Activ8rlives Blood Pressure3 Monitor Instructions For Use Manual Download Page 1

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Dist

Aseptika Limited (Activ8rlives), Suite 5,

SiTwo (formerly

LDH House,

EC REP

Guangdong Transtek Medical Electronics Co., Ltd.

Zone A, No.105,

Dongli Road, Torch Development District,

528437,

Zhongshan,Guangdong,

China

ASL TF-020 MAN

IFU01

Blood Pressure3

Connected Monitor (V

.0)

Last Updated:

.202

Upper-arm Cuff 22 - 42cm

(8¾-16½”)

Instructions for Use

Parsons Green, St Ives, Cambridgeshire, PE27 4AA,

United Kingdom

Medical Device Safety Service GmbH

Schifgraben 41, 30175 Hannover, Germany

MDSS-UK RP Ltd., 6 Wilmslow Road, Rusholme,

Manchester, M14 5TP, United Kingdom

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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