Quantel Medical AXIS NANO User manual

SERVICE MANUAL
APRIL 2015

This QUANTEL MEDICAL equipment, including the associated software and
documentation are proprietary products of Quantel Medical under international
copyright law and all rights are reserved. This manual may only be reproduced in
whole or in part with written permission of Quantel Medical. This manual is furnished
for informational use only and Quantel medical reserves the right to modify the
equipment characteristics and manual without previous notice. Photos and diagrams
are not contractual. Quantel Medical cannot be held responsible for any damage or
injury which results from a failure to follow, or incorrect use of, the instructions
contained in this manual. The guarantee of the equipment will be void if the
equipment is opened (even partially), modified or repaired in any way by persons who
are not authorized by QUANTEL MEDICAL.
Any question regarding the installation or the use of the AXIS NANO system should
be directed to the QUANTEL MEDICAL Service Department or to a local distributor:
International
QUANTEL MEDICAL
11, rue du bois joli,
63808 Cournon d’Auvergne
FRANCE
Tel. : [phone]
Fax : [phone]
E-mail : [e-mail]
Web site: www.quantel-medical.com
U.S.A.
QUANTEL USA MEDICAL UNIT
601, Haggerty Lane
BOZEMAN MT 59715
U.S.A.
Tel : [phone]
Fax : [phone]
E-mail : [email protected]
Web site www.quantel-medical.com
© 2015 Quantel Medical
All rights reserved
AXIS NANO Service Manual
(Ref: XE_AXN_MT_AN)
April 28, 2015

CONTENTS
1. Introduction.................................................................................................................................... 1
2. Service manual terms and safety symbols.................................................................................... 1
3. Warnings ....................................................................................................................................... 1
4. Technical specifications ................................................................................................................ 4
4.1. Classification....................................................................................................................... 4
4.2. Electrical requirements ....................................................................................................... 4
4.3. Compliance......................................................................................................................... 4
4.4. Dimensions ......................................................................................................................... 5
4.5. Environmental conditions.................................................................................................... 5
4.6. Computer minimum requirements....................................................................................... 5
4.7. Block diagram ..................................................................................................................... 6
5. Accessories and spare parts......................................................................................................... 6
5.1. External view....................................................................................................................... 6
5.2. Spare parts.......................................................................................................................... 7
6. Markings........................................................................................................................................ 8
7. Disassembling............................................................................................................................... 9
7.1. Probe holder removal.......................................................................................................... 9
7.2. Cover removal..................................................................................................................... 9
7.3. Acquisition board............................................................................................................... 10
8. Location and connector pin description....................................................................................... 11
9. Database information and backup .............................................................................................. 12
9.1. Automatic backup (only available from version over 1.03)............................................... 12
9.2. Database information........................................................................................................ 12
9.3. Manual database backup and restoration......................................................................... 13
9.3.1. To manually make a database backup.............................................................. 13
9.3.2. To manually restore the database on the axis nano unit................................... 13
10. Software installation.................................................................................................................... 14
10.1. Software compatibilities .................................................................................................... 14
10.1.1. Software and operating system compatibilities................................................. 14
10.1.2. Software upgrade and compatibilities ............................................................... 14
10.1.3. Software and screen resolution compatibilities................................................. 14
10.1.4. Axis nano software behavior with UAC on or UAC off ...................................... 15
10.2. Installation warnings and cautions.................................................................................... 16
10.3. Upgrade procedure........................................................................................................... 16
10.3.1. Uninstalling previous software version.............................................................. 16
10.3.2. In case the axis nano software version 1.04 cannot be uninstalled.................. 17
10.4. Installation procedure........................................................................................................ 17
11. Hardware installation................................................................................................................... 20
12. USB driver installation................................................................................................................. 21
13. AXIS NANO software display & adustments............................................................................... 22
13.1. Navigation properties setup with windows®eight (8.1).................................................... 22
13.2. Adjust magnifier tool.......................................................................................................... 23
13.3. Suppressing the access to switch « user account »......................................................... 23
14. AXIS NANO setup....................................................................................................................... 23
15. Hidden screen ............................................................................................................................. 25
15.1. Accessing the hidden screen............................................................................................ 25
15.2. Hidden screen functions ................................................................................................... 26
a.“zero” field and “position of marker #1 in contact” ............................................................ 26
b.Retina slope test ............................................................................................................... 26
c. Biometry default mode...................................................................................................... 27
d.Field “d2/low dyn”.............................................................................................................. 27
e.Keycode ............................................................................................................................ 27
f. Main icons displayed by default........................................................................................ 27
16. Probes calibration........................................................................................................................ 28
16.1. Calibration check............................................................................................................... 28
16.2. Calibration adjustment ...................................................................................................... 30
16.3. Using the hidden screen to reset the “ position of marker #1 in contact ” to zero ............ 32
17. AXIS NANO – no top most mode................................................................................................ 33

