Safety
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 7
In the case of electrical products, individual components or the product itself may be live. Live
parts can cause electric shocks in the event of contact and injure patients, users, and third
parties.
Do not open the product.
Have servicing carried out by KARLSTORZ or a company authorized by KARLSTORZ.
Failure to do so will void the guarantee.
Do not touch the output jacks of the product and the patient at the same time during use.
Always pull out the mains plug before carrying out any cleaning and maintenance work.
3.6 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.
3.7 Electromagnetic interference
Medical electrical devices 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 devices and impair their
performance.
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 30cm from the product, including
cables specified by the manufacturer.
Observe the information on electromagnetic compatibility; see chapter Electromagnetic
compatibility [p.18].
To prevent increased electromagnetic emissions or reduced electromagnetic immunity of
the product, only use accessories, transducers, and cables recommended or supplied by
the manufacturer.
The use of accessories and cables other than those specified in the instructions for use may
result in increased emissions or decreased immunity of the product. When using other
accessories and cables, the operator is responsible for checking compliance with
IEC60601-1-2 for this particular product.
To prevent increased electromagnetic emissions or reduced electromagnetic immunity of
the product, only use accessories, transducers, and cables recommended or supplied by
the manufacturer.
3.8 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
result in injuries.
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