Alaris Tri-Site Thermometer Directions for Use

GENERAL CONTACT INFORMATION Cardinal Health Alaris® Products 10221 Wateridge Circle

San Diego, California 92121

Customer Advocacy - North America Clinical and technical feedback. Phone: 800.854.7128, Ext. 7812 E-Mail: [email protected]

Technical Support - North America Maintenance and service information support; troubleshooting. United States: Phone: 858.458.6003 800.854.7128, Ext. 6003

Canada: Phone: Eastern: 800.908.9918 Western: 800.908.9919

Customer Care - North America Instrument return, service assistance, and order placement. United States: Phone: 800.482.4822

Canada: Phone: 800.387.8309

TABLE OF CONTENTS INTRODUCTION ABOUT THE THERMOMETER... FEATURES AND DEFINITIONS... SYMBOLS... FEATURE SUMMARY...

1 2 3 4

GETTING STARTED WARNINGS AND CAUTIONS... General... OPERATING FEATURES, CONTROLS AND INDICATORS... THERMOMETER ACCURACY... INSTALLATION PROCEDURE... Unpacking Thermometer... Set-Up Procedure... ANTI-THEFT FEATURE... GENERAL SET-UP AND USE... Installing and Ejecting Probe Covers... Fast Oral Temperature Measurement... Fast Axillary Temperature Measurement... Fast Rectal Temperature Measurement... Continuous Method Operating Instructions... Change Mode Operating Instructions... RECALL PREDICTED TEMPERATURE... CHANGE TEMPERATURE SCALE FROM F° TO C°... PULSE TIMER OPERATION... INFORMATION DISPLAY...

5 5 8 10 11 11 11 13 13 14 15 17 18 18 19 19 20 20 21

ALARMS, ERRORS, MESSAGES CUSTOMER ERROR MESSAGES- PROBLEMS AND SOLUTIONS... BIOMED MESSAGES- PROBLEMS AND SOLUTIONS...

23 25

MAINTENANCE SPECIFICATIONS... Performance Specifications... Environmental Specifications... CONFIGURABLE SETTINGS AND DEFAULTS... Settings and Defaults... Modifying Configurable Settings... CLEANING... Cleaning Thermometer Buttons... INSPECTION REQUIREMENTS... CALIBRATION SELF-CHECK... BATTERY DISPOSAL... LCD DISPLAY TEST... SERVICE INFORMATION... Technical Support... Product Return... WARRANTY...

27 27 28 28 28 28 29 30 31 32 32 33 34 34 34 35

REGULATIONS AND STANDARDS TRADEMARKS... COMPLIANCE... EMC COMPLIANCE...

37 37 38

APPENDIX ACCESSORIES...

Alaris® Tri-Site Thermometer Directions for Use

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Alaris® Tri-Site Thermometer Directions for Use

INTRODUCTION

The Alaris® Tri-Site Thermometer is a simple to use, clinical electronic thermometer to be used by healthcare professionals to provide temperatures in either predictive or continuous modes. The Alaris® Tri-Site Thermometer is intended for use in clinical environments to measure temperatures in three body sites: oral, rectal and axillary. Fast temperatures (predictive) can be obtained quickly, depending on patient condition. The Continuous Method displays direct temperature readings and reaches a stabilized temperature in approximately three to five minutes, depending on body site. The Alaris® Tri-Site Thermometer is appropriate for use on adults and children of all ages.

WARNING Read all instructions for the Alaris® Tri-Site Thermometer before using the thermometer.

The Alaris® Tri-Site Thermometer is available in six models and uses only P850A Disposable Probe Covers. Each of the following provides an anti-theft feature with either a wallmounted or portable home base: • Single oral probe (blue) for oral and axillary use • Single rectal probe (red) for rectal use • Dual oral and rectal probes (blue and red) for oral, axillary and rectal use Accessories for the Alaris® Tri-Site Thermometer include an optional carrying strap and portable stand.

Alaris® Tri-Site Thermometer Directions for Use

INTRODUCTION 1

INTRODUCTION

About the Thermometer

Features and Definitions Body Site

One of three body areas where this thermometer can take a temperature: • Oral - the sublingual pocket underneath the tongue at the back of the mouth. • Rectal - Inside the rectum per hospital protocol. • Axillary- Deep in the armpit, with the probe pointed upward toward the shoulder.

Continuous Method

Thermometer takes temperature continuously without prediction. Time to reach steady state will vary depending on body site.

Fast (Predictive) Method

Thermometer takes multiple readings/second and calculates temperature according to a body-site related formula.

Mode

This is a combination of temperature method (fast v. continuous) and the body site chosen. For example, "fast oral" is a mode. Default modes are set by the facility for each thermometer according to its most frequent use; in order to change the mode, press the MODE button until the desired mode appears on the screen BEFORE removing the appropriate probe from its well. As a safety measure, the mode and the removed probe must match. If not, the mode will default to the appropriate mode for the chosen probe.

Probe

The long object used to take a temperature. The most accurate temperatures will be taken when the tip is in firm contact with the tissue at the body site. Holding the probe like a pen or pencil - without covering the top of probe - will allow easy application/ejection of the probe cover and will lengthen the life of the probe.

Probe Cover

The disposable thin plastic cover used to prevent cross contamination when taking temperatures. A probe cover must be attached to the probe before any temperature measurement is taken. After taking a temperature, simply press the button on the top of the probe to eject the used cover into an appropriate container/receptacle.

Recall

This feature allows the clinician to bring the last fast temperature recorded to the screen.

Temp Scale

The Alaris® Tri-Site Thermometer has the option of choosing either Celsius (Centigrade) or Fahrenheit measurements. Press the button marked F° C°/Recall to choose the appropriate measurement scale.

Well

Each probe rests in a holder called a "well." The oral/axillary (blue) probe should be placed in the blue well, and the rectal (red) probe should be placed in the red well. Once the probe is removed from its well, the thermometer is activated.

2 INTRODUCTION

Alaris® Tri-Site Thermometer Directions for Use

Symbols

75

Consult operating instructions.

Type BF Applied part.

IPX0

This device is not water resistant.

Manufacturing Date: Number adjacent to symbol indicates month and year of manufacture. MM-YYYY

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Alaris® Tri-Site Thermometer Directions for Use

INTRODUCTION 3

INTRODUCTION

+

Canadian and U.S. Certification Mark: Products bearing this mark have been tested and certified in accordance with applicable U.S. and Canadian electrical safety and performance standards.

Feature Summary The Alaris® Tri-Site Thermometer is capable of taking fast, accurate temperatures. Its many features include: • Large digital display panel with automatic backlight • User selectable thermometry mode and temperature scale in (C)Celsius or (F)Fahrenheit • Configurable defaults for mode and temperature scale • Recall function displays last reading in Fast Modes. • Sixty second countdown timer which can be used for timing pulse, respiration rates, etc. Audible tones at fifteen, thirty, and sixty seconds • Tissue contact indicator (Fast Modes only) • Broken probe indicator • Automatic 45 second sleep mode to conserve battery power. Simple push of mode button reactivates instrument • Portable units include carrying strap; wall mount units include security screws for permanent mounting • Home base for storage and theft protection • Internal timer to deter theft • Rugged design and construction utilizing advanced microprocessor technology • Uses Alaris® product P850A disposable probe covers • Audible tone signals final temperature reading (Fast Mode only) • Visual and audio indications signal the switch to Continuous Mode when a Fast Mode temperature cannot be achieved

4 INTRODUCTION

Alaris® Tri-Site Thermometer Directions for Use

GETTING STARTED Warnings and Cautions Warnings and Cautions throughout this Directions for Use (DFU) provide information needed to safely and effectively use the Alaris® Tri-Site Thermometer and accessories. Read all Alaris® Tri-Site Thermometer instructions prior to use.

Only

GETTING STARTED

A WARNING is an alert to a potential hazard which could result in serious personal injury and/or product damage if proper procedures are not followed. A CAUTION is an alert to a potential hazard which could result in minor personal injury and/or product damage if proper procedures are not followed. General WARNINGS • Temperature readings can be affected by high and low ambient environmental conditions and extreme patient conditions. • The Alaris® Tri-Site Thermometer is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. • If uncertain about the accuracy of any measurement, assess patient’s condition and temperature by alternate means. • Hold the probe still and in the correct position to ensure an accurate measurement. • Patient movement during temperature procedure may cause injury to the patient. • DO NOT use the Alaris® Tri-Site Thermometer without a probe cover. • Use only Alaris® product P850A probe covers with the Alaris® Tri-Site Thermometer. Use of any probe cover other than those specified may produce temperature errors and may invalidate the instrument’s specifications and warranty. • The Alaris® Tri-Site Thermometer probe covers are designed for single patient use, and are not to be reprocessed. Do not attempt to disinfect or reuse probe covers as damage or cross-contamination may occur.

Alaris® Tri-Site Thermometer Directions for Use

GETTING STARTED 5

Warnings and Cautions (Continued) General (Continued) WARNINGS • Do not use this instrument for any purpose other than is specified in these instructions. • Oral probes (blue) are to be used for taking oral and axillary temperatures only. Rectal probes (red) are to be used for taking rectal temperatures only. The use of the wrong probe will produce temperature errors and is unsanitary. • Inspect thermometer and accessories before use. Do not use any thermometer or accessory that appears damaged. • Do not lift the Alaris® Tri-Site Thermometer by the probes because they may disconnect from the device, causing it to drop onto the patient. Do not place the Alaris® Tri-Site Thermometer in any position that may cause it to fall on the patient. • Carefully locate the probe cord to reduce the possibility of patient entanglement or strangulation. • This device is for authorized use only. Do not leave unattended. Keep out of reach of patient when not in use. • Dispose of used batteries in accordance with local regulations. • Do not use the Alaris® Tri-Site Thermometer in or near any Magnetic Resonance Imaging (MRI) equipment. • Do not use the Alaris® Tri-Site Thermometer within a hyperbaric chamber. • Do not use the Alaris® Tri-Site Thermometer if it fails to perform as indicated. Contact qualified service personnel. • Do not open the device case. There are no user serviceable parts inside. The device case should only be opened by qualified service personnel using proper grounding techniques. The rear tray case should only be opened to replace batteries.

6 GETTING STARTED

Alaris® Tri-Site Thermometer Directions for Use

Warnings and Cautions (Continued) General (Continued) WARNINGS • Dropping/Jarring

GETTING STARTED

Should a device be dropped or severely jarred, it should be immediately taken out of use and inspected by qualified service personnel, to ensure its proper function prior to reuse.

• Operating Environment Do not use in the presence of flammable gases, anesthetics or liquids.

• Radio Frequency Interference Operating the system near equipment which radiates high energy electromagnetic radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular telephones, etc.) may cause incorrect readings. If this happens, reposition the device away from the source of interference or turn off the device and manually monitor the vital parameters using an appropriate clinical alternative. This device is compliant to the EMC Standard IEC 606011-2. In Accordance with this Standard, tables are being provided to describe the compliance. See Guidance and Manufacturer’s Declaration tables in the Regulations and Standards section of this Directions for Use.

Alaris® Tri-Site Thermometer Directions for Use

GETTING STARTED 7

Operating Features, Controls and Indicators Front View Probe Ejection Button

Probe Storage Well

Display

MODE

PULSE TIMER

Pulse Timer Button

Mode Button F

F°

O

O

C

RECALL

C°/Recall Button

Probe Probe Cover

8 GETTING STARTED

Alaris® Tri-Site Thermometer Directions for Use

Operating Features, Controls and Indicators (Continued) Rear View

GETTING STARTED

Press here to remove

Alaris® Tri-Site Thermometer Directions for Use

GETTING STARTED 9

Thermometer Accuracy NOTE: If the probe tip temperature is less than 16°C (60.8°F) or higher than 33.3°C (92°F) when taken out of the probe well, the thermometer will not be able to quickly predict the patient's temperature. With an audio tone and visual indication, the device will enter the Continuous Method for the selected site.

WARNING If uncertain about the accuracy of any measurement, assess patient’s condition and vital signs by alternate means.

The Alaris® Tri-Site Thermometer is built to exacting standards and is designed to provide accurate temperature measurement when used in accordance with the manufacturer’s use and care instructions in this DFU. Some situations may cause inaccurate measurement or loss of signal to the thermometer. These situations include but are not limited to: Inaccurate measurement: • • • • • • • • •

Incorrect probe and probe cover application or use. Probe is disconnected or not securely connected. Placement too close to electrosurgical equipment. Inappropriate probe cover. Incorrect placement in body site. Incorrect mode selected. Premature ejection of probe cover. Patient biting on probe or probe cover during use. Operation outside of the related temperature and humidity range. • Storage outside of the rated temperature and humidity range. • The patient’s temperature is below the ambient temperature. Loss of a temperature signal: • • • •

Incorrect probe and probe cover application or use. Probe is disconnected or not securely connected. Loss of tissue contact. Placement too close to electrosurgical equipment.

• Excessive patient movement.

10 GETTING STARTED

Alaris® Tri-Site Thermometer Directions for Use

Installation Procedure Thermometers are tested before they are packaged for shipment. To ensure proper operation after shipment, it is recommended that an incoming inspection is performed before putting the device into use. Unpacking Thermometer Remove product from its carton.

2.

Check thermometer, probe(s), and accessories for sharp edges, damage, excessive wear or any other defects prior to use.

GETTING STARTED

1.

If the product or parts are damaged, do not use and contact Cardinal Health for return authorization.

Set-Up Procedure 1.

2.

3.

Using the adhesive mounting tape attached to the back of the dispenser, or the screws supplied, attach the Probe Cover Dispenser Bracket (Model 896) to a convenient location and install a box of 200 probe covers. Attach the home base to a convenient location using either the adhesive tape or screws supplied with the device. The home base may be attached to either a horizontal or vertical surface.

WARNING Do not use in the presence of flammable gases, anesthetics or liquids.

WARNING Dispose of used batteries in accordance with local regulations.

Install three (3) size AA batteries and install cover. NOTES: • Batteries must be installed exactly as shown on the battery compartment or the device will not function. Install negative end of battery first to prevent damage to the battery contacts. To open battery compartment, press one side of battery cover until latch releases, then press other side.

CAUTION Remove batteries if thermometer is to be taken out of use for an extended period.

• Whenever batteries are replaced, the device will perform a self-test routine of the device hardware. Should the device fail its self-test, an error code number will appear in the display. Refer to the Calibration Self-Test and Service Information sections of this manual for further information. At the end of the self-test routine, the device will emit beeps continuously and display RETURN TO BASE. The Alaris® Tri-Site Thermometer must be returned to the home base to reset the anti-theft timer whenever batteries are replaced. • Batteries must be replaced as a set. Do not mix old and new batteries. Alaris® Tri-Site Thermometer Directions for Use

GETTING STARTED 11

Installation Procedure (Continued) Set-Up Procedure (Continued) 4.

Insert the connector(s) on the probe cord(s) (oral/axillary and/or rectal) into the appropriate connector sockets on the back of the thermometer, and route the probe cord through the cord guide channel along the back of the thermometer. Insert the probe(s) into the probe storage well(s) at the top of the device. Ensure the oral/axillary (blue) probe plug is connected to the #2 socket and/or the rectal (red) probe is connected to #1 socket.

5.

a. Set-up procedure - Portable Models Only - Attach carrying strap to thermometer. Place the thermometer in the home base to activate. Always store the device in the home base when not in use. NOTES:

CAUTION Do not use any kind of extender cables between oral/axillary or rectal probe cables and device as this will cause inaccurate readings.

• Inspect the strap and connection to thermometer prior to use. Do not use a strap that is defective. • To avoid injury, ensure the thermometer does not swing, drop onto or entangle the patient by the strap. • To avoid damage to other medical equipment, do not swing device by carrying strap.

CAUTION Device will not operate if probes are misconnected.

b. Attach wall mount home base to wall. c. Set-up procedure - Wall Mounted Models Only Remove the two hex drive screws on both sides of the home base using the tool provided. Place the thermometer in the home base to activate. Tighten the screws.

12 GETTING STARTED

Alaris® Tri-Site Thermometer Directions for Use

Anti-Theft Feature

GETTING STARTED

The Alaris® Tri-Site Thermometer comes equipped with antitheft timer and alarm. The anti-theft timer and alarm are reset by returning the thermometer to the home base. When the anti-theft timer is configured for eight hour operation (FACTORY DEFAULT), the RETURN TO BASE message will be displayed approximately one hour before the eight hour timer interval expires. When the anti-theft timer is configured for one hour operation, the RETURN TO BASE message will be displayed approximately ten minutes before the one hour timer interval expires. When the anti-theft timer interval expires the device will alarm, the message RETURN TO BASE will flash and the unit will cease to function until it is reset by returning it to the home base.

