VISUPHOR 500 Digital phoropter Documentation set
© 2022, Carl Zeiss Meditec AG, Jena All rights reserved in the event of granting of patents or registration as a utility patent. All names of companies and products cited in this documentation set may be trademarks or registered trademarks. Third party products are cited for information purposes only. This does not represent approval or recommendation of these products. Carl Zeiss Meditec AG accepts no liability for the performance or use of such products.
Contents User manual VISUPHOR 500 Digital Phoropter [000000-2075-933-GA-enGB-230822] 000000-2075-933-Inhalt0-en-GB-230822
VISUPHOR 500 Digital phoropter User manual
Notice FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
IC Statement This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe B est conforme á la norme NMB-003 du Canada. This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
Contents 1 Contents Contents.................................................................................... 1 Notes on the user manual ......................................................... 3 Purpose and availability of the documentation.............................................. 3 Questions and comments.............................................................................. 3 Explanation of symbols used ..........................................................................
2 Contents Operation of the device ........................................................... 35 Shutting down ......................................................................... 42 Switching off the device.............................................................................. 42 Maintenance and care ............................................................. 43 Troubleshooting...........................................................................................
Notes on the user manual 3 Notes on the user manual Purpose and availability of the documentation This user manual describes the safety precautions, functions, usage, performance parameters and care and maintenance measures of the VISUPHOR 500 Digital Phoropter. Correct operation of the system is imperative for its safe and successful function. You should therefore ensure that you are thoroughly familiar with this user manual before setting up and using the VISUPHOR 500 the first time.
4 Notes on the user manual Explanation of symbols used The symbols used in this user manual refer to important safety information which may warn against possible health risks or fatal injuries and contain useful notes. Whenever you see these symbols, read the accompanying information carefully and observe all safety notes and information in this user manual and on device labels.
Package check list 5 Package check list The package includes the basic device comprising the phoropter head and junction box and also the parts shown below. 1 2 3 4 5 6 7 8 9 10 11 Fig. 1 Phoropter head connecting cable Fastening screws with screw covers for covering the connector compartment (Fig.
Package check list 6 Adapter for mounting the Adapter for mounting the Adapter for mounting in axial device to the bottom part device to the front part of a direction of a support arm of a support arm support arm ZDR10 including mounting set (4 Allen screws M4x12mm and 4x corresponding E-rings D 7.4 mm) ZDR18 with 3 spacers ZDR14 ZDR19 ZDR20 (optional) ZDR15 ZDR16 ZDR17 Fig. 2 Mounting set 1: 4 Allen screws M3x10 mm, 4 corresponding E-rings D 5.
Country-specific information and labels 7 Country-specific information and labels Classification/Manufacturer's declaration WARNING - GENERAL HAZARD This device may be set up, operated and used only for the intended use and in accordance with local country-specific regulations, generally accepted engineering standards and occupational safety and accident prevention regulations. Further notes on classification are to be found in Section Technical data, page 56 and following.
8 Country-specific information and labels Intended use VISUPHOR 500 Digital Phoropter is used to identify refractive values based on feedback from the patient being examined (subjective refraction). The device is used to support eye care/ophthalmology specialists (ophthalmologists, optometrists and opticians) when prescribing corrective eyeglasses and contact lenses. VISUPHOR 500 Digital Phoropter is a computer-controlled unit for the subjective refraction of patients.
Country-specific information and labels 9 Notification to manufacturers and authorities In member states of the European Union, the responsible organization or person must report serious incidents to his competent authority. In all other countries, comparable rules apply where national legislation so requires. Disposal of the product The packing material should be kept to be used for a future move or for repairs.
10 Country-specific information and labels External labels 3 10 14 12 6 7 8 5 4 1 11 9 Fig.
Country-specific information and labels Item Label 11 Explanation Type label 1 Manufacturer Date of manufacture Applied part type B DC voltage Identification label 2 Catalogue number/part number Serial number Serial number as barcode REF SN Bottom: 3 4 Device identification code (data matrix, serial number, and device name) Not applicable Not applicable 5 "Observe user manual" information label 6 CE approval label and disposal advice for EU EU conformity symbol with identification number of
Country-specific information and labels 12 Item Label Explanation Country of origin label 9 10 Not applicable Not applicable 11 Not applicable Not applicable Label for marking the device as a medical device 12 13 Not applicable Not applicable 14 Not applicable Not applicable 000000-2075-933-GA-en-GB-230822
Country-specific information and labels 13 6 9 10 3 1 5 2 8 4 Fig.
