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1.3 The instructions in this manual are only applicable to the product which it was delivered
with.
2. Introduction
2.1 These reprocessing instructions provide instructions for cleaning, disinfection, steriliza-
tion and packaging of manufacturer reusable products intended to be reprocessed in
medical facilities.
2.2 The goal of reprocessing reusable products is to reduce bioburden and to achieve sterility
of those products in order to eliminate the risk of product reuse related infection. Deci-
sions regarding cleaning, disinfecting or sterilizing manufacturer's medical and dental
instruments are based on the potential risk of infection associated with their use.
2.3 It is recommended to use steam sterilization.
2.4 Remember that sterilization or high-level disinfection cannot be achieved unless the ele-
ments of the assembly are cleaned first.
2.5 If you find that the reprocessing instructions from the manufacturer seem to be inade-
quate, please inform manufacturer about those inadequacies.
2.6 We encourage you to report adverse events related to device reprocessing. Report such
events directly to manufacturer.
3. Reprocessing - instructions for reusable products
3.1 The instructions are binding for the reprocessing of all reusable products (Here after
called "products") of manufacturer. When necessary, additional product-specific instruc-
tions are included with the product to provide additional information.
Important: Before use, carefully read the operating instructions of the manufacturer in-
strument and devices with which the product will be used.
3.2 Reusable products must be cleaned, disinfected and sterilized prior to first use. Repro-
cessing procedures have only limited implications to this device. The limitation of the
numbers of reprocessing procedures is therefore determined by the function / wear of
the device. From the processing side there is no maximum number of allowable repro-
cessing. The device should no longer be reused in case of signs of material degradation.
In case of damage the product should be reprocessed before sending back to the man-
ufacturer for repair.
4. Preparation - basic principles
4.1 It is only possible to carry out effective sterilization after the completion of effective clean-
ing and disinfection. Please ensure that, as part of your responsibility for the sterility of
products during use, only sufficiently validated equipment and product-specific proce-
dures are used for cleaning/disinfection and sterilization, and that the validated parame-
ters are adhered to during every cycle.
4.2 Please also observe the applicable legal requirements in your country as well as the
hygiene regulations of the hospital or clinic. This applies especially with regard to the
additional requirements for the inactivation of prions.
5. Preparation at the point of use
Disconnect product. Remove gross soiling of the products with cold water (<40° C) imme-
diately after use. Don't use a fixating detergent or hot water (>40 ° C) as this can cause the
fixation of residuals which may influence the result of the reprocessing process.
Store the products in a humid surrounding.
6. Transportation
Safe storage and transportation to the reprocessing area to avoid any damage and contam-
ination to the environment.
7. Preparation for decontamination
The products must be reprocessed in a disassembled state, as far as possible.
8. Pre-cleaning
Do a manual pre-cleaning, until the products are visually clean. Submerge the products in a
cleaning solution and flush the lumens with a water jet pistol with cold tap water for at least
10 seconds. Clean the surfaces with a soft bristle brush.
9. Cleaning
Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and
automated reprocessing methods. Preference is to be given to automated reprocessing
methods, especially due to the better standardizing potential and industrial safety.
Automated Cleaning:
Use a washer-disinfector (WD) meeting the requirements of the ISO 15883 series.
Put the products into the machine on a tray. Connect the products with the WD by using
suitable adapter and start the program:
4 min pre-washing with cold water (<40° C)
Emptying
5 min washing with a mild alkaline cleaner at 55° C
Emptying
3 min neutralising with warm water (>40° C);
Emptying
5 min intermediate rinsing with warm water (>40° C)
Emptying
The automated cleaning processes have been validated by using 0.5% neodisher MediClean
forte (Dr. Weigert).
Acc. to EN ISO 17664 no manual reprocessing methods are required for these de-
vices. If a manual reprocessing method has to be used, please validate it prior to use.
10. Disinfection
Automated Thermal Disinfection in washer/disinfector under consideration of national re-
quirements in regards to A0 value (see EN 15883).
A disinfection cycle of 5 min disinfection at 93° C has been validated for the product to
achieve an A0 value of 3000.
