BC Biomedical SA-2500 User Manual
Operating Instructions
BC Biomedical SA-2500
Automated Safety Analyzer
User Manual
Standard Equipment
Contacts
Standard Accessories (included with Unit)
Product Support
Technical Questions
If required please contact:
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SA-2500 Safety Analyzer
16 A country specific power cable for SA-2500,
not DUT, BC20-20400
Kelvin Coiled Chassis Cable, BC20-20150
Plug-on alligator clip, BC20-20152
CD-ROM with remote control software
USB Cable, BC20-41352
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BC Biomedical
BC Group International, Inc.
Phone:
E-Mail
1-800-242-8428
1-314-638-3800
sales@bcgroupintl.com
Optional Accessories
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•
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ECG adapters, accepts 3&4 mm plugs, BC20-17024
ECG adapters, accepts 3mm plugs only, BC20-17025
International DUT
Test socket adapter, BC20-20200
Carrying case, BC20-30108
Replacement Fuses, BC80-00829
The accessories available for your instrument are checked for
compliance with currently valid safety regulations at regular intervals, and are amended as required for new applications. Currently
up-to-date accessories which are suitable for your measuring instrument are listed at the following web address along with photo,
order number, description and, depending upon the scope of the
respective accessory, data sheet and operating instructions:
www.bcgroupstore.com
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BC Biomedical
Contact Persons
Calibration Service
We calibrate and recalibrate all instruments supplied by BC
Biomedical, as well as by other manufacturers, at our service
center.
Competent Partner
BC Biomedical is certified in accordance with ISO
9001:2008.
Our calibration lab is accredited in accordance with
ISO/IEC 17025:2005 under registration number L2299 .
We offer a complete range of expertise in the field of metrology:
from test reports and factory calibration certificates, right on up to ISO17025 calibration certificates. Our spectrum of offerings is rounded
out with test equipment management. If errors are discovered during
calibration, our specialized personnel are capable of completing
repairs using original replacement parts. As a full service calibration
lab, we can calibrate instruments from other manufacturers as
well.
Services
Repair and Calibration Center*
If required please contact:
BC Biomedical
Service Center
3081 Elm Point Industrial Drive
St. Charles, MO 63304
Phone:
E-Mail
1-800-242-8428
1-314-638-3800
service@bcgroupintl.com
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Device and software updates to current standards
Replacement parts and repairs
Help desk
Calibration lab per ISO/IEC 17025:2005 Service
Contracts and test equipment management
Disposal of old instruments
*
accredited in accordance with ISO/ IEC 17025
Accredited quantities: AC/DC voltage, AC/DC current, resistance,
alternating voltage, alternating current value, capacitance, frequency,
force, pressure, and temperature
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Table of contents
Contents
Page
Contents
Page
1
1.1
1.1.1
1.1.2
Applications .................................................................. 5
Classification of Devices Under Test .................................... 6
Protection Classes ............................................................. 6
Applied Parts (electrical medical devices) ............................ 6
8 Index .............................................................................. 37
2 Safety Features and Precautions ..................................... 7
3 Terminals ........................................................................ 9
4
4.1
4.1.1
4.2
4.3
Initial Start-Up ................................................................ 10
Connection to the Mains (90 to 240 V, 50 to 400 Hz) ....................10
Automatic Recognition of Mains Connection Errors ........................10
Switching the Measuring Instrument On ............................. 10
Configuring Device Parameters – Setup Menu ................... 10
5
5.1
5.2
Manually Triggered Measurements .............................. 11
General Procedure ........................................................... 12
Overview ......................................................................... 12
6 Technical Data .............................................................. 30
7
7.1
7.2
7.3
7.4
7.5
Maintenance and Calibration ......................................... 34
Housing Maintenance ....................................................... 34
Replacing the Fuses ......................................................... 34
Recalibration .................................................................... 34
Manufacturer’s Guarantee ................................................ 35
Return and Environmentally Sound Disposal ....................... 35
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BC Biomedical
Applications and Classification of Devices Under Test
1 Applications
Measuring Categories and their Significance per IEC 61010-1
The measuring instrument is intended for quick, safe
measurement of repaired or modified electrical medical devices
and their components (e.g. applications parts) in accordance with
IEC 62353.
