OCULUS Pentacam AXL User manual

OCULUS Pentacam®AXL
INSTRUCTION MANUAL
System for measuring the anterior eye
segment and optical biometry

Notes on this instruction manual
i / iii Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
Notes on this instruction manual
The Pentacam® AXL has been manufactured and tested according to strict quality
criteria.
To ensure safe operation, it is essential that you use the device correctly. For this reason
you should familiarise yourself thoroughly with the contents of this instruction manual
before operating the device. In particular, pay attention to the safety instructions.
This instruction manual describes how to manage patient data, the default
settings of the Pentacam® AXL program and the measuring process.
The Pentacam® AXL reference manual contains information supplementing the
description of the operating concept.
Due to ongoing development, the diagrams shown may depict minor changes to the
actual device delivered.
If you have any queries or would like additional information about your device, do not
hesitate to call or send us an email or a fax. Our service team will gladly assist.
OCULUS Optikgeräte GmbH
Revision 04
Release: 05.11.2021
OCULUS is certified according to DIN EN ISO 13485, setting high standards of quality
where development, manufacture, quality assurance and service regarding the entire
range of products are concerned.

Table of Contents
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) ii / iii
Table of Contents
1 Delivery and Deliverables ......................................................................................................... 1
2 Symbols ......................................................................................................................................... 3
3 Structure of the Documentation............................................................................................ 4
4 Safety Instructions..................................................................................................................... 5
4.1 About this Manual......................................................................................................... 5
4.1.1 Pictogram Used in this Manual................................................................ 5
4.2 Safety Instructions for Use ......................................................................................... 6
4.3 Cybersecurity Instructions.........................................................................................11
5 Intended Use..............................................................................................................................14
6 Device Description....................................................................................................................16
6.1 Overview of the device components ......................................................................16
6.2 How the Pentacam® AXL works...............................................................................17
7 Setup and Connection.............................................................................................................18
7.1 Electrical Connection..................................................................................................19
7.2 Switching On.................................................................................................................20
7.3 Switching Off................................................................................................................20
7.4 Software Installation on separate PCs...................................................................21
8 Patient Data Management ....................................................................................................22
8.1 Starting Patient Data Management .......................................................................22
8.1.1 Entering a New Patient ............................................................................22
8.1.2 Selecting an Existing Patient..................................................................23
8.2 Starting the Pentacam® AXL Software..................................................................24
9 Pentacam® AXL Program........................................................................................................25
10 Scan Menu..................................................................................................................................27
10.1 Screen layout ................................................................................................................27
10.1.1 Scheimpflug image settings....................................................................28
10.2 Information for recording Scheimpflug images..................................................30
11 Measuring Procedure...............................................................................................................31
11.1 Measuring Procedure to Measure the Axial Length ..........................................31
11.2 Measuring Procedure for the Anterior Segment of the Eye ............................39
11.3 Quality Specifications.................................................................................................45
11.3.1 Quality Specifications in the Pentacam® AXL program..................45
11.3.2 Quality Specifications in the Pentacam® program...........................49
12 Managing Patient Data...........................................................................................................52
12.1 Rename Patient Data..................................................................................................52
12.2 Exporting Patient Data...............................................................................................52
12.3 Importing Patient Data ..............................................................................................54
12.4 Data Backup ..................................................................................................................55
12.4.1 Backup Data.................................................................................................56
12.4.2 Reconstructing Data..................................................................................56

Table of Contents
iii / iii Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
12.4.3 Automatic Backup......................................................................................57
13 Test measurement with the Pentacam® AXL....................................................................57
13.1 Test measurement: Tomography (3D scan) ..........................................................57
13.2 Test measurement: Axial length..............................................................................57
13.2.1 Attach the test eye ....................................................................................57
13.2.2 Carrying out the test measurement......................................................59
14 Cleaning, Disinfection and Maintenance...........................................................................62
14.1 Cleaning..........................................................................................................................62
14.2 Disinfection....................................................................................................................64
14.3 Maintenance .................................................................................................................65
14.4 Attaching Paper to the Chin Rest ...........................................................................66
15 Troubleshooting ........................................................................................................................67
16 Transport and Storage.............................................................................................................68
16.1 Information on Transport and Storage..................................................................68
16.2 Disassembly ...................................................................................................................69
16.3 Transport and Storage ................................................................................................69
17 Disposal .......................................................................................................................................70
18 Terms of Warranty and Servicing ........................................................................................70
18.1 Terms of Warranty.......................................................................................................70
18.2 Assumption of Liability for Functions and Damage...........................................71
18.3 Manufacturer and Service Address.........................................................................71
19 Technical Data...........................................................................................................................72
20 Annex...........................................................................................................................................75
20.1 Electromagnetic Compatibility ................................................................................75
20.2 Guidance and Manufacturer’s Declaration - Electromagnetic
Emisssions for the Pentacam® AXL.........................................................................76
20.3 Description of the Connection.................................................................................80
20.4 Data Sheet HEMG 49-S240210-7 (05150150)...................................................81
20.5 Instructions for integration into an IT-Network.................................................83

