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Performance specifications

000000-1520-928_GA_EN_021013

16

Service life

WARNING - GENERAL HAZARDS

The development, production and maintenance of this device, together

with associated risks, are based on an expected useful life of eight years.
Only specialist personnel trained by the manufacturer may make

modifications to the product.
Unauthorized changes will void the warranty.
Changes to the product or failure to follow the manufacturer’s instructions

may substantially reduce the expected service life and significantly increase

the risk associated with use of this device.

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Содержание i.Profiler plus

Страница 1: ...i Profiler plus User manual...

Страница 2: ...ows is a registered trademark of Microsoft Corporation Inc Other brand names software and hardware names used in this user manual are generally subject to trademark or patent protection Naming other p...

Страница 3: ...tional description 12 Wavefront measurement 12 Topography measurement 14 Service life 16 Description of the device 17 Installation 19 Installation 21 Electrical connection 22 Calibration touch screen...

Страница 4: ...xplaining the i Profiler plus measurement procedure to the patient 42 Positioning the patient for measurements 44 Shutting down 45 Switching off the device 45 Maintenance and care 47 Fault remedy 47 P...

Страница 5: ...imperative for its safe and successful function You should therefore ensure that you are thoroughly familiar with this user manual before using the i Profiler plus the first time The user manuals and...

Страница 6: ...appropriately marked in the user manual and on equipment labels WARNING Indicates a hazardous situation which may result in fatal or serious bodily injury if the appropriate safety precautions are not...

Страница 7: ...tware conforming to the requirements stated in this user manual may be used The device is delivered with the following components Power cable Paper for chin rest Printing paper roll Stylus pointer for...

Страница 8: ...Further notes on classification are to be found in section Technical data The device complies with EC Directive 93 42 MDD concerning medical devices Device class according to MDD IIa Laser class Class...

Страница 9: ...on the human eye for optimization of measurement quality Standard acoustic and optical warning signals displays on medical devices during a measuring procedure on the human eye Standard device interfa...

Страница 10: ...er cataract surgeon refractive surgeon ophthalmologist should have the experience described under user profiles I IA and IB In addition he she should have a sound knowledge of Accuracy interpretation...

Страница 11: ...the relevant national regulations Disposal of the product within the EU In accordance with applicable EU guidelines and national regulations at the time at which the product was brought onto the mark...

Страница 12: ...Country specific information and labels 000000 1520 928_GA_EN_021013 10 Labels Fig 1 Type plate on the i Profiler plus...

Страница 13: ...520 928_GA_EN_021013 11 1 Type plate of i Profiler plus Application part type B EU conformity mark Fuse P N Catalog number part number S N Serial number Crossed waste bin see chapter Disposal of the p...

Страница 14: ...i Profiler plus offers two basic measuring options Precision wavefront measurement with Hartmann Shack technology Placido disc corneal topography with central and peripheral keratometry Wavefront meas...

Страница 15: ...cro lens array and a video CCD camera Each micro lens of the array creates a light spot on the camera chip forming a pattern of light spots Fig 3 The position of the light spots is evaluated with the...

Страница 16: ...is Other abnormalities higher order aberrations result in characteristic irregular structures in the wavefront map A wavefront measurement is only a snapshot of the optical state of the patient s eye...

Страница 17: ...rnea The smaller the radius of curvature of the cornea the narrower the rings and the closer they are together The flatter the cornea the wider the rings and the farther apart they are If the corneal...

Страница 18: ...are based on an expected useful life of eight years Only specialist personnel trained by the manufacturer may make modifications to the product Unauthorized changes will void the warranty Changes to t...

Страница 19: ...tical measuring head 2 LCD touch screen swivel mounted 3 On Off button 4 Stylus pointer Fig 6 i Profiler plus view from the operator side Fig 6 and Fig 7 show the i Profiler plus from the operator and...

Страница 20: ...0 928_GA_EN_021013 18 1 Device base with computer and electronics 2 Motorized chin rest 3 Two button control of chin rest on both sides 4 Exit aperture of measuring optics 5 Forehead rest Fig 7 i Prof...

Страница 21: ...ctive earth conductor Ensure that the power supply plug is suitable and certified for the local connection If the supplied power cable must be replaced at least the following specifications must be ad...

