Caution: U.S. Federal law restricts this device to sale by or on the order of
a dentist.
Prior to use with air-driven handpiece, please read the “Directions For
Use” that was included with the Interproximal Reduction System (IRS)
handpiece, sold separately.
Do not apply excessive pressure on strips,
which may lead to premature fracture of the plastic handle.
INTENDED USE/INDICATIONS FOR USE:
Intended for use as a method for achieving interproximal reduction of teeth,
including joined enamel, composite, amalgam, porcelain or gold.
CONTRAINDICATIONS:
The IRS is contraindicated for use with patients if it has not been sterilized
as recommended in the Directions For Use.
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 degree of crowding.
WARNINGS:
Files are made from stainless steel and contain 6-8% of nickel by weight.
Nickel may cause allergic reactions in some patients.
PRECAUTIONS:
Read the Directions for Use thoroughly and comply with them during use.
Any use of this product inconsistent with these directions for use, is at the
discretion and sole responsibility of the practitioner.
Perform a visual inspection of the respective SpaceFile® fi le. Do not use fi les
that are damaged, bent, or broken.
Prior to use on a patient, observe the recommended sterilization
instructions below.
Use care when installing File in Grip as Files may be sharp.
Grip is provided for manual use only and must not be used with the air-
driven handpiece.
Lifetime of the fi les is dependent on physical usage; no expiry date is provided.
It is recommended that fi les are only used a maximum of 20 times. If wear
or damage becomes obvious, fi les should be discarded. Used fi les should be
discarded safely according to standard biohazard waste procedures.
ADVERSE REACTIONS:
Allergic Reactions
STEP BY STEP INSTRUCTIONS:
SpaceFile® fi les can be used with the specifi ed IRS handpiece or manually
with or without the included Grip. If using the handpiece, refer to its
Directions for Use.
Use the double-sided or single-sided File of appropriate grit in sequence as
needed to create the desired space. A serrated File is also available to assist
in breaking initial contact.
To insert SpaceFile® File in Grip:
1.
Place the shank of the SpaceFile® File into the hole on the Grip until
resistance is felt. The opposite side of the Grip can be bent out of the
way to facilitate this.
2.
With the base of the SpaceFile® File resting on a fi rm surface, press
down on the middle of the Grip until positive engagement is felt.
3.
Push the end of the Grip without the hole towards the File to complete
engagement of the File within the Grip.
To Remove SpaceFile® File from Grip:
1.
Grasping the Grip at the end with the shank, pull the opposite end of the
Grip upwards and away from the File.
2. Pull the File straight out of the hole in the Grip.
CLEANING GUIDELINES:
Scope
The SpaceFile® File and Grip should be both cleaned and then sterilized
after each use. Refer to the Sterilization Guidelines for sterilization
instructions. Cleaning should be completed immediately after use to avoid
contaminants drying, thereby making cleaning more diffi
cult.
Manual Cleaning Procedure
1.
Rinse under running cold water to remove gross contamination.
2.
Keeping it immersed, brush thoroughly away from the body using an
enzymatic cleaning/disinfecting agent validated for use on dental
instruments. Follow the agent manufacturer’s instructions.
3.
Special care should be taken to clean crevices, holes and other hard-to-
reach areas thoroughly.
4.
Perform fi nal thorough rinse and visual inspection to confi rm the
removal of debris. Repeat the cycle if needed.
5.
Dry using a lint-free wipe or clean compressed air.
6.
Inspect for damage or wear that could prevent proper function.
STERILIZATION GUIDELINES:
Scope
The SpaceFile® Interproximal Reduction Kit should be sterilized before and
after each use.
Packaging
1.
Remove the inner tray from the outer case by pulling up on the tab.
DO NOT sterilize the outer case.
2.
Pack the Grip and/or SpaceFile® Files in the insert.
3.
Insert in pouches validated for sterilization.
Steam Sterilization Procedure
Cycle
Type
Minimum Sterilization
Exposure Time
Minimum Sterilization
Exposure Temperature
Minimum
Dry Time
Gravity
10 minutes
134° (+3) C or 274° (+5.4) F
15 minutes
Storage
The device should be stored in the sterilization pouch until required.
Additional Information
These cleaning and sterilization processes have been validated as being
capable of preparing the SpaceFile® Interproximal Reduction Kit for use.
Any deviation from these instructions should be properly validated for
eff ectiveness and potential adverse results.
Figure 1:
Shank of File
fully inserted into Grip
hole
Figure 2:
Press down
on mid-section of Grip
until engagement is felt
Figure 3:
File fully
inserted in Grip
ENG
SpaceFile® Interproximal
Reduction Files
