management. In the [Manual Therapy Setup] menu, set [Sync After Shock] to [On].

4.

Adjust the energy setting of the equipment to be 10J.

5.

Press the [Sync On] soft key to start synchronous defibrillation. If Remote Sync is switched on, press the [Sync On] soft key and select [Local] to start synchronous defibrillation

6.

Select [Pads] or [Paddles] as the ECG source and begin charging. 4-6

7.

When charging finishes, press and hold the “Shock” button to deliver a shock.

8.

Verify that synchronous discharge succeeds and the delivery energy measured by the analyzer is 10J±2J.

9.

Verify that the delay time of synchronous defibrillation measured by the analyzer is less than 60ms.

10. Verify that the synchronous discharge mark appears on the R wave. 11. Verify that the prompt messages are correct during testing. 12. Select lead II as ECG source and perform charging. Repeat steps 7 to 11. 13. Use multifunctional electrode pads. Repeat steps 2 to 12.

4.6.2 Pacing Test Test tools: „

Defibrillator/pacer analyzer

1.

Run the equipment on fully charged battery. Move the Mode Select knob to Pacer. Set [Pacer Mode] to [Fixed].

2.

Connect the pads cable to the equipment and properly place the pads on the defibrillator/pacer analyzer.

3.

Set the analyzer to Pacing Measurement mode. Use test load of 50Ω.

4.

On the equipment, set [Pacer rate] to [70ppm] and [Pacer Output] to [30mA].

5.

Press the [Start Pacing] soft key. Verify that the pacer rate measured by the analyzer is 70 ppm±1ppm and the pacer output measured is 30 mA±5mA.

6.

Press the “Stop Pacing” soft key, and then set [Pacer rate] to [170ppm] and [Pacer Output] to [200mA].

7.

Press the [Start Pacing] soft key. Verify that the pacer rate measured by the analyzer is 170 ppm±2ppm, and the measured current is 200 mA±10mA.

4-7

4.6.3 ECG Test Performance Test Test tools „

ECG simulator

1.

Connect the simulator to the equipment’s ECG connector with ECG leadwires.

2.

Set the patient simulator as follows: ECG sinus rhythm, HR=80 bpm with the amplitude as 1mV.

3.

Check the ECG waves are displayed correctly without noise and the displayed HR value is within 80 ± 1 bpm.

4.

Disconnect the simulator from the equipment’s ECG connector. Verify that ECG Lead Off alarm behaves correctly.

5.

On the equipment, set [Paced] to [Yes], the simulator is configured as pace signals. Verify that pace signals are detected and pace pulse marks are displayed.

6.

Connect the simulator to the equipment’s therapy module with pads.

7.

Set the patient simulator as follows: ECG sinus rhythm, HR=80 bpm with the amplitude as 1mV.

8.

Check the ECG waves are displayed correctly without noise and the displayed HR value is within 80 ± 1 bpm.

9.

Disconnect the simulator from the equipment’s therapy module. Verify that ECG Lead Off alarm behaves correctly.

10. On the equipment, set [Paced] to [Yes], the simulator is configured as pace signals. Verify that pace signals are detected and pace pulse marks are displayed.

ECG Calibration Tool required: „

Vernier caliper

1.

Connect the simulator to the equipment’s ECG connector with ECG leadwires.

2.

Select the ECG parameter area to enter the [ECG Setup] menu.

3.

Select [Others>>]→ [Calibrate]. A waveform signals appear on the screen and the message [ECG Calibrating] is displayed in the prompt information area in the lower left corner of the screen.

4.

Compare the amplitude of the waveform with the wave scale. The difference should be within 5%. If needed, you can also print out the waveform and the wave scale.

4-8

5.

After ECG calibration is completed, select [Stop Calibrating].

6.

Connect the simulator to the equipment’s therapy module with pads.

7.

Repeat steps 3–5.

4.6.4 Resp Test Test tools „

Resp Patient simulator

1.

Connect the patient simulator to the ECG connector on the module.

2.

On the defibrillator/monitor, select the Resp widow to enter the Resp Setup menu. Set [Lead] to [II].

3.

Configure the simulator as follows: set Lead to II, base impedance line to 1500 Ω; delta impedance to 0.5 Ω, and respiration rate to 40 rpm.

4.

Check that respiration waveform is not distorted and the displayed Resp value does not exceed 40±2 rpm.

4.6.5 SpO2 Test Test tool „

Patient simulator.

1.

Connect the patient simulator to the equipment’s SpO2 connector.

2.

Select the model and manufacturer of the SpO2 module under test. Configure the parameter as SpO2 96% and PR 80 bmp.

3.

The displayed SpO2 and PR values should be within the ranges listed below SpO2 (%)

PR (bmp)

Mindray

96% ±2%

80±3

Masimo

96% ±2%

80±3

Nellcor

MAX-A, MAX-N, MAX-P, MAX-I

96% ±2%

DS-100A, OXI-A/N, OXI-P/I

96% ±3%

4.7 Electrical Safety Tests See A Electrical Safety Inspection..

4-9

80±3

4.8 Recorder Check Tools required: „

None.

1.

Print ECG waveforms. The recorder should print correctly and the printout should be clear.

2.

Simulate some recorder problems, such as out of paper, paper jam, etc. the defibrillator/ monitor should give corresponding prompt messages. After the problem is removed, the recorder should be able to work correctly.

3.

Switch automatic alarm recording for each parameter ON and then set each parameter’s limit outside set alarm limits. Corresponding alarm recordings should be triggered when parameter alarms occur.

4.9 Factory Service 4.9.1 Password for Service Mode Accessing service mode is password protected. The required password is set to 332888 before the equipment leaves the factory.

4.9.2 Accessing Service Mode Menu To access the factory service menu, Press the Main menu button on the equipment’s front panel. Select [Others>>]→ [Maintenance>>]→ [Service Mode>>]→ enter the required passwords. The Service Mode-Main menu is shown below.

4-10

4.9.3 Calibrating/Zeroing Impedance Normally impedance calibration and zeroing is unnecessary. However, you can perform impedance checking after replacing the therapy module. 1.

If not pre-connected, connect the pads cable to the equipment.

2.

Connect a test load of 300 ohms to the pads cable.

3.

Start the equipment and select the Monitor mode. Press and hold the [Event] hardkey, and then press the [Lead Select] hardkey on the front panel, the following screen appears.

4.

Verify that the reading of “RT Imped” is between 3000±450.

NOTE z

If 300 ohms test load is not available, you can use a 50 ohms test load to perform impedance checking. In this case, Verify that the reading of “RT Imped” is between 500±75.

If the reading of “RT Imped” is not correct, perform impedance calibration/zeroing. 1.

Press the Main menu button on the equipment’s front panel. Select [Others>>]→ [Maintenance>>]→ [Service Mode>>]→ enter the required passwords→[Calibrate/Zero Impedance] to enter the Calibrate/Zero Impedance screen.

2.

Connect a test load of 0 ohm to the pads cable; then select “Zero”. A message “Zero Completed” shall be shown. If the message “Zero Failed” is displayed, check the connection of pads cable.

3.

Connect a test load of 100 ohms to the pads cable; then select “Calibrate”. A message “Calibration Completed” shall be shown. If the message “Calibration Failed” is displayed, check the connection of pads cable.

Replace the therapy module if impedance calibration/zeroing fails.

4-11

4.9.4 Device Information Press the Main menu button on the equipment’s front panel. Select [Others>>]→ [Maintenance>>]→ [Service Mode>>]→ enter the required passwords→ [Device Information]. In the Device Information list, you can view the device information such as software version, system status, and etc, as shown below.

In the Device Information screen, you can select [Export] to export error codes and shock delivery data to a USB flash memory.

4.9.5 Checking Failure Code Press the Main Menu button on the equipment’s front panel. Select [Others>>]→ [Maintenance>>]→ [Service Mode>>]→ enter the required passwords→ [Failure Code] to check error codes. This helps the service personnel to identify failures.

Refer to 6.8 Error Codes for the description of each error code.

4-12

4.9.6 Inputting Serial Number Press the Main Menu button on the equipment’s front panel. Select [Others>>]→ [Maintenance>>]→ [Service Mode>>]→ enter the required passwords→ [Input Serial Number] to input the equipment’s serial number. After inputting the serial number, you can view it by accessing Installation Mode and select [Version].

4.9.7 Paddle Open Circuit Display This [Paddle Open Circuit Display] switch is for testing only. In normal operation, it should be set to [Off]].

4-13

Test Report Customer name Customer address Servicing person Servicing company Equipment under test (EUT) Model of EUT SN of EUT Hardware version Software version Test equipment

Model/No.

Effective date of calibration

4-14

Test items

Test records

Visual inspection The case, display screen, buttons, knob, modules, power cord, and accessories have no obvious signs of damage. The external connecting cables are not frayed and the connector pins are not loose or bent. The external connectors are not loose or their pins are not bent. The safety labels and data plate are clearly legible. Power-on test The power-on test is passed. The power indicator and alarm system work correctly and the equipment start up properly. Performance test Manual Defibrillation Test When the equipment runs on AC mains and external paddles are used, the equipment can be properly charged and discharged; the energy delivered meets the requirement for accuracy, and the shock information is correctly recorded. When the equipment runs on fully charged battery and external paddles are used, the equipment can be properly charged and discharged; the energy delivered meets the requirement for accuracy, and the shock information is correctly recorded. When the equipment runs on AC mains and multifunctional electrode pads are used, the equipment can be properly charged and discharged; the energy delivered meets the requirement for accuracy, and the shock information is correctly recorded. When the equipment runs on fully charged battery and multifunctional electrode pads are used, the equipment can be properly charged and discharged; the energy delivered meets the requirement for accuracy, and the shock information is correctly recorded.

4-15

Test results (Pass/Fail)

Performance test Manual Defibrillation Test When external paddles are used, the charge tone is correctly issued when the equipment is being charged. The prompt «Charged Removed» is shown on the screen and the charge done tone stops when the Disarm hotkey is pressed. The equipment does not discharge externally. When [Time to Auto Disarm] is set to [60s], the prompt «Charged Removed» is shown on the screen and the charge done tone stops after 60 seconds at the completion of charging. The equipment does not discharge externally. When pads are used, the charge tone is correctly issued when the equipment is being charged. The prompt «Charged Removed» is shown on the screen and the charge done tone stops when the Disarm hotkey is pressed. The equipment does not discharge externally. When [Time to Auto Disarm] is set to [60s], the prompt «Charged Removed» is shown on the screen and the charge done tone stops after 60 seconds at the completion of charging. The equipment does not discharge externally. When external paddles are used for synchronous defibrillation and ECG source is paddles and lead II respectively, the prompt is correct and a Sync mark appears above each R wave. The delivered energy measured is 10J±2J and the synchronous shock is delivered within 60 ms of the peak of the R-wave. When pads are used for synchronous defibrillation and ECG source is paddles and lead II respectively, the prompt is correct and a Sync mark appears above each R wave. The delivered energy measured is 10J±2J and the synchronous shock is delivered within 60 ms of the peak of the R-wave. Pacing Test When set [Pacer rate] to [70ppm] and [Pacer Output] to [30mA], the pacer rate measured by the analyzer is 70 ppm±1ppm and the pacer output measured is 30 mA±5mA. When set [Pacer rate] to [170ppm] and [Pacer Output] to [200mA], the pacer rate measured by the analyzer is 170 ppm±2ppm, and the measured current is 200 mA±10mA.

