kENDALL GENIUS 2 Operation manual
kENDALL
GENIUS™
2
Infrared Tympanic Electronic Thermometer
Operation and Service Manual
Thermom
è
tre
é
lectronique infrarouge auriculaire
–
Manuel d
’
utilisation et d
’
entretien
’entretien’
Elektronisches Infrarot-Ohrthermometer
–
Gebrauchs- und Wartungsanweisung
Termometro elettronico timpanico a infrarossi
–
Manuale operativo e di assistenza
Termómetro timpánico electrónico infrarrojo
–
Manual de operación y servicio
Infraröd elektronisk örontermometer
–
Användar- och servicemanual
Infrarode tympane elektronische thermometer
–
Handleiding voor bediening en onderhoud
Termómetro Auricular Electrónico por Infra-Vermelhos
–
Manual de funcionamento e assistência
Tympaaninen sähkökäyttöinen infrapunalämpömittari
–
Käyttö- ja huolto-opas
Infrarødt, elektronisk, tympanisk termometer
–
Betjenings- og servicehåndbog
Ηλεκτρονικό
θερμόμετρο
υ
π
ερύθρων
τυμ
π
άνου
–
Εγχειρίδιο
λειτουργίας
και
συντήρησης
Infračervený bubínkový elektronický teploměr
–
Uživatelská a servisní příručka
Infravörös, timpanikus, elektronikus hõmérõ
–
Kezelési és karbantartási kézikönyv
Инфракрасный электронный термометр для
измерения тимпанической температуры
–
Руководство по эксплуатации и
техническому обслуживанию
Elektroniczny termometr b
ę
benkowy na podczerwie
ń
–
Instrukcja obs
ł
ugi i serwisowania
Kızılötesi Timpanik Elektronik Termometre
–
Kullanım ve Servis Kılavuzu
Infrarødt, elektronisk øretermometer
–
Bruker- og vedlikeholdshåndbok
�
�
�
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 Identification
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Section
V — Instructions for Use
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Peak Select
System
™
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Equivalence Modes
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Probe Covers
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
T
emperature Measurement
Temperature MeasurementT
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
Temperature Recall
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
Temperature Display - Toggle
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
Sleep Mode
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
Pulse Timer Mode
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
Thermometer Display Icons and Alarms
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
B
iotech Mode
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
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 — Specifications
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
Section
XII — Customer Service
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
Section XIII — Warranty
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
T
his product contains software soley owned by Tyco. Tyco grants the user a non-exclusive
, limited license to use the software according to
the operating instructions. A copy of the lic
ense can be obtained
from Tyco.
English
GENIUS
™
2
1
Infrared Tympanic Electronic Thermometer
Section I — Introduction
This operator’s manual was prepared for the operator of the GENIUS 2 Infrared Tympanic Electronic Thermometer. 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
• U
npack the GENIUS
2
Infrared Tympanic Electronic Thermomete
r
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.
• W
hen fir
st used, the GENIUS
2 Thermometer
will show the factory preset settings: ear mode (EAR) and the celsius scale (°C).
Section II — General Information
The GENIUS 2
Infrared Tympanic Electronic Thermometer
is a fast, accurate, and convenient clinical instrument for measuring patient
temperatures. The
GENIUS 2 Thermometer
is an ear canal thermometer with measurement site equivalence modes including oral,
axillary, 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
Infrared Tympanic Electronic Thermometer
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 Thermometer
.
• 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 fingerprints and/or debris.
GENIUS
™
2
2
Infrared Tympanic Electronic Thermometer
•
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 Thermometer
probe covers. Use of probe covers manufactured by
any company other than
Tyco Healthcare/Kendall
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 Thermometer
should be placed in the thermometer base unit.
•
The
GENIUS 2 Thermometer
should not be used on patients with ear drainage, blood, cerebrospinal fluid, 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 affect ear temperature.
•
Pressure equalization (PE) or tympanostomy tubes will not adversely affect accuracy. For patient comfort, wait one week
after
surgery
before using GENIUS
2 Thermometer
.
•
When assessing pat
ient 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 affect 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.
•
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.
