Directions for Use
Tympanic Thermometer System Thermometer
Directions for Use
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TABLE OF CONTENTS INTRODUCTION 1 2 2 3
GETTING STARTED 5 5 5 5 6 7
OPERATING INSTRUCTIONS PROBE COVER DISPENSE/LOAD INSTRUCTIONS... Probe Cover Dispenser... Load Probe Cover Onto Thermometer... TAKING A TEMPERATURE...
9 9 9 10
WARNINGS AND CAUTIONS... Definitions... Warnings... Cautions... INSTRUMENT FEATURES... SETUP PROCEDURE...
ABOUT THE SYSTEM... FEATURE SUMMARY... Thermometer Features... DEFINITIONS...
INFORMATION DISPLAYS CORE•CHECK® THERMOMETER LCD DISPLAY SCREENS...
SERVICE INFORMATION... Customer Service... Technical Support...
18 18 18
Product Return... WARRANTY...
INFORMATION DISPLAYS MAINTENANCE
TABLE OF CONTENTS i
GENERAL CONTACT INFORMATION
Customer Advocacy For clinical and technical questions, feedback, and troubleshooting assistance. Phone, toll-free, within the United States and Canada: (800) 854-7128, Ext. 7812 E-Mail: [email protected]
Technical Support and Service Center Addresses: AE ALARIS Medical Systems Middle East Office, PO Box 5527 Dubai, United Arab Emirates. Tel: (971) 4 28 22 842 Fax: (971) 4 28 22 914 AU ALARIS Medical Australia Pty Ltd, 8/167 Prospect Highway, Seven Hills, NSW 2147 Australia. Tel: (61) 2 9838 0255 Fax: (61) 2 9674 4444 BE ALARIS Medical Belgium B.V., Otto De Mentockplein 19, 1853 Strombeek- Bever, Belgium. Tel: (32) 2 267 38 99 Fax: (32) 2 267 99 21 CA ALARIS Medical Canada Ltd, 5975 Whittle Road, Suite # 120, Mississauga, Ontario L4Z 3N1 Canada. Tel: (1) 905-507-1131 Fax: (1) 905-507-6664 CN ALARIS Medical Systems Office, Suite 401 No. 88 Chang Su Rd. Shanghai, PC 200040, China. Tel: (56) 8621-62488591 Fax: (56) 8621-62482567 DE ALARIS Medical Deutschland, GmbH, Pascalstr. 2, 52499 Baesweiler, Deutschland, Tel: (49) 2401 604 0 Fax: (49) 2401 604 121
ES ALARIS Medical España, S.L., Avenida Valdelaparra 27, Edificio, Alcor, 28108 - Alcobendas, Madrid, España, Tel: (34) 91 657 20 31 Fax: (34) 91 657 20 42
NL ALARIS Medical Holland, B.V., Kantorenpand “Hoefse Wing”, Printerweg 5, 3821 AP Amersfoort, Nederland. Tel: (31) 33 455 51 00 Fax: (31) 33 455 51 01
FR ALARIS Medical France, S.A., 95, rue Péreire, 78105 St Germain en Laye Cedex. France. Tél: (33) 1 39 10 50 00 Fax: (33) 1 30 61 22 23
NO ALARIS Medical Norway A/S Solbréveien 10A, 1383 ASKER, Norge. Tel: (47) 66 98 76 00 Fax: (47) 66 98 76 01NO
GB- Manufacturer’s ALARIS Medical UK Ltd, The Crescent, Jays Close, Basingstoke, Hampshire, RG22 4BS, United Kingdom. Tel: (44) 0800 389 6972 Fax: (44) 1256 388 411 HU ALARIS Medical Hungary, Döbrentei ter 1,, H-1013 Budapest, Magyar, Tel: (36) 14 88 0232 Fax: (36) 12 01 5987 IT ALARIS Medical Italia S.P.A. Via Ticino 4, 50019 Sesto Fiorentino, Firenze, Italia, Tél: (39) 055 34 00 23 Fax: (39) 055 34 00 24
NZ ALARIS Medical NZ Ltd. Unit 14, 13 Highbrook Drive. East Tamaki, Auckland New Zeland. Tel: (64) 9 273 3901 Fax: (64) 9 273 3098 SE ALARIS Medical Nordic, AB. Hammarbacken 4B,. 191 46 Sollentuna, Sverige. Tel: (46) 8 544 43 200 Fax: (46)8 544 43 225 US ALARIS Medical Systems, Inc. 10221 Wateridge Circle,. San Diego, CA 92121 USA. Tel: (1) 800 854-7128 Fax: (1) 800 854-6179 ZA ALARIS Medical S.A. (Pty) Ltd, Unit 2 Oude Molen Business Park Oude Molen Road, Ndabeni, Cape Town 7405, South Africa. Tel: (27) 0860 597 572 Fax: (27) 21 5107567
INTRODUCTION About the System INTRODUCTION
