mininavident DENACAM User manual

USER MANUAL
VERSION 2.5

CONTACT INFORMATION
DENACAM System | User Manual | REF M1000-1001 I Version 2.52
CONTACT INFORMATION
Manufacturer’s address
mininavident AG
Gerberstrasse 5
4410 Liestal
Switzerland
www.mininavident.com
[email protected]
EC representative
Axxos GmbH
Im Sägenloh 3
78333 Stockach
Germany
Authorized service partners
mininavident’s authorized service partners cover all
service needs for the entire system life cycle.
To find your local authorized service partner visit our
website:
www.mininavident.com/servicepartner
Ordering components
Only use original accessories and spare parts. Order
DENACAM components from an authorized mininavident
service partner.
For order information, see "Reference numbers" on page 106
FAQ
www.mininavident.com/faq
INTENDED USE OF THE DENACAM
SYSTEM
The DENACAM navigation system is a real-time
computerized navigational system intended to provide
assistance in the intra-operative surgical phases of dental
implantation surgery.
The system provides precise navigational guidance of
surgical instruments according to the preoperative
planning in the dental implantation procedure.
Patient population
Partially edentulous patients who require dental implants
as part of their treatment plan.
Intended user
Oral surgeons, cranio maxillofacial surgeons, and general
practitioners with knowledge of dental implant surgery
and preoperative planning software, who understand
written and spoken English, and who have successfully
completed training on the DENACAM System.
Anatomical location
Complete upper and lower jaw, depending on the
individual mouth opening and the placement and line of
sight of the marker.
Intended medical indication
All dental implantations are indications for using this
navigation system.

INTENDED USE OF THE DENACAM SYSTEM
DENACAM System | User Manual | REF M1000-1001 I Version 2.5 3
Intended medical contraindication
All contraindications for dental implants apply as well as
a contraindication for this navigation system.
Dental implants contraindications
General:
Serious internal medical problems, bone metabolism
disturbances, uncontrolled bleeding disorders,
inadequate wound healing capacity, poor oral hygiene,
maxillary and mandibular growth not completed, poor
general state of health, uncooperative, unmotivated
patient, drug or alcohol abuse, psychoses, prolonged
therapy-resistant functional disorders, xerostomia,
weakened immune system, illness requiring periodic use
of steroids, titanium allergy, uncontrollable endocrine
disorders.
Relative contraindications:
Previously irritated bone, diabetes mellitus,
anticoagulation drugs/hemorrhagic diatheses, bruxism,
parafunctional habits, unfavorable anatomic bone
conditions, tobacco abuse, uncontrolled periodontitis,
temporomandibular joint disorders, treatable pathologic
diseases of the jaw and changes in the oral mucosa,
pregnancy, inadequate oral hygiene.
Local contraindications:
Inadequate bone volume or quality, local root remnants.
Navigation system contraindications
Heavy artefacts in region of marker, preventing
unambiguous detection.
Electromagnetic compatibility (EMC)
The DENACAM System is a medical device that requires
special safety precautions and must be installed and
placed in operation in accordance with the attached EMC
information.
mininavident only guarantees compliance of the
DENACAM System with the EMC directives when it is
used with original spare parts, consumables, and
accessories. The use of spare parts, consumables, and
accessories that have not been approved by mininavident
may lead to increased emission of electromagnetic
interference or to reduced resistance to electromagnetic
interference.
For more information about the EMC manufacturer’s declaration,
see "EMC manufacturer’s declaration for the DENACAM System" on
page 114

NOTES ON THE USER MANUAL
DENACAM System | User Manual | REF M1000-1001 I Version 2.54
NOTES ON THE USER MANUAL
General information on the User Manual
Table 1 Revision history
Publication version Software version Revision date Change description
1.0 1.0.0 August 2017 First version
1.1 1.0.0 January 2018 Additional information about the
precision of the optical system
1.2 1.1.0 July 2018 Software update. Minor content
changes. New address
1.3 1.1.1 February 2020 Software update. Screenshots
updated. The "To export log
files" task moved to System
overview. Minor content
changes.
2.0 1.2.0 July 2020 Additional content: Setting up
the database, workflows for
marker setup, registering
different instruments, customize
the screens. Changed
procedure about take a dental
impression. Minor content
changes.
2.1 1.2.0 May 2021 Address of EC representative
added. EC representative
symbol added in table “Symbols
used on the components”.
Open-source licenses
information added in appendix.