4-16

Performance test ECG performance test ECG waves are displayed correctly without noise and the HR value is within 80±1 bpm. ECG Lead Off alarm behaves correctly. Paced signals are detected and pace pulse marks are displayed when [Paced] is set to [Yes] The difference between the amplitude of the ECG calibration square wave and that of the wave scale is not greater than 5%. Resp test The Resp wave is not distorted and the Resp value is within 40±2 rpm. SpO2 test The displayed SpO2 and PR values should be within the specified ranges. Electrical safety tests Refer to Appendix A Electrical Safety Inspection. Recorder check The recorder can print ECG waves correctly and the printout is clear. Set the recorder to some problems such as out of paper, paper jam, etc. the equipment gives corresponding prompt messages. After the problem is removed, the recorder is able to work correctly. Automatic alarm recording for each parameter functions correctly when parameter alarms occur.

Tested by: _________________________

Date: ________________________

4-17

FOR YOUR NOTES

4-18

5 Hardware and Software Upgrade 5.1 Hardware Upgrade 5.1.1 Upgrade MPM module from ECG only to ECG plus SPO2 You can upgrade MPM module from ECG only to any of the following configuration: „

ECG plus Mindray SpO2: 801-0652-00036-00 MPM upgrade kit

„

ECG plus Masimo SpO2: 801-0652-00037-00 MPM upgrade kit

„

ECG plus Nellcor SpO2: 801-0652-00038-00 MPM upgrade kit

The upgrade procedure is as follows: 1.

Remove the MPM module assembly and parameter panel assembly as described in. 7.3.5 Disassembling the MPM Module Assembly and 7.3.6 Removing the Parameter Panel Assembly.

2.

Replace the old measurement module panel and MPM module with those in the MPM upgrade kit.

3.

Reassemble the equipment.

If the upgrade MPM module is equipped with Masimo SpO2, you need to stick a Masimo label at the lower left corner of the front housing and a No Implied License label below the measurement module panel, as indicated in the following pictures.

No Implied License label

Masimo label

5-1

If the upgraded MPM module is equipped with Nellcor SpO2, you need to stick a Nellcor label at the lower left corner of the front housing, as indicated in the following pictures.

Nellcor label After upgrade the MPM module, perform the tests described in 4.6.3 ECG Test, 4.6.4 Resp Test, 4.6.5 SpO2 Test, 4.7Electrical Safety Tests, and 4.8 Recorder Check.

5.1.2 Upgrade the Therapy Module You can use 801-0652-00039-00 pacer function upgrade kit to upgrade the therapy module so that equipment has pacing function. After upgrading the therapy module, choose Mode label (with pacing function) with the language you need. Follow this procedure to upgrade the therapy module: 1.

Remove therapy module as described in 7.3.7 Removing the Therapy Module. Be noted that you need not to remove the parameter panel assembly and MPM module assembly.

2.

Take off the Mode Select knob. Peel off the Mode label, see the picture below.

3.

Replace the old therapy module using the one with pacing function in the upgrade kit.

4.

Replace the old Mode Select knob and Mode label using new ones in the upgrade kit.

5.

Reassemble the equipment.

5-2

Mode Select knob

Mode label

After upgrade the therapy module, perform the tests described in 4.6.1 Manual Defibrillation Test, 4.6.2 Pacing Test, and 4.7 Electrical Safety Tests.

5.2 Software Upgrade through a PC You can upgrade system software and module software using Mindray Patient Monitor Software Upgrade Tool. You can also view software upgrade log. Mindray Patient Monitor Software Upgrade Tool can directly run on a PC. By connecting the defibrillator/monitor to a PC via a crossover network cable, you can upgrade the following software: „

Bootstrap

„

System software

„

Language library

„

BMP files (including screen icons, start-up screens, standby screens)

„

General configurations (including passwords, company logo)

„

System functional configuration

„

FPGA program

„

Power module software

„

MPM module software and therapy module software

5-3

5.2.1 Installing Mindray Patient Monitor Software Upgrade Tool 1.

Find the installation program installation.

and double click it to start

2.

Select installation language.

3.

Click [Ok] and the following screen appears. Click [Next] to go to the next step.

4.

Enter User Name, Company Name and Serial Number.

5-4

5.

Specify the destination folder for installing this program. Then select [Next].

7.

Select Program Folder. Then select [Next].

8.

Click [Finish] to complete installation.

5-5

5.2.2 Software Upgrade Procedure 1.

Connect the defibrillator/monitor to be upgraded with a PC.

2.

Set IP address to 77.77.XX.XX and subnet mask to 255.255.255.0.

3.

Run Mindray Patient Monitor Software Upgrade Tool on the PC and set Machine to BneneHeart.

4.

On the Mindray Patient Monitor Software Upgrade Tool screen, select [Select Package] and select packages you want to upgrade. Then select [Start].

5.

Simultaneously hold the [Record] key and [Menu] key on the defibrillator/monitor’s front panel, and then turn on the equipment.

After software upgrade is finished, turn off the equipment, and then disconnect AC mains and remove the battery. If you do not disconnect the power supply after software upgrade, the status indicator will flash and the beeper will sound. For the details of software upgrade, refer to help and instructions for use of Mindray Patient Monitor Software Upgrade Tool.

CAUTION z

Disconnect the equipment from the patient and make sure the important data are saved before upgrade.

z

Do not shut down or power off the equipment when upgrading the boot program. Otherwise, it may cause the equipment to break down.

z

Program upgrade should be performed by qualified service personnel only.

z

Crossover network cable shall be used if a PC is connected for equipment upgrade.

NOTE z

After upgrading the boot program, re-upgrade the system program and other programs to ensure compatibility.

z

Make sure the version of the upgrade package is the one that you desired. If you want to obtain the latest upgrade package, contact Mindray Customer Service Department.

5-6

5.3 Software Upgrade through a USB Memory You can upgrade the defibrillator/monitor’s system software and module software using a USB memory. All software that can be upgraded through a PC can be upgraded through a USB memory.

5.3.1 Precautions 1.

Software upgrade through USB memory is only applied to defibrillator/monitors with BIOS version 2.0 or later.

2.

If you are going to upgrade the software through a PC, do not plug a USB memory to the defibrillator/monitor’s USB connector.

3.

Up to 15 upgrade files can be placed to the “UPGRADE_0651” folder. If more files are placed, only the first 15 can be displayed and chosen.

4.

Only one upgrade file can be chosen at a time. Repeat steps 3 to 5 as described in 5.3.2 Software Upgrade Procedure to upgrade files one by one.

5.

The name of files in directory “UPGRADE_0651” should be in English. Otherwise the file name will be unreadable.

6.

Both .pkg and .mpkg files can be upgraded. Bootstrap cannot be included in the .mpkg files.

7.

The bootstrap of main control should be upgrade separately. That is to say, it cannot be included in the upgrade package.

5.3.2 Software Upgrade Procedure 1.

Create a folder named “UPGRADE_0651” in the root directory of the USB memory.

2.

Copy the file “updatecontrol.bin” and upgrade files to directory “UPGRADE_0651”.

3.

Turn off the defibrillator/monitor. Plug the USB memory to the equipment’s USB connector.

4.

Simultaneously hold the [Record] key and [Menu] key on the defibrillator/monitor’s front panel, and then turn on the equipment.

5.

Follow the on-screen instructions to upgrade the software. Choose a file to be upgraded by rotating the navigation knob. Press down the navigation knob to confirm the selection. You have to choose the upgrade file within 120 s. If not, software upgrade fails. The system will upgrade automatically when the upgrade file is selected and confirmed.

5-7

FOR YOUR NOTES

5-8

6 Troubleshooting 6.1 Overview In this chapter, the defibrillator/monitor problems are listed along with possible causes and recommended corrective actions. Refer to the tables to check the defibrillator/monitor, identify and eliminate the problems. The problems we list here are frequently arisen difficulties and the actions we recommend can correct most problems, but not all of them. For more information on troubleshooting, contact our Customer Service Department.

6.2 Part Replacement Printed circuit boards (PCBs), major parts and components in the defibrillator/monitor are replaceable. Once you isolate a defective PCB, follow the instructions in 0 Disassembly and Repair to replace the PCB with a known good one and check that the trouble disappears or the defibrillator/monitor passes all performance tests. If the trouble remains, replace the PCB with the original suspicious PCB and continue troubleshooting as directed in this chapter. To obtain information on replacement parts or order them, refer to 8 Parts.

6.3 Checking Defibrillator/Monitor Status Some troubleshooting tasks may require you to identify the hardware version and status of your defibrillator/ monitor. To check equipment status, 1.

Select [Main Menu] →[Review >>]→[Event Review >>]. Then you can view the information on system start time, self check, etc.

2.

You can also view the information on the defibrillator/monitor’s current status by pressing the Menu key on the equipment’s front panel, and then selecting [Others>>]→[Maintenance >>]→[Service Mode>>]→ enter the required password →[Device Information>>].

6-1

6.4 Checking Device Information Some troubleshooting may involve software compatibility. Thus it requires you to know your defibrillator/monitor configuration and software version. For detailed information on version compatibility, please contact our Customer Service Department. To identify your software version, press the Menu key on the equipment’s front panel, and then select [Others>>]→[Maintenance>>]→[Installation Mode>>]→enter the required password →[Version]. In the Version screen, you can view system software version and module software version. You can also press the Menu key on the equipment’s front panel, and then select [Others>>]→[Maintenance>>]→[Service Mode>>]→ enter the required password →[Device Information>>] to check system software version, module software version, and device status .

6.5 Checking Technical Alarm Before troubleshooting the defibrillator/monitor, check for technical alarm message. If an alarm message is presented, eliminate the technical alarm first. For detailed information on technical alarm message, possible cause and corrective action, refer to the defibrillator/monitor’s Operation Manual.

6-2

6.6 Troubleshooting Guide 6.6.1 Defibrillation Problems Symptom

The equipment does not charge by pressing the Charge button on the front panel.

The equipment cannot be charged by pressing the Charge button on the external paddles.

Possible Cause

Corrective Action

Keypad board failure.

1. Connect external paddles. Press the “Charge” button on the Apex paddle to start charging. If the “Charge” button on the paddles works, it indicates the keypad board fails. 2. Replace the keypad board.

The Charge button fails to be pressed down effectively due to the damaged or dislocated silica gel keypad.

Disassemble the keypad board to replace or reshuffle the keypad.

Paddles not connected properly.

Reconnect the paddles.

Paddles failure.

1. Isolate the problem by connecting pads to perform charging/discharging. 2. If the paddles are failed, replace them.

Failure of therapy module.

Replace the therapy module.

Failure of connection wire to the therapy module.

Replace the connection wire.

