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Summary of Contents for OCULUS Pentacam Cornea OCT
- Page 1 OCULUS ® Pentacam Cornea OCT High-Resolution Corneal Visualization INSTRUCTIONS FOR USE...
- Page 2 2 / 60 Instructions for Use Pentacam Cornea OCT (10028197 / EN - Rev01)
- Page 3 If you have any additional questions or require further information about your device, please feel free to call, email, or fax us. Our Service Team will be happy to assist you. OCULUS Optikgeräte GmbH Article number: 10028197 / EN Revision: 01 Release: 23.01.2025...
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Page 4: Table Of Contents
Updating software and/or installation on separate PCs .........25 8 Pentacam® Program ................26 Start Screen and Menu Bar..................26 Scan Screen........................27 Loading existing examinations..................28 Direct help .........................28 4 / 60 Instructions for Use Pentacam Cornea OCT (10028197 / EN - Rev01) - Page 5 16.2 Guidance and manufacturer’s declaration: Electromagnetic emissions and immunity ............50 16.3 Connection diagram......................54 16.4 Data sheet for GSM90B24-P1M power adapter (10029038)......55 16.5 Instructions for integration into an IT network...........58 5 / 60 Instructions for Use Pentacam Cornea OCT (10028197 / EN - Rev01)
- Page 6 Table of Contents 6 / 60 Instructions for Use Pentacam Cornea OCT (10028197 / EN - Rev01)
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Page 7: Scope Of Delivery
1 Scope of Delivery Scope of Delivery Standard Components Pentacam Cornea OCT OCT measuring head OCT measuring box Ophthalmic table Chin-forehead-rest All-in-one PC Pentacam® basic software OCT epithel map User information Optional accessories Hard drive package ... -
Page 8: Symbols
2 Symbols Symbols On the Device / Name Plate Fig. 1 Name plate (example) Beschreibung Beschreibung Manufacturer logo Do not dispose of in household trash Name and address of the manufacture Application part type B CE mark and no. of notified body Medical device Date of manufacture Power adapter details... - Page 9 2 Symbols Symbol Description Do not stack Do not roll Protect from heat Permissible temperature range for transport Permissible temperature range for storage Permissible range for humidity Permissible range for air pressure 9 / 60 Instructions for Use Pentacam® Cornea OCT (10028197 / EN - Rev01)
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Page 10: Structure Of The User Information
3 Structure of the User Information Structure of the User Information With the Pentacam® Cornea OCT, you receive the following user information: Instruction Manual: This document provides a detailed description of the structure of the device. The Instruction Manual also provides you with basic information on working with Patient Data Management and all safety-related instructions for use of the Pentacam®... -
Page 11: Safety Instructions
4 Safety Instructions Safety Instructions All safety-relevant instructions on the use of the Pentacam® Cornea OCT are only provided in the Instruction Manual for the device. This is why it is mandatory that you have fully read and understood the instruction manual prior to using the Pentacam® Cornea OCT. -
Page 12: Safety Instructions For Use
Follow the information provided in Chapter 12 “Transport and storage” on page 43 4.2.3 Instructions for setup and connection The Pentacam® Cornea OCT must only be set up and connected by OCULUS or an authorized dealer. Do not use the Pentacam® Cornea OCT in moist locations and never set ... -
Page 13: Patient Environment Information
All devices belonging to the ME system must meet IEC 60601-1 or IEC 62368-1 requirements. 4.2.6 Instructions for operation Before first-time use: Allow OCULUS or an authorized dealer instruct you in the operation of the device. Never put a damaged Pentacam® Cornea OCT into operation. ... -
Page 14: Instructions For Maintenance
A graph showing the relative spectral output of the instrument between 305 nm and 1100 nm when the instrument is operating at maximum light intensity and maximum aperture will be provided by OCULUS on request. The spectral output will be shown for the beam after it exits the instrument. -
Page 15: Instructions On Electrical Safety
If using a new computer for the Pentacam® Cornea OCT, have the electrical safety inspected. Call OCULUS Service to do this. Attention Personal injury and/or property damage due to electromagnetic interference Portable and mobile HF communication devices (high frequency) may interfere with medical electrical devices (See chapter 4.2.5 “Instructions for the operation of an ME... -
Page 16: Instructions For Cybersecurity
4 Safety Instructions Instructions for cybersecurity Note Please also observe the regulations, instructions and recommendations of the Fed- eral Office for Information Security regarding the protection of critical infrastructures. The device does not require a network or Internet connection to work. The device itself is not designed to connect to the Internet or another network or to portable media through a connected computer. -
