Filac 3000 EZ and EZA Operating Manual Dec 2012

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

Normal Body Temperatures by Patients Age 0-2 Years

3-10 Years

11-65 Years

> 65 Years 96.4° - 99.5°F 35.7°- 37.5°C

Ear

97.5°- 100.4°F 36.3°- 38.0°C

97.0°- 100.0°F 36.1°- 37.7°C

96.6° - 99.7°F 35.8°- 37.6°C

Oral

-

95.9° - 99.5°F 35.3°- 37.5°C

97.6° - 99.6°F 36.7°- 37.8°C

96.4° - 98.5°F 35.7°- 36.9°C

Core

97.5° - 100.0°F 36.3°- 37.7°C

97.5° - 100.0°F 36.3°- 37.7°C

98.2° - 100.2°F 36.7°- 37.8°C

96.6° - 98.8°F 35.8°- 37.1°C

Rectal

97.9° - 100.4°F 36.6°- 38.0°C

97.9°- 100.4°F 36.5°- 38.0°C

98.6° - 100.6°F 37.0°- 38.1°C

97.1° - 99.2° 36.1°- 37.3°C

Axillary

94.5° - 99.1°F 34.7°- 37.2°C

96.6° - 98.0°F 35.8°- 36.6°C

95.3° - 98.4°F 35.1°- 36.8°C

96.0° - 97.4°F 35.5°- 36.3°C

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

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 1

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.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 2

IV.

Icon Identification ORAL Temperature Mode Works only with BLUE probe and isolation chamber

Out of Range - High Temperature measurement is above 109°F (43°C)

Keep away from sunlight

AXILLARY Temperature Mode Works only with BLUE probe and isolation chamber

Out of Range - Low Temperature measurement is below 86°F (30°C)

Keep dry

Non-Sterile

EN 50419 Dispose of as Electrical and Electronic waste

Site Button Use to change measurement location

Latex-free

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

°C/°F Button Use to change temperature scale

Single use

Non-ionizing electromagnetic radiation

Direct Mode Non-predictive temperature measurement mode

By prescription only

Medical Electrical Equipment

Install/Remove Probe Cover Flashing probe cover reminder to install probe cover prior to use and remove cover after use

DEHP-free

CE mark

Low Battery Battery voltage is low – replace batteries as soon as possible

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

RECTAL Temperature Mode Works only with RED probe and isolation chamber

0123 Manufacturer Serial Number

95% Dead Battery Unit will not operate until new batteries are installed

Progress Bar Temperature measurement status indication

Humidity limitations

Date of Manufacture

10% 131°F 55°C Temperature limitations

Manufacturer

-13°F -25°C

Authorized representative in the European Community

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 3

V.

Instructions For Use Probe Covers -Applying & Removing 1. Open probe cover box by lifting tab at top corner and pulling to remove top panel. 2. Insert box of probe covers into top of isolation chamber. (To aid infection control, never switch boxes between blue and red isolation chambers. Also, never switch probes between blue and red isolation chambers. Keep like colors together.) 3. Remove probe from the probe well. This automatically turns on the thermometer. 4. To help remind the user to apply or remove a probe cover, a probe icon with flashing probe cover will be displayed when the probe is withdrawn from the probe well and following a completed temperature measurement. 5. Insert the probe end into a cover in the box. Push the handle firmly until you feel the cover “snap” into place. 6. Take appropriate temperature measurement (oral, axillary or rectal). 7. Eject the used cover into bio-waste container by pressing top button. 8. Remove, discard and replace box when empty. Changing Isolation Chambers and Probes 1. For aiding in infection control, use only the Blue probe and Blue isolation chamber for Oral and Axillary temperature taking. The Red probe and Red isolation chamber must only be used for Rectal temperature taking. 2. Do not attach a Red probe to a Blue isolation chamber or vice-versa. 3. To remove or replace any isolation chamber/probe assembly, grasp the isolation chamber from each side as shown. 4. Squeeze inward releasing the snaps and slide the isolation chamber up to pull off. 5. To replace, align probe well finger with opening in the top of the unit. 6. Slide the isolation chamber down until the side snaps “click” into place. 7. The probe is connected to the thermometer automatically. 8. To change probes, remove the isolation chamber as described previously. 9. Grasp the sides of the L-shaped connector piece with one hand and then using other hand pull backward on the latch holding the end of the L-shaped connector. 10. Once free of the latch, slide the L-shaped connector out of isolation chamber. 11. To replace, properly align the top of the L-shaped connector to the slot on the back of the isolation chamber. 12. Then slide the connector up into the slot pressing firmly on the bottom of the connector until it “clicks” into place.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 4