This manual is a guide for using the CORE•CHECK® Tympanic Thermometer System Model 2090. The CORE•CHECK® Thermometer is designed to measure infrared energy emitted from the tympanic membrane. Infrared energy is generated by the vibration and movement of molecules in all matter. As temperature increases so does molecular activity, causing an increase in the radiation of infrared energy. Infrared energy emitted from the tympanic membrane in the ear canal provides an excellent measurement of the body's core temperature. The blood supply for the tympanic membrane is common with the hypothalamus, the area of the brain that regulates body temperature. The CORE•CHECK® Thermometer is positioned in the external auditory canal. The thermometer senses infrared radiation emitted from the surface of the tympanic membrane and surrounding tissue. This reading is quickly processed through the CORE•CHECK® Thermometer technology to provide an accurate measurement of core body temperature. The CORE•CHECK® Tympanic Thermometer System includes the thermometer, Probe Cover Dispenser - Model 2992, Home Base - Model 2993, and Probe Cover Bracket - Model 2994. The thermometer uses ALARIS Medical Systems® Disposable Probe Covers, Model P90. For additional information, contact your ALARIS Medical Systems® representative.
Feature Summary Thermometer Features
• Accurate, non-invasive determination of core temperature • Temperature measurement within 3 seconds • Anti-theft feature • Durable by design and construction • User-selectable Celsius or Fahrenheit temperature readings • Display backlight for low-light conditions • Powered by a single 9-volt battery • Home base holds thermometer and dispenser • Disposable probe covers and probe cover detectors reduce the risk of cross-contamination • Dispenser conveniently stores and dispenses probe covers • Thermometer performs a self-test
Disposable Probe Cover
PROBE COVER BRACKET Attaches to the wall and holds a box of five probe cover packets. HOME BASE Holds thermometer and dispenser, also resets the anti-theft feature. THERMOMETER DISPENSER Holds and dispenses P90 probe covers. Combines with thermometer to provide a hand-held unit.
DISPOSABLE PROBE COVERS Reduce the risk of crosscontamination and easily loads onto thermometer probe tip.
USE ONLY 9V ALKALINE
ENSURE LENS IS CLEAN BEFORE USE
Alkaline battery used.
OPEN PRESS TO SLIDE
Instructions for probe cover dispenser.
CLOSE AND LOCK
External Auditory Canal
A narrow, tube-like passage through which sound enters the ear, also named an external auditory canal.
Relating to the range of invisible radiation wavelengths from 750 nanometers. Generating, using, or sensitive to infrared radiation.
Temperature is a measure of molecular motion. Pressure is a measure of molecular activity. The higher the pressure, the faster the molecules are moving and greater energy equals greater temperature.
The membrane in the ear that vibrates to sound.
Conformance to the Medical Device Directive 93/42/EEC
Manufactured Date; expressed in four digits as the year and two digits as the month. Attention: Refer to accompanying documentation.
Indicates degree of protection, fluid ingress. INTRODUCTION 3
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GETTING STARTED To ensure proper performance of the CORE•CHECK® Thermometer and to reduce potential injury, observe the following precautions.
