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OCULUS Pentacam AXL Wave Instruction Manual

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OCULUS Pentacam
AXL Wave
INSTRUCTION MANUAL
System for measuring and analyzing the anterior eye segment,
optical biometry, wavefront aberrometry of the entire eye and retroillumination

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Summary of Contents for OCULUS Pentacam AXL Wave

  • Page 1 ® OCULUS Pentacam AXL Wave INSTRUCTION MANUAL System for measuring and analyzing the anterior eye segment, optical biometry, wavefront aberrometry of the entire eye and retroillumination...
  • Page 2 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 Article number: G/70020/XXXX/EN Release: 06.05.2022...

  • Page 3: Table Of Contents

    Table of Contents Table of Contents 1 Delivery and Deliverables................1 2 Symbols........................ 4 3 Structure of the Documentation ..............5 4 Safety Instructions.................... 6 About this Manual ................6 4.1.1 Pictogram Used in this Manual ........6 Safety Instructions for Use ..............7 Cybersecurity Instructions ...............12 5 Intended Use.....................15 6 Device Description ..................17...
  • Page 4 Table of Contents 11.4 Measuring Procedure to Measure the Axial Length ....42 11.4.1 Quality Specifications for Biometry ......46 11.5 Measuring Procedure for Tomography .........48 11.5.1 Quality Specifications for the Tomography....50 11.6 CSP Pro measurement...............53 11.6.1 Quality specification for CSP Pro measurement..55 11.6.2 Perform further measurements........56 11.7 Perform a Single Scan for an Examination Mode .....59...
  • Page 5 Table of Contents 20 Annex........................89 20.1 Electromagnetic Compatibility ............89 20.2 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions and Immunity for the Pentacam® AXL Wave ...............91 20.3 Description of the Connection............95 20.4 Data Sheet HEMG 49-S240210-7 (05150150) ......96 20.5 Instructions for integration into an IT-Network......98 Instruction Manual Pentacam®...

  • Page 6: Delivery And Deliverables

    1 Delivery and Deliverables Delivery and Deliverables Product and accessories Order number Pentacam® AXL Wave 70020 x-y base 70480 Support plate 78060 Cograil 027051701004 Cover 027051701005 Sliding plate 017051701007 Chinrest paper 65313 Head and chinrest 70518 Pentacam® AXL Test eye 70108 ®...
  • Page 7 1 Delivery and Deliverables Software module Order number Standard software package Pentacam® AXL Wave: Floating License Key 77900  with manual SI/77900/XXXX/EN Basic software  70015  Viewing License 70768  Fast Screening Report 70927 Pentacam® AXL Wave Data-USB-Stick  017090901001 Optional software module Order number...
  • Page 8 1 Delivery and Deliverables Optional software module Order number Software Package Refractive 70810 Refractive Software  Corneal Optical Densitometry  Full Sequence measurement 10006911 Display Full Sequence Overview 10006910 Display Aberrometry 10006909 Visual Performance Ophthalmology 70040 Display "Compare 4 examinations" 10009400 Show 2 examinations 10009401...

  • Page 9: Symbols

    2 Symbols Symbols Symbols on the device Symbols, packaging Manufacturer Protection class Keep dry Date of IP XX Type of protec- This way up manufacture tion Conformité eu- Article number Fragile ropéenne Follow instruction Serial number Limit of temperature for Transport for use transport...

  • Page 10: Structure Of The Documentation

    3 Structure of the Documentation Structure of the Documentation A folder containing documentation is supplied with your Pentacam® AXL Wave: 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®...

  • Page 11: Safety Instructions

    4 Safety Instructions Safety Instructions 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. If standards are named without an issue date, the current version always applies.

