OnTrak 90227 Users Manual 4th Edition Rev B

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In the event of a serious incident, notify Spacelabs and the competent authority of the EU Member State.

©2021 Spacelabs Healthcare Ltd. 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. Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the equipment only if: • assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by Spacelabs Healthcare, and • the electrical installation of the relevant room complies with the requirements of the standard in force, and • the equipment is used in accordance with the operations manual. Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists, descriptions, calibration instructions or other information which will assist appropriately qualified technical personnel to repair those parts of the equipment which are classified by Spacelabs Healthcare as field repairable. Spacelabs Healthcare is committed to providing comprehensive customer support beginning with your initial inquiry through purchase, training, and service for the life of your Spacelabs Healthcare equipment.

CORPORATE OFFICES Manufactured for: Spacelabs Healthcare Ltd. Unit B, Foxholes Centre, John Tate Road Hertford. SG13 7DT UK Tel: +44 1992 507700 Fax: +44 1992 501213

Spacelabs Healthcare Inc 35301 SE Center Street Snoqualmie, WA 98065 USA Tel: +1 425 396 3300 Fax: +1 425 396 3301

EC REP

MediMark® Europe, 11 rue E. Zola, 38100 Grenoble. France

Brands and product names are trademarks of their respective owners.

Caution: Federal (USA) law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the state in which he practices to use or order the use of the device. CE marked in accordance with the Medical Device Directive, 93/42/EEC Medical Device Security-related information is indicated in the following manner in this manual:. “WARNING”

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

“CAUTION”

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Actions or circumstances that could damage the equipment, produce inaccurate data, or invalidate a procedure. Useful information to a product feature, function, or procedure.

“NOTE”

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Table of Contents 1 Operation 1.1 1.2 1.2.1 1.2.2

1.3 1.3.1 1.3.2

1.4 1.5 1.5.1 1.5.2 1.5.3 1.5.4 1.5.5 1.5.6 1.5.7 1.5.8 1.5.9

1.6 1.6.1 1.6.2 1.6.3 1.6.4 1.6.5

1.7 1.7.1

Overview

1-1

Indications for Use

1-1

Important Notes for the Doctor Possible Adverse Reactions

1-3 1-3

ABP Monitor

1-4

Front Panel Other Features

1-4 1-5

Replacing the Batteries

1-5

Initializing the Monitor

1-6

Powering ON/OFF the monitor Initialization from PC Interface Independent Initialization Taking Manual Readings Unlock User Interface Office Check Mode Review Readings Ending Monitoring test Activity Graph

1-6 1-7 1-8 1-10 1-10 1-10 1-11 1-12 1-12

Preparing the Patient and Precautions for Use

1-13

Using Cuff Support Accessories Correlating with Manual Readings Patient Instructions Warnings

1-16 1-17 1-17 1-18 1-18

Data Transfer and Reports

1-19

Printing a Report

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1.8 1.8.1

1.9

Maintenance

1-20

Home Environment

1-20

Cleaning/Disinfecting

1-21

Cleaning the Cuff and Carrying Pouch Removing/Installing the Bladder (Washable Cuff only)

1-22 1-22

1.10

Event Codes

1-23

1.11

Disposal of the OnTrak 90227 at the end of life

1-25

1.9.1 1.9.2

2 Accuracy 2.1

Checking Accuracy

2-1

3 Technical Data 3.1 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5

OnTrak 90227 ABP Monitor

3-1

Electromagnetic Compatibility

3-4

General Notes 3-5 Guidance and manufacturer’s declaration – electromagnetic emissions 3-6 Guidance and manufacturer’s declaration – electromagnetic immunity 3-8 Guidance and manufacturer’s declaration – electromagnetic immunity 3-9 Recommended separation distances between portable and mobile RF communications equipment and the 90227 3-10

4. Troubleshooting 4.1

Problem Solving Checklist

4-1

4.2

Servicing

4-2

Appendix 1 - Independent Initialization Appendix 2 - Set Date & Time Appendix 3 - Print a Report Appendix 4 - Changing the Language Appendix 5 - Signs and Symbols

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1

Operation

1.1

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. The device shall be operated only by suitably competent personnel trained in the use and procedures of Ambulatory Blood Pressure monitors for diagnostic purposes.

