ABPM 6100 Hardware Manual
Contents
1. 19 5 CALIBRATION CHEGK nant ut neci nae cauta na sme n canone Daran rra auae nnmnnn 20 6 SPECIFICATIONS me 21 Te CLASSIFICATION sei PN 22 8 DISCARDING THE 22 9 TROUBLESHOOTING AND ERROR 23 9 1 Error CodeS ses EE 23 9 2 Troubleshooling esre 24 10 GUIDANCE AND MANUFACTURER S 25 DIR 80012720 Ver E 5 28 WelchAllyn ABPM 6100 Hardware Manual 1 Overview The purpose of this manual is to provide an overview of information that you will need to safely and effectively use the ABPM 6100 monitor Information about the CardioPerfect Workstation Software is available in the CardioPerfect Workstation software manual Make sure that you familiarize yourself with all of the safety precautions listed in this chapter before attempting to use either device or the software Intended Use PROPER USE OF THE ABPM 6100 MONITORS 1 The ABPM monitors are intended for use by a trained medical practitioner Interpretation of blood pressure measurements should always be performed by a physician 2 The reliability of all the monitors and the software depend upon conformance with th2. e Remember the patient s comfort and ability to perform normal tasks can significantly impact the relevance of monitoring data e f the display is on briefly review with the patient how to read the data e Explain to the patient the kind of information required in the Patient Diary e f the Start button is enabled explain to the patient that he or she has the option to initiate readings using the Start Stop button OTHER INSTRUCTIONS FOR PATIENTS The patient should also be advised of the following e Pressing the Start Stop button during a reading will cancel that reading and deflate the cuff regardless of whether the Start button is set to On or Off in the Study Parameters e Advise the patient to undress carefully at bedtime using caution not to disconnect the hose from the monitor e Placing a pillow over the monitor during sleep will reduce any electrostatic hum from the ABPM 6100 unit e Alldata is stored internally after deactivation DIR 80012720 Ver E 17 28 WelchAllyn ABPM 6100 Hardware Manual PATIENT DO S AND DON TS Finally familiarize the patient with the following list of do s and don ts Do e Wear a loose fitting blouse or shirt Record time symptom mood and activity position in the patient diary Activate a reading if the Start Stop button is activated at the first sign of symptoms Remain motionless during readings Keep vehicle driving and travel to a minimum Bring diary upon return Don
3. Effectiveness Warnings Make sure that you are familiar with all Safety and Effectiveness considerations before using the ABPM 6100 monitor IMPORTANT WARNINGS The following warnings apply to the ABPM 6100 Ambulatory Blood Pressure Monitors The ABPM 6100 has not been designed for use with high N frequency HF surgical equipment and does not protect against Warning hazards to the patient Ensure the location of the ABPM 6100 provides maximum separation away from all sources of high frequency energy DO NOT use the ABPM 6100 monitor in the presence of flammable anaesthetics due to risk of explosion DO NOT immerse the ABPM 6100 monitor in any fluid place any fluid on the monitor or attempt to clean either monitor with liquid detergents or cleaning agents If any of these instances occurs return the unit to an authorized Welch Allyn Service Center The ABPM 6100 may be cleaned with a damp cloth only DO NOT remove the ABPM 6100 covers Neither unit contains any serviceable parts DO NOT use the monitor if it has failed any diagnostic self test DO NOT use the unit if it displays a pressure greater than zero when no cuff is attached This could lead to inaccurate measurements DO NOT attach the cuff to a limb being used for intravenous infusions This may cause the infusion to be blocked and cause the patient harm DO NOT substitute any component for those supplied by Welch Allyn DO NOT attempt to repair the unit yours
4. all the hardware devices installed amp on your computer Use the Device Manager to change the properties of any device Device Manager Double click Ports COM amp LPT Plug the ABPM 6100 PC Interface Cable into a USB port on your PC Allow Windows to install the driver Ports COM 8 LPT 7 Bluetooth Communications Port COM7 Communications Port COM1 Intel R Active Management Technology SOL COM3 Printer Port LPT1 RIM Virtual Serial Port v2 COMB RIM Virtual Serial Port v2 COME USB Serial Port COMB oo DIR 80012720 Ver E Windows 7 Windows 8 1 Right click on Computer Manage Scan for threats Map network drive Disconnect network drive Create shortcut Delete Rename Properties 2 Select Properties 3 Click the Device Manager Control Panel Home y Device Manager fy Remote mm System protection fy Advanced system settings 4 Double click Ports COM amp LPT 5 Plug the ABPM 6100 PC Interface Cable into a USB port on your PC Allow Windows to install the driver 2 Y9 Ports COM amp LPT Intel R Active Management Technology SOL COM3 i NN RIM Virtual Serial Port v2 COMS Y RIM Virtual Serial Port v2 COM6 f USB Serial Port COM8 Processors 13 28 WelchAllyn ABPM 6100 Hardware Manual To configure Welch Allyn CardioPerfect Workstation for use with the reco
