011807-EN--B (2022-12_S617 S717F S900 S950 C50_IFU)
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2 SAFETY INSTRUCTIONS
2.1 CONTRAINDICATIONS
None known.
2.2 WARNINGS
• The maximum temperature at the light emission is 53°C for SOPROCARE, 50°C for SOPROLIFE and 51°C for SOPRO
717FIRST.
• When handling camera and intraoral tips (SOPROTIPS or C50TIPS), always take the appropriate hygiene measures and
precautions to prevent cross contamination.
• Follow the Cleaning / Disinfection / Sterilization procedures described in §6 between each patient; failure to do this
could result in cross-contamination.
• Use a single-use protective sheath on the camera throughout the procedure. Check that the protective sheath is not
damaged. If the protective sheath is torn while examining a patient or if the handpiece was “contaminated” while
withdrawing the protective sheath, it is essential to disinfect the camera with a disinfectant wipe.
• The handpiece should NEVER be immersed in any liquid nor autoclaved; this could result in electric shock.
• Do not pull on the connection cable; this could damage the cable and could result in electric shock.
• Do not compress or nip the handpiece cable; this could damage the cable and could result in electric shock.
• Do not drop the handpiece; this could damage the housing and could result in electric shock.
• The camera is a product using Group 1 LEDs according to IEC 62471. To avoid risk of ocular damage, do not look
directly at the light (Non-applicable for SOPRO 617 intraoral camera).
• Do not insert metal objects into the device to avoid any risk of electric shock, fire, short-circuit or hazardous emissions.
• Do not use the device in an oxygen-rich environment.
• Do not use the device if it is damaged. Prior to-each use, make sure the devices do not have any rough surfaces, sharp
edges or protuberances which could lead to safety problems.
• Do not use products containing: Ammoniac, Trichloroethylene Dichloroethylene, Ammonium, Hydrochloride,
chlorinated and aromatic Hydrocarbon, Ethylene Dichloride, Methylene Chloride or Ketones.
Use of these chemicals subject plastic parts to risk of deterioration.
• Do not use corrosive or abrasive products to clean the device, but only the disinfectant liquids recommended in the
chapter on “CLEANING”.
• Do not place heavy objects on top of the device.
• Do not splash water on the device nor store it in damp areas.
• Never place the device near a heat source or in a location where it is exposed to vibration and/or shock.
2.3 PRECAUTIONS
• SOPROTIPS and C50TIPS are not provided sterile; they must be cleaned, packaged and steam sterilized before use.
• The camera is not suitable for use in the presence of a flammable anaesthetic mixture containing air, oxygen, or
nitrous oxide.
• The surface temperature in the light emission area can reach above 43°C (after several minutes of use).
Therefore, avoid maintaining this emission area in contact with the patient’s mouth (Non-applicable for C50 and
SOPRO 617 intraoral cameras).
• Install the camera in a clean, dry, and well-ventilated place.
• Use only the accessories supplied with the device or recommended by SOPRO.
• The devices that connect to video or USB outputs should comply with the IEC 62368-1 standard.
• The camera is not provided sterile; it must be wipe disinfected before use. The camera is not sterilisable.
• The protective sheaths are not provided sterile; they do not need cleaning and sterilization before use.
• Throw away the protective sheath after use.
• Do not submit the device to excessive dust.
• Do not apply excessive force on the medical device.
• Where you are using multiple adapters, the requirements of IEC 60601-1 must be observed. Do not place the multiple
adapters on the ground. Other systems must not be connected to the same multiple adapter.
Unplugged the intraoral dental camera before decontaminating it.
• Computer systems connected to the docking station have to comply with the international safety standard for
Information Technology Equipment, IEC 62368-1.
• The camera must always be stored on its handpiece holder after use.
• This device must not be modified without the manufacturer’s authorization.
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