Refine ADAE MaxSurgery III User manual

ADAE

Accessories/
Components Specications Quantity Replacement Reference
Foot switch RFS05 See packing list Can be used long-term. Replace it according to the manual after damage. Fig3-H
Handpiece rack / See packing list Can be used long-term. Replace it according to the manual after damage. Fig4-O
Warning: to avoid safety risks, the fuse of the main unit or power supply should not be changed by users.
P
B
A
D
F
C
L
E
Fig 1 Fig 2
I
J
H
G
Fig 3
K
M
N
O
Fig 4
2 Product Installation
2.1 Safety requirements during installation
Danger：The wiring system of the premises where the apparatus is installed and used must comply with the applicable standards
and the relevant electrical safety requirements.
Danger：Do not install the apparatus in places where there is a risk of explosion. The apparatus may not be used in areas where
there are inammable atmospheres (anesthetic mixtures, oxygen, etc.)
Danger：Install the apparatus in a place where it will be protected from blows and from accidental sprays of water or other liquids.
Danger：Do not install the device on or in the vicinity of sources of heat. Install it in such a way that there is adequate circulation of air
around it. Leave sufcient free space around it, in particular concerning the fan on the rear. (Fig.5)
Warning：Do not expose the apparatus to direct sunlight or sources of UV light.
Warning：The apparatus is transportable, however, it must be handled with care when it is moved.
Warning：Keep dry around the junctions before connecting cables. Blow-dry it with an air gun if necessary.
2.2 Initial Installation
To ensure perfect operation, the equipment must be installed in strict accordance with the manual.
2.3 Accessory connection
Warning：The accessories listed as follow should be connected with the MaxSurgery III
2.3.1. Installation of Foot switch
Connect the foot switch to the casting of the device by inserting
the plug into the foot switch socket; (Fig5-Ref.D)
2.3.2. Power Supply Connection
Plug the power cable into the connector on the casting of the
device and then into the power outlet; (Fig5-Ref.E)
2.3.3. Infusion bottle rod installation
Insert the rod for supporting the bag into the holes provided
for it (Fig.5- Ref. A)
D
E
B
A
2.3.4. Tubes and Handpiece connection Fig 5
1) See the sterilize box (Fig4-Ref.M), and insert the smaller end of the pump tube connector into the handle water supply pipe (Fig6-Ref.A)
2) Connect the round end of the infusion bag needle (Fig2-Ref.L) to the other end of the pump tube.
3) Insert the tip of the infusion bag into the saline bag (infusion bag)
Notice：Disposable infusion tubes and infusion bottles mentioned in the above attachments need to be purchased separately. It is
recommended to purchase ones with the registration of the Food and Drug Administration.
A B
Fig 6
2.3.5. Handpiece Installation
1) Put the handpiece on the handpiece rack (Fig.4-Ref. O), and clamp the end of the handpiece tail wire into the small groove of the rack
to avoid falling off.
2) Insert the handpiece plug into the socket of the device (Fig.7)
Fig 7
2.3.6. Installation of pump tube on peristaltic pump
1) Open the pump cover (Fig.8-Ref. A) as wide as possible.
2) Place the pump tube in the impeller (Fig.8-Ref. B)
3) Close the pump cover completely (Fig.8-Ref. C)
Danger：Must make sure the pump cover is completely closed.
The foot switch of the Ultrasonic Surgical System should never be activated with the lid of the peristaltic pump open. The operating
parts may hurt the operator. The pump tube shall be installed in the corresponding slot of the peristaltic pump, otherwise, it may cause
the stepper motor to block.
Put into the
silicon tube
A
C
B
D
Fig 8
2.3.7. Ultrasonic Surgical System tip installation
1) Choose a Ultrasonic Surgical System tip needed from the sterilize box (see a box full of tips)
2) Screw the tip on the handpiece (Fig.9)
3) Tighten the tip with the torque wrench until you hear a “click” sound.
Torque wrench Tip
Torque wrench Rotate
Handpiece
Fig 9
2.3.8. Turn on the power switch (Fig.5-Ref. B). After the screen displays normally, you can start to operate the device.
Step on the foot switch to start working, and the LED on the handpiece is on. Release the foot switch to stop working and the LED light
will be off in 10 sec.
3 Controls
3.1 Panel control
This section introduces the front operation panel of MaxSurgery III, enabling users to better use the device with an intuitive display op-
eration interface.
Operation panel instruction:
Bone cutting
function
Perio treatment
function
Endo treatment
function Cleaning function
Water touch
adjustment and
indication
Power touch
adjustment and
indication
Water intensity
Power intensity
Fig 10
3.2 Descriptions and Functions of the Screen
MaxSurgery III has the functions of bone-cutting (BONE), periodontal treatment (Perio), root canal treatment (Endo), and cleaning mode (Clean).
First, users can set a specic mode through the operation panel, and then set the appropriate power intensity and water output intensity.
Both power intensity and water output intensity cannot be adjusted when the foot switch is stepped on.