5. correct cuff sizing is vital to the accuracy of monitoring data make sure that you read this section carefully and understand all of the information contained herein before sizing the cuff to the patient USING THE CUFF RANGE MARKS Each cuff has two range marks To size using the range marks wrap the cuff around the patient s non dominant arm If the edge of the cuff falls within the range marks the cuff is the correct size for the patient If the cuff edge does not fall within the range marks try a different size cuff USING THE SIZING TABLE For proper cuff selection find the circumference of the patient s upper arm and refer to this cuff sizing chart DIR 80012720 Ver E 14 28 WelchAllyn ABPM 6100 Hardware Manual Arm Circumference Cuff Size Reusable sleeve cuffs Pediatric Cuff NA Part 101340 Small Adult Cuff 18 27 cm Part 101341 Adult Cuft 101342 Adult Plus Cuff 33 40 cm Part 101343 39 46 cm Large Adult Cuff 3 4 Traditional Cuff Placement Proper cuff placement is very important to achieve accurate blood pressure measurements Follow these instructions to ensure the cuff is accurately placed on the patient Traditional cuff 1 Wrap the cuff snugly around the patient s non dominant arm as shown in the picture making sure that the air hose leading from the cuff is not crimped or damaged The cuff may be worn over a thin shirt without compromisi
6. indicator is at the top of the cuff The cuff should be midway between the elbow and shoulder 2 Be sure the ARTERY indicator is over the patient s brachial artery between the biceps and triceps muscles see illustration showing left arm placement Wrap the cuff snugly around the patient s upper arm Take the initial BP reading and ensure hookup is working Refer to figures 1 2 and 3 on inside flap for an illustrated overview Step 3 Prepare the Patient 1 Preparing the patient is the most important step in obtaining an accurate reliable blood pressure measurement 2 Review the following instructions with your patient e Avoid excess movement during readings e Relax the instrumented hand slightly away from the body e Avoid hand movement DIR 80012720 Ver E 16 28 WelchAllyn ABPM 6100 Hardware Manual e Avoid flexing muscles during the reading Do remove the cuff between readings 3 6 Office Readings Once the ABPM 6100 monitor has been properly attached to the patient and the PC interface cable has been removed from the unit it is important and necessary to perform office readings in order to make sure that the unit is functioning properly and does not cause discomfort to the patient The ABPM 6100 monitor will not begin regular runs until at least one manually initiated reading has been taken Follow these instructions to perform an Office Reading 1 If the unit is in Sleep Mode no display on the LCD
7. 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 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people DIR 80012720 Ver E 28 28
8. parts orders a purchase order or credit card number e For parts order the required spare or replacement part number s Repairs If your product requires warranty extended warranty or non warranty repair service please call first the nearest Welch Allyn Technical Support Center A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone avoiding potential unnecessary return In case the return cannot be avoided the representative will record all necessary information and will provide a Return Material Authorization RMA number as well as the appropriate return address A Return Material Authorization RMA number must be obtained prior to any return Note Welch Allyn does not accept returned products without an RMA Packing Instructions If you have to return goods for service follow these recommended packing instructions e Remove all hoses cables sensors power cords and ancillary products as appropriate before packing unless you suspect they are associated with the problem e Wherever possible use the original shipping carton and packing materials e Include a packing list and the Welch Allyn Return Material Authorization RMA number It is recommended that all returned goods be insured Claims for loss or damage to the product must be initiated by the sender DIR 80012720 Ver E 3 28 WelchAllyn ABPM 6100 Hardware Manual Limited Warranty Stateme
9. problem solving Trouble Response to Trouble Cycle starts but cuff will not fully inflate Ensure a connection with the ABPM 6100 monitor is secure and check bladder for leak replace if needed Replace batteries and try again Blood Pressure readings are not displayed during Regular Runs Verify that the display setting is ON in the Basic Parameters menu Patient activation button does not initiate readings while in the Regular Run mode Verify that Start Button is ON in the Basic Parameters menu Time Regular Runs do not initiate Make sure that the time period is not set for MAN manual operation Blood Pressure readings are failing with error codes being displayed Refer to the Error Codes section CardioPerfect Workstation Software manual DIR 80012720 Ver E 24 28 WelchAllyn ABPM 6100 Hardware Manual 10 Guidance and Manufacturer s Declarations N CAUTION The ABPM6100 needs special precautions regarding EMC and needs to be installed and put into service according to the following EMC information provided Portable and mobile RF communications equipment can affect the ABPM6100 Electromagnetic Emissions The ABPM6100 is intended for use in the electromagnetic environment specified below The customer or the user of the ABPM6100 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guid
