IVAC CORE CHECK Model 2090 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

GETTING STARTED

WARNINGS AND CAUTIONS... Definitions... Warnings... Cautions... INSTRUMENT FEATURES... SETUP PROCEDURE...

INTRODUCTION

ABOUT THE SYSTEM... FEATURE SUMMARY... Thermometer Features... DEFINITIONS...

INFORMATION DISPLAYS CORE•CHECK® THERMOMETER LCD DISPLAY SCREENS...

13

SPECIFICATIONS...

15

THERMOMETER CLEANING...

16

SERVICE INFORMATION... Customer Service... Technical Support...

18 18 18

Product Return... WARRANTY...

18 19

OPERATING INSTRUCTIONS

MAINTENANCE

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.

INTRODUCTION 1

Feature Summary Thermometer Features

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• 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.

2 INTRODUCTION

IVAC

DISPOSABLE PROBE COVERS Reduce the risk of crosscontamination and easily loads onto thermometer probe tip.

Definitions

USE ONLY 9V ALKALINE

INTRODUCTION

ENSURE LENS IS CLEAN BEFORE USE

Cleaning Advisory.

Alkaline battery used.

Anti-Theft notification.

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.

Infrared Energy

Relating to the range of invisible radiation wavelengths from 750 nanometers. Generating, using, or sensitive to infrared radiation.

Molecular Activity

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.

Tympanic Membrane

The membrane in the ear that vibrates to sound.

Conformance to the Medical Device Directive 93/42/EEC

MM-YYYY

Manufactured Date; expressed in four digits as the year and two digits as the month. Attention: Refer to accompanying documentation.

IPX1

Indicates degree of protection, fluid ingress. INTRODUCTION 3

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4 INTRODUCTION

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

Instrument Features

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.

IVAC

TEMPERATURE SWITCH Initiates temperature measurement.

GREEN INDICATOR LIGHT Flashes once to indicate temperature measurement is complete.

BATTERY COMPARTMENT

Figure 2 Probe Cover Dispenser THERMOMETER RECEPTACLE SLIDER PROBE COVER LEVEL INDICATOR

6 GETTING STARTED

DOOR

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

GETTING STARTED

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).

Quick Guide

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

Battery Cover

Figure 4 Probe Cover Detector

Press

Figure 5

CORE

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

OPERATING INSTRUCTIONS

• 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

CAUTION

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.

OPERATING INSTRUCTIONS

• 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.

CORE

C

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.

REPLACE COVER

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

CORE

INFORMATION DISPLAYS

CORE

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.

CORE

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).

CORE

c CAL

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

ERROR

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).

Accuracy:

±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)

Response Time:

Less than 3 seconds

Battery:

Approximately 8,000 readings on one 9 volt alkaline battery, under normal use

Size:

7.5 x 1.5 x 3.0 inches (19.05 x 3.81 x 7.62 centimeters)

Weight:

8 ounces with battery (266 grams)

Case Material:

Durable, impact resistant plastic

Disposable:

ALARIS Medical Systems®, P90 Probe Covers

Humidity:

15% to 90% Noncondensing

Storage Temperature:

-35°C to 60°C (-32°F to 140°F)

Anti-Theft Feature:

40 measurements are available before return to base is displayed.

Display Messages:

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

MAINTENANCE

Measurement Range :

MAINTENANCE

15

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.

16 MAINTENANCE

CAUTION Do not autoclave or immerse the CORE•CHECK® Thermometer as damage will occur.