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- Page 1 Cod. 141012EN 2015-07-14 Rev.B JANUS BIOMETER/PACHYMETER MANUAL FOR INSTALLATION AND USE OPTIKON 2000 S.p.A. Via del Casale di Settebagni, 13 - 00138 Rome Tel. +39 06 8888355 - Fax. +39 06 8888440 e-mail sales@optikon.com - www.optikon.com...
- Page 2 OPTIKON 2000 S.p.A. is an ISO 9001 and ISO 13485 certified company that manufactures surgical and diagnostic ophthalmological instruments. All OPTIKON 2000 products are manufactured in conformity with the requirements of directive 93/42/CEE for medical instruments.
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Page 3: Table Of Contents
Manufacturer’s guidebook and statement - Electromagnetic emissions ..........5-8 5.3.2 Manufacturer’s guidebook and statement – Electromagnetic immunity ..........5-9 5.3.3 Recommended separation distances between mobile and portable radiocommunication devices and Janus 5-10 ........................... 5-11 IRCUIT DIAGRAMS INSTALLATION ............................... 6-1 ............................6-1 NTRODUCTION .................. -
Page 4: Preliminary Statement
OPTIKON 2000 1 PRELIMINARY STATEMENT OPTIKON 2000 S.p.A requires that the user of this system should carefully read the specific warnings detailed in this manual. It is the responsibility of the operator to ensure that authorized personnel are fully acquainted with the correct functioning of the device before using it. -
Page 5: Terms And Conditions Of Limited Warranty
OPTIKON S.p.A. authorised service technician. In the event of any faults, OPTIKON S.p.A. reserves the right to verify whether the device and/or its accessories have been altered or in any way manhandled, or damaged by improper use. -
Page 6: Warnings
) anaesthetics , unless the gases have been evacuated using a suitable system for gas aspiration. Do not dispose of the Janus unit as undifferentiated urban refuse. It should be disposed of separately in accordance with local laws and regulations relating to disposal of electrical and electronic appliances . -
Page 7: Electrical Warnings
In such conditions it is necessary, during installation, the use of an isolation transformer which will be connected to the Janus unit, to your PC and to the peripherals connected to In the event of an emergency, or if the operator considers it urgently necessary to disconnect Janus from the power supply, simply remove the power block from the power supply. -
Page 8: Biometry Scan
Janus Installation and Operation Manual OPTIKON 2000 3.5 Biometry scan Apply the probe gently to the damp cornea and avoid altering its normal geometrical configuration. 3.6 Pachymetry scan Apply the probe gently to the patient’s cornea using the minimum pressure necessary to keep the tip in contact. -
Page 9: Symbols
Sometimes, one or more symbols are combined to provide special meanings. These are the symbols used on the Janus label. Before using the unit, users should acquaint themselves with the symbols and their definitions shown in the table. -
Page 10: General Information
5.1 System description The Janus ultrasound device – OPTIKON 2000 – is an instrument used for calculating the axial length of the eye, for calculating the intraocular lens suitable for restoring emmetropia after the removal of a cataract, and to measure corneal thickness. - Page 11 Janus Installation and Operation Manual OPTIKON 2000 Figure 1: Janus front panel: 1- Connector for external power block; 2-Foot pedal connector; 3-USB connector; 4-LED signals indicating the device is on; 5-Probe connector. Code 141012EN 2015-07-14 Rev.B...
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Page 12: Biometry Scan
Janus Installation and Operation Manual OPTIKON 2000 The main features of the ultrasound device are: 5.1.1 Biometry scan • Precision Differentiated measurements for pseudophakic eyes depending on the different materials of the implants. • Safety Automatic criteria for accepting the measurements on the basis of the type of eye examined (normal, pseudophakic, etc.). -
Page 13: Specifications
Janus Installation and Operation Manual OPTIKON 2000 5.2 Specifications Manufacturer: OPTIKON 2000 S.p.A. Via del Casale di Settebagni, 13 00138 Rome – Italy Model: Janus Bio/Pachymeter Regulatory Compliance: 93/42/CEE directive for medical devices Technical standards: EN 60601-1 EN 60601-1-1 EN 60601-1-2 5.2.1 Environmental specifications... -
Page 14: Technical Specifications
Janus Installation and Operation Manual OPTIKON 2000 5.2.3 Technical specifications General Gain Variable up to 130dB Sound signals Biometry scan Probe: Piezoelectric with fixation light, can be mounted on tonometry slide Frequency: Approx. 10 MHz Measurement depth: From 1 to 60 mm Electrical resolution: Approx. - Page 15 Janus Installation and Operation Manual OPTIKON 2000 Pachymetry scan Probe: piezoelectric Frequency approx. 50MHz Measurement depth: from 100 to 1000µm in automatic mode Resolution: approx. 0.5µm Clinical accuracy ±5µm Available maps: 5 predefined + 5 customizable Number of points per map:...
