Covidien Genius 2 Manuel utilisateur
GeniusTM 2
Tympanic Thermometer and Base
Operating Manual
Tympanic Thermometer and Base
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Table of Contents
Page
Section I Introduction 1
Initial Set Up 1
Section II General Information 1
Features 1
Section III Important Precautions 2
Section IV Icon Identication 3
Section V Instructions for Use 4
Peak Select System™ 4
Equivalence Modes 4
Probe Covers 4
Temperature Measurement 5
Temperature Recall 6
Temperature Display - Toggle 6
Sleep Mode 6
Pulse Timer Mode 6
Thermometer Display Icons and Alarms 7
Biotech Mode 8
Section VI Preventative Maintenance 9
Section VII Cleaning 9
Section VIII Battery Replacement 9
Section IX Mounting Instructions 9
Section X Troubleshooting 10
Section XI Specications 10
Section XII Customer Service 12
Section XIII Warranty 13
Section XIV Electromagnetic
Conformity Declaration 13
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.
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Tympanic Thermometer and Base 1Table of Contents
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 forUse.
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.
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Tympanic Thermometer and Base 2Table of Contents
Section III — Important Precautions
• Warning: No modication of this equipment is allowed.
• 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.
• 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
ofaccuracy.
• 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 aect ear temperature.
• Pressure equalization (PE) or tympanostomy tubes will not adversely aect 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 aect 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.
• Do not use lithium batteries with this device.
• Do not mix alkaline and rechargeable batteries.
• Removal of the batteries is recommended if the unit is not going to be used for an extended period of time.
• 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, or in an oxygen rich environment.
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Tympanic Thermometer and Base 3Table of Contents
Section IV — Icon Identication
Humidity
limitations
0%
95%
Medical Electrical Equipment
Genius 2 Tympanic Thermometer and Base
(1) Classied with respect to electrical
shock, re and mechanical hazards in
accordance with UL60601-1
(2) Classied with respect to electrical
shock, re, mechanical and other
specied hazards in accordance with
CAN/CSA C22.2 No. 60601-1-08
Probe cover installed Probe cover not installed
Serial number Date of manufactureManufacturer
0123
CE mark Authorized
representative in the
European Community
Catalog numberType BF Protection
(Degree of protection
against electrical
shock -there is no
conductive connection
to thepatient)
Non-ionizing
electromagnetic
radiation
Dispose of as
Electrical and
Electronic waste
-13°F
-25°C
131°F
55°C
Temperature
limitations
Keep away from
sunlight
Keep dryDEHP-free
Latex-free
Consult instructions
for use
By prescription only
Scan Button Choking Hazard Non-Sterile°C/°F Button Timer ButtonEject Button
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Tympanic Thermometer and Base 4Table of Contents
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, andadults.
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, dierent absolute temperatures would be obtained. The Genius 2 Tympanic
Thermometer and Base compensates for the average dierence in temperature at each of these sites by adjusting the
displayedtemperature.
A checker / calibrator is available for this device. The device should be checked if it is dropped or if it is stored at less than -25°C or
above 55°C.
“ASTM laboratory accuracy requirements in the display range of 37 to 39°C (98 to 102°F) for Infrared thermometers is ± 0.2°C (±
0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM Standards E 667-86 and E 1112-86 is
± 0.1°C (± 0.2°F).”
The following equivalence modes are available on the Genius 2 Tympanic Thermometer and Base. Data is available from
Covidien llc on request.
Ear: In ear (EAR) mode, the display will indicate the absolute temperature without adjustment.
Oral: In oral (ORL) mode, the tympanic temperature is adjusted to display an oral temperature equivalent.
Oral Mode = Ear Mode + 0.60°C.
Core: In core (CORE) mode, the tympanic temperature is adjusted to display the core temperature equivalent.
Core Mode = Ear Mode + 1.04°C.
Rectal: In rectal (REC) mode, the tympanic temperature is adjusted to display the rectal temperature equivalent.
Rectal Mode = Ear Mode + 1.16°C.
Probe Covers
The Genius 2 Tympanic Thermometer and Base utilizes a single use disposable probe cover during temperature measurement.
The probe cover was designed especially for use with the Genius 2 Tympanic Thermometer and Base. The use of probe covers
produced by any company except Covidien llc will result in erroneous temperature measurement. In order to aid in infection
prevention and control, always install a new probe cover prior to taking a temperature. The probe covers are contained in a
cassette that is located in the thermometer base. To load a probe cover on the thermometer, rmly insert the probe tip into the
probe cover. When installed on the thermometer, the probe cover membrane should be smooth with no holes, tears, or wrinkles.
After the patient temperature has been taken, eject the probe cover by pressing the eject button and then dispose of properly.
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Tympanic Thermometer and Base 5Table of Contents
Temperature Measurement
Training on the use of the Genius 2 Tympanic Thermometer and Base is important for user competence. Please follow these basic
steps below and for further information please visit www.Genius2Training.com
1. Visually inspect the patient’s ear canal. Remove the Genius 2 Tympanic Thermometer and Base from
thebase.