Oral & Axillary Temperature Taking 1. Make certain that the Blue isolation chamber/probe unit is attached. 2. Withdraw probe and apply a probe cover. The thermometer turns on automatically. 3. An icon identifying Oral or Axillary mode is displayed. The Rectal icon can not be displayed when a blue isolation chamber/probe is attached. 4. Press the Site button on the front panel to select either the Oral or Axillary mode. 5. For Oral temperatures, insert the probe tip deep into the sublingual pocket next to the frenulum linguae, (vertical fold of tissue in middle of tongue), on one side or the other, toward the back of the mouth. Note: Accurate body temperature readings can only be obtained in one of these two “heat pocket” locations as shown. Temperatures taken in other mouth locations will result in inaccurate body temperature readings. 6. Patient’s mouth must be closed.* 7. Securely hold the probe in place until the temperature is displayed. 8. For Axillary temperatures, have the patient raise the arm, then place the probe tip in the axilla. Press gently to assure good contact. For the most accurate temperature the probe tip should be placed directly against the patients skin. 9. Have the patient then lower the arm and remain as still as possible. Hold the probe parallel to the arm as shown.* 10. If two short beeps are heard, it means the unit switched to Direct (slow) mode for this temperature only. 11. A “long beep” is sounded when measurement is complete and the final temperature is displayed. 12. To change between Celsius and Fahrenheit scales, press the °C/°F button. Press again as needed. 13. Eject the used cover into a bio-waste container by pushing top button. 14. After returning the probe to the probe well, the temperature is stored for recall until the probe is once again withdrawn. If the probe is returned to the probe well before the “long beep” is heard, no temperature will be stored for the recall function.

Heat Pockets

Rectal Temperature Taking 1. Make certain that the Red isolation chamber/probe unit is attached. 2. Withdraw the probe and apply a probe cover. Thermometer turns on automatically. 3. An icon identifying Rectal mode is always displayed provided the Red isolation chamber/probe assembly is attached. Pressing the Site button on the front panel to change modes has no effect. 4. If desired, apply medical grade lubricant as per institutional protocol. 5. Insert the probe into the patient’s rectum. To ensure proper tissue contact, angle the probe slightly after insertion.* 6. Depth of insertion is recommended at 1/2” to 3/4” (12 mm - 19 mm) for adults and 1/4” to 1/2” (6 mm - 13 mm) for children. 7. If two short beeps are heard, it means the unit switched to Direct (slow) mode for this temperature only. 8. A “long beep” is sounded when measurement is complete and the final temperature is displayed. 9. To change between Celsius and Fahrenheit scales, press the °C/°F button. Press again as needed. 10. Eject the used cover into a bio-waste container by pushing top button. 11. After returning the probe to the probe well, the temperature is stored for recall until the probe is once again withdrawn. If the probe is returned to the probe well before the “long beep” is heard, no temperature will be stored for the recall function. *Probe movement during a measurement can affect the thermometer’s ability to accurately measure the site temperature and may lengthen the time required to obtain a reading.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 5

