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17

ELECTROMAGNETIC COMPATIBILITY INFORMATION
Table 1

For all ME EQUIPMENT and ME SYSTEMS

Table 2

For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacture’s declaration - electromagnetic emissions

The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified

below. The customer or the user of the Wireless Blood Pressure Monitor should assure that it is used in

such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions 

CISPR 11

Group 1

The Wireless Blood Pressure Monitor uses RF energy only

for its internal function. Therefore, its RF emissions are very

low and are not likely to cause any interference in nearby

electronic equipment.

RF emissions 

CISPR 11

Class B

The Wireless Blood Pressure Monitor is suitable for use in all

establishments, including domestic establishments and

those directly connected to the public low-voltage power

supply network that supplies buildings used for domestic

purposes.

Harmonic 

emissions 

IEC 61000-3-2

Class A

Voltage  uctuations/

flicker emissions IEC

61000-3-3

Complies

Guidance and manufacturer’s declaration - electro magnetic immunity

The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The cus-

tomer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.

IMMUNITY

test

IEC 60601test level

Compliance level

Electromagnetic environ-

ment - guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or ce-

ramic tile. If floors are covered with syn-

thetic material, the relative humidity

should be at least 30 %.

Electrical fast

transient/burst

IEC 61000-4-4

± 2 kV for power

supply lines

± 2 kV for power

supply lines

Mains power quality should be that of a

typical commercial or hospital environ-

ment.

Surge

IEC 61000-4-5

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

Mains power quality should be that of a

typical commercial or hospital environ-

ment.

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

<5 % U

T

(>95 % dip in U

T

) for 0.5 cy-

cles

40 % U

T

(60 % dip in U

T

) for 5 cycles

70 % U

T

(30 % dip in U

T

) for 25 cycles

<5 % U

T

(>95 % dip in U

T

) for 5 s

<5 % U

T

(>95 % dip in U

T

) for 0.5 cy-

cles

40 % U

T

(60 % dip in U

T

) for 5 cycles

70 % U

T

(30 % dip in U

T

) for 25 cycles

<5 % U

T

(>95 % dip in U

T

) for 5 s

Mains power quality should be that of a

typical commercial or hospital environ-

ment. If the user of the wireless blood

pressure monitor requires continued

operation during power mains interrup-

tions, it is recommended that the wire-

less blood pressure monitor be powered

from an uninterruptible power supply or

a battery.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic  fields should

be at levels characteristic of a typical lo-

cation in a typical commercial or hospital

environment.

NOTE: U

T

 is the a. c. mains voltage prior to application of the test level.

Summary of Contents for BP5

Page 1: ...Wireless Blood Pressure Monitoring System BP5 ABI Syst me de Monitorage de Tension Art rielle sans Fils BP5 ABI...

Page 2: ...e used with the following iPad models iPad 4th generation iPad 3rd generation iPad Mini The iOS version of these devices should be V5 1 or higher Device description Position for blood pressure measure...

Page 3: ...rical equipment Part 1 General requirements for safety Collateral Standard Electromagnetic compatibility Requirements and tests EN 1060 1 1995 A1 2002 A2 2009 Non invasive sphygmomanometers Part 1 Gen...

Page 4: ...NT FIELDS 6 CHANGING MEASUREMENT UNITS 6 TAKING A MEASUREMENT 6 BLOOD PRESSURE 6 ANKLE BRACHIAL INDEX ABI 6 PRINTING A REPORT 7 HISTORY SCREEN 7 WHAT IS SYSTOLIC AND DIASTOLIC PRESSURE 7 WHAT IS PULSE...

Page 5: ...s or calculates not only blood pressure but also a host of other cardiovascular vectors such as Ankle Brachial Index ABI Pulse Pressure PP Mean Arterial Pressure MAP Cardiac Output CO and Stroke Volum...

Page 6: ...THE MODULES TO YOUR iPad Once the devices are fully loaded press the START STOP button on the side of the devices The Bluetooth Indicator Light on the devices will begin flashing On your iPad turn th...

Page 7: ...e cuff over the ankle so that the up label points in the direction of the pa tient s head and the down label points towards the patient s foot Gently secure the cuff with the Velcro in such a way that...

Page 8: ...s field is limited to 10 charac ters in length CHANGING MEASUREMENT UNITS To change measurement units tap the SETUP icon TAKING A MEASUREMENT Ensure that the device batteries are fully charged Ensure...

Page 9: ...eading is taken with the patient seated and the arm slightly bent and at the same level as the heart A is wrapped around the arm an inch above the elbow and an oscillometric sen sor or auscultatory se...

Page 10: ...or higher than an adult s pulse rate during strenuous exercise WHAT IS ANKLE BRACHIAL INDEX ABI The Ankle Brachial Index ABI is a comparison between the systolic levels of the arms and ankles It is a...

Page 11: ...f the usual resting pulse pressure is consistently greater than 40 mmHg e g 60 or 80 mmHg the most likely basis is stiffness of the major arteries aortic regurgitation a leak in the aortic valve an ex...

Page 12: ...is may result in inaccurate measurements Blood pressure measurements determined by this device are equivalent to those obtained by professional healthcare practitioners using the cuff stethoscope ausc...

Page 13: ...infectious person to avoid cross infection This device is designed for adults and should not be used on infants young chil dren pregnant or pre eclamptic patients Please do not use any other cuff than...

Page 14: ...al temperature for operation 5 C 40 C Environmental humidity for operation 90 RH Environmental temperature for storage and transport 20 C 55 C Environmental humidity for storage and transport 90 RH En...