NOTES ON THE USER MANUAL
DENACAM System | User Manual | REF M1000-1001 I Version 2.5 5
2.2 1.2.0 June 2022 Adjustment of "Intended use of
the DENACAM system" section
"Patient population".
2.3 1.3.0 September 2022 Software update. Screenshots
updated. Changed procedure
about take a dental impression.
Renamed Drilling screen to
Navigation screen. Minor
content changes.
2.4 1.4.0 March 2023 Software update. Additional
information added in appendix.
Updated EMC Manufacturer`s
Declaration based on updated
norm IEC 60601-1-2:2014/
AMD1:2020. Added FCC Notice.
Minor content changes.
2.5 1.4.0 October 2023 Address of EC representative
changed. Additional marker
(M1501), registration tool
(M1801), and adapter (M1204)
mentioned. New touchscreen
(M1401) integrated. Changed
the term “teaching” to
“calibration” throughout the
manual. System cart replaced
with new version. Care and
cleaning procedures added and
updated. Adjustments to the
cleaning agents used.
Illustrations updated. Applicable
standards updated. Minor
content changes and additions.
Table 1 Revision history
Publication version Software version Revision date Change description

NOTES ON THE USER MANUAL
DENACAM System | User Manual | REF M1000-1001 I Version 2.56
Edition notice
This User Manual is intended for operators of the
DENACAM System.
Every effort has been made to ensure that all the
information contained in this User Manual is correct at the
time of publishing. However, mininavident may need to
update the User Manual information as a result of product
surveillance.
Observe the User Manual information
Please familiarize yourself with the unit by reading
through this User Manual before putting it into operation.
It is essential that you comply with the specified warning
and safety information.
For more information about safety, see "Safety information" on
page 11
Keep the User Manual safe
Always keep the User Manual handy in case you or
another user requires information later. Save the User
Manual on the computer or print it out. If you sell the unit,
make sure that the User Manual is included with it either
as a hard copy or on an electronic storage device so that
the new owner can familiarize himself with its functions
and the specified warning and safety information.
Online portal for technical documents
mininavident has set up an online portal for the technical
documents at http://www.mininavident.com/manuals.
From there, you can download this User Manual along
with other documents.
Help
If you continue to have difficulties despite having
thoroughly studied the User Manual, please contact an
authorized service partner.
For information about your local authorized service partner, see
"Authorized service partners" on page 2
Other valid documents
Equipment options
This document describes the full version of the DENACAM
System. It may therefore cover components that are not
included in the package you purchased.
Documents Supplement of
Quick Start Guide DENACAM®System

NOTES ON THE USER MANUAL
DENACAM System | User Manual | REF M1000-1001 I Version 2.5 7
Names, symbols, and abbreviations
Component names
Symbols used on components
Component name Descriptor
DENACAM®System System
DENAOPT®Camera
DENACOMP®Computer
DENASOFT®Software
DENASCREEN®Touchscreen
DENADAPT®Adapter
DENAREG®Registration tool
DENACART®System cart
DENAMARK®Marker
DENATRAY®Tray
Symbol Explanation
CE mark
with identification number of the notified
body
Consult instructions for use
Consult User Manual
Data matrix code for product information
including UDI
EC representative
Date of manufacture
Do not dispose of with domestic waste
Federal law restricts this system to sale by
or on the order of a dentist, physician or
any other practitioner licensed by the law
of the state in which he or she practices to
use or order the use of the system.
Limited protection against dust ingress
(no harmful deposit).
Protected against low pressure water jets
from any direction. Limited ingress
permitted.
Keep dry
Manufacturer
Non sterile
Not for re-use
Reference number
Serial number
Thermo washer disinfectable
Sterilizable in a steam sterilizer (autoclave)
at the specified temperature
Electrical security. Applied part type B
Batch code or Lot number
Symbol Explanation

NOTES ON THE USER MANUAL
DENACAM System | User Manual | REF M1000-1001 I Version 2.58
Abbreviations
Abbreviation Definition
3D Three-dimensional
AC Alternating current
ANSI American National Standards Institute
CBCT Cone beam computed tomography
DC Direct current
DIN Deutsches Institut für Normung
EMC Electromagnetic compatibility
EN European standard
ESD Electrostatic discharge
FAQ Frequently asked questions
HDMI High-definition multimedia interface
HF High frequency
IEC International Electrotechnical Commission
IFU Instructions for use
ISO International Organization for
Standardization
LED Light emitting diode
RF Radio frequency
UDI Unique device identification
USB Universal serial bus

WARRANTY AND LIABILITY
DENACAM System | User Manual | REF M1000-1001 I Version 2.5 9
WARRANTY AND LIABILITY
Care and cleaning
The owner is responsible for making sure that all care and
cleaning activities are performed.
Repair
As manufacturers of medical electrical equipment,
mininavident can assume responsibility for the safety
properties of the system only if repairs on the system are
performed by authorized service partners, and if
components of the system are replaced only by original
spare parts in case of failure.
Exclusion of liability
Any customer modification of the system renders the
warranty or service agreement null and void.
In the event that the system owner fails to fulfill its
obligation to perform care and cleaning activities or
ignores error messages, mininavident and its authorized
dealers cannot assume liability for any damage thus
incurred.
Duration
mininavident grants a product warranty of 24 months
from the date of purchase.

