SHENZHEN ROGIN MEDICAL CO.
, LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
Instructions for use
Of
Stainless Steel Hand Use K-Files
Doc. No.: LJYL-IFU-B001
Version: A1
Effective: 2022-12-10
Page 1 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
Before using the products, please see the instruction manual as indicated below.
Revision History
Item Rev description release date
1 A0 The first release 2020-06-02
2 A1 Add signs and suggestions 2022-12-10
Page 2 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
Page 3 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
1. Brief of the product
The Stainless Steel Hand Use K-Files is one type of Dental Root Canal Instruments which
is used for enlarging root canal by the movements of lifting and vertical reciprocation.
It is standard instrument with 2% taper, which is type 1 classification base on ISO 3630-
1:2019.
It is non sterile instruments.
2. Intended Use
The Dental Root Canal Instruments is designed to explore, shape, clean and/or help filling a root
canal system.
3. Product Structure and materials
The Stainless Steel Hand Use K-Files is composed of handle and operative part.
The cross section of K Files is square.
The main Materials:
1) Operative part: Stainless steel
2) Handle: White plastic grains (CAN20-037986.002)
3) Stoppers: Colorless translucent rubber (CAN19-259705.001)
Page 4 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
Working part Handle
Stoppers
4. Before Using
<Warnings>
3.1 Only skilled dentists are allowed to use.
3.2 Be sure to sterilize this product for each use.
3.3 Do not use this product except for the dental service and treatment. Use it in
accordance with the intended use.
<Contraindications and prohibitions>
Do not use this product for a patient who indicates sensitization and allergic reaction.
5. Re-Processing
Our Dental Root Canal Instruments are single use and not approved for re-use.
Repeated sterilization is not recommended。
Page 5 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
6. Specifications and Method of Use
5.1 The Specification of ROGIN stainless Steel Hand Use K-Files as the below table
(based on ISO 3630-1):
Working Length Tip Diameter Color of
Size Taper
(mm) (mm) handle
006 0.06 Pink
008 0.08 Grey
010 0.10 Purple
015 0.15 White
020 0.20 Yellow
21mm(white
025 0.25 Red
stopper)
030 0.30 Blue
L25mm(yellow
035 0.35 2% Green
stopper)
040 0.40 Black
L28(red stopper)
045 0.45 White
L31(black stopper)
050 0.50 Yellow
055 0.55 Red
060 0.60 Blue
070 0.70 Green
080 0.80 Black
5.2 According to its intended use, the dentists can choose the most appropriative type
for each case and follow the general method.
Page 6 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
5.3 This ROGIN Stainless Steel Hand Use K-Files is under the provisions of ISO 3630
performance test, products’ durability for twisting and bending must exceed specified
value of our standard
7. Precautions for use:
6.1 To prevent infection, Please clean and disinfect the product (Please see item 7) and
make sure sterilization is completed before using.
6.2 Choose the most appropriative type for each case and follow the general method.
6.3 Before using, make sure the instruments outside of oral cavity that there are no
deformations, scratches and cracks.
6.4 If the head of product is thin, long or large, there are possibilities for breaking or
twisting. Because of this, be sure to avoid using unreasonable angle and excessive pressure.
6.5 Wear rubber dam etc. to avoid accidental ingestion and falling.
6.6 Do not use this instrument for any purposes except for listed applications above.
6.7 Only for use by dentists.
6.8 This product should be treated as medical waste when disposed.
6.9 Dispose the product if damaged or contaminated.
6.10 After using, wash it with medical cleaning agent and brush, then wash away foreign
substances like adherent body fluids and body tissues.
6.11 Set the product to a stand when cleaned by ultrasonic cleaner to avoid deterioration of
cutting part.
6.12Use this product with great care to avoid puncturing fingers because of its possession
of sharp-edged part.
Page 7 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
6.13 This product has possibility that be corrosive if sunk into NaOC1, EDTA and etc. for a
long time.
8. Cleaning and Disinfection (base on ISO 17664: 2017)
7.1General Recommendation
7.1.1 Please use cleaning agents suitable for cleaning surgical instruments, rubber, medical plastics,
instruments and other medical instruments, such as multi-enzyme cleaning agents. When using,
please strictly abide by the manufacturer's regulations on the concentration, temperature, action
time and shelf life of the solution used. Do not use hydrogen peroxide (H2O2) solution.