10. t Remove the cuff Get the monitor wet Use power tools or heavy equipment during a reading Remove the batteries from the unit Wear long sleeved sweaters or dresses during monitoring period Swim shower or bathe during monitoring Operate heavy equipment or power tools as vibrations may functionally disrupt the monitor 3 8 Data After the ABPM 6100 monitor is disconnected from the patient you will need to reconnect the monitor to the PC in order to read data from the unit To reattach the monitor to the PC simply locate the monitor smaller end of the PC Interface Cable and insert it into the communications port located at the bottom of the unit the PC end of he PC Interface Cable should still be attached to the PC Reading Data from the Unit Whenever data is contained in the unit it can be read from the unit into the ABPM 6100 software The CardioPerfect Workstation software will then allow you to view the data and configure reports See the CardioPerfect Workstation software manual for more information To read data from the unit 1 Make sure that the ABPM 6100 monitor is properly connected to the PC 2 Open the CardioPerfect Workstation software 3 Select the Patient Study that you wish to read data into by clicking the representative date under the appropriate patient name If no Patient Study has been created yet create a Patient Study by following the instructions in the Creating a New Patient Study section o
11. the ABPM6100 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 n a d 12 JP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 12 JP 8010800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 4 2 3 800MHzto 2 5 GHz where P is the maximum output power rating of the transmitter in watts W 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 NOTE 1 At 80 MHz and 800 MHz 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 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 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 ABPM6100 is used exceeds the applic
12. Displays flashing time for 20 seconds after 20 seconds the units turns itself off and goes into Sleep Mode to conserve battery life The LCD Display The LCD displays the following information depending upon the state that the unit is in The time is displayed whenever the unit is in Normal Mode and ready for an action A sun symbol is displayed whenever the buzzer is on usually during the day A Crescent Moon symbol is displayed when the buzzer is off usually during programmed sleeping periods A clock is displayed whenever the unit is in Study Mode A battery symbol is displayed whenever the battery voltage is low and the batteries need to be replaced A printer symbol indicates that the unit contains readings in the memory DIR 80012720 Ver E 12 28 WelchAllyn ABPM 6100 Hardware Manual 3 Interface This section describes how to connect the ABPM 6100 monitor to your PC and how to set up patients for monitoring sessions To set up the ABPM 6100 for communication to your PC for the first time Windows XP 1 Right click on My Computer Open Explore Search Manage Scan for threats Map Network Drive Disconnect Network Drive Create Shortcut Delete Rename 2 Select Properties 3 Click the Hardware tab 4 Click the Device Manager System Properties System Restore Automatic Updates Remote General __ Computer Name Hardware Advanced Device Manager The Device Manager lists
13. WelchAllyn ABPM 6100 Hardware Manual EC REP Regulatory Affairs Welch Allyn Representative 4341 State Street Road Welch Allyn Limited Skaneateles Falls NY Navan Business Park 13153 0220 USA Dublin Road www welchallyn com Navan County Meath i Republic of Ireland C 0297 DIR 80012720 Ver E Welch Allyn ABPM 6100 Hardware Manual Copyright Copyright 2013 Welch Allyn All rights are reserved To support the intended use of the product described in this publication the purchaser of the product is permitted to copy this publication for internal distribution only from the media provided by Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of Welch Allyn to provide accurate and up to date information to users and operators alike Welch Allyn CardioPerfect Workstation and SpiroPerfect are registered trademarks of Welch Allyn Software in this product is Copyright 2013 Welch Allyn All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitle
14. able RF compliance level above the ABPM6100 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ABPM6100 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m DIR 80012720 Ver E 27 28 WelchAllyn ABPM 6100 Hardware Manual Recommended separation distances between portable and mobile RF communications equipment and the ABPM6100 The ABPM6100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ABPM6100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ABPM6100 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of transmitter 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 VP d 223 4P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 8 10 3 7 3 7 7 4 100 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
15. ance RF emissions Group 1 The ABPM6100 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic emissions n a The ABPM6100 is suitable for use in all establishments IEC 61000 3 2 including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations n a flicker emissions IEC 61000 3 3 DIR 80012720 Ver E 25 28 WelchAllyn ABPM 6100 Hardware Manual Electromagnetic Immunity The ABPM6100 is intended for use in the electromagnetic environment specified below The customer or the user of the ABPM6100 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are 8 kV air 8 kV air covered with synthetic material 61000 4 2 the relative humidity should be at least 30 Electrical fast 2 kV for power supply n a Mains power quality should be transient burst lines that of a typical commercial or hospital environment IEC 61000 4 4 1 kV for input output lines Surge 1 kV diffe
