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OCULUS Pentacam Instruction Manual

Anterior segment tomography
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Anterior Segment Tomography
INSTRUCTION MANUAL

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  • Page 1 Anterior Segment Tomography INSTRUCTION MANUAL...
  • Page 2 2 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)
  • Page 3 In particular, pay attention to the safety instruc- tions. The operating concept of the Oculus Pentacam® and Pentacam® HR is basical-  ly identical.

  • Page 4: Table Of Contents

    Patient group ..................... 21 6 Device Description ................22 Overview of the device components ............22 Applied parts...................... 23 Functionality of the Pentacam® / Pentacam® HR ......23 7 Setup and Installation................25 Setup ........................25 4 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)
  • Page 5 11.2.3 Cleaning the illuminated slit............51 11.3 Disinfection ......................51 11.4 Test measurements..................52 11.5 Maintenance....................... 52 11.6 Attaching Paper to the Chin Rest............... 53 12 Troubleshooting..................55 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 5 / 72...
  • Page 6 Electromagnetic Emissions and Immunity for the Pentacam® / Pentacam® HR....................63 17.3 Description of the Connection ..............67 17.4 Data sheet HEMG 49-S240210-7 (05150150)........68 17.5 Instructions for integration into an IT-Network ........70 6 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 7: Delivery And Deliverables

    Floating License Key 77900  with manual SI/77900/.../en Viewing License Pentacam®  Fast Screening Report software modul 70927  Full Sequence Measurement 10006911  Pentacam® Data-USB-Stick 017090901001  Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 7 / 72...
  • Page 8 Have the damages noted on the bill of lading, so that your claim  for damages can be handled properly. sec. 13, For more information regarding shipping and handling, see page 56 8 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 9: Symbols

    UDI number (example), consisting of: Model number UDI-DI (Device-Identification) UDI-PI (Product Identifier) and machine-readable matrix code Safety class Article number Disposal in household trash is pro- Device type hibited Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 9 / 72...

  • Page 10: On The Packaging

    On the packaging Symbol Description Keep dry This way up Fragile Transport Limit of temperature for transport Storage Limit of temperature for storage Limit of humidity Limit of air pressure 10 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 11: Structure Of The Documentation

    3 Structure of the Documentation Structure of the Documentation A folder containing documentation is supplied with your Pentacam® / Pentacam® HR: Short Guide: This document describes the measurement process  and can used as a checklist. This document supports you when...

  • Page 12: Safety Instructions

    Pentacam® / Pentacam® HR 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® / Pentacam® HR. Carefully read through the Instruction Manual.

  • Page 13: Safety Instructions For Use

    Transport and Storage Instructions Refer to the notes in chap. “13 Transport and Storage” on page 56. Instructions for Setup and Connection Only OCULUS or an authorized dealer is allowed to set up and to  connect the device. Do not use or store the device in rooms that are humid, see chap.

  • Page 14: Patient Environment Information

    (ME equipment) or with another person being in contact with the ME equipment. Only use devices that are compliant with IEC 60601-1 in the patient  environment. Fig. 4-1: Patient environment 14 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 15: Instructions For The Operation Of A Me System

    All devices of the ME system must comply with the requirements of  IEC 60601-1 or IEC 62368-1. Instructions for Operation Before first use: Let OCULUS or an authorized dealer train you in  the operation of the device. Never operate a damaged device.

  • Page 16: Instructions For Maintenance

    225 treatments (per patient eye). Instructions for Maintenance In order to retain the high measurement accuracy of the device OCULUS Optikgeräte GmbH recommends to perform a maintenance service every two years or after 25000 scans. A corresponding message appears.

  • Page 17: Instructions On Cyber Security

    Recommendation: Maintain a minimum distance (refer "17.1  Electromagnetic Compatibility” on page 62). If the distance is shorter, you must ensure that the Pentacam® / Pentacam® HR functions correctly. 4.12 Instructions on Cyber Security The device does not require a network or internet connection to work.

  • Page 18: User Responsibility

    4.12.5 Unavailable Service Users should report unavailable service or prohibited access to information to their local Healthcare Organization’s IT department. 18 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 19: Precautions If The Computer Is Connected To A Lan Or Internet Network

    The usage of a firewall (software or hardware) is recommended.  Follow the instructions for integration into an IT network (see chap.  “17.5 Instructions for integration into an IT-Network” on page 70). Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 19 / 72...

