BIOSECURITY
Medical devices that run on electricity, whatever its value, and that is in contact with human body parts (hands, electrodes on skin, intravascular electrodes, etc), insulation failures when they can cause serious damage.
Biosafety tests consist of a series of regulated procedures to those who submit various pieces of equipment in the studio, precision instruments, to verify proper insulation, within the range declared by the manufacturer or required by international standards.
All equipment used for measurements in turn must have a rigorous control of functioning demonstrated, measured and documented, as required by quality and safety standards.
All medical equipment should be monitored periodically in custody for life and a mandatory each time they are repaired or disassembled for any reason.

 

FUNCTIONALITY TESTING
Many medical equipment to perform their function by providing metered electricity, fluids, radiation or other elements, to monitor or replace biological functions. It is of fundamental trust that the team delivers the values selected by the operator, but not always match. Therefore we must note with specific instrumental operating a reliable measuring equipment operating parameters. There is a wide range of equipment (not all) are supported by measurement tools that let you adjust the output values with selected parameters.

Item   Sample test report recurrent Defibrillators
Item   Sample test report defibrillator electrical safety

Electromedik has a wide range of instruments calibrated and controlled, allowing you to accurately measure the characteristics of bio-security and operation of electromedical equipment to provide the user and patient the highest reliability.

 

Type Equipment features Functions

Dinatech Nevada 453 A - Electrical safety and performance

Electrosurgical units analyser Electrosurgical units test performance. - Power Output /current mode
- RF leakages

TSI Certifier FA Plus Gas Analyzer - Operation

 

Performance Analyzer respirators

The purpose of Certifier FA Gas Analyzer Plus is to serve as instruments to control various types of equipment or parameters, including respirators. The device is not designed for use with patients, only used for measuring equipment. 

It is a device controlled by a microprocessor that measures mainly flow, pressure and oxygen concentration of the gases passing through the measuring tube. The processor will then take those values and transforms them into various parameters and graphs that can be seen on the screen.
- Flow Measurement + 0 to 20 liters per minute with the form of low flow and from 0 to 300 with the conventional form 
- Volume from 0 to 10 liters 
- Volume minutes from 0 to 99 liters 
- Pressure: peak, PEEP, mean, minimum, differential from -25 to + 150 cm H2O and from -10 to 150 PSI 
- Barometric pressure between 375 and 1200 mm Hg 
- Frequency respiratory cycles pr 1500 minutes 
- Inspiratory time, expiratory muscles, breaks from 0.04 to 30 seconds 
Relationships + I: E from 1:1000 to 100.0:1 
0 to 100% Oxygen 
Temperature from + 10 ° C to 40 ° C 
- Possibility to connect to computer via USB 
- Operation with line voltage or conventional Battery

Bio-Tek Index SpO2 - Operation

 

Analyzer and simulator for pulse oximeters Measurement and performance of individual teams or families oximeters - Different SpO2 level programs - between 35 and 100 %
- Programming of pulse frequencies between 30 and 250 BPM

Dinatech Nevada Impulse 3000 Bio-Tek Qed 6 - Operation

 

Defibrillators - electric shock analyser

Tests defibrillator performance

- Defibrillator energy output

- Ventricular fibrillation and/or ventricular tachycardy and automatic signal.

- Defibrillation signal
- Synchronism
- Tension peak, current and overshoot
- Charging Time
- Pacemakers
- Refractory Periods Pacemakers

DETAIL OF SOME ANALYZERS/SIMULATORS

Model Functions

ESA615

It provides automatic testing of electrical safety in medical equipment. This versatile device performs all electrical safety tests, including mains voltage, wire resistance mass (protective earthing), insulation resistance, device current and leakage current tests on referrals (patient).
It has a built-in automatic test sequences for quick checks and easily meet safety standards (ANSI / AAMI ES1 (NFPA-99), IEC62353 (VDE751), IEC60601-1 2nd and 3rd edition automation, and AS / NZS 3551)

Tests and ECG waveform measurements double bypass combine the functions of a simulator, multimeter and safety analyzer in a single test tool

ProSim 4

 

Vital signs simulator has an advanced touch screen through which offers quick and simple tests that allow performance tests under various conditions of patients
- Functions of the ECG, including arrhythmias, fibrillation, tachycardia, pacemaker pulses, Locks, asystole, etc.
- Simulation of breathing transthoracic impedance variation
- Electrical simulation of invasive blood pressure to an accuracy of 1% dynamic waveforms synchronized with the ECG, static pressures, etc.

- Pneumatic simulation noninvasive blood pressure for adults and neonatal patients in normal conditions, hypertension, hypotension, leak test, etc.

Spot Light E

 

It is a compact, portable and functional simulator to measure performance monitors SpO2 (pulse oximeters).
The product uses light emission and detection for its findings.
The findings examine the state of the pulse oximeter and sensor.

Spot Light is set in seconds to send SpO2 saturation, heart rate, perfusion, transmission, artifact noise, and eight curves R customized from different manufacturers to a pulse oximeter or patient monitor.

Impulse 7000DP

 

The analyzer defibrillators / pacemakers is a precision instrument whose testing capabilities span the spectrum of internationally established pulse shapes, featuring compatibility with AED technology.
The equipment includes an extensive range of test loads and measurement algorithms needed to test external transcutaneous pacemakers.

Its simulation capabilities in different ECG waveforms include the generation of arrhythmias and conduction disorders for testing different types of pacemakers, synchronous, on demand with frequent or occasional sinusoidal beats, AV sequential, without capture, etc.

QA-ES II

 

This is an analyzer of electrosurgical units quickly and accurately, some of its features:
• Ability to run tests automatically power distribution including power, current, peak to peak voltage (for closed load only), and crest factor
• Measurements of high frequency leakage to an accuracy of ± 2% of reading
• 128 internal test loads selectable by the user

 

 
Rental, repair, sale and manufacture of medical equipment
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