Section IV — Icon Identification
Eject Button
European
Union’s W
aste Electrical and Electric Equipment
(WEEE) Directive in accordance with European Stand
ard
EN 50419
°
C/
°
F Button
Type BF Protection (Degree of protection against electrical
shock - there is no conductive connection to the patient)
Timer Button
Medical Electrical Equipment
GENIUS 2 Infrared Tympanic Electronic Thermometer
(1) Classified with respect to electical shock, fire and mechanical
hazards in accordance with UL60601-1
(2) Classified with respect to electrical shock, fire, mechanical and
other specified hazards in accordance with CAN/CSA C22.2 No. 601.1
Scan Button
See Acco
mpanying Choking Hazard
Documents
Documents
Documents
Documents
Documents
Documents
GENIUS
™
2
3
Infrared Tympanic Electronic Thermometer
�
The
G
ENIUS 2
Infrared
Tympanic
Electronic Thermometer
is a reliable and accurate temperature-taking device. The reason for the
accuracy of the
G
ENIUS 2 Thermometer
is the design, controlled calibration methods and stringent manufacturing controls. One
of the most critical functional parts of a thermometer is the ACCUSYSTEM
√
is the design, controlled calibration methods and stringent manufacturing controls. One
√
is the design, controlled calibration methods and stringent manufacturing controls. One
probe cover produced by
Tyco Healthcare/Kendall
. The
G
ENIUS 2 Thermometer
ACCUSYSTEM
√
of the most critical functional parts of a thermometer is the ACCUSYSTEM
√
of the most critical functional parts of a thermometer is the ACCUSYSTEM
probe cover, when placed on a
G
ENIUS 2 Thermometer
, serves as an infection control barrier
between the patient and the device and the medium for heat transmission from the patient to the thermometer. The functionality
of the
G
ENIUS 2 Thermometer
ACCUSYSTEM
√
between the patient and the device and the medium for heat transmission from the patient to the thermometer. The functionality
√
between the patient and the device and the medium for heat transmission from the patient to the thermometer. The functionality
probe cover is extremely important for preventing device contamination and also for
allowing accurate patient temperature measurements.
The reason the
G
ENIUS 2
Infrared
Tympanic
Electronic Thermometer
and
G
ENIUS 2 Thermometer
ACCUSYSTEM
√
probe covers have
satisfied our customers’ expectations is due to the integration of these two parts during the manufacturing process. The
G
ENIUS 2
Thermometer
ACCUSYSTEM
√
satisfied our customers’ expectations is due to the integration of these two parts during the manufacturing process. The
√
satisfied our customers’ expectations is due to the integration of these two parts during the manufacturing process. The
probe cover molding process parameters are tightly controlled at
Tyco Healthcare/Kendall
to minimize
variation and produce consistent and reliable products. The special grades of thermoplastic materials are also tightly controlled and
are specifically chosen to deliver consistent temperature measurements with GENIUS 2 Thermometers. The factory calibration and
final determination of an acceptable
G
ENIUS 2 Thermometer
is dependent on the use of acceptable
Tyco Healthcare/K
endall.
G
ENIUS
2 Thermometer
ACCUSYSTEM
√
final determination of an acceptable
√
final determination of an acceptable
probe covers. The use of generic probe covers or other probe covers not produced by
Tyco Healthcare/
Kendall
is not supported or sanctioned by
Tyco Healthcare/Kendall
. The use of unauthorized
G
ENIUS 2 Thermometer
probe covers
could jeopardize the accuracy of the
G
ENIUS 2 Thermometer
. Check your probe cover carton for the
ACCUSYSTEM
√
logo to be certain
that your thermometer will deliver an accurate temperature every time it is utilized.
Section V — Instructions for Use
Peak Select System
The GENIUS 2 Thermometer 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 Thermometer uses 100 readings.
Equivalence Modes
GENIUS 2
Infrared
Tympanic
Electronic Thermometer
is an ear canal thermometer for neonates**, newborns,
Electronic Thermometer is an ear canal thermometer for neonates**, newborns, Electronic Thermometer
children, and adults.
Prior to the introduction of tympanic thermometry, patient temperatures were measured in the mouth (oral), in the rectum
(rectal), under the arm (axillary), or in special cases with an indwelling Swan-Ganz™* catheter (core). If a patient’s temperature
was measured simultaneously with each of these methods, different absolute temperatures would be obtained. The GENIUS 2
Thermometer compensates for the average difference in temperature at each of these sites by
adjusting
the displayed temperature.
