6.2.4 STERILISATION
1. Package the dispenser and the rack separately in two bags (paper/plastic sterilisation bags) (fig. 3.1) conforming to ISO
11607 and ANSI/AAMI ST76:2017, then place the bags in an autoclave that can perform a pre-vacuum cycle.
2. Use the sterilisation parameters given in the table below:
Parameters
Values
Type of cycle
Pre-vacuum
Reference temperature
132 °C
Exposure time
3 minutes
Drying time
20 minutes
Once sterilised, store the dispenser and rack in their sterilisation packages in a closed, clean and dry place. Inspect the
sterilisation packages before assembling the device again. If the packages appear damaged or damp, recondition the
dispenser and rack again before use.
6.2.5 ASSEMBLING THE DEVICE
WARNINGS/PRECAUTIONS:
•
The dispenser must ALWAYS be cleaned, disinfected and sterilised before assembly (see sections
6.2.2, 6.2.3 and 6.2.4). This should be done only a short time before the dispenser is reused
.
• To reduce the risk of cross-contamination, always apply disposable covers / barrier envelopes to the dispenser
before using it for any new patient, and remove them after every use. The use of disposable covers / barrier
envelopes does not eliminate the need for cleaning, disinfection and sterilisation as instructed.
1. Disinfect your hands and put on a new pair of disposable gloves.
2. Remove the sterilised dispenser and rack from their bags (fig. 4.1).
3. Use a clean and sterilised Phillips screwdriver to remove the screws from the two disks on the rack (fig. 4.2).
4. Press the black lever (fig. 4.3/1) and push in the rack in the direction shown by the arrow (fig. 4.3/2).
5. Replace the two disks and their screws on the rack using the same Phillips screwdriver (fig. 4.4).
6. The dispenser is now assembled and ready to receive the cartridge (fig. 4.5).
7. Push in the black lever under the rack (fig. 4.6/1) and pull the rack out from the dispenser to the start of its stroke
(fig. 4.6/2)
8. Lift up the cartridge lock (4.7/1).
9. Insert the cartridge, making sure that it is facing the right way. The cartridge must be inserted with the “V” on its base
facing downwards (fig. 4.7/2). The cartridge lock can now be lowered easily (fig. 4.8).
10. With the cartridge in the dispenser, proceed as instructed by the cartridge manufacturer.
11. It is advisable to protect the dispenser and cartridge with a disposable cover/barrier envelope (fig. 4.9), to be removed
after each use.
7. DISPOSAL
Always wear gloves when handling the device. If the device is contaminated, dispose of it as special waste characterised
by a risk of biological contamination. If it is not contaminated, dispose of it according to applicable local regulations.
8. IMPORTANT REMARKS
Information provided in any way, even during demonstrations, does not invalidate the instructions for use. Operators are
required to check that the product is suitable for the application envisaged. The manufacturer cannot be held responsible
for damage, including to third parties, deriving from failure to follow instructions or from unsuitability for an application.
The manufacturer’s liability is, in any case, limited to the value of the products supplied. Report any serious incident
involving the medical device to the manufacturer and to the relevant authorities.
This symbol identifies a medical device as defined by EU Regulation 2017/745.
