ProBP 2400 Digital Blood Pressure Device
Contents
1. Protocol Embedded Protocol Embedded WHO ESH WelchAllyn Protocol Embedded Advancing Frontline Care d ProBP 2400 Digital Blood Pressure Device Directions for use EH gt 1 powered by CAUTION Federal law restricts this device to sale by or on the order of a physician or licensed healthcare provider l Ch ol l f C Introduction This directions for use manual is a comprehensive guide designed to help you understand the capabilities and operation of the ProBP 2400 digital blood pressure device Read this manual thoroughly before attempting to setup configure use troubleshoot or maintain the device Intended use The ProBP 2400 is a non invasive digital blood pressure device using oscillometric technique and an upper arm blood pressure cuff to measure systolic and diastolic blood pressures pulse rate and mean arterial pressure MAP The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia The ProBP 2400 combines the advantages of an automatic blood pressure device and auscultatory sohygmomanometer It is designed to provide convenient accurate and reliable office blood pressure measurements according to guidelines of the European Society of Hypertension E2. 1 kV for input output lines that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment 1 Guidance and manufacturer s declaration electromagnetic emission The ProBP 2400 Digital Blood Pressure Device is intended for use in the 2 electromagnetic environment specified below The customer or the user of ProBP 2400 Digital Blood Pressure Device should assure that it is used in such an environment 3 Emissions test Compliance Electromagnetic environment guidance The ProBP 2400 Digital Blood Pressure RF emissions Device uses RF energy only for its internal 4 Group 1 function Therefore its RF emissions are CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment RF emissions 5 Class B CISPR 1 Harmonic emissions 6 Class A The ProBP 2400 Digital Blood Pressure IEC 61000 3 2 Device is suitable for use in all establishments i including domestic establishments and those Voltage fluctuations directly connected to the public low wot i voltage power supply network 7 flicker emissions Complies that supplies buildings used for domestic purposes IEC 61000 3 3 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000
3. Manual Three Reading Average Systolic Value 3 3 L ta OI x za rey Unit of Measure 7 c Diastolic Value Maximum inflation Pressure Mean Arterial Pressure 180 24 0 Rest Count Down Auto Inflation Irregular Hear Beat IHB Memory Pulse Rate lt l ols x lt Pulse Detected Welch Allyn ProBP 2400 digital blood pressure device ProBP 2400 components and accessories 1 X Power Adapter 4 X Power Plugs US Europe UK Australia Input 100 240V 50 60Hz 0 48A Output 7 5V 1 5A 1 X ProBP 2400 1 X Adult 22cm 32cm 1 XCD Directions For Use 1 X Large adult 32cm 42cm Initial set up Attaching the power plug to the power adapter Select a proper power plug and attach to the power adapter as shown below Charge the battery completely When using for the first time charge the battery until the recharge indicator on the device turns to green cs Refer to page 27 for the section of Using a power adapter c Refer to page 27 for the section Rechargeable Battery Welch Allyn ProBP 2400 digital blood pressure device 13 Initial set up cont Selecting units of measure 1 Make sure the device is switched off 2 Press and hold the M Button and then turn on the power with the On Off Switch 3 Release the M Button when backlight illuminates 4 Press the Start Stop Button to select the preferred pressure unit mmHg or kPa 5 Pre
4. C The 60 second wait period before the first measurementis not adjustable but may be bypassed by pressing the Start Stop Button a second time This will start the first reading immediately Welch Allyn ProBP 2400 digital blood pressure device 1 E Special Functions MAP Mean Arterial Pressure The device measures the true mean arterial pressure MAP of the patient Each measurement includes a single MAP value The MAP value will always be displayed together with the systolic and diastolic blood pressure value e l mmHg SYS 260 240 J D an 2 L 200 DIA 180 160 140 C The Mean Arterial Pressure MAP is determined from the maximum peak of the oscillometric envelope curve Irregular heartbeat detector in 1x Mode The device detects irregular heartbeat in 1x Mode The irregular heartbeat symbol shows up if during a blood pressure measurement the heart rate has varied by more than 25 In case of an irregular heartbeat the blood pressure measurement might be affected Itis recommended to repeat the measurement or to choose the Manual Mode for verification im zx m fan AR mmHg 260 240 220 200 180 160 140 22 Set maximum inflation pressure 1 Press and hold the M Button for 3 seconds until the column with pressure values flashes 2 Press the Start Stop Button to select the preferred pressure value after value 260 has been reached the next selection optio
