Dentsply Sirona Spacefile Manual

DIRECTIONS FOR USE
INSTRUCCIONES DE USO
INSTRUÇÕES DE UTILIZAÇÃO
MODE D’EMPLOI
ISTRUZIONI PER L’USO
GEBRAUCHSANWEISUNG
GEBRUIKSAANWIJZING
Spacefile®
Interproximal Reduction System

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Spacefile® Interproximal Reduction System (IRS)
DIRECTIONS FOR USE
Caution: U.S. Federal law restricts this device to sale by or on the order of a dentist.
INTRODUCTION
Dentsply Sirona hopes that you will benefit greatly from working with your new quality product – Spacefile®Interproximal
Reduction System. This product has been developed, manufactured and subjected to final inspection according to legal
regulations, quality norms and industry standards. The IRS consists of components –
1. Air Motor Complex AM
2. Contra-Angle Complex ITS (transmission instrument)
For your safety and the safety of your patients
Prior to initial use, please read the DIRECTIONS FOR USE. This explains how to use your product and guarantees its
smooth/ecient operation.
INDICATIONS
Dental system intended for use as a method for achieving interproximal reduction of teeth.
CONTRAINDICATIONS
The IRS is contraindicated for use with patients if it has not been sterilized as recommended in the Directions For Use.
ENG

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The IRS is contraindicated for use in patients who –
• are hypersensitive,
• don’t accept stripping,
• have low enamel density (hypoplasia) or a high caries index,
• display poor hygiene,
• have rectangular-shaped teeth, and/or,
• display a high grade of overcrowding.
In these cases, making extractions may be the treatment of choice.
The IRS is contraindicated for high-risk patients that need the care and attention of a specialist.
The IRS is contraindicated for use by patients in any way or manner even if the Spacefile®strips are used manually
to cause any reduction at home.
The IRS is contraindicated for use in patients for any purpose other than the one(s) indicated above.
WARNINGS
Prior to initial use, we advise sterilization of the Air Motor Complex AM and Contra-Angle Complex ITS.
As a user, always ensure the correct operating condition, and thus, correct application of the air motor.
This motor is made to be powered by AIR only. Do not use with electricity.

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Check on each occasion when fitting a transmission instrument (contra-angle) that it is securely connected on the air motor by
pulling on it lightly. If it does not connect securely, send in the motor for inspection to W&H Impex Worldwide, Inc.
We strongly advise sterilization prior to each use of the air motor and the Contra-angle. The air motor and contra-angle must be
dry when removed from the sterilizer. As part of your infection control procedures, we recommend sterilization after each use as
well before storage of these components on the shelf.
Do not assemble/remove the contra-angle during operation. Insert the Spacefile®strip into the contra-angle when it is stationary.
Never touch a strip while it is still moving.
Always insert the strip into the contra-angle by holding the plastic handle between two fingers (thumb and index).
Never push the strip into the slot with just the thumb as this action may cause the strip to break.
Strips should be removed from the head of the handpiece ONLY with the use of the Tip Ejector.
Disinfect and clean the contra-angle immediately after every treatment to flush out any liquid (like residues of blood or saliva
solution), which may settle on internal parts.
During operation, this device is intended to have some form of water irrigation from an external supply in case of heat build-up.
Improper use, e.g. poor hygienic maintenance, non-compliance with our Instructions, or the use of accessories and spare parts
which are not approved by Dentsply Sirona, invalidates all claims under warranty and any other claims.

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PRECAUTIONS
Read the Directions For Use thoroughly and comply with them during practice. Any use of this product inconsistent with these
directions for use, is at the discretion and sole responsibility of the practitioner.
Prior to initial use of the Air Motor – following lubrication and initial test (see IRS Assembly/Pre-Sterilization) – sterilization is
recommended. This is also valid for the Contra-Angle (transmission instrument).
The air motor provided does not have a water system. To avoid undesired pressure in the unit and the supply hose, we recommend
switching “o” the water when the air motor is in use.
During operation, we advise some form of water irrigation from an external source to prevent the case of excessive heat build-up.
Always ensure the correct operating conditions. Check the contra-angle handpiece for damage and loose parts prior to use.
To lubricate, use only W&H SERVICE OIL. This oil is classified as “highly flammable” (aerosol UN no. 1950) due to the use of CFC-free
propellants. Keep the W&H SERVICE OIL away from ignition sources and do not smoke near this product.
Regularly check leak-tightness between the air motor and the supply hose. Tighten it firmly to ensure leak-tightness.
Perform a visual inspection of the respective Spacefile®strip. Do not use strips that are damaged, bent, or broken.
Use only non-contaminated, filtered, oil-free and dry compressed air to operate the air-motor.

