VIDEONISTAGMOSCOPE SYSTEM VNYS ED600 OPERATING MANUAL Rev.4 Iscritta S.P.A.
Contents: CONTENTS:...2 MANUFACTURER IDENTIFICATION...0 PRODUCT IDENTIFICATION...1 CE MARKING...4 DECLARATION OF CONFORMITY...4 USE DESTINATION...5 EQUIPMENT PLACEMENT... 5 ENVIROMENTAL COMPLIANCE... 5 OPERATOR COMPLIANCE... 6 KIND OF FUNCTIONNING... 6 FUNCTIONING FAULTS... 6 ENVIROMENTAL COMPLIANCE... 7 COUNTER EFFECTS... 7 WARNING, POSSIBLE UNDESIRED EFFECTS... 8 SYMBOL MEANING...9 DESCRIPTION OF INSTALLATION AND/OR ASSEMBLING PROCEDURE...12 ENVIRONMENT COMPLIANCE... 12 ACTIONS TO BE EXECUTED BEFORE SWITCHING THE SYSTEM ON... 12 FIRST ACTIONS TO BE EXECUTED... 13 EMERGENCY SIGNAL AND WARNING... 14 PERIODICAL START UP...15 Iscritta S.P.A.
MANUFACTURER RESPONSIBILITIES...16 USE INDICATIONS...17 GENERAL DESCRIPTION... 17 CONTROLS DESCRIPTION...18 FORE PANEL MASTER STATION... 18 BACK PANEL MASTER STATION... 19 FAULTS RESEARCH...20 THE EQUIPMENT DOES NOT START... 20 NO IMAGES ON THE MONITOR... 20 TECHNICAL ASSISTANCE SERVICE...22 Iscritta S.P.A.
MANUFACTURER IDENTIFICATION EUROCLINIC S.r.l. Via dell'artigianato, 305/319 48014 Castel Bolognese (RA) Tel: ++39 0546 656031 Fax: ++39 0546 656691 ITALY P.IVA 02110630395 www.euroclinic.it info@euroclinic.it
PRODUCT IDENTIFICATION 1. 12V DC power supplier 2. Stopper 3. Control box 1
4. B/W Ir Camera System 5. AD9240 mask 2
6. 14 monitor 4) Operating manual 3
CE MARKING DECLARATION OF CONFORMITY The undersigned LONGO MAURILIO, in my capacity as legal representative of the EUROCLINIC S.r.l. Company, with registered office in Via dell'artigianato, 305/319 in Castel Bolognese (RA) / ITALY declares that the VNYS ED600 equipment answers to the 93/42CEE(Cap.2 All.IX; Cap.3 All.IX) Directive on Medical Devices and it is classified as Class 1 Medical Device. Castel Bolognese, 13/01/07 EUROCLINIC S.R.L. THE LEGAL REPRESENTATIVE MAURILIO LONGO 4
USE DESTINATION VNYS ED600 Videonistagmoscope system facilitates the Nyustagmus visualisation and registration got with the standard vestibular tests (both position and instrumental proofs). This device allows to view patient eyes images on the monitor during the tests. EQUIPMENT PLACEMENT Please, put the equipment on an horizontal surface that must be sufficiently large, solid and stable. ENVIROMENTAL COMPLIANCE The environment to use the equipment in must be hospital-type exempt from strong electric interferences and therefore far from high tension conductors, from large transformers, from x-ray implants, from diathermy and marconitherapy generators. Further inconvenience elements are elevator s contactors, automatic gearcases, some lacks of the electric implant, such as conductors not perfectly fixed to the lamp-holders, to the current plugs, to the switches, etc. In normal conditions the machine is capable of functioning without particular precautions. 5
In critical conditions, that is when the inconveniences menace to compromise the performance of the good performance of the test, it is necessary to connect all equipment to a single efficient ground outlet. OPERATOR COMPLIANCE The operator, in charge of use VNYS ED600 must have read and understood the instruction manual, therefore he must be able to recognize a potential malfunctioning and capable of following the procedure recommended in the manual. KIND OF FUNCTIONNING VNYS ED600 wireless camera system is an equipment with a continuous kind of working. FUNCTIONING FAULTS Not being an explosion-proof system, it is necessary the user not to use it near flammable anaesthetic. Do not let VNYS ED600 let out to atmospheric factors. Do not let it unnecessarily turned on if nobody is using it. 6
Functioning faults are represented by specific situations when mask is not preferably usable and, as a result, the device must be in case used with a defined limit, with regard to benefits/costs ratio that resting with the system in point. ENVIROMENTAL COMPLIANCE The environment to use the equipment must be hospital-type exempt from strong electric interferences and therefore far from high tension conductors, from large transformers, from x-ray implants, from diathermy and marconitherapy generators. Further inconvenience elements are elevator s contactors, automatic gearcases, some lacks of the electric implant, such as conductors not perfectly fixed to the lamp-holders, to the current plugs, to the switches, etc. In normal conditions the machine is capable of functioning without particular precautions. In critical conditions, that is when the inconveniences menace to compromise the good performance of the test, it is necessary to connect all equipment to a single efficient ground outlet. COUNTER EFFECTS Counter effects are those specific situations in which Videonostagmoscope mask is not preferably usable and, as a result, the device must be in case used 7
