Safety
Instructions for use • OR1™ Table Interface • ZWV442_EN_V1.0_02-2021_IFU_CE-MDR 8
3.5 Danger from electrical current
An improper power supply may cause an electric shock and injure patients, users, or third
parties. All electrical installations of the operating room in which the product is connected and
used must meet the applicable IEC standards. Input and output equipment connected to the
product must comply with IEC60601-1.
Use either the power cord supplied by KARLSTORZ or a power cord which has the same
properties and which bears a national mark of conformity.
The product may only be operated with the line voltage stated on the rating plate.
Position the product appropriately so that the power cord can be unplugged at any time.
The product is only voltage-free when the mains plug has been disconnected.
Connect the product to a power supply with protective conductor.
The product’s ground line should be installed by a qualified electrician.
Ensure potential equalization according to the applicable national rules and regulations.
Routinely inspect the power plug and power cord and replace if the inspection reveals
damage.
If several devices are connected to the product, note the maximum leakage current.
In the case of electrical devices, 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 observe this 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 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 electrical medical products 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.
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