Storz 8404ZX, Instructions For Use Manual, Page: 9 / 60

Safety
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 9
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Only make changes to the product if these changes are approved by KARL STORZ.
3.5 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.
3.6 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.
3.7 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.
3.8 Patient leakage current
If several products supplied with energy are used simultaneously, the patient leakage currents
of the product can accumulate. Excessively high leakage current levels may result in the
patient becoming injured.
Only use products of the same type together, particularly if CF products are required.
If the product is connected to a type BF generator, the product will also correspond to
type BF.
3.9 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,
or RFID) emit electromagnetic radiation, the function of the product may be impaired. High-
frequency communication equipment can affect medical electrical products and impair their
performance.
Do not use the product in the vicinity of a magnetic resonance tomograph (MRT).
Do not use the product next to or together with other devices. If such use is required,
monitor the product and the other devices, and follow the relevant instructions for use in
the event of malfunctions.
Portable RF communications equipment including peripheral devices (e.g., antenna cables
and external antennas) should be used no closer than 30 cm from the product, including
cables specified by the manufacturer.
Observe the information on electromagnetic compatibility, see chapter Electromagnetic
compatibility [p. 48].