Direct Mode 1. The Filac 3000 EZ/EZA Electronic Thermometer normally operates in Predictive mode for accurate temperature measuring. In certain cases, such as with a hypothermic patient, the thermometer will automatically shift to Direct (slow) mode and will then act as a temperature monitor. 2. The Filac 3000 EZ/EZA Electronic Thermometer can be set to operate exclusively in Direct mode (disable Predictive mode). See the Direct Mode Lock Section for instructions on configuring the thermometer to operate exclusively in Direct mode. 3. In Direct mode the device may require up to 60 seconds to reach equilibrium and display patient temperature. 4. A turtle icon will be continuously displayed whenever the thermometer is functioning in Direct mode. 5. To change between Celsius and Fahrenheit scales, press and release the °C/°F button. Press and release again as needed. 6. An Up or Down arrow will appear on the display whenever the current temperature reading is out of range, either High or Low, respectively. 7. The Direct mode auto feature is always functional regardless of Red or Blue isolation chamber/ probe. 8. A “long beep” is sounded when measurement is complete and the final temperature is displayed. 9. After returning the probe to the probe well, the temperature is stored for recall until the probe is once again withdrawn. If the probe is returned to the probe well before the “long beep” is heard, no temperature will be stored for the recall function. Direct Mode Lock 1. To configure the thermometer so it always operates in Direct mode, press and hold the Site and °C/°F buttons at the same time for 4 seconds. A long “beep” will be sounded. On the LCD, the turtle will flash and “ON” will be displayed for approximately 2 seconds before the unit turns off. (Note: The thermometer must be off before configuring Direct mode lock.) 2. In this mode of operation, the turtle icon will be continuously displayed during use to indicate Direct mode operation. 3. To exit Direct mode lock and return to normal operation, again press and hold the Site and °C/°F buttons at the same time for 4 seconds. A long “beep” will be sounded. On the LCD, the turtle will flash and “OFF” will be displayed for approximately 2 seconds then the unit will turn off. Recall Last Temperature 1. After each temperature measurement, a “long beep” is heard. The “beep” indicates the temperature measurement has been completed and stored and is available for recall. This temperature can be recalled after the probe is returned to the probe well. 2. To recall the most recent temperature measurement, press and release °C/°F button on the front panel. The last measurement taken will appear for several seconds. 3. While the recalled measurement is displayed, the user may press and release the °C/°F button again to change between the Celsius and Fahrenheit scales. 4. Withdrawing the probe from the probe well erases last temperature memory. 5. If the most recent temperature measurement was incomplete or out of range, dashes will appear on the display during the recall operation.

VI.

Cleaning and Sterilization 1. The entire device may be easily wiped clean. Water temperature should not exceed 130° F (55° C). Do not submerge or soak under water. 2. A mild detergent may be added to water. Use of cleaners such as Spray NineTM*, pHisoHexTM*, HibiclensTM*, Vesta-SydeTM*, or CidexTM* may result in damage to the thermometer case. 3. Use of 10:1 water and hypoclorite mixture or a damp isopropyl alcohol wipe occasionally, is acceptable. Prolonged and repeated use of these chemicals may result in damage to the thermometer case and display area. 4. Use of a cloth or sponge is recommended for cleaning. Abrasive pads may result in damage to the thermometer case and display area. 5. This thermometer is provided non-sterile. Do not use ethylene oxide gas, heat, autoclave, or any other harsh methods to sterilize this unit. 6. Isolation chambers may be replaced inexpensively instead of cleaning. 7. After cleaning the unit, shake the probe handle to drain out any excess solution. Thoroughly dry the electrical contacts on both probe and thermometer.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 6

VII. Battery Replacement / Installation 1. To access the batteries, remove the isolation chamber by depressing the tabs on the sides of the unit and slide off upwardly. 2. Pull back on the finger tab on the top of the battery door. The battery door should hinge open to expose the batteries. 3. The batteries may be removed by pressing firmly on the positive end (opposite the compressed spring) and lifting up. 4. Be certain to dispose of used batteries in a manner consistent with local environmental and institutional policy for lithium or alkaline battery disposal. 5. To install new batteries, place the negative end on the spring. Press down firmly to compress spring and tilt battery into place. 6. To replace the battery door, insert the tab on the bottom of the door into the slot on the bottom of the unit to create a hinge. Swing the top half of the door upwards pressing firmly on the top of the door until the small tab on the main unit “clicks” into the catch on the battery door. 7. Reinstall isolation chamber with probe attached.