A) Bone-cutting, touch the “B” on the screen to switch the mode (Fig.10)
In bone function, both the water and power model are available. Ten power levels as follows:
① Power 9-10: D1, Very high bone density ② Power 6-8: D2, High bone density
③ Power 3-5: D3, Middle bone density ④ Power 1-2: D4, Low bone density
B) Periodontal treatment (Perio), touch the “P” on the screen to switch the mode (Fig.10)
In Perio function, both the water and power model are available. (Fig.10)
C) ENDO function, touch the “E” on the screen to switch the mode (Fig.10)
In ENDO function, both the water and power model are available.
D) Cleaning mode (Clean), touch the “C” on the screen to switch the mode (Fig.10)
In cleaning mode, the main unit can be cleaned after stepping the foot switch once (while cleaning, the handpiece does not vibrate and
only ushes the tubes and Ultrasonic Surgical System tip)
3.3 Safety requirements during use
Danger：Contraindications.
Do not use the MaxSurgery III on patients with pacemakers or other implantable electronic devices. This requirement also applies to the
operator.
Danger：Breakage and wear of the tips.
The high-frequency vibrations and wear may, very occasionally, lead to the breakage of the tip. Tips of which the shape has been
changed or which are otherwise damaged are liable to break during use. Any such tips should denitely not be used. It is necessary to
instruct the patient to breathe through his nose during the treatment in order to avoid ingestion of the broken fragment of the tip.
Danger：Control of infections.
For maximum safety of both the patient and the operator, clean, disinfect and sterilize the piezo electronic handpiece, the tips, and the
torque wrench after each treatment.
Warning：Contraindication.
Do not carry out this treatment on metal or ceramic prosthetic artifacts. The ultrasonic vibrations could lead to decrementing of such artifacts.
Warning：Contraindication.
After autoclave sterilizing of the handpiece, wait for it to cool down completely before using it.
Danger：The electrical contacts inside the cord connector must be dry.
Before connecting the handpiece to the device, make sure the electrical contacts of the connector are perfectly dry, in particular after the
autoclave sterilization cycle. If necessary, dry the contacts by blowing air onto them with the syringe.
Warning：To use the device correctly, it is necessary to press the foot switch and start it up without letting the tip rest on the part to be treated.
This will allow the electronic circuit to detect the point where resonance of the tip is without any interference, thus enabling optimum performance.
If this is not done, contact with the part to be treated or with other surfaces before start-up could cause tripping of the protection systems.
Warning：For spray treatment, use only tips through which liquid is passed.
3.4 Protection systems and alarms
The device has a diagnostics circuit that is used to recognize the tripping of the protection system and of the alarms. These are shown
on the display, as follows:
Warn01, Abnormal interior part of handpiece, please make sure it is completely dry or replace a new one.
Warn03, Abnormal cooling fan, please check whether it is spinning or poor-connected.
Warn06, Abnormal output of handpiece, please make sure the handpiece is connected and the Ultrasonic Surgical System tip is tightened.
3.5 Instruction for use
Open the air intake on the drip system; Screw the chosen tip onto the MaxSurgery III handpiece until it is ush against it;
To use the torque wrench correctly (Fig.9) proceed as follow:
① Hold the body of the handpiece rmly;
Warning：Do not grip the end part of the handpiece or the cord, only the plastic casting (Fig.9), and do not turn it while fastening the tip in place;
② Turn the wrench in a clockwise direction until the clutch engages (till making a clicking sound);
③ The tip is now properly tightened in place;
Make sure that the MaxSurgery III handpiece is correctly connected to the handpiece connector.
Check the display to see the type of power that has been set. If the type of power required is different from the type that has been set,
use “B”, ”P”, ”E”, and ”C” on the screen to switch.
Check the display to see the power level that has been set, if the type of power required differs from the level that has been set, touch the
screen for resetting power and water intensity, depending on the type of function that has been set.
3.6 Instruction for the major components of the detachable handpiece
3.6.1 Conical head: detachable, can be periodically removed for cleaning the main rod with alcohol.
3.6.2 Handpiece (with tail wire): the transducer, can be autoclaved.
3.6.3 Tail plug: the joint part between the detachable handpiece and waterway system and the circuit of the main unit.
3.6.4 LED light: Can be autoclaved or cleaned with puried water.
3.7 Instructions for torque wrench
The torque wrench adopts a special structural design, which can reasonably and effectively control the strength of screwing and
unscrewing tips, ensuring users’ better use experience. And it protects users’ hands from being scratched by Ultrasonic Surgical System
tips during screwing and unscrewing.
a) Take out the torque wrench, screw or unscrew the Ultrasonic Surgical System tip as shown in Fig.9
b) Install Ultrasonic Surgical System tip: hold the handpiece tightly, and use the torque wrench to rotate the Ultrasonic Surgical System
tip in the direction shown in Fig.9 until it cannot be rotated anymore, and continue to rotate for another circle, then the Ultrasonic
Surgical System tip is tightly installed.
c) Uninstall Ultrasonic Surgical System tip: hold the handpiece tightly, and use the torque wrench to rotate the Ultrasonic Surgical
System tip in the counterclockwise direction shown in Fig.4 to remove it.
d) After each use, please put the torque wrench in the disinfecting cabinet for disinfection
e) Wait until the torque wrench is cooled down to avoid scalding due to the high temperature on the surface after disinfection.
f) The torque wrench shall be placed in a ventilated and dry place and kept clean when it is not used.
