BC Biomedical SA-2010S, SA-2010S-INTL, SA-2010S-AUS User Manual

SA-2010S-INTL SA-2010S-AUS
SAFETY ANALYZER
ELECTRICAL
SA-2010S
USER MANUAL
i
BC BIOMEDICAL
TABLE OF CONTENTS
This User Manual covers the following units:
SA-2010S SERIES
WARNINGS, CAUTIONS, NOTICES ............................................................................ ii
DESCRIPTION ............................................................................................................. 1
LAYOUT ....................................................................................................................... 4
TESTING ...................................................................................................................... 10
PATIENT SIMULATOR ................................................................................................ 15
COMMUNICATION PROTOCOL ................................................................................ 16
MANUAL REVISIONS .................................................................................................. 19
LIMITED WARRANTY .................................................................................................. 19
SPECIFICATIONS ....................................................................................................... 20
NOTES ......................................................................................................................... 24
SA-2010S & SA-2010S-R SA-2010S-INTL & SA-2010S-INTL-R SA-2010S-AUS & SA-2010S-AUS-R
ii
WARNING - USE
or any other capacity where they would come in
contact with a patient.
WARNING - MODIFICATIONS
beyond these specifications or any unauthorized
improper operation.
WARNING - CONNECTIONS
not connect any leads from the patient directly to
SA-2010S.
WARNING - CLEANING
2010S should be cleaned by wiping gently with a
used if desired.
The SA-2010S is intended for testing only and
should never be used in diagnostics, treatment
All connections to patients must be removed
before connecting the DUT to the SA-2010S. A
serious hazard may occur if the patient is
connected when testing with the SA-2010S. Do
the SA-2010S or DUT while it is powered by the
The SA-2010S is intended for use within the
published specifications. Any application
user modifications may result in hazards or
Disconnect Line Power to the SA-2010S before
attempting to clean it. Do not immerse. The SA-
damp, lint-free cloth. A mild detergent can be
iii
WARNING - LIQUIDS
2010S. In the event of a spill onto the SA-2010S,
type.
CAUTION - ENVIRONMENT
30 minutes before attempting to operate it.
CAUTION - USAGE
The SA-2010S is not a continuous duty device, it current limits and duty periods specified. Do not
Do not to drop the SA-2010S.
WARNING - VOLTAGE
voltage is applied to the Patient lead connectors
and/or External test leads. Although this voltage
depressed.
Do not submerge or spill liquids on the SA-
Do not operate the SA-2010S regardless of fluid
When the SA-2010S is in Lead Isolation mode
and the ISO key is depressed, 110% of line
is applied through an internal current limiting
resistance of 121 kΩ (per standard test
specifications), Do not touch the test leads,
connections or DUT while the ISO key is
is intended for short duration testing within the
leave the DUT connected to the SA-2010S for
extended time periods.
Exposure to environmental conditions outside
the specifications can adversely affect the
performance of the SA-2010S. Allow SA-2010S
to acclimate to specified conditions for at least
iv
NOTICE – SYMBOLS
Symbol
Description
Caution
(Consult Manual for Further Information)
Electrical Caution
(Consult Manual for Further Information)
Per European Council Directive 2002/95/EC, do not dispose of this product as unsorted municipal waste.
CAUTION - SERVICE
The SA-2010S is intended to be serviced only by
performed by qualified technical personnel.
CAUTION - INSPECTION
serviced if any parts are in question.
CAUTION - FUSE
specified type and rating.
The SA-2010S should be inspected before each
use for obvious signs of abuse or wear. The SA-
2010S should not be used and should be
authorized service personnel. Troubleshooting
and service procedures should only be
Only replace the SA-2010S fuse with the
v
NOTICE – ABBREVIATIONS
Amp
Ampere(s)
AHA
American Heart Association
Association for the Advancement of Medical Instrumentation
BPM
Beats Per Minute
C
Celsius
cm
centimeter(s)
°
degree(s)
DUT
Device Under Test
ECG
Electrocardiogram
Euro
European
ft
feet
FS
Full Scale
Hz
hertz
IEC
International Electrotechnical Commission
ISO
Isolation
kg
kilogram(s)
kHz
kilohertz
kΩ
kilohm(s)
LED
Light Emitting Diode
MAP
Mains on Applied Parts
MHz
Megahertz
µA
microampere(s)
mA
milliampere(s)
mm
millimeter(s)
National Electrical Manufacturers Association
Ω
Ohm(s)
p-p
peak-to-peak
PC
Personal Computer
Lbs
pounds
RH
Relative Humidity
RMS
Root Mean Square
USA
United States of America
V
Volt(s)
VA
Volt-Ampere(s)
VAC
Volt(s) Alternating Current
W
Watt(s)
AAMI
NEMA
vi
NOTICE – DISCLAIMER
BC GROUP INTERNATIONAL, INC. WILL NOT BE RESPONSIBLE FOR ANY INJURIES SUSTAINED DUE TO UNAUTHORIZED EQUIPMENT MODIFICATIONS OR APPLICATION OF EQUIPMENT OUTSIDE OF THE PUBLISHED INTENDED USE AND SPECIFICATIONS.