16. btain a return authorization from Welch Allyn to return your Product before you send it to Welch Allyn s designated service center for repair THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A 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 FROM A PRODUCT DEFECT COVERED BY THE WARRANT Y DIR 80012720 Ver E 4 28 WelchAllyn Table of contents ABPM 6100 Hardware Manual UO ERR WV ER 6 2 ABPM 6100 MONITOR cc cree cr rni nato nacre ao e ca rum S oa nins Canina xus Pa samE c andes 10 M MED riore Velo PETIT 10 2 2 Operation PN 11 3 INTERFACE soc ecce ED 13 S21 Preliminary te t nen eter eec ont enia Ead 14 3 2 HOOKUP m 14 SEE 14 3 4 Traditional Cuff 15 3 5 Sleeve Placement eter ence ttr t Dee ea ke t exeo aba kae ad E uon toe 16 3 6 Office Readings corre et etd enacted plecti eap Aaa eataa aata doo Ced n qu uud 17 3 7 17 SEMI E 18 4 MAINTENANCE AND CLEANING
17. d to use the copy of the software provided on the original distribution medium The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ownership of the software remains with Welch Allyn The information contained in this manual is subject to change without notice All changes will be in compliance with regulations governing manufacture of medical equipment User responsibility This product is designed to perform in conformity with the description thereof contained in this manual and accompanying labels and inserts when assembled operated maintained and repaired in accordance with the instructions provided A defective product should not be used Parts that are broken plainly worn missing or incomplete distorted or contaminated should be replaced immediately Should any repair or replacement become necessary we recommend that service be performed at the nearest approved service center The user of the product shall have the sole responsibility for any malfunction which results from improper use faulty maintenance improper repair damage or alteration by anyone other than Welch Allyn or their authorized service personnel Accessories The Welch Allyn warranty can only be honored if you use Welch Allyn approved accessories and replacement parts Caution Use of accessories other than t
18. e operation and maintenance instructions in this manual 3 The ABPM 6100 monitors are designed for use with patients with normal sinus rhythms 4 Measurement accuracy for the ABPM 6100 monitors may be affected by position of the subject physical conditions movement and use outside of the operating instructions contained in this manual Conventions Caution consult accompanying documents Identifies information within the manual to avoid injury A SN Serial Number 1 Defibrillation proof type BF applied part C 0297 Meets essential requirements of European Medical Device Directive 93 42 EEC Manufacturer No protection against the ingress of liquids Identifies the battery Do not dispose of this product as unsorted municipal waste Prepare this product for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If this product is contaminated this directive does not apply For more specific disposal information see www welchallyn com weee or contact Welch Allyn Customer Service DIR 80012720 Ver E 6 28 WelchAllyn ABPM 6100 Hardware Manual C N344 EMC Framework of Australia Recycle DIR 80012720 Ver E 7 28 WelchAllyn ABPM 6100 Hardware Manual Safety and Effectiveness Warnings and Cautions Safety and
19. elf Repairs should be performed only by authorized Welch Allyn Service Centers DO NOT attach the cuff to a patient while the PC Serial Connector is attached to the unit DIR 80012720 Ver E 8 28 WelchAllyn ABPM 6100 Hardware Manual A caion The ABPM 6100 is intended to be used as an ambulatory blood pressure recorder that is sent home with the patient to record their blood pressure over a 24 hour period It is used to gather trending information in non critical settings It is not intended to provide clinicians with real time monitoring of patients in an ER or critical care environment The ABPM 6100 monitors are not intended for use on pregnant women or neonates The ABPM 6100 units may not yield accurate blood pressure measurements for patients experiencing moderate to severe arrhythmias Check to ensure that the operation of the unit does not result in prolonged impairment of the patient s circulation Instruct the patient to manually remove the cuff if it fails to deflate within three minutes Avoid compression or restriction of pressure tubes The ABPM 6100 the cuff and tubing are defibrillator protected The ABPM 6100 has no specific precautions during defibrillation and defibrillation has no effect on the ABPM 6100 monitor DIR 80012720 Ver E 9 28 WelchAllyn ABPM 6100 Hardware Manual 2 ABPM 6100 Monitor 2 1 Introduction The ABPM 6100 Unit is worn by the patient in a belt or should
20. er strap and is connected to a cuff which is wrapped around the non dominant arm ABPM 6100 inflates the cuff at pre programmed intervals throughout the day and measures blood pressure using the oscillometric method which senses the cessation of pressure waves in the artery when occluded by pressure in the cuff Heart rate can also be measured using the frequency of pressure waves Blood pressure measurements made by the ABPM 6100 are equivalent to those made by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Electronic or Automated Sphygmomanometers To get the most out of the ABPM 6100 you should read this section of the manual thoroughly You will also need to read and understand the CardioPerfect Workstation software manual to properly interface the ABPM 6100 monitor with the software Checklist Check to make sure that the ABPM 6100 package contains the following 6100 Monitor PC Interface Cable Belt and Shoulder Strap Warranty Card Patient Diary and Cuff Anchors pads Adult Size Cuff Batteries CardioPerfect Workstation Software Manual CD Monitor Pouch Substitution of a component different from that supplied might Caution result in measurement error Remember to fill out your warranty registration card and send it to Welch Allyn as soon as possible Report any damaged or missing components to your authorized We