A field calibration checker 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.
“
AST
“AST“
M
ASTM AST
laboratory accuracy requirements in the display range of 37
to 39
laboratory accuracy requirements in the display range of 37 to 39laboratory accuracy requirements in the display range of 37
°
C (98
°C (98°
to 102
C (98 to 102C (98
°
F) for Infrared thermometers is
°F) for Infrared thermometers is °
±
0.2
°
C (
°C (°
±
C (±C (
0.4
°
F)
°F)°
,
F), 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
°C°
(
±
(±(
0.2
°
F).”
°F).”°
GENIUS
™
2
4
Infrared Tympanic Electronic Thermometer
The following equivalence modes are available on the
GENIUS 2 Infrared Tympanic
Electronic Thermometer. Data is
available from Tyco Healthcare/Kendall 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.
Axillary:
In axillary (AX) mode, the tympanic temperature is adjusted to display an axillary temperature equivalent.
Axillary Mode = Ear Mode
+
0.04°C
.
** In neonates the axillary equivalence is recommended because it is the current standard in neonates.
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 eq
uivalent.
Rectal Mode = Ear Mode + 1.16
°
C.
Probe Covers
The G
ENIUS 2 Thermometer
utilizes a single use disposable probe cover during temperature measurement. The probe cover
was designed especially for use with the G
ENIUS 2 Thermometer
. The use of probe covers produced by any company except
Tyco Healthcare/Kendall
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, firmly 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.
Temperature Measurement
1. Remove the GENIUS 2 Thermometer
from the base.
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. Install a probe cover by firmly 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 film.
GENIUS
™
2
5
Infrared Tympanic Electronic Thermometer
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. Press and release the scan button.
7. Remove the probe from the ear as soon as the triple beep is heard.
8. The patient temperature and the probe eject icons will be displayed.
9. Press the eject button to eject the probe cover.
1
0. Return the thermometer to base for storage.
Temperature Recall
After a temperature has been acquired, the thermometer will enter “off“ 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
butto
n.
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 Thermometer 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.
GENIUS
™
2
6
Infrared Tympanic Electronic Thermometer
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 “off“ 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.
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.
GENIUS
™
2
7
Infrared Tympanic Electronic Thermometer
If the display shows a
s
ystem error 4 and the system err
or icon, the ambient conditions are changing too rapidly for the d
e
vice to be
used. Allow the de
vice 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.
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.
GENIUS
™
2
8
Infrared Tympanic Electronic Thermometer
Temperature mode
Site mode
GENIUS
™
2
9
Infrared Tympanic Electronic Thermometer
Site text
Pressing the
°
C
/
°
F
button when in this mode turns the body site text labels on or off.
The labels will remain on when an “X” appears inside the box icon, and the text will remain off when the box is empty.
Section V
I — Preventative Maintenance
Functional checks
must be performed by technicians trained by Tyco
Healthcare/Kendall
and based on the procedure in the
G
ENIUS
2 Infrared
Tympanic
Electronic Thermometer
Checker Operation Manual. Contact your
Tyco Healthcare/Kendall
representative for
details.
Tyco Healthcare/Kendall
recommends functional checks at 12 month intervals. Harsh use or environmental conditions may
require reduced functional check intervals at some facilities. If the unit is dropped or abused, check the unit prior to next use.
Section V
II — Cleaning
• T
he GENIUS 2 Thermometer body may be wiped clean with a damp cloth. Water temperature should not exceed 55°C (130°F).
Do not soak, rinse, or submerge the
G
ENIUS 2 Thermometer
under water.
•
The pr
obe tip can be cleaned with a lint free swab. If the probe tip becomes soiled, it can be cleaned with a dampened swab. After
the foreign matter has been removed, the window at the end of the probe tip should be cleaned with a lint free swab or lens wipe.
The thermometer lens must be free from fingerprints and/or smudges for proper operation.
•
A mild detergent may be added to the water. Do not use cleaners such as Spray-Nine™*, Phisohex™*, Hibiclens™*, or
Vesta-Syde™* disinfectants, as they may result in damage to the thermometer case.
