Medit i500 User manual

Revision 9 (Nov 2020)

CONTENTS
English
中文(简体)
中文(繁體)
Dutch
Français
Deutsch
Italiano
日本語
Português
Polskie
русский
Español
Svenska
한국어
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English

English
1 About this guide
2 Introduction and Overview
2.1 Intended Use
2.2 Indication for Use
2.3 Contraindications
2.4 Quali󽗉cations of the Operating User
2.5 Symbols
2.6 i500 Components Overview
2.7 Setting up the i500 Device
2.7.1 Basic settings of i500 
2.7.2 Placing on Desktop Cradle 
2.7.3 Installation of Wall Mount Holder
3 Image Acquisition Software Overview
3.1 Introduction
3.2 Installation
3.2.1 System Requirements
3.2.2 Installation Guide
4 Maintenance
4.1 Calibration
4.2 Cleaning, Disinfection, Sterilization Procedure
4.2.1 Reusable tip
4.2.2 Disinfection and Sterilization
4.2.3 Mirror
4.2.4 Handpiece
4.2.5 Other Components
4.3 Disposal
4.4 Updates in Image Acquisition Software
5 Safety Guide
5.1 System Basics
5.2 Proper Training
5.3 In Case of Equipment Failure
5.4 Hygiene
5.5 Electrical Safety
5.6 Eye Safety
5.7 Explosion Hazards
5.8 Pacemaker and ICD Interference Risk
6 Electro – Magnetic Compatibility Information
6.1 Electro-Magnetic Emissions
6.2 Elector-Magnetic Immunity
7 Speci󽗉cation
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English

4User Manual 5
Intraoral Scanner i500
1 About this guide
Convention in this guide
This user guide uses various symbols to highlight important information so as to ensure
correct usage, prevent injury to the user and others, and prevent property damage. The
meanings of the symbols used are described below.
The WARNING symbol indicates information that, if ignored, could result in medium risk of
personal injury.
WARNING
The CAUTION symbol indicates safety information that, if ignored, could result in slight risk
of personal injury, property damage or damage to the system.
CAUTION
The TIPS symbol indicates hints, tips and additional information for optimal operation of
the system.
TIPS
2 Introduction and Overview
2.1 Intended Use
The i500 system is a dental 3D scanner intended to be used to digitally record
topographical characteristics of teeth and surrounding tissues. The i500 system produces
3D scans for use in computer-assisted design and manufacturing of dental restorations.
2.2 Indication for Use
The i500 system should be used on patients who require 3D scanning for dental
treatments such as:
The i500 system can also be used in full arch scans but various factors (intraoral
environment, operator's expertise, and laboratory work󽗊ow) may a󽗈ect the 󽗉nal results.
Single custom abutment
Inlays & Onlays
Single Crown
Veneer
3 Unit Implant Bridge
Up to 5 Unit Bridge
Orthodontics
Implant Guide
Diagnosis Model
▪
▪
▪
▪
▪
▪
▪
▪
▪

5
Intraoral Scanner i500
English
2.3 Contraindications
▪ The i500 system is not intended to be used to create images of the internal structure of 
teeth or the supporting skeletal structure.
2.4 Quali󽗉cations of the Operating User
▪ The i500 system is designed for use by individuals with professional knowledge in
dentistry and dental laboratory technology.
▪ The user of i500 system is solely responsible for determining whether or not this 
device is suitable for a particular patient case and circumstances.
▪ The user is solely responsible for the accuracy, completeness and adequacy of all data 
entered into i500 system and the provided software. The user has to check the 
correctness and accuracy of the results and assess each individual case.
▪ The i500 system must be used in accordance with its accompanying user guide.
▪ Improper use or handling of the i500 system will void its warranty, if any. If you require 
additional information on the proper use of the i500 system, please contact your local 
distributor.
▪ The user is not allowed to modify the i500 system.
2.5 Symbols
No Symbol Description
01 The serial number of the object
02 Date of manufacture
03 Manufacturer
04 Caution
05 Warning
06 Instructions for User Manual
07 The o󽗋cial mark of Europe Certi󽗉cate
08 Authorized representative in the European
Community
09 Type of applied part
10 WEEE Mark

