Nouvag Mos 5000 User manual

Osseo Scalpel Sagittal Micro Saw MOS5000

Instructions for use

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 damage through use. The instrument is designed for sterilization cycles.

General handling . 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!

. The electronic motor should always be treated with utmost care when being transported, cleaned, serviced, sterilised and stored.

. 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.

. 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.

. Follow precisely the operating instructions of the devices and chemicals etcetera, used during preparation.

. Adhere exactly to the chemical dosages, action times and exposure temperatures during cleaning and disinfection.

. 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 sterilization cycles, that they’re designed for, due to wear and tear.

. Do not overload washer. Avoid rinsing blind spots. Pay attention to secure storage in the machine.

. Follow the applicable regulations in your country for reprocessing medical devices.

. 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.

. NOUVAG recommends using a screen basket with a rinse strip from mach (NOUVAG REF ), 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.

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.

. Wipe visible impurities with a moist expandable cloth/tissue paper from the micro saw and accessories.

. Brush the handpiece and accessories under running tap water using a soft brush (manufacturer for example Insitumed GmbH,

REF MED.).

. Rinse the outer surface of the micro saw handpiece for  seconds with a water pistol (at a pressure of at least .bar; manufac-

turer for example HEGA Medical, REF  or REF ). 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.

. Rinse the cooling clip with a cleaning gun with a jet nozzle attachment (manufacturer for example HEGA Medical, REF ) for at

least seconds.

SYMBOLS

General warning sign Observe instructions for use Note Suitable for thermal

disinfection

Manufacturer Date of manufacture Autoclave at 134°C Separate collection required

(WEEE)

Batch code Catalog number Serial number Authorized representative in

the European Community

0197

European Conformity mark

OVERVIEW

Cooling clip

Handpiece

Jaw spanner

Coupling for

motor attachment

Fastening nut

Collet

Saw blade

with shank

POSSIBLE COMBINATIONS

REF CONTROL UNIT INTENDED USE

 MD 30 Dental Implantology

 HighSurg 30 Plastic Surgery

Spinal Surgery

ENT Surgery

Hand and foot surgery

 HighSurg 11 OFA-Drill Foot surgery

 TCM 3000 BL Dermabrasion and Reconstructive Surgery

Rhinoplasty

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

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.

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 press-

ing the button. Check for proper seating.

Press the button and decouple handpiece from

electronic motor.

Remove saw blade out of the col-

let and replace it if needed.

Loosen cooling clip by twisting it

left and right.

Pull cooling clip off the sawing

handpiece.

Loosen the nut with the jaw

spanner.

Continue the opening of the nut

with your fingers.

DISASSEMBLY AND ASSEMBLY OF THE COMPONENTS TO REPLACE THE SAW BLADES AND TO FEED THE COMPONENTS INTO THE REPROCESSING

OPERATION

COUPLING HANDPIECES WITH A GROOVE WITH THE ELECTRONICMOTOR21 WITH TWIST PROTECTION LOCK

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 eect of surgical saws is ostheonecrosis, caused by saw blade speed

and vibration.

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 TRANSPORT AND STORAGE DURING USE

Relative humidity max.  % max.  %

Temperature  –  °C  –  °C

Atmospheric pressure  – ’ hPa –’hPa

INTENDED PURPOSE

0197

MANUFACTURER AND SERVICE POINTS

A complete list of NOUVAG certiﬁed service points are found on the NOUVAG

website: Nouvag.com > Service

POST MARKET SURVEILLANCE

In the event of incidents related to the use of the medical device,

please contact immediately the manufacturer by email

[email protected]om or by phone.

To provide adequate information, please compile the incident question-

naire at the web address

Nouvag.com > Contact us > Incident questionnaire.

Switzerland

NOUVAGAG

St. Gallerstrasse 25

9403 Goldach

Phone +41 71 846 66 00

[email protected]

www.nouvag.com

Germany

NOUVAGGmbH

Schulthaissstrasse 15

78462 Konstanz

Phone +49 7531 1290 - 0

info-[email protected]

www.nouvag.com

Cleaning Mechanical cleaning

. After pre-cleaning place the micro saw and its accessories in the strainer

basket.

. Mechanical cleaning is only successful if the pre-cleaning, described above,

is adhered to!

. Cleaning is done using the Vario TD programme in the cleaning and dis-

infection unit (CDU). For the cleaning process it is advisable to use DI

water (fully desalinated water).

. After completingthe cleaning programme (inc. Thermal disinfection)check

the micro saw, the nut and the cooling clip for visible contamination in

grooves and gaps. Repeat the cleaning cycle, if necessary.

Automatic cleaning process (Vario TD programme)

. Pre-clean with cold water for minutes.

. Empty

. Clean for minutes at °C with . % alkaline or at

°C with . % enzymatic cleaner.

. Empty

. Neutralise with cold water for minutes.

. Empty

. Inter-rinse for minutes with cold water.

. Empty

Disinfection Mechanical disinfection

The cleaning/disinfection unit has a thermal disinfection programme which

follows after the cleaning. When performing mechanical thermal disinfec-

tion, give due consideration to the national requirements relating to the A

value (see DINENISO-). We recommend an A value of . for the

instrument. Disinfection must be carried out with DI water.

Warning

When inadequately rinsed or exposed to the disin-

fectant or detergent for too long, the instrument can

corrode. Please see the corresponding detergent and

disinfectant’s package insert for dwell times.

Drying Mechanical drying

Dry the micro saw using the cleaning/disinfection unit’s (CDU) drying cycle. If

required, manual drying can also be achieved by using a lint-free cloth. When

drying manually, take particular care with the grooves and gaps of the instru-

ment. Then spray the instrument again with Lubrifluid.