with a defined limit, with regard to benefits/costs ratio that resting with the system in point WARNING, POSSIBLE UNDESIRED EFFECTS Please, do not forget to make always a careful medical history to identify situations where it is advised against mask use for Nystagmus research, before starting to use VNYS ED600 Videonistagmoscope system. 8
SYMBOL MEANING This symbol requires to consult the operating manual before starting the system use. Where it is present and selected, this symbol informs that the equipment belongs to B Category. Where it is present and selected, this symbol informs that the equipment belongs to BF Category. field. this symbol, where it is present and selected, indicates the protection 9
Where it is present and selected, this symbol informs that the power supply tension is alternated. Where it is present and selected, this symbol communicates that the power supply tension is continuous. Where it is present and selected, this symbol communicates that this equipment belongs to II class category. The symbol of crossed out garbage bin (on the back of the equipment) indicates that the product at the end of its working life must be collected separately from other garbage. This refers to the following law: art. 13 of D.L: 25 /07/2005, n.151: Implementation of the regulations 2002/95/CE, 2002/96/CE and 2003/108/CE, about decrease of dangerous substances on electric and electronic equipments and moreover it refers to garbage disposal. The separate collection of rubbish of this equipment (felt into disuse) must be arranged and coordinated by the manufacturer. When the user wants to throw away the equipment, he will contact the Manufacturer Company that will indicate all procedures to follow for the disused equipment separate collection 10
of rubbish. Therefore, the appropriate separate collection of rubbish, aimed to actuate afterwards disused equipment recycling, treatment and to ambient garbage disposal, contributes to avoid possible bad effects on the environment and on the health. In addition, these procedures raise the reemployment and/or the recycling of the materials of which the equipment is composed. The unauthorized garbage disposal, on the part of the holder, requires administrative law sanctions application. 11
DESCRIPTION OF INSTALLATION AND/OR ASSEMBLING PROCEDURE ENVIRONMENT COMPLIANCE The environment in which the equipment is used must be hospital-type exempt from strong electric interferences and therefore far from high tension conductors, from large transformers, from x-ray implants, from diathermy and marconitherapy generators. Further inconvenience elements are elevator s contactors, automatic gearcases, some lacks of the electric implant, such as conductors not perfectly fixed to the lamp-holders, to the current plugs, to the switches, etc. In normal conditions the machine is capable of functioning without particular precautions. In critical conditions, that is when the inconveniences menace to compromise the performance of the good performance of the test, it is necessary to connect all equipment to a single efficient ground outlet. ACTIONS TO BE EXECUTED BEFORE SWITCHING SYSTEM ON THE Push away all non-used cables and those near the system, they might cause encumbrance. Furthermore not being an explosion-proof system, it is necessary not to use it near flammable anaesthetic. Check all system device components integrity. 12
FIRST ACTIONS TO BE EXECUTED Please, insert the power supplier connector to the back panel (12V DC). Check the green led (placed high on the right side of the fore panel) to be turned on. Please, insert Camera connector into the fore panel on In 1 Video position and, moreover, when the second camera is present, on In 2 Video position. Check that, pressing light switch (placed on the fore panel) on Led1 and/or Led2, the red led (placed above camera lens) will light up. Connect one video cable edge (RCA or BNC kind) to the correspondent exit (on the equipment back side). Connect the other end either to monitor entrance or to another peripheral area of visualization / acquisition entrance, or to Quad (splitter video) entrance. 13
EMERGENCY SIGNAL AND WARNING The two green leds (placed on the fore panel) allows to view functioning condition about the two B/W Ir camera systems. After connecting the camera, the ignition of correspondent green led a (placed alongside of the connector) informs video signal keep within good parameters. 14
