Genius™ 2 Tympanic Thermometer Operation Manual
Contents
1. 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 aid2. Genius 2 Tympanic Thermometer and Base 1 Classified with respect to electrical shock fire and mechanical hazards in accordance with UL60601 1 Probe cover installed Probe cover not installed 2 Classified with respect to electrical shock fire mechanical and other specified hazards in accordance with CAN CSA C22 2 No 601 1 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 Tympanic Thermometer and Base 3 English
3. E33 COVIDIEN Operating Manual Table of Contents Genius 2 Tympanic Thermometer and Base E covipiEN Operating Manual Genius 2 Tympanic Thermometer and Base English Table of Contents Page Section Introduction 1 Initial Set Up 1 Section Il General Information 1 Features 1 Section Ill 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 Maintenance 8 Section VII Cleaning 8 Section VIII Battery Replacement 9 Section IX Mounting Instructions 9 Section X Troubleshooting 9 Section XI Specifications 9 Section XII Customer Service 11 Section XIII Warranty 12 Section XIV Electromagnetic Conformity Declaration N 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 Tympanic Thermometer and Base English Section 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 a
4. 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 e 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 e 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 e 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 e Always wait at least two minutes before taking another measurement in the same ear e Used probe covers must be treated as infectious biological waste and disposed of i
5. 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 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 2 Tympanic Thermometer and Base advisory and alarm conditions are described in the Thermometer Display Icons and Alar
6. 0 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 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 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 Tympanic Thermometer and Base 10 Table of Contents 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 e 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 E19
7. 0787590 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 Genius 2 Thermometer with Base 303000 Genius 2 Probe Cover 303030 Genius 2 Checker Calibrator 303097 Genius 2 Replacement Base F31949WT Genius 2 Replacement Coil Cord F31950WT Genius 2 Replacement Battery Door F31951WT Genius 2 Locking Mount for Wall 303058 Genius 2 Cart with Locking Mount 303059 Tympanic Thermometer and Base 11 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 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
8. 65 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 In the event that it is necessary to return a unit for repair please observe the following 1 Contact Covidien technical service as shown below for the correct return procedure 2 Ship insured parcel to your local service contact or the appropriate location below United States Canada Outside US amp Canada Covidien llc Covidien llc Covidien IIc UK Energy Based Devices 7300 Trans Canada Highway Unit 2 Talisman Business Center 5920 Longbow Drive Pointe Claire QC London Road Boulder CO 80301 HOR 1C7 Bicester United Kingdom USA 1 877 664 8926 or Oxon OX26 6HR 1 800 448 0190 514 695 1220 44 0 1869328065 Covidien llc Italy Covidien llc Germany Covidien Ilc Spain Covidien llc France Laboratorio Assestenzalecnica Service Centre A A Servicio T cnico Parcd affaires Technopolis Via Rivoltana 2 D Raffineriestr 18 GEB II C Fructu s Gelabert 6 pl S tano 3 Avenue du Canada Segrate MI Neustadt Donau Sant Joan Despi LP851 LES Ulis Italy Germany Barcelona Spain Courtaboeuf France 20090 93333 91940 0039 0270308131 0049 09445 959374 0034 934758669 0033 081
9. Genius 2 Tympanic Thermometer and Base should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile ESD EN 61000 4 2 per 8 kV air X 8 kV air If floors are covered with synthetic material the EN 60601 1 2 2007 relative humidity should be at least 30 96 Electrical fast transient 2 kV for power supply lines not applicable Mains power quality should be that of a typical burst IEC 61000 4 4 commercial or hospital environment 1 kV for input output lines not applicable Surge IEC 61000 4 5 t 1 kV differential mode not applicable Mains power quality should be that of a typical commercial or hospital environment 2 kV common mode not applicable Voltage dips short 596 UT gt 95 dipin UT not applicable Mains power quality should be that of a typical interruptions and for 0 5 cycle commercial or hospital environment If the user voltage variations on 2 of the Genius 2 Tympanic Thermometer and power supply input 40 UT 60 dip in UT Base requires continued operation during power lines IEC 61000 4 11 for 5 cycles mains interruptions it is recommended that 70 96 UT 30 96 dip in UT the P STIM be powered from an uninterruptible for 25 cycles power supply or a battery lt 5 96 UT gt 95 96 dip in UT for 5 sec Power frequen