Country-specific information and labels 14 Item Label Explanation Type label 1 Manufacturer Date of manufacture Applied part type B AC voltage DC voltage Identification label 2 REF Catalogue number/part number SN Serial number Bottom: Serial number as barcode 3 Not applicable Not applicable 4 "Observe user manual" information label 5 CE marking label and disposal advice for EU EU conformity symbol with identification number of notified body Disposal advice for EU 6 Label with the MAC address
Country-specific information and labels Item Label 15 Explanation Approval label for Brazil 10 11 Not applicable Not applicable 12 Not applicable Not applicable 000000-2075-933-GA-en-GB-230822
16 Performance specifications Performance specifications Functional description The VISUPHOR 500 digital phoropter allows the subjective refraction for a patient to be determined easily within a very brief period. Objective refraction data, as provided by an automated refractometer/keratometer (ARK) can be transferred directly to the phoropter control unit via a digital interface. It then can be used as the starting point for the interactive optimization phase controlled by patient feedback.
Performance specifications 17 Characteristics VISUPHOR 500 offers the following functions: • Set-up for sphere, cylinder, prism • Various special lenses: cross-cylinder, Maddox rod, red/green filter, polarizing filter, ... • Automated occlusion of the examination window to minimize the adaptation of the patient’s eye during the change of lens • Setting up pupil distance • Variation of working distance for close range Detailed information on value ranges, tolerances, etc.
Description of the device 18 Description of the device Phoropter head 1 2 3 4 5 6 7 8 9 10 11 ZDR19 assembly adapter Spirit level Leveling screw to orient the phoropter head on the horizontal plane using the spirit level Control window for the patient’s corneal vertex distance Illumination for near-point chart Adjustment screw for forehead rest to set up the corneal vertex distance Mount for the fixing rod of the near-point chart Control lamp forehead rest Forehead rest Face rest Examination window Fig
Description of the device 19 Junction box Power connection - appliance socket for connection to the power cable Fuse compartment - slot for device fuses Power switch (on/off) - toggle switch for switching the device on (I) and off (O) Interface Com2 for connecting an autorefractor or digital lensmeter Interface Com1 for connecting an autorefractor or digital lensmeter Two-color status LED (green/blue) green: device is ready for use blue: Bluetooth connection with VISUSCREEN control unit is available 7 Se
20 Description of the device Near-point chart 1 2 3 4 5 6 7 8 Fig.
Installation 21 Installation Notes on installation and use WARNING - GENERAL HAZARD Do not store or operate the device in ambient conditions other than those prescribed (see Section Technical data, page 56 ). The device should be set up so that the power cable can be disconnected from the power supply quickly and easily without any tools. WARNING - RISK OF ELECTRIC SHOCK When connecting external devices to the interfaces of the device, you are configuring a medical system.
22 Installation WARNING - FIRE HAZARD The device is not suitable for operation in explosion risk areas (e.g. combustible mixture of anesthetic, cleaning or disinfecting agents with air, oxygen or nitrous oxide). The electrical installation must conform to IEC 60364-7-710. CAUTION - PROPERTY DAMAGE Do not store or use this device in damp rooms. Do not expose the device to water splashes, dripping water or sprayed water.
Installation 23 Interfaces to mount the phoropter head 1 Fixing bolts Fig. 8 Interface dimensions for vertical mounting of the phoropter head 1 Assembly adapter ZDR10 2 Screws (M3x14 mm) and corresponding E-rings belonging to ZDR19 (see 3, Fig. 15) 3 Screws and corresponding E-rings for mounting set belonging to ZDR10 Fig.
