90217 Service Manual Rev E

Copyright 2003 Datex-Ohmeda, Inc. All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Datex-Ohmeda, Inc. Products of Spacelabs Medical, a Division of Instrumentarium, Datex-Ohmeda, Inc. (“Spacelabs Medical”) are covered by U.S. and foreign patents and/or pending patents. Printed in U.S.A. Specifications and price change privileges are reserved. Spacelabs Medical 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 Medical, 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 Medical 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 Medical as field repairable. Spacelabs Medical is committed to providing comprehensive customer support beginning with your initial inquiry through purchase, training, and service for the life of your Spacelabs Medical equipment.

CORPORATE OFFICES U.S.A.

CHINA

ITALY

Spacelabs Medical 5150 220th Ave SE Issaquah, WA 98029 Telephone: 425-657-7200 Telephone: 800-345-2700 Fax: 425-657-7212

Datex-Ohmeda Pte Ltd Shanghai Representative Office Room 2509 Lippo Plaza No. 222 Huaihai Road (M) Shanghai 200021 Telephone: 86-21-5382-5657 Fax: 86-21-5382-1691

Datex-Ohmeda S.p.A. Via Cassanese, 100 20090 Segrate (MI) Telephone: 39-02-216-931 Fax: 39-02-2692-6226

FRANCE

Datex-Ohmeda SL Manuel Tovar, 26 28034 Madrid Telephone: 34-91-3342600 Fax: 34-91-3581284

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CANADA

HONG KONG

Datex-Ohmeda Inc. 1093 Meyerside Drive, Unit 2 Mississauga, Ontario L5T 1J6 Telephone: 905-565-8572 Fax: 905-565-8592

Spacelabs Medical Limited Suite 901 Tower 1 China Hong Kong City 33 Canton Road, Tsimshatsui Kowloon Telephone: 852-2376-1370 Fax: 852-2376-2502 INDIA Datex-Ohmeda India Pvt. Ltd. International Trade Tower S 3 Level, Block E Nehru Place New Delhi 110019 Telephone: 91-11-621-6060 Fax: 91-11-621-3003

SPAIN

TAIWAN Datex-Ohmeda Pte Ltd Taiwan Representative Office 2/FI No. 85 Sec. 2 Chien-Kuo N. RD. Telephone: 8862-2515-0457 Fax: 8862-2501-9136 THE NETHERLANDS Datex-Ohmeda B.V. De Wel 18 3871 MV Hoevelaken Telephone: 31-33-25-41-222 Fax: 31-33-25-41-223 Authorized EC Representative UNITED KINGDOM Datex-Ohmeda Ltd 71 Great North Road, Hatfield Herts AL9 5EN Telephone: 44-1707-263-570 Fax: 44-1707-260-065

CAUTION: • US Federal law restricts the devices documented herein to sale by, or on the order of, a physician.

Contents Chapter

Page

Introduction Overview... 1-1 User Controls... 1-2 Display... 1-2 Programming Options...1-3

Setup Installing the Batteries...2-1 Initializing the Monitor... 2-2 Operational Tests... 2-7

Theory Pressure Amplifier... 3-1 Oscillometric Amplifier...3-2 90217 Block Diagram... 3-4 Digital Circuitry...3-5 Unit Power... 3-6 Software Flow Chart... 3-8

Maintenance Cleaning... 4-1 Calibration Check... 4-3 Calibration Procedures... 4-4 Operational Verification... 4-10 Manifold Kit - P/N 050-0110-00... 4-13 Disassembly Procedures... 4-14

Troubleshooting Monitor Event Codes... 5-1 Base Station Report Event Codes... 5-3 Problem Solving Checklist...5-5

Parts 90217 Field Replaceable Parts Lists... 6-1 Drawings... 6-3

Symbols

i

Introduction Contents Overview... 1 User Controls... 2 Display... 2 Programming Options... 3

Overview The Model 90217 is a small, lightweight battery-powered Ambulatory Blood Pressure (ABP) monitor that uses the non-invasive Oscillometric method to measure blood pressure and heart rate. This data is then stored into memory for later transfer to an ABP Analysis System (FT1000A/FT2000A or equivalent), a PC Interface, a Base Station, or a Report Generator for data analysis, report printing, and archiving. The 90217 monitor is housed in a plastic case with a removable battery cover that provides access to its three AA cells. Inside the monitor are three printed circuit boards: the Main, Power, and Display boards. Programming resides in an internal 128k RAM and Microprocessor ROM. Most of the code exists in the RAM and can be updated via an infrared (IR) serial port located at the rear of the unit. The internal ROM contains a boot code and other codes for downloading and completing special tasks. The IR serial port transfers collected data to a report generator and sends setup changes to the ABP monitor. A rechargeable lithium battery keeps the RAM and real-time clock backed up during periods when the AA batteries are removed.