1 Delivery and Deliverables
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 1 / 85
1 Delivery and Deliverables
Product and accessories Order number
Pentacam® AXL 70100
Pentacam® AXL®accessories
x-y base
Power supply
Dark sheet
Washing manual
Wire clip
Hexagon screwdriver
Test eye
External hard drive
70701
-
05150150
027070000006
027070000007
027075000004
05520010
70108
05460335
Additional Export package with head- and chinrest
Support plate
Cograil
Cover
Sliding plate
Chinrest paper
Head and chin rest
70734
017051501012
027051701004
027051701005
017051701006
65313
70518
Instruction Manual
User Guide
Software Installation
G/70100/EN 1121 Rev04
UG/70700/xxxx/ EN
SI/50000/xxxx/EN
Additional accessories:
Dustcover
Y cable with galvanic isolation 2 m
Extension cable for Y cable 4 m
Electric cable EU
Electric cable US
Electric cable GB
Electric cable Australia
026010005001
70002
10002173
05200320
05200210
05200211
05200212

1 Delivery and Deliverables
2 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
We reserve the right to change the scope of delivery in line with ongoing
technical development.
If you find transport damage upon delivery, immediately file a claim
with the transport company.
Have the damages noted on the bill of lading, so that your claim for
damages can be handled properly.
For more information regarding shipping and handling, see sec. 16,
page 68.
Software module Order number
Standard software package Pentacam® AXL:
Floating License Key
with manual
77900
SI/77900/.../de
Viewing License Pentacam® AXL 70725
Fast Screening Report 70927
IOL Calculator 70110
Belin/Ambrósio Enhanced Ectasia Display 70728
Contact Lens Fitting incl. Fourier Analysis 70726
Holladay Report & Holladay EKR65 Detail Report 70729
Software Package Cataract
Cataract Software
PNS and 3D Cataract Analysis
Zernike Analysis
70820
Software Package Refractive
Refractive Software
Corneal Optical Densitometry
70810
Pentacam® AXL Data-USB-Stick 017090901001
Optional software module Order number
3D pIOL Simulation Software and Aging Prediction 70928
Module DICOM PACS 70718

2 Symbols
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 3 / 85
☞
The software version of the patient data management appears in the
settings of the patient data management software.
The software version of the Pentacam® AXL program appears in the
Pentacam® AXL settings.
The minimum screen resolution of the Pentacam® displays is
1280x720 with a text size of 100%.
2Symbols
Symbols on the device Symbols, packaging
Manufacturer Protection class Keep dry
Date of
manufacture
IP XX Type of protec-
tion
This way up
Conformité eu-
ropéenne
Article number Fragile
Follow instruction
for use
Serial number Limit of temperature for
transport
Disposal in house-
hold trash is prohib-
ited
Medical device Limit of temperature for
storage
Applied part Type B Attention Limit of humidity
Example: UDI number, consisting UDI-
DI (Device-Identification)
UDI-PI (Product Identifier)
machine-readable matrix code
Limit of air pressure
Transport
Storage
Fig. 2-1: Name plate (example)

3 Structure of the Documentation
4 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
3 Structure of the Documentation
A folder containing documentation is supplied with your Pentacam® AXL:
Instruction Manual: The design of the unit is described in detail in
this document. The instruction manual also gives you general
information about working with the Patient Data Management
system and all safety-related instructions for use of the
Pentacam® AXL.
Attention
All safety-related instructions for use of the Pentacam® AXL are given in
the Instruction Manual for the unit. It is imperative that you read and
understand the whole Instruction Manual before you use the
Pentacam® AXL.
User Guide: All features of the examination and analysis software
are described in the User Guide, along with detailed information
about the Patient Data Management system.
Software Installation: The introduction to the Software Installation
describes how to install the Pentacam® AXL software and the
associated drivers.
Manual Floating License Key: information on the use of the
Pentacam® AXL within networks.

