MaxPiezo1

MP1-M002-1.1 2021/05/20

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Contents
1 Product introduction ····························································································································1
2 Installation and adjustment····················································································································3
3 Function and Operation·························································································································54 Instruction for main components of detachable handpiece (showed in picture 2) ··············································65 Cleaning, disinfecting and sterilizing ·······································································································7
6 Transportation, Storage And Maintenance·································································································8
7 Trouble shooting ·································································································································8
8 Environmental protection····················································································································· 1 0
9 EMC - Declaration of conformity··········································································································· 1 0
Attachment 1. Table of operating power of the tips (Compatible with EMS)································································· 1 6

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Safety Precautions
WARNING: If you neglect these safety precautions, you may cause personal injury such as electric shock, fire ordamage to the product.
1.Use a separate, grounded power outlet. Never use wet hands to unplug the power cord.
2.Please put the power plug into the socket easy to pull out, to make sure it can be pulled out in emergency. Please do not use
other than the specified voltage.
3.Do not damage, modify, pull, over bend or twist the power cord, do not place heavy objects on the power cord.
4.Do not place the product on unstable workbenches, such as shaky tables, bevels, or vibrations.
5.Keep the scaler clean before and after operation. The scaling tip, wrench and handpiece (detachable) must be sterilized before
each treatment.
6.The tip must be tightened to the handpiece with torque wrench. While scaler is working, the heat of scaling tip may become
higher if there is no water flowing out, make sure the irrigation is good.
7.Don't twist or rub the tip. Change a new one when the tip is damaged or worn excessively.
8.Don't screw the scaling tip while stepping on the foot switch.
9.Don't use impure water source, and be sure not to use normal brine instead of pure water source.
10.If use the water source without hydraulic pressure, the water surface should be one meter higher than the head of the patient.
11.Don't knock or rub the handpiece. Do not pull the cable while the device is working, to avoid damage to the cable.
12.After operating, turn off electrical source, and then pull out the plug.
13.The screw thread of the scaling tips produced by other manufacturers is maybe coarse, rusty and collapsed, which will
damage the screw thread of the handpiece irretrievably. Please use our scaling tip.
14.This equipment is only applicable to the corresponding type of power adapter produced by our company.
15.As a professional manufacturer of medical instruments, we are only responsible for the safety on the following conditions:• The maintenance, repair and modification are made by the manufacturer or the authorized dealer.
• The changed components are original of our company and operated correctly according to instruction manual.
16.This product is intended for use in hospitals and dental clinics only. The user must be professionally trained and qualified dentists.
17.Indicator light: Other colours: Meaning other than red, yellow, or green, indicated the device ready for use.
18.Statement: the third conductor in the POWER SUPPLY CORD is only a functional earth.

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Symbol instruction
Symbol220VAC
110VAC

Instruction

SymbolInstruction

Warning, Caution and Important! Check theInstruction Manual

Consult the accompanying documents

Date of manufacture

Manufacturer

According to the type of protection against electric
shock: CLASS II EQUIPMENT

According to the degree of protection againstelectric shock:Type B applied part

Foot switch interface

Used indoor only

Adjustment for the water flow

Can be autoclaved

24VAC power supply socket

Appliance compliance WEEE directive, Disposeof as required by the law.

220VAC power supply socket
110VAC power supply socket

Function selection

Atmospheric pressure for storage

Water entrance pressure:0.01MPa-0.5MPa

Temperature limitation for storage

Humidity limitation for storage

Protected against dripping water

European authorized representative

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1 Product introduction
1.1 Product overview

Guilin Refine Medical Instrument Co.,Ltd. is a professional manufacturer to research, develope, produce and sell ultrasonicscalers. The product is used for teeth cleaning and also an important device for teeth disease prevention and treatment. The
Ultrasonic scaler is composed of main unit, handpiece, cable, water pipe, tip, torque wrench, foot switch, and power supply.
The ultrasonic scaler has following features:
1.1.1 Detachable handpiece can be autoclaved under 134°C and 0.22 Mpa.
1.1.2 Automatic frequency tracking ensures that the device always works on the best frequency, stable and efficient performance.

