Gossen MetraWatt SECULIFE ST PRO Manual de usuario

Condensed Operating Instructions

SECULIFE STPRO

Tester for Testing the Electrical Safety of Medical Devices 3-447-033-03

1/7.19

Please read the full operating instructions as well,

which are available as a PDF file at

www.gossenmetrawatt.com.

The condensed operating instructions do not

replace the full operating instructions!

Important

Read carefully before use.

Recommendation: Keep on file for future reference!

Download Center

2GMC-I Messtechnik GmbH

Operating and Connection Overview

MEM: Database

ESC

: Return

HELP: Help images

START

: Start/Stopp

– Single meas.

– Test seq.

Finger contact

: Print via USB

Softkeys

Fixed Function Keys

2 USB-Master

– For keyboard

– For scanner

– For printer

– For USB stick

1 USB-Slave

– For PC

Test socket for

connecting DUTs

Caution!

Depending on the measur-

ing task, the test probe may

be charged with line voltage.

Rotary-

Selector Switch

Test sequences A1 ... A9

(test sequences per standard)

Rotary switch level: orange

Single measurements

Rotary switch level: green

LCD panel

Connection for

voltage supply

SECUTEST CLIP

(Z745H)

test probe

Fuse compartment

Voltage measurement

Sockets

test probe

Special Symbol Displays:

– Measurement at IT line active

– OFFSET for RPE active

– for devices connected to the USB

master interface see above

AP A ... K

Applied parts sockets

Provided test sequences

Provided individual

measurements

See Page 7

Test sequence per

VDE 0701-0702 ✔

IEC 62353 ✔

IEC 60601 KA01

IEC 60974-4 ✔

White/silver

identified and

fused high

current path

Kink protection grommet:

black: max. 16 A

green: max. 25 A

mains to test socket

SFC: normal condition

mains to test socket

SFC: N interrupted

SECULIFE ST PRO Operating and Connection Overview

GMC-I Messtechnik GmbH 3

Table of Contents Page

1 Safety Precautions .....................................4

2 Initial Start-Up ...........................................6

2.1 Mains Connection ........................................6

2.2 Detection of Mains Connection Errors ............6

Functions Overview of Instrument ................ 7

4 User Interface Symbols – Parameter and

Softkey Symbols ........................................8

5 Internal Database ......................................9

5.1 Creation of Test Structures ...........................9

5.2

Export – Transmission and Storage of Test

Structures and Measurement Data ................... 9

5.3

Import ............................................................. 9

6 Data Input ..................................................9

6.1 Entry via Touch Screen .................................9

7 Notes on Saving Single Measurements

and Test Sequences ................................10

8 Single Measurements ..............................11

8.1 RPE – Protective Conductor Resistance for

Protection Class I Devices ...........................12

8.2 RINS – Insulation Resistance Measurement

for Protection Class I Devices ......................13

8.3 RINS – Insulation Resistance Measurement

for Protection Class II Devices .....................14

8.4 IPE – Protective Conductor Current .............15

8.5 IT – Touch Current .....................................16

8.6 IE – Device Leakage Current .......................17

8.7 IA –

Leakage Current from the Appl. Part ...........18

8.8 IP – Patient Leakage Current ......................19

8.9 IPA – Patient Auxiliary Current ....................20

8.10 U – Probe Voltage ......................................21

8.11 U – Measuring Voltage ...............................22

8.12 FT – Functions Test ...................................23

8.13 EL1 – Function Testing of Extension Cords ..24

8.14 EXTRA – Special functions ..........................25

8.15 2-Pole Measurements with P1 &

P2 Test Probes ..........................................27

8.16 Measurement with Current Clamp Sensor at

Permanently Installed DUTs of Safety Class I

8.17 Measurements with Test Adapter ...............28

9 Test Sequences in AccordanSce with

Standards ................................................ 29

9.1 General Procedure .................................... 29

9.2 Evaluation Procedure ................................. 29

9.3 Sample Test Sequence .............................. 30

10 Parameters for Individual Measurements

and Test Sequences ................................ 34

11 Repair and Replacement Parts Service

Calibration Center and Rental Instrument

Service .................................................... 34

12 Product Support ...................................... 34

13 Declaration of Conformity ....................... 35

14 Database Software ................................. 36

Scope of Delivery

Standard Version (country-specific)

