Spacelabs Healthcare OnTrak 90227 Operation Manual
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Spacelabs Healthcare OnTrak 90227 Operation Manual

Ambulatory blood pressure monitor
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OnTrak 90227
Ambulatory Blood Pressure Monitor
070-2582-04 Rev. C |
www.spacelabshealthcare.com
O P E R A T I O N S
M A N U A L

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Summary of Contents for Spacelabs Healthcare OnTrak 90227

  • Page 1 OnTrak 90227 Ambulatory Blood Pressure Monitor 070-2582-04 Rev. C | www.spacelabshealthcare.com O P E R A T I O N S M A N U A L...
  • Page 2 Consult Documents THIS SYMBOL MEANS YOU MUST READ THE ACCOMPANYING DOCUMENTS (Note: All further instances of this symbol may be represented in black & white) WARNING Actions or circumstances that may result in personal injury or death. (Note: Further instances of this symbol may be represented in black & white) In the event of a serious incident, notify Spacelabs and the competent authority of the EU Member State.
  • Page 3 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or pending patents. Specifications and price change privileges are reserved.
  • Page 4 This page is intentionally blank OnTrak 90227 Operations Manual...

  • Page 5: Table Of Contents

    Table of Contents 1 Operation Overview Indications for Use 1.2.1 Important Notes for the Doctor 1.2.2 Possible Adverse Reactions ABP Monitor 1.3.1 Front Panel 1.3.2 Other Features Replacing the Batteries Initializing the Monitor 1.5.1 Powering ON/OFF the monitor 1.5.2 Initialization from PC Interface 1.5.3 Independent Initialization 1.5.4...
  • Page 6 1-22 1.9.2 Removing/Installing the Bladder (Washable Cuff 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 Checking Accuracy 3 Technical Data OnTrak 90227 ABP Monitor Electromagnetic Compatibility 3.2.1 General Notes 3.2.2...

  • Page 7: Operation

    Operation Overview The Spacelabs Healthcare OnTrak 90227 Ambulatory Blood Pressure (ABP) monitor is a small, lightweight, battery-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 Software or to CardioNavigator or Sentinel Cardiology Information Management Systems.
  • Page 8 The OnTrak 90227 ABPM is intended for use on patients aged 3 years and above and the data obtained is highly accurate and useful for managing a wide variety of hypertensive situations including: • For excluding White Coat Hypertension •...

  • Page 9: Important Notes For The Doctor

    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.

  • Page 10: Abp Monitor

    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 buttons, and an ACTION button. OnTrak 90227 Operations Manual...

  • Page 11: Other Features

    1.4 Replacing the Batteries Power for the OnTrak 90227 monitor is supplied by two "AA" alkaline (LR6), Lithium (FR6) or rechargeable NiMH (HR6) batteries. These should be replaced or recharged by the operator before the start of each patient monitoring session.

  • Page 12: Initializing The Monitor

    1.5 Initializing the Monitor The OnTrak 90227 monitor must be initialized prior to the start of patient monitoring. Initialization specifies the monitoring period, time format, measurement interval, monitor tone ON/OFF during selected periods and whether or not to display pressure values. The monitor can be initialized by either connecting it directly to the PC interface or by using the Independent Initialization.

  • Page 13: Initialization From Pc Interface

    5. The unit will shut down. 1.5.1.3 Temporary Reading Suspension The OnTrak 90227 monitor allows the patient to temporarily suspend readings for the purposes of taking a bath/shower etc. Switching the unit back on (see Sec 1.5.1.1) will resume readings. It is recommended that the maximum suspension time should not exceed 1 hour.

  • Page 14: Independent Initialization

    1.5.3 Independent Initialization The OnTrak 90227 monitor provides an initialization option without the need of a 1. Power the monitor ON. 2. A splash screen will be displayed for 2 seconds, followed by the Initialization screen. 3. Use UP/DOWN buttons to navigate through the menu options.
  • Page 15 Automatic Programmed Inflations For subsequent programmed inflations, the monitor will inflate to 30 mmHg above the last recorded systolic. If the systolic has increased to a higher level than this, the unit will deflate, wait 2 minutes, reinflate and increase the pressure in steps of approximately 30 mm until a systolic is found or the maximum cut off pressure is reached.

  • Page 16: Taking Manual Readings

    The reading can be cancelled at any time by pressing the ACTION button once again. The OnTrak 90227 enforces a 30 second minimum period between measurements to allow reperfusion. If the ACTION key is pressed too soon after a measurement, the monitor will display the time left before another reading can be taken.

  • Page 17: Review Readings

    Office Check mode readings. 1.5.6.2 Reinstating Office Check Mode The Office Check mode may be reinstated in the OnTrak 90227 monitor. To reinstate the Office Check mode: 1. Power OFF the monitor (refer to 1.5.1.2).

  • Page 18: Ending Monitoring Test

    1.5.8 Ending Monitoring test A monitoring test in the OnTrak 90227 can be finished at any time as follows: 1. Unlock the User Interface. (Refer to section 1.5.5). 2. Use UP/DOWN buttons to highlight “End test” menu option and press ACTION button.

  • Page 19: Preparing The Patient And Precautions For Use

    • If such a value is computed in the OnTrak 90227 monitor, it appears on the report in angle brackets, e.g., < value>. On the monitor display, dashes are displayed instead of the estimated value.
  • Page 20 PROCEDURE, and that 5 min should elapse before the first reading is taken. Ensure that there is no restriction of the air flow to the cuff as this may cause a bad reading and an event code showing on the screen. OnTrak 90227 Operations Manual 1-14...
  • Page 21 Patient motion, trembling, shivering); • The performance of the OnTrak 90227 can be affected by extremes of temperature, humidity and altitude that are outside the product’s operating parameters 7.

  • Page 22: Using Cuff Support

    3. Fasten the front strap to the top layer of the cuff material at the location where the hose exits the cuff. Adjust the length of these straps to apply a minor amount of tension to hold the cuff in the correct position. OnTrak 90227 Operations Manual 1-16...

  • Page 23: Accessories

    Luer connect Micro-B USB Cable 012-0934-00 Patient Diary, 000-0536-00 The use with the correct Spacelabs Healthcare accessories ensures compliance with the emissions and immunity requirements of EMC standard EN 60601-1- 2:2015 1.6.3 Correlating with Manual Readings The monitor bleeds pressure in discrete steps (not continuously), using the oscillometric method of blood pressure determination.

  • Page 24: Patient Instructions

    The patient should make every effort to keep the monitor dry. However, there is no hazard if the monitor does get wet. If this occurs, power the monitor OFF and return it to Spacelabs Healthcare for service. Do not modify this equipment without authorization of the manufacturer.

  • Page 25: Data Transfer And Reports

    Medical Electronic Equipment on the same limb; • Check (for example, by observation of the limb concerned) that operation of the OnTrak 90227 does not result in prolonged impairment of the circulation of the blood of the PATIENT. If this occurs stop immediately •...

  • Page 26: Printing A Report

    If damage is found the cuff should be replaced, only approved Spacelabs cuffs should be used with this equipment. The OnTrak 90227 should be serviced on an annual basis. As part of the Service test routine the calibration of the OnTrak 90227 will be checked.
  • Page 27 • Do not expose the product to surfaces that are too hot to touch. • Do not leave in a situation where the product would be accessible to mice, rats or other pests. 1.9 Cleaning/Disinfecting Visually inspect the monitor, air hose, and pressure cuff for dirt, debris, frayed or worn areas, etc.
  • Page 28 (refer to Figure 1-5: Bladder configuration). Opening for Opening for Right Arm Left Arm BLADDER (shown inserted into cuff wrap for left arm application) ARTERY Figure 1-5: Bladder Configuration OnTrak 90227 Operations Manual 1-22...
  • Page 29 Note: The cuff hose can exit from either opening in the cuff, depending on whether you plan a right arm or left arm application. 1.10 Event Codes The monitor displays an event code whenever an event prevents the monitor from successfully completing a blood pressure measurement.
  • Page 30 Cuff pressure baseline is out of limits. The monitor should correct the baseline 1.11 Disposal of the OnTrak 90227 at the end of life Disposal of the OnTrak 90227 and it’s accessories should be arranged with the Spacelabs service representative who will ensure that the OnTrak 90227 is disposed of in accordance with WEEE regulations.
  • Page 31 Accuracy Checking Accuracy Spacelabs Healthcare recommends annual calibration of your ABP device by an authorized repair centre. This must only be performed by qualified personnel following the procedure in the Service Manual (070-2566-00). 070-2582-04 Rev. C...
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  • Page 33 Technical Data OnTrak 90227 ABP Monitor Summary Lightweight design and small size maximize patient comfort and compliance. Uses oscillometry, the most widely accepted and validated method of automatic NIBP measurement. Measures systolic, diastolic, mean blood pressure, and heart rate. Ability to make 500 measurements over periods of 24 hours to 7 days.
  • Page 34 Comfort mode allows a user to change the first inflation limit to 110 mmHg or 130 mmHg as desired, thereafter, the cuff inflates to approximately 30 mmHg above the previous systolic measurement. Maximum cuff 250 mmHg inflation pressure Auto-zeroing Pressure is automatically zeroed before each reading. OnTrak 90227 Operations Manual...
  • Page 35 Failsafe mechanisms limit the inflation period to less than 180 seconds and the absolute maximum pressure to 300 mmHg. The air hose is detachable by the patient. Service Life The service life of the OnTrak 90227 and associated accessories will be 7 years minimum. Classification EN 60601-1 Internally powered equipment.
  • Page 36 The sphygmomanometer was clinically investigated according to the requirements of ISO 81060-2:2013 (excluding ISO 81060-2:2013 section 5.2.6). ETL certified: UL 60601-1:2003, IEC 60601-2-30:1999 and IEC 60601-1-6:2004 Accessories For information about supplies, please contact your Spacelabs Healthcare representative. 3.2 Electromagnetic Compatibility Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents.
  • Page 37 The use with the correct Spacelabs Healthcare accessories ensures of compliance with the emissions and immunity requirements of EMC standard EN60601- 1-2:2015. The use of other accessories may result in increased emissions or decreased immunity which may result in improper operation.
  • Page 38 Harmonic emissions Not applicable Not applicable as the 90227 Monitor is battery IEC 61000-3-2 powered. Voltage fluctuations/ Not applicable Not applicable as the 90227 Monitor is battery flicker emissions powered. IEC 61000-3-2 OnTrak 90227 Operations Manual...
  • Page 39 Relocate the equipment with respect to the receiver • Move the equipment away from the receiver If necessary, the user should consult Spacelabs Healthcare or an experienced radio/television technician for additional suggestions. The user may find the following booklet prepared by the Federal Communications Commission helpful: “How to Identify and Resolve Radio-TV Interference Problems”...
  • Page 40 Power frequency magnetic fields (50/60 Hz) & 60 Hz Power should be at levels characteristic 30 A/m at 50 & magnetic field frequency of a typical location in a 60 Hz IEC 61000-4-8 magnetic typical commercial or hospital environment. OnTrak 90227 Operations Manual...
  • Page 41 3.2.4 Guidance and manufacturer’s declaration – electromagnetic immunity The 90227 is intended for use in the electromagnetic environment specified below. The customer or the user of the 90227 should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance Electromagnetic environment - guidance test test level level...