5. Mode 25 Attaching the power plug to the power adapter 0see 13 Viewing the stored values ccccccscscscsssssssssssssssseesssssevse 26 Selecting Units of MCAS UNS ssiisnsaceesadsaransmatnientdendctnsantenncanoean 14 Appendix Selecting the Correct CUPf ccccscssssssetsesssessesseessetesseeeseees 15 Rechargeable battery and power adapter cecceeeeerees 27 Fitting the cuff properly ec sess teseeseeeseses 16 17 Troubleshooting sssssssessssssssesesssesssseessensssssseesenssusseesenssasseees 28 Eror messages nespi pe E 29 30 Taking measurements in Single Reading 1x Manual and Three Safety care accuracy test and disposal ccccceeeeees 31 34 Reading Average 3x Mode oo Technical Specifications ccsecssssesssesessssssessssseesssssseseees 35 Co MOE ansann adna 18 Welch Allyn ProBP 2400 digital blood pressure device 5 Symbols Documentation symbols WARNING Thewaming statements in this manual identify conditions or practices that could lead toillness injury ordeath practices thatcould resultin damage to the equipmentor other property CAUTION The caution statements in this manual identify conditions or A orlossofdata Consultoperating instructions directions for use DFU Acopyofthe 74 DFUis available onthis website Aprinted copy ofthe DFU can be welchallyncom Ordered from WelchAllyn fordelivery within 7 calendar days S Helpfulnotes Shipping storing and
6. ProBP 2400 also when using the AC power 3 If the battery starts losing capacity contact your local dealer for replacement battery The battery is user replaceable Welch Allyn ProBP 2400 digital blood pressure device Troubleshooting Problem Possible cause Solutions No power No LCD display Power supply is not properly plugged in Plug the power supply into the wall socket Battery is fully discharged Recharge the rechargeable battery by plugging in the power supply Cuff does not inflate properly Loose connection of the tube Leakage of the tube bladder Make sure the tube of the cuff is securely connected to the device Check for cracks on the tube or the bladder Replace the blood pressure cuff if necessary No result displayed after measurements Device is in Manual Mode Switch to 1x or 3x Mode and repeat the measurements 28 Error messages If an error occurs during a measurement the measurementis interrupted and an error message Err is displayed I m L L 1 Error Description Potential cause and remedy Err 1 Signal too The pulse signals on the weak cuff are too weak Re position the cuff and repeat the measurement Err 2 Error signal During the measurement error signals were detected by the cuff caused for instance by movement or muscle tension Repeat the measurement keeping patient
7. continue deflation An additional push and hold of the M Button will allow reinflation past 200mmHg to a max of 299mmHg 20 When the cuff pressure reaches 20mmHg during the deflation cycle the remaining pressure is vented and the ProBP 2400 goes into the Stand by mode Push the Start Stop at any time to start fast deflation and set the ProBP 2400 to Stand by Take note Take note of the systolic and diastolic values in the same manner as performed with sohygmomanometer measurements Set to Stand by The device can be set to Stand by by pressing the Start Stop Button without turning off the power The device will automatically switch to Stand by if there is no operation for one minute cs Standby 3x Mode automatic three reading average Select 3x Mode then press the Start Stop Button to perform automatic triple blood pressure measurements to determine a three reading average The countdown time before the first measurementis set at 60 seconds The interval times between measurements is user adjustable to 15 30 45 or 60 seconds The average measurement reading is displayed and saved after the measurements are complete im ogg cs The user can manually select up measurement interval times 60 sec 15 30 45 15 30 45 or 60 sec or 60 sec of 15 30 45 or 60 seconds in 3x Mode Please refer to special functions section page 21 Setting measurement interval times
