BeneHeart R3 and R3A Electrocardiograph Operators Manual Rev 15.0 Feb 2020

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 

This equipment must be operated by skilled/trained clinical professionals.



It 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.

II

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]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

III

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.

IV

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 Applied Parts... 2-1 2.3 Main Unit ... 2-1 2.3.1 Front View... 2-1 2.3.2 Side View... 2-3 2.3.3 Back View ... 2-3 2.3.4 Bottom View ... 2-4 2.4 Display Screen ... 2-4 2.5 Operating Mode ... 2-6 2.5.1 Normal Mode ... 2-6 2.5.2 Standby Mode ... 2-7 2.5.3 Demo Mode ... 2-7 2.5.4 Maintenance Mode ... 2-7

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... 3-3 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 Connecting the Barcode Reader ... 3-5 3.2.6 Checking the Equipment before Power On ... 3-5 3.2.7 Turning On the Equipment ... 3-6 3.2.8 Configuring the Equipment... 3-6 3.2.9 Turning off the Equipment ... 3-6

4 System Setup ... 4-1 4.1 Accessing the Main Menu ... 4-1 4.2 Waveform Setup ... 4-2 4.3 Report Setup ... 4-3 4.4 File Management ... 4-8 1

4.5 Basic Setup ... 4-9 4.6 Maintenance ... 4-11

5 Patient Information ... 5-1 5.1 Setting Patient Information ... 5-1 5.2 Entering Patient Information ... 5-2 5.2.1 Quickly Entering Patient Information ... 5-2 5.2.2 Reading Patient ID Using the Barcode Reader ... 5-2 5.2.3 Entering Patient Information from Patient Info Screen... 5-3

6 Patient Preparation ... 6-1 6.1 Relaxing a Patient ... 6-1 6.2 Preparing the Skin ... 6-1 6.3 Connecting Lead Wires and Electrodes ... 6-1 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 ... 6-3 6.4.1 Electrode Placement ... 6-3 6.4.2 Pediatric Lead Placement ... 6-4 6.4.3 Lead Wire Colour Code ... 6-4 6.4.4 Applying Reusable Electrodes ... 6-5 6.4.5 Applying Disposable Electrodes ... 6-6 6.5 When Lead Off Occurs ... 6-6

7 Acquiring an ECG ... 7-1 7.1 Setting ECG Waveforms ... 7-1 7.2 Setting ECG Report... 7-1 7.3 Recording an ECG ... 7-2 7.3.1 Auto Measurement ... 7-2 7.3.2 Manual Measurement ... 7-2 7.3.3 Rhythm Measurement... 7-3 7.4 Printing a Report ... 7-3 7.5 Copying an Report ... 7-4 7.6 Saving Patient Report... 7-4 7.7 Resting 12-lead ECG Analysis ... 7-4 7.8 ECG Report ... 7-6

8 File Management ... 8-1 8.1 Accessing File Management ... 8-1 8.2 Managing Patient Archives ... 8-1 8.2.1 Accessing the Directory Screen ... 8-1 8.2.2 Searching the Patient’s Archives ... 8-3 8.3 Managing Configuration ... 8-3 8.3.1 Loading Configuration ... 8-3 8.3.2 Exporting Configuration... 8-4 2

8.4 Sending Files ... 8-4

9 Troubleshooting ... 9-1 9.1 General Problems ... 9-1 9.2 Messages ... 9-2 9.2.1 Message List 1 ... 9-2 9.2.2 Message List 2 ... 9-6

10 Battery ... 10-1 10.1 Overview ... 10-1 10.2 Charging the Battery ... 10-1 10.3 Replacing the Battery ... 10-1 10.4 Battery Guidelines ... 10-2 10.5 Battery Maintenance ... 10-3 10.5.1 Conditioning a Battery ... 10-3 10.5.2 Checking a Battery ... 10-3 10.6 Battery Recycling ... 10-4