18. Operating System reinstallation procedure................................................................................. 34
19. Care of the unit............................................................................................................................ 37
20. Care of the different probes ........................................................................................................ 37
21. Computer battery exchange........................................................................................................ 37
22. HIPAA compliance ...................................................................................................................... 38
22.1. Security awareness and training....................................................................................... 38
22.2. Contingency plan .............................................................................................................. 39
22.3. Access controls................................................................................................................. 39
22.4. Audit controls .................................................................................................................... 40
22.5. Integrity ............................................................................................................................. 41
22.6. Person or entity authentication ......................................................................................... 41
22.7. Transmission security ....................................................................................................... 41

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1. INTRODUCTION
This service manual gives AXIS NANO technical information such as:
- the technical specifications,
- the accessories and spare parts,
- disassembling the unit and connectors pin description,
- calibration,
- software installation,
- servicing the unit.
2. SERVICE MANUAL TERMS AND SAFETY
SYMBOLS
WARNING
Potential hazards which, if not avoided, could result in serious injury or death
CAUTION
Potential hazards which, if not avoided, could result in minor or moderate injury
and/or product damage
NOTE
Significant additional information or explanation
3. WARNINGS
SERVICING WARNINGS
oWarranty will be void unless the following recommendations are strictly respected:
•Any adjustment and calibration procedure described in this manual shall be
performed by QUANTEL MEDICAL authorized technicians only or by personnel who
has been previously trained by QUANTEL MEDICAL.
•Any faulty part should/will be replaced by a strictly identical one provided by
QUANTEL MEDICAL.
•For safety reasons, QUANTEL MEDICAL considers any electronic board as a whole
partial assembly :
- Defective boards must be returned to QUANTEL MEDICAL for replacement.
- Warranty will be void if a board has been damaged during servicing or an attempt to
repair.
oA special training delivered by QUANTEL MEDICAL is required for any technicians
prior to perform maintenance on the equipment to ensure optimum adjustments and
maximum instrument reliability.
oBefore performing any maintenance or repair on the equipment, ensure that all the
database, as well as the system/user configuration and parameters have been saved
in order to restore them afterwards if needed.