8. 4 11 lt S U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the ProBP 2400 Digital Blood Pressure Device requires continued operation during power mains interruptions it is recommended that the ProBP 2400 Digital Blood Pressure Device be powered from an uninterruptible power supply Set peer or a battery gt 95 dip in U gt 95 dip in U for 5 sec for 5 sec Power frequency Power frequency magnetic fields 50 60 Hz should be at levels characteristic magnetic field 3 A m 3 A m of a typical location in a IEC 61000 4 8 typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level 36 Guidance and manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic immunity The ProBP 2400 Digital Blood Pressure Device is intended for use in the electromagnetic environment specified below The customer or the user of the ProBP 2400 Digital Blood Pressure Device should assure that it is used in su
9. SH American HeartAssociation AHA and World Health Organization WHO with the only modification that the ProBP2400 performs 3 repeated measurements always regardless of the result of the first two measurements Pregnancy Approximately 20 of women develop hypertension during pregnancy Pre eclampsia or Toxemia which may affect pregnancy Pre eclampsia can usually be recognized by a clear increase in blood pressure and high urine protein levels after 20 weeks of gestation Since many oscillometric devices appeared to be unsuitable for use in pregnancy and Pre eclampsia health care authorities require that blood pressure monitors used for this vulnerable patient group are specifically tested The Welch Allyn ProBP 2400 digital blood pressure monitor has successfully passed this validation and therefore may be recommended for use during pregnancy and Pre eclampsia Pickering TG Hall JE Appel LJ et al Recommendations for blood pressure measurement in humans and experimental animals part 1 blood pressure measurement in humans a statement for professionals from the subcommittee of professional and public education of the american heart association council on high blood pressure research Circulation 2005 111 697 716 2Whitworth JA 2003 World Health Organization WHO International Society of Hypertension ISH statement on management of hypertension J Hypertens 2003 21 1983 92 3 O Brien E Asmar R Beilin L et al Practice gui
10. TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ProBP 2400 Digital Blood Pressure Device is used exceeds the applicable RF compliance level above the ProBP 2400 Digital Blood Pressure Device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ProBP 2400 Digital Blood Pressure Device e Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between Device power of the communications equipment portable and mobile RF communications equipment and the ProBP 2400 Digital Blood Pressure The ProBP 2400 Digital Blood Pressure Device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ProBP 2400 Digital Blood Pressure Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ProBP 2400 Digital Blood Pressure Device as r
11. ch an environment Immunity test IEC 60601 test Compliance Electromagnetic environment guidance level level Portable and mobile RF communications equipment should be used no closer to any part of the ProBP 2400 Digital Blood Pressure Device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3V 3 5 IEC 61000 4 6 150 kHz to 80 d Ee MHz ai Radiated RF 3 V m 3 V m d P 80 MHz to 800 MHz 1 IEC 61000 4 3 80 MHz to 2 5 GHz d VP 800 MHz to 2 5 GHz Fi where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol A NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and
12. date of purchase is 1 the invoiced ship date if the device was purchased directly 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 distributor This warranty does not cover damage caused by 1 handling during shipping 2 use or maintenance contrary to labeled instructions 3 alteration or repair by anyone not authorized by Welch Allyn and 4 accidents The product warranty is also subject to the following terms and limitations Shipping cost to return a device to a Welch Allyn Service center is not included Aservice notification number must be obtained from Welch Allyn prior to returning any products or accessories to Welch Allyn s designated service centers for repair To obtain a service notification number contact Welch Allyn Technical Support THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FORA PARTICULAR PURPOSE WELCH ALLYN S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROMAPRODUCT DEFECT COVERED BY THE WARRANTY 38 2014 Welch Allyn All rights are reserved To support the intended use of the product described in this publication the purchaser
