Instructions for use
Page 1 / 2

Jiffy™ Composite Polishing Brushes

Date of issue:

2019-10-29

Last revision date:---

User group
The instruments may only be used by appropriately qualified personnel in dental surgery or clinics.
➢ Maxillo-facial surgeons, dentist, dental/oral surgeons.
Target patient group
Patients with dental medical indications in the area of the described indications and applications.
Materials / Components➢ Instruments with brass shank (nickel-plated) and working part of fibres impregnated with silicon carbide (SiC)➢ Partial gold plating
Product description
Jiffy™ Composite Polishing Brushes are suitable for ceramics, composites and similar materials. The abrasive
effect of the Jiffy™ Composite Polishing Brushes results from the specially selected fibers impregnated with anabrasive grain such as silicon carbide.
Indication➢ Polishing of natural teeth➢ Polishing of dental filling materials (ceramics and composites)
Contraindication➢ The instruments may not be used for any other than the described indication or application area.
➢ Excessive temperatures due to insufficient water cooling must be avoided (possible damage of pulp)➢ The indicated speed may not be exceeded (risk of injury)
Application mode
➢ For best results observe the recommended speeds as per the attached chart➢ Insert the instrument into the mouth prior to rotation to avoid risk of injury➢ Instrument must be rotating before touching the tooth or the dental material➢ Water cooling can be used if desired➢ Only use in indicated direction/mode.
➢ Polishing time should not exceed 15 sec. and be done in intermittent or dabbing mode
Observe the instructions of the drive unit manufacturer.
Speed specification
Maximum speed for Jiffy™ Composite Polishing Brushes
Shank type

Instrument

Speed

RA

Jiffy™ Composite Polishing Brushes

1‘ – 3.000 rpm

Frequency benchmark for the application of rotary instruments
The following values serve as a reference only; the actual service life may differ depending on the application,
usage and material but must not exceed the maximum number of reprocessing cycles.
➢ Jiffy™ Composite Polishing Brushes

10x

Ultradent Products, Inc. │ 505 West Ultradent Drive (10200 South) │ South Jordan, UT 84095 (USA) │ ultradent.com

Instructions for use
Page 2 / 2

Jiffy™ Composite Polishing Brushes

Date of issue:

2019-10-29

Last revision date:---Reprocessing
For reprocessing (cleaning, disinfection and sterilization) see the separate instructions for reprocessing.
Protective measures / Warnings➢ Do not store instruments in plastic pouches (damaged pouches can cause contamination of the instruments)➢ Store in dry conditions➢ Protect yourself by wearing appropriate protective gear (gloves, goggles, face mask)
Residual risks
Possible residual risks may be unintentionally detaching fibres from the working part due to gross faulty handlingor contamination due to inappropriate sterilization which may lead to harm of the patient, user or third persons.
These residual risks are highly unlikely and are not expected in case of appropriate use and handling over the
lifecycle of the instrument.
Traceability
We recommend keeping the original packaging over the entire lifetime of the instrument in order to ensure
traceability via the lot number.
Disposal
Used and/or defective instruments need to be sterilized before disposal to avoid transmission of germs. Pleasebe careful with sharp edges or tips.
After sterilization instruments can be discarded with general clinical waste.
Notification to competent authorities
Competent national authorities and the manufacturer need to be notified about all serious incidents occurring in
the context of the product without delay.
DFS-Diamon GmbH
Ländenstraße 193339 Riedenburg
Germany 0297

Distributed by
Ultradent Products, INC.
505 West Ultradent Drive (10200 South)
South Jordan, UT 84095
ultradent.com

Ultradent Products, Inc. │ 505 West Ultradent Drive (10200 South) │ South Jordan, UT 84095 (USA) │ ultradent.com