1.2 Contraindications:1) The hemophilia patient is forbidden to use this equipment.
2) The patients or doctors with heart pacemaker are forbidden to use this equipment.
3) The heart disease patient, pregnant woman and children should be cautious to use the equipment.

1.3 Equipment safety classification

1) Operating mode: Continuous operation
2) Type of protection against electric shock: Class II3) Degree of protection against electric shock: Type B applied part
4) Applied part of the equipment: Tip
5) Degree of protection against harmful ingress of water: Ordinary equipment
6) Degree of protection against harmful ingress of water: protection degree against water (used on foot switch ):IPX1
7) Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide:
Equipment can not be used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide1

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1.4 Model and technical Parameters
Size (mm)169.5mm*147mm*85mm

Weight of main unit

0.75kgWeight of power supply

Input Power0.93kg220VAC 50Hz /110VAC 60Hz
38VA

Fuse of main unit

T1.6AL 250V

Fuse of power supply

T0.5AL 250V

Rated input

Primary tip vibration excursion<200μm

Tip vibration frequency

28kHz±5kHz

output power of tip

3W-20W

half-excursion force

0.5N-5N

Water entrance pressure

0.01MPa-0.5MPa

Function setting

G, P

Touch control

NO

Water bottle

Without

Note 1: In addition to the above, the electronic components used to clarify their electrical properties are exactly the same.
Note 2: Function Annotation:“G”means “Scaling mode” ; “P”means “Periodontal mode” ; “E”means “Endodontic mode”
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Note 3: Do not replace the fuse of main unit nor the power supply, to avoid safety risks.

1.5 Working condition

1) Environment temperature: +5°C-+40°C2) Relative humidity: 30%-75%
3) Atmosphere pressure: 70kPa-106kPa
4) Temperature of the water at the inlet: not higher than +25°C

2 Installation and adjustment
2.1 Product installation steps

2.1.1 Unpack the package, make sure that all the parts and accessories are complete according to the packing list, take themain unit out of the box, and put it on the stable plane facing to the operator.
2.1.2 Turn the water control knob to the max, Do not screw it over tight in case of damage.
2.1.3 Insert the plug of the foot switch to the socket.
2.1.4 Connect one end of the water pipe to the water entrance, and the other end to the clean water source.
2.1.5 Connect the handpiece (detachable) to the cable.
2.1.6 Install the tip on the handpiece and turn on the power switch to start operation.

2.2 The function instructions and the connection diagram

2.2.1 Power adjustment: The models with potentiometer are adjusted by potentiometer, turn on/off the potentiometer to adjust
the power; for the models with touch panel, power can be adjusted by finger touch.
2.2.2 Water adjustment: Turn on/off the water adjustment switch to adjust the water volume; for MaxPiezo 7, water is adjusted bytouch panel.

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ON/OFF

Picture 1-A The front view of the main unit

24V AC

Picture 1-B The back view of the main unit

2.3 Instruction for main components of handpiece (showed in picture 2).

Picture 2-A The handpiece without LED lamp

Picture 2-B The handpiece with LED lamp

2.4 Instruction for using the wrench to install tip
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Picture 2-C UnDetachable handpiecePicture 3a) The torque wrench’s structure is designed in special way which can control the strength of the scaling tip installation properly
and correctly. It also can guarantee the operator screw or unscrew the scaling tip effectively and keep their hands away from being
scratched.
b) Operation•Take the tip into the torque wrench then install or uninstall the scaling tip as picture 3 showed.
•Installation: Hold the handpiece and turn the tip toward clockwise direction with the torque wrench. Turn one more circle when
the tip stops, then the tip is installed.
•Uninstallation: Hold the handpiece, turn the wrench toward anti-clockwise direction.

Note: The connection of handpiece (detachable) and the plug must be kept dry.