Every CDU must provide a corresponding drying procedure through the

manufacturer (see ISO-). Please follow the corresponding CDU-manu-

facturer’s directions and operating instructions.

Manual drying

Set up the micro saw in an upright position without the

nut and the cooling clip attached.

Dry the instrument for at least minutes. Then spray

it with Lubrifluid. Afterwards reassemble the nut and

the cooling clip back onto the instrument.

Manual

cleaning and

disinfection

. Immerse the micro saw handpiece after pre-cleaning for minutes in a bath with enzymatic

cleaner. Clean accessories such as e.g. the cooling clip and the nut for minutes in an ultra-

sonic bath. Follow the instructions of the manufacturer of the detergent.

. Perform a complete post-clean of the product under running drinking water, using a soft brush.

Intensely rinse, if there is any cavities and lumens existing, with a water pressure gun (or simi-

lar) for at least seconds.

. To remove the detergent, rinse the products under running city water (drinking quality) for at least

seconds.

Warning

Do not clean micro saw (hand-

piece) in an ultrasonic bath!

Manual

disinfection

After cleaning, immerse the products for minutes in a bath with a suitable disinfectant. It must be ensured that all surfaces are com-

pletely wetted with the disinfectant. Follow the manufacturers instructions of the disinfectant. After disinfection thoroughly rinse all

products with deionised water to remove the disinfectant ( >min.).

Manual

drying

Set up the micro saw handpiece vertically, separated from the cooling clip, to make sure the outflow of water is favored. Dry products

with a lint-free paper towel. Then dry with suitable compressed air in accordance with the RKI recommendation. Pay particular atten-

tion to the drying of hard to reach areas.

Inspection and

care

. First unscrew the union nut and remove the cooling clip.

. Perform a visual inspection for damage, corrosion and wear.

. Spray the handpiece for cleaning and care. NOUVAG recommends the use

of Lubrifluid. Attach the blue spray adapter to the spray can and spray

the handpiece from the coupling side for about seconds until only

clear liquid flows out of the electronic motor.

. Then wipe with a damp cloth (observe the instructions for use of the prod-

uct).

. After spraying the handpiece, re-install the cooling clip on the handpiece

and screw the union nut onto the collet chuck.

Sterilisation Sterilisation of the micro saw handpiece is performed with a fractionated pre-vacuum steam sterilisation technique (in accordance with

DINEN / DINEN) giving due consideration to the respective national requirements. Minimum requirements:

. Pre-vacuum phases: 

. Sterilisation temperature: minimum °C – maximum °C

. Holding time: At least minutes (full cycle)

. Drying time: At least minutes

When sterilising several products during one sterilisation cycle, do not exceed the maximum steriliser load (see manufacturer’s details).

A drying cycle must be added in the case of autoclaves without a vacuum function. After sterilisation an immaculate sterilisation result

must be detected by examining the appropriate indications. According to the Robert-Koch Institute preparation ends with the document-

ed release for use of the medical device. If the sterilised micro-pencil saw is not used immediately after sterilisation, it must be labelled

with the sterilisation date on the packaging.

Storage Storing the sterile packaging

The sterilised product must be stored away from dust, humidity and contami-

nation. During storage, direct sunlight should be safely avoided. After the

expiry date has passed, do not use the product any longer.

Handling the sterile packaging

Before taking out the product, check for the packaging

to be intact. When taking out the product, follow the

respective aseptic procedures.

Information for

validating the

preparation

The above preparation process has been verified by a validated procedure. The following materials and machines were used:

. Alkaline cleaner: Neodisher®Mediclean; Chemische Fabrik Dr. Weigert GmbH & Co. KG

. Enzymatic cleaner: Neodisher®MediZyme; Chemische Fabrik Dr. Weigert GmbH & Co. KG

. Cleaning and disinfection unit: Miele G  CD

. Rack trolley: Miele E

. Strainer basket/flush socket bar: mach (NOUVAG REF )

. Autoclave: Selectomat -HP (MMM)

. Sterile packaging: Sterisheet ; Broemeda Amcor Flexibles GmbH

Chemicals and machines other than those mentioned can also be used. In such a case consult the manufacturers or suppliers to find out

whether their products confer the same performance as the products that the procedure was validated with. If you should opt for a dif-

ferent procedure for reprocessing to the one given above, you are required to correspondingly establish the suitability

PROBLEM CAUSE SOLUTION

Motor is running but

saw is not moving

Saw handpiece is not

correctly coupled with

motor

Press saw handpiece firmly

against the motor until it snaps

into place. Check seat with coun-

termovement.

Saw blade is not

moving regularly

Saw blade is not cor-

rectly clamped

Clamp saw blade correctly and

tighten nut with the jaw spanner.

ACCESSORIES AND SPARE PARTSMALFUNCTIONS AND TROUBLESHOOTING

INFORMATION ON DISPOSAL

When disposing of the device, device components and accessories, the

regulations issued by the legislator must be followed.

When discarding the device components and accessories, please comply

with the issued statutory regulations.

REF DESCRIPTION QUANTITY

 Jaw spanner 

 Lubricant spray LUBRIFLUID 

 Cooling clip 

TECHNICAL DATA

REF nou

Weight  g

Torque max.  Ncm

Speed max. ’ rpm

Oscillation angle saw blade °

Transmission ratio  : 

Coupling to motor ISO 

Clamping depth saw blade shank  mm

Thickness saw blade , mm

There is no experience available from conducting other sterilisation procedures such as plasma sterilisation, low temperature sterilisation procedure, etc. Users

bear full responsibility if they use a procedure which differs from the validated sterilisation procedure described!

Please also comply with the applicable legislation in your country and the medical practice or hospital’s hygiene rules. This especially applies to the varying

requirements for an effective inactivation of prions.

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