Safety
Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR
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Observe the instructions for use and interface specifications of the combined devices and
system components.
Only use approved accessories.
3.6 Failure of products
The product may fail during use.
Have a replacement product ready for each application or plan for an alternative surgical
technique.
3.7 Modifications to the product
Modifications to the product reduce the safety of the product. Patients, users, and third parties
may be injured as a result.
Do not modify the product.
3.8 Opened product
If the product is opened, it presents a risk of life-threatening electrical shock.
Do not open the product.
Arrange for service work to be carried out by authorized personnel only.
3.9 Damage due to ingress of liquid in electrical
components
In the case of electrical products, individual components or the product itself may be live.
Liquid ingress into an electrical product may result in a short circuit or an unintentional transfer
of current. The product is damaged as a result and patients, users and third parties may be
injured.
Do not store liquids near the product or on the product.
If liquid has entered the product, pull out the plug and allow the product to dry completely.
3.10 Patient leakage current
Patient leakage currents from products may add up if powered products and powered
endotherapy devices are used simultaneously. Excessively high leakage current levels may
result in the patient becoming injured.
Only use products of the same type together, particularly in the case of CF products.
3.11 High light intensity
The high level of light intensity produced by the light source may lead to permanent eye
damage or blindness, and may cause tissue and items facing the light output to heat up.
Do not look into the light output.
Set the light source output to a level that is just high enough to ensure optimal illumination
of the operating area.
Make sure the light output is sufficiently far away from tissue and operating accessories.
3.12 Electromagnetic interference
Medical electrical products are subject to special precautions regarding electromagnetic
compatibility and must be installed and commissioned according to the tables on
electromagnetic compatibility. If other products (e.g., for MRT, CT, diathermy, electrocautery,