3 Function and Operation
3.1 Scaling & periodontal treatment function

3.1.1 Turn on the power switch, the power indicator lighted and the machine is ready for work.
3.1.2 Choose the scaling tip according to the requirement, and fix the scaling tip with the wrench. ( see picture 3) Please select a5

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suitable power when using different type of tips (refer to "TABLE OF OPERATING POWER OF THE TIPS").
3.1.3 The handpiece can be handled in the same gesture as a pen in hand.
3.1.4 Vibrating intensity: Adjust the vibrating intensity according to your need, usually adjust to the middle grade, and adjust thevibrating during the clinical treatment according to the patient's sensitivity and the rigidity of the tartar.
3.1.5 Step on the foot switch, the tip begins to vibrate, and the LED lamp (model with LED) on the top of the handpiece lights up.
Release the foot switch, the LED lamp keep shining for 10 seconds.
3.1.6 Under normal working condition, the frequency of the tips is very high, light touch and a certain to-and-fro motion will
eliminate the tartar without obvious heating, overexertion and overstay are forbidden.
3.1.7 Water volume adjustment: Step on the foot switch, and the tip begins to vibrate, then turn the water control switch to finespray to cool down the handpiece and clean the teeth.
3.1.8 After finishing operation, keep the machine working for 30 seconds with the water supply to clean the handpiece and thetip.
3.1.9 Unscrew the scaling tip and sterilize it.

Note: Be sure not to make the end of the tip touch the teeth vertically, and not use too much force when the tip touching thesurface of the teeth, in case of hurting the teeth and damaging the tip.

Note: Don't screw the scaling tips when stepping on the foot switch, while the machine is working.
Note: When the water is lower than water level lower limit, please open the lid, fill the bottle with adequate purified water andcover the lid.

4 Instruction for main components of detachable handpiece (showed in picture 2)a) Cap: The Cap can be removed. You can screw out the Cap and clean the pole with alcohol termly.
b) Decorative ring: can be disassembled and cleaned with alcohol regularly, can be autoclaved under the high temperature andpressure.
c) Handpiece: The main part of the whole handpiece, can be autoclaved under the high temperature and pressure.
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d) Symbol: Autoclaved (134°C, 0.22MPa)e) The connector of the cable: Connect the handpiece with the water source and power supply of the main unit.
f ) LED lamp, Light conductor (The models that the handpiece with LED lamp): Clean them with purified water and sterilize themunder the high temperature of 134°C and high pressure of 0.22Mpa.

Note: The connection of handpiece and the plug must be kept dry.

5 Cleaning, disinfecting and sterilizing
5.1 Please conform to the recommendations of the manual "Reprocessing Instructions of Cleaning, Disinfecting And Sterilizing"delivered with your product regarding the procedure of cleaning, disinfecting, sterilizing and packing of the components.
5.2 The handpiece (detachable), scaling tips, endochuck, torque wrench, endo wrench, LED lamp and Light conductor (thehandpiece with LED lamp) can be sterilized. The handpiece (undetachable), cable and water pipe cannot be sterilized.

Notice:a) Clean the handpiece (detachable) with compressed air before sterilization.
b) Be sure that the scaling tip has been unscrewed from the handpiece and it cannot be sterilized with others.
c) Please notice whether the outer of the handpiece is damaged during the treatment and sterilization. Don’t smear any
protective oil on the surface of handpiece.
d) There are two waterproof “O” rings at the end of the handpiece. Please lubricate them with dental lube frequently, as
sterilization and repeated pulling and inserting will reduce their using life. Change a new one once it is damaged or worn
excessively.
e) The following sterilizing methods are forbidden:•Boil in water.
•Dip in iodine, alcohol and glutaraldehyde.
•Bake in oven or microwave oven.

Notice: We are not responsible for any damage caused in the above items.
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6 Transportation, Storage And Maintenance
6.1 Transportation

6.1.1 Excessive impact and shake should be prevented in the transportation. Lay it carefully and lightly and don’t invert it.
6.1.2 Don’t put it together with dangerous goods during transportation.
6.1.3 Avoid solarization and getting wet in rain or snow during transportation.

