EDGEENDO EdgeApex HP Endodontic Motor Instruction Manual

EDGEENDO EdgeApex HP Endodontic Motor

Product Information

The EDGEAPEX HP is a cordless endo motor designed for use in endodontic treatment. It functions as both an endo motor for preparation and enlargement of root canals and as a device for measuring canal length. The motor features a cordless and portable design, allowing for easy maneuverability during procedures. It also incorporates real-time feedback technology and dynamic torque control for precise and controlled operation.

The EDGEAPEX HP Endodontic Motor comes with a charging base, motor handpiece, and contra angle. Additional accessories included in the box are measuring wire, silicon cover (x2), spray nozzle, o-rings (x2), and disposable sleeves (1 pack).

Product Usage Instructions

1. Before operating the EDGEAPEX HP, it is essential to read the user manual thoroughly.
2. The device is intended for use in hospitals and clinics by licensed professionals only.
3. CAUTION: This device is restricted by US law and should only be sold by or on the order of a licensed professional.
4. Ensure that the device is not placed near a heat source and is operated and stored in a suitable environment.
5. Special precautions regarding electromagnetic compatibility (EMC) must be followed during installation and use. Avoid using the device near fluorescent lamps, radio transmitting devices, remote control devices, handheld and mobile high-frequency communication devices.
6. Always use the original contra angle provided with the device. Using any other contra angle may render the device unusable or cause adverse consequences.
7. Do not make any changes to the device without the manufacturer’s consent, as it may violate safety regulations and harm the patient. The manufacturer will not be liable for any unauthorized device modifications.
8. Use only the original power adapter supplied with the device. Using other power adapters may result in damage to the lithium battery and control circuit.
9. The motor handpiece should not be autoclaved. Instead, wipe its surface with a disinfectant of neutral pH value or ethyl alcohol.
10. Do not press the push cover of the contra angle before it stops rotating, as it may cause damage to the contra angle.
11. Wait for the motor handpiece to stop rotating before removing the contra angle to prevent damage to both the contra angle and the gear inside the motor handpiece.
12. Before starting the motor handpiece, ensure that the file is properly installed and locked in place.
13. Set the torque and speed of the motor handpiece as per the recommended guidelines.

Product introduction

Product description
EDGEAPEX HP is mainly used in Endodontic treatment. It is a cordless endo motor with root canal measurement capability. It can be used as a endo motor for preparation and enlargement of root canals, or device for measuring canal length. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal.

Features:

• a) Efficient brushless motor, low noise, long service life.
• b) Cordless portable endo motor with combined length determination.
• c) 360 degrees rotation of contra angle.
• d) Adopt real-time feedback technology and dynamic torque control, effectively preventing file separation.

Model and specification
EDGEAPEX HP Endodontic Motor Please see section 1.9 & 1.10 for device specification.

Device parts and accessories
The device is composed of charging base, motor handpiece & contra angle. Additional accessories included in the box are: measuring wire, lip hook (×2), file clip (×4), touch probe (×2), power adapter, protective silicon cover (×2), spray nozzle, o-rings (×2), disposable sleeves (1 Pack)

Indications for Use
EDGEAPEX HP Endodontic Motor is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring D the position of the file tip inside the canal.

Intended Use

• The device can be used for preparation and enlargement of root canals, or device for measuring canal length.
• The device must be operated only in hospitals and clinics by
• CAUTION: Federal (US) law restricts this device to sale by or on the order of a licensed professional.

Contraindication

• a) Doctors with a pacemaker are forbidden to use this device.
• b) This device may not be used on patients with cardiac pacemakers (or other electrical equipment) or those warned not to use small appliances (such as Electric razors, hair dryers, etc.).
• c) This device may not be used on hemophilia patients.
• d) Use with caution in patients with heart disease, pregnant women and young children.

Warnings

• Please carefully read this Instruction Manual before first operation.
• This device should be operated by professional and qualified
• Do not directly or indirectly place this device near heat source. Operate and store this device in a suitable environment.
• This device requires special precautions regarding electromagnetic compatibility (EMC) and must be in strict accordance with the EMC information for installation and use. Do not use this equipment especially in the vicinity of fluorescent lamps, radio transmitting devices, remote control devices, handheld and mobile high-frequency communication devices.
• Please use the original contra angle. Otherwise the device will be unusable or cause adverse consequences.
• Please do not make any changes to the device. Any changes may violate safety regulations, causing harm to the patient. The manufacturer will not be liable for any device changes made without the manufacturer’s consent.
• Please use the original power adapter. Other power adapters will result in damage to the lithium battery and control circuit.
• The motor handpiece cannot be autoclaved. Use disinfectant of neutral pH value or ethyl alcohol to wipe its surface.
• Do not press the push cover of contra angle before the contra angle stops rotating. Otherwise the contra angle will be broken.
• Do not remove the contra angle before the motor handpiece stops rotating. Otherwise the contra angle and the gear inside motor handpiece will be broken.
• Please confirm that the file is properly installed and locked in place before starting the motor handpiece.
• Please set torque and speed as per the recommended
• Error in replacing lithium batteries can lead to unacceptable risks, so use the original lithium battery and replace the lithium battery according to the correct steps in the instructions.
• Please remove the battery if the motor handpiece is not likely to be used for some time.
• Wireless charging will generate heat, and the surface temperature of charging base and motor handpiece will rise. It is recommended not to come in contact with the motor handpiece and charging base during wireless charging for more than 10 seconds.

