Safety Information - Stryker ENT Bedienungsanleitung

2.

Safety Information

WARNING
– Always inspect the product and all system components for damage before each use. Do
not use the product if damage is apparent; contact Stryker.
– Do not disassemble, modify, service, or repair this product without the authorization of
the manufacturer. Failure to comply may result in substandard performance and/or void
warranty. Contact Stryker for service.
– Do not bend or kink cables, or use cables that are damaged. Position measurements from
a system with damaged tool cables may result in possible personal injury.
– Do not use the system in atmospheres with potential for explosion. The system is not
protected against explosion.
– Do not block the ventilation slots on the product's bottom and backside.
– Position the product outside the reach of the patient.
– Do not use the device in the environment of a magnetic resonance imaging (MRI) scan-
ner.
– In case of emergency, shut down the product immediately and remove it from patient
or staff. Then arrange for the necessary check-ups and repairs conducted by qualified
service staff.
– Do not use the system during the discharge of a defibrillator. All navigated instruments
must be removed from the patient and the operating area beforehand.
– The system should not be used by users who suffer from dyschromatopsia (color blind-
ness); in particular, red-green-impairment or red-green-blindness affect the ability to
use the system.
– Navigated instruments are delivered in a non-sterile condition. Before the first use as
well as before each following use, the instrument must be processed (cleaned, disinfect-
ed, and/or sterilized) according to a validated procedure.
– Only those accessories listed in the manual may be used in combination with the navi-
gation system. When combining medical products, safety is only ensured if:
– the combination is specified in the respective user manuals as a safe combination, or
– the intended use and the interface specifications of the combined medical products
are suited for combination (compare IEC 60601-1).
– Using non-listed instruments and accessories (including cables) will lead to loss of the
product conformity.
– The medical electrical devices used in combination must comply with the safety stan-
dard IEC 60601-1 and the standard for data handling devices IEC 60950-1, if applicable.
When connecting additional devices to the signal in- and outputs, you are configuring
a medical system and will be responsible for making sure that the system meets the re-
quirements of the system standard IEC 60601-1.
– Do not expose or immerse the electrical components of the navigation system to liquids.
Do not place liquids on or above the devices. Liquids or other objects penetrating into
the device may result in equipment damage, produce a fire or shock hazard.
– Do not use mobile or other phones or portable radio frequency (RF) equipment in the vi-
cinity of medical devices. Devices emitting electromagnetic radiation may interfere with
operation of the product.
– Non-observance of the permitted environmental conditions may lead to a decalibration
of the measuring system. Should this happen, deviations can occur while measuring.
These deviations can only be remedied with a new calibration by the manufacturer. Re-
fer to Section 10 "Technical Specifications."
– If the device or its accessories are used on a patient who suffers from a disease whose
pathogens cannot be eliminated with conventional, standardized procedures, it must be
disposed of or processed according to the requirements of the responsible public author-
ity.
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