Brief Description - MIMSAL MS User Manual

ENG

2. BRIEF DESCRIPTION

INTENDED USERS
These operating instructions are intended for the health professionals who use, clean, and
disinfect MISMAL lighting units.
INTENDED USE
This lighting unit is intended for carrying out very meticulous work that requires a high level of
precision. It is suitable for use in hospitals, medical research, laboratories, clinics, etc.
INDICATION
The light is only intended to provide optimal visibility of the surface being examined and has no
diagnostic or therapeutic effect. The light is external to the body and the device never enters
into contact with patients.
CONTRAINDICATION
The products must not be used close to strong magnetic fields.
The device must not be used in oxygen-enriched environments or in close to flammable
anesthetic gases.
RESIDUAL RISKS – RISK IN THE EVENT OF DAMAGE TO THE LIGHTING UNIT
Protect the lighting unit from knocks. Collision with other objects could result in the failure of
the device and/or damage to the cover and the support arm system, causing parts to fall off.
The lighting unit does not include a fail-safe power source. A power cut will cause the device
to switch off.
Do not aim the light source directly at the eyes of the patient and/or operator.
Always properly protect the patient's eyes.
Failing to comply with these precautions could cause blinding and damage to the retina.
Never place and/or hang any object on the lighting unit. If this precaution is not taken, the unit's
position will be unstable and these objects could fall onto the work area.
Never hang the body weight of a person from the lighting unit. Failing to comply with this
precaution could damage the structure of the device.
INCIDENTS AND REPORTS
The user and/or the patient must notify MISMAL and the competent authority in the country if
any serious incident occurs whilst using the device.
In accordance with the Medical Devices Regulation (MDR), the competent authority must be
notified immediately.
6