OnTrak 90227 Service Manual Rev D

Consult Documents THIS SYMBOL MEANS YOU MUST READ THE ACCOMPANYING DOCUMENTS

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90227 Ambulatory Blood Pressure Monitor Service Manual

©2017 Spacelabs Healthcare Inc. 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 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 Hertford. SG13 7DT UK Tel: +44 (0) 1992 507700 Fax: +44 (0) 1992 501213

Brands and product names are trademarks of their respective owners. Caution: US Federal law restricts the devices documented herein to sale by, or on the order of, a physician Before use, carefully read the instructions, including all warnings and cautions. CE marked in accordance with the Medical Device Directive, 93/42/EEC

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Table of Contents Introduction ... 4 Overview ... 4 User Controls ... 5 Display ... 5 Communications ... 5 Programming Options ... 6 Day or Night Modes ... 6 Measurement Intervals and Periods... 6 Clinical Verification Mode ... 6 Blood Pressure/Heart Rate Measurements Displayed ... 6 Cuff Pressure Displayed ... 6 Setup ... 7 Installing the Batteries ... 7 AA Batteries ... 7 Initializing the Monitor ... 8 Self-test and Patient Protection ... 9 Power-on Built-in Test Cyclic Built-in Test Measurement Verification Tests ... 9 Patient Protection ... 9 Maintenance ... 10 Cleaning ... 10 Air Bladder Removal ... 11 Air Bladder Reinstallation ... 11 Calibration Check ... 12 Service Maintenance Reminder Message ... 13 Clock Cell Recharging ... 13 90227 Functional Test and Calibration Procedure ... 14 Introduction ... 14 Equipment ... 14 Preparation... 15 Procedure... 20 Monitor Revision Info ... 21 Log File ... 22 20XX_90227_Summary_Results.txt ... 22 Disassembly Procedures ... 23 LCD Removal ... 24 PCB Removal... 25 Lithium Backup Battery Replacement ... 26 Valve Removal ... 27 Pump Removal... 28 Valve Assembly and Pump Replacement ... 29 Battery Spring Removal ... 32 Firmware update ... 33 Test Procedure... 36 Event Codes and Problem-Solving... 38 Event Codes ... 38 Drg No. 070-2566-00 Rev D

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Problem Solving Checklist ... 40 Parts ... 41 90227 Monitor Parts List ... 41 Service Tools ... 42 Appendix A ... 43 Unit assembly drawings ... 43 Schematic Diagrams... 51

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Introduction This chapter contains the following sections: Overview User controls Display Programming options

Overview The Spacelabs OnTrak Model 90227 Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

See the latest Data Sheet for current product specifications.

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Introduction

User Controls The 90227 ABP monitor provides three user controls: Menu UP Menu DOWN Activation OFF/ON/SELECT.

External Connections Cuff hose (Quick-connect) USB

Display Menus, ABP measurement readings, and status information are shown on the LCD display.

Communications Communication is made through the USB connector.

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Programming Options These monitor options are user programmable:

Day or Night Modes Day mode = beeper ON, inflation time approximately 15 seconds Night mode = beeper OFF, inflation time approximately 20 seconds

Measurement Intervals and Periods Measurement intervals are selectable from 6 to 120 minutes (in one minute increments) for each period. You may also choose to not have readings taken during a specified period. Up to 12 periods may be defined.

Clinical Verification Mode In Clinical Verification mode, the monitor is forced to bleed to 40 mmHg or to one step below diastole (whichever is lower) for each reading.

Office Check Mode Office Check mode verifies monitor operation and enables a user to view cuff pressure and blood pressure results regardless of any previous disabling of the display. During Office Check mode, the monitor bleeds an additional pressure step below diastole. This mode is enabled for the first five successful blood pressure readings (or attempted readings) following monitor initialization. You may cancel Office Check mode and then re-enable this mode by cycling the power OFF then ON. Depress the START/STOP button when the last digit of the software version displays.

Blood Pressure/Heart Rate Measurements Displayed These measurements may be selected to appear, or not to appear, at the end of a measurement.

Cuff Pressure Displayed This measurement may be selected to appear, or not to appear, during the measurement cycle.

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Setup This chapter contains the following sections: Installing the batteries Initializing the monitor

Installing the Batteries Two types of batteries are used in the 90227 ABP Monitor: two standard AA batteries to power the circuit and air pump, and one rechargeable lithium battery to back up the clock when the AA batteries are removed or are exhausted. This lithium battery receives its charge from the AA batteries and does not normally require replacement. If alkaline batteries (Spacelabs Healthcare P/N 146-5011-01) are used as the AA batteries, they must be changed after each patient use. Nickel metal hydride batteries (Spacelabs Healthcare P/N 146-0129-00) require a full charge before each use.

AA Batteries To change the two AA batteries: Power the monitor OFF. Remove the battery compartment cover by sliding back.

