Arthrex AR-3200-1018, Instructions For Use Manual

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Symptom Possible Cause Corrective Action
Laser does not
activate.
• Verify control cable connected
between Synergy
ID
console
and laser light source.
• Suspect control cable.
• Control cable connected to
wrong connector on
Synergy
ID
.
• Synergy
ID
LED powered off.
• Plug control cable securely into both
Synergy
ID
console and laser light
source.
• Replace control cable.
• Confirm control cable connected to
laser input connector on Synergy
ID
console.
• Turn on Synergy
ID
LED.
4.0 Technical Information
NOTE: Technical data is subject to modification, revision and improvement without notice.
Safety, EMC and Regulatory Requirements
Parameter Parameter Value
System Classification
FDA Class Class II
EU Class Class IIa
Health Canada Class Class II
Safety Certifications
Domestic Certification
• ANSI/AAMI ES60601-1:2005/A1:2012
excluding Biocompatibility (clause 11.7),
Usability (clauses 12.2 and 15.1), PEMS
(clause 14) and EMC (clause 17)
• IEC 60825-1:2007 (2nd edition) and 2014
(3rd edition)
Canadian Certification
•
CAN/CSA C22.2 No 60601-1: 2014
excluding Biocompatibility (clause 11.7),
Usability (clauses 12.2 and 15.1), PEMS
(clause 14) and EMC (clause 17).
EU Certification
• ANSI/AAMI ES60601-1:2005/A1:2012
excluding Biocompatibility (clause 11.7),
Usability (clauses 12.2 and 15.1), PEMS
(clause 14) and EMC (clause 17)
• EN 60601-1:2006/A1:2013 excluding
Biocompatibility (clause 11.7), Usability
(clauses 12.2 and 15.1), PEMS (clause
14) and EMC (clause 17).
• IEC 60825-1:2007 (2nd edition) and 2014
(3rd edition)
EMC Certifications
CISPR 11 EMC Class Class A
CISPR 11 EMC Group Group 1
EMC Certification Certification to EN 60601-1-2:2015 (4th edition)