VIII. Troubleshooting 1. If device fails to function properly after washing & reconnecting probe, rinse all contacts in de-ionized water and blow dry. 2. Icons indicate all other possible errors and remedies. 3. Device Error Codes: E01 - System error during synchronization E02 - System error during patient thermistor calibration E03 - System error during heater thermistor calibration E04 - System timing error E05 - Heater error E06 - LCD communication error E07 - Shut off error P01 - Probe configuration (or no probe connected) error P02 - Direct Mode patient thermistor unstable or out of range P03 - Direct Mode heater thermistor unstable or out of range P04 - Predict Mode patient thermistor unstable or out of range P05 - Predict Mode heater thermistor unstable or out of range P06 - Unable to pre-heat probe tip 4. No user-serviceable parts inside. 5. Refer to a factory or qualified Biomedical Technician for service.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 7

IX.

Specifications Medical Electrical Equipment Filac 3000 EZ/EZA Electronic Thermometer Classified with respect to electrical shock, fire, and mechanical hazards only in accordance with UL60601-1 Classified with respect to electrical shock, fire, and mechanical hazards only in accordance with CAN/CSA C22.2 No. 60601-1-08

Dimensions (Approximate, without base): Dimensions (Approximate, with base): Weight (Approximate, without base): Temperature Measurement Range: Ambient Operating Temperature Range:

in.- 3.2 W x 6.0 H x 2.1 D ; mm - 84 W x 152 H x 56 D in.- 4.1 W x 7.5 H x 3.1 D ; mm - 105 W x 190 H x 79 D 13.5 Ounces; 385 Grams 30°C to 43°C; 86°F to 109°F 10°C to 40°C; 50°F to 104°F; at 10% - 95% RH, non-condensing.

Average prediction times (after insertion into measurement site): Oral (EZ model): 3-5 seconds (non-fever temps), 8-10 seconds (fever temps) Oral (EZA model): 6-10 seconds Axillary Mode: 8-12 seconds Rectal Mode: 10-14 seconds Direct Mode (All Sites): 60-120 seconds Typical times for switch to Direct Mode: If no measurement site detected: 60 seconds (after pulling probe from probe well) If temperature does not stabilize: 70 seconds (after measurement site insertion) Pulse Timer: 60 Second count with a “beep” at 15 seconds, 2 “beeps” at 30 seconds, 1 “beep” at 45 seconds and 2 “beeps” at 60 seconds Water Bath Accuracy (35.5°C/95.9°F to 42.0°C/107.6°F):

Direct Mode: Standard Prediction Mode**: Quick Prediction Mode (Oral Only)**:

+/-0.1°C - +/- 0.2°F +/-0.1°C - +/- 0.2°F +/-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.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 8

Device Materials:

Thermometer Case: Isolation Chamber: Probe Handle: Probe Shaft: Probe Cable: Tip:

Flame retardant Polycarbonate/Polyester Blend Flame retardant Polycarbonate/Polyester Blend Flame retardant Polycarbonate/Polyester Blend Flame retardant Polyester Polyurethane jacket with TPE over mold 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 EZ/EZA 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

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 9

X.