•
Occasional use of a 10:1 water and hypochlorite mixture or a damp isopropyl alcohol wipe or Cidex™* or ManuKlenz™* or V
IROX
™*
or
CaviWipes
™* cleansing agents
is acceptable. However, prolonged or repeated use of these chemicals may result in damage to
the thermometer case and display area.
•
Use of a cloth or sponge is recommended for cleaning. Never use an abrasive pad or an abrasive cleaner on the
G
ENIUS 2 Thermometer
.
ENIUS 2 Thermometer.ENIUS 2 Thermometer
•
The
t
hermometer is non-sterile. Do not use ethylene oxide gas, heat, autoclave, or any other harsh method to sterilize this thermometer.
•
Allow sufficient time for drying before attempting to use the thermometer.
Section VIII — Battery Replacement
The
G
ENIUS 2 Infrared
Tympanic
Electronic Thermometer
batteries should be replaced when the low battery icon is shown on the LCD
display. After the
low battery icon is displayed, the user will be able to take approximately 100 temperatures before the dead battery
icon is displayed and the unit will not allow a temperature to be taken.
To replace the batteries, access the battery compartment by
unscrewing the battery door that retains the battery cover. Note the polarity of the installed batteries. Remove the old batteries and
install fresh batteries, ensuring the correct polarity. Reinstall the battery cover and secure it with the screw.
Section IX — Mounting Instructions
If usi
ng the wall or cart mount options (sold separately) fo
r the base unit, consult the installation sheet provided with the
respective system.
GENIUS™
2
10
InfraredTympanic ElectronicThermometer
Section X — Troubleshooting
If the GENIUS 2 Infrared Tympanic Electronic Thermometer is not functioning properly, check the following items:
Symptom Action
Temperature reading unusually high Check the probe cover for tears or gaps
Temperature reading unusually low Check the probe cover and thermometer tip for obstructions.
Check the patient ear canal for obstructions.
Low battery indicator lit Replace battery
Dead battery indicator lit Replace battery
Display blank Replace battery
System error displayed If system error “4”, then let the thermometer equilibrate in the
room for 20 minutes before using. For all other system errors, reset
the thermometer by installing a probe cover. If the system error
does not clear, send the thermometer to the facility Biomedical
Engineering department or contact the factory for available service
options. The service information is located in Section XII, Customer
Service.
The GENIUS 2Thermometer advisory and alarm conditions are described in theThermometer Display Icons and Alarms subheading of
SectionV, Instructions for Use.
Section XI — Specifications
Clinical accuracy characteristics and procedures are available from the manufacturer on request. To verify accuracy, use a certified
blackbody as specified in EN 12470-5-2003, Annex C or use a Genius 2 Checker/Calibrator – order part number 303097.
Calibrated Accuracy Limits:
Ambient Temperature Target Temperature Accuracy
25°C 36.7°C to 38.9°C ± 0.1°C
(77°F) (98.1°F to 102°F) (± 0.2°F)
16°C to 33°C 33°C to 42°C ± 0.2°C
(60.8°F to 91.4°F) (91.4°F to 107.6°F) (± 0.4°F)
Calibrated Accuracy Limits (after Recalibrtion*):
Ambient Temperature Target Temperature Accuracy
16°C to 33°C 36°C to 39°C ± 0.2°C
(60.8°F to 91.4°F) (96.8°F to 102.2°F) (± 0.4°F)
16°C to 33°C less than 36°C ± 0.3°C
(60.8°F to 91.4°F) (less than 96.8°F) (± 0.5°F)
16°C to 33°C greater than 39°C ± 0.3°C
(60.8°F to 91.4°F) (greater than 102.2°F) (± 0.5°F)
*Post recalibration accuracy using the GENIUS 2 Checker/Calibrator may not necessarily be equivalent to factory calibration.