21. f the CardioPerfect Workstation software manual 4 Follow the instructions in the CardioPerfect Workstation Software Manual chapter 2 3 5 Within a few seconds the data will be retrieved from the unit If the Patient ID in the Unit does not match the Patient ID in the CardioPerfect Workstation software Patient Study a message will appear stating Patient ID in unit and study do not agree Use ID in unit Select Yes to use the Patient ID currently stored in the unit select No to use the Patient ID in the CardioPerfect Workstation software The data from the unit will now be stored in the CardioPerfect Workstation software If you receive an error message when you try to read data from the unit make sure the PC Interface Cable is properly attached to both the monitor and the PC and repeat the Read Data from Unit command See the CardioPerfect Workstation software manual for instructions on using the software and the data handling and reporting options it offers DIR 80012720 Ver E 18 28 WelchAllyn ABPM 6100 Hardware Manual 4 Maintenance and Cleaning Preventative maintenance should be routinely performed to ensure the safe and efficient operation of the ABPM 6100 monitor In addition the monitor should be cleaned after each use Maintenance The following inspections of the ABPM 6100 unit should be performed on a regular basis e The PC connection cable should be inspected for any cracks exposed wires or other damage e T
22. he monitor itself should be visibly inspected for any signs of damage e Pneumatic tubing should be inspected for any cracks fraying or kinks Donotremove any covers or break the warranty seal while inspecting the unit If any signs of damage are detected do not use the ABPM 6100 monitor It should be sent to an authorized Welch Allyn service center See the Service and Warranty section of this manual for a list of authorized Welch Allyn service centers Cleaning CLEANING THE ABPM 6100 UNIT IMPORTANT The ABPM 6100 cannot be sterilized DO NOT immerse the monitor in any fluid or use liquid detergents cleaning agents or solvents to clean it If the unit is immersed in any liquid do not use the unit again The unit should be sent to an authorized Welch Allyn service center The ABPM 6100 unit should be cleaned after every use Use a soft damp cloth to remove any dirt and dust from the unit CLEANING AND DISINFECTING THE CUFF 1 Medical Disinfectant The cuff may be sprayed with a mild disinfectant solution Spray e g Cidezyme ENZOL or 10 bleach solution Follow the direction on the solution rinsed with distilled water and line dry Ensure that no liquid enters the bladder tubing 2 Medical Disinfect Wipe Use a mild disinfectant wipe e g Sani Cloth and thoroughly wet cuff surface and line dry 3 Machine Wash Remove bladder to machine wash the cuff shell Machine wash warm 50 130 F 10 54 C with a m
23. hose recommended by Welch Allyn may compromise product performance DIR 80012720 Ver E 2 28 WelchAllyn ABPM 6100 Hardware Manual Warranty Service and Spare Parts Warranty All repairs on products under warranty must be performed or approved by Welch Allyn Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall exclusively be performed by Welch Allyn certified service personnel Assistance and Parts If the product fails to function properly or if assistance service or spare parts are required contact the nearest Welch Allyn Technical Support Center USA 1 800 535 6663 Canada 1 800 561 8797 Latin America 1 305 669 9003 South Africa 27 11 777 7555 European Call 353 46 90 67790 Australia 61 2 9638 3000 Center United Kingdom 44 207 365 6780 Singapore 65 6419 8100 France 33 1 55 69 58 49 Japan 81 42 703 6084 Germany 49 695 098 5132 China 86 21 6327 9631 Netherlands 31 202 061 360 Sweden 46 85 853 65 51 Before contacting Welch Allyn it is helpful to attempt to duplicate the problem and to check all accessories to ensure that they are not the cause of the problem When calling please be prepared to provide Product name and model number and complete description of the problem The serial number of your product if applicable The complete name address and phone number of your facility For out of warranty repairs or spare
24. ild detergent and line dry DIR 80012720 Ver E 19 28 WelchAllyn ABPM 6100 Hardware Manual 5 Calibration Check Welch Allyn recommends that the calibration of the ABPM 6100 monitor be verified annually by the user using the following procedure 1 With the ABPM 6100 unit already powered up remove one of the AA batteries from the battery compartment Then immediately replace the battery back in its proper orientation which will result in the unit to start the power up cycle 2 While the LCD is displaying dashes press and hold down the Start Stop button The unit will display the software version the battery voltage followed by a click as the valves are closed When the process is finished a pressure value will be displayed on the LCD and the unit is ready to have the calibration checked 3 Disconnect the ABPM 6100 monitor cuff assembly from the unit 4 Attach the appropriate end of ABPM 6100 Y connector Welch Allyn Part 6100 25 to the monitor Attach a cuff to the appropriate end of the Y connector and wrap around a suitably sized can or bottle This acts as the reservoir for the unit Connect the third leg of the Y connector to a high quality known pressure standard Refer to the calibration figure below for a sketch of the test set up 5 Pressurize gauge to 250 mmHg and compare against pressure standard see Note below If the unit does not meet the required calibration unit needs to be returned to Welch Allyn for ca
