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10 Symbols and labeling

KaVo Scan eXam One

10.2 Main label

The unit is class I, type B and with IPX0 protection.

Direct current power supply unit

inlet

Ethernet connector

CE (0537) Symbol MDD

93/42/EEC

This unit is marked according to

the Medical Device Directive 93/

42/EEC (if the unit contains the

CE mark)

ETL symbol

GOST-R symbol

This symbol indicates that the

waste of electrical and electronic

equipment must not be disposed

as unsorted municipal waste and

must be collected separately.

Please contact an authorized rep-

resentative of the manufacturer

for information concerning the

decommissioning of your equip-

ment.

Scan eXam™ One

This product complies with DHHS 21 CFR Chapter I,
Subchapter J at the date of manufacture.

Type: eXam6-1
Ser. No:

KL1300001

3155129

CONFORMS TO UL STD 60601-1.
CERTIFIED TO CSA
STD C22.2 NO 601.1.

Manufactured:

June 2013

24 V

30 VA

IEC 60601-1

Rx only

Manufactured by PaloDEx Group Oy
Nahkelantie 160, FI-04300 TUUSULA, Finland
Made in Finland

Approved:

Reviewed: Jalkanen Joni 2017-02-13 16:00

Reviewed

See PDM system to determine the status of this document. Printed out: 2017-03-17 10:35:17

D510414, 5

Содержание Scan eXam One

Страница 1: ...stem User Manual ENGLISH 209643 rev 5 0 805 5080 Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 2: ...proved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 3: ... the prior written permission of PaloDex Group Oy This is the original approved English language version The manufacturer reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your representative for the most current information Manufacturer PaloDEx Group Oy Nahkelantie 160 FI 04300 Tuusul...

Страница 4: ...proved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 5: ... projection imaging not included in delivery 21 4 Accessories introduction 23 4 1 Hygiene accessories 23 4 2 Imaging plates 24 4 3 Imaging plate storage box 25 4 4 Holders 25 4 5 Occlusal projection imaging with Occlusal 4C start up kit and accessories 26 4 6 Microfiber cloth 26 4 7 Imaging plate care 26 4 8 Imaging plate cleaning 27 5 Introduction to imaging plate technique 29 5 1 Imaging plate 2...

Страница 6: ...on 47 8 1 Quality control 47 8 2 Unit care 47 8 3 Unit cleaning 47 8 4 Disinfecting the unit 48 8 5 Maintenance 48 8 6 Repair 48 8 7 Disposal 48 9 Technical specifications 49 9 1 Unit 49 9 2 System requirements and connections 51 9 3 Imaging plate specifications 52 9 4 Hygiene bag specifications 53 9 5 Electromagnetic Compatibility EMC tables 54 10 Symbols and labeling 58 10 1Symbols 58 10 2Main l...

Страница 7: ...proved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 8: ...proved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 9: ...d plate carrier 6 Power supply CAUTION Only use the power supply deliv ered with the unit or an approved spare power supply supplied by an authorized distributor See chapter Technical Specifica tions 7 Documentation and imaging application software media 8 Hygiene accessories 9 Imaging plates 10 Imaging plate storage box 10 8 9 7 6 3 2 1 5 4 Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewe...

Страница 10: ...ection optional recommended 5 Optional workstation WS computers not in cluded For more options and details of installing and setting up the Scan eXam One system see chapters 6 Installation of the imaging plate system and 9 Technical specifications 1 2 3 4 5 Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35...

Страница 11: ...and by mode Press the ON OFF key or the START key to wake the unit START key Use the start key to wake the unit from the stand by mode or to start processing in the manual mode or to cancel skip the 2nd plate in the Occlusal 4C mode to access startup screen information IP se rial number when the scanner is not re served by any user 4 1 2 3 Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed ...

Страница 12: ...ifier is shown in the pad lock The name of the current patient is shown The green plate feeding indicator is showing readiness for plate insert Express Share ready Unit has a connection to a software using Ex press Share The unit is not reserved by any workstation in the system Unit is activated The unit is activated for image processing The name of the current patient is shown The green plate fee...

