Mindray BeneHeart R3, BeneHeart R3A Service Manual

BeneHeart R3/BeneHeart R3A

Electrocardiograph

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: October 2014

© 2013-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

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 equipments

Passwords

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

 Maintain Mode: 888888
 Demo Mode: 2088

II

Contents

1 General .............................................................................................................................. 1-1

1.1 Revision History ............................................................................................................. 1-1

1.2 Safety Information .......................................................................................................... 1-1

1.2.1 Warnings ............................................................................................................. 1-2

1.2.2 Cautions ............................................................................................................. 1-2

1.2.3 Notes .................................................................................................................. 1-3

1.3 Equipment Symbols ........................................................................................................ 1-3

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

2.1 Introduction ..................................................................................................................... 2-1

2.2 Connectors for External Equipment ................................................................................ 2-2

2.3 Main Unit ........................................................................................................................ 2-4

2.4 Top housing assembly ..................................................................................................... 2-5

2.4.1 Main Control Board ........................................................................................... 2-5

2.4.2 Keypad Board..................................................................................................... 2-6

2.4.3 AC/DC Power Board .......................................................................................... 2-6

2.4.4 Recorder Drive Board ........................................................................................ 2-6

2.4.5 Parameter Board ................................................................................................. 2-6

3 Unpacking and Installation ............................................................................................. 3-1

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

3.2 Preparation for Installation .............................................................................................. 3-1

3.3 Turning On the Equipment .............................................................................................. 3-2

4 Hardware and Software Upgrade ................................................................................... 4-1

4.1 Hardware Upgrade .......................................................................................................... 4-1

4.1.1 Upgrading the Equipment to have Wi-Fi Function ............................................ 4-1

4.2 Software Upgrade............................................................................................................ 4-2

4.2.1 Installing Software Upgrade Tool ...................................................................... 4-3

4.2.2 Software Upgrade Procedure ............................................................................. 4-5

5 Testing and Maintenance ................................................................................................. 5-1

5.1 Introduction ..................................................................................................................... 5-1

5.1.1 Test Equipment ................................................................................................... 5-1

5.1.2 Test Report ......................................................................................................... 5-1

5.1.3 Preventative Maintenance .................................................................................. 5-1

5.1.4 Recommended Frequency .................................................................................. 5-2

5.2 Visual Inspection ............................................................................................................. 5-2

5.3 Power-on Test .................................................................................................................. 5-3

1

5.4 ECG Performance Test .................................................................................................... 5-3

5.5 Recorder check ................................................................................................................ 5-3

5.6 Battery Check .................................................................................................................. 5-4

5.7 Maintenance Mode .......................................................................................................... 5-4

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

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

6.2 Parts Replacement ........................................................................................................... 6-1

6.3 Quickly Identifying Failure ............................................................................................. 6-1

6.4 General Problems and System Messages ........................................................................ 6-1

6.5 Troubleshooting Guide .................................................................................................... 6-2

6.5.1 Power On/Off Failures ....................................................................................... 6-2

6.5.2 Recorder Failures ............................................................................................... 6-3

6.5.3 Wrong system time ............................................................................................. 6-4

6.5.4 Wi-Fi Related Failures ....................................................................................... 6-5

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

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

7.2 Preparations for Disassembly .......................................................................................... 7-1

7.3 Disassembling the Main Unit .......................................................................................... 7-2

7.3.1 Removing Bottom housing assembly ................................................................. 7-2

7.3.2 Remove the Power Board ................................................................................... 7-3

7.3.3 Removing the Main Control Board .................................................................... 7-3

7.3.4 Upgrading to Have Wi-Fi Function and Repair the Wi-Fi Module .................... 7-4

7.3.5 Removing the Display ........................................................................................ 7-6

7.3.6 Removing the Parameter Board ......................................................................... 7-6

7.3.7 Removing the Keypad Board ............................................................................. 7-7

7.3.8 Removing the Recorder Drive Board ................................................................. 7-8

7.3.9 Removing the Thermal Print Head ..................................................................... 7-9

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 ............................................................................................................ 8-3

8.3 Top Housing Assembly (115-017634-00 or 115-017793-00) .......................................... 8-5

8.3.1 Exploded View ................................................................................................... 8-5

8.3.2 Parts List ............................................................................................................ 8-5

8.4 Recorder door assembly (115-017633-00) ...................................................................... 8-6

x

8.4.1 E

8.4.2 Parts List ............................................................................................................ 8-6

8.5 Bottom housing assembly (115-017792-00 or 115-018387-00) ...................................... 8-7

8.5.1 Exploded View ................................................................................................... 8-7

8.5.2 Parts List ............................................................................................................ 8-7

ploded View ................................................................................................... 8-6

2

9 Replacement Parts, Software Upgrade Package and Accessories ................................ 9-1

9.1 BeneHeart R3/R3A BOM (V1.0) for Repair, Upgrade and Accessories ......................... 9-1

9.2 Material Change .............................................................................................................. 9-2

A Electrical Safety Inspection ........................................................................................... A-1

A.1 Power Cord Plug ........................................................................................................... A-1

A.2 Device Enclosure and Accessories ................................................................................ A-2

A.3 Device Labeling ............................................................................................................ A-2

A.4 Protective Earth Resistance ........................................................................................... A-2

A.5 Earth Leakage Test ........................................................................................................ A-4

A.6 Patient Leakage Current ................................................................................................ A-7

A.7 Mains on Applied Part Leakage .................................................................................... A-9

A.8 Patient Auxiliary Current .............................................................................................. A-9

A.9 Scheduled Electrical Safety Inspection ....................................................................... A-14

A.10 Electrical Safety Inspection after Repair ................................................................... A-16

3

FOR YOUR NOTES

4

1 General

1.1 Revision History

Manual
Version

1.0 First release April 2013

2.0

Description of Changes

Add information on Wi-Fi upgrade, repairing and

troubleshooting

Update Chapter 9 replacement parts, software upgrade

package and accessories list.

Change
Time

October 2014

SN Since

1.2 Safety Information

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.

NOTE

 Provides application tips or other useful information to ensure that you get the

most from your product.

1-1

1.2.1 Warnings

WARNING

 All installation operations, expansions, changes, modifications and repairs of this

product are conducted by authorized personnel.

 Disconnect the equipment from external power source and remove the battery

before disassembling the equipment.

 When you disassemble/reassemble the equipment, a patient leakage current test

must be performed before it is put in use.

 The equipment must be connected to a properly installed power outlet with

protective earth contacts only. If the installation does not provide for a protective
earth conductor, disconnect it from the power line and operate it on battery power,
if possible.

 Dispose of the package material, observing the applicable waste control regulations

and keeping it out of children’s reach.

1.2.2 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.

1-2

1.2.3 Notes
NOTE

 Refer to Operation Manual for detailed operation and other information.

1.3 Equipment Symbols

Caution (Attention, consult

accompanying documents)

Battery indicator

DEFIBRILLATION-PROOF

TYPE CF APPLIED PART

Network connector

DATE OF

MANUAFACTURE

Dispose of in accordance to

your country’s requirements

Authorized representative in

the European Community

ON/OFF for part of

equipment

Alternating current (AC)

Equipotentiality

USB connector

Serial number

Environment-friendly

Used Period per Chinese

Standard SJ/T11363-2006

China Metrology

Certification

Manufacturer

The product bears CE mark indicating its conformity with the provisions of

the Council Directive 93/42/EEC concerning medical devices and fulfils

the essential requirements of Annex I of this directive.

NOTE

 Some symbols may not appear on your equipment.

1-3

FOR YOUR NOTES

1-4

2 Theory of Operation

2.1 Introduction

BeneHeart R3/BeneHeart R3A Electrocardiograph (hereafter referred to as “the equipment”

or “the system”) is intended to acquire, analyze, display, store, and record the patient’s

electrocardiographic information for clinical diagnosis and study.

The equipment provides the following functions:

 Display 12-lead ECG waveforms in real time; print manual, auto, and rhythm

measurements.

 Perform resting ECG interpretation, output measurements and diagnosis in auto

measurement mode.

 Save ECG data in internal memory and export the data through a USB memory.
 Enables program upgrade over the network.

Internet

Mobile Viewer

PC / ECG Management

B

u

i

l

t

ECG Server

B

USB

u

ilt

-

i

n

W

i

-

F

i

-

in

W

i

-

F

i

L
A
N

2-1

The above figure shows the system consists of the electrocardiograph and its peripheral

devices. The electrocardiograph:

 Acquires, processes and reviews 12-lead resting ECG data;
 Prints ECG reports;
 Runs on AC power source or a battery.
 Exports data through a USB memory.
 Connects LAN or Wi-Fi to send ECG data.
 Connects a barcode reader to enter patient information.

2.2 Connectors for External Equipment

The connectors for external devices are located on the left and rear of the equipment.

Side View

1. Patient cable connector: connects the patient cable for ECG acquisition

2. Recorder door latch: opens the recorder door

1. Network connector: connects the equipment to the network for software upgrade

2. USB connector: connects USB disc for data transfer

1

1

2

2 2

2-2

Back View

1. AC power input

2. Equipotential Grounding Terminal: When the equipment and other devices are to be

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

eliminate the potential difference between them.

1

2

Bottom View

1. Battery compartment

1

2-3

2.3 Main Unit

The equipment consists of the following parts:

 Top housing assembly: consists of main control board, keyboard assembly, display,

power switch, power board (AC/DC), recorder, and parameter board.

 Lower housing: includes a battery compartment.

The following figure shows the main unit architecture:

Thermal head

module

W7

Power board

W1

USB
RJ45

Battery

W5

Keypad board

W2

Main control board

W6

LCD

Recorder drive

board

W3

Parameter BoardW4

Wi-Fi

(reserved)

2-4

2.4 Top housing assembly

Recorder drive board

Power board

Bosses for screwing

top and bottom

housings together

2.4.1 Main Control Board

The main control board provides the following functions:

 Drives display and control back light
 Stores data
 Processes printing

Keypad board

Bosses for screwing

top and bottom

housings together

Main control board Parameter board

 Implements serial port communication
 Drives the buzzer
 Provides USB and wired network connection
 Processes data
 Implements power supply conversion
 Charges the battery
 Implements power management
 Implements network communication

2-5

2.4.2 Keypad Board

The keypad board drives the keys. The power on/off switch, AC indicator and battery

indicator are also located on the keypad board.

2.4.3 AC/DC Power Board

The power board transforms AC power to DC power.

2.4.4 Recorder Drive Board

The recorder drive board drives the recorder module.

2.4.5 Parameter Board

Parameter board is responsible for ECG data acquisition.

2-6

3 Unpacking and Installation

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 the equipment is accepted.

