Wahl 392HP Especificações descarregar pdf (Página 16)

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10/08

172 Years of Continued Innovation

ISO9001:2000 CERTIFIED

Wahl

DST600

Solution

WARRANTY

Calibration Services Available

Complete Calibration Services Available

FDA Proposed Rule 21CFR Part 113 Wahl DST600 Solution

Items 1 and 2 are from the Preamble.

4b Ambient Temperature variations Ambient Temperature coefficient of no

greater than .003°/°. This equates to no

more than .03° change in reading for a 10°

ambient temperature change.

4c Vibration Tested in accordance with MIL STD 202G

Method 201A extended to 60Hz vibration: 10

to 60 Hz.

4d Each temperature-indicating device and refer-

ence device shall have a tag, seal, or other

means of identity.

DST600's are clearly marked with unique

serial numbers visible from the front panel.

Serial numbers are also electronically stored

in internal memory and cannot be tampered

with by the user. Custom user identification

numbers may be added by user.

5 113.40 (ii) Written documentation of the accuracy of

the temperature-indicating device and the

reference device shall be established and

maintained.

Processor is responsible for establishment

and maintenance of documents. All NIST

traceable certifications performed by Wahl

are provided in writing and include test data

showing "as received" analysis and "as

returned" accuracy of the instrument. Copies

of these certifications are maintained in our

facility for the life of the instrument if you

have Palmer Wahl certify your DST600 every

year.

6 113.40 (A) Documentation of the accuracy of the tem-

perature-indicating device shall include a ref-

erence to the tag, seal, or other means of

identity used by the processor to identify the

temperatur

e-indicating device, the name of

the manufacturer of the temperature-indicat-

ing device, the identity of the reference

device used for the accuracy test and of

equipment and procedures used to adjust or

calibrate the temperature-indicating device,

the date and results of each accuracy test,

the name of the person or facility that per-

formed the accuracy test and adjusted or cal-

ibrated the temperature-indicating device,

and the date of the next scheduled accuracy

test.

Wahl’s NIST traceable certificate includes all

of the requirements of this paragraph.

ahl

recommends you return product to Palmer

Wahl for re-calibration.

If pr

ocessors per

form their own testing,

compliance to this paragraph is required.

Wahl's calibration software is simple, fast

and easy to use.

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