background image

 

1A

 

1RWH

 Only use recommended AC 

adapter model. Unplug adapter to stop 

using power.

* Do not wash the cuff in a washing machine or dishwasher!

* The service life of the cuff may vary by the frequency of washing, skin condition, and 

storage state. The typical service life is 10000 times.

* It is recommended that the performance should be checked every 2 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 ME EQUIPMENT according 

to the local guidelines.

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

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

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

device in a position where it is difficult to disconnect from the supply mains to safely 

terminate operation of ME equipment.

* The operator shall not touch output of batteries /adapter 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.

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

contact the SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself 

in the event of malfunctions. The device must only be serviced, repaired and opened by 

individuals at authorized sales/service centers.

* Please report to Transtek if any unexpected operation or events occur.

* Keep the unit out of reach of infants, young children or pets to avoid inhalation or 

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

* Be careful to strangulation due to cables and hoses, particularly due to excessive length.

* At least 30 min required for ME equipment to warm from the minimum storage temperature 

between uses until it is ready for intended use. At least 30 min required for ME equipment to 

cool from the maximum storage temperature between uses until it is ready for intended use.

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

information provided in the ACCOMPANYING DOCUMENTS;

* 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 at least adistance d away from the equipment. The distance 

d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and 

Table 9 of IEC 60601-1-2:2014, as appropriate.

* Please use ACCESSORIES and detachable partes specified/ authorised by 

MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the 

user/patients.

* There is no luer lock connectors are used in the construction of tubing, there is a possibility 

that they might be inadvertently connected to intravascular fluid systems, allowing air to be 

pumped into a blood vessel.

* Please use the device under the environment which was provided in the user manual. 

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

9

8

Monitor Components

List

Blood Pressure

3

 Monitor

Instructions for Use

Upper-arm 

Cuff  (22cm-42cm)

4× AAA batteries

To p

rotect your device and obtain consistent readings, please use the 

correct batteries and authorised power adapter

,

 which complies with CE 

safety standard

s

.

• Open the battery cover.

• Install batteries by matching the

correct polarity, as shown.

• Replace battery cover.

Installing and Replacing Batteries

CAUTION

CAUTION

Replace batteries when:

The

shows.

 The display is dim.
The display does not light up.

Choice of Power Supply

AC adapter 

Battery powered mode:

6V

 

DC 4×

 

AAA batteries

AC

 

adapter powered mode:

6V 

(Optional not include

d

).

      

Do not use new and used batteries together. 

Do not use different types of batteries together.

Do not dispose of batteries in fire. Batteries may explode or leak.

Remove batteries if the device is not being used for some time.

B

atteries are harmful to environment

, d

ispose 

of correctly for your region

.

 

Remove old batteries from device and follow your local recycling guidelines.

UPPER-ARM 

CUFF

AIR HOSE

AI

R

 

CONNECTOR 

PLUG

LCD DISPLAY

MEM BUTTON

ST

ART/STOP BUTTON

 

BATTERY COMPARTMENT

SET BUTTON

DC POWER SOCKET

MODEL: TMB-1491-BS

Summary of Contents for Blood Pressure3 Monitor

Page 1: ...28437 Zhongshan Guangdong China ASL TF 020 MAN_IFU016 Blood Pressure3 Connected Monitor V2 0 Last Updated 13 02 2022 Upper arm Cuff 22 42cm 8 16 Instructions for Use Parsons Green St Ives Cambridgeshire PE27 4AA United Kingdom Medical Device Safety Service GmbH Schifgraben 41 30175 Hannover Germany UK RP MDSS UK RP Ltd 6 Wilmslow Road Rusholme Manchester M14 5TP United Kingdom ...

Page 2: ...BIHS for Home Use General Description Thank you for selecting the Activ8rlives Blood Pressure3 Connected Monitor The monitor measures blood pressure Systolic Diastolic heart beat bpm and includes irregular heartbeat detection IHD Readings taken by this model are equivalent to those obtained by a trained observer using the cuff and stethoscope method The Instructions for Use contains important safe...

Page 3: ... the START STOP button to release the air immediately from the cuff Loosen the cuff and remove it from your arm to prevent injury WARNING If the cuff pressure reaches 40kPa 300mmHg the unit will automatically deflate Should the cuff not deflate when pressures reach 40kPa 300mmHg detach the cuff from the upper arm and press the START STOP button to stop inflation After the cuff has been inflated fo...

Page 4: ...diagnosis If you experience any serious incident that occurs in relation to this device please report this to Aseptika Limited Activ8rlives and the Competent Authorities of the country in which you reside The technical specifications for this device and the contents of the Instructions for Use are subject to change without notice by the manufacturer 6 7 List of Compatible Devices Works with Blueto...

Page 5: ...atteries when The shows The display is dim The display does not light up Choice of Power Supply AC adapter Battery powered mode 6V DC 4 AAA batteries AC adapter powered mode 6V Optional not included Do not use new and used batteries together Do not use different types of batteries together Do not dispose of batteries in fire Batteries may explode or leak Remove batteries if the device is not being...

Page 6: ... Tip 5 When placing the device on your upper arm ensure that the cuff is secured within the OK region and the air hose runs down the inside of your arm Tip 6 The bottom of the cuff should be 1 2 cm about 1 or 2 fingers above the bend in your arm Tip 7 The device has a small to large sized circumference cuff Ensure that the cuff is secured firmly together at the Velcro patches to stop the cuff slip...

Page 7: ...entricles contract and pump blood out of the heart the blood pressure reaches its maximum value in the cycle which is called systolic pressure When the ventricles relax the blood pressure reaches its minimum value in the cycle which is called diastolic pressure What is the standard blood pressure classification Blood pressure classification published by World Health Organization WHO and Internatio...

Page 8: ...mid and unstable temperature environments Do not wash the reusable cuff with water To obtain the best performance from your device follow the maintenance instructions below Heartbeat Blood pressure monitor is detecting a heartbeat during measurement User 1 User G User 2 Start measurement for User 1 User 2 The bluetooth icon blinks when the bluetooth is working Bluetooth icon LCD display signal SYM...

Page 9: ...alue 40 199 beat minute Temperature 20 C 60 C Relative humidity range 93 non condensing at water vapour pressure up to 50hPa Temperature range 5 C 40 C Relative humidity range 15 90 non condensing but not requiring water vapour partial pressure greater than 50hPa Atmospheric pressure range 700 1060 hPa 5 C 40 C Problem Symptom Check This Remedy No power Low batteries Error message Display will not...

Page 10: ... EQUIPMENT or ME SYSTEM is suitable for home healthcare environments Warning Do not be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging where the intensity of EM disturbances is high Warning Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is nec...

Page 11: ...ance Collateral standard Electromagnetic disturbances Requirements and tests EN ISO 81060 1 2012 Non invasive sphygmomanometers Part 1 Requirements and test methods for non automated measurement type IEC 80601 2 30 2018 Medical electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers EN 1060 4 2004 Non invasiv...

Page 12: ...gdong Transtek Medical Electronics Co Ltd Guangdong Transtek Medical Electronics Co Ltd Zone A No 105 Dongli Road Torch Development District Zhongshan 528437 Guangdong China Need to contact Customer Support We take Customer Support seriously so we provide 7 days a week support for you between 09 00 18 00 You can contact us UK 44 0 1480 352 821 support aseptika com www activ8rlives com Look for in ...

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