3.2 Preparation for Installation

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 equipment needs to be connected to

the wired network.

Environmental Requirements

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

anaesthetics, vapours or liquids. The environment where the equipment 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.

 Enviornment

Check and make sure that there is no electromagnetic interference source around the

equipment, especially large medical electrical equipment such as radiological

equipment and magnetic resonance imaging equipment etc. Switch off these devices

when necessary.

Keep the examination room warm (no less than 18℃) to avoid muscle action voltages

in ECG signal caused by cold.

3-1

 Power supply

Check that power supply specification is met and the power cord is securely connected

if mains power is used. Use only power socket that is properly grounded.

AC mains
Input voltage
Input power
Frequency
Battery

Battery Type

Run time

Shutdown delay

100-240V～ (±10%)

60 VA

50 Hz/60 Hz (±3 Hz)

When powered by a new fully-charged battery and at ambient temperature
25 ℃±5 ℃,

≥500 auto measurement reports, or 2 hours of continuous recording, or 6

hours of measurement without recording

With equipment power off and at ambient temperature 25 ℃±5 ℃,

≤3 h to 90% capacity

≤3.5 h to 100% capacity

at least 5 minutes (after a low battery message first occurs)

3.3 Turning On the Equipment

Once the equipment has been installed and checked, you can get ready for measurement and

recording:

1. Connect the equipment with AC mains. If you run the equipment on battery power,

ensure that the battery is sufficiently charged.

2. Press the power on/off switch.

3-2

4 Hardware and Software Upgrade

4.1 Hardware Upgrade

4.1.1 Upgrading the Equipment to have Wi-Fi Function

For the equipment not configured with the Wi-Fi function, there is no Wi-Fi module socket

on the main board. To upgrade the equipment, use a main board with Wi-Fi module socket

to replace the original main board.

The Glasgow 12-lead resting ECG algorithm and the PDF software package are included in

the Wi-Fi upgrade package.

The Wi-Fi upgrade package (PN: 115-029558-00) consists of the following items:

 Main board PCBA, with Wi-Fi module socket
 Wi-Fi module kit
 System software package
 Glasgow 12-lead resting ECG algorithm
 PDF software package

Refer to 7.3.4 Upgrading to Have Wi-Fi Function and Repair the Wi-Fi Module for the

upgrade procedure.

4-1

4.2 Software Upgrade

You can upgrade the system by installing and running the Mindray Patient Monitor

Software Upgrade Tool (PN: 110-000493-00) on a PC with Windows operating system.

Connect the equipment to be upgraded and the PC running the upgrade tool to the same

network, or directly connect the equipment and the PC via a crossover network cable. Then

configure the IP address of the PC. You can upgrade the following software:

No.

1

2

3 110-002545-00

4 110-001201-00 TR8A recorder drive chip writing software

5

6 115-018007-00 Glasgow upgrade pack (FRU, English)

7 115-017996-00 PDF format upgrade pack (FRU)

Software type

System softwar

package

Module software

Software function

upgrade package

Note: No specific sequence is required for the upgrading of above software. For detailed

information, please refer to 4.2.2 Software Upgrade Procedure.

PN Description

110-002535-00

/

110-002525-0 Power management program

115-017992-00 Glasgow upgrade pack (FRU, Chinese)

System software package (Simplified

Chinese)

System software package (Traditional

Chinese)

M501 ECG module STM32 chip writing

software

4-2

4.2.1 Installing Software Upgrade Tool

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

installation.

2. Select language.

3. Click [Ok] and the following screen is displayed. Click [Next] to go to the next step.

4. Enter User Name, Company name, and Serial Number "26582640". Then click [Next].

4-3

5. Specify the destination folder for installing this program. Then select [Next].

6. Select Program Folder. Then select [Next].

7. Click [Finish] to complete installation.

4-4

4.2.2 Software Upgrade Procedure

1. Connect the equipment to be upgraded and the PC running the upgrade tool to the

same network, or directly connect the equipment and the PC via a crossover network

cable.

2. Set the IP address of the PC to "77.77.1.XX" and subnet mask to "255.255.255.0".

3. Run Mindray Patient Monitor Software Upgrade Tool on the PC and set Machine to

[BeneHeart R3/R3A].

4. On the Mindray Patient Monitor Software Upgrade Tool screen, select [Select

Package] and then the packages you want to upgrade. Then select [Start].

5. Turn on the equipment to be upgraded. Press and hold "F1" key and "F4" key for 2 to 3

seconds. Then the equipment enters upgrade mode and starts software upgrade

automatically. Corresponding prompt messages are displayed to be upgraded on both

the equipment and PC.

When software upgrade is finished, restart the equipment and check if the software is

correctly upgraded.

For details of software upgrade, please refer to help and instructions for use of Mindray

Patient Monitor Software Upgrade Tool.

CAUTION

 Disconnect the equipment from the patient and make sure the important data are saved

before upgrade.

 Do not shut down or power off the equipment when upgrading the system software.

Otherwise, it may cause the equipment to break down.

 Software upgrade should be performed by qualified service personnel only.
 Crossover network cable is recommended when a PC is connected for software upgrade.

NOTE

 Make sure the version of the upgrade package is what you desired. To obtain the latest

upgrade package, please contact Mindray Customer Service Department.

4-5

5 Testing and Maintenance

5.1 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 equipments and frequency.

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

and use appropriate test equipments.

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 replacements must be done to correct the problem. If you

have any question, contact our Customer Service Department.