1 Test instrument SECULIFE ST PRO

1 Mains connection cable

1 Test probe, 2 m, not coiled

1 USB cable, USB A to USB B, length: 1.0 m

1 Plug-on alligator clip

1 Cable set KS17-ONE

1 Calibration certificate

1 Condensed operating instructions

– Complete operating instructions avail-

able for download from our website

1 Card with registration key for

IZYTRONIQ BUSINESS Starter software

(software available for web download)

Order Options

* for voltage measurement, for connecting current clamp

sensors or AT3 adapters as well as for temperature

measurement via RTD

M7050- without with

Touch screen —E01

10 A RPE test current — G01

25A RPE test current — G02

2nd test probe —H01

Voltage measuring input * —I01

Applied parts sockets —J01

Test sequence per IEC 60601 KA00 KA01

Z853R – SECUTEST DB+ —KB01

IZYTRONIQ compatible —KC01

Z853S – SECUTEST DB COMFORT

—KD01

Bluetooth®M00 M01

SECULIFE ST PRO Contents / Scope of Delivery

4GMC-I Messtechnik GmbH

1 Safety Precautions

SECUTEST BASE(10), SECUTEST PRO and

SECULIFE ST BASE(25) test instruments are

manufactured and tested in accordance with

the following safety regulations:

IEC/EN 61010-1 / VDE 0411-1, DIN VDE

0404, IEC/EN 61577 / VDE 0413-2,-4 / DIN

EN 61557-16 / VDE 0413-16

The safety of the user, the test instrument

and the device under test (electrical equip-

ment or electrical medical device) is only

assured when the instrument is used for its

intended purpose.

Read these condensed operating instructions and

the full operating instructions carefully and com-

pletely before placing your test instrument into

service (available at our homepage www.gossen-

metrawatt.com for download). Follow all instruc-

tions contained therein. Make sure that the oper-

ating instructions are available to all users of the

instrument.

Tests may only be performed by a qualified

electrician, or under the supervision and

direction of a qualified electrician. The user

must be instructed by a qualified electrician

concerning performance and evaluation of

the test.

Suitable personal safety equipment is

required.

If you use any active or passive implanted

medical devices, please consult your doctor

or the manufacturer of these devices.

Note!

Manufacturers and importers of electrical

medical devices must provide documen-

tation for the performance of mainte-

nance by trained personnel.

Observe the following safety precautions:

• The instrument may only be connected

to electrical systems (TN, TT or IT) with a

maximum of 240 V which complies with

applicable safety regulations (e.g. IEC

60346, VDE 0100) and is protected with

a fuse or circuit breaker with a maximum

rating of 16 A.

• Measurements within electrical systems

are prohibited.

• Be prepared for the occurrence of unex-

pected voltages at devices under test (for

example, capacitors can be dangerously

charged).

• Make certain that the measurement

cables are in flawless condition, e.g. no

damage to insulation, no cracks in

cables or plugs etc.

• When using a test probe with coil cord

(SK2W):

Grip the tip of the test probe firmly, for

example during insertion into a jack

socket. Tensioning at the coil cord may

otherwise cause the test probe to snap

back resulting in possible injury.

•Measurement of insulation resistance and

equivalent leakage current (leakage current

alternative measuring methods)

Testing is conducted with up to 500 V.

Current limiting is utilized (I < 3.5 mA),

but if terminals L or N at the test socket

are touched, electrical shock may occur

which could result in consequential acci-

dents.

•Leakage current measurement during opera-

tion with line voltage: Please note that the

device under test is operated with line

voltage during measurement. Exposed

conductive parts may conduct danger-

ous touch voltage during testing. Do not

touch under any circumstances! (Mains

power is disconnected if leakage current

exceeds approx. 10 mA.)

Attention!

The function test may only be per-

formed after the DUT has successfully

passed the safety test!

•Probe check for probe connector P1: Please

perform a probe check after each test.

Attention!

