Related Manuals for Spacelabs Healthcare 90217A
Summary of Contents for Spacelabs Healthcare 90217A
- Page 1 Ambulatory Blood Pressure Monitor 90217A www.spacelabshealthcare.com 070-2177-01 Rev B | 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 will be represented in black & white) WARNING - Actions or circumstances that may result in personal injury or death. (Note: All further instances of this symbol will be represented in black &...
- 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.
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Page 5: Table Of Contents
1.4.2 Optional Accessories 1-11 1.4.3 Correlating with Manual Readings 1-11 1.4.4 Patient Instructions 1-12 1.5 Data Transfer and Reports 1-12 1.6 Cleaning/Disinfecting 1-12 1.6.1 Cleaning the Cuff and Carrying Pouch 1-13 1.6.2 Removing/Installing the Bladder 1-14 1.7 Event Codes 1-14 Accuracy Checking Accuracy 2.1.1 Accuracy Procedure Technical Data 90217A Ultralite ABP Monitor 3.2 Electromagnetic Compatibility 070-2177-01 Rev B... - Page 6 3.2.1 General notes 3.2.2 Guidance and manufacturer’s declaration – electromagnetic emissions 3.2.3 Guidance and manufacturer’s declaration – electromagnetic immunity 3.2.4 Guidance and manufacturer’s declaration – e lectromagnetic immunity 3.2.5 Recommended separation distances between p ortable and mobile RF communications equipment and the 90217A Troubleshooting 4.1 Problem Solving Checklist 4.2 Servicing Appendix - Signs and Symbols ABP 90217A Operations Manual...
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Page 7: Operation
1. Operation Overview The Spacelabs Healthcare Models 90217A Ambulatory Blood Pressure (ABP) monitors are small, lightweight, battery-powered monitors designed to take blood pressure and heart rate measurements for 24 or 48 hours, or for longer periods of time. These measurements are recorded within the monitors and may be transferred to Local Report Generator 90239A, to Report Management Software (90121 or 92506) (optionally in Remote Connection mode using modems) or to CardioNavigator or Sentinel Cardiology Information Management Systems. -
Page 8: Replacing The Batteries
• Spacelabs Healthcare is not responsible for product damage incurred as a result of “AA” 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. -
Page 9: Initializing The Monitor
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. 1.3.1 Connecting Directly to a Local Report Generator For a direct connection, place the 90217A monitor into the chute on the Report Generator (Model 90239A), See Fig. 1-1. Figure 1-1: Report Generator 070-2177-01 Rev B... -
Page 10: Connecting Directly To The Pc Interface
Figure 1-3: Modem connection configuration Note: The actual initialization procedure is discussed in the 90121 ABP Report Management System Operations Manual (P/N 070-0529-xx) and in the 92506 ABP Report Management System Client Application Operations Manual (P/N 070-2160-xx). ABP 90217A Operations Manual... -
Page 11: Modem Speed And Compatibility Issues
9600 baud. When the communications cable is plugged into the monitor it should display 0999/9999 1.3.4.1 Connection Procedure Connect the serial port cable (P/N 012-0096-01) between the 90217A monitor and the modem. Note: If call waiting or call forwarding are options on a telephone used to transfer data, ensure that both are deactivated. -
Page 12: Office Check Mode
Note: The 90217A enforces a 30 second minimum pause between measurements to allow reperfusion. If the START/STOP key is pressed too soon after the previous measurement, the monitor will count down the required period before automatically starting the measurement. -
Page 13: Preparing The Patient And Precautions For Use
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. 1.3.5.2 Reinstating Office Check Mode The Office Check mode may be reinstated in the 90217A. To reinstate the Office Check mode without initialization of the monitor: Power ON the monitor. Press and hold the START/STOP key when the version displays on the LCD. - Page 14 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. Ensure the accuracy of blood pressure measurements through proper cuff selection and application. To select the proper cuff, first measure the ABP 90217A Operations Manual...
- Page 15 circumference of the limb at the point where the cuff will be applied. Match the limb measurement to the range of appropriate circumferences (in centimetres) specified on each cuff. Table 2: Cuff Sizes, Circumference Ranges and Part Numbers Part Number Description Shelf Life Warranty Child cuff, 12-20cm, latex free with Quick/ 015-0118-04Q 5 years 90 days Luer connect Small adult cuff, 17-26cm, latex free, with 015-0067-04Q...