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Ambulatory Blood Pressure Monitor

User Controls The 90217 ABP monitor provides two user controls: a START/STOP button and Power ON/OFF switch.

Power ON/OFF Switch When turned ON, this switch activates the monitor and begins executing the timed blood pressure program.

START/STOP Button This front panel control manually starts a blood pressure measurement, stops a measurement already in progress, or sets special modes of operation (refer to the 90207, 90217 Ambulatory Blood Pressure Monitors Operations Manual, P/N 070-0137-xx).

Display The monitor display is a 4-digit LCD that presents the following information (refer to the 90217 Ambulatory Blood Pressure Monitors, Operations Manual (P/N 070-0137-xx) for instructions on use).

Systolic/Diastolic Pressure and Heart Rate Patient information appears on the display sequentially with systolic first, diastolic next, and then heart rate. Each parameter appears for approximately one second. The screen is blanked for one second and the sequence of readings is re-displayed two more times. A bar indicator at the left of the display identifies which parameter is currently being displayed. It appears next to the “sys” for systolic, next to “dia” for diastolic pressure, and next to the heart symbol for heart rate.

Time of Day A real-time clock provides the time of day, which appears between measurement cycles and can be programmed in either a 12- or 24-hour mode.

1-2

Introduction

Cuff Pressure This pressure can be shown while the monitor is taking a measurement. If cuff pressure is not selected, “----” appears. Cuff pressure can be enabled or disabled in software.

Event Code Event codes are 4-digit LCD messages that begin with “EC” or, in some cases, show specific codes such as “LLL” for a low battery. If enabled, a beep sounds during an event code and the code is displayed on the monitor. Refer Troubleshooting on page 5-1 for event code information.

Count Down Sequence Whenever the monitor begins a measurement cycle, it turns its tone ON (if beep is enabled) and counts down from 5555 to 1111 on the display.

IR Communications During IR communications, the monitor first displays “9999” on the LCD to indicate that it has detected a cable connect and has gone into the communication mode. The monitor periodically attempts to contact a modem. The left two digits on the monitor display indicate the steps in the communication process. For more information, refer to Base Station via Modem on page 2-3.

Programming Options These monitor options are user programmed:

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. It is also possible to not have readings taken during a specified period. Up to 12 periods may be defined.

Clinical Verification Mode When set to this 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 This mode verifies monitor operation and allows 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.

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Ambulatory Blood Pressure Monitor

This mode is enabled for the first five successful blood pressure readings (or attempted readings) following monitor initialization. Office Check can be disabled by a patient cancel and can be reenabled after turning the power switch ON and holding the START/STOP button in while the last digit of the software version number is being displayed.

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

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

1-4

Setup Contents Installing the Batteries... 1 Initializing the Monitor... 2 Operational Tests... 7

Installing the Batteries Two types of batteries are used in the 90217 ABP Monitor: three standard AA batteries (Spacelabs Medical P/N 146-5011-xx) to power the cuff air pump, and one rechargeable lithium battery to backup the clock and RAM circuits 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. Its expected life is at least nine years. If alkaline batteries are used as the AA batteries, they must be replaced after each patient use. Nickel cadmium batteries require a full charge before each use.

AA Batteries To replace the three AA batteries: 1.

Switch the monitor’s power switch to OFF.

2.

Remove the battery compartment cover plate by sliding it to the right until it can be pulled free.

2-1

Ambulatory Blood Pressure Monitor

3.

3. If present, remove the old AA batteries from the monitor and replace each with a fresh alkaline battery (or fully charged nickel cadmium), being careful to match polarities where indicated (+ or -).

!

•

The monitor will not operate if batteries are incorrectly installed.

•

If the monitor is going to be stored longer than two weeks, remove the AA batteries to prevent the possibility of leakage or discharge. Spacelabs Medical 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.

4.

After correctly inserting the batteries, gently slide the battery cover back into place.

5.

Switch the monitor ON and verify that the display appears. If there is no display, switch the monitor OFF and refer to the Troubleshooting chapter in this manual. When power is first switched ON, the first four digits of the RAM code revision are displayed for about 1 second, followed by a blanked display, followed by the last two digits of the revision number.

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, connect it to one of the following analysis systems.