GENIUS™
2
11
InfraredTympanic ElectronicThermometer
Displayed Temperature Measurement Range:
Temperature Range Depends On Site Mode as follows:
Mode Range °C Range °F
Ear 33.0 to 42.0 91.4 to 107.6
Oral 33.6 to 42.0 92.5 to 107.6
Axillary 33.0 to 42.0 91.4 to 107.6
Core 34.0 to 42.0 93.2 to 107.6
Rectal 34.2 to 42.0 93.6 to 107.6
Ambient Temperature Range:
16°C to 33°C (60.8°F to 91.4°F) where as CEN defines the standard as 16°C to 35°C (60.8°F to 95°F), 10 to 95%RH, non-condensing
Storage Temperature Range:
-25°C to 55°C (-13°F to 131°F), up to 95% RH non-condensing. If the unit is stored at extremes, it is recommended that the unit be
checked on the field calibration checker or at the factory before returning to service.
Clinical Repeatability:
Meets Section A.5 of EN 12470-5: 2003 (E) per Tyco Healthcare/Kendall technical report. Data is available from
Tyco Healthcare/Kendall on request.
Response Time:
Less than 2 seconds
Pulse Timer:
60 seconds
Temperature Resolution:
0.1°C or 0.1°F
Power:
3 AAA alkaline batteries
Battery Life:
Minimum of 15,000 temperature readings
Size:
Thermometer — 17.8 cm (7”)
Base — 20.3 cm (8”)
Weight:
Thermometer (with batteries) — 160 grams
Base — 100 grams
GENIUS™
2
12
InfraredTympanic ElectronicThermometer
Regulatory and Safety standards:
The GENIUS 2Thermometer follows international regulatory standards.
• EN 12470-5:2003 (E) Clinical Thermometers – Part 5: Performance of infrared ear thermometers where sections
6.3.4 and 6.5.5 were met based on Tyco Healthcare/Kendall technical report. Data is available from Tyco Healthcare/Kendall on
request.
• UL 60601-1 • EN 60601-1
• EN 60601-1-2 • MDD 93/42/EEC
• BS EN 980: 2003 • ASTM E1965-98
• IEC 1000-4-2: 1995 • IEC 1000-4-3:1995
The device meets EN12470-5:2003 (E) and ASTM E1965-98 subject to the following conditions:
1. The software was modified during testing to increase the precision of the measurements taken from one significant digit to two
significant digits.
2. The increased precision numbers were then averaged to account for the known variance in measurements taken due to human
factors.
Section XII — Customer Service
Tyco Healthcare/Kendall will make available on request circuit diagrams, component part lists, descriptions, or other information to
assist qualified institutional technical personnel in repairing parts of this device designated by Tyco Healthcare/Kendall as repairable.
In the event that it is necessary to return a unit for repair, please observe the following:
1. Contact Tyco Healthcare/Kendall as shown below for an Authorized Return Number and shipping instructions.
2. Ship insured parcel to your local service contact or the appropriate location below.
United States Canada Outside US & Canada
Tyco Healthcare Group LP Tyco Healthcare Canada Tyco Healthcare Group LP
98.6 Faichney Drive 7300 Trans Canada Highway Unit 2 Talisman Business Center, London Road
Watertown, NY 13601 Pointe-Claire, QC Bicester, OX266HR, UK
1-800-448-0190 or H9R 1C7 +44-1869-328065
(315) 788-5246 1-877-664-8926 or
(514) 698-1220
GENIUS™
2
13
InfraredTympanic ElectronicThermometer
Parts Listing
To order repair parts, please contact your local customer service center or sales representative for the parts listed below.
Description Order Part Number
GENIUS2ThermometerwithBase..............................................................................303000
GENIUS2ProbeCover.........................................................................................303030
GENIUS 2 Field Checker/Calibrator..............................................................................303097
GENIUS2ReplacementBase................................................................................F31949WT
GENIUS2ReplacementCoilCord.............................................................................F31950WT
GENIUS2ReplacementBatteryDoor.........................................................................F31951WT
GENIUS 2 Locking Mount for Wall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .303058
GENIUS 2 Cart with Locking Mount..............................................................................303059
Section XIII — Warranty
LIMITED WARRANTY: Kendall, a Tyco Healthcare Group LP company, warrants to the original purchaser (“Customer”) that this
product will be free of defects in materials and workmanship, under normal use, for one (1) year from the date of original purchase
from Tyco Healthcare/Kendall or its authorized distributor. If this product does not operate as warranted above during the applicable
warranty period, Tyco Healthcare/Kendall may, at its option and expense, replace the defective part or product, or, if neither
replacement nor repair is reasonably available, refund to Customer the purchase price for the defective part or product. Dated proof
of original purchase will be required.