Battery failure.

Replace the battery or connect the equipment with external power supply.

Power management board failure.

Replace the power management board.

Therapy module failed.

Replace the therapy module.

A shock cannot be delivered by pressing the Shock button on the equipment’s front panel in Manual Defib Mode or AED Mode.

Keypad board failure.

1. Locate the problem by connecting paddles to perform charging / discharging.

The Charge Button fails to be pressed down effectively due to the failure or dislocated silica gel keypad.

Disassemble the keypad board to replace or reshuffle the keypad.

A shock cannot be

Paddles not connected properly.

Reconnect the paddles.

The equipment is charged too slowly

2. If the keypad board is defective, replace it.

6-3

Symptom

Possible Cause

Corrective Action

delivered by pressing the Shock button on the paddles.

Paddles failure.

1. Locate the problem by connecting pads to perform charging/discharging. If normal discharge can be performed, it indicates the paddles are defective. 2. Replace the paddles.

Failure of therapy module.

Replace the therapy module.

Connection wire to the therapy module broken.

Replace the connection wire.

The message. “Disarming Failed” is displayed.

Failure of therapy module.

Replace the therapy module.

The equipment can be properly charged, but the energy is disarmed automatically at the completion of charging or when the equipment is being discharged.

Too high or too low patient impedance detected.

Failure of therapy module.

Replace the therapy module.

Defibrillation malfunction.

Defibrillation hardware circuit defective.

Replace the therapy module.

Keypad board failure.

1. Locate the problem by connecting paddles to perform energy setting.

Energy Select buttons on the equipment front panel do not work.

Energy Select buttons on the paddles do not work

1. Pads/paddles are detached from the patient. 2. Pads/paddles failure.

Ensure good connection between the patient and pads/paddles. If the problem persists, replace Pads, paddles or Pads cable.

3. Pads cable failure.

2. If the keypad board is defective, replace it. The Energy Select Buttons fail to be pressed down due to the damaged or dislocated silica gel keypad.

Disassemble the keypad board to replace or reshuffle the keypad.

Paddles not connected properly.

Reconnect the paddles.

Paddles failure.

Replace the paddles.

Failure of therapy module.

Replace the therapy module.

Connection wires to the therapy module broken.

Replace the connection wires.

6-4

6.6.2 Pacing Problems Symptom

Possible Cause

Corrective Action

Does not deliver correct pacing current.

Failure of the therapy module

Replace the therapy module.

Does not deliver correct pacing rate.

Failure of the therapy module.

Replace the therapy module.

Pacer Equip Malfunction

Pacer hardware failure.

Replace the therapy module.

6.6.3 Power On/Off Problems Symptom

Possible Cause

Corrective Action

The defibrillator/monitor fails to start. AC LED or battery LED does not light

AC mains not connected or battery too low.

Check that AC mains is properly connected or battery capacity is sufficient.

Power supply protection.

Refer to 6.6.10 Power Supply Problems.

Cables defective or poorly connected.

1. Check that the cables between the power switch and the keypad board, the keypad board and the power management board and between the power module and the power management board are correctly connected. 2. Check that wires and connectors are not defective.

Power switch or keypad board failure

Replace the power switch or keypad board.

AC/DC board defective

Replace the AC/DC board.

Power management board failure

Replace the power management board.

6-5

6.6.4 Display Problems Symptom

Possible Cause

Corrective Action

The LCD screen is blank, but the defibrillator/monitor works properly.

Connection cable defective or poorly connected.

1. Check that wires between the display and the keypad board, and between the keypad board and the power management board are correctly connected. 2. Check that the cables and connectors are not defective.

Secondary display does not function.

LCD Display failure

Replace the display.

Keypad board failure

Replace the keypad board.

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

Cable failure

1. Check that the wires between the display and the defibrillator/monitor are correctly connected. 2. Check that the cables and connectors are not defective.

Secondary display displays snows or flashing specks

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

Connection cable defective or poorly connected.

1. Check that the wires between the display and the defibrillator/ monitor are correctly connected. 2. Check that the cables and connectors are not defective.

Images overlapped or distorted

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

FPGA failure

Update or upgrade FPGA.

Connection cable defective or poorly connected.

1. Check that the wire between the display and keypad board is correctly connected. 2. Check that the cables and connectors are not defective.

6-6

Symptom

Possible Cause

Corrective Action

The colour of images deviates from the standard configuration.

Connection cable defective or poorly connected.

1. Check that wires between the display and the keypad board and between the keypad board and the power management board are correctly connected. 2. Check that the cables and connectors are not defective.

Display failure

Replace the display.

Keypad board failure

Replace the keypad board.

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

6.6.5 Alarm Problems Symptom

Possible Cause

Corrective Action

The alarm lamp is not light or extinguished but alarm sound is issued

Connection cable defective or poorly connected.

1. Check that wire between alarm LED board and keypad board are properly connected.

No alarm sound is issued but alarm lamp is lit

2. Check that connection wires and connectors are not defective. Alarm LED board failure

Replace the alarm LED board.

Keypad board failure

Replace the keypad board.

Power management board failure.

Replace the power management board.

Audio alarm disabled

Check that alarm tone volume is set to a value other than zero by pressing the Menu key on the equipment’s front panel, and then selecting [Alarm Setup >>].

Connection cable defective or poorly connected.

1. Check that the wire between the speaker and keypad board is properly connected. 2. Check that connection wires and connectors are not defective.

FPGA audio logic ERROR

Upgrade the audio logic part of the FPGA program.

Speaker failure

Replace the speaker.

Power management board failure.

Replace the power management board.

6-7

6.6.6 Button and Knob Problems Symptom

Possible Cause

Corrective Action

Buttons do not respond.

Connection cable defective or poorly connected.

1. .Check that the wire between the keypad and the keypad board is properly connected. 2. Check that that the wire between the keypad board and the power management board is properly connected. 3. Check if the connection wires and connectors are defective.

Mode Select knob does not respond.

Keypad board failure

Replace the keypad board.

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

Connection cable defective or poorly connected.

1. Check that wires between the knob to keypad board, and between the keypad board and the power management board are properly connected. 2. Check that connecting wires and connectors are not defective.

Navigation knob does not respond.

Knob failure

Replace Mode Select knob.

Keypad board failure

Replace the keypad board.

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

Connection cable defective or poorly connected.

1. Check that wires between the knob to keypad board, and between the keypad board and the power management board are properly connected. 2. Check that connection wires and connectors are not defective.

Knob failure.

Replace the navigation knob.

Keypad board failure

Replace the keypad board.

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

6-8

6.6.7 Recorder Problems Symptom

Possible Cause

Corrective Action

No printout

Connection cable defective or poorly connected.

1. Check the wire between the recorder and the keypad board is connected properly.

Recorder power supply failure

Check if the power module outputs 5 V DC and 12V DC correctly.

Recorder failure

Replace the recorder.

Paper roll not properly installed

Stop the recorder and re-install the paper roll.

Print head dirty

1. Check the thermal print head and the paper roller for foreign matter.

Poor print quality or paper not feeding properly

2. Check that connection wires and connectors are not defective.

2. lean the thermal print head with an appropriate clean solution.

Blank printout

Recorder failure

Replace recorder.

Paper-roll installed reversely.

Reload paper-roll.

Recorder failure

Replace the recorder.

6.6.8 Output Interface Problems Symptom

Possible Cause

Corrective Action

Sync input failure

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

CPU board failure.

Replace the CPU board.

Power management board failure.

Replace the power management board.

USB Device does not function (provided that the peripheral devices are good)

6-9

6.6.9 CF Card Problems Symptom

Possible Cause

Corrective Action

CF card malfunctions

Wrong CF card or limited memory space

Use only INNODISK-manufactured CF storage cards. Those with minimum 1GB memory space are recommended.

CF card defective

Insert a known good CF card into the defibrillator/monitor. If it works normally, the original CF card fails.

CF card slot failure

Replace the CPU board.

CPU board failure.

Replace the CPU board.

CF card failure

Format the CF card.

6.6.10 Power Supply Problems Symptom

Possible Cause

Corrective Action

Battery failure

Battery damaged.

Replace battery.

Battery interface failure.

1. Check batteries are installed properly. 2. Check if the battery interface is defective. 3. If the battery interface is defective, replace the power management board.

Batteries can not be fully charged.

Power management board failure.

Replace the power management board.

Battery damaged.

Replace batteries.

Battery interface failure.

1. Check batteries are installed properly. 2. Check if the battery interface is defective. 3. If the battery interface is defective, replace the power management board.

Battery cannot be charged

Power management board failure.

Replace the power management board.

Battery failure.

Replace battery and recharge the replacement battery. If the replacement battery can be recharged, the original one fails.

Cable defective or poorly connected

1. Check batteries are installed properly. 2. Check if the battery interface is defective. 3. If the battery interface is defective, replace the power management board.

Power management board failure.

Replace the power management board.

6-10

Symptom

Possible Cause

Corrective Action

No +3.3 V A output

1. Power supply failure 2. Power management board failure.

1. Turn off the defibrillator/monitor then restart it. 2. If the problem remains, disconnect the AC mains for 5 s and reconnect it, then restart the defibrillator/ monitor. 3. If the problem still remains, replace the power management board.

No +3.3 V B output Not +5.0 V output No +12 V output

NOTE z

When the power module has a failure, it may cause problems to other components, e.g. the defibrillator/monitor suddenly breaks down during start-up, as the power module may have a power supply protection. In this case, troubleshoot the power module per the procedure described in the table above.

z

Components of the main unit, SMR and parameter modules are powered by the power module. In the event that a component malfunctions, check if the operating voltage is correct. Refer to chapter 2 Theory of Operation for the operating voltage and measurement points of each component.

6.6.11 Software Upgrade Problems Symptom

Possible Cause

Corrective Action

Boot file upgrade fails

Power failure or unintended power off during boot file upgrade

Return the CPU board to factory for repair.

Program upgrade fails

Incorrect network connection

1. Check that the network cable is properly connected and is not too long (shorter than 50m). 2. Make sure that the network cable is of the right type. Network cable with crossed wires inside is used for LAN upgrade and those with parallel wires inside for WAN.

Wrong upgrade package

Upgrade package shall be .pkg files. Select package according to system requirement.

Incorrect IP address configuration

Configure a fixed IP address in range C as specified for the defibrillator/monitor. We recommend not to upgrade a program when the defibrillator/monitor is connected to a network with multiple PCs. 6-11

6.7 Technical Alarm Messages Measurement

Alarm Message

Cause and solution

XX

XX SelfTest Err

An error occurred to the XX module, or there is a problem with the communications between the module and the host. Restart the equipment.

XX Init Err XX Comm Err XX Comm Stop

ECG

XX Overrange

The measured XX value is not within the specified range for XX measurement. Check input signal and equipment setting.

ECG Lead Off

The ECG electrode has become detached from the patient or the lead wire has become disconnected from the trunk cable. Check the connection of the electrodes and leadwires.

ECG YY Lead Off (YY represents the leadwires V, LL, LA, and RA, as per AHA standard, or C, F, L and R as per IEC standard.)

