Warning and Safety Instructions

There are no contra-indications identified for the CS 9600. When operating the unit, observe the following warning and safety instructions:

IMPORTANT:

All known residual risks or undesirable side-effects are listed in this guide. If any serious incident occurs in relation to the device, you must report it to Carestream Dental and to the competent authority in your country.

DANGER OF ELECTRIC SHOCK

This is an electrical unit. Do NOT expose it to water spray. Such action may cause an electric shock or a malfunction of the unit.

WARNINGS:

Unit:

Read and understand this Safety Information before using the unit.
You are responsible for the operation and maintenance of this unit. Only legally qualified persons can operate this unit. They MUST have training to use the radiological equipment. Do NOT open the cover of the unit. When necessary, have a trained authorized service technician carry out inspection and maintenance operations.
Install this unit in an X-ray room that complies with current installation standards. From this location, you must be able to maintain visual or audio communication with the patient and be able to access the Acquisition interface module during exposure.
This unit must be permanently connected to the ground with a fixed power supply cable. To avoid the risk of electric shock, this equipment must ONLY be connected to a mains supply with protective earth.
Do NOT operate the unit if there is the threat of an earthquake. Following an earthquake, ensure that the unit is operating satisfactorily before using it again. Failure to observe this precaution may expose patients to hazards.
X-ray equipment is hazardous to patients and the operator if you do not observe the exposure safety factors and operating instructions.
Considering radiation safety of pediatric population, protocol for Acquisition on Pediatric patients must be followed. For more information on imaging pediatric patients more safely and effectively, refer to FDA Pediatric X-ray Imaging webpage:

http://www.fda.gov/radiation-emittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm298899.htm

Do NOT place objects within the field of operation of the unit.
The patient should wear a protective lead-lined shoulder apron, unless other Radiation Protection Protocols apply locally.
While adjusting the height of the unit, ensure that the patient is kept clear of the mechanism.
When the unit is not in use, ensure that the ON/OFF switch is set to OFF (O).
If the unit develops a fault, switch it to off (O), display an “Unserviceable” notice and contact a service technician.
To dispose of the unit or its components, contact a service technician.
Ask the patient to refrain from moving during the entire period of exposure.
Ask the patient to remain still until the unit arm has stopped moving and the RESET movement has completed.
Do NOT use this unit in conjunction with oxygen-rich environments. This unit is not intended for use with flammable anesthetics or flammable agents.
It is not recommended to use accessories other than those specified in this document and sold by Carestream Dental.
If the touchscreen does not work, do NOT operate the unit and contact a service technician.
If the installation of the Product is not carried out by qualified personnel or if the Product is installed incorrectly and as a result is not operating correctly or is damaged, it is the responsibility of the Distributor. The above will lead to an expiration of the warranty and the liability of Carestream Dental; Carestream Dental accepts no responsibility for failures caused by sub-standard or incorrect installations.

Computer:

Do NOT place the computer and the peripheral equipment connected to it in the immediate vicinity of the patient in the unit. Leave at least 1.50 m distance from the unit. The computer and the peripheral equipment must conform to the IEC 60950-1 or IEC 62368-1 standard.
See your computer installation guide for details of the data processing system and screen. Leave a sufficient amount of clear space around the CPU to ensure that it is properly ventilated.
To obtain maximum image quality and visual comfort, position the screen to avoid direct light reflections from internal or external lighting.
Always use Microsoft Windows Update to make sure that the latest security patches are correctly installed.

Disposal:

This equipment contains certain materials and chemical compounds incidental to the manufacture of electrical and electronic equipment, and improper “end-of-life” disposal of such equipment can result in environmental contamination. Therefore, this equipment should not be disposed of as ordinary household waste but should instead be delivered to a designated electrical and electronic waste disposal or recycling center. For further information on disposing of electrical and electronic waste, contact the cognizant authority within the local jurisdiction.

To dispose of the unit or its components, contact a service technician.