6.2 Storage

6.2.1 Don’t store the machine together with the articles that are combustible, poisonous, caustic, or explosive.
6.2.2 This equipment should be stored in a room where the relative humidity is 10%-93%, atmospheric pressure is 70kPa106kPa, and the temperature is -20°C-+40°C.

6.3 Maintenance6.3.1 The equipment should be handled carefully and lightly. Be sure that it is far from the vibration, and installed or kept in acool, dry and ventilated place.
6.3.2 Please turn off the electrical source if not use it, if not use for a long time, please make the machine get through to thepower and water once 3 months for five minutes.

7 Trouble shooting
Fault
Possible cause
The scaling tip doesn't vibrate and there is The power plug is in loose contact.
no water flowing out when stepping on the The foot switch is in loose contact.
The fuse in the main unit is broken.
foot switch.

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Solutions
Make the plug insert to the socket well.
Insert the foot switch to its socket tightly.
Contact our dealers or us.

FaultPossible cause
The tip is in loose contact.

The scaling tip doesn't vibrate
but there is water flowing out when
stepping on the switch.

The connect plug between the handpieceand the circuit board is in loose contact.

Solutions
Screw the tip on the handpiece tightly(See Picture 3).
Contact our dealers or us.

Something wrong with the cable.

Send the handpiece to ourcompany to repair.
Contact our dealers or us.

The scaling tip vibrates but there is no
spray when stepping on the foot switch.

The water control knob is not on.

Turn on the water control knob [note 1].

The vibration of the tip becomes weak.

The tip hasn't been screwed on to thehandpiece tightly.
The tip is loose because of vibration.
The coupling between the handpiece andthe cable isn't dry.
The tip is damaged [note 2].

Screw the tip on the handpiece tightly(See Picture 4).
Screw on the tip tightly (See Picture 4).

The waterproof "O"ring is damaged.

Change a new waterproof "O"ring.

There is water seeping from the coupling
between the handpiece and cable.
There is water flowing out when turnoff the power.
The handpiece generates heat.

Something wrong with the handpiece.

There is impurity in the solenoid valve.
The amount of spouting water is too little.
The potentiometer is broken.

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Dry it by the hot air.
Change a new one.
Contact with the local distributor or
manufacturer.
Turn the water control switch to a higher
grade [note 1].
Change a new one.

Fault
The amount of spouting water is too little.
The vibrating intensity control knob
is seizes up.
The u-file doesn't vibrate.

Possible cause
The water control knob is a low grade.
The water pressure is not enough.

The screw is loose.

Solutions
Turn the knob to a high grade [note 1].
Enhance the water pressure.
Clean water pipe with multi-function
syringe [note2].
Contact with the local distributor
or our company.
Tighten it.

Endochuck is damaged.

Change a new one.

The water pipe is jammed.
The potentiometer is damaged.

There is noise coming from the endochuck. The screw is loose.

Tighten it.

LED light don't work
(Handpiece with LED lamp)

Contact tightly
Change a new one

Poor contact
Something wrong with LED light

There is no water coming out from the
There is air in the water pipe.
handpiece (automatic water supply mode).

Turn the water control to the Max, reinsert
the bottle.

If the problem still can't be solved, please contact with local dealer or manufacturer.

8 Environmental protection
Please dispose according to the local laws.

9 EMC - Declaration of conformity
The device has been tested and homologated in accordance with EN 60601-1-2 for EMC. This does not guarantee in any way that10