PERIODICAL START UP The user must pay attention to the actions that are necessary to keep the device in good conditions, in order to make a "periodical start up" it in total efficiency: Check at sight the integrity of device and of its components (control box, power supplier, mask, video camera, cables) place the device in an environment with the following features: Temperature from 10 to 45 C Relative humidity from 30 to 75% Atmospheric pressure from 700 to 1060 hpa After checking 12V DC power supplier disconnection, take away the dust from the control box using an humid cloth. in case of prolonged inactivity, it is preferable to cover VNYS ED600 together with its accessories (mask, camera and 12VDC power supplier) in a hiding place, after providing to a simple removal of the possible dust. Require periodical checks (every years) to Euroclinic Company in order to verify light power supply of the equipment. Check to have the equipped power supplier of system electricity connection 15
MANUFACTURER RESPONSIBILITIES VNYS ED600 Videonystagmoscope system, produced by Euroclinic S.r.l., is guaranteed against potential production and/or material defects for one year from the purchasing date and according to the following conditions: The room interior wiring must comply with the current IEC regulations. The equipment must be used following the instructions and regulations as in the present manual. Installation, modifications and repairs must be executed by technicians authorized by Euroclinic S.r.l. Company. The following voices are not under warranty: Defects caused by normal deterioration Parts subject to wearing out Malfunction caused by damaging (accidental causes), by maintenance or modifications executed by non-authorized persons. Defects caused by the machine s use for different purposes from those it s been built for, or modifications made by personnel not authorized by Euroclinic S.r.l.. 16
USE INDICATIONS GENERAL DESCRIPTION This manual describes VNYS ED600 videonistagmoscope functioning. The equipment is composed of a control box (power supply feeder and sorting) a mask together with a camera, a stopper and a 14 high definition black-andwhite monitor. To integrate the base equipment supply, you can connect a second camera for the second eye, an environment camera (obviously in these cases you must use a Quad that consents to view signals (coming from many cameras) on one unique monitor. VNYS ED600 videonistagmoscope allows to view three images coming from the cameras on one unique monitor and, simultaneously, to send on three different monitors or video-registration systems individually. It consents to get a red led, inside the mask, during tests execution, to make suppression visual test. 17
CONTROLS DESCRIPTION FORE PANEL MASTER STATION 1. Video1 IN IN Outlet Camera N1 2. Video2 IN IN Outlet Camera N2 3. Switch to select the 1 or 2 camera on Aux exit 4. Ignition led button of the camera1 5. Ignition led button of the camera2 6. on/off Led 18
BACK PANEL MASTER STATION 1. Entrance power Power 2. OUT (RCA) Outlet Camera1 Video1 OUT 3. OUT (BNC) Outlet Camera1 Video1 OUT 4. Aux OUT outlet(rca) VideoAux OUT 5. Aux OUT outlet(bnc) VideoAux OUT 6. OUT (RCA) outlet Camera2 Video2 OUT 7. OUT (BNC) outlet Camera2 Video2 OUT 8. IN outlet Environment camera Video3 IN 9. OUT (RCA) outlet Environment camera Video3 OUT 10. OUT (BNC) outlet Environment camera Video OUT3 19
FAULTS RESEARCH It could happen that the equipment could not execute the desired function. Tray to solve the problems alone, before calling Assistance technician. The following checking list could help to identify and cancel possible faults. THE EQUIPMENT DOES NOT START Make sure that power supply cable plug is inserted on the outlet (that must be active 220V~) Call Euroclinic technical assistance service Send the equipment to Technical assistance service NO IMAGES ON THE MONITOR Make sure that the power supply cable plug is inserted into the outlet that must be activated (220V~) and check monitor ignition Check the I/O switch to be in I position Make sure to have connected the camera to the control box Check the correspondence between the selected exit and the used entrance Check the correspondence between the selected exit and the used entrance: if you selected Aux exit, check the selected entrance to be deviated in the right way, through the apposite deviator, placed on the 20
fore panel Call Euroclinic technical assistance service Send the equipment to technical assistance service 21
TECHNICAL ASSISTANCE SERVICE OF EUROCLINIC S.R.L. TEL. / PHONE: +39 0546 656031 FAX: +39 0546 656691 E-MAIL: info@euroclinic.it!!!!!! VERY IMPORTANT ADVICE!!!!!! Before sending back the equipment, even if it is covered by its warranty, it is necessary to forewarn and require Euroclinic S.r.l. authorisation. Otherwise, the warranty could fall into decay. In case, due to any reason, the equipment must be delivered to the technical assistance service, we suggest to use the original packing, in order to avoid eventual damages due to transport. Therefore Euroclinic S.r.l. declines any responsibility in relation to these damages and will charge the new packing to be used for sending again the equipment to the customer. 22