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13.9 Classification
Description
Data
MDD 93/42/EEC Notified body
MDD 93/42/EEC Risk class
IIb
active therapeutic device and active diagnostic device
60601-1
Protection against electric
shock
Class I,
IEC 60601-1
Protection against harmful
ingress of water or particulate
matter
IP00
IEC 60601-1
Mode of operation
Continuous operation
IEC 60601-1
Overvoltage category
II (2500 Vpeak mains transient voltage)
IEC 60601-1
Applied part
Type B (whole device)
IEC 60601-1
Pollution degree
Degree 2
ISO 20957-1
Usage class
S (Studio): professional and / commercial use
I (inclusive): professional and/or commercial use provided for inclusive use for
people with special needs
EN 957-6
Accuracy class
A
IEC 62304
Risk class
B
13.10 Certificates
Description
Data
MDD 93/42/EEC
CE declaration of conformity
MDD 93/42/EEC
EC certificate, quality assurance
MDD 93/42/EEC
Free sales certificate
EN ISO 13485
Certificate, quality management medical devices
IEC 60601-1
CB certificate
UL 60601-1
NRTL certificate
Certificates see accompanying documents and
https://www.h-p-cosmos.com/en/contact-support/media-downloads/security-certificates
13.11 Interfaces (RS232, D-SUB, 9-pole)
Description
Data
COM 1 (standard)
Baud rate 9600 bps / 115200 bps
COM 2 (optional)
Baud rate 9600 bps
COM 3 (service)
Baud rate 115200 bps
COM 4 (optional)
Baud rate 115200 bps