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Spacelabs Healthcare 90217A, Operation Manual

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Ambulatory Blood Pressure Monitor

90217A

070-2177-01  Rev B  |  

www.spacelabshealthcare.com

O P E R A T I O N S   M A N U A L

Summary of Contents for 90217A

Page 1: ...Ambulatory Blood Pressure Monitor 90217A 070 2177 01 Rev B www spacelabshealthcare com O P E R A T I O N S M A N U A L...

Page 2: ...ACCOMPANYING DOCUMENTS Note All further instances of this symbol will be represented in black white WARNING Actions or circumstances that may result in personal injury or death Note All further instan...

Page 3: ...f the equipment which are classi ed by Spacelabs Healthcare as eld repairable Spacelabs Healthcare is committed to providing comprehensive customer support beginning with your initial inquiry through...

Page 4: ...ABP 90217A Operations Manual iv This page is intentionally blank...

Page 5: ...5 1 3 5 Office Check Mode 1 6 1 4 Preparing the Patient and Precautions for Use 1 7 1 4 1 Using Cuff Support 1 11 1 4 2 Optional Accessories 1 11 1 4 3 Correlating with Manual Readings 1 11 1 4 4 Pati...

Page 6: ...and manufacturer s declaration electromagnetic immunity 3 7 3 2 4 Guidance and manufacturer s declaration electromagnetic immunity 3 8 3 2 5 Recommended separation distances between portable and mobi...

Page 7: ...nel Cardiology Information Management Systems The device shall be operated only by suitably competent personnel trained in the use and procedures of Ambulatory Blood Pressure monitors for diagnostic p...

Page 8: ...AA batteries provide the main power source for the monitor These batteries should be replaced or recharged before the start of each patient monitoring session Use either alkaline or rechargeable batte...

Page 9: ...must be initialized prior to the start of patient monitoring Initialization specifies the monitoring period patient information time format measurement interval monitor tone ON OFF during selected per...

Page 10: ...Manual or the Sentinel Operations Manual for more information on the report management system ABP Monitor PC with 92506 or Sentinel software installed USB or Serial interface cable Fig 1 2 Configurati...

Page 11: ...ion only 2 Ask the base station operator to initialize the monitor Give the following information to the operator Patient s name Patient ID number Whether monitor display is to be active or not Time o...

Page 12: ...1 3 4 3 Setup Test Note Verify that the cable connections are secure Power ON the ABP monitor It will display 9999 While the monitor is being read or initialized the digits will change to indicate th...

Page 13: ...unit is NOT for neonatal use do not use on patients under the age of 3 years The effectiveness of this unit has not been established in pregnant including pre eclamptic patients and therefore its use...

Page 14: ...tory methods accurate readings may not always be achieved under some conditions Patient movement the position of the cuff relative to the level of the heart extreme heart rates and blood pressures var...

Page 15: ...tre of the bladder location is marked on the outside of the cuff Once the proper position is determined the cuff must be tightened to ensure that it is equally snug at the top and bottom edges and tha...

Page 16: ...at conforms to local regulations 5 Lead the hose up the arm with the cuff Alternative Position Position 1 and place it across the back of the patient Drape the hose so it does not cause the patient di...

Page 17: ...the straps fits well back on the shoulder towards the neck 2 Fasten the rear short strap to the rear of the armpit Be careful to clip to the material only and not to the bladder 3 Fasten the front st...

Page 18: ...tient knows how to correctly reposition the cuff for successful readings If the cuff is not properly positioned event codes may appear on the monitor The patient should make every effort to keep the m...

Page 19: ...by gently wiping with a clean damp cloth Wipe dry with a clean dry cloth Use only the following recommended cleaning solutions Mild soap and water solution U S Pharmacopoeia USP green soap Sodium hypo...

Page 20: ...its into the long end of the cuff refer to Bladder configuration Note The cuff hose can exit from either opening in the cuff depending on whether you plan a right arm or left arm application 1 7 Event...

