Zeiss i.Profiler plus, User Manual

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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