Spacelabs Healthcare OnTrak 90227 User manual

OnTrak 90227
Ambulatory Blood Pressure Monitor
070-2582-04 Rev. C | www.spacelabshealthcare.com
OPERATIONS MANUAL

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iii
070-2582-04 Rev. C
©2019 Spacelabs Healthcare Ltd.
All rights reserved. Contents of this publicaon may not be reproduced in any form without the
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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: [phone]
Fax: [phone]
Manufactured for: 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.
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
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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
vi
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

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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
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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.

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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.