1.2

Indications for Use

Ambulatory blood pressure monitoring is a fully accepted clinical tool for collecting multiple blood pressure measurements over a set period of time. This data better 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 information that a 24 hour study can provide and is therefore superior in predicting target organ damage, morbid events, or cardiovascular risk. 070-2582-05 Rev. B

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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 • 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 interpretation of blood pressure measurements gathered by the OnTrak 90227 monitor should only be made by a qualified physician. The accuracy of any blood pressure recording may be affected by the position of the subject, his or her physical condition, and use outside the operating instructions 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. OnTrak 90227 - Users Manual

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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 Reactions

Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including the formation of urticaria (allergic reaction including raised edematous patches of skin or mucous membranes and intense itching) caused by the fabric material of the cuff. 070-2582-05 Rev. B

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Petechia (pinpoint reddish or purplish spots on the skin that are usually flat to the touch and resulting from bleeding under the skin) formation on the forearm following the application of the cuff, may lead to Idiopathic thrombocytopenia (isolated low platelets count associated with hemorrhagic conditions) or phlebitis (inflammation of a vein) may be observed.

1.3

ABP Monitor

The software revision is displayed on the LCD screen for two seconds after 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 patient. Blood pressure and heart rate measurements are taken using a blood pressure cuff attached to the patient’s arm. This information 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: • • • • • •

1.3.1

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

Front Panel

The OnTrak 90227 monitor front panel includes the 2.4” LCD display, UP/DOWN buttons, and an ACTION button. OnTrak 90227 - Users Manual

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1.3.2

Other Features

The cuff hose connector is mounted at the top of the unit and the USB connector is on the bottom of the unit.

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. • •

Do not use any other power source for the OnTrak 90227 as this could be hazardous and will void the warranty The Operator should not touch the batteries or battery connector and the PATIENT simultaneously.

The backup battery for the OnTrak 90227 monitor is not user serviceable and should not require replacement. In the unlikely event a problem with the backup battery occurs, see section 4-2 for details on servicing.

Main Battery Replacement 1.

Power the monitor OFF (refer to section 1.5.1.2), and remove the battery compartment cover (see illustration below).

2.

Replace the batteries, being careful to observe polarities. The correct battery orientation is shown on the inside of the battery compartment.

3.

Gently replace the battery cover.

4.

Power the monitor ON (refer to section 1.5.1). Check that the LCD display is ON. If there is no display, power the monitor OFF and refer to the problem-solving checklist in Troubleshooting on page 4-1.

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• •

•

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 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

Note: this product does not recharge batteries. • The patient should not remove the battery cover in any circumstances. If the unit stops working the patient should return it to the operator

Please ensure that discharged batteries, of all types, are disposed of in accordance with local regulations.

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. To initialize the monitor, first power the monitor ON. If “Memory Full” is displayed then the OnTrak memory has reached its capacity of 500 measurements. Please transfer the data to a PC and then start a new test.

1.5.1

Powering ON/OFF the monitor

1.5.1.1 Powering ON the monitor Hold down any button for 3 seconds, an audible beep will sound and the display will switch ON within 7 seconds.

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1.5.1.2 Powering OFF the monitor 1.

Hold down the ACTION button for 3 seconds.

2.

A screen asking to confirm your decision to power the unit OFF will be displayed.

3.

Press DOWN button once to highlight the “Yes” option.

4.

Press ACTION button once to confirm selection.

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.

1.5.2

Initialization from PC Interface

The OnTrak 90227 monitor can be initialized using the following Spacelabs Healthcare Software :Sentinel and 92506 (refer to the appropriate manuals for more information about these applications). 1.

Connect one end of the USB cable to the appropriate port on the computer where the Sentinel or 92506 software is installed.

2.

Connect the other end of the interface cable to the ABP monitor.

3.

Set up the unit for a new test using the PC interface.

Refer to the 92506 ABP Report Management System Client Application Operations Manual and the Sentinel Operations Manual for more information on the report management system. After a successful PC Initialization disconnect the USB cable from the 90227 unit. The new test will start immediately and readings will be taken following the scheduled initialization by the PC. Refer to section 1.5.4 for taking manual readings.

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1.5.3

Independent Initialization

The OnTrak 90227 monitor provides an initialization option without the need of a PC. 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.

4.

Press ACTION button to modify any parameter of the monitor.

5.

Setup the current Time and Date and format to be displayed (refer to section 1.5.3.5).

6.

When the desired initialization is specified, navigate to “Start New Test” menu option and press ACTION button once.