NOTICE – DISCLAIMER
BC GROUP INTERNATIONAL, INC. RESERVES THE RIGHT TO MAKE CHANGES TO ITS PRODUCTS OR SPECIFICATIONS AT ANY TIME, WITHOUT NOTICE, IN ORDER TO IMPROVE THE DESIGN OR PERFORMANCE AND TO SUPPLY THE BEST POSSIBLE PRODUCT. THE INFORMATION IN THIS MANUAL HAS BEEN CAREFULLY CHECKED AND IS BELIEVED TO BE ACCURATE. HOWEVER,
NO RESPONSIBILITY IS ASSUMED FOR INACCURACIES.
NOTICE – CONTACT INFORMATION
sales@bcgroupintl.com
NOTICE – PERFORMING TESTS
SA-2010S Series User Manual Copyright © 2012
www.bcgroupintl.com Made in the USA
06/12 Rev 11
REFER TO DUT MANUFACTURER’S SERVICE MANUAL FOR
TEST PROCEDURES AND MEASUREMENT LIMITS.
BC BIOMEDICAL
BC GROUP INTERNATIONAL, INC.
3081 ELM POINT INDUSTRIAL DRIVE
ST. CHARLES, MO 63301
1-800-242-8428 1-314-638-3800
www.bcgroupintl.com
USA
1
BC BIOMEDICAL
WITH PATIENT SIMULATOR
SA-2010S SERIES
ELECTRICAL SAFETY ANALYZER
The Model SA-2010S Series is a Microprocessor based Electrical Safety Analyzer with a built-in Patient Simulator. It allows for a multitude of tests to be performed on a device using the same unit and lead connections. It provides a full Electrical Safety Analyzer, as well as, ECG Simulation with four waveforms with constant QRS duration and six machine performance testing waveforms. There is Patient Lead testing for 10 inputs. The following are highlights of some of the main features:
SA-2010S:
LED STATUS INDICATORS AUDIO FEEDBACK TOUCH CONTROL KEYS – NO KNOBS 10 UNIVERSAL PATIENT LEAD INPUTS HIGH IMPACT PLASTIC CASE
SAFETY ANALYZER:
LINE VOLTAGE MEASUREMENT DEVICE UNDER TEST CURRENT MEASUREMENT EARTH / GROUND LEAD RESISTANCE EARTH / GROUND LEAKAGE CURRENT ENCLOSURE / CHASSIS LEAKAGE CURRENT EXTERNAL RESISTANCE EXTERNAL LEAKAGE CURRENT SOURCE WIRING INTEGRITY MONITOR TRUE RMS MEASUREMENTS AAMI ES1-1993 or IEC 601 SELECTABLE TEST LOADS 90 TO 264 VAC OPERATION 20 AMP RATING (SA-2010S and SA-2010S-INTL Models) 10 AMP RATING (SA-2010S-AUS Models) SELF TEST POINTS EXTERNALLY REPLACEABLE GROUND FUSE AUTOMATIC LOAD REVERSAL DELAY PATIENT LEAD TO LEAD LEAKAGE CURRENT PATIENT LEAD TO EARTH / GROUND LEAKAGE CURRENT PATIENT ISOLATION LEAKAGE CURRENT EXTERNAL ISOLATION LEAKAGE CURRENT
2
PATIENT SIMULATOR:
ECG: 30, 60, 120 AND 240 BPM SINE: 10, 60 AND 100 Hz SQUARE: 0.125 AND 2.0 Hz TRIANGLE: 2 Hz HIGH LEVEL OUTPUT (1 V p-p) AMPLITUDE ACCURACY: +/- 2% FREQUENCY ACCURACY: +/- 0.5%
