Applicable To; Safe Handling; Product Description; Scope Of Supply - B.Braun Aesculap OP950 Instrucciones De Manejo/Descripción Técnica

Aesculap
LED light source OP950 with sterile adapter OP941
1.

Applicable to

►
For item-specific instructions for use and information on material
compatibility, see
https://extranet.bbraun.com
2.

Safe handling

CAUTION
Federal law restricts this device to sale by, or on order of a physician!
Risk of death by electric shock!
►
Do not open the product.
DANGER
►
Connect the product only to a grounded power
supply.
Risk of injury from current leakage when touching
the patient!
►
WARNING Never touch the patient and the device housing
or accessible contacts of electric devices at the
same time.
►
Never touch the patient and non-medical elec-
tric devices at the same time.
►
Prior to use, check that the product is in good working order.
►
Observe "Notes on Electromagnetic Compatibility (EMC)", see
TA022130.
►
To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►
Only allow products and accessories to be operated and used by indi-
viduals who have been trained in the use of endoscopic procedures.
►
Keep the instructions for use accessible for the user.
►
Always adhere to applicable standards.
►
In the sterile field only use sterile processed sterile adapter OP941.
►
Ensure that the electrical facilities in the room in which the device is
being used conform to IEC norms.
►
Unplug the device by pulling on the plug, and never on the power cord.
►
Do not use LED light sources in areas where there is a risk of explosion.
►
Make certain that the ambient temperature does not exceed 40 °C.
►
Make certain that the device's ventilation ducts are not covered.
4
®
also the Aesculap
3.

Product description

Extranet at
3.1

Scope of supply

Designation
LED light source
Sterile adapter
Instructions for use
EMC brochure
3.2

Components required for operation

Designation
LED light source
Sterile adapter
Optical cable with a diameter of 4.8 mm of type
Aesculap/Storz, Olympus or Wolf
Power cord
3.3

Intended use

The OP950 light source is intended for use in endoscopy systems for
human medicine. In combination with a light lead, endoscope, camera and
monitor, its purpose is to illuminate the inside of the human body.
3.3.1

Indication

There are no medical indications associated with the use of the OP950
light source itself if separated from the endoscopic system.
The indications for an endoscopic application depend on the condition of
the patient and the individual risk/benefit analysis by the surgeon.
3.3.2

Contraindication

There are no medical contraindications associated with use of the OP950
light source itself if separated from the endoscopic system.
Depending on the intended use of the applied part, contraindications may
exist in respect of the patient's general condition or the specific present-
ing disease.
The decision to perform an endoscopic procedure remains with the
responsible surgeon and should be made on the basis of an individual ben-
efit/risk analysis.
Art. no.
OP950
OP941
TA014627
TA022130
Art. no.
OP950
OP941
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