System Two LED Installation and Service Manual (1003385 Rev. C)
Page 2
System Two LED
Agency Approvals
Medical Electrical Equipment
With respect to electric shock, fire
And mechanical hazards only
In accordance with IEC60601-1:2006/CAN/CSA C22.2
No.601.1-M90 with updates 1 & 2
Classifications:
1. Protection against electrical shock (5.1, 5.2). Class I permanently connected,
2. Protection against harmful ingress of water (5.3). None.
3. Degree of safety in the presence of flammable anesthetics or oxygen (5.5). Not suitable for use in the
presence of flammable anesthetics or oxygen.
4. Mode of operation (5.6). Continuous
5. Surgical luminaries (IEC60601-2-41)
Electromagnetic compatibility for immunity
And emissions in accordance with
IEC/EN 60601-1-2:2007 edition 3.0 (with 1:2008+A2:2009) and
CISPR 11 Class A
Medical Electrical Equipment
Particular requirements for the safety of surgical
luminaries and luminaries for diagnosis
In accordance with IEC-60601-2-41
Intended use:
Professional Medical Lighting for Hospital, Clinic, Minor Surgery, Examination or Diagnosis, within
suitable facilities designated for such purposes. This light system is mounted centrally in a room such that access is
available all around the operating environment.
User interface:
The System Two LED lighting systems are intended to be used by medical professionals in
surgeries and exam rooms. The functional interfaces are 360° positioning horizontally and vert15° to -65°.
The light head can be rotated continuously. An ON/OFF button is provided with 5 levels of dimming and Endo
mode.
Misuses:
For any purpose or use at any facility other than stated above. Caution shall be exercised when
positioning the light head and avoid contact or collision with the patent, other medical professionals or other
lights/equipment.
Cautions:
Do not apply excessive force to motion range stop features.