CAUTION

 All tests should be performed by qualified service personnel only.
 Service personnel should acquaint themselves with the test tools and make sure that

test tools and cables are applicable.

5.1.1 Test Equipment

See the following sections.

5.1.2 Test Report

Upon the completion of the tests, the table of preventative maintenance test reports and the

table of maintenance test reports in this chapter should be kept properly.

5.1.3 Preventative Maintenance

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

See the following sections for detailed maintenance procedures.

5-1

5.1.4 Recommended Frequency

Check/Maintenance Item Frequency
Visual inspection

Power-on test

ECG test

Electric safety
tests

Recorder check

Battery check

Performance Test

Module

Calibration

Refer to A

Electrical Safety

Inspection

Functional test

Performance test

1. When first installed or reinstalled.

1. When first installed or reinstalled.

2. Following any repairs or replacement of any main

unit parts.

1. If the user suspects that the measurement is incorrect.

2. Following any repairs or replacement of relevant

module.

3. At least once every two years.

1. Following any repair or replacement

2. After the equipment drops.

3. At least once every two years.

Following any repair or replacement of the recorder.

1. When first installed.

2. Whenever a battery is replaced.

Once per year, or if the battery run time reduced

significantly.

5.2 Visual Inspection

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 case, display screen, keys, and knob for obvious signs of damage.
 Inspect the power cord, wall mount, and accessories for obvious 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.

5-2

5.3 Power-on Test

This test is to verify that the equipment can power up correctly. The test is passed if the

equipment starts up by following this procedure:

1. Install the battery, and connect the equipment to AC power. The AC mains indicator

and battery indicator are illuminated.

2. Press the Power On/Off switch to turn on the equipment.

Then the equipment performs self-test as soon as the equipment is powered on.

5.4 ECG Performance Test

Tool required:

Patient simulator, eg. Medsim300B or equivalent equipment

Test Method:

1. Connect the patient cable to the equipment under test and the lead wires to the patient

simulator.

2. Set the patient simulator as follows: ECG sinus rhythm, HR = 80 bpm, with the

amplitude as 1 mV (default setting).

3. Check that the displayed ECG waveforms are clear and complete without obvious

noise.

4. Press the [ECG] key to start automatic ECG measurement. Print out the waveforms

and diagnosis.

5. Check that the displayed ECG waveforms are clear and complete with the amplitude of

lead II waveform about 10 mm (assumed the Gain is set to 10mm/mV), and diagnosis

indicating sinus rhythm and HR 80 bpm.

6. Disconnect each of the leads in turn and observe the corresponding lead off message

displayed on the screen.

5.5 Recorder check

Tool 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, and etc., and then

the equipment should present the message "Check Recorder". After the problem is

removed, the recorder should be able to work correctly.

5-3

5.6 Battery Check

Tool required:

 None

Functional Test

1. If the equipment is installed with a battery, remove the battery first.

2. Verify that the equipment works correctly when running powered form an AC source.

3. Verify that battery is installed. If not, install the battery.

4. Remove the AC power cord and verify that the equipment still works correctly.

Performance Test

Perform the test by referring to the chapter 10 Battery in the Operator’s Manual and verify

the operating time of the battery meets the product specification.

5.7 Maintenance Mode

The equipment includes maintenance mode for you to check the equipment conveniently.

To enter the maintenance mode, select [Menu]→[System Setup]→[Maintain
Mode]→enter required password.

The password for the maintenance mode is 332888 when the equipment left the factory. You

cannot change this password. If you have problem to enter the maintenance mode, please

contact your service personnel. You can perform the following tests in the maintenance

mode:

 Display test
 Sound test
 Keypad test
 Lead wire check
 Recorder test
 Internal communication test
 USB test
 Internal storage Test

Select a test item you want to perform, and follow the on-screen prompt.

5-4

In the maintenance mode, you can also

 View device information
 Check work log
 Set the frequency of AC filter
 Format the internal memory
 Input the equipment's serial number
 Import hospital and department name

To exit the maintenance mode, turn off the equipment.

5-5

Maintenance and Test Report

(See the above sections for detailed test procedures and contents)

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. Expiration Date for

Calibration

Test Contents Test Record

Visual Inspection

The housing, display screen, keys, 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 self test is passed. The power indicator works

5-6

Test Result

(Pass/Fail)

correctly and the equipment starts up properly.

Performance test

ECG performance test and calibration

The ECG waveforms displayed and printed out should be clear

and complete without obvious noise. The amplitude of lead II

waveform is about 10 mm and diagnosis indicate sinus rhythm

and HR 80 bpm.

ECG Lead Off prompt behaves correctly.

Recorder check

The recorder can print ECG waves correctly and the printout is

clear.

Simulate recorder problems, such as out of pater and paper

jam, the message "Check Recorder" shall be presented.

Battery Check

The equipment can operates correctly from battery power

when an AC power failure accidentally occurs.

The equipment can operate independently on a single battery.

Test conclusion:

Tested by: Test date:

5-7

6 Troubleshooting

6.1 Overview

In this chapter, equipment problems are listed along with possible causes and recommended

corrective actions. Refer to the tables to check the equipment, identify and eliminate the

troubles.

The troubles 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 Parts Replacement

The equipment's PCBs, major parts and components are replaceable. Once you isolate a

PCB you suspect defective, follow the instructions in Chapter 7 Disassembly and Repairto

replace the PCB with a known good one and check that the trouble disappears or the

equipment passes all performance tests. Defective PCB can be sent to us for repair. If the

trouble remains, exchange the replacement 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 9

Upgrade Package and Accessories.

