Olympus CelonLab ENT Instruction Download Page 2

 

Safety Check Instruction

 

 

 

 

 

 

 

©  Celon AG 

Page 2 / 9 

 

Issue date: 01.09.2008 

SCI.991007-1.4 

Safety Check 

Instruction.doc 

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 

Summary of Contents for CelonLab ENT

Page 1: ...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...

Page 2: ...ountry 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...

Page 3: ...nnection 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...

Page 4: ...Celon AG Page 4 9 Issue date 01 09 2008 SCI 991007 1 4 Safety Check Instruction doc Fig 1 Sample of the backside of the CelonLab ENT power control unit Fig 2 Sample of the front panel of the CelonLab...

Page 5: ...Documentation 110 Document the test results in SCR 991007 3 Power output No Procedure Test equipment Electrosurgical analyzer Example QA ES Metron Connection cables HF output banana to the electrosurg...

Page 6: ...l analyzer according to the analyzer s instructions for use Set the power level of the unit to 12 and measure the following parameter Attention Start check procedure if not already done after setting...

Page 7: ...loaded and unloaded at rated load Connect the unit via the power cord with a rated supply voltage Connect the footswitch with the unit 280 Connect the load resistor 100 with the HF output 1 and 2 and...

Page 8: ...ety tester Example Unimet 1000 ST Bender Load resistor 100 25 W or more 5 tolerance low inductive part short time load Connection cables HF output banana to the load resistor Test accessories Power co...

Page 9: ...c 8 Inspection label No Procedure 430 Cover or exchange an inspection label as shown below at the enclosure back of the unit and mark the due date of the next periodic safety check month year The unit...

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