Olympus CelonLab ENT Instruction
Safety Check Instruction
SCI.991007-1.4
Product name:
Hardware version:
CelonLab ENT (100...120 V~)
30
REF no.:
WB991007
LAB991.025.007
The unit must undergo a safety check at annual intervals in accordance with the national statutory regulations. Please follow these test
instructions. All tests must be done with fully functional and calibrated test equipment and by technicians trained in the service / maintenance
of electrical medical devices. Record the test results in the “safety check report” for reference in future tests and provide the user of the unit
with a signed report. If the unit fails to meet any of the checks, contact the manufacturer.
During service / maintenance take care of the different hardware versions which may be applicable (see below).
The hardware version of the unit can be identified by the serial number which can be found on the type plate at the back side of the unit. The
table below shows the serial number range to identify the hardware version.
Hardware version
Serial number (SN)
30 … 31
A22701LE01.0001 ... A58702LE01.9999
32 … ≥ 35
1000-1001 … 6172-9999
From hardware version 35 the serial number itself includes already the hardware version. This code was introduced for units manufactured
since February 2005.
Example: 1234W35-567
Recommended test equipment and accessories
Electrical safety tester (Example: Unimet 1000 ST, Bender)
Electrosurgical analyzer (Example: QA-ES, Metron)
Load resistor 100 Ω, 25 W (or more), 5 % tolerance, low inductive part, short time load
Connection cables, HF-output (banana) to electrosurgical analyzer or load resistor
Power cord
Footswitch
Hardware version
© Celon AG Page 1 / 9
, Issue date: 01.09.2008
Safety Check Instruction
SCI.991007-1.4
1. Inspection of the unit and the accessories
No.
Procedure
010
Accompanying documents are present and legible:
- Instructions for Use
- EMC-Guidelines
- final test report (incl. test protocols according to the final test report)
- optional (depending on the country): medical device information (“Medizinproduktebuch”)
020
Labels present and legible:
Sample of symbol: “Unit is defibrillator-safe”
Visible on the front panel (see fig. 2)
Sample of symbol: “Caution! Read the Instructions for Use!”
Visible on the front panel (see fig. 2)
Samples of type plates: Details of the manufacturer, supply voltage, supply frequency, moisture
protection class (IP), reference number, serial number (e.g. 1234W34-567), power input, power
output, and output frequency.
Visible on the back of the unit (see fig. 1)
SN: 3580-1001
3580A34-567
1234W34-567
1234W34-567
© Celon AG Page 2 / 9
, Issue date: 01.09.2008
Safety Check Instruction
SCI.991007-1.4
No.
Procedure
020
030
Unit and accessories are externally undamaged:
- Enclosure and front panel have no serious destructions
040
Lift up the unit and shake it gentle. No clatter noise should be audible.
Documentation
050
Document the test results in “SCR.991007.
Sample of symbol: Connection for equipotential bonding
Visible on the back of the unit (see fig. 1)
Samples of label for power fuses:
Visible on the back of the unit (see fig. 1)
Sample of symbol: “Non-ionizing radiation”
Visible on the back of the unit (see fig. 1)
Sample of label for volume switch:
Visible on the back of the unit (see fig. 1)
Sample of label: Product name
Visible on the front panel (see fig. 2)
SPEAKER VOLUME
HIGH
LOW
Sample of symbol: “Waste electrical and electronic equipment”
Visible on the back of the unit, only applicable for
units within the European Union and sold after
August 13th, 2005. (see fig. 1)
© Celon AG Page 3 / 9
, Issue date: 01.09.2008
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