Страница 13: ... settings Remove plate Remove the imaging plate from the plate carrier Rotate the plate Rotate the imaging plate Light blue side to the left Remove cover Remove the hygienic cover gently leaving the imaging plate in the plate carrier Press Start to treat the first plate as a single size 3 image Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this...

Страница 14: ...ror ID and a short description is displayed Contact service Press START Press the START button to wake the unit from a standby mode Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 15: ...ftware manual for more information Position and take an exposure See chapter 2 2 for more information Process the imaging plate See chapter 2 4 for more information 1 2 5 4 3 6 1 2 3 4 Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 16: ...n 24 hours Imaging plates have stored in dark not ex posed to ambient light susceptible for back ground radiation for more than 24 hours This will remove any potential fogging due to collected natural background radiation Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx G...

Страница 17: ...ctive side of the imaging plate has a light blue color NOTICE Keep the imaging plates packed max 24 hours before using Packaged plates accumulate radiation from the background Plates can be erased by reading the plate Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group...

Страница 18: ...of interest and on the intraoral X ray tube in use Find guidelines of exposure times in seconds for a standard DC X ray unit in the table below Correct exposure settings depend on the X ray unit type in use For an AC unit or for a low tube current i e portable X ray apply higher exposure times Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this ...

Страница 19: ...s close to F speed film are often appropriate Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 20: ...aging plate with the cover NOTICE Do not partially slide the imaging plate from the cover You can place the plate with cover and leave it to the plate car rier Unit will not start the processing before removing the cover Remove the cover Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyri...

Страница 21: ... within one hour after ex posure Processed imaging plate is ready to be packed and exposed again Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 22: ... Scan eXam One Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 23: ...n software you are using select unit Setup Scanner page for more instruction on how to access setup page review application software manual 3 1 1 Status Shows the scanner type firmware version and unit serial number Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group O...

Страница 24: ...r resolution but may require longer exposure time to compensate High recommended default gives a pixel size of 60 μm This results in images with less noise especially if short exposure times are used 3 1 5 Image Processing Noise Filtering Noise filtering makes images smoother when they are taken at short exposure times There are two options available Classic mode offers traditional noise filtering...

Страница 25: ...o cessed image is automatically transferred to the PC 2 PC If the image is not automatically transferred to the PC select the Setup Scanner page from the imaging application software your are using 3 PC In the Last Image field click Retrieve now to retrieve the last processed image NOTICE If required you can select different pa rameters e g resolution show image preview etc for the image to be ret...

Страница 26: ...late processing The Start after options all ow to select when the unit starts image plate processing After Plate insert processing starts auto matically when it detects right way inserted imaging plate in the plate carrier After Cover removal after the imaging plate and protective cover have been inserted into Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine th...

Страница 27: ...s Select Manual if you want processing to start only when the START key is pressed NOTICE Processing starts even if the plate is Wrong way round Not detected Not inserted at all NOTICE Unit turns off in manual mode if user is pressing ON OFF key regardless of imaging plate sensing in the plate carrier Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status ...

Страница 28: ...ith more care and reduce wear and tear on them This option extends service life of the imaging plates and allows greater hygiene standards to be observed 3 4 Power options From the imaging application software you are using select unit Setup Power options page Standby after seconds Allows you to select the period of time the unit remains unused before it enters the standby mode plate carrier is dr...

Страница 29: ...ion software unit Setup Occlusal page Occlusal 4C projection image is formed from two sequential size 3 plates Image plates are processed separately and then stitched together to form a single Occlusal 4C projection image Following text shortly describe how Occlusal 4C projection image is taken For more information refer to instructions supplied with the Occlusal 4C kit 1 Place two size 3 imaging ...

Страница 30: ...rride the mode and process a single size 3 imaging plate Insert the size 3 imaging plate into the unit so that it can be processed When the insert second plate symbol appears on the unit user interface press the start key This cancels the Occlusal 4C mode for this operation and produce a single size 3 image Size 3 image mode from each size 3 plate allows size 3 imaging plates to process as individ...

