EN
REF
31893
EN, V47/18
Micro Compass Saw MSS 5000,
REF 5040nou
Operating instructions
• 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.
• 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.
Safety measures
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
Autoclave at 135°C
Suitable for thermal
disinfection
Date of manufacturing
Order number
Warning
Manufacturer
CE symbol with
notified body
Serial number
Observe instructions
for use
Important
information
Do not reuse
Technical data, Electronic motor 21
Overview
5040nou
Weight
122 g
Max. torque
6 Ncm
Max. speed
15 000 rpm
Transmission ratio
1 : 1
Coupling to motor
ISO 3964
Saw blade shank
10 mm
Saw blade thickness
0.40 mm
Operation
Coupling handpieces with a groove with the electronic motor with twist protection lock
Saw blade
with shank
Fastening nut
End wrench
Saw handpiece
Cooling clip
Coupling for
motor attachment
Collet
Twist protection lock with
release button.
Handpiece coupling with
groove for twist protection.
Align groove at handpiece with the twist protection
and connect handpiece with electronic motor by
pressing the button. Check for proper seating.
Press the button and decouple handpiece from
electronic motor.
Loosen fastening nut with end
wrench.
Continue opening the nut with
your fingers.
Remove the saw blade from the
collet and replace if necessary.
Loosen the cooling clip by pulling
while turning it back and forth.
Remove the cooling clip from
the saw handpiece.
Disassembly and assembly of the components to replace the saw blades and to feed the components into the reprocessing
Possible combinations
Micro Compass Saw MSS 5000, REF 5040nou
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.
Ambient conditions
Transport and storage:
Operation:
Relative humidity:
Max. 90 %
Max. 80 %
Temperature:
0 – 60°C
10 – 30°C
Atmospheric pressure:
700 – 1060 hPa
800 – 1060 hPa
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.
Reprocessing instructions
Reprocessing
restrictions
Frequent reprocessing has only a limited impact on the handpiece. The end of the products service life is normally determined by wear and dam-
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 (silicatis-
ing) the instruments.
4. Only commercial grade DGHM-/VAH-listed agents may be used for cleaning and disinfection. See these agent manufacturers’ specifications
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 cycle
and also during and after sterilisation until the products are used. The screen basket is suitable for use with sterilisation paper or a rigid ster-
ilisation 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
the point of use
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.
Safe-keeping
and transport
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.
Cleaning and
disinfection,
pre-cleaning
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 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 ex-
ample 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.