  • Page 42 (m) can be calculated. The distance (d) is calculated by multiplying the root of the power (P) times 6 dived by immunity level (E); d = Vp x 6 / E. OnTrak 90227 Operations Manual 3-10...
  • Page 43 Troubleshooting Problem Solving Checklist Problem Possible Cause Solution Monitor display is Low or no power. Check the batteries for a full incorrect charge; if needed, replace or recharge the batteries. May be one of the following: Isolate cause and correct. timeout, no reading due to air leak in the system, improper cuff size, cuff not properly attached to the...
  • Page 44 90 day warranty). Field service for the ABP monitor is limited to replacing batteries and accessories. If other repair is required, return the monitor to Spacelabs Healthcare or authorized distributor. Contact your Spacelabs Healthcare Customer Service Representative for shipping details.
  • Page 45 Appendix 1 - Independent Initialization Press the DOWN Button Press ACTION Button Switch unit ON Switch unit ON by once to highlight the Once to edit the pressing the ACTION monitoring period and highlighted field button measurement interval Note the white stripes Note the stripes have Repeat previous steps until above and below the...
  • Page 46 UP/DOWN buttons to following the scheduled change the initialization highlight “Start New time as per settings we state (Enable/Disable) Test” option and press have edited before ACTION button once Screen will switch OFF after displaying the time. OnTrak 90227 Operations Manual A1-2...
  • Page 47 Appendix 2 - Set Date & Time Press DOWN Button Press ACTION Button Switch unit ON Switch unit ON by pressing six times to highlight Once to select the the ACTION button “Advanced Setup” menu highlighted field option Press ACTION Button Use ACTION Button to set Note the white stripes above again to select “Set Time...
  • Page 48 Repeat with the other fields and select OK when finished setting the Date Screen will Display the Time and Date we have setup and will go back to settings screen afterwards OnTrak 90227 Operations Manual A2-2...
  • Page 49 Appendix 3 - Print a Report Connect the USB cable Current test must be ended The unit will detect the host from the printer. in order to get the data. Press device (PC or Printer) the DOWN Button once followed by the ACTION Button to end the test.
  • Page 50 Disconnect readings and the number the USB cable to finish of readings. From here you printing. can review the readings or start a new test setup. OnTrak 90227 Operations Manual A3-2...
  • Page 51 Appendix 4 - Changing the Language Press DOWN Button six times Press ACTION Button Switch unit ON Switch unit ON by pressing until “Advanced setup” menu Once to go to the “Advanced the ACTION button option is higlighted setup” menu Press DOWN Button once In this screen you can change All the menus will be...
  • Page 52 Press DOWN Button e.g. Press DOWN Button Once your desired language once once is displayed on the screen, press ACTION Button once All the menus will be displayed on your selected language OnTrak 90227 Operations Manual A3-4...
  • Page 53 Appendix 5 - Signs and Symbols The following list of international and safety symbols describes all symbols used on Spacelabs Healthcare products. No one product contains every symbol. General Safety Consult Documents Consult instructions for use available on accompanying THIS SYMBOL MEANS...
  • Page 54 General Use ON — Power Connection to OFF — Power Disconnection Mains from Mains OFF Position for Push Button ON/OFF Power Switch STANDBY Key Power ON/OFF START (NIBP) Key START/STOP STOP or CANCEL Key OnTrak 90227 Operations Manual A4-2...
  • Page 55 Frequently Used Functions Video Output Infra 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 PCMCIA Card Keyboard Connection Mouse Connection Serial Port 070-2582-04 Rev.
  • Page 56 (Ni-Cd) must be recycled. Please of the manufacturer for follow your internal procedures information concerning the and or local (provincial) laws decommissioning of your regarding disposal or recycling. equipment. Not made with natural rubber Keep Dry latex OnTrak 90227 Operations Manual A4-4...
  • Page 57 Certification and Compliance Canadian Standards Association ETL Laboratory Approved Approved CE marked in accordance with Radio transmission device. High the Medical Device Directive, levels of ionizing radiation 93/42/EEC Manufacturer Information and Traceability Manufacturer Date of Manufacture Serial Number The letters ‘SN’ stand for Catalog Number ‘Serial Number’...
  • Page 58 This page is intentionally blank OnTrak 90227 Operations Manual A4-6...
  • Page 60 U n i t B , F o x h o l e s C e n t r e , J o h n Ta t e R o a d , H e r t f o r d . S G 1 3 7 D T. U K | T + 4 4 ( 0 ) 1 9 9 2 5 0 7 7 0 0 | F + 4 4 ( 0 ) 1 9 9 2 5 0 1 2 1 3 www.spacelabshealthcare.com © 2019 Spacelabs Healthcare Ltd. Specifications subject to change without notice. 070-2582-04 Rev. C...

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