24 Installation 1 2 3 4 Assembly adapter ZDR14 Screws and E-rings from mounting set 1 Screws and E-rings from mounting set 2 Screws not included in the package (use screws (M5) fitting to supporting arm) Fig.
Installation 25 1 Assembly adapter ZDR15 2 Screws and E-rings from mounting set 1 3 Screws not included in the package (use screws (M4) fitting to supporting arm) Fig.
26 Installation 1 2 3 4 5 Assembly adapter ZDR16 Screws not included in the package (use screws (M4) fitting to supporting arm) Assembly adapter ZDR14 Screws and E-rings from mounting set 1 Screws and E-rings from mounting set 2 Fig.
Installation 27 1 Assembly adapter ZDR17 2 Screws and E-rings from mounting set 1 Fig. 13 Interface dimensions for mounting the phoropter head with the assembly adapter ZDR17 For assembly, add corresponding drill holes and threads into the supporting arm.
28 Installation 1 2 3 4 5 Assembly adapter ZDR18 Spacers (3 pc.) Screws not included in the package (use corresponding screws (M3)) Screws not included in the package (use corresponding screws (M4)) Screws not included in the package (use corresponding screws (M4)) Fig.
Installation 1 2 3 4 5 29 Assembly adapter ZDR19 or ZDR20 Fixing bolts Screws M3x14 mm and E-rings D 5.4 mm to screw the adapter to the fixing bolt Screws for vertical fixing of the phoropter head Knurled screw Fig.
30 Installation 1 Mounting for fixing rod 2 Screw for horizontal fixing of phoropter head (use one of the screws from mounting set 3 depending on the thread) Fig. 16 Interface dimensions for mounting the phoropter head with the assembly adapter ZDR19 1 Mounting for fixing rod Fig.
Installation 31 Interfaces to connect external devices The following devices can be connected to the ports Com1 (5, Fig. 6) and Com2 (4, Fig. 6): - VISULENS 500 Digital Lensmeter from software version v1.2.3 - VISUREF 100 Autorefractometer/Keratometer from software version v2.1.7 Proceed as follows: • Please turn all of the equipment involved off. • Connect the data interfaces for the devices listed above with the connections in the junction box to be used for this purpose.
Installation 32 • Close the unit again by slightly tilting the cover onto the retaining tabs of the housing, and then pressing the lower side inwards. • Retighten the knurled screw (1, Fig. 18). 1 2 3 4 5 Knurled screw VISUSCREEN housing cover Bluetooth/USB adapter USB port Antenna at junction box Fig.
Daily startup 33 Daily startup WARNING - GENERAL HAZARD Prior to using the device, the user must ensure that it is in a good condition and fully functioning. Furthermore, the user must follow the instructions in the user manual. The following inspections must be carried out each working day prior to use: • Visual inspection of the housing, exterior markings, user manual, accessories and power cable to ensure that they are present and intact.
34 Daily startup Switching on WARNING - GENERAL HAZARD If you notice smoke, strong smells, or suspicious noises, turn the device off immediately and remove the electrical plug. Contact your dealer. The power switch can be turned off at any time. The device requires no time to shut down. To remove the power cable, grip the plug. Do not pull the cable. Do not touch conductive components and the patient at the same time.
Operation of the device 35 Operation of the device CAUTION - PROPERTY DAMAGE Do not hit or drop the device. Impacts may damage the device and lead to a malfunction. Pay attention to ensure that the device does not become dirty, and do not expose it to any metallic dust or chips. CAUTION – HAZARD DUE TO MOVING PARTS Do not place your hands or fingers between the left and right wings of the phoropter head, and pay attention to ensure that your patients also do not place their hands or fingers there.
36 Operation of the device Preparation of the device: • Leveling - Check the horizontal mounting of the phoropter head using the spirit level (2, Fig. 5). - If necessary use the leveling screw (3, Fig. 5) to align the head. • Cleaning - Clean the face shield, the forehead rest and the examination window. Please note the information given in section Care and cleaning on page 48. • Use the near-point chart.