  • Page 12: Safety Instructions For Use

    16, page Instructions for Setup and Connection  Only OCULUS or an authorized dealer is allowed to set up and to connect the Pentacam® AXL Wave.  Do not use or store the Pentacam® AXL Wave in rooms that are humid, see sec.
  • Page 13 4 Safety Instructions  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 Wave so that the power plug is easy to access.
  • Page 14 4 Safety Instructions 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.
  • Page 15 4 Safety Instructions Instructions for Operation  Before first use: Let OCULUS or an authorized dealer train you in the operation of the Pentacam® AXL Wave.  Never operate a damaged Pentacam® AXL Wave.  Only operate the Pentacam® AXL Wave with the original accessories supplied by us and only when the unit is in technically perfect condition.
  • Page 16 4 Safety Instructions Instructions for Maintenance In order to retain the high measurement accuracy of the Pentacam® AXL Wave OCULUS Optikgeräte GmbH recommends to perform a maintenance service every two years or after 25 000 scans. A corresponding message appears, see sec.

  • Page 17: Cybersecurity Instructions

    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 Wave, you must have the electrical safety checked. Call OCULUS Service for this purpose. Attention Electromagnetic Compatibility (EMC) / Cables...
  • Page 18 4 Safety Instructions when not in use, to ensure that non-authorized medical, professional, or 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.
  • Page 19 4 Safety Instructions  Choose an adequate time setting for starting the screen saver if software session is inactive (e.g. 10 minutes). Adequate time setting should consider duration of examination, number of patients, time between examinations, use of other devices in the examination room, several user, etc.

  • Page 20: Intended Use

    Federal law restricts this device to sale by or on the order of a physician. The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of ...
  • Page 21  who have been instructed by OCULUS staff or an authorized dealer before the initial operation. Patient group Children from 3 years up to geriatric patients. No restrictions on weight, health and condition Instruction Manual Pentacam®...

  • Page 22: Device Description

    6 Device Description Device Description Overview of the device components 1 Ventilation opening 5 Y-cable connector 2 Measuring window 6 Cross slide 3 Camera opening 7 Joystick 4 On/Off Switch with indicator light 8 Name plate Fig. 6-1: Device components 17 / 100 Instruction Manual Pentacam®...

  • Page 23: How The Pentacam® Axl Wave Works

    IOL inclination and centration can be performed. Attention OCULUS Optikgeräte GmbH shall not be liable in any form for further use of the data recorded by a Pentacam® AXL Wave and for the evaluations it has calculated.

  • Page 24: Setup And Connection

     Before first use, make sure the installation and connection of the Pentacam® AXL Wave are completed by our service or by a professional authorized by OCULUS. Note  Do not expose the Pentacam® AXL Wave to any vibrations, shocks, contaminants, moisture, or high temperatures.

  • Page 25: Electrical Connection

    7 Setup and Connection Electrical Connection Attention Electrical safety hazard  Do not use the Pentacam® AXL Wave adjacent to or stacked with other equipment.  If you have to use the Pentacam® AXL Wave adjacent to or stacked with other equipment, verify the correct operation of the Pentacam® AXL Wave.

  • Page 26: Switching On

    7 Setup and Connection Note Risk of equipment damage due to incorrect connection If you do not connect the Pentacam® AXL Wave properly, and the connection is live, the unit can be damaged within a short period of time.  Do not use excessive force when connecting the electrical plug.

  • Page 27: Software Installation On Separate Pcs

    7 Setup and Connection Software Installation on separate PCs The Pentacam-Software is network compatible. This makes it possible to install the Pentacam® AXL Wave Software on several PCs, connected in a local network. Make sure, that all PC in a network do have the same Pentacam® AXL Wave software version installed.

  • Page 28: Patient Data Management

    8 Patient Data Management Patient Data Management Starting Patient Data Management You can enter and use the patient data by the patient data management. After you have switched on the PC, it first loads the operating system.  Click the Pentacam® AXL Wave icon. The user interface for the Patient Data Management appears.

  • Page 29: Entering A New Patient

    8 Patient Data Management 8.1.1 Entering a New Patient  Press the [New] button to enter a new patient in the Patient Data Management system.  Enter the patient's last name, first name and date of birth in the patient window. Fig.

  • Page 30: Starting The Pentacam® Axl Wave Software

    8 Patient Data Management Extended Patient Search: [Extended] Checkbox  Click on the [Extended] checkbox. The screen displays additional search parameters which reference previous examinations. Proceed as for the input of a patient name. Fig. 8-4: Advanced search Starting the Pentacam® AXL Wave Software Switching from Patient Data Management to the Pentacam®...

