Medartis WSD-90 Manual de usuario
Angulated screwdriver
WSD-90
Instructions for use
MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
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MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
Contents
Symbols..............................................................................................................3 – 4
1. Introduction......................................................................................................5 – 7
2. Before use – safety notes.........................................................................................8 – 9
3. Product description WSD-90......................................................................................... 10
4. Operation ......................................................................................................11 – 17
Assembly/removal , rotating instruments, changing the rotating instrument,
use of the screwholding fork and the retaining clip, test run
5. Hygiene and maintenance ......................................................................................18 – 33
General, pre-disinfection, disassembly, manual cleaning, manual disinfection,
mechanical cleaning and disinfection, reassembly, oil service, sterilization
6. Accessories ........................................................................................................ 34
7. Technical data..................................................................................................35 – 36
8. Recycling and disposal..........................................................................................37 – 38
Explanation of warranty terms ........................................................................................... 39
Authorized service partners ............................................................................................. 40
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MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
Symbols
Symbols in the instructions for use
WARNING!
(risk of injury)
ATTENTION!
(to prevent damage
occurring)
General explanations,
no risk to persons or
objects
Caution:
According to the federal law of the USA, the sale of this device is only permitted by or on instruction of a dentist, a
doctor or another medical practitioner who is licensed to work in the state in which they are practising and in which
they want to use or arrange the use of this device.
Do not dispose of with
domestic waste
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MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
Symbols
Symbols on the 90° screwdriver
Catalogue number
Serial numberThermo washer disinfectable
Sterilizable up to the stated
temperature
Date of manufacture
Identification number of
notified body REF
SN
Equipment number
EN
5
MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
1. Introduction
Customer satisfaction is the main priority of our quality policy. This product has been developed, manufactured and
subjected to final inspection according to legal regulations, quality norms and industry standards.
For your safety and the safety of your patients
Please read the instructions for use booklet before using this product for the first time. This explains to you how to
use your product and guarantees smooth, efficient and safe operation.
Intended use
Surgical treatment of dental hard tissue.
Misuse can damage the 90° screwdriver and involves risk and danger to the patient, user and third parties.
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MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
Qualifications of the user
Only suitably qualified medical, technical and specialist trained staff may use the 90° screwdriver. We have based our
development and design of the 90° screwdriver on the "physician" target group.
Production according to EU directive
The 90° screwdriver is a medical product according to EU Directive 93/42/EEC.
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the
90° screwdriver when the following directions are complied with:
> The 90° screwdriver must be used in compliance with these instructions for use.
> The 90° screwdriver contains no parts which are repairable by the user. Modifications or repairs must only
be undertaken by an authorized service partner (see page 40).
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MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
Skilled application
The 90° screwdriver is intended only for skilled application in surgery according to its purpose of use in compliance
with the valid health and safety at work regulations, the valid accident prevention regulations as well as in
compliance with these instructions for use. The 90° screwdriver should only be prepared for use and maintained by
staff who have been trained in procedures for infection control, personal safety and patient safety. Improper use
(e.g. poor hygiene and maintenance), non-compliance with our instructions or the use of accessories and spare
parts which are not approved by us for the WSD-90, invalidate all claims under warranty and any other claims.
Service
If you observe any problems, contact an authorized service partner immediately (see page 40). Repair and
maintenance work must only be carried out by an authorized service partner.
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MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
> The operation of the 90° screwdriver is permitted only on drive units which comply with the medical
device directives.
>
The screwdriver should only be operated with sufficiently powerful drive motors (see page 35).
> The maximum permitted drive speed of 1750 rpm must not be exceeded.
> Always ensure that you have the correct operating conditions.
> Check the 90° screwdriver for damage and loose parts prior to use (e.g. retaining clip).
> Do not operate the 90° screwdriver if it is damaged.
> Only fit the 90° screwdriver when the motor is at a complete standstill.
> Never touch the rotary instrument when it is still rotating.
> Carry out a test run prior to each use.
> Avoid overheating at the treatment site.
> Unintended use may result in the 90° screwdriver getting hot (risk of burning)!
> During surgery, we recommend to have two angled screwdrivers ready for use.
2. Before use – safety notes
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MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
Hygiene and maintenance prior to initial use
> Oil service prior to initial use.
> Sterilize the 90° screwdriver and the rotation knob.
> Oil service page 30
> Sterilization page 32
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MANDIBLE-00000901_RevG
Instructions for Use for MODUS 90° Screwdriver
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland
3. Product description WSD-90
90° Screwdriver
Head
Sheath
Shaft
Tension clamp
Screwholding fork
Retaining clip
Clip
Rotation knob
Symbol description
= Sheath open
= Sheath locked
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