SpO2

Pads/Paddles off

The pads/paddles have been detached from the patient or the therapy cable is loose. Check that the pads/paddles and therapy cable are properly connected.

ECG Noise

The ECG signal is noisy. Check for any possible sources of signal noise form the area around the cable and electrode, and check the patient for excessive motion.

ECG Signal Invalid

ECG amplitude is so low that ECG signal is undetectable. Check for any possible source of interference from the area around the cable and electrode; check the patient’s condition.

SpO2 Sensor Off

The SpO2 sensor has become detached from the patient or the module, or there is a fault with the SpO2 sensor, or an unspecified SpO2 sensor has been used. Check the sensor application site and the sensor type, and make sure the sensor is not damaged. Reconnect the sensor or use a new sensor.

SpO2 Sensor Fault SpO2 No Sensor SpO2 Unknow Sensor SpO2 Sensor Incompatible SpO2 Too Much Light

There is too much light on the SpO2 sensor. Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light. 6-12

Measurement

Alarm Message

Cause and solution

SpO2 Low Signal

The SpO2 signal is too low or too weak. Check the patient’s condition and change the sensor application site. If the error persists, replace the sensor.

SpO2 Weak Signal SpO2 Weak Pulse SpO2 Low Perf SpO2 Interference

The SpO2 signal has been interfered. Check for any possible sources of signal noise form the area around the sensor, and check the patient for excessive motion.

SpO2 Non-Pulsatile

Main control system

Power board

SpO2 Board Fault

There is a problem with the SpO2 measurement board. Replace the SpO2 module.

No Fan

Make sure that the fan is connected.

No Speaker

Make sure that the speaker is connected.

No Data Card

Make sure that the CF card is in place or format the CF card.

Power Board Comm Err

An error occurred to the power board, or there is a problem with the communications between the power board and the host. Restart the equipment.

Keyboard Comm Err

An error occurred to the keypad board, or there is a problem with the communications between the keypad board and the host. Restart the equipment.

Therapy Module Comm Err

An error occurred to the therapy module, or there is a problem with the communications between the therapy module and the host. Restart the equipment. If the problem persists, replace the therapy module.

Main Control Selftest Err

The main control voltage is abnormal. Replace the main control board.

RT Clock Need Reset

Reset system time.

RT Clock Err

An error occurred to the RTC chip, or the button cell is depleted. Replace corresponding part.

Data Card Err

There is a problem with the data card. Check or replace the data card if necessary.

Power System Selftest Err

An error occurred to the system power supply. Restart the equipment.

Power Board Volt Err Low Battery

Change battery or connect the equipment to the AC power source to charge the batteries. 6-13

Measurement

Therapy module

Monitoring module

Recorder

Alarm Message

Cause and solution

Battery Err

There is a problem with the batteries. Check the batteries for damage; verify that correct batteries are used. Replace the batteries if necessary.

Battery Depleted! System will shut shown imminently. Connect to AC Mains or Replace Battery.

Connect the equipment to AC mains.

Battery Aged

Replace the battery.

Battery failed charging

Battery failure or power board hardware failure. Replace the battery. If the problem persists, replace the power board.

Therapy Equip selftest Err

An error occurred during therapy module self test. Restart the equipment or replace the therapy module.

Defib Malfunction

The defibrillation function fails or both the defibrillation and pacing functions fail. Restart the equipment and test defibrillation function. If the problem persists, replace the therapy module.

Pacer Malfunction!

The pacing function fails. Restart the equipment and test pacer function. If the problem persists, replace the therapy module.

Disarming Failed

There is a problem with the therapy module disarming circuit. Replace the therapy module.

Last User Test Failed

Run a succesful user test.

Last Auto Test Failed

Run a succesful user test again.

Mornitor Module Selftest Err

An error occurred during MPM module power-on self test. Replace the MPM module.

Mornitor Module Reset Err

MPM module reset abnormally. In this case, the MPM module restores to default configuration. You can ignore this problem.

Mornitor Module Voltage Err

The voltage of MPM module is abnormal. Replace the MPM module.

Recorder Init Err

Restart the equipment.

Recordhead Overheated

The recorder has been working for a prolonged time. Clear the recording tasks and resume the recording till the recorder’s print head cools down.

6-14

Measurement

Alarm Message

Cause and solution

Recorder Overcurrent

Re-load the recorder paper.

Others

Config Err

Check if the configuration is correct, or restore the factory configuration.

Pacer

Pads cable Off

Check that pads cable is properly connected.

Pads Off

Check that pads are properly connected.

ECG Lead Off

Check that ECG leadwires are properly connected.

Pacer Stopped Abnormally

Check paddles. Check that pads well contact with patient’s skin. Make sure pads are properly applied, and then start pacing again.

6.8 Error Codes 6.8.1 Therapy Module Error Codes Error codes

Error description

00

No error

01

MCU register selftest error

02

MCU RAM selftest error

03

MCU FLASH selftest error

04

MCU watchdog selftest error

05

MCU ADC selftest error

06

DSP register selftest error

07

DSP RAM selftest error

08

DSP FLASH selftest error

09

DSP watchdog selftest error

10

ECG hardware selftest error

11

Power selftest error

12

MCU abnormal reset

13

DSP abnormal reset

14

Computation selftest error

15 to 20

Reserved

21

Impedance circuit error

22

Impedance zeroing failed

23

Impedance calibration failed

6-15

Error codes

Error description

24

Impedance measurement is interfered

25

Great measurement difference between two impedance measuring methods

26 to 30

Reserved

31

Charging is not complete after 25 s

32

Charging is not complete after 30 s

33

Over-charging

34

Charging trend error

35 to 40

Reserved

41

Self-discharging failure

42

IGBT failure

43

Defibrillation relay failure

44

Abnormal discharging current

45 to 70

Reserved

71

Abnormal pacer power

72

Pacer relay failure

73

Pacer frequency error

74

Abnormal pacer current

75

Pacer DA error

76

Pacer voltage error

77

Pacer overcurrent protection point high

78

Pacer overcurrent protection failure

79 to 90

Reserved

91

Comm is interfered (data error)

92 to 99

Reserved

6-16

6.8.2 Power Module Error Codes Error codes

Error contents

100/register value

Battery permanent failure

101/register value

Battery recoverable failure

102

Battery comm error

103

Abnormal battery voltage (not enough voltage)

104

Battery charging failure

105

Power-on selftest error

106

Main control failure (comm handshake overtime)

107 to 199

Reserved

6.8.3 Main Control Error Codes Error codes

Error contents

200

Fan not connected

201

Speaker not connected

202

Storage card does not exist

203

Power board comm error

204

Therapy module comm error

205/register value

Main control system power-on selftest error

206

Realtime clock error

207

Storage card read/write error

208

Button board comm error

209

Machine type recognition error

210

Recorder failure (not including thermal printing head overheat)

211 to 299

Reserved

6-17

6.8.4 MPM Error Codes Error codes

Error contents

300

DSP CPU failure

301

DSP SDRAM failure

302

DSP FLASH failure

303

DSP watchdog failure

304

7024 CPU failure

305

7024 RAM failure

306

7024 ROM failure

307

7024 A/D failure

308

7024 ECG failure

309

7024 TEMP failure

310

7024 watchdog failure

311

2131 CPU failure

312

2131 RAM failure

313

2131 ROM failure

314

2131 A/D failure

315

2131 watchdog failure

316

ECG channel 1 failure

317

ECG channel 2 failure

318

ECG channel 3 failure

319

ECG channel 4 failure

320

ECG channel 5 failure

321

ECG channel 6 failure

322

ECG channel 7 failure

323

ECG channel 8 failure

324

Mindray SpO2 board CPU failure

325

Mindray SpO2 board RAM failure

326

Mindray SpO2 board ROM failure

327

Mindray SpO2 board A/D failure

328

Mindray SpO2 board watchdog failure

329

NIBP selftest failure (2)

330

NIBP system error (15)

331 to 399

For future use

6-18

7 Disassembly and Repair 7.1 Tools Required To disassemble and replace the parts and components, the following tools may be required: „

Phillips screwdrivers

„

Tweezers

„

Sharp nose pliers

„

7# socket wrench

„

Adjustable spanner

7-1

7.2 Preparations for Disassembly Before disassembling the equipment, finish the following preparations: „

Stop patient monitoring and therapy, turn off the equipment and disconnect all the accessories and peripheral devices.

„

Disconnect the AC power source and remove the battery.

„

To avoid high voltage hazard, strictly follow the procedure as defined in section 7.3.4 Discharging the Capacitor for disassembling.

WARNING z

Before disassembling the equipment, be sure to eliminate the static charges first. When disassembling the parts labeled with static-sensitive symbols, make sure you are wearing electrostatic discharge protection such as antistatic wristband or gloves to avoid damaging the equipment.

z

Properly connect and route the cables and wires when reassembling the equipment to avoid short circuit.

z

Select appropriate screws to assemble the equipment. If unfit screws are tightened by force, the equipment may be damaged and the screws or part may fall off during use, causing unpredictable equipment damage or human injury.

z

Follow correct sequence to disassembly the equipment. Otherwise, the equipment may be damaged permanently.

z

Disconnect all the cables before disassembling any parts. Be careful not to damage any cables or connectors.

z

Place removed screws and disassembled parts properly, preventing them from being lost or contaminated.

z

Place the screws and parts from the same module together to facilitate reassembling.

z

To reassemble the equipment, first assemble the assemblies, and then the main unit. Carefully route the cables.

z

Make sure that the waterproof material is properly applied during reassembling.

7-2

7.3 Disassembling the Main Unit WARNING z

To disassemble the equipment, first remove the external assemblies, such as the hook mount (if configured), paddle tray assembly, and front housing assembly in turn, and then the internal assemblies and parts.

z

The power supply assembly and recorder can be removed without removing any other assemblies.

z

To disassemble the equipment, place the equipment on a work surface free from foreign material, avoiding damaging the antiglare screen, LCD and the knob. Be careful not to break the two cotters on the front ends of rear housing.

z

All the operations should be performed by qualified service personnel only. Make sure to put on the insulating gloves during service operations.

z

Before remove the therapy board, you must use the dicharge fixture to discharge the capacitor first. If you do not have a discharge fixture, disconnect AC mains and remove batteries, wait for at least 2 hours before removing the capacitor.

7.3.1 Removing Hook Mount (if configured) 1.

Stand the equipment on the work surface with the back of the equipment facing to you. Loose and remove the two M3×16 Philips screws; take off the φ3 flat washers and spring washers.

2. Pull out the hooks. 7-3

7.3.2 Removing Paddle Tray 1.

Stand the equipment on the work surface with the back of the equipment facing to you. Tweeze the five plastic plugs filling the screw holes.

2.

Loose and unscrew the five M3×8 Philips screws. Remove the paddle tray.

Paddle tray assembly

3.

Unscrew the two PT3×10 Philips tapping screws and two M3×6 Philips combined screws. Disconnect and remove the test load cable.