If there is a fuse defect in test probe

P1 after having started the test, all

subsequent measurements which

are performed with this measure-

ment path might be erroneously

rated as good!

SECULIFE ST PRO Safety Precautions

GMC-I Messtechnik GmbH 5

Fuse replacement

The fuses may only be replaced when the

instrument is voltage-free, i.e. the instrument

must be disconnected from mains supply

power and may not be connected to a mea-

suring circuit. The fuse type must comply

with the specifications in the technical data

or the labeling on the instrument.

Opening the instrument / repairs

The instrument may only be opened by

authorized, trained personnel in order to

ensure flawless operation and to assure that

the guarantee is not rendered null and void.

Even original replacement parts may only be

installed by authorized, trained personnel.

If it can be ascertained that the instrument

has been opened by unauthorized person-

nel, no guarantee claims can be honored by

the manufacturer with regard to personal

safety, measuring accuracy, compliance

with applicable safety measures or any con-

sequential damages.

Any warranty claims will be forfeited when

the warranty seal has been damaged or

removed.

Switching power consumers (max. 16 A*)

Be absolutely sure to adhere to the

sequence specified below when switching

the live device under test. This prevents

excessive wear of the mains relays at the

test instrument.

Before measurement:

1) DUT: Turn the DUT off via its own switch.

2) Test er:

Switch line voltage to the test

socket.

3) DUT: Turn the DUT on via its own switch.

After measurement:

4) DUT: Turn the DUT off via its own switch.

5) Test er:

Deactivate line voltage to the test

socket.

* for currents > 16 A AC please use adapter

AT3-IIS32 (Z745X)

The test instrument may not be used:

• If external damage is apparent, for example

if parts which conduct dangerous touch

voltage are freely accessible, if the display

is broken or defective (in which case dan-

gerous voltage or mains connection errors

might no longer be indicated)

• If the seal or sealing lacquer has been

removed as the result of repairs or manipu-

lation carried out by a non-authorized/non-

certified service provider.

• With damaged connection and/or mea-

surement cables and patient ports, e.g.

interrupted insulation or kinked cable

• If the instrument no longer functions flawlessly

• After serious damage due to transport

In such cases, the instrument must be

removed from operation and secured

against unintentional use.

Meanings of Symbols on the Instrument

The symbols on the instrument have the fol-

lowing meanings:

Warning regarding dangerous

electrical voltage

Warning concerning a point of

danger (attention: observe docu-

mentation!)

Indicates European Conformity

This device may not be disposed of

with the trash. Further information

regarding the WEEE mark can be

accessed on the Internet at

www.gossenmetrawatt.com by

entering the search term „WEEE“.

If the guarantee seal is damaged

or removed, all guarantee claims

are rendered null and void.

QR CODE QR CODE is a registered

trademark of

DENSO WAVE INCORPORATED

SECULIFE ST PRO Safety Precautions

6GMC-I Messtechnik GmbH

2 Initial Start-Up

2.1 Mains Connection

Nominal mains values: 100 to 240 V, 50 Hz to 400 Hz

➭Connect the test instrument to the mains

cable via its inlet plug and insert the

mains plug into an electrical outlet. The

function selector switch can be set to

any position. If a mains outlet (earthing

contact outlet) is not available, or if only a

3-phase outlet is available, the adapter

socket can be used to connect the

phase conductor, the neutral conductor

and the protective conductor. The

adapter socket has three permanently

attached cables and is included with the

KS13 cable set (see wiring diagram in

the operating instructions).

Attention!

If connection is not possible via an

earthing contact outlet: Shut down

mains power first. Then connect the

cables from the coupling socket to

the mains using pick-off clips in ac-

cordance with the diagram. Discon-

nection from mains power is only

possible with the mains plug.

Measurements in IT Systems (as from FW 1.5.0)

The setting IT system can be activated in

selector switch position SETUP (Setup 1/3)

under sub-menu All Measurement:

Parameter „Meas. at IT-mains“ = Yes: active

leakage current measurements (and/or all

measurements which include the PE at the

mains connection end) are blocked. Test

sequences which contain such kind of mea-

surements are disabled as well.