3.8 Rules for keeping the device in proper working order
3.8.1. Check the state of wear of the tips periodically and replace any for which a drop in performance is noted;
3.8.2. Do not deform the shape of the tips by bending or lling them;
3.8.3. Replace any tip that has become deformed or damaged by impacts;
3.8.4. Always make sure that any threaded parts and their contact surfaces are perfectly clean;
3.8.5. If a tip becomes too worn, the device will stop working.
4 Reprocessing instructions of cleaning, disinfecting and sterilizing
4.1 Beginning Work!
4.1.1 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.
4.1.2 To prevent injury to people and damage to property, please heed the corresponding directives.
4.1.3 The instructions in this manual are only applicable to the product which it was delivered with.
4.2 Introduction
4.2.1 These reprocessing instructions provide instructions for cleaning, disinfection, sterilization and packaging of manufacturer reusable
products intended to be reprocessed in medical facilities.
4.2.2 The goal of reprocessing reusable products is to reduce bioburden and to achieve sterility of those products in order to eliminate
the risk of product reuse related infection. Decisions regarding cleaning, disinfecting or sterilizing manufacturer's medical and dental
products are based on the potential risk of infection associated with their use.
4.2.3 It is recommended to use steam sterilization.
4.2.4 Remember that sterilization or high-level disinfection cannot be achieved unless the elements of the assembly are cleaned rst.
4.2.5 If you nd that the reprocessing instructions from the manufacturer seem to be inadequate, please inform manufacturer about those inadequacies.
4.2.6 We encourage you to report adverse events related to device reprocessing. Report such events directly to manufacturer.
4.3 Reprocessing - Instructions for Reusable Products
4.3.1 During use, it is advisable to use a protective lm (or protective cover) to insulate the tail wire and the main unit, so as to reduce the
cleaning possibility. The protective lm (or protective cover) may be damaged and become invalid, which is hard to recognize and easy to
contaminate the instrument once the damage occurs.Therefore, cleaning, disinfection and sterilization shall be carried out for the whole unit.
4.3.2 Before reprocessing, Start the cleaning function -- clean the waterway system.
Warning：Failure to clean the waterway system will cause serious damage to the equipment due to salt crystals.
Warning：The handpiece and the tail wire cannot be detached.
a) Replace the infusion bottle or infusion bag, and the liquid within must be desalted water;
b) Check whether the waterway system is correctly installed;
c) Start the cleaning function (Fig.10)
d) Step on the pedal to start the machine peristaltic pump to ush the inner pipe with water. It is recommended that the continuous
ushing and cleaning time should not be less than 25 seconds;
e) After washing and cleaning, you can switch back to the original mode by touching other mode functions and touching the key;
f) After the cleaning operation is completed, dry the parts after the cleaning cycle.
4.3.3 Handpiece (with tail wire), Ultrasonic Surgical System tip, torque wrench, pump tube, pump tube connector, infusion bag needle,
power cable, pedal switch, and handpiece rack can be obtained by disassembling the device before reprocessing.
Warning：Only the following accessories can be carry out cleaning, disinfection and sterilization procedure.
a) Handpiece (Fig.2-Ref.D) b) Ultrasonic Surgical System tips (Fig.3-Ref.J) c) Ultrasonic Surgical System tip holder (Fig.3-Ref.I)
d) Torque wrench (Fig.2-Ref.C) e) Pump tube (Fig.6) f) Pump tube connector (Fig.2-Ref.E)
Danger：The shell cannot be automatic cleaning, disinfection, sterilization.
The shell’s surface, infusion bag needle, power cable, pedal switch, and handpiece rack canbe clean and disinfect with a damp cloth
containing a mild detergent or a disinfectant with a pH of 7, and air dry after disinfection is allowed.
Warning：Handpiece and tail wire cannot be detached.
03 04 05

Warning：Do not immerse the handpiece in any disinfection liquid, which may cause damage.
Warning：Do not leave the Ultrasonic Surgical System tip tightened on the handpiece during disinfection.
Warning：The power connection between then handpiece plug and the socket must be kept dry.
4.3.4 The instructions are binding for the reprocessing of all reusable products (Here after called "products") of manufacturer. When
necessary, additional product-specic 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.
4.3.5 Reusable products must be cleaned, disinfected and sterilized prior to rst use. Reprocessing procedures have only limited implications to this device.
In case of damage the product should be reprocessed before sending back to the manufacturer for repair.
4.4 Preparation - Basic Principles
4.4.1 It is only possible to carry out effective sterilization after the completion of effective cleaning and disinfection. Please ensure that, as part
of your responsibility for the sterility of products during use, only sufciently validated equipment and product-specic procedures are used for
cleaning/disinfection and sterilization, and that the validated parameters are adhered to during every cycle.
4.4.2 Please also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic.
This applies especially with regard to the additional requirements for the inactivation of prions.