Device safety classification

• Type of operation mode: Continuous operating device
• Type of protection against electric shock: Class II equipment with internal power supply
• Degree of protection against electric shock: B type applied part
• Degree of protection against harmful ingress of water: Ordinary equipment (IPX0)
• Degree of safety application in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide: Equipment cannot be used in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
• Applied part: contra angle, lip hook,file clip,touch probe. 1.8.7 The contact duration of applied part: 1 to 10 minutes.
• The temperature of the surface of applied part may reach 46.6℃.
• Primary technical specifications

Battery

• Lithium battery in motor handpiece: 3.7V /2000mAh
• Power adapter (Model: ADS-6AM-06N 05050/UE08WCP-050100SPA)
  • Input: ~100V-240V 50Hz/60Hz, 0.4A Max
  • Output: 5V 1A
• Torque range: 0.4Ncm-5.0Ncm（4mNm ~ 50mNm）
• Speed range: 100rpm~2500rpm
• Wireless charging
  • Frequency range: 112-205KHz
  • Maximum RF output power of the product: 9.46dBuA/m@3m 1.10
• Environment parameters
  • 1.10.1 Environment temperature: +5℃ ~ +40℃
  • Relative humidity: 30% ~ 75%
  • 1.10.3 Atmospheric pressure: 70kPa ~ 106kPa

Installation

Basic accessories of product

Display Screens
Display Screens for 5 Operation Modes and Standby

• EAL Mode
  This mode is for canal measurement. The motor handpiece does not run in this mode.

• CW Mode
  The motor handpiece rotates forward 360º, clockwise direction.

• CCW Mode
  The motor handpiece rotates counterclockwise direction only. This mode is used to inject calcium hydroxide and other medicant. When this mode is being used, a double-beep sounds continuously.

• SGP Mode
  Safety Glide Path Mode
  F: Forward angle, R: Reverse angle
  The rotation angle is adjustable, but the forward angle must be equal to the reverse angle.

• ATR Mode
  ATR: Adaptive Torque Reverse function.
  Normal continuous forward rotation, when the load of the file is greater than the set torque limit, the file will start to rotate forward & reverse alternately at the set angle.

Torque Display
This appears when the motor is running. Meter shows the torque load on the file.

Canal Measurement Display
This appears when a file is inside the canal and the lip hook is in contact with the patient mouth. Bars in meter show the location of the be enlarged.

The meter numbers 1.0, 2.0, 3.0 and digital numbers 00-16 do not represent the actual length from the apical foramen. It simply indicates the file progression towards the apex. The digital numbers -1 and -2
indicate that the file has reached the apex foramen. Subtract 0.5-1mm
used to estimate the canal’s working length.

Instructions for contra angle

• The contra angle adopts precision gear transmission, and the transmission ratio is 6:1.
• Before the first use and after treatments, please clean and disinfect contra angle with disinfectant of neutral PH value. After disinfection, lubricate it with specific cleaning oil. Finally, sterilize it under high temperature and high pressure (134℃, 2.0bar~2.3bar (0.20MPa~0.23MPa)).
• The contra angle can only be used together with this device. Otherwise the contra angle will be damaged.

Installation and removal of contra angle.

Installation
Align any locating pin of the contra-angle with the positioning slot on the motor handpiece and push the contra-angle horizontally. The three locating pins on the contra-angle are inserted into the three positioning holes on the motor handpiece. A “click” sound indicates that the installation is in place. The contra-angle can be rotated 360° freely.

The contra-angle is free to rotate, adapting to the root canal of different positions, and it is convenient to watch the screen when operating.

Removal
Pull out the contra angle horizontally when the motor handpiece has stopped running.

Warnings:

• a) Before inserting or pulling out the contra angle, please first stop the motor handpiece.
• b) After installation, please check and confirm that the contra angle has been properly installed.

Installation and removal of file

Installation of file
Before starting the device, insert the file into the hole of contra angle head. Hold down the push button on the contra angle and insert the file. Turn the file back and forth until it is lined up with interior latch groove and slips into place. Release the button to lock the file into the contra angle.

Warnings: After inserting the file into contra angle, let go the hand on the push button cover to ensure that the file cannot be taken out. Be careful when inserting files to avoid injury to fingers. Inserting files without holding the push button may damage the chuck of contra angle. Please use files with shanks that meet the ISO standard. (ISO standard: 2.334-2.350 mm)

Removal of file
Press the push button cover. and then directly pull out the file.

Warnings:
Before inserting and pulling out the file, the motor handpiece must be stopped. Be careful when removing files to avoid injury to fingers. Removing files without holding the push button will damage the chuck of contra angle.