Warnings and Cautions Definitions WARNING A warning is an alert to potential serious outcomes (death, injury or serious adverse events) to the patient or user. GETTING STARTED
CAUTION A caution is an alert to take special care for the safe and effective use of the device. Cautions CAUTION Do not autoclave or immerse the CORE•CHECK® Thermometer as damage will occur. CAUTION Operating the CORE• CHECK® Thermometer near equipment which radiates high energy frequencies (for example electrosurgical/cauterizing equipment), may affect temperature readings. CAUTION If unusually low or high temperature readings are obtained, remove the probe cover, verify the probe lens is clean, shiny, dry, undamaged, and free of debris. Attach a new probe cover and repeat measurement. CAUTION Keep lens clean. Lens should be cleaned with a dry-lint free scrub or tissue. Replace lens if it remains cloudy. CAUTION Damage may occur if alcohol or acetone is used.
GETTING STARTED 5
Figure 1 CORE•CHECK® Tympanic Thermometer System PROBE LENS
PROBE COVER DETECTOR Assures a new temperature is not displayed unless probe cover is replaced after each measurement. (Use P90 probe covers).
PROBE TIP INFORMATION DISPLAY Displays temperature for approximately four minutes or until next measurement is taken.
BACKLIGHT BUTTON Lights the display for use in low light conditions.
TEMPERATURE SWITCH Initiates temperature measurement.
GREEN INDICATOR LIGHT Flashes once to indicate temperature measurement is complete.
Figure 2 Probe Cover Dispenser THERMOMETER RECEPTACLE SLIDER PROBE COVER LEVEL INDICATOR
6 GETTING STARTED
Setup Procedure 1. Carefully unpack the CORE•CHECK® Tympanic Thermometer System and ensure the thermometer, dispenser, and home base are undamaged. Packaging will include a battery, battery compartment cover, extra probe tips and a probe cover wall bracket.
Set °C/ °F switch mode Install battery Self-test Mount home base
2. Set Temperature mode: Set thermometer to Celsius (°C) or Fahrenheit (°F) by sliding the recessed switch located on left side of the battery compartment. Use a small screwdriver or pen tip to slide the switch into position (°F = toward the outside; °C = toward the center).
3. Install Battery : Place a 9-volt alkaline battery into the compartment as shown in Figure 3 and snap connector onto battery terminals. 4. Attach battery compartment cover. Orient the cover's arrow as shown in Figure 3. Slide cover over opening until cover locks in place. If necessary to remove the cover, begin by firmly pressing center of cover with thumb causing a corner to lift, then using the other hand, push cover at loosened corner and slide off. DO NOT PRY COVER WITH SHARP OBJECT. 5. Self Test: Press and hold probe cover detector flush against outer case (Figure 4). While holding, press and release temperature switch once to initiate thermometer self-test to verify both the display and thermometer's internal electronics are in working order. • The display is in working order if all segments momentarily appear (Figure 5). If all segments do not appear, do not use thermometer and refer to Service Information section of this manual. • The thermometer's internal electronics are in working order if a temperature measurement or a "lo" message appears on the display. If a numbered ERROR message appears on the display, the thermometer has detected an internal malfunction. (Refer to ERROR message in the Information Display section of this manual.) 6. After a successful self-test routine, the thermometer is ready for temperature measurement. 7. Home Base: The home base should be mounted to a convenient location using either adhesive tape or screws supplied with the instrument. Always store thermometer and dispenser in the home base when system is not in use, which resets the AntiTheft feature.
GETTING STARTED 7
Setup Procedure (Continued)
Figure 3 Battery Compartment °C/°F Switch
Battery Terminals Battery
Figure 4 Probe Cover Detector
Information Display REPLACE BATT LOW COVER CAL ERROR RETURN TO BASE
8 GETTING STARTED
OPERATING INSTRUCTIONS The following instructions assist in dispensing and loading probe covers onto the thermometer.
Probe Cover Dispense/Load Instructions Probe Cover Dispenser
• Remove thermometer and dispenser from the home base. • Press and slide dispenser door up until it locks in open position. • Install a package of P90 probe covers into the dispenser, with arrow pointing up toward opened sliding door. • Slide door down until locked in closed position, leaving the tab outside the door. • Firmly grasp tab and pull it out of the dispenser. NOTE: Use only ALARIS Medical Systems® P90 probe covers with the CORE•CHECK® Thermometer. The size and thermal characteristics of the probe cover affect thermometer’s performance. Inaccurate readings may occur unless recommended probe covers are used.