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Page 16: Peripheral Devices And Connections
OPTIKON 2000 5.2.4 Peripheral devices and connections The Janus system is based on a 32 bit PC with Windows Operating System, and can therefore use all the peripherals that the PC to which it is connected can support: printers, modems, video projectors, masterisers, video printers, backup units, local networks, etc. -
Page 17: Electromagnetic Compatibility Charts
5.3.1 Manufacturer’s guidebook and statement - Electromagnetic emissions Janus has been designed to operate in an electromagnetic environment detailed below. It is the responsibility of the client or Janus operator to ensure that it is used in such an environment. -
Page 18: Manufacturer's Guidebook And Statement - Electromagnetic Immunity
5.3.2 Manufacturer’s guidebook and statement – Electromagnetic immunity The Janus unit is designed to operate in an electromagnetic environment described below. The client or Janus operator is responsible for ensuring that it is used in such an environment. Immunity test... -
Page 19: Recommended Separation Distances Between Mobile And Portable Radiocommunication Devices And Janus
5.3.3 Recommended separation distances between mobile and portable radiocommunication devices and Janus Janus is designed to operate in an electromagnetic environment in which RF radiated RF noises are controlled. The client or operator of Janus can contribute to avoiding electromagnetic interference by ensuring that the minimum distance between mobile and portable RF communication devices (transmitters) and Janus as recommended below with regard to the maximum output power of radio-communication devices are observed. -
Page 20: Circuit Diagrams
Installation and Operation Manual OPTIKON 2000 5.4 Circuit diagrams On request, OPTIKON 2000 S.p.A. will make available circuit diagrams, a list of components, descriptions, instructions for calibration or other information of assistance to qualified technical personnel authorized to set-up or repair the instrument. -
Page 21: Installation
Before opening the box, check that the packing is not damaged and that the contents do not appear to be damaged. In the event of damage due to transport, notify the carrier, the dealer or the OPTIKON 2000 sales office directly, who will take measures to repair or replace the instrument or its components. -
Page 22: Installation Procedure
• Connect the USB cable provided to Janus and to the USB2.0 port of the PC. If the USB port of the PC is not able to deliver sufficient current to run Janus try to connect the red connector to the PC. -
Page 23: Sound Signals
Janus Installation and Operation Manual OPTIKON 2000 Figure 2: Connections for the various Janus components: 1-PC; 2–USB Cable; 3-Foot-pedal; 4– Power block; 5–Console; 6–Pachymetry probe; 7–Biometry probe; 8–Probe base. 6.4 Sound signals Janus software emits sound signals when: • The pachymetry probe is calibrated. -
Page 24: Software Description
• Test opens the test database • Settings opens the window for general settings and settings. • Operator opens the operator database • opens the software information window • exits the Janus environment Code 141012EN 2015-07-14 Rev.B... -
Page 25: Patient Database
Janus Installation and Operation Manual OPTIKON 2000 7.2 Patient database Figure 3: |Management of patient database Once the patient database window has been opened, various functions can be carried out: • New Patient: creates a new patient profile to be completed with name, surname (mandatory) and a series of additional information. -
Page 26: Test Database
Janus Installation and Operation Manual OPTIKON 2000 7.3 Test database Figure 5: Management of test database From the Test Selection window the following actions can be performed: Right mouse click on a test, session or patient: • Export selection: export the selected item (test, session or patient) •... -
Page 27: General Settings
Janus Installation and Operation Manual OPTIKON 2000 • Preview window: display the graphics of each measurement that is part of the test. Figure 6: Management of biometry tests database Figure 8: Management of pachymetry tests database 7.4 General settings Figure 7: General settings window Code 141012EN 2015-07-14 Rev.B... - Page 28 Janus Installation and Operation Manual OPTIKON 2000 In this window, various operating parameters of the machine can be set. • Selecting Play sound on footswitch the software will emit a sound signal every time the foot pedal is pressed. • Selecting Play sound on each measure, the software will emit a sound every time a measurement is acquired.
