LICNAME INSTITUT MARINA 15/11/2017

Fluke Biomedical Ansur

Test and Inspection Procedure
Copyright © 2000 - 2014 Fluke Biomedical

Test Record
TEST PASSED
Test Performed Ansur Components Used
Date: 15/11/2017 Ansur Version 3.0.0
Record: Test Sequence 1 Plug-In: ESA620 Version 1.1.11
Template: monitor.mtt
Template Version: 1.0.5

Test Setup
Selections
Service Events Performed Standards Performed
IEC 60601 User defined

Device under test

Serial Number US61101159 Type CLASE I
Appliance Code . Model SURESIGNS VM4
Group MONITORES Location .
Status . Address 1 .
Manufacturer PHILIPS Address 2 .

MTI Data
Test Instrument Serial Number Firmware Version
ESA 620 3617067 v2.11

Signatures

Test Record 1 Page 1 of 3

Fluke Biomedical Ansur Test Report LICNAME INSTITUT MARINA 15/11/2017

Test Result
Test Element Test Type Fail
IEC 60601-1 - CL1 Auto Sequence
Procedure:
(1) Connect the DUT to the ESA620 as indicated in the operators manual.
(2) Ensure that DUT power is On.
(3) Click module setup and specify the patient leads that are to be tested.
(4) Connect patient leads as indicated to the right.
(5) Click Start Test to perform the safety test.

Applied Part setup

# Applied Part info Class Leads
1 A.P. Code ECG CF 3
Serial No.
Type
2 A.P. Code SPO2 BF 1
Serial No.
Type
3 A.P. Code PANI BF 1
Serial No.
Type

Protective Earth Resistance Protective Earth Resistance

Configuration:
Test Current: Low
Result: Value Unit High Limit Low Limit Standard
PE Resistance1 0,050 Ohm 0,2 IEC 60601
User defined

Enclosure Leakage Current Enclosure Leakage Current

Configuration:
Unused Applied Parts: Floating
Result: Value Unit High Limit Low Limit Standard
Test Group 77,5 uAAC+DC IEC 60601
User defined

Enclosure Leakage Current

Normal Condition Normal Condition
Procedure:
es la medida de la corriente de fuga entre las partes metálicas expuestas del
Instrumento y partes del sistema dentro del entorno del paciente
polaridad normal e invertida
Result: Value Unit High Limit Low Limit Standard
Normal Condition 1,1 uAAC+DC 100 IEC 60601

Enclosure Leakage Current

Open Earth Open Earth
Procedure:
Es la medida de la corriente de fuga de las partes metálicas expuestas del
Instrumento bajo prueba (IUT) con el circuito abierto de Protección (PE) (S4 =
abierto) y entre las partes del sistema dentro del entorno del paciente

polaridad normal e invertida usando S2.

Result: Value Unit High Limit Low Limit Standard
Open Earth 77,5 uAAC+DC 500 IEC 60601

Test Record 1 Page 2 of 3

Fluke Biomedical Ansur Test Report LICNAME INSTITUT MARINA 15/11/2017

Test Element Test Type Fail

Enclosure Leakage Current
Normal Condition, Reversed mains Normal Condition, Reversed mains
Result: Value Unit High Limit Low Limit Standard
Normal Condition,
1,1 uAAC+DC 100 IEC 60601
Reversed mains

Enclosure Leakage Current

Open Earth, Reversed Mains Open Earth, Reversed Mains
Result: Value Unit High Limit Low Limit Standard
Open Earth, Reversed
77,4 uAAC+DC 500 IEC 60601
Mains

Patient Leakage Current Patient Leakage Current

Configuration:
Total Leakage: No
Unused Applied Parts: Floating

Patient Leakage Current

Open Neutral Open Neutral
Result: Value Unit High Limit Low Limit Standard
SPO2 0,5 uAAC+DC User defined
PANI 0,2 uAAC+DC User defined
ECG 0,6 uAAC+DC User defined

Patient Leakage Current

Open Earth Open Earth
Result: Value Unit High Limit Low Limit Standard
SPO2 0,8 uAAC+DC User defined
PANI 0,5 uAAC+DC User defined
ECG 2,4 uAAC+DC User defined

Patient Leakage Current

Open Neutral, Reversed Mains Open Neutral, Reversed Mains
Result: Value Unit High Limit Low Limit Standard
SPO2 0,5 uAAC+DC User defined
PANI 0,2 uAAC+DC User defined
ECG 0,6 uAAC+DC User defined

Patient Leakage Current

Open Earth, Reversed Mains Open Earth, Reversed Mains
Result: Value Unit High Limit Low Limit Standard
SPO2 0,8 uAAC+DC User defined
PANI 0,5 uAAC+DC User defined
ECG 2,4 uAAC+DC User defined

Test Record 1 Page 3 of 3