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this device will not be effected by electromagnetic interference. Avoid using the device in high electromagnetic environment.
Guidance and manufacturer’s declaration - electromagnetic emissions
The Ultrasonic scaler are intended for use in the electromagnetic environment specified below. The customer or the user of the Ultrasonic scaler
should assure that it is used in such an environment.
Emissions test
ComplianceElectromagnetic environment - guidance
The Ultrasonic scaler use RF energy only for its internal function. Therefore, its RF emissions are very
RF emissions CISPR 11
Group 1
low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR11
Class B
Harmonic emissions lEC
Class A
61000-3-2
The Ultrasonic scaler are suitable for being used in domestic establishment and in establishment directly
connected to a low voltage power supply network which supplies buildings used for domestic purposes.
Voltage fluctuations/ flicker emissions
ComplieslEC 61000-3-3
Guidance & Declaration — electromagnetic immunity
The Ultrasonic scaler are intended for use in the electromagnetic environment specified below. The customer or the user of the Ultrasonic scaler
should assure that It is used in such an environment.
Immunity test
IEC 60601 test level Compliance level
Electromagnetic environment - guidance±8 kV contact±8 kV contact ±2
Electrostatic discharge (ESD)
Floor should be wood, concrete or ceramic tile. If floors are covered with
±2 kV, ±4 kV, ±8 kV, kV, ±4 kV, ±8 kV,lEC 61000-4-2
synthetic material, the relative humidity should be at least 30%.
±15 kV air±15 kV air±2kV for power supply ±2kV for power
supply lines ±1kV Main power quality should be that of a typical commercial or hospital
Electrical fast transient/burst lines
IEC 61000-4-4±1 kV for Input/output for interconnecting environment.
lines
cable
Surge
±1 kV line to line
Main power quality should be that of a typical commercial or hospital±1 kV line to line
lEC 61000-4-5±2 kV line to earth
environment.

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Voltage dips, shortinterruptions and voltage
variations on power supply
input lines
IEC 61000-4-11.

<5 % UT<5 % UT(>95% dip in UT.) for (>95% dip in UT.)
0.5 cycle
for 0.5 cycle
40 % UT
40 % UT
Main power quality should be that of a typical commercial or hospital(60% dip in UT) for 5 (60% dip in UT) for
environment. If the user of the Ultrasonic scaler requires continued
cycles5 cyclesoperation during power mains interruptions, it is recommended that the
70% UT
70% UT
Ultrasonic scaler is powered from an uninterruptible power supply or a
(30% dip in UT) for (30% dip in UT) forbattery.
25 cycles
25 cycles<5% UT<5% UT(>95 % dip in UT) for (>95 % dip in UT)
5 sec
for 5 sec

Power frequency (50/60 Hz)
magnetic field
30A/m
30A/m
lEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.

Power frequency magnetic fields should be at levels characteristic of atypical location in a typical commercial or hospital environment.

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Guidance & Declaration - Electromagnetic immunity
The Ultrasonic scaler are intended for use in the electromagnetic environment specified below. The customer or the user of the Ultrasonic scaler
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level Compliance level Electromagnetic environment - guidance

Conducted RF
lEC 61000-4-6

3 Vrms150 kHz to 80 MHz

3 VrmsRadiated RF lEC 3 V/m
61000-4-3
80 MHz to 2.5 GHz

3 V/mPortable and mobile RF communications equipment should be used no closer to any
part of the Ultrasonic scaler, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distanced=[3,5/V1]×P1/2
d=1.2×P1/2 80 MHz to 800 MHz
d=2.3×P1/2 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter In watts (W)according to the transmitter manufacturer and d Is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey,a should be less than the compliance level in each frequency range.b
Interference may occur In the vicinity of equipment marked with the following
symbol:NOTE 1 At 80 MHz end 800 MHz. the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should beconsidered. If the measured field strength in the location in which the Ultrasonic scaler are used exceeds the applicable RF compliance level
above, the model Ultrasonic scaler should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the Ultrasonic scaler.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
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Recommended separation distances between
portable and mobile RF communications equipment and the Ultrasonic scaler
The Ultrasonic scaler are intended for use in electromagnetic environment in which radiated RF disturbances is controlled. The customer or theuser of the Ultrasonic scaler can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Ultrasonic scaler are recommended below, according to the maximum output power of thecommunications equipment.
Rated maximum output power
Separation distance according to frequency of transmitterof transmittermW
150kHz to 80MHz
80MHz to 800MHz
800MHz to 2,5GHz
d=1.2×P1/2
d=1.2×P1/2
d=2.3×P1/2
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) accordable
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
The normal function of the Serial 6 / Serial 5 Ultrasonic scaler may be disturbed by strong Electro Magnetic Interference. If so, simply reset
the product to resume normal operation by following the instruction manual. In case the function could not resume, please use the product in otherlocation.
Without the express consent of manufacture, unauthorized alteration or modification of the equipment may cause electromagnetic compatibility
problems of the equipment or other equipment.
Warning: this device should not be used close to or stacked with other devices. If it must be used close to or stacked, it should be observed
and verified to work normally under the configuration used.