4 Safety Instructions
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 5 / 85
4SafetyInstructions
4.1 About this Manual
Carefully read through the Instruction Manual.
Keep the Instruction Manual in good condition near the device.
Observe the legal regulations with regard to accident prevention.
4.1.1 Pictogram Used in this Manual
Attention
Identifies a potentially dangerous situation which may cause minor injury
or damage to property.
Note
Denotes situations which could result in incorrect findings, denotes user
instructions and useful or other important information.
☞
Identifies important information about the product and its use which
require special attention.
>This symbol denotes menu paths and screen shots. Example for
starting a new examination:
Pentacam® AXL > Examination > Scan
which means:
Select the "Examination" menu from the menu bar.
Select the menu item "Scan".

4 Safety Instructions
6 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
4.2 Safety Instructions for Use
Attention
Personal injury or property damage due to improper operation
Observe the following safety instructions.
Personal injury or property damage due to equipment modifications that
could jeopardize safety
No modifications may be made to this device without the permission
of the manufacturer. Only the OCULUS service and authorized
dealers are allowed
to modify the device or the associated lifting table
to install software and software updates.
Any serious-incident that has occurred in relation to the device should be
reported to the manufacturer ([e-mail]) and the competent
authority of the region in which the user and/or patient is established.
Instructions for Operating Personnel
Make certain that the Pentacam® AXL is used exclusively in clinics
and by eye specialists and opticians (trained staff etc.). It must be
used in the area designated for carrying out examinations.
For this reason the device may only be operated by personnel
instructed to do so, who, with appropriate training, knowledge and
practical experience, are able to ensure proper handling of the
device.
Transport and Storage Instructions
Refer to the notes in sec. 16, page 68.
Instructions for Setup and Connection
Only OCULUS or an authorized dealer is allowed to set up and to
connect the Pentacam® AXL.
Do not use or store the Pentacam® AXL in rooms that are humid, see
sec. 16, page 68.
Keep the Pentacam® AXL away from water that may drip, splash or
spray on it, and make sure that no liquids can get into the
Pentacam® AXL. Do not place any containers holding liquids in the
vicinity of the Pentacam® AXL.
Germany: Only operate the Pentacam® AXL in rooms used for
medical purposes after they have been set up according to the VDE
Regulation 0100-710.

4 Safety Instructions
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 7 / 85
Do not operate the devices included in the delivery in areas where
explosions may occur, or in proximity to flammable anesthetics or
volatile substances such as alcohol, benzine or similar products.
Set up the Pentacam® AXL so that the power plug is easy to access.
That way, you can easily disconnect it from the power supply for any
repairs or maintenance work.
Do not force any plug connections.
If you are unable to make a plug connection, check whether the plug
fits the socket.
If you detect damage to the connection, you should let authorized
dealer repair the damage.
Only use a device which is mounted at the lifting table properly.

4 Safety Instructions
8 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
Patient environment information
Patient environment is the area where patients can come into contact
with any part of a medical electrical equipment (ME equipment) or with
another person being in contact with the ME equipment.
Attention
In the patient environment, use devices that conform to IEC 60601-1. If
a multiple power socket is to be used, or if a device is to be used that does
not meet the IEC 60601-1 standard, use an isolating transformer.
Information about the operation of an ME system
The Pentacam® AXL and a connected computer form a medical
electrical system (ME system) according to IEC 60601-1. If you connect
Fig. 4-1: Patient environment

