BeneHeart R12 and R12A Electrocardiograph Operators Manual Rev 14.0 March 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

BeneHeart R12/BeneHeart R12A

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

BeneHeart R12/BeneHeart R12A

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 conveniently referenced 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

IV



Italic text is used to quote the referenced chapters or sections.



[ ] is used to enclose screen texts.



→ is used to indicate operational procedures.

BeneHeart R12/BeneHeart R12A

Contents 1 Safety ... 1-1 1.1 Safety Information ... 1-1 1.1.1 Warnings ... 1-2 1.1.2 Cautions ... 1-3 1.1.3 Notes ... 1-3 1.2 Equipment Symbols ... 1-4

2 Equipment Overview ... 2-1 2.1 Intended Use... 2-1 2.2 Applied Parts... 2-1 2.3 Major Functions ... 2-1 2.4 Main Unit ... 2-2 2.4.1 Front and Side View ... 2-2 2.4.2 Back View ... 2-6 2.5 Screen Layout ... 2-7 2.6 Operating Mode ... 2-9 2.6.1 Normal Mode ... 2-9 2.6.2 Standby Mode ... 2-9 2.6.3 Demo Mode ... 2-9 2.6.4 Maintenance Mode ... 2-10

3 Setting up the Equipment ... 3-1 3.1 Installation ... 3-1 3.1.1 Unpacking and Checking ... 3-1 3.1.2 Environmental Requirements ... 3-2 3.2 Setting up the Equipment ... 3-3 3.2.1 Connecting the AC Mains ... 3-3 3.2.2 Using the Battery ... 3-3 3.2.3 Loading the 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 ... 4-1 4.3 Report Setup ... 4-3 4.4 File Management ... 4-5 4.5 Basic Setup... 4-6 4.6 Maintenance ... 4-8 BeneHeart R12/BeneHeart R12A

1

5 Patient Information ... 5-1 5.1 Setting Patient Information ... 5-1 5.2 Entering Patient Information ... 5-1 5.3 Editing Patient Information ... 5-3

6 Patient Preparation ... 6-1 6.1 Relaxing the 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 Color 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 ... 6-6

7 Acquiring an ECG ... 7-1 7.1 Configuring the ECG Waveforms ... 7-1 7.2 Configuring the ECG Reports ... 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 ... 7-4 7.5 Copying a Report ... 7-4 7.6 Saving a Patient Report ... 7-4 7.7 Resting 12-lead ECG Analysis ... 7-5 7.8 ECG Report ... 7-6

8 File Management ... 8-1 8.1 Accessing File Management ... 8-1 8.2 Managing Patient Records ... 8-1 8.2.1 Accessing Directory List ... 8-1 8.3 Managing the Configuration ... 8-2 8.4 Sending Files... 8-2

9 Troubleshooting ... 9-1 9.1 General Problems... 9-1 9.2 Messages... 9-3 9.2.1 Message List 1 ... 9-4 9.2.2 Message List 2 ... 9-7

2

BeneHeart R12/BeneHeart R12A

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 Calibrating the Touchscreen ... 11-4 11.4 Maintaining the Battery ... 11-5 11.5 Storing Thermal Recording Paper ... 11-5 11.6 Storing Cables and Lead Wires... 11-5 11.7 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 System Specifications ... A-3 A.7 Wireless Network ... A-3 A.8 Measurement Specifications ... A-3

B EMC and Radio Regulatory Compliance ... B-1 B.1 EMC ... B-1 B.2 Radio Regulatory Compliance ... B-5 B.3 Cable Information ... B-6

C Symbols and Abbreviations ... C-1 C.1 Units ...C-1 C.2 Symbols ...C-2 C.3 Abbreviations ...C-3

BeneHeart R12/BeneHeart R12A

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

BeneHeart R12/BeneHeart R12A

1 Safety 1.1 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.

BeneHeart R12/BeneHeart R12A

1-1

1.1.1 Warnings

WARNINGS 

This equipment is used for a 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.



To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 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 for use with high frequency surgical units.



Do not contact the patient 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 the risk of entanglement or strangulation by patients or clinical personnel.



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

1-2

BeneHeart R12/BeneHeart R12A

1.1.2 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.

1.1.3 Notes NOTES 

Locate the equipment where you can easily see the screen, access the operating controls, and disconnect the equipment from AC power.



Keep this manual in the vicinity of the equipment so that it can be conveniently referenced 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 basing on the maximum configuration. Your equipment may not have all of them.

BeneHeart R12/BeneHeart R12A

1-3

1.2 Equipment Symbols

Equipotentiality

Analog out

Network connector

USB connector

Telephone line connector

ON/OFF for part of equipment

Battery indicator

Alternating current (AC)

General warning sign

Refer to instruction manual/ booklet

DEFIBRILLATION-PROOF TYPE CF APPLIED PART

Serial number

Manufacturer

DATE OF MANUAFACTURE

Non-ionizing electromagnetic

Authorized representative in the

radiation

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

Dispose of in accordance to your country’s requirements

NOTE 

1-4

Some symbols may not appear on your equipment.

BeneHeart R12/BeneHeart R12A

2 Equipment Overview 2.1 Intended Use BeneHeart R12/BeneHeart R12A electrocardiographs (hereafter referred to as “the equipment” or “the system”) are intended to acquire, analyze, display, store, and record electrocardiographic information for adult and children of any age from birth upwards 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 Major Functions The equipment can be used to: 

Acquire, analyze, display, and record 12-lead ECG information.