6User Manual 7
Intraoral Scanner i500
11 Prescription use (U.S)
12 MET mark
13 AC
14 DC
15 Protective Earth (ground)
2.6 i500 Components Overview
No Item Qty Appearance
01 i500 Handpiece + Power Hub 1ea
02 i500 Handpiece Cover 1ea
03 Reusable Tip 4ea
04 Calibration Tool 1ea
05 Desktop Cradle 1ea
06 Wall Mount Holder 1ea
07 USB 3.0 Cable 1ea
08 Medical Adapter + Power Cord 1set
09 USB Memory (Pre-loaded with
image acquisition software)
1ea
10 User Guide 1ea
2 Introduction and Overview

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2.7.1 Basic settings of i500
①②
③
④
⑤
② Connect Medical Adapter to
the Power Hub
① Connect the USB 3.0
Cable to the Power Hub
2.7 Setting up the i500 Device
③ Connect Power Cord
to the Medical Adapter
④ Connect Power Cord to
a Power Source
⑤ Connect the USB 3.0
Cable to the PC

8User Manual 9
Intraoral Scanner i500
Wait until the USB connection indicator turns
blue
Turn on i500
Press the power button on i500.
Turn o󽗈 i500
Press and hold the power button of i500 for 3 seconds
2.7.2 Placing on Desktop Cradle 2.7.3 Installation of Wall Mount Holder
3 Image Acquisition Software Overview
The image acquisition software provides a user-friendly working interface to digitally
record topographical characteristics of teeth and surrounding tissues using the i500
system.
3.1 Introduction
2 Introduction and Overview

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Intraoral Scanner i500
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3.2.1 System Requirements
3.2 Installation
Minimum System Requirements
Laptop Desktop
CPU
Intel Core i7-8750H/9750H
Intel Core i7-8700K/9700K
AMD Ryzen 7 4800H
RAM 16 GB 16 GB
Graphic Nvidia GeForce GTX 1060 6GB Nvidia GeForce GTX 1060 6GB
OS Window 10 Pro 64-bit
Recommend System Requirements
Laptop Desktop
CPU
Intel Core i7-9850H/10850H
Intel Core i7-9900K/10900K
AMD Ryzen 9 4900H
RAM 32 GB 32 GB
Graphic Nvidia GeForce GTX 2060 8GB Nvidia GeForce GTX 2060 8GB
OS Window 10 Pro 64-bit
Use PC and monitor certi󽗉ed IEC 60950, IEC 55032, IEC 55024
3.2.2 Installation Guide
① Run Medit_iScan_X.X.X.X.exe ② Select the setup language and click “Next”

10 User Manual 11
Intraoral Scanner i500
⑤ It may take up to several minutes to
󽗉nish the installation process. Please 
do not shut down the PC until the 
installation is complete.
⑦ If the scanner is connected, please disconnect the scanner from the PC by removing
the USB cable.
⑥ After the installation is complete, restart 
the PC to ensure optimal program 
operation.
3 Image Acquisition Software Overview
③ Select the installation path ④ Read the “License Agreement” 
carefully before checking “I agree to 
the License ~” and then click Install

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Intraoral Scanner i500
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4 Maintenance
▪
▪
CAUTION
Equipment maintenance should only be carried out by a MEDIT employee or a MEDIT-
certified company or personnel.
In general, users are not required to perform maintenance work on the i500 system 
besides calibration, cleaning and sterilization. Preventive inspections and other regular 
maintenance are not required.
4.1 Calibration
Periodic calibration is required to produce precise 3D models.
You should perform the calibration when:
▪ The quality of the 3D model is not reliable or accurate as compared to the previous 
results.
▪ Environmental conditions such as temperature has changed.
▪ Calibration period has expired.
You can set the calibration period in the Menu > Settings > Calibration Period (Days)
The calibration panel is a delicate component. Do not touch the panel directly.
Check the calibration panel if the calibration process is not performed properly.If
the calibration panel is contaminated, please contact your service provider.
We recommend performing the calibration periodically.
You can set the calibration period via Menu > Settings > Calibration Period (Days).
The default calibration period is 14 days.
How to calibrate i500
▪ Turn on i500 and launch the image acquisition software.
▪ Run Calibration Wizard from Menu > Settings > Calibration
▪ Prepare the Calibration Tool and the i500 handpiece.
▪ Turn the dial of the calibration tool to position
1
.
▪ Put the Handpiece into the calibration tool.
Click “Next” to start the calibration process.
▪ When the calibration tool is mounted properly in the correct position, the system will
automatically acquire the data at position
1.
▪ When data acquisition is complete at position
1
, turn the dial to the next position.
▪ Repeat the steps for positions
2
~
8
and the
LAST
position.
▪ When data acquisition is complete at the
LAST
position, the system will automatically
calculate and show the calibration results.