4.5 Preparation at the Point of Use
Disconnect product. Remove gross soiling of the instrument with cold water (<40°C) immediately after use. Don’t use a xating detergent or hot
water (>40°C) as this can cause the xation of residuals which may inuence the result of the reprocessing process.
Store the products in a humid surrounding.
4.6 Transportation
Safe storage and transportation to the reprocessing area to avoid any damage and contamination to the environment.
4.7 Preparation for Decontamination
The products must be reprocessed in a disassembled state, as far as possible.
4.8 Pre-cleaning
Do a manual pre-cleaning, until the products are visually clean. Submerge the products in a cleaning solution and ush the lumens with
a water jet pistol with cold tap water for at least 10 seconds. Clean the surfaces with a soft bristle brush.
4.9 Cleaning
Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and automated reprocessing methods. Preference is to
be given to automated reprocessing methods, especially due to the better standardizing potential and industrial safety.
Automated Cleaning:
Use a washer-disinfector (WD) meeting the requirements of the ISO 15883 series.
Put the instrument into the machine on a tray. Connect the instrument with the WD by using suitable adapter and start the program:
4 min pre-washing with cold water (<40°C);
emptying
5 min washing with a mild alkaline cleaner at 55°C
emptying
3 min neutralising with warm water (>40°C);
emptying
5 min intermediate rinsing with warm water (>40°C)
Emptying
The automated cleaning processes have been validated by using 0.5% neodisher MediClean forte (Dr. Weigert).
Acc. to EN ISO 17664 no manual reprocessing methods are required for these devices. If a manual reprocessing method has to be
used, please validate it prior to use.
4.10 Disinfection
Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A0 value (see EN 15883).
A disinfection cycle of 5 min disinfection at 93°C has been validated for the product to achieve an A0 value of 3000.
4.11 Drying:
Automated Drying:
Drying of outside of instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed
through lint free towel. Insufate cavities of products by using sterile compressed air.
4.12 Packaging
Visual inspection for cleanliness of the products and reassembling if required. Functional testing according to instructions of use. If nec-
essary, perform reprocessing process again until instrument is visibly clean.
Before packaging and autoclaving, make sure that the products have been maintained acc. to manufacturer’s instruction.
4.13 Packaging
Pack the products in an appropriate packaging material for sterilization. The packaging material and system refer to EN ISO 11607.
4.14 Sterilization
Sterilization of products by applying a fractionated pre-vacuum steam sterilization process (according to EN 285/EN 13060/EN ISO
17665) under consideration of the respective country requirements.
Minimum requirements: 3 min at 134 °C (in EU: 5 min at 134 °C)
Maximum sterilization temperature: 138°C
Drying time:
For steam sterilization, we recommend a drying time of 15 to 40 minutes. Choose a suitable drying time, depending on the autoclave
and load. Refer to the autoclave’s instructions for use.
After sterilization:
a. Remove the product from the autoclave.
b. Let the product cool down at room temperature for at least 30 minutes. Do not use additional cooling.
Check that the sterilization wraps or pouches are not damaged.
Flash sterilization is not allowed on lumen instruments.
The manufacturer assumes no responsibility for the use of other sterilization procedures (e.g. ethylene oxide, formaldehyde and low
temperature plasma sterilization). In such cases, please observe the respective valid standards (EN ISO 14937/ANSI AAMl ISO 14937 or
the procedure-specic standard) and verify the suitability and effectiveness in principle of the procedure (if necessary, including investi-
gations on sterilizing agent residue), taking into account the specic product geometry as part of the validation.
4.15 Storage
Storage of sterilized products in a dry, clean and dust free environment at modest temperatures, refer to label and instructions for use.
4.16 Service Life
The products have been designed for a large number of sterilization cycles. The materials used in their manufacture were selected
accordingly. However, with every renewed preparation for use, thermal and chemical stresses will result in aging of the devices. If the
number of permissible re-sterilization cycles is restricted, this will be pointed out in the product specic instructions.
The use of ultrasound baths and strong cleaning and disinfection uids (alkaline pH>9 or acid pH<5) can reduce the life span of de-
vices. The manufacturer accepts no liability in such cases.
The devices may not be exposed to temperatures above 138 °C.
It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel are capable to reach the re-
quired results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly.
5 Transportation, storage, and maintenance
5.1 Transportation
5.1.1. Prevent excessive shock and vibration during transportation, and handle with care.
5.1.2. It should not be mixed with dangerous goods during transportation.
5.1.3. Avoid exposure to sun or rain or snow during transportation.
5.2 Storage
5.2.1. Do not store the machine together with articles that is poisonous, combustible, caustic, or explosive.
5.2.2. This machine should be stored in a room where the relative humidity is 10% - 93%, atmospheric pressure is 70kPa - 106kPa, and
the temperature is-20℃ - +40℃.
5.3 Maintenance
5.3.1. The device should be handled carefully and lightly. Be sure that it is far from the vibration, and installed or kept in a cool, dry, and ventilated place.
5.3.2. When the device is not in use, turn off the power supply and unplug the power plug. If it is not used for a long time, it should be
energized and connected to water and air once a month for ve minutes.
Danger：Always make sure the cable is intact. If it is damaged, please replace it with accessories produced by REFINE.
