Safety Measures For Electromagnetic Measuring Systems; Data Privacy Information - Stryker ENT Bedienungsanleitung

2.1. Safety Measures for Electromagnetic Measuring Systems

WARNING
– Electromagnetic instruments are highly precise measuring instruments. Restrictions
concerning lifetime and handling must be observed. Damaged and inaccurate instru-
ments must be exchanged.
– Do not operate the Field Generator within 200 mm of an installed pacemaker. The
magnetic field produced by the Field Generator may interfere with the operation of the
pacemaker. This interference may result in personal injury.

2.2. Data Privacy Information

WARNING
Connecting the navigation unit to a network/data aggregate can put the patient, the opera-
tor, or third parties at risk. Your organization's risk management should determine, analyze,
evaluate, and control these risks to avoid potential damages (see especially IEC 80001-1).
Regarding this product, it is necessary to pay special attention to risks regarding the privacy
of patient image data and data integrity.
CAUTION
Prior to sending the device for maintenance, remove the data drive so that any private pa-
tient data is not shared with Stryker.
Note:
– The user must adhere to the respective national requirements regarding protection
of patient data. The navigation system may only be used by authorized personnel.
We recommend protecting the system from unauthorized use by means of a pass-
word.
– In public hospitals, it is necessary to inform the data protection commissioner about
the system.
– Due to data security, it is necessary to back up data regularly. Stryker does not as-
sume liability for data loss.
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