Warnings And Cautions - Morita Veraview iX Operation Instructions Manual

Warnings and Cautions

• This X-ray unit may be dangerous to PATIENT and OPERATOR unless safe exposure factors and operating instructions are
observed.
• Only dentists and other legally qualified and authorized personnel are allowed to operate this equipment.
• Do not use this equipment for patients when it is being maintained or serviced.
• Make sufficient space around the power switch so that it is easily accessible in case of emergency.
• Make sufficient space around the power plug so that it is easily unplugged in case of emergency (R-Type).
• Make sufficient space around the power distribution panel so that it is easily turned the breaker open in case of emergency
(WA-Type).
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• To avoid the risk of electric shock, do not replace the power supply cord.
• The EQUIPMENT should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is neces-
sary, the EQUIPMENT should be observed to verify normal operation in the configuration in which it will be used.
• When an examination requires X-ray irradiation to implantable or wearable electronic medical device, the operator must take
proper care after referring to the operation manual (and related safety information) for such implantable or wearable electronic
medical devices because if a diagnostic X-ray device directly irradiates an implantable or wearable electronic medical device, it
can cause sufficient electronic interference to affect the function and operation of the medical device.
* For reference, U.S.A. FDA published about interference with cardiac implantable electronic devices (pacemakers and im-
plantable cardioverter defibrillators), insulin pumps, and neurostimulators on the following web site. (Accessed July 2018)
Title: Interference between CT and Electronic Medical Devices
URL:
https://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm489704.htm
• Do not use this unit for fluoroscopic examinations.
• Judgment and caution should be used in regards to radiographs of pregnant women. The decision should be based on "clinical
need of diagnostic information".
• Do not use the wireless transmission devices listed below in the examination area; electromagnetic interference from these de-
vices could cause this X-ray unit to operate in a random, unexpected and dangerous manner.
1. Cell phone terminals.
2. Wireless transmitting devices such as ham radios, walkie-talkies, and transceivers.
3. Cell phones.
4. Routers for intra-building paging systems, wireless LAN, cordless analogue telephones, and other electric wireless devices.
• Interference from the Veraview iX, devices listed below might malfunction or operate in a random, unexpected and dangerous
manner.
1. Electric medical devices for examination, diagnosis and treatment.
2. Personal computers.
• The Unit must be installed in an X-ray shield location. Local regulation for radiation protection must be observed.
• The emission button must be operated in a radiation protected area.
• If the unit is not enclosed by an X-ray booth or other protective barrier, everyone except the patient must stay outside from a
distance not less than 2 m from tube head during X-ray emission.
• The user must restrict access to the equipment in accordance with local regulations for radiation protection.
• The operator must not enter the X-ray beam during exposure. The residual radiation exists even behind the radiography media
(film, sensor, and imaging plate).
• The patient and operator must be provided with appropriate X-ray protection gear such as lead-impregnated clothing that con-
forms to local regulations.
• The operator must be able to see the exposure emissions lights and hear the audible signal during operation of the equipment.
• The operator must be able to see and hear the patient during the operation of the equipment.
• Responsible organization in medical institution needs for providing means for audio and visual communication between the
operator and the patient.
• Proper radiation safety precautions must be established in accordance with local, state and governmental regulations in re-
gards to operator and patient protection. The ultimate responsibility lies with the owner/operator to ensure that the protection
requirements of national and local codes are met.
• Proper infection control procedures must be established and maintained for each patient.
• Do not use multiple portable socket outlet nor extension cord for the power supply.
4 Operation 2018-10-22