Nouvag 21 Instructions For Use

Instructions for use
EN
Electronic Motor 21
REF 2098nou | REF 2099nou | REF 2112nou
SYMBOLS
General warning sign
Manufacturer
Batch code
Serial number
INTENDED PURPOSE
The electronic motors 21 are equipped with handpiece carriers according to
ISO 3964, which enable the attachment of handpieces and contra angles and
ensure secure hold.
MEDICAL INDICATIONS
The electronic motor 21 in conjunction with a control unit and corresponding
handpiece is used in the following medical indications:
// ENT surgery (REF 2098nou | REF 2099nou)
// Neurosurgery (REF 2098nou | REF 2099nou)
// Orthopaedic hand and foot surgery (REF 2099nou)
// Rhinoplasty and reconstructive surgery (REF 2112nou)
CONTRA INDICATIONS
Relative or absolute contra indications can arise from the general medical diag-
SAFETY INFORMATION
We deliver an unsterile electronic motor. Clean, disinfect, and sterilize
the electronic motor before the first application and immediately after
each use!
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.
Improper use or repair of the device, or failure to observe these instruc-
tions, relieves NOUVAG from any obligation arising from warranty
provisions or other claims.
OVERVIEW
Twist protection Release button
lock
Handpiece carrier
OPERATION
COUPLING HANDPIECES WITH A GROOVE WITH THE ELECTRONIC MOTOR 21 WITH TWIST PROTECTION LOCK
Twist protection lock with release
button on the electronic motor.
REPROCESSING INSTRUCTIONS
In relation to patients with Creutzfeldt Jakob disease or its variant (vCJK) no responsibility can be assumed for re-use of the electronic motor. The Robert-Koch
Institute recommends removing used products from circulation after use in order to avoid infecting other patients, users and third parties.
Never clean the electronic motor in an ultrasonic bath! This impairs the functionality of the electronic motor.
Reprocessing
restrictions
General handling
Preparation at the
point of use
Safe-keeping and
transport
Cleaning and
disinfection,
pre-cleaning
Warning! Hot surface
Date of manufacture
Catalog number
Authorized representative in
the European Community
Ventilation slits
Motor cover
Electronic motor with plug and cable
Handpiece coupling with groove
for twist protection.
Frequent reprocessing has only a limited impact on the electronic motor. The end of the products service life is normally determined by
wear and damage through use. The electronic motor is designed for 250 sterilization cycles.
1. The electronic motor must be thoroughly cleaned, disinfected and sterilised before initial operation (products straight from the fac-
tory) and also immediately following each use. Only a cleaned and disinfected electronic motor enables correct 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 mildly alkaline and enzymatic cleaners with as low a silicate content as possible to avoid staining (silica-
tization) on the electronic motor.
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. Instructions for use for the equipment and chemicals etc. used during reprocessing must be strictly followed.
6. Dosage of chemicals, exposure times and exposure temperatures for cleaning and disinfection must be strictly followed.
7. The end of product life may be reached before the 250 sterilization cycles in case of excessive wear and damage from use.
8. Do not overload the washer. Avoid rinsing blind spots. Ensure secure storage in the machine.
9. Observe the regulations valid in your country for the reprocessing of medical devices.
10. NOUVAG recommends the use of a screen basket with rinsing bar from 3mach (NOUVAG REF 51401), a reusable container for con-
venient preparation and storage (including transport) of the products. The screen basket can be used for safe storage of the prod-
ucts during the rinsing process as well as during and after sterilization until the products are used. The screen basket is suitable for
use with sterilization paper or a rigid sterilization container. It does not have a barrier effect on its own to protect 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.
1. Wipe the electronic motor with a damp disposable cloth / paper towel, removing all visible dirt.
2. Unscrew motor cap and remove cable including motor cap.
3. Unscrew handpiece carrier and remove O-ring.
4. Clean the plastic parts of the electronic motor and its accompanying parts under running tap water using a soft brush (e.g. Insitu-
mend GmbH, REF MED100.33).
5. Rinse the outer surface of the electronic motor for 10 seconds with a water pressure gun 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
electronic motor.
Observe instructions for use
Importer
Autoclavable at 134 °C
Separate collection required
(WEEE)
nose, or in special cases by a significantly increased risk to the patient through
the use of motor-driven devices. Relevant cases in the literature must be taken
into consideration.
INTENDED USERS
Intended users are trained and qualified personnel, in professional settings (e.g.
hospital, ambulatory).
AMBIENT CONDITIONS
Relative humidity
Temperature
Atmospheric pressure
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 handpiece only when the motor is at a standstill.
The device shall only be operated by qualified and trained personnel.
To avoid cable breakage, do not bend the motor cable!
The electronic motor may only be connected with connection sockets
marked with the symbol « Type BF »
POSSIBLE COMBINATIONS
REF
2098nou
2099nou
2112nou
Align groove at handpiece with the twist protection
and connect handpiece with electronic motor by press-
ing the button. Check for proper seating.
© NOUVAG AG • 20470 • V20240805 • All rights reserved
TRANSPORT AND STORAGE
max. 90 %
0 °C – 50 °C
700 hPa – 1'060 hPa
.
CONTROL UNIT INTENDED USE
HighSurg 30 Neurosurgery
ENT surgery
HighSurg 30 Neurosurgery
ENT surgery
HighSurg 11 ENT surgery
HighSurg 11 OFA-Drill Orthopaedic hand and foot surgery
TCM 3000 BL Rhinoplasty and reconstructive surgery
Press the button and decouple handpiece from
electronic motor.
Note
Suitable for
thermal disinfection
Type BF applied part
DURING USE
max. 80 %
10 °C – 30 °C
800 hPa – 1'060 hPa