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Remove the old AA batteries, if present, from the monitor and replace each with a fresh alkaline battery (or fully charged nickel metal hydride), being careful to match polarities where indicated (+ or -). Never mix battery types, or old and new batteries. Correctly insert the batteries and gently slide the battery cover back into place. Note: The monitor will not operate if batteries are incorrectly installed. Remove the AA batteries when the device is stored and not in use. Spacelabs Healthcare is not responsible for product damage caused by battery leakage. If your unit has been damaged by a leaky battery, contact the battery manufacturer for any recoverable repair costs. Power the monitor ON and verify that the display appears. If there is no display, power the monitor OFF and refer to the Problem-Solving section.

Initializing the Monitor The ABP monitor must be initialized prior to use. 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, use either Sentinel, CardioNavigator, or 92506 ABP Report Management system. Refer to the appropriate operations manual for setup and operation.

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Self-test and Patient Protection Power-on Built-in Test Cyclic Built-in Test Measurement Verification Tests These tests run during the measurement and can generate event codes relating to measurement circumstances rather than hardware integrity. Examples are patient arrhythmia, movement artifact, failure to find systolic pressure, cuff not fitted, hose kinked, low battery etc. A full list of these event codes is given in the Operations Manual.

Patient Protection The 90227 meets the requirements of IEC/EN 80601-2-30 both normally and under single fault conditions: Cuff pressure is always less than 300 mmHg Cuff pressure is never above 15 mmHg for longer than 180 seconds Cuff pressure is below 15 mmHg for at least 30 seconds between measurements Single faults are detected In general the Main uP software ensures that these limits are respected, the Safety uP’s protective functions are only invoked under extraordinary circumstances. However, the Safety uP’s software and controls are used in all measurement cycles, to discover any failures in the redundant elements. For example, the Main uP requests a measurement cycle: in response the Safety uP checks its power supplies, clocks, etc., and then checks that the cuff has been deflated for more than 30 seconds. If these checks pass the Safety uP will close the normally-open Safety Bleed Valve and remove its lock-out on the pump operation. After the measurement is completed the Main uP asks the Safety uP to open the bleed valve: if this does not deflate the cuff the Main uP concludes that the valve is stuck and opens the Measurement Bleed Valve to deflate the cuff. An EC75 will be recorded to alert the user to the hardware fault.

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Maintenance Periodic maintenance consists of cleaning the unit, replacing or recharging the batteries, testing the unit for accurate operation, and calibrating when necessary. This chapter contains the following sections: Cleaning Calibration check Service reminder Clock cell recharging Functional test and calibration procedure Disassembly procedure Reassembly procedure Firmware update

Cleaning Use a soft, damp cloth and mild detergent mixed with water to wipe the exterior of the monitor. Clean the carrying pouch and air hose with isopropyl alcohol. Do not use cleaners containing bleach or abrasives. TruCuff The cuff wrap may be sterilized only with ethylene oxide (ETO) sterilization methods using standard hospital procedures. Use standard aeration techniques after sterilization. Small soiled or stained areas may be cleaned by gentle scrubbing with a sponge or cloth soaked in a mild soap and water solution. The cuff wrap with the air bladder removed is machine washable on “delicate” cycle only. Do not wash with bed linens, gowns, or in large commercial-type washers. To remove the bladder for cleaning, refer to the figures below and follow these steps: 1

Using your fingers, fold or roll up the bladder inside the cuff. Do not use pencils, pens, or other hard objects as damage to the bladder could easily occur.

2

Remove the bladder through the hose exit opening. Once the bladder has been removed, be sure to attach the hook and loop surfaces on the cuff before washing.

3

After washing and drying the cuff, reinstall the bladder in the reverse order of its removal. Make certain that all folds in the bladder are removed prior to inserting it back inside the cuff.

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Note: The bladder may be installed with the hose exiting the second cuff opening. However, the bladder must be positioned with its long side toward the center of the cuff. TruCuff Air Bladder Removal

TruCuff Air Bladder Reinstallation

UltraCheck® Cuff The cuff has a fluid barrier which helps prevent staining and simplifies cleaning. The cuff can be cleaned with mild detergents or a (1-2%) bleach solution or disinfected with solutions such as Enzol, Cidezyme, Cidex, Sporicidin, Isopropyl Alcohol (70%), or Ethanol (70%).

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Calibration Check To verify calibration of the 90227 monitor: 1

Obtain a full-size liquid sphygmomanometer (manometer) or aneroid gauge.

2

Disconnect the cuff hose from the monitor.

3

Connect the T-tube splitter to the monitor pneumatic connector and the sphygmomanometer.

4

Wrap the pressure cuff around the rigid cylinder, and fasten the cuff. Connect the cuff hose to the remaining connection on the T-tube splitter. The figure below illustrates the test setup.

5

Press the Activation button on the front of the monitor. After the pump has stopped, the monitor display should read approximately 165 mmHg. Compare the readings on the monitor and the manometer while the pressure bleeds down. The monitor reading should be within three millimeters of the manometer reading or 2% of the reading, whichever is greater (± the accuracy of the manometer). At the end of this procedure, the monitor will display an event code indicating that no dynamic measurements were obtained.

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6

Disconnect the T-tube splitter from the monitor. Disconnect the air hose and sphygmomanometer from the T-tube. Re-connect the cuff to the monitor.