Operation of the device 1 2 3 4 5 6 7 Intersection between the head piece and the scale foot Mounting the near-point chart to the fixing rod Moving the near-point chart to set up the distance from the eye Turning the chart to select the front or rear Turning the turntable to select the optotype card Field for showing card number Fixing rod with scale Fig. 19 - 37 Set up near-point chart Select the desired optotype card. To select the card turn the chart to select the front or rear (4, Fig.
38 Operation of the device Selection table for optotype card Rearside Frontside Card number Description Number shown on the examiner’s side 1 Landolt rings 8 2 Optotype sequence for visual acuity 0.1, 0.2, 0.25, 0.32 7 3 Optotype sequence for visual acuity 0.4, 0.5, 0.63, 0.8, 1.0 6 4 Grid 5 5 Fan chart 4 6 Vertical number series 3 7 Horizontal number series 2 8 Optotype sequence for visual acuity 0.
Operation of the device 39 1 Near-point chart (collapsible) 2 Joint to fold up the fixing rod. Fig. 20 Fold up the near-point chart and fixing rod Transferring data • Take over the objective refraction data for the patient from FORUM, iCom or your practice management system into the control software.
40 Operation of the device Positioning the patient • Ask your patient to sit down in front of the phoropter or bring the phoropter into position in front of the patient. The patient has to be sitting comfortably and lean his head onto the middle of the forehead rest (9, Fig. 5). Pay attention to ensure that the head is in an upright position. • Adjust the corneal vertex distance (CVD) to 17 mm. To do this, look through the control window (1, Fig. 21).
Operation of the device 1 2 3 4 5 41 Control window Adjusting screw to set the CVD Reference line Reference triangles Vertex of the patient’s eye Fig. 21 Positioning the patient and setting up the CVD Perform examination When the PD data that have been set up are taken over into the control software, the illumination of the patient’s eyes ceases and the set-up for the objective refraction data (sphere, cylinder and axis) taken over from the PMS are used in place of the reticules.
42 Shutting down Shutting down Switching off the device If one of the following events should occur, switch the instrument off immediately at the power switch and disconnect the cable from the power supply. • Electric shocks • Penetration of substances • Smoke, sparks or strange noises • Faults that cannot be remedied based on the information provided in this user manual. Label the instrument clearly as being out of service and report the problem to the ZEISS service (contact details see reverse).
Maintenance and care 43 Maintenance and care WARNING - GENERAL HAZARD The device may only be opened, put into operation, modified and repaired by the manufacturer’s customer service technicians or specialists expressly authorized in writing by Carl Zeiss Meditec. If in doubt, insist on seeing the written authorization or contact Carl Zeiss Meditec directly. The manufacturer is not liable for damage caused by unauthorized tampering with the device. Such actions will render any warranty claims invalid.
44 Maintenance and care Replacing the forehead rest • Remove the forehead rest by pulling this away from the device. Fig. 22 000000-2075-933-GA-en-GB-230822 Avoid pushing the forehead rest up further than its stopping point. This could cause the holding bridges on the back of the forehead rest to break off.
Maintenance and care 45 • To insert the forehead rest (1, Fig. 23) place the holding bridges (2, Fig. 23) on the back of the forehead rest on the forehead rest insertion point on the device side (3, Fig. 23). 1 Forehead rest 2 Holding bridges 3 Mount for forehead rest Fig. 23 Inserting the forehead rest • Press lightly against the forehead rest, until this clicks into place.
46 Maintenance and care Replacing the face rest • To remove the face rest, press its lower edge up slightly and remove the face rest carefully as shown in Fig. 24. • To insert the face rest, place this into position and let it go. Fig.
Maintenance and care 47 Replacing the fuses WARNING - RISK OF ELECTRIC SHOCK The VISUPHOR 500 must be switched off and disconnected from the power supply before being cleaned or serviced. Before changing the fuses, disconnect the device from the power supply to prevent the risk of serious injury or death. WARNING - RISK OF ELECTRIC SHOCK Internal fuses may only be changed by service staff specially trained in maintenance and service work.