4 Safety Instructions
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 9 / 85
additional devices, such as, for example a printer, those devices become
part of the ME system.
Make sure that all devices of the ME system meet the requirements
of IEC 60601-1 or IEC 60950-1/IEC 62368-1.
Instructions for Operation
Before first use: Let OCULUS or an authorized dealer train you in the
operation of the Pentacam® AXL.
Never operate a damaged Pentacam® AXL.
Only operate the Pentacam® AXL with the original accessories
supplied by us and only when the unit is in technically perfect
condition.
Do not cover the ventilation openings.
Do not touch the patient and the device at the same time.
Make sure that the device cannot tip over by leaning against it or
sitting on it.
Do not put the Pentacam® AXL, including rechargeable battery or
cable, down onto devices that produce heat, heaters (for example
radiators), microwaves or similar.
Only operate the device if you have understood the operating
instructions.
Caution
The light emitted from this instrument is potentially hazardous. The
longer the duration of exposure and the greater the number of pulses, the
greater the risk of ocular damage. Exposure to light from this instrument
when operated at maximum output will exceed the safety guideline after
48 treatments.
Instructions for Laser Use
Attention
Risk of personal injury or material damage due to invisible laser radiation
The Pentacam® AXL contains a Class 1 laser according to IEC 60825-1:
2014. It is an encapsulated laser system. When the Pentacam® AXL cover
is opened, you may be exposed to invisible, Class 3R (5 mW) laser
radiation.
Never open the unit.
For authorized service personnel only: When doing maintenance
jobs, avoid looking directly into the laser beam.

4 Safety Instructions
10 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
Instructions for Maintenance
In order to retain the high measurement accuracy of the Pentacam® AXL
OCULUS Optikgeräte GmbH recommends to perform a maintenance
service every two years or after 25000 scans. A corresponding message
appears, see sec. 14.3, page 65. Additionally to that it is usefull to
accomplish a test measurement of the axial length measuring mode
everyday before you start working with the Pentacam® AXL.
If an error occurs which you cannot correct, label the Pentacam® AXL as
being "out-of-order" and contact our service department, see sec. 18,
page 70.
Instructions for Disassembly and Disposal
When disconnecting electrical connections, pull on the respective
plug and not on the cable itself.
Dispose of the device according to legal regulations.
Instructions on Electrical Safety
Attention
Risk of personal injury or damage to property due to an incorrect level of
safety
Connecting the Pentacam® AXL with its non-medical electrical
equipment (e.g. data processing equipment) to a medical electrical
system must not result in a patient safety level below that prescribed by
IEC 60601-1. If making this connection leads to the leakage current
threshold being exceeded, protective measures including a circuit breaker
must be in place.
Ensure that connections with non-medical devices are made
correctly.
Only use the power adapter listed in the packing list.
Use only a computer that meets the specifications given in this
instruction manual, sec. 19, page 72.
Use of a multiple socket extension cord
Risk of personal injury or material damage caused by unsafe multiple
socket extension cord
If you use a multiple socket extension cord to connect the
Pentacam® AXL to the power supply, you must heed the following
information:
Use an extension cord that complies with the requirements of IEC
60601-1, section 16.
Do not place the multiple socket extension cord on the floor.
Do not use more than one multiple socket extension cord.

4 Safety Instructions
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 11 / 85
Plug only the Pentacam® AXL and the computer that is being used
with the unit (if applicable) into the multiple socket extension cord.
If you are using a multiple socket extension chord it has to be supplied
with a isolation transformer.
If you are using a new computer for the Pentacam® AXL, you must have
the electrical safety checked. Call OCULUS Service for this purpose.
Attention
Electromagnetic Compatibility (EMC) / Cables
Risk of personal injury or damage to property due to electromagnetic
interference
Portable and mobile RF communications equipment can affect medical
electrical equipment sec. 20, page 75.
Make sure that portable and mobile RF communications equipment
do not cause interference.
Recommendation: Maintain a minimum distance of 4 m. If the
distance is shorter, you must ensure that the Pentacam® AXL
functions correctly.
4.3 Cybersecurity Instructions
☞
The device itself was not designed to connect via a coupled computer to
the internet or other network, or to portable media, as the device does not
require a network or internet connection to function.
User who elect to connect the device coupled computer to the internet or
other network for other purposes are responsible for ensuring that it is
done so in a controlled manner.
Data responsibility:
The device itself is not designed to connect with the internet, but only
with a computer. It does not require the internet to function.
Do not connect with the internet while using the device. It is considered
misuse.
If you elect to connect the computer to the internet for other purposes you
are responsible for ensuring data security.
Device Security
It is the responsibility of the authorized user to ensure that the
Pentacam® AXL device is not left unlocked, or otherwise unsecured when
not in use, to ensure that non-authorized medical, professional, or

