Safety Information - Stryker Flosteady Handbuch

Safety Information

EN
Federal Law (only for U.S. market)
Exclusion of liability
Authorized service technician
Intended use
Care and maintenance
Contamination
Waste management
Batteries
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.
Caution: No modification of this equipment is allowed.
Only an authorized service technician may perform repairs, adjustments, or al-
terations on the device or accessories and use the service menu. Any violation will
void the manufacturer's warranty. Authorized service technicians are only
trained and certified by the manufacturer.
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 complete and
functional before each use.
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.
The Batteries Directive 2006/66/EC introduces new requirements from Septem-
ber 6, 2006 on removability of batteries from waste equipment in EU Member
States. To comply with this Directive, this device has been designed for safe re-
moval of the batteries at end-of-life by a waste treatment facility. Infected units
should be decontaminated before they are sent for recycling.