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undesired operation of the device.

 

This product is approved in accordance to R&TTE directive transmitter. 
Hereby, [iHealth Labs Inc],declares that this BPM1AE is in compliance 
with the essential requirements and other relevant provisions of 
Directive 1999/5/EC. Directive 1999/5/EC declaration of conformity can 
be downloaded on the following link: 
https://www.ihealthlabs.eu/support/certifications 
 

Ce produit est conforme à l'Industry Canada. IC: RSS-247 
DECLARATION IC 
Le présent appareil est conforme aux CNR d'Industrie Canada applicablesaux appareils ra
dio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes :  
(1) l'appareil ne doit pas produire de brouillage, et  
(2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le br
ouillage est susceptible d'en compromettre lefonctionnement. 
Ce produit a été approuvé conformément au directives R&TTE de l'émetteur. 
 Par la présente, [iHealth Labs Inc.] déclare que l’appareil [BPM1AE] est conforme aux 
exigences essentielles et aux autres dispositions pertinentes de la directive 1999/5/CE. La 
déclaration de conformité, les documents réglementaires et certifications iHealth peuvent 
être consultés via ce lien : https://www.ihealthlabs.eu/support/certifications 
 

 

OTHER STANDARDS AND COMPLIANCES 

 
The Blood Pressure Monitor corresponds to the following standards:   

IEC 60601-1:2005 +A1:2012(E)/EN 60601-1

2006/A11: 2011 (Medical 

electrical equipment -- Part 1: General requirements for basic safety 
and essential performance), IEC 60601-1-2:2014(Medical electrical 
equipment -- Part 1-2: General requirements for basic safety and 
essential performance - Collateral standard: Electromagnetic 

compatibility - Requirements and tests), IEC80601-2-30:2009+AMD1

2013/EN 80601-2-30:2010/A1

2015(Medical electrical equipment –Part 

2-30: Particular requirements for the basic safety and essential 
performance of automated non-invasive sphygmomanometers)EN 1060-1: 
1995 +  A2: 2009 (Non-invasive sphygmomanometers - Part 1: General 
requirements), EN 1060-3: 1997 + A2: 2009 (Non-invasive 
sphygmomanometers - Part 3: Supplementary requirements for 
electro-mechanical blood pressure measuring systems). 
 

ELECTROMAGNETIC COMPATIBILITY INFORMATION 

 
This product is applicable to the equipment and system requirements 
for the purpose of receiving radio frequency energy for the purpose 
of the work, Wi-Fi receive bandwidth 22M. This product can also be used 
to include RF transmitter equipment and system requirements and 

Summary of Contents for BPM1AE

Page 1: ...ealth App 3 Set Wi Fi 3 OPERATING PROCEDURES 4 Connecting The Cuff To The Monitor 4 Apply The Cuff 4 Body Posture 5 OPERATION INSTRUCTIONS 5 SPECIFICATIONS 6 GENERAL SAFETY AND PRECAUTIONS 7 BATTERY H...

Page 2: ...ent system It is designed to measure the systolic and diastolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm T...

Page 3: ...th App from the App Store iOS device or Google Play Android device Use keyword search terms iHealth BPM1AE or Blood Pressure Monitor Set Wi Fi Step 1 Press and hold the user2 key for 10s the monitor w...

Page 4: ...f tubing connector the monitor will turn on Apply The Cuff a Pull the cuff end through the metal loop positioning it outward away from your body b Place a bare arm through the cuff and position the cu...

Page 5: ...placed at the same level as your heart Note Blood pressure can be affected by the position of the cuff and your physiologic condition OPERATION INSTRUCTIONS a After applying the cuff and your body is...

Page 6: ...asurements SPECIFICATIONS 1 Product name Blood Pressure Monitor 2 Model BPM1AE 3 Classification Internally powered Type BF applied part IP20 No AP or APG Continuous operation 4 Machine size approx 4 7...

Page 7: ...ressure exceed 300 mmHg or maintained above15 mmHg for longer than 3 minutes of the bladder may cause ecchymoma of your arm 7 Consult your physician for any of the following situations a The applicati...

Page 8: ...ranges 15 Please do not share the cuff with any infectious person to avoid cross infection 16 This product should not be used as a USB device 17 If the determined blood pressure systolic or diastolic...

Page 9: ...charging If the cuff doesn t connect with the monitor press any key the door temperature outdoor tempetature if Wi Fi set done the battery valume and clock if Wi Fi set done will display on monitor If...

Page 10: ...ated range specified in part SPECIFICACIONS In this case you should consult a physician or check if your operation violated the instructions The technical alarm condition outside the rated range is pr...

Page 11: ...f supplication instructions and retest Body posture was not correct during testing Review body posture instructions and retest Speaking moving arm or body being angry excited or nervous during test Re...

Page 12: ...n the safety and performance characteristics for a minimum of 10 000 measurements or three years of usage and the cuff integrity is maintained after 1 000 open close cycles of the closure 10 The batte...

Page 13: ...cal authority or retailer for recycling advice Symbol for MANUFACTURER Symbol for COMPILES WITH MDD93 42 EEC REQUIREMENTS Symbol for DATE OF MANUFACTURE Symbol for SERIAL NUMBER Symbol for EUROPEAN RE...

Page 14: ...oduct does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or m...

Page 15: ...r glementaires et certifications iHealth peuvent tre consult s via ce lien https www ihealthlabs eu support certifications OTHER STANDARDS AND COMPLIANCES The Blood Pressure Monitor corresponds to th...

Page 16: ...munity test levels Home Healthcare Environment Electrostatic Discharge IEC 61000 4 2 8 kV contact 2kV 4kV 8kV 15kV air Radiated RF EM field IEC 61000 4 3 10V m 80MHz 2 7GHz 80 AM at 1kHz Proximity fie...

Page 17: ...kV 100kHz repetition frequency Surges Line to line IEC 61000 4 5 0 5 kV 1 kV Surges Line to ground IEC 61000 4 5 0 5 kV 1 kV 2 kV Conducted disturbances induced by RF fields IEC 61000 4 6 3V 0 15MHz...

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