  • Page 31: Using The Pentacam® Axl Wave Program

    9 Using the Pentacam® AXL Wave Program Using the Pentacam® AXL Wave Program If no error message appears after starting the software with the device connected and switched on (for example component failure, camera not detected, missing references data, etc.), the device is safely ready for operation.

  • Page 32: Starting An Examination

    9 Using the Pentacam® AXL Wave Program Starting an examination An examination sequence with the Pentacam® AXL Wave combines the following modi: total wavefront aberrometry  retroillumination  axial length  Scheimpflug tomography   Select the [Examination] tab and click [New Full Sequence] to start the full sequence examination.
  • Page 33 9 Using the Pentacam® AXL Wave Program The patient view shows the respective image or fixation target,  where the patient has to look where the patient has to look at during the measurement (2). The slider of the fixation target (3) adjusts itself automatically based ...

  • Page 34: Loading Previous Examinations

    9 Using the Pentacam® AXL Wave Program QS (2): Quality Specification factor including different parameters  depending on mode. If the value  is green and reads OK, the measurement is correct and can be used for the evaluation of the examination. ...

  • Page 35: Information On Modes

    10 Information on Modes Information on Modes The user guide contains detailed information on the settings and default settings of the Pentacam® AXL Wave. An examination sequence with the Pentacam® AXL Wave combines the following modi: total wavefront aberrometry  ...

  • Page 36: Information For Tomography Mode

    10 Information on Modes 10.4 Information for Tomography Mode Based on 25 or 50 captured Scheimpflug images and resulting 3D model, the anterior eye segment can be measured, displayed and analyzed for different applications like early ectasia screening, cataract evaluation etc. Type of Examination mode Images...

  • Page 37: Measuring Procedure

    11.7, page 59 Attention Risk of incorrect measurement due to incorrect use  Before first use: Let OCULUS or an authorized dealer train you in the operation of the Pentacam® AXL Wave. Risk of incorrect measurements due to improper setup ...
  • Page 38 11 Measuring Procedure Rough adjustment  The black ring marking between the chin rest and the forehead rest (1) should be used for gauging the required height of the patient’s eyes. 1 Marking (black ring) 2 Twist grip Fig. 11-1: Rough adjustment of the chin and forehead rest ...
  • Page 39 11 Measuring Procedure  Example of a rough adjustment for the right eye: Move the cross slide (1) until the marking at the end of the cross slide roughly coincides with the circle R (4) on the sliding plate. Cross slide 4 Right marking Sliding plate 5 Marking on the cross slide...
  • Page 40 11 Measuring Procedure Fine adjustment  Make any fine adjustments required based on the information in the adjustment window. Example (with blue arrows): distance and position to patient´s eye is not correct.  Move the joystick backwards and to the left. Example (with blue arrows): Move or rotate the joystick in the specified direction.

  • Page 41: Measuring Procedure To Measure The Wavefront Aberration

    11 Measuring Procedure 11.2 Measuring Procedure to Measure the Wavefront Aberration  Prepare the measurement and adjust the patient, sec. 11.1, page 32 1 [Automatic Release] checkbox 3 Objective refraction parameter 2 [Request 4x alignment] checkbox 4 Current examination mode Fig.
  • Page 42 11 Measuring Procedure  Move the image with the cross towards the patient until the four infrared LEDs are clearly seen. Fig. 11-4: Adjustment You can use the adjusting aid of the fine adjustment alternatively, see “Fine adjustment” page  Shortly before you have reached the final position ask the patient to widen his or her eye and not to blink.

  • Page 43: Quality Specifications And Parameter For Wavefront Aberrometry

    11 Measuring Procedure 11.2.1 Quality Specifications and parameter for wavefront aberrometry After you have begun measuring either automatically or manually, the Pentacam® AXL Wave program opens. The "QS" value appears in field (2). 1 "QS" value 2 [+New Scan] button Fig.
  • Page 44 11 Measuring Procedure  Click on the "QS" button. The following dialog box appears: Fig. 11-7: Examination Quality Specification  Check the measurement results.  If you have any doubts, repeat the measurement. Parameters  Measured Points: If analyzed data is less than the permissible threshold.

