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