Страница 31: ...e use of the system and long service life for the imaging plates NOTICE Never use hygiene accessories more than once 4 1 Hygiene accessories Protective covers Hygiene bags Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 32: ...ing plates have individual identification marking that appear on the images Standard STD imaging plates optional have no identification mark on the sensitive side of the plate Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 33: ...C 272 F The top cover cannot be autoclaved 4 4 Holders It is recommended to use imaging plate holders to ensure accurate patient positioning and consistently good image quality Problems caused by manually positioning the imaging plate include incorrect vertical alignment distortion cone cut off poor projection standardization inferior image quality contamination risk Contact your distributor for m...

Страница 34: ...se 4 6 Microfiber cloth Imaging plate microfiber cloth is used for dry cleaning of the imaging plates comparable to eyeglasses cleaning 4 7 Imaging plate care Sensitive surface handle with care Use only original accessories Single use only You can bend Do not fold or bend excessively Touch the edges only Do not touch the sensitive surface Do not scratch Do not stab Approved Reviewed Jalkanen Joni ...

Страница 35: ... sunlight and UV radiation Not household waste Use ONLY 70 Ethanol Do not apply Ethanol directly on the plate Apply Ethanol on lint free soft fabric Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 36: ...han 24 hours before the exposure Wipe the plate gently Wipe dry or let dry for 1 minute Pack the plate Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 37: ...ish photo stimulable layer does not contain any prosphor phosphorus On top of the blueish material is a top coat protective layer and the edges are closed with lacquer The phosphorescent side of the plate records and stores the image This side is sensitive and should be protected against dust and dirt Visible light clears the image information from the plate so it must be protected from ambient li...

Страница 38: ...E OF ORIGINAL HYGIENE ACCESSORIES ENSURES THE BEST IMAGE QUALITY AND MAXIMUM SERVICE LIFE OF THE IMAGING PLATES The packed imaging plate is positioned with a holder in the patient s mouth The exposure is made as with film The hygiene bag should be disinfected after exposure and disposed off after single use 1 Imaging plate is inserted together with the pro tective cover all the way into the plate ...

Страница 39: ...ique KaVo Scan eXam One 31 1 2 3 Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 40: ... formed from the measured light intensity variation After stimulating imaging plate is exposed to bright light which clears the remaining image information from the plate The imaging plate is dropped out of the unit X ray exposures and processing are not aging the imaging plate so it is re usable hundreds of times In practice mechanical wearing limits the service life of the plate 1 2 4 Approved R...

Страница 41: ...ngle intraoral imaging is approximately the same as the dose one person gets from natural background radiation during one day Imaging plates may gather radiation also during transportation from the manufacturer Therefore it is recommended to perform initial erasing for the new plates This means that all imaging plates should be processed once prior to use Approved Reviewed Jalkanen Joni 2017 02 13...

Страница 42: ...ation fogging NOTICE Ambient light is harmful for the image information on the plate between the exposure and processing NOTICE UV light is harmful for the imaging plates Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 43: ...patient area 6 1 Positioning the unit Position the unit on a stable flat surface so that any potential vibrations do not degrade the image quality The unit must not be positioned so that it is touching other equipment It must not be placed on top of or under other equipment Do not position the unit in direct sunlight or near bright light Sunlight or bright light must not be allowed to shine direct...

Страница 44: ...to a network The unit can be connected directly to a single PC or several PC using a wired local area network LAN It is recommended to use a LAN in all installations Also any workstation used for managing an image capture should be connected to a wired LAN It is recommended to have an internet connection from the LAN This makes registering potential software license easier Approved Reviewed Jalkan...

Страница 45: ... for storing the patient data and images and client software for operating the system and the units Both parts can be on the same computer but there must be only one computer acting as database server in a network If the imaging plate system is operated and images are viewed from multiple PC in a network install only the client software on the remaining other PC The PC that is acting as a server m...

Страница 46: ...tween the scanner unit and the operators software The automatic connection is based on automatically detecting the scanner in the network This is a preferred method 6 4 1 Direct connection method uses the unit s n NOTICE It may not be possible to connect the unit to the PC using the direct connection method if another device is al ready connected to the PC using direct connection If the direct con...