48 Maintenance and care • Remove the defective fuse (2, Fig. 25) from the fuse carrier (1, Fig. 25) and replace it with a new fuse. • Replace the fuse compartment (1, Fig. 25) and ensure the locking mechanism clicks in. Maintenance Care and cleaning WARNING - RISK OF ELECTRIC SHOCK Repair and maintenance work may only be carried out by authorized service staff. Do not remove any parts of the casing or carry out any repairs yourself, especially not on the interior parts of the device.
Maintenance and care 49 Contaminated parts with which the patient has come into contact during the examination (forehead rest and face shield) should be cleaned with a disinfectant approved for the purpose. These parts are designed to be wiped down using mild cleaning agents and disinfectants such as suds, disinfectants based on quaternary ammonium compounds (0.2 %), glutoral (2 %) or isopropanol (60 %).
50 Maintenance and care Safety inspections Proceed as follows to perform a safety check of the device: • Check the protective earth conductor resistance. For this purpose, connect the device to the measuring instrument using the power cable. To perform a measurement, press the measuring tip to the screw (measurement point) shown in Fig. 26 on the left side of the power switch (on/off button). The measured value may not exceed 0.3 Ω. 1 Measuring point Fig.
Replacement of components 51 Replacement of components If, after discussion with your dealer, it should be necessary to replace a device or a component, please proceed as follows: Document your structure carefully before removing a component. In so doing, pay particular attention to the specific points for your installation. Your records must enable you, together with the following notes, to recreate the current status of your installation. • Switch off all devices and disconnect the power cables.
52 Replacement of components Replacing the phoropter head Disassembly • Remove the forehead rest, see chapter Replacing the forehead rest on page 44. • Remove the four screw covers (,,,, Fig. 27). • Loosen and remove the four fixing screws (2, Fig. 27). • Take the cover off the connector compartment (1, Fig. 27). 1 2 Cover for the connector compartment Fixing screws Upper left screw cover Lower left screw cover Upper right screw cover Lower right screw cover Fig.
Replacement of components 53 • Loosen the two fixing screws (1, Fig. 28) for the connector cable. • Pull the connector cable off upwards (2, Fig. 28). In so doing, hold the cable directly at the plug. • Hold the phoropter head firmly during removal to prevent this from falling. • Loosen the fixing screws on the assembly adapter for your installation (see chapter Interfaces to mount the phoropter head on page 23). 1 Fixing screws for the connector cable 2 Connector cable with plug Fig.
54 Replacement of components Replacing the junction box Disassembly • Loosen all of the cables attached to the junction box and fold in the antenna (1, Fig. 29). • Unscrew the screws fixing the junction box to the installation environment. 1 Antenna Fig. 29 Disassembly of junction box Mounting • Attach the junction box to its installation environment using the screws. • Connect all of the associated cables to the junction box and unfold the antenna (1, Fig. 29).
Optional accessories 55 Optional accessories WARNING - GENERAL HAZARD If the device has been modified, it must be tested and checked in order to ensure the safe operation of the device after its modification. Use only accessories and spare parts approved by Carl Zeiss Meditec. A current and complete list of accessories can be obtained from your retailer.
56 Technical data Technical data Dimensions (W x D x H) Digital Phoropter 361 mm x 108 mm x 280 mm Junction box 71 mm x 240 mm x 251 mm Weight Digital Phoropter 4.74 kg Junction box 1.88 kg Mains voltage 100 V to 240 V AC Line frequency 50/60 Hz Power consumption 1.0 A to 0.5 A AC Classification of the device Fuse T2.
Technical data 57 Setting range Spherical lenses -29.00 D to +26.75 D. -19.00 D to +16.75 D (when using a cross cylinder or a prism) (steps of 0.125 D) Toric lenses Cylinder power 0.00 D to 8.75 D (steps of 0.25 D) Cylinder axis 0° to 180° (steps of 1˚) Cross cylinder ± 0.25 D ± 0.50 D ±0.25 D (dual cross clyinder) Prismatic lenses PD 0 ∆ to 20 ∆ (steps of 0.1 ∆) 48 mm to 80 mm (steps of 0.25 mm) Near-point examination PD Working distance, Retinoscope lenses 50 mm to 74 mm 35 cm to 70 cm +1.