25. lch Allyn representative DIR 80012720 Ver E 10 28 WelchAllyn ABPM 6100 Hardware Manual 2 2 Operation This section provides a brief overview of the ABPM 6100 unit how to load the batteries and the unit controls i WelchAll y ament 7 INS omm y 7 Sy A C N 82 Ser 21 ee f M The ABPM 6100 features a simple design One Start Stop button functions as the primary control The LCD liquid crystal display displays easy to read information The CardioPerfect Workstation Software allows you to program the unit before the study and retrieve data after the study A single air hose connector allows you to connect the cuff to the unit The Start Stop button allows you to perform the following functions the unit On when it is Off Putthe unit into Study Mode and take a reading when the unit is in Normal Mode The time will flash on the LCD when the unit is in Normal Mode Turn the unit Off from Normal or Study mode when the button is pressed and held until the unit beeps five times approximately five seconds initiate a reading when the unit is in Study Mode Abort a reading and deflate the cuff if pressed when the unit is taking a reading On the back of the ABPM 6100 monitor a label lists the model and serial number of the unit The first four digits of the serial number correspond to the year that the unit was manufactured The battery compartment is on the back
26. libration or repair 6 Bleed pressure down no faster than 10 mmHg per second stopping to check the pressure at 250 200 150 100 and 50 mmHg 7 When finished remove one of the AA batteries from the battery compartment Then immediately replace the battery back in its proper orientation which will cause the unit to start the power up cycle Cuff Wrapped Around Cylinder Typical Office Manometer Attach to Unit Note Your ability to measure the accuracy of the ABPM 6100 depends upon the sensitivity of the pressure standard you use for the calibration procedure e lf using a manometer mercury column or aneroid gauge rated at 3 0 mm Hg you will be able to determine the accuracy of the unit being tested to within 6 0 mm Hg e f using a device e g digital pressure standard rated at 1 0 mm Hg you will be able to determine the accuracy of the unit being tested to within 4 0 mm Hg e Welch Allyn recommends using the most sensitive pressure standard possible when performing calibration checks A Setra Pressure Meter 2270 01 which is calibrated for 0 1 mm Hg works well for this application DIR 80012720 Ver E 20 28 WelchAllyn ABPM 6100 Hardware Manual 6 Specifications This section provides the unit specifications for the ABPM 6100 ambulatory blood pressure monitor Power Requirements e Two AA alkaline batteries or high capacity rechargeable batteries NimH Dimensions e 124x 70 x 33 mm a
27. nections 85 valves or pneumatics and make certain air tubing is not crimped 86 Reading aborted manual Push Start Stop button to abort restart reading 87 Reading aborted inflate Check air hose and cuff time out or air leak Reading aborted safety Push Start Stop button to 88 time out restart reading If problem persists return for servicing 89 Reading aborted cuff Check air hose for blockage overpressure or kinking Service Required power Replace batteries If problem 90 supply out of range or other persists return for hardware problem servicing Service Required safety Push Start Stop button to 91 override fitted or autozero retry reading If problem out of range persists return for servicing 97 Service Required Return for servicing Transducer out of range 98 Service Required A D out Return for servicing of range Service Required EEPROM Unit needs to be 99 calibration data CRC failure recalibrated Return for servicing The codes mentioned above are the codes as shown on the device display Please refer to the CPWS ABP Software manual for the codes as used by the software DIR 80012720 Ver E 23 28 WelchAllyn ABPM 6100 Hardware Manual Always return ABPM 6100 monitor to an authorized service center for repairs Unauthorized service will void all warranties 9 2 Troubleshooting The following table contains a list of troublesome scenarios accompanied by suggestions for
28. neral requirements for safety Collateral Standard Electromagnetic compatibility requirements and tests e EN 1060 1 1996 Specification for Non invasive sphygmomanometers Part 1 General requirements e EN 1060 3 1997 Non invasive sphygmomanometers Part 3 Supplementary requirements for electro mechanical blood pressure measuring systems AAMI SP 10 ES1 Category C 1992 battery powered Electronic or automated sphygmomanometers Calibration e Minimally once per year Safety System e Maximum Inflation pressure limited to 300 mmHg e Auto safety release valve for power failure e Maximum BP measurement time limited to less than 180 seconds Data Connector DIR 80012720 Ver E 21 28 WelchAllyn ABPM 6100 Hardware Manual e Stereo mini plug headphone type connector Operator Control e 1 control and LCD Automatic Measurement Intervals e Programmable up to four separate time periods at 5 to 120 minute intervals 7 Classification Protection against electric shock e internally powered BF Protection against the ingress of liquids IPX per IEC 60529 8 Discarding the Equipment SN Discard the old battery appropriately In the USA call 1800 SAV LEAD for instructions on recycling it ww International users contact your local authorities concerning recycling Discard the ABPM 6100 and accessories according to local laws Do not dispose of this product as un
