NATIVA S.R.L.

19/01/2018

Fluke Biomedical Ansur

Test and Inspection Procedure
Copyright © 2000 - 2014 Fluke Biomedical

Test Record
TEST PASSED
Test Performed Ansur Components Used
Date: 19/01/2018 Ansur Version 3.0.0
Record: QA_ES_ep_1.0.1.mtr Plug-In: AVPI Version 2.4.11
Template: QA_ES_ep_1.0.1.mtt Plug-In: QA-ES Version 1.4.8
Template Version: 1.0.1

Test Setup
Selections
Service Events Performed Standards Performed
User defined

Device under test

Serial Number 1066240 Type Electrobisturí
Manufacturer Minicomp Model Kairos

Signatures

Test Record 1 Page 1 of 2

Fluke Biomedical Ansur Test Report NATIVA S.R.L. 19/01/2018

Test Result
Test Element Test Type Fail
Visual Inspection Checklist Checklist
Procedure:
Perform a visual inspection of the ESU and all available accessory cables, electrodes, etc.
Result: Recorded Value
Exterior of ESU is free
Pass
from damage and clean
Footswitch and
connecting cable are free Pass
from damage
Patient connection
cables to ground return
pad, cut/coag electrode,
Pass
and special accessory
electrodes are free from
damage and clean
Power cord, including
mains power
Pass
plug/connector and strain
relief are free from damage
Interior of ESU is free
Pass
from dust and other debrie

QA-ES output test Output test

Test Conditions Results
Power Load Low Limit Power High Limit CF Current Vp-p
50 W 500 Ohms 40 67,8W 80 1,6 369,7mA 597,3V
100 W 500 Ohms 80 150,5W 160 1,7 550,9mA 936,5V
150 W 500 Ohms 120 231,2W 240 1,8 682,8mA 1196,0V
200 W 500 Ohms 160 313,4W 320 1,8 795,0mA 1413,1V
250 W 500 Ohms 200 388,2W 400 1,8 884,9mA 1596,5V
300 W 500 Ohms 240 417,7W 480 1,8 917,9mA 1669,3V
350 W 500 Ohms 280 417,5W 560 1,8 917,6mA 1666,4V
400 W 500 Ohms 320 417,9W 640 1,8 918,1mA 1673,0V

QA-ES output test

700,0

600,0

500,0
Power [Watts]

400,0

300,0

200,0

100,0

0,0

50 100 150 200 250 300 350 400

ESU Power Setting [W]

QA-ES H.F. leakage test H.F. leakage test

Test Conditions High Limit Results
Power Mode Act. Neu. Act.1 Neu.1
100W Cut 137,8 mA 140,1 mA

Test Record 1 Page 2 of 2