58 Electromagnetic compatibility Electromagnetic compatibility ZEISS VISUPHOR 500 satisfies the requirements of electromagnetic compatibility pursuant to IEC 60601-1-2:2014. CISPR 11: Group 1 CISPR 11: Class B Ambient conditions for intended use With regard to electromagnetic compatibility, ZEISS VISUPHOR 500 is intended for use in a domestic professional healthcare environment pursuant to IEC 60601-1-2:2014.
Electromagnetic compatibility 59 CAUTION – RISK OF ELECTROMAGNETIC RADIATION The ZEISS VISUPHOR 500 may not be placed next to or stacked together with other equipment, except in the device configurations described in this user manual. If operation close to or with other devices is necessary, the ZEISS VISUPHOR 500 must be closely observed to monitor its proper functioning in this configuration.
60 Electromagnetic compatibility Emission Emission Standard Compliance Conducted emission CISPR 11 Group 1 Radiated emission CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies 000000-2075-933-GA-en-GB-230822
Electromagnetic compatibility 61 Immunity Phenomenon Standard Electrostatic discharge IEC 61000-4-2 Radiated RF EM fields IEC 61000-4-3 Test level ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air (housing, connections) 10 V/m 80 MHz to 2.7 GHz 80 % AM at 1 kHz Electrical fast transients/bursts Surges line·to·line IEC 61000-4-4 IEC 61000-4-5 Surges line-to-ground ±2 kV, 100 kHz repetition rate (power cable) ±1 kV, 100 kHz repetition rate (data cable) ±0.5 kV, ±1 kV (power cable) ±0.
62 Phenomenon Electromagnetic compatibility Standard Test frequency (MHz) Radio service Immunity test level (V/m) 385 TETRA 400 27 450 GMRS 460, FRS 460 28 LTE Band 13,17 9 710 745 780 810 870 Immunity to radiated radio frequencies, caused by wireless communications equipment in accordance with IEC 60601-1-2 930 IEC 61000-4-3 1720 1845 1970 2450 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS 28 28 Bluetooth, WLAN 8
Abbreviations/Glossary 63 Abbreviations/Glossary ARK Automatic refractometer / keratometer CISPR Comité international spécial des perturbations radioélectriques (Special International Committee on Radio Interference) CVD Vertex distance D Diopters dBi Decibel isotropic dBm Decibel relative to 1 milliwatt DIN Deutsches Institut für Normung (German standards association) EC European Community EMC Electromagnetic compatibility EN Europäische Norm (European standard) ESD Electrostatic dis
64 Figures Figures Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5 Fig. 6 Fig. 7 Fig. 8 Fig. 9 Fig. 10 Fig. 11 Fig. 12 Fig. 13 Fig. 14 Fig. 15 Fig. 16 Fig. 17 Fig. 18 Fig. 19 Fig. 20 Fig. 21 Fig. 22 Fig. 23 Fig. 24 Fig. 25 Fig. 26 Fig. 27 Fig. 28 Fig. 29 000000-2075-933-GA-en-GB-230822 Package check list (without assembly adapter).............................. 5 Package check list of assembly adapters and corresponding mounting sets.............................................................................
Index 65 Index A Abbreviations ............................................................................................ Accessories, optional ................................................................................. Assembly.................................................................................................. 62 55 22 C Care.......................................................................................................... Classification of the device.......................
66 Index O Operation of the device ............................................................................ Optotype charts....................................................................................... 35 38 P Package check list...................................................................................... Performance specifications...................................................................... 5 16 S Safety inspections .......................................................
Index 67 000000-2075-933-GA-en-GB-230822
Index 68 Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 07745 Jena Germany Telephone: +49 3641 220 333 Fax: Email: Internet: +49 3641 220 112 info.meditec@zeiss.com www.zeiss.
Your contact The address of your contact person may be found in a separate document or on a label attached to the device. Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 07745 Jena Germany Telephone: Fax: Email: Internet: +49 3641 220 333 +49 3641 220 112 info.meditec@zeiss.com www.zeiss.