`

7-4

7.3.3 Separating the Housing 1.

Lay the equipment on a padded work surface with the display facing down and the bottom of the equipment nearest to you. Be careful not to damage the LCD and controls. Loose and remove the seven M3×10 Philips screws.

2.

Stand the equipment on the work surface. Carefully separate the front housing assembly and the rear housing assembly. Disconnect the cable between the main board and keypad board, and then remove the front housing.

Cable between main board and keypad board

NOTE z

When reassemble the equipment, be sure to check if front housing water proof strip is correctly placed.

7-5

7.3.4 Discharging the Capacitor 1.

Use the high-voltage discharge fixture (0651-TF11) to discharge the capacitor by hooking the high-voltage ground end (TP1) with the black probe of the fixture, and hooking the high-voltage socket (TP3) with the fixture’s red probe. Wait till all the indicating lamps on the fixture turns off. The capacitor is not completely discharged if the indicator remains on.

2.

Set the multimeter to DC 1000V. Measure the discharge resistance and check if the reading of the multimeter is lower than 30V. If yes, you can safely disassemble the equipment now.

7-6

7.3.5 Disassembling the MPM Module Assembly 1.

Lay the equipment on the work surface, remove the two M3×8 Philips screws, and then pull the MPM module upward to remove the MPM module.

MPM module

2.

Pull out the right end of the FPC plug holder, and then the left end. Remove the FPC plug holder from the MPM module.

Right end of FPC plug holder

FPC plug holder

3.

Disconnect the ECG flexible cable and SpO2 flexible cable from the MPM module. The SpO2 flexible cable is connected to the leftmost end of the J5 MPM module socket.

SPO2 socket

ECG socket

7-7

7.3.6 Removing the Parameter Panel Assembly 1.

Pull the recorder fixing latch upward to remove the recorder, and then disconnect the recorder cable from the power management board.

Recorder cable

Recorder fixing latch

2.

Push the parameter panel to the left and take it out.

Measurement module board

7-8

7.3.7 Removing the Therapy Module

WARNING z

Before removing the therapy board, you should discharge the capacitor first, refer to 7.3.4 Discharging the Capacitor for the instructions.

1.

Disconnect the on-position switch cable, the capacitor cable, and the therapy port cable from the therapy board.

Capacitor cable

Therapy port cable

On-position switch cable

2.

Remove the six M4×8 combined screws securing the therapy board with a screwdriver, and then take out the therapy board.

7-9

7.3.8 Disassembling the Power Base Assembly 1.

Lay the equipment on a padded work surface with the display side facing down and the bottom of the equipment nearest to you. Loose and remove the three M3×8 Philips screws and pull out the power base assembly.

2. Disconnect the cable between the power management board and AC/DC power supply module. Remove the power base assembly.

Cable between the power management board and AC/DC module

7-10

7.3.9 Disassembling the AC/DC Power Supply Board 1.

Loose and remove the two M3×8 Philips screws and one M3×8 combined screw. Disconnect the AC input socket connecting cable, and then remove the AC/DC board.

M3×8 combined screw

AC socket connecting cable 2.

Loose and remove the three M3×8 Philips screws to separate the AC/DC power supply board and power management board metal sheet. Remove the AC/DC power supply board.

7-11

7.3.10 Disconnecting the Therapy Port Cable 1.

First take out the therapy board insulating plate, and then remove the magnetic ring on the therapy port cable.

Magnetic ring on therapy port cable

2.

Pull the therapy port latch upward, and then disconnect the therapy port cable.

Therapy port latch

7-12

7.3.11 Removing the Main Board Assembly 1.

Disconnect the cable between the main board and keypad board.

Cable between main board and keypad board

2.

Unscrew the seven M3×8 Philips screws, and then remove the M4×20 bolt using 7# socket wrench. M4×20 bolt

If you only need to remove the main board and CF data card, unscrew the four M3×6 Philips screws securing the main board.

7-13

3. Pull out the cable connecting the power management board and AC/DC power supply board from the rear housing. Remove the main board assembly.

Cable connecting the power management board and AC/DC power supply board 4. Remove the two M3×6 Philips screws. Take out the capacitor bracket and then the capacitor. Capacitor bracket

7.3.12 Checking Waterproof Strips before Reassembling Before reassembling the equipment, make sure that the waterproof material on the rear housing assembly and power base assembly is stuck to the proper places. 1. Check that the waterproof strip is properly stuck on battery socket.

Waterproof strip for battery socket

7-14

2. Check that the white waterproof strip is adhered to the proper place.

White waterproof strip (about 40cm long)

The joint of the waterproof strip should be located at the bottom and the gap should be less then 1mm. 3. Check that the waterproof strip on the power base is adhered to the proper place. White waterproof strip (about 38 cm long) is stuck in the power base slot

7.4 Disassembling the Front Housing Assembly NOTE z

To disassemble the equipment, place the equipment on a work surface free from foreign material, avoiding damaging the antiglare screen, LCD and the knobs.

z

Make sure the speaker is not damaged after repairing any other front housing assembly. Verify that the speaker works properly by powering on the equipment and testing the speaker.

z

Clear the LCD before reassembling it.

7-15

7.4.1 Removing the Keypad Board 1. Disconnect all the cables from the keypad board, namely the mode select knob cable, encoder cable, speaker cable, LCD cable, assistant keypad board cable, and the cable between the inverter and the keypad board.

Mode select knob cable

Assistant keypad cable

Cable between inverter and keypad board

Encoder cable

Speaker cable

LCD cable

2. Remove the two M3×8 Philips screws securing the grounding plate, and the six M3×8 Philips screws from the keypad board. Take out the kayped board.

7-16

7.4.2 Removing Display Assembly 1. Remove the four M3×8 Philips screws securing the keypad board. If the grounding plate is not removed, you need to unscrew the two M3×8 Philips screws securing the grounding plate. Remove the LCD bracket before removing the display assembly.

LCD bracket

2. Remove the hot-melt adhesive applied on the LCD cable, and then disconnect the LCD cable. Take out the LCD from the silicone jacket.

Remove the hot-melt adhesive applied on the LCD cable

Display assembly

7-17

7.4.3 Removing the Alarm Lamp Board and Assistant Keypad Board To remove the alarm lamp board and assistant keypad board, remove the LCD bracket first, see 7.4.2 Removing Display Assembly. 1.

Disconnect the alarm lamp cable.

2. Remove the two M3×8 Philips screws, and then take out the alarm lamp board and assitant keypad board. Alarm lamp board

Alarm lamp cable Assistant keypad board

7.4.4 Removing the Speaker 1. Remove the two M3×8 Philips screws. Take off the speaker bracket, and then remove the speaker.

Speaker bracket After repairing any part of the front housing assembly, verify that the speaker is not damaged by powering on the equipment and testing the speaker. 7-18

7.4.5 Removing the Mode Select Knob Pull the switch off its shaft. Loosen and remove the nut and washer using a socket wrench or sharp nose pliers. Disconnect the cable from the knob.

Mode select knob cable

Washer and nut with the knob

Mode select knob

When assemble the Mode Select knob, check that it is aligned with the labelling. Adjust the knob using sharp nose pliers if necessary.

7.4.6 Removing the Encoder 1. Remove the navigation knob. 2. Disconnect the encoder cable. 3. Pull the encoder off its shaft. Loosen and remove the nut and washer using a socket wrench. Disconnect the encoder cable.

Encoder

Washer and nut with the encoder

7-19

navigation knob

7.4.7 Checking Waterproof Material on the Front Housing Before reassembling the equipment, make sure that the waterproof material on the front housing are placed to the proper places. Check that the white waterproof strip is properly adhered to the slot around the edge of the front housing.

White waterproof strip (98 cm long)

The joint of the waterproof strip located at the bottom, the gap less then 1mm

7.5 Removing the Recorder 1.

Remove the two M3×6 Philips screws. Pull the recorder out of the recorder well.

2.

Disconnect the cable from the recorder, and then remove the recorder.

7-20

7.6 Disassembling the Recorder 1.

Loosen the two snaps and remove the recorder drive board.

Snaps

Cut this cable if it is there

Recorder drive board

2.

Loosen and remove the two PT2×6 crosshead tapping screws. Disconnect the flexible cable and the connection cable between the recorder drive board and recorder keypad board. Remove the thermal print head and recorder drive board.

Thermal print head

PT2×6 crosshead tapping screw

Cable between the recorder drive board and recorder keypad board

Flexible cable

7-21

3.

Remove the two PT2×6 crosshead tapping screws, and then remove the keypad board.

Keypad board

PT2×6 crosshead tapping screw

7-22

8 Parts 8.1 Introduction This chapter contains the equipment’s exploded views and parts lists. It helps the engineer to identify the parts during disassembling the equipment and replacing the parts. This manual is based on the maximum configuration. Your equipment may not have some parts and the quantity of the screws, stacking sleeves, and etc may be different with those included in the parts lists. The figure below shows the hardware architecture of the equipment’s main unit. Main Unit Front housing assembly

Rear housing assembly

Paddle tray assembly

Other assemblies

Front housing

Rear housing

Paddle tray

External paddle set

Anti-glare screen

Power management board

Handle kit

Lithium battery

LCD

Main board assembly

Paddle sheet metal

Hook mount

Therapy mode select knob

Therapy module

Paddle holding reed

Conductive gel container

Silicone therapy buttons

Defibrillator capacitor

Self test resistance

Monitor mode select knob

MPM module

Silicon pad

Silicone monitor buttons

Parameter panel assembly

Keyboard

Parameter interface FPC

Alarm lamp board

Recorder

Waveform keyboard

Therapy port assembly

Status indicator shade

Capacitor fixing sheet

Alarm lamp shade

On-position detection switch kit

Speaker

Power base assembly

Microphone

Hook hole cover Discharge board spring 8-1

8.2 Main Unit 8.2.1 Exploded View

8.2.2 Parts List SN

P/N

Description

Qty

1

801-0652-00030-00

Rear cover assembly

1

2

/

Therapy waterproof pad

1

3

009-001325-00

Defibrillator socket cable

1

4

009-001107-00

Cable, power management to AC/DC power

1

5

801-0652-00025-00

Power base assembly

1

6

/

Philips screw, M3×16

1

7

/

Spring washerGB93.3

1

8

/

Flat washer GB97.13

1

8-2

SN

P/N

Description

Qty

/

Pothook assembly

1 (Optional)

/

Hook hole cover

1 (Standard)

10

/

Philips screw, M3×8

15

11

801-0652-00014-00

Electrode base assembly

1

12

/

Stopple

5

13

/

Discharge plate spring

2

14

801-0652-00027-00

On-position detection switch kit

1

15

043-000987-00

Lock-recorder

1

801-0652-00015-00

Parameter Panel assembly (ECG), (FRU)

801-0652-00016-00

Parameter Panel SPO2), (FRU)

assembly

(ECG+mindray

801-0652-00017-00

Parameter Panel SPO2), (FRU)

assembly,

(ECG+masimo

801-0652-00018-00

Parameter Panel SPO2), (FRU)

assembly,

(ECG+nellcor

17

801-6800-00080-00

TR6F Recorder

1

18

/

Philips screw, M3×6

2

19

801-0652-00028-00

0652 Main board assembly (FRU)

1

20

/

Philips screw, M3×6

9

801-0652-00020-00

MPM assembly, (ECG), (FRU)

