Nouvag MOS 5000 Instructions For Use

Instructions for use
EN
Osseo Scalpel Sagittal Micro Saw MOS 5000
SYMBOLS
General warning sign
Manufacturer
Batch code
European Conformity mark
0197

INTENDED PURPOSE

MEDICAL INDICATIONS

MOS 5000 is used with a saw blade (instrument) to cut and remodel bones in the
following medical indications:
// ENT surgery // Maxillofacial surgery // Plastic surgery // Neurosurgery
// Hand surgery

CONTRA INDICATIONS

Contra indications are the those generally indicated for the specific medical indi-
cation, and those for active medical devices.
SIDE EFFECTS
Main side effect of surgical saws is ostheonecrosis, caused by saw blade speed
and vibration.

SAFETY INFORMATION

Prior to using the device, before startup, and before operation, the user must always ensure that the device and accessories are in good working order and are
clean, sterile and operational.
The use of the product other than that for which it was designed is not permitted. The responsibility is solely carried by the operator.
The use of third-party products is the responsibility of the operator. Functionality and patient safety cannot be guaranteed with third-party accessories.
Manipulate the instrument only when the motor is at a standstill.
Improper use or repair of the device, or failure to observe these instructions, relieves NOUVAG from any obligation arising from warranty provisions or other
claims.
Do not close the clamping mechanism without a saw or a pin inserted in the collet.
The device shall only be operated by qualified and trained personnel
OVERVIEW
Collet
Saw blade
with shank
Fastening nut

OPERATION

COUPLING HANDPIECES WITH A GROOVE WITH THE ELECTRONIC MOTOR 21 WITH TWIST PROTECTION LOCK
Twist protection lock with release
button.
DISASSEMBLY AND ASSEMBLY OF THE COMPONENTS TO REPLACE THE SAW BLADES AND TO FEED THE COMPONENTS INTO THE REPROCESSING
Loosen the nut with the jaw
spanner.

REPROCESSING INSTRUCTIONS

In relation to patients with Creutzfeldt Jakob disease or its variant (vCJK) no responsibility can be assumed for re-use of the micro saw. The Robert-Koch Insti-
tute recommends removing used products from circulation after use in order to avoid infecting other patients, users and third parties.
Reprocessing
restrictions
General handling
Preparation at the
point of use
Safe-keeping and
transport
Cleaning and
Disinfection,
pre-cleaning
Observe instructions for use
Date of manufacture
Catalog number
Coupling for
Cooling clip motor attachment
Handpiece
Jaw spanner
Handpiece coupling with groove
for twist protection.
Continue the opening of the nut
with your fingers.
Frequent reprocessing has only a limited impact on the handpiece. The end of the products service life is normally determined by wear
and damage through use. The instrument is designed for 250 sterilization cycles.
1. The micro saw must be thoroughly cleaned, disinfected and sterilised before initial operation (products straight from the factory) and
also immediately following each use. Only a cleaned and disinfected instrument permits proper sterilisation!
2. The electronic motor should always be treated with utmost care when being transported, cleaned, serviced, sterilised and stored.
3. We recommend the use of mild alkaline and enzymatic cleaners with as low a content of silicate as possible in order to avoid staining
(silicatising) the instruments.
4. Only commercial grade DGHM-/VAH-listed agents may be used for cleaning and disinfection. See these agent manufacturers' specifi-
cations for the method of use, action time and suitability of disinfection and cleaning substances.
5. Follow precisely the operating instructions of the devices and chemicals etcetera, used during preparation.
6. Adhere exactly to the chemical dosages, action times and exposure temperatures during cleaning and disinfection.
7. The end of the products service life is determined by wear and damage through use. For the micro saw it can be reached even before
the 250 sterilization cycles, that they're designed for, due to wear and tear.
8. Do not overload washer. Avoid rinsing blind spots. Pay attention to secure storage in the machine.
9. Follow the applicable regulations in your country for reprocessing medical devices.
10. Only the cooling clip may be cleaned in an ultrasonic bath. The micro saw must never be subjected to ultrasonic cleaning! This will
impair the functionality.
11. NOUVAG recommends using a screen basket with a rinse strip from 3mach (NOUVAG REF 51401), a re-usable container for comfort-
able preparation and storage (including transport) of products. The screen basket can be used to keep products safe both during
the rinsing cycle and also during and after sterilisation until the products are used. The screen basket is suitable for use with sterili-
sation paper or a rigid sterilisation container. It has no barrier effect itself in order to maintain sterility.
After surgery immediately remove blood, secretion, tissue and bone residue with a disposable cloth/paper towel, do not allow to dry!
Dried residues cause corrosion.
Contaminated products must be stored and transported to the preparation site in a closed container to avoid damaging the products
and the contamination of the environment.
Remove saw blade, cooling tube, clips for the cooling tube attachment and cooling clip from the micro saw handpiece.
1. Wipe visible impurities with a moist expandable cloth/tissue paper from the micro saw and accessories.
2. Brush the handpiece and accessories under running tap water using a soft brush (manufacturer for example Insitumed GmbH,
REF MED100.33).
3. Rinse the outer surface of the micro saw handpiece for 10 seconds with a water pistol (at a pressure of at least 2.0 bar; manufac-
turer for example HEGA Medical, REF 6010 or REF 7060). Local tap water is sufficient for this purpose, since the last step is always
a machine cleaning with deionized water, so possibly hard water with lime traces from the pre-cleaning cannot remain on the
handpiece.
4. Rinse the cooling clip with a cleaning gun with a jet nozzle attachment (manufacturer for example HEGA Medical, REF 4270) for at
least 30 seconds.
Note
Autoclave at 134°C
Serial number
INTENDED USERS
Intended users are trained and qualified personnel, in professional settings (e.g.
hospital, ambulatory).

TARGET POPULATION

The target population includes both minor and adult patients, depending on the
medical indication.
AMBIENT CONDITIONS
Relative humidity
Temperature
Atmospheric pressure
POSSIBLE COMBINATIONS
REF CONTROL UNIT
3330 MD 30
3360 HighSurg 30
3363 HighSurg 11 OFA-Drill
3285 TCM 3000 BL
Align groove at handpiece with the twist protection
and connect handpiece with electronic motor by press-
ing the button. Check for proper seating.
Remove saw blade out of the col-
let and replace it if needed.
© NOUVAG AG • 31886 • V20230412 • All rights reserved
TRANSPORT AND STORAGE
max. 90 %
0 – 60 °C
700 – 1'060 hPa
INTENDED USE
Dental Implantology
Plastic Surgery
Spinal Surgery
ENT Surgery
Hand and foot surgery
Foot surgery
Dermabrasion and Reconstructive Surgery
Rhinoplasty
Press the button and decouple handpiece from
electronic motor.
Loosen cooling clip by twisting it
left and right.
Suitable for thermal
disinfection
Separate collection required
(WEEE)
Authorized representative in
the European Community
DURING USE
max. 80 %
10 – 30 °C
800 – 1'060 hPa
Pull cooling clip off the sawing
handpiece.