Safety Information; Hazards - Surgiquest AirSeal i.F.S. Gebrauchsanweisung

Safety Information

EN
Federal Law (only for U.S. market)
Exclusion of liability
Autorisierte Servicetechniker
Intended use
Care and maintenance
Contamination
Waste management
4
2 Safety Information
U.S. federal law restricts use of this device to use by or on the order of a physician.
The manufacturer is not liable for direct or consequential damage and the war-
ranty is null and void if:
• the device and/or the accessories are improperly used, prepared, or main-
tained,
• the instructions and rules in the manual are not adhered to,
• non-authorized persons perform repairs, adjustments, or alterations on or to
the device or accessories,
• non-authorized persons open the device,
• the prescribed inspection and maintenance schedules are not adhered to.
Receipt of technical documentation from the manufacturer does not authorize
individuals to perform repairs, adjustments, or alterations on or to the device or
accessories.
Only a SurgiQuest technician may perform repairs, adjustments, or alterations
on the device or accessories and use the service menu. Any violation will void the
manufacturer's warranty.
The device may be used only as intended.
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 properly con-
nected and functional.
Before shipping, decontaminate device and accessories in order to protect the
service personnel. Follow the instructions listed in this manual. If this is not pos-
sible,
• the product must be clearly marked with a contamination warning and
• is to be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
This symbol indicates that the waste of electrical and electronic equipment must
not be disposed of as unsorted municipal waste and must be collected separately
instead. Please contact the manufacturer or an accordingly authorized disposal
or waste management company for further information.
2.1

Hazards

WARNING!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.
WARNING!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient
and determine if the use of this device is indicated. The physician must deter-
mine the specific technique and procedure that will accomplish the desired clin-
ical effect.