OCULUS Pentacam Manuale utente
OCULUS
PENTACAM®/
PENTACAM HR®
INSTRUCTION MANUAL
System for measuring and analysing the front part of the eye
i / iii Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en)
Notes on this instruction manual
Thank you for your purchase and the trust you have placed in this OCULUS product. The
Pentacam®/ Pentacam HR®has been manufactured and tested according to strict qual-
ity criteria. You have selected a modern and well-engineered product.
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.
The operating concept of both the Oculus Pentacam and Pentacam HR is basically
identical.
This instruction manual describes how to manage patient data, the default settings
of the Pentacam program and the measuring process.
Additional functions pertaining to the Pentacam HR (high resolution) are indicated
accordingly.
The Pentacam reference manual contains information supplementing the descrip-
tion of the operating concept.
Due to ongoing development, the diagrams shown may depict minor changes to the ac-
tual device delivered.
If you have any queries or would like additional information about your device, do not
hesitate to call or send us a fax. Our service team will gladly assist.
OCULUS Optikgeräte GmbH
OCULUS is certified according to DIN EN ISO 9001:2000 and 13485:2003, setting high
standards of quality where development, manufacture, quality assurance and service re-
garding the entire range of products are concerned.
Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en) ii / iii
Table of Contents
1 Scope of Delivery......................................................................................................................................1
2 Safety instructions...................................................................................................................................2
2.1 Safety instructions concerning organisation .................................................................2
2.2 Pictogram definitions...............................................................................................................2
2.3 Safety instructions regarding the use of the Pentacam............................................3
3 Proper Usage..............................................................................................................................................4
4 Transportation and Disposal................................................................................................................4
4.1 Transport and storage instructions ....................................................................................4
4.2 Disposal of used devices .........................................................................................................5
5 Device Description ...................................................................................................................................6
5.1 Overview of device components..........................................................................................6
5.2 How the Pentacam works.......................................................................................................6
6 Operation.....................................................................................................................................................7
6.1 First-time operation..................................................................................................................7
6.2 Daily operation............................................................................................................................7
6.3 Switching the Pentacam off..................................................................................................8
7 Patient Data Management ...................................................................................................................8
7.1 Starting Patient Data Management ...................................................................................8
7.2 Entering new patients..............................................................................................................9
7.3 Selecting existing patients .....................................................................................................9
7.4 Starting the Pentacam program ........................................................................................10
8 Pentacam Program................................................................................................................................10
9 Scan Menu ................................................................................................................................................11
9.1 Screen layout .............................................................................................................................11
9.1.1 Scheimpflug image settings.............................................................................12
9.1.2 Parameters applicable only to the Pentacam HR....................................13
9.2 Information for recording Scheimpflug images..........................................................14
10 Measuring Procedure............................................................................................................................15
11 Quality Specifications...........................................................................................................................19
12 Transferring Measurement Results.................................................................................................21
12.1 Exporting patient data ...........................................................................................................21
12.2 Importing patient data...........................................................................................................22
13 Test measurements with the Pentacam........................................................................................23
14 Troubleshooting......................................................................................................................................23
15 Cleaning and Care..................................................................................................................................24
15.1 Instructions for cleaning.......................................................................................................24
15.2 Sterilising and disinfecting...................................................................................................24
15.3 Cleaning .......................................................................................................................................24
16 Terms of Warranty and Servicing....................................................................................................25
iii / iii Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en)
16.1 Terms of warranty................................................................................................................... 25
16.2 Assumption of liability for functions and damage.................................................... 25
16.3 Address of the manufacturer and service department............................................ 26
17 Declaration of Conformity................................................................................................................. 27
18 Technical Specifications / Minimum PC Requirements......................................................... 28
1 Scope of Delivery
Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en) 1 / 29
1ScopeofDelivery
[We reserve the right to change the scope of delivery in line with ongoing technical
development]
Component Order number
Pentacam
Pentacam HR
70700
70900
Pentacam mounted on an x-y-z mobile unit 70518
Head and chin rest
Plate for mounting on a refraction unit or table
(Dimensions 28 cm x 36 cm)
70517-01-006
Power supply, input 100 V-240 V, output 24 V, 2.1 A, Hitron HES 49 05150150
USB cable 70900-07-001
Licence key (dongle) 70740
Testing log, electrical safety
Instruction Manual G / 70700
(HR): G / 70900
Dust protection cover 60100-5/1
Paper for chin support 65313
Software package and books
Windows(tm) software package and operating instructions
Dark sheet 027070000006
Standard software module Order number
Software module: Pachymetry 70721
Software module: Densitometry 70722
Software module: 3D chamber analysis 70723
Software module: Corneal topography, front and rear surface 70724
Optionally available modules Order number
Colour printer 70520
Simulation program for adjusting contact lenses 70726
Simulation program for fitting phakic IOLs, incl. age simulation
(Pentacam HR only)
70928
2 Safety instructions
2 / 29 Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en)
2 Safety instructions
2.1 Safety instructions concerning organisation
The law requires that the manufacturer expressly informs the user about safety aspects
concerning the handling of the Pentacam® / Pentacam HR®. This chapter contains a
summary of the most important points regarding these safety matters.
Attention
Do not use the device if you have not understood the instruction manual.
