Nanjing Xijian Information Technology E H19 User Manual
Nanjing Xijian Information Technology Co., Ltd.
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ECG Recorder
(Model: E-H19)
Nanjing Xijian Information Technology Co., Ltd.
Nanjing Xijian Information Technology Co., Ltd.
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About this instruction
1 .Description of this instruction
This instruction is a description of the function, safety and operation of the ECG recorder. In order
to ensure that you can use the dynamic ECG correctly and safely, please read all sections of this
instruction carefully before using this product.
The manufacturer shall not bear any responsibility for the unauthorized parts.
2.Version information
Version of this instruction: REV 1.1
Date of revision: December 2017
The version number of this instruction may be upgraded due to changes in software or technical
specifications. We will try to modify it as much as possible, but it may not be consistent with some
descriptions. Please kindly understand.
3.Copyright
The copyright of this instruction shall be owned by Nanjing Xijian Information Technology Co.,
Ltd., without any permission of the Company, any photocopy, copy, duplication or translation to
this instruction shall be forbidden.
Without permission, any copy or modification of the content of this document is illegal.
4.Applicable objects
This instruction is applicable to all users of this product.
5.Product information
Product name: ECG recorder
Product model: E-H19
Product Registration Certificate No.: No. 2211254 of JiangSu Food and Drug Supervision (Quasi)
Word 2014
Product Technical Requirement Number: No. 2211254 of JiangSu Food and Drug Supervision
(Quasi) Word 2014
Registered person / manufacturing enterprise: Nanjing Xijian Information Technology Co., Ltd.
Residence: （ BDA,Jiangning ） 3/F, No.4 Jinjulong Building,9 Gaohu Road, Jiangning
District,Nanjing,China
Production address: （BDA,Jiangning）3/F, No.4 Jinjulong Building,9 Gaohu Road, Jiangning
District,Nanjing,China
Production License No. : No.20140022 of JiangSu Food and Drug Supervision Production License
Nanjing Xijian Information Technology Co., Ltd.
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European Representative Name: WellKang Ltd
European Representative Address: 29 Harley St.,London W1G 9QR,UK
After-sales service information:
Service unit: Nanjing Xijian Information Technology Co., Ltd.
Address: （ BDA,Jiangning ） 3/F, No.4 Jinjulong Building,9 Gaohu Road, Jiangning
District,Nanjing,China
Postcode: 211100
Contact number: +86 4008871788
Fax:+86 025-86136515
6.Patent
The patent of the dynamic ECG shall be owned by Nanjing Xijian Information Technology Co.,
Ltd.
7.Responsibility of manufacturer
Only in the following cases, the manufacturer shall be responsible for the impact of the safety,
reliability and performance of the equipment:
All of the assembly, installation, commissioning, modification or maintenance shall be
carried out by the personnel approved by the manufacturer;
The electrical facilities in the room shall be in accordance with the relevant requirements.
The equipment shall be used in accordance with the requirements of this instruction.
8.Guarantee
Nanjing Xijian Information Technology Co., Ltd. shall reserve the right to modify this instruction
and the products described.
If the product specifications are changed, we will not be able to notify you at that time, please
understand.
Neither the content of this instruction involves proposals, warranties, commitments or contractual
terms, nor should it be considered such projects.
Nanjing Xijian Information Technology Co., Ltd.
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Contents
Chapter 1 Security ............................................................................................................... 4
1.1 Brief introduction .............................................................................................................. 4
1.2 Overall security information .................................................................................... 4
Chapter 2 An Introduction to ECG Recorder .......................................................................... 7
2.1 Scope of application ................................................................................................... 7
2.2 Principle of this product ............................................................................................. 7
2.5 Identification ............................................................................................................. 8
Chapter 3 Installation and debugging..................................................................................... 9
3.1 Unpacking ............................................................................................................... 9
3.2 Download and installation of software ......................................................................... 9
3.3 Instructions ............................................................................................................... 9
3.4 Battery replacement description ................................................................................ 18
Chapter4 Service and maintenance ...................................................................................... 20
Chapter 5 Fault and elimination ............................................................................................. 21
Appendix A Product specification ....................................................................................... 22
Appendix B Common sense of heart health .......................................................................... 24
Appendix C Product pollution control sign .......................................................................... 25
Appendix D Guidance and manufacturer´s declaration –Electromagnetic compatibility........... 26
Appendix E Packing list ..................................................................................................... 31
Nanjing Xijian Information Technology Co., Ltd.
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Chapter 1 Security
1.1 Brief introduction
Danger
Prompt that a direct risk that cannot be avoided will immediately cause death or serious injury.
Warning
Prompt that a potential risk that cannot be avoided may immediately cause death or serious injury.
Caution
Prompt that potential danger or unsafe operations that cannot avoided may cause mild or moderate
damage, injury, or financial loss.
Notice
Emphasize important matters of attention, provide instructions or explanations for better use of
this product.
1.2 Overall security information
Danger
The ECG recorder does not involve information of danger level.
Warning
Do not use this product in an environment with flammable anesthetic gases, oxygen
or nitrogen oxides.