13. delines of the European Society of Hypertension for clinic ambulatory and self blood pressure measurement J Hypertens 2005 23 697 701 E Asmar R Beilin L Imai Y et al European Society of Hypertension recommendations for conventional ambulatory and home blood pressure measurement European Society of Hypertension Working Group on Blood Pressure Monitoring J Hypertens 2005 23 697 701 2003 21 1983 1992 Welch Allyn ProBP 2400 digital blood pressure device 3 El Table of Contents SV IND ONS cose ecnstsstieesca casera issn dats oe eae wattle 6 Manual Mode jie cases exsctissistncceserdennhstiedaneesiastialectensicand ales 19 20 Warnings and cautions KSX MOQE one soesssesstssetneeseeenetneetaetaessenneniaennenneeneii 21 General warnings and cautions c ccsscesseeseesseeseeseeseeeseeee 7 8 Special Functions NIBP non invasive blood pressure warnings and cautions 9 MAP Mean Arterial PreSSuUre asics acssiaihtvaassacits ins docetuaseht dekciveds 22 Productdescription pear tee hie IN 1X MOde sceeessesseetseeeerees 22 Name of parts and display raa 10 11 Setting maximum inflation pressure ccseseceseteeeeseteeeeeees 23 Taking fewer than three measurements cccceceeeeeeees 24 Components and ACCESSOTPICS ccccccsesessesssesseseesssessseeeesees 12 Skipping the countdown tIME cccceececsesetecsesesseseeesesseeees 24 Before using ProBP 2400 Setting measurement interval times in 3x
14. e mmHg SYS 260 rl 240 b 2 Ly 200 DIA 180 160 BE 140 M MIN 2 In 3x Mode Press the M Button to reveal the average of the triple measurements Continue pressing the M Button to review individual measurements M amp O M M gt cs The device stores only the last measurement completed in 1x Mode and the last three measurements completed in 3x Mode 26 Rechargeable battery and power adapter Rechargeable Battery The ProBP 2400 features a built in rechargeable Ni MH battery pack that provides up to 600 700 measurement cycles ona full charge The battery can be recharged with the power adapter provided The empty battery indicator is displayed when the battery is low charge the battery until the recharge indicator turns to green c The orange recharge indicator means that the recharge is in progress cs Agreen recharge indicator means that the recharge is completed S When using for the first time Using a power adapter Only use the adapter supplied with ProBP 2400 to recharge the device 1 Plug the adapter cable into the power socket of the device 2 Plug the adapter plug into the wall socket The battery will be recharged as long as the device is attached to an AC power source After the battery is fully recharged the charging will stop No battery power will be used as long as the adapter is plugged in The battery has to remain in the
15. ecommended below according to the maximum output Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Rated maximum output of transmitter 3 5 3 5 7 d wP d lwP d WP w Vi Ei Ei 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Welch Allyn ProBP 2400 digital blood pressure device 7 WARRANTY Welch Allyn will warranty the ProBP 2400 device to be free of defects in material and workmanship and to perform in accordance with manufacturer specifications for a period of two years from the date of purchase from Welch Allyn or its authorized distributors or agents Accessories are covered for a period of one year from date of purchase from Welch Allyn or its authorized distributors or agents The warranty period shall start on the date of purchase The
16. ence ofexcessive motion artefact Minimize extremity and cuff motion during blood pressure readings WARNING The position and physiologic condition of the subject can affect a blood pressure reading CAUTION Ifthe blood pressure cuffis notatheartlevel note the difference in reading dueto the hydrostaticeffect CAUTION Proper blood pressure cuffsize and placementis essential to the accuracy ofthe blood pressure determination See Blood pressure cuff selection for sizing information CAUTION The blood pressure cuff must be properly positioned to ensure blood pressure accuracy and patientsafety Wrapping the cufftoo loosely preventing proper inflation may resultin inaccurate blood pressure readings CAUTION Thepatients should be comfortably seated legs uncrossed feetflaton thefloor back and arm supported The middle of the cuffshould be atthe level of theheart CAUTION Recommend the patients to sitdown and relax foratleast5 minutes prior tothe measurementand nottalk during the measurementprocedure Welch Allyn ProBP 2400 digital blood pressure device Product description Name of parts On Off Switch a a Battery Compartment Cuff Socket 9 Recharge Indicator lo Display M Button Memory Mode Switch 2 D Start Stop Button Display Power Low Battery Mode Selection Single Reading
