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nd
ETL Listed:
2
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)
rd
Optional 3
Edition Compliant Systems available
rd
ETL Listed:
3
Class 1 equipment (Europe); Class 2 equipment (USA)
rd
3
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).
TM
All Foam Aire
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).
Patents:
US & International Patents Pending
Certificate of Origin:
All products are manufactured in Corona, CA, USA.
SAFETY AGENCY APPROVALS
Edition
Edition
K-1 & K-2 Series Owner's Manual
MADE IN THE USA
Page 7
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