Shenzhen mindray BeneHeart R3 User manual

BeneHeart R3/BeneHeart R3A
Electrocardiograph
Operator’s Manual

I
© Copyright 2013 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
For this Operator’s Manual, the issue date is April 2013.

II
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property
rights to this Mindray 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 intends to maintain the contents of this manual as confidential information. Disclosure of the information in
this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner
whatsoever without the written permission of Mindray is strictly forbidden.
, , and are the registered trademarks or trademarks owned
by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial
purposes without the intention of improperly using them. They are the property of their respective owners.
Responsibility on the Manufacturer Party
Contents of this manual are subject to changes without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein
nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this product are conducted by
Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and local requirements;
the product is used in accordance with the instructions for use.
WARNING
zThis equipment must be operated by skilled/trained clinical professionals.
zIt is important for the hospital or organization that employs this equipment to carry out a reasonable
service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

III
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
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.
This warranty shall not extend to
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address Mindray Building,Keji 12th Road South,High-tech industrial
park,Nanshan,Shenzhen 518057,P.R.China
Website www.mindray.com
E-mail Address: [email protected]om.cn
Tel: [phone]
Fax: [phone]
EC-Representative: Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestraβe 80, 20537 Hamburg, Germany
Tel: [phone]
Fax: [phone]

IV
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. If you
have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained
conveniently when needed.
Intended Audience
This manual is geared for clinical professionals who are expected to have corresponding working knowledge of medical
procedures, practices and terminology as required for the treatment of patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on
your equipment.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.
[ ] is used to enclose screen texts.
is used to indicate operational procedures.→

I
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 Intended Use........................................................................................................................................................................................................ 2-1
2.2 Main Unit ............................................................................................................................................................................................................... 2-1
2.2.1 Front View...............................................................................................................................................................................................2-1
2.2.2 Side View.................................................................................................................................................................................................2-3
2.2.3 Back View ................................................................................................................................................................................................2-3
2.2.4 Bottom View ..........................................................................................................................................................................................2-4
2.3 Display Screen ..................................................................................................................................................................................................... 2-4
2.4 Operating Mode ................................................................................................................................................................................................. 2-5
2.4.1 Normal Mode ........................................................................................................................................................................................2-5
2.4.2 Standby Mode.......................................................................................................................................................................................2-6
2.4.3 Demo Mode...........................................................................................................................................................................................2-6
2.4.4 Maintenance Mode .............................................................................................................................................................................2-6
3 Basic Operations...........................................................................................................................................................3-1
3.1 Installation ............................................................................................................................................................................................................ 3-1
3.1.1 Unpacking and Checking .................................................................................................................................................................3-1
3.1.2 Environmental Requirements .........................................................................................................................................................3-2
3.2 Getting Started.................................................................................................................................................................................................... 3-2
3.2.1 Connecting AC Mains.........................................................................................................................................................................3-2
3.2.2 Using a Battery......................................................................................................................................................................................3-3
3.2.3 Loading Paper .......................................................................................................................................................................................3-4
3.2.4 Connecting the Patient Cable .........................................................................................................................................................3-5
3.2.5 Checking the Equipment before Power On ...............................................................................................................................3-5
3.2.6 Turning On the Equipment...............................................................................................................................................................3-6
3.2.7 Configuring the Equipment.............................................................................................................................................................3-6
3.2.8 Turning off the Equipment...............................................................................................................................................................3-6
4 System Setup ................................................................................................................................................................4-1
4.1 Accessing the Main Menu ............................................................................................................................................................................... 4-1
4.2 Wave Setup ........................................................................................................................................................................................................... 4-2
4.3 Record Setup........................................................................................................................................................................................................ 4-3
4.4 File Management................................................................................................................................................................................................ 4-6
4.5 Patient Info Setup............................................................................................................................................................................................... 4-7
4.6 System Setup ....................................................................................................................................................................................................... 4-8

