Spacelabs Healthcare 90217A User manual

Ambulatory Blood Pressure Monitor
90217A
070-2177-01 Rev B | www.spacelabshealthcare.com
OPERATIONS MANUAL

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iii
070-2177-01 Rev B
©2016 Spacelabs Healthcare Ltd.
All rights reserved. Contents of this publicaon may not be reproduced in any form without the
wrien permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by
U.S. and foreign patents and/or pending patents. Specificaons and price change privileges are
reserved.
Spacelabs Healthcare considers itself responsible for the eects on safety, reliability and
performance of the equipment only if:
• assembly operaons, re-adjustments, modificaons or repairs are carried out by
persons authorized by Spacelabs Healthcare, and
• the electrical installaon of the relevant room complies with the requirements of
the standard in force, and
• the equipment is used in accordance with the operaons manual.
Spacelabs Healthcare will make available, on request, such circuit diagrams, component part
lists, descripons, calibraon instrucons or other informaon which will assist appropriately
qualified technical personnel to repair those parts of the equipment which are classified by
Spacelabs Healthcare as fi eld repairable.
Spacelabs Healthcare is commied to providing comprehensive customer support beginning
with your inial inquiry through purchase, training, and service for the life of your Spacelabs
Healthcare equipment.
CORPORATE OFFICES
Spacelabs Healthcare Inc
35301 SE Center Street
Snoqualmie, WA 98065.
USA.
Tel: [phone]
Fax: [phone]
Spacelabs Healthcare Ltd
Unit B, Foxholes Centre,
John Tate Road,
Herord.
SG13 7DT. UK.
Tel: [phone]
Fax: [phone]
Brands and product names are trademarks of their respecve owners.
Caution:
Federal (USA) law restricts this device to sale by or on the order of a
medical praconer licensed by the law of the state in which he pracces
to use or order the use of the device.
CE marked in accordance with the Medical Device Direcve, 93/42/EEC
Security-related informaon is indicated in the following manner in this manual:.
“WARNING” - Actions or circumastances that may result in personal injury or
death.
“ATTENTION” - Acons or circumastances that could damage the equipment, produce
inaccurate data, or invalidate a procedure.
“NOTE” - Useful informaon for a product feature, funcon, or procedure.

ABP 90217A Operations Manual
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070-2177-01 Rev B
1. Operaon
1.1 Overview 1-1
1.1.1 ABP Monitor 1-1
1.2 ReplacingtheBaeries 1-2
1.2.1 MainBaeryReplacement 1-2
1.3 InializingtheMonitor 1-3
1.3.1 ConnecngDirectlytoaLocalReportGenerator 1-3
1.3.2 ConnecngDirectlytothePCInterface 1-4
1.3.3 ConnecngtotheBaseStaonviaModem 1-4
1.3.4 ModemSpeedandCompabilityIssues 1-5
1.3.5 OceCheckMode 1-6
1.4 PreparingthePaentandPrecauonsforUse 1-7
1.4.1 UsingCuSupport 1-11
1.4.2 OponalAccessories 1-11
1.4.3 CorrelangwithManualReadings 1-11
1.4.4 PaentInstrucons 1-12
1.5 DataTransferandReports 1-12
1.6 Cleaning/Disinfecng 1-12
1.6.1 CleaningtheCuandCarryingPouch 1-13
1.6.2 Removing/InstallingtheBladder 1-14
1.7 EventCodes 1-14
2 Accuracy
2.1 Checking Accuracy 2-1
2.1.1 Accuracy Procedure 2-2
3. Technical Data
3.1 90217A Ultralite ABP Monitor 3-1
3.2 ElectromagnecCompability 3-5
Table of Contents

ABP 90217A Operations Manual
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3.2.1 Generalnotes 3-5
3.2.2 Guidanceandmanufacturer’sdeclaraon–electromagnecemissions 3-6
3.2.3 Guidanceandmanufacturer’sdeclaraon–electromagnecimmunity 3-7
3.2.4 Guidanceandmanufacturer’sdeclaraon–electromagnecimmunity 3-8
3.2.5 RecommendedseparaondistancesbetweenportableandmobileRF 
communicaonsequipmentandthe90217A 3-9
4. Troubleshoong
4.1 ProblemSolvingChecklist 4-1
4.2 Servicing 4-2
Appendix - Signs and Symbols

