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Air Techniques CamX Elara, Инструкция по установке и эксплуатации

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2108100003L29  1602V006

 

23

12  Information concerning EMC in accordance with  

IEC 60601-1-2 

12.1 General information 

This information contains excerpts from the international standards for electrical, medical appliances� 
It must be observed during the installation and combination of Air Techniques appliances with prod-
ucts made by other manufacturers� In the event of uncertainties, the complete standard must be con-
sulted�

12.2 Abbreviations 

EMC

Electromagnetic compatibility

HF

High frequency

U

T

Rated voltage of the appliance (supply voltage)

V

1

, V

2

Compliance level for the test according to IEC 61000-4-6

E

1

Compliance level for the test according to IEC 61000-4-3

P

Rated power of the transmitter in Watts (W) in accordance with the specifications of the 
transmitter manufacturer

d

Recommended safety distance in meters (m)

Appendix 

EN 
US

Содержание CamX Elara

Страница 1: ...J2001 CamX Elara CamX Spectra Installation and Operating Instructions 2108100003L29 1602V006 EN US ...

Страница 2: ......

Страница 3: ... Abbreviations 23 12 3 Guidelines and manufacturer dec laration 24 12 4 Calculation table 29 EN US Contents Important information 1 Concerning this documentation 2 1 1 Warnings and Symbols 2 1 2 Copyright and property rights infor mation 3 2 Safety 3 2 1 Indication for use Intended use 3 2 2 Contraindication 3 2 3 General safety notes 4 2 4 Connecting appliances securely 4 2 5 Qualified personnel ...

Страница 4: ...arket Air Techniques cannot be held liable and cannot offer guarantees for safe and smooth operation of this unit if notes and instructions contained in these Installa tion and Operating Instructions are not observed 1 1 Warnings and Symbols Warning notes The warning notes in this document highlight potential dangers to people and equipment They are marked with the following warning symbols Genera...

Страница 5: ... 2 Contraindication WARNING Risk of explosion due to inflammation of combustible materials i i Do not use the appliance in rooms in which combustible mixtures may be present e g in operating rooms CAUTION The light from the camera is very bright i i Do not shine the light directly into the eye Any use of this appliance these appliances above and beyond that described in the Installa tion and Opera...

Страница 6: ...ep a minimum distance of 30 cm between the appliance and mobile radio devices i i Note that cable lengths and cable extensions have effects on electromagnetic compatibility The following accessories can have an effect on electromagnetic compatibility USB connection cable for CamX Elara Spectra 8 2 ft J2020 2 3 General safety notes US Federal law restricts this device to sale by or on the order of ...

Страница 7: ...ies special accesso ries or any parts other than original spare and replacement parts 2 8 Transport Only the original packaging ensures optimum protection for the unit during transport If necessary the original packaging for this unit can be ordered from Air Techniques Air Techniques cannot be held responsi ble for any damage resulting from trans port in unsuitable packaging even during the warran...

Страница 8: ...es are necessary to operate the appliance depending on particular applica tion Part no As sold Handpiece holder for CamX J2040 non sterile USB connection cable for CamX 8 2 ft J2020 non sterile Spacer for CamX Spectra only 5 pieces J2320 non sterile to be sterilized by user spacer is reusable must be sterilized before use see 9 3 Preparing the spacer 3 3 Disposable materials The following material...

Страница 9: ... accordance with IEC 61000 3 2 Not applicable Voltage fluctuations flicker in accordance with IEC 61000 3 3 Not applicable Electromagnetic compatibility EMC Interference immunity tests Discharge of static electricity in accordance with IEC 61000 4 2 Fulfilled Magnetic field for a supply frequency 50 60 Hz in ac cordance with IEC 61000 4 8 Fulfilled Emitted HF disturbance variables in accordance wi...