  • Page 45: Capturing Procedure For The Retroillumination

    11 Measuring Procedure 11.3 Capturing Procedure for the Retroillumination Immediately after measuring the wavefront aberration, a single retroillu- mination exposure is automatically carried out. Use this measurement mode for further retroillumination exposures. Attention You have to carry out an image capture with manual release. ...
  • Page 46 11 Measuring Procedure Retroillumination parameters (2) Fig. 11-9: Objective Retroillumination parameter Use: Activate this checkbox to use the data for the full sequence  analysis. Use only one exam of each exam mode for the full sequence examination.  Z: Distance of the device to the focus level Pupil: Diameter of the pupil ...

  • Page 47: Measuring Procedure To Measure The Axial Length

    11 Measuring Procedure 11.4 Measuring Procedure to Measure the Axial Length Before the measurement It is mandatory to select the correct eye status before every axial length measurement. Different eye status lead to different results for the axial length measurement, hence influence the IOL power calculation. The eye status has to be selected by the user before every AXL-Scan.
  • Page 48 11 Measuring Procedure Attention Risk of incorrect measurement caused by unchecked plausibility  Check both eyes on plausibility. Recommended differences between both eyes should be below:  Axial length AXL <0,3mm Curvature< 0,18mm. This equals approximately in 1dpt (based on a ...
  • Page 49 11 Measuring Procedure Measuring of the axial length  Move the image with the cross towards the patient until the four infrared LED are clear. Fig. 11-11: Adjustment  Focus the pupil image by moving the joystick, see “Fine adjustment” page ...
  • Page 50 11 Measuring Procedure If the measured axial length value has a probability of < 1%, the following message may occur. Fig. 11-13: Message: dirty optical window Warning Faulty measurements due to dirty window  Clean the optical window.  Carry out a test measurement. If you do not carry out the test measurement, then this message will be stored in the Pentacam®...

  • Page 51: Quality Specifications For Biometry

    11 Measuring Procedure 11.4.1 Quality Specifications for Biometry After you have measured one examination either automatically or manually, the Pentacam® AXL Wave program opens. The "QS" value appears in field (3) Single scans with SNR values 3 "QS" value Signal to noise ratio of the axial length measurement 4 [+New Scan] button Fig.
  • Page 52 11 Measuring Procedure If the "QS" display is highlighted in yellow or red, check the QS values.  Click the "QS" button. The following dialog box appears: Fig. 11-15: Examination Quality Specification  Check the measurement results.  If you have any doubts, repeat the measurement. Parameter ...

  • Page 53: Measuring Procedure For Tomography

    11 Measuring Procedure 11.5 Measuring Procedure for Tomography  Prepare the measurement and adjust the patient, sec. 11.1, page 1 [Automatic Release] checkbox 4 Tomography parameter 2 [Slit light] checkbox 5 Current examination mode 3 Live Scheimpflug image Fig. 11-16: Scan screen "Tomography" Measuring of the tomography ...
  • Page 54 11 Measuring Procedure  Adjust the left/right position of the Pentacam® AXL Wave and its height setting. Move the joystick to the left or right and rotate the joystick clockwise or anticlockwise. The tentative final position of the camera is reached when the four bars frame the blue circle.

  • Page 55: Quality Specifications For The Tomography

    11 Measuring Procedure 11.5.1 Quality Specifications for the Tomography After measuring either automatically or manually, the Pentacam® program opens. The "QS" value appears in field (1) 1 "QS" value 3 [Use] checkbox 2 [+New Scan] button Fig. 11-18: Pentacam® AXL Wave program with "QS"display Note All examinations are automatically saved, regardless of the quality of the measurement taken.
  • Page 56 11 Measuring Procedure  Click the "QS" button. The following dialog box appears: Fig. 11-19: Examination Quality Specification  Check the measurement results.  If you have any doubts, repeat the measurement. Notes on individual parameters Analysed Area  If this value is less than the permissible threshold, the patient must widen his or her eye.
  • Page 57 11 Measuring Procedure Terminating "QS"  If required, delete the measurement if the image is inadequate.  If required, click the [+New Scan] button (2) for a new measurement.  Click [Close] to return to the Pentacam® AXL Wave program. Instruction Manual Pentacam®...