801-0652-00021-00

MPM assembly, (ECG+mindray SPO2), (FRU)

801-0652-00022-00

MPM assembly, (ECG+masimo SPO2), (FRU)

801-0652-00023-00

MPM assembly, (ECG+nellcor SPO2), (FRU)

22

/

Philips screw, M3×8

2

23

/

Bracket-FPC

1

24

/

Capacitor pad 1

1

25

0651-20-76870

Cable, main board to button board

1

26

/

Front panel assembly

1

27

/

Capacitor bracket

1

28

/

Capacitor protective layer

1

29

801-0651-00040-00

Capacitor maintain package (FRU)

1

30

/

M4×8

6

31

/

Capacitor pad 2

1

32

/

Stainless steel screw, M4×20+7-8

1

801-0652-00033-00

Therapy board subassembly(with Pace), (FRU)

801-0652-00034-00

Therapy board subassembly(without pace), (FRU)

34

/

Therapy board insulation sheet

1

35

/

Therapy interface plug

1

047-003793-00

Alarm overlay (D3/Chinese)

047-003794-00

Alarm overlay (D3/English)

1 (As configured)

9

16

21

33

36

8-3

1 (As configured)

1 (As configured)

1 (As configured)

SN

37

P/N

Description

Qty

047-004565-00

Alarm label (D3/Polish)

047-004566-00

Alarm label (D3/German)

047-004567-00

Alarm label (D3/Russian)

047-004568-00

Alarm label (D3/French)

047-004569-00

Alarm label (D3/Dutch)

047-004570-00

Alarm label (D3/Czech)

047-004571-00

Alarm label (D3/Portuguese Brazil)

047-004572-00

Alarm label (D3/Turkish)

047-004573-00

Alarm label (D3/Spanish)

047-004574-00

Alarm label (D3/Hungarian)

047-004575-00

Alarm label (D3/Italian)

047-003795-00

Operation overlay (D3/Chinese)

047-003796-00

Operation overlay (D3/English)

047-004576-00

Operation overlay (D3/Polish)

047-004577-00

Operation overlay (D3/German)

047-004578-00

Operation overlay (D3/Russian)

047-004579-00

Operation overlay (D3/French)

047-004580-00

Operation overlay (D3/Dutch)

047-004581-00

Operation overlay (D3/Czech)

047-004582-00

Operation overlay (D3/Portuguese Brazil)

047-004583-00

Operation overlay (D3/Turkish)

047-004584-00

Operation overlay (D3/Spanish)

047-004585-00

Operation overlay (D3/Hungarian)

047-004586-00

Operation overlay (D3/Italian)

8-4

1 (As configured)

8.3 Front Housing Assembly (115-007249-00) 8.3.1 Exploded View

8.3.2 Parts List SN 1

2

P/N

Description

Qty

801-0652-00011-00

Encoder (no pace), (FRU)

801-0652-00012-00

Encoder (with pace), (FRU)

1 (As configured)

047-003788-00

Mode overlay (D3/Chinese)

047-003789-00

Mode overlay (D3/English)

043-001384-00

Mode label (D3/No pacer/Chinese)

043-001385-00

Mode label (D3/No pacer/English)

047-004598-00

Mode Label (D3/Polish)

047-004599-00

Mode Label (D3/No Pacer/Polish)

047-004601-00

Mode Label (D3/No Pacer/German)

047-004602-00

Mode Label (D3/Russian) 8-5

1 (As configured)

SN

P/N

Description

047-004603-00

Mode Label (D3/No Pacer/Russian)

047-004604-00

Mode Label (D3/French)

047-004605-00

Mode Label (D3/No Pacer/French)

047-004606-00

Mode Label (D3/Dutch)

047-004607-00

Mode Label (D3/No Pacer/Dutch)

047-004608-00

Mode Label (D3/Czech)

047-004609-00

Mode Label (D3/No Pacer/Czech)

047-004610-00

Mode Label (D3/Port. Brazil)

047-004611-00

Mode Label (D3/No Pacer/Port. Brazil)

047-004612-00

Mode Label (D3/Tuikish)

047-004613-00

Mode Label (D3/No Pacer/Turkish)

047-004614-00

Mode Label (D3/Spanish)

047-004615-00

Mode Label (D3/No Pacer/Spanish)

047-004616-00

Mode Label (D3/Hungarian)

047-004617-00

Mode Label (D3/No Pacer/Hungarian)

047-004618-00

Mode Label (D3/Italian)

047-004619-00

Mode Label (D3/No Pacer/Italian)

043-000986-00

Alarm lamp

1

801-0652-00009-00

Front panel service kit (D3/No label)

801-0652-00010-00

Front panel service kit (D2/No label)

1 (As configured)

5

/

Cushion-alarm lamp

1

6

801-0652-00004-00

0652 Alarm light board PCBA (FRU)

1

7

0651-21-76884

Mode switch cable

1

8

049-000215-00

Defib. Key (D3)

1

9

801-0652-00003-00

0652 Keyboard PCBA (FRU)

1

10

049-000170-00

Status indicator

4

11

/

Cushion-speaker

1

12

801-0652-00006-00

Speaker (FRU)

1

13

/

Bracket-speaker

1

14

049-000218-00

Screen key 2 (D3)

1

15

801-0652-00005-00

0652 Assistant keyboard PCBA (FRU)

1

16

049-000217-00

Screen key 1 (D3)

1

17

/

Cushion-monitor knob

1

18

0010-30-43089

Encoder, PM8, 8E, 9E

1

19

049-000216-00

Monitor Key (D3)

1

20

/

Speaker buffer

1

21

009-001102-00

Assistant keyboard cable

1

22

/

Jack-lock

1

23

/

Grounding plate

1

24

9200-21-10460

Encoder cable

1

25

043-001114-00

Knob-monitor

1

3 4

Qty

8-6

SN

P/N

Description

Qty

26

/

Sheet status

1

047-003790-00

Monitor key overlay (D3/Chinese)

047-003791-00

Monitor key overlay (D3/English)

047-004587-00

Monitor Key Label (D3/Polish)

047-004588-00

Monitor Key Label (D3/German)

047-004589-00

Monitor Key Label (D3/Russian)

047-004590-00

Monitor Key Label (D3/French)

047-004591-00

Monitor Key Label (D3/Dutch)

047-004592-00

Monitor Key Label (D3/Czech)

047-004593-00

Monitor Key Label(D3/Portuguese Brazil)

047-004594-00

Monitor Key Label (D3/Tuikish)

047-004595-00

Monitor Key Label (D3/Spanish)

047-004596-00

Monitor Key Label (D3/Hungarian)

047-004597-00

Monitor Key Label (D3/Italian)

28

/

Anti-glare screen

1

29

/

Conductive sponge

2

801-0652-00007-00

AU LCD service kit (FRU)

801-0652-00008-00

CHI MEI LCD service kit (FRU)

1 (As configured)

/

Wrap-AU screen

/

Wrap-CHI MEI screen

801-0652-00001-00

(AU) LCD cable (FRU)

801-0652-00002-00

LCD cable (FRU)

/

AU LCD mounting plate

/

CHI MEI LCD mounting plate

1 (As configured)

/

Philips screw, M3×8

1

009-001104-00

(AU) inverter cable

009-001322-00

(CHI MEI) inverter cable

1 (As configured)

27

30 31 32 33 34 35

8-7

1 (As configured)

1 (As configured) 1 (As configured)

8.4 Rear Cover Assembly (115-007255-00) 8.4.1 Exploded View

8.4.2 Parts List SN

P/N

Description

Qty

1

/

Rear cover

1

2

/

Philips screw, M3×6

1

3

/

Bracket-pothook

1

4

/

Waterproof Silicone strip

1

5

/

Rubber feet (0651)

2

6

/

Strip-waterproof

1

7

/

Sheet metal fixture for top cover

2

8-8

8.5 Power Base Assembly（115-007253-00） 8.5.1 Exploded View

8.5.2 Parts List SN

P/N

Description

Qty

1

801-0652-00026-00

Power base service kit (FRU)

1

2

/

Silicone tube waterproof strip

1

3

/

Philips screw, M3×8

6

4

/

Pad, AC heat conduction 2

1

5

/

Pad, AC heat conduction 1

1

6

801-0652-00024-00

0652 AC/DC Power Supply PCBA (FRU)

1

7

/

Insulator

1

8

/

Base support

1

9

/

M3×8 combination bolt

2

10

/

Spring, EMI

1

11

/

Bracket earth

1

12

/

Serrated lock washers external teeth

1

13

/

Nuts M6

2

14

/

Flat washer

1

15

/

Waterproof strip for AC power socket

1

16

/

Bottom housing waterproof strip

1

8-9

SN

P/N

Description

Qty

17

/

Rubber feet (0651)

2

18

/

Grounding terminal

1

19

/

AC inlet protection hook

1

20

/

Power input overlay (D3)

1

21

/

AC power socket & connecting cable

1

8.6 Main Board Assembly (115-007254-00) 8.6.1 Exploded View

8.6.2 Parts List SN

P/N

Description

Qty

1

801-0652-00029-00

0652 Power management board PCBA (FRU)

1

2

/

Holder-plug

1

3

/

Stud screw, M3×7+8-6

4

4

0000-10-11158

Storage Card, CF, 1 GB

1

5

/

Philips screw, M3×6

4

6

801-0652-00040-00

Main board (FRU)

1

7

/

PCB fixed bosses

1

8

/

Stainless steel nut, GB6170 M4

1

9

/

Stainless steel nut, GB6170 M3

4

10

/

Output interface seal pad

1

8-10

8.7 Treatment Board Subassembly (115-007913-00) 8.7.1 Exploded View

8.7.2 Parts List SN

P/N

Description

Qty

801-0652-00031-00

Therapy Board (no pace) (FRU)

801-0652-00032-00

Therapy Board (with pace) (FRU)

1 (As configured)

2

/

Fan bracket insulator

1

3

/

Fan bracket

1

4

024-000132-00

FAN 12V 6.5CFM 22dB 35*35*10mm

1

5

/

Screw, Pan head, Philips

4

6

/

Cross pan head screw with washer

2

1

8-11

8.8 Parameter Panel Assembly (115-007258-00) 8.8.1 Exploded View

8.8.2 Parts List SN

P/N

Description

Qty

1

/

Label parameter

1

2

/

Frame-recorder

1

3

/

ECG connector

1

4

/

SPO2 connector (mindray)

1

5

/

Cushion-parameter socket

2

6

/

0652 SPO2 flex cable

1

7

/

0652 ECG flex cable

1

8

/

Button-FPC

1

9

009-001324-00

Recorder connecting cable

1

8-12

Memo

8.9 MPM Assembly (ECG + masimo SpO2) (115-007264-00) 8.9.1 Exploded View

8.9.2 Parts List SN

P/N

Description

Qty

1

/

Bracket-MPM

1

801-0651-00086-00

MPM digital board

1

801-0651-00001-00

MPM digital board

1

3

/

Insulation washer Ф3×0.5

4

4

/

Plastic hexagon bolt

4

801-0651-00085-00

MPM analog board

1

801-0651-00090-00

MPM analog board (Masimo 2011)