Customer Service The circuitry of the Filac 3000 EZ/EZA Electronic Thermometer is not customer serviceable. In particular, electronic assembly re-work will likely affect accuracy. Certain replacement items such as probes and isolation chambers are available from the service centers listed below. All service personnel must be properly trained, qualified and familiar with operation of the thermometer. Improper service may impair proper operation of the Filac 3000 EZ/EZA Electronic Thermometer. A Filac 3000 EZ/EZA Electronic Thermometer Calibration Plug (reorder number 500099) is available to check accuracy of the Filac 3000 EZ/EZA Electronic Thermometer. It replaces the regular probe and verifies the accuracy of the main unit electronics. Replace the main unit if accuracy is deficient. Follow the instructions that accompany the Filac 3000 EZ/EZA Electronic Thermometer Calibration plug. Probe accuracy can be checked in any mode using a calibrated water bath. A Filac 3000 EZ/EZA Electronic Thermometer should provide direct mode accuracy to within ±0.1°C of the calibrated water bath temperature. A Filac 3000 EZ/EZA Electronic Thermometer should have a standard predict mode accuracy within ±0.1°C of the calibrated water bath temperature. A Filac 3000 EZ/EZA Electronic Thermometer should have a quick predict mode accuracy within ±0.3°C of the calibrated water bath temperature. The probe cable connector is designed to exceed 1,000 insertions. Do not lubricate or solvent clean. Replace the probe if the connector is thought to be faulty. In the event that it becomes necessary to return a unit for service, please follow these instructions: 1. Call the appropriate phone number listed below for an Authorized Return Number and shipping instructions. 2. Pack the instrument carefully and ship insured parcel to the appropriate location: United States Covidien 5920 Longbow Drive Boulder, CO 80301, USA Phone: 1-800-448-0190

Canada Covidien 7300 Trans Canadian Hwy Pointe-Claire, QC H9R 1C7, Canada Phone: 1-877-664-8926

Outside US & Canada Covidien Unit 2 Talisman Business Center, London Road Bicester, OX266HR, UK Phone: +44-1869-328065

Covidien llc (Italy) Laboratorio AssestenzaTecnica Via Rivoltana 2/D Segrate – MI, Italy 20090 Phone: (0039) 0270308131

Covidien llc (Germany) Service Centre Raffineriestr. 18, GEB.II Neustadt/Donau, Germany 93333 Phone: (0049) 09445 959374

Covidien llc (Spain) A/A Servicio Técnico C/Fructuós Gelabert, 6, pl. Sótano Sant Joan Despi, Barcelona, Spain 08970 Phone: (0034) 934758669

Covidien llc (France) Parcd’affaires Technopolis 3 Avenue du Canada, LP851-LES Ulis, Courtaboeuf, France 91940 Phone: (0033) 0810787590

If not listed please contact Covidien Customer Service or representative for details of your nearest service center.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 10

To Order/Reorder/Replace device components and accessories, specify one or more of the following Reorder Numbers: Probe Covers

Case of 500 Case of 2,000

Reorder No. 500500 Reorder No. 502000

Note: Use of any other brand or style probe cover will result in erroneous temperature readings. Complete Oral /Axillary Thermometer Includes electronic thermometer with Blue - Oral/Axillary isolation chamber and Blue - Oral/Axillary probe, with 4-foot (1.2 m) cord, and global manual on CD Filac 3000 EZ Reorder No. 504000 Filac 3000 EZA Reorder No. 504003 Filac 3000 AD Reorder No. 505000 Filac 3000 ADA Reorder No. 505003 Complete Rectal Thermometer Includes electronic thermometer with Red - Rectal isolation chamber and Red - Rectal probe, with 4-foot (1.2 m) cord, and global manual on CD Filac 3000 EZ Reorder No. 504005 Filac 3000 EZA Reorder No. 504008 Filac 3000 AD Reorder No. 505005 Filac 3000 AD Reorder No. 505008 Isolation Chamber Blue - Oral/Axillary Red - Rectal

Reorder No. 500028 Reorder No. 500038

Probe (with 4-foot standard cord) Blue - Oral/Axillary Red - Rectal

Reorder No. 500026 Reorder No. 500036

Probe (with 9-foot standard cord) Blue - Oral/Axillary Red - Rectal

Reorder No. 500027 Reorder No. 500037

Calibration Plug

Reorder No. 500099

Mounting Base for Wall

Reorder No. 500046

Mounting Base for Rolling Stand

Reorder No. 500047

Mounting Base with Pole Clamp

Reorder No. 500048

Rolling Stand

Reorder No. 303059

Rolling Stand Basket

Reorder No. 8884813711

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 11

XI.