7.1.2 For your own safety, please wear personal protective equipment (gloves, glasses, masks).
7.1.3 The user should be responsible for the sterilization or disinfection of the product in the first
cycle and each subsequent use, as well as the use of damaged or dirty equipment after
sterilization.
7.1.4 In the final rinsing step, deionized water must be used regardless of whether an automatic
washer sterilizer or manual cleaning method is used. Tap water can also be used for other
rinsing steps.
7.1.5 Only immerse the operative part of the instrument in contact with the patient into the NaOCl
solution concentrate with a concentration not exceeding 5%.
7.1.6 Before or during disinfection or cleaning, avoid equipment drying out. Dry biological materials
may be difficult to remove.
7.1.7 Only use the appropriate support of the device for post-processing.
7.1.8 Do not use labeling systems or identification marks directly on the device.
7.1.9 Only use washer-disinfectors approved in accordance with EN ISO 15883 and regularly
maintained and verified.
Page 8 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
7.2 Operation Steps
7.2.1 Disassembling: Remove the stopper from the instrument and dispose of it
7.2.2 Rinsing: Rinse extensively (at least 1 minute) under flowing deionized water
(ambient temperature). While rinsing, use a soft brush (made of nylon,
polypropylene, acrylic) for pre-cleaning until visible impurities are removed.
7.2.3 Cleaning and Disinfection
[Link] Manual Cleaning assisted by an ultrasonic device:
[Link].1 Manual cleaning with ultrasonic equipment
[Link].2 Place the instrument in a kit, stand or container (made of stainless steel, polypropylene or
titanium).
[Link].3 Immerse in a detergent solution(for example, Metrex EmPowder concentration 1:128) with
cleaning properties, if appropriate, soak for at least 15 minutes with the aid of ultrasonic
equipment.
[Link].4 Flushing: Perform a large amount of flushing (at least 1 minute) under flowing deionized
water temperature 20°C ~ 40°C.
[Link].5 Drying: Dry with a disposable non-woven fabric or hot air dryer not exceeding 110°C.
[Link] Automated Cleaning using a cleaning and disinfecting device
[Link].1 Place the instrument in a kit, stand or container (made of
stainless steel or titanium).
[Link].2 Perform the defined cycle with detergent solution (for example,
Metrex EmPowder concentration 1:128 ~ 1:512) for at least 5 minutes in the
washer-disinfector with temperature 20°C ~ 40°C.
[Link] Disinfection using a washer-disinfector device
Page 9 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
[Link].1 Place the instrument in a kit, stand or container (made of
stainless steel or titanium).
[Link].2 Perform the defined cycle with mild neutral enzyme cleaning
agent solution (for example, Metrex EmPowder concentration 1:128) for at
least 5 minutes in the washer-disinfector with temperature >90°C, A0 >3000.
Note:
1) Discard any instruments with obvious defects (broken, bent, etc.).
2) When the instruments are placed in the cleaning kit, support or
container, avoid any contact with each other.
3) Follow the instructions and concentration provided by the detergent
solution manufacturer (see also general recommendations).
4) Follow the instructions of the washer-disinfector and verify the success
criteria after each cycle is reached according to the manufacturer's
instructions.
5) The final rinse step should use deionized water. For other steps, follow
the water quality defined by the manufacturer. Place the devices in a kit,
support, or container (made from stainless steel or titanium) to avoid any
contact between devices or posts.
7.2.4 Rinsing: Abundant rinsing (at least 1 min) under running water (ambient
temperature).
1) Use deionized water for rinsing.
2) If the previously used cleaning solution contains a corrosion inhibitor, it is
recommended to do the rinsing step just before starting the autoclaving.
Page 10 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
7.2.5 Drying: Devices should be thoroughly dried before inspection and packaging.
1) Dry on a single use non-woven cloth, or with a hot air drier at not more
than 110°C.
2) Devices should be dried until visual traces of moisture are eliminated.
3) Particular attention has to be paid to effectively dry joints or cavities
within a device.
7.2.6 Inspection:
[Link].1 Inspect the devices functionality.