Canal measurement functional connection
This is not required if the canal measurement function will not be used.
Connect the measuring wire to the motor handpiece. Line up the measuring wire plug with the notch on the back of the motor and push it all the way in.
Connect the file clip plug into the socket (black) on the measuring wire. Connect the lip hook to the socket (white) on the measuring wire.

Warnings:
Connect the lip hook to the socket (white) on the measuring wire. Otherwise, the function of root canal preparation and root canal length measurement cannot be used together.

Installation and removal of disposable isolation sleeves

Installation
Before each use of the handpiece and after the handpiece is cleaned and disinfected,put on a disposable isolation sleeve. Take the isolation sleeve out of the isolation sleeve box, then insert the isolation sleeve into the motor handpiece from the thin end of the handpiece, and install the isolation sleeve until there is no obvious wrinkle.
around the handpiece surface. After that, clean and disinfect the surface of the handpiece. Refer to Chapter 6.3 for cleaning and disinfection procedures.

Removing
sleeve from the thin end of the handpiece.
Warning: Isolation sleeves are not reusable

Function and operation of product

Button definition and settings

• a. Turn power on
  Press Main button to turn on motor handpiece.

• b. Turn power off Hold down the Setting button “P”, then press Main button to turn off motor handpiece.

• c. Customized program change
  Press Adjusting button “+/-” during standby sate.

• d. Parameter setting
  Press Setting button “P” to cycle through parameters, press Adjusting button “+/-” to change them, then press Main button or wait 5 seconds to confirm.

• e. Preset program selection
  Long press Setting button “P” to enter preset program during standby state, press Adjusting button “+/-” to select file system, press Setting button “P” to entry enter file number selection, press Adjusting button”+/-” to select file number, then press Main button to confirm.

• f. Handpiece functions setting With the motor handpiece turned off, hold down the Setting button “P” and press Main button to enter handpiece functions setting, press Setting button “P” to cycle through settings, press Adjusting button “+””-” to adjust, then press Main button to confirm.

Screen display Terms and definition

Operation instruction

Power on and power off
Starting and stopping of motor handpiece

• a) Under the power off state of motor handpiece, press Main button, and then the motor handpiece will enter Standby interface. The interface displays is as follows:
• b) Under Standby interface, press Main button, and then the motor handpiece will enter Working interface. The interface displays is as follows:
• c) Press the Main button again, and then the motor handpiece returns to Standby interface.
• d) Hold down the Setting button “p”, then press Main button to turn off motor handpiece. In Standby Interface, the motor handpiece would automatically shut down after 3 minutes without any button-pressing operation. The motor handpiece will also automatically shut down when put on charge.

Selecting customized program sequence number
The motor handpiece has 10 memory programs(MO-M9) and 5 preset programs, press Adjusting button “+»*_” to change customized program sequence number during standby state. MO-M9 is a memory program for canal shaping and measurement, every memory program has its own parameters such as Operation mode, speed and torque, all these parameters can be changed.

Parameter setting

Preset program selection

Handpiece functions setting.
With the motor handpiece turned off, hold down the Setting button “p” and press Main button to enter handpiece function settings, press Setting button “P” to cycle through settings, press Adjusting button “+/-” to adiust. then press Main button to confirm.

Protective function of automatic reverse
During operation, if the load value exceeds the preset torque value, the file rotation mode will automatically change to Reverse Mode And the file would return to normal rotation mode when the load is below the preset torque value again.

Cautions:

1. Protective function of automatic reverse is ONLY suitable for CW mode.
2. This function is not available for CCW mode, ATR mode.
3. When the motor handpiece battery indicator indicates a low battery capacity, the low battery capacity is insufficient for the motor handpiece to reach the torque value limit, therefore, the auto-reverse function will not work properly. Please charge it in time.
4. If the motor handpiece is under load all the time, the machine may stop automatically as a result of overheat protection. If it happens, turn off the motor handpiece for a while until the temperature drops.

Motor operation
Please set operation mode, torque and speed as per the recommended specifications of file manufacturer.

Canal measurement operation

Battery Charging
The motor handpiece has built-in rechargeable lithium battery. When charging the battery, leave approximately 10cm around the charging base for easy access to inlet and the power cord.
Insert the power adapter plug into the charging base power socket and confirm that they are correctly connected. Then insert the motor handpiece into the charging base (the motor handpiece needs to be correctly aligned with the charging base in the same direction for charging). When the blue indicator on the charging base flashes, it is charging. When the motor handpiece is fully charged, the blue indicator on the charging base is always on.
After charging, please unplug the power adapter.

Replacing Battery
Replace the battery if it seems to be running out of power sooner than it should. Please use the original lithium battery.

• a) Turn the motor handpiece power off.
• b) Use tweezers etc. to open the rubber cover and then remove the screw.
• c) Remove the battery cover.
• d) Remove the old battery and disconnect the connector.
• e) Connect the new battery and put it in the motor handpiece.
• f) Replace the cover and its screw. It is recommended to contact local distributors or manufacturer to replace the battery.

Oiling of contra angle
Only the original oil injection nozzle can be used for oiling of contra angle. The contra angle needs to be lubricated after cleaning and disinfection, but before sterilization.