II
5 File Management......................................................................................................................................................... 5-1
5.1 Accessing File Management ...........................................................................................................................................................................5-1
5.2 Managing Patient Archives..............................................................................................................................................................................5-1
5.2.1 Accessing the Directory Screen......................................................................................................................................................5-1
5.2.2 Searching the Patient’s Archives....................................................................................................................................................5-3
5.3 Managing Configuration..................................................................................................................................................................................5-3
5.3.1 Loading Configuration ......................................................................................................................................................................5-3
5.3.2 Exporting Configuration...................................................................................................................................................................5-4
6 Patient Preparation ..................................................................................................................................................... 6-1
6.1 Preparing a Patient .............................................................................................................................................................................................6-1
6.2 Preparing the Skin ..............................................................................................................................................................................................6-1
6.3 Connecting Lead Wires and Electrodes ......................................................................................................................................................6-2
6.3.1 ECG Accessories ...................................................................................................................................................................................6-2
6.3.2 Connecting Chest Lead Wires with Chest Electrodes.............................................................................................................6-3
6.3.3 Connecting Limb Lead Wires with Limb Electrodes ...............................................................................................................6-3
6.4 Applying Electrodes...........................................................................................................................................................................................6-4
6.4.1 Electrode Placement ..........................................................................................................................................................................6-4
6.4.2 Pediatric Lead Placement .................................................................................................................................................................6-4
6.4.3 Lead Wire Colour Code ......................................................................................................................................................................6-5
6.4.4 Applying Reusable Electrodes........................................................................................................................................................6-5
6.4.5 Applying Disposable Electrodes....................................................................................................................................................6-6
6.5 When Lead Off Occurs.......................................................................................................................................................................................6-7
6.6 Entering Patient Information ..........................................................................................................................................................................6-7
6.6.1 Quickly Entering Patient Information ..........................................................................................................................................6-7
6.6.2 Entering Patient Information from Patient Info Screen.........................................................................................................6-8
7 Acquiring an ECG ......................................................................................................................................................... 7-1
7.1 Measurement Mode...........................................................................................................................................................................................7-1
7.1.1 Auto Measurement.............................................................................................................................................................................7-1
7.1.2 Manual Measurement........................................................................................................................................................................7-1
7.1.3 Rhythm Measurement.......................................................................................................................................................................7-2
7.2 Acquiring an ECG ................................................................................................................................................................................................7-2
7.3 Setting ECG Waveforms ....................................................................................................................................................................................7-2
7.4 Setting ECG Report.............................................................................................................................................................................................7-2
7.5 Copying an Report..............................................................................................................................................................................................7-3
7.6 Saving Patient Report........................................................................................................................................................................................7-3
7.7 Resting 12-lead ECG Analysis..........................................................................................................................................................................7-3
7.8 ECG Report ............................................................................................................................................................................................................7-4
8 Troubleshooting .......................................................................................................................................................... 8-1
8.1 General Problems................................................................................................................................................................................................8-1
8.2 Messages................................................................................................................................................................................................................8-2
8.2.1 Message List 1.......................................................................................................................................................................................8-3
8.2.2 Prompt Message List 2.......................................................................................................................................................................8-4

III
9 Battery..........................................................................................................................................................................9-1
9.1 Overview ................................................................................................................................................................................................................9-1
9.2 Charging the Battery..........................................................................................................................................................................................9-1
9.3 Replacing the Battery ........................................................................................................................................................................................9-1
9.4 Battery Guidelines...............................................................................................................................................................................................9-2
9.5 Battery Maintenance..........................................................................................................................................................................................9-3
9.5.1 Conditioning a Battery...................................................................................................................................................................... 9-3
9.5.2 Checking a Battery ............................................................................................................................................................................. 9-3
9.6 Battery Recycling.................................................................................................................................................................................................9-4
10 Care and Maintenance ............................................................................................................................................10-1
10.1 Cleaning and Disinfecting .......................................................................................................................................................................... 10-1
10.1.1 Cleaning.............................................................................................................................................................................................10-2
10.1.2 Disinfecting ......................................................................................................................................................................................10-3
10.1.3 Sterilization.......................................................................................................................................................................................10-3
10.2 Regular Check ................................................................................................................................................................................................. 10-4
10.3 Maintaining the Battery............................................................................................................................................................................... 10-4
10.4 Storing Thermal Recording Paper............................................................................................................................................................ 10-5
10.5 Storing Cables and Lead Wires.................................................................................................................................................................. 10-5
10.6 Electrical Safety Tests.................................................................................................................................................................................... 10-5
11 Accessories...............................................................................................................................................................11-1
11.1 ECG Accessories.............................................................................................................................................................................................. 11-1
11.2 Others................................................................................................................................................................................................................. 11-1
A Product Specifications................................................................................................................................................A-1
A.1 Classifications...................................................................................................................................................................................................... A-1
A.2 Environmental Specifications........................................................................................................................................................................ A-1
A.3 Power Supply Specifications.......................................................................................................................................................................... A-2
A.4 Physical Specifications ..................................................................................................................................................................................... A-2
A.5 Hardware Specifications.................................................................................................................................................................................. A-3
A.6 Measurement Specifications ......................................................................................................................................................................... A-4
B EMC...............................................................................................................................................................................B-1
C Symbols and Abbreviations........................................................................................................................................C-1
C.1 Units........................................................................................................................................................................................................................ C-1
C.2 Symbols ................................................................................................................................................................................................................. C-2
C.3 Abbreviations and Acronyms ........................................................................................................................................................................ C-3
D Electrical Safety Inspection....................................................................................................................................... D-1
D.1 Power Cord Plug.................................................................................................................................................................................................D-1
D.2 Device Enclosure and Accessories...............................................................................................................................................................D-2
D.3 Device Labeling..................................................................................................................................................................................................D-2
D.4 Protective Earth Resistance............................................................................................................................................................................D-2
D.5 Earth Leakage Test.............................................................................................................................................................................................D-3

