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Product categories
07 Medical Services and Publications
07.15 Technical equipment management, test houses / certification bodies
Technical equipment management, test houses / certification bodies
07 Medical Services and Publications
07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
Our products
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
SECULIFE ST SERIE (BASE/BASE25/PRO) Safetytester IEC 60601
Tester with test sequences according to EN 62353, EN 60601, EN 61010, EN 60335, EN 60950, GOST R (ГОСТ Р) 60601, VDE 0701-0702
Future-proof, with 4mm connections for application parts and antimicrobial equipment, the SECULIFE ST PRO offers safety in all areas of device safety in the medical environment. The SECULIFE testing devices enable electrotechnically instructed persons to carry out safe and rapid testing in accordance with a large number of different application and product standards. The new SECULIFE SERIES now gives you even more safety and ease of use when testing electrical devices in all medical technology applications. The unique, intuitive operating concept via a rotary switch with two operating levels ensures error-free, fast and safe testing.
Product highlights of the ST series
Housing with antimicrobial activity
Data management and storage concept
Automatic connection recognition
Push-Print Function
4mm AWT sockets (SECULIFE ST PRO)
Two-tree structure
Automatic test sequences
10A Test current (SECULIFE ST BASE and ST PRO)
25 A Test current (SECULIFE ST BASE25)
Verification of electrical safety
Electromedical devices according to DIN VDE 0751 / IEC 62353 and EN 60601 2nd and 3rd edition
Electrical equipment according to DIN VDE 0701-0702
Unit tests according to EN 61010, EN 60950, EN 60335
Measurement capabilities
Protective conductor resistance with 200mA and 10A test current
Insulation resistance
Earth leakage current
Contact current (housing leakage current)
Patient leakage current AC and DC
Patient auxiliary power
Equivalent leakage current method
Direct measurement method
Differential current measuring method
Connection possibility for 10 application parts 4 mm, individually groupable
Internal memory for 125 tests
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
SECULIFE IF PRO Infusionpumptester
Infusion pump tester with modular design, 1-4 channel
The SECULIFE IF PRO is the most compact, full-featured four-channel analyzer on the market. Tests according to DIN EN 60601-2-24 (VDE 0750-2-24) are performed manually or automatically.
The SECULIFE IF PRO is a high-precision, easy-to-use system that includes the entire touchscreen control of all processes without the use of old-fashioned keys and buttons. The new patent-pending test system is a stepper motor driven system that allows continuous monitoring of fluid flow without the need to stop and intermittently clean. This provides a more realistic flow path for the infusion device under test and therefore more accurate readings.
The concept of a modular test instrument with independently operating test modules allows the calibration of individual test modules without downtime for the entire instrument.
Product Highlights
PCA / Bolus
Back Pressure Simulation
Occlusion Alarm
trumpet curve analysis
1,2,3 and 4 channel models available (can be retrofitted by customer)
Interchangeable test modules
Calibration of the test modules takes place without base unit
Auto test sequences
Advantages
Intuitive user guidance
Automatic test procedures feasible
Independent operation of the individual channels
Large internal memory for test results
OnSite retrofittable and upgradeable
Low noise emission
High test speed
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
SECULIFE SP BASE / PRO SpO2 Simulator
Digital SpO2 Simulator
The SECULIFE SP BASE and SECULIFE SP PRO are digital SpO2 simulators with many functions.
The small external dimensions paired with an intuitive menu via the 2.4″ colour touch screen,
distinguish the powerful devices.
The simple operating structure enables easy access and a simple view of all
setting and function parameters.
A manual mode is available for carrying out more specific evaluations.
control over each parameter.
The available presets for Nellcor, Masimo, Nonin, Nihon Kohden, Mindray, GE-Ohmeda, Philips/HP
and BCI enable simple and convenient testing of SpO2 monitors.
With the SECULIFE SP PRO, the transmittance can be selected between small, medium and large fingers. In addition, artifacts such as respiration or ambient light can be selected for simulation.
The SpO2 rate can be set in 1% steps. The BPM rate can be set in BPM steps.
will be.
Highlights
Intuitive user interface with colour touch screen
Preset & manual mode
6 saturation steps from 80-99% with 2% accuracy (SP BASE)
Saturation adjustable from 10-100% with 2% accuracy (SP PRO)
Heart rates from 30-240 BPM with 1% accuracy
Adjustable perfusion index
Adjustable transmission level (SP PRO)
Selectable artifacts (SP PRO)
Pulse synchronized with SECULIFE BP PRO, PS200 and PS300
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
SECULIFE UP Digital Ultrasonic Power Meter
The SECULIFE UP ultrasound power meter model has been developed for testing diagnostic and
therapeutic transducers.
