background image

Industry Canada (IC) compliance

To ensure compliance with FCC and Industry Canada RF exposure requirements, this

device must be installed in a location where the antennas of the device will have a

minimum distance of at least 20 cm from all persons. Using higher gain antennas and

types of antennas not certified for use with this product is not allowed. The device shall

not be co-located with another transmitter.

Pour s'assurer de la conformité des exigences aux expositions RF de la FCC et de

l'Industry Canada, cet appareil doit être installé dans un emplacement où les antennes

de l'appareil sont au moins à 20 cm de distance de toute personne. L'utilisation

d'antennes et de types d'antennes à gain supérieur non garantis avec ce produit est

interdite. L'appareil ne doit pas être installé à proximité d'un autre émetteur.

This device complies with Industry Canada licence-exempt RSS standard(s). Operation is

subject to the following two conditions: (1) this device may not cause interference, and

(2) this device must accept any interference, including interference that may cause

undesired operation of the device.

Cet appareil est conforme aux normes RSS exemptes de licence de l'Industry Canada.

Son fonctionnement est soumis aux deux conditions suivantes : (1) l'appareil ne doit pas

produire d'interférences, et (2) l'appareil doit accepter toute interférence radioélectrique

subie, même si l'interférence est susceptible d'en compromettre le fonctionnement.

This radio transmitter (IC: 12725A-TMB1591A) has been approved by Industry Canada to

operate with the antenna listed in the specification table.

Ce transmetteur de radio (IC: 12725A-TMB1591A) a été approuvé par l'Industry Canada

pour fonctionner avec l'antenne répertoriée dans le tableau des spécifications.

This Class B digital apparatus complies with Canadian ICES-003.

Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.

European Union

Czech

Guangdong Transtek Medical Electronics Co., Ltd. tímto prohlašuje, že tento vysíla

č

 s nízkým

výkonem je v souladu se základními požadavky a dalšími p

ř

íslušnými ustanoveními sm

ě

rnice 2014/

53/ ES

Danish

Guangdong Transtek Medical Electronics Co., Ltd. erklærer herved, at denne lavt strøm transmitter

er i overensstemmelse med de væsentlige krav og andre relevante bestemmelser i direktiv 2014/53/

EF

Dutch

Hierbij verklaart Guangdong Transtek Medical Electronics Co., Ltd. dat deze low power transmitter

voldoet aan de essentiële eisen en andere relevante bepalingen van Richtlijn 2014/53/EG

English

Hereby, Guangdong Transtek Medical Electronics Co., Ltd. declares that this low power transmitter

is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/

EC.

Estonian

Käesolevaga Guangdong Transtek Medical Electronics Co., Ltd. teatab, et see väikese võimsusega

saatja on vastavus olulistele nõuetele ja teistele asjakohastele sätetele direktiivi 2014/53/ EÜ

Finnish

Näin ollen Guangdong Transtek Medical Electronics Co., Ltd. vakuuttaa, että tämä pienitehoinen

lähetin on direktiivin 2014/53/EY olennaisten vaatimusten ja muiden asiaa koskevien säännösten

mukainen

24  General radio compliance

Welch Allyn ProBP™ 2000 Digital Blood Pressure Device

Summary of Contents for ProBP 2000

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

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

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

Page 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...

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

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Reviews: