COVIDIEN 2 Tympanic Thermometer User Manual

Operating Manual

TM

Genius

2

Tympanic Thermometer and Base

Table of Contents

Operating Manual

TM

Genius

2

Tympanic Thermometer and Base

Table of Contents

Page

Section I Introduction 1

Initial Set Up 1

Section II General Information 1

Features 1

Section III Important Precautions 1

Section IV Icon Identication 2

Section V Instructions for Use 3

Peak Select System™ 3

Equivalence Modes 3

English

Probe Covers 4

Temperature Measurement 4

Temperature Recall 6

Temperature Display - Toggle 6

Sleep Mode 6

Pulse Timer Mode 6

Thermometer Display Icons and Alarms 6

Biotech Mode 7

Section VI Preventative Maintenance 8

Section VII Cleaning 8

Section VIII Battery Replacement 9

Section IX Mounting Instructions 9

Section X Troubleshooting 9

Section XI Specications 9

Section XII Customer Service 11

Section XIII Warranty 12

Section XIV Electromagnetic

Conformity Declaration 12

This product contains software solely owned by Covidien llc. Covidien llc grants the user a non-exclusive, limited license to use the
software according to the operating instructions. A copy of the license can be obtained from Covidien llc.

Tympanic Thermometer and Base

English

Section I — Introduction

This operator’s manual was prepared for the operator of the Genius™ 2 Tympanic Thermometer and Base. This manual contains
instructions for use, precautions, and available maintenance and service information. To achieve satisfactory results, the operator
must read this manual thoroughly before attempting to use the thermometer.

Initial Set Up

• Unpack the Genius 2 Tympanic Thermometer and Base and examine it for structural integrity.

• If using the wall or cart mount options (sold separately) for the base unit, consult the installation sheet provided with the
respective system.

• When rst used, the Genius 2 Tympanic Thermometer and Base will show the factory preset settings: ear mode (EAR) and the
celsius scale (°C).

Section II — General Information

The Genius 2 Tympanic Thermometer and Base is a fast, accurate, and convenient clinical instrument for measuring patient
temperatures. The Genius 2 Tympanic Thermometer and Base is an ear canal thermometer with measurement site equivalence
modes including oral, core, and rectal equivalent temperatures. The equivalence modes are explained further in Section V,
Instructions forUse.

Features

• Very fast temperature acquisition that meets CEN and ASTM standards - see Section XI.

• Peak Select System

• Temperature measurement range of 33.0°C to 42.0°C (91.4°F to 107.6°F).

• After a temperature has been acquired, the °C/°F button alternates the displayed temperature between °C and °F.

• Audible and visual indication of completed temperature acquisition.

• Disposable single use probe covers aid in the prevention of a cross contamination of infectious diseases.

• Low and dead battery indicators.

• “Sleep” mode stores the last temperature and conserves battery life.

• 15, 30, 45, and 60 second pulse timer functions.

• The thermometer housing can be wiped clean with common cleaning agents. See Section VII, Cleaning for instructions.

• Base unit protects the thermometer tip and stores probe covers for easy access.

• Easy to read LCD display with icons.

• Unit is designed for ambidextrous use.

• Improved probe design to allow ease of use on the pediatric population.

Section III — Important Precautions

• The Genius 2 Tympanic Thermometer and Base is a precision optical instrument. For reliable and trouble free operation, handle
carefully and do not drop.

• Read the operator’s manual thoroughly before using the Genius 2 Tympanic Thermometer and Base.

• Prior to use, ensure that the probe tip is clean and clear of any material. If the thermometer tip becomes soiled, gently clean with
a lens wipe or lint free swab. The tip should appear shiny and free of ngerprints and/or debris. For further cleaning instructions
refer to Section VII Cleaning.

Tympanic Thermometer and Base

1

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English

Important Precautions continued

• Always install a new probe cover prior to taking a temperature. The probe cover membrane should be smooth with no holes,
tears, or wrinkles.

• The thermometer was designed to be used only with Genius 2 Tympanic Thermometer and Base probe covers. Use of probe
covers manufactured by any company other than Covidien llc may result in erroneous readings.

• Ensure that the probe tip seals the ear canal prior to taking a temperature. Failing to seal the ear canal will result in a loss
ofaccuracy.

• When not in use, the Genius 2 Tympanic Thermometer and Base should be placed in the thermometer base unit.

• The Genius 2 Tympanic Thermometer and Base should not be used on patients with ear drainage, blood, cerebrospinal uid,
vernix, ear wax plugs, or foreign bodies in the ear canal.

• Patients with removable hearing aids should remove the device at least 10 minutes prior to ear temperature assessment.
Implanted devices generally do not aect ear temperature.

• Pressure equalization (PE) or tympanostomy tubes will not adversely aect accuracy. For patient comfort, wait one week after
surgery before using Genius 2 Tympanic Thermometer and Base.

• When assessing patient temperatures during cold weather conditions, allow the patient to equilibrate to room temperature
before use.

• Excessive eardrum scarring may cause lowered temperature readings.

• Under normal conditions, ear wax does not aect accuracy. However, cerumen plugs or impactions containing debris can lower
the temperature measurement by several tenths of a degree.

• Always wait at least two minutes before taking another measurement in the same ear.

• Used probe covers must be treated as infectious biological waste and disposed of in accordance with current medical practices
and local regulations. Removal of batteries is recommended if the unit is not going to be used for an extended period of time.

• Lithium or alkaline batteries must be disposed of in accordance with local environmental and institutional policies.

• Expired or old equipment must be disposed of in accordance with institutional policy.

• Fluid ingress may cause a reduction in battery life and interfere with unit functionality. Cleaning guidelines should be followed
as per Section VII to prevent uid entering the unit. Do not use this device near ammable anesthetics. Not suitable for use in the
presence of ammable anesthetic mixture with air, oxygen, or nitrous oxide.

Section IV — Icon Identication

Scan Button Choking Hazard Non-Sterile°C/°F Button Timer ButtonEject Button

131°F
55°C

By prescription only

Tympanic Thermometer and Base

for use

-13°F

-25°C

Temperature

limitations

2

Keep away from

sunlight

Keep dryDEHP-free Consult instructions

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0123

English

Dispose of as
Electrical and

Electronic waste

Medical Electrical Equipment

Genius 2 Tympanic Thermometer and Base
(1) Classied with respect to electrical

shock, re and mechanical hazards in
accordance with UL60601-1

(2) Classied with respect to electrical

shock, re, mechanical and other
specied hazards in accordance with
CAN/CSA C22.2 No.601.1

(Degree of protection

against electrical

shock -there is
no conductive

connection to

thepatient)

Serial number Date of manufactureManufacturer

Non-ionizing

electromagnetic

radiation

Probe cover installed Probe cover not installed

CE mark Authorized

representative in the

European Community

Catalog numberType BF Protection

Section V — Instructions for Use

Peak Select System

The Genius 2 Tympanic Thermometer and Base uses the patented Peak Select System. This system is well known from our Genius
Thermometer. It reduces technique errors by taking multiple readings and automatically selecting the most accurate temperature
for display. Whereas the Genius only used 32 readings for Peak Select, the new and improved Genius 2 Tympanic Thermometer
and Base uses 100 readings.

Equivalence Modes

Genius 2 Tympanic Thermometer and Base is an ear canal thermometer for neonates, newborns, children, andadults.

Prior to the introduction of tympanic thermometry, patient temperatures were measured in the mouth (oral), in the rectum
(rectal), or in special cases with an indwelling Swan-Ganz™* catheter (core). If a patient’s temperature was measured
simultaneously with each of these methods, dierent absolute temperatures would be obtained. The Genius 2 Tympanic
Thermometer and Base compensates for the average dierence in temperature at each of these sites by adjusting the
displayedtemperature.

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