Braun WelchAllyn ThermoScan PRO 4000 Manuel de l'opérateur

ThermoScan

PRO 4000

Type 6021

1-800-327-7226

Type: 6021

I / O

mem

6021221_PRO4000_S1 Seite 1 Freitag, 17. März 2006 11:19 11

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 1 of 9

This documentation provides only technical information - technical data, calibration instruction, general

information and regulations for medical products.

The function of the thermometer is described in the Operating Instructions, Welch Allyn P/N 701622

Technical data: Display: LCD-Display.

Display resolution: 0.1 °C / °F.

Displayed temperature range: 20.0 °C - 42.2 °C (68 .0 °F - 108.0 °F).

Work place temperature range: 10.0 °C - 40.0 °C (5 0.0 °F - 104.0 °F).

Work place humidity: up to 95 %.

In the range between: 35.5 °C - 42.0 °C (95.9 °F - 107.6 °F).

the accuracy of allowable

tolerance with probe cover is: ± 0.2 °C (± 0.4 °F ).

Outside the range from: 35.5 °C - 42.0 °C (95.9 °F - 107.6 °F).

the accuracy of allowable

tolerance with probe cover is: ± 0.3 °C (± 0.5 °F ).

Probe tip: heated up to approximately 37°C.

Power supply: rechargeable Braun battery-pack with

base-station and smart plug

or 2 1.5 V type AA (LR 6) batteries.

Smart plug: 100-240 V - input / 12 V – output.

Base-station: 12 V - input / approx. 2.4 V – output.

Battery-life time: 3 month (with *) / 1000 measurements.

Rechargeable battery lifetime: 3 month / 500 measurements per charge.

Rechargeable battery charging: Thermometer stored in basis-station.

Rechargeable battery charging time: 14 hours.

Base-station function indications: 1 LED, green for power connection

1 LED, yellow for charging indication.

Electronic anti-theft *: for Pro 4000 appliances only and with

the base-station in use.

Automatic turn off: If no button is pressed within 60 seconds, the

appliance will turn off automatically.

Manual turn off: Push - button for >3 seconds.

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 2 of 9

General hints

Production code Near the battery storage LOT 4042.

4= Year / 042 = Day.

Attention:

Do not dispose of empty batteries or defective rechargeable batteries in household

waste. Disposal can take place at appropriate collection sites provided in your country

Hint:

Type BF equipment

This appliance conforms to the following standards: DIN EN 60601-1

<<Medical electrical equipment>>-Part 1: General requirements for safety.

Hint:

0297

This product conforms to the provisions of the EC directive 93/42/EEC

(Medical Device Directive).

Labour Group: 03

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 3 of 9

Special tools: The accuracy of infrared thermometers can only be tested with a blackbody device

(BB-3200 Series, no longer available for purchase) or the 9600 PLUS Calibration

Tester.

The Model 9600 PLUS Calibration Tester can be ordered through Welch Allyn

Customer Service (see page 8) for Welch Allyn contact information.

Model Welch Allyn P/N Braun P/N

9600 PLUS Calibration Tester 01802-110 N/A

The following additional data will be necessary:

Bill to address

Ship to address

Quantity

Billing contact person with fon/fax extension

Shipping contact person with fon/fax extension

Shipping method

Purchase Order / Credit Card

The blackbody has to be calibrated every 12 months by the manufacturer. Contact

Welch Allyn Customer Service to get a Return Material Authorization number to have

your unit calibrated. Refer to Customer Service Listing (see page 8) for Welch Allyn

contact information.

Please direct all requirements and questions concerning blackbodies directly to the

Welch Allyn Service Center. Refer to Customer Service Listing (see page 8) for

Welch Allyn contact information.

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 4 of 9

General: Braun ThermoScan infrared thermometers are classified as medical devices. This

implies that the manufacturer, the distributor and all service functions have to fulfil

certain legal requirements.

Special care has to be taken, to ensure that only products are handed back to the

consumer, which are safe and perform according to its specifications. Furthermore,

you are obliged to notify Braun Corporate Quality of any unusual defects of the

appliance (see also section "customer complaints").

Products sent in by consumers as defective, must be checked thoroughly for any

technical deficiencies. If there is any doubt about the performance of the unit, it must

be exchanged. A repair, except cleaning, is not possible and strictly forbidden.

If the result of the check shows, that the product is working within specifications, it

will be sent back to the consumer. In this case it is important to include information

on the condition of the unit that was initially received as defective and to give

guidance for the correct use of the appliance.

Initial inspection: The checking should always start with a visual inspection of the unit for any external

damage. Especially the probe tip and probe cover should be examined for any dirt

(earwax), which could adversely affect the measuring accuracy.

After pressing the “On” button, the unit performs a self-test and all segments of the

unit should show up. For any error messages refer to technical data and

troubleshooting sections or to use instructions.

The measuring accuracy can only be tested with a blackbody (BB-3200) or 9600

PLUS, which has a precisely defined temperature.

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 5 of 9

Calibration general: Checking the measuring accuracy with blackbody BB 3200 or 9600 PLUS

NOTE: It is recommended that the PRO-4000 have an Operational

Verification performed annually using the 9600 Plus Blackbody device.

•

Testing must only be done in Calibration mode (see page 6).

•

Use a new probe cover for calibration check (transparent protection cap).

•

Make sure that...

The ambient temperature is within the range 20...25 °C and is stable (no

drafts).

The appliances to be checked have had time to adapt to ambient temperature,

i.e. they have been placed unpacked in the room for at least half an hour prior

to the test.

After reaching the calibration mode (CAL) wait for 1 minute, insert the

appliance into the black body and wait for 3 seconds again to start the

measuring.