1. Firstly, screw the injecting nozzle into jet of oil bottle. (Around 1 to 3 circles)
2. Next, plug the nozzle into the end part of contra angle, and then part.
3. Place the contra-angle upright for 30 minutes for leftover oil to flow out.

Warnings
Motor handpiece cannot be filled with oil.

Cautions

• a: To avoid the contra angle from flying due to pressure, use hand to safely hold the contra angle while lubricating.
• b: Please use the appropriate nozzle suitable for handpiece lubrication.

Troubleshooting

Foreword
For hygiene and sanitary safety purposes, the contra-angle, the lip hook, the file clip,the protective silicon cover and the touch probe must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use, as well as all subsequent uses.

General recommendations

• Use only a disinfecting solution which is approved for its efficacy (VAH/DGHM-listing, CE marking, FDA and Health Canada approval) and in accordance with the DFU of the disinfecting solution manufacturer.
• Do not place the contra-angle in a disinfectant solution or in an ultrasonic bath.
• Do not use chloride detergent materials.
• Do not use bleach or chloride disinfectant materials.
• For your own safety, please wear personal protective equipment (gloves, glasses, mask).
• The user is responsible for the sterility of the product for the first cycle and each further usage as well as for the usage of damaged or dirty instruments where applicable after sterility.
• The water quality has to be convenient to the local regulations especially for the last rinsing step or when using a washer-disinfector.
• To sterilize the endodontic files, refer to the manufacturer’s instructions for use.
• The contra-angle needs to be lubricated after cleaning and disinfection, but before sterilization.

Cleaning and disinfection steps for the motor handpiece, the AC adapter and the base.
Before and after each use, all the objects that were in contact with infectious agents should be cleaned using towels impregnated with a disinfecting and detergent solution (a bactericidal, fungicidal and aldehyde free solution) approved by VAH/DGHM-listing, CE marking, FDA and Health Canada.
Warning: Do not sterilize the motor handpiece, the AC adapter and the base.

Pre-Op processing
Before each use, the handpiece, charger, and base must be cleaned and disinfected. The specific steps are as follows:

Warning: The handpiece, charger, and base cannot be cleaned and disinfected with automatic equipment. Manual cleaning and disinfection is required.

Manual cleaning steps:

1. Take out the handpiece, charger, and base on the workbench.
2. Wet the soft cloth completely with distilled water or deionized water, and then wipe all the surfaces of the components such as the handpiece, charger, base, etc. until the surface of the component is not stained.
3. Wipe the surface of the component with a dry soft nap-free cloth
4. Repeat the above steps at least 3 times.

Note:
Use distilled water or deionized water for cleaning at room temperature.

Manual disinfection steps:

1. Soak the dry soft cloth with 75% alcohol.
2. Wipe all surfaces of headpiece, charger, base and other components with a wet soft cloth for at least 3 minutes.
3. Wipe the surface of the component with a dry soft nap-free cloth.

Note:

• a) The cleaning and disinfection must be performed within 10min before use.
• b) The disinfectant used must be used immediately, no foaming is allowed.
• c) In addition to 75% alcohol, you can use non-residue disinfectants such as Cavicide, but you must respect the concentration, temperature and time specified by the disinfectant manufacturer.
• d) After cleaning and disinfecting the handpiece, you must install a disposable isolation sleeve before use.

Post-Op processing
After each use, clean and disinfect the handpiece, charger, and base within 30 minutes. The specific steps are as follows:
Tools: Nap-free soft cloth, tray

1. Remove the contra-angle from the handpiece, place it in a clean tray, and then remove the disposable isolation sleeve from the handpiece.
2. Soak the nap-free soft cloth with distilled water or deionized water, and then wipe all the surfaces of the components such as the handpiece charger, base, etc. until the surface of the component is not stained.
3. Wet the dry soft cloth with 75% alcohol, and then wipe all surfaces of the handpiece, charger, base and other components for 3 minutes.
4. Put the handpiece, charger, base and other components back into the clean storage area.

Note:

• a) The cleaning and disinfection must be performed within 10min before use.
• b) The disinfectant used must be used immediately, no foaming is allowed.
• c) In addition to 75% alcohol, you can use non-residue disinfectants such as Cavicide, but you must respect the concentration,temperature and time specified by the disinfectant manufacturer.

The cleaning, disinfection and sterilization of contra-angle, lip hook, file clip,protective silicon cover, touch probeare as follow. Unless otherwise stated, they will be hereinafter referred to as “products”.

Warnings: The use of strong detergent and disinfectant (alkaline pH>9 or acid pH <5) will reduce the life span of products. And in such cases, the manufacturer takes no responsibility. The products may not be exposed to temperature above 138°C.

Processing limit
The products have been designed for a large number of sterilization cycles. The materials used in manufacture were selected accordingly. However with every renewed preparation for use, thermal and chemical stresses will result in ageing of the products. The maximum number of sterilizations for products is 250 times.

Initial processing

Processing principles
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 sufficiently validated equipment and product-specific procedures are used for cleaning/disinfection and sterilization, and that the validated parameters are adhered to during every cycle. Please also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic, especially with regard to the additional requirements for the inactivation of prions.

