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ENGLISH

For patients with severe disturbances of blood coagulation, whether automatically measure the blood pressure should be based on the clinical 

evaluation, because limb friction with the cuff may cause the risk of hematoma.

For severe blood circulation disorder or arrhythmia patients, please use the device under the guidance of a doctor. If the arm is squeezed during 

measurement, it may cause acute internal hemorrhage or inaccurate measurement results.

Measurement Limitations

To different patient conditions, the oscillometric measurement has certain limitations. The measurement is in search of regular arterial pressure pulse. In 

those circumstances when the patient’s condition makes it difficult to detect, the measurement becomes unreliable and measuring time increases. The user 

should be aware that the following conditions could interfere with the measurement, making the measurement unreliable or longer to derive. In some cases, 

the patient’s condition will make a measurement impossible.

Patient Movement

Measurements will be unreliable or can not perform if the patient is moving, shivering or having convulsions. These motions may interfere with the detection 

of the arterial pressure pulses. In addition, the measurement time will be prolonged.

Cardiac Arrhythmia’s

Measurements will be unreliable and may not be possible if the patient’s cardiac arrhythmia has caused an irregular heartbeat. The measuring time 

thus will be prolonged.

Heart-lung Machine

Measurements will not be possible if the patient is connected to a heart-lung machine.

Pressure Changes

Measurements will be unreliable and may not be possible if the patient’s blood pressure is changing rapidly over the period of time during which the 

arterial pressure pulses are being analyzed to obtain the measurement.

Severe Shock

If the patient is in severe shock or hypothermia, measurements will be unreliable since reduced blood flow to the peripheries will cause reduced 

pulsation of the arteries.

Heart Rate Extremes

Measurements can not be made at a heart rate of less than 40 bpm and greater than 240 bpm.

Round Patient

The thick fat layer of body will reduce the measurement accuracy, because the fat that come from the shock of arteries can not access the cuffs due 

to the damping

 Warning

 

Self-diagnosis and treatment using measured results may be dangerous. Follow the instructions of your physician.

Please hand measurement results to the doctor who knows your health and accept diagnosis.

For Infant and 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 time.

Otherwise it may cause risk.

Do not use the device in the case of there are flammable anesthetic gasses mixing with the air or nitrous oxide.

Otherwise it may cause risk.

If liquid splashes on the device or accessories, especially when liquids may enter the pipe or device, stop using and contact the service department.

Otherwise it may cause risk.

Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of children’s reach.

Otherwise it may cause harm to the environment or children.

Please use approved accessories for the device and check that the device and accessories are working properly and safely before use.

Otherwise the measurement result may be inaccurate or an accident may occur.

When the device is accidentally damp, it should be placed in a dry and ventilated place for a period of time to dissipate moisture.

Otherwise the device may be damaged due to moisture.

Do not store and transport the device outside the specified environment.

Otherwise it may cause measurement error.

It is recommended that you check if there is any damage on the device or the accessories regularly, if you find any damage, stop using it, and contact 

the biomedical engineer of the hospital or our Customer Service immediately. Do not disassemble, repair and modify the device without permission. 

Otherwise it cannot be accurately measured.

This device can not be used on mobile transport platforms.

Otherwise it may cause measurement error.

This device can not be used on a tilted tabletop.

Otherwise there is a risk of falling.

Dispose of packaging materials, waste batteries and end-of-life products in accordance with local laws and regulations. The end-of-life products and 

materials are properly disposed of by the user in accordance with the authority’s decree.

Replace accessories which not provided by our company may lead to the occurrence of errors.

Without our company or other approved maintenance organizations trained service personnel should not try to maintain the product.

This device can only be used for one test object at a time.

If the small parts on the device are inhaled or swallowed, please consult a doctor promptly.

The device and accessories are processed with allergenic materials. If you are allergic to it , stop using this product.

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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