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510(k) Data Aggregation
K Number
K190437Device Name
Delta 3300
Manufacturer
Date Cleared
2019-08-28
(187 days)
Product Code
Regulation Number
870.5325Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
Device Description
Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
The portable battery-powered device is intended for use by trained service technicians. Delta 3300 is a waveform analyzer that determines the characteristics of an electrical discharge signal produced by a defibrillator and transcutaneous pacemaker.
It provides a basis for verifying the energy output of a defibrillator, including energy, peak current, and peak voltage. The device incorporates a simulation function of ECG and arrhythmia waveforms for verifying the performance of defibrillator monitors.
Delta 3300 also verifies transcutaneous pacemaker parameters such as pulse rate, width, amplitude, and energy as well as refractory and sensitivity measurement.
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K Number
K182905Device Name
UniPulse
Manufacturer
Date Cleared
2018-12-14
(59 days)
Product Code
Regulation Number
870.5325Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UniPulse 400 Defibrillator/Pacemaker Analyzer is used to determine that a defibrillator equipped with transcutaneous pacemaker capability are performing within their performance specifications through the measurement of energy output. The UniPulse 400 is intended to be used in the laboratory environment, outside of the patient care vicinity and is not intended to be used on patients or to test devices while connected to patients.
Device Description
The Rigel Medical UniPulse 400 is a portable, rechargeable battery operated (with AC Adapter) defibrillator tester used to determine that a defibrillator and a defibrillator with a transcutaneous pacemaker function perform to their published performance specifications. The UniPulse 400 is connected to a defibrillator output and is used to measure the output energy delivered from the device into a standard resistive test load. It also provides waveform information on its integrated display. For pacemaker testing, a variable load from 50 to 1600 ohms is available in 50-ohm steps. Defibrillator paddles are connected directly to the UniPulse 400 for hands free operation, or to contact plates if using the paddles. When the defibrillator is discharged, the UniPulse 400 will display the energy delivered. Included in the UniPulse 400 is an ECG simulator with normal sinus rhythm and arrhythmia simulation to trigger automated defibrillation.
UniPulse 400 is used by biomedical and/or clinical engineers to verify performance of defibrillators used in their hospital. The UniPulse 400 provides statistical data measured from the device and can communicate to an external Bluetooth printer and a PC / Laptop via Bluetooth and USB.
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K Number
K153210Device Name
Defibrillator Analyzer Variable Load
Manufacturer
Date Cleared
2015-12-21
(46 days)
Product Code
Regulation Number
870.5325Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DA-2006-VL is used to determine that defibrillators are performing within their performance specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P.
Device Description
The BC Group International DA-2006-VL Variable Load is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with international standards IEC 60601-2-4 and AAMI DF80.
The DA-2006-VL is a non-powered, selectable resistive load bank. Through various series and parallel resistor combinations. the DA-2006-VL allows a user to select 25, 50, 75, 100, 125, 150, 175, and 200 Ohm loads.
The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P Defibrillator Analyzer.
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K Number
K110192Device Name
DEFIBRILLATOR ANALYZER - DA-2006P
Manufacturer
Date Cleared
2011-02-08
(15 days)
Product Code
Regulation Number
870.5325Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DA-2006/DA-2006P are used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output. The DA-2006 tests defibrillators while the DA-2006P additionally tests transcutaneous pacemakers.
Device Description
The BC Group International DA-2006 Defibrillator Tester is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with specified requirements.
The DA-2006 is a microprocessor-based instrument that is used in the testing of defibrillators. It measures the energy output and provides information about the pulse. It is used on manual, semi-automatic and automatic defibrillators with monophasic or biphasic outputs.
The DA-2006P model additionally provides a Transcutaneous Pacemaker analysis function. It measures and displays pacer pulse information as well as performing Refractory Period, Sensitivity and Immunity testing,
All models have a built in 50 ohm human body simulation load as well as 12 lead ECG with arrhythmias and performance waveforms. Additionally, they have a centronics printer port, a serial port, oscilloscope output, high level ECG output, as well as provision for a batterv eliminator.
The DA-2006P makes viewing and selecting the desired waveforms and test data quick and intuitive, with all operational information being available on the 240 by 64 pixel graphic display, allowing for easy maneuvering through parameters and scrolling through available options.