Adherence to technical safety requirements assures safe handling
of electrical medical devices for users of the measuring
instrument. The safety of the patient is also assured during use of
tested electrical medical devices.
Use for Intended Purpose
•
The measuring instrument can be used as a benchtop device
which must be isolated and set up on a solid base while
measurements are being performed.
Only those measurements which are descr ibed in the following
chapters may be performed with the measuring instrument.
The measuring instrument, including the measuring probe,
may only be used within the specified measuring category (see
page 8, as well as the table below regarding significance).
Overload limits may not be exceeded. See technical data on
page 30 for overload values and overload limits.
Measurements may only be performed under the specified
ambient conditions. See page 32 regarding operating temperature range and relative humidity.
The measuring instrument may only be used in accordance
with the specified degree of protection (see page 33).
!
Attention!
The measuring instrument may not be used for
measurements within electrical systems!
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CAT
Definition
I
Measurements in electrical circuits which are not directly connected to
the mains: for example electrical systems in motor vehicles and
aircraft, batteries etc.
II
Measurements in electrical circuits which are electrically connected to
the low-voltage mains: via plug, e.g. in household, office and
laboratory applications
III
Measurements in building installations: stationary power consumers,
distributor terminals, devices connected permanently to the distributor
IV
Measurements at power sources for low-voltage installations:
meters, mains terminals, primary overvoltage protection devices
Applications and Classification of Devices Under Test
1.1 Classification of Devices Under Test
1.1.1 Protection Classes
Devices assigned to all of the following protection classes are
equipped with basic insulation, and provide for protection against
electrical shock by means of various additional precautions as well.
1.1.2 Applied Parts (electrical medical devices)
Type B Applied Parts
(body)
Devices of this type are suitable for both internal and external
patient applications, except for use in direct proximity to the heart.
These devices provide for adequate protection against shock,
especially as regards:
•
Reliable leakage current
•
Reliable protective conductor connection if utilized
Protection Class I Devices
Exposed, conductive parts are connected to the protective
conductor so that they are not charged with voltage if the basic
insulation should fail.
Type BF Applied Parts
(body float)
Same as type B, but with type F insulated applied parts.
Protection Class II Devices
These devices are equipped with double insulation or reinforced
insulation.
Type CF Applied Parts
(cardiac float)
Devices of this type are suitable for use directly at the heart. The
application pa rt may not be grounded.
Protection Class III Devices
These devices are powered with safety extra-low voltage (SELV).
Beyond this, no voltages are generated which exceed SELV.
These devices may not be connected to the mains.
Note: Only a visual inspection can be conducted for devices of this
protection class with the BC Biomedical SA-2500.
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BC Biomedical
Safety Warnings
2 Safety Features and Precautions
Observe the following safety precautions:
•
The instrument may only be connected to electrical supply
systems with which conform to the valid safety regulations
(e.g. IEC 60364, VDE 0100) and are 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 unexpected voltages at
devices under test (for example, capacitors may be
dangerously charged).
Make certain that the measurement cables are in proper
working condition, e.g. no damage to insulation, no cracks in
cables or plugs etc.
Insulation Resistance Measurement (alternative leakage current):
Testing is conducted with up to 500 V. Current limiting is
utilized (I < 10 mA), but if the terminals (L and N) are touched,
electrical shock may occur which could result in consequential
accidents.
Leakage Current Measurement
It is absolutely essential to assure that the device under test is
operated with line voltage during performance of leakage
current measurements. Exposed conductive parts may
conduct dangerous contact voltage during testing, and may
not under any circumstances be touched (mains power is
disconnected if leakage current exceeds approx. 10 mA).
Function Test
This instrument fulfills the requirements of applicable European
and national EC directives. This is confirmed by means of the CE
mark. A corresponding declaration of conformity can be
requested from BC Biomedical.
The SA-2500 measuring instrument has been manufactured and
tested in accordance with the following safety regulations:
IEC 61010-1 / DIN EN 61010-1 / VDE 0411-1, DIN VDE 0404
IEC 61577 / EN 61577 / VDE 0413 part 1, 2 and 3
When used for its intended purpose, the safety of the user, the
measuring instrument and the device under test (electrical
equipment or electrical medical device) is assured.
