Safety Information; User Qualifications; Cyber Security And Patient Data Privacy - Stryker ENT Bedienungsanleitung

2.

Safety Information

2.1. User Qualifications

WARNING
The Scopis ENT Software with TGS is intended solely for use by medical professionals and
may only be used by physicians who have the corresponding qualifications and have re-
ceived the necessary training. Enclosed information, such as this manual, cannot substitute
for lacking medical expertise.
The user must adhere to the respective national requirements regarding protection
of patient data. The navigation system may only be used by persons that have been
authorized to do so. We recommend protecting the system from unauthorized use by
means of a password.
Stryker does not assume liability for any diagnoses or interpretations created with this
product. The user is the only one responsible for acquiring medical knowledge and for its
diagnostic and therapeutic consequences.
To ensure the safe and efficient use of the product, the user must be instructed on how to
use the product as authorized by the manufacturer and retailer. The medical product's op-
erator must ensure that the user receives such instruction in accordance with the respective
local laws, and that the instruction is refreshed at the prescribed intervals. Additionally, the
instructions in all accompanying manuals must be respected.
During a surgery in connection with the navigation system, the patient has to be treated and
observed with the usual medical care. This includes the follow-up to the treatment process,
the monitoring of the vital signs and the state of anesthesia, as well as maintaining sterile
application conditions, if required for a respective operation.
Aside from your own knowledge, a correct usage as well as regular cleaning and mainte-
nance works are crucial for the operational safety and utility of the product.
In public clinics, it is necessary to inform the data protection supervisor about the system.

2.2. Cyber Security and Patient Data Privacy

The Scopis ENT Software with TGS (Target Guided Surgery) and the Electromagnetic Navi-
gation Unit must be secured against cyber security attacks by you as the operator to ensure
confidentiality of patient data, availability and integrity of the device for surgery. In par-
ticular, connecting the Electromagnetic Navigation Unit to a network via Ethernet, connect-
ing USB media or allowing physical access to the device by third parties may result in cyber
security being violated.
WARNING
– Connecting the navigation unit to a network or USB media can put the patient, the user,
or third parties at risk. Your organization's risk management should determine, analyze,
evaluate, and control these risks to avoid potential damages (see especially ISO 80001-
1). Regarding this product, it is necessary to pay special attention to risks regarding the
privacy of patient image data, system and data integrity, as well as system availability.
– Always keep the device in separate high-risk network. Track MAC addresses and only
give known devices access to this network.
– If a cyber security attack has been detected, do not use the device until the attack has
been responded to adequately and the device integrity has been recovered.
EN Safety Information | 5/21