Local Report Generator For a direct connection to a Local Report Generator, place the monitor into the chute on the Report Generator (Model 90239A or equivalent):

Local Report Generator Direct Connect Configuration

Model 90217

Ensure that the monitor lines up against the side to align IR ports Local Report Generator (90239A)

2-2

Setup

PC Interface For a direct connection to an IBM XT/AT/PS2 (or equivalent) via a Model 90219-02/90219-03 (or equivalent): 1.

Connect the ABP monitor to the 90219 Analysis System.

2.

Connect the 90219 Analysis System cable from the monitor to the serial port on the PC:

PC Interface Direct Connect Configuration

Model 90219 Analysis System 90217 ABP Monitor

cable to serial port

3.

Refer to the 90219 Ambulatory Blood Pressure PC Interface/Base Station Operations Manual (P/N 070-0238-xx) for instructions for operating the Analysis System.

Base Station via Modem For a modem connection to a remote IBM XT/AT/PS2 (or equivalent) base station:

Modem Connection Configuration

TO BASE STATION MODEM

PUBLIC TELEPHONE NETWORK

cable to serial port ABP Monitor

MODEM

PHONE

! 1.

•

The initialization procedure is provided in the 90219 Ambulatory Blood Pressure PC Direct/Base Station Operations Manual (P/N 070-0238-xx).

The 90217 can use one of the following modems for communication:

• Hayes Smartmodem 1200 • Hayes Optima 9600 or equivalent • Most 2400 baud modems If the remote site also has 90202 or 90207 monitors, a Hayes Smartmodem 1200 must be used with those monitors.

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Ambulatory Blood Pressure Monitor

High Speed modems are setup via software commands. The Hayes Smartmodem 1200 which attaches to the monitor must be setup as follows:

2.

!

Switch #

Setting at Monitor Site

1

down

2

up

3

down

4

down

5

down

6

up

7

up

8

down

9

up

10

up

Connect the serial port cable (P/N 012-0096-00) between the monitor and the modem. •

If call waiting or call forwarding are options on the telephone used to transfer data, ensure that both are deactivated or modem communications may be interrupted. In addition, telephone systems such as CBX or PBX can cause interference with the modem, or the modem can cause interference with the switching system.

To initialize the monitor for a remote connection: 1.

Contact the base station by telephone (for remote operation only).

2.

Ask the base station operator to initialize the monitor. Give the following information to the operator: • Patient's name. • Patient ID number. • If the monitor display is to be active or inactive. • Time of day (12- or 24-hour format). • If measurements are to be displayed (systolic/diastolic and heart rate). • Multiple or single cycle times. If using a single cycle for the 24-hour monitoring period, indicate the cycle interval and whether the tone is ON or OFF. For multiple cycle time, specify each cycle interval and whether the tone is ON or OFF for each cycle. • Any other information the base station operator may request.

3.

The base station operator enters the patient information in the computer.

4.

Prepare the monitor to receive the patient data from the base station. • Switch the modem ON. • When instructed by the base station operator, switch the ABP monitor ON.

! 2-4

•

The modem link must be established within 45 seconds for the 90217. If this does not happen, switch the monitor OFF and return to step 1.

Setup

5.

When the information transfer is complete, the ABP monitor beeps and voice communication is restored. • Switch the monitor OFF and disconnect it from the modem. • If there is a direct connection between the monitor and the base station, switch the monitor OFF and disconnect it from the ABP data interface unit.

To transfer readings from the monitor to the base station: 1.

Contact the base station by telephone (for remote operation only).

2.

Ask the base station operator to read the monitor. Give the following information to the operator: • Patient's name. • Patient ID number. • Any other information that the base station operator may request.

3.

The base station operator enters the patient information into the computer. (If the monitor is in a remote location, the operator must turn power to the base station modem ON.)

4.

Prepare the monitor to transfer data to the base station. • Switch the modem ON. • When instructed by the base station operator, switch the ABP monitor ON (for remote operation only).

! 5.

•

The modem link must be established within 45 seconds for the 90217. If this does not happen, switch the monitor OFF and return to step 1.

When the information transfer is complete, the ABP monitor beeps and voice communication is restored. • Switch the monitor OFF and disconnect it from the modem.

Modem Indicator Lights When the monitor is switched ON, the modem’s RD (receive data) and SD (send data) lights flash for several seconds. The OH (on hook) indicator is lit when the monitor starts communicating with the remote modem. When both modems connect, the CD (carrier detect) is lit. The SD and RD lights flash as data is being transferred. After the transmission is complete and the monitor is turned OFF, the HS, TR and MR indicators will always remain lit at the local modem.