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K Number
K083347Device Name
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
Manufacturer
Date Cleared
2008-12-24
(41 days)
Product Code
Regulation Number
870.5325Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Impulse 7010 is used to determine that a defibrillator is performing within its operating specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The Impulse 7010 is used in conjunction with the Impulse 7000DP Defibrillator Analyzer.
Device Description
The Impulse 7010 Defibrillator Selectable Loads is an optional accessory to the Impulse 7000DP to simulate 25 to 200 Ohm thoracic impedance. Four 50 Ohm resistors are switched in combinations to make series or parallel circuits of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. Defibrillator output energy is measured by the Impulse 7000DP Defibrillator Tester.
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K Number
K072114Device Name
IMPULSE 6000D/7000DP
Manufacturer
Date Cleared
2008-01-28
(180 days)
Product Code
Regulation Number
870.5325Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Impulse 6000D/7000DP is used to determine that defibrillators and transcutancous pacemekers are performing within their performance specifications through the measurement of energy output.
Device Description
The Impulse 600013/7000DP is a portable, rechargeable, battery-operated defibrillator tester. The Impulse 7000DP also functions as a transcutaneous pacemaker tester. The device's defibrillator input is connected to the output of a defibrillator under test which provides a 50-Ohm test load, approximately the impedance of the human body. The Impulse 6000D/7000DP simulates patient electrocardiogram signals to trigger automated defibrillation when a ventricular fibrillation waveform is presented, and the device tests that the automated defibrillator does not advise shock when a normal sinus rhythm electrocardiogram is presented. The energy output delivered by the defibrillator under test is measured. The Impulse 7000DP also tests transcutaneous pacemaker outputs by presenting a low level electrocardiogram at various pulse rates and measures the response of the pacemaker under testing rate and amplitude. For pacemaker testing, the device incorporates inputs of 50 to 1500 Ohm impedance test loads. The Impulse 6000D is a defibrillator tester only without the pacemaker test option. Both models have 10 electrocardiogram outputs to simulate patient milli-volt level electrocardiogram signals to test combination patient monitors/defibrillators/pacemakers.
The Impulse 7000DP has a USB type "B" interface to a PC to allow data download to a PC. It is electrically isolated from the measurement circuitry and allows remote control of the test from a PC. A BNC type connector on the rear panel also allows an oscilloscope to record the waveform output from the defibrillator under test, attenuated to a lower voltage level, and also electrically isolated from the measurement circuitry. Another BNC connector outputs a higher level signal (greater amplitude) to view the electrocardiogram signal on a second oscilloscope channel.
The accessories for the Impulse 6000D/7000DP include an external power supply to operate and re-charge the internal battery. Optional adapters to connect defibrillators marketed by different manufacturers to the standard 4 mm banana style input jacks are available.
Waveform analysis determines the characteristics of a defibrillator discharge pulse. Peak voltage amplitude, current, timing, overall energy and the refractory period of a pacemaker are recorded. Measurement is done by attenuating the high voltage signal to a lower voltage level, which is then input into an analog to digital converter. A digital signal processor calculates the measurements and corrects hardware error sources with mathematical calibration constants for any offset and gain errors.
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K Number
K062099Device Name
PHASE 3, MODEL DT-1
Manufacturer
Date Cleared
2007-01-25
(185 days)
Product Code
Regulation Number
870.5325Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Datrend Systems Inc. Phase 3 Defibrillator / Pacer Analyzer is a precision instrument for ensuring that defibrillators and defibrillators with transcutaneous pacemakers comply with performance specifications.
Phase 3 is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. It can also provide waveform information.
Phase 3's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohms, which roughly corresponds to the impedance of the human body. The defibrillator paddles are connected to Phase 3 contact plates, or directly connected to the energy input if using the hands-free defibrillator function. Thus, the defibrillator is connected through the load resistance of Phase 3. When the defibrillator is discharged, Phase 3 will calculate and display the energy delivered.
The intended end user is a trained / skilled biomedical equipment technician who is required to perform incoming inspections, scheduled periodic maintenance, and repair servicing of defibrillators, both stand alone and with pacing. Such end users may be associated with public, private, or commercial institutions, including: hospitals, clinics, third-party service companies that repair or calibrate medical equipment. In general, the end user is a technically trained individual, at a post-secondary school level, specializing in medical instrumentation technology.
Phase 3 is intended to be used in the laboratory environment, outside of the patient care vicinity, and is not intended to be used on patients or to test devices while connected to patients.
