Burke TRI-FLEX II Operating Instructions

8
SAFETY AGENCY APPROVALS
ETL Listed:
To standard for safety of Medical Electrical Equipment
Conforms To: UL STD 60601-1 with respect to
Electrical Shock, Fire and Mechanical Hazards
Flame
Resistance: Unit components meet UL 94V-0.
Mattress components pass
Standard for California117.
FDA REGISTRATION
The Manufacturer is an FDA registered company as a manufacturer and as a contract
manufacturer whose quality system meets the requirements of FDA 21 CFR, PART
820-Good Manufacturing practices for medical devices and ISO 9001.
Products are FDA listed.
PATENTS
US & INTL.: Patent Pending
Complies with Medical Device Directive
93 / 42 / EEC

Burke TRI-FLEX II Specifications

General

Brand	Burke
Model	TRI-FLEX II
Category	Medical Equipment
Language	English