Replacement Parts, Software

6.3 Quickly Identifying Failure

Some troubleshooting tasks may require you to identify the hardware version and status of

your equipment. To check equipment information,

Select [Menu]→[System Setup]→[Maintain Mode]→Enter the required password to

enter the maintenance mode. In the maintenance mode, you can perform related tests to

primarily identify the failure.

6.4 General Problems and System Messages

Refer to Chapter 9 Troubleshooting of the operator’s manual.

6-1

6.5 Troubleshooting Guide

6.5.1 Power On/Off Failures

6-2

6.5.2 Recorder Failures

Recorder not work

1. Check platen in position.

2. Check paper correctly loaded.

3. Close battery door.

Message “Please

N

End

check recorder”

presented?

Replace

print head

Recording paper

incorrectly loaded

Message “Recorder

unavailable!” presented?

N

Message “Please

Y

check recorder”

presented?

N

Y

Recorder runs by pressing

“Manual” key?

Y

N

Message

“Paper type error”

presented?

Y

Y

N

Cable between

recorder and main

board loose or

failed?

N

Ok after recorder drive

board replaced？

N

Replace main board

Perform keypad test in

maintenance mode.

Replace keypad board if

failed.

Y

Reconnect or
replace cable

EndY

Set “Paper Type”correctly

6-3

6.5.3 Wrong system time

Displayed system time is

wrong

Message

“RT clock error”

is presented?

N

N

No cell button or
cell button failed

N

Replace main control board

Y

Y OKReset system time

Y Replace button cell

Replace main

control board

6-4

6.5.4 Wi-Fi Related Failures

Symptoms Possible Cause Action

Wi-Fi function does not

work. No Wi-Fi icon shows

at the top of the screen.

The equipment is frequently

off line or disconnects from

the network.

Unable to connect the

network. The network

disconnected symbol

shows at the top of the

screen.

Wi-Fi module is not properly

installed.

Wi-Fi module fails Replace the Wi-Fi module.

Main board fails Replace the main board.

The Wi-Fi antenna is

detached from the equipment

housing, or detached from

the Wi-Fi module, or the

antenna is damaged.

Wi-Fi module failure. Replace the Wi-Fi module.

Wi-Fi signal is unstable Check that the hospital Wi-Fi

Wrong network parameter

settings, for example, IP

address is not correctly set or

the password is not correct.

The Wi-Fi signal is weak. Check that hospital Wi-Fi

Reinstall the Wi-Fi module

properly.

1. Visually check if the Wi-Fi

antenna is damaged. If yes,

replace the antenna.

2. If the antenna is not

damaged, check that the

Wi-Fi antenna is properly

connected with the module.

Secure the antenna properly.

signal is stable.

Check if there is IP conflict.

Re-set the IP address

correctly and enter correct

password.

signal is stable and strong.

The Wi-Fi antenna is

detached from the equipment

housing, or detached from

the Wi-Fi module.

Main board fails Replace the main board.

Secure the antenna properly.

6-5

FOR YOUR NOTES

6-6

7 Disassembly and Repair

7.1 Tools Required

To disassemble and replace the parts and components, the following tools may be required:

 Philips screwdrivers
 Tweezers
 Sharp nose pliers
 Clamp

7.2 Preparations for Disassembly

Before disassembling the equipment, finish the following preparations:

 Stop measuring, turn off the equipment, and disconnect all the accessories and

peripheral devices.

 Disconnect the AC power source and remove the battery.

WARNING

 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.

 Properly connect and route the cables and wires when reassembling the equipment to

avoid short circuit.

 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.

 Follow correct sequence to disassembly the equipment. Otherwise, the equipment

may be damaged permanently.

 Be sure to disconnect all the cables before disassembling any parts. Be sure not to

damage any cables or connectors.

 Be sure to place removed screws and disassembled parts properly, preventing them

from being lost or contaminated.

 Place the screws and parts from the same module together to facilitate reassembling.
 To reassemble the equipment, first assemble the assemblies, and then the main unit.

Carefully route the cables.

7-1

7.3 Disassembling the Main Unit

NOTE

 To disassemble the equipment, place the equipment on a work bench free from

foreign material, avoiding damaging the screen.

 All the operations should be performed by qualified service personnel only.

When disassembling the PCBAs and 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.

7.3.1 Removing Bottom housing assembly

1. Lay the equipment on the work bench. Unscrew the M3×6 screw to open the battery

compartment door. Then remove the battery.

2. Unscrew the four M4×10 screws and remove the bottom housing assembly.

7-2

7.3.2 Remove the Power Board

Unscrew the four M3×6 screws. Disconnect the AC input receptacle and the cable.

Disconnect the connection cable between the main control board and the power board. Then

take out the power board and the insulator.

AC input receptacle

and cable

7.3.3 Removing the Main Control Board

1. Release the latch locking the flexible PCB connecting the display to the main control

board by pushing the latch from Position 1 to Position 2 as shown in the picture below.

Disconnect the flexible PCB.

Position 1

Position 2

NOTE

 Make sure to disconnect the flexible PCB between the main control board and the

display before removing the main control board.

7-3

2. Unscrew the four M3×6 screws. Disconnect the recorder cable, the connecting cable

between the main control board and the parameter board, the connecting cable between

the main control board and the keypad board, and the connecting cable between the

main control board and the power board.