Post-operative treatment
The post-operative treatment must be carried out immediately, no later than 30 minutes after the completion of the operation. The steps are as follows:

1. Remove the products from the base, and rinse away the dirt on the surface of handpiece with pure water (or distilled water/deionized water);
2. Dry the products with a clean, soft cloth and place it in a clean tray.

Notes:
The water used here must be pure water, distilled water or deionized water.

Preparation before cleaning Steps:
Tools: tray, soft brush, clean and dry soft cloth.

1. Remove the shanks/files.
2. Remove the file clip, isolation sleeve,Contra-angle and connecting wire from the handpiece in sequence, and then put them into a clean tray;
3. Use a clean soft brush to carefully brush lip hook, file clip,protective silicon cover,touch probe, head and back cover of the contra-angle until the dirt on surface is not visible. Then use soft cloth to dry the products and put them into a clean tray. The cleaning agent can be pure water, distilled water or deionized water.

• a) Press the push-button and pull out the shank/file.
• b) When removing the protective silicon cover, pull it straight out slowly.
• c) When inserting and removing the contra-angle, turn thehandpiece power off beforehand.

Cleaning

The cleaning should be performed no later than 24 hours after the operation. The cleaning can be divided into automated cleaning and manual cleaning. Automated cleaning is preferred if conditions permit.

Automated cleaning

• The cleaning device is proved to be valid by CE certification in accordance with EN ISO 15883.
• There should be a flushing connector connected to the inner cavity of the product.
• The cleaning procedure is suitable for the product, and the irrigating period is sufficient. It is recommended to use a washer-disinfector in accordance with EN ISO 15883. For the specific procedure, please refer to the automated disinfection section in the next section “Disinfection”.

Notes:

• a) The cleaning agent does not have to be pure water. It can be distilled water, deionized water or multi-enzyme. But please ensure that the selected cleaning agent is compatible with the product.
• b) In washing stage, the water temperature should not exceed 45 °C, otherwise the protein will solidify and it would be difficult to remove.
• c) After cleaning, the chemical residue should be less than 10mg / L. 6.4.4 Disinfection Disinfection must be performed no later than 2 hours after the cleaning phase. Automated disinfection is preferred if conditions permit.

Automated disinfection-Washer-disinfector

• The washer-disinfector is proved to be valid by CE certification in accordance with EN ISO 15883.
• Use high temperature disinfection function. The temperature does not exceed 134 ° C, and the disinfection under the temperature cannot exceed 20 minutes.
• The disinfection cycle is in accordance with the disinfection cycle in EN ISO 15883

Cleaning and disinfecting steps by using Washer-disinfector

1. Carefully place the product into the disinfection basket. Fixation of product is needed only when the product is able to move in the device. The products are not allowed to contact each other.
2. Use a suitable rinsing adaptor, and connect the internal water lines to the rinsing connection of the washer-disinfector.
3. Start the program.
4. After the program is finished, remove the product from the washer- disinfector, inspect (refer to section “Inspection and Maintenance”) and package (refer to chapter “Packaging”). Dry the product repeatedly if necessary (refer to section “Drying”).

Notes:

• a) Before use, you must carefully read the operating instructions provided by the equipment manufacturer to familiarize yourself with the disinfection process and precautions.

• b With this equipment. cleaning. disinfection and drving will be carried out together.

• c) Cleaning: (c1) The cleaning procedure should be suitable for the product to be treated. The flushing period should be sufficient (5-10 minutes). Pre-wash for 3 minutes, wash for another 5 minutes, and rinse it for twice with each rinse lasting for 1 minute. (c2) In the washing stage, the water temperature should not exceed 45 °C, otherwise the protein will solidify and it is difficult to remove. (c3) The solution used can be pure water, distilled water, deionized water or multi-enzyme solution, etc., and only freshly prepared solutions can be used. (c4) During the use of cleaner, the concentration and time provided by manufacturer shall be obeyed. The used cleaner is neodisher MediZym (Dr. Weigert).

• d) Disinfection:
  For disinfection, the temperature is 93 ° C, the time is 5 min, and A0>3000

• e) Only distilled or deionized water with a small amount of microorganisms (<10 cfu/ml) can be used for all rinsing steps. (For example, pure water that is in accordance with the European Pharmacopoeia or the United States Pharmacopoeia).

• f) After cleaning, the chemical residue should be less than 10mg / L.

• g) The air used for drying must be filtered by HEPA.

• h) Regularly repair and inspect the disinfector.

Drying
If your cleaning and disinfection process does not have an automatic drving function. dry it after cleaning and disinfection.

Methods:

1. Spread a clean white paper (white cloth) on the flat table, point the product against the white paper (white cloth), and then dry the product with filtered dry compressed air (maximum pressure 3 bar). When no further liquid is sprayed onto the white paper (white cloth), the product drying is completed.
2. It can also be dried directly in a medical drying cabinet (or oven). The recommended drying temperature is 80°C~120°C and the time should be 15-40 minutes.