  • Page 58: Csp Pro Measurement

    11 Measuring Procedure 11.6 CSP Pro measurement In a CSP Pro measurement, not only the cornea, but also parts of the sclera are measured. This means larger diameter contact lenses such as scleral lenses can be fitted. Before the measurement By default, a tomography measurement is carried out after the axial length measurement.
  • Page 59 11 Measuring Procedure Perform CSP Pro measurement  Move the cross slide towards the patient until the live Scheimpflug image shows the cornea of the eye that you are examining. Fig. 11-21: Scheimpflug image (left) and overview image (right) The image is sharpest when the red dot coincides with the red line in the Scheimpflug image.

  • Page 60: Quality Specification For Csp Pro Measurement

    11 Measuring Procedure 11.6.1 Quality specification for CSP Pro measurement After measuring either automatically or manually, the Pentacam® AXL Wave program opens. The "QS" value appears in field (2) 1 [+New Scan] button Display sum of all individual measurements 2 "QS" value Individual measurements 3 Value for the overall coverage [+] button...

  • Page 61: Perform Further Measurements

    11 Measuring Procedure If an error message is displayed in the “QS” field, the measurement must also be repeated. 1 Error message [Repeat measurement] button 2 [Delete measurement] button Fig. 11-23: Error message after a CSP Pro measurement 11.6.2 Perform further measurements Repeat or delete measurement If the QS value of a measurement is not sufficient to use this for evaluation, repeat this measurement or delete it.
  • Page 62 11 Measuring Procedure The eye needs to be held open wide enough for the desired measurement area not to be covered by the eyelids to achieve good coverage of the cornea and sclera. We recommend holding up the upper eyelid with the LidStick®...
  • Page 63 11 Measuring Procedure  Click the [Finish] button to complete the CSP Pro measurement. 1 Parameters of the CSP Pro measurement Elevation map 2 Scheimpflug images Fig. 11-25: Completed CSP Pro measurement CSP Pro measurement parameter (4) Use: Examination can be used for the evaluation. ...

  • Page 64: Perform A Single Scan For An Examination Mode

    11 Measuring Procedure 11.7 Perform a Single Scan for an Examination Mode You can perform single scans for each examination mode, for example to check values after a surgery.  Adjust the table height.  Check that fresh paper has been put onto the chin rest or the chin rest has ...

  • Page 65: Procedure To Take A Single Scan

    11 Measuring Procedure  Select the [Examination] tab and click [Scan]. 1 Display of currently examined eye 6 [Start Scan] button 2 Overview image with adjusting aid 7 Adjustment window 3 Examination mode area 8 Fixation Target 4 [Slit Light] checkbox 9 [Quit] button 5 [Automatic Release] checkbox 10 "Orientation"...

  • Page 66: General Settings

    11 Measuring Procedure 11.7.2 General settings Click the [Slit Light] checkbox (4) to activate/deactivate the blue  light for illuminating the eye. Click the [Automatic Release] checkbox (5) to activate automatic  measurement. Clicking the [Start Scan] button (6) activates manual measurement. ...
  • Page 67 11 Measuring Procedure "Cornea Fine" group box Select this option for a more detailed image of the cornea.  The camera does not capture the deeper-lying layers. You can select 50 Scheimpflug images with a recording time of one second, or 100 Scheimpflug images with a recording time of two seconds.
  • Page 68 11 Measuring Procedure  Select the "Eye Status":  Phakic: Default status. Presence of crystalline lens. Aphakic: Absence of the crystalline lens. Correction of  measured axial length by +0.200 mm Pseudophakic (Silicone IOL or similar): IOL of silicone or similar ...

