Spacelabs Healthcare OnTrak 90227 Bedienungsanleitung

OnTrak 90227

Ambulatory Blood Pressure Monitor

070-2582-04 Rev. C | www.spacelabshealthcare.com

OPERATIONS MANUAL

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WARNING

Acons or circumstances that may result in personal injury or

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In the event of a serious incident, nofy Spacelabs and the

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iii

070-2582-04 Rev. C

wrien permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by

U.S. and foreign patents and/or pending patents. Specica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, modica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

qualied technical personnel to repair those parts of the equipment which are classied by

Spacelabs Healthcare as 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 St

Snoqualmie, WA 98065

U.S.A

Tel: +1 425 396 3300

Fax: +1 425 396 3301

Manufactured for: Spacelabs Healthcare Ltd.

Unit B, Foxholes Centre,

John Tate Road,

Herord, SG13 7DT

Tel: +44 (0) 1992 507700

Fax: +44 (0) 1992 501213

Brands and product names are trademarks of their respecve owners.

Cauon:

US Federal law restricts the devices documented herein to sale by, or on the

order of, a physician.

CE marked in accordance with the Medical Device Direcve, 93/42/EEC.

This guide was developed to provide key concepts about safety precauons.

WARNING - Actions or circumstances that may result in personal injury or death.

CAUTION - Acons or circumstances that could damage the equipment, produce

inaccurate data or invalidate a procedure.

NOTE - Useful informaon about a product feature, funcon, or procedure.

OnTrak 90227 Operaons Manual

This page is intenonally blank

070-2582-04 Rev. C

1 Operaon

1.1 Overview 1-1

1.2 Indicaons for Use 1-1

1.2.1 Important Notes for the Doctor 1-3

1.2.2 Possible Adverse Reacons 1-3

1.3 ABP Monitor 1-4

1.3.1 Front Panel 1-4

1.3.2 Other Features 1-5

1.4 Replacing the Baeries 1-5

1.5 Inializing the Monitor 1-6

1.5.1 Powering ON/OFF the monitor 1-6

1.5.2 Inializaon from PC Interface 1-7

1.5.3 Independent Inializaon 1-8

1.5.4 Taking Manual Readings 1-10

1.5.5 Unlock User Interface 1-10

1.5.6 Oce Check Mode 1-10

1.5.7 Review Readings 1-11

1.5.8 Ending Monitoring test 1-12

1.5.9 Acvity Graph 1-12

1.6 Preparing the Paent and Precauons for Use 1-13

1.6.1 Using Cu Support 1-16

1.6.2 Accessories 1-17

1.6.3 Correlang with Manual Readings 1-17

1.6.4 Paent Instrucons 1-18

1.6.5 Warnings 1-18

1.7 Data Transfer and Reports 1-19

1.7.1 Prinng a Report 1-20

Table of Contents

OnTrak 90227 Operaons Manual

1.8 Maintenance 1-20

1.8.1 Home Environment 1-20

1.9 Cleaning/Disinfecng 1-21

1.9.1 Cleaning the Cu and Carrying Pouch 1-22

1.9.2 Removing/Installing the Bladder (Washable Cu only) 1-22

1.10 Event Codes 1-23

1.11 Disposal of the OnTrak 90227 at the end of life 1-24

2 Accuracy

2.1 Checking Accuracy 2-1

3 Technical Data

3.1 OnTrak 90227 ABP Monitor 3-1

3.2 Electromagnec Compability 3-4

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 3-8

3.2.4 Guidance and manufacturer’s declaraon – electromagnec immunity 3-9

3.2.5 Recommended separaon distances between portable and mobile RF

communicaons equipment and the 90227 3-10

4. Troubleshoong

4.1 Problem Solving Checklist 4-1

4.2 Servicing 4-2

Appendix 1 - Independent Inializaon

Appendix 2 - Set Date & Time

Appendix 3 - Print a Report

Appendix 4 - Changing the Language

Appendix 5 - Signs and Symbols

1-1

070-2582-04 Rev. C

1 Operaon

1.1 Overview

The Spacelabs Healthcare OnTrak 90227 Ambulatory Blood Pressure (ABP)

monitor is a small, lightweight, baery-powered monitor designed to take blood

pressure and heart rate measurements for 24 hours to 7 days.

These measurements are recorded within the monitor and may be transferred

to Report Management Soware or to CardioNavigator or Sennel Cardiology

Informaon Management Systems.

The device shall be operated only by suitably competent personnel trained in

the use and procedures of Ambulatory Blood Pressure monitors for diagnosc

purposes.

1.2 IndicaonsforUse

Ambulatory blood pressure monitoring is a fully accepted clinical tool for

collecng mulple blood pressure measurements over a set period of me. This

data beer assists clinicians in the diagnosis and subsequent management of

hypertension by providing the following:

• Blood pressure variability

• An estimation of true blood pressure

• Overnight changes in blood pressure

• Morning surge in blood pressure

Several studies have shown that In-clinic and home blood pressure measurements

are unable to provide the same level of in-depth informaon that a 24 hour study

can provide and is therefore superior in predicng target organ damage, morbid

events, or cardiovascular risk.