11 Care and Maintenance ... 11-1 11.1 Cleaning and Disinfecting ... 11-1 11.1.1 Cleaning ... 11-2 11.1.2 Disinfecting ... 11-3 11.1.3 Sterilization ... 11-3 11.2 Regular Check ... 11-4 11.3 Maintaining the Battery ... 11-4 11.4 Storing Thermal Recording Paper ... 11-5 11.5 Storing Cables and Lead Wires... 11-5 11.6 Electrical Safety Tests ... 11-5

12 Accessories... 12-1 12.1 ECG Accessories... 12-1 12.2 Others ... 12-2

A Product Specifications... A-1 A.1 Classifications ... A-1 A.2 Environmental Specifications ... A-1 A.3 Power Supply Specifications... A-1 A.4 Physical Specifications ... A-2 A.5 Hardware Specifications... A-2 A.6 Wireless Network ... A-3 A.7 Measurement Specifications ... A-3

B EMC and Radio Regulatory Compliance ... B-1 B.1 EMC ... B-1 B.2 Radio Regulatory Compliance ... B-5

3

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

E Declaration of Conformity ... E-1

4

1 Safety 1.1 Safety Information

DANGER 

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

WARNING 

Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.

CAUTION 

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

NOTE 

Provides application tips or other useful information to ensure that you get the most from your product.

1-1

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 

This equipment is used for single patient at a time.



Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.



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.



To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).



Do not open the equipment housings. All servicing and future upgrades must be carried out by the personnel trained and authorized by our company only.



Do 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.



This equipment is not intended to be in use with high frequency surgical units.



Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result.



For 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.



The physiological data and waveforms displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation.



To avoid electric shock or equipment malfunction liquids is not allowed to enter the equipment. If liquids have entered the equipment, remove the equipment from use and have it checked by service personnel before it is used again.



To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement or strangulation by patients or personnel.



Properly dispose of the package material according to applicable waste control regulations and keeping it out of children’s reach.

1-2

1.1.3 Cautions

CAUTIONS 

Use only parts and accessories specified in this manual.



This equipment contains no user serviceable parts. Refer servicing to qualified service personnel.



At 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.



Magnetic 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.



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.



Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.

1.1.4 Notes NOTES 

Put the equipment in a location where you can easily see the screen and access the operating controls.



Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.



The software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized.



This manual describes all features and options. Your equipment may not have all of them.

1-3

1.2 Equipment Symbols Refer to instruction

General warning sign

manual/booklet

Manufacturer

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

Authorized representative in the

Non-ionizing electromagnetic

European Community

radiation

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: The product complies with the Council Directive 2011/65/EU.

Dispose of in accordance to your country’s requirements

NOTE 

Some symbols may not appear on your equipment.

1-4

2 The 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 Applied Parts The applied parts of the equipment are: 

ECG electrodes



Patient cable

2.3 Main Unit 2.3.1 Front View

2

1 3

1.

Display screen: presents waveforms and texts

2.

Recorder: print reports

3.

Operating panel: see the table below for details

2-1

Key

Function

F1

Function key, select the option that appears at the right side of the screen.

(Numerical key “1”)

In numeric keypad mode, enter the number “1”.

F2

Function key, select the option that appears at the right side of the screen.

(Numerical key “4”)

In numeric keypad mode, enter the number “4”.

F3

Function key, select the option that appears at the right side of the screen.

(Numerical key “7”)

In numeric keypad mode, enter the number “7”.

F4

Function key, select the option that appears at the right side of the screen.

(Enter key)

In numeric keypad mode, confirm the input or selection. Access the main menu.

Menu

Exit the menu when a menu is opened.

(Numerical key “2”)

In numeric keypad mode, enter the number “2”. Switch the frequency of muscle artifact filter.

Filter

In numeric keypad mode, enter the number “5”.

(Numerical key “5”) Switch the leads to be recorded in manual measurement mode. (Numerical key “8”)

In numeric keypad mode, enter the number “8”. Start recording real-time ECG report.

Manual

Stop recording.

(Numerical key “0”)

In numeric keypad mode, enter the number “0”. Press this key, and then press numeric keys to enter patient’s ID.