- Page 16 • Do not apply cuff to areas of breached or injured skin. • Use only Spacelabs Healthcare cuffs with this monitor. Using other manufacturer’s cuffs may result in inaccurate readings, even if the manufacturer’s recommended size is observed.
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Page 17: Using Cuff Support
8. Show the patient how to enter information in the Patient Diary. Make sure the patient knows what to do if the cuff becomes very uncomfortable during a measurement, if it slips out of place, or if event codes are displayed on the monitor screen (refer to Patient Instructions on page 1-9). Also, ensure that the patient knows how to care for the monitor. When you are satisfied that the monitor is operating properly, the remaining measurements in the Office Check mode may be cancelled. Refer to Office Check Mode on page 1-8. 1.4.1 Using Cuff Support Note: Keeping the blood pressure cuff in place is very important both for patient comfort and for the accuracy of the readings. This becomes particularly challenging when the arm has considerable taper, as is often the case with obese patients. -
Page 18: 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. • The monitor should be kept within the pouch at all times. -
Page 19: Cleaning The Cuff And Carrying Pouch
• Isopropyl alcohol (70% solution). Note: Over time, repeated use of a chlorine bleach solution may cause some colors to fade. Tape adhesive can be removed with Spacelabs Healthcare adhesive tape remover pads (P/N 392196-001). Questions and concerns about cleaning issues should be directed to a Spacelabs Healthcare field service engineer. 1.6.1 Cleaning the Cuff and Carrying Pouch Small soiled or stained areas may be cleaned by gentle scrubbing with a sponge or cloth soaked in a mild soap and water solution. -
Page 20: Removing/Installing The Bladder
Event Code Report. Monitor Report Condition EC00 Excess movement artifact. Frequent EC10 messages may indicate an air EC10 leak. A) A very large number of movement artifacts EC20 B) Heart rate arrhythmia A) Movement artifact at mean arterial pressure EC30 B) Heart rate arrhythmia A) Movement artifact at systole EC40 B) Heart rate arrhythmia A) Movement artifact at diastole EC50 B) Heart rate arrhythmia ABP 90217A Operations Manual 1-14... - Page 21 Monitor Report Condition A) Movement artifact EC60 B) Heart rate arrhythmia Systole was found to be above the highest cuff pressure. However, this EC70 result appears to be an error caused by motion artifact. Therefore, the cuff will not be inflated to a higher pressure on the next measurement attempt. A) Movement artifact EC80 B) Heart rate arrhythmia A) Movement artifact EC90 B) Heart rate arrhythmia EC01 EC11 Did not pump above the mean arterial level. EC21 Did not pump above systolic pressure. EC91 Systole appears higher than the selected maximum cuff pressure limit.
- Page 22 EC07 Clogged connector filter. EC78 EC08 Too few data entries to accurately determine blood pressure. This message may indicate that the cuff is not being worn by the patient (taken off but EC18 left connected to the monitor). The message may also indicate that motion artifacts cause the majority of the incomplete data. Diastole above 200mmHg. EC28 Pulse pressure less than 16mmHg. EC38 A) Movement artifact at mean arterial pressure EC48 B) Heart rate arrhythmia A) Movement artifact at diastole EC58 B) Heart rate arrhythmia EC68 Division by zero. ABP 90217A Operations Manual 1-16...
- Page 23 Monitor Report Condition EC09 Contradictory instructions sent to hardware (e.g., “pump ON and valve EC19 open”). Diastolic pressure value cannot be obtained from the data available. EC29 Algorithm could not process input data quickly enough, resulting in an input EC39 queue overflow. This monitor must be initialized. EC49 Heart rate value cannot be obtained from the data available. EC59 Heart rate value cannot be obtained from the data available. EC69 Bleed steps were too small. This may be caused by a partially obstructed air hose. All blood pressure attempts following this message are inhibited.