  • Page 20: Intended Purpose

     cornal thickness.  Intended Medical Indication The Pentacam® / Pentacam® HR is indicated as an aid to screen several eye diseases for example, but not limited to: Keratoconus classification and progression  Early ectatic diseases ...

  • Page 21: Intended Users

    5 Intended Purpose Intended users The Pentacam® / Pentacam® HR is intended exclusively for use in: ophthalmology practices  clinics  opticians or optometrists  The Pentacam® / Pentacam® HR is intended for use by trained personnel: Who can ensure proper handling based on their knowledge, ...

  • Page 22: Device Description

    Fig. 6-1: Device components No. Description Ventilation opening Measuring window Camera opening On/off switch with indicator light Y-cable connector Cross slide Sliding plate Circular markings on sliding plate Joystick Nameplate 22 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 23: Applied Parts

    Scheimpflug images created during an examination are transmitted to the connected PC. Up to 50 (Pentacam) or 100 (Pentacam HR) Scheimpflug images can be captured within maximum two seconds. Up to 25,000 (HR: 138,000) genuine height values are measured and analysed from the Scheimpflug images.
  • Page 24 6 Device Description Caution OCULUS Optikgeräte GmbH shall not be liable in any form for further use of the data recorded by a Pentacam® and for the evaluations it has calculated. 24 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 25: Setup And Installation

    Handle the device with care.  Set up the Pentacam® / Pentacam® HR 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.

  • Page 26: Electrical Connection

    Plug of the Y-cable Fig. 7-1: Electrical Connection Attention If the device is not connected correctly and voltage is applied, the device may be damaged after a short time. 26 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 27: Switching On

    The Pentacam-Software is network compatible. This makes it possible to install the Pentacam® Software on several PCs, connected in a local network. Make sure, that all PC in a network do have the same Pentacam® software version installed. A Floating License Key is part of every Pentacam® shipment. Please ensure a proper installation based on the Manual for the Floating License Key.

  • Page 28: Pentacam® -Program And Scan Menu

    After starting, the patient data management opens (see chap. “10 Patient Data Management” on page 42). The Pentacam® program is not to be used to dictate therapy without professional correlation with other clinical findings and diagnostic tests. ®...
  • Page 29 The Pupil Image (2) shows the vertical / horizontal positioning of  the Pentacam. The object is to position the yellow dot marking the apex of the cornea in the centre of the crosshairs. The blue dot marks the centre of the pupil, while the blue ring frames the pupil.

  • Page 30: Scheimpflug Image Settings

    You can also use the Return key. Inside the adjustment window (7), there are arrows showing you  the direction in which you must move the Pentacam® to activate automatic measurement (Automatic Release). This line (8) shows messages about the device, for example if a ...

  • Page 31: Parameters Applicable Only To The Pentacam® Hr

    8.2.2 Parameters applicable only to the Pentacam® HR Note The parameters described below apply only to the Pentacam® HR. The Pentacam® HR has additional options for selecting image types (see Scan Menu “Image Options" box (3)). "Cornea Fine" group box Select this option for a more detailed image of the cornea.

  • Page 32: Loading Previous Examinations

     The Pentacam® program will load the examination you have selected. Online help The Pentacam® program provides you a direct help. You can recognize that by a yellow mark. Examples: Open the direct help by clicking on the yellow mark.
  • Page 33 Examination mode Imag- Automatic meas- Notes examination urement IOLs, ICLs, PIOLs 3D scan for PIOLs, 25-50 If the pupil is insufficiently dilated, possibly longer ex- apply mydriatic drops posure Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 33 / 72...

  • Page 34: Measuring Procedure

    Due to small movements of the patient or caused by a wheelchair, the patient is no longer positioned appropriately to the Pentacam® / Pentacam® HR, which can lead to incorrect measurements. Perform a Pentacam® / Pentacam® HR scan only if the patient sits  in a stationary chair.

  • Page 35: Darkening The Room/Dark Sheet

    Example of a rough adjustment for the right eye: Move the cross  slide (1) until the marking at the end of the cross slide (4) roughly coincides with the circle R (3) on the sliding plate. Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 35 / 72...
  • Page 36 Look at the patient’s eye you are examining from one side and  make sure that the blue slit light illuminates the cornea. If necessary, adjust the position of the cross slide to the left or right.  36 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)
  • Page 37 Focus the pupil image by moving the joystick towards the  Pentacam® or away from it. Adjust the left/right position of the Pentacam® and its height  setting. Move the joystick to the left or right and rotate the joystick clockwise or anticlockwise.