  • Page 69: Manual Measurement Function In The Scheimpflug Image

    11 Measuring Procedure Warning Faulty measurements due to dirty window  Clean the optical window.  Carry out a test measurement. If you do not carry out the test measurement, then this message will be stored in the Pentacam® AXL Wave programme accordingly marked by a red flagged QS value, for example in the IOL calculator.
  • Page 70 11 Measuring Procedure Fig. 11-30: Measurement function in the Scheimpflug image The arrow head and the associate distance will now be permanently displayed.  Click on the button . The last measuring line is deleted. 65 / 100 Instruction Manual Pentacam® AXL Wave (G/70020/XXXX/EN – Rev08)

  • Page 71: Managing Patient Data

    12 Managing Patient Data Managing Patient Data Once you have completed an examination, you can do the following with the patient data: Rename it, sec. 12.1, page 66  Export it, sec. 12.2, page 66  Import it, sec. 12.3, page 68 ...
  • Page 72 12 Managing Patient Data The default options for import and export of data are configured in the "Settings" field, see also the User Guide. Depending on the settings, you may not have to perform all of the following steps (e.g. selection of the directory). ...

  • Page 73: Importing Patient Data

    12 Managing Patient Data 12.3 Importing Patient Data If you receive patient data, for example, on a USB stick, you can import these data. Note Risk of loss of data due to computer viruses Computer viruses can cause loss of data. ...

  • Page 74: Data Backup

    12 Managing Patient Data  Press the [...] button. (2).  In the dialog box, select the directory or the file where the patient data are located.  Confirm your selection with [OK] or [Open]. The patients and the associated examinations that are found are displayed in the lower part of the dialog.

  • Page 75: Backup Data

    12 Managing Patient Data 12.4.1 Backup Data  Press the [Backup] button at the top right of the Patient Data Management system. The following dialog is displayed: Backup data selection Backup directory and button [...] [Restore] button [Save] button Display free storage space Fig.

  • Page 76: Automatic Backup

    User Guide. Test Measurements with the Pentacam® AXL Wave The Pentacam® AXL Wave is tested and calibrated in the Oculus factory. OCULUS Optikgeraete GmbH recommends to perform regular test measurements of the Pentacam® AXL Wave. You will be prompted by the software for test measurements.

  • Page 77: Perform The Axial Length Test Measurement Routine

    13 Test Measurements with the Pentacam® AXL Wave  Make sure that the test eye is in park/home position when it is not being used. Fig. 13-2: Test eye in park/home position 13.1.2 Perform the Axial length test measurement routine The axial length test measurement routine has to be performed daily before the first "Full Sequence Examination".
  • Page 78 13 Test Measurements with the Pentacam® AXL Wave For the case the test measurement is skipped it is saved in the software and all following AXL scans receive a bad QS value including the message "Missing test measurement" Align the Pentacam® AXL Wave to the test eye, “Fine adjustment” page 35.
  • Page 79 13 Test Measurements with the Pentacam® AXL Wave  To finish the process click "OK". In case the test measurement failed the following message appears:  Exclude all possible reasons (see screen) for a fail test measurement.  Repeat the test measurement again. ...

  • Page 80: Test Measurement: Tomography (3D Scan)

    13.2 Test Measurement: Tomography (3D scan) The Pentacam® AXL Wave is tested and calibrated at OCULUS. OCULUS Optikgeräte GmbH recommends to carry out additional regular test measurements with thePentacam® AXL Wave.
  • Page 81 13 Test Measurements with the Pentacam® AXL Wave The following table depicts the tolerance range between the result of the initial measurement and the result of the current measurement: Tolerance range Curvature +/- 0,1 D Pachymetry +/- 10 µm If the difference between the initial value and the current value lies out- side the tolerance range, contact our service or your marketing authori- sation holder.

  • Page 82: Cleaning, Disinfection And Maintenance

    14 Cleaning, Disinfection and Maintenance Cleaning, Disinfection and Maintenance Cleaning and disinfection of the Pentacam® AXL Wave is described in this chapter. Sterilization is not required.  Heed the product descriptions and instruction manuals of products and equipment you use to care for, clean, and disinfect the unit and/ or its accessories.