Страница 10: ...e reaches a maximum surface temperature of 140 F Electromagnetic compatibility EMC Interference immunity tests Discharge of static electricity in accordance with IEC 61000 4 2 Fulfilled Magnetic field for a supply frequency 50 60 Hz in ac cordance with IEC 61000 4 8 Fulfilled Emitted HF disturbance variables in accordance with IEC 61000 4 3 Fulfilled See also 12 Information concerning EMC in accor...

Страница 11: ...eight without cable oz 1 7 Cable length ft 8 2 4 3 Ambient conditions Ambient conditions during operation Temperature F 50 to 104 Rel humidity 20 to max 75 Air pressure inHg 22 15 31 30 Ambient conditions for storage and transport Temperature F 32 to 170 Rel humidity max 75 non condensing Air pressure inHg 20 67 31 30 EN US ...

Страница 12: ...ressure point of the capture button is tangible When changing the mode the cam era vibrates slightly Optionally the camera can also be operated by a foot switch The image sensor in the handpiece digitizes the image The camera transmits the image to a computer via the USB connection cable 4 4 Model identification plate The model identification plate is on the hand piece 4 5 Evaluation of conformity...

Страница 13: ...inutes As soon as the camera is moved it switches on again 5 1 CamX Elara The camera has a fixed focus optical lens with a depth of field appropriate for intraoral imaging Eight LEDs are arranged around the optical lens which provide even illumination Figure 2 CamX Elara 5 2 CamX Spectra The camera is used to create intraoral images for detecting caries plaque and tartar It has a fixed focus optic...

Страница 14: ...ns Healthy tooth enamel Early stage caries incipient enamel caries Enamel caries up to enamel den tine junction Dentin junction already exceeded Dentin caries Use gold standard techniques to examine for potential caries 5 3 Disposable protective cover Disposable protective covers provide an effec tive barrier preventing any hazard to the patient Do not use the device without fitting a dispos able ...

Страница 15: ...et outlet for the pow er supply are easily accessible and that the appliance can be unplugged if neces sary Where a Tower or Desktop PC is being used then always use one of the USB connections at the back of the PC Do not connect the unit to a front USB con nection i i Wait for the instruction of the installation wiz ard before you connect the unit to the PC for the first time see 7 2 Installing t...

Страница 16: ...rom these images where interferences are compensated to the great est possible extent Capture ring Function Time when the image is created if a capture button is pressed Trigger function on release default Trigger function on press Settings Image export Each image is automatically copied into a defined path The path file format and other settings are set in the Light Table module 7 2 Installing th...

Страница 17: ... default WDM driver Driver The WDM driver is selected automatically Pressure sensitive release Function The function of the capture buttons can be selected Record Pause is default Trigger event Time when the image is created if the capture button is pressed By pressing By releasing default i i To change the configuration click on i i To save the configuration click on 7 5 Acceptance tests Electric...

Страница 18: ...the camera by dropping or scratching i i Always store the camera in the hand piece holder i i Do not place the camera on a storage surface i i Do not place the camera between oth er instruments 8 1 Switching on the appliance i i Connect the camera to a USB port of the computer using the connection cable i i To start the imaging program see software manual 8 2 Using the disposable protective cover ...

Страница 19: ...ce tip into the curved end opening of the spacer i i Push the handpiece completely in until the tip is fully inserted into the spacer i i Make sure that the spacer is properly aligned with the illuminated tip of the handpiece 8 3 Taking an image using CamX Elara Taking a picture CAUTION The blue violet LED light i i Do not peer into the light source i i Do not use or point the camera directly on t...

Страница 20: ...t source i i Do not use or point the camera directly on the eyes When you remove the camera from the hand piece holder the camera shows a moving image Live mode Each time the mode is switched between Live mode and Freeze mode the handpiece vibrates slightly i i Start imaging program i i Remove the camera from the handpiece hold er i i Select the required image section in Live mode i i Press on one...