This product is not allowed to be modified in any way.
This product is not allowed to be used with defibrillator devices.
This product is not allowed to be used together with electrosurgical instruments.
This product is not allowed to be used with CT or MRI equipment.
Do not subject the product to high temperature, high pressure, gas fumigation or
liquid immersion. Shut down the product before cleaning or disinfecting.
The physiological waveforms, physiological parameters and prompts displayed in
this product are for reference only and cannot be directly used as the basis for
clinical treatment.
Do not squeeze the product hard, if the shell is broken, please stop using it.
Waste (including the product itself scrapped) in accordance with the relevant laws
and regulations for processing.
During use, do not charge the intelligent display device connected with the product.
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To keep the ECG recorder away from fire, do not heat it, otherwise the internal
battery may explode.
Please keep the ECG recorder out of the reach of children.
Caution
Do not use, maintain and repair the ECG recorder before reading the manual in
detail.
Keep the ECG recorder dry, and avoid strong collision.
The ECG recorder should be far away from the strong magnetic field, because it
may affect the accuracy of the test. If the ECG recorder accidentally gets wet, turn off
the power immediately, dry the shell of the ECG before use, and contact the supplier.
Notice
The user should avoid excessive and vigorous exercise, especially avoid excessive
movement of upper limbs.
Bluetooth transmission distance ：Mobile phones and ECG Recorder in the
absence of barriers, transmission distance of 5 meters -10 meters range
This product cannot be used for baby monitoring records weighing less than 10kg.
FCC Notice
This device complies with Part 15 of the FCC rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference. (2) This device must
accept any interference received, including interference that may cause undesired
operation.
NOTE: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:
---Reorient or relocate the receiving antenna.
---Increase the separation between the equipment and receiver.
---Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
---Consult the dealer or an experienced radio/TV technician for help.
WARNING: Changes or modifications not expressly approved by the party responsible
for compliance could void the user's authority to operate the equipment.
RF Exposure
The equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. This device should be installed and operated with minimum distance 0mm
between the radiator & your body.
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Nanjing Xijian Information Technology Co., Ltd.
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SN
Symbol name
Meaning
1
Indicator light
Flash indicates that it has failed to be connected; and slow
flash indicates it has been connected successfully
2
Electrode
For measurement
3
Battery cover
Button battery cover
Chapter 2 An Introduction to ECG Recorder
2.1 Scope of application
This product's real-time transmission and display of ECG information and waveform signals.
2.2 Principle of this product
Through human contact, this product carries out the measurement and record of the ECG
information, and the ECG information is transferred to the intelligent display device via blue tooth,
and then the display and storage of the ECG data and waveform may be completed in the display
device, which has the function of waveform display, heart rate display, data storage, trend charts
and prompt, in addition, it can generate PDF for the data and send it to share.
2.2.1 The calculation method of heart rate value: 60*1000/RR interphase.
2.2.2 Breathing identification method: RR interphase ≥ optional absolute threshold.
2.3 Applicable population and contraindication
Applicable population: all groups of people (except for infants underweight 10kg).
Contraindication: None
2.4 Structure composition
Product composition: The ECG recorder consists of a ECG recorder and ECG analyser software.
Among them, the structure of ECG recorder is shown in the following figure.
E-H19
Nanjing Xijian Information Technology Co., Ltd.
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Identificatio
n
Description for identification
Identification
Description for
identification
Fragile; be careful
Batch code
Fear of Rain; Avoid Rain
Recycle
Manufacturer
Authorized representative
in the European
community
date of manufacture
Term of Use
Product Sequence Number
Environmental Protection
Service Life is 10 Years
Waste Disposal Should Conform
to WEEE Standard
CF Application Domain
Attention ！ Refer to the
Attached Files
consult instructions for use
2.5 Identification
Nanjing Xijian Information Technology Co., Ltd.
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Chapter 3 Installation and debugging
3.1 Unpacking
Open the packing box and carefully remove the ECG recorder and accessories. Please check if the
item is complete or damaged. If there is any missing piece or damage, please contact the supplier
immediately.
Notice
Description: electrical schematic and components list only provide qualified maintenance station
or personnel confirmed by manufacturer.
The production date and expiry date can be seen in the external package.
3.2 Download and installation of software
The ECG shall be used in conjunction with the intelligent display device. The Bluetooth for the
system of intelligent display device shall be Version 4.2 or above.
Download and installation steps for the palmtop ECG software:
(1) Installation package download: you can login the related webpages of the palmtop ECG
official website www.mhealth365.com/en/, or scan the two-dimensional code on the back of the
package.and then download the installation package from these prompts .
(2) Click on the installation package downloaded and complete the installation of the software
according to the prompt.
Caution: if the software version has been upgraded, please use the latest version.
3.3 Instructions
（1）Search for ECG recorder: follow the prompts on the software page, turn on the Bluetooth,
make sure it is in the Bluetooth search state, and then touch the front dual electrodes of the
dynamic ECG with your fingers to start the product, the product's indicator should flash quickly.
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