Rev. 10/19

Instructions for cleaning, disinfection and sterilization of Jiffy™ composite
polishing brushes
Preparation (cleaning, disinfection and sterilization) of reusable rotary dental instruments
According to DIN EN ISO 17664
General principles
All instruments must be cleaned, disinfected and sterilized before each use; this applies in particular to the first use after delivery since all instruments are shipped non-sterile (cleaning and disinfection after removing the protective transport packaging; sterilization after packaging). Efficientcleaning and disinfection are indispensable prerequisites for effective sterilization.
Please note the following within the scope of your responsibility for the sterile use of your instruments:➢
only those procedures sufficiently validated for cleaning / disinfection and sterilization of the specific devices and products are always used,➢the equipment used (WD, sterilizer) is regularly serviced and inspected and➢the validated parameters are complied with for each cycle.
Please observe also the legal regulations applying in your country as well as the hygiene regulations of the medical office or hospital. This applies
especially for the different stipulations regarding effective prion inactivation (not applicable for the U.S.).
Cleaning and Disinfection
Basics
A mechanical method (WD (Cleaning and Disinfection Device)) should preferably be used for cleaning and disinfection. A manual procedure –because of the significantly lower effectiveness and reproducibility, even when using an ultrasonic bath – should only be used if a mechanicalprocedure is not available.
Pretreatment shall be performed in both cases.

Pretreatment
Coarse soiling must be removed from the instruments immediately after their use (within max. 2 hours):
Procedure

1. Disassemble the instruments as much as possible (refer to the chapter “Special Notes”).
2. Rinse the instruments at least for 1 min under running water (temperature < 35 °C/95 °F).
If applicable (see chapter “Special Notes”):
Rinse all lumina of the instruments three times using a disposable syringe (min. volume 5 ml) with a disposable needle attached.
3. Place the disassembled instruments at least for the provided action time in the pre-cleaning bath1 so that the instruments are sufficiently covered. Make sure the instruments do not touch each other. Support pre-cleaning by completely brushing off all inside and outside surfaces (at the beginning of the action time, auxiliary means, see chapter “Special Notes”) and ultrasound use (for the minimum action time, but not less than 5 min).
If applicable (see chapter “Special Notes”):
Rinse all lumina of the instruments at least three times using a disposable syringe (min. volume 5 ml) with a disposable needle attached.
4. Activate the ultrasound again for the specified action time (but not less than 5 min).
5. Now remove the instruments from the pre-cleaning bath and follow by rinsing them thoroughly at least three times (atleast 1 min) with water.
If applicable (see chapter “Special Notes”):
Rinse all lumina of the instruments at least three times using a disposable syringe (min. volume 5 ml) with a disposable needle attached.
6. Check the instruments. In case of visible residue repeat steps 2 to 4 and check again. Discard the instrument if residue is still visible.

Make sure when selecting the cleaning agent1 that➢
it is principally suitable for cleaning instruments from metals and plastics,➢
the cleaning agent – if applicable – is suitable for ultrasonic cleaning (no foam development),➢
the cleaning agent is compatible with the instruments (see chapter “Material resistance”).
The concentrations, temperatures and action times as well as stipulations for follow-up rinsing specified by the manufacturer of the cleaning agent
or cleaning and disinfection agents must be absolutely complied with. Use only solutions that have been freshly prepared as well as water that issterile or has a low-microbe count (max. 10 microbes/ml) as well as low-endotoxin content (max. 0.25 endotoxin units/ml) (e.g. purified water/highly purified water); for drying, use only a soft, clean and lint-free cloth and/or filtered air.
1

If – e.g. for occupational protection reasons – you are using a cleaning and disinfection agent, please remember that it should be free from aldehydes (otherwise fixing of blood soiling), shouldhave certified effectiveness (e.g. VAH/DGHM or FDA/EPA approval/clearance/registration or CE marking), is suitable for disinfection of the instruments and compatible with the instrument (seechapter “Material resistance”). Please note that the disinfectant used for pretreatment is only for personal protection and cannot replace the disinfection step to be carried out later, after cleaning has taken place.

