Dentsply Sirona Endo IQ Manual

EN
Endo IQ®iPad Mini Protective
Case
Directions For Use

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Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6 Step by Step Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.1 Document Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
6.2 Protective Case compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
6.3 Package content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
6.4 Using Endo IQ®iPad Mini Protective Case . . . . . . . . . . . . . . . . . . . . . . . 9
6.5 Activating the Assistive Touch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . . . . 14
7.1 Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.2 Single use of disposable custom barrier sleeve . . . . . . . . . . . . . . . . . . . 14
7.3 Cleaning procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.4 Disinfection procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8 Technical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
9 Protective Case error codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
12 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
13 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

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Indications for Use
For Dental Use Only
Introduction
These Directions For Use (DFU) are kept current by Dentsply Sirona. The most current
version can be accessed at dentsplysirona.com.
The DFU has been compiled with the utmost care.
Nevertheless, it is not always possible to completely rule out the risk of error, despite all
efforts to do so. Some images in the DFU may vary slightly from the current device. We
would appreciate your feedback in this area. If any errors are noted, please contact
Dentsply Sirona.
1 INDICATIONS FOR USE
The Endo IQ®iPad Mini Protective Case is an accessory designed by Dentsply Sirona to
protect your iPad Mini™ during use. It is also designed to stabilize your iPad Mini™ and
improve visibility of the information displayed by the Endo IQ®App.
To guarantee the safety, intended functionalities and good maintenance of the Endo IQ®
iPad Mini Protective Case, follow the indications given in the present DFU. Keep the DFU
updated as described in the Introduction section. Dentsply Sirona will not accept any
liability if the Endo IQ®iPad Mini Protective Case is used, stored or manipulated outside
of the indications given in the DFU.
2 CONTRAINDICATIONS
There are no known contraindications.
Maillefer Instruments Holding Sàrl
Chemin du Verger 3
CH-1338 Ballaigues
Switzerland
Telephone [phone]
Fax [phone]
[email protected]
dentsplysirona.com

Warnings
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3 WARNINGS
Read the following warnings before use.
•Endo IQ®iPad Mini Protective Case is supplied un-disinfected. You must reprocess
it prior to first use and between patients (Follow instructions given in section
7 Cleaning, Disinfection and Sterilization).
• Dentsply Sirona recommends using the Endo IQ®iPad Mini Protective Case for
your iPad Mini™.
•X-Smart IQ®Handpiece Case can be magnetically attached to the Endo IQ®iPad
Mini Protective Case. The combined devices can fall if subjected to abrupt
movements. Ensure the iPad Mini™ and the accessories are in a stable position
during treatment.
• The Endo IQ®iPad Mini Protective Case and the X-Smart IQ®Handpiece Case
contain permanent magnets. Magnets could affect the normal functioning of
pacemakers, implanted heart defibrillators and hearing aid devices. Do not place the
Endo IQ®iPad Mini Protective Case or the X-Smart IQ®Handpiece Case near
these devices or any other object sensitive to static magnetic fields.
• Do not reprocess the Endo IQ®iPad Mini Protective Case if the protective plugs are
not properly inserted.
• It is mandatory to reprocess the Endo IQ®iPad Mini Protective Case before shipping
it to the service centre (follow instructions given in section 7 Cleaning, Disinfection
and Sterilization).
• Protect the Endo IQ®iPad Mini Protective Case with appropriate packaging when
sending it for service.
iPad Mini™
• The operating conditions and limitations specified by Apple®must be complied with.
• Always check to ensure that the iPad Mini™ has sufficient battery charge before
starting treatment.
Some sections / texts of this DFU are dedicated uniquely to readers from a specific
territory. When this happens the section / text will be clearly identified with a sentence
similar to: For US / EU readers.
If nothing is indicated, the text is applicable to all of the intended territories.

