Safety and warning
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 9
3.5 Dangers from electrical current
An improper power supply may cause an electric shock and injure patients, users, or third parties.
Do not use multiple socket outlets with this device.
If the use of a multiple socket outlet cannot be avoided: Only use a multiple socket outlet with an
isolation transformer in accordance with IEC 60601-1.
3.6 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.
3.7 Electromagnetic interference
Medical electrical devices are subject to special precautions regarding electromagnetic compatibility.
If other devices (e.g., MRT, CT, diathermy, electrocautery, or RFID) emit electromagnetic radiation, the
product’s functionality may be impaired. High-frequency (HF) communication equipment can affect
electrical medical devices and impair their performance.
During installation and operation of the product, please take note of the information on
electromagnetic compatibility, see chapter Electromagnetic compatibility.
3.8 Appropriate combination of product and fiber optic light
cable
If the fiber bundle diameter of the fiber optic light cable is too large, the product will heat up at the
light connection. This may cause damage to the product.
If the fiber bundle diameter of the fiber optic light cable is too small, not enough light will enter the
product. This may mean that the operating area is not sufficiently illuminated.
Use the product with a fiber optic light cable that has an appropriate fiber bundle diameter; see
Possible combinations.
3.9 Hot components
The high level of light intensity produced by the light source may cause the distal end, the light
connections, and adjacent components to heat up. This can cause burns to patients, users, or third
parties.
Set the output of the adjustable light sources to a level that is just high enough to ensure optimal
illumination of the operating area.
Avoid contact with the distal end of the exoscope.
The surface of the product can get hot. This can cause burns to patients, users, or third parties.
Do not hold the product for an extended period of time.
Use a holding system instead.
3.10 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.
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