17. environment symbols 9 Fragile handle with care LAY 8 Recovery Recyclable X Recycle the product separate from other disposables Keepdry Control symbols o Poweron Poweroff b Start Stop Memory es pa Adjust measurement interval times Adjustmaximum inflation pressure Single Reading Mode Manual Mode Three ReadingAverage Mode Miscellaneous symbols Meets essential requirements of European Medical Device Directive 93 42 EEC Regulatory Affairs Representative Type BF applied parts oul Manufacturer General warnings and cautions A WARNING The information in this directions foruse is a comprehensive guide tothe operation of ProBP 2400 Forbestresults read this directions for use thoroughly before using the device WARNING The device is intended for use only in environments with clinician supervision WARNING The device is designed for medical clinician use Although this directions foruse may illustrate medical spot check techniques only a trained clinician should use this device WARNING The device isnotintended for use during patienttransport WARNING Fireand explosion hazard Do notoperate the device in the presence ofa flammable anesthetic mixture with air oxygen ornitrous oxide in oxygen enriched environments WARNING Every three months inspectthe blood pressure cuffand other accessories for fraying or other damage Replace as necessary WARNING Inaccurate mea
18. erformance and accuracy CAUTION Federallawrestricts this device to sale by oron the order ofa physician or licensed health care provider NIBP non invasive blood pressure warnings and cautions A A WARNING ProBP 2400 is notintended to measure blood pressure on children younger than 12 years ofage WARNING Donotcompress the blood pressure hose or cuff This may cause system errors orpatientsafety risks to occur WARNING Inaccurate measurementrisk Donotuse the device on patients who are experiencing convulsions or tremors WARNING Use only blood pressure cuffs and hoses listed as approved accessories toensure safe and accurate of blood pressure measurements WARNING Patientinjury risk When several blood pressure measurements are taken onthe same patient regularly check the cuff site and extremity for possible ischemia purpura and or neuropathy WARNING Donotallowa blood pressure cuffto remain on the patientmore than 5minutes when inflated above 15 mmHg Excessive cufftightness may cause venous congestion peripheral nerve injury discoloration of the limb and patient distress WARNING Patientinjury risk Neverinstall Luer Lock connectors on WelchAllyn blood pressure tubing Using these connectors on blood pressure cuff tubing creates the risk ofmistakenly connecting this tubing to a patient s intravenous line and introducingairinto the patient s circulatory system WARNING NIBP measurements may be inaccurate in the pres
19. isposed of in accordance with the locally applicable regulations and not as domestic Mm waste 34 Technical specifications Operation temperature 10 to 40 C 50 to 104 F humidity Storage temperature 20 to 55 C 4 to 131 F humidity 15 90 relative maximum humidity Weight 800 g including rechargeable battery pack Dimensions 200 x 125 x 90 mm Measuring method Oscillometric Systolic blood pressure K1 Diastolic blood pressure K5 Measurementrange 30 280 mmHg blood pressure 40 200 beats per minute pulse Cuff pressure display Range 0 299 mmHg Resolution 1 mmHg Static accuracy pressure within 3 mmHg Pulse accuracy 5 of the readout value Power source Rechargeable battery pack 4 8V 2400 mAh optional 4 8V 3500mAh Mains power supply DC 7 5V 1 5A Welch Allyn reserves the right to alter technical specifications without prior written notice Reference to Standards Device corresponds to the requirements of the standard for non invasive blood pressure monitor IEC 60601 1 2005 A1 2012 IEC 60601 1 2 2007 AC 2010 ANSI AAMI ISO 81060 2 ANSI AAMI ISO IEC 80601 2 30 Electromagnetic Device fulfills the stipulations of the standard IEC Compatibility 60601 1 2 C 0 0 4 4 Thestipulations ofthe EU Directive 93 42 EEC for Medical Devices Class lla have been fulfilled SPESE pA ETL CLASSIFIED C US LISTED ec rer Microlife AG Intertek Espenstrasse 139 5000497 9443 Widnau Switzerla
20. ith a battery recommended for or supplied with the device WARNING Improper disposal ofbatteries may create an explosion or contamination hazard Never dispose of batteries in refuse containers Donotdispose ofthe battery in fire Always recycle batteries according tolocal regulations WARNING Improper handling of the battery can lead toheat generation smoke bursting orfire WARNING Donotdisassemble modify or solder the battery WARNING For proper patientelectrical isolation and battery charging use only the provided extemal power supply tocharge the device WARNING Electricshock hazard Before cleaning the device disconnectthe power cord from the power source and the device WARNING Take care to preventwater or other fluid from entering any connectors onthe device Should this occur dry the connectors with warmair Check the accuracy ofall operating functions A A Avoid simultaneously connecting patients to the device and high frequency surgical equipment CAUTION Thedeviceisnotheat resistant Donotautoclave CAUTION Use thedevice within stated operating temperature ranges The device willnotmeet performance specifications if used outside these temperatures ranges CAUTIONAlways unplug the extemal power source from the outletbefore moving the device toanewlocation CAUTION Useonly WelchAllyn approved accessories Useofunapproved accessories with the device can affectpatientand operator safety and can reduce product p