7.

The time will be displayed for 15 seconds.

8.

The monitor has started a new test.

Readings will be carried out following the protocol settings stated in the Initialization screen. Refer to Appendix 1 for more information about Independent Initialization. Refer to section 1.5.4 for taking manual readings.

1.5.3.1 Child Mode Child mode should be selected if the unit is going to be worn by a 3 to 12 years old child. The main characteristic of child mode is setting a lower Initial target pressure of 130 mmHg.

1.5.3.2 Comfort Mode Initial Inflation Sets the initial pressure inflation target to 110 mmHg, 130 mmHg, 150 mmHg or 170 mmHg as desired (the default is 170 mmHg). The monitor will inflate to this initial pressure and make a reading. If this reading is successful, the monitor goes into its programmed timing to take further readings. If however the initial reading was not successful due to higher actual Systolic than that set in comfort mode, the monitor will increase the pressure in steps of approximately 30 mmHg until a systolic is found or the maximum cut off pressure is reached. OnTrak 90227 - Users Manual

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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.

1.5.3.3 Display Results and Cuff Pressure Tick the display results checkbox to display the results of the readings after every measurement. Tick the display cuff pressure checkbox to display the cuff pressure during a measurement.

1.5.3.4 Language Selection 90227 can operate in different languages. Refer to Appendix 4 for information on how to change the language.

1.5.3.5 Time and Date Setup During Independent Initialization, the Time and Date can be updated following the steps below: 1.

Use UP/DOWN buttons to navigate in the user interface and highlight “Advanced Setup” menu option.

2.

Press ACTION button to access the Advanced Setup screen.

3.

Use UP/DOWN buttons to navigate in the user interface and highlight “Time/Date” menu option.

4.

Press ACTION button to access the “Time/Date” screen.

5.

The current saved value will be displayed. Use ACTION button to select the Date Format to be displayed : (DD/MM/YY or MM/DD/YY)

6.

Use UP/DOWN to step over the next field to be updated, and press ACTION button to update that field.

7.

The selection bars will change from white color to blue indicating we are editing a field. Use UP/DOWN to Increment/Decrement the value.

8.

Press ACTION button again to finish editing the field.

9.

Repeat for rest of the fields and select “OK” once finished.

10. Repeat the previous steps to setup the Time. 070-2582-05 Rev. B

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11. The Time and Date will be displayed as confirmation of the update success. Refer to Appendix 2 for more information about setting up the Time and Date.

1.5.4

Taking Manual Readings

After a test is successfully initialized, manual readings can be taken by pressing the ACTION button once.

To take a manual reading: 1.

Press ACTION button once.

2.

An audible beep will indicate the reading will start after 5 seconds countdown.

3.

A manual reading will be taken and saved afterwards for review.

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.

1.5.5

Unlock User Interface

After 10 seconds of inactivity the unit will enter Low Power Mode. This is characterized by a screen displaying the time, followed by a blank screen. To Unlock the User Interface, press and hold both UP and DOWN buttons for 2 seconds. After unlocking the User Interface, the buttons can be used to navigate in the menus as normal. During Initialization the unit will shut down after 60 seconds of inactivity. To switch the unit back ON refer to section 1.5.1.1

1.5.6

Office Check Mode

The monitor automatically enters an Office Check mode for the first five measurements immediately following initialization. This allows you to verify the performance of the monitor on an individual patient without the need for re-initialization to reset the display features. The OnTrak 90227 enforces a 30 second minimum inhibition between measurements to allow reperfusion. If the ACTION key is pressed too soon after measurement, the monitor will display the time left before another reading can be taken. OnTrak 90227 - Users Manual

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While in the Office Check mode, the monitor operates as follows: • Displays the cuff pressure on each bleed step • Displays systole, diastole, and heart rate at the end of the measurement • Bleeds one step below the diastolic value as determined by the monitor

1.5.6.1 Terminating Office Check Mode In order to terminate Office Check mode, a single blood pressure reading must be cancelled. 1.

Press ACTION button once to start a new test. An audible beep can be heard followed by a countdown screen to next blood pressure reading.

2.

Press ACTION button again to manually cancel current blood pressure reading.

3.

Office check mode is terminated and the next blood pressure reading will be as per parameters specified during the initialization of the unit.

Any event that prevents a successful blood pressure measurement (other than a manual cancel) is not counted as one of the five 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).

2.