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GENERAL WARNINGS
oThis device is required to be sold only by on the prescription of a physician.
oThis device is not intended for foetal use.
oSwitch off the computer, disconnect AC power and unplug the AXIS NANO before
cleaning the unit.
oAC power should be disconnected every time after turning the system OFF
oTo avoid risk of electric shock, this equipment must only be connected to supply
mains with protective earth.
oThe AXIS NANO IOL calculator will calculate negative IOL values if such is predicted
by the entered data. These are displayed with a minus sign (-). Do not ignore this
sign.
oBe careful not to compress the cornea when measuring axial length.
oNo modification of this equipment is allowed.
oBefore adding any other equipment to the basic configuration, please refer to the:
AXIS NANO User Manual: II- Technical information
Section 4.3: Connections
oDo not modify the equipment (AXIS NANO + Computer) without authorization of the
manufacturer.
oIn case the equipment (AXIS NANO + Computer) is modified, appropriate inspection
and testing must be conducted to ensure continued safe use of the equipment.
oOnly connect Medical Electrical Equipment which has been specified as some parts
of the equipment or as compatible with the equipment.
oThe computer has to be disconnected from the telecom, IT network and/or USB
accessories during examination.
oOnly use a computer, network device or USB accessories that comply with IEC
60601-1 and IEC 60950-1 standards.
oEach time new equipment (not delivered by Quantel Medical) is connected to the
equipment (via USB, network...), the leakage current measurements and checks have
to be performed by the responsible organizations with the new equipment installation:
clause 16 IEC 60601-1, third edition.
oDo not use flammable anesthetics product.
oDo not use in oxygen rich atmosphere.
oSome persons are extremely allergic to isopropyl alcohol.
oConsidering the current concern for possible unknown hazards, and despite the
extremely low output intensities used in ultrasound biometry, QUANTEL MEDICAL
recommends that patient exposure time during measurement be minimized.
CAUTIONS
oTo preserve the finish of the case, avoid the use of abrasive cleaners. If possible,
clean spots before they dry.
oThe probes should never be autoclaved or subjected to excessive heat.
oDo not install Non Quantel Medical software onto the computer, as it may
compromise the AXIS NANO software. Installing non-QUANTEL MEDICAL software
will cause the warranty to be void. QUANTEL MEDICAL is not responsible for any
errors caused by adding programs to the computer’s hard drive.
oDo not connect the AXIS NANO computer to the Internet: the AXIS NANO computer
may not have antivirus protection. Connecting the unit to the INTERNET will cause
the warranty to be void. QUANTEL MEDICAL is not responsible for any errors caused
by connecting the AXIS NANO computer to the INTERNET.
oDo not update Windows Operating System.

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oThe installation of an antivirus may use computer resources that are necessary to the
normal functioning of the AXIS NANO unit and thus reduce the system performances.
The acquisition in real time by the AXIS NANO system might be altered: risk of
delays, saccades, image interruption… It is up to the person who would install this
type of software to set the appropriate parameters and validate that the software does
not disrupt the normal functioning of the AXIS NANO system.
oThe AXIS NANO software is designed to provide the optimum information flow and
performances if used with the adequate computer specifications and operating
system as indicated in:
Section 4.6: Computer minimum requirements
If not, the AXIS NANO software may not offer the optimum results.
oThe AXIS NANO software version 2.00 is an update of the AXIS NANO software
V1.04: Quantel Medical cannot be held responsible for problems caused by the
installation of this update on a system with a version older than the AXIS NANO
software V1.04.
oBetween two patients, the probes must be cleaned to prevent patient-to-patient
transfer of infection.
Quantel Medical advocated a preventive action and a cleaning procedure. Refer to:
AXIS NANO User Manual: I- Regulatory and safety information
Section 3: How to prevent a transfer of infection
oPrecautions to take concerning wastes and elimination of device and accessories:
This product complies with the WEEE Directive (2012/19/UE) marking requirements.
The AXIS NANO is an electrical / electronic product and must not be discarded with
domestic household waste
Do not dispose with domestic
household wastes!
Product category:
With reference to the equipment types in the WEEE Directive annex I, this product is
classed as category 8 among the "Medical devices (with the exception of all
implanted and infected products)".
To completely dispose of the device and its accessories, contact QUANTEL
MEDICAL.