  • Page 38: Fine Adjustment

    Rotate the joystick counter-clockwise When you have achieved the expected position, a cross will appear in the centre of the ring, surrounded by four lines. The Pentacam® will automatically begin measuring, alternately you can start the measuring procedure manually.

  • Page 39: Quality Specifications

    9 Measuring Procedure Quality Specifications After you have begun measuring either automatically or manually, the Pentacam® program opens. The "QS" button appears in a field below the patient data. Fig. 9-5: Pentacam® program with "QS" button No. Description "QS" button All examinations are automatically saved, regardless of the quality of the measurement taken.
  • Page 40 CSP Fixation  If this value exceeds the permissible threshold, you must repeat the measurement. If necessary explain to the patient that he has to fix the black ring. 40 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)
  • Page 41 Terminate the current examination which has been saved.  If required, make preparations to examine another patient. In the  "Pentacam" overview, select the "Examination" menu and click [New Patient/End]. Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 41 / 72...

  • Page 42: Patient Data Management

    The user interface for the Patient Data Management appears: Fig. 10-1: Patient Data Management user interface No. Description "Functions" group box Previous examinations [Delete exam.] button [Delete Patient] button 42 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 43: Entering A New Patient

    [Export] button [Import] button Patient list Patient data group box To get into the Pentacam® / Pentacam® HR program, you must first enter a new patient (8) or select an existing patient from the examination list (2). 10.2 Entering a New Patient Press the [New] button to enter a new patient in the Patient Data ...
  • Page 44 10 Patient Data Management up a list of any previous examinations for that patient in the examination window (bottom right side). 44 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 45: Extended Patient Search: [Extended] Checkbox

    Click [Export] button below the patient list. The following dialog  appears: Fig. 10-5: "Export patient data" dialog No. Description Saving destination selection [...] button [Cancel] and [Export] buttons Options for data export Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 45 / 72...
  • Page 46 You can send data stored on the hard drive as an e-mail attachment. Requirements for transferring data to another PC: The Pentacam® program must be installed on the other PC. If the  program is updated on the Pentacam® PC (sender), the program on the other PC (recipient) must also be updated.

  • Page 47: Importing Patient Data

    (e.g. selection of the directory). Select the option (1) where the source data are contained ("Folder"  or "U12" (single file)). Recommendation: Export the patient data using the "Single file (U12)" option. Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 47 / 72...

  • Page 48: Data Backup

    10.8.1 Backup Data Press the [Backup] button at the top right of the Patient Data  Management system. The following dialog is displayed: Fig. 10-7: "Backup" dialog 48 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 49: Reconstructing Data

    Patient Data Management system. The settings required for this can be made in the "Settings" area, User Guide In the patient data management you record and manage patient data. Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 49 / 72...

  • Page 50: Cleaning, Disinfection And Maintenance

    Maintenance by OCULUS Service or an authorized dealer after 25 000 measurements 11.2 Cleaning Attention Risk of electric shock if the Pentacam® / Pentacam® HR is not completely disconnected from the mains for these jobs. sec. 7.5, page 27 Turn the Pentacam® / Pentacam® HR off, ...

  • Page 51: Cleaning The Chin-Forehead Rest

    Disinfect the forehead rest after each examination.  If you do not use paper for the chinrest, disinfect the chinrest after  each examination. Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 51 / 72...

  • Page 52: Test Measurements

    11 Cleaning, Disinfection and Maintenance 11.4 Test measurements The Pentacam® / Pentacam® HR is tested and calibrated in the Oculus factory. OCULUS Optikgeraete GmbH recommends to perform regular test measurements of the Pentacam® / Pentacam® HR. A human eye should be measured initially. Minimum 5 consecutive measurements per eye should be done and the arithmetic mean has to be calculated and recorded.

  • Page 53: Attaching Paper To The Chin Rest

    Fig. 11-4: Information when service is due In examinations (it will be stored): Fig. 11-5: Sign to perform maintenance Let the Pentacam® / Pentacam® HR checked by our service depart- ment or an authorized dealer. 11.6 Attaching Paper to the Chin Rest If you want to attach new chin rest paper, follow these instructions: Fig.
  • Page 54 11 Cleaning, Disinfection and Maintenance Insert the two pins (1) in the chin rest.  54 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 55: Troubleshooting

    Pentacam® on as soon as Patient Data Management becomes active. When you start the Pentacam® program, the message, "Load Bootloader" must appear. Contact the service department or  your authorised dealer Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 55 / 72...

