BC BIOMEDICAL SA-2600 SERIES TABLE OF CONTENTS WARNINGS, CAUTIONS, NOTICES ................ii DESCRIPTION ........................ 1 LAYOUT .......................... 4 GETTING STARTED ....................... 6 TESTING ......................... 9 PATIENT SIMULATOR ....................15 AUTOSEQUENCES ..................... 16 SETTINGS ........................22 MANUAL REVISIONS ....................25 LIMITED WARRANTY ....................25 SPECIFICATIONS ......................
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To ensure the accuracy of the SA-2600, BC Group International, Inc. recommends that it be calibrated at least once every 12 months. Calibration must be done by qualified personnel. Contact BC Group International, Inc. for calibration. WARNING - USE The SA-2600 is intended for testing only and...
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WARNING - LIQUIDS Do not submerge or spill liquids on the SA-2600. In the event of a spill onto the SA-2600, Do not operate the SA-2600 regardless of fluid type. WARNING - VOLTAGE When the SA-2600 is in Lead Isolation mode and the ISO button is highlighted, 110% of line voltage is applied to the Patient lead connectors and/or External test leads.
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CAUTION - INSPECTION The SA-2600 should be inspected before each use for obvious signs of abuse or wear. The SA- 2600 should not be used and should be serviced if any parts are in question. CAUTION - SERVICE The SA-2600 is intended to be serviced only by authorized service personnel.
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NOTICE – ABBREVIATIONS Ampere(s) American Heart Association Association for the Advancement of AAMI Medical Instrumentation Beats Per Minute Celsius centimeter(s) ° degree(s) Device Under Test Electrocardiogram Euro European feet Full Scale hertz International Electrotechnical Commission Isolation kilogram(s) kilohertz kΩ kilohm(s) Light Emitting Diode Mains on Applied Parts Megahertz...
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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.
BC BIOMEDICAL SA-2600 SERIES ELECTRICAL SAFETY ANALYZER WITH PATIENT SIMULATOR The SA-2600 Series is an automated 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.
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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: •...
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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-2600-INTL DUT INTERNATIONAL RECEPTACLE ADAPTER • BC20-20221 SCHUKO GROUNDING ADAPTER • BC20-41377 MICRO USB CABLE (MICRO TO USB A) SA-2600-INTL LINE CORDS: (REFER TO PAGE 6 FOR DETAILS) •...
LAYOUT This section looks at the layouts of the SA-2600 Models and gives descriptions of the elements that are present. There is an audio click when any key is depressed, while a “Razz” or error tone consisting of a rapid succession of beeps is sounded if an invalid key is depressed. 10 Universal Patient Lead Inputs High Level Output (ECG)
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SA-2600 Layout Universal International Australian 10A @ 240V Receptacle for DUT Receptacle for DUT SA-2600-INTL Layout SA-2600-AUS Layout The SA-2600-INTL and SA-2600-AUS Model Layouts are shown above, note that the only differences from the standard model are the Line cords and the DUT test Receptacles.
GETTING STARTED Power Cord The Power Cord, which is connected internally, provides power to both the Safety Analyzer and the DUT through the Test Receptacle. The Power Cord varies depending on the Analyzer model. SA-2600 models use a NEMA 5-15P plug designed to plug into a NEMA 5-15R or 5-20R Receptacle.
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Analyzer Test Receptacle Control There are four keys that allow the manual control of the power connections that are made to the DUT. Note: The Forward/Reverse Polarity key has a safety delay feature, preventing damage to the internal relays and the DUT. When the key is depressed, the DUT power is disabled and the safety delay is activated.
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HI Level Output (+) A HI Level connector is located on the side of the unit for the high level ECG output signal (1 V p-p). The connection is between the High Level (+) snap and the RL (-) ECG lead. Self-Test Snaps There are two snaps on the side of the unit that allow for a quick self-test of the Analyzer.
TESTING The SA-2600 Models allow the user a great deal of flexibility in testing. The information in this section presents a systematic approach that is just one way to proceed. It is only presented as a guide, and it is the responsibility of the user to establish which tests are required.
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Mains Voltage Screen The Mains Voltage Screen will display the Voltage that is present on the incoming power lines. This is measured from Line to Neutral. Note that the voltage may drop when the DUT is turned on. Ensure that this value is within the DUT specifications. Device Current Screen The Device Current Screen will display the current draw of the DUT.
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Earth Resistance Screen The Earth Resistance Screen will display the resistance between the Chassis Test lead and Receptacle Earth/Ground. This resistance is a combination of the resistance within the DUT enclosure and the resistance of the Earth/Ground Lead in the DUT power cord. The SA-2600 uses a 200 mA test current to measure the Earth Resistance.
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Leakage Modes Screen The Leakage Modes Screen allows for multiple selectable leakage modes. The mode can be changed by pressing the up/down arrows on the Mode side. If leads are valid for the selected mode, they can also be changed with the up/down arrows on the Lead side. All of the leakage modes will measure the current that flows through a 1000 Ω...
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Lead to Lead Leakage In Lead to Lead Leakage Mode, the display will show the leakage current between the selected Patient Lead and all other patient leads. Attach the patient leads to the connectors on the top of the Safety Analyzer. The Up and Down arrow keys may then be used to select any individual lead.