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4. TECHNICAL SPECIFICATIONS
4.1. Classification
The system is intended for continuous operation and has the following classification:
4.2. Electrical requirements
The AXIS NANO is supplied by the computer through USB connection (the AXIS
NANO works if the computer is supplied by the mains or by its battery).
A green LED (under the test block) is switched on when the AXIS NANO is supplied.
WARNING
Only use the power supply module delivered with the computer.
4.3. Compliance
Standards
Descriptions
IEC 60 950-1
Information technology equipment – Safety (Power supply and
enclosure)
IEC 60 601-1-2
Medical electrical equipment part 1-2: general requirements for safety -
collateral standard: electromagnetic compatibility - requirements and
tests
93/42/EEC
European Medical Device directive
CAUTION
Precautions to take with other devices using power supplies (other than those
provided for the AXIS NANO):
The AXIS NANO conforms to the IEC standard:
Standards
Descriptions
IEC 60 601-1
Medical electrical equipment-Part 1: General requirements for basic
safety and essential performance
All the other devices used in conjunction with the AXIS NANO must conform to this
standard.
CAUTION
Precautions to take to avoid electromagnetic interferences with other devices:
The AXIS NANO conforms to the IEC standard:
Standards
Descriptions
IEC 60 601-1-2
Medical electrical equipment part 1-2: general requirements for safety -
collateral standard: electromagnetic compatibility - requirements and
tests
Make sure that all other devices used in the same room are in accordance with this
standard.
Electric security class
EN 60 601-1 Standard
Protective class
I
Type
BF (protection against electrical shocks)
Protection degree
IP20 (protection from solid substances (diameter >12.5mm)
AXIS NANO power supply
5V
400mA

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4.4. Dimensions
4.5. Environmental conditions
The room temperature where the device is operated must be within the following
range: 10°C < T° < 35°C (50°F < T° < 95°F)
The relative humidity must not exceed 95% without condensation.
The device storage and transportation temperature must be within the following
range: -20°C < T° < 70°C (-4°F < T° < 158°F)
WARNING
Do not use flammable anaesthetic product.
Do not use in an oxygen rich atmosphere.
4.6. Computer minimum requirements
Processor
Intel DUAL CORR 1,66GHz
Screen format
Minimum resolution 1024 x 600 (WSVGA) (not recommended from Software
Version 2.00)
Maximum resolution 1366 x 768 (WXGA) (recommended)
Maximum recommended format: 16/9 (do not exceed 13’’)
Minimum recommended format: 10”1
Note: do not use a resolution over 768 because the page setup could be altered,
especially if the dpi size has been changed. If text is truncated with 125%, adjust
the dpi size to 100%.
Operating
system
Microsoft® Windows® Seven (32 bits)
Microsoft® Windows® Seven (64 bits)
Windows® Eight (Windows 8.1 is recommended for desktop access)
Memory
If Windows starter:
1Go DDR SDRAM
If other Windows 7 or Windows 8 version:
Minimum 2Go DDR SDRAM
(4Go DDR SDRAM recommended)
Graphic card
128MB RAM hardware compatible with DIRECTX® 9.0 (pixel shalder version 2.0)
or higher
Example of compatible graphics card:
Dual Core W, Intel®GMA 3600 Series GeForce 410M, Intel® Graphics Media
Accelerator 3150
Boot hard drives
250Go SATA
Computer and
peripherals
2 - 3 USB 2.0 minimum.
Note: the footswitch, potentiometer and mouse are connected to the PC through
USB port. In case there is not enough USB port, a hub may be used.
The computer has to be in conformity with the IEC 60950 standard / the peripherals
connected to the computer also have to be in conformity with the IEC 60950
standard.
Dimensions
AXIS NANO
Width
15cm (5.91in)
Depth
7cm (2.76in)
Height
2cm (0.79in)
Weight
125g (0.28lbs)

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4.7. Block diagram
5. ACCESSORIES AND SPARE PARTS
5.1. External view
Probe holder
Biometry test block
Biometry probe
Green led (under test block): indicates when the Nano is power
supplied.

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5.2. Spare parts
The following items may be ordered independently from Quantel Medical:
PART LIST
REFERENCE
DESCRIPTION
XEAXNBOIT
Complete housing
XEAXNPSD
Probe holder
XEAX2TESTBLOCK
Test block
XEAXNERM
Acquisition board
ACCESSORIES / OPTIONS LIST
REFERENCE
DESCRIPTION
XEAX2PRBBIO
Biometry probe (TP01-b)
XEAAAPAM
Handpiece for TP01-b probe
XEPRBBIOL
Biometry probe with laser pointer (TP02-las)
XEPCMINAZ
Mini PC (AZERTY)
XEPCMINQW
Mini PC (QWERTY)
XESOURIS2
Mouse
XEIMPUSB
USB printer
XEPEDUSB
USB footswitch
XEAXNPOT
USB potentiometer / to adjust GAIN
XEIMPUSBLASER
Laser USB printer