Страница 47: ...on can be done using an IP address 1 Follow steps 1 to 5 from the previous section Direct connection method uses the unit s n 2 PC From the Settings tab select IP based and then select the Enable changing IP address box Obtain an IP address for the unit from your net work administrator and key it into the IP field in the Scanner IP address area NOTICE The PC and the unit must be in the same subnet...

Страница 48: ...ngth of time that the unit remains reserved and un used by a PC before the PC automatically re leased the unit so that it can be used by another PC in the system the scanner can be reserved in advance from another PC The default setting is 40 seconds This can be changed by keying in a new value 2 Click OK to connect the PC to the unit 3 NOTICE An automatic technique automatically locates the unit ...

Страница 49: ... the manufacturer of the unit The PC connected to the unit should not be used in the patient environment The minimum horizontal distance between the patient and the PC is 1 5 m 4 5 ft The minimum vertical distance between the patient and the PC is 2 5 m 6 5 ft Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10...

Страница 50: ...e system 42 KaVo Scan eXam One Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights reserved ...

Страница 51: ...accesso ries use Improper storing of the imaging plates or excessively high X ray dose used Imaging plate has been exposed to ultravi olet UV radiation Imaging plate has collected background radiation because Plate has been stored near X ray unit Plate has been stored in the bag or in dark too long Use dedicated imaging plate storage box to avoid these Alternatively perform initial erasing for the...

Страница 52: ...ay dose Too light noisy image with decreased diagnostic value Showing only part of the image Showing wrong size of the image Image smaller than imaging plate Too short exposure time Too low X ray dose Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by PaloDEx Group Oy All rights re...

Страница 53: ...leds are monitored during normal operation If leds are defected ap plication SW shows warning Circular shape on the image Imaging plate has been exposed from the wrong side which shows the phantom of the metal disc on the rear side of the plate Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5...

Страница 54: ...traoral X ray unit Use proper holders Too long exposure time may have been used Use shorter exposure time increase kV if necessary to compensate effect of shorter exposure time Geometry distortion Improper patient positioning Use proper holders to avoid this NOTICE Never do accurate measurements on in traoral images unless having known size of refer ence object in the imaging plane Approved Review...

Страница 55: ... cleaning does not help Pay attention on handling storing and maintenance Ensure that only the genuine hygiene accessories are used Spots dots white or gray or any visible pattern Most probably caused by wearing of the imaging plate Can be caused by moisture or improper cleaning Clean the plate s ONLY 70 ETHANOL MUST BE USED Replace if cleaning does not help Pay attention on handling storing and m...

Страница 56: ...nnected prop erly laser detection erasing movement control 13 K300 board not connected prop erly imaging plate sensing detection 23 K200 error erase LED linear movement detection sensor or laser synchronization error 24 Plate carrier movement error 34 Plate sensor error imaging plate cannot be detected 123 Door movement error position of the door not detected or movement is blocked 124 Safety cove...

Страница 57: ... To clean the unit use a non abrasive cloth moistened with cool or lukewarm water soapy water mild detergent isopropyl alcohol or ethanol ethyl alcohol 70 96 CaviCide CaviWipes by Metrex FD322 by Dürr Dental Easydes by Kiilto After cleaning wipe the unit with a non abrasive cloth moistened with water Never use solvents or abrasive cleaners to clean the unit Never use unfamiliar or untested cleanin...

Страница 58: ...ot require any maintenance 8 6 Repair The unit does not require any maintenance If the unit is damaged or malfunctions in any way it must only be repaired by service personnel authorized by the manufacturer of the unit 8 7 Disposal At the end of the useful working life of the unit and or its accessories make sure that you follow national and local regulations regarding the disposal of the unit its...

Страница 59: ...ard Environmental management system In accordance with ISO14001 standard Conformity to standards IEC 60601 1 1988 and A1 A2 IEC 60601 1 1 2000 IEC 60601 1 4 1996 and A1 IEC 60601 1 2 2001 IEC 60601 1 2005 EN 60825 1 2007 UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 and S1 A2 DHHS 21 CFR Chapter I Subchapter J at the date of manufacture In conformity with the provisions of Council Directive 93 42 EEC...