Load Probe Cover Onto Thermometer • Dispense a probe cover by pushing dispenser slide completely in and slowly releasing. • Center probe tip onto probe cover film then press firmly to engage base of probe. This will actuate the probe cover detector. • The clear film will stretch smoothly over the entire probe. Failure to fully load the probe cover will result in a REPLACE COVER message.
NOTE: If probe cover backing is not fully seated against the base of the probe, a REPLACE COVER message will appear on the display when the measurement is initiated. If this occurs, replace the cover.
OPERATING INSTRUCTIONS 9
Taking A Temperature
• The most important step in obtaining accurate temperatures is correct placement of the probe tip with a P90 disposable probe cover in the patient's ear. • Center the probe tip far enough into the ear canal to firmly seal the ear canal opening and point in the direction of the tympanic membrane. Gently restrain the head if necessary. Press and hold the temperature switch until the green light flashes and temperature reading is displayed. Correct positioning of the probe tip is necessary for accurate readings. (See Figure 6 below).
Figure 6 Positioning of Thermometer
Evaluate condition of the patient's ear and adjacent skin. The thermometer should not be used on patients with ear drainage, infected or chafed skin adjacent to the ear, or on patients with incisions adjacent to the ear. Such usage may increase the risk of cross-contamination. CAUTION
Operating the CORE• CHECK Thermometer near equipment which radiates high energy frequencies (for example electrosurgical/cauterizing equipment), may affect temperature readings. CAUTION
GENTLY PUSH TO SEAL EAR CANAL
10 OPERATIONAL INSTRUCTIONS
If an unusually low or high temperature reading is obtained, remove probe cover, verify the probe lens is clean, shiny, dry, undamaged, and free of debris. Attach a new probe cover and repeat measurement.
Taking A Temperature (Continued) • Hold thermometer in place until temperature reading is displayed (Approximately three seconds). The green indicator light (below the display) will flash briefly. NOTE: Removal of the thermometer from the ear before a temperature is displayed will result in a low temperature reading.
• Remove thermometer from patient's ear and pull off probe cover. The used probe cover must be replaced by a new one before another measurement can be taken.
• Record the displayed temperature. Another temperature reading can be taken immediately after replacing the probe cover. The temperature will remain displayed for approximately four minutes, unless another measurement is taken. • Store in home base.
OPERATING INSTRUCTIONS 11
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12 GETTING STARTED
INFORMATION DISPLAYS The following examples are LCD display screens modes.
CORE • CHECK® Thermometer LCD Display Screens Self-Test - Displays with initiation of each measurement. Inspect display to ensure all segments are operating as shown. NOTE: If this self-test display continues to flash, it indicates the battery should be replaced.
CORE - Displays with each temperature measurement.
REPLACE COVER (Replace Probe Cover) - A temperature reading was initiated without a probe cover, a used probe cover, or an improperly attached probe cover. Check lens for cleanliness, attach a new probe cover, and reinitiate the measurement.
RETURN TO BASE (Anti-Theft Feature) - A limited number of measurements can be taken until thermometer displays a continuous RETURN TO BASE message. Place thermometer into home base to reset the anti-theft feature.
RETURN TO BASE
RETURN TO BASE - Displays as a flashing message when the limit of temperature measurements have been met. Return to base to reset.
C RETURN TO BASE
Anti-theft feature has been reset. Thermometer can be used immediately.
INFORMATION DISPLAYS 13
CORE • CHECK® Thermometer LCD Display Screens (Continued) BATT LOW (Battery Low) - Battery is low and requires replacement.
c BATT LOW
REPLACE BATT (Replace Battery) - Battery must be replaced. (Figure 3). REPLACE BATT
CAL (Recalibrate Instrument) - Indicates calibration of the thermometer should be checked. (Refer to Maintenance section of this manual for information concerning calibration).
ERROR (Accompanied by a number) - Thermometer has detected an internal malfunction. Remove and reinstall battery. To perform a Self Test: Press and hold probe cover detector flush against outer case (Figure 4). While holding, press and release temperature switch once to initiate thermometer self-test to verify the display and thermometer's electronics are in working order. If error message appears again, record the number, and contact qualified service personnel. The display messages indicates the ambient (room) temperature is outside the thermometer's operating range: lo A - Ambient temperature is below 15.6°C (60°F). hi A - Ambient temperature is above 43.3°C (110°F).