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To avoid injury and minimize the risk of infection during maintenance procedures –
• Wear tear-resistant and liquid-proof protective gloves.
• Wait until the air motor has stopped before disconnecting.
• Remove the contra-angle from the air motor and set the motor’s speed ring to maximum (position F or R).
Do not set a speed during operation.
Do not place the air motor and the contra-angle in an ultra sonic or disinfection bath. Do not use chlorine, strong alkaline or
acid-based disinfectants. The pH value of any disinfectant used should be in the range of 2.5 – 9.
Please observe the recommended sterilization methods (see Sterilization and Storage) and comply with the drying process.
All handpiece components (Air Motor and Contra-Angle) must be dry when removed from the sterilizer.
Use only approved sterile goods packaging material.
ADVERSE REACTION
None Known

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TECHNICAL DATA
Air Motor Complex AM – Contra-Angle Motor Complex ITS –
Maximum rated speed 25,000 rpm
Performance Up to 20 W
Weight 77 g
Coupling: Hose side ISO 9168, standard 4-hole
Operating pressure 2.2 – 3 bar
32 – 43 psi
Transmission Ratio 2:1
Coupling: Motor side ISO 3964 (front end)
• Strips (accessory) • Spacefile®Interproximal
Reduction Strips
• Chucking • By friction
Maximum released
motor speed 25,000 rpm
Stroke Length 1.6 mm
Weight 70 g

ETHYL
ALCOHOL
80%
Spray
for
surface
dis-
infection
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STEP-BY-STEP INSTRUCTIONS FOR USE
1. Disinfection –
a) The Contra-Angle and Air Motor can be manually or mechanically
disinfected after use with a patient. Please observe the following points
for
manual disinfection.
b) If heavily soiled, clean first with disinfectant cloths. Disinfect using
certified surface disinfectants (pH 2.5-9) or 80% ethyl alcohol.
c) Spray disinfection is recommended; Note the action times of the
disinfectants used.
Note: Wear Protective Gloves during these procedures!
Do not use chlorinated disinfectants as these may cause corrosion!
Do not immerse the handpiece and motor in an ultrasonic cleaning bath or
in liquid disinfectants as this may cause irreparable damage!

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2. Manual Cleaning –
Air Motor:
a) Ensure that the speed regulating ring is set to position F or R.
b) Remove the air motor from the supply hose.
c) Wipe o the air motor with cellulose paper and prepare it for sterilization.
Contra-Angle and Motor:
d) Rinse under de-mineralized water (<38ºC) with the aid of a brush.
Prevent water from entering the contra-angle.
e) Then, remove any liquid residues (absorbent cloth, blow dry with
compressed air) and dry completely.
Note: Doctors are requested to note the labeling information
(concentration,
application time, etc.) of the cleaning agents they use
and
take necessary precautions.

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3. Lubrication –
a) Use only ORIGINAL W&H Service Oil F1, MD-400.
b) For the Air Motor, place spray cap no. 02036100 onto spray can.
Shake
spray can, keep can upright and spray for approx. 1 second
into
the drive airline.
c) For the Contra-Angle, place spray cap no. 02038200 onto spray can.
Shake
spray can, keep can upright and spray for approx. 1 second.
d) Alternatively, lubrication can be performed using W&H ASSISTINA
301
PLUS (no. 00030135) – a device that lubricates with a precise dose of oil.
Please observe the Instructions for Use of Assistina before you proceed.
Note: The Air Motor and Contra-angle must be cleaned and
lubricated
before placing into autoclave for sterilization.
Recommended Lubrication Cycle: Essential before each sterilization,
(or
twice daily), or after 30 minutes of continuous use.

