Covidien Filac 3000 EZ User manual

Table of Contents
FilacTM
3000 EZ/EZA Electronic Thermometer
Operating Manual

Filac™
3000 EZ/EZA Electronic Thermometer
Operating Manual

Filac™3000 EZ/EZA Electronic Thermometer
Table of Contents
Section Page
I. AboutBodyTemperatures ....................................................................1
II. GeneralInformation...........................................................................1
III. SafetyandWarnings..........................................................................2
IV. IconIdentification.............................................................................3
V. InstructionsForUse...........................................................................4
ProbeCovers—Applying&Removing....................................................4
ChangingIsolationChambersandProbes.................................................4
Oral&AxillaryTemperatureTaking.......................................................5
RectalTemperatureTaking...............................................................5
DirectMode.............................................................................6
DirectModeLock........................................................................6
RecallLastTemperature .................................................................6
VI. Cleaning and Sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
VII. BatteryReplacement/Installation .............................................................7
VIII. Troubleshooting..............................................................................7
IX. Specifications.................................................................................8
X. CustomerService ............................................................................10
XI. Warranty....................................................................................12
XII. ElectromagneticConformityDeclaration ......................................................12
This product contains software solely owned by Covidien. Covidien 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.
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Filac™3000 EZ/EZA Electronic Thermometer
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Table of Contents
I. About Body Temperature
It is a common myth that 98.6°F (37°C) is the “normal body temperature.” The truth is that 98.6°F (37°C) is an average body
temperature. Normal body temperature is actually a range that varies with age, gender, and measurement site. Body temperatures
also fluctuate through out the day, typically cooler temperatures in the morning, warmer in the afternoon, and cooling down again
in the evening. Other factors that can influence body temperature are: the patient’s recent level of activity, metabolism rate, or
medications. Normal body temperatures also tend to decrease with age.
Please see the chart below for normal temperature ranges by patient age and site. Readings from different body sites, even when
taken at the same time, should not be directly compared; body temperatures will vary by site.
References:
Chamberlain, J, Terndrup, T., et al. (1995) Determination of Normal Ear Temperature with an Infrared Emission Detection Thermometer. Annals of Emergency
Medicine, Volume 25, Issue 1, Pages 15-20
Braim. S., Preston, P., and Smith, R. (1988) Getting a better read on thermometry. RN. 1998 Mar; 61(3):57-60
Munk, P, Woods, S, Leduc, D., et al Canadian Paediatric Society Statement; Temperature Measurement in Paediatrics; Paediatric Child Health Vol 5 No 5: July/
August, 2000
Brunner, L. and Suddarth, Dl, et al. (1982) The Lippincott Manual of Nursing Practice, Third Edition; J. B. Lippincott Company, Philadelphia, PA; 1982; p.1145
Houdas, Y. and Ring, E. F. J. Human Body Temperature, Its Measurement and Regulation; Plenum Press, NY, 1982; p.81-87.
II. General Information
1. The Filac 3000 EZ/EZA Electronic Thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring
patient temperatures by Oral, Axillary or Rectal means.
2. The electromagnetic compatibility of this device has been verified by test according to the EN60601-1-2:2001requirements.
3. This device requires no user maintenance other than periodic cleaning and replacement of expired batteries.
Features
• Fasttemperaturemeasurements
• Measurementrange:30°Cto43°C(86°Fto109°F)
• PushbuttonalternatesCelsius/Fahrenheitscale
• Audibleindicationofcompletion(“beep”sound)
• Interchangeable,color-codedisolationchamberswithmatchingprobes.
Helps keep probe covers and probes together for aiding in infection control (Blue -oral/axillary; Red -rectal)
• Easilywipedclean
• Usesfourstandarddisposable“AA”batteries
• “Auto-On”whenprobeiswithdrawnfromtheprobewell
• “Auto-Off”conservesbatterylife
• LowBatteryandDeadBatteryindicators
• LasttemperatureRecall
• Easilyaccessibleprobecoverbox
• EasytoreadLCDdisplaywithbacklight
Temperature
Site
Ear
Oral
Core
Rectal
Axillary
Normal Body Temperatures by Patients Age
> 65 Years
96.4° - 99.5°F
35.7°- 37.5°C
96.4° - 98.5°F
35.7°- 36.9°C
96.6° - 98.8°F
35.8°- 37.1°C
97.1° - 99.2°
36.1°- 37.3°C
96.0° - 97.4°F
35.5°- 36.3°C
11-65 Years
96.6° - 99.7°F
35.8°- 37.6°C
97.6° - 99.6°F
36.7°- 37.8°C
98.2° - 100.2°F
36.7°- 37.8°C
98.6° - 100.6°F
37.0°- 38.1°C
95.3° - 98.4°F
35.1°- 36.8°C
0-2 Years
97.5°- 100.4°F
36.3°- 38.0°C
-
-
97.5° - 100.0°F
36.3°- 37.7°C
97.9° - 100.4°F
36.6°- 38.0°C
94.5° - 99.1°F
34.7°- 37.2°C
3-10 Years
97.0°- 100.0°F
36.1°- 37.7°C
95.9° - 99.5°F
35.3°- 37.5°C
97.5° - 100.0°F
36.3°- 37.7°C
97.9°- 100.4°F
36.5°- 38.0°C
96.6° - 98.0°F
35.8°- 36.6°C

Filac™3000 EZ/EZA Electronic Thermometer
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Table of Contents
III. Safety and Warnings
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
1. Read this booklet thoroughly before using the Filac 3000 EZ/EZA Electronic Thermometer.
2. 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 an oxygen rich environment.
3. Do not use this thermometer without first installing a new Filac 3000 EZ/EZA Electronic Thermometer probe cover.
4. Use only Filac 3000 EZ/EZA Electronic Thermometer probe covers with this device.
Use of any other probe cover will result in erroneous temperature readings.
5. The device and probe covers are Non-sterile. Do not use on abraded tissue.
6. To limit cross contamination, use Blue devices for Oral and Axillary temperature taking only.
7. Use red devices only for rectal temperatures.
8. Thoroughly dry all electrical contacts on both probe and thermometer after washing, or device may fail to functionproperly.
9. For re-calibration, service or integrity checks, refer to a qualified Biomedical Technician or return to manufacturer.
10. Warning: No modification of this equipment is allowed. Do not open unit. No user-serviceable parts inside. Opening of device
may affect calibration and voids warranty.
11. Disposal of used probe covers must be performed in accordance with current medical practices or local regulations regarding
disposal of infectious, biological medical waste.
12. Do not use lithium batteries with this device.
13. Do not mix alkaline and rechargeable batteries.
14. Removal of the batteries is recommended if the unit is not going to be used for an extended period of time.
15. Dispose of batteries in a manner consistent with local environmental and institutional policy for Alkaline batterydisposal.
16. Dispose of old battery-powered electronic equipment in a manner consistent with institutional policy for expired
equipmentdisposal.
17. Cleaning frequency and practices must be consistent with institutional policy for cleaning of non-sterile devices.
18. Device to be used by trained personnel.
Note:
Even though this device has been designed to minimize the effects of electromagnetic interference, it does generate radio frequency
energy. If not used in accordance with the instructions, the device could cause interference in other equipment operating within its
vicinity. If the device is causing interference, the following actions may be taken in an attempt to correct the interference:
• Re-orientorre-locatethereceivingdevice.
• Increasetheseparationbetweenthedevices.
• Consultacustomerservicerepresentative.