2.2 Detection of Mains Connection Errors

The device automatically recognizes mains

connection errors if the conditions in the fol-

lowing table have been fulfilled. The user is

informed of the type of error, and all measuring

functions are disabled in the event of danger.

10 A/25 A

measurements are only possible with line

voltages of 115/230 V and line frequencies of 50/60 Hz.

if the test person is highly insulated, the following error

message may appear: „Interference voltage at PE of

mains connection“

Attention!

In the event of mains connection er-

rors as described in either of the first

two cases in the table above, imme-

diately disconnect the test instrument

from the mains and arrange to have

the error eliminated!

Note!

Voltage at the

electrical system’s

protec-

tive conductor PE

may result in distorted

measurement values during testing for

the absence of voltage, or during leak-

age voltage measurements.

Type of

Connection Error

Message Condition Measure-

ments

Voltage at protec-

tive conductor PE

to finger contact

(START/STOP key)

Display at the

instrument

Press START/

STOP button

U25 V

Button PE:

< 1 M2

All measure-

ments

disabled

Protective conduc-

tor PE & phase

conductor L

reversed and/or

neutral conductor

N interrupted

Voltage at PE

>100V

Impossible

(no supply

power)

Line voltage

< 180 V / < 90 V

(depending on mains)

UL-N < 180 V

UL-N <90V

Possible

under certain

circum-

stances

Test on I T / TN

system

Display at the

instrument

Connection

N PE

> 20 k

Possible

under certain

circumstances

SECULIFE ST PRO Initial Start-Up

GMC-I Messtechnik GmbH 7

3 Functions Overview of Instrument

10 A/25 A-R

measurements are only possible with line

voltages of 115 V/230 V and line frequencies of 50 Hz/60 Hz.

2 Voltage measuring inputs

3 Measurement of time to trip not possible in IT systems.

No checking for reversed polarity takes place when the

EL1 adapter is used.

Note!

Changes in test sequences A1 ... A9

are preserved even after switching off

the test instrument.

Switch

setting

Measuring functions,

test current/voltage

Single measurements,

rotary switch level: green

Measurements at voltage-free objects

RPE

Page 12

RPE protect. conductor resistance

Ip test current 200 mA

test current 10 A 1(Feature G01)

test current 25 A 1) (Feature G02)

RINS

Page 13

RINS insulation resistance

UINS test voltage

Measurements at DUTs with line voltage

IPE

Page 15

IPE

prot. conductor current, TRMS

IPE~ AC component

IPE= DC component

ULPE test voltage

UGen reference voltage (alternative)

Page 16

ITtouch voltage, TRMS

IT~)AC component

IT= DC component

ULPE test voltage

UGen reference voltage (alternative)

Page 17

device leakage current, TRMS

IE~ AC component

IE= DC component

ULPE test voltage

UGen reference voltage (alternative)

Page 18

leakage current from app. part

ULPE test voltage

UGen voltage at applied part

Page 19

patient leakage current, TRMS

IP~ AC component

IP= DC component

ULPE test voltage

IPA

Page 21

IPA

Patientenhilfsstrom effektiv

IPA~ AC component

IPA= DC component

ULPE test voltage

Page 21

Uprobe voltage, TRMS

U~ AC voltage component

U= DC voltage component

URMS Voltage 2

U~ AC voltage component 2

U= DC voltage component 2

P (FT)

Page 23

Function test at the test socket

Icurrent between L and N

Uvoltage between L and N

ffrequency

Pactive power

Sapparent power

PF power factor

Probe measuring functions

EL1

Page 24

Function test of extension cord with EL1/VL2E/

AT3-IIIE adapter: continuity, short-circuit,

reversed wires

EXTRA

Page 25

Reserved for expansions in connection with

software updates

°C Temperature measurement

with Pt100/Pt1000

IZ Measurement of current at clamp with

current clamp sensor

tA3)

time to trip for 10/30 mA PRCD

Test sequences per standard

rotary switch level: orange

Page 29

Preconfigured (freely selectable) test sequences

Features * KA00 / ** KA01 (IEC 60601 3rd edition)