Page 15: ...mble this device Battery replacement should only be performed by a qualified iHealth technician C EXPLANATION OF SYMBOLS Symbol for TYPE BF APPLIED PARTS C Symbol for THE OPERATION GUIDE MUST BE READ...

Page 16: ...tructions and retest Speaking moving arm or body being angry excited or nervous during test Retest when calm avoid speaking or movement during the test Bluetooth connection unstable Bluetooth connecti...

Page 17: ...ffect wireless performance iPad is a trademarks of Apple Inc registered in the U S and other countries The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any us...

Page 18: ...use harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this product does cause harmful interference to radio or...

Page 19: ...vel Compliance level Electromagnetic environ ment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ce ramic tile If floo...

Page 20: ...transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the wireless blood pressure monitor is used exceeds the applicable RF complian...

Page 21: ...e utilis avec les mod les d iPad suivants iPad 4 me g n ration iPad 3 me g n ration Mini iPad La version iOS de ces dispositifs devrait tre V5 1 Description de l appareil Position pour mesure de tensi...

Page 22: ...urit IEC 60601 1 2 2007 quipements lectriques m dicaux Partie 1 Exigences g n rales pour la s curit compatibilit standard lectromagn tique exigences et essais EN 1060 1 1995 A1 2002 A2 2009 tensiom tr...

Page 23: ...LIQUE IPS IMPRESSION D UN RAPPORT HISTORIQUE QU EST CE QUE LA PRESSION SYSTOLIQUE ET DIASTOLIQUE QU EST CE QUE LE POULS QU EST CE QUE L INDEX DE PRESSION SYSTOLIQUE IPS QU EST CE QUE LA PRESSION ART R...

Page 24: ...ule non seulement la pression art rielle mais aussi une multitude d autres param tres cardiovasculaires tels que l index de pression systolique IPS La pression puls e PP la pression art rielle moyenne...

Page 25: ...LED rouge clignotant pendant quelques secondes tat anormal LED rouge fixe RELIER LES MODULES A VOTRE iPad Appuyez sur la touche START STOP le voyant Bluetooth commencera clignoter Activez le Bluetooth...

Page 26: ...r la cheville de sorte que l tiquette Up pointe dans la direction de la t te du patient et l tiquette Down vers le pied du patient Fermez le brassard avec le Velcro de telle mani re qu il soit confort...

Page 27: ...tives du BP5 ABI ne fonction neront pas s ils ne sont pas renseign s IDENTIFIER UN PATIENT ID Patient Ce champ est une identit unique qui identifie chaque patient Les patients peuvent avoir des noms i...

Page 28: ...e l cran QU EST CE QUE LA PRESSION SYSTOLIQUE ET DIASTOLIQUE La pression art rielle indique la force qu exerce le flux sanguin sur les parois des vais seaux La pression systolique indique la pression...

Page 29: ...stress il peut monter jusque 200 240 BPM En g n ral le pouls est plus lev chez les jeunes Il n est pas rare que le pouls d un enfant au repos soit aussi lev voire plus lev que celui d un adulte en eff...

Page 30: ...rs d un exercice physique cause de l accroissement du d bit san guin jusqu pouvoir atteindre 100 mmHg Elle doit revenir autour de 40 mmHg 10 minutes apr s l effort Si la Pression Puls e est affich e e...

Page 31: ...lisateur et d autres consignes fournies avant de mettre l unit en marche Ne pas utiliser ce produit dans un v hicule en d placement car ceci peut provoquer l inexactitude des mesures Ne pas appliquer...

Page 32: ...tensiom tre no tamment l ASP5 05010002JU entr e 100 240V 50 60Hz 200mA sortie CC 5V 1 0A Veuillez remarquer sur la taille de la prise du tensiom tre est un mini USB B Ce tensiom tre sans fil est con u...

Page 33: ...400mAh Plage de mesure Pression du brassard 0 300 mmHg Systole 60 260 mmHg Diastole 40 199 mmHg Fr quence de pouls 40 180 battements minute Pr cision Pression 3 mmHg Pouls 5 Communication sans fil Bl...

Page 34: ...du bras sard est maintenue apr s 1 000 cycles d ouverture fermeture de la fermeture La batterie restera performante pendant un minimum de 300 cycles de recharge Il est conseill de d sinfecter le bras...

Page 35: ...cet appareil ou de sa conformit avec les normes s curitaires et r glementaires Veuillez remarquer que l utilisation de cet accessoire avec un iPad peut affecter la performance sans fil iPad est une ma...

Page 36: ...s patients soufrant d arythmie Brassard mal pos R examiner les instructions relatives l application du brassard L cran a che un r sultat anormal La position du brassard n est pas appropri e ou il n es...

Page 37: ...35...

Page 38: ...e ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Lesplanchersdoivent treenbois cimentou carreauxdec ramique Sileplancherestcou vertdemat rielsynth tique l humidit rela tivedoit treaumoi...

Page 39: ...ayonn es sont contr l es Le client et l utilisateur du tensiom tre sans filpeut permettre d viter l interf rence lec tromagn tique en maintenant une distance minimum entre les appareils de communicati...

Page 40: ...Art Ref IB iHealth ABI08 01 2013 BP5 ABI SMSP01 V1 0 Manufactured for iHealthLabs Europe by ANDON HEALTH CO LTD No 3 JinPing Street Ya An Road Nankai District Tianjin 300190 China www iHealthLabs eu...

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