Tyco Healthcare/Kendall does not assume any liability for loss arising from unauthorized repair, misuse, neglect, or accident.
Removal, defacement, or alteration of serial lot number voids warranty. Tyco Healthcare/Kendall disclaims all other warranties,
expressed or implied, including any implied warranty of merchantability or fitness for a particular purpose or application other than
expressly set forth in the product labeling.
™Trademark of Tyco Healthcare Group LP or its affiliate.
™*CAVI WIPES is a trademark of Metrex Research Corporation
™*CIDEX is a trademark of Johnson & Johnson
™*HIBICLENS is a trademark of Regent Medical Limited
™*MANU-KLENZ is a trademark of Steris Inc.
™*PHISOHEX is a trademark of The Mentholatum Company
™*SPRAY NINE is a trademark of Spray Nine Corporation
™*SWAN-GANZ is a trademark of Edwards Lifesciences Corporation
™*VESTA-SYDE is a trademark of Steris Inc.
™*VIROX is a trademark of Virox Technologies, Inc.
This product is covered by one or more U.S. Patents: 6,179,785; 7,108,419; 7,237,949; 7,354,194; 7,140,764; 7,434,991;
7,478,946; 7,507,019; 7,520,671; 7,536,568; Patents Pending.
TYCO HEALTHCARE GROUP LP • 15 HAMPSHIRE ST. • MANSFIELD, MA 02048 • MADE IN CHINA • © 2009 TYCO HEALTHCARE
GROUP LP • ALL RIGHTS RESERVED • 090730 • PRODUCT INFO IN U.S. 1-800-962-9888 • www.tycohealthcare.com
TYCO HEALTHCARE U.K. LTD • GOSPORT, PO13 0AS, U.K.
SMF0509-005
kENDALL
Norwegian
GENIUS™ 2
English
JOB NO.................................................................................................................15125
ARTWORK NO............................................................................................... 182500-04
PACKAGE TYPE.............................................................................................CD interface
SIZE.................................................................................................................8.5” x 11”
PRINTED.............................................................................................................. 1 SIDE
INK COLOR................................................................................. PMS 2945 BLUE/BLACK
BAR CODE INK COLOR................................................................................................N/A
kENDALL
GENIUS™
2
Infrared Tympanic Electronic Thermometer
Operation and Service Manual
Thermomètre électronique infrarouge auriculaire
– Manuel d’utilisation et d’entretien
Elektronisches Infrarot-Ohrthermometer
– Gebrauchs- und Wartungsanweisung
Termometro elettronico timpanico a infrarossi
– Manuale operativo e di assistenza
Termómetro timpánico electrónico infrarrojo
– Manual de operación y servicio
Infraröd elektronisk örontermometer
– Användar- och servicemanual
Infrarode tympane elektronische thermometer
– Handleiding voor bediening en onderhoud
Termómetro Auricular Electrónico por Infra-Vermelhos
– Manual de funcionamento e assistência
Tympaaninen sähkökäyttöinen infrapunalämpömittari
– Käyttö- ja huolto-opas
Infrarødt, elektronisk, tympanisk termometer
– Betjenings- og servicehåndbog
Ηλεκτρονικό θερμόμετρο υπερύθρων τυμπάνου
– Εγχειρίδιο λειτουργίας και συντήρησης
Infračervený bubínkový elektronický teploměr
– Uživatelská a servisní příručka
Infravörös, timpanikus, elektronikus hõmérõ
– Kezelési és karbantartási kézikönyv
Инфракрасный электронный термометр для
измерения тимпанической температуры
– Руководство по эксплуатации и
техническому обслуживанию
Elektroniczny termometr bębenkowy na podczerwień
– Instrukcja obsługi i serwisowania
Kızılötesi Timpanik Elektronik Termometre
– Kullanım ve Servis Kılavuzu
Infrarødt, elektronisk øretermometer
– Bruker- og vedlikeholdshåndbok
™
0123
ºF
C
º
™
GENIUS
™
Table of contents
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