IV
D.6 Patient Leakage Current.................................................................................................................................................................................. D-3
D.7 Mains on Applied Part Leakage.................................................................................................................................................................... D-4
D.8 Patient Auxiliary Current................................................................................................................................................................................. D-4

1-1
1Safety
1.1 Safety Information
DANGER
zIndicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING
zIndicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.
CAUTION
zIndicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or
product/property damage.
NOTE
zProvides application tips or other useful information to ensure that you get the most from your product.

1-2
1.1.1 Dangers
There are no dangers that refer to the product in general. Specific“Danger” statements may be given in the respective
sections of this manual.
1.1.2 Warnings
WARNINGS
zThis equipment is used for single patient at a time.
zBefore putting the system into operation, the operator must verify that the equipment, connecting cables
and accessories are in correct working order and operating condition.
zThe 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.
zTo avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres,
flammable anesthetics, or other flammable agents (such as gasoline).
zDo not open the equipment housings. All servicing and future upgrades must be carried out by the
personnel trained and authorized by our company only.
zDo not touch the patient when connecting peripheral equipment via the I/O signal ports to prevent patient
leakage current exceeds the requirements of applicable standards.
zThis equipment is not intended to be in use with high frequency surgical units.
zDo not come into contact with patients during defibrillation. Otherwise serious injury or death could
result.
zFor paced patients, the equipment may mistake a pace pulse for a QRS complex if several adverse
conditions exist simultaneously. Always keep these patients under close surveillance.
zThe physiological data and waveforms displayed on the equipment are for reference only and cannot be
directly used for diagnostic interpretation.
zTo 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.
zProperly dispose of the package material according to applicable waste control regulations and keeping it
out of children’s reach.

1-3
1.1.3 Cautions
CAUTIONS
zUse only parts and accessories specified in this manual.
zAt the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance
with the guidelines regulating the disposal of such products. If you have any questions concerning
disposal of the equipment, please contact us.
zMagnetic and electrical fields are capable of interfering with the proper performance of the equipment.
For this reason make sure that all external devices operated in the vicinity of the equipment comply with
the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of
interference as they may emit higher levels of electromagnetic radiation.
zBefore 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.
zAlways install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration
or other mechanical force.
1.1.4 Notes
NOTES
zPut the equipment in a location where you can easily see the screen and access the operating controls.
zKeep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.
zThe software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from
software errors is minimized.
zThis manual describes all features and options. Your equipment may not have all of them.

1-4
1.2 Equipment Symbols
NOTE
zSome symbols may not appear on your equipment.
Caution (Attention, consult
accompanying documents) ON/OFF for part of equipment
Battery indicator Alternating current (AC)
DEFIBRILLATION-PROOF TYPE CF
APPLIED PART
Equipotentiality
Network connector USB connector
DATE OF MANUAFACTURE Serial number
Dispose of in accordance to your
country’s requirements
Environment-friendly Used Period
per Chinese Standard
SJ/T11363-2006
CCC Mark – China Compulsory
Certification mark
China Metrology Certification
Authorized representative in the European Community
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.

2-1
2The Basics
2.1 Intended Use
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 is intended to be used by clinical professionals or under their guidance. It must only be used by persons
who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on
it.
2.2 Main Unit
2.2.1 Front View
1. Display screen: presents waveforms and texts
2. Recorder: print reports
3. Operating panel: see the table below for details
1
2
3