Service Maintenance Reminder Message The service reminder is displayed for 10 days before, and 10 days after the “maintenance due” date. This is to help the customer to plan for preventive maintenance and avoid a sudden failure. The service period/timer is reset to 12 months during the functional/calibration test (using the 90227 Functional Test Utility). It begins counting when the monitor has taken 10 consecutive measurements in a single procedure. The reminder periods are not configurable, and the reminder cannot be disabled.

Clock Cell Recharging The clock cell recharges (a) while the OnTrak is communicating with the PC, and (b) when it is in “Study Mode”, meaning that the test is in progress, following the configured protocol. Under all other conditions the clock cell will gradually discharge. If it becomes so low that the clock resets, this is indicated by event code EC85. If the clock cell was fully charged, this could occur between 72 hours to 4 weeks of inactivity. Any stored measurement data will not be lost. To minimize clock cell discharge, remove the AA batteries when the device is stored and not in use. The clock is set up when the device is configured for the next test. If the test is not started, the OnTrak will “sleep”, and the clock cell is not charging.

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90227 Functional Test and Calibration Procedure Introduction The test covers all circuit functions, pump and valve performance, and power consumption. Sensor linearity and leak rate are tested at 50, 150 and 250 mmHg. The pressurization steps pump over target and then bleed down. The secondary safety system hold-off time, measurement time limit, and pressure limit are all explicitly tested. The Utility writes a log file for each test. The Utility sets the time and date and initializes the unit.

Equipment 1. PC minimum specification: PC Operating System Processor RAM Disk space (for the program)

Windows 7 (32/64 bit) 1GHz 512MB 5MB

2. Functional Test Utility, PN: 163-2019-XX, and Test Limits Configuration File, PN: 163-1881-XX. 3. 300cc test volume PN 067-0151-00 4. T-piece and a female quick-disconnect PN: 016-0040-00., test volume 5. Silicone tubing PN: 166-7038-00. 6. System Test Battery Adapter (PN 067-0172-XX) (Items 2, 3, 4, 5, and 6 are also available as Kit PN: 025-0059-00.) 7. Micro USB cable (PN: 012-0934-00) 8. Calibrated digital manometer with peak reading mode, PCE-P15, Meriam 350 or equivalent 9. Bench power supply, set for 2.9V DC +/- 1% @ 2.0A 10. Digital voltmeter. 11. Squeeze bulb with tubing to male quick-disconnect, with a clamp to close the tubing (used for checking the test volume assembly for leaks.)

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Preparation Ensure that the power supply is switched *OFF*. Assemble the apparatus as shown below.

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Note To avoid contact voltage-drop you must use the battery adapter, PN 067-0172-XX.

Example functional layout is shown below, your equipment may differ in appearance.

USB to PC Assembly Leakage Test 1. Clamp the hose that connects to the 90227 monitor. 2. Connect the squeeze bulb assembly, pump to 250 mmHg and then clamp the hose that connects to the squeeze bulb. 3. Allow the air temperature to stabilize for 5 minutes. Drg No. 070-2566-00 Rev D

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4. Verify that the leak rate is less than 0.5 mmHg/minute. 5. Remove the clamps, disconnect the squeeze bulb assembly. Functional Test Utility Preparation The Functional Test Utility comprises an installer “setup.exe”, and a test limits file “90227_Service_Test_Limits_File_163_1881_XX.config”. It requires a dongle to run. 1. Install the utility 163-2019-XX by running “setup.exe”. The program creates a desktop shortcut. 2. Copy the “Test Limits” file (163-1881-XX.config) to any convenient location on the PC, (for example, the Desktop). 3. Connect the Test Utility Dongle to the PC, and wait for Windows to see it. 4. You must remove any existing OnTrak driver and install the latest driver. In Windows control Panel, select “Programs and Features”. If it exists, double-click the entry named “90227 OnTrak ABP Driver”, and then click “Yes” to uninstall.

5. Put the CD labelled “90227 ABP DRIVERS V4” (PN: 063-2358-XX) into your CD drive. If the installer does not begin automatically, Windows may prompt you to run “setup.exe”. Otherwise, browse the CD contents and double-click setup.exe. If prompted, allow the program to make changes to your PC. 6. The new driver may take several minutes to install, and then display a “Green

check-mark” for a few seconds when it completes. The window will then close.

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7. Launch the Test Utility. (Note: do NOT select “Install Device Driver”, the utility does not contain the latest version which you have just installed.)

8. Connect the USB Cable between the PC and the OnTrak. 9. Connect the test battery contact to the power supply and the OnTrak. Important: this must be used, to prevent contact resistance voltage drops causing test failure. 10. Set the power supply adjustment to zero, switch on the power supply, and then carefully increase the voltage to between 2.87V - 2.93V. 11. Press the activation button on the OnTrak. 12. If Windows does not install the OnTrak device driver automatically, locate the “90227.inf” file, in C:Program Files (x86)Spacelabs Healthcare90227 OnTrak ABP Driverx6490227_CDC_PID_0006_0007.inf 13. After installing the device driver, open Windows Device Manager and note the COM port assigned to the device.

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