3. Remove the main control board.

7.3.4 Upgrading to Have Wi-Fi Function and Repair the Wi-Fi

Module

Follow this procedure to upgrade the equipment to have the Wi-Fi function:

1. Remove the main control board as instructed by 7.3.3 Removing the Main Control

Board.

2. Install the Wi-Fi module on the main control board FRU that has a Wi-Fi module

connector. Connect the Wi-Fi antenna.

3. Install the main control board FRU on the electrocardiography. Secure the main

control board FRU with four M3×6 screws.

4. Stick the antenna as indicated by the following picture. Secure the antenna cable with a

tape.

7-4

Stick the Wi-Fi

p

antenna here

Stick the Wi-Fi

antenna here

Secure the Wi-Fi

cable under the

insulating plate

-

To repair the Wi-Fi module,

1. Remove the Wi-Fi antenna cable from the Wi-Fi module.

2. Remove the Wi-Fi module and replace with a new one.

Place the Wi-Fi cable below the plastic

frame and secure the cable with a ta

e.

Wi-Fi

7-5

7.3.5 Removing the Display

Before removing the display, remove the main control board as described in 7.3.3

Removing the Main Control Board.

Then you can remove the display. Follow this procedure:

1. Unscrew the four PT3×6 tapping screws to remove the displayfixing kit.

2. Remove the TFT display.

7.3.6 Removing the Parameter Board

1. Unscrew the four M3×6 tapping screws.

2. Disconnect the cable between the main control board and the parameter board.

7-6

7.3.7 Removing the Keypad Board

Before removing the keypad board, remove the parameter board as described in Section

7.3.6 Removing the Parameter Board.

Then follow this procedure to remove the keypad board:

1. Unscrew the four PT3×6 tapping screws.

2. Disconnect the cable between the main control board and the keypad board. Then

remove the keypad board.

7-7

7.3.8 Removing the Recorder Drive Board

1. Unscrew the two M3×6 screws. Disconnect the recorder cable

NOTE

 Make sure to the flexible PCB which is located under the TR8A recorder and

connects the thermal print head before disassembling the recorder drive board.

7-8

2. Release the latch locking the flexible PCB connecting thermal print head to the

recorder drive board by pushing the latch from Position 1 to Position 2 as shown in the

picture below. Disconnect the flexible PCB and remove the recorder drive board.

Position 1

Position 2

7.3.9 Removing the Thermal Print Head

Before removing the thermal print head, remove the recorder drive board as described in

Section 7.3.8 Removing the Recorder Drive Board

Then follow this procedure to remove the thermal print head:

1. Unscrew the two M3×6 screws, and the take out the thermal print head.

NOTE

 Open the recorder door before removing and installing the thermal print head.

7-9

FOR YOUR NOTES

7-10

8 Parts

8.1 Introduction

This chapter contains the exploded views and parts lists of the main unit. 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 same

parts and the quantity of the screws or stacking sleeves etc. may be different with those

included in the parts lists.

NOTE

 The part number listed in the Parts List is only for checking the FRU part number

which is also included in the Parts List. Please provide the FRU parts number if
you want to purchase the spare parts.

8-1

8.2 Main Unit

8.2.1 Exploded View

8-2

8.2.2 Parts List

SN PN Description FRU part number Remarks

1 021-000108-00 Display 021-000108-00 /

2 051-001353-01 Main control board

(512MB)

051-001882-00 Main control board

(512MB, Wi-Fi)

3 / Keypad (BeneHeart

R3/Chinese)

/ Keypad (BeneHeart

R3A/Chinese)

/ Keypad (BeneHeart

R3/symbol)

/ Keypad (BeneHeart

R3A/symbol)

115-017993-00 512M/Glasgow/PDF,

115-017994-00 512M/PDF, FRU

115-017995-00 512M/Glasgow, FRU

115-029555-00 512M/Glasgow/PDF,

115-029556-00 512M/Glasgow,

115-029557-00 512M/PDF, Wi-Fi,

/

/

/

/

FRU

FRU

Wi-Fi, FRU

FRU

/

/

/

/

4 047-010217-00 Display lens 047-010217-00 /

5 9211-20-87221 AC input receptacle / /

6 115-017634-00 BeneHeart R3 top

housing assembly

115-017793-00 BeneHeart R3A top

housing assembly

7 051-001354-01 Keypad board 051-001354-01 /

8 009-003326-00 Cable between main

board and keypad board

9 022-000125-00 Power board 022-000125-00 /

047-010840-00

10

11 009-003327-00 Cable between the main

12 115-018611-00 Parameter Board (FRU) 115-018611-00 /

Power board insulator

(M501)

control board and power

board

115-017634-00 /

115-017793-00

009-003326-00 /

047-010840-00 /

009-003327-00 /

/

8-3

SN PN Description FRU part number Remarks

13 009-003325-00 Cable between the main

control board and

parameter board.

