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14

ENGLISH

FOREWORD

Please read the User Manual carefully before using this product. The User Manual which describes the operating procedures should be followed 

strictly. 

This manual detailed introduce the steps must be noted when using the product, operation which may result in abnormal, the risk may cause 

personal injury and product damage and other contents, refer to the chapters for details. Any anomalies or personal injury and device damage arising 

from use, maintain, store do not follow requirements of the User Manual, Our company is not responsible for the safety, reliability and performance 

guarantees! The manufacturer’s warranty service does not cover such faults!

Our company has a factory record and user profile for each device, users enjoy free maintenance services for one year from the date of purchase. In 

order to facilitate us to provide you with a comprehensive and efficient maintenance service, please be sure to return the warranty card when you need 

repair service.

Note: Please read the User Manual carefully before using this product.

Described in this User Manual is in accordance with practical situation of the product. In case of modifications and software upgrades, the information 

contained in this document is subject to change without notice.

The warning items

Before using this product, you should consider the safety and efficacy of the following described:

Described each measurement results combined with clinical symptoms by qualified doctors.

The reliability and operation of using this product whether meets the operation of this manual relate to the maintenance instructions.

The intended operator of this product may be the patient.

Do not perform maintenance and service while the device is in use.

Warning: Replace accessories which not provided by our company may lead to the occurrence of errors. Replace adapters, cuffs at will may result 

in wrong measurement results. Without our company or other approved maintenance organizations trained service personnel should not try to 

maintain the product.

Responsibility of operator

The operator must carefully read the User Manual before use this product, and strictly follow the operating procedure of the User Manual.

F

ully consider the security requirements during product design, but the operator should not ignore the observation for the patient and the 

state 

of machine

.

The operator ha

s

 the responsibility to provide the use condition of the product to our company.

Responsibility for our company

Our company have the responsibility to provide qualified product which conform to company standard of this product

Our company will provide the circuit diagram, calibration method and other information at the request of the user to help the appropriate and 

qualified technicians to repair those parts designated by our company.

Our company have the responsibility to complete product maintenance according to the contract

.

Our company have the responsibility to respond the requirements of user in time.

In the following case, our company is responsible for the impact on the safety, reliability and performance of the device:

Assembly, addition, debugging, modification or repair are carried out by personnel approved by our company.

The electrical facilities in the room are in compliance with the relevant requirements and the device is used in accordance with the User Manual.

The User Manual is written by our company. All rights reserved.

CHAPTER 1 - FUNCTIONS AND PURPOSE

1.1 Main Functions

Measure blood pressure and store the measurement results.

Data storage function, up to 199 records can be stored.

With data review interface which is convenient for reviewing blood pressure parameter.

The screen will prompt message when the power is low.

When the measurement result can not be obtained due to some factors during the measurement, the device will display the corresponding error 

information.

Measurement units: mmHg and kPa, which can be switched by the button.

With automatic shutdown function, if there is no operation, the device will automatically turn off.

Voice broadcast(optional for devices with vioce function)

1.2 Purpose

The device apply to measure the non-invasive blood pressure of human. Record parameter value of blood pressure

 to

 provide the reference for the 

health care professional

.

CHAPTER 2 - SAFETY PRECAUTIONS:

In order to use it correctly, please read the “Safety Precautions” carefully before using it.

Operators do not need professional training, but should use this product after fully understanding the requirements in this manual.

To prevent users from suffering damage or loss due to improper use, please refer to “Safety Precautions” and use this product properly.

For safety reasons, be sure to comply with safety precautions.

 Note

 

If not use correctly, it exists the possibility of damage for personnel and goods.

Good damage means the damage of house, property, domestic animal and pet.

 

Contraindication

 

No.

 

Warning

 

You must not perform NIBP measurements on patients with sickle-cell disease or under any condition which the skin is damaged or expected to 

be damaged.