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Precautions
Cleaning, Disinfection and Sterilization
• Never place the Endo IQ®iPad Mini Protective Case in a washer-disinfector,
autoclave or ultrasonic bath.
• If you use a disinfectant in the form of a spray, never spray the accessories directly.
Instead, spray a paper towel with the surface disinfectant or use a pre-moistened
disinfectant towelette (wipe).
• Only use surface disinfectants that are certified by officially recognized institutes that
do not contain chlorine and have been declared aldehyde-free.
• Use only cleaning agents that do not have a protein-binding effect.
Repairs and defects
• Do not use the Endo IQ®iPad Mini Protective Case if you suspect damage or
defects. If a defect should occur, contact Dentsply Sirona (Telephone
[phone] or fax [phone]).
Transport
• Intact devices and defective devices can be transported by land freight or air freight
in the original packaging. The applicable requirements must be met.
4 PRECAUTIONS
There are no known precautions to take before use.
5 ADVERSE REACTIONS
There are no known adverse reactions.
6 STEP BY STEP INSTRUCTIONS
Refer to the section 3 Warnings to verify any special care to exercise before starting to
use the Endo IQ®iPad Mini Protective Case.
Before use check the exact contents of the package. See 6.3 Package content.

Step by Step Instructions
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6.1 Document Symbols
6.2 Protective Case compatibility
The Endo IQ®iPad Mini Protective Case is compatible with iPad Mini™ 2, iPad Mini™ 3
and iPad Mini™ 4.
6.3 Package content
Symbol Identification
Additional information, explanation on operation and
performance.
Suggestion or advice.
See Endo IQ®App User Manual - 6 Step by Step Instructions for information on the
iPad®models that are compatible with the Endo IQ®App.
Apple®, the Apple logo, iPad®, iPad Pro®and iPad Mini™ are trademarks of Apple Inc., registered in the U.S. and
other countries. App Store®is a service mark of Apple Inc.
List of components
Endo IQ®iPad Mini
Protective Case
Endo IQ®iPad Mini
Protective Case
Opener

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Step by Step Instructions
6.4 Using Endo IQ®iPad Mini Protective Case
To correctly use the Endo IQ®iPad Mini Protective Case, place it on a clean, dry, flat
surface, and follow the steps described below.
Accessories* for iPad
Mini™ 2, 3 or 4
(Rubber plugs and
foams).
*These accessories may not be available in all kits
Components not included
iPad with iOS
Operating System.
List of components
Accessories for iPad MiniTM 2 or 3
N° Action
ARemove carefully the Endo IQ®iPad Mini Protective Case from its
packaging and place it on a flat surface.

Step by Step Instructions
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B
According to your iPad Mini™ model, use the suitable kit. Stick the foams of
your kit at the places indicated on the Endo IQ®iPad Mini Protective Case.
C
Enclose and center the iPad Mini™ in the Endo IQ®iPad Mini Protective
Case. Place the corresponding plugs on the camera and the charging port.
N° Action
B
C

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Step by Step Instructions
Pay attention to the iPad Mini™ orientation. In case of error, use the red key
to open the protective case.
D
Separate X-Smart IQ®Handpiece Case from X-Smart IQ®Handpiece
Support.
E
Install the X-Smart IQ®Handpiece Case as a protective case holder.
Place the Endo IQ®iPad Mini Protective Case and holder on a steady
surface. Multiple configurations are possible.
N° Action
D
E
1 2 3

Step by Step Instructions
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6.5 Activating the Assistive Touch
The AssistiveTouch feature replaces the actions of the iPad Mini™ Home button which is
not accessible when in the Endo IQ®iPad Mini Protective Case.
To activate the Assistive Touch.
FActivate the Assistive Touch function on your iPad Mini™ (see following
section).
N° Action
Position 1 has a limited stability. Monitor the device carefully if you choose this
position.
The X-Smart IQ®Handpiece Case is available in X-Smart IQ®Handpiece kit (see
X-Smart IQ®Directions For Use) or you can buy it from your dealer or Dentsply Sirona
Endodontics customer service.
None of the accessories are supplied disinfected or sterilized.
N° Key Action
ASelect Settings.
BSelect General.
CSelect Accessibility.
DSelect Assistive Touch.
ESet Assistive Touch to ON.
A virtual Home key is displayed.

