3
Conformance Standards
1.The following classifications are in accordance with the IEC/EN 60601-1:6.8.1:
1) According to 93/42/EEC Medical Device Directive, this is Class IIa medical Device.
2) According to IEC/EN 60601-1.
• Equipment is Class I, BF Part.
3) According to IEC 60529:2001-02.
The protection level of monitor is IPX0.
The protection level of endoscope is IPX7.
2. Certification
The general electrical medical system is CE, ISO9002, ISO9001 certified.
3. Original Documentation
The original document is written in English.
Note
DISASSEMBLY AND REPAIR BY THE CUSTOMER ITSELF IS NOT
PERMITTED, IF THIS LEAD TO SOME DAMAGE, THE CUSTOMER
SHOULD TAKE RESPONSIBILITY OF IT.