10. N Manual No SMF0211 041 U S Patents 7 108 419 7 237 949 7 354 194 7 434 991 7 478 946 7 507 021 7 520 671 7 536 568 7 556 424 7 686 506 7 731 418 7 841 767 COVIDIEN COVIDIEN with logo and Covidien logo are U S and internationally registered trademarks of Covidien AG Trademark of its respective owner Other brands are trademarks of a Covidien company 2011 Covidien Made in USA wl Covidien llc 15 Hampshire Street Mansfield MA 02048 USA Ec REP Covidien Ireland Limited IDA Business amp Technology Park Tullamore T 1 800 448 0190 www covidien com REV 09 2011 Tympanic Thermometer and Base
11. according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for 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 Tympanic Thermometer and Base 14 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 Immunity Test IEC 60601 testlevel Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Genius 2 Tympanic Thermometer and Base including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 3Vrms 150 kHz to 80 Not applicable Not applicable ME Mie d 1 2 P 80 MHz to 800 MHz Radiated RF EN 3 V m 80 MHz to 2 5 61000 4 3 perEN GHz 60601 1 2 2007 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m d 2 3 P 800 MHz to 2 5 GHz Field str
12. cy 50 60 3 A m 3 A m Power frequency magnetic fields should be at Hz magnetic field levels characteristic of a typical location in a EN 61000 4 8 per EN typical commercial or hospital environment 60601 1 2 2007 Note UT is the a c mains voltage prior to application of the test level Tympanic Thermometer and Base 13 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 The customer or the user of the Genius 2 Tympanic Thermometer and Base can help prevent electromagnetic interference by maintaining the minimum distance between portable and mobile RF communications equipment transmitters and the Genius 2 Tympanic Thermometer and Base recommended below according to the maximum output power of the communication equipment Rated maximum output power Separation distance according to frequency of transmitter of transmitter m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 JP d 1 2 P d 2 3VP 8 o e L3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W
13. e unit is dropped or abused 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 chemica
14. engths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol A Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note 1 At 80 MHz and 800 MHz the higher frequency range applies 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 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Tympanic Thermometer and Base 15 English Identification of a substance that is not contained or present within the product or packagi
15. er 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 TIE Temperature mode C unlocked Locked C Locked F F unlocked Tympanic Thermometer and Base 7 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 Contact your Covidien llc representative for details Covidien llc recommends functional checks at 12 month intervals Harsh use or environmental conditions may require reduced functional check intervals at some facilities If th
16. 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 Alarm Condition Display Mode Patient temperature above specified range Patient temperature below specified range Ambient Temperature above specified range Ambient Temperature below specified range 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 is displayed Low Battery Dead Battery The LCD displays the dead battery co
17. 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 1 Visually inspect the patient s ear canal Remove the Genius 2 Tympanic Thermometer and Base 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 Press the scan button to verify functionality and mode selection on the LCD screen 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 Tympanic Thermometer and Base 4 English 4 Inspect the probe cover to make sure it is fully seated n
18. including any implied warranty of merchantability or fitness for a particular purpose or application other than expressly set forth in the product labeling 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 601 1 and EN60601 1 2 Standards Guidance and manufacturer s declaration electromagnetic emissions 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 RF emissions The Genius 2 Tympanic Thermometer and Base uses RF energy CISPR 11 only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Genius 2 Tympanic Thermometer and Base is suitable for CISPR 11 use in all establishments including domestic establishments Harmonic emissions Not applicable and those directly connected to the public low voltage IEC 61000 3 2 power supply network that supplies buildings used for domestic purposes Tympanic Thermometer and Base 12 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
19. ls Spray a cloth or sponge lightly dampening it with the cleaning agent and then apply it to the thermometer e 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 Tympanic Thermometer and Base 8 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