21. n will be AUTO at the bottom of the list 3 Press the M Button to confirm the selected value Push and hold for 3 seconds C The inflation pressure selection mmHg kPa can be done in 1x 3x or Manual Mode The default setting is AUTO When set to AUTO the ProBP 2400 will automatically determine the maximum inflation pressure as it inflates the cuff Ifthe maximum inflation pressure selected or the maximum inflation pressure as determined while in AUTO mode is not adequate to determine systolic pressure the device will reinflate to a pressure 30 mmHg higher than the previous inflation pressure and attempt another cycle This can be repeated increasing the maximum inflation by 30 mmHg each time If a maximum inflation pressure of 280 mmHg is reached and the ProBP 2400 is unable to determine a blood pressure an error code will be displayed Itis recommended at this point to switch to the manual mode and determine blood pressure with a stethoscope using traditional Korotkoff method See Manual Mode Welch Allyn ProBP 2400 digital blood pressure device 2 Special Function cont Taking fewer than three measurements in 3x Mode The measurement sequence can be stopped at any time during the measurement sequence by pressing the Start Stop Button The device enters Stand by and remaining measurements are cancelled Data from the measured blood pressure can be viewed by pushing
22. nd CONFORMS TOAAMI STD ES 60601 1 IEC STD 60601 1 6 IEC STD aul Microlife Corporation 80601 2 30 9F 431 RuiGuang Road NeiHu Taipei 11492 Taiwan ROC CERTIFIED TO CSASTD 22 2 NO 60601 1 NO 60601 1 6 NO 80601 2 30 Welch Allyn ProBP 2400 digital blood pressure device 35 E Annex of Report Manufacturer s Declaration of the EUT altogether 5 pages Report No TRE14120020 A2 Issued 2014 12 15 Guidance and manufacturer s declaration electromagnetic emission for all EQUIPMENT AND SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity The ProBP 2400 Digital Blood Pressure Device is intended for use in the electromagnetic environment specified below The customer or the user of the ProBP 2400 Digital Blood Pressure Device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Floors should be wood concrete or discharge ESD S poan o kVcontact ceramic tile If floors are covered with synthetic material the relative IEC 61000 4 2 A Oey humidity should be at least 30 2 kV for power Electrostatic supply lines ae oe Mains power quality should be transient burst IEC 61000 4 4 1 kV for input output lines
23. nect the cuff to the device by inserting the cuff connector into the cuff connector socket ed JIL 1x Z 3x Select an operation mode There are three measurement modes that can be used Slide the switch to select 1x standard single measurement Manual or 3x Mode automatic three reading average 1X Mode standard single measurement Select 1x Mode then press the Start Stop Button to perform a single blood pressure measurement The measurement reading is displayed and saved after the measurement Welch Allyn ProBP 2400 digital blood pressure device 19 Taking measurements in 1x Manual and 3x Mode cont Manual Mode Select Manual Mode if auscultatory blood pressure measurement is preferred above using the oscillometric method In Manual Mode the device serves only asa pressure gauge No oscillometric measurements will be taken The user can hear the systolic and diastolic Korotkoff sounds by means of a stethoscope placed over the Brachial artery Start inflation Press the Start Stop Button to start inflation of the cuff When maximum inflation pressure is reached the ProBP 2400 will automatically begin linear deflation at a rate of 3mmbHg sec Re inflate Push and Hold the M Button during deflation when the cuff pressure is below 200mmHg to re inflate for as long as the button is held up to a max of 200mmHg Release the button to
24. of the product is permitted to copy this publication for internal distribution only from the media provided by Welch Allyn No other use reproduction or distribution of this publication or any part of it is permitted without written permission from Welch Allyn For the addresses and phone numbers of all Welch Allyn regional locations visit welchallyn com locations IB ProBP 2400 EN_FDA 1615 Welch Allyn ProBP 2400 digital blood pressure device 39