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This test measures the leakage current that would flow through the lead(s) if the patient were to come into contact with Line voltage. This is referred to as MAP (MAINS on Applied Parts). Point to Point Leakage Current In Point to Point mode, the display will show the leakage current between the test leads. The test requires that the Chassis Test Lead be plugged into the Chassis Connector and the External Test Lead (Red, BC20-21111 or BC20-21113) be plugged into the External Connector.
PATIENT SIMULATOR The SA-2600 provides ECG and Performance Waveforms to aid in the verification of the basic operational characteristics of cardiac-monitoring equipment. The information in this section presents a listing of available waveforms. It is the responsibility of the user to establish which waveform verifications are required.
AUTOSEQUENCES Creating an Autosequence The SA-2600 has custom and fixed Autosequences. There are three customizable Autosequences depending on the user’s needs. To customize one of the custom Autosequences press the Autosequence button on the home screen. Then tap on the desired Autosequence to customize.
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Pressing the dots will toggle the test on/off for that polarity setting. The limit for each state configuration can also be set from 0 – 2000 uA, the same limit will be used for Normal and reverse polarities. If a reading that is recorded during the Autosequence is over its respective limit, it will show up as a failure in the review screen.
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Running an Autosequence To run an Autosequence, select the desired Autosequence to run from the Autosequence menu. Double check that all the tests you want to run are selected with the correct limits. Then tap the next arrow in the top right of the screen to navigate to the DUT Information screen.
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The next screen will be the set-up screen. Check that all the connections to the DUT are made. Typically, this includes the DUT power cord plugged into the SA-2600 receptacle, the chassis cable connected to the DUT enclosure, and any patient connections connected to the patients leads.
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Reviewing an Autosequence The results screen will show all measurements taken throughout the Autosequence. If the Autosequence was ended early, any test after the step that was stopped at will be shown as “N.T.” for Not Tested. If a test step is not part of the current Autosequence, it will be indicated as “OFF”...
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If one of the leakage tests is pressed, it will show a detailed view of the measurements taken. Any measurements that were over limit will be red, any test in the sequence that was not tested will be red and indicated by “N.T.”, and any test that was not in the sequence will be grayed out and indicated with “OFF”.
SETTINGS The Settings screen can be navigated to by pressing on the cog symbol on the Main Screen on the bottom left-hand side. This screen displays some basic information about the SA-2600 and has configurable settings like Screen Brightness, Date and Time, Communication setting, and Outlet Status.
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Date and Time To switch between the Date settings and the Time settings, select the desired tab near the top of the screen The date format can be changed by selecting which format is desired. There are two date formats: MM/DD/YYYY and DD/MM/YYYY. The day, month and year values can be changed by selecting the date boxes to the right of the date format options.
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Communication Setting The Communication setting can be changed to either Bluetooth or USB. In Bluetooth mode, the SA-2600 can be connected to with the myBC Mobile app and the micro-USB port is disabled. In USB mode, the SA-2600 can be connected to a PC with the micro- USB port and the Bluetooth is disabled.
IMPLIED, INCLUDING, BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. BC GROUP INTERNATIONAL, INC. IS NOT LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES. NO PERSON OTHER THAN AN OFFICER IS AUTHORIZED TO GIVE ANY OTHER WARRANTY OR ASSUME ANY LIABILITY.
SPECIFICATIONS MAINS VOLTAGE RANGE 90.00 to 264.00 VAC, 50/60 Hz ACCURACY ± 3% of Reading, ± 1 V DEVICE CURRENT RANGE 0.000 to 19.999 Amps, RMS ACCURACY ± 5% of Reading, ± 0.010 A EARTH RESISTANCE 0.00 to 19.999 Ω RANGE 0.000 to 1.999 Ω...
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PATIENT SIMULATOR NORMAL SINUS RHYTHM 30, 60, 120, 240 BPM SINE – 10, 60, 100 Hz PERFORMANCE SQUARE – 0.125, 2.0 Hz WAVEFORMS TRIANGLE – 2.0 Hz FREQUENCY ± 0.5 % ACCURACY AMPLITUDE ± 2 % Lead II LEAD 1 1.75 mV OUTPUTS LEAD 2...
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ELECTRICAL (continued) 20 Amps @ 250 VAC Capacity International Receptacle Compatible with: o NEMA 5-15P, NEMA 5-20P, NEMA 6-15P NEMA 6-20P (US/NORTH AMERICA) o UK1-13P and UK3-5P (UK) o SW1-10P SA-2600-INTL MODELS (SWITZERLAND) o IT1-10P (ITALY) o IS1-16P (ISRAEL) DUT RECEPTACLE o JA1-15P (JAPAN) (continued) o EU1-16P...
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PHYSICAL & ENVIRONMENTAL (continued) SIZE 8.65 x 5.73 x 2.40 Inches (219.7 x 145.5 x 61.0 mm) ≤ 3.5 Lbs (1.6 kg) WEIGHT 15 to 40 °C (59 to 104 °F) OPERATING RANGE 10 to 90% RH, Non-Condensing STORAGE RANGE -20 to 65 °C (-4 to 149 °F)
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