Nouvag OMS 5000 Operating Instructions

Operating instructions
EN
Micro Oscillating Saw OMS 5000, REF 5090nou

Safety measures

•
The Micro Saw is delivered in non sterile condition. Clean, disinfect, and
sterilize the Micro Saw before the first application and immediately after
each use!
•
Operate the Micro Saw with a maximum speed of 15 000 rpm.
•
Attache the Micro Saw to the motor only when it's standing still.
•
Perform manipulations on the instrument only when the motor is at a
standstill.

Intended use / indication

The saws are intended for bone-working surgery. This includes ENT surgery, maxillofacial surgery, plastic surgery, neurosurgery and hand surgery. With the bone saw
and clamped saw blade (standalone medical device), a piece of bone is removed to correct misalignments. In dental facilities, this is used in jaw osteotomy to convert
the jawbone. The saws may only be operated by expert and trained personnel. The intended use is obvious to the trained user.
Contraindication / Limitations
Relative or absolute contra indications can arise from the general medical diagnose, or in special cases by a significantly increased risk to the patient through the use
of motor-driven systems. Relevant cases in the literature must be taken into consideration.
Symbols
LOT number
Warning
Important
information
Technical data, Electronic motor 21
Weight, without cable
Maximum torque
Max. Speed
Oscillation angle saw blade
Transmission ratio
Coupling
Clamping depth, saw blade
Ø saw blade shank
Operation
Coupling handpieces with a groove with the electronic motor with twist protection lock
Twist protection lock with Handpiece coupling with
release button. groove for twist protection.
Disassembly and assembly of the components to replace the saw blades and to feed the components into the reprocessing
Loosen the nut with the wrench. Continue the opening of the nut
Possible combinations
Micro Oscillating Saw, OMS 5000, REF 5090nou
Is exclusively used:
•
In combination with the surgical motor systems HighSurg 11 (REF 3361),
HighSurg 11 OFA-Drill (REF 3363) and HighSurg 30 (REF 3360), which control
the sawing handpiece via the upstream electronic motor 21 and enable set-
tings for speed and torque according to the tools used.
•
In combination with the surgical motor system TCM 3000 BL (REF 3285),
which controls the sawing handpiece via the upstream electronic motor 21
and holds a program with a fixed speed for the micro saw.
•
In combination with the MD 30 implant motor system (REF 3330), which
controls the sawing handpiece via the upstream electronic motor 21 and
enables settings for speed and torque according to the tools used.
Reprocessing instructions
Reprocessing Frequent reprocessing has only a limited impact on the handpiece. The end of the products service life is normally determined by wear and dam-
restrictions age through use. The instrument is designed for 250 sterilization cycles.
General handling 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 (silica-
tising) the instruments.
4. Only commercial grade DGHM-/VAH-listed agents may be used for cleaning and disinfection. See these agent manufacturers' specifica-
tions 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 product service life is determined by wear and damage through use. The micro saw is designed for 250 sterilisation cycles.
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 AG recommends using a screen basket with a rinse strip from 3mach (NOUVAG REF 51401), a re-usable container for comfortable
preparation and storage (including transport) of products. The screen basket can be used to keep products safe both during the rinsing cy-
cle and also during and after sterilisation until the products are used. The screen basket is suitable for use with sterilisation paper or a rigid
sterilisation container. It has no barrier effect itself in order to maintain sterility.
Attention! 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 Institute recommends removing used products from circulation after use in order to avoid infecting other patients, users and
third parties.
Preparation at After surgery immediately remove blood, secretion, tissue and bone residue with a disposable cloth/paper towel, do not allow to dry! Dried
the point of use residues cause corrosion.
Safe-keeping Contaminated products must be stored and transported to the preparation site in a closed container to avoid damaging the products and the
and transport contamination of the environment.
Cleaning and Remove saw blade, cooling tube, clips for the cooling tube attachment and cooling clip from the micro saw handpiece.
disinfection, 1. Wipe visible impurities with a moist expandable cloth/tissue paper from the micro saw and accessories.
pre-cleaning 2. Brush the handpiece and accessories under running tap water using a soft brush (manufacturer 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; manufacturer for
example HEGA Medical, REF 6010 or 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 HEGA Medical, REF 4270) for at least 30 seconds.
Autoclave at 135°C
Manufacturer
Do not reuse
5090nou
142 g
6 Ncm
80 000 rpm
25°
1 : 1
acc. to ISO 3964
16 mm
2.35 m
Align groove at handpiece with the twist protection
and connect handpiece with electronic motor by
pressing the button. Check for proper seating.
with your fingers.
• Any guarantees on our part or other claims against us become void in the
case of inappropriate use of the electronic motor or failure to comply with
our instructions!
•
Without a saw blade clamped, the Micro Saw should not be stored with
the tensioning mechanism tightened.
•
The instrument may only be used by competent and trained personnel.
Suitable for thermal
disinfection
CE symbol with
notified body
Overview
Saw blade
with shank
Remove saw blade out of the
collet and replace it if needed.
Wrong combination of products
Damage to the product and injury to the patient, user or third parties are
possible.
•
Only use the different products together if the purpose and the relevant
technical data, such as working lengths, diameters, and so on match.
•
Always follow the instructions for use of the products used in combination.
Ambient conditions
Relative humidity:
Temperature:
Atmospheric pressure:
Date of manufacturing
Serial number
Cooling clip
Collet
Nut
Press the button and decouple handpiece from
electronic motor.
Loosen cooling clip by twisting
it left and right.
Transport and storage:
Max. 90 %
0 – 60°C
700 – 1060 hPa
REF 31695 EN, V47/18
Order number
Observe instructions
for use
Coupling for
motor attachment
Handpiece
End wrench
Pull cooling clip off the sawing
handpiece.
Operation:
Max. 80 %
10 – 30°C
800 – 1060 hPa