Operating Manual Genius 2 TM Tympanic Thermometer and Base Table of Contents
Operating Manual Genius 2 TM Tympanic Thermometer and Base
English Table of Contents Section I Page Introduction 1 Initial Set Up 1 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 Temperature Measurement 4 Temperature Recall 6 Temperature Display - Toggle 6 Sleep Mode 6 Pulse Timer Mode 6 Thermometer Display Icons and Alarms 6 Biotech Mode 7 Section VI Preventative
English Section I — Introduction This operator’s manual was prepared for the operator of the Genius™ 2 Tympanic Thermometer and Base. This manual contains instructions for use, precautions, and available maintenance and service information. To achieve satisfactory results, the operator must read this manual thoroughly before attempting to use the thermometer. Initial Set Up • Unpack the Genius 2 Tympanic Thermometer and Base and examine it for structural integrity.
English Important Precautions continued • Always install a new probe cover prior to taking a temperature. The probe cover membrane should be smooth with no holes, tears, or wrinkles. • The thermometer was designed to be used only with Genius 2 Tympanic Thermometer and Base probe covers. Use of probe covers manufactured by any company other than Covidien llc may result in erroneous readings. • Ensure that the probe tip seals the ear canal prior to taking a temperature.
English 0123 Dispose of as Type BF Protection Non-ionizing Electrical and (Degree of protection electromagnetic Electronic waste against electrical radiation shock -there is no conductive connection to the patient) Manufacturer Serial number CE mark Authorized Catalog number representative in the European Community Date of manufacture Medical Electrical Equipment Genius 2 Tympanic Thermometer and Base (1) C lassified with respect to electrical shock, fire and mechanical hazards in accordance with U
English 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).
English 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. 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 the thermometer. 7.
English 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.
English 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.
English 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 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 VI — Preventative Maintenance Functional checks must be performed by technicians trained by Covidien llc and based on the procedure in the Genius 2 Tympanic Thermometer and Base Checker Operation Manual.
English 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.
English Calibrated Accuracy Limits (after Recalibration*): Ambient Temperature Target Temperature Accuracy 16°C to 33°C (60.8°F to 91.4°F) 36°C to 39°C (96.8°F to 102.2°F) ± 0.2°C (± 0.4°F) 16°C to 33°C (60.8°F to 91.4°F) less than 36°C (less than 96.8°F) ± 0.3°C (± 0.5°F) 16°C to 33°C (60.8°F to 91.4°F) greater than 39°C (greater than 102.2°F) ± 0.3°C (± 0.5°F) *Post recalibration accuracy using the Genius 2 Checker/Calibrator may not necessarily be equivalent to factory calibration.
English 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.
English 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, for three (3) years from the date of original purchase from Covidien llc or its authorized distributor.
English Guidance and manufacturer’s declaration – electromagnetic immunity The Genius 2 Tympanic Thermometer and Base is intended for use in the electromagnetic environment specified below. The user of the Genius 2 Tympanic Thermometer and Base should assure that it is used in such an environment.
English Recommended separation distances between portable and mobile RF communications equipment and the Genius 2 Tympanic Thermometer and Base The Genius 2 Tympanic Thermometer and Base is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
English Guidance and manufacturer’s declaration – electromagnetic immunity The Genius 2 Tympanic Thermometer and Base is intended for use in the electromagnetic environment specified below. The customer or the user of the Genius 2 Tympanic Thermometer and Base should assure that it is used in such an environment.
English Identification of a substance that is not contained or present within the product or packaging. Identification d’une substance non présente dans le produit ou l’emballage. Identifizierung einer Substanz, die weder im Produkt noch in der Verpackung enthalten bzw. vorhanden ist. Identificazione di una sostanza che non è contenuta né presente nel prodotto o nella confezione. Identificación de una sustancia no contenida o que no esté presente dentro del producto o embalaje.