  • Page 83: Disinfection

    14 Cleaning, Disinfection and Maintenance  Wipe off any residue from painted surfaces with the mixture for painted surfaces. Cleaning the Chin-Forehead Rest  Make sure that no liquid gets into any of the openings of the Pentacam® AXL Wave. Do not use liquid from aerosol cans.

  • Page 84: Maintenance

    14.3 Maintenance In order to retain the high measurement accuracy of the Pentacam® AXL Wave OCULUS Optikgeräte GmbH recommends to perform a maintenance service every two years or after 25 000 scans. A corresponding message appears. By daily pop up window: Fig.

  • Page 85: Attaching Paper To The Chin Rest

    14 Cleaning, Disinfection and Maintenance Let the Pentacam® AXL Wave checked by our service department or an authorized dealer. Attention Risk of personal injury or material damage due to invisible laser radiation The Pentacam® AXL Wave contains a Class 1 laser according to IEC 60825-1: 2014.

  • Page 86: Troubleshooting

    15 Troubleshooting Troubleshooting Attention If an error occurs which you are unable to correct by following the instructions below, label the device as "out of order" and contact our service department or an authorised dealer. Error Possible cause Remedy After you have started the Penta- No power to the power adapter.

  • Page 87: Transport And Storage

    16 Transport and Storage Transport and Storage The Pentacam® AXL Wave, must be properly dismantled and packed before being transported or stored. 16.1 Information on Transport and Storage Storage Ambient temperature range -10 – +55°C Relative humidity, including condensation 10 – 95% Air pressure range 700 –...

  • Page 88: Disassembly

    16 Transport and Storage 16.2 Disassembly  End the current session.  Switch off the device.  Disconnect the cable from the computer/laptop and the power adapter. Fig. 16-1: Disassembly  Loosen the screw connection of the Y cable and pull it out. Only pull on the plugs, not on the cables itself.

  • Page 89: Disposal

    17 Disposal Disposal In accordance with Directive 2012/19/EC of the European Parliament and the Council of 4th of July 2012, and in accordance with German law governing the marketing, return and environmentally compatible disposal of used electrical and electronic devices, such appliances must be recycled and may not be discarded as household waste.

  • Page 90: Assumption Of Liability For Functions And Damage

    If assembly work, modifications, adjustments, repairs, changes or service are performed by unauthorized personnel, or if the Pentacam® AXL Wave is improperly maintained or handled, then any liability by OCULUS is voided. If the above-referenced work is performed by authorized persons, ...

  • Page 91: Technical Data

    19 Technical Data Technical Data Measuring equipment Camera Digital CMOS camera Light source Blue LED (475 nm, UV-free) Processor DSP with 2746 Mio. floating point operations per second Speed 100 images in 2 seconds (Cornea Fine Scan) Dimensions W x D x H 278 x 320 to 400 x 502 to 532 mm (measuring head) (10.9 x 12.6 to 15.7 x 19.8 to 21.0 in)
  • Page 92 19 Technical Data Power supply Pentacam® AXL Wave Output voltage 24 V DC Max. power consumption 35 W Other information Contraindications none known Lifecycle expectancy Up to 10 years Classification according to IEC 60601 - 1 Type of protection against electrical shock Protection class 2 Level of protection against electrical shock Type B...
  • Page 93 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 94: Annex

    EMC, and must be installed and operated according to the EMC-Instructions contained in the accompanying paperwork. No special measures need be observed in respect of OCULUS devices and systems. Portable and mobile RF-communications devices can interfere with electrically operated medical devices.
  • Page 95 20 Annex To be in compliance with the requirements of the IEC 60601-1-2. 6.1 and 6.2 the following types of equipment, accessories, power adapters and cables must be used. Order number Description 70020 Pentacam® AXL Wave 05200320 Cable with connector 2.5 m (98.4 in) plug, EU standard 05200210...