Warranty Limited Warranty: Covidien 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 or its authorized distributor. If this product does not operate as warranted above during the applicable warranty period, Covidien may, at its option and expense, replace the defective part or product with a comparable part or product, repair 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 does not assume any liability for loss arising from unauthorized repair, misuse, neglect, or accident. Removal, defacement, or alteration of serial lot number voids warranty. Covidien disclaims all other warranties, expressed or implied, including any implied warranty of merchantability or fitness for a particular purpose or application other than as expressly set forth in the product labeling.

Section XII – Electromagnetic Conformity Declaration The Filac 3000 Electronic Thermometer has been build and tested according to IEC 60601-1, CAN/CSA C22.2 No. 60601-1-08 and EN 60601-1-2 Standards. Guidance and manufacturer’s declaration – electromagnetic emissions The FILAC 3000 Electronic Thermometer is intended for use in the electromagnetic environment specified below. The user of the FILAC 3000 Electronic Thermometer should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF emissions (CISPR 11)

Group 1

T he FILAC 3000 Electronic Thermometer uses RF energy 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 (CISPR 11)

Class B

Harmonic emissions (IEC 61000-3-2)

Not applicable

The FILAC 3000 Electronic Thermometer is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 12

Guidance and manufacturer’s declaration – electromagnetic immunity The Filac 3000 Electronic Thermometer is intended for use in the electromagnetic environment specified below. The user of the Filac 3000 Electronic Thermometer should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD) (EN 61000-4-2 per EN 60601-1-2: 2001)

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient / burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

not applicable not applicable

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV differential mode ± 2 kV common mode

not applicable not applicable

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5 % UT (>95 % dip in UT ) for 0,5 cycle 40 % UT (60 % dip in UT ) for 5 cycles 70 % UT (30 % dip in UT ) for 25 cycles < 5 % UT (>95 % dip in UT ) for 5 sec

not applicable

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Filac 3000 Electronic Thermometer requires continued operation during power mains interruptions, it is recommended that the P-STIM be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field (EN 61000-4-8 per EN 606011-2: 2001)

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note UT is the a. c. mains voltage prior to application of the test level. Recommended separation distances between portable and mobile RF communications equipment and the Filac 3000 Electronic Thermometer The Filac 3000 Electronic Thermometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Filac 3000 Electronic Thermometer can help prevent electromagnetic interference by maintaining the minimum distance between portable and mobile RF communications Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d= 1,2√P

80 MHz to 800 MHz d=1,2√P

800 MHz to 2,5 GHz d = 1,2√P

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

2

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

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) 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 reflections from structures, objects and people.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 13

Guidance and manufacturer’s declaration – electromagnetic immunity The Filac 3000 Electronic Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Filac 3000 Electronic Thermometer should assure that it is used in such an environment. Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic environment –guidance Portable and mobile RF communications equipment should be used no closer to any part of the Filac 3000 Electronic Thermometer, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Not applicable

Radiated RF (EN 61000-4-3 per EN 60601-1-2: 2001)

3 V/m 80 MHz to 2,5 GHz

3 V/m

Not applicable d = 1,2√P 80 MHz to 800 MHz d = 2,3√P 800 MHz to 2,5 GHz 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). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1 At 80 MHz and 800 MHz, 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. a 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 Filac 3000 Electronic Thermometer is used exceeds the applicable RF compliance level above, the Filac 3000 Electronic Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Filac 3000 Electronic Thermometer. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Filac™ 3000 EZ/EZA Electronic Thermometer

Table of Contents 14

Manual No. SMF0212-004

Identification of a substance that is not contained or present within the product or packaging.

U.S. Patents (when used with a thermometer probe cover 6,619,837); 6,634,789; 6,839,651; 7,316,507; 7,494,274; 7,549,792; 7,648,268; 7,654,735; D532,710; D535,202; D548,626; D554,008. COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG.

0123

TM* Trademark of its respective owner. Other brands are trademarks of a Covidien company. © 2012 Covidien. Made in China. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business & Technology Park, Tullamore. www.covidien.com 1-800-962-9888 [T] REV 12/2012