AVAILABLE MODELS:
SA-2010S – STANDARD MODEL WITH HOSPITAL-GRADE NEMA 5-15P LINE
PLUG AND HOSPITAL-GRADE NEMA 5-20R DUT TEST RECEPTACLE FOR USE IN THE US AND OTHER COMPATIBLE COUNTRIES
SA-2010S-INTL – INTERNATIONAL MODEL, IEC C20 RECEPTACLE PIGTAIL
(MUST USE COUNTRY-SPECIFIC LINE CORD – SEE ACCESSORIES SECTION) AND UNIVERSAL DUT TEST RECEPTACLE THAT WORKS WITH THE FOLLOWING COUNTRY-SPECIFIC PLUGS:
o NEMA 5-15P, NEMA 5-20P, NEMA 6-15P and NEMA 6-20P (US/NORTH
AMERICA)
o UK1-13P and UK3-5P (UK) o SW1-10P (SWITZERLAND) o IT1-10P (ITALY) o IS1-16P (ISRAEL) o JA1-15P (JAPAN) o EU1-16P (EURO) CEE 7/7 “SCHUKO” (NOTE: MUST USE SCHUKO
GROUNDING ADAPTER TO PERFORM LEAKAGE MEASUREMENTS, SEE OPTIONAL ACCESSORIES SECTION)
o DE1-13P (DENMARK) (NOTE: NO EARTH/GROUND PIN, THEREFORE
LEAKAGE MEASUREMENTS NOT APPLICABLE)
o EUROPLUG CEE 7/16 (NOTE: NO EARTH/GROUND PIN, THEREFORE
LEAKAGE MEASUREMENTS NOT APPLICABLE)
SA-2010S-AUS – AUSTRALIAN MODEL, AU1-10P LINE PLUG AND AU1-10R
DUT TEST RECEPTACLE FOR USE IN AUSTRALIA/NEW ZEALAND AND OTHER COMPATIBLE COUNTRIES
OPTIONS
-R ADDS RS-232 SERIAL COMMUNICATIONS AVAILABLE MODELS:
o SA-2010S-R o SA-2010S-INTL-R o SA-2010S-AUS-R
3
STANDARD ACCESSORIES
BC20-20110 8 FT CHASSIS TEST LEAD (BLACK) BC20-30107 SOFT CARRYING CASE UF-0250-01 REPLACEMENT GROUND LEG FUSE BC20-204XX (SA-2010S-INTL ONLY) – REFER TO PAGE 9
OPTIONAL ACCESSORIES
BC20-20111 8 FT EXTERNAL TEST LEAD (RED) BC20-20112 16 FT CHASSIS TEST LEAD (BLACK) BC20-20113 16 FT EXTERNAL TEST LEAD (RED) BC20-20200 REPLACEMENT SA-2010S-INTL DUT INTERNATIONAL
RECEPTACLE ADAPTER
BC20-20221 SCHUKO GROUNDING ADAPTER BC20-41337 RS-232 COMMUNICATIONS CABLE (DB-9M to DB-9F) BC20-41339 USB TO RS-232 ADAPTER CS-2000-U 1 AMP CURRENT SOURCE - USA/NORTH AMERICA CS-2000-E 1 AMP CURRENT SOURCE - EURO (SCHUKO)
SA-2010S-INTL LINE CORDS: (REFER TO PAGE 9 FOR DETAILS)
BC20-20400 NEMA 5-20P PLUG LINE CORD (USA/NORTH AMERICA) BC20-20401 JA1-15P PLUG LINE CORD (JAPAN) BC20-20402 UK1-13P PLUG LINE CORD (UK) BC20-20403 CEE 7/7 “SCHUKO” PLUG LINE CORD (EURO)
NOTE: INCLUDES BC20-20221 GROUNDING ADAPTER
BC20-20409 BSS546A PLUG LINE CORD (INDIA/SOUTH AFRICA) BC20-20410 SW1-10P PLUG LINE CORD (SWITZERLAND) BC20-20412 IT1-10P PLUG LINE CORD (ITALY) BC20-20416 AUSTRALIA PLUG LINE CORD
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