SybronEndo Contra Angle, Руководство пользователя

Страница: 3 / 70

2 3
With the motor stopped, install the MD on the motor
connection until ratcheting. Apply light traction to the
MD to check that it is properly attached to the motor
connection. Test the MD by switching on the motor;
start at low speed, then gradually increase, outside of
the patient’s mouth.
If you notice overheating, irregularities, vibrations,
abnormal noises when using the MD , immediately contact
your After-Sales Support.
V.2 – Disconnection of motor
Remove the MD by keeping it in-line with the motor
axle.
In the event of prolonged non-use of the device,
do not leave it connected to the motor. Risk of
damaging the motor.
V.3 – Connection / disconnection of rotary
instrument
For all handlings of rotary instruments, wear
protective gloves. Risk of cutting and
contamination. All handling must be carried out when
the motor is stopped.
Disengage lock on
MD (Figs. 2-4) , insert the rotary
instrument up to the stop in the head of the MD , and
re-engage lock. Ensure that the instrument is fully
secured in the MD by pulling the instrument axially.
Only use rotary instruments in good condition.
Risk of fracture or necrosis.
HYGIENE AND MAINTENANCE VI.
- Sterilization of medical devices must be done
by properly trained and protected staff, in
compliance with current regulations. The
sterilization protocol must be appropriate to
the infectious risk.
- Wear appropriate protective clothing: risk of
infection and injury.
- Only use products for the maintenance of
medico-surgical equipment compatible with
aluminium. Instruments made out of aluminium
may be damaged by detergent solutions that
are alkaline (pH > 7). Do not use antiseptics
intended for use on skin and mucous. Do not
use products containing aldehyde, alcohol or
other products likely to bind proteins.
- For each product used: refer to the
manufacturer’s instructions.
Comply with the concentrations, exposure
durations, and life span of products. Do not
mix the products and follow the instructions
for their disposal.
VI.1 – Preparation of MD for sterilization
To be done immediately after surgery (maximum time
of 2 hrs):
- Disconnect the MD from the motor
- Remove the rotary tool (see § V.3 )
- Remove the largest organic contaminants with
disinfectant wipes.
Do not use the MD and inform your distributor
or SybronEndo After-Sales (AS) in the following
situations:
- Visible failure or damage
• Risk of damage to the device and injury:
Wait until the motor has completely stopped to:
- connect/disconnect the MD from the motor
- turn the locking/unlocking system for the rotary
instrument on
- handle the rotary instrument
• Assess the risk of septic substances penetrating
tissue if used with a central air cooling motor
(refer to the motor manufacturer’s leaflet).
• Risk of burning and injury:
Apply pressure to the MD with a rotary
instrument (refer to the manufacturer’s
instructions).
• Risk of electrical discharge due to MD being
badly connected to a SybronEndo non-compatible
system:
In the event of the MD being assembled
and used in other manufacturer’s treatment
devices and installations, refer to « Protection
against the risk of electrocution », « Leaking
current » and « Non-earthing of use part »
according to the IEC 60601-1 standard.
• Do not use in explosive atmospheres.
•
MDs can only be used on low-voltage medical
units in accordance with the Community Directive
93/42/CEE.
TECHNICAL CHARACTERISTICS IV.
• Motor connection standard: NF EN 23964
• Maximum speed of motor: 40,000 RPM
• Rotary instruments according to EN ISO
1797-1: Ø 2.35mm
• Rotary instruments according to ISO 3630-1:
instruments for radicular canals
• Gear reduction: see marking on body of contra-
angle. Maximum output RPM from contra-angle
is determined by dividing motor speed by the
gear reduction. For example, if the motor speed
is 3,000 RPM, and an 18:1 gear reduction is used,
the maximum output from the contra-angle will be
approximately 167 RPM.
INSTALLATION OF MD V.
The MD is supplied non sterile .
Before first use, the MD must be cleaned,
decontaminated and sterilized (See § VI ).
V.1 – Connection to the motor (Fig. 1)
Check that the MD is completely dry before connecting
it to the motor.