25. s arm still Welch Allyn ProBP 2400 digital blood pressure device 2 Err 3 Err 5 No pressure in the cuff No valid results An adequate pressure cannot be generated in the cuff Aleak may have occurred Replace the blood pressure cuff if necessary Repeat the measurement The measuring signals are inaccurate therefore no result can be displayed Switch to Manual Mode and determine blood pressure with a stethoscope using traditional Korotkoff method Hb Pulse rate or cuff pressure too high The pressure in the cuff is too high over 300 mmHg OR the pulse is too high over 200 beats per minute Have the patient relax for 5 minutes and repeat the measurement LO Pulse too low The pulse is too low less than 40 beats per minute Repeat the measurement 30 Safety care accuracy test and disposal Safety and protection This device may be used only for the purpose described in this directions for use manual The device comprises of sensitive components and must be treated with care The manufacturer cannot be held liable for damage caused by incorrect application IN e Only activate the pump when the cuffis connected to the device e Donotuse the device if you think it is damaged or if anything appears unusual e Read further safety instructions in the individual sections of the instruction manual Observe
26. ss M Button to confirm the selection MAP or Topf 1 y r we fe Factory default setting 2 y ro P NOME D D D x x D x mmHg mmHg kPa 260 260 34 7 Cs MAPis the abbreviation of Mean Arterial Pressure c PAM or MAP is chosen depending on language preference Before using the device Selecting the correct cuff Avariety of different cuff sizes are available Adult and Large Adult cuffs are provided with the device Use the cuff marker to select the cuff size that best matches the circumference of the patient s upper arm Cuff Size Circumference Circumference inch cm Child 14 22 5 5 8 7 Adult 22 32 8 7 12 6 Large Adult 32 42 12 6 16 5 Large Adult 32 52 12 6 20 5 Long C Each cuff is provided with 130 cm air tube c Use only cuffs provided by Welch Allyn c Contact Welch Allyn or its authorized distributor to purchase cuffs Child Adult Large Adult Large Adult Long c Adult and Large Adult cuffs are included as standard accessories cs Child and large adult long cuffs are not available in the USA Check your local representative for availability Welch Allyn ProBP 2400 digital blood pressure device 15 Before using the device cont Fitting the cuff properly 3 Wrap and tighten the c
27. surementrisk Donotuse the device on patients who are connected to heart lung machines WARNING Electric shock hazard Donot open the device orattemptrepairs There are no user serviceable parts inside ProBP 2400 other than battery replacement Only performroutine cleaning and maintenance procedures specifically described in this directions for use Inspection and servicing ofintemal parts shall onlybe performed by qualified service personnel WARNING The device complies with applicable domestic and intemational standards for electromagneticinterference and should not present problems to other equipmentorbe affected by otherdevices Asa precaution avoid using the device in close proximity to other equipment Welch Allyn ProBP 2400 digital blood pressure device WARNING WelchAllynis notresponsible for the integrity ofany mounting installation WelchAllyn recommends that customers contacttheir Biomedical Engineering Department or maintenance service to ensure professional installation for safety and reliability of any mounting accessory WARNING The device may notfunction properly ifdropped ordamaged Donotuse the device ifyou notice any signs of damage Qualified service personnel must check any device thatis dropped or damaged for proper operation before putting the device back intouse WARNING Defective batteries can damage the device Ifthe battery shows any signs of damage leakage or cracking it mustbe replaced immediately and only w