Provide ECG algorithm to automatically analyze the acquired ECG waveforms; output measurements and diagnosis.



Support auto measurement, manual measurement, and rhythm measurement.



Print ECG reports through either an internal thermal recorder or an external printer.



Store, preview, and review ECG reports.



Connect LAN or Wi-Fi to send ECG data.



Support entering patient information through the keyboard or a barcode reader.



Present messages in case of lead off, interference, low battery, or other abnormity.

BeneHeart R12/BeneHeart R12A

2-1

2.4 Main Unit 2.4.1 Front and Side View 3 4 2

5

6 1

2

7

9 8 1.

Thermal recorder: prints reports.

2.

Hard keys: see Hard Keys and Indicators below.

3.

Indicators: see Hard Keys and Indicators below.

4.

Display screen: presents waveforms and text.

5.

Soft keys: for the equipment configured with a touchscreen. Press the soft keys to select the options. Soft key labels: for the equipment not configured with a touchscreen. See Soft Keys below.

6.

Soft keys: only for equipment not configured with a touchscreen. The soft keys illuminate when the equipment is powered on. Press the soft keys to select the options that appear on the right side of the screen. For the equipment configured with a touchscreen, there are no keys in this area.

2-2

7.

USB connector: connects USB devices, such as a USB drive, external printer, or barcode reader.

8.

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

9.

Keyboard: see Keyboard Layout below.

BeneHeart R12/BeneHeart R12A

Hard Keys and Indicators Key

Function

Power switch

Turns on the equipment when the equipment is powered off. Turns off the equipment by pressing and holding this key for 0.5 second when the equipment is powered on. Forcefully shuts down the equipment by pressing and holding this key for 10 seconds when it cannot be shut down normally.

Setup key

Accesses the main menu. Exits a menu and returns to the normal screen when the menu is open.

Leads key

Switches the format and leads to be displayed. Switches leads to be printed during a manual measurement.

ID key

Enters the [Patient Info] menu.

ECG key

Starts an auto measurement. Stops the ongoing auto measurement when the preview option is disabled.

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 and 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 the AC mains is connected. Off: when the AC mains is not connected.

BeneHeart R12/BeneHeart R12A

2-3

Keyboard Layout

1

2

13

3 4

12

5

5

6

11

7

8

9

10

9

No.

Key

Description

1

Alphanumeric keys

Enters corresponding letters, digits, and symbols.

2

Esc key

Returns to the previous screen.

3

Tab key

Moves the cursor to the next item.

4

Caps Lock key

Locks the capital letters and upper case symbols.

5

Shift key

Uses in conjunction with alphanumeric keys to enter the upper case characters. For example, press Shift + a to enter a capital A, and press Shift + = to enter the symbol +.

6

Ctrl key

7

Not currently used. Prints the latest auto or rhythm report.

key Switches input method.

8

key

9

Alt key

Not currently used.

10

Space bar

Enters a space.

11

Arrow keys

Moves the cursor left, right, up, or down.

12

Enter key

Confirms the selection.

13

Back key

Deletes the character in front of the cursor.

2-4

BeneHeart R12/BeneHeart R12A

Soft Keys Key

Function Adjusts the current waveform speed.

Adjusts the current waveform size.

Adjusts the current frequency of the muscle artifact filter.

Enters the Directory List.

Starts a manual measurement.

Starts a rhythm measurement.

Switches the rhythm leads.

Returns to the previous menu.

Moves to the previous menu item.

Moves to the next menu item.

Selects the highlighted menu item.

Cancels the highlighted selection.

Confirms the selection.

Returns to the normal screen.

Sends the selected files to an external device.

Sends the selected files through the network.

Sent the selected files to a USB drive.

Reviews the highlighted report.

Reviews the next page of the current report.

Reviews the next report.

BeneHeart R12/BeneHeart R12A

2-5

Key

Function Deletes the selected files.

Starts printing.

Stops printing.

Searches for patients.

Edits patient information.

Saves patient information to the internal memory.

Places a 1 mV square wave on the manual report.

2.4.2 Back View

1

2

3

4

5

6

7

1.

Battery compartment

2.

USB connector: connects USB devices, such as a USB drive, external printer, or barcode reader.

3.

Telephone line connector: for future external devices. Do not use.

4.

Network connector: a standard RJ45 connector for software upgrade and sending ECG data.

5.

Analog output connector: for future external devices. Do not use.

6.

Equipotential Grounding Terminal: when using the monitor together with other devices, connect their equipotential grounding terminals together to eliminate the potential differences between them.

7.

2-6

AC power input: connects the power cord to run the equipment on AC power supply.

BeneHeart R12/BeneHeart R12A

2.5 Screen Layout Normal Screen 2

1

3

4

5

6

7

8

10

9

11 1.

12

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.

4.

Heart rate: displays the heart rate and heartbeat symbol

.

5.

Network status icon: indicates the current status of network connection 

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.

BeneHeart R12/BeneHeart R12A

2-7

6.

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 soft keys. For the equipment not configured with a touchscreen, this area shows the labels of the soft keys located rightward. 11. Message area 1: displays lead off and noise related messages. 12. Message area 2: displays other messages.

Main Menu

1

2

1.

4 3 Heading: shows the menu heading and system information including network and USB device connecting status, system time, battery status; etc.

2-8

2.

Options of the main menu

3.

Options of the highlighted submenu

BeneHeart R12/BeneHeart R12A