Page 17: Responsibility Of The User
4 Safety Instructions 4.3.2 Responsibility of the user Do not share user names or passwords with colleagues or anyone else, even if authorized by law and employer policy to view the same type of information (e.g., two users reviewing the same patient samples). The users have access to sensitive patient data (ePHI). -
Page 18: Intended Purpose
5 Intended Purpose Intended Purpose The Pentacam® Cornea OCT is intended exclusively for the use specified in this manual and in compliance with the safety instructions. Intended Use The Pentacam® Cornea OCT is designed to take photos of the anterior segment of the eye by Scheimpflug and OCT imaging. -
Page 19: Intended Users
The Pentacam® Cornea OCT is intended for use by trained staff: Who, based on their knowledge, training and practical experience, can ensure professional handling. Who have been instructed by OCULUS personnel or an authorized dealer prior to putting the device into operation. Patient group Children ages 5 and older up to unlimited. -
Page 20: Device Description
6 Device description Device description Device components Fig. 3 Device components No. Description Forehead rest Iris camera with blue slit lamp Scheimpflug camera Chin rest Twist grip Cross slide Basis Mains connection USB port Sliding plate with circle marks Plug Joystick On/off switch ... -
Page 21: Applied Parts
6 Device description Applied parts No. Description Forehead rest Chin rest Fig. 4 Applied parts The chin and forehead rests are Type B applied parts. Principle of operation While rotating around the eye, the Pentacam® Cornea OCT captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. - Page 22 Attention OCULUS Optikgeräte GmbH is by no means responsible for further use of the data recorded with the Pentacam® Cornea OCT and for the valuations it has calculated. 22 / 60...
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Page 23: Setup And Connection
Setup Attention Improper setup may cause faulty measurements or even damage to the device. Have our Service or an OCULUS authorized specialist set up and connect the device. Set up the device so that it cannot fall over. Mount the device onto an examina- ... -
Page 24: Electrical Connection
Do not apply excessive force when connecting electrical plug connections. Observe the information on the nameplate. If the plug is defective, contact OCULUS Service or an authorized dealer to alle- viate the damage. 24 / 60 Instructions for Use Pentacam® Cornea OCT (10028197 / EN - Rev01) -
Page 25: Switching On
PCs that are connected on a local network. The Floating License Key is supplied with each Pentacam® Cornea OCT. The software and any software updates may only be installed by OCULUS Service and/or an authorized dealer. -
Page 26: Pentacam® Program
8 Pentacam® Program ® Pentacam Program The device is definitely ready for use if no error message is displayed after starting the software with the device connected and switched on. Start Screen and Menu Bar Fig. 6 Start screen: Overview No. -
Page 27: Scan Screen
8 Pentacam® Program Scan Screen Menu [Examination] > Scan Fig. 7 “Scan” screen No. Field Description Adjustment window with pupil image shows a live image of the subject's eye and uses the arrows shown to indicate where the device must be moved with the joystick in order to trigger the automatic measurement. -
Page 28: Loading Existing Examinations
8 Pentacam® Program No. Field Description “Cornea Fine” 3D scan with 50 or 100 cross-sectional images (instead of the normal 25 cross-sectional images) “3D Scan” You can select here how many images per scan you want to record. The difference is in the duration of the examination and the number of measuring points evaluated. -
Page 29: Information On Recording Scheimpflug Images
8 Pentacam® Program Examples: Open direct help by clicking on the yellow mark. Information on recording Scheimpflug images Examination goals Examination Images Trigger Notes mode measurement automatically Topography 3D scan 25-50 Pachymetry 3D scan 25-50 Anterior chamber 3D scan 25-50 Do not dilate eye with drops! analysis... -
Page 30: Measuring Procedure
9 Measuring Procedure Measuring Procedure Improper setup may cause faulty measurements. Before first-time use: Allow OCULUS or an authorized dealer instruct you in the operation of the Pentacam® Cornea OCT. Faulty measurements if the device is not ready for operation The device must have been switched on for at least an hour before taking mea- ... -
Page 31: Device Rough Adjustment
9 Measuring Procedure Device rough adjustment Fig. 8 Positioning the patient (example device) No. Description Black ring for orientation of the eye level Twist grip for adjusting the height of the chin rest Description Cross slide ‘L’ left circle mark ‘R’... - Page 32 9 Measuring Procedure Use the twist grip to adjust the height of the chin rest. The patient is seated properly if the forehead and chin touch the rests and the eye are at the height of the mark (black ring). To roughly adjust (example for the right eye), move the cross slide until the mark at the end of the cross slide roughly coincides with the circle mark ‘R’...