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4. Test Run –
a) Start the air motor and run it for about 30 seconds keeping the
head pointed downwards to remove any remaining traces of oil.
b) Vary the speed-regulating ring of the air motor from minimum to maximum
while it is running.
c) Wipe the angle and motor with gauze or soft cloth.
d) If you observe any problems (e.g. vibrations, unusual noise)
get in touch with your service agent.
5. Adjustment of Air-motor Operating Pressure –
a) The operating pressure is measured as flow pressure.
b) Screw the manometer (no. 02049500, or any other standard 4-hole manometer)
between air motor and supply hose.
c) Set the speed regulation ring to the position of maximum speed (position
F or R).
d) Start the air motor and adjust the desired operating pressure
(2.2–3 bar, or, 32–43 psi).
Note: The motor operates at a higher speed when the pressure is higher
(within the operating limits suggested).

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6. IRS Assembly/Pre-Sterilization –
a) Push the back end of the air motor onto the supply hose by hand
(standard 4-hole coupling) and tighten well to prevent leaks.
b) Check to ensure a secure connection.
Leakage reduces performance of the air motor!
c) Push the contra-angle handpiece onto the air motor until it engages
audibly. Check to ensure a secure connection.

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d) For operation, insert the desired strip (see Spacefile®Strip Selection)
into the contra-angle by holding the plastic handle between two fingers
(thumb and index). Never push the strip into the slot with just the thumb as
this action may cause the strip to break.
e) Reciprocating movement (of 1.6 mm stroke) of the insert
(Spacefile®
Strip) achieves interproximal reduction of teeth.
f) Check for a secure connection by applying slight axial tension.
Remember to switch the unit “o”!
g) To remove the strip, press the tip ejector on top of the shaft of the strip
into the hole so that it pushes the strip out.
Do not eject the strip with bare hands.

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h) Remove the contra-angle handpiece from the motor by
pulling
in an axial direction.
i) Fully unscrew union nut of the hose anti-clockwise.
j) Remove the air motor.
k) Wipe the air motor and the contra-angle with cellulose paper.
Prepare components for sterilization!
Components should be sterilized in individual packages only!

Note: Standard ISO 7785-2/ISO 14457
stipulates a durability of at least 250
sterilization cycles. We recommend you
to have regular service carried out after
1,000 cycles or at least once a year.
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7. Sterilization and Storage –
Dentsply Sirona recommends sterilization according to EN 13060 (type B).
a) Only sterilize cleaned and lubricated Air Motor(s) and Contra-Angle
handpiece(s).
b) Use only acceptable sterilization materials (bags, pouches, etc.).
c) Ensure instruments are dry following sterilization.
d) Store sterile goods dust-free and dry.
Permitted Sterilization Methods –
e) Steam vacuum sterilization according to EN 13060, using a sterilization
holding time of a minimum of 3 minutes at 134°C or 273.2°F.
OR
f) Steam gravity sterilization by a sterilization holding time of a minimum
of 3 minutes at 134°C or 273.2°F.
Note: We strongly recommend sterilization after every patient as part of
your infection control procedure.

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8. IRS Operation –
a) Assemble the components of the IRS as described in IRS Assembly/Pre-Sterilization.
b) Pre-treatment: Stripping in crowded situations is often much less unpleasant for both the patient and the operator if the
teeth have been separated, to a certain degree, during initial pre-treatment phase. Clear anterior separators may be placed
interproximally to accomplish such separation.
c) While the contra-angle is operating, insert the moving strip slowly into the buccal cavity in swing direction like playing
the violin to desire working space with a reciprocal absorb movement that translates into an ultrasound vibration in a
buccal-lingual reduction without forcing the strip or using it like a lever. This prevents the instrument from jamming between
the contact points interproximally.