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Page 29: Institution Settings
Janus Installation and Operation Manual OPTIKON 2000 7.5 Institution settings Figure 8: Institution settings window In this window, all the information which will form the heading of the printouts can be input. Code 141012EN 2015-07-14 Rev.B... -
Page 30: Biometry
Janus Installation and Operation Manual OPTIKON 2000 7.6 Biometry Figure 9: Biometry environment If the unit is connected to the PC (the little circle bottom right of the monitor is green), the following actions can be performed: • : access the patient database. - Page 31 Janus Installation and Operation Manual OPTIKON 2000 Figure 10: Biometry environment in action In the table below, up to 15 measurements are displayed. The average axial length is indicated in the Mean axial length box. The standard deviation is indicated in the Standard deviation σ and its background colour will depend on its value.
- Page 32 Janus Installation and Operation Manual OPTIKON 2000 In automatic mode, once the measurements table has been completed, all future measurement will substitute the one that makes the worst contribution to the standard deviation. In manual mode, once the measurements table has been completed, all future measurements will replace the one that is currently selected (blue column).
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Page 33: Iol Calculation
Janus Installation and Operation Manual OPTIKON 2000 7.7 IOL calculation Figure 12: IOL calculation window The IOL calculation window enables the automatic calculation of the value of the intraocular lens to be implanted. It is composed of 4 overlapping independent reports, each of which is organised in the following manner: •... - Page 34 Janus Installation and Operation Manual OPTIKON 2000 Figure 15: Pachymetry values window for Post –Refractive formula application • IOL Editor: enables the operator to access the lens database to create, modify or erase lenses Figure 13: IOL database management • Calculated IOL: displays the IOL power closest to the result of the chosen formula and its related refractive power after implant.
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Page 35: Pachymetry
Janus Installation and Operation Manual OPTIKON 2000 7.8 Pachymetry Figure 14: Pachymetry environment If the unit is connected to the PC (the small circle bottom right of the screen is green), the operator can carry out the following functions: •... - Page 36 Janus Installation and Operation Manual OPTIKON 2000 Figure 15: Map selection menu By clicking the right button of the mouse on one of the maps between #1 a User#5, the operator can access the window that will enable him/her to create a customised map.
- Page 37 Janus Installation and Operation Manual OPTIKON 2000 How to operate the device in a pachymetry environment By activating the instrument using the Freeze/Unfreeze button or the foot-pedal, the operator can display the signal from the pachymetry probe on top right of the screen.
- Page 38 Janus Installation and Operation Manual OPTIKON 2000 At the end of the test, the value of the central corneal thickness (CCT) is displayed in two of the boxes next to the map, and also of the delta pressure to be used as a corrective factor in Goldman tonometry (∆IOP).
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Page 39: Calibrating The Pachymeter
Should this occur, try shaking the probe in water to remove any micro-bubbles from its sensitive surface and repeat the calibration procedure pressing “Calibration”. If the problem persists, contact the Optikon 2000 service department. The operator is strongly advised to calibrate the instrument every time the pachymetry probe is changed, and in any event, at regular intervals, in order to guarantee the proper functioning of the pachymeter. -
Page 40: Verify Functionality On The Pachymetry Tester
Janus Installation and Operation Manual OPTIKON 2000 7.10 Verify functionality on the Pachymetry Tester To verify that the probe is in good conditions to be able to carry out pachymetry it is possible to perform a functionality test on the pachymetry tester, located on the top of the probe. - Page 41 Janus Installation and Operation Manual OPTIKON 2000 Revision index: Rev.A: Multiple corrections. Rev. B: Included new software functions. Update notice on Class A. Code 141012EN 7-18 2015-07-14 Rev.B...