COVIDIEN Filac™ 3000 AD/ADA Electronic Thermometer User Manual

Page 14

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Filac

3000 AD/ADA Electronic Thermometer

11

Table of Contents

Water Bath Accuracy
(35.5°C/95.9°F to 42.0°C/107.6°F):

Direct Mode:

+/-0.1°C - +/- 0.2°F

Standard Prediction Mode**:

+/-0.1°C - +/- 0.2°F

Quick Prediction Mode (Oral Only)**:

+/-0.3°C - +/- 0.5°F

**Greater than 95% of the prediction mode readings will be within the specified accuracy.

Patient Accuracy:

In standard predict mode, thermometer accuracy meets EN 12470-3

A Standard Prediction Mode reading and a Direct Mode reading will differ by

less than ±0.2°C (±0.4°F) on 98% of tested patients

Batteries:

Four “AA” Required. Standard IEC package size. Alkaline – 1.5 Volt

Approximately 6000 temperature readings.

Probe:

Replaceable.

For probe integrity/safety checks, refer to qualified Biomedical Technician or
return to Covidien.

Isolation Chamber:

Removable, replaceable, washable, Polycarbonate/polyester blend.

Device Materials:

Thermometer Case:

Flame retardant Polycarbonate/Polyester Blend

Isolation Chamber:

Flame retardant Polycarbonate/Polyester Blend

Probe Handle:

Flame retardant Polycarbonate/Polyester Blend

Probe Shaft:

Flame retardant Polyester

Probe Cable:

Polyurethane jacket with TPE over mold

Tip:

Aluminum

All materials are latex-free.

Type of Protection Against Electrical Shock:

Internally Powered Equipment. 4 AA Batteries.

Degree of Protection Against Electrical Shock: Type BF

Degree of Protection Against Ingress of Fluids: Not Protected-IPX0

Mode of Operation:

Continuous Use . Intended for hand held use.

Degree of Safety of Application in the Presence: Not suitable for use in the presence of flammable anesthetic mixture with air,

oxygen or nitrous oxide.

Transport and Storage:

Not to exceed 30 days

Transport and store this device between temperatures of
-25°C to 55°C (-13°F to131°F).

Relative humidity range should be between 10%-95% RH, non-condensing.

Return unit to the factory if the device is dropped and performance appears degraded, or in the event that the environmental
conditions for transport, storage and operation are exceeded.

The Filac 3000 AD/ADA Electronic Thermometer is in compliance with the following International Regulatory and

Safety standards:
UL60601-1

CAN/CSA C22.2 No. 60601-1-08

EN60601-1:2005

EN60601-1-2:2001

EN 12470-3:2000

MDD 93/42/EEC

EN980:2008

ASTM E 1112: 2006

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