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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
DATREND SYSTEMS, INC.
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
K980165Device Name
INFUTEST 2000 INFUSION DEVICE ANALYZER
Manufacturer
Date Cleared
1998-04-20
(94 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
DATREND SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infutest 2000 Infusion Device Analyzer (Infutest) is intended to verify the correct operation of infusion pumps. Infutest is designed to be used by biomedical electronics technicians, third party service personnel, and others who may be charged with the responsibility of determining the functionality of an infusion pump.
Device Description
The Infutest 2000 Infusion Pump Analyzer is an instrument for measuring the volume of fluid delivered by an infusion pump. The instrument is based on an optically instrumented burette. Flow rates from 0.1 to 999.9 millilitres per hour can be derived from the incremental volume measurements in relation to the time of delivery. Infutest 2000 is a two channel system, which can be expanded to four channels by the addition of an accessory two channel sensor assembly called the Remote Sensor Module.
The Infutest 2000 is designed to accurately measure volumes and rates on a wide variety of infusion pump types, including syringe, linear and rotary peristaltic, cassette based, enteral and patient controlled analgesia.
In addition to volume and flow rate, Infutest can measure the pressure developed by an infusion pump that is pumping into an occluded line. This feature is designed to measure the occlusion pressure alarm limits of the infusion pump.
Results of all tests performed can be printed to paper and/or sent to an external device using the serial communications port.
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