Страница 22: ...expose the device to water splashes dripping or sprayed water The manufacturer accepts no liability for damage caused by unauthorized access to the interior of the device Such actions will also render...

Страница 23: ...r plus Set up the device so that no light sources ceiling lamps spots etc are directed at the measuring zone or surrounding area forehead rest measuring head We recommend the use of a height adjustabl...

Страница 24: ...r power cable 8 In built printer paper prints 9 USB port Fig 9 Connection panel on the i Profiler plus WARNING RISK OF ELECTRIC SHOCK If connecting external devices to the interfaces of the i Profiler...

Страница 25: ...by clicking on OK Double click on the Save Configurations program icon on the Microsoft Windows desktop to save the new configuration The device will restart Connection of an external monitor Connect...

Страница 26: ...grating the i Profiler plus into an existing network via DHCP Connect the i Profiler plus to the practice network LAN using a network cable After the start quit the i Profiler plus software by pressin...

Страница 27: ...elect the Ethernet connection used by your network in the Network Adapter field The left connection is marked 00000000 the right connection 00000001 Enter the new IP address in the IP Address field Th...

Страница 28: ...vironment it must be additionally connected via an isolation transformer CAUTION RISK DUE TO FAULTY DATA Only a PostScript capable network printer may be used The i Profiler plus only supports PostScr...

Страница 29: ...ware description of the i Profiler plus select the Printer configuration option administrator privileges required The Message dialog will open Confirm with Yes The Printer Setup dialog for configuring...

Страница 30: ...configuration option administrator privileges required The Message dialog will open Confirm with Yes A dialog for configuring the printer will appear Press the Add New Printer button The Printer Conf...

Страница 31: ...ns instructions for configuring a network attached storage device or NAS device for use with the i Profiler plus These instructions specify the requirements and recommendations for the NAS device Eith...

Страница 32: ...at least 3 m long so that the NAS device can be located outside the reach of patients see above safety precautions Recommendations for the NAS device Storage capacity Should be at least as large as t...

Страница 33: ...ofiler plus A light at the front of the NAS device often indicates by a change of color that initialization has been completed For more detailed instructions see the manufacturer s operating manual In...

Страница 34: ...Close Application button in the Shut Down window and switch to the Microsoft Windows desktop administrator rights required The LAN connection may be indicated in the task bar bottom right when the NAS...

Страница 35: ...ktop administrator rights required The LAN connection may be indicated in the task bar bottom right when the NAS device is connected Ignore this message for the time being Open Windows Explorer Enter...

Страница 36: ...type and length Switch on the PC Configure the PC with the aid of the user manual provided with the device as follows IP address 192 168 103 101 when using the right network connection or 192 168 100...

Страница 37: ...n the Review Station The Archive directories to be synchronized dialog is displayed Click on Add and use the Open dialog to select the ATLAS i Profiler plus archive file Archive xml in the local direc...

Страница 38: ...er or create a new folder to which the data from the i Profiler plus is to be saved Open the Tools menu from the menu bar Select Map Network Drive The Map Network Drive dialog appears Select a free dr...

Страница 39: ...e and password of the user account previously created on the storage device must be re entered Configuration of the Atlas Review Station Click on Archive and then on Synchronize volume in the Review S...

Страница 40: ...out of service The ventilation slits in the casing should not be covered or otherwise obstructed Test of measuring functions on the test eye pair WARNING RISK OF ELECTRIC SHOCK Please take care that...

Страница 41: ...eye pair must be performed pursuant to the instructions in the i Profiler plus Software description CAUTION RISK OF MEASURING ERRORS The calibration of the test eye pair should be checked each day pr...

Страница 42: ...ise and judgment Users should compare measurement results obtained with the i Profiler plus with other diagnostic data e g ophthalmometer patient s refraction data WARNING GENERAL HAZARDS The patient...

Страница 43: ...e window Position the patient for measurement see page 44 Select the patient to be measured in the database and start measurements Measurement window Complete the measurements and evaluate your result...

Страница 44: ...f upright in front of the medical device Lacking transparency of the optical media of the eye for wavefront refraction measurements e g cataract with lens clouding stronger than grade NO1 according to...