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6. MARKINGS
Label
Description
Identification label:
Displays all information:
-
Quantel Medical (address and telephone);
-
The unit: serial number, Electric security Class
(EN 60 601-1 standard).
The protection standard degree of the AXIS
NANO is IP20: protection from solid substances
(diameter >12.5).
Federal USA law label.
“BF Type”:
Protection against electrical shocks. The hand
piece tip is the only part in contact with the
patient. This part is insulated from ground.
Indoor use symbol.
Caution
Refer to the attached documentation.
WEEE marking:
European
directive for disposal of electronic
products.
1
2

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7. DISASSEMBLING
7.1. Probe holder removal
1 – Pivot the probe holder
2 – Pull out the probe holder
7.2. Cover removal
Turn over the AXIS NANO to see the back side and remove all five screws
(see below) :

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Remove the top cover from the lower cover:
7.3. Acquisition board
Remove the 4 screws (see below) holding the acquisition board in the inferior cover:
NOTE
Position the cable before placing the acquisition board in the bottom cover.
Screws to remove
Screws to remove

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8. LOCATION AND CONNECTOR PIN DESCRIPTION
J1 J3 J4
J2

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9. DATABASE INFORMATION AND BACKUP
9.1. Automatic backup (only available from version over 1.03)
Before upgrading the AXIS NANO to the latest available software version 2.00, carry
out a backup of the AXIS NANO database on an external USB storage device:
In the General Setup screen, select “Save all data”:
A window will open up that allows the user to select a backup folder location and
name. Three backup files/folders are created:
- Two files in the “Data” folder (for Soft ≤V1.04) or “Backup Touch 24-Mar-2015” folder
(from Soft ≥V2.00): Touch Data and Touch xml
- One text file with the date of the backup
9.2. Database information
The AXIS NANO database is organized in different files:
1. Unit configuration data file: “ Config.bin ”
Under: “ C:\ProgramData\Quantel Medical\AXIS NANO\1.0.0.0 ”directory.
This file contains all unit data such as Keycode, Position of first marker in contact,
Zero, Bio and Probeam activation.
2. Physicien/Patient/Operator data directory: “ Data ”
Under: “ C:\ProgramData\Quantel Medical\AXIS NANO\1.0.0.0 ”directory.
This directory contains the following data:
o Physician files: “Operators.bin”file,
o Patient files: “Patients.bin”file,
o Operator files: “Operators.bin”file,
o Images of the patient biometry tests: native images: folders called with a unique code,
composed of letters and numbers.
3. Report images directory: “ Data ”
Under “ C:\AXIS NANO ” directory.
This directory contains the images of reports (JPEG).

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4. Automatic data backup
Under “ C:\ProgramData\Quantel Medical\AXIS NANO\1.0.0.0\Data ”
To avoid the problem of losing data when the unit is incorrectly switched off: the
software duplicates the data files (“.bin”, “.svg” and “.bin2” files).
NOTE
The “ ProgramData ” file is a hidden file: it is necessary to type
“ ProgramData ” in the explorer tool bar to access it.
9.3. Manual database backup and restoration
9.3.1. To manually make a database backup
The following files should be copied to the backup folder:
o“ 1.0.0.0 ” folder located under “C:\ProgramData\Quantel Medical\AXIS NANO ”
directory (this folder contains the “ Data ” folder and the “Config.bin” file)
o“Data”folder located under “C:\AXIS NANO ” directory.
9.3.2. To manually restore the database on the AXIS NANO unit
Under Data directory:
oCopy the “1.0.0.0” folder from the backup folder (which is the “Touch Data” folder in
case the backup has been done automatically). Paste this folder under:
“C:\Program Files\Quantel Medical\AXIS NANO” directory.
oCopy the “Data” folder from the backup folder (which is the “Touch xml” folder in
case the backup has been done automatically). Paste this folder under “C:\AXIS
NANO”directory.
NOTE
oBy default, the “Data” folder is located under the “ C:\AXIS NANO ” directory.
However, the user can decide to change the folder where to export the EMR files (in
the General Setup screen). If this is the case, this other created folder should be
saved / restored instead.
oIt is highly recommended that the user select the “EMR directory” on the unit’s hard
disk to export the EMR files because the “EMR” data are used by the AXIS NANO to
visualize the reports. If the “EMR directory” is saved on an external key or network
(for example), make sure the external key or the network is still connected to the unit
to visualize the reports and saved exams. Also, the backup function (Save All Data)
may not work in case the EMR file path has been changed, moreover if it is not
located under the AXIS NANO hard drive.