Notes:

• a) The drying of product must be performed in a clean place.
• b) The drying temperature should not exceed 138 °C;
• c) The equipment used should be inspected and maintained regularly.

Inspection and maintenance

Inspection
In this chapter, we only check the appearance of the product. 1.

1. Check the product. If there is still visible stain on the product after cleaning/disinfection, the entire cleaning/disinfection process must be repeated.
2. Check the product. If it is obviously damaged, smashed, detached, corroded or bent, it must be scrapped and not allowed to continue to be used.
3. Check the product. If the accessories are found to be damaged, please replace them before use. And the new accessories for replacement must be cleaned, disinfected and dried.
4. If the service time (number of times) of the product reaches the specified service life (number of times), please replace it in time.

Maintenance
Sterilizable Oil lubrication shall be applied to dried contra angle. The nozzle of cleaning lubricant is to be aligned with the air intake hole at the end of the contra angle to inject oil for 1-2 seconds.

Packaging Install the disinfected and dried product and quickly package it in a medical sterilization bag (FDA cleared wrap or pouch).

Notes:

• a) The package used conforms to ISO 11607;
• b) It can withstand high temperature of 138 °C and has sufficient steam permeability;
• c) The packaging environment and related tools must be cleaned regularly to ensure cleanliness and prevent the introduction of contaminants; d) Avoid contact with parts of different metals when packaging.

Sterilization
Use only the following steam sterilization procedures (fractional pre- vacuum procedure*) for sterilization, and other sterilization procedures are prohibited:
The steam sterilizer complies with EN13060 or is certified according to EN 285 to comply with EN ISO 17665 or is cleared by FDA; The validated sterilization cycle is one (1) fraction cycle, three (3) consecutive half cycle and one (1) full cycle. The parameters are provid- ed in the table below.

PreVac

|

– 80 kPa

|

(132-134) °C

| Fraction| 30 seconds| 20 minutes
Half 1| 2 minutes| 20 minutes
Half 2| 2 minutes| 20 minutes
Half 3| 2 minutes| 20 minutes
Full| 4 minutes| 20 minutes

Verification of the fundamental suitability of the products for effective steam sterilization was provided by a verified testing laboratory.

Notes:

• a) Only products that have been effectively cleaned and disinfected are allowed to be sterilized;
• b) Before using the sterilizer for sterilization, read the Instruction Manual provided by the equipment manufacturer and follow the instructions.
• c) Do not use hot air sterilization and radiation sterilization as this may result in damage to the product;
• d) Please use the recommended sterilization procedures for sterilization. It is not recommended to sterilize with other sterilization procedures such as ethylene oxide, formaldehyde and low temperature plasma sterilization. The manufacturer assumes no responsibility for the procedures that have not been recommended. If you use the sterilization procedures that have not been recommended, please adhere to related effective standards and verify the suitability and effectiveness.
  Note: Fractional pre-vacuum procedure = steam sterilization with repetitive pre-vacuum. The procedure used here is to perform steam sterilization through three pre-vacuums. 6.4.9

Storage

1. Store in a clean, dry, ventilated, non-corrosive atmosphere with a relative humidity of 10% to 93%, an atmospheric pressure of 70KPa to 106KPa, and a temperature of -20 °C to +55 °C;
2. After sterilization, the product should be packaged in a medical sterilization bag or a clean sealing container, and stored in a special storage cabinet. The storage time should not exceed 7 days. If it is exceeded, it should be reprocessed before use.

Notes:

• a) The storage environment should be clean and must be disinfected regularly;
• b) Product storage must be batched and marked and recorded.

Transportation

1. Prevent excessive shock and vibration during transportation, and handle with care;
2. It should not be mixed with dangerous goods during transportation.
3. Avoid exposure to sun or rain or snow during transportation.

Storage, maintenance and transportation

Storage

• This equipment should be stored in a room where the relative humidity is 10% ~ 93%, atmospheric pressure is 70kPa to106kPa, and the temperature is -20°C ~ +55°C.
• Avoid the storage in a too hot condition. High temperature will shorten the life of electronic components, damage battery, reshape or melt some plastic.
• Avoid the storage in a too cold condition. Otherwise, when the temperature of the equipment increases to a normal level, there will be dew that will possibly damage PCB board.

Maintenance

• This device does not include tools for repair, the repair should be carried out by authorized person or authorized after-service center.
• Keep the equipment in a dry storage condition.
• Do not throw, beat or shock the equipment.
• Do not smear the equipment with pigments.
• Calibration is recommended when using a new/other contra angle or after an extend period of operation, as the running properties can change with usage, cleaning and sterilization.
• Replace the battery if it seems to be running out of power sooner than it should.

Transportation

• Excessive impact and shake should be prevented in transportation. Lay it carefully and lightly and don’t invert it.
• Don’t put it together with dangerous goods during transportation.
• Keep out of direct sunlight and avoid getting wet in rain and snow during transportation.

Environmental protection
Please  dispose according to the local laws.