29. ng the readings 2 Attach an adhesive cuff anchor to the clear tab on the cuff and fasten the cuff anchor to the patient Note Make sure that the parameters have been written to the ABPM 6100 monitor before proceeding The monitor should be in sleep mode 3 Attach the tubing from the ABPM 6100 monitor to the cuff tubing and insert the ABPM 6100 monitor into the monitor pouch Attach the pouch to the shoulder strap or the belt depending upon which is more comfortable to the patient Be sure to allow enough slack for the patient to move comfort ably DIR 80012720 Ver E 15 28 WelchAllyn ABPM 6100 Hardware Manual 3 5 Sleeve Cuff Placement Using an incorrect cuff size could result in erroneous and misleading blood pressure measurements Sleeve cuff uw AL Step 1 To determine the correct cuff size for your patient follow these simple steps 1 To find the right sized cuff wrap the cuff around the patient s upper arm without sliding the arm through the sleeve 2 Usethe color coded RANGE indicator on the inside of the cuff and the bold INDEX marker to check that the arm circumference falls within the cuff range 3 Ifthe arm is within range this cuff size is correct for your patient If the measurement is outside the RANGE indicator select a new cuff size as indicated by color Step 2 Applying the Cuff 1 apply the Welch Allyn ABPM 6100 cuff simply slide the sleeve up the patient s arm ensuring the color size
30. nt Welch Allyn Inc warrants that the Welch Allyn CardioPerfect Workstation computer based product you have purchased meets the labelled specifications of the Product and will be free from defects in materials and workmanship that occur within 1 year after the date of purchase Accessories used with the Product are warranted for 90 days after the date of purchase The date of purchase is 1 the date specified in our records if you purchased the Product directly from us 2 the date specified in the warranty registration card that we ask you to send to us or 3 if you don t return the warranty registration card 120 days after the date on which the Product was sold to the dealer from whom you bought the Product as documented in our records This warranty does not cover damage caused by 1 handling during shipping 2 use or maintenance contrary to labelled instructions 3 alteration or repair by anyone not authorized by Welch Allyn and 4 accidents You assume all responsibility for use of the Product with any hardware or software that does not meet the system requirements described in the Product documentation If a Product or accessory covered by this warranty is determined to be defective because of defective materials components or workmanship and the warranty claim is made within the warranty period described above Welch Allyn will at its discretion repair or replace the defective Product or accessory free of charge You must o
31. of the unit The connector on the bottom of the unit allows you to connect the unit to a PC using the PC Interface Cable Batteries The ABPM 6100 monitor requires 2 AA batteries Batteries are installed into the ABPM 6100 unit in the battery bay located at the back of the unit If rechargeable batteries are used please refer to the manufacturer s guidelines for safe use and adequate maintenance When batteries are properly loaded and first installed the unit will display the following ncrementing dashes for 2 seconds Two sets of numbers the first set of three being the Software Version Battery voltage displayed for 2 seconds prior to the voltage the letter b will present Three quick audible beeps number of BP readings if any in memory along with a flashing printer symbol for 3 seconds the number of readings may not be displayed if the batteries were removed before the unit was turned off One long audible beep Displays flashing time for 20 seconds after 20 seconds the units turns itself off and goes into Sleep Mode to conserve battery life DIR 80012720 Ver E 11 28 WelchAllyn ABPM 6100 Hardware Manual At this point the unit will be ready to upload a BP Study When the unit is turned on subsequently the unit will display the following Three quick audible beeps The number of BP readings if any in memory along with a flashing printer symbol for 3 seconds One long audible beep
32. pproximate Weight 2709 including batteries approximate Environmental Operating Condition e Atmospheric Pressure Range of 700 to 1060 HPA Protection against electric shock e Internally powered Type BF Operating Ambients e Temperature 10 C 50 F to 50 C 122 F e Humidity 20 to 95 RH non condensing Storage Ambients e Temperature 20 C 68 F to 70 C 158 F e Humidity 15 to 95 RH non condensing 170 to 1 700 meters Gauging Ranges e Systolic Blood Pressure 60 to 250 mmHg e Diastolic Blood Pressure 25 to 200 mmHg e Maximum Inflation 270 mmHg e Heart Rate 40 to 200 bpm Memory e Upto 250 readings using Alkaline batteries e Upto 110 reading using rechargeable NimH Method of Measurement Oscillometric with step deflation Accuracy 3mmHg International Standards e EN 60601 1 1 2001 Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems Specific requirements for the protection against hazards of ignition of flammable anesthetic mixtures and to control the risk of fire Fire prevention e EN 60601 2 30 2000 Medical electrical equipment Part 2 30 Particular requirements for the safety including essential performance of automatic cycling non invasive blood pressuring monitoring equipment e EN 60601 1 2 2001 Medical Electrical Equipment Part 1 2 Ge