5.4 Fuse replacement
Danger：Switch off the power.
Always turn off the apparatus by means of the switch, and disconnect it from the power outlet before carrying out the following
maintenance activities.
AB
Fig 11
a) Insert a straight screwdriver into the recess in the fuse compartment below the power socket and use it as a lever (Fig.11-Ref.A);
b) Pull out the fuse compartment (Fig.11-Ref.B);
Danger：Replace the fuses, using fuses of the type indicated on the identication label on the bottom of the apparatus;
c) Put the compartment back into place (Fig.11-Ref.B).
6 Troubleshooting
If the device does not seem to be working properly, read the instruction again and then check the following table:
Problems Possible causes Solutions
The screen of the device
does not display when it’s
switched on.
The connector on the end of the power cable is plugged into
the socket on the rear of the device properly.
Check that the power cable is rmly con-
nected
The power cable is faulty. Check that the power outlet is working
properly. Replace the power cable.
The fuses blew out Replace the fuses.
The device is powered on but
does not work with no error
displayed on the screen.
The connector of the foot foot switch is not properly
plugged into the socket. Insert the foot switch connector properly
The foot switch will not work. Contact the nearest dealer or authorized
REFINE service center
A faint whistle can be heard
coming from the MaxSurgery III
handpiece during operation.
The tip is not correctly tightened onto the handpiece. Unscrew the tip and screw it back into
place correctly.
The device is switched on but
will not work, the message
Warn01 appears on the dis-
play.
The connection joint between the handpiece and tail
wire is not completely dry Dry them completely
Aging handpiece and abnormal parameters Replace a new one
Aging, damage, and deformation of Ultrasonic Surgical System tips Replace a new one
Malfunctioning of the tuning circuit. Contact the nearest dealer or authorized
REFINE service center
The device is switched on but
will not work, the message
Warn03 appears on the dis-
play.
The cooling fan connecting terminal falls off Contact the nearest dealer or authorized
REFINE service center
Aging cooling fan, decreasing parameters
Replace the bag with a full one. Contact
the nearest dealer or authorized REFINE
service center
Short circuit of cooling fan caused by liquid Contact the nearest dealer or authorized
REFINE service center
Abnormal drive circuit of the cooling fan Contact the nearest dealer or authorized
REFINE service center
The device is switched on but
will not work, the message
Warn06 appears on the dis-
play.
The tip is not correctly tightened onto the handpiece Unscrew the tip and screw it back into
place correctly.
The tail wire is not connected to the device Check whether it is well-connected
Aging handpiece, decreasing parameters Replace a new one.
Abnormal ultrasonic circuit of the main unit Contact the nearest dealer or authorized
REFINE service center
No liquid comes out of the tip
during operation.
The tip is of the type with no through-ow of liquid. Use an tip of the type with through-ow of liquid.
The bag of liquid is empty Replace the bag with a full one.
The cover of pump that connected with the water tube is open. Close the cover.
The tubes of the drip system and of the pump have not
been correctly installed. Check the connections of the tubes.
The tip is clogged Free the passage in the tip through
which the water passes.
The handpiece is clogged Contact the nearest dealer or authorized
REFINE service center
Problems Possible causes Solutions
The device is working properly,
but the pump is being forced.
Too much pressure by the impeller on the tube in the
peristaltic pump.
Check whether the tube in the peristaltic
pump has been correctly inserted.
The pump is running correctly
but liquid leaks from the hand-
piece when it stops
The cover of the peristaltic pump is not closed tightly. Make sure that the cover of the peristal-
tic pump is properly closed.
Insufcient power
The tip is not correctly tted to the handpiece (the mes-
sage Warn06 appears on the display).
Unscrew the tip and screw it back into
place correctly.
The tip is worn, broken or deformed (the message
Warn06 appears on the display). Replace a new one
Please contact the nearest dealer or our company if the problems remain unsolved.
7 Environmental Protection
Parts Toxic or harmful substances or elements
Pb Hg Cd Cr6+ PBB PBDE
Main unit ○ ○ ○ ○ ○ ○
handpiece ○ ○ ○ ○ ○ ○
Tip ○ ○ ○ ○ ○ ○
Foot switch ○ ○ ○ ○ ○ ○
Mechanical elements, including
bolts, nuts, washers, etc. ○ ○ ○ ○ ○ ○
○：Indicates that the content of the toxic substance in all homogeneous materials of the part is below the limit
requirement stipulated in SJ/T-11363-2006 Limit Requirements for Toxic and Hazardous Substances in Electronic
Information Products.
X : Indicates that the content of the toxic substance in at least one of the homogeneous materials of the part exceed the
limit requirement specied in SJ/T-11363-2006. (This product meets the RoHS environmental protection requirements of
the European Union; at present, there is no mature technology in the world that can replace or reduce the lead content
in electronic ceramics, optical glass, steel and copper alloys). Please dispose according to the local laws or consult with
dealer from whom you purchased it about waste disposal.
8 Disposal procedures and precautions
Danger：Medical waste
Medical waste is dened according to the following points, please replace it in time:
• Aging or damage of Ultrasonic Surgical System tips. • Infusion tube, after each treatment.