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d) In some cases, it may be necessary to irrigate using water from an external supply to prevent excess heat build-up.
e) Contact Pressure: bend the strip 1 mm to 1.5 mm to achieve the ideal Newton (1 - 2.5 N) contact pressure.
f) Contra-angle turning at approximately 10,000 rpm, maximum 25,000 rpm.
g) Stroke length: 1.6 mm
9. Safe Disposal of the Device –
a) Follow your country-specific laws, directives, standards and guidelines for the disposal of used electrical devices.
b) Ensure that the parts are not contaminated upon disposal.

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Spacefile® Interproximal Reduction System (IRS)
DIRECCIONES DE USO
Precaución: Las leyes federales de EE.UU. restringen la venta de este aparato exclusivamente con autorización de un dentista.
INTRODUCCIÓN
Dentsply Sirona espera que se beneficie trabajando con este Nuevo producto de calidad - el sistema redactor interproximal
Spacefile®. Este producto ha sido desarrollado, fabricado y revisado siguiendo los requisitos legales, las normas de calidad
y los estándares industriales. El IRS se compone de componentes:
1. Motor neumático AM
2. Contra ángulo ITS (instrumento de transmisión)
Por su seguridad y la de sus pacientes
Antes de usarlo por primera vez, lea las DIRECCIONES DE USO. Éstas explican cómo utilizar su producto y garantizan su manejo
sencillo y eficaz.
INDICACIONES
Sistema dental diseñado para conseguir la reducción proximal de los dientes.
CONTRAINDICACIONES
El IRS está contraindicado en pacientes cuando no se ha esterilizado siguiendo las Direcciones de uso.
ESP

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El IRS está contraindicado en pacientes que:
• sean hipersensibles,
• no acepten las bandas reductoras,
• tengan poca densidad de esmalte (hipoplasia) o muchas caries,
• tengan poca higiene,
• tengan dientes de forma rectangular, y/o,
• tengan demasiada concentración.
En estos casos, las extracciones pueden ser una mejor opción.
El IRS está contraindicado en pacientes con alto riesgo que necesiten el cuidado de un especialista.
El IRS está contraindicado para ser usado por pacientes en casa incluso aunque se usen manualmente las bandas
reductoras
Spacefile®.
El IRS está contraindicado en pacientes en usos distintos de los indicados anteriormente.
ADVERTENCIAS
Antes del uso inicial, recomendamos esterilizar el complejo AM de motor neumático y el complejo ITS contra-ángulo.
Como usuario, asegúrese siempre de que existan unas condiciones de funcionamiento adecuadas, para garantizar
la
aplicación correcta del motor neumático. Este motor sólo debe funcionar con AIRE. No lo use con electricidad.

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Siempre que instale un instrumento de transmisión (contra-ángulo), compruebe que esté conectado de modo seguro al motor
neumático tirando ligeramente de él. Ni no está bien conectado, envíelo para que sea revisado por W&H Impex Worldwide, Inc.
Recomendamos fervientemente esterilizar los aparatos antes de cada uso (motor neumático y contra-ángulo).
El motor neumático y el contra-ángulo deben estar secos al sacarlos del esterilizador. También aconsejamos, como parte del
procedimiento de control de infecciones, esterilizarlos después de cada uso antes de almacenarlos.
No monte/desmonte el contra-ángulo durante la operación. Meta la banda Spacefile®en el contra-ángulo cuando este quieta.
No toque nunca una banda que esté en movimiento.
Meta siempre la banda en el contra-ángulo sujetando el asa de plástico entre dos dedos (pulgar e índice).
No empuje nunca la banda en la ranura sólo con el dedo pulgar ya que podría romper la banda.
Las bandas reductoras deben quitarse del cabezal de la pieza de mano usando EXCLUSIVAMENTE el extractor de puntar.
Desinfecte y limpie el contra-ángulo inmediatamente después de cada tratamiento para eliminar cualquier líquido (como restos
de sangre o saliva), que pueda acumularse en las piezas internas.
Durante la operación, este aparato debe tener algún tipo de suministro de agua desde una fuente exterior para que no se
acumule el calor.
El uso inadecuado, p.ej. mantenimiento poco higiénico, no seguimiento de nuestras instrucciones o uso de accesorios y piezas de
repuesto no aprobadas por Dentsply Sirona, invalidará todas las reclamaciones hechas bajo garantía y cualquier otra reclamación.