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Page 33: Darkening The Room
9 Measuring Procedure Darkening the room Darken the room. If the lighting in the examination room cannot be switched off or the room cannot be darkened, use the dark sheet supplied to cover the patient and the device. Fig. 11 Patient and device with dark sheet Fine adjustment Chap-... - Page 34 9 Measuring Procedure Ask the patient to widen his/her eye and to not blink. Move or turn the joystick for the fine adjustment in the direction specified by the arrows. Arrow Moving the camera Joystick movement Right Push the joystick to the right Left Push the joystick to the left Forw...
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Page 35: Check The Quality (Qa) Of The Measurement And Detect Measurement Errors
9 Measuring Procedure Check the quality (QA) of the measurement and detect measurement errors The evaluation via the “QA” field helps to evaluate the quality of the measurement performed and to detect errors in the measurement process. The 'General Overview' screen opens automatically after a measurement. Clicking on the 'QA' field opens the quality specifications. - Page 36 9 Measuring Procedure Display > OCT Images Fig. 14 „QS“ field in OCT Images In the example image you can see a failed measurement. The patient blinked during the recording. The measurement results are incomplete and cannot be used. The measurement must be repeated.
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Page 37: Finish Measurement
9 Measuring Procedure Field If an error occurs here, ... Valid data ... no continuous data points could be determined in the Scheimpflug images, which can sometimes be the case with irregular or very cloudy corneas. In such a case, a maximum of yellow highlighted values can be expected even if the mea- surement is repeated. -
Page 38: Cleaning, Disinfection And Maintenance
Disinfect the forehead rest Monthly Clean the device (housing, illuminated slit) Monthly Perform a test measurement Every year or Maintenance by OCULUS Service or by an authorized dealer after 25,000 measurements 10.2 Consumables Chinrest paper 400 sheets, Art.-No. 65313 LidStick 2 rolls of 100 each, Art.-No. -
Page 39: Cleaning
10 Cleaning, Disinfection and Maintenance 10.3 Cleaning Attention Risk of electric shock if the Pentacam® Cornea OCT is not disconnected from the power supply at all poles for these tasks. chapter 7.5, page 25 Switch the Pentacam® Cornea OCT off, ... -
Page 40: Disinfection
If you do not use paper on the chin rest, disinfect the chin rest after each exam- ination. 10.5 Conducting test measurements The Pentacam® Cornea OCT is tested and calibrated in-house at OCULUS prior to delivery. Moreover, OCULUS recommends conducting test measurements regularly. Start the test by measuring a human eye. ... -
Page 41: Attaching Paper To The Chin Rest
During an examination (this is saved), a symbol appears next to the QA field. Please contact OCULUS Service or your local dealer to arrange a maintenance appointment. 10.7 Attaching paper to the chin rest Take the following steps to place the chin rest paper: Fig. -
Page 42: Troubleshooting
11 Troubleshooting Troubleshooting Attention Personal injury and/or property damage due to improper troubleshooting If an error occurs that you cannot alleviate based on the following instruction, label the device as out-of-order and notify our Service or your authorized dealer. Fault Possible cause Remedy... -
Page 43: Transport And Storage
12 Transport and storage Transport and storage The Pentacam® Cornea OCT must be properly dismantled and packed before transporting and storing it. 12.1 Disassembly Terminate the current session. Switch off the device. Disconnect the USB cable to the computer/laptop from the measuring box. Disconnect the mains cable from the measuring box. -
Page 44: Disposal
13 Disposal Attention Risk of device damage due to improper transport and storage Avoid shock, vibrations, and contamination. Avoid high temperatures and humidity. Use the original packaging with foam parts for safe transportation. Do not kink or crush the fiber optic cable. ... -
Page 45: Warranty Terms And Service
14.2 Assumption of liability for functions and/or damage OCULUS will only accept responsibility for the safety, reliability and suitability for use of the Pentacam® Cornea OCT if you observe the following provisions: Use the device in conformance with this instruction manual. -
Page 46: Technical Data
15 Technical data Technical data Measuring head Camera digital CMOS camera Light source blue LEDs (475 nm, UV-free) Processor DSP with 2746 million floating point operations/s Speed (Scheimpflug) 100 recordings in 2 seconds (Cornea Fine Scan) Number of evaluated max. 276,000 measuring points Dimensions W x D x H 305 x 259-404 x 512-542 mm... - Page 47 15 Technical data IR-Illumination Purpose Lighting for iris image Wave length 840 nm Fixation light Purpose Fixation light for the patient Wave length 640 nm Power supply Voltage 24 V DC Max. power consumption 75 W Life expectancy Expected life time Up to 10 years The IT equipment (computer, monitor etc.) must meet the requirements defined in specifications...