Phase 3 is not intended for over-the-counter use.
Device Description
Phase 3 Defibrillator / Pacer Analyzer is a portable, line or rechargeable batterypowered defibrillator and transcutaneous pacemaker tester. Phase 3 is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. It can also provide waveform information. Phase 3 incorporates one fixed 50 ohm test load, which roughly corresponds to the impedance of the human body, for defibrillator testing. It also includes an option to vary the test load from 25 to 175 ohms in 25 ohm steps. For pacer testing, Phase 3 incorporates an integrated, variable internal test load, selectable from 50 ohms to 1,600 ohms in 50 ohm steps. The defibrillator paddles are connected to Phase 3 contact plates, or directly connected to the energy input if using the hands-free defibrillator function. Thus, the defibrillator is connected through the load resistance of Phase 3. When the defibrillator is discharged, Phase 3 will calculate and display the energy delivered.
Phase 3 implements connectivity through one USB Type "B" port (USB device), and through a bi-directional RS-232 port. The RS-232 port is intended for low-speed interface for data download and remote control operation, and provides the connection for an accessory Barcode Wand. The USB port is intended for highspeed interface with a PC and provides a full set of features for real-time data acquisition, remote control, and data download. Phase 3 also incorporates a nonvolatile memory or "data log" to save test results or "records" obtained from multiple tests.
Phase 3 optional accessories include a barcode reader and a PS/2 keyboard for rapid data entry of equipment control numbers, and a Serial Printer which may be . used to generate a hard copy of test results saved in the instrument's data logy The barcode reader and printer interface with Phase 3 by means of the RS-232 Port, and a separate 6-pin mini DIN is provided on Phase 3 for the PS/2 keyboard connection.
Phase 3 conducts the following tests and includes the features listed below:
a. Energy measurements
Optional variable loads for energy measurements (25 175 ohms)
Cardioversion tests
Peak Voltage and Current measurement
e. Storage and playback of output waveforms
f. 12 lead ECG simulation
ECG, Performance and Arrhythmia simulation g.
Transcutaneous Cardiac Pacemaker testing h.
Automatic External Defibrillator (AED) Test procedures i.
Large Graphical display 1.
Integrated Pacemaker Loads, selectable from 50 ohms to 1,600 ohms K.
RS-232, Centronics and USB (type B) communication interface
Principle of operation
i. Phase 3 is a waveform analyzer that determines the characteristics of an electrical discharge signal produced by a defibrillator and/or transcutaneous pacemaker. These characteristics include: energy, peak current, peak voltage, pulse width, pulse rate, and refractory intervals.
ii. Measurements are accomplished by sampling a defibrillator signal from the defibrillator pads or from the pacer terminals at a high speed (~87ksps). Sampling is triggered by the rising or falling edge of the input. Triggering cran occur of enther edge to ensure that the waveform will be captured even if the operator places the defibrillator pads or connects the pacer leads in the reverse order.
iii. The defibrillator signal is digitized and stored into internal RAM. The test results are calculated based on standard numerical integration principles to deterroine the energy level. This process is applicable regardless of the value of the test load. These results are stored into a test record in RAM. Once all tests are completed, the user can save the test record by entering an equipment control number for identification and then transferring the record to non-volatile (NV) memory.
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K Number
K061606Device Name
DEFIBRILLATOR CABLE TESTER, MODEL DT2200
Manufacturer
Date Cleared
2006-06-21
(12 days)
Product Code
Regulation Number
870.2910Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.
Device Description
The device has a built-in load resistance of 50 ohms with a test lamp which briefly illuminates if defibrillator energy of greater than 200 joules is detected. The device has a connector which is compatible with the PadPro System disposable defibrillator pads (K003548, K014209, K020288, K020203, and K020743).
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K Number
K030547Device Name
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
Manufacturer
Date Cleared
2003-07-11
(141 days)
Product Code
Regulation Number
870.5325Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ZAP GUARD II is intended to be used for the testing of the continuity and the integrity of the wires of Biphasic Defibrillator Systems.
Device Description
The ZAP GUARD II device consists of an electrical circuit incorporating resistors and a neon light within the pathway. Upon contact with the paddles of a biphasic defibrillator system which is operational, energy is delivered through the circuit. If the defibrillator system's wires are intact and energy delivery is continuous, then the neon lamp will illuminate.
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