background image

French

Par conséquent, Guangdong Transtek Medical Electronics Co., Ltd. déclare que cet émetteur de

faible puissance est conforme aux exigences essentielles et autres dispositions pertinentes de la

directive 2014/53/CE

German

Hiermit erklärt Grason-Stadler, dass dieser Niedrigleistungssender den grundlegenden

Anforderungen und anderen relevanten Bestimmungen der Richtlinie 2014/53/EG entspricht

Greek

Με

 

αυτό

 

τον

 

τρόπο

η

 Guangdong Transtek Medical Electronics Co., Ltd. 

δηλώνει

 

ότι

 

αυτός

 

ο

πομπός

 

χαμηλής

 

ισχύος

 

είναι

 

σύμφωνος

 

με

 

τις

 

βασικές

 

απαιτήσεις

 

και

 

άλλες

 

σχετικές

διατάξεις

 

της

 

οδηγίας

 2014/53/

ΕΚ

Hungarian

A Guangdong Transtek Medical Electronics Co., Ltd. ezúton kijelenti, hogy ez az alacsony

teljesítmény

ű

 adó megfelel a 2014/53/EK irányelv alapvet

ő

 követelményeinek és egyéb vonatkozó

rendelkezéseinek

Italian

In questo modo, Guangdong Transtek Medical Electronics Co., Ltd. dichiara che questo trasmettitore

di bassa potenza è conforme ai requisiti essenziali e alle altre pertinenti disposizioni della direttiva

2014/53/CE.

Latvian

Ar šo, Guangdong Transtek Medical Electronics Co., Ltd. pazi

ņ

o, ka šis mazjaudas raid

ī

t

ā

js atbilst

b

ū

tiskaj

ā

m pras

ī

b

ā

m un citiem attiec

ī

giem noteikumiem Direkt

ī

v

ā

 2014/53/EK

Lithuanian

Šiuo dokumentu Guangdong Transtek Medical Electronics Co., Ltd. deklaruoja, kad šis mažas

energijos si

ų

stuvas atitinka esminius reikalavimus ir kitas susijusias nuostatas Direktyva 2014/53/

EB

Malti

Hawnhekk, Guangdong Transtek Medical Electronics Co., Ltd. jiddikjara li din trasmettitur ener

ġ

ija

baxxa hija konformi mar-rekwi

ż

iti essenzjali u dispo

ż

izzjonijiet rilevanti o

ħ

ra tad-Direttiva 2014/53/

KE

Polish

Niniejszym Guangdong Transtek Medical Electronics Co., Ltd. o

ś

wiadcza, 

ż

e ten nadajnik o małej

mocy jest zgodny z zasadniczymi wymaganiami i innymi istotnymi przepisami dyrektywy 2014/53/

WE

Portuguese

Por este motivo, a Guangdong Transtek Medical Electronics Co., Ltd. declara que este transmissor de

baixa potência está em conformidade com os requisitos essenciais e outras disposições relevantes

da Diretiva 2014/53/CE

Slovak

Guangdong Transtek Medical Electronics Co., Ltd. týmto vyhlasuje, že tento vysiela

č

 s nízkym

výkonom je v súlade so základnými požiadavkami a 

ď

alšími príslušnými ustanoveniami smernice

2014/53/ES

Slovene

S tem, Guangdong Transtek Medical Electronics Co., Ltd. izjavlja, da je ta nizka mo

č

 oddajnik v

skladu z bistvenimi zahtevami in drugimi ustreznimi dolo

č

bami Direktive 2014/53/ES

Spanish

Por este medio, Guangdong Transtek Medical Electronics Co., Ltd. declara que este transmisor de

baja potencia cumple con los requisitos esenciales y otras disposiciones pertinentes de la Directiva

2014/53/EC

Swedish

Guangdong Transtek Medical Electronics Co., Ltd. förklarar härigenom att denna låg effekt sändare

överensstämmer med de väsentliga kraven och andra relevanta bestämmelser i direktiv 2014/53/EG

This product can be used with the following restriction(s):

France — Outdoor use is limited to 10mW EIRP within the band 2454 to 2483.5MHz.

Norway — Does not apply for the geographical area within a radius of 20km from the

center of Ny-Ålesund.

Effective Isotropic Radiated Power (EIRP)

Directions for use

General radio compliance  25

Содержание ProBP 2000

Страница 1: ...Welch Allyn ProBP 2000 Digital Blood Pressure Device Directions for use Software Version 1 X...

Страница 2: ...served The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the sof...

Страница 3: ...the patient 12 Maintenance 13 Maintain the device 13 Troubleshooting 14 Specifications 17 Transducer accuracy test 19 Complied standards list 21 General radio compliance 23 Federal Communication Comm...

Страница 4: ...iv Contents Welch Allyn ProBP 2000 Digital Blood Pressure Device...

Страница 5: ...ed for use in measuring blood pressure and heart rate in pediatric and adult patient populations 3 years with arm circumferences between 15 cm to 55 cm approximately 5 9 to 21 7 inches The Welch Allyn...

Страница 6: ...structions directions for use DFU mandatory action A copy of the DFU is available on this website A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days Power sy...

Страница 7: ...ndex marker Limb circumference Minimum Maximum Lot Code Not made with natural rubber latex Miscellaneous symbols Authorized Representative in the European Community Manufacturer Date of manufacture Ty...

Страница 8: ...d foreign objects of 12 5mm and greater and against vertically falling water drops when ENCLOSURE is tilted up to 15 Prescription only or For Use by or on the order of a licensed medical professional...

