Ivoclar Vivadent PrograPrint PR5 Guía Breve página 6

2.1.1 Potential improper use
The device is not suitable for 3D printing procedures outside of the dental field.
The following is considered as misuse of the system:
– Non-compliance with the specified intended use, intended operator specifications or
intended environment
– Modifications, maintenance and repairs without prior authorization from Ivoclar
– Operation with inappropriate parameters
Improper use of the device can lead to the following:
– Danger for patients and operating personnel
– Impairment of the operability of the device
Ivoclar assumes no liability for damages resulting from improper use.
Typical misapplications of the device to be avoided:
Improper use
Use of non-approved materials
Incorrect cleaning and disposal (build
platform, build chamber, hood etc.)
Operation without cartridge, tank or build
platform
Operation with incorrectly inserted tank
or build platform
Shut-down of the device by the user
during printing
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Consequences
The device cannot execute any printing
jobs
– Skin irritations
– Environmental damage
– Damage to the device
Damage to the device
– Damage to the device
– Deficient printed object
Deficient printed object
Improper use
Mixing of different materials
Failure to observe the specified fill level
when filling the tank manually
2.1.2 Intended user
The device may only be operated by dental technicians and qualified dental staff for the
fabrication of dental objects for dental applications.
The user is responsible for selecting the correct device settings.
2.1.3 Intended environment
The device is only permitted for use in closed rooms within the specified ambient
conditions (see technical data in the Operating Instructions, "Documents of equal
applicability and required files", Page 5) and in compliance with the requirements for
safe installation (see requirements regarding the location site, "Documents of equal
applicability and required files", Page 5).
2.2. Operator's obligations
The operator is responsible for the safe operation of the device.
f Ensure compliance and control:
– Intended use
– Statutory or other safety and accident prevention regulations
Consequences
– Damage to the patient's health
– Cross-contamination of materials
– Deficient printed object
– Damage to the material, cartridge and
material bottle
– In case of overfilling: Unpolymerized
material will overflow during printing
– In case of insufficient material filling:
Material will run out during printing
– Deficient printed object