ACCEPTANCE PROTOCOL / TRAINING
DENACAM System | User Manual | REF M1000-1001 I Version 2.510
ACCEPTANCE PROTOCOL / TRAINING
Training intended for users - Training about the
DENACAM System is provided by mininavident in English
or local language.
The following are the training materials in English or in
local language:
•Scope of training
•User Manual
•Basic user training presentation
•Quick Start Guide (if planned and available)
•Workflow steps
•User feedback about the training provided - Training
questionnaire
Only qualified trainer are allowed to train users. Qualified
means they passed successful an advanced training.
Product name:
DENACAM®System
Serial number (SN):
The product is: Purchased
Rented
Loaned until:
Manufacturer (incl. address):
mininavident, Gerberstrasse 5, 4410 Liestal, Switzerland
Distributor (incl. address):
Name of user:
Hospital / practice / departement (incl. address):
Signature of user:
The signature confirms that the user has been successfully trained on the DENACAM system, in
accordance with the legal regulations (medical devices marketing regulation, medical devices act) and has
understood the content of this manual. Particular attention has been paid to the chapter of safety notes,
operation, care, and cleaning.
The signature confirms the hand over of the the fully functional DENACAM system.
Name of instructor / authorized service partner Date of instruction / handover
Address of instructor / authorized service partner
Signature of instructor / authorized service partner

SAFETY INFORMATION
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Safety classifications . . . . . . . . . . . . . . . . . . . . 12
Safety messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Safety precautions . . . . . . . . . . . . . . . . . . . . . . 13
Warning messages . . . . . . . . . . . . . . . . . . . . . . 14
Caution messages. . . . . . . . . . . . . . . . . . . . . . . 15
Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Safety labels on the components. . . . . . . . . . . . . . . . 17

SAFETY INFORMATION
GENERAL
DENACAM System | User Manual | REF M1000-1001 I Version 2.512
GENERAL
General attention
To avoid serious or fatal injury, read this User Manual
thoroughly before you use the system and its
components.
•Pay particular attention to all safety precautions.
•Always follow the instructions in this User Manual.
•Do not use the system in a way that is not described
in this User Manual.
•Keep this User Manual in a safe place to ensure that
it is not damaged and remains available for use.
•This User Manual must always be easily accessible.
Safety classifications
The safety precautions and important user notes are
classified according to the ANSI Z535.6-2011 standard.
Familiarize yourself with the following meanings and
icons:
Safety alert
The safety alert symbol is used to alert you to
potential physical injury hazards. Comply with all
safety messages that follow this symbol to avoid
possible damage to the system, injury, or death.
These symbols and signal words are used for specific
hazards:
Important information that is not safety relevant is
indicated with the following icon:
Warning
Warning...
...indicates a hazardous situation which, if not
avoided, could result in death or serious injury.
Caution
Caution...
...indicates a hazardous situation which, if not
avoided, could result in minor or moderate
injury.
Notice
Notice...
...indicates a hazardous situation that, if not
avoided, may result in damage to the system or
components.
Note
Indicates additional information on correct use or useful tips.

