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7

INTRODUCTION

INTRODUCTION

6

CAUTION

* The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable 

anesthetic mixture with air of with oxygen or nitrous oxide.

* Warning: No servicing/maintenance while the ME equipment is in use.

* The patient is an intended operator.

* The patient can measure data and change batteries under normal circumstances and maintain the device 

and its accessories according to the user manual.

* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated 

interference signal or electrical fast transient/burst signal.

* The blood pressure monitor and the cuff are suitable for use within the patient environment. If you are 

allergic to polyester, nylon or plastic, please don't use this device. 

* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and 

found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any 

potential sensization or irritation reaction.

* If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press 

the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from 

your wrist.

* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not 

deflate when pressure reaches 40 kPa (300 mmHg), detach the cuff from the wrist and press the 

START/STOP button to stop inflation.

* Before use, make sure the device functions safely and is in proper working condition. Check the device, do 

not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, 

improper results, or serious danger.

* Manufacturer will make available on request circuit diagrams, component part lists, descriptions, 

calibration instructions,etc., to assist to service personnel in parts repair.

* The operator shall not touch output of batteries and the patient simultaneously.

* Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth to clean the 

whole unit before and after use. Don’t use any abrasive or volatile cleaners.

* The device doesn’t need to be calibrated within two years of reliable service.

* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.

*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around 

simultaneously, because this could cause temporary loss of function of those simultaneously-used 

monitoring ME equipment.

*On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff 

immediately. Prolonged high pressure (cuff pressure 

 300mmHg or constant pressure 

 15mmHg for 

more than 3 minutes) applied to the wrist may lead to an ecchymosis.

*Please check that operation of the device does not result in prolonged impairment of patient blood 

circulation.

* When measuring, please avoid compression or restriction of the connection tubing.

* The device cannot be used with HF surgical equipment at the same time.

* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER is clinically 

investigated according to the requirements of ISO 81060-2:2013.

* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.

* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing 

inaccurate readings, the effects of this device on the fetus are unknown.

* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.

* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, 

the patient’s wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood.

* When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust 

and direct sunlight. Never place any heavy objects on the storage case.

* This device may be used only for the purpose described in this booklet. The manufacturer cannot be held 

liable for damage caused by incorrect application.

*This device comprises sensitive components and must be treated with caution. Observe the storage and 

operating conditions described in this booklet.

* The maximum temperature that the applied part can be achieved is 42.5

 while the environmental 

temperature is 40

.

CAUTION

Содержание Medel Soft TMB-1581-S

Страница 1: ...Co Ltd Zone A No 105 Dongli Road Torch Development District Zhongshan 528437 Guangdong China To use the monitor correctly and safely please read the manual thoroughly Thank you very much for selectin...

Страница 2: ...tenance ABOUT BLOOD PRESSURE 26 What are systolic pressure and diastolic pressure What is the standard blood pressure classification Irregular heartbeat detector Why does my blood pressure fluctuate t...

Страница 3: ...rement pulse rate measurement and the result storage The design provides you with two years of reliable service Readings taken by the TMB 1581 S are equivalent to those obtained by a trained observer...

Страница 4: ...d for patient transport outside a healthcare facility The device is not intended for public use This device is intended for no invasive measuring and monitoring of arterial blood pressure It is not in...

Страница 5: ...ore and after use Don t use any abrasive or volatile cleaners The device doesn t need to be calibrated within two years of reliable service Warning Do not apply the cuff over a wound otherwise it can...

Страница 6: ...s and their base stations walkie talkies can affect this equipment and should be kept at least a distance d away from the equipment The distance d is calculated by the MANUFACTURER from the 80 MHz to...

Страница 7: ...ar Hour Minute Heartbeat Blood pressure monitor is detecting an irregular heartbeat during measurement Blood pressure level indicator Indicate the blood pressure level Blood pressure monitor is detect...

Страница 8: ...A 2 Air Pipe 3 Pump 4 Valve 5 Cuff List 1 Wrist Blood Pressure Monitor TMB 1581 S 2 2 AAA batteries 3 User manual Slide off the battery cover Install the batteries by matching the correct polarity as...

Страница 9: ...mful to the environment Do not dispose with daily garbage Remove the old batteries from the device following your local recycling guidelines Setting Date Time and Measurement Unit It is important to s...

Страница 10: ...lection and it will turn to the next step 4 Repeat step 2 and 3 to confirm MONTH and DAY 5 6 Repeat step 2 and 3 to confirm HOUR and MINUTE Repeat step 2 and 3 to confirm the MEASUREMENT UNIT After co...

Страница 11: ...measurement please sit comfortably with legs uncrossed feet flat on the floor back and wrist supported Rest for 5 minutes before measuring Wait at least 3 minutes between measurements This allows you...

Страница 12: ...it will display the next record and so on During the process of displaying the results if there is no operation the blood pressure monitor will turn off in one minute Or you can press START STOP butt...

Страница 13: ...the right display will be shown Note To exit out of delete mode without deleting any records press START STOP button before pressing MEM to confirm any delete commands 1 2 Press MEM to confirm deletin...

Страница 14: ...a very cold environment When you want to discharge urine Maintenance To obtain the best performance please follow the instructions below INFORMATION FOR USER INFORMATION FOR USER TROUBLESHOOTING Avoi...

Страница 15: ...n the heart relaxes between heartbeats the lowest blood pressure is diastolic pressure Irregular Heartbeat Detector CAUTION The appearance of the IHB icon indicates that a pulse irregularity consisten...

Страница 16: ...s but there will be some different results for different people We suggest you measure the same wrist every time The cuff is not secure Refasten the cuff and then measure again This section includes a...

Страница 17: ...0 C within 3mmHg 0 4kPa Pulse value 5 Rated cuff pressure 0mmHg 299mmHg 0kPa 39 9kPa Measurement pressure SYS 60mmHg 230mmHg 8 0kPa 30 7kPa DIA 40mmHg 130mmHg 5 3kPa 17 3kPa Pulse value 40 199 beat mi...

Страница 18: ...ectronics Co Ltd SPECIFICATIONS CONTACT INFORMATION A01 Internally Powered ME Equipment IP22 The first number 2 Protected against solid foreign objects of 12 5mm and greater The second number Protecte...

Страница 19: ...labelling and information to be supplied Part 1 General requirements EN 1060 3 1997 A2 2009 Non invasive sphygmomanometers Part 3 Supplementary requirements for electro mechanical blood pressure measu...

Страница 20: ...eased electromagnetic immunity of this equipment and result in improper operation Warning Portable RF communications equipment including peripherals such as antenna cables and external antennas should...

Страница 21: ...4 11 Electrical fast transient burst IEC 61000 4 4 Surge IEC61000 4 5 IEC 60601 1 2 Test level 2 kV 4kV 8 kV 15 kV air Not application Not application Not application Not application Not application N...

Страница 22: ...odulation b 18Hz 1 8 450 430 470 GMRS 460 FRS 460 FM c 5kHz deviation 1kHz sine 2 0 3 28 710 704 787 745 780 LTE Band 13 17 Pulse modulation b 217Hz 0 2 0 3 9 810 870 930 800 960 GSM 800 900 TETRA 800...

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