After service
These products are designed for use in a dental office and this warranty is not applicable to other uses. The products are warranted against manufacturing defects in materials and workmanship for the following periods:

• Base, motor handpiece, power adapter: 2 years
• Contra-angle: one year
• Other spare parts: 6 months

Edge Endo will repair or replace products at its sole discretion. This warranty shall be limited to replacement or repair of the prod-ucts or their parts and shall not extend to any other claims, including but not limited to loss of profit, cost of removal or replacement, incidental or consequential damages or other similar claims arising from use of this product. Damage to products resulting from acts of God, faulty installation, misuse, tampering, accident, abuse, negli-gence, alterations, unauthorized repairs or problems unrelated to materials and workmanship are not covered by this warranty.

Symbol instruction

Statement
All rights of modifying the product are reserved to the manufacturer without further notice. The pictures are only for reference.

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 that this device will not be effected by electromagnetic interference Avoid using the device in high electromagnetic environment.

Technical Description Concerning Electromagnetic Emission
Table 1: Declaration – electromagnetic emissions

Guidance and manufacturer’s declaration – electromagnetic emissions

The model EDGEAPEX HP is intended for use in the electromagnetic environment specified below. The customer or the user of the model EDGEAPEX HP should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment – guidance

RF emissions CISPR 11

|

Group 1

| The model EDGEAPEX HP energy only for its internal function. Therefore,

its RF emissions are very low and are not likely to cause any interference in

nearby electronic equipment.

RF emissions CISPR11| Class B| The model EDGEAPEX HP is suitable for used in all establishments, including domestic establishments and those directly connected to the public

low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions lEC 61000-3-2| Class A

emissions

lEC 61000-3-3

|

Complies

Technical Description Concerning Electromagnetic Immunity
Table 2: Guidance & Declaration – electromagnetic immunity

Guidance & Declaration — electromagnetic immunity

The model EDGEAPEX HP is intended for use in the electromagnetic environment specified below. The customer or the user of the model EDGEAPEX HP should assure that it is used in such an environment.
Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD)

lEC 61000-4-2

| ±8kV contact

±2, ±4, ±8, ±15kV

air

| ±8kV contact

±2, ±4, ±8, ±15kV air

| Floors should be wood, concrete

covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4| ±2kV for power supply lines

±1kV for Input/

output lines

| ±2kV for power supply lines| Mains power quality should be that of a typical commercial or hospital environment.
Surge

lEC 61000-4-5

| ±0.5, ±1kV line to line

±0.5, ±1, ±2kV line

to earth

| ±0.5, ±1kV line to line

±0.5, ±1, ±2kV line to earth

| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| <5 % UT

(>95% dip in UT.) for 0.5 cycle

<5 % UT

(>95% dip in UT.) for 1 cycle

70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95 % dip in UT) for 250 cycles

| <5 % UT

(>95% dip in UT.) for 0.5 cycle

<5 % UT

(>95% dip in UT.) for 1 cycle

70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95 % dip in UT) for 250 cycles

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the models EEDGEAPEX HP requires continued operation during power mains interruptions, it is recommended that the models EDGEAPEX HP be powered from an uninterruptible power supply or a battery.
---|---|---|---
Power frequency (50/60 Hz)

lEC 61000-4-8

| 30A/m| 30A/m| ****

should be at levels characteristic of a typical location in a

typical commercial or hospital

environment.

NOTE            UT is the a.c. mains voltage prior to application of the test level.

Table 3: Guidance & Declaration – electromagnetic immunity concerning Conducted RF & Radiated RF

Guidance & Declaration – Electromagnetic immunity

The model EDGEAPEX HP is intended for use in the electromagnetic environment specified below.The

customer or the user of the model EDGEAPEX HP 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

Conducted RF lEC 61000-4-6

Radiated RF lEC 61000-4-3

| ****

3 Vrms

150 kHz to 80 MHz

6 Vrms

ISM frequency band

3 V/m

80 MHz to 2.7 GHz

| ****

3V

6V

3V/m

| Portable and mobile RF communications equipment should be used no closer to any part of the models EDGEAPEX HP, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmit- ter.Recommended separation distance d=1.2×P1/2

d=2×P1/2

d=1.2×P1/2 80 MHz to 800 MHz

d=2.3×P1/2 800 MHz to 2.7 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).

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 I 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. a Field 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 be considered. If the measured field strength in the location in which the model EDGEAPEX HP is used exceeds the applicable RF compliance level above, the model EDGEAPEX HP should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the model EDGEAPEX HP. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 4: Recommended separation distances between portable and mobile
RF communications equipment and the model EDGEAPEX HP

Recommended separation distances between

portable and mobile RF communications equipment and the model EDGEAPEX HP

The model EDGEAPEX HP is intended for use in electromagnetic environment in which radiated RF

disturbances is controlled. The customer or the user of the model EDGEAPEX HP can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model EDGEAPEX HP as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power

of transmitter W

| Separation distance according to frequency of transmitter m
150kHz to 80MHz d=1.2×P1/2| 80MHz to 800MHz d=1.2×P1/2| 800MHz to 2,7GHz 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 I At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies.