- Page 48 15 Technical data Classification according to IEC 60825-1 classified as a class 1 laser SLED 1,2 mW Maximum output value of the laser radiation: 9,4 µs Pulse duration: typically 50.000 Number of pulses: 780-1000 nm Wave length: according to IEC 60601-1 Protection against electric shock Protection class 2 Insulation of applied parts...
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Page 49: Appendices
Attention Use of accessories, transducers, and lines not specified by OCULUS may result in increased emissions or decreased immunity of the Pentacam® Cornea OCT. In connection with the Pentacam® Cornea OCT only use accessories, ... -
Page 50: Guidance And Manufacturer's Declaration: Electromagnetic Emissions And Immunity
Electromagnetic emissions and immunity Electromagnetic radiation The Pentacam® Cornea OCT offered by OCULUS is intended for operation in the electromagnetic environment defined below. The user of the Pentacam® Cornea OCT should ensure that it is in fact used in such an environment. - Page 51 16 Appendices Electromagnetic immunity Immunity tests IEC 60601 Compliance lev- Electromagnetic environment Test level – guidance Electrostatic discharge electricity ± 8 kV contact ± 8 kV Floors should be made of wood (ESD) in accordance with discharge ± 15 kV or concrete or covered with IEC 61000-4-2 ±...
- Page 52 16 Appendices Electromagnetic immunity Immunity tests IEC 60601 test Compliance Electromagnetic environment – guidance level level Portable and mobile radio equipment should not be used at a distance to the Pentacam® Cornea OCT any less than the recommended separation distance, which is calculated based on the equation applicable to the transmitting frequency.
- Page 53 16 Appendices Recommended separation distance: between portable and mobile RF telecommunication devices and the Pentacam® Cornea OCT The Pentacam® Cornea OCT is intended for operating in an electromagnetic environment where RF interference is controlled. The user of the Pentacam® Cornea OCT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device –...
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Page 54: Connection Diagram
16 Appendices 16.3 Connection diagram Pentacam®Cornea OCT Measuring box/base Power adapter Computer/PC/laptop Mains connection 54 / 60 Instructions for Use Pentacam® Cornea OCT (10028197 / EN - Rev01) -
Page 55: Data Sheet For Gsm90B24-P1M Power Adapter (10029038)
16 Appendices 16.4 Data sheet for GSM90B24-P1M power adapter (10029038) 55 / 60 Instructions for Use Pentacam® Cornea OCT (10028197 / EN - Rev01) - Page 56 16 Appendices 56 / 60 Instructions for Use Pentacam® Cornea OCT (10028197 / EN - Rev01)
- Page 57 16 Appendices 57 / 60 Instructions for Use Pentacam® Cornea OCT (10028197 / EN - Rev01)
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Page 58: Instructions For Integration Into An It Network
16 Appendices 16.5 Instructions for integration into an IT network The device in combination with the connected computer and the device software that runs on it form a programmable medical electrical system (PEMS system) in accordance with IEC 60601-1. It is essential to observe the section Chapter 4.3 “Instructions for cybersecurity” on page 16 in the chapter “Safety Instructions”... - Page 59 16 Appendices risks. Any changes to the IT network later on may involve new risks and require additional analyses. Changes in the IT network may include:are: Changes in IT network configuration Connecting additional items to the IT network Disconnecting elements from the IT network ...
- Page 60 WW W. OCUL US .D E OCULUS Optikgeräte GmbH Münchholzhäuser Str. 29 • 35582 Wetzlar • GERMANY Phone +49 641 2005-0 • Fax +49 641 2005-255 E-mail: sales@oculus.de • www.oculus.de...
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