2-2
Key Function
F1
(Numerical key “1”)
Function key, select the option that appears at the right side of the screen.
In numeric keypad mode, enter the number “1”.
F2
(Numerical key “4”)
Function key, select the option that appears at the right side of the screen.
In numeric keypad mode, enter the number “4”.
F3
(Numerical key “7”)
Function key, select the option that appears at the right side of the screen.
In numeric keypad mode, enter the number “7”.
F4
(Enter key)
Function key, select the option that appears at the right side of the screen.
In numeric keypad mode, confirm the input or selection.
Menu
(Numerical key “2”)
Access the main menu.
Exit the menu when a menu is opened.
In numeric keypad mode, enter the number “2”.
Filter
(Numerical key “5”)
Switch the frequency of muscle artifact filter.
In numeric keypad mode, enter the number “5”.
(Numerical key “8”)
Switch the leads to be recorded in manual measurement mode.
In numeric keypad mode, enter the number “8”.
Manual
(Numerical key “0”)
Start recording real-time ECG report.
Stop recording.
In numeric keypad mode, enter the number “0”.
ID
(Numerical key “3”)
Press this key, and then press numeric keys to enter patient’s ID.
When [Detailed Patient Info] is enabled, enter the Patient Info menu.
In numeric keypad mode, enter the number “3”.
Age
(Numerical key “6”)
Press this key, and then press numeric keys to enter patient’s age.
When [Detailed Patient Info] is enabled, press this key to enter the Patient Info menu.
In numeric keypad mode, enter the number “6”.
Gender
(Numerical key “9”)
Switch patient’s gender.
When [Detailed Patient Info] is enabled, enter the Patient Info menu.
In numeric keypad mode, enter the number “9”.
Rhythm
(Backspace)
Record a rhythm report.
Stop recording.
In numeric keypad mode, delete characters.
Power on/off switch
Turn on the equipment.
Turn off the equipmentby pressing and holding this key for 0.5 second.
Forcefully shut down the equipmentby pressing and holding this key for 6 seconds when it
could not be shut down normally or under some special situations.
ECG
Start recording auto ECG report.
Stop recording.

2-3
Indicator Description
Power indicator
On: when the equipment is powered on.
Off: when the equipment is powered off.
Battery indicator
Green: when the equipment operates on battery power or the battery is being charged.
Yellow: when the equipment operates on battery power and the battery is low.
Yellow, blink: when the equipment operates on battery power and the battery is depleted.
Off: when no battery is installed or the battery is fully charged.
AC indicator
On: when AC mains is connected.
Off: when AC mains is not connected.
2.2.2 Side View
1. Patient cable connector: connects the patient cable for ECG acquisition
2. Recorder door latch: opens the recorder door
3. Network connector: connects the equipment to the network for software upgrade
4. USB connector: connects USB disc for data transfer
2.2.3 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 4 4
2
1
3

2-4
2.2.4 Bottom View
1. Battery compartment
2.3 Display Screen
Normal Screen
1. Patient and system information area
This area shows patient information including patient ID, gender, age, and heart rate, as well as system information,
including Wi-Fi and USB memory connecting status, system time, battery status, and etc.
2. Waveform area: displays ECG waveforms.
3. Message area 1: displays lead off and noise information.
4. Message area 2: displays messages except lead off and noise.
5. Muscle artifact filter setting: displays the setting of muscle artifact filter. If the filter is disabled, the display is 150Hz.
6. Soft key area: shows the labels of Function Keys located rightwards.
1
2
1
6
3 45

2-5
Main Menu
1. Heading: shows system information
2. Options of main menu
3. Options of submenu
4. Function Key labels area
Pressing F1 returns to previous menu.
Pressing F2 and F3 selects the previous or next option, or toggles between settings when an option is
selected.
Pressing F4 confirms the selection.
2.4 Operating Mode
2.4.1 Normal Mode
The equipment enters Normal Mode after being turned on.
In Normal Mode, you can acquire the patient’s electrocardiographic information, record ECG waveforms, measurements,
and diagnoses. You can also perform system setup and export data.
1
2
34

2-6
2.4.2 Standby Mode
In the case that any of the limb leads is detached, the equipment automatically enters Standby Mode if there is no
operation within the defined time.
To set the time,
1. Press the [Menu] key to enter the main menu.
2. Select [System Setup]→[Auto Standby].
3. Set the time to automatically enter the standby mode.
In Standby Mode, the screen is off. This helps reduce power consumption and extend the life of the equipment.
To returns to Normal Mode, press any key.
2.4.3 Demo Mode
In Demo Mode, the equipment can demonstrate its major functions when patient or patient simulator is not connected.
Demo Mode is password protected.
To enter Demo Mode,
1. Press the [Menu] key to enter the main menu.
2. Select [System Setup]→[Demo Mode].
3. Enter the password.
To exit Demo Mode, turn off the equipment and restart it.
WARNING
zThe Demo mode is for demonstration purpose only. To avoid that the simulated data are mistaken for the
measurements, you must not enter Demo mode during ECG acquisition.
2.4.4 Maintenance Mode
The equipment provides Maintenance Mode for service personnel to check and test the equipment. Maintenance Mode
is password protected.