  • Page 56: Transport And Storage

    13 Transport and Storage Transport and Storage The Pentacam® / Pentacam® HR, must be properly dismantled and packed before being transported or stored. Caution Risk of equipment damage due to incorrect shipment or from improper storage Avoid shocks, vibrations, and contamination.

  • Page 57: Disassembly

    Loosen the screw connection of the Y cable and pull it out.  When disconnecting electrical connections, pull on the respective plug and not on the cable itself. Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 57 / 72...

  • Page 58: Disposal

    Dispose the Pentacam® / Pentacam® HR in a compliant manner.  58 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 59: Terms Of Warranty And Servicing

    Assumption of Liability for Functions and Damage OCULUS will only accept responsibility for the safety, reliability and serviceability of the Pentacam® / Pentacam® HR if the unit is used in compliance with the following terms: Only use the equipment in conformance with this instruction ...

  • Page 60: Technical Data

    Power adapter HEMG49-S240210-7 (05150150) Mains connection 100 – 240 V AC Frequency 50/60 Hz Power input, max. 85 VA Output voltage 24 V DC Fuses Integrated overcurrent shut-off 60 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 61: Power Supply

    CE in accordance with Regulation (EU) 2017/745 on Medical Devices (MDR) The unit is a class IIa product. Conformity assessment procedure: (EU) 2017/745 MDR, Annex IX, chap- ter I and III. Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 61 / 72...

  • Page 62: Annex

    Caution The use of accessories, transducers and cables specified by OCULUS with devices other then the Pentacam® / Pentacam® HR may result in increased emissions or decreased immunity of the other device. 62 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)

  • Page 63: Guidance And Manufacturer's Declaration - Electromagnetic Emissions And Immunity

    Guidance and manufacturer´s declaration electromagentic emmissions IEC 60601-1-2 The OCULUS Pentacam® / Pentacam® HR is intended for operation in the electromagnetic environment specified below. The user of the Pentacam® / Pentacam® HR should ensure that it is being used in such an environment. Emissions test...
  • Page 64 0% U ; 250/300 0% U ; 250/300 τ τ periods periods Note: U is the a.c. mains voltage prior to application of the test level τ 64 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)
  • Page 65 To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be con- sidered. If the measured field strength in the location in which the Pentacam® / Pentacam® HR is used exceeds the ap- plicable RF compliance level above, the Pentacam® / Pentacam® HR should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Pentacam®...
  • Page 66 The Pentacam® / Pentacam® HR in intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pentacam® / Pentacam® HR can help pre- vent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pentacam®...

  • Page 67: Description Of The Connection

    17 Annex 17.3 Description of the Connection Pentacam® Pentacam® HR Y cable Power supply adapter (05150150) Computer/PC/laptop Mains connection Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 67 / 72...

  • Page 68: Data Sheet Hemg 49-S240210-7 (05150150)

    (3) The exact obtainable load regulation depends upon the output cord selected and load current. (4) Due to requests in market and advances in technology, specifications subject to change without notice. For the details of safety approval, please consult the factory. 68 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)
  • Page 69 IEC320-C8(DT8) 4.0A HEMG49-S120400-8 12.0Vdc HEMG49-S150330-7 IEC320-C14(DT7) 15.0Vdc 3.3A HEMG49-S150330-8 IEC320-C8(DT8) 15.0Vdc 3.3A HEMG49-S240210-7 IEC320-C14(DT7) 24.0Vdc 2.1A HEMG49-S240210-8 IEC320-C8(DT8) 24.0Vdc 2.1A MECHANICAL DIMENSIONS: MM [INCHES] WEIGHT: 373.0g (13.2 Oz.) Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 69 / 72...

  • Page 70: Instructions For Integration Into An It-Network

    License handling from local license server to PEMS and vice versa  Storage and data export to local network storage and loading from  local network storage Printout to local printer  70 / 72 Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00)
  • Page 71 Changes to the IT-Network include: changes in IT-Network configuration  connection of additional items to the IT-Network  disconnecting items from the IT-Network  update of equipment connected to the IT-Network  Instruction Manual Pentacam® / Pentacam® HR (10028075 - Rev00) 71 / 72...
  • Page 72 WW W. OCUL US .D E OCULUS Optikgeräte GmbH Postfach • 35549 Wetzlar • GERMANY Phone +49 641 2005-0 • Fax +49 641 2005-255 E-mail: sales@oculus.de • www.oculus.de...

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