The display messages indicates the patient's temperature is outside the thermometer measurement range: lo - Measured temperature is below 25°C (77°F). hi - Measured temperature is above 43.3°C (110°F).
14 INFORMATION DISPLAYS
MAINTENANCE CORE•CHECK® Thermometer Technical Service Manuals are available from ALARIS Medical Systems. They include routine service schedules, interconnect diagrams, component parts lists and descriptions, test procedures and/or references, and other technical information to assist service personnel in repair and maintenance of each instrument’s repairable components. Maintenance procedures are intended to be performed only by qualified personnel.
Specifications 25°C to 43.3°C (77°F to 110°F).
±0.1°C (± 0.2°F). Meets ASTM Specifications No. E1112-86, at ambient temperature range of 18.3 to 32.2°C (65-90°F)
Less than 3 seconds
Approximately 8,000 readings on one 9 volt alkaline battery, under normal use
7.5 x 1.5 x 3.0 inches (19.05 x 3.81 x 7.62 centimeters)
8 ounces with battery (266 grams)
Durable, impact resistant plastic
ALARIS Medical Systems®, P90 Probe Covers
15% to 90% Noncondensing
-35°C to 60°C (-32°F to 140°F)
40 measurements are available before return to base is displayed.
Batt Low, Replace Batt, Return to Base, hi A (high ambient), lo A (low ambient), lo (low temperature), hi (high temperature and numbered error messages for internal malfunctions
Measurement Range :
Thermometer Cleaning • The LCD display is tested before each measurement by lighting all of its segments for a brief period. It is recommended to inspect the display during this time to ensure all segments are operating properly. The display test ends when the temperature or “lo” is displayed. • ALARIS Medical Systems recommends the CORE•CHECK® Thermometer be calibrated every ten thousand readings or every six months, whichever comes first. The CAL message automatically flashes after ten thousand readings. • Calibration must be performed using the ALARIS Medical Systems® CORE•CHECK® Thermometer Calibrator - Model 9000. (Refer to the calibrator's operating instructions for calibration procedure). • If thermometer is dropped, inspect the lens and probe tip for damage. The lens and probe tip can be replaced without opening the instrument. (Refer to the Technical Manual for procedure). Calibrate the CORE•CHECK® Thermometer if lens replacement was required. • The CORE•CHECK® Thermometer can be cleaned with a moist cloth warm water and a mild detergent (such as dish washing liquid) or with a variety of other agents. See Figure 7 for appropriate cleaning methods and acceptable cleaning agents for the different thermometer components. • Do not immerse the CORE•CHECK® Thermometer. • Frequently check the lens for cleanliness. Incorrect readings can result from debris or fingerprints. Lens should appear clear, shiny, and unobstructed from protective probe tip.
CAUTION Do not autoclave or immerse the CORE•CHECK® Thermometer as damage will occur.
Thermometer Cleaning (Continued) If a specific cleaning agent or disinfectant is currently used, ALARIS Medical Systems recommends examining chemical ingredients prior to use on the thermometer. If an uncertain cleaning agent or disinfectant is currently being used on the instrument, call ALARIS Medical Systems. PROBE LENS (In Probe Tip): Wipe lens with a lint-free swab. If soil or debris remain, use a cotton-tip swab slightly dampened with alcohol followed with a lintfree wipe to remove any alcohol film. Allow 30 to 45 minutes for evaporation before using thermometer.
Figure 7 Cleaning of Thermometer PROBE TIP/ THERMOMETER/ DISPENSER/HOME BASE/ WALL MOUNTING BRACKET (not shown): Wipe surfaces using a cloth dampened with mild detergent or a less than 40% bleach solution. See table below for other cleaning agents.
DISPLAY SCREEN: DO NOT USE alcohol on screen. Wipe screen using a cloth dampened with a mild detergent solution or a less than 40% bleach solution. See table below for other cleaning agents.
CAUTION Only use Isopropanol Alcohol on the lens as directed. Do not use Alcohol on other parts of the system.