 0297

DFS-Diamon GmbH
Ländenstraße 193339 Riedenburg
Germany

Distributed by
Ultradent Products, INC.
505 West Ultradent Drive (10200 South)
South Jordan, UT 84095

ultradent.com

Issued by:Date of issue:
Last revision Date:

TB
2019-10-29
---

Rev.:

10/19

Page 1 / 5

Instructions for cleaning, disinfection and sterilization of Jiffy™ composite
polishing brushes
Mechanical cleaning / disinfection (WD (Cleaning and Disinfection Device)
Make sure when selecting the WD,➢
that the WD principally complies with DIN EN ISO 15883 and has a certified effectiveness (e.g. DGHM or FDA approval/clearance/registration or CE marking),➢
that, if possible, a certified program is used for thermal disinfection (A 0 value > 3000 or – with older devices – at least 5 min at 90 °C/194 °F)(with chemical disinfection there is a risk of disinfectant residues on the instrument),➢
that the program used is suitable for the instruments and has sufficient rinse cycles,➢that only water that is sterile or has a low-microbe count (max. 10 microbes/ml) as well as low-endotoxin content ((max. 0.25 endotoxin
units/ml) (e.g. purified water/highly purified water) is used for follow-up rinsing,➢that the air used for drying is filtered (oil-free, low microbe and particle content) and➢that the WD is regularly serviced and inspected.
Make sure when selecting the cleaning agent system,➢that it is principally suitable for cleaning instruments from metals and plastics,➢
that – if no thermal disinfection is used – a suitable disinfection agent with certified effectiveness (e.g. VAH/DGHM or FDA/EPA approval/clearance/registration or CE marking) is used in addition and that this is compatible with the cleaning agent used and➢that the chemicals used are compatible with the instruments (see chapter “Material resistance”).
The concentrations, temperatures and action times as well as stipulations for follow-up rinsing specified by the manufacturer of the cleaning agent
or disinfection agent must be absolutely complied with.
Procedure:

1.
2.
3.
4.
5.

Disassemble the instruments as much as possible (refer to the chapter “Special Notes”).
Place the disassembled instruments in the WD using a small parts basket.
Start the program.
Remove the instruments from the WD after the program is completed.
Check and package the instruments immediately after removal, if possible (see chapter “Control and Maintenance”
and “Packaging”, if necessary, after additional follow-up drying at a clean location).

Evidence of the general qualification of the instruments for an effective mechanical cleaning and disinfection was provided by an independent ,officially accredited and recognized (§ 15 (5) MPG) test laboratory using the WD G 7836 CD (thermic disinfection, Miele & Cie. GmbH & Co.,
Gütersloh) and pre-cleaning and cleaning agent Neodisher medizym (Dr. Weigert GmbH & Co. KG, Hamburg). The procedure described above
was considered.
Manual cleaning and disinfection
Make sure when selecting the cleaning and disinfection agents to be used,➢that they are principally suitable for cleaning and disinfecting instruments from metals and plastics,➢
that the cleaning agent – if applicable – is suitable for ultrasonic cleaning (no foam development),➢
that a disinfection agent with certified effectiveness (e.g. VAH/DGHM or FDA/EPA approval/clearance/registration or CE marking) is used
and that this is compatible with the cleaning agent used and➢that the chemicals used are compatible with the instruments (see chapter “Material resistance”).
Cleaning agent/disinfectant combinations should not be used, if possible. Cleaning agent/disinfectant combinations may be used only in cases ofvery low contamination (no visible contamination).
The concentrations, temperatures and action times as well as stipulations for follow-up rinsing specified by the manufacturer of the cleaning anddisinfection agent must be absolutely complied with. Use only solutions that have been freshly prepared as well as water that is sterile or has alow-microbe count (max. 10 microbes/ml) as well as low-endotoxin content ((max. 0.25 endotoxin units/ml) (e.g. purified water/highly purified
water); for drying, use only a soft, clean and lint-free cloth and/or filtered air.
Procedure

Cleaning
1. Disassemble the instruments as much as possible (refer to the chapter “Special Notes”).
2. Place the disassembled instruments at least for the provided action time in the cleaning bath so that the instruments
are sufficiently covered. Make sure the instruments do not touch each other. Support cleaning by completely brushing
off all inside and outside surfaces with a soft brush
If applicable (see chapter “Special Notes”):
Rinse all lumina of the instruments at least five times using a disposable syringe (min. volume 5 ml) with a disposableneedle attached.
3. Activate the ultrasound again for the specified action time (but not less than 5 min).
4. Now remove the instruments from the cleaning bath and follow by rinsing them thoroughly at least three times (at least
1 min) with water.
If applicable (see chapter “Special Notes”):
Rinse all lumina of the instruments at least five times using a disposable syringe (min. volume 5 ml) with a disposableneedle attached.
5. Check the instruments (see chapter “Control and Maintenance”).