1

801-0651-00003-00

MPM analog board (Nellcor)

1

6

/

Screw, metric, GB/T818-2000 M3×6, pan head

3

7

801-0651-00091-00

MPM masimo SpO2 transform board

1

8

/

Masimo board installation socket wrench

3

801-0651-00022-00

MPM SpO2 board (Mindray)

1

801-0651-00121-00

MASIMO MS-2011 BOARD

1

801-0651-00088-00

Nellcor SPO2 board service kit

1

10

/

Screw, GB/T818-2000 M3×14

3

11

009-001101-00

Fan (With wire)

1

12

/

Plastic hexagon bolt

3

13

/

Plastic hexagon bolt

2

14

801-0652-00019-00

MPM and power board connective PCBA

1

2

5

9

8-13

Memo As configured

As configured

As configured

8.10 Capacitor Assembly (801-0651-00040-00) 8.10.1 Exploded View

8.10.2 Parts List SN

P/N

Description

Qty

1

/

Capacitor pad 2

1

2

/

Phase I capacitor cable

1

3

/

Capacitor protective layer

1

4

/

Capacitor pad 1

1

8-14

8.11 Paddle Tray Assembly 8.11.1 Exploded View

8.11.2 Parts List SN

P/N

Description

Qty

1

/

Handle kit

1

2

/

Top waterproof strip

1

3

/

Flat washer 4

2

4

/

Spring washer 4

2

5

/

Philips screw, M4×20

2

6

801-0652-00013-00

Electrode base service kit

1

7

801-0651-00124-00

Test load cable

1

8

/

Large flat washer 3

2

9

/

Screw, self-tapping, PT3×10

2

10

/

M3×6 combination screw

2

11

/

Travel switch insulation plate

1

12

/

Silicon pad

2

13

/

Bracket-electrode

2

14

/

Paddle fixing leaf

2

15

034-000159-00

Elasticity block

2

8-15

8.12 External Paddles Assembly (0651-30-76937) 8.12.1 Exploded View

8.12.2 Parts List SN

P/N

Description

Qty

1

/

Pediatric sternum paddle kit

1

2

/

Adult sternum paddle kit

1

3

/

Pediatric apex paddle kit

1

4

/

Adult apex paddle kit

1

5

/

External paddle cable

1

8-16

8.13 Pediatric Sternum Paddle Kit (0651-30-76920) 8.13.1 Exploded View

8-17

8.14 Adult Sternum Paddle Kit (0651-30-76922) 8.14.1 Exploded View

8.14.2 Parts List SN

P/N

Description

Qty

1

/

Adult sternum paddle base

1

2

/

Adult paddle labelling

1

3

/

Paddle push bar reed

1

4

/

Paddle push bar

1

5

/

Adult paddle electrode

1

8-18

8.15 Pediatric Apex Paddle Kit (0651-30-76921) 8.15.1 Exploded View

8.15.2 Parts List SN

P/N

Description

0651-20-76849-51

Overlay, apex paddle, Chinese

047-001607-00

Overlay, apex paddle, German/Spanish/French/Dutch/Brazil Portuguese

047-001608-00

Overlay, apex paddle, Polish

047-001610-00

Overlay, apex paddle, Italian

047-001611-00

Apex paddle label (Turkish)

047-001612-00

Overlay, apex paddle, Russian

2

/

Philips screw, M3×8

2

3

/

Apex paddle handle cover

1

4

/

External paddle cable

1

5

/

Pediatric paddle electrode

1

6

/

Pediatric paddle electrode EVA pad

1

7

/

Pediatric apex paddle base (0651)

1

8

801-0651-00029-00

Apex paddle keypad board

1

9

/

Apex paddle button bracket

1

10

/

Crosshead tapping screws, PT3×10

1

/

Apex paddle P+R button (Chinese)

/

Apex paddle P+R button

1 (As configured)

/

Silicone tube

1

1

11 12

Qty

8-19

1 (As configured)

8.16 Adult Apex Paddle Kit (0651-30-76923) 8.16.1 Exploded View

8.16.2 Parts List SN

P/N

Description

Qty

1

/

Adult apex paddle base

1

2

/

Adult paddle labelling

2

3

/

Paddle push bar reed

1

4

/

Paddle push bar

1

5

/

Adult paddle electrode

1

8-20

8.17 External Paddle Cable (0651-20-76827) 8.17.1 Exploded View

8.17.2 Parts List SN

P/N

Description

Qty

1

/

Paddle cable connector

1

2

/

Torsion spring

1

3

/

Connector lock (0651)

1

4

/

Silicone pad

1

5

/

Paddle cable

1

6

/

Sternum paddle cable anchorage

1

7

/

Apex paddle cable anchorage

1

8-21

8.18 Pothook Assembly (0651-30-76864) 8.18.1 Exploded View

8.18.2 Parts List SN

P/N

Description

Qty

1

/

Hook

2

2

/

Pin

2

3

/

Spring

2

4

/

Hook base

1

5

/

Sleeve

2

6

/

Philips screw, M3×10

2

8.19 Replacement Parts To replace parts, refer to 5 Disassembly and Repair and the explosive views above.

NOTE z

Here we list most replacement parts. If you need more parts, please contact our Customer Service Department. 8-22

8.19.1 Main Unit P/N

Description

Qty

051-000489-00

0652 Keyboard PCBA

1

049-000215-00

Defib. Key (D3)

1

049-000216-00

Silicone keypad, defibrillation

1

—-(No PN so far)

7〞 AU

1

801-0651-00044-00

Rotating encoder

1

801-0651-00043-00

Mode Select knob

1

115-007249-00

Front panel assembly

1

020-000004-00

Speaker, 8ohm, 1W 40 (dia)*6.8 (hgt) mm

1

051-000491-00

0652 Alarm light board PCBA

1

051-000619-00

0652 Assistant keyboard PCBA

1

115-001280-00

Power seat

1

115-007255-00

Rear cover assembly

1

115-007583-00

LCD assembly (AU)

1

115-007584-00

LCD assembly (CHI MEI)

1

051-000488-00

Power management board (FRU)

1

801-0651-00034-00

PADS ECG board

1

0000-10-11158

Storage card, CF card, 1GB. iCF4000Y

1

115-007262-00

MPM assembly (ECG)

1

115-007263-00

MPM module (ECG+mindray SPO2)

1

115-007264-00

MPM assembly (ECG+masimo SPO2)

1

115-007265-00

MPM assembly (ECG+nellcor SPO2)

1

115-007266-00

MPM assembly (ECG)

1

115-007267-00

MPM assembly (ECG＋mindray SPO2)

1

115-007268-00

MPM assembly (ECG＋masimo SPO2)

1

115-007269-00

MPM assembly (ECG＋nellcor SPO2)

1

115-007254-00

Main board assembly

1

115-007258-00

Parameter panel assembly (ECG)

1

115-007259-00

Parameter panel assembly (ECG+mindray SPO2)

1

115-007260-00

Parameter panel assembly (ECG+masimo SPO2)

1

115-007261-00

Parameter panel assembly (ECG+nellcor SPO2)

1

051-000231-00

MPM module digital board (Defibrillator monitor)

1

051-000230-00

MPM module analog board (Mindray/defibrillator monitor)

1

051-000058-00

9008 SpO2 Board

1

M51A-30-80851

MPM digital board

1

051-000331-00

MPM analog board (Masimo 2011)

1

Front housing

Rear housing

8-23

P/N

Description

Qty

051-000332-00

MPM Masimo transform board

1

040-000362-00

MASIMO MS-2011 board

1

M51A-30-80854

MPM analog board (Nellcor)

1

0010-10-42656

Nellcor SpO2 board

1

External paddle 801-0651-00006-00

External paddle (Chinese, FRU)

801-0651-00010-00

External paddle (English, FRU)

801-0651-00101-00

External paddle (Spanish, FRU)

801-0651-00102-00

External paddle (German/French/Dutch, FRU)

801-0651-00103-00

External paddle (Polish, FRU)

801-0651-00105-00

External paddle (Italian, FRU)

801-0651-00106-00

External paddle (Turkish, FRU)

801-0651-00107-00

External paddle (Russian, FRU)

801-0651-00108-00

External paddle (Brazil Portuguese, FRU)

1 (As configured)

Miscellaneous 801-0651-00037-00

Electrode base assembly

1

022-000034-00

Lithium-ion battery, 14.8V, 3000mAh, LI24I001A

2

801-0651-00005-00

Pothook assembly

1

TR6F-30-67306

TR6F recorder

1

0651-20-77032

Test plug (MR6901)

1

040-000099-00

Test plug for validation

1

040-000098-00

Test plug for regulation

1

801-0651-00007-00

Software package (FRU)

1

8.19.2 Connecting Cables P/N

Description

009-001102-00

Assistant keyboard connecting line

020-000004-00

Speaker 8ohm 1W round cable

009-001104-00

AU inverter cable

9200-21-10460

Encoder cable

009-001034-00

Test load cable

009-001073-00

On-position detection switch kit

0651-20-76879

AC power socket & connecting cable

009-001107-00

Cable, power management to AC/DC power

0651-20-76870

Cable, main board to button board

0651-21-76881

Defibrillator capacitor phase I & connecting cable

009-001325-00

Defibrillator socket cable

009-001324-00

Recorder connecting cable

8-24

A Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations. All tests can be performed using commercially available safety analyzer test equipment. These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer. Other popular testers complying with IEC 60601-1 used in Europe such as Fluke, Metron, or Gerb may require modifications to the procedure. Follow the instructions of the analyzer manufacturer. The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is emphasized as a mandatory step if an approved agency status is to be maintained. The safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line voltage and grounding, as well as total current loads.

A.1 Power Cord Plug A.1.1 The Power Plug Test Item The power plug

The power cord

Acceptance Criteria The power plug pins

No broken or bent pin. No discolored pins.

The plug body

No physical damage to the plug body.

The strain relief

No physical damage to the strain relief. No plug warmth for device in use.

The power plug

No loose connections. No physical damage to the cord. deterioration to the cord.

No

For devices with detachable power cords, inspect the connection at the device. For devices with non-detachable power cords, inspect the strain relief at the device.

A-1

A.2 Device Enclosure and Accessories A.2.1 Visual Inspection Test Item

Acceptance Criteria No physical damage to the enclosure and accessories.

The enclosure and accessories

No physical damage to meters, switches, connectors, etc. No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No loose or missing parts (e.g., knobs, dials, terminals, etc.).

A.2.2 Contextual Inspection Test Item

Acceptance Criteria No unusual noises (e.g., a rattle inside the case).

The enclosure and accessories

No unusual smells (e.g., burning or smoky smells, particularly from ventilation holes). No taped notes that may suggest device deficiencies or operator concerns.