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Step by Step Instructions
To press the Home button with Assistive Touch.
A
Tap on the virtual Home button.
BSelect HOME.
It is also possible to use the 5 fingers to swipe in and to return to the Home
screen.

Cleaning, Disinfection and Sterilization
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7 CLEANING, DISINFECTION AND STERILIZATION
The following parts shall be reprocessed before and after each treatment.
7.1 Foreword
The Endo IQ®iPad Mini Protective Case has not been disinfected when it is delivered.
Please perform the necessary steps before the first treatment.
Always ensure that only validated methods of cleaning and disinfection are used, that
regular maintenance and inspections are performed on the equipment used (disinfector)
and that the validated parameters are maintained in every cycle.
Comply with your national guidelines, standards and requirements for cleaning and
disinfection.
You must consult the special reprocessing X-Smart IQ®Getting Started Guide before
proceeding with cleaning disinfection and sterilization.
Part Reprocessing steps
•Endo IQ®iPad Mini Protective Case. Clean and disinfect.
Do not sterilize.
Dentsply Sirona accepts no liability in the event that these instructions are disregarded
or processes that have not been validated are used to reprocess the accessories.

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Cleaning, Disinfection and Sterilization
7.2 Cleaning procedure
The components of the kit must be cleaned and subjected to a wipe-down with a
disinfection wipe prior to and following each treatment.
Cleaning is intended to remove all the visible soiling (e.g. organic and inorganic) from the
surface of the device and accessories so that the subsequent disinfection process can be
efficient.
7.3 Disinfection procedure
Disinfection shall be done immediately after cleaning using the procedure described
below.
The Endo IQ®iPad Mini Protective Case and the other elements in this kit are not
approved for machine-based cleaning (i.e. Thermal disinfection, washer disinfectors) and
they should not be sterilized.
N° Cleaning steps
AAlways wear protective clothes for you own safety (gloves, mask, glasses
and a waterproof gown) for the reprocessing process.
BAfter any pre-cleaning, lightly soak a paper tissue or soft cloth in a mild,
aldehyde-free disinfection and cleaning solution (bactericidal and fungicidal)
and use it to clean/disinfect the Endo IQ®iPad Mini Protective Case.
Refer to Section 3 Warnings for important information on the reprocessing of the
Protective Case.
For wipe-down disinfection of components proceed as follows.
Please refer to the manufacturer's information on use of the disinfectant.

Cleaning, Disinfection and Sterilization
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N° Action
AAlways wear protective clothes for you own safety (gloves, mask, glasses
and a waterproof gown) for the reprocessing process.
BSeparate X-Smart IQ®case from the Endo IQ®iPad Mini Protective Case.
CDisinfect the surface of Endo IQ®iPad Mini Protective Case paying special
attention to grooves of the device. Use a single-use wipe or soft clean
cloth lightly soaked in disinfectant.
DRemove all disinfectant residue. No visible impurities or liquid should remain
on the Endo IQ®iPad Mini Protective Case after disinfection.
EIf the Endo IQ®iPad Mini Protective Case is not being used immediately
after the reprocessing process, keep it in a safe and clean environment and
follow the instructions for storage and transport.
Dentsply Sirona recommends the use of a disinfectant with Alcohol
Quaternary Ammonium active ingredients (e.g. CaviWipes™ or
CaviCide™).
Do not use CaviCide1™ or CaviWipes1™ on any items shown or listed in
this section.
Use only EPA-registered disinfectants with a tuberculocidal claim. A list of EPA-
registered disinfectants is available at https://www.epa.gov/pesticide-registration/list-b-
epas-registered-tuberculocide-products-effective-against-mycobacterium.
In addition, the disinfectant should be aldehyde-free and compatible with the device
and accessories (see 8 Technical Characteristics).
Leave the disinfectant to act in accordance to manufacturer's instructions. Avoid
leaving the disinfectant in contact with the device surfaces for a time longer than that
recommended by the manufacturer of the disinfectant product. It can result in damage
to the device.
Endo IQ®iPad Mini Protective Case

