TAU STERIL
N° 11 - Rev. 3 03/02/20
User Manual
Page 4
FAST B
1.1 Relevant standard
Tau Fast B is a class II b medical device in accordance with rule 15 of annex IX to Council Directive 93/42 EEC. It is
further compliant with the national standards derived form the following harmonised standards:
EN 13060 , EN 61010-1, EN 61010-2-040, IEC 62304, EN 60601-1-6, IEC 62366, EN 61326-1, EN ISO 14971
The autoclave Fast B complies with RoHS 2011/65 / EU of the European Parliament and of the Council of 8 June 2011
on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
1.2 Intended use
This device, known as an
“
autoclave steriliser
”
, is used to sterilise the instruments placed on the trays supplied, using
specific sterilisation processes with steam from demineralised or distilled water, permitting the treatment of compact,
solid objects, compact, porous materials and hollow bodies of type A and B, not packaged or in single or double pack-
aging.
1.3 Recommendations
The user is responsible for the installation, operation and maintenance of the steriliser in accordance with the in-
structions defined in the user manual.
The autoclave has not been designed or tested for the sterilisation of liquids.
At the end of the sterilisation cycle, the trays and their load are still very hot. Use the
specific tongs to pull the
trays out of the sterilisation chamber (see Appendix 9).
Comply with the maximum load as fixed, checked and validated by Tau Steril for each type of material to be steri-
lised (table, page 16), in order to ensure normal operation and effective sterilisation.
Do not remove the registration plate or any other labels from the device.
Do not pour water or other liquids onto the device, this could cause a short circuit.
Before carrying out any service or maintenance operation on the appliance, disconnect the plug from the socket.
Any technical work must be carried out only by assistance centres approved by Tau Steril and using only original
spare parts.
Operations to be carried out before any maintenance and/or return to factory of the steriliser:
- Empty the sterilisation tanks (section 3.2, page 9)
- Allow the sterilisation chamber to cool down
- Only use and always keep the original packaging.
Note, failure to comply with the instructions in this manual can:
make it dangerous to use the appliance
present risks for the operator and to the patient
1.4 Personnel requirements
The personnel assigned to the use and maintenance of the device must meet the following requirements:
- General culture enough to understand the contents of this manual;
- Knowledge of the device and the place where it is installed;
- Knowledge of hygiene, and accident prevention techniques;
- Must be aware of the technical methods, procedures and risks regarding the sterilization process.
OPERATOR is the person who physically uses the device for its intended purpose.
THE PROPER AUTHORITY is the person or group, responsible for the use, maintenance equipment and for operator trai-
ning.
The responsible authority is legally responsible with regard to the obligations concerning the installation, operation and
use of the device.
CAUTION !! TAU STERIL accepts no responsibility for training staff is not properly performed.
"For the date of validity of the aforementioned standards, refer to the Technical File to be requested from the manu-
facturer".