2. Inspect the probe lens. If any debris is present, clean the probe tip per the directions in Section VII,
Cleaning. If the probe tip is clean, proceed to step 3.
3. Press the scan button to verify functionality and mode selection on the LCD screen. Install a probe cover
by rmly inserting the probe tip into a probe cover. After the probe cover is installed, the thermometer
will perform a system reset. The thermometer will then display dashes, the equivalence mode, and the
thermometer icon.
4. Inspect the probe cover to make sure it is fully seated (no space between cover and tip base) and no
holes, tears, or wrinkles are present in the plastic lm.
5. Place the probe in the ear canal and seal the opening with the probe tip. For consistent results, ensure
that the probe shaft is aligned with the ear canal.
6. Once positioned lightly in the ear canal press and release the scan button. Wait for the triple beep
before removing thethermometer.
7. Remove the probe from the ear as soon as the triple beep isheard.
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Tympanic Thermometer and Base 6Table of Contents
8. The patient temperature and the probe eject icons will bedisplayed.
9. Press the eject button to eject the probe cover into a suitable waste receptacle.
10. Always return the thermometer to base forstorage.
Temperature Recall
After a temperature has been acquired, the thermometer will enter “o“ mode after approximately 10 seconds. The temperature
can be recalled by pressing and releasing the scan button or by pressing and holding the °C/°F button.
Temperature Display - Toggle °C or °F
When a temperature is in the display, the user may press and hold the °C/°F button to toggle between degrees Celsius and
degrees Fahrenheit.
Sleep Mode
The Genius 2 Tympanic Thermometer and Base enters sleep mode after 30-40 seconds of non-use. To wake up the thermometer,
eject the attached probe cover and/or install a new probe cover. This energy conserving function optimizes battery life.
Pulse Timer Mode
1. Press and hold the timer button to enter Timer mode. Press again to start the timer. The timer will run from 0 to 60 seconds.
2. The thermometer will issue a single beep at 15 seconds, a dual beep at 30 seconds, a triple beep at 45 seconds, and four beeps
at 60 seconds.
3. Pressing the timer button at any point during the timer function will return the thermometer to “o“ mode.
4. At the end of the 60 seconds, the thermometer will wait two seconds and then enter sleep mode.
5. Return the thermometer to base for storage.
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Thermometer Display Icons and Alarms
Thermometer operation is communicated to the user via the LCD display and an audible device contained inside the thermometer
case. After the probe cover is installed or the batteries have been changed, the thermometer will perform a system reset. The
thermometer will perform an internal test to verify that the system components are functioning properly.
Alarm Condition Display Mode
The LCD displays the low battery icon. The low battery icon will remain on until the
battery is replaced or until the dead battery icon is displayed. After the low battery
icon is displayed, the user may take approximately 100 temperatures until the dead
battery icon isdisplayed.
Dead Battery The LCD displays the dead battery condition. When any button is pressed, the
battery icon will ash several times and then the LCD will turn OFF. After the battery
icon is displayed, the batteries must be changed before the thermometer can
beused.
Low Battery
Ambient Temperature below specied range
Ambient Temperature above specied range
Patient temperature below specied range
Patient temperature above specied range
If the display shows a system error 4 and the system error icon, the ambient conditions are changing too rapidly for the device to
be used. Allow the device to equilibrate for 20 minutes before using.
If the display shows any other system error, then reset the thermometer by installing a probe cover. If the system error does not
clear, then contact the factory for available service options. The applicable manufacturer addresses are located in Section XII,
Customer Service.
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Tympanic Thermometer and Base 8Table of Contents
Biotech Mode
The biotech function is used to select the operational mode of the thermometer and to verify the installed software version. All
operational mode settings in biotech mode are stored in nonvolatile memory and retained through system power cycles, such as
changing batteries. All factory calibration parameters are also stored in nonvolatile memory.
The factory default settings are shown below:
Temperature mode °C (unlocked)
Site mode Ear
Site text On
The biotech mode is accessed by pressing and holding the timer and °C/°F buttons for four seconds. All LCD segments will light for
one second, the thermometer will issue a single beep, and the display will show scrolling dashes. Pressing the timer button cycles
through the biotech modes. When options are available within a mode, the °C/°F button cycles through the options.
Pressing the timer button after the site text display will return the user to the installed software version. To exit biotech mode,
two options are available: (1) press and hold the °C/°F and timer buttons for one second, or (2) the device will automatically exit
biotech mode after about 30 seconds of inactivity. Any changes are saved.
The biotech mode sequence is shown below:
Software version
Displays the installed software version of device. Where “00” is the current software version.
Temperature mode
°C (unlocked) Locked °C Locked °F °F (unlocked)
Site mode
Oral Core Rectal Ear
Site text
Pressing the °C/°F button when in this mode turns the body site text labels on or o. The labels will remain on when an “X” appears
inside the box icon, and the text will remain o when the box is empty.
Autres manuels pour Genius 2
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Autres manuels Covidien Thermomètre