Power ON the monitor (refer to 1.5.1.1).

3.

The OnTrak 90227 enters Office Check Mode for the next five measurements.

1.5.7

Review Readings

The OnTrak 90227 provides the option to review the readings while a monitoring test is running. 1.

Unlock the User Interface. (Refer to section 1.5.5).

2.

Use UP/DOWN buttons to step over “Review Readings” menu option.

3.

Press ACTION button once to select the option.

4.

Use UP/DOWN buttons to review Next/Previous measurement results of current test.

5.

Once you have finished reviewing the results, allow the unit to go inactive (10 seconds) without pressing any button.

6.

The time will be displayed for 15 seconds and the monitor will be back to the test. 070-2582-05 Rev. B

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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.

3.

A confirmation screen will be displayed. Use UP/DOWN buttons to positioning over “Yes” menu option.

4.

Press ACTION button. A summary of the previous monitoring test will be displayed.

From this last screen, you can start a new monitoring test using UP/DOWN buttons and ACTION button to select. You can also review readings (Refer to section 1.5.7) or print a test report (refer to section 1.7.1).

1.5.9

Activity Graph

OnTrak units with firmware version 4 and higher are supplied with an accelerometer. This is always activated. Customers who review the ABP data in Sentinel 10 will be shown an activity graph which also prints into the final report The activity graph reflects movement and volatility of activity by the patient based on accelerometer data from the recorder. This feature does not affect 92506 or previous versions of Sentinel.

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1.6

Preparing the Patient and Precautions for Use

Note:

• As in manual auscultatory methods, accurate readings may not always be achieved under some conditions. Patient movement, the position of the cuff relative to the level of the heart, extreme heart rates and blood pressures, various arrhythmias, and the subject’s physiological condition and other factors may hinder an accurate reading. Vibration, such as that in a moving automobile, is an environmental problem that may affect readings • When some of the above factors prevent an accurate reading, an event code is provided to indicate the reason for the missed blood pressure reading. When only a single blood pressure parameter (systole, diastole, or mean arterial pressure) is obscured and the other two parameters are measured, the obscured parameter may be replaced with a computed value • 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. The ratio used in the formula is determined by the previous successful measurements of the pressure, rather than a fixed ratio • Consult a physician for interpretation of pressure measurements It can be unsafe to use the OnTrak 90227 monitor outside its pouch for patient monitoring purposes.

After the monitor has been initialized, prepare the patient for monitoring as follows: 1.

Power ON the monitor, it performs self-tests at start-up. When the LCD displays the current time, the monitor is ready for operation.

2.

Strap the monitor to the patient’s hip opposite the side on which the cuff is worn. Secure the monitor using the patient’s own belt or the ABP pouch strapped over the opposite shoulder. When using the shoulder strap, use the belt supplied with the monitor or the patient’s belt to provide additional security.

3.

Ensure the accuracy of blood pressure measurements through proper cuff selection and application. To select the proper cuff, first measure the circumference of the limb at the point where the cuff will be applied. Match the limb measurement to the range of appropriate circumferences (in centimeters) specified on each cuff.

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Table 2: Cuff Sizes, Circumference and Ranges Description

Limb Circumference

Pediatric Cuff

12 to 20 cm

Small Adult Cuff

17 to 26 cm

Adult Cuff

24 to 32 cm

Large Adult Cuff

32 to 42 cm

Extra-Large Adult Cuff

38 to 50 cm

4.

The Cuff is typically applied, above the elbow, to the non dominant arm (if safe to do so) and positioned so that the center of the inflatable bladder is directly over the brachial artery. The center of the bladder location is marked on the outside of Position 1 the cuff. Once the proper position is determined, the cuff must be tightened to ensure that it is equally snug at the top and bottom edges and that it is not kinked. This is especially important on larger arms. Insert a finger between the cuff and the limb Alternative Position to ensure it is not too tight. It may be necessary to wrap the cuff with its tail at an angle to achieve uniform tightness. If the cuff is not equally snug at the top and bottom edges, the number of readings available will be limited and the monitor may indicate that the cuff is improperly applied.

5.

To ensure the best results the patient should be: 1) comfortably seated. 2) legs uncrossed. 3) both feet flat on the floor. 4) back and arm supported. 5) The middle of the CUFF at the level of the right atrium of the heart. It is recommended that the PATIENT relax as much as possible and not talk during the measurement 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.

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