Page 21: ...may be an air leak EC22 Overpressure EC32 Overpressure EC42 No cuff attached EC52 Kinked hose EC62 Cuff applied too loosely EC82 EC03 EC03 Patient canceled reading by pressing STOP key No retry attemp...

Page 22: ...f EC85 occurs replace batteries and use as normal if problem persists return to Spacelabs Healthcare EC05 EC95 EC95 Cuff pressure baseline is out of limits The monitor should correct the baseline auto...

Page 23: ...he data available EC79 Bleed steps were too small This may be caused by a partially obstructed air hose All blood pressure attempts following this message are inhibited Attempts can be enabled by powe...

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Page 25: ...uracy of the device can be checked using the following procedure Required Equipment A full size mercury sphygmomanometer or aneroid gauge Note Ensure the mercury sphygmomanometer or aneroid gauge is c...

Page 26: ...e 2 1 712 0039 00 Calibration Kit 3 Press START STOP on the monitor the monitor should read approximately 165 mmHg Compare the readings on the monitor and the manometer as the pressure bleeds down The...

Page 27: ...ves patient comfort and measurement reliability Independently programmable measurement periods and inflation frequencies Telecommunications feature allows remote programming and data retrieval Feature...

Page 28: ...flation to 165 mmHg thereafter the cuff inflates to approximately 30 mmHg above the previous systolic Maximum Cuff Pressure Up to 270 mmHg may be set during initialization Note Cuff Pressure may be li...

Page 29: ...t operation Electrical Requirements Power Requirement Three AA size LR6 or equivalent alkaline or rechargeable batteries Physical Dimensions Height 0 97 in 2 5 cm Depth 3 94 in 10 0 cm Width 2 77 in 7...

Page 30: ...601 1 and IEC 60601 1 1990 IEC 60601 2 30 1999 NIBP CE marked in accordance with the Medical Device Directive 93 42 EEC EN 60601 1 2006 A1 2013 IEC 80601 2 30 2009 A1 2013 Clinically investigated to T...

Page 31: ...may terminate early with an event code Portable and mobile communications equipment can affect medical electrical equipment In particular emergency service radios and walkie talkies can generate very...

Page 32: ...he limits for a class B computing device in accordance with the specifications in Subpart J of Part 15 of FCC Rules which are designed to provide reasonable protection against interference to radio an...

Page 33: ...kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IE...

Page 34: ...ld 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 equip...

Page 35: ...Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8...

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Page 37: ...and correct Monitor displays LLL and alarm sounds Low main battery condition Power OFF the monitor immediately Monitor displays event code Lbb during selftesting 90207 only Low backup battery conditio...

Page 38: ...bs Healthcare Contact your Spacelabs Healthcare Customer Service Representative for shipping details Any attempt to perform service or repair to the monitor will result in cancellation of the warranty...

Page 39: ...via the Spacelabs Healthcare website Consult Documents THIS SYMBOL MEANS YOU MUST READ THE ACCOMPANYING DOCUMENTS Warning Caution hazardous voltages To reduce risk of electric shock do not remove the...

Page 40: ...pplied part which contains and adequate degree of protection against electric shock and is defibrillator proof IEC 60601 1 Type BF equipment The unit displaying this symbol is an F Type isolated float...

Page 41: ...nfra Red Communications Port PRINT REPORT Key Universal Serial Bus USB Network Connection Power Indicator LED Audio Output Speaker HELP Explain Prior Screen Key Data Input Output Keypad Arterial Pulse...

Page 42: ...tilted up to 15 3 Protection against spraying water 4 Protection against splashing water Environmental Shipping Storage Temperature imitations Environmental Shipping Storage Humidity Limitations This...

Page 43: ...ber Serial Number The letters SN stand for Serial Number Each device has its own unique serial number Notations and Abbreviations Abbreviations used as symbols are shown below CH ch ECG Channel ECG Ch...

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Page 45: ......

Page 46: ...425 396 3300 F 1 425 396 3301 Unit B Foxholes Centre John Tate Road Hertford SG13 7DT UK T 44 0 1992 507700 F 44 0 1992 501213 www spacelabshealthcare com 2016 Spacelabs Healthcare Specifications subj...

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