• Pump tube, after 8 sterilization cycles. • Aging or damage of torque wrench.
9 After-sale service
9.1. After the equipment is sold, the manufacturer will be responsible for quality problem according to the warranty card. For specic
items, please refer to the warranty instructions in the warranty card.
9.2. This product does not contain self-maintaining parts. All maintenance, adjustment, calibration, and modication of technical
parameters of the product can only be carried out by the technicians or special repair shops. If the customer needs to repair by himself,
the manufacturer can provide circuit diagrams, component lists, legends, calibration rules, or other information necessary to help
the user's qualied technicians repair the equipment parts designated by the manufacturer, but the manufacturer will not bear the
consequences arising therefrom.
9.3. The user must use the original accessories, please contact your local dealer or the manufacturer to purchase. It is forbidden to use
accessories of other brands to avoid damage to the equipment or other dangers.
9.4. After the handpiece, tips and other accessories are damaged, users should not repair them by themselves. Please purchase new
parts and replace them before use. If you need relevant information, please contact the manufacturer.
9.5. The service life of the product is 10 years. See the packaging label for the production date.
10 EMC-Declaration of conformity
EMC conformity is necessary to ensure the safety of devices and systems because there are electromagnetic phenomena of
various strength levels in the areas where these devices are normally used. This means that in order to ensure electromagnetic
compatibility, the equipment must operate correctly in its intended operating environment. The MaxSurgery III must be installed
and used according to the electromagnetic compatibility information in this manual to ensure specic precautions related to
electromagnetic compatibility.
Notice：
• Users shall install and use according to the electromagnetic compatibility information provided in the accompanying documents.
• Portable and mobile radio frequency communication equipment may affect the performance of MaxSurgery III ultrasonic bone tissue
surgery equipment, and avoid strong electromagnetic interference when using, such as near mobile phones, microwave ovens, etc.
Warning：
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Use of accessories, transducers and cables other than those specied or provided by the manufacturer of this equipment could result
in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Other electrical equipment used in the same room or adjacent rooms, or portable and mobile RF communication equipment such
as mobile phones, walkie talkies, or nearby radio equipment, TV or microwave transmission equipment, may cause the performance
of MaxSurgery III to be reduced. If electromagnetic interference (EMI) affects the normal operation of MaxSurgery III, it may be
necessary to move MaxSurgery III to another place or take corresponding electromagnetic interference suppression measures.
• MaxSurgery III has special precautions for EMC. It needs to be installed and used according to the information provided in the manual.
• The accessories of our company have been tested according to the requirements of YY 0505-2012 standard and conrmed
to meet the Class B radiation standard of Group 1. Please use our original accessories.
• The use of power cord, handpiece tail wire and foot switch connecting wire not designated for the MaxSurgery III may increase its
radiation of it or reduce its anti-interference capability. Please use our original accessories. Specic information is shown in the table below.
10.1 Requirements for cord installation
1）Requirements for the device’s cords
NO Name Length(m) Shielded or not
1Power cord 1.8 No
2Ultrasonic handpiece cord 2.2 No
06 0807

3Foot switch cord 2.0 No
10.2 Key EMC components
The key EMC components of the product are switching power supply, power cord, IC chip. The use or replacement of accessories,
cables, transducers, etc. that are not matched with the design will result in a signicant reduction of EMC emission and immunity
performance. Do not replace machine parts without authorization.
10.3 Guidance and manufacturer’s declaration - electromagnetic emissions
Guidance and manufacturer’s declaration - electromagnetic emissions
The MaxSurgery III is intended to be used in the electromagnetic environment specied below, and the purchaser or user
shall ensure that it is used in these conditions:
Emissions test Compliance Electromagnetic environment – Guidelines
RF emissions GB 4824 Group 1
MaxSurgery III uses RF energy only for its internal functions.
Therefore, its RF emission is very low, and the possibility of
interference with nearby electronic equipment is very small
RF emissions GB 4824 Class B
MaxSurgery III is suitable for use in all facilities, including
household facilities and directly connected to the public
low-voltage power supply network of the household
Harmonic emissions GB 17625.1 Group A
Voltage uctuations/ icker emissions GB/
T 17625.2 Applicable
10.4 Guidance and manufacturer’s declaration - electromagnetic Immunity
Guidance and manufacturer’s declaration - electromagnetic immunity
The MaxSurgery III is intended to be used in the electromagnetic environment specied below, and the purchaser or user
shall ensure that it is used in these conditions:
Immunity Test IEC 60601-1-2 Test level Compliance level Electromagnetic environment
– Guidelines
Electrostatic dis-
charge (ESD)
GB/T 17626.2
±6kV contact
±8 kV air
±6kV contact
±8 kV air
Floors should be wood, con-
crete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
Electrical fast tran-
sient/burst GB/T
17626.4
±2kV power supply lines
±2kV power line
±2kV power line to protective ground (PE)
±1kV pair connecting cable
Mains power quality should
be that of a typical commer-
cial or hospital environment
Surge
GB/T 17626.5
±1 kV line to line
±2 kV line to ground
±1kV differential mode voltage
±2kV common mode voltage
Mains power quality should
be that of a typical commer-
cial or hospital environment
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines GB/T 17626.11
＜5% UT, for 0.5 cycles
(>95% dip in UT)
40% UT, for 5 cycles
(60% dip in UT)
70% UTfor 25 cycles
(30% dip in UT)
＜5% UT, for 5s
(>95% dip in UT)
＜5% UT, for 0.5 cycles
(>95% dip in UT)
40% UT, for 5 cycles
(60% dip in UT)
70% UTfor 25 cycles
(30% dip in UT)
＜5% UT, for 5s
(>95% dip in UT)
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
the MaxSurgery III requires
continued operation during
power mains interruptions,
it is recommended that the
MaxSurgery III be powered
from an uninterruptible
power supply or a battery
Power frequency
magnetic eld
(50/60Hz)
GB/T 17626.8
3A/m 3A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical lo-
cation in a typical commer-
cial or hospital environment
Notice: UTis the a.c. mains voltage prior to application of the test level.
