background image

6

7

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

blood circulation.

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

• 

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 device is not suitable for continuous monitoring during medical emergencies or 

operations. 

 When not in use, store the device with the adapter

 

in a dry room and protect it against 

extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the 

device.

 This device may be used only for the purpose described in this INSTRUCTION MANUAL. 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 INSTRUCTION MANUAL.

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

flammable anesthetic mixture with oxygen or nitrous oxide.

 Warning: DO NOT service or perform maintenance while the device is in use.

 The patient is the intended operator.

 The patient can measure, change batteries under normal circumstances and maintain the 

device and its accessories according to the INSTRUCTION MANUAL.

 To avoid measurement errors, please avoid strong electromagnetic field adiated interference 

signals or electrical fast transient/burst signals.

 The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient 

environment. If you are allergic to polyester, nylon or plastic, please do not 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. The device is not known to cause any potential irritation.

 If you experience discomfort during a measurement, such as pain in the arm or other 

complaints, press the START/STOP button to release the air immediately from the cuff. 

Loosen the cuff and remove it from your arm.

 If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should 

the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the 

arm and press the START/STOP button to stop inflation.

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

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. 

• DO NOT wash the cuff in a washing machine or dishwasher.

• The service life of the cuff may vary by the frequency of cleaning, skin condition, and storage 

state. The typical service life is 10000 uses.

WARNING

 It is recommended that the performance should be checked every two years and after 

maintenance and repair, by retesting at least the requirements in limits of the error of the 

cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).

 Please dispose of accessories, detachable parts, and the device according to the local 

guidelines.

• 

The plug / adapter plug pins insulate the device from the main supply. Do not position the 

device where it is difficult to disconnect from the main power supply to safely terminate 

operation of the device.

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

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

 If you have any problems with this device, such as setting up, maintaining or using, please 

contact customer service. Do not open or repair the device by yourself in the event of 

malfunctions. This device must only be serviced, repaired and opened by individuals at 

authorized sales/service centers.

 Keep this device out of reach of infants, young children or pets to avoid inhalation or 

swallowing of small parts. It is dangerous or even fatal.

 DO NOT wrap cuff or tube around the neck.

 Allow 30 minutes for the device to adjust to the temperature in the room when taking it 

out of storage. Follow the temperature guidelines in the SPECIFICATIONS section of this 

INSTRUCTION MANUAL.

 This equipment needs to be installed and put into service in accordance with the 

information provided in this INSTRUCTION MANUAL.

 Wireless communications equipment such as wireless home network devices, mobile 

phones, cordless telephones and their base stations, walkie-talkies can affect this 

equipment and should be kept away from the equipment. 

 Please use accessories and detachable parts specified/authorized by the manufacturer.

Otherwise, it may cause damage to this device or danger.

 Please use this device under the environment which are provided in this INSTRUCTION 

MANUAL. Otherwise, the performance and lifetime of the device will be impacted and 

reduced.

WARNING

Summary of Contents for TMB-1583-S

Page 1: ...Upper Arm Blood Pressure Monitor with Comfort Inflate Technology Instruction Manual Model TMB 1583 S Item 16985 Manual Version V1 0 Issue Date 2021 07 12...

Page 2: ...od Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 8 16 about 22 cm to 42 cm It is intended for indoor adult u...

Page 3: ...end medical treatment without asking a physician for treatment advice If you are taking medication consult your physician to determine the most appropriate time to measure your blood pressure Never c...

Page 4: ...0 kPa 300 mmHg detach the cuff from the arm and press the START STOP button to stop inflation Before use make sure the device functions safely and is in proper working condition DO NOT use the device...

Page 5: ...ee records in memory Current Time Time and date year month day hour minute I I Blood pressure level Indicates the blood pressure level H Hour The hour in the clock mode M Minute The minute in the cloc...

Page 6: ...pose of the batteries in fire Batteries may explode or leak Remove batteries if the device is not likely to be used for some time Worn batteries are harmful to the environment Do not dispose with hous...

Page 7: ...monitor is off press and hold SET to enter the mode for year setting 3When you reach the correct year press SET to confirm the entry 4 Repeat steps 2 and 3 to set the DATE FORMAT then set the MONTH an...

Page 8: ...Wait at least 3 minutes between measurements This allows your blood circulation to recover Take the measurement in a silent room Relax as much as possible and do not move or talk during the measuremen...

Page 9: ...ned to the first 1 record All other records are pushed back one digit e g 2 becomes 3 and so on and the last record 60 is dropped from the list NOTE The current measurement is 01 The corresponding dat...

Page 10: ...SUREMENT Measurements may be inaccurate if taken in the following circumstances Within 1 hour of eating or drinking Immediately after tea coffee or smoking Within 20 minutes of bathing While talking o...

Page 11: ...0 DIA 80 80 84 85 89 90 99 100 109 110 Grade 3 hypertension severe Grade 1 hypertension mild Grade 2 hypertension moderate An irregular heartbeat is detected when a heartbeat rhythm varies while the u...

Page 12: ...he same arm everytime PROBLEM DISPLAY CAUSE SOLUTION NO POWER Display will not light up Batteries are exhausted Replace with new batteries Batteries are inserted incorrectly Insert the batteries corre...

Page 13: ...F 104 F 5 C 40 C within 3 mmHg 0 4 kPa Pulse value 5 Normal working condition A temperature range of 41 F 104 F 5 C 40 C A relative humidity range of 15 to 90 non condensing but not requiring a water...

Page 14: ...ic Compatibility EN 60601 1 2 2015 IEC 60601 1 2 2014 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic disturba...

Page 15: ...ctromagnetic emissions Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3...

Page 16: ...430 470 GMRS 460 FRS 460 FM c 5k Hz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation b 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5...

Page 17: ...pm EST Monday Friday or contact us at info stareliteinc com Our customer service will be happy to assist you 2021 Sunbeam Products Inc All rights reserved Distributed by Star Elite Inc 1175 Place du F...

Reviews: