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DGH 555B – Pachette 4 (English, 01/06/15)

1. terere rere 8 4 2 USING ULTRASOUND TO ASCERTAIN CORRECT PROBE 8 43 WLTRASONIC MEASUREMENT 9 4 4 PROPER APPLANATION FOR TAKING A 10 5 ULTRASONIC EXPOSURE AND INTENSITIES sccsssssccssssccccssscccssssccccssseccssssscecessaccscssssccecssssecees 11 5 1 TISSUE EXPOSURE TO ULTRASOUND ENERGY 11 5 2 ULTRASONIC INTENSITIES h e E E TE E E EE EEEE 11 5 3 BIOMETRIC MEASUREMENT CAPABILITIES ccccccccscsccccecececececececececececececesecececscecesscaseussesauseesessussseseeueeseees 12 6 PHYSICAL DESCRIPTION vsssssccssssasessseess sostectssvevecsssesseessssscecessossseteescssossceasseseensdsnsecssssuteessa sess sists etss 13 61 TBRONT E E OS 13 6 2 BACK VIEW 15 63 ISIDE VIEW eU Se scl 16 64 BACK OF UNIT PROTECTIVE HOLSTER REMOVED ss cccesssecesseseeeeseececeesaececseceecesaeeeceesaececsesaeeseseeeenaes 17 OGNI TO DH LEE M 18 6 6 CALIBRATION VERIFICATION BOX CALBOX enne enne nennen erret nennen nennen nns 19 7 PROBE USE AND INDICATORS
2. eh ieee 30 10 3 CHANGING PATIENT MODES 32 10 4 ADDING PATIENT IDENTIFICATION nnn nnn nnn nennen 33 10 5 CLEARING PATIENT INFORMATION 34 TL MEASUREMENT 35 11 1 CONTINUOUS AVERAGING MEASUREMENT eene 35 11 2 MAPPING MEASUREMENT tette tese serere rennen 36 11 3 CHANGING MEASUREMENT MODES 37 12 TAKING MEASUREMENTS 38 12 1 POWER UP SEQUENGE 38 12 2 MEASUREMENT IN CONTINUOUS AVERAGING MODE eee eene nre rn nennen 40 12 3 MEASUREMENT IN MAPPING eere eee nene e a rrr 43 12 4 VIEWING DXTE AND TIME eee EE EEA 46 13 CONFIGURING THE PA CHET TES oe 47 13 1 ENTERING AND NAVIGATING THE CONFIGURATION
3. 20 7 1 INSERTING AND REMOVING THE 20 7 2 HODNO THE PROBE e Ue eeu e 21 7 3 CHECK PROBE ERROR MESSAGE eerte r 22 TA SPLUG IN PROBE ERROR MESSAGE eere 22 75 PQF FAILED ERROR MESSAGE 22 8 VERIFYING PACHETTE 4 CALIBRATION ccsssccsssssccssssscccssssccccssscccssssccccsseccecssccecesseccccssssececssscecees 23 8 1 PROCEDURE FOR VERIFYING 23 9 POWER 2 26 91 MEASUREMENT MODE a sade 26 9 2 32STANDBY MODE 26 Page 2 of 92 DGH 555B INS OMENG Rev 0 ZSEBEP MODB 5 utem Dont re F EE De 27 9 4 POWERING DOWN 27 9 5 CHECKING BATTERY POWER ccccccccscscscscscececececececececececececececececacecacecacececececacacacacecacacacacasasauasesasseseaeeuenenags 27 10 PATIENT MODES P 28 10 1 SINGLE PATIENT MODE 28 10 2 MULTEPATIENT dere tod tee E edite e d
4. 555B DGH2006 gt 00 2 2 4 Wem The acoustic output values given above based a presumed attenuation of ultrasound on tissue as developed by the U S Food and Drug Administration in 1985 and later incorporated into other international Standards The attenuated intensity in the eye at the transducer focus corresponding to maximum intensity may be calculated according to the formula recommended by the FDA _ 0 069 fx z lt 1 xe Page 11 of 92 DGH 555B INS OMENG Rev 0 where Z is the estimated in situ intensity is the measured intensity in water at the focus of the transducer f is the ultrasonic frequency and z is the distance from face of the probe to transducer focus which is the point of measurement 3 millimeter The nominal piezoceramic crystal frequency of these transducers is 20 MHz The actual frequency of a particular transducer may vary from this value The tissue calculations above were done with the measured frequency of the transducer used for the tests 5 3 Biometric Measurement Capabilities The following table shows the measurement range for the DGH 555B Ultrasonic Pachymeter Pachette 4 Measurement Option Range Accuracy um Display Resolution um Measurement Option Range um Accuracy um Display Resolution um Standard Unit 200 1100 pm 5um 95
5. Contains Transmitter Module FCC ID TTVEBMU IC 2160EBMU This note only to appear on devices that contain a Bluetooth wireless module 3 Battery Door This door provides access to the battery compartment See section 16 1 and 16 2 for information on accessing the battery door and changing batteries Page 17 of 92 DGH 555B INS OMENG Rev 0 6 5 Probe 3 Fig 6 5 1 The DGH 555B Pachette 4 probe 1 Probe Tip The portion of the probe energized when taking a measurement 2 Transducer Housing Contains the transducer and is held by the operator during measurement 3 Probe Connector The probe connector plugs into the Pachette 4 unit See section 7 1 for instructions on proper connection and disconnection of probe Page 18 of 92 DGH 555B INS OMENG Rev 0 6 6 Calibration Verification Box CalBox To check Pachette 4 calibration an electronic Calibration Verification Box 1 is used to simulate the thickness of the cornea Instructions for using the Cal Box are given in section 4 and they are also printed on the CalBox label TECHNOLOGY INC 1 With the 4 tumed off disconnect the probe and then connect the CalBox cable to the Pachette 4 2 Enter Pachette 4 CalBox Mode by pressing and holding the DEL key while pressing the PWR key 3 Press the CalBox START key until the LED lights up 4 Observe that all Pachette 4 measurements are within 5 See