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Technical Characteristics
8 TECHNICAL CHARACTERISTICS
Specification Description
Manufacturer
Maillefer Instruments Holding Sàrl
Chemin du Verger 3
CH-1338 Ballaigues
Switzerland
Telephone [phone]
Fax [phone]
[email protected]
dentsplysirona.com
Dimensions
Endo IQ®iPad Mini Protective Case:
Length: 212 mm
Width: 143 mm
Height: 13mm
Weight Endo IQ®iPad Mini Protective Case:
174g (0.38 lbs)
Material TPE (thermoplastic elastomer) ABS/
PC Somalac VP290 Glass
Ambient conditions
• Use: in enclosed spaces
• Ambient temperature:
15°C - 35°C
(59°F - 95°F)
• Relative humidity:
• < 80%, non-condensing at
0°C (32°F)
• Operating altitude:
<2000 m (~ 6561ft 8in)
above see level
• Maximum housing temperature
according to IEC 60601-1
Conditions for transport and storage
• Ambient temperature:
-20°C - +50°C
(-4°F - 122°F)
• Relative humidity:
20% - 80%, non-condensing at
> 40°C (104°F)

Protective Case error codes
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9 PROTECTIVE CASE ERROR CODES
N/A
10 TROUBLESHOOTING
N/A
11 WARRANTY
Dentsply Sirona Endodontics offers customers the following product warranty:
• Dentsply Sirona Endodontics guarantees proper manufacturing of the product, the
use of top quality materials, performance of all required tests and compliance with all
applicable relevant laws and regulations relating to the product. The full functionality
of the Endo IQ®iPad Mini Protective Case is covered by a 6-month warranty.
Warranty period begins on the date of equipment purchase. The customer is only
entitled to warranty services within the warranty period and under the condition that
Dentsply Sirona has been informed of the defect within a one-month period from the
date of discovery of the defect.
• This warranty covers only the exchange or repair of individual components or parts
affected by manufacturing defects. The cost for personnel to be dispatched for
purposes of technical assistance from the dealer to the customer, and / or packaging
expenses of the customer will not be covered by Dentsply Sirona. Any customer
claims beyond the realm of repair, such as claims for damages, will not be covered.
This warranty does not include any compensation for direct or indirect personal
injuries or material damage of any kind. The customer will not be entitled to damages
covering downtime of the equipment.
• The warranty does not extend to damage for which evidence can be provided by
Dentsply Sirona that such damage has been caused by negligence on the part of the
user as related to Directions For Use. The warranty explicitly excludes any defects
arising on the basis of:
• damage occurring during transportation to Dentsply Sirona for the purposes of
repair;
• damage occurring through environmental events such as lightning strikes, fire
and / or humidity. This warranty shall automatically become cancelled and void
if the product has been improperly repaired, modified or manipulated in any
manner by the user, by non-authorized persons or by third party personnel.
• Legal claims, such as under product liability law remain unaffected.
Component Warranty period
Protective Case 6 months

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Disposal of the Product
12 DISPOSAL OF THE PRODUCT
Comply with your national and regional regulations, guidelines and requirements for the
disposal of this product.
13 IDENTIFICATION OF SYMBOLS
Normative Symbols
Symbol Identification
Serial number
Batch Code
Catalogue number
Consult Instructions for Use
Manufacturer
Date of manufacture
Opened packages are not replaced
Temperature limit
Humidity limitation
Keep dry
Fragile, handle with care
Accessory
Do not sterilize
Plastic
CE Mark
Caution, consult instructions for use
SN
xxx C
°
P

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dentsplysirona.com
Maillefer Instruments Holding Sàrl
Chemin du Verger 3
CH-1338 Ballaigues
Switzerland
Telephone [phone]
Fax [phone]
[email protected]
dentsplysirona.com