A1 IEC 62353 passive TS BF APs A-K SK I

A2 IEC 62353 passive TS BF APs A-K SK II

A3 IEC 62353 passive TS BF APs A-K SK I+II

A4 IEC 62353 active auto.

det

. BF APs A-K SK I

A5 IEC 62353 active auto.

det

. BF APs A-K SK II

A6 IEC 62353

active

auto. det. BF

APs

A-K SK I+II

A7 * VDE 0701-0702 passive

auto. DUT det. SK I+II

A8 * VDE 0701-0702 active

auto. DUT det. SK I+II

A9 *

VDE 0701-0702 EDV

active auto. DUT det. SK I+II

A7 ** IEC 60601 active auto.

det

. BF APs A-K SK I

A8 ** IEC 60601 active auto.

det

. BF APs A-K SK II

A9 **

IEC 60601

active

auto. det. BF

APs

A-E SK I+II

IEC 60601

active

auto. det. CF

APs

F-K SK I+II

Switch

setting

Measuring functions,

test current/voltage

SECULIFE ST PRO Scope of Features

8GMC-I Messtechnik GmbH

4 User Interface Symbols – Parameter and Softkey Symbols

Sym-

bols

Setup

Page

Parameters and their significance

Complete overviews of all symbols are included in the full operating instructions.

1/3

All measurements

: Ref.voltage L-PE: voltage to which the measured values for leakage current

have been standardized; Gnd fault sens.: continuous residual current monitoring (10/30 mA)

Automatic measurements: set parameters for test sequences: start and end view,

inclusive operation uncertainty (yes/no), auto measurement point (yes/no)

1/3 Database: deletion, statistics,

with inserted USB stick : save, restore database

1/3 System: set general device parameters;

date/time, volume, brightness, default settings, self-test

2/3 Printer: printer selection for USB master interface

connected, disconnected

2/3 Tester: select tester from list, add new tester

2/3 Culture: select language for operating instructions, keyboard and measuring

sequences by acknowledging the respective national flag; Reboot necessary!

2/3 Optionally connected external devices

USB stick, keyboard / barcode scanner, printer

3/3 System information: query software and hardware version, serial number, build

number, calibration data and storage occupancy

— Functions and their significance

Set classification parameters for the respective test sequence

(test sequences: switch settings A1 ... A9)

Accept parameters, acknowledge message

Abort single measurement or test sequence

Evaluate measurement of visual inspection with OK or not OK (toggle key)

Continue test, next test step in the test sequence

Symbol left: Direct selection key measurement type (connection type...) or measur-

ing method (direct ...) / Symbol right: Selection between two states (no submenu)

Start evaluation – record measured value. Each time this softkey is pressed, an

additional measured value is saved and the number is increased by one.

Symbol left: Repeat measured value recording

Symbol right: Repeat test step in the test sequence

Symbol left: Delete measured value

Symbol right: Skip individual tests in the test sequence

Display measured values from performed measurements and test sequences

Magnifying glass symbol: show (+) or hide (–) details regarding database objects

or selected measurements

Enter a new ID for a test object either before or after a test, and in case the ID

has not yet been entered to the structure

Save measurement data / save measurement data as (with display of directory

path / ID or new entry of an ID other than the preselected one)

SECULIFE ST PRO Symbols

GMC-I Messtechnik GmbH 9

5 Internal Database

5.1 Creation of Test Structures

A complete test structure with data regard-

ing customers and devices under test be

created in the test instrument. This structure

makes it possible to store the results of sin-

gle measurements or test sequences of test

objects belonging to various customers.

Manual single measurements can be

grouped together into a so-called „manual

sequence“.

A complete description of data-

base creation is included in the full operating

instructions for your test instrument.

5.2 Export – Transmission and Storage of

Test Structures and Measurement Data

Structures set up in, and measurement data

saved to the test instrument can be imported

to the IZYTRONIQ report generating software

via a plugged-in USB stick (PRO and/or Fea-

ture KB01 only) or via the USB slave port.

Data can then be saved to the PC and

reports can be generated.

Note!

Data transfer to IZYTRONIQ should not

be started during single measure-

ments or test sequences.

Furthermore, you can save the database to

a plugged-in USB stick for subsequent

restoring to the device memory.