14 115-017792-00 Bottom housing assembly 115-017792-00 /

009-003325-00 /

115-018387-00 Bottom housing assembly

(BeneHeart R3A)

15 022-000122-00 Li-ion battery, 11.1V,

2500 mAh, LI13S001A

16 043-003114-00 Battery door 043-003114-00 /

043-003451-00 Battery door (M501 for

bidding)

17 043-002861-00 Z-fold paper jam

protector

18 115-017633-00 Recorder door assembly 115-017633-00 /

19 043-003112-00 Recorder link 043-003112-00 /

20 043-003110-00 Recorder button 043-003110-00 /

21 DA6H-20-22947 Battery block spring

22 024-000134-00 Thermal print head, 8

dot/mm, 72 mm, 60

mm/sec, FPC lead

115-018387-00 /

022-000122-00 /

043-003451-00 /

043-002861-00 /

DA6H-20-22947 /

024-000134-00 /

23 051-000487-00 TR8A recorder drive

board

24 009-003231-00 Recorder cable 009-003231-00 /

051-000487-00 /

8-4

8.3 Top Housing Assembly (115-017634-00 or

115-017793-00)

8.3.1 Exploded View

8.3.2 Parts List

SN PN Description FRU part number Remarks

1 / Display lens

2 / Upper housing /

3 / Display dust-proof strip, short /

4 / Display dust-proof strip, long /

5 / AC input receptacle and cable /

115-017634-00 or

115-017793-00

/

8-5

8.4 Recorder door assembly (115-017633-00)

8.4.1 Exploded View

8.4.2 Parts List

SN PN Description FRU part number Remarks

1 043-002861-00

2 / Recorder door latch

3 / Reset spring /

4 / Platen /

5 / Overlay with instructions /

6 / Recorder door /

Z-fold paper jam
protector

/ /

/

115-017633-00

8-6

8.5 Bottom housing assembly (115-017792-00 or

115-018387-00)

8.5.1 Exploded View

8.5.2 Parts List

SN PN Description

1 / Rubber foot

2 / Recorder instruction labelling /

3 / Lower housing /

4 / Device labelling (Chinese) /

FRU part
number

115-017792-00 or

115-018387-00

Remarks

/

8-7

FOR YOUR NOTES

8-8

9 Replacement Parts, Software Upgrade

Package and Accessories

9.1 BeneHeart R3/R3A BOM (V1.0) for Repair, Upgrade

and Accessories

SN PartNumber PartDescription

1. 051-001353-01 PCBA,Low-End 3-CHA ECG Mainboard(ALL)

2. 115-017993-00 Main board(512M/Glasgow/PDF)

3. 115-017994-00 Main board(512M/PDF)

4. 115-017995-00 Main board(512M/Glasgow)

5. 022-000125-00 POWER SUPPLY BOARD 15V 40W

6. 047-010840-00 Main Board Insulation(M501)

7. 115-018611-00 cardiofax signal acquisition board PCBA

8. 051-000487-00 Recorder driver board PCBA

9. 051-001354-01 PCBA,3-Channel ECG KeyBoard

10. 021-000108-00 LCD panel TFT 5" 800*480

11. 024-000134-00 printer 8dot/mm 72mm 60mm/secFPC

12. 115-017634-00 top cover assembly

13. 115-017793-00 top cover assembly

14. 047-010217-00 lens(M501)

15. 049-000544-00 silica gel key(Beneheart R3/icon)

16. 049-000575-00 silica gel key(Beneheart R3A/icon)

17. 115-017633-00 Recorder bin gate assembly

18. 043-002861-00 fan fold paper platen

19. 043-003112-00 recorder link

20. 043-003110-00 recorder button

21. DA6H-20-22947 battery block pole spring

22. 115-017792-00 bottom cover assembly

23. 115-018387-00 bottom cover assembly(beneHeart R3A)

24. 043-003114-00 battery door

25. 043-003451-00 battery door(M501 bid inviting)

9-1

SN PartNumber PartDescription

26. 009-003231-00 recorder connecting cable

27. 009-003325-00 Cable for to parameter

28. 009-003326-00 Cable for to keypad

29. 009-003327-00 Cable for MB to power

30. 0651-20-76879 AC power socket & connecting cable

31. 046-004749-00 Physician's Guide, Glassgow

32. 046-004817-00 Glasgow Physician's Guide(for ECG-EN)

33. 046-004650-00 BeneHeart R3 Operator's Manual (Chinese)

34. 046-004651-00 BeneHeart R3 Operator's Manual (English)

35. 046-004737-00 BeneHeart R3 Operator's Manual (German)

36. 046-004738-00 BeneHeart R3 Operator's Manual (French)

37. 046-004739-00 BeneHeart R3 Operator's Manual (Czech)

38. 046-004740-00 BeneHeart R3 Operator's Manual (Italian)

39. 046-004741-00 BeneHeart R3 Operator's Manual (Spanish)

40. 046-004742-00 BeneHeart R3 Operator's Manual (PTBL)

41. 046-004743-00 BeneHeart R3 Operator's Manual (Brazil)

42. 046-004744-00 BeneHeart R3 Operator's Manual (Russian)

43. 046-004745-00 BeneHeart R3 Operator's Manual (Turkish)

44. 046-004746-00 BeneHeart R3 Operator's Manual (Polish)

45. 046-004747-00 BeneHeart R3 Operator's Manual (Romania)

46. 046-004748-00 BeneHeart R3 Operator's Manual (HU)

47. 046-004653-00 BeneHeart R3 Quick Guide (English)

48. 115-018007-00 Glasgow upgrade Glasgow

49. 115-017996-00 PDF upgrade package

50. 043-004232-00 yoke holder

51. 043-000386-00 Bin,overmolded,value stand

52. 043-004231-00 handle

53. 034-000302-00 casters.3''

54. 043-000389-00 Base cover,value stand

9.2 Material Change

Update the service manual as per the latest BOM.