Wait about 1 minute before taking repeat measurements; during waiting, the

unit should be put down and not kept in hand.

A series of 3 measurements should be taken. All three measurements should

be with in the specific range.

•

Due to the design of this black body, its emission factor is only 0.99. Since

PRO/IRT 4000 models are calibrated on a blackbody with emission factor 1.00 in

the factory, a correction has to be made for the black body effective temperature.

This correction is -0,1°C for PRO/IRT 4000. Due to the heated probe tip, this

value is different compared to PRO/IRT 3000.

•

Appliances with readings outside the permissible range where the probe tip is

contaminated can be cleaned carefully with a cloth soaked with alcohol. After

cleaning wait at least 5 minutes before retest.

•

All measured values must be documented according to Welch Allyn Quality

procedures, stating the date of measurement, the serial number of the unit, the

measured values and the final decision. All data will be documented via SAP or

current data collection system.

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 6 of 9

Calibration Mode: To enter the calibration mode, perform the following steps:

•

Use a new probe cover for calibration check.

•

Turn the product on by push the -button. Following symbols and functions

will be shown on the display.

- Automatic self-check.

- After few seconds a beep signal is audible, the display shows these symbols.

•

Push the -button again and keep it pressed for the following steps:

- After approximately 3 seconds the "OFF"-symbol is flashing on the display.

- After approximately 5 more seconds a beep signal is audible, now ...

release the -button immediately.

The product is now in calibration check mode: the display is flashing and

showing "CAL" and "

- - -

" alternately. The probe tip is heated up to the

correct temperature.

After each measurement the display is flashing and showing "CAL" and

only (two)

"- -

" alternately, the probe tip is not heated up. No measurement is

possible.

Push the "start" - button for new heating up of the probe tip. The appliance will

show again ("CAL" and "

- - -

"). It is now ready for a new measurement.

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 7 of 9

Calibration: Follow the operating instructions for the BB-3200 or 9600 PLUS closely.

The measured value must be within: 39.7 °C to 40.1 °C

(103.5 °F to 104.3 °F ).

NOTE: The measured temperature will vary with ambient temperature.

Advanced Display

(High resolution))

•

Calibration mode must be activated: the display is flashing and showing

"CAL" and "

- - -

" alternately.

•

One temperature measuring with probe cover must be done.

•

Push once the - button short time.

- High resolution mode: the display is flashing and showing "hr" and

measured temperature e.g "736" (37.36 = hundredth °C) alternately.

The first digit will be not showing.

•

Push once again the - button short time.

- Ambient temperature mode: the display is flashing and showing "AT"

and ambient temperature e.g. "23.6 °C " alternately.

•

Push once again the - button short time.

- Probe tip temperature mode: the display is flashing and showing "ST"

and probe tip temperature e.g. "37.0 °C " alternately.

•

Push once again the - button short time for reset to the

first display ("CAL" and "

- - -

").

For leaving the CAL-mode wait approx.4 minutes, the appliance will turn off

automatically or push -button for > 3 seconds.

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 8 of 9

Customer complaints: Welch Allyn encourages all service centers to report customer complaints.

This information is valuable for the improvements of products.

All complaints where it is alleged, that our product has caused or contributed to a

death or a serious deterioration in the state of health of a patient, user or other

person, must be reported immediately to your local Welch Allyn Organization.

A serious deterioration in the state of health can include a life-threatening illness or a

condition necessitating medical intervention to prevent permanent damage.

Also all cases should be reported where the circumstances indicate, that the incident

was such that, if it occurred again, it may lead to death or serious deterioration in

health.

Yearly Calibration of

Professional units: NOTE: It is recommended the PRO-4000 device have an Operational

verification performed annually using the Model 9600 Plus Blackbody device.

In general, the accuracy for the PRO-4000 unit should be checked any time you

suspect the unit is not reading correctly.

Some countries, e.g. Germany, require by legislation a regular check of the

measuring accuracy for all medical devices used by professionals.

For infrared thermometers, this check must be done yearly and it is required to verify

the measuring accuracy for the full temperature range. This implies to test at three

different temperatures the correct reading and to document the results in a test

protocol.

If similar regulations should apply for your country, please contact your Welch Allyn

Service Center for details on necessary equipment and procedures. Please note that

the above described test procedure with the BB 3200 is not sufficient for this

purpose.

The 9600 PLUS Calibration device should be used to verify these parameters.

The PRO-4000 can’t be calibrated in the field. By using the Black Body device, you

can verify accuracy of the unit only.

Welch

Allyn

Service Documentation

Part Number: 701627 Rev. G

Welch Allyn

701627 REV. G

Page 9 of 9

Authorized Welch Allyn The following is a listing of authorized Welch Allyn Service Centers and Customer

Service contact numbers:

United States Service Center

Welch Allyn

North Dock

4619 Jordan Road

Skaneateles Falls, NY 13153

Customer Service: 800-535-6663

Service Fax: 315-685-3361

Canada Service Center

Welch Allyn Canada

160 Matheson Blvd. E

Unit 2

Mississauga, ON L4Z 1V4

Customer Service: 905-890-0004

Service Fax: 905-890-0008

Australia Service Center

Welch Allyn Australia

The Metro Centre Unit 5

38-46 South Street

Rydalmere, NSW 2116

Customer Service: 61-2-9638-3000

Service Fax: 61-2-9638-3500

EMEA Service Center

Welch Allyn GMBH

Product Service Center

Zollerstrasse 2-4

Jungingen, 72417

Germany

Customer Service: 011 49 7477 9271 0

Fax: 011 49 7477 9271 90

South Africa

Welch Allyn South Africa

394 Surrey Ave.

Ferndale

Randburg, GP 2194

Customer Service: 011-2711-777-7509

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