Safety
Instructions for use • OR1™ Table Interface • ZWV442_EN_V1.0_02-2021_IFU_CE-MDR 7
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 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
result in injuries.
Combinations of medical devices are only assured to be safe if they are identified as such in
the respective instruction manuals or the intended use and interface specifications of the
products used in combination permit this.
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 IEC60601-1-1 or clause 16 of IEC60601-1).
Only combine the product with devices and components that are approved for joint use by
the manufacturer.
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.
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
Only use approved accessories.
Comply with national and local regulations.
Only make changes to the product if these changes are approved by KARLSTORZ.
3.4 Damaged products
Damaged products can result in injury to patients, users, or third parties. In the event of a fault,
the housing may heat up.
Before each use, check all components of the product for damage.
Do not use damaged products.
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