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Attachment 1. Table of operating power of the tips (Compatible with EMS)
ScalingCavity Preparation

Tip Model

Power

Tip Model

Power

G1

1-10(G)
1-10(G)
1-10(G)
1-10(G)
1-10(G)
1-10(G)
1-10(G)
1-10(G)
1-10(G)
1-10(G)
1-10(G)

SB1

1-10(P)
1-10(P)
1-10(P)
1-10(P)
1-10(P)

G2
G3
G4
G5
G6
G7
G8
G9
G10
G11

SB2
SB3
SBLL
SBR

Periodontics

15

Endodontics

Tip Model

Power

Tip Model

Power

P1

1-10(P)E1

1-5(E)P2L

1-3(P)E2

1-5(E)P2LD

1-2(P)E3

1-6(E)P2R

1-3(P)E3D

1-3(E)P2RD

1-2(P)E4

1-6(E)

P3/PD3

1-6(P)E4D

1-3(E)P3D
P4P4D

1-6(P)
1-6(P)
1-6(P)

E5
E5D
E6

1-6(E)
1-3(E)
1-6(E)

E7

1-6(E)

E8

1-10(E)E9

1-10(E)E10

1-6(E)

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E10D

1-6(E)

E11

1-6(E)E11D

1-6(E)

E14

1-3(E)

E15

1-3(E)

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Attachment 2. Reprocessing instructions of cleaning, disinfecting and sterilizing
1. BEGINNING WORK!

2.5 If you find that the reprocessing instructions from the
manufacturer seem to be inadequate, please inform manufacturer
about those inadequacies.
2.6 We encourage you to report adverse events related to device
reprocessing. Report such events directly to manufacturer.

1.1 Please read these operating instructions carefully as they
explain all the most important details and procedures. Please
pay special attention to the safety precautions. Always keep this
instruction
close at hand.
1.2 To prevent injury to people and damage to property, please heed
the corresponding directives.
1.3 The instructions in this manual are only applicable to theequipment which it was delivered with.

3. REPROCESSING - INSTRUCTIONS FOR
REUSABLE PRODUCTS

The instructions are binding for the reprocessing of all reusable
products (Here after called "products") of manufacturer. Whennecessary, additional product-specific instructions are included
with the product to provide additional information.Important: Before
use, carefully read the operating instructions of the manufacturer
instrument and devices with which the product will be used.
Reusable products must be cleaned and sterilized prior to first use.
They must be replaced after the number of operations specified
by the manufacturer. Disposable products (single use) cannot bereused.

2. INTRODUCTION

2.1 These reprocessing instructions provide instructions forcleaning, disinfection, sterilization and packaging of manufacturer
reusable products intended to be reprocessed in medical facilities.
2.2 The goal of reprocessing reusable products is to reduce
bioburden and to achieve sterility of those products in order toeliminate the risk of product reuse related infection. Decisions
regarding cleaning, disinfecting or sterilizing manufacturer's medical
and dental instruments are based on the potential risk of infection
associated with their use.
2.3 It is recommended to use steam sterilization.
2.4 Remember that sterilization or high-level disinfection cannot be
achieved unless the elements of the assembly are cleaned first.

