Regulatory Notice - Delmont imaging iCare Instrucciones Para El Uso

- Do not use corrosive or abrasive products to clean the device but only the disinfectant liquids recom-
mended in the corresponding chapter.
- Before each use, make sure that the unit has no rough surfaces, sharp edges or protrusions that could
cause safety problems.
- The surface temperature can exceed 41°C (after a few minutes of use). Therefore, avoid contact with
skin.
- To avoid the risk of electric shock, this device may only be connected to a power supply equipped with
a protective ground.
- The devices connected to the inputs/outputs must comply with IEC 60950-1.
- This device may not be modified without the manufacturer's permission. If the medical device is modi-
fied, a check and test must be carried out to ensure that the medical device complies with the safety instructions.
- Check with the manufacturer the compatibility of your endoscope before use.
- To prevent errors or delays in diagnosis, it is important to ensure that the monitor settings used are
optimized for the procedure being performed so that a clear, noise-free colour image is obtained.
- This device should be used on individuals (patients) suitable for endoscopic procedures.
- Applied parts of electro-medical devices that can be used in conjunction with iCare shall be of BF-type
or CF according to standard 60601-2-18. Check this compatibility before each operation for safe use.
It is recommended to have a second camera and light source available to use in case an absence or
degradation of performance is observed.
2.2. Instructions specific to the light source
- Never look at the light output or the end of the light cable.
- Do not insert anything other than a light cable into the hole provided for this purpose, otherwise the
optical system may be damaged.
- Use of cables or accessories other than those specified may result in increased emissions or decreased
immunity of the unit.
- After using the source, when removing the fiber from its light guide, the temperature on the metal cou-
pler of the fiber is very high and can cause burns.
- The light power at the light cable outlet can cause eye damage. Handle the light cable carefully when the
device is in use.
- Do not place the distal end of the light cable or endoscope directly on the patient or on any other flam-
mable material (sheets, gauze, operating fields, etc.) as this can be very hot and cause burns.
This product is equipped with Group 1 LEDs according to IEC 62471. Do not look directly at the light
to avoid any ocular risk.
2.3. Contraindication
The use of iCare is contraindicated when endoscopic practice is contraindicated for the patient.

3. Regulatory notice

3.1. Compliance
This product was designed and manufactured by a company with a certified quality system.
D900 700 053 B
Instructions for use: iCare imaging station
Rev 09/2018
delmont
imaging
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