RD 160.iCare+.OPM.ENG.V16 04.27.2020
p. 8
ENG
4.5 Validation test
4.5.1 On-site validation
Prior to first use, your installer must perform an installation qualification (IQ), Operational qualification (OQ) and
Performance qualification (PQ).
According to ISO 15883-1, the aim of this procedure is to obtain and document evidence that your device has been
provided and installed in accordance with its specification.
Caution
•
The warranty applies only to the extent that the on-site validation of the device has been observed
•
Achievement of on-site validation is limited exclusively to professional dental installers who have
been trained and qualified under the control of NSK
•
After on-site validation keep a permanent record of the validation report
4.5.2 Periodical validation
Following ISO 15883-1, requalification of your device shall be performed at defined intervals. The defined interval
can be determined by regulatory authorities or by risk analysis. We recommend to perform this periodical
validation every year, in order to validate that the performance of iCare+ is still optimum or:
-
If a review of records of routine tests of equipment performance indicates unacceptable deviation from data
determined during the initial validation
-
If changes are carried out on the equipment and installation that could affect the performance
-
If equipment performance is unacceptable
-
If process conditions are changed
Caution
•
For periodical validation, only use your authorized supplier or NSK. Validation performed by an
unauthorized person could result in your iCare+ being unsafe for you and your patients.
•
Periodical validation is limited exclusively to professional dental installers who have been trained
and qualified under the control of NSK.
CHAPTER 5 – DAILY USE
The function of the iCare+ is to ensure the cleaning and disinfection of internal and external surfaces of dental
rotary and dynamic instruments, as well as their lubrication. Such items are potentially contaminated with
pathogens and can be a source of infection for humans. Therefore, before being reprocessed using iCare+, these
medical devices require a previous preparation as defined by Robert Koch Institute: RKI.
Caution
Before reprocessing, it is necessary:
•
To check the product compatibility with the reprocessing method to be used
•
To perform proper preparation as defined below
5.1 Preparation
Preparation must be performed in accordance with accepted engineering practice. It must also ensure that the
concerned medical devices pose no risk to health when it is subsequently used, specifically focusing on infections.
Therefore, the following precautions shall be considered:
Warning
•
For your safety during reprocessing, you shall minimize the risk of infection wearing protective
gloves, spectacles, as well as mouth and nose protection
•
Preparation must be performed within 10 minutes after the end of treatment. If this is not possible,
the handpieces must be pre-treated with a non-protein-fixing cleaning solution, such as IC100 from
Alpro Medical, according to the manufacturer's instructions
•
Never immerse NSK handpieces such as contra-angles and turbines inside disinfecting solutions
nor in ultrasonic baths
Содержание iCare+
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