10.5 Guidance and manufacturer’s declaration - electromagnetic Immunity
Guidance and manufacturer’s declaration - electromagnetic immunity
The MaxSurgery III is intended to be used in the electromagnetic environment specied below, and the purchaser or user
shall ensure that it is used in these conditions:
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidances
Conducted RF
GB/T 17626.6
Radiated RF
GB/T 17626.3
3V (effective value)
150 kHz～80 MHz
3V/m
80MHz～2.5GHz
3V
(effective value)
3V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the MaxSugeryIII,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter. Recommended separation
distance = 3V
d=1.2×P1/2 80MHz~800MHz d=2.3×P1/2 800MHz~2.5GHz
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, ashould 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 and 800 MHz. the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and re-
ection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accu-
racy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should
be considered. If the measured eld strength in the location in which MaxSurgery III is used exceeds the applicable RF
compliance level above, the MaxSurgery III should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the MaxSurgery III.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3V/m.
10.6 Recommended separation distances between portable and mobile RF communications equipment and the MaxSurgery III.
Recommended separation distances between portable and mobile RF communications equipment and the MaxSurgery III.
The MaxSurgery III is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the MaxSurgery III can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the MaxSurgery III are recommended below,
according to the maximum output power of the communications equipment
Rated maximum output power
of transmitter (W)
Separation distance according to the frequency of transmitter (m)
150kHz～80MHz
d=1.2×P1/2
80MHz～800MHz
d=1.2×P1/2
800MHz～2.5GHz
d=1.2×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 is applied.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and re-
ection from structures, objects and people.
MaxSurgery III is used in the above-specied electromagnetic environment, which will work safely and provide the basic information described in
Article 7.2
Performance: 1. When Bone, Perio and Endo functions are performed, the working tip on the handle will vibrate and water will ow
out. When Clean functions are performed, the working tip on the handle will not vibrate and only water will ow out; 2. Controllable
operation of foot switch.
The equipment has passed the test according to YY 0505-2012/EN 60601-1-2:2004, which does not guarantee that it will not be affected
by electromagnetic interference in any way. The equipment shall not be used in a harsh electromagnetic environment.
11 Statements
11.1. All equipment and components manufactured by Guilin Rene Medical Instrument Co., Ltd. have been thoroughly inspected and tested.
11.2. During the test, all components withstood a certain working cycle.
11.3. The test emphasizes that any fault is caused by faulty components.
11.4. This step ensures the normal function and reliability of all components.
11.5. The Company reserves the right to modify the product technology, accessories, operation instructions, and product packaging
content at any time without notice,
The pictures are for reference only, and Guilin Rene Medical Instrument Co., Ltd. reserves the right of nal interpretation.
12 Guarantee
12.1. Before being placed on the market, all REFINE equipment undergoes a thorough nal check to ensure that it
is in proper working order.
12.2. REFINE guarantees that all its products can be replaced free of charge during the warranty period due to defects in
production by the seller or importer of new products purchased from REFINE. See the warranty card for warranty details.
12.3. Throughout the warranty period, REFINE undertakes to repair (or, at their sole discretion, to replace) free of
charge any parts that, in their opinion, are faulty. Complete replacement of REFINE products is excluded.
12.4. REFINE cannot accept any liability for direct or incidental damage or personal injury in the following cases:
(1) If the device is used for any purpose beyond the mentioned range of application;
(2) If the user does not use the device according to the procedures and requirements written in the manual.
(3) If the wiring system of the usage scenario does not meet the appropriate standards and requirements.
(4) If any assemble operations, extensions, settings, alterations, or repairs have been carried out by personnel not authorized by REFINE;
(5) If the environmental conditions in which the device is kept and stored do not comply with the requirements indicated in
the chapter on technical specications.
12.5. Accidental damages due to transport, incorrect use, or carelessness or to connect to power supplies other than
as envisaged and damage to the signaling lamps handpiece and all accessories are excluded from the warranty. The
warranty will no longer apply if the apparatus has been tampered with or repaired by unauthorized personnel.