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Page 25: Accuracy
Accuracy Checking Accuracy Spacelabs Healthcare recommend calibration of your ABP device annually The accuracy of the device can be checked using the following procedure. Required Equipment: • A full-size mercury sphygmomanometer or aneroid gauge. Note: Ensure the mercury sphygmomanometer or aneroid gauge is calibrated and indicates “0” with no pressure. • T-tube (P/N 016-0040-00). • A pressure cuff and a rigid cylinder sized to fit the pressure cuff. 070-2177-01 Rev B... -
Page 26: Accuracy Procedure
Figure 2-1:712-0039-00 Calibration Kit Press START/STOP on the monitor; the monitor should read approximately 165 mmHg. Compare the readings on the monitor and the manometer as the pressure bleeds down. The monitor reading should be within three millimeters or 2% of the manometer reading, whichever is greater (± the accuracy of the manometer). At the end of the procedure, the monitor displays an event code indicating that no dynamic blood pressure measurements were obtained. 4. Disconnect the T-tube splitter from the monitor. Disconnect the air hose and sphygmomanometer. ABP 90217A Operations Manual... -
Page 27: Technical Data
3. Technical Data 90217A Ultralite 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 over a period of 24 to 48 hours or more. Real-time clock facilitates diary notations. No chest electrodes or microphones — reduces operating cost, improves patient comfort and measurement reliability. Independently programmable measurement periods and inflation frequencies. Telecommunications feature allows remote programming and data retrieval. Features, Controls, Connectors and Indicators On/Off: Two-position slide switch “On” - Normal operation; automatically initiates measurements at pre-programmed time intervals. - Page 28 Note: Cuff Pressure may be limited to a pressure lower than the unit’s absolute maximum. Auto-zeroing Pressure automatically zeroed before each reading. Artifact Rejection Discriminates between pressure signals, patientmovement, and respiratory artifact. Cuff Inflation/Deflation Inflation and deflation rates under microprocessor control. Data Storage System Nonvolatile; information retained until reprogrammed; timing of events provided by real- time clock. Digital Display 4-digit, 7 segment, liquid crystal display; systolic, diastolic, and heart rate information alternately displayed; time display and blinking colon provided to indicate when the unit is ABP 90217A Operations Manual...
- Page 29 EN 60601-1 Internally powered equipment. Type BF-defibrillator proof applied part. Not suitable for use with flammable gases. Rated for intermittent operation. Electrical Requirements Power Requirement - Three AA size (LR6 or equivalent), alkaline or rechargeable batteries. Physical Dimensions Height 0.97 in (2.5 cm) Depth 3.94 in (10.0 cm) Width 2.77 in (7.0 cm) Weight excluding batteries. 90217A 6.1oz (172g) Environmental Requirements Storage Temperature 29 °F to 149 °F (-34 °C to 65 °C) Humidity 95% (non-condensing) Altitude 500 to 15,000 ft (-152 to 4,572 m) Operating Temperature 41°F to 104 °F (5 °C to 40 °C) Humidity 90% (non-condensing) Altitude 0 to 10,000 ft (0 to 3.48 m)
- Page 30 Immunity IEC 61000-4-2 ESD 6 kV contact, 8 kV air IEC 61000-4-3 RF Fields 3 V/m 80 MHz to 2.5 GHz Regulatory Approvals CSA certified. Meets electrical safety standards CSA C22.2 No. 601.1, UL 60601-1, and IEC 60601-1: 1990. IEC 60601-2-30: 1999, NIBP. CE marked in accordance with the Medical Device Directive 93/42/EEC. EN 60601-1:2006/A1:2013 IEC 80601-2-30:2009/A1:2013 Clinically investigated to «The British Hypertension Society (BHS) protocol for the evaluation of blood pressure measuring devices» and ANSI/AAMI SP10:2002 Accessories For information about supplies, please contact your Spacelabs Healthcare representative. ABP 90217A Operations Manual...