Страница 60: ...esolution 16 7 lp mm Firmware version 1 0 or higher Interface connection Connection type RJ 45 Unshielded CAT 6 Ethernet cable Plastic materials Used materials are phthalate free containing 0 1 w w of DEHP and is not manufactured from raw materials containing or derived from Bisphenol A BPA Operating environment 10 C 40 C 30 90 RH 700 1060 mbar Storage transportation environment 10 C 50 C 0 90 RH ...

Страница 61: ...unique IP address otherwise they may cause communication problems with existing LAN devices Place unit and PC with imaging application software to same subnet in LAN NOTICE Image is not transferred from unit to PC imaging application software in case of connection lost during image processing Image is stored in unit memory until it has been transferred to PC Unit cannot be turned off in that case ...

Страница 62: ... material Shielded with a protective top coat layer on the sensitive surface and encapsulated with lacquer around the edges Imaging plates do not not in clude phosphorous phosphorus P Use The typical service life for an imaging plate is several hundreds of cycles provided that the imaging plate is handled with care and according to the supplied instruc tions The use of genuine hygiene accessories ...

Страница 63: ... used within two years from the date of manufacture The date of manufacture is printed on the bottom of the box con taining the hygiene bags DDMMYYXX Extended storage time or exceeding the specified storage conditions may compromise the performance of the adhesive tape and or the plastic mate rial from which the hygiene bags are made of Disposal Observe relevant national requirements Approved Revi...

Страница 64: ...c environment guidance RF emissions CISPR 11E Group 1 The eXam6 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The eXam6 is suitable for use in all establish ments including domestic establishments and those directly connected to the public low voltage po...

Страница 65: ...mmer cial or hospital environment Surge IEC 61000 4 5 1 kV differ ential mode line to line 1 kV differ ential mode Mains power quality should be that of a typical commer cial or hospital environment Voltage dips short inter ruptions and voltage vari ations on power supply lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cy cle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 ...

Страница 66: ...ance and manufacturer s declaration electromagnetic immunity The eXam6 is intended for use in the electromagnetic environment specified below The customer or the user of the eXam6 should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environ ment guidance Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to d...

Страница 67: ...mitter Recommended Separation Distance where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommend ed separation distance in metres m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in t...

Страница 68: ... verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting of relocating the eXam6 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Guidance and manufacturer s declaration electromagnetic immunity The eXam6 is intended for use in the electromagnetic environment specified below The customer or the user ...

Страница 69: ...00 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the rec ommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maxi mum output power rating of the transmitter in watts W acco...

Страница 70: ...ing instructions for more information The operating instructions can be supplied elec tronically or in paper format CLASS II equipment Double insulated electrical appli ance UL symbol Indoor use Dangerous voltage Laser radiation Approved Reviewed Jalkanen Joni 2017 02 13 16 00 Reviewed See PDM system to determine the status of this document Printed out 2017 03 17 10 35 17 D510414 5 Copyright by Pa...

Страница 71: ...ease contact an authorized rep resentative of the manufacturer for information concerning the decommissioning of your equip ment Scan eXam One This product complies with DHHS 21 CFR Chapter I Subchapter J at the date of manufacture Type eXam6 1 Ser No KL1300001 3155129 CONFORMS TO UL STD 60601 1 CERTIFIED TO CSA STD C22 2 NO 601 1 209995 r1 Manufactured June 2013 24 V 30 VA IEC 60601 1 Rx only Man...

Страница 72: ...ssories must not be modified altered or remanufactured in any way Only the manufacturer s authorized service personnel are authorized to carry out main tenance and repair of the unit There are no user serviceable parts inside the unit Unit is not suitable for use in the presence of flammable anaesthetic mixture with air or with oxygen or nitrous oxide In order to maintain safe and correct func tio...

Страница 73: ...the Medical Device Directive 93 42 EEC and or FDA if applica ble Do not position the PC where it could be splashed with liquids Clean the PC in accordance with the manu facturer s instructions Image is not transferred from unit to PC im aging application software in case of connec tion lost during image processing Image is stored in unit memory until it has been transferred to PC Unit cannot be tu...

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