33. press the Start Stop button to wake the unit 2 Press the Start Stop button again to initiate a manual reading This will cause the cuff to inflate and a reading to be taken 3 Record the readings that are taken in the office as office readings into the patient diary so that information can be taken into account in the analysis of the study This is also a good opportunity to instruct the patient about the use of the patient diary If the Start button is disabled when the parameters are written to the unit thus disallowing initiation of manual readings the ABPM 6100 monitor still allows you to manually initiate measurement for up to 30 minutes after parameters have been written to the unit and the unit has been woken from Sleep Mode This allows you to initiate manual office readings even if you do not wish the patient to be able to initiate readings 3 7 Regular Runs Once at least one manual office reading has been taken regular readings will initiate based upon the interval configured for the first time period BEFORE THE PATIENT LEAVES Make sure of the following before the patient leaves the office e belt or shoulder strap and pouch are positioned comfortably e Start Stop button is accessible to the patient Even if the Start button is disabled in the Study Parameters the Start Stop button will still allow the patient to cancel a reading e The ABPM 6100 monitor is concealed according to the patient s wishes
34. rder Start Welch Allyn CardioPerfect Workstation In the File menu click Settings and click Ambulatory blood pressure Click the Advanced tab Select device g oe oN Set the COM port number to the number of the serial port to which the ABP recorder is connected 6 Click OK to save the settings 3 1 Preliminary Directive Advise the patient to Wear a loose fitting blouse or shirt Avoid wearing long sleeved sweaters or dresses during monitoring period Avoid swimming showering or bathing during monitoring Avoid operating heavy equipment or power tools as vibrations may functionally disrupt the monitor 3 2 Prior to Hook up Before hooking the ABPM 6100 unit up to the patient make sure you have performed the following tasks Be sure the patient name and ID are on the diary and logged separately to avoid confusion with other patient data sure that the ABPM 6100 monitor contains new or charged batteries For new studies make sure that all old data has been downloaded to the CardioPerfect Workstation Software and the ABPM 6100 monitor s memory has been cleared out Make sure that the proper Study parameters have been written from the CardioPerfect Workstation Software to the unit Seat the patient comfortably If the patient has long sleeves have the patient remove his or her shirt Ask the patient which is the non dominant arm You will place the cuff on this arm 3 3 Sizing Since
35. rential mode n a Mains power quality should be that of a typical commercial or IEC 61000 4 5 2 kV common mode hospital environment Voltage dips short 5 Ur n a Mains power quality should be interruptions and gt 95 dip in Ur that of a typical commercial or voltage variations on for 0 5 cycle hospital environment If the user power supply input of the ABPM6100 requires lines 40 96 Ur continued operation during 60 dip in Ur power mains interruptions it is IEC 61000 4 11 for 5 cycles recommended that the ABPM6100 be powered from an 70 96 Ur uninterruptible power supply or 30 96 dip in Ur a battery for 25 cycles 5 96 Ur gt 95 dip in Ur for 5 sec Power frequency 50 60 3 A m 3 A m Power frequency magnetic fields Hz magnetic field IEC 61000 4 8 should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level DIR 80012720 Ver E 26 28 WelchAllyn ABPM 6100 Hardware Manual Electromagnetic Immunity The ABPM6100 is intended for use in the electromagnetic environment specified below The customer or the user of the ABPM6100 should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Portable and mobile RF communications equipment should be used no closer to any part of
36. sorted municipal waste Prepare this product for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If this product is contaminated this directive does not apply For more specific disposal information see www welchallyn com weee or contact Welch Allyn Customer Service DIR 80012720 Ver E 22 28 WelchAllyn ABPM 6100 Hardware Manual 9 Troubleshooting and Error Codes 9 1 Error Codes The ABPM 6100 monitor displays error codes whenever an error situation is encountered Error codes will display on the unit s LCD Error codes that apply to a specific reading will also display in the CardioPerfect Workstation Software when the data is read from the unit The following table explains error codes generated by the ABPM 6100 monitor along with possible solutions for each error code Error Code Description Solution 4 Weak or no oscillometric Check cuff position and cuff signal tightness Artifact Erratic Oscillometric Instruct patient to remain still 2 Signal during reading Try reading again Exceeded retry count 4 Instruct patient to remain still 3 inflate attempts during reading Try reading again Exceeded measurement Check air hose connections 4 time limit and make certain cuff is tight enough Reading aborted blocked Check air hose con
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