K-1 & K-2 Series Owner’s Manual
Page 7
SAFETY AGENCY APPROVALS
ETL Listed:
2
nd
Edition
The standard for safety of Medical Electrical Equipment
Conforms To: UL STD 60601-1 with respect to Electrical Shock, Fire and Mechanical Hazards
Certified To:
CAN/CSA STD C22.2 No. 601.1
CE Mark:
Class 1 equipment (Europe); Class 2 equipment (USA)
Optional 3
rd
Edition Compliant Systems available
ETL Listed:
3
rd
Edition
Class 1 equipment (Europe); Class 2 equipment (USA)
3
rd
Edition CE Mark:
Flame Resistance:
Unit components meet UL 94V-0 and Mattress components pass California117.
Optional California TB 106, TB 129, 16 CFR 1632, 16 CFR 1633, BS 6607 (CRIB 5), BS 597-1, & BS-597-2
compliant mattresses lined with Kevlar fire barrier available (Kevlar lining based on flammability standard).
All Foam Aire
TM
mattresses are TB129, 1632 & 1633 compliant.
FDA Registration:
FDA registered company as a manufacturer and as a contract manufacturer.
KAP MEDICAL’S quality system meets the requirements of:
FDA 21 CFR, PART 820- QSR-Current Good Manufacturing Practices (CGMP) for medical devices.
Products are FDA listed.
Health Canada Medical Device Licensed.
ISO 13485 certified company.
Medicare coded (SADMERC).
US & International Patents Pending
Patents:
All products are manufactured in Corona, CA, USA.
Certificate of Origin:
MADE IN THE USA
