Dentsply Sirona Endo IQ Manual

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Endo IQ®Accessories
Directions For Use

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Table of contents
Table of contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6 Step by Step Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.1 Accessories compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.2 Package content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3 Using Endo IQ®iPad Stand and Sleeves . . . . . . . . . . . . . . . . . . . . . . . . 8
7 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . . . . . 9
7.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.2 Cleaning Procedure of Endo IQ®iPad Stand . . . . . . . . . . . . . . . . . . . . . 9
7.3 Disinfection procedure for Endo IQ®iPad Stand . . . . . . . . . . . . . . . . . . 10
7.4 Use of Endo IQ®Barrier Sleeves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8 Technical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
9 Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
12 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
13 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Indications for Use
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RX ONLY
Introduction
Dear Customer,
These Directions for Use (DFU) are kept up-to-date by Dentsply Sirona. The most current
version can be accessed at dentsplysirona.com and is also available from Endo IQ®
App. We strongly recommend that you periodically check this website for updates
of this DFU.
The DFU is available in other languages upon request. If a printed version in your
language is not enclosed, Dentsply Sirona will send a free copy to any address in North
America. To order a free copy of the DFU, send a request to
[e-mail].
We would appreciate your feedback. If any errors or discrepancies are noted with the
DFU, the packaging or the accessories, please contact Dentsply Sirona Endodontics
Customer Service.
1 INDICATIONS FOR USE
Endo IQ®iPad stand is an iPad®support designed to facilitate the use of
Dentsply Sirona IQ®devices and to fit all sizes of iPad®.
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for
dental instruments and equipment. Endo IQ®Barrier Sleeve for iPad is non-sterile and
intended for single patient use only.
2 CONTRAINDICATIONS
There are no known contraindications.
Manufactured For:
Dentsply Tulsa Dental Specialties
Dentsply International Inc.
608 Rolling Hills Drive
Johnson City,Tennessee
37604 USA
Phone [phone]
Fax [phone]
[e-mail]
dentsplysirona.com

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Warnings
3 WARNINGS
Read the following warnings before use.
•Endo IQ®Accessories are supplied un-disinfected. You must reprocess the
Endo IQ®iPad stand prior to first use and before each treatment (Follow instructions
given in section 7 Cleaning, Disinfection and Sterilization).
• It is mandatory to reprocess the Endo IQ®iPad stand before shipping it to the
service center (follow instructions given in section 7 Cleaning, Disinfection and
Sterilization).
• Always place Endo IQ®iPad stand on a flat, steady surface during treatment.
• Always ensure a stable positioning of the iPad®on Endo IQ®iPad stand during
treatment or if they must be displaced.
• Do not use an iPad®on Endo IQ®iPad stand with accessories other than the
Endo IQ®Disposable Polyethylene Barrier Sleeve for iPad.
• Protect the Endo IQ®iPad stand with appropriate, clean and dry packaging when
sending it for service.
4 PRECAUTIONS
There are no known precautions to take before use.
5 ADVERSE REACTIONS
There are no known adverse reactions.
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.

Step by Step Instructions
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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®Accessories.
6.1 Accessories compatibility
Specification Description
iPad®
iPad Mini™ 2
iPad Mini™ 3
iPad Mini™ 4
iPad® (6th gen)
iPad Pro®10.5"
iPad®12.9" (2nd gen)
*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..

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Step by Step Instructions
6.2 Package content
List of components
Endo IQ®iPad Stand
DFU
Components not included
iPad with iOS
Operating System
Endo IQ®Disposable
Polyethylene Barrier
Sleeve for iPad and
Unit Numbers (for
separate supply) For iPad Mini™ T 00 IQ00 079 BAR
For iPad®(6th gen) T 00 IQ00 097 BAR
For iPad Pro®10.5" T 00 IQ00 105 BAR
For iPad Pro®12.9" (2nd gen) T 00 IQ00 129 BAR

Step by Step Instructions
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6.3 Using Endo IQ®iPad Stand and Sleeves
Place Endo IQ®iPad Stand on a clean, dry, flat surface. Place the iPad®horizontally on
Endo IQ®iPad Stand. Ensure that the iPad®and the stand are stable.
N° Action
ARemove carefully the accessories from their packaging and place them on a
flat surface.
B
Use the appropriate Endo IQ®Barrier Sleeve for iPad for your iPad®size
and insert your device into that sleeve.
C
Close the sleeve and place your iPad®horizontally onto the Endo IQ®iPad
Stand, ensuring that the lower side of the iPad®is securely inserted into the
mechanical stop of the Endo IQ®iPad Stand.