Страница 21: ...iece i i Place the camera in the handpiece holder Result The camera switches off automatically Figure 6 Caries view The color scale provides information on carious lesions Healthy tooth enamel Early stage caries incipient enamel caries Enamel caries up to enamel den tine junction Dentin junction already exceeded Dentin caries Use gold standard techniques to examine for potential caries EN US ...

Страница 22: ...250 F for 30 minutes and dry time of 20 minutes before use Use a new replacement spacer as needed Storage i i Store the product protected against contami nation i i After sterilization store the parts in a steriliza tion packaging cleared by FDA under 21 CFR 880 6850 product code FRG i i Shelf life is determined and identified per in struction for use of sterilization packaging used 9 Disinfection...

Страница 23: ...2108100003L29 1602V006 21 Use 10 Maintenance The appliance is maintenance free EN US ...

Страница 24: ...itself i i Place the disposable protective cover correctly on the window of the camera lens Window of the camera lens is dirty i i Clean the window of the camera lens see 9 2 Cleaning the camera lens Handpiece is defective i i Send handpiece for repair Image too dark LEDs defective i i Send handpiece for repair No image USB connection cable is not con nected i i Connect the USB connection cable US...

Страница 25: ...ucts made by other manufacturers In the event of uncertainties the complete standard must be con sulted 12 2 Abbreviations EMC Electromagnetic compatibility HF High frequency UT Rated voltage of the appliance supply voltage V1 V2 Compliance level for the test according to IEC 61000 4 6 E1 Compliance level for the test according to IEC 61000 4 3 P Rated power of the transmitter in Watts W in accord...

Страница 26: ...y low and un likely to interfere with nearby electronic appliances HF emissions in accor dance with CISPR 11 Group 2 The appliance must emit electromagnetic energy in or der to guarantee its intended function Nearby electronic appliances may be influenced HF emissions in accor dance with CISPR 11 Class A or B The appliance is suitable for use in all facilities including those in the living area an...

Страница 27: ... in accor dance with IEC 61000 4 5 1 kV voltage outer conductor outer conductor 2 kV voltage outer conductor earth 1 kV differential mode 2 kV common mode The quality of the supply voltage should correspond to a typical business or hospital environ ment Voltage dips short term interruptions and fluctuations of the supply voltage in accordance with IEC 61000 4 11 0 UT for 1 2 peri od 0 UT for 1 per...

Страница 28: ...tationary radio transmitters for all frequencies should be lower than the compliance levelb in accordance with inspections on site a Interferences are possible in the vicinity of appliances that have the following symbols Note 1 The higher frequency range applies for 80 MHz and 800 MHz Note 2 These guidelines may not apply in all cases The spreading of electromagnetic field sizes is influenced by ...

Страница 29: ...M 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS Impulse modulationb 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Impulse modulationb 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11a n Impulse modulationb 217 Hz 0 2 0 3 9 Table 4 Test specifications for the interference immunity factor for appliances to mobile radios a For some services only the uplink ...

Страница 30: ...fety distance depending on the transmission frequency m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Table 5 Recommended safety distances between mobile HF communication appliances and the appliance For transmitters whose maximum rated power is not specified in the table shown above the recom mended safe...

Страница 31: ...ompliance level for the test according to IEC 61000 4 3 Interference im munity tests IEC 60601 test level Compliance level Recommended safety dis tances Conducted HF dis turbance variables in accordance with IEC 61000 4 6 3 Veff 150 kHz to 80 MHz V1 V d 3 5 V1 P Emitted HF distur bance variables in accordance with IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz E1 V m d 3 5 E1 P for 80 MHz to 800 MHz d 7 E1...

Страница 32: ... the need is digital imaging utility room equipment or merchandise Air Techniques can provide the solution via our network of authorized professional dealers Proudly designed tested and manufactured in the U S our products are helping dental professionals take their practices to the next level Air Techniques family of quality products for the dental professional include Digital Imaging Digital Rad...

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