[Link].2 Inspect devices and sort out those with defects.
1) Dirty devices must be cleaned again.
2) Do not re-use silicon stops.
3) Discard devices, which show any defect
7.2.7 Packing: Place the devices in a kit, support or container to avoid any contact
between instruments or posts and pack the devices in “Sterilization pouches”.
1) Avoid any contact between instruments or posts during sterilization. Use
kits, supports or containers.
2) For sharp devices that are not contained within a box, silicon tubes should
be placed around the devices to prevent packaging piercing.
3) Seal the pouches according to the recommendation of the pouch
manufacturer. If a thermo-sealer is used, the process must be validated.
4) Check the validity period of the pouch given by the pouch
manufacturer to determine the shelf life.
Page 11 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
7.2.8 Sterilization:
[Link] Steam sterilization at 132°C / 273°F during 4 min is recommended for these
devices, for the purpose of de- activating potential prions.
[Link] The instruments and posts must be sterilized according to the packaging labelling.
[Link] Place the pouches in the steam sterilizer according to the recommendation given
by the sterilizer manufacturer.
[Link] Use only steam sterilizer that are matching the requirements of EN 13060 (class B,
small sterilizer), EN 285 (full size sterilizer).
[Link] Use a validated sterilization procedure according to ISO 17665 with a minimum
drying time of 20 min
[Link] Respect the maintenance procedure of the sterilizer given by the sterilizer
manufacturer.
[Link] Control the efficiency and acceptance criteria of the sterilization procedure
(packaging integrity, no humidity, no colour change of packaging, positive
physico-chemical indicators, conformity of actual cycle parameters, to reference
cycle parameters).
[Link] Store traceability records and define shelf-life according to packaging manufacturer
guidelines.
[Link] Shorter sterilization cycles according to local regulations are possible but are not
guaranteed to de-activate prions.
7.2.9 Storage
Page 12 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
Keep devices in sterilization packaging in a clean environment, away from sources of
moisture and direct sunlight. Store at ambient temperature.
1) Sterility cannot be guaranteed if packaging is open, damaged or wet.
2) Check the packaging and the medical devices before using them (packaging
integrity, no humidity and use by date).
8. Transportation
8.1 To prevent damage to the medical device during transit, use a specific racks, trays
or rigid containers may be recommended.
8.2 When the package was broken, then it is non-sterilize, must be cleaned,
disinfected and sterilized before using.
9. Storages and duration of use
9.1 Avoid storing at high temperature, humidity and direct sunlight. Keep liquids away. Store it at
room temperature.
9.2 Do not damage or make a pinhole to packaging materials.
9.3 The product is subject to be improved without previous notice. Enforce the first-in first-out
method for stock management.
9.4 Do not keep under germicidal lamp to avoid deterioration.
9.5 The shelf time of root canal files are 5 years.
10. Disposal
For proper disposal, always observe national laws and recommendations of the authorities.
Page 13 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
11. Packaging
11.1 Minimum packaging unit: 6pcs/package in plastic box.
11.2 Assortment: 1pcs from each size in one package
12. Explanation of related symbols
Symbols Explanation
Medical device
CE notify body code
For Dental Use Only
Do not reuse
Material of the operative part
Batch code
Identification symbols of K Files
Non-Sterile
Catalogue Number
Expired Date
Consult instructions for use
Authorized representative in the European
Community
Manufacturer
Can be sterilized at the specified
temperature
Page 14 of 15
SHENZHEN ROGIN MEDICAL CO., LTD
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District, Shangkeng community, Guanhu Street, Long
hua District, Shenzhen, China
Assortment
6pcs/pack
<Legal manufacturer>
Shenzhen Rogin Medical Co., Ltd
Address:5th Floor, Block I, Jinchangda Science Park, Shangwei Industry District,
Shangkeng community, Guanhu Street, Longhua District, Shenzhen, China
Tel.: 86 755 26758272 / Fax.: 86 755 26758272
[Link]
< EU representative>
※ Always keep this document near at hand. In case of loss, please contact dental department of the
manufacturer for a copy.
※ The specifications, structures and materials are subject to be changed without previous notices for the
demands of improvement.
※ The contents of this instruction manual are subject to be revised without previous notices.
Page 15 of 15