A.3 Device Labeling Check the labels provided by the manufacturer or the healthcare facility are present and legible. „

Main unit label

„

Integrated warning labels

A-2

A.4 Protective Earth Resistance Protective Earth Resistance is measured using the RED test lead attached to the DUT Protective Earth terminal or enclosure. Select the test current by pressing SOFT KEY 3 to toggle between 1AMP, 10AMP, and 25AMP. The front panel outlet power is turned off for this test. The following conditions apply: L1 and L2 Open.

Preparation 1.

First select the test current that will be used for performing the Protective Earth Resistance test by pressing AMPERES (SOFT KEY 3).

2.

Connect the test lead(s) between the RED input jack and the GREEN input jack.

3.

Press CAL LEADS. The 601PRO will measure the lead resistance, and if less than 0.150 Ohms, it will store the reading and subtract it from all earth resistance readings taken at the calibrated current.

  If the calibration fails, the previously stored readings will be used until a passing calibration has occurred.:

WARNING z

During Earth Resistance testing, the DUT must be plugged into the 601PRO front outlet. If the DUT fails Earth Resistance, discontinue tests and label the device defective.

A-3

To Perform the Test 1.

From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet.

2.

Attach the 601PRO RED input lead to the device’s Protective Earth terminal or an exposed metal area.

3.

Press shortcut key 3. The Protective Earth Resistance test is displayed.

4.

Press SOFT KEY 3 to select a test current (1AMP, 10AMP, or 25AMP). The selected test current is displayed in the upper right corner of the display.

5.

Press START TEST to start the test. The test current is applied while resistance and current readings are taken. This takes approximately 5 seconds.

6.

Press the print data key at any time to generate a printout of the latest measurement(s).

NOTE z

When «Over» is displayed for Ohms, this signifies that a valid measurement was not obtained because either an open connection was detected or that the measurement was not within range. Readings greater than 9.999 Ohms will be displayed as Over.

In Case of Failure Once it reaches the limitation, stop using and inform the Customer Service Engineer for analysis and disposal.

Limits „

R = 0.1Ω Maximum

A-4

A.5 Earth Leakage Test Run an Earth Leakage test on the device being tested before performing any other leakage tests. Leakage current is measured the following ways: „

Earth Leakage Current, leakage current measured through DUT outlet Earth

„

Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth), leakage current measured through DUT outlet Earth

There is no need to attach a test lead; the 601PRO automatically connects the measuring device internally.

To Perform the Test 1.

From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device.

2.

Attach the device’s applied parts to the 601PRO applied part terminals if applicable.

3.

Press shortcut key 4.The Earth Leakage test appears on the display, and the test begins immediately:

„

SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse.

„

SOFT KEY 2 toggles the DUT outlet from Earth to No Earth.

„

SOFT KEY 3 toggles the DUT outlet from L2 to No L2.

„

SOFT KEY 4 toggles the AP to Earth to No AP to Earth.

4.

Press the print data key at any time to generate a printout of the latest measurement.

A-5

In Case of Failure „

Check any broken of the enclosure. Replace any defective part.

„

Inspect wiring for bad crimps, poor connections, or damage.

„

Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead.

„

Change another probe to confirm if the fail is caused by console.

„

Inspect wiring for bad crimps, poor connections, or damage.

„

If the leakage current measurement tests fail on a new unit and if situation can not be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation.

„

If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.

Limits ‹

300 μA in Normal Condition

‹

1000 μA in Single Fault Condition

A.6 Patient Leakage Current Patient leakage currents are measured between a selected applied part and mains earth. All measurements may have either a true RMS or a DC-only response.

Preparation Perform a calibration from the Mains on Applied Part menu. The following outlet conditions apply when performing this test: „

Normal Polarity, Earth Open, Outlet ON

Normal Polarity, Outlet ON

„

Normal Polarity, L2 Open, Outlet ON

Reversed Polarity, Outlet ON

„

Reversed Polarity, Earth Open, Outlet ON

Reversed Polarity, L2 Open, Outlet ON

A-6

WARNING z

If all of the applied parts correspond to the instrument type, the applied parts will be tied together and one reading will be taken. If any of the applied parts differ from the instrument type, all applied parts will be tested individually, based on the type of applied part. This applies to Auto and Step modes only.

To Perform the Test 1.

From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device.

2.

Attach the applied parts to the 601PRO’s applied part terminals.

3.

Press shortcut key 6. The Patient Leakage test is displayed, and the test begins immediately.

  4.

Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current.

5.

Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO.

6.

Press the print data key at any time to generate a printout of the latest measurement.

NOTE z

If the current test standard being used does not include Patient Leakage DC readings, or the DC option is not enabled, then DC readings will not be available through the APPLIED PART SOFT KEY selections. Refer to Chapter 8, Standards and Principles.

z

For external or internal paddle, the patient leakage current test should be tested when the EUT was charging.

A-7

In Case of Failure „

Check any broken of the enclosure. Replace any defective part.

„

Inspect wiring for bad crimps, poor connections, or damage.

„

Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead.

„

Change another probe to confirm if the fail is caused by console.

„

Inspect wiring for bad crimps, poor connections, or damage.

„

If the leakage current measurement tests fail on a new unit and if situation can not be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation.

„

If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.

Limits „

„

For ECG (Defibrillator proof) and other CF applied parts ‹

10 μA in Normal Condition

‹

50 μA in Single Fault Condition

For BF applied parts ‹

10 μA DC,100μA AC in Normal Condition

‹

50 μA DC,500μA AC in Single Fault Condition

A-8

A.7 Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage, through a limiting resistance, to selected applied part terminals. Current measurements are then taken between the selected applied part and earth. Measurements are taken with the test voltage (110% of mains) to applied parts in the normal and reverse polarity conditions as indicated on the display. The following outlet conditions apply when performing the Mains on Applied Part test. „

Normal Polarity;

„

Reversed Polarity

Preparation To perform a calibration from the Mains on Applied Part test, press CAL (SOFT KEY 2). 1.

Disconnect ALL patient leads, test leads, and DUT outlet connections.

2.

Press CAL to begin calibration, as shown:

If the calibration fails, the previously stored readings will be used until a passing calibration has occurred. Also, the esc/stop key has no effect during calibration. 3.

When the calibration is finished, the Mains on Applied Part test will reappear.

WARNING z

A 2-beep-per-second signal indicates high voltage present at the applied part terminals while a calibration is being performed.

z

High voltage is present at applied part terminals while measurements are being taken.

A-9

To Perform the Test 1.

From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601

2.

Attach the applied parts to the 601PRO applied part terminals.

3.

Attach the red terminal lead to a conductive part on the DUT enclosure.

4/

Press shortcut key 7. The Mains on Applied Part test is displayed.

5.

Select the desired outlet configuration and applied part to test using the appropriate SOFT KEYS:

6.

Press START TEST (SOFT KEY 1) to begin the test.

7.

Press the print data key to generate a printout of the latest measurement.

NOTE z

If all of the applied parts correspond to the instrument type, the applied parts will be tied together and one reading will be taken. If any of the applied parts differ from the instrument type, all applied parts will be tested individually, based on the type of applied part. This applies to Auto and Step modes only.

In Case of Failure „

Check any broken of the enclosure. Replace any defective part.

„

Inspect wiring for bad crimps, poor connections, or damage.

„

Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead.

„

Change another probe to confirm if the fail is caused by console.

„

Inspect wiring for bad crimps, poor connections, or damage.

„

If the leakage current measurement tests fail on a new unit and if situation can not be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation.

„

If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. A-10

Limits „

For ECG (Defibrillator proof) and other CF applied parts ‹

„

50 μA

For BF applied parts ‹

5000 μA

A.8 Patient Auxiliary Current Patient Auxiliary currents are measured between any selected ECG jack and the remaining selected ECG jacks. All measurements may have either a true RMS or a DC-only response.

Preparation 1.

From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device.

2.

Attach the patient leads to the 601PRO ECG jacks.

3.

Define the Lead Types from the View Settings Option (refer to: Lead Type Definitions in Section 5 of this chapter).

4.

Press shortcut key 8. The Patient Auxiliary Current test is displayed, and the test begins immediately. Display values are continuously updated until another test is selected.

5.

Press SOFT KEYS 1-4 to select leakage tests

6.

Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current:

7.

Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO:

8.

Press the print data key at any time to generate a printout of the latest measurement.

A-11

NOTE z

If the current test standard being used does not include Patient Auxiliary Current DC readings, or the DC option is not enabled, then DC readings will not be available through the APPLIED PART SOFT KEY selections.

z

For external or internal paddle, the patient auxiliary current test should be tested when the EUT was charging.

In Case of Failure „

Check any broken of the enclosure. Replace any defective part.

„

Inspect wiring for bad crimps, poor connections, or damage.

„

Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead.

„

Change another probe to confirm if the fail is caused by console.

„

Inspect wiring for bad crimps, poor connections, or damage.

„

If the leakage current measurement tests fail on a new unit and if situation can not be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation.

„

If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.

Limits „

„

For ECG (defibrillator proof) and other CF applied parts ‹

10μA in Normal Condition

‹

50μA in Single Fault Condition

For BF applied parts ‹

10μA DC,100μA AC in Normal Condition

‹

50μA DC,500μA AC in Single Fault Condition

A.9 Functional test For functional test items, please refer to relevant functional tests in 4 Testing and Maintenance.

A-12

ELECTRICAL SAFETY INSPECTION FORM Overall assessment: „

Scheduled inspection: Test item 1, 2, 3, 9

„

Unopened repair type: Test item 1, 2, 3, 9

„

Opened repair type, not modify the power board and patient circuit board: Test item 1, 2, 3, 4, 5, 9

„

Opened repair type, modify the power board or patient circuit board: Test item 1, 2, 3, 4, 5, 6, 7, 8, 9

A-13

Location:

Technician:

Equipment:

Control Number:

Manufacturer:

Model:

SN:

Measurement equipment /SN

Date of Calibration:

INSPECTION AND TESTING

Pass/Fail

Comments

1

Power Cord Plug

2

Device Enclosure and Accessories

3

Device Labelling

4

Protective Earth Resistance

_____Ω

Max 0.1 Ω

5

EARTH Leakage

Normal condition(NC)

____μA

Max

Single Fault condition(SFC)

____μA

NC:500μA, SFC:1000μA

Normal condition(NC)

____μA

Max

Single Fault condition(SFC)

____μA

6*

Patient Leakage Current

CF AP NC:10μA, SFC: 50μA BF AP NC:100μA, SFC: 500μA

7*

Mains on Applied Part Leakage

Max CF AP: 50μA BF AP: 5000μA

8*

Patient Auxiliary Current

Normal condition(NC)

____μA

Max CF AP

Single Fault condition(SFC)

____μA

NC:10μA, SFC: 50μA BF AP NC:100μA, SFC: 500μA

9

Functional test (parameters tested): Note: The test items marked “*” are required only for incoming inspections, after repairs or modifications that may affect lead leakage [NFPA 99 (2005)8.5.2.1.3]. Deficiency / Note:

Name: ________________________

Date/Signature___________________________

A-14

P/N: 046-001655-00 (2.0)

Источник

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