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14 Cleaning, Disinfection and Maintenance

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Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)

14.2

Disinfection



Recommendation: Use disinfection wipes suitable for medical
devices, for example:

Mikrozid sensitive wipes premium; Fa. Schülke & Mayr

Softpack 48 Stück / Art. Nr. 165711

Schülke & Mayr GmbH; Tel: +4940521000 / Fax: +494052100318

[email protected]; www.schuelke.com

Note

Equipment damage caused by disinfectant solution

The disinfectant solution may damage the surface of the device if it is
sprayed directly on it.



Spray the disinfectant solution onto a cleaning cloth, do not spray it
directly on the device.



Disinfect the forehead rest after each examination.



If you do not use paper for the chinrest, disinfect the chinrest after
each examination.

Содержание Pentacam AXL

Страница 1: ...OCULUS Pentacam AXL INSTRUCTION MANUAL System for measuring the anterior eye segment and optical biometry...

Страница 2: ...e patient data the default settings of the Pentacam AXL program and the measuring process The Pentacam AXL reference manual contains information supplementing the description of the operating concept...

Страница 3: ...nagement 22 8 1 Starting Patient Data Management 22 8 1 1 Entering a New Patient 22 8 1 2 Selecting an Existing Patient 23 8 2 Starting the Pentacam AXL Software 24 9 Pentacam AXL Program 25 10 Scan M...

Страница 4: ...in Rest 66 15 Troubleshooting 67 16 Transport and Storage 68 16 1 Information on Transport and Storage 68 16 2 Disassembly 69 16 3 Transport and Storage 69 17 Disposal 70 18 Terms of Warranty and Serv...

Страница 5: ...0 70108 05460335 Additional Export package with head and chinrest Support plate Cograil Cover Sliding plate Chinrest paper Head and chin rest 70734 017051501012 027051701004 027051701005 017051701006...

Страница 6: ...der number Standard software package Pentacam AXL Floating License Key with manual 77900 SI 77900 de Viewing License Pentacam AXL 70725 Fast Screening Report 70927 IOL Calculator 70110 Belin Ambr sio...

Страница 7: ...bols on the device Symbols packaging Manufacturer Protection class Keep dry Date of manufacture IP XX Type of protec tion This way up Conformit eu rop enne Article number Fragile Follow instruction fo...

Страница 8: ...entacam AXL Attention All safety related instructions for use of the Pentacam AXL are given in the Instruction Manual for the unit It is imperative that you read and understand the whole Instruction M...

Страница 9: ...Attention Identifies a potentially dangerous situation which may cause minor injury or damage to property Note Denotes situations which could result in incorrect findings denotes user instructions and...

Страница 10: ...certain that the Pentacam AXL is used exclusively in clinics and by eye specialists and opticians trained staff etc It must be used in the area designated for carrying out examinations For this reaso...

Страница 11: ...e or similar products Set up the Pentacam AXL 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 Do not force any...

Страница 12: ...on 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 n...

Страница 13: ...entacam AXL including rechargeable battery or cable down onto devices that produce heat heaters for example radiators microwaves or similar Only operate the device if you have understood the operating...

Страница 14: ...y or damage to property due to an incorrect level of safety Connecting the Pentacam AXL with its non medical electrical equipment e g data processing equipment to a medical electrical system must not...

Страница 15: ...shorter you must ensure that the Pentacam AXL functions correctly 4 3 Cybersecurity Instructions The device itself was not designed to connect via a coupled computer to the internet or other network...

Страница 16: ...red or suspected the Healthcare Organization s IT network administrators suspend and modify the user login criteria and issue new login credentials for the user to access their account securely Unavai...

Страница 17: ...nect the computer to the LAN or internet you are responsible for ensuring data security Prefer wired connections of the computer to the network If you are using Wi Fi connections nevertheless please e...

Страница 18: ...opacity analyze the location of cataracts nuclear sub capsular and or cortical using cross slit imaging with densitometry corneal thickness axial length white to white distance The Pentacam AXL also p...

Страница 19: ...xclusively in clinics and by clinical persons or eye specialists who can guarantee proper handling due to their knowledge training and practical experience who have been instructed by OCULUS staff or...

Страница 20: ...6 Device Description 6 1 Overview of the device components 1 Ventilation opening 5 Y cable connector 2 Measuring window 6 Cross slide 3 Camera opening 7 Sliding plate with circular markings 4 On off...