OnTrak 90227 Operaons Manual

1-2

The OnTrak 90227 ABPM is intended for use on paents aged 3 years and above

and the data obtained is highly accurate and useful for managing a wide variety of

hypertensive situaons including:

• For excluding White Coat Hypertension

• Resistant Hypertension

• Masked Hypertension

• Nocturnal Hypertension

• Assisting in the diagnosis of patients with borderline hypertension

• Assisting decisions on treatment for elderly patients

• As a guide to determining the efficiency of drug treatment

• Episodic Hypertension and/or anxiety disorders

Note: This device has been designed to be used on patients with normal

sinus rhythms. Some factors can affect the performance of the

OnTrak 90227 and/or its blood pressure reading e.g. common

arrhythmias such as atrial or ventricular premature beats or

atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age,

pregnancy, preeclampsia, renal diseases, Patient motion, trembling,

shivering.

The interpretaon of blood pressure measurements gathered by the OnTrak

90227 monitor should only be made by a qualied physician. The accuracy of any

blood pressure recording may be aected by the posion of the subject, his or her

physical condion, and use outside the operang instrucons contained within

this manual.

The OnTrak 90227 ABP is NOT to be used in the following conditions:

• DO NOT use on neonates or children under the age of 3

• DO NOT use in close proximity to high frequency surgical

equipment

• DO NOT use in an Oxygen rich environment

• DO NOT use for blood pressure monitoring during surgery

• DO NOT use the unit in the vicinity of an MRI scanner

• DO NOT connect to a PC or laptop while the unit is attached to a

patient

• Only use a PC or laptop that is IEC 60950-1 compliant

The effectiveness of this unit has not been established in pregnant

(including pre-eclamptic) patients and therefore its use in these

circumstances is not recommended.

1-3

070-2582-04 Rev. C

Ensure the patient is instructed in the removal of the cuff in the event

that it fails to deflate within two and a half minutes

The inflation of the cuff during an oscillometric blood pressure

measurement may increase the risk of bruising in susceptible

patients, such as those taking anti-coagulant medication. The use

of the OnTrak monitor on these patients should be subject to clinical

discretion.

1.2.1 Important Notes for the Doctor

• A measurement can be stopped at any time by pressing the 'ACTION'

key. This will deflate the cuff and the unit will continue at the next

scheduled measurement time.

• Instruct your patients that in the event of a measurement causing

discomfort how to switch the unit off (see section 1.5.1.2) and in the

removal and replacement of the cuff. Also if discomfort persists they

should fully remove the cuff and inform the doctor.

• Ensure that patients are aware that the air hose must not be knotted,

twisted or compressed.

• Ensure patients are made aware that the cuff must only be worn on the

upperarm only and precautions taken to ensure that neither the air hose

or shoulder strap can ever become wrapped around the neck and that

the air hose is worn under outer clothing especially at night.

• Ensure that patients are made aware that the unit should be positioned

in such a manner that ensure the air hose cannot be compressed or

twisted, especially when sleeping.

• In the case of non fully competent patients, the unit is only to be worn

under supervision.

• It is the doctors responsibility to ensure that, according to the health of

the patient, the use of the monitor will not impede or damage the blood

circulation to the arm.

Due to the risk of strangulation by the air hose, the OnTrak 90227

Monitor must only be used in children with special care and under

the permanent supervision after specific prescription by the doctor.

1.2.2 PossibleAdverseReacons

Allergic exanthema (symptomac erupon) in the area of the cu may result,

including the formaon of urcaria (allergic reacon including raised edematous

patches of skin or mucous membranes and intense itching) caused by the fabric

material of the cu.

OnTrak 90227 Operaons Manual

1-4

Petechia (pinpoint reddish or purplish spots on the skin that are usually at to

the touch and resulng from bleeding under the skin) formaon on the forearm

following the applicaon of the cu, may lead to Idiopathic thrombocytopenia

(isolated low platelets count associated with hemorrhagic condions) or phlebis

(inammaon of a vein) may be observed.

1.3 ABP Monitor

The soware revision is displayed on the LCD screen for two seconds aer the

monitor is powered on.

The monitor has the following features:

• 2.4” color LCD

• Battery powered

• USB communications port

• PictBridge printing feature

• Independent Initialization

• 3 function buttons (UP, DOWN and ACTION)

• Blood pressure cuff

• Temporary reading suspension

• Child Mode

The monitor is carried in a pouch that is strapped and/or belted to the side of the

paent. Blood pressure and heart rate measurements are taken using a blood

pressure cu aached to the paent’s arm. This informaon is recorded in the

monitor and can be transferred over USB to the ABP analysis systems.

The monitor 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

• Comfort Mode

• Child Mode

1.3.1 Front Panel

The OnTrak 90227 monitor front panel includes the 2.4” LCD display, UP/DOWN

buons, and an ACTION buon.

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