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
�



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
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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
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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).”°