Страница 21: ...recorded and taken into account A quality specification QS lets you gauge the quality of the measurement taken The mathematical 3D model corrected for eye movements provides the basis for all subseque...

Страница 22: ...rom the power supply for any repairs or maintenance work Place the device so that direct light cannot affect the measurement Make sure the examination is free from light reflections To achieve this da...

Страница 23: ...75 If you use a power strip to connect the Pentacam AXL Use a power strip that complies with the requirements of DIN EN 60601 1 Do not place the multiple socket extension cord on the floor Do not use...

Страница 24: ...authorized distributor to repair the damage Firmly tighten the connection Connect the Y cable to the PC laptop and the power adapter 7 2 Switching On Attention Risk of incorrect measurements due to i...

Страница 25: ...me Pentacam AXL software version installed A Floating License Key is part of every Pentacam AXL shipment Please ensure a proper installation based on the Manual for the Floating License Key This allow...

Страница 26: ...a Management appears To get to the Pentacam AXL program you must first enter a new patient 8 or select an existing patient from the patient list 7 For more information on Patient Data Management refer...

Страница 27: ...oose Search to quickly find the patient you are looking for in the list Enter the patient s name or the first letter of the name in the Last name field Alternatively you can search for the patient usi...

Страница 28: ...t name 8 2 Starting the Pentacam AXL Software Switching from Patient Data Management to the Pentacam AXL program After selecting a patient Press the Pentacam button to start the Pentacam AXL program f...

Страница 29: ...ssional correlation with other clinical findings and diagnostic tests Loading previous examinations Select the menu item Examination and click Load The dialog box Load Examination appears Make a selec...

Страница 30: ...o starting the measuring process and loading previous examinations The Reference manual contains detailed information on the functions of the Pentacam AXL program Helpful information The Pentacam AXL...

Страница 31: ...d 1 The Overview Image 2 shows the pupil and a cross hair as an adjusting aid You can set the type of image required for the respective examination in the Image Options area 3 sec 10 1 1 page 28 and s...

Страница 32: ...e Pentacam AXL to activate automatic measurement Automatic Release The Fixation Target setting 8 is a parameter to optimize the fixation This line 9 shows messages about the device for example if a se...

Страница 33: ...on group box If you select this option the camera will record Scheimpflug images from 50 different positions while performing a full rotation twice around the eye Accommodation group box If you select...

Страница 34: ...n accurate representation of phakic IOLs If you select this recording mode colours and evaluations are neither calculated nor displayed Fixation Target slider Use of the Fixation Target enables a bett...

Страница 35: ...correct measurement caused by little movements of the patient Due to the little movements caused by the wheel chair or rolling stool the patient is not proper aligned to the Pentacam AXL Perform a Pen...

Страница 36: ...mm Curvature 0 18mm equals approximately in 1D based on a refractive index of 1 3375 Difference of IOL power to reach emmetropia by same target refraction 1D The following conditions may influence the...

Страница 37: ...and the Pentacam AXL simultaneously 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 Adjust th...

Страница 38: ...side and make sure that his her eye is in front of the measuring window If necessary adjust the position of the cross slide to the left or right Darkening the room dark sheet If the lighting in the ex...

Страница 39: ...re the better is the adjustment Adjust the left right position of the Pentacam AXL and its height setting Move the joystick to the left or right and rotate the joystick clockwise or anticlockwise The...

Страница 40: ...e ring surrounded by four black lines The Pentacam AXL will automatically begin measuring alternately you can start the measuring procedure manually For measuring manually Start measuring by clicking...

Страница 41: ...population Check the axial length values of both eyes The plausibility is marked by a yellow flagged QS value This will be stored in the Pentacam AXL programme accordingly This symbol related to the...

Страница 42: ...ty 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 programme ac...

Страница 43: ...onto the chin rest or the chin rest has been cleaned and disinfected sec 14 page 62 the forehead rest has been cleaned and disinfected after each examination sec 14 page 62 the illuminated slit with t...

Страница 44: ...hinrest Swing the test eye to the side and then adjust the chinrest 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 coi...

Страница 45: ...light is not visible ensure that you have activated the Slit Light checkbox on the Scan screen Darkening the room dark sheet If the lighting in the examination room has not been turned down or switche...