  • Page 96: Guidance And Manufacturer's Declaration

    IEC 60601-1-2: 2015, based to table 1 The OCULUS Pentacam® AXL Wave is intended for operation in the electromagnetic environment specified be- low. The user of the Pentacam® AXL Wave should ensure that it is being used in such an environment.
  • Page 97 20 Annex Electromagentic immunity, IEC 60601-1-2: 2015, based on table 4 Immunity test IEC 60601 Compliance level Electromagnetic environment - test level guidance Electrostatic discharge ± 8 kV contact ± 8 kV Floors should be made of wood (ESD) ± 15 kV or concrete or covered with ce- ±...
  • Page 98 20 Annex Electromagentic immunity, IEC 60601-1-2: 2015, based on table 4, 5 Immunity test IEC 60601 Compliance level Electromagnetic environment - Guidelines test level Portable and mobile RF communications equip- ment should be used no closer to any part of Pentacam®...
  • Page 99 20 Annex Recommended separation distances between portable and mobile RF communications equipment and the Pentacam® AXL Wave, IEC 60601-1-2:2007, table 6 The Pentacam® AXL Wave in intended for us e in an electromagnetic environment in which radiated RF distur- bances are controlled. The customer or the user of the Pentacam® AXL Wave can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters ) and the Pentacam®...

  • Page 100: Description Of The Connection

    20 Annex 20.3 Description of the Connection Pentacam® AXL Wave Y cable Power supply adapter (05150150) Computer/PC/laptop Mains connection 95 / 100 Instruction Manual Pentacam® AXL Wave (G/70020/XXXX/EN – Rev08)

  • Page 101: Data Sheet Hemg 49-S240210-7 (05150150)

    20 Annex 20.4 Data Sheet HEMG 49-S240210-7 (05150150) H HiTRON UNIVERSAL INPUT AC-DC MEDICAL & ITE APPLICATION EXTERNAL DESKTOP SWITCHING ADAPTER 48-50 WATTS GREEN POWER SINGLE OUTPUT HEMG49 SERIES FEATURES: ACCOMMODATE UNIVERSAL AC INPUT MEET MEDICAL STANDARDS IEC60601-1 & ITE STANDARDS IEC60950-1 EMI MEET EN 55011 &...
  • Page 102 20 Annex OUTPUT VOLTAGE / CURRENT RATINGS CHART SINGLE OUTPUT MODEL NO. AC INLET O/P VOLTAGE O/P CURRENT IEC320-C14(DT7) 4.0A HEMG49-S120400-7 12.0Vdc IEC320-C8(DT8) 4.0A HEMG49-S120400-8 12.0Vdc IEC320-C14(DT7) 3.3A HEMG49-S150330-7 15.0Vdc IEC320-C8(DT8) 3.3A HEMG49-S150330-8 15.0Vdc HEMG49-S240210-7 IEC320-C14(DT7) 24.0Vdc 2.1A HEMG49-S240210-8 IEC320-C8(DT8) 24.0Vdc 2.1A MECHANICAL DIMENSIONS:...

  • Page 103: Instructions For Integration Into An It-Network

    20 Annex 20.5 Instructions for integration into an IT-Network The device, in conjunction with the connected computer and the device software running on it, forms a programmable electrical medical system (PEMS) according to IEC 60601-1. It is essential that you follow the section “Cybersecurity Instructions” page 12 of “Safety Instructions”...
  • Page 104 20 Annex List of hazard situations that result from the IT-Network being unable to provide the features that are required to fulfill the purpose of inte- grating the PEMS into to meet the IT-Network:  Loss of data unsuitable data exchange ...
  • Page 105 20 Annex Instruction Manual Pentacam® AXL Wave (G/70020/XXXX/EN – Rev08) 100 / 100...
  • Page 106 Manufacturer and Service Address Headquarters: OCULUS Optikgeräte GmbH Münchholzhäuser Straße 29 • 35582 Wetzlar • GERMANY Tel. +49 641 2005-0 • Fax +49 641 2005-295 E-Mail: export@oculus.de • www.oculus.de 101 / 101 Instruction Manual Pentacam® AXL Wave (G/70020/XXXX/EN – Rev08)

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