Страница 45: ...m removal of the lens to the time of measurement should be at least three weeks Two measurements must be made of the central keratometry and two of the manifest refraction at an interval of at least o...

Страница 46: ...pes on the balloon If the patient fails to see the balloon at first ask him or her to continue looking until the balloon appears Ask the patient shortly before the measurement to avoid any movement du...

Страница 47: ...lete disconnection from the power supply is only possible by pulling the power cable WARNING GENERAL HAZARDS If one of the following events should occur switch the device off immediately at the power...

Страница 48: ...goes off before switching off at the power switch 6 Fig 9 pulling the power supply plug or switching off at the main room switch If you switch off the device while it is in operation pull the power su...

Страница 49: ...ms persist please contact Carl Zeiss Vision Problems with the electric system Fault Problem Possible causes Remedy The standby control lamp does not light up when the power switch has been switched on...

Страница 50: ...per Problems with the flexible optical measuring head Fault Problem Possible causes Remedy The optical measuring head does not move Cable problem Controller problem Switch the device off wait a minute...

Страница 51: ...e right or left and cannot be centered with the aid of the touchscreen error message appears The patient s head is laterally misaligned The patient s head is tilted Correct the position of the patient...

Страница 52: ...s a cataract Gradually increase sensor sensibility The device does not measure at all The patient has a cataract Electrical problem Gradually increase sensor sensibility Switch the device off wait a m...

Страница 53: ...witch of the i Profiler plus 1 Fuses 2 Fuse carrier 3 Lid of fuse box Fig 10 Replacing fuses in the i Profiler plus Unplug the power cable The fuse box can only be opened after unplugging the power ca...

Страница 54: ...per compartment Care and cleaning WARNING RISK OF ELECTRIC SHOCK Prevent moisture from penetrating the instrument or keyboard Disconnect the power cable from the power supply before cleaning or disinf...

Страница 55: ...ponents Damage caused by such disinfectants is not covered by our warranty Never use aggressive or abrasive cleaning agents Never clean the exit aperture of the measuring optics 4 Fig 7 page 18 The ex...

Страница 56: ...f protection against the penetration of water and foreign bodies IP 20 Degree of protection against electric shock B Laser data at device output Laser class at device output Wavelength Maximal power o...

Страница 57: ...ion sphere 20 D to 20 D 3 5 mm pupil Range of action sphere 15 D to 15 D 5 5 mm pupil Range of action cylinder 0 D to 8 D Axis 0 to 180 Measuring surface 2 0 mm to 7 0 mm three zones Number of measuri...

Страница 58: ...environment guidance RF emissions CISPR 11 Group 1 The i Profiler plus uses RF energy only for its internal function Therefore its RF emissions are therefore very low and are not likely to cause any...

Страница 59: ...output lines Mains power quality should be that of typical commercial or hospital environments Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to eart...

Страница 60: ...termined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Rad...

Страница 61: ...f transmitter P W Separation distance according to frequency of transmitter d m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d P U 3 5 1 d P E 3 5 1 d P E 7 1 0 01 0 117 0 117 0 233 0 1 0 37...

Страница 62: ...ernational Electrotechnical Commission LAN Local area network Local network LOCS III Lens opacity classification system III Lens clouding classification system NAS Network attached storage Network att...

Страница 63: ...il 13 Fig 4 Imaging beam path of a topography measuring device with a Placido disc 14 Fig 5 The image of the rings of the Placido disc on the camera for a normal cornea A and a distorted cornea B 15 F...

Страница 64: ...s 22 Controls 17 D Data entry 20 Description of the device 17 Disposal 9 E Electromagnetic compatibility 56 F Fault remedy 47 Figures 61 First time set up 38 Function test 39 Functional description 12...

Страница 65: ...itioning 44 Performance specifications 12 Printer installation 26 R Recessed handles 21 S Service life 16 Shutting down 45 Software description 40 Specified purpose 7 Symbols 4 T Technical data 54 Top...

Страница 66: ...Carl Zeiss Vision GmbH Turnstrasse 27 73430 Aalen Germany 000000 1520 928_GA_EN_021013 i Profiler plus Specifications subject to change...

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