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Ambulatory Blood Pressure Monitor

90217 Modem Connection Status Indications The left-most digit of the 90217 display shows the various stages of the modem connection process: 1 Sending modem identify query. 2 Waiting for response to identify query. 3 Sending modem reset commands. 4 Sending modem setup commands. 5 Send off-hook command. 6 Waiting for contact. 7 Contact established. 9 Not attempting to contact modem. Once contact has been established, the second digit from the left on the 90217 display indicates the baud rate of the connection. On high speed modems, the indicated speed refers to the connection between the ABP monitor and the modem. The two modems may be communicating at some speed other than that at which the modem is communicating with the monitor. The baud rate codes are as follows: 0 1200 1 not used 2 2400 3 4800 4 9600 5 19.2 k 6 38.4 k

Setup Test

!

•

Verify that all cable connections are installed correctly and are connected securely.

Switch the ABP monitor ON. It initially displays “9999”. When the monitor is being read or initialized, these digits change to indicate that communication is taking place between the monitor and the analysis system. When communication is complete, the digits stop changing. The right-most digit indicates that a message has been sent from the monitor to the base station. The second digit from the right indicates that a non-garbled message has been received by the monitor. A common failure mode is with only the right digit spinning. This indicates garbled messages are being received and an “I don’t understand” response is being transmitted by the monitor.

2-6

Setup

Operational Tests Conduct the following procedures to verify proper operation of the Model 90217 ABP Monitor.

Equipment Required • • • • • • • •

90219-02 system 90219-03 ABP Base Station software Type AA alkaline batteries (3) Cable, 90217 to PC, P/N 012-0097-xx (greater than -02) Setup for air leaks (see Air Leak Test for illustration) Analog manometer (optional) Stop watch or equivalent Battery spring insertion tool, P/N 003-0084-00

Visual Inspection 1.

Check the display window and ensure that it is clear (free from scratches, contamination, etc.) with the words “SYS DIA” appearing on the left side.

2.

Verify that the front panel START/STOP button responds with a clear “snap” when depressed.

3.

Inspect inside the battery compartment to ensure that the battery springs are clean and provide a good electrical contact with the batteries.

4.

Install the three AA batteries and verify that the battery door closes and latches properly.

Air Leak Test 1.

!

Connect the test setup illustrated below: •

This figure shows the use of both an analog and digital manometer. Both or either can be used in these tests. If only one manometer is used, block off the unused hose.

2-7

Ambulatory Blood Pressure Monitor

2.

Close the squeeze bulb valve.

3.

Turn the 90217 ON and press the START/STOP button.

4.

Verify the following monitor response: • Two beeps are sounded. • The display counts down: 5555, 4444, 3333, 2222, 1111. • Pumping begins and “_ _ _ _” is displayed (could display the pump pressure, depending upon how the monitor was initialized).

5.

!

Verify that the system pumps up to 165 mmHg, +/- 8 mmHg, before the pressure begins to drop in 7 to 9 mmHg steps. Ensure that the pressure does not drift down. •

It may take 3 or 4 steps before the cuff size is learned by the monitor and the steps fall within this range.

6.

Verify that the display reads “EC18”.

7.

Open the bulb valve and remove the monitor from the manometer setup.

PC Interface Test 1.

Connect the system as illustrated:

2.

Power ON all devices.

3.

Start the 90219-03 Base Station software (loaded on hard drive).

4.

Type: ABP (or ABPPCI) and press the Enter key on the base station.

! 2-8

•

If the file name has been changed from ABP, type DIR and press Return to determine the new name.

Setup

5.

Switch the 90217 power switch ON.

6.

Press in this order: Space Bar 1

(ABP communication)

3

(direct connect - skip this step if a PC Interface data key is attached instead of a base station data key)

2

(read ABP unit)

7.

Press any key (wait).

8.

Type 8, Enter key, and Y (yes).

! 9.

•

“8” is the name of a dummy file which should be setup on the computer already.

Press the END key.

10. Verify that the clinical data appears on the computer screen. The last reading on this screen is the results of the test done earlier in these procedures. 11. Verify that the date and time are correct and that the event code “EC18” appears. 12. Press the ESC key. 13. Initialize the 90217 by typing: 1

(initialize ABP)

14. Press the END key and use the up arrow key until PATIENT NAME is selected. 15. Type: TEST and press the Enter key 1234567890 and press the Enter key NONE and press the END key 16. Verify that the display reads “***MONITOR INITIALIZED***”. 17. Press: Space Bar ESC key ESC key ESC key Y key (yes) 18. Remove the 90217 from the system and switch power OFF. 19. Remove one AA battery. 20. Wait one minute and reinstall the battery. 21. Switch 90217 power ON and verify that the time remained correct.

