Covidien Genius 2 Tympanic Ear Thermometer Manual

INSTRUCTION MANUAL

Genius 2 Tympanic Ear Thermometer

Tympanic Thermometer and Base

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.

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 first 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

Warning: No modification 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 fingerprints 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 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 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 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 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.
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 fluid entering the unit.
Do not use this device near flammable anesthetics. Not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide, or in an oxygen rich environment.

Section IV — Icon Identification

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, different absolute temperatures would be obtained. The Genius™ 2 Tympanic Thermometer and Base compensates for the average difference in temperature at each of these sites by adjusting the displayed temperature.
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, 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

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

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 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

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.
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.
Pressing the timer button at any point during the timer function will return the thermometer to “off“ mode.
At the end of the 60 seconds, the thermometer will wait two seconds and then enter sleep mode.
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.

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.

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.

Default Settings

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

Section VI — Preventative Maintenance

Functional checks must be performed by technicians trained by Covidien and based on the procedure in the Genius™ 2 Thermometer Checker/Calibrator Operation Manual. The device must be checked for calibration every 25 weeks or whenever calibration is in question. Contact your Covidien representative for details. Harsh use or harsh environmental conditions may result in the need for more frequent checks. If the unit is dropped, abused, or stored at less than -25°C, or above 55°C, check the unit prior to next use.

Section VII — Cleaning

The Genius™ 2 Tympanic Thermometer and Base body may be wiped clean with a damp cloth. Water temperature should not exceed 55° C (130°F). Do not soak, rinse, spray or submerge the Genius™ 2 Tympanic Thermometer and Base. When cleaning the thermometer body a probe cover should be installed on the thermometer. This will prevent harsh chemicals from damaging the tip and probe lens.
A mild detergent or detergent wipe may be used for cleaning purposes. Do not use cleaners such as Spray-Nine™, Phisohex™, Hibiclens™, Vesta-Syde™ , Anios DDSH™, Sufanios Citroen™, Perasafe powder™, Sekusept Pulver, Classic™, Sekulyse™, Diesin HG™, Incides N™, Surfa`Safe™ disinfectants as they may result in damage to the thermometer case or electronics.
We do not recommend using a cleaning agent that contains Chlorine, but if it is necessary, use a 10:1 water hypochlorite mixture. A damp isopropyl alcohol wipe, Cidex™, Manuklenz™, VIROX™* or CaviWipes™* cleansing agents are acceptable. However, prolonged or repeated use of these chemicals may result in damage to the thermometer case, display or electronics. When cleaning the thermometer, make sure the wipe has all excess fluid squeezed from it. If too wet, the chemical may penetrate the handset and affect the thermometer functionality. Never spray the thermometer directly with cleaning chemicals. Spray a cloth or sponge lightly dampening it with the cleaning agent and then apply it to the thermometer.
The probe tip can be cleaned using an Isopropyl alcohol wipe such as Webcol™* or Curity™*. Remove all foreign matter from the thermometer tip. After the foreign matter has been removed, dry the window at the end of the probe tip using a lint free swab, cotton ball or lens wipe. The thermometer lens must be free from fingerprints and / or smudges for proper operation. After cleaning the tip allow the thermometer to air dry for 30 minutes prior to use.
Use of a clean cloth or sponge is recommended for cleaning. Never use an abrasive pad or an abrasive cleaner on the Genius™ 2 Tympanic Thermometer and Base.
The thermometer is a non-sterile device. Do not use ethylene oxide gas, heat, autoclave, or any other harsh method to sterilize this thermometer.
Allow sufficient time for air drying (30 minutes) before attempting to use the thermometer after cleaning.

Section VIII — Battery Replacement

The Genius™ 2 Tympanic Thermometer and Base 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 using the wall or cart mount options (sold separately) for the base unit, consult the installation sheet provided with the respective system.

Section X — Troubleshooting

If the Genius™ 2 Tympanic Thermometer and Base is not functioning properly, check the following items:

The Genius™ 2 Tympanic Thermometer and Base advisory and alarm conditions are described in the Thermometer Display Icons and Alarms subheading of Section V, 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:

Displayed Temperature Measurement Range:

Temperature Range depends on Site Mode as follows:

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.
Transport and 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 Covidien llc technical report. Data is available from Covidien llc on request.
Response Time:
Less than 2 seconds
Pulse Timer:
60 seconds
Temperature Resolution:
0.1°C or 0.1°F
Power:
Internally Powered ME Equipment
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
Degree of Protection Against Electrical Shock:
Type BF
Mode of Operation:
Continuous
Degree of Protection Against Ingress of Fluids:
Not Protected-IPX0

Regulatory and Safety standards:

The Genius™ 2 Tympanic Thermometer and Base 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 Covidien llc technical report. Data is available from Covidien llc on request.
• UL 60601-1
• EN 60601-1:2005
• EN 60601-1-2:2007
• 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:

The software was modified during testing to increase the precision of the measurements taken from one significant digit to two significant digits.
The increased precision numbers were then averaged to account for the known variance in measurements taken due to human factors.
Post-calibration with the Checker/Calibrator, the Genius™ 2 Tympanic Thermometer has been tested to meet the accuracy requirements of ASTM E1965-98 at 90% reliability with 95% confidence.

Section XII — Customer Service

In the event that it is necessary to return a unit for repair, please observe the following:

Contact Covidien technical service as shown below for the correct return procedure.
Ship insured parcel to your local service contact or the appropriate location below.

Section XIII — Warranty

Limited Warranty: Covidien llc warrants to the original purchaser (“Customer”) that this product will be free of defects in materials and workmanship, under normal use, (a) within the United States, for three (3) years from the date of original purchase from Covidien llc or its authorized distributor, or (b) outside the United States for one (1) year from the date of original purchase from Covidien llc or its authorized distributor, provided that this does not affect warranty rights under local legislation outside the United States. If this product does not operate as warranted above during the applicable warranty period, Covidien llc 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.

Covidien llc does not assume any liability for loss arising from unauthorized repair, misuse, neglect, chemical damage or accident. Removal, defacement, or alteration of serial lot number voids warranty. Covidien llc 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.

EXCEPT AS OTHERWISE REQUIRED OR PROHIBITED UNDER LOCAL LAW, THE WARRANTY SET FORTH IN THIS SECTION IS THE SOLE AND EXCLUSIVE WARRANTY AS TO THE PRODUCTS, AND IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTY, ORAL OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY ORAL OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT AS OTHERWISE REQUIRED OR PROHIBITED UNDER LOCAL LAW, COVIDIEN SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE (INCLUDING, WITHOUT LIMITATION, LOST PROFITS) DIRECTLY OR INDIRECTLY ARISING FROM THE SALE, INABILITY TO SELL, USE OR LOSS OF USE OF ANY PRODUCT.

Section XIV – Electromagnetic Conformity Declaration

The Genius™ 2 Tympanic Thermometer and Base has been built and tested according to IEC60601-1, CAN/CSA C22.2 No. 60601-1-08, and EN60601-1-2 Standards.

Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Genius™ 2 Tympanic Thermometer and Base is used exceeds the applicable RF compliance level above, the Genius™ 2 Tympanic Thermometer and Base should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Genius™ 2 Tympanic Thermometer and Base. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.