SAFETY INFORMATION
SAFETY MESSAGES
DENACAM System | User Manual | REF M1000-1001 I Version 2.5 13
SAFETY MESSAGES
Safety precautions
To avoid serious or fatal injury, read and comply
with the following safety precautions.
RESPONSIBILITY OF THE SURGEON
This is a supporting device, providing additional
information to the decision-making process during the
surgical procedure. It is by no means intended to replace
the surgeon’s judgment.
•The final decisions as to the exact location and
depth of the surgery are the sole responsibility of the
surgeon.
•Under no circumstances does the device relieve the
surgeon of his or her ultimate clinical responsibility.
ON-SITE INSTALLATION
•Only an authorized mininavident service partner
shall install the system.
•The installation must have been performed
according to the requirements of mininavident.
For more information about the installation, see "Installation and
setup" on page 33
EXCHANGE OR REMOVAL OF PARTS
Unauthorized exchange or removal of system parts can
damage the system or stop it from functioning correctly.
•Do not exchange or remove any part of the system
not specified in the user documentation.
•Leave replacement of components to an authorized
mininavident service partner.
NON-SPECIFIED ACCESSORIES AND CONSUMABLES
Use of non-specified accessories and/or consumables
can lead to incorrect navigation.
•Do not use components, accessories, or
consumables that are not intended for use with the
system.
For a list of supported materials, see "Overview of the system
components" on page 21
UNSUITABLE OPERATING CONDITIONS
Operation outside of the specified ranges may lead to
incorrect navigation or malfunction of the system.
•Use the system indoors only, and avoid heat and
humidity outside of the specified range.
•Keep the User Manual undamaged and available for
use. It must be easily accessible for all users.
•The system is not intended for use in conjunction
with oxygen rich environments or flammable
anesthetics.
UNAUTHORIZED ACCESS
Unauthorized access to the components of the system
can result in data loss, system damage, or system
unavailability.
•Only authorized persons may access system
components.
TOUCHSCREEN
The touchscreen is equipped with touch-sensitive control
technology. Operating with pointed objects such as
ballpoint pens, pencils, etc. could damage or scratch its
surface.
•Always operate the touchscreen by pressing it
gently with your fingertip.
ELECTROMAGNETIC COMPATIBILITY
Medical electrical equipment is subject to special
precautionary measures with regard to electromagnetic
compatibility (EMC).
•The installation must have been performed
according to the requirements of The installation
must have been performed according to the
requirements of mininavident.
•The use of spare parts, consumables, and
accessories that have not been approved by
mininavident may lead to increased emission of
electromagnetic interference or to reduced
resistance to electromagnetic interference.
•Operate the product in a place with a maximum
distance to electrical and magnetic interfering
transmitters. If it is necessary to operate the product
close to other devices or in a stack with other

SAFETY INFORMATION
SAFETY MESSAGES
DENACAM System | User Manual | REF M1000-1001 I Version 2.514
devices, observe the correct functioning of the
system.
•HF surgical equipment can influence the operation
of the system and may not be operated in
combination with the system.
•Portable wireless communications equipment such
as wireless home network devices, mobile phones,
cordless telephones and their base stations, walkie-
talkie etc. can affect the system and should be kept
at least a distance of 30 cm away from any part of
the system.
For more information about the EMC manufacturer’s declaration,
see "EMC manufacturer’s declaration for the DENACAM System" on
page 114
ELECTROSTATIC DISCHARGE
Electrostatic discharge (ESD) from people can damage
electronic components when the components are
touched. Damaged components usually have to be
replaced. Repairs must be performed by qualified
personnel.
Measures to protect against ESD include:
•Procedures to avoid electrostatic charging via:
•Air conditioning
•Air humidification
•Conductive floor coverings
•Non-synthetic clothing
•Procedures to avoid discharging the electrostatic
charges from your own body through contact with:
•A metallic unit casing
•A larger metallic object
•Any other metal part grounded with the
protective earth
mininavident recommends that all persons working with
this system are made aware of the significance of the ESD
warning label.
Warning messages
List of warning messages
Failure to observe warning messages may result in death
or serious injury.
•Before operating the system, read the warning
messages carefully.
OPERATOR QUALIFICATION - INSUFFICIENT KNOWLEDGE
AND SKILLS
As an operator, ensure that you know the relevant safety
precaution guidelines and standards and the information
and procedures contained in this User Manual.
•Do not carry out operation and maintenance unless
you have read and understood the information
provided in the user documentation.
•Leave installation, repair, and preventive
maintenance to an authorized mininavident service
partner.
•Carefully follow the procedures specified in the
instructions for operation and maintenance.