12 User Manual 13
Intraoral Scanner i500
Clean the tip immediately after use, with soap water and a brush. We recommend
using a mild dishwashing liquid. Make sure the mirror of the tip is completely clean
and stain-free after cleaning. If the mirror appears stained or foggy, repeat the
cleaning process and rinse thoroughly with water. Dry the mirror carefully with a
paper towel.
Disinfect the tip using Wavicide-01 for 45 to 60 minutes. Please refer to the
Wavicide-01 Solution instruction manual for proper use.
After 45 to 60 minutes, remove the tip from the disinfectant and rinse thoroughly. 
Use a sterilized and non-abrasive cloth to gently dry the mirror and the tip.
▪
▪
▪
▪
4.2.2 Disinfection and Sterilization
CAUTION
The mirror found in the tip is a delicate optical component which should be handled
with care to ensure optimal scan quality. Be careful not to scratch or smudge it as any
damage or blemishes may a󽗈ect the data acquired.
Make sure to always wrap the tip before autoclaving. If you autoclave an exposed tip, this
will cause stains on the mirror which cannot be removed. Check the autoclave manual
for more information.
New tips need to be cleaned and sterilized / autoclaved before their 󽗉rst use. 
Scanner tips can be re-sterilized up to 50 times and must thereafter be disposed as
described in the disposal section (4.3).
▪
▪
▪
▪
4 Maintenance
4.2 Cleaning, Disinfection, Sterilization Procedure
4.2.1 Reusable tip
The reusable tip is the part which is inserted into the patient’s mouth during scanning.
The tip is reusable for a limited number of times, but needs to be cleaned and sterilized
between patients to avoid cross-contamination.
The tip should be cleaned manually using disinfecting solution. After cleaning and
disinfection, inspect the mirror inside the tip to ensure that there are no stains or
smudges.
Repeat the cleaning and disinfection process, if necessary.
Carefully dry the mirror using a paper towel.
Insert the tip into a paper sterilization pouch and seal it, making sure that it is
airtight. Use either a self-adhesive or heat-sealed pouch.
Sterilize the wrapped tip in an autoclave with the following conditions:
At 121℃ (249.8°F) for 30 minutes, and 15 minutes drying period
Use an autoclave program that dries the wrapped tip before opening the autoclave.
▪
▪
▪
▪
▪

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Intraoral Scanner i500
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»The number of autoclave is 20 times in Main China and Japan ONLY due to local
approval issue.
Medit will not be responsible for any damage including distortion, blackening etc.
4.2.3 Mirror
The presence of impurities or smudges on the tip mirror may lead to poor scan
quality and an overall poor scanning experience. In such a situation, you should
clean the mirror following the steps below:
4.2.4 Handpiece
Recommended cleaning and disinfecting solution:
After treatment, clean and disinfect all other surfaces of the handpiece except for the
scanner front (optical window) and end (air vent hole).
Cleaning and disinfecting must be done with the device turned o󽗈. Use the device only
after it is completely dry.
CAUTION
Do not clean the handpiece when the device is turned on as the fluid may enter the
scanner and cause malfunction.
Use the device after it is completely dry.
▪
▪
Disconnect the scanner tip from the i500 handpiece.
Pour alcohol on a clean cloth or cotton-tipped swab and wipe the mirror. Make sure to
use alcohol that is free of impurities or it may stain the mirror. You can use either ethanol
or propanol (ethyl-/propyl alcohol).
Wipe the mirror dry using a dry, lint-free cloth.
Make sure the mirror is free of dust and 󽗉bers. Repeat the cleaning process, if necessary.
▪
▪
▪
▪
Turn o󽗈 the device using the power button.
Unplug all the cables from the power hub.
Attach the handpiece cover to the front of the scanner.
Pour the disinfectant onto a soft, lint-free and non abrasive cloth.
Wipe the scanner surface with the cloth
Dry the surface with a clean, dry, lint-free and non-abrasive cloth.
▪
▪
▪
▪
▪
▪
The general cleaning and disinfecting procedure is as follows:
Denatured alcohol (aka. ethyl alcohol or ethanol) – typically 60-70% Alc/Vol.
▪