This compact and lightweight model meets all the requirements of a portable tester with
the reliability and proven performance of the SECULIFE-U series. The SECULIFE UP uses
a test tank with a diameter of 12.7 cm and a height of 8.9 cm.
The most reliable and reproducible method for measuring ultrasonic energy is the sound field force method. The transducer to be tested is centered in degassed water above a 45° air bearing cone target. A coupling is made with a precision balance, which is set to ± 0.15 Watt exactly.
Highlights
Resolution 50 mW
Measuring range 0 to 30 Watt
Frequency range 0.5 to 10 MHz
Pulse current measurement
Measurement of continuous current
Result in Watt
Result in grams
Battery-powered
Mains operated (adapter for external power supply)
Digital liquid crystal display
Automatic zero adjustment
Automatic stabilization
Five-point certificate
Traceable to NIST
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
SECULIFE ES XTRA / PRIME Multimode Electrosurgery Analyzer
SECULIFE ES PRIME for functional testing and analysis of electrosurgery – Generators
The SECULIFE ES XTRA / ES PRIME represents a completely new standard for electrosurgical analyzers with comprehensive functionality due to its unprecedented features. It offers unprecedented features and applications; all in a self-contained electrosurgical analyzer. The SECULIFE ES PRIME offers an unprecedented sampling rate of 16 million data points. This enables ultra-stable measurements of the output waveforms of the latest generation of RF generators. Even multiple pulsed waveforms can be acquired and analyzed.
By the use of internal, induction-free precision test loads in the range from 0 Ω to
6400 Ω in previously available 1 Ω steps, the SECULIFE ES XTRA / ES PRIME offers hospitals and manufacturers the necessary compatibility. In all cases, the ability to add an external load has been added, ensuring 100% compatibility for test load requirements for years to come.
With an RF current range from 2 mA to 7000 mA RMS (power range of 500 Watt RMS) exceeds
the SECULIFE ES XTRA / ES PRIME, as far as the measuring range is concerned, all the other currently available or analyzers offered so far.
Highlights
Industry standard RF current measurement for multiple pulsed waveforms (SECULIFE ES PRIME)
Ultrafast digitization of the complex HF waveform.
Compatible for continuous or pulse output waveforms.
Built-in real-time operating system with ¼ VGA color touch screen
Displays up to 15 different measurement parameters on selectable and definable screens.
Internal precision test loads from 1 Ω to 6400 Ω in 1 Ω steps
Compatible with external test loads
Automated current load curves with different power levels per load value setting
Automated, freely definable test sequences
Printing of test results on printers with RS232 or USB connection
USB (3), RS232, and Ethernet communication ports
Compatible with external keyboard and mouse through dedicated connectors
Automatic or manual activation of the HF generator during a load curve test
Remote control of the HF generator possible
REM/ARM/CQM testing using 500 Ω load, adjustable in 1 Ω steps
HF leakage current measuremen
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
IZYTRONIQ Test Data Management Software
IZYTRONIQ enables the recording of electrical systems via tree structure as well as a component-oriented assignment of test results via push/print communication via Bluetooth or USB. Alternatively, the complex tree structure can be transferred bidirectionally to the test device. The dynamic protocol generation with the option of photo documentation supports you in generating time-saving and efficient reports.
IZYTRONIQ meets this requirement with individually programmable test sequences. Notes and auxiliary images can be stored for each sequence step to support the inspector during his work.
Inspection and documentation of:
Electromedical devices according to IEC/EN 62353 (VDE 0751)
Electromedical equipment EN 60601 (2nd and 3rd edition)
Unit tests according to EN 60950, EN 60335
E-charging stations according to VDE 0122-1
Electrical systems according to DIN VDE 0100-600
Electrical systems according to DIN VDE 0105
Electrical systems according to DIN VDE 0105-100
Machines according to DIN EN 60204-1 (VDE 0113-1)
Lightning protection systems according to DIN EN 62305
Foundation earth electrodes according to DIN 18014
PV systems according to VDE 0126-23
Low-voltage switchgear and controlgear combinations according to DIN EN 61439
Electrical devices according to DIN VDE 0701-0702
Arc welding equipment according to IEC/EN 60974-4 (VDE 0544-4)
ad: contact information
GHX Europe GmbHGIMMI GmbH Endoscopic Technology
Gläserne Redaktion
Gonotec GmbH
fzmb GmbH
G. Heinemann Medizintechnik GmbH