 0297

DFS-Diamon GmbH
Ländenstraße 193339 Riedenburg
Germany

Distributed by
Ultradent Products, INC.
505 West Ultradent Drive (10200 South)
South Jordan, UT 84095

ultradent.com

Issued by:Date of issue:
Last revision Date:

TB
2019-10-29
---

Rev.:

10/19

Page 2 / 5

Instructions for cleaning, disinfection and sterilization of Jiffy™ composite
polishing brushes
Disinfection
6. Place the disassembled, cleaned and checked instruments for the provided action time in the disinfection bath so thatthe instruments are sufficiently covered. Make sure the instruments do not touch each other.
If applicable (see chapter “Special Notes”): Rinse all lumina of the instruments at least five times at the beginning andthe end of the action time using a disposable syringe (min. volume 5 ml) with a disposable needle attached.
7. Now remove the instruments from the disinfection bath and follow by rinsing them thoroughly at least five times (atleast 1 min) with water.
If applicable (see chapter “Special Notes”): Rinse all lumina of the instruments at least five times using a disposable
syringe (min. volume 5 ml) with a disposable needle attached.
8. Dry the instruments by blowing them off/out with filtered compressed air.
9. Package the instruments immediately after removal, if possible (see chapter “Packaging”, if necessary, after additional
follow-up drying at a clean location).
Evidence of the general qualification of the instruments for an effective manual cleaning and disinfection was provided by an independent , officially accredited and recognized (§ 15 (5) MPG) test laboratory using pre-cleaning and cleaning agent Cidezyme/Enzol and disinfectant Cidex OPA(Johnson & Johnson GmbH, Norderstedt). The procedure described above was considered.
Control and MaintenanceCheck all instruments after cleaning or cleaning / disinfection for corrosion, damaged surfaces, chipping, soiling as well as discolorations, and sortout damaged instruments (numbered limitation of reuse, see chapter “Reusability”). Instruments that are still soiled must be cleaned and disinfected again.
Reassemble the disassembled instruments (see chapter “Special Notes”).
Instrument oils or greases must not be used.
Packaging
Please package the instruments in disposal sterilization packaging (single or double-packaging), meeting the following requirements (material /process):➢DIN EN ISO/ANSI AAMI ISO 11607 (for the U.S.: FDA clearance)➢
Suitable for steam sterilization (temperature resistance up to min. 138 °C (280 °F) adequate vapor permeability)➢
Sufficient protection of the instrument or sterilization packaging against mechanical damages
Sterilization
Only the sterilization processes listed below shall be used for sterilization; other sterilization processes are not permitted.
Steam sterilization➢
Fractionated vacuum process2, 3 (with adequate product drying4)➢
Steam sterilizer according to DIN EN 13060/DIN EN 285 o ANSI AAMI ST79 (for the U.S.: FDA clearance)➢
Validated according to DIN EN ISO 17665 (valid IQ/OQ (picking & packing) and product-specific performance assessment (PQ))➢
Maximum sterilization temperature 134 °C (273 °F; plus tolerance according to DIN EN ISO 17665)➢
Sterilization time (exposure time with sterilization temperature):

2
3

4

5

Country

Fractionated vacuum process

Gravitation process

U.S.

min. 4 min at 132 °C (270 °F), drying time min. 20 min4

not recommended

other countries

min. 5 min5 at 132 °C (270 °F) / 134 °C (273 °F)

not recommended

min. three vacuum steps
Use of the less effective gravitation process is permitted only if the fractionated vacuum process is not available; it requires much longer sterilization times and must be validated at thesole responsibility of the user in regard to the product, device, process and parameters.
The actual drying time required depends directly on parameters at the sole responsibility of the user (loading configuration and spacing, sterilizer condition, ...) and must therefore be
determined by the user. Nonetheless, drying times should not be shorter than 20 min.
or 18 min (prion inactivation, not relevant for the U.S.)