Read the operating instructions carefully and completely before placing
your measuring instrument into service. Follow all instructions contained
therein. Make sure that the ope rating instructions are available to all
users of the instrument.
Tests may only be performed by qualified personnel, or under
the supervision and direction of qualified personnel. The user
must be instructed by qualified personnel in the execution and
evaluation of tests.
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•
•
• •
Note
Manufacturers and importers of electrical medical devices
must provide documentation for the performance of
maintenance by trained personnel.
•
!
Attention!
The function test may only be performed after the DUT has
successfully passed the safety test!
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Safety Warnings
•
Power Consumers with High Inrush Current (> 16 A) – Function Test
(e.g. fluorescent tubes, halogen lamps, headlights etc.):
Observe the following instructions in order to prevent
excessive contact loads.
Meanings of Symbols on the Instrument
300 V CAT II
Maximum permissible voltage and measuring category
between connections 1 through 4, the test socket and
ground
I
System with maximum 16 A nominal current
!
Attention!
Starting the Function Test
For reasons of safety, the device under test must be
switched off before the function test is started. This
precaution prevents inadvertent start-up of a device under
test which may represent a hazard during operation, e.g. a
cetrifuge.
Ending the Function Test
After completion of the function test, devices under test
must be turned off with their own switch – especially
devices with motors or other inductive loads.
Warning regarding dangerous electrical voltage
Warning concerning a point of danger
(attention: observe documentation!)
!
Per European Council Directive WEEE
2012/19/EU, do not dispose of this product as
unsorted municipal waste.
The measuring instrument may not be used:
•
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If it demonstrates visible damage
With damaged connector cables, measuring cables or
patient ports
If it no longer functions properly
•
In such cases, the instrument must be removed from operation
and secured against unintentional use.
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BC Biomedical
Terminals
3 Terminals
Jacks 1 through 10 for Applied Parts
USB Slave, to PC
1
10
Standard Socket (test socket)
for connecting the DUT
S1 S2
nection
Connections for Probes
Insert the double plug of the probe into sockets 1 and 2 such that
the plug with the white ring makes contact with socket 1 (silver
ring).
If 2 probes are used: If the first probe is, for example, the 25 m cable
drum (1-2), the test point is contacted with the second probe (3-4).
1)
For a lot of measurements, the protective conductor of the
test socket is not connected with the protective conductor
of the mains terminal.
1)
4-wire measurement possible
2)
4-wire measurement not provided for, see ”Measuring and Storing an
Offset Value when Using a 2
nd
Probe” on page 15
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Connection
Application
Top Connections
Standard socket
Test socket
Sockets 1 through 10
Applied parts connection
USB-SI
USB slave, to PC
Bottom Connections
Sockets 1 and 2
Test probe connection (max. 300 V CAT II)
Sockets 3/4 (green)
Terminal for second test probe
2)
(max. 300 V CAT II)
Inlet socket
Connection for supply power (90 to 240 V, 50 to 400 Hz)
Mains Con
Fuses
Initial Start-Up – Setup
4 Initial Start-Up
4.1 Connection to the Mains (90 to 240 V, 50 to 400 Hz)
➭
Connect the mains plug at the measuring instrument to the
mains power outlet.
4.1.1 Automatic Recognition of Mains Connection Errors
The measuring instrument’s protective conductor connection is
tested each time the start-stop key is pressed.
If a voltage of greater than 25 V is detected between the
protective conductor and the finger contact, no measurements
are possible. Disconnect the measuring instrument from the
mains immediately in the event of a mains connection error, and
arrange for the error to be corrected!
Selecting Nominal Line Voltage VLN
Measured values acquired by
means of leakage current measurement are normalized to the
selected VLN voltage value. Line
voltage parameter VLN (100, 110,
115, 117, 120, 127, 220, 230,
240 or 250 V) can be selected
with the
keys, and adjusted
with the +/– keys. The voltage
value selected here is generated
by the measuring instrument for alternative measurement.
Setting Nominal Frequency
The frequency selected here is generated by the measuring instrument for alternative measurement of leakage cur rent. Nominal
line frequency parameter F (50 or 60 Hz) can be selected with the
keys, and adjusted with the +/– keys. This setting is irrelevant
for direct measurement and differential current measurement.