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Cleaning, Disinfection and Sterilization
7 CLEANING, DISINFECTION AND STERILIZATION
7.1 General
The Endo IQ®iPad stand shall be reprocessed before and after each treatment.
Clean and disinfect the Endo IQ®iPad stand.
7.2 Cleaning Procedure of Endo IQ®iPad Stand
Cleaning is intended to remove all the visible soiling (e.g. organic and inorganic) from the
surface of Endo IQ®iPad Stand so that the subsequent disinfection process can be
efficient.
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.
Use only properly maintained equipment and approved materials according to national
laws and/or regulations.
Do not sterilize.
N° Cleaning steps
AAlways wear protective clothes for your own safety (gloves, mask, glasses
and a waterproof gown) for the reprocessing process.
B
Clean Endo IQ®iPad Stand paying special attention to
grooves of the device. Use a single-use wipe or soft clean cloth lightly
soaked in disinfectant containing Alcohol Quaternary Ammonium active
ingredients (e.g. VoloWipes™ or CaviWipes™ or CaviCide™).
CClean the grooves and device screws by using a clean brush with soft
bristle (e.g. nylon) slightly soaked in cleaning solution.
DContinue steps Band Cuntil no debris appear on the wipe / brush. Replace
the wipe and clean the brush as necessary.

Cleaning, Disinfection and Sterilization
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7.3 Disinfection procedure for Endo IQ®iPad Stand
Disinfection shall be done immediately after cleaning using the following procedure:
7.4 Use of Endo IQ®Barrier Sleeves
The Endo IQ®Disposable Polyethylene Barrier Sleeves are single-use barriers. Remove
and discard the Barrier Sleeve from the iPad®after each patient and replace itwith a new,
unused Sleeve before starting the next treatment. Use of the Endo IQ®Disposable
Polyethylene Barrier Sleeves does not replace cleaning of the iPad®in accordance with
the manufacturer's instructions.
N° Disinfection steps
AAlways wear protective clothes for your own safety (gloves, mask, glasses
and a waterproof gown) for the reprocessing process.
B
Disinfect the surface of Endo IQ®iPad Stand paying special attention to
grooves of the device. Use a single-use wipe or soft clean cloth lightly
soaked in disinfectant containing Alcohol Quaternary Ammonium active
ingredients (e.g. VoloWipes™ or CaviWipes™ or CaviCide™).
CRemove all disinfectant residue. No visible impurities or liquid should remain
on the Endo IQ®iPad Stand after disinfection.
DIf the Endo IQ®iPad Stand 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.
Use only disinfectants with Alcohol Quaternary Ammonium active ingredients
(e.g. VoloWipes™ or CaviWipes™ or CaviCide™).
Use only disinfectants, which are FDA-approved 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.

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Technical Characteristics
8 TECHNICAL CHARACTERISTICS
Specification Description
Manufacturer
Dentsply Tulsa Dental Specialties
Dentsply International Inc.
608 Rolling Hills Drive
Johnson City,Tennessee
37604 USA
Phone [phone]
Fax [phone]
[email protected]
dentsplysirona.com
Model Endo IQ®iPad Stand
Endo IQ®Barrier Sleeve for iPad
Dimensions
Endo IQ®iPad Stand:
Length: 160 mm
Width: 165 mm
Height: 72 mm
Weight iPad stand:
200 g (0.44 lbs)
Material
Endo IQ®iPad Stand:
ABS
Disposable Barrier Sleeve:
LDPE/LLDPE
Ambient conditions
• Use: in enclosed spaces
• Ambient temperature:
15°C - 35°C
(59°F - 95°F)
• Relative humidity:< 80%
Conditions for transport and storage
• Ambient temperature:
-20°C - +50°C
(-4°F - 122°F)
• Relative humidity:
20% - 80%,
• Pressure:
50 kPa - 106 kPa
Not to use or store system in a
flammable environment
Endo IQ®iPad Stand usage lifetime 1 year

Error Codes
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9 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 Stand is covered by a 12-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
Endo IQ®iPad Stand 12 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.
Endo IQ®Barrier Sleeves for iPad are single-use sleeves and must be discarded after
each patient.
13 IDENTIFICATION OF SYMBOLS
Normative Symbols
Symbol Identification
Batch Code
Catalogue number
Consult Instructions for Use
Electronic Instructions for Use (relevant information for use of the product is
available in electronic format from dentsplysirona.com).
Date of manufacture
Temperature limit
Humidity limitation
Keep dry
Do not steam sterilize
Do not re-use
Caution, consult instructions for use
Do not use if package is damaged
Accessory
Open packages are not replaced
Polyethylene
Latex free
xxx C
°
PE
LATEX

TUSIQ00DFUMAS / Rev.2 / 08-2018
dentsplysirona.com
Manufactured For:
Dentsply Tulsa Dental Specialties
Dentsply International Inc.
608 Rolling Hills Drive
Johnson City,Tennessee
37604 USA
Phone [phone]
Fax [phone]
[email protected]
dentsplysirona.com