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10.SOFTWARE INSTALLATION
10.1. Software compatibilities
10.1.1. Software and Operating System compatibilities
NOTE
* Compatible with the UAC (User Account Control) activated or not.
10.1.2. Software upgrade and compatibilities
NOTE
** To upgrade the AXIS NANO software: it is mandatory to install intermediary software
versions.
V 1.02 => V1.03 => V1.04 => V2.00
10.1.3. Software and screen resolution compatibilities
Software version
Screen resolution
≤1.04
1024 x 600
≥1.04
1366 x 768

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10.1.4. AXIS NANO software behavior with UAC ON or UAC OFF
As described Section 13.3. Suppressing the access to switch “user account”:
It is not advised to create several User Accounts on the AXIS NANO computer.
However, if several Window sessions have been created, the AXIS NANO software
behavior is different when the UAC ON or the UAC OFF is selected.
In the following case, only one database is created. This database is the same for
every Windows session.
By default, the AXIS NANO unit is set with the UAC ON and the USER GROUP (called
AXIS NANO) is set on ADMINISTRATOR.
For SOFT
Version <2.00
UAC ON UAC OFF
3 Windows Sessions created:
QM1 QM2 QM3
User Settings:
QM1: Standard User
User Settings:
QM2 and QM3: Administrator Users
UAC OFF
UAC ON
UAC ON or UAC OFF
Error message
The AXIS NANO software
cannot be used (impossible to
freeze or record an image)
One database is common to each windows
session. The AXIS NANO data are the same
for each session.
Data are located in the directories:
“C:\Axis Nano”
“C:\ProgramData\Quantel Medical\AXIS
NANO”
When several sessions are created, it is necessary to
close the AXIS NANO software before moving on to the
next session.
For SOFT
Version ≥2.00

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10.2. Installation warnings and cautions
NOTE
Do not connect the AXIS NANO unit yet.
WARNING
The upgrade installation procedure has to be performed by persons authorized by
Quantel Medical.
WARNING
A probe calibration (“Position of Marker #1 in Contact (mm) adjustment / ZERO) may
be lost during software upgrade. As a consequence, the user should record the
“Position of Marker #1 in Contact (mm) adjustment / ZERO value to re-enter and
check after software release. Please refer to the:
Section 16: Probes calibration
CAUTION
In the process of re-installation or software upgrade, we recommend the user to save
the database on an USB key, on the computer desktop or on external hard disk
before going through the software installation process. To save database, please
refer to :
Section 9: Database information and backup
CAUTION
Do not modify the UAC (User Account Control) after having installed the AXIS NANO
software as it may create problems with the database.
NOTE
All security messages related to the UAC (when it is activated) are not mentioned in
this installation notice: you have to validate them.
CAUTION
Do not create different user accounts under Windows. Quantel Medical recommends
to use only one account in Administrator mode.
10.3. Upgrade procedure
In case of an upgrade, the previous AXIS NANO software version and some other
software have to be uninstalled as explained below.
Then, follow Section 10.4: Installation procedure to install the new software version
(2.00). If the AXIS NANO module is not detected, re-install the driver as explained in
Section 12: USB driver installation.
10.3.1. Uninstalling previous software version
In case of an upgrade, the previous AXIS NANO software version and some other
software have to be uninstalled:
a. Close the AXIS NANO application: press “Alt” + F4 (in the AXIS NANO software)
b. Right click on the Windows icon and select “Control Panel”