28. the M Button Cancel remaining measurements at any time during the measurement sequence n Skipping countdown time in 3x Mode The countdown before and between measurements in 3x Mode can be skipped by pressing the Start Stop Button When the Start Stop Button is pressed during countdown the device will immediately begin the next measurement Skip the countdown time and begin the measurement cs The device can be setin Stand by Mode by pressing the Start Stop Button after completion of measurements The device will automatically switch to Stand by Mode if left unattended for 1 minute C3 Stand by 24 Setting measurement interval times in 3x Mode The default measurement interval time is 60 seconds The interval times can be set as 15 30 45 or 60 seconds 1 Press and hold the Start Stop Button for 3 seconds Press and hold for 3 seconds 2 Press the M Button to adjust the measurement interval time then press the Start Stop Button to confirm The device will go back to Stand by F M x DL z Welch Allyn ProBP 2400 digital blood pressure device 5 E Viewing stored values Viewing stored values The device only stores blood pressure values of the last measurement procedure in 1x and 3x Mode Press the M Button to review the stored readings when the device is in Stand by mode 1 In 1x Mod
29. the storage and operating conditions described in the Technical specifications section of this directions for use manual NA Protect the device from water and moisture X os y Protect the device from direct sunlight Protect the device from extreme heat and cold Avoid proximity to electromagnetic fields such as those produced by mobile phones Never open device Protect device from impact and drops Welch Allyn ProBP 2400 digital blood pressure device 3 E Device care Cleaning the cuff Use a soft cloth with one of the following recommended Remove the bladder Fold and place the cuff cover inside a cleaning solutions to wipe the exterior of the device washing bag Wash the cuff cover with warm water 43 C 1 Mild soap and water 110 F and a mild detergent in the washing machine 2 Hydrogen peroxide solution 3 diluted with water Pasteurization wash the cuff cover in 75 C 1 67 F hot 3 Sodium hypochlorite solution 1 10 dilution of wares 30 minutes household chloride bleach in water Air dry the cuff DO NOT iron the cuff cover ZA Do not iron the cuff 32 Transducer accuracy test Calibration Verification We recommend the device to be tested for accuracy every 2 years or after mechanical impact e g been dropped 1 Setup for accuracy test 2 Push and hold Start Stop Button and turn the power on then release the Start S
30. top Button Wait until CA 0 then 0 O is displayed Ew m7 D CI CI T pieces 350 500 ml Calibrated Vaggal reference manometer Air release valve WelchAllyn Squeeze bulb or Pressure source ProBP 2400 E a 1 WHI y f h 4 CE A I 6u EE l 3 sec ix ax Welch Allyn ProBP 2400 digital blood pressure device 33 Pump the pressure to nearly 100mmHg Compare the pressure displayed on the screens of the device and the reference manometer For example the 100 9 displayed on the device stands for 100 9 mmHg Pump the pressure to nearly 200mmHg Compare the pressure displayed on the screens of the device and the reference manometer For example the 201 0 displayed on the device stands for 201 0 mmHg Pump the pressure to nearly 300mmHg Compare the pressure displayed on the screens of the device and the reference manometer For example the 301 2 displayed on the device stands for 301 2 mmHg lf the difference between the device and the reference manometer at any calibration point exceeds t3mmHg plus the stated accuracy of the reference manometer you may contact Welch Allyn to obtain calibration service v LO CI v Ea Disposal Batteries and electronic instruments must X be d
31. uff around the arm 1 Place the cuff over the upper arm so that the air tube 4 Leave free space with the size of 2 fingers between and artery mark arrow point towards the lower arm the arm of the patient and the cuff Excessive tightness The artery mark on the cuff must be placed over the may cause venous congestion and discoloration of brachial artery the limb If the cuff is wrapped too loosely it cannot 2 Lay the cuff on the arm Make sure that the lower edge be inflated properly and the measured values may be of the cuff lies approximately 2 to 3 cm to 1 inch inaccurate Remove all clothing covering or constricting above the elbow the measurement arm Clothing may interfere with measurement accuracy _ 23 em 7 3 4to 1 inch 5 Cuffs that do not fit properly may lead to inaccurate readings Use a different size cuff if the range index at the end of the cuff does not fall into the range specified by the range stripes cs The range index of the cuff should fall into this range Welch Allyn ProBP 2400 digital blood pressure device 17 Taking measurements in 1x Manual and 3x Mode Turn on the power Set maximum inflation pressure Turn on the device by pressing the On Off Switch atthe back Select desired maximum inflation pressure or AUTO of the device to the ON position P C Refer to page 22 for the section of Set maximum inflation Connect the cuff to the device pressure Con
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