SAFETY INFORMATION
SAFETY MESSAGES
DENACAM System | User Manual | REF M1000-1001 I Version 2.5 15
Caution messages
List of caution messages
Failure to observe them may result in minor or moderate
injury.
•Before operating, read the caution messages
carefully.
INJURY TO THE PATIENT DUE TO POWER INTERRUPTION
A power failure or momentary drop in voltage may stop
the navigation procedure or lead to data loss.
•Always keep case planning data available on a USB
storage device during surgery.
For information about how to proceed after a power failure, see
"Software Messages/Warnings" on page 100
INJURY TO THE PATIENT DUE TO WRONG INSTALLATION
Incorrect installation and setup of the system may lead to
injury to the patient and/or inaccurate navigation
procedure.
•Leave installation, repair, and preventive
maintenance to an authorized mininavident service
partner.
•The person assembling the system is responsible
for ensuring conformity according to e.g. Directive
93/42/EEC.
•The system must only be connected to AC mains
supply with protective earth.
•Make sure the power supply connector can be easily
unplugged in case of an emergency.
For more information about the installation, see "Installation and
setup" on page 33
INJURY TO THE PATIENT DUE TO USE OF NON-FUNCTIONAL
OR NON-CONFORM COMPONENTS
Use of damaged, contaminated, or not correctly working
components may lead to inaccurate navigation
procedure.
•Do not use USB storage devices with a separate
power supply. USB storage devices with a separate
power supply may seriously interfere with the
electrical safety of the system.
•Replace damaged components prior surgery.
•Do not use components that are contaminated.
•Do not use components that may not work correctly
(e.g. after falling down).
•Do not use components that are not intended for use
with the system.
•Do not use components that passed their service
interval.
For a list of supported materials, see "Overview of the system
components" on page 21
INJURY TO THE PATIENT DUE TO NOT SPECIFIED
TEMPERATURE CONDITIONS OF THE COMPONENTS
Distortion of camera housing in case of heating by built-
in parts (e.g. LED) or an external source (solar radiation).
•Avoid heat sources close to the system and its
components. Exposure to heat may cause the
temperature inside of the components to rise.
For information about operating conditions, see "Specifications" on
page 106
For information about cooling down the system, see "To cool down
the system" on page 102

SAFETY INFORMATION
SAFETY MESSAGES
DENACAM System | User Manual | REF M1000-1001 I Version 2.516
Notices
List of notices
Failure to observe the notices may result in damage to the
system.
•Before operating, read the notices contained in this
summary carefully.
DAMAGE TO THE COMPONENTS DUE TO MECHANICAL
STRESS
Shock, vibration, or pressure can damage the
components of the system.
•Keep sources of vibration away from the
components.
•Do not place objects on the components.
INFECTION BY BIOHAZARDOUS WASTE
•Treat the system as biohazardous waste.
Decontamination (cleaning, disinfection, and
sterilization) is required before reuse, recycling, or
disposal of the system.
•Dispose of the system according to the local
regulations. For more information, contact your
Service representative.

SAFETY INFORMATION
SAFETY LABELS ON THE COMPONENTS
DENACAM System | User Manual | REF M1000-1001 I Version 2.5 17
SAFETY LABELS ON THE COMPONENTS
The system has warning labels to draw your attention to
areas of potential hazard.
The following list explains the meanings of the labels at
the locations where you find the labels.
Table 2 Safety labels on the components
Label Where to find Meaning
Computer Consult User Manual
Computer Do not dispose of with domestic waste
Marker / Tray The component has not been sterilized or
treated with a process during manufacturing
to eliminate potential microorganisms
Marker / Tray The component must only be used with one
patient and must not be reprocessed
Adapter - Bien-Air ventilated with cable Electrical security. Applied part type B.

SAFETY INFORMATION
SAFETY LABELS ON THE COMPONENTS
DENACAM System | User Manual | REF M1000-1001 I Version 2.518

SYSTEM OVERVIEW
DENACAM workflow . . . . . . . . . . . . . . . . . . . . . . . . . 20
Overview of the system components . . . . . . . . . . . . . 21
The DENAOPT camera. . . . . . . . . . . . . . . . . . . . 22
The DENADAPT adapter . . . . . . . . . . . . . . . . . . 22
The DENACOMP computer . . . . . . . . . . . . . . . . 23
The DENASCREEN touchscreen. . . . . . . . . . . . . 24
The DENAREG registration tool . . . . . . . . . . . . . 25
The DENATRAY tray . . . . . . . . . . . . . . . . . . . . . 26
The DENAMARK marker . . . . . . . . . . . . . . . . . . 26
The DENACART system cart . . . . . . . . . . . . . . . 27
Overview of the software. . . . . . . . . . . . . . . . . . . . . . 28
System and user information . . . . . . . . . . . . . . 30

SYSTEM OVERVIEW
DENACAM WORKFLOW
DENACAM System | User Manual | REF M1000-1001 I Version 2.520
DENACAM WORKFLOW
For more information about operation, see "Operation" on page 47
Picture 1 DENACAM workflow
Preoperative Before surgery During surgery After surgery
1Preparing and
positioning tray and
marker
2Performing CBCT
scan
Case planning
3Importing case 4Starting up system
Loading case
5Placing tray with
marker
Viewing 3D-scan
6Registering
instrument
7Selecting instrument
8Performing accuracy
check test
9Guided surgery 10 Exporting case report
Shutting down
system