5.3 Import

The test structures created at the PC with

the help of the report generating software

can be loaded into the test instrument via an

USB stick or via the USB slave port.

6 Data Input

6.1 Entry via Touch Screen

After selecting ID or any other object param-

eter, a keyboard is displayed which allows

for the entry of alphanumeric characters via

touch screen. Alternatively, entries can also

be made with the help of a USB keyboard or

barcode scanner which is connected to the

instrument.

Procedure

(example: entering a DUT designation)

1 Switch the keyboard between upper-

case and lowercase via the field.

2 Switch the keyboard from numeric to

special character or alphabetic character

entry mode via the „123“, „sym“ or „abc“

field.

3 After pressing on the respective charac-

ter, it appears in the display field.

4 Repeat steps 1 through 3 until the com-

plete designation is shown in the display

field.

5 After pressing the green check-

mark, the selected character string

is saved.

The touch screen allows for the convenient

entry of data and comments, parameters

and direct parameter selection.

Delete characters

Accept entry *

Display Field

Key Field

from right *

Switching between

uppercase and lowercase

* also possible via the associated softkey

SECULIFE ST PRO Database – Keyboard

10 GMC-I Messtechnik GmbH

7 Notes on Saving Single Measurements and Test Sequences

At the end of each test, test results can be

saved under an ID number which is unequiv-

ocally assigned to the respective test object.

Depending on the initial situation, i.e.

whether or not a test structure or database

is already available or an ID has already been

entered, the following different procedures

are used for saving:

Variant 1 – pre-selection of an existing ID

You’ve already set up a test structure in the

test instrument

or loaded one from the

IZYTRONIQ

Open the database view before starting the

measurement by pressing the MEM key.

Then select the test object or its ID within the

test structure by pressing the respective

scroll key. Exit the database view (MEM navi-

gation) by pressing ESC and start the mea-

surement. Press the Save as key at the

end of the measurement. The display is

switched to the SAVE view. The ID appears

with a green or orange background. Press

the Save key in order to complete the pro-

cedure.

Variant 2 – entry of an existing ID at the end of the

test

You’ve already set up a test structure in the

test instrument

or loaded one from the

IZYTRONIQ

(

SECUTEST PRO

only)

. You perform the

measurement without first opening the data-

base. No test object was previously selected

in the database. Press the Save as key at

the end of the measurement. The following

message appears: „No DUT selected!“

Press the ID key. The softkey keyboard

appears.

If you enter an ID here which is already in the

database, the database view appears auto-

matically (MEM navigation) and the test

object’s ID is displayed inversely. Acknowl-

edge the entry by pressing the key. The

display is switched to the SAVE view. The ID

appears with a green or orange background.

Press the Save key once again in order to

complete the procedure.

Variant 3 – entry of a new ID at the end of the test

You haven’t yet set up a test structure in the

test instrument, or the ID is not included in

the existing structure.

Press the Save as key at the end of the

measurement. The following message

appears: „No DUT selected!“ Press the ID

key in order to enter the test object’s ID. The

softkey keyboard appears.

If you enter an ID here which is not yet

included in the database, a prompt appears

asking you if you want to enter a new object.

– :If you press , the display is switched

to the SAYVE view. The ID appears with a

green background. Press the key once

again in order to complete the procedure.

– :If you press , the database view

appears (MEM navigation). Go to the next

page (Process objects 2/3) by pressing ,

and then enter a new test object. Press

to this end. All possible object types

are displayed. Press „DUT“. The newly

entered ID appears in red to the right of

the ID parameter. Acknowledge the entry

by pressing the key. The display is

switched to the database view (MEM navi-

gation). The newly entered test object is

displayed inversely in the structure. Press

ESC in order to return to the SAVE view. The

ID appears with a green or orange back-

ground. Press the key once again in

order to complete the procedure.

–ESC: If you don’t want to save any mea-

sured values, press ESC twice in order to

go to the measuring view. If you press ESC

again, a prompt appears asking whether

or not you want to delete the measuring

points in order to continue with the mea-

surement without saving.

SECULIFE ST PRO Saving

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