Safety Information - Arthrex AR-3210-0006 Instrucciones De Uso

Safety Information

EN
Federal Law (only for U.S. market)
Exclusion of liability
Intended use
Contamination
Care and maintenance
Disposal
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2 Safety Information
CAUTION: Federal Law restricts this device to sale by or on the order of a physi-
cian.
The manufacturer is not liable for direct or consequential damages, and the war-
ranty becomes null and void if:
• the device and/or the accessories are improperly used, prepared, or main-
tained;
• the instructions and rules in the instructions for use are not adhered to;
• unauthorized persons perform repairs, adjustments, or alterations on the de-
vice or accessories;
• unauthorized persons open the device;
• the prescribed inspection and maintenance schedule is not adhered to.
The handing over of technical documents does not constitute authorization to
make repairs or alterations to the device or accessories.
The manual is intended as a tool for the use of the C-Mount HD Optical Zoom
Coupler. It is not intended as a reference for surgical endoscopy procedures or
techniques.
WARNING: Modifying the device C-Mount HD Optical Zoom Coupler is not per-
mitted.
The device may be used only as intended (chapter 3.2, page 7).
Before shipping, decontaminate device and accessories in order to protect the
service personnel. Follow the instructions listed in this User Manual. If this is not
possible,
• the product must be clearly marked with a contamination warning and
• must be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
The service and maintenance of the device and its accessories has to be carried
out as per instructions to ensure the safe operation of the device. For the protec-
tion of the patient and the operating team, check that the device is complete and
functional before each use.
Maintenance of the device may not be performed during the operation.
Comply with country-specific regulations and laws as well as the local regula-
tions when disposing of the product.