Страница 9: ...nutes might lead to bruising and discolored skin WARNING Patient injury risk This unit is not suitable for continuous monitoring during medical emergencies or operations WARNING Patient injury risk Ta...

Страница 10: ...s might cause damage to the unit and injure users WARNING Injury risk No modification to this equipment is allowed Modifying the equipment could damage the unit or endanger the user WARNING The power...

Страница 11: ...eration or events to the manufacturer CAUTION Use a soft cloth to clean the entire unit Do not use any abrasive or volatile cleaners See the cleaning instructions presented later in this Directions fo...

Страница 12: ...rm to take a blood pressure measurement 2 Power button Powers on the blood pressure device and starts and stops a blood pressure measurement 3 LCD Display Displays blood pressure reading and other per...

Страница 13: ...outlet 2 Battery compartment behind cover Houses 4 AA alkaline batteries Power options CAUTION To get optimal performance and protect your device use only the correct batteries or the Welch Allyn app...

Страница 14: ...tolic blood pressure result mmHG measurement unit of the blood pressure Diastolic blood pressure result mmHG measurement unit of the blood pressure Pulse in beats per minute Irregular heartbeat Device...

Страница 15: ...n Insert or replace the batteries WARNING Injury risk Do not burn batteries Batteries may leak or explode CAUTION Remove the batteries if the device is not used regularly CAUTION Dispose of old batter...

Страница 16: ...on a bare arm 2 Use the proper size cuff If two cuff sizes fit use the larger one 3 Place the artery marker over the brachial artery 4 Apply the cuff snugly allowing room for no more than two fingers...

Страница 17: ...N Use a soft cloth to clean the entire unit Do not use any abrasive cleaners CAUTION Quaternary Ammonium cleaning products are not recommended as they may cause the plastic to crack Clean the device o...

Страница 18: ...incorrectly Insert the AC adapter tightly Low batteries The display indicates the BAT LO message pauses for 3 seconds The battery icon shows empty does not flash Batteries are low Replace with new ba...

Страница 19: ...n Measure again If the problem persists contact www welchallyn com for further assistance Alarm priority Low Out of range Either SYS 50mmHg or DIA 25mmHg The symbol may appear in either the SYS or DIA...

Страница 20: ...16 Maintenance Welch Allyn ProBP 2000 Digital Blood Pressure Device...

Страница 21: ...mmHg to 130mmHg Pulse value 40 to 199 beats per minute Accuracy Pressure 0 4kPa 3mmHg Pulse value 4 Operating environment Temperature 5 C to 40 C Relative Humidity 85 RH Atmospheric Pressure 86kPa to...

Страница 22: ...etime of the device is two 2 years The manufacture date of the device can be found on the device label Welch Allyn will service ProBP 2000 Digital Blood Pressure Devices that are within their lifetime...

Страница 23: ...est manifold bulb and valve 2 a pressure meter simulator 3 the device with the Flexiport connector removed For further information or to order the test equipment contact Welch Allyn Technical Support...

Страница 24: ...alling the battery 6 When tESt appears on the screen release the Power button 7 Press and hold the Power button again for approximately 3 seconds As the device enters internal mode begin the Transduce...

Страница 25: ...ment Part 1 General requirements for basic safety and essential performance Electromagnetic compatibility IEC EN 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basic safety a...

Страница 26: ...22 Specifications Welch Allyn ProBP 2000 Digital Blood Pressure Device...

Страница 27: ...stallation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications...

Страница 28: ...as been approved by Industry Canada to operate with the antenna listed in the specification table Ce transmetteur de radio IC 12725A TMB1591A a t approuv par l Industry Canada pour fonctionner avec l...

Страница 29: ...u dispo izzjonijiet rilevanti o ra tad Direttiva 2014 53 KE Polish Niniejszym Guangdong Transtek Medical Electronics Co Ltd o wiadcza e ten nadajnik o ma ej mocy jest zgodny z zasadniczymi wymaganiam...

Страница 30: ...26 General radio compliance Welch Allyn ProBP 2000 Digital Blood Pressure Device...

Страница 31: ...irectly from Welch Allyn 2 the date specified during product registration 3 the date of purchase of the product from a Welch Allyn authorized distributor as documented from a receipt from said distrib...

Страница 32: ...28 Warranty Welch Allyn ProBP 2000 Digital Blood Pressure Device...

Страница 33: ...Item Description REUSE 11L Adult long cuff 25 34cm 107041 RPM BP AC Adapter This adapter is an alternate power source for the blood pressure device For a list of additional cuff sizes visit www welcha...

Страница 34: ...30 Approved accessories Welch Allyn ProBP 2000 Digital Blood Pressure Device...

Страница 35: ...unit This may result in incorrect operation of the unit 3 WARNING Patient injury risk The device has not been designed for use with high frequency HF surgical equipment and does not protect against h...

Страница 36: ...for use in the electromagnetic environment specified below The customer or the user of the ProBP 2000 Digital Blood Pressure Device should assure that it is used in such an environment Immunity test...

Страница 37: ...ProBP 2000 Digital Blood Pressure Device including cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended separation...

Страница 38: ...ax output power of transmitter W 150 kHz to 80 MHz d 3 5 80 MHz to 800 MHz d 1 2 800 MHz to 2 7 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 37 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitt...

Страница 39: ...ME EQUIPMENT or ME SYSTEM may be reduced to 1 m The 1 m test distance is permitted by IEC 61000 4 3 a For some services only the uplink frequencies are included b The carrier shall be modulated using...

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