9-2

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. Please

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

Test Item 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 power plug

The strain relief

The power plug No loose connections.

The power cord

No physical damage to the strain relief. No plug

warmth for device in use.

No physical damage to the cord. No deterioration to

the cord.

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.

No physical damage to meters, switches, connectors, etc.

The enclosure and accessories

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.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 25AMP. The front panel outlet power is turned off for this test.

The following conditions apply: L1 and L2 Open.

A-2

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

 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.

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 (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).

A-3

NOTE

 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

ALL COUNTRIES R = 0.2 Ω Maximum

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:

A-4

 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.

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.
 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 UL60601-1,

 300 μA in Normal Condition
 1000 μA in Single Fault Condition

For IEC60601-1,

 500 μA in Normal Condition
 1000 μA in Single Fault Condition

A-5

A.6 Patient Leakage Current

Patient leakage currents are measured between a selected applied part and mains earth. All

measurements have a true RMS 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

WARNING

 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.

A-6

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.
 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 CF applied parts

 10μA in Normal Condition
 50μA in Single Fault Condition

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

A-7

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

 A 2-beep-per-second signal indicates high voltage present at the applied part

terminals while a calibration is being performed.

 High voltage is present at applied part terminals while measurements are being

taken.

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.

A-8

NOTE

 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.
 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 CF applied parts: 50 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 a true RMS 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.

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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.

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.
 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 CF applied parts,

 10μA in Normal Condition
 50μA in Single Fault Condition

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A.9 Scheduled Electrical Safety Inspection

For scheduled electrical safety inspection, test items 1, 2, 3, 4, 5, 6, 7, and 8 included in the

ELECTRICAL SAFETY INSPECTION FORM shall be performed.

ELECTRICAL SAFETY INSPECTION FORM

Location: Technician:
Equipment: Control Number:
Manufacturer: Model: SN:
Measurement equipment /SN: Date of Calibration:
INSPECTION AND TESTING Pass/Fail Limit

1 Power Cord Plug

2 Device Enclosure and Accessories

3 Device Labeling

4 Protective Earth Resistance Ω Max 0.2 Ω

Normal condition

(NC)

5

Earth

Leakage

Single Fault

condition (SFC)

____μA

____μA

Max:

NC: 300μA(refer to

UL60601-1) *

NC: 500μA(refer to

IEC60601-1) *

SFC: 1000μA

Normal condition

Patient

6

Leakage

Current

(NC)

Single Fault

condition (SFC)

7 Mains on Applied Part Leakage

Normal condition

Patient

8

Auxiliary

Current

(NC)

Single Fault condition

(SFC)

□BF____μA

□CF____μA

□BF____μA

□CF____μA

□BF____μA

□CF____μA

□BF____μA

□CF____μA

□BF____μA

□CF____μA

Max:

CF applied part:

NC:10μA, SFC: 50μA

Max:

CF applied part: 50μA

Max:

CF applied part:

NC:10μA, SFC: 50μA

Note: The equipment sold to the United States shall comply with the requirement of

UL60601-1; others shall comply with the requirement of IEC60601-1.

Name/ Signature: __________________________

Date:_____________________________

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A.10 Electrical Safety Inspection after Repair

The following table specifies test items to be performed after the equipment is repaired.

Repair with main unit not disassembled
Repair with

main unit
disassemble
d

When neither power supply

PCBA nor patient

electrically-connected PCBA is

repaired or replaced

When power supply PCBA is

repaired or replaced

When patient

electrically-connected PCBA is

repaired or replaced

When both power supply

PCBA and patient

electrically-connected PCBA are

repaired or replaced

Test items: 1, 2, 3

Test items: 1, 2, 3, 4

Test items: 1, 2, 3, 4, 5

Test items: 1, 2, 3, 4, 6, 7, 8

Test items: 1, 2, 3, 4, 5, 6, 7, 8

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ELECTRICAL SAFETY INSPECTION FORM

Location: Technician:
Equipment: Control Number:
Manufacturer: Model: SN:
Measurement equipment /SN: Date of Calibration:
INSPECTION AND TESTING Pass/Fail Limit

1 Power Cord Plug

2 Device Enclosure and Accessories

3 Device Labeling

4 Protective Earth Resistance Ω Max 0.2 Ω

Normal

condition(NC)

5

Earth

Leakage

Single Fault

condition(SFC)

____μA

____μA

Max:

NC: 300μA(refer to

UL60601-1) *

NC: 500μA(refer to

IEC60601-1) *

SFC: 1000μA

Normal

Patient

6

Leakage

Current

condition(NC)

Single Fault

condition(SFC)

7 Mains on Applied Part Leakage

Normal condition(NC)

Patient

8

Auxiliary

Current

Single Fault

condition(SFC)

□BF____μA

□CF____μA

□BF____μA

□CF____μA

□BF____μA

□CF____μA

□BF____μA

□CF____μA

□BF____μA

□CF____μA

Max:

CF applied part:

NC:10μA, SFC: 50μA

Max:

CF applied part: 50μA

Max:

CF applied part:

NC:10μA, SFC: 50μA

Note: The equipment sold to the United States shall comply with the requirement of

UL60601-1; others shall comply with the requirement of IEC60601-1.

Name/ Signature: __________________________

Date:_____________________________

A-13

FOR YOUR NOTES

A-14

P/N: 046-005000-00 (2.0)