Страница 46: ...121 Rev04 1 Eye field 7 Adjustment window 2 Overview image 8 Fixation Target 3 Image Options area 9 Message about device 4 Slit Light checkbox 10 Quit button 5 Automatic Release checkbox 11 Orientatio...

Страница 47: ...ck towards the Pentacam or away from it Adjust the left right position of the Pentacam AXL and its height setting Move the joystick to the left or right and rotate the joystick clockwise or anticlockw...

Страница 48: ...automatically begin measuring alternately you can start the measuring procedure manually For measuring manually Start measuring by clicking Start Scan or by pressing the return key Attention It may n...

Страница 49: ...y Specifications in the Pentacam AXL program After you have measured either automatically or manually the Pentacam AXL program opens The QS value appears in field 1 Note All examinations are automatic...

Страница 50: ...f only one of six SNR values is valid it will only be displayed as an red single value even though the SNR value is above the limit 1 6 x mm y mm z mm Display of all six single scans with results Via...

Страница 51: ...roduced SNR 6 3 is yellow you may want to repeat the measurement SNR 5 0 is red must repeat the measurement SNR 5 0 If the QS displayis highlighted in yellow click on the QS button The following dialo...

Страница 52: ...del Deviation deviation of measured cornea from calculated 3D model Alignment XY and Alignment Z If one of these values exceeds the permissible threshold you may have moved the cross slide at the mome...

Страница 53: ...tions in the Pentacam program After you have begun measuring either automatically or manually the Pentacam program opens The QS value appears in field 1 Note All examinations are automatically saved r...

Страница 54: ...patient must widen his or her eye Valid Data If this value is less than the permissible threshold you must darken the room Lost Segments and Lost Seg Continuous If one of these values exceeds the per...

Страница 55: ...minating QS Click Cancel to return to the Pentacam program If required delete the measurement if the image is inadequate Terminate the current examination which has been saved If required make prepara...

Страница 56: ...tient data you can edit it Press the Change button The input boxes for patient data are now enabled and the cursor jumps to the Last name field Change the entries in the individual boxes Press the Sav...

Страница 57: ...ld be exported Confirm your selection with OK or Save Select whether the data with or without camera images and possibly to be exported anonymously Click Export to export the data The patient and exam...

Страница 58: ...ta Run a virus check before importing data from the USB flash drive Press the Import button The following dialog appears The default options for import and export of data are configured in the Setting...

Страница 59: ...mination data at regular intervals In case of loss of data you can reconstruct the data from a previously created backup with the help of this function Since data backup takes several minutes dependin...

Страница 60: ...that appears select the folder to which the data should be backed up Confirm your selection with OK To back up the data press the Save button 5 The previously selected data will then be backed up to...

Страница 61: ...ve successive measurements on each eye Calculate the arithmetic mean and log the results Once a month this measurement sequence should be carried out on the same eye as described above Compare the ari...

Страница 62: ...100 EN 1121 Rev04 Use the Allen key to attach the test eye to the chin and head rest directly underneath the retainer for the head rest Make sure that the test eye is in park home position when it is...

Страница 63: ...formed daily before the first Full Sequence Examination After the Full Sequence Mode is selected the following screen appears Follow the instructions on the screen type in the axial length of the test...

Страница 64: ...gn the Pentacam AXL to the test eye Fine adjustment page 44 Press Start Scan or press the return button to start the test measurement manually In case the test measurement is ok the following message...

Страница 65: ...f also this test measurement is not successfull please call your authorized dealer To finish this process click OK In case you had to replace the test eye because of any reason you have to type in the...

Страница 66: ...the Pentacam AXL with aggressive chlorine containing abrasive or sharp cleaning agents Clean the cover glass from time to time to retain the high measurement accuracy of the Pentacam AXL and to avoid...

Страница 67: ...of the Pentacam AXL Do not use liquid from aerosol cans Clean the chin forehead rest with a soap solution or with alcohol if very dirty Use a lint free damp cloth Cleaning the illuminated slit The op...

Страница 68: ...65711 Sch lke Mayr GmbH Tel 4940521000 Fax 494052100318 E Mail schuelke com www schuelke com Note Equipment damage caused by disinfectant solution The disinfectant solution may damage the surface of t...

Страница 69: ...fter 25000 scans A corresponding message appears By daily pop up window In the settings see User Guide In the scan menu sec 10 page 27 In examinations it will be stored Let the Pentacam AXL checked by...