Setting Brightness and Contrast
Brightness (1 ... 40 ... 100) and contrast (0 ... 40 ... 63) for the LCD panel
can be selected with the
keys, and adjusted with the +/– keys.
Activating Device Parameters
Changed values are permanently saved after acknowledging with
Note
Voltage at the mains protective conductor may cause
erroneous measured values during the measurement of
leakage current.
4.2 Switching the Measuring Instrument On
Initial Window
The initial window shown at the right appears in the event of mains connection.
the key. The display is then switched to the main menu. If the
setup menu is exited with the ESC key, the changed values only remain active until supply power to the instrument is interrupted.
Function Test
For testing the keys, LCD segments and the acoustic warning sig-
nal.
4.3 Configuring Device Parameters – Setup Menu
All of the settings which are required for operation of the
measuring instrument can be entered in the setup menu.
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BC Biomedical
Local Operating Mode
Manual Test
5 Manually Triggered Measurements
Adjustable measuring parameters
are displayed as softkeys.
DIR
DIF
ALT
Direct measurement
Diff. current measurement
Alternative meas. method
PRINT:
Key for hardcopy functions
(in preparation)
L/N
N/L
ESC: Return to previous level
Mains polarity
ARROW
UP HELP:
Access context sensitive help
Select measuring function
ARROW
DOWN:
MENU:
Access the main menu
(R
PE
measuring function)
Select measuring function
STARTSTOP: Start or stop measurement /
function test
SETUP:
Access the setup menu
–
Line voltage
–
Line Frequency
–
LCD brightness
–
LCD contrast
Contact Surface
For finger contact – PE potential check
Main Menu Display
!
Attention!
Remote control of the SA-2500 should always be coordinated
with the user who is in contact with the measuring
instrument at the same time, for example in order to exclude the possibility of contact hazards.
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Operating Mode Display
–
Remote: highlighted display
–
Local: display not highlighted (see below)
Local Operating Mode
Manual Test
5.1 General Procedure
5.2 Overview
➭
➭
Select the main menu: MENU key.
Select a menu function:
keys.
Depending upon the measuring function select either
–
Type of test current: DIR / DIF / ALT / DL key.
or
–
Protection class and type of connection: PC1 / PC2 / FIX key.
Connect the device under test in accordance with the
previously selected type of test current.
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➭
Depending upon the type of test current, it may be necessary to
use the probe.
The device under test is checked for short circuiting for all active
measurements during which the mains are connected to the test
socket (e.g. for leakage current measurements).
➭
Start the test with the STARTSTOP
During measurement, a symbol representing a runner appears
at the upper left-hand corner instead of the measurement icon.
During measurement and after the measurement has been completed, measurement data can be read from the display.
➭
If necessary, repeat the test with reversed mains
power polarity: L/N N/L key.
➭
The display is returned to the main menu by pressing the ESC
key or the MENU key.
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AP = applied part; PC1/2 = protection class I/II; FIX = permanent connection
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BC Biomedical
Abbreviation
Measurement Type Parameter
Description
Measured Quantity /
Method
Type of
’Connection
Sockets:
Probe 1–2
AP A ... K
Resistance Measurements
R PE
Protective conductor
resistance
PC1
l
Probe 1–2
Page
R INS
Insulation resistance
PC1
—
Page
16
PC2
l
Probe 1–2
FIX
Leakage Current Measurement
I E
Equipment leakage
current
DIR Direct measurement
Test socket
l
AP A ... K
Probe 1–2
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DIF
Differential current
measurement
ALT
Alternative measurement
(alternative equipment
leakage current)
I T
Touch current
DIR Direct measurement
Test socket
l
Probe 1–2
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DIF
Differential Current
Measurement
ALT
Alternative measurement
(alternative equipment
leakage current)
DL
Measurement with 2 probes
(cable drum at 1–2)
Probe 1–2
Probe 3–4
I P
Patient leakage current
DIR
Patient leakage current,
direct
Test socket
l
AP A...K
Page
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I AP
Applied parts leakage
current
DIR
Direct measurement
(mains at applied part)
Test socket
l
AP A...K
Page
ALT
Alternative measurement
(altern. patient leakage current)
Functions Tests
TEST
Voltage / Load current
Active/apparent power P/A
Power factor PF
Test socket
Page
28
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