ID

When [Detailed Patient Info] is enabled, enter the Patient Info menu.

(Numerical key “3”)

In numeric keypad mode, enter the number “3”. Press this key, and then press numeric keys to enter patient’s age.

Age

When [Detailed Patient Info] is enabled, press this key to enter the Patient Info menu.

(Numerical key “6”)

In numeric keypad mode, enter the number “6”. Switch patient’s gender.

Gender

When [Detailed Patient Info] is enabled, enter the Patient Info menu.

(Numerical key “9”)

In numeric keypad mode, enter the number “9”. Record a rhythm report.

Rhythm

Stop recording.

(Backspace)

In numeric keypad mode, delete characters. Power on/off switch Turn on the equipment. Turn off the equipment by pressing and holding this key for 0.5 second. Forcefully shut down the equipment by pressing and holding this key for 10 seconds when it could not be shut down normally or under some special situations. Start recording auto ECG report.

ECG

Stop recording.

2-2

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.

2.3.2 Side View

2

1

3

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

4

4

2.3.3 Back View

1

2

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.

2-3

2.3.4 Bottom View

1

1.

Battery compartment

2.4 Display Screen Normal Screen 2

3

4

5

6

7

8

1

10 9

12

11 1.

13

Patient ID: displays the ID of the patient You can input up to 20 digits. If not inputted, the ID information is left blank.

2.

Gender icon: indicates the gender of the patient If set to [Male],

3.

is displayed. If set to [Female],

is displayed. If not set,

is displayed.

Age: displays the age of the patient The unit can be set to [Years], [Months], or [Days]. The input range is 0 to 199 for [Years], 0 to 2400 for [Months], and 1 to 73050 for [Days], If not set, the age area is left blank.

2-4

4.

Heart rate: displays the heart rate and heartbeat symbol

5.

Network status icon: indicates the current status of network connection

6.

.



indicates that the equipment is connected to a wire network successfully.



indicates that the equipment is disconnected from a wire network.



indicates that the equipment is connected to a wireless network successfully.



indicates that the equipment has failed to connect a wireless network.



indicates that the equipment is connected to the CardioVista ECG viewer with a network cable.



indicates that the equipment is connected to the CardioVista ECG viewer via a wireless network.

USB device connecting status icon: indicates the connection status of an external USB device If successfully connected,

is displayed. If not, this area is left blank.

7.

System time: displays the set system time in 12 hour format or 24 hour format

8.

Battery status icon: indicates the battery status. For details, refer to chapter 10 Battery.



Indicates that the battery works properly. The solid green portion represents the current battery charge level. Each block represents a charge of approximately 20% capacity.



Indicates that the battery has low charge level and needs to be charged. In this case, the LED turns yellow and the message “Low Battery” shows at the bottom of the screen.

9.



Indicates that the battery is almost depleted and needs to be charged immediately.



Indicates that no battery is installed or charging battery fails.

Waveform area: displays ECG waveforms.

10. Soft key area: shows the labels of Function Keys located rightwards. 11. Message area 1: displays lead off and noise information. 12. Message area 2: displays messages except lead off and noise. 13. Muscle artifact filter setting: displays the setting of muscle artifact filter. If the filter is disabled, the display is 150Hz.

2-5

Main Menu

1 2

4

3 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.

2.5 Operating Mode 2.5.1 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.

2-6

2.5.2 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 [Basic 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.

2.5.3 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 [Maintenance] →enter the required password→[Demo Mode 1] or [Demo Mode 2].

3.

Enter the password.

To exit Demo Mode, turn off the equipment and restart it.

WARNING 

The 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.

2.5.4 Maintenance Mode In the Maintenance mode, you can change network and configuration related settings. You can also change UI language. Accessing the [Maintenance] menu is password protected.

CAUTIONS 

The maintenance settings can only be changed by authorized personnel. Contact your department manager or biomedical engineering department for the passwords used at your facility.

2-7

FOR YOUR NOTES

2-8