Operative Manual
MO082-IT
22/04/13
Rev.0
Pag. 7 di 12
3.
Importance of personal safety
3.1
Intended use
The Product is made to light up the area occupied by the patient undergoing diagnostic or observation, and has
been designed for use in medical surgeries.
The Product correctly lights up the field of work from a minimum distance of 40cm to a maximum distance of
70cm from the point of light emission.
The Product, in compliance with the standard IEC 60601-2-41,
is assesses as luminaire for diagnosis:
-
Luminaire to illuminate the body of the patient locally in order to support diagnosis or treatment which could
be interrupted without any hazard for the patient in case of failure of the light. (Is not intended to be used in
operating rooms)
3.2
Environmental conditions.
-
The Product is not suitable for use in explosion-risk areas.
-
The Product is not suitable for use in the presence of inflammable mixtures of anaesthetics with air, oxygen or
NO
2
(laughing gas).
-
During operation, the ambient temperature must be between 10°C and 40°C.
-
Relative humidity must be between 30% and 75%.
-
Atmospheric pressure must be between 700 and 1060hPa.
3.3
Other secondary conditions (secondary effects)
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Do not direct the light source into the patient’s and/or operator’s eyes.
-
Obligation to adequately protect the patient’s eyes.
Failure to follow such precautions could cause glare and potential damage to the retina.
-
Never place and/or hang anything on the Product.
Unless this precaution is taken, positioning will not be reliable and the danger exists of such objects falling in
the operating area.
-
Never hang on the Product with the body weight of a person.
Unless this precaution is taken, mechanical parts of the Product could be damaged.
-
Never cover the head of the Product during operation.
Failure to comply could prevent heat exchange with the environment and the Product could overheat.
-
Avoid knocking the rocker arms and Product head.
A violent knock could damage the Product and pieces of paint could chip off and fall onto the operating field in
the patient area.
4.
Description of the operations
The Product requires no keyboard for its functioning. The turning on is controlled by the switch “I-O” situated on
the base of the Product.
5.
Cleaning and disinfection
5.1
Cleaning the Product
Switch the Product off by means of the removing of plug, and make sure it cannot be switched back on.
Protect the Product against water spray and do not clean it/disinfect it with liquids.
Leave the lamp body to cool down. Only clean the lamp body when it is cold.
Clean with appropriate detergent with low alkaline content and chlorine free.
Do not use abrasive products, petrol, paint thinners, alkaline detergents, acids, containing alcohol or aldehydes;
Dose the detergents so no liquids penetrate into the lamp bodies and into the support arm system.
Clean the Product with a damp but not wet cloth.