12.6. Warning:
The warranty is valid only if the warranty slip enclosed with the product has been completed in full and returned to us or,
if appropriate, to your REFINE dealer or importer within 20 days from the date of purchase, as proven by the consignment
note/invoice issued by the dealer/importer. In order to benet from the warranty service, the customer must return the
apparatus to be repaired to the REFINE dealer/importer from which it was purchased, at his own expense.
12.7. The apparatus should be returned suitably packed (possibly in its original packing material).
12.8. Accompanied by all the accessories and by the following information:
(1) Owner’s details, including his telephone number;
(2) Details of the dealer/importer;
(3) Photocopy of the consignment note/purchase invoice of the apparatus issued to the owner and indicating, in addition
to the date, also the name of the 30 apparatus and its serial number;
(4) A description of the problem.
12.9. Transport and any damages caused during transport are not covered by the warranty. If the problem is caused by a free
accident or an accident caused by improper use, the repair of Sharp products shall be charged according to the actual cost.
Appendix: Publication of compatibility description and output characteristics of Ultrasonic
Surgical System tips.
Model
speci-
cation
Type of
tips
Working
mode
Power
intensity
Primary tip
vibration
excursion
(μm)
Primary
acoustic
output area
Drive frequency
(kHz)
Derived output
acoustic
power(mW)
Type of
system
frequency
control
Secondary
tip vibration
excursion
(μm)
Power reserve
index
US1 Sharp
Bone
(Bone
cutting)
P1 30±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤4 2.0±1.0
P5 36±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤62.0±1.0
P10 42±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤82.0±1.0
US2 Sharp
Bone
(Bone
cutting)
P1 28±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤4 2.0±1.0
P5 35±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤62.0±1.0
P10 40±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤82.0±1.0
US4 Smoo-
thing
Bone
(Bone
cutting)
P1 26±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤4 2.0±1.0
P5 34±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤62.0±1.0
P10 39±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤82.0±1.0
US5 Smoo-
thing
Bone
(Bone
cutting)
P1 27±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤4 2.0±1.0
P5 35±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤62.0±1.0
P10 42±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤82.0±1.0
UL3 Blunt
Bone
(Bone
cutting)
P1 26±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤4 2.0±1.0
P5 34±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤62.0±1.0
P10 39±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤82.0±1.0
UC1 Smoo-
thing
Bone
(Bone
cutting)
P1 30±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤4 2.0±1.0
P5 37±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤62.0±1.0
P10 43±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤82.0±1.0
UP1 Sharp
Perio
(Perio
Treat-
ment)
P1 28±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤4 2.0±1.0
P5 35±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤62.0±1.0
P10 40±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤82.0±1.0
UE1 Blunt
Endo
(Endo
Treat-
ment)
P1 27±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤4 2.0±1.0
P5 36±10 ＜12mm226.0±3.0kHzkHz 200～600mW Load
independent ≤62.0±1.0
P10 41±10 ＜12mm226.0kHz±3.0kHz 200～600mW Load
independent ≤82.0±1.0
Notice：
(1) Sharp Ultrasonic Surgical System tips
The sharp edges of these tips can be used to treat bone structures efciently and effectively. Sharp tips are used in
osteotomy and osteoplasty when a ne and well-dened cut in the bone structure concerned is required, there are also tips
with sharp edges for osteoplasty techniques and for removing bone fragments.
(2) Smoothing tips
The smoothing tips have surfaces shaped in such a way that they can be used to work the bone structures with precision
and in a controlled manner. Smoothing tips are used in osteotomy when it is necessary to prepare difcult and delicate
structures such as those for preparing a maxillary sinus window or to complete preparation of the site of an implant.
(3) Blunt tips
Blunt tips are used for separating the soft tissues, for example for detaching Schneider’s membrane or for lateralizing
nerves. In periodontology, these tips are used to smooth the root surfaces.
(4) Primary tip vibration excursion: The head of Ultrasonic Surgical System tip shifts in the direction of maximum amplitude on the
peak-to-peck value, and the measuring point is located at the position where the head of the Ultrasonic Surgical System tip is not over 1
mm away from the free end (tail end).
(5) Primary acoustic output area: In the direction of the principal amplitude of tips, and the projected area of the solid part
of the head of the Ultrasonic Surgical System tip.
(6) Drive frequency: the average frequency of drive voltage or current.
(7) Derived output acoustic power: the acoustic power emitted from the head of the Ultrasonic Surgical System tip under
water based on the measurement results of the hydrophone method.
(8) Type of system frequency control: Refer to the percentage change of principal tip amplitude from the max to the min
for systems with modulated electric excitation power.
(9) Power reserve index: The ratio of maximum electric power to static (no-load) electric power.
09 10
The company reserves the right to modify the machine design, product technology or accessories, operating instructions, and machine
packaging content at any time without notice. The product pictures are subject to real objects, and the 󽗉nal interpretation right belongs
to Guilin Re󽗉ne Medical Device Co., Ltd.
No.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin, Guangxi,
541004, P.R. China Tel: [phone] Email:re󽗉ne@re󽗉ne-med.com
Website: http://www.re󽗉ne-med.com
Guilin Re󽗉ne Medical Instrument Co., Ltd.