General Set-Up and Use To begin use of thermometer: 1.

Install a box of 20 probe covers in the storage compartment at the rear of the device. • Make certain the box fits behind probe cords and does not interfere with the cords.

2.

Factory defaults are Fast Oral and scale in F°. If needed, set thermometer mode and/or scale to other than default. NOTE: Using incorrect mode will result in incorrect reading.

3.

With your thumb and forefinger, grasp the base of a probe and withdraw it from the probe storage well. NOTE: Withdrawing the probe from the probe storage well automatically turns the device on.

4.

Verify that all display segments except the pulse timer clock momentarily appear and that the device beeps once.

CAUTION The probes should be stored in their wells when not being used.

• When this sequence is complete, the device will display advancing dashes (Fast Mode) or Lo (Continuous Mode) indicating the device is ready for use. 5.

Install probe cover.

Alaris® Tri-Site Thermometer Directions for Use

GETTING STARTED 13

General Set-Up and Use (Continued) Installing and Ejecting Probe Covers To install a probe cover: Insert the probe completely and firmly into a new probe cover to ensure a secure fit. Failure to firmly install the probe cover may result in the probe cover becoming loose or disengaging during use which will affect the accuracy of the temperature reading. • Be careful not to press the probe ejection button (where the cord exits the probe) as this might loosen or eject the probe cover and damage the probe. • To avoid contamination, do not remove the probe covers from the probe cover box. • Inspect probe covers before use; do not use probe covers that appear dirty or contaminated.

To eject probe cover: Hold the probe as shown and press the probe ejection button at the base of the probe to eject the used probe cover into an appropriate waste container.

14 GETTING STARTED

CAUTION ®

Use only Alaris product P850A Probe ® Covers with the Alaris Tri-Site Thermometer. Inaccurate readings will ® occur unless Alaris product P850A probe covers are used. The Alaris® TriSite Thermometer probe covers are designed for single patient use, and are not to be reprocessed. Do not attempt to disinfect or reuse probe covers as cross-contamination may occur.

WARNING Unintended ejection of probe cover may cause patient injury.

Alaris® Tri-Site Thermometer Directions for Use

General Set-Up and Use (Continued) Fast Oral Temperature Measurement For oral temperature measurement use the blue, oral/axillary probe. Before removing probe from well, initially press the MODE button for one second, then toggle until the Fast Oral mode appears on screen.

2.

Install probe cover.

3.

Holding the probe loosely, place the probe tip deep into the sublingual pocket where the richest blood supply is located.

If the probe is not placed within the sublingual pocket, inaccurate readings may result.

GETTING STARTED

1.

CAUTION

NOTES: • Temperatures in the mouth can vary as much as 3°F from the relatively cool hard palate to the warm sublingual area. To take an accurate oral temperature reading, place the thermometer tip in either the right or left posterior pocket (heat pocket) at the base of the tongue. • With an audio tone and visual indication, the device will enter the Continuous Method for the selected site under the following conditions: i Ambient temperature is less than 60.8°F or greater

than 92.0°F i Patient’s predicted temperature is below 95.0°F or

above 106.0°F i Improper technique or inconsistent tissue contact i Over one minute between probe removal from well

and tissue contact

Hold the probe steady during the entire temperature measurement process keeping the probe tip in contact with tissue at all times. Do not allow patient to reposition or hold the probe.

Alaris® Tri-Site Thermometer Directions for Use

GETTING STARTED 15

General Set-Up and Use (Continued) Fast Oral Temperature Measurement (Continued) 4.

Once patient tissue contact is established, the rotating pinwheel will appear indicating the measurement is in progress. Three audible tones indicate that the measurement is complete, and the patient's temperature will appear on the display panel. The display will clear as the probe is returned to the storage well.

5.

Observe the temperature, remove the probe from the patient’s mouth and eject probe cover. Be sure to discard used probe cover according to health care facility protocol.

6.

Return the oral (blue) probe to the blue probe storage well. This will automatically reset the thermometer for the next temperature.

7.

To recall the last fast temperature reading, press the C°/RECALL button. DO NOT withdraw the probe F° from the well as this will cause the memory to be erased.

16 GETTING STARTED

Alaris® Tri-Site Thermometer Directions for Use