COVIDIEN 3000 EZ-EZA Electronic Thermometer User Manual

Operating Manual

TM

Filac

3000 EZ/EZA Electronic Thermometer

Table of Contents

Operating Manual

™

Filac

3000 EZ/EZA Electronic Thermometer

en

Table of Contents

Section Page

I. About Body Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

II. General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

III. Safety and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

IV. Icon Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

V. Instructions For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Probe Covers —Applying & Removing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Changing Isolation Chambers and Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Oral & Axillary Temperature Taking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Rectal Temperature Taking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Direct Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Direct Mode Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Recall Last Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

VI. Cleaning and Sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

VII. Battery Replacement / Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

VIII. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

IX. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

X. Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

XI. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

XII. Electromagnetic Conformity Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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.

Filac

3000 EZ/EZA Electronic Thermometer

™

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.

Temperature
Site

Ear

Oral

Core

Rectal

Axillary

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.

Normal Body Temperatures by Patients Age

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

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

> 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

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

Filac

3000 EZ/EZA Electronic Thermometer

™

Table of Contents

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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

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.

11. Disposal of used probe covers must be performed in accordance with current medical practices or local regulations regarding

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

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.

red

devices only for

Warning:

may affect calibration and voids warranty.

disposal of infectious, biological medical waste.

equipmentdisposal.

No modification of this equipment is allowed. Do not open unit. No user-serviceable parts inside. Opening of device

rectal

temperatures.

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.

Filac

3000 EZ/EZA Electronic Thermometer

™

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IV. Icon Identification

ORAL
Temperature Mode

Works only with BLUE probe
and isolation chamber

AXILLARY
Temperature Mode

Works only with BLUE probe
and isolation chamber

RECTAL
Temperature Mode

Works only with RED probe
and isolation chamber

Site Button

Use to change
measurementlocation

°C/°F Button

Use to change
temperaturescale

Direct Mode

Non-predictive temperature
measurement mode

Out of Range - High

Temperature measurement
is above 109°F (43°C)

Out of Range - Low

Temperature measurement
is below 86°F (30°C)

Non-Sterile

Latex-free

Single use

By prescription only

Keep away from sunlight

Keep dry

EN 50419

Dispose of as Electrical and
Electronic waste

Type BF Equipment

Degree of protection against
electrical shock – no
conductive connection
to the patient

Non-ionizing
electromagnetic radiation

Medical Electrical
Equipment

Install/Remove Probe Cover

Flashing probe cover reminder
to install probe cover prior to
use and remove cover after use

Low Battery

Battery voltage is low – replace
batteries as soon as possible

Dead Battery

Unit will not operate until
new batteries are installed

Progress Bar

Temperature measurement
status indication

10%

-13°F

-25°C

DEHP-free

Follow instructions for use -

This manual must be read prior
to use of the thermometer
(Symbol appears blue
ondevice)

95%

Humidity limitations

131°F
55°C

Temperature limitations

CE mark

0123

Manufacturer
Serial Number

Date of Manufacture

Manufacturer

Authorized
representative in the
European Community

Filac

3000 EZ/EZA Electronic Thermometer

™

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