14 User Manual 15
Intraoral Scanner i500
5 Safety Guide
Please adhere to all the safety procedures as detailed in this user guide to prevent human
injury and equipment damage. This document uses the words WARNING and CAUTION when
highlighting precautionary messages.
Carefully read and understand the guidelines, including all precautionary messages as prefaced
by the words WARNING and CAUTION. To avoid bodily injury or equipment damage, make sure
to adhere strictly to the safety guidelines. All instructions and precautions as specified in the
Safety Guide must be observed to ensure proper functionality of the system and personal safety.
4 Maintenance
Pour the cleaning and disinfecting solution onto a soft, lint-free and non-abrasive cloth. 
Wipe the component surface with the cloth.
Dry the surface with a clean, dry, lint-free and non-abrasive cloth.
▪
▪
▪
4.3 Disposal
4.4 Updates in Image Acquisition Software
Chemical cracks may appear if improper cleaning solution is used during cleaning.
CAUTION
CAUTION
The scanner tip must be sterilized before disposal.
Sterilize the tip as described in section 4.2.1. 
Dispose the scanner tip as you would any other clinical waste.
Other components are designed to conform with the following directives: 
RoHS, Restriction of the Use of Certain Hazardous Substances in Electrical and
Electronic Equipment. (2011/65/EU)
WEEE, Waste Electrical and Electronic Equipment Directive. (2012/19/EU)
▪
▪
▪
▪
▪
The image acquisition software automatically checks for updates when the software is in
operation.
If there is a new version of the software being released, the system will automatically
download it.
4.2.5 Other Components
CAUTION
Chemical cracks may appear if improper cleaning and disinfecting solutions are used
during cleaning.
▪

15
Intraoral Scanner i500
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5.1 System Basics
The USB 3.0 cable connected to the Power Hub is the same as a regular USB cable
connector. However, the device may not operate normally if a regular 3.0 USB cable
is used with i500.
The connector provided with the Power Hub is designed speci󽗉cally for i500 and
should not be used with any other device.
If the product has been stored in a cold environment, give it time to adjust to the
temperature of the environment before use. If used immediately, condensation may
occur which may damage the electronic parts inside the unit.
Ensure that all components provided are free from physical damage. Safety cannot
be guaranteed if there is any physical damage to the unit.
Before using the system, check that there are no issues such as physical damage or
loose parts. If there is any visible damage, do not use the product and contact the
manufacturer or your local representative.
Check the i500 body and its accessories for any sharp edges.
When not in use, i500 should be kept mounted on a desk stand or wall mount stand.
Do not install the desk stand on an inclined surface.
Do not place any object on the i500 body.
Do not place i500 on any heated or wet surface.
Do not block the air vents located at the rear of the i500 system. If the equipment
overheats, the i500 system may malfunction or stop working.
Do not spill any liquid on the i500 device.
Do not pull or bend the cable connected to i500.
Carefully arrange all the cables so that you or your patient do not trip or get caught
in the cables. Any pulling tension on the cables may cause damage to the i500
system.
Always place the power cord of the i500 system in an easily accessible location. 
Always keep an eye on the product and your patient while using the product to
check for abnormalities.
If you drop the i500 tip on the floor, do not attempt to reuse it. Discard the tip
immediately as there is a risk that the mirror attached to the tip may have been
dislodged.
CAUTION
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
The i500 system should only be operated by dental professionals and technicians who are
trained to use the system. Using the i500 system for any purpose other than its intended
usage as outlined in section "2.1 Intended Use" may result in injury or damage to the
equipment. Please handle the i500 system according to the guidelines in the safety guide.