Bleach (<40 %)
G l u ta r a l d e h y d e
Only use a cloth dampened with one of the following cleaning agents to clean the system. Avoid contact with the lens.
Service Information NOTE: If the instrument shows evidence of damage in transit, notify the carrier’s agent immediately. Do not return damaged equipment to the factory before the carrier’s agent has authorized repairs.
If the instrument fails to respond as described in this manual and the cause cannot be determined, do not use the instrument. Contact qualified ALARIS Medical Systems® service personnel. Customer Service Information or assistance may be obtained by calling one of the following Customer Service numbers: United States UK: Phone Fax
(800) 482-4822 44 1256 388229 01256 330 860 Technical Support
Technical support, service information, applications, and manuals may be obtained by contacting an ALARIS Medical Systems® representative. United States
(800) 854-7128, extension 6003
44 1256 388229
When submitting any request for service, include: • • • • •
a description of difficulty experienced instrument settings administration set/lot number solution(s) used message displayed at time of difficulty
Product Return If it is necessary to return the instrument for service, obtain a return authorization number prior to shipment. Carefully package the instrument (preferably in the original packaging), reference the return authorization information, and return it to the appropriate service or distribution center. ALARIS Medical Systems does not assume any responsibility for loss of, or damage to, returned instruments while in transit.
INTERNATIONAL WARRANTY ALARIS Medical Systems, Inc. (hereinafter referred to as "ALARIS Medical Systems") warrants that: A.
Each new infusion instrument (pump, controller or peripheral instrument) is free from defects in material and workmanship under normal use and service for a period of two (2) years from the date of delivery by ALARIS Medical Systems to the original purchaser.
Each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of delivery by ALARIS Medical Systems to the original purchaser.
Each Mains Cable, Battery, Flow Sensor (ECD) and non-disposable probe is free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of delivery by ALARIS Medical Systems to the original purchaser.
Each new Thermometer is free from defects in material and workmanship under normal use and service for a period of one (1) year from the date of delivery by ALARIS Medical Systems to the original purchaser.
If any product requires repair during the applicable warranty period, the purchaser should communicate directly with its local ALARIS Medical Systems® service centre to determine the appropriate service facility. Except as provided otherwise in this warranty, repair or replacement will be carried out at ALARIS Medical Systems' expense. The product requiring service should be returned promptly, properly packaged, and postage prepaid by purchaser. Loss or damage in return shipment to ALARIS Medical Systems shall be at purchaser's risk. In no event shall ALARIS Medical Systems be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any ALARIS Medical Systems® product. This warranty shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and ALARIS Medical Systems shall not be responsible for, any loss or damage arising in connection with the purchase or use of any ALARIS Medical Systems® product which has been:
(B) altered in any way so as to affect, in ALARIS Medical Systems' judgement the stability or reliability of the product or has had the product's serial or lot number altered, effaced or removed; (C) subjected to misuse or negligence or accident; or (D) improperly maintained or used in any manner other than in accordance with the written instructions furnished by ALARIS Medical Systems. This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of ALARIS Medical Systems, and ALARIS Medical Systems neither assumes nor authorises any representative or other person to assume for it any other liability in connection with the sale of ALARIS Medical Systems® products. ALARIS MEDICAL SYSTEMS DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
(A) repaired by anyone other than an authorised ALARIS Medical Systems® service representative;
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ALARIS Medical Systems, Inc. 10221 Wateridge Circle San Diego, CA 92121 USA. Mail: P.O. Box 85335 San Digo, California 92186-5335 USA. Authorized EU Representative ALARIS Medical UK Ltd. The Crescent, Jays Close Basingstoke, Hampshire RG22 4BS, UK
ALARIS®, ALARIS Medical Systems®, IVAC® and CORE• CHECK® are registered trademarks of ALARIS Medical Systems, Inc. All other trademarks belong to their respective owners.
U.S. Patent Nos. 4,907,895; 6,332,090; CA Patented/Breveté Nos. 2037775; 2037940; DE D.B.P. No. 446788; GB Patent No. 446788; JP Patent Nos. 2603003 ; 2603004 . Other Patents Pending.
Copyright© 2003 ALARIS Medical Systems, Inc.
All rights reserved.