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3 Safety
3.1 Serious incidents
According to the Medical Device Regulation (MDR), a "serious incident" includes incidents that
directly or indirectly had, could have had, or could have any of the following consequences
(MDR, Art. 2, No. 65 [1]):
–
Death of a patient, user, or another person
–
Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
–
A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Unsterile product
The product is not sterile when delivered. The use of non-sterile products poses a risk of
infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and
every subsequent use.
3.3 Contaminated products
Contaminated products pose a risk of infection for users, patients, and third parties.
Comply with national laws and regulations.
Observe the guidelines of the Employer's Liability Insurance Association and equivalent
organizations.
3.4 Single-use product
The product must only be used once. Using the product more than once exposes patients,
users, and third parties to a risk of infection and injury.
Dispose of the product properly after using it once. Do not continue to use it.
3.5 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
result in injuries.
Additional devices connected to electrical medical equipment must comply with the relevant
IEC or ISO standards. Furthermore, all configurations must comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or Clause 16 of the 3rd edition of IEC 60601-1).
Only combine the product with devices and components that are approved for joint use by
the manufacturer.
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Connect only devices that comply with IEC 60601 to signal inputs and signal outputs.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
The product should not be used immediately adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the product should be observed to verify normal
operation in the configuration in which it will be used.
Comply with national and local regulations.
Instructions for use • S-PILOT
®
• PYB194_EN_V1.0_02-2021_IFU_CE-MDR
Safety
9
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