Safety
Instructions for use • AIDA C WD310 • AAB272_EN_V2.0_12-2021_IFU_CE-MDR 10
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 IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1).
Only combine the product with devices and components that are approved for combined
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.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
Only use devices with display capability that are identified as "display".
Comply with national and local regulations.
Only make changes to the product if these changes are approved by KARLSTORZ.
3.6 Damaged products
Damaged products can result in injury to patients, users, and third parties.
Before every use, check all components of the product for damage.
Do not use damaged products.
Have defective products checked by KARLSTORZ or by companies authorized by
KARLSTORZ.
Have regular safety inspections performed by KARLSTORZ or by companies authorized
by KARLSTORZ.
3.7 Dangers 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.
Have the device installed and put into service by authorized and trained electricians of
KARLSTORZSE&Co.KG or by companies authorized by KARLSTORZ.
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.
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.
Ensure potential equalization according to the applicable national rules and regulations.
To ensure reliable protective earth grounding, connect the product to a properly installed
socket that is approved for use in the operation room. Routinely inspect the electrical plug
and cord and do not use if the inspection reveals damage.
Connect the product to a power supply with protective conductor.
If several devices are connected to the product, note the maximum leakage current.
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.