Welch Allyn ABPM 6100, Hardware Manual

Page 1: ...0012720 Ver F Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road Navan County Meath Republic of Ireland Welch Allyn Inc 4341 State Street Road Skaneateles Falls NY 13153 USA www welchallyn com 0297 ...

Page 2: ...e 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 med...

Page 3: ...ble The complete name address and phone number of your facility For out of warranty repairs or spare parts orders a purchase order or credit card number 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 ass...

Page 4: ...uctions 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 wa...

Page 5: ... to Hook up 14 3 3 Sizing 14 3 4 Traditional Cuff Placement 15 3 5 Sleeve Cuff Placement 16 3 6 Office Readings 17 3 7 Regular Runs 17 3 8 Data 18 4 MAINTENANCE AND CLEANING 19 5 CALIBRATION CHECK 20 6 SPECIFICATIONS 21 7 CLASSIFICATION 22 8 DISCARDING THE EQUIPMENT 22 9 TROUBLESHOOTING AND ERROR CODES 23 9 1 Error Codes 23 9 2 Troubleshooting 24 10 GUIDANCE AND MANUFACTURER S DECLARATIONS 25 ...

Page 6: ... 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 Serial Number Defi...

Page 7: ...ABPM 6100 Hardware Manual DIR 80012720 Ver F 7 28 EMC Framework of Australia Recycle ...

Page 8: ...y 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...

Page 9: ...rs 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...

Page 10: ...ts 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 ...

Page 11: ...BPM 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 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 ins...

Page 12: ...ep 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 cl...

Page 13: ...ws XP Windows 7 Windows 8 1 Right click on My Computer 1 Right click on Computer 2 Select Properties 2 Select Properties 3 Click the Hardware tab 4 Click the Device Manager 3 Click the Device Manager 5 Double click Ports COM LPT 4 Double click Ports COM LPT 6 Plug the ABPM 6100 PC Interface Cable into a USB port on your PC Allow Windows to install the driver 5 Plug the ABPM 6100 PC Interface Cable...

Page 14: ...M 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 pa...

Page 15: ...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 compromising 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 mo...

Page 16: ...s indicated by color Step 2 Applying the Cuff 1 To apply the Welch Allyn ABPM 6100 cuff simply slide the sleeve up the patient s arm ensuring the color size 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 placemen...

Page 17: ... 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 The belt or shoulder strap and pouch a...

Page 18: ...ion 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 appropri...

Page 19: ... this manual for a list of authorized Welch Allyn service centers Cleaning CLEANING THE ABPM 6100 UNIT 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 Spray The cuff may be sprayed with a mild disinfectant solution e g Cidezyme ENZOL or 10 bleach solution Follow the direct...

Page 20: ... 1 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 calibration 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 ...

Page 21: ...al Standards 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 EN 60601 2 30 2000 Medical electrical equipment Part 2 30 Particular requireme...

Page 22: ...priately In the USA call 1800 SAV LEAD for instructions on recycling it 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 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 o...

Page 23: ... Reading aborted blocked valves or pneumatics Check air hose connections and make certain air tubing is not crimped 86 Reading aborted manual abort Push Start Stop button to restart reading 87 Reading aborted inflate time out or air leak Check air hose and cuff 88 Reading aborted safety time out Push Start Stop button to restart reading If problem persists return for servicing 89 Reading aborted c...

Page 24: ...re 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...

Page 25: ... ABPM6100 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The ABPM6100 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The ABPM6100 is suitable for use in all...

Page 26: ...spital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode n a Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec n a Mains ...

Page 27: ...ined by an electromagnetic site survey a should be less than the compliance level in each frequency range b 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 ob...

Page 28: ...f transmitter W Separation distance according to frequency of transmitter m 150 KHz to 80 MHz P d 2 1 80 MHz to 800 MHz P d 2 1 800 MHz to 2 5 GHz P d 3 2 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 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 t...