1-1
070-2177-01 Rev B
1. Operaon
1.1 Overview
The Spacelabs Healthcare Models 90217A Ambulatory Blood Pressure (ABP) monitors are
small, lightweight, battery-powered monitors designed to take blood pressure and heart
ratemeasurementsfor24or48hours,orforlongerperiodsoftime.
ThesemeasurementsarerecordedwithinthemonitorsandmaybetransferredtoLocal
ReportGenerator90239A,toReportManagementSoftware(90121or92506)(optionally
in Remote Connection mode using modems) or to CardioNavigator or Sentinel 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purposes.
EachABPmonitorwhenpurchasedcomeswithaStandardCuff,anABPpouch,1xbelt,1x
shoulder harness, 1 x Patient Instruction Diary.
1.1.1 ABP Monitor
The monitor has the following features:
• Four-digitliquidcrystaldisplay(LCD)
• Battery powered
• Serial communications port
• Power ON/OFF switch
• Reading START/STOP button
• Bloodpressurecuff
Themonitorsarecarriedinpouchesthatarestrappedand/orbeltedtothesideofthe
patient. Blood pressure and heart rate measurements are taken using a blood pressure

ABP 90217A Operations Manual
1-2
cuffattachedtothepatient’sarm.Thisinformationisrecordedinthemonitorsandcanbe
transferredoveramodemlinkorbydirectconnectionbetweenthemonitorsandoneof
the ABP analysis systems.
The monitors can be programmed to either activate or deactivate the following
features:
• Displaythecuffpressureateachbleedstep.
• Displaythesystole,diastole,andheartrateattheendofeachmeasurement.
• Bleedto40mmHgratherthanstoppingatthediastolicvalue.
• Beepbeforeandaftereachreading.
1.1.1.1 Front Panel
The90217AmonitorfrontpanelsincludetheLCDdisplay,cuffhoseconnector,andaSTART/
STOP switch.
1.1.1.2 Rear Panel
Therearpanelofthemonitorcontainsprograminputandoutputcommunicationports.
The ON/OFF switch is located on the top panel.
1.2 Replacing the Batteries
Three“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 batteries.
The90217Amonitorbackupbatteryshouldnotrequirereplacement.
1.2.1 Main Battery Replacement
1. Power the monitor OFF, and remove the door over the battery compartment.
2. Replacethe“AA”alkalineorrechargeablebatteries,beingcarefultoobserve
polarities.
• The monitor will not operate if the batteries are incorrectly installed. If
the monitor is going to be stored for an extended period of time, remove
the batteries to prevent the possibility of leakage or discharge.
• Spacelabs Healthcare is not responsible for product damage incurred
as a result of “AA” battery leakage. In the event your monitor has been
damaged by a leaking battery, contact the battery manufacturer for any
recoverable repair or replacement costs. Spacelabs Healthcare will assist
you in determining those costs.
3. Gently replace the battery cover and secure the latch.

1-3
070-2177-01 Rev B
PowerthemonitorON.CheckthattheLCDdisplayisON.Ifthereisnodisplay,powerthe
monitorOFFandreviewtheproblem-solvingchecklistinSection4.Troubleshooting.
Please ensure that discharged batteries, of all types, are disposed of in
accordance with local regulations.
1.3 Initializing the Monitor
TheABPmonitors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 periods, event code display, and whether or not to
displaypressurevalues.Toinitializethemonitor,connectittooneofthefollowinganalysis
systems.
1.3.1 Connecting Directly to a Local Report Generator
For a direct connection, place the 90217A monitor into the chute on the Report Generator
(Model 90239A), See Fig. 1-1.
Figure 1-1: Report Generator

ABP 90217A Operations Manual
1-4
1.3.2 Connecting Directly to the PC Interface
ForadirectconnectiontoaPC-compatiblecomputerviaaModel90121,92506orSentinel:
1. ConnectoneendoftheABPinterfacecabletotheappropriateportonthe
computerwherethe90121,92506orSentinelsoftwareisinstalled.
2. ConnecttheotherendoftheinterfacecabletotheABPmonitor.
Refertoeitherthe90121ABPReportManagementSystemOperationsManual,the92506
ABP Report Management System Client Application Operations 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: Configuration of direct connection to PC
1.3.3 Connecting to the Base Station via Modem
ForamodemconnectiontoaremotePCbasestation,refertoFigure1-3below.
To base station
modem Public telephone
network Modem
Phone
Cable to
serial port ABP
Monitor
Figure 1-3: Modem connection configuration
Note: The actual initialization procedure is discussed in the 90121 ABP Report
Management System Operations Manual (P/N 070-0529-xx) and in the 92506
ABP Report Management System Client Application Operations Manual (P/N
070-2160-xx).