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Page 31: Electromagnetic Compatibility
Electromagnetic Compatibility 3.2.1 General notes The following notes and tables refer to the 90217A ABP monitor; for simplicity, these are refered to in this section as ‘the Monitor’. In testing the immunity of the 90217A, the following were regarded as ESSENTIAL PERFORMANCE per EN60601-1-2: • Less than 5mmHg variation in BP readings with a SD less than 2 mmHg. • Maintenance of stored blood pressure readings and patient data. • Maintenance of correct time and date. • No changes of operating mode or set-up selections. • No damage, failure, or safety hazard. • The following were regarded as acceptable responses to electrostatic discharges (ESD) only: • Reset followed by automatic recovery within 10 seconds. A measurement that is in progress may terminate early with an event code Portable and mobile communications equipment can affect medical electrical equipment. In particular, emergency service radios and walkie-talkies can generate very strong interference signals. -
Page 32: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
IEC applicable 61000-3-2 Voltage fluctuations/ applicable flicker emissions IEC 61000-3-2 3.2.2.1 Continuation for manuals that may be used in the USA: This equipment has been tested and found to comply with the limits for a class B computing device in accordance with the specifications in Subpart J of Part 15 of FCC Rules, which are designed to provide reasonable protection against interference to radio and television reception. This equipment generates and uses radio frequency energy and if not installed and used in accordance with the instructions it may cause interference. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause interference to radio or television reception, which can be determined by turning the equipment off or on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient the receiving antenna. • 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”. This booklet is available from the U.S. Government Printing Office, Washington, DC 20402, Stock No. 004-000-00345-4 ABP 90217A Operations Manual... - Page 33 3.2.3 Guidance and manufacturer’s declaration – electromagnetic immunity The Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Monitor should assure that it is used in such an environment. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be wood, (ESD)IEC61000-4-2 concrete or ceramic tile. ± 8 kV air ± 8 kV air If floors are covered with synthetic material, the relative humidity should be at least 30%.
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Page 34: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Interference may occur in the vicinity of equipment marked with the adjacent symbol: NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. * Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. ** Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. ABP 90217A Operations Manual... - Page 35 3.2.5 Recommended separation distances between portable and mobile RF communications equipment and the 90217A The Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Monitor as recommended below, according to the maximum output power of the communications equipment. Rated maximum output Separation distance according to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2√P d = 1.2√P d = 2.3√P 0.01 0.12 0.12 0.23 0.38 0.38 0.73 For transmitters rated at a maximum output power not listed above, the recommended separation...
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Page 37: Troubleshooting
4. Troubleshooting Problem Solving Checklist Problem Possible Cause Solution Check the batteries for a full Low or no power. charge; if needed, replace or recharge the batteries. Monitor display is May be one of the following: incorrect time-out, no reading due to air leak in the system, improper Isolate cause and correct. cuff size, cuff not properly attached to the monitor. Monitor displays “LLL”... -
Page 38: Servicing
Servicing There is a 12-month warranty on this product (with exception to cuffs which carry a 90 day warranty & batteries which carry no 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. Contact your Spacelabs Healthcare Customer Service Representative for shipping details. Any attempt to perform service or repair to the monitor will result in cancellation of the warranty. 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. ABP 90217A Operations Manual... -
Page 39: Appendix - Signs And Symbols
Appendix - 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 THIS SYMBOL MEANS available on accompanying YOU MUST READ CD or via the Spacelabs THE ACCOMPANYING Healthcare website DOCUMENTS Caution - hazardous voltages. - Page 40 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/ START (NIBP) Key OFF Key START/STOP STOP or CANCEL Key ABP 90217A Operations Manual...
- Page 41 Frequently Used Functions Infra Red Communications Video Output Port PRINT REPORT Key Universal Serial Bus (USB) Network Connection Power Indicator LED HELP (Explain Prior Screen) Audio Output, Speaker Data Input/Output Keypad Arterial Pulse PCMCIA Card Keyboard Connection Mouse Connection Serial Port 070-2177-01 Rev B...
- Page 42 Batteries such as lead-acid municipal waste and must be collected (Pb) and nickel-cadmium (Ni-Cd) must separately. Please contact an authorized be recycled. Please follow your internal representative of the manufacturer procedures and or local (provincial) laws for information concerning the regarding disposal or recycling. decommissioning of your equipment. Keep Dry Latex Free ABP 90217A Operations Manual...
- Page 43 Certification and Compliance Canadian Standards ETL Laboratory Approved Association Approved CE marked in accordance with Radio transmission device. the Medical Device Directive, High levels of ionizing 93/42/EEC radiation Manufacturer Information and Traceability Manufacturer Date of Manufacture Serial Number The letters ‘SN’ stand for Catalog Number ‘Serial Number’ Each device has its own unique serial number Notations and Abbreviations Abbreviations used as symbols are shown below. ECG Channel C.O.
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- Page 46 35301 SE Center St, Snoqualmie, WA 98065. USA | T +1 425 396 3300 | F+1 425 396 3301 Unit B, Foxholes Centre, John Tate Road, Hertford, SG13 7DT. UK | T +44 (0)1992 507700 | F +44 (0)1992 501213 www.spacelabshealthcare.com © 2016 Spacelabs Healthcare Specifications subject to change without notice. 070-2177-01 Rev B...