4. PREPARATION - Basic principles

4.1 It is only possible to carry out effective sterilization after thecompletion of effective cleaning and disinfection. Please ensure
that, as part of your responsibility for the sterility of products duringuse, only sufficiently validated equipment and product-specificprocedures are used for cleaning/disinfection and sterilization, and17

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that the validated parameters are adhered to during every cycle.
4.2 Please also observe the applicable legal requirements in yourcountry as well as the hygiene regulations of the hospital or clinic.
This applies especially with regard to the additional requirements forthe inactivation of prions.

A machine cleaning and disinfection method should always be used
for cleaning / disinfection because of the increased effectiveness of
this method.
6.2 MECHANICAL CLEANING AND DISINFECTION
6.2.1 Thermal disinfection should be used if this function is available
on your disinfector. Use if possible a disinfecting cycle compliant
with the standard EN ISO 15883.
6.2.2 Note that there is a risk of disinfectant residue on products
when using chemical disinfectants.
6.2.3 Ensure the following criteria are met when selecting adisinfector system:•Disinfector is proven effective through testing (E.g. FDA approvedor CE marked / EN ISO 15883 compliant).
•Disinfector has suitable baskets to hold small fragile products andhas rinsing connections for the attachment to product lumina.
•The cleaning program is suitable for products to be processed andthe rinsing cycle is sufficient.
•Only low microbe count (<10 cfu/ml) distilled or deionized water
is used for all rinsing steps. (E.g. Aqua purificata, as per the
specifications of Pharm. Eur. or USP).
•Air used for drying is HEPA filtered.
•Disinfector is serviced and checked on a regular basis.
6.2.4 Ensure the following criteria are met when selecting a cleaningand disinfection agent:•Chemicals are compatible with products.
•With non-thermal disinfection, a suitable disinfectant with tested

5. POST-OPERATIVE TREATMENT

The post-operative treatment must be carried out immediately,
no later than 30 minutes after the completion of the operation.
Additional information, while necessary, is provided in the respective
product-specific usage instructions.

Steps:

1.Rinse away any surface soiling on the product with distilled
deionized water or with a cleaning agent.
2.Rinse through all lumina (E.g. irrigation and aspiration connection)
at least 3 times in the normal direction of flow (no back rinsing)using a disposable syringe (min. volume 50 ml) filled with distilled/
deionized water applied to the back nozzle.
3.An aldehyde-free cleaning and disinfection solution that iscompatible with the products may also be used as an alternativerinsing solution. In such cases, it is necessary to rinse thoroughly
afterwards at least 3 times with distilled, or deionized water.

6. CLEANING/DISINFECTION:

6.1 MECHANICAL REPROCESSING
Disinfection must be performed no later than 2 hours after thecleaning phase.
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effectiveness (E.g. FDA approved or CE marked), that is compatible
with the cleaning agent, must be used.

(see section Inspection and maintenance) after the program ends.
8) Wrap the products directly following disinfection and drying (seesection Packaging and sterilization). If necessary, repeat drying of
the product in a clean place.

Concentrations and contact times specified by the
manufacturer of the cleaning and disinfection agent must be
followed. Only freshly prepared solutions may be used.
6.2.5 Steps for mechanical cleaning and disinfection with adisinfector
1) Load the WD with the instruments on the tray and start the WD
with a full load. Run the cleaning cycle of the "surgical instrument"
programme in accordance with the manufacturer's instructions.
Instrument cleaning program:• pre-wash (5 minutes, ambient temperature water)• cleaning (5 minutes, 0.5% neutral pH detergent, 40℃)
• rinse I (1 minute, ambient temperature water)• rinse II (1 minute,ambient temperature water)• disinfection (2.5 minutes, pure water 93℃)
2) Immediately after the cleaning cycle, interrupt the program andunload the samples.
3) After cleaning in the WD, examine the instruments visually.
4) Carefully place the products in the disinfection basket. Fasteningof the products is only permissible if they are freely moveable in the
fixture. The products are not permitted to make contact with one
another.
5) Using a suitable rinsing adaptor, connect the product lumina to
the rinsing connections of the disinfector.
6) Start the program.
7) Remove the products from the disinfector and start the inspection

7. INSPECTION AND MAINTENANCE

If stains are still visible on the product after cleaning/disinfection, theentire cleaning/disinfection procedure must be repeated. Productswith visible damage, chip/flake loss, corrosion or bent out of shapemust be disposed of (no further use is permissible).