ÎMake sure to keep this instruction manual in a safe place and available to operating
personnel at all times.
ÎObserve the legal regulations with regard to accident prevention.
The Pentacam is a high-quality technical product. To ensure that it functions correctly
and safely we recommend the following: Have the Pentacam checked by our service per-
sonnel or an authorised dealer every two years. If an error occurs which you are unable
to correct, label the device as "out of order" and contact our service department.
2.2 Pictogram definitions
Attention
Identifies a potentially dangerous situation which may cause minor injury or damage to
property.
Note
Instructions for use, and useful or important information.
☞
Note
Identifies important information about the product or on how to use it, which requires
special attention.
2 Safety instructions
Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en) 3 / 29
2.3 Safety instructions regarding the use of the
Pentacam
☞
Note
Before you use the Pentacam for the first time you must be instructed either by us or an
authorised dealer.
Attention
No modifications may be made to this device without the permission of the
manufacturer.
ÎOnly operate the Pentacam using original accessory parts supplied by us, and when
the device is in technically correct working order.
ÎNever operate a Pentacam that is damaged. Should such a situation arise, contact
the supplier.
ÎDo not operate the devices included in the delivery in areas where explosions may
occur, where there are inflammable anaesthetics, volatile substances such as alcohol
or petrol nearby.
ÎDo not operate or store the Pentacam in damp rooms.
ÎKeep the Pentacam away from water that may drip, surge or splash and make sure
that no liquids can enter the Pentacam. Do not place any containers with liquid ei-
ther close to or on the Pentacam.
ÎWhen cleaning, use a damp cloth and make sure that no liquid enters the Pentacam.
ÎOnly operate the Pentacam in rooms used for medical purposes if VDE 0100 instal-
lation procedures have been observed.
ÎDo 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 our service personnel repair
the damage.
ÎWhen disconnecting electrical connections, pull on the respective plug instead of
the cable itself.
ÎDo not cover the ventilation openings.
Attention
Any additional equipment that is to be connected to either analogue or digital interfaces
must verifiably fulfil appropriate EN or IC specifications. Furthermore, all configurations
must comply with the IEC 601 - 1 system norm.
3 Proper Usage
4 / 29 Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en)
Attention
If you connect the Pentacam with non-medical equipment (e.g. data processing equip-
ment) to a medical electrical system, doing so must not cause patient-relevant safety
levels to fall below IEC 601 - 1. If making this connection leads to the leakage current
threshold being exceeded, protective measures including a circuit breaker must be in
place.
3 Proper Usage
The OCULUS Pentacam is a measuring device for examining the front part of the eye and
may only be used for the purpose described in this instruction manual.
The OCULUS Pentacam is designed for use in clinics and by eye specialists and opticians.
It must be used in the area designated for carrying out examinations.
Only operate the Pentacam using original accessory parts supplied by us, and when the
device is in technically sound condition.
You must use the power supply belonging to the device in order to operate it. There is no
other method of connecting the device possible.
OCULUS guarantees that the Pentacam will function correctly only if no extra software
or programs (except for Microsoft updates and, if required, patient data management) are
installed on the laptop or desktop PC.
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.
4 Transportation and Disposal
4.1 Transport and storage instructions
Note
Great care must be taken when transporting the Pentacam from one location to another.
ÎAvoid operating or storing the device next to heaters/radiators or in damp areas.
ÎCheck the Pentacam for damage every time it has been transported.
4 Transportation and Disposal
Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en) 5 / 29
The requirements for transporting and storing the device according to IEC 601 - 1 are as
follows:
These levels apply in conjunction with the use of appropriate packaging and for a maxi-
mum period of 15 weeks.
4.2 Disposal of used devices
In accordance with Directive 2002/96/EC of the European Parliament and the Council of
27 January 2003, and in accordance with German law governing the circulation, return
and environmentally friendly disposal of used electrical and electronic devices, such ap-
pliances must be recycled and may not be discarded as household waste.
Ambient temperature: -40 °C to +70 °C
Relative humidity, including condensation: 10% to 100%
Air pressure: 500hPa to 1060hPa
5 Device Description
6 / 29 Instruction Manual Pentacam® / Pentacam HR® (G/70700/0109/en)
5 Device Description
5.1 Overview of device components
Fig. 5-1: Device components
5.2 How the Pentacam works
While rotating around the eye, the Pentacam creates Scheimpflug images of the front
part of the eye through varying axes. The images which this rotation produces are the
basis for calculating height data which is used to extrapolate all other results and to cre-
ate a 3D model.
The entire measuring process takes less than two seconds. Up to 25,000 (HR: 138,000)
genuine height values are measured and analysed. At the same time any eye movement
is recorded, which the 3D model takes into account.
When the PC has received the appropriate data record it calculates a 3D model of the
front part of the eye. The 3D model provides the basis for all subsequent analysis.
The topography of the front and rear surfaces of the cornea and the pachymetry are
calculated and displayed from limbus to limbus for the entire surface of the cornea.
1 Ventilation opening 6 Cross slide
2 Measuring window 7 Sliding plate
3 Camera opening 8 Circular markings on sliding plate
4 On/off switch with indicator light 9 Joystick
5 Y-cable connector 10 Nameplate
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