ISO 13485 Certificate for CorTec

After the audit at the end of last year, CorTec’s quality management system is now officially certified according to DIN EN ISO 13485.

For us, the certificate gives evidence of a successful establishmet and implementation of our quality policy in all our processes.

More about our quality policy

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SPECIFICATIONS

FEATURE 

Recording channels 

Sampling rate 

Sampling dynamic range 

High pass filter cut-off 

Low pass filter cut-off 

Amplifier band pass gain 

Band pass roll-off 

Reference


Stimulation 

Stimulation channels 

Current 

Current source 

Pulse width 

Power supply 

Wireless data transmission 

Closed Loop latency

VALUE

32 

1 kHz 

16 bit (74 nV smallest increment) 

ca. 2 Hz 

325 Hz 

Adjustable: 100-750 

20 dB/dec 

Any (subset) of the recording channels selectable by software or one dedicated hard-wired additional contact 

Current-controlled, biphasic, rectangular, asymmetric stimulus pulses (cathodic amplitude with pulse width followed by an anodic counter pulse of 1/4x amplitude and 4x pulse width) 

 32 

Max. -6 mA / +1.5 mA (24 µA increments) within

 compliance voltage range of -11 V to +5 V 

Can be directed to any of the 32 electrode contacts 

Negative phase: 10 µs – 2,500 µs

Wireless inductive, 120-140 kHz

Bi-directional, radio frequency in 2400-2483.5 MHz band ≤ 40 ms