4 Safety Instructions
12 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
otherwise unapproved personnel are not exposed to, or gain access to,
ePHI.
User Responsibility
User names or passwords must not be shared with colleagues or others,
even if they are permitted by law and provider policy to view the same
type of information (e.g. two operators reviewing the same patient
samples).
Operators have access to patients’ ePHI and must not take snap-shots,
screenshots or pictures (e.g. using another device) of any information
viewed through the device.
Operators should not enter identifying data into the device. All the data
on the device should be de-identified and relate to the sample id and not
to the patient.
Reporting Device Security or Privacy Breaches
Operators must contact their local IT department and disclose any
suspected or confirmed compromised user accounts, and any other
privacy or security breaches.
Recovering from Compromised Accounts or Devices
When accounts are considered compromised, devices are lost, or
unauthorized access is discovered or suspected, the Healthcare
Organization’s IT network administrators suspend and modify the user
login criteria and issue new login credentials for the user to access their
account securely.
Unavailable Service
Users should report unavailable service or prohibited access to
information to their local Healthcare Organization’s IT department.
Precautions
To ensure cyber security in order to the usage of the device, the following
security measures should be considered. Contact your computer
administrator:
Precautions for access control of the computer
Secure the computer with a password (for example at Windows start
up).
Choose a complex password: A good password should be at least
eight characters long and are not in the dictionary. In addition to
letters, it should also include numbers and special characters.
Do not choose a name or device name for a password (for example
“Pentacam”).
Change the password regularly.
Do not note the password in an accessible location.
Use different passwords for different users.
Enable the screen saver and use the option for the necessity of
reentering the password when exit the screen saver.
Choose an adequate time setting for starting the screen saver if
software session is inactive (e.g. 10 minutes). Adequate time setting

4 Safety Instructions
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 13 / 85
should consider duration of examination, number of patients, time
between examinations, use of other devices in the examination
room, several user, etc.
Lock the computer if you are leaving the workstation (shortcut:
‘windows logo key’ + ‘L’).
Precautions if the computer is connected to a LAN or internet network
If you elect to connect the computer to the LAN or internet, you are
responsible for ensuring data security.
Prefer wired connections of the computer to the network.
If you are using Wi-Fi connections nevertheless, please ensure the
usage of adequate security methods (for example WPA2/AES – Wi-
Fi Protected Access / Advanced Encryption Standard – with a strong
network key).
The usage of a firewall (software or hardware) is recommended.
Heed the instructions for integration into an IT-Network (sec. 20.5,
page 83).
☞
Do not use the Pentacam® AXL with wireless technology, for example
with wireless USB (connection between device and computer).

5 Intended Use
14 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
5 Intended Use
Attention
Federal law restricts this device to sale by or on the order of a physician.
The Pentacam® AXL is designed to take photos of the anterior segment of
the eye which includes the cornea, pupil, anterior chamber and lens of the
eye. To evaluate:
corneal shape,
analyze condition of the lens (opaque crystalline lens),
analyze the anterior chamber angle,
analyze anterior chamber depth,
analyze the volume of the anterior chamber,
analyze anterior or posterior cortical opacity,
analyze the location of cataracts (nuclear, sub capsular and or
cortical), using cross slit imaging with densitometry,
corneal thickness,
axial length,
white-to-white distance.
The Pentacam® AXL also performs calculations to assist physicians in
determining the power of the intraocular lens for implantation.
Intended medical indication
The Pentacam® AXL is indicated as an aid to screen several eye diseases
e.g but not limited to:
Keratoconus classification and progression
Early ectatic diseases
Quantification of optical corneal density
Quantification of optical lens density
Close angle glaucoma
Planning support for IOLs.
The Pentacam® AXL may only be used for the purpose described in this
instruction manual.
Heed the safety instructions listed above.

5 Intended Use
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 15 / 85
Contraindication
none known
Possible side effects
After-image
Headache
Vertigo
Tearing eyes
Intended users
Make certain that the Pentacam® AXL is used exclusively in clinics and by
clinical persons or eye specialists.
who can guarantee proper handling due to their knowledge, training
and practical experience.
who have been instructed by OCULUS staff or an authorized dealer
before the initial operation.
Patient group
Children from 3 years up to not limited. No restrictions on weight,health
and condition: Patient is awake and able to understand and to look into
a fixation target.

6 Device Description
16 / 85 Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
6 Device Description
6.1 Overview of the device components
1 Ventilation opening 5 Y-cable connector
2 Measuring window 6 Cross slide
3 Camera opening 7 Sliding plate with circular markings
4 On/off switch with indicator light 8 Joystick
Fig. 6-1: Device components
1
4
7
8
6
3
2
5