Страница 70: ...to invisible Class 3R 5 mW laser radiation Never open the unit For authorized service personnel only When doing maintenance jobs avoid looking directly into the laser beam 14 4 Attaching Paper to the...

Страница 71: ...the power adapter Check whether the indicator light on the power supply is on If not connect the power supply to the mains Connection cable of the Pentacam AXL is not plugged properly Check wether th...

Страница 72: ...ed before being transported or stored 16 1 Information on Transport and Storage Storage Transport Ambient temperature range 10 C to 55 C Relative humidity including condensation 10 to 95 Air pressure...

Страница 73: ...ting electrical connections pull on the respective plug and not on the cable itself 16 3 Transport and Storage Attention Risk of equipment damage due to incorrect shipment or from improper storage Avo...

Страница 74: ...e device it is important that you heed the instruction manual and safety instructions In accordance with legal regulations you are entitled to a warranty for the Pentacam AXL If modifications are made...

Страница 75: ...rized persons request a certification of the scope and type of repair and if necessary the changes to the standard values or to the operating range from the service technician This certification must...

Страница 76: ...max 138 000 Dimensions W x D x H measuring head 275 x 320 to 400 x 500 to 530 mm 10 8 x 12 6 to 15 7 x 19 7 to 20 9 in Weight Pentacam AXL measuring head 8 4 kg 18 5 lbs Corneal topographer according...

Страница 77: ...pectancy Up to 10 years Type of protection against electrical shock protection class 2 Level of protection against electrical shock type B Level of protection against damaging water entry IP20 Tempera...

Страница 78: ...Devices MDR The unit is a Class IIa product Conformity assessment procedure EU 2017 745 MDR Annex IX excluding chapter II Classifikation according to IEC 60825 1 2014 Recommended computer specificati...

Страница 79: ...of permitted degradations during or as a consequence of the EMC test without affecting the basic safety A short interruption of the USB connection during the examination is permissible because it will...

Страница 80: ...A 70002 Y cable with galvanic isolation 2 m Guidance and manufacturer s declaration electromagentic emissions IEC 60601 1 2 5 2 2 1 table 1 The OCULUS Pentacam AXL is intended for operation in the ele...

Страница 81: ...kV differential mode 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply in...

Страница 82: ...s than the compliance level in each frequency range b Interferences may occur in the vicinity of equip ment marked with the following symbol Note 1 Note 2 At 80 Hz and 800 MHz the higher frequency ran...

Страница 83: ...t Rated maximum output pow er of transmitter W Separation distance according to frequency of transmitter m 150 KHz to 80 Mhz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12...

Страница 84: ...20 Annex 80 85 Instruction Manual Pentacam AXL G 70100 EN 1121 Rev04 20 3 Description of the Connection Pentacam AXL Y cable Computer PC laptop Power supply adapter 05150150 Mains connection...

Страница 85: ...dard Meet Medical IEC60601 1 ITE IEC60950 1 Class I for DT7 C14 or Class II for DT8 C8 Operating Temperature 0 C to 40 C Storage Temperature 20 to 85 C Cooling Free air convection Construction Impact...

Страница 86: ...IGHT 373 0g 13 2 Oz SINGLE OUTPUT MODEL NO AC INLET O P VOLTAGE O P CURRENT HEMG49 S120400 7 IEC320 C14 DT7 12 0Vdc 4 0A HEMG49 S120400 8 IEC320 C8 DT8 12 0Vdc 4 0A HEMG49 S150330 7 IEC320 C14 DT7 15...

Страница 87: ...s minimum Required configuration of the IT Network into which the PEMS is to be integrated Licensing required opened ports 3968 TCP 51371 51372 UDP Storage printing data export File and Printer Shari...

Страница 88: ...n unauthorized access to data Connection of the PEMS to an IT Network that includes other equipment could result in previously unidentified risks to patients operators or third parties The responsible...

Страница 89: ...20 Annex Instruction Manual Pentacam AXL G 70100 EN 1121 Rev04 85 85...

Страница 90: ...turer and Service Address Headquarters OCULUS Optikger te GmbH M nchholzh user Stra e 29 35582 Wetzlar GERMANY Tel 49 641 2005 0 Fax 49 641 2005 295 E Mail export oculus de www oculus de G 70100 EN LO...

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