20. ms 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 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 Tympanic Thermometer and Base 9 English Calibrated Accuracy Limits after Recalibration Ambient Temperature Target Temperature 16 C to 33 C 36 C to 39 C 60 8 F to 91 4 F 96 8 F to 102 2 F 16 C to 33 C less than 36 C 60 8 F to 91 4 F less than 96 8 F 16 C to 33 C greater than 39 C 60 8 F to 91 4 F greater than 102 2 F Accuracy 0 2 C 0 4 F 0 3 C 0 5 F 0 3 C 0 5 F Post recalibration accuracy using the Genius 2 Checker Calibrator may not necessarily be equivalent to factory calibration Displayed Temperature Measurement Range Temperature Range depends on Site Mode as follows Mode Range C Ear 33 0 to 42 0 Oral 33 6 to 42 0 Core 34 0 to 42 0 Rectal 34 2 to 42 0 Ambient Temperature Range Range F 91 4 to 107 6 92 5 to 107 6 93 2 to 107 6 93 6 to 107 6 16 C to 33 C 6
21. n accordance with current medical practices and local regulations Removal of batteries is recommended if the unit is not going to be used for an extended period of time e 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 e 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 Section IV Icon Identification i O A A Eject Button C F Button Timer Button Scan Button Choking Hazard Non Sterile 131 F 55 C We e 40 Rx Hed ZA ONLY ee By prescription only DEHP free Consult instructions Temperature Keep away from Keep dry for use limitations sunlight Tympanic Thermometer and Base 2 English m EJ S EC REP Dispose of as Type BF Protection Non ionizing CE mark Authorized Catalog number Electrical and Degree of protection electromagnetic representative in the Electronic waste against electrical radiation European Community shock there is no conductive connection to the patient ul oy Manufacturer Serial number Date of manufacture Medical Electrical Equipment
22. nd 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 e If using the wall or cart mount options sold separately for the base unit consult the installation sheet provided with the respective system e 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 Il 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 e 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 e Audible and visual indication of completed temperature acquisition Disposable single use probe covers aid in the prevention of a cross contamination of i
23. ndition When any button is pressed the battery icon will flash several times and then the LCD will turn OFF After the battery icon is displayed the batteries must be changed before the thermometer can Ix y be used Tympanic Thermometer and Base 6 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 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 tim
24. nfectious 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 e Base unit protects the thermometer tip and stores probe covers for easy access Easy to read LCD display with icons e Unit is designed for ambidextrous use Improved probe design to allow ease of use on the pediatric population Section IIl Important Precautions 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 Tympanic Thermometer and Base 1 English Important Precautions continued e 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
25. ng Identification d une substance non pr sente 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 contenuta n presente nel prodotto o nella confezione Identificaci n de una sustancia no contenida o que no est presente dentro del producto o embalaje Identifiering av ett mne som inte ing r eller f rekommer i produkten eller f rpackningen Identificatie van een stof die niet in het product of de verpakking is vervat of aanwezig is Identifica o de uma subst ncia n o contida ou n o existente no produto ou embalagem Tuotteessa tai pakkauksessa olemattoman aineen tunnistus Identifikation af et stof der ikke er indeholdt eller til stede i produktet eller emballagen Avayv pion ouo ac mou dev rrepi yerat rj Sev urr pyei oro ripoi v rj OTN ovokeuoo a Identifikace l tky kter neni obsa ena nebo p tomna v produktu nebo obalu Olyan anyag azonos t sa amelyet sem a term k sem a csomagol s nem tartalmaz vagy amely azokban nincs jelen Onpegeneuue BeujecrBa He cogepxauleroca unu He npucyrcrByloujero B NposykKTe N yrnakoBke Identyfikacja substancji nie zawartej i nieobecnej w produkcie lub jego opakowaniu Ur n veya ambalajinda bulunmayan veya var olmayan bir madde tanimlamasi Identifikasjon av et stoff som ikke er til stede i produktet eller emballasjen A RX CE 0123 E covipiE
26. o 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 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 into a suitable waste receptacle 10 Always return the thermometer to base for storage Tympanic Thermometer and Base 5 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 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
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