Evidence of the general qualification of the instruments for an effective steam sterilization was provided by an independent , officially accredited
and recognized (§ 15 (5) MPG) test laboratory using steam sterilizer HST 6x6x6 (Zirbus technology GmbH, Bad Grund) and fractionated vacuum
process. Typical conditions in clinics and surgery as well as the procedure described above were considered.
The rapid sterilization process is principally not permitted.
Also, do not use any hot air sterilization, radiation sterilization, formaldehyde or ethylene oxide sterilization as well as plasma sterilization.

 0297

DFS-Diamon GmbH
Ländenstraße 193339 Riedenburg
Germany

Distributed by
Ultradent Products, INC.
505 West Ultradent Drive (10200 South)
South Jordan, UT 84095

ultradent.com

Issued by:Date of issue:
Last revision Date:

TB
2019-10-29
---

Rev.:

10/19

Page 3 / 5

Instructions for cleaning, disinfection and sterilization of Jiffy™ composite
polishing brushes
Storage
After sterilization the instruments must be stored dry and dust-free in the sterilization packaging.
Material resistance
Please ensure when choosing the cleaning and disinfection agent that they do not contain the following ingredients:➢
Organic, mineral and oxidizing acids (minimum permissible pH value 6.5)➢
Alkaline solutions (maximum permissible pH value 8.5, neutral/enzymatic cleaner recommended)➢
Organic solvents (e.g. alcohols, ethers, ketones, benzenes)➢
Oxidants (e.g. hydrogen peroxides)➢
Halogens (chlorine, iodine, bromide)➢
Aromatic/halogenated hydrocarbons
Never clean any instruments with metal brushes or steel wool.
All instruments must not be exposed to temperatures higher than 138 °C (280 °F)!

Reusability
When exercising appropriate care and if the instruments are not damaged or soiled, they can be reused up to the number of times listed in thechapter “Special Notes”; any continued use beyond this or the use of damaged and/or soiled instruments is at the responsibility of the user.
Any liability is excluded in case of disregard.
Additional information
Do not store instruments in plastic bags
Contact
Distributor
Ultradent Products, INC.
505 West Ultradent Drive (10200 South)
South Jordan, UT 84095
ultradent.com

Manufacturer
DFS-Diamon GmbH
Ländenstrasse 1
D-93339 Riedenburg
Germany 0297

DFS-Diamon GmbH
Ländenstraße 193339 Riedenburg
Germany

Distributed by
Ultradent Products, INC.
505 West Ultradent Drive (10200 South)
South Jordan, UT 84095

ultradent.com

Issued by:Date of issue:
Last revision Date:

TB
2019-10-29
---

Rev.:

10/19

Page 4 / 5

Instructions for cleaning, disinfection and sterilization of Jiffy™ composite polishing brushes
Special Notes
Special/additional procedure for
Genus

Brushes

 0297

Product name

Jiffy™ Composite Polishing Brushes

DFS-Diamon GmbH
Ländenstraße 193339 Riedenburg
Germany

RinsevolumeBrush-Standard

Manualcleaning /disinfection

Mechanicalcleaning /disinfection

Maintenance/
Assembly

Packaging

Sterilization

Pretreatment

Max. permissible
number ofcyclesStandard, spread
bristles in addition
with follow-up
rinsingStandard, spread
bristles in addition
with follow-up
rinsing

Small parts
basketOiling not
permitted

Standard
procedureStandard
procedure

10

Issued by:Date of issue:
Last revision Date:

TB
2019-10-17---

Distributed by
Ultradent Products, INC.
505 West Ultradent Drive (10200 South)
South Jordan, UT 84095

ultradent.com

Classification recommendations in accordance with
KRINKO/RKI/BfArM
recommendation(Germany only, if used
as intended)

Semi-critical B

Rev.:

10/19

Page 5 / 5