8. PACKAGING AND STERILIZATION
Do not exceed the maximum number of sterilization cycles.
Only cleaned and disinfected products are permitted to be sterilized.
Prior to sterilization, the products need to be placed in a suitablesterilization container:•Compliant with EN ISO 11607,•Resistant to 138°C, with adequate steam permeability,•Maintained on a regular basis.
If double, single-use sterilization packaging (double bag) is to be
used, this must also comply with EN ISO 11607 and be suitable forsteam sterilization (temperature resistant to 138°C with adequate
steam permeability).
Use only the following listed steam sterilization procedures forsterilization; other sterilization procedures are not permissible:•Fractional pre-vacuum procedure (steam sterilization with repetitive
pre-vacuum.)•Steam sterilizer in accordance with EN 13060 or EN 285 validated
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in compliance with EN IS0 17665,•Maximum sterilization temperature 138°C,•Sterilization time at least 3 min. at 134°C (fractional pre-vacuum
procedure).
•Sterilization at 134°C for a maximum of 20 minutes is permissible.
The hot-air sterilization and radio-sterilization procedure
may not be used (as it causes the destruction of products).
The manufacturer assumes no responsibility for theuse of other sterilization procedures (E.g. ethylene oxide,
formaldehyde and low temperature plasma sterilization). In
such cases, please observe the respective valid standards (EN IS014937/ANSI AAMl IS0 14937 or the procedure-specific standard)
and verify the suitability and effectiveness in principle of theprocedure (if necessary, including investigations on sterilizing agent
residue), taking into account the specific product geometry as partof the validation.

9. SERVICE LIFE

The products have been designed for a large number of sterilization
cycles. The materials used in their manufacture were selectedaccordingly. However with every renewed preparation for use,
thermal and chemical stresses will result in aging of the products.
If the number of permissible re-sterilization cycles is restricted, thiswill be pointed out in the product specific instructions.
The use of ultrasound baths and strong cleaning and disinfection
fluids (alkaling pH > 9 or acid pH< 5) can reduce the life span ofproducts. The manufacturer accepts no liability in such cases.
The products may not be exposed to temperatures above 138°C.
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Note: We reserve the rights to change the design of the equipment, the technique, fittings,
the instruction manual and the content of the original packing list at any time without notice.
If there are some differences between blueprint and real equipment, take the real equipment
as the norm.

Guilin Refine Medical Instrument Co., Ltd.
No.8-3, Information Industrial Park, High-Tech Zone,
Qixing District, Guilin, Guangxi, 541004, P.R. China
Tel: +86-773-7796686 Email:refine@refine-med.com
Website: http://www.refine-med.com

https://www.kadashika.jp

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After service and warranty instruction
1 Period validity:
Five year’s free repair for the main unit, one year's free repair for the handpiece from the date of purchase. Lifetime maintenance.
2 Range of warranty:
Within the warranty period of validity, we are responsible for any troubles caused by quality problems or products technique andstructure.
3 The followings are beyond our warranty:
1) The damage caused by disobeying the operation instruction or lack of the needed condition.
2) The damage caused by unsuitable operation or disassembly without authorization.
3) The damage caused by unadvisable transportation or preservation.
4) There isn’t the seal of distributor or the warranty card isn’t filled in completed.

Guilin Refine Medical Instrument Co., Ltd.
No.8-3, Information Industrial Park, High-Tech Zone,
Qixing District, Guilin, Guangxi, 541004, P.R. China
Tel: +86-773-7796686 Email:refine@refine-med.com
Website: http://www.refine-med.com

https://www.kadashika.jp

After service and Warranty Instruction
Name of Customer
Address
Post CodeTel
E-mailPurchase Date
Distributor
Model
Product No.
Handpiece No.
 Production Date

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