14

Summary of Contents for 49880

Page 1: ... ψηφιακο πιεσομετρο زاهج ةبقارم طغض مدلا يمقرلا M49880 M Rev 0 10 22 PROFESSIONAL MEDICAL PRODUCTS Contect Medical System Co Ltd Adress No 112 Qinhuang West Street Economic Technical Development Zone Qinhuangdao Hebei Province People s Republic of China Made in China CONTEC08E GIMA 49880 Shanghai International Holding Corp Gmbh Europe Address Eiffestrasse 80 20537 Hamburg Germany Gima S p A Via Ma...

Page 2: ...oduct to our company Responsibility for our company Our company have the responsibility to provide qualified product which conform to company standard of this product Our company will provide the circuit diagram calibration method and other information at the request of the user to help the appropriate and qualified technicians to repair those parts designated by our company Our company have the r...

Page 3: ...nd the person who can t express oneself please use the device under the guidance of a doctor Otherwise it may cause accident or dissension Please do not use for any other purpose except BP measurement Otherwise it may cause accident or holdback Please use special cuff Otherwise it is possible that measurement result is incorrect Please do not keep the cuff in the over inflated state for a long tim...

Page 4: ...e manganese or alkaline batteries do not use batteries of other types Otherwise it may cause fire Do not mix old and new batteries and batteries of different types Otherwise it may cause battery leakage heat rupture and damage to Electronic Sphygmomanometer Please don t put wrong the positive and negative of battery When the batteries power exhausts replace with four new batteries at the same time...

Page 5: ...nd digital equipment connected to this device must be certified to IEC standards such as IEC60950 Information technology equipment Safety and IEC60601 1 Medical electrical equipment Safety and all equipment should be connected to in accordance with the requirement of the valid version of the IEC60601 1 1 system standard The person connecting the additional equipment to the signal input and output ...

Page 6: ...ur legs Advice Try to measure your blood pressure at the same time each day with the same arm and the same pose for consistency The high and low location of cuff will cause changes in measure results Do not touch the sphygmomanometer cuff and windpipe during measure Measurements should be taken in a quiet place and the body relax Remain still 4 5 minutes before measurement Do not talk and movement...

Page 7: ...ay be dangerous Follow the instructions of your physician Note Wait at least 4 5 minutes between measurements When repeatedly measuring the accurate blood pressure value may not be measured due to congestion in the arm Please measure after the blood flow is smooth When the screen displays Err the measure can t be carried out correctly Irregular pulse icon is displayed in the measurement results if...

Page 8: ...er Medical Device complies with Directive 93 42 EEC Authorized representative in the European community Class II applied Socket for power adapter Interface for connecting cuff Voice deactivation Voice activation Great movement when measuring Cuff tied correctly Artery indicator label CHAPTER 10 ERROR MESSAGE When the high pressure position appears Err and the low pressure position appears the erro...

Page 9: ...ion start before press the measurement button Stop using the device and contact us Cuff never deflation Stop using the device and contact us Air pressure error Deflation error Pull out the cuff to deflate Stop using the device and contact us Others Keep arm body still measure again No press value displayed or the value unaltered when cuff inflating Pull out the cuff to deflate Stop using the devic...

Page 10: ...hod Oscillometric method Working mode Automatic Operation mode Continuous operation Pressure Range 0 297 mmHg 0 39 6 kPa Measurement range Pressure SYS 30 270 mmHg 4 36 kPa DIA 10 220 mmHg 1 3 29 3 kPa Pulse 40 240 min Inflation 160 5 mmHg 21 33 0 67 kPa Overpressure protect 297 3 mmHg 39 6 0 4 kPa Resolution Pressure 1 mmHg 0 133 kPa Accuracy Static pressure 3 mmHg 0 4 kPa Error The BP value meas...

Page 11: ...elow The customer or the user of the device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at l...

Page 12: ...ixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is ...

Page 13: ... the pins of connectors marked with an ESD warning symbol unless electrostatic discharge precautions are used the device should not connect to these connectors In order to avoid the accumulation of electrostatic charge it is recommended to store maintain and use the equipment at a relative humidity of 30 or more The floor should be covered with ESD dissipated carpets or similar materials In the us...

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