2-9

Theory Contents Pressure Amplifier... 1 Oscillometric Amplifier... 2 90217 Block Diagram... 4 Digital Circuitry... 5 Unit Power... 6 Software Flow Chart... 8

Pressure Amplifier The pressure amplifier monitors the voltage produced across the pressure transducer. This voltage is proportional to the pressure in the arm cuff. The pressure transducer circuits require temperature compensation to account for changes in sensitivity. This is accomplished by using a reference current to provide a constant current source into the bridge. Any change in bridge resistance due to temperature will change the bridge voltage in an amount that compensates for any change in sensitivity. Voltage across the transducer is amplified differentially and turned into a single ended voltage that is amplified, offset and sent to the processor’s A/D converter, the oscillometric amplifier and the overpressure detector.

Offset Adjust Both transducer offset and operational amplifier offset are nulled out using a pressure offset adjustment. Minor variations in the offset are tracked and compensated for in software.

Gain Adjust Changes in gain are compensated for with a gain adjustment. The voltage gain to the A/D converter is +15 mv/mmHg, and the voltage is offset by approximately 0.09 volts. This 0.09 volts is inserted to prevent the A/D converter signal from going negative during drifts in the offsets. The 0.09 volt offset is subtracted in software.

3-1

Ambulatory Blood Pressure Monitor

Oscillometric Amplifier Gain, Offset and Filtering The oscillometric amplifier is DC coupled. A D/A convertor provides large amounts of DC offset to the amplifier to prevent the large static pressure component of the waveform from over driving the amplifier. It provides gain (x64), DC offset, and high frequency filtering (3dB point = approximately 80 Hz). The oscillometric filtering that was present in earlier designs is now done by software.

RAM Protect and Reset Circuit When the +5 volt power supply begins to drop, the RAM protect circuit asserts a reset signal to the processor that protects RAM data during power collapse. This same circuit provides a start up processor reset signal at power up. Reset time is a product of the reset R-C time constant and the hold off time necessary for the power convertor to reach +5 volts (the reset time constant is 350 msec).

A/D Voltage References The A/D reference (+ADR) is generated from a LM4041-1.2 band gap reference. Its reference output of 1.2 volts is amplified to 4.608V by a gain adjustable amplifier (+ADR = +4.608 volts, adjustable).

30 Second Pulse The real-time clock produces a pulse every minute with a 30 second duration. This pulse’s leading and trailing edges are conditioned into separate pulses and applied through a diode to the processor’s WAKE_UP line to awaken it every 30 seconds.

Second Pulse The SECONDS line goes to the LCD where it blinks the colon and changes the LCD polarity.

Cable Connected If a cable is connected to the RS-232 communications connector with the power switch ON, the power converter activates and awakens the processor. A cable connected condition prevents the power converter from going down as a result of a shutdown fault generated by the watch dog timer, but cannot prevent an over-pressure shutdown. Once a cable has been connected, the processor goes into a listening mode, awaiting instructions from the RS-232 port. These instructions adhere to the ABP communications protocol.

3-2

Theory

Watch Dog Timers The watch dog timers ensure that the cuff cannot remain inflated because of a software crash. There are two watch dog timers in the Model 90217: one resides inside the processor; the other inside the real-time clock. Each counts 180 seconds before timing out. Both timers start at converter power up. The real-time clock watch dog timer triggers the hold off that disables the pump, opens the bleed valve, and informs the CPU of its action. In 16 seconds after the hold off is asserted (if the software does not end the reading) fault shutdown resets the system. The hold off is also asserted at the end of every reading. The hold off always stays active for 32 seconds or until a manual reading is started.

Fault Shutdown The fault shutdown circuitry resets the system because of two conditions: • There is an over-pressure condition not detected by software. • Pressure reading takes longer than 180 seconds (this indicates a software crash since a software time out should have already stopped the reading).

Over-Pressure Detector In addition to software over-pressure detection, there is also a hardware over-pressure detector that activates at approximately <295 mmHg. A one-half second delay in initiating an over-pressure response prevents motion artifacts from causing a false over-pressure detection.

3-3

Ambulatory Blood Pressure Monitor

90217 Block Diagram

3-4