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Instruction Manual
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11. Drying
Automated Drying:
Drying of outside of products at 40°C , 5 min through drying cycle of washer/disinfector. If
needed, additional manual drying can be performed through lint free towel. Insufflate cavities
of products byusing sterile compressed air.
12. Functional testing, maintenance
Visual inspection for cleanliness of the products and reassembling if required. Functional
testing according to instructions of use. If necessary, perform reprocessing process again
until products is visibly clean.
Before packaging and autoclaving, make sure that the products have been maintained acc.
to manufacturer's instruction.
13. Packaging
Pack the products in an appropriate packaging material for sterilization. The packaging ma-
terial and system refer to EN ISO 11607.
14. Sterilization
Sterilization of products by applying a fractionated pre-vacuum steam sterilization process
(according to EN 285/EN 13060/EN ISO 17665) under consideration of the respective coun-
try requirements.
Minimum requirements: 3 min at 134 ° C (in EU: 5 min at 134 ° C)
Maximum sterilization temperature: 138° C
Drying time:
For steam sterilization, we recommend a drying time of 15 to 40 minutes. Choose a suitable
drying time, depending on the autoclave and load. Refer to the autoclave's instructions for
use.
After sterilization:
a. Remove the product from the autoclave.
b. Let the product cool down at room temperature for at least 30 minutes. Do not use addi-
tional cooling.
Check that the sterilization wraps or pouches are not damaged.
Flash sterilization is not allowed on lumen products.
The manufacturer assumes no responsibility for the use of other sterilization pro-
cedures (e.g. ethylene oxide, formaldehyde and low temperature plasma sterilization).
In such cases,
please observe the respective valid standards (EN ISO 14937/ANSI AAMl ISO 14937 or
the procedure specific standard) and verify the suitability and effectiveness in principle of
the procedure (if necessary, including investigations on sterilizing agent residue), taking into
account the specific product geometry as part of the validation.
• Maximum sterilization temperature 138° C
15. Storage
Storage of sterilized products in a dry, clean and dust free environment with a relative humid-
ity of 10% to 93%, an atmospheric pressure of 70KPa to 106KPa, and a temperature of-20 °
C to +55 ° C; refer to label and instructions for use.
After sterilization,the product should be packaged in a medical sterilization bag or a clean
sealing container, and stored in a special storage cabinet. The storage time should not ex-
ceed 7 days. If it is exceeded, it should be reprocessed before use.
16. Service life
The products have been designed for a large number of sterilization cycles. The materials
used in their manufacture were selected accordingly. However with every renewed prepara-
tion for use, thermal and chemical stresses will result in aging of the devices. If the number of
permissible re-sterilization cycles is restricted, this will be pointed out in the product specific
instructions.
The use of ultrasound baths and strong cleaning and disinfection fluids (alkaling pH>9 or
acid pH<5) can reduce the life span of devices. The manufacturer accepts no liability in such
cases.
The devices may not be exposed to temperatures above 138° C.
It is the duty of the user to ensure that the reprocessing processes including resources,
materials and personnel are capable to reach the required results. State of the art and often
national law requiring these processes and included resources to be validated and main-
tained properly.
10 Disposal and Scrapping
The product doesn't contain battery or toxic substances. And there are no components which
should be removed specially from the main unit for disposal and scrapping.
After the device is out of its service life, you must not discard it in domestic household waste.
Please comply with the Waste Electrical and Electronic Equipment (WEEE) directives and
the medical waste disposal regulations of your country.
Torque wrench, endo wrench and handpiece, those which could easily contact to the bi-
ological sources and cause biological hazards, shall be detached from the main unit and
reprocessed according to the reprocessing treatment in Chapter 5 before the disposal and
scrapping.
11 Statement
Refine reserves the right to modify the product technology, accessories, instruction manual
and product packaging content at any time without notice. The product is subject to the actual
product, and the pictures are for reference only. The final interpretation right belongs to Guilin
Refine Medical Instrument Co., Ltd.
Shelf life: 10 years, the date of manufacture see product label.
02/07/24 16:55
02/07/24 16:55
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