16 User Manual 17
Intraoral Scanner i500
Before using your i500 system on patients:
»Handling and replacing the tip.
For clean working conditions and patient safety, ALWAYS wear clean surgical gloves
when:
▪
5.2 Proper Training
5.3 In Case of Equipment Failure
5.4 Hygiene
WARNING
WARNING
WARNING
You should have been trained to use the system, or you should have read and fully
understood this user guide.
You should be familiar with the safe use of the i500 system as detailed in this user guide.
Before use or after changing any settings, the user should check that the live image is
displayed properly in the camera preview window of the program.
▪
▪
▪
Remove the device from the patient’s mouth and discontinue use immediately.
Disconnect the device from the PC and check for errors.
Contact the manufacturer or authorized resellers.
Modifications to the i500 system are prohibited by law as they may compromise the
safety of the user, patient or a third party.
▪
▪
▪
▪
Due to its fragile nature, i500 tips should be handled with care. To prevent damage
to the tip and its internal mirror, be careful to avoid contact with a patient’s teeth or
restorations.
If i500 is dropped on the floor or if the unit is impacted, it must be calibrated before
use. If the instrument is unable to connect to the software, consult the manufacturer or
authorized resellers.
If the equipment fails to operate normally, such as having issues with accuracy, stop
using the product and contact the manufacturer or authorized resellers.
Install and use only approved programs to ensure proper functionality of the i500
system.
▪
▪
▪
▪
5 Safety Guide
If your i500 system is not working properly, or if you suspect that there is a problem with the
equipment:

17
Intraoral Scanner i500
English
»Disinfect the i500 system
»Use a sterilized tip
»Using the i500 scanner on patients.
»Touching the i500 system.
The i500’s main unit and its optical window should be kept clean at all times.
Before using the i500 scanner on a patient, be sure to:
▪
5.5 Electrical Safety
WARNING
The i500 system is a Class I device.
To prevent electric shock, the i500 system must only be connected to a power source
with a protective earth connection. If you are unable to insert the i500-supplied plug into
the main outlet, contact a quali󽗉ed electrician to replace the plug or outlet. Do not try to
circumvent these safety guidelines.
The i500 system only uses RF energy internally. The amount of RF radiation is low and
does not interfere with surrounding electromagnetic radiation.
There is a risk of electric shock if you attempt to access the inside of the i500 system.
Only quali󽗉ed service personnel should access the system.
Do not connect the i500 system to a regular power strip or extension cord as these
connections are not as safe as grounded outlets. Failure to adhere to these safety
guidelines may result in the following hazards:
The total short circuit current of all connected equipment may exceed the limit speci󽗉ed
in EN / IEC 60601-1.
The impedance of the ground connection may exceed the limit specified in EN / IEC
60601-1.
Do not place liquids such as beverages near the i500 system and avoid spilling any liquid
on the system.
Condensation due to changes in temperature or humidity can cause moisture buildup
inside the i500 unit, which may damage the system. Before connecting the i500 system
to a power supply, be sure to keep the i500 device at room temperature for at least two
hours to prevent condensation. If condensation is visible on the product surface, the i500
should be left at room temperature for more than 8 hours.
You should only disconnect the i500 system from the power supply via its power cord.
The radiation characteristics of the i500 system makes it suitable for use in industry and
hospitals.(CISPR 11 class A). If the i500 system is used in a residential environment (CISPR
11 class B), it may not provide adequate protection from radio frequency communications.
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪

18 User Manual 19
Intraoral Scanner i500
The i500 system is not designed to be used near 󽗊ammable liquids or gases, or in
environments with high oxygen concentrations.
There is a risk of explosion if you use the i500 system near 󽗊ammable anesthetics.
Do not use the i500 system on patients with pacemakers and ICD devices.
Check each manufacturer's instructions for interference by peripheral devices, such
as computers used with the i500 system.
The i500 system projects a bright light from its tip during scanning.
The bright light projected from the tip of the i500 is not harmful to the eyes.
However, you should not look directly at the bright light nor aim the light beam into
the eyes of others. Generally, intense light sources can cause eyes to become brittle,
and the likelihood of secondary exposure is high. As with other intense light sources
exposure, you may experience temporary reduction in visual acuity, pain, discomfort,
or visual impairment, which increases the risk of secondary accidents.
Disclaimer for risks involving patients with epilepsy
The Medit i500 should not be used on patients that have been diagnosed with
epilepsy due the risk of seizures and injury. For the same reason, dental sta󽗈 who
have been diagnosed with epilepsy should not operate Medit i500.
Before disconnecting the power cord, make sure to turn o󽗈 the power on the device
using the power switch on the main unit.
Only use the power adaptor supplied together with the i500. The use of other power
adaptors may result in damage to the system.
Avoid pulling on the communication cables, power cables, etc. used in the i500
system.
5.7 Explosion Hazards
5.8 Pacemaker and ICD Interference Risk
5.6 Eye Safety
WARNING
WARNING
WARNING
▪
▪
▪
▪
▪
▪
▪
▪
▪
5 Safety Guide