Endodontic Motor Troubleshooting
This guide is suitable for the users who use Endodontic Motor for the first time, and those who get unstable readout because of improper operation.

contact
Measuring wire| Measuring wire broken or poor contact Poor contact between measuring wire and socket
Root canal problem| Endo     is too small for a large root canal The root canal is rinsed by pure water

Root canal is blocked by dentin chippings or residual pulp

Root canal is blocked by gum

Root canal is too dry

Metal prosthesis| Metal prosthesis
Lip hook| Poor contact between lip hook and measuring wire socket
The screen displays that endo     reaches apical foramen before the endo

actually does

| Endo| Endo     hasn’t actually got into root canal
Metal prosthesis| Flush       touches the metal prosthesis of dental crown

Endo     touches metal prosthesis

Dental crown problem| Blood oozes out to dental crown Dental crown is broken or gum hyperplasia
Pulp cavity problem| Root canal is cracked

There are residue, metal residue or debri in pulp cavity

Perforation| Endodontic perforation
Cavity problem| Proximal caries
Handing method shows that endo

reaches apical foramen, but apex locator

shows it hasn’t

| File clip| Poor contact in     clip wire
Root canal problem| The root canal is rinsed by pure water Root canal is too dry

There’s ledge in root canal(without X ray  There are gums and dental debris

Solutions

Replace the     clip
Replace the measuring wire

Make sure of proper contact between socket and measuring wire

Use the endo     with larger diameter Rinse root canal with saline solution

Remove the dentin chippings or residual pulp

Remove the gum

Moist the root canal with saline solution.

Avoid endo     touching metal prosthesis
Reconnect the lip hook or replace lip hook
Keep pushing endo      near to apical foramen, screen display will become normal
Reduce                avoid contacting metal prosthesis

Avoid endo     touching metal prosthesis

Completely stop bleeding and clean the blood

Insulate the endo     and dental crown with insulator or cut off the gum hyperplasia

Combine X-ray      to get the length Remove residue, metal residue and debris
Repair perforation
Clean necrotic tissue of the proximal caries, if it’s the same with adjacent dental surface and periodontium, temporarily    the adjacent surface
Replace     clip
Rinse root canal with saline solution Moist the root canal with saline solution

With help of X ray  avoid touching ledge with endo Remove the gutta-percha or debris and moist the root canal

EdgeApex HP statement regarding reciprocating function:
This EdgeApex HP features a new ATR mode that enables torque-based reciprocation. If the file torque is less than the set trigger torque value, the file will keep rotating in the cutting direction. When the file torque is more than the set trigger torque value, the file will automatically reciprocate in the non-cutting and cutting directions repeatedly at the set angles. Furthermore, ATR Mode can operate files for which the cutting direc- tion is counterclockwise [EdgeOne Fire] as well as normal files for which the cutting direction is clockwise. (The cutting direction of the file is designated in the name of the ATR mode i.e. CW-ATR/CCW-ATR.)

The EdgeApex HP comes pre-programmed with 5 preset systems:

• EdgeFile X7 Basic
• EdgeFile X7 Advanced
• EdgeTaper Basic S1 & SX & S2
• EdgeTaper Basic F1-F5
• EdgeTaper Platinum Basic S1 & SX & S2
  A long press on “P” in any of the pre-programmed presets will open access to the full program of preset files as listed in the chart below. Use “+”/”-“ to highlight the desired file system and “P” to select and the Main on/off button to confirm.

EdgeApex HP Preset Systems:

EdgeFile X7 Basic| EdgeFile X7 Advanced|
EdgeTaper Basic| EdgeTaper Plat Basic| EdgeTaper Plat Adv
EdgeSequel Sapphire| EdgeOne Fire (use same for EdgeOne Platinum)|
Match Protaper| Match Pathfile| Match Mtwo
Match K3| Match TF| Match Revo-S
Match One Flare| Match One G| Match Hero Gold
Match One Curve| Match 2Shape| Match Hero Shaper
Match R-Endo| Match iRace|

Settings for other EdgeEndo systems:
You can utilize the open program slots M0-M9 to customize and save as your favorites. The below chart details the recommended settings for customizing program slots M0-M9 for our given file systems.
Use the CW mode and adjust to the following ROTARY settings:

Torque Limit listed is specific to this handpiece:

EdgeFile X3, X5 and XR, EdgeEvolve| 300-500 RPM, Torque Limit 2.9 N-cm
EdgeGlidePath| 300-500 RPM, Torque Limit 2.0 N-cm
EdgeTaper Retreat| 350 RPM, Torque Limit 3.0 N-cm
EdgeTaper Encore Platinum, EdgeV-Taper HT| 300-400 RPM, Torque Limit 4.0 N-cm
EdgeMorphology| 500 RPM, Torque Limit 1.5 N-cm
EdgeGates| 800-1200 RPM
EdgeFind| 300-500 RPM, Torque Limit 4.5 N-cm

Use the CCW-ATR mode and adjust to the following RECIPROCATING settings, each with Forward Angle 30°, Reverse Angle 150°, Trigger Torque listed is specific to this handpiece:

EdgeEndo, LLC 5600 Wyoming Blvd. NE, Suite 100 Albuquerque, NM 87109 1-855-985-3636 • EdgeEndo.com

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