Spacelabs Healthcare 90217A Bedienungsanleitung

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

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: +1 425 396 3300

Fax: +1 425 396 3301

Spacelabs Healthcare Ltd

Unit B, Foxholes Centre,

John Tate Road,

Herord.

SG13 7DT. UK.

Tel: +44 1992 507700

Fax: +44 1992 501213

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

This page is intentionally blank

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

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).

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