6. nnne 47 13 2 PARAMETERS FOR CONTINUOUS AVERAGING MEASUREMENT MODE eere eee 50 13 3 PARAMETERS FOR MAPPING MEASUREMENT nnne nn 51 13 4 GENERAL DEVICE PARAMETERS eee eene rrr rrr teneret tette tette tenen nn 52 13 5 BLUETOOTH PARAMETERS cccccsscscecscsesesececssscsescscecsssveusssucsesesvsusssnsseseacacscacsususasacaesvavsusnsnsaescacacavaveueueeese 54 14 CONFIGURING BLUETOOTH CONNECTIONS uwccsccscscsssssscsssssssssssessessssssesssessessssssesessesesscsssesessesesscsess 56 14 0 ENABLING BLUETOOTH ascen nm edet teta etie tu UR ON 56 14 2 PAIRING WITH A BLUETOOTH ENABLED PRINTER eerte trt EI En A En 56 14 3 SENDING MEASUREMENTS TO A BLUETOOTH ENABLED WIRELESS PRINTER csecessssssesescsesesesececsesesesesesees 58 14 4 PAIRING WITH A BLUETOOTH ENABLED 59 14 5 APPNO COM POR hs 2 62 14 6 SENDING AND RECEIVING INFORMATION VIA BLUETOOTH CONNECTION TO A PC 63 14 7 RECALLING PAIRED DEVICE erret rrr nnn 64 14 8 CLEARING A SINGLE PAIRED BLUETOOTH DEVICE ceret ttes 64 14 9 CLEARING ALL PAIRED BLUETOOTH DEVICES eterne trt
7. 555 4 ULTRASONIC PACHYMETER 555 OPERATOR S MANUAL For Use with Firmware v3 0 0 And DGH Connect Software v1 1 0 Equipment Manufactured By TECHNOLOGY INC 110 SUMMIT DRIVE SUITEB EXTON PA 19341 USA 610 594 9100 Page 1 of 92 Authorized Representative EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 70 345 8570 0120 DGH 555B INS OMENG Rev 0 Table of Contents TABLE OB ELMO oS 2 1 INTRODUCTION CLASSIFICATION AND INDICATIONS FOR USE 5 1 1 GENERAL DEVICE DESCRIPTION tecto etre 5 1 2 DEVICECLASSIEICATION ee tete sete eed tbe tele tete ead ete aed bet reae 5 1 3 INDICATIONS EOR USE ee eae tek an eec e N 5 2 DESCRIPTION OF SYMBOLS sisssssscccsesssssesesscesesosssssecsscosvscescsdescoscoessssssveccodescecssbubieessesssecesbeesesencessessbebsvesse 6 3 GENERAL CAUTIONS AND WARNINGS PRESCRIPTION DEVICE STATEMENT AND OPERATOR QUALIFICA TIONS scbesosecssusoosssouscenessess 7 3 1 GENERAL CAUTIONS AND WARNING So serino T 3 2 PRESCRIPTION DEVIGE STATEMENT aean 7 3 3 OPERATOR QUALIFICATIONS gt ee Di Dente D EE eS 7 4 USE OF ULTRASOUND IN OPHTHALMIC MEASUREMENT cssssccsssssscessscccssseccssssccsessscccessnee 8 4 1 INTRODUCTION TO ULTRASOUND
8. default system printer 15 7 10 To open the patient reports that have been imported go to the Settings File Open Report The software will open a window that shows aging all patient records that have been imported 15 7 11 The report will show all measurement and patient ne OR information PDF reports cannot be edited DOC m ar reports can be edited using a word processing DEAE rogram P 5 Average 509 05 Average um 513 Std Dev um 0 7 Std Dev am 0 9 Page 77 of 92 DGH 555B INS OMENG Rev 0 16 Changing Batteries Please observe the following instructions when changing batteries to avoid damaging the device 16 1 Removing the molded rubber case 16 1 1 Detach the probe entirely from Pachette 4 See section 7 1 The probe pulls straight out from the connector DO NOT TWIST THE PROBE CONNECTOR Place the probe in a safe place being careful to avoid any surface that could scratch or damage the probe tip 16 1 2 Place the Pachette 4 face down on a clean flat surface Page 78 of 92 DGH 555B INS OMENG Rev 0 16 1 3 Place the left hand with 3 fingers under the top left corner of the rubber case and the left thumb on the back of the rubber pad 16 1 4 Place the right hand with 3 fingers under the top right corner of the rubber case and the right thumb on the
9. 1100 5um Page 12 of 92 DGH 555B INS OMENG Rev 0 6 Physical Description 6 1 Front View ULTRASONIC PACHYMETER Bluetooth 34 6 7 9 10 11 12 Fig 6 1 1 The DGH 555B Pachette 4 Front View 1 LCD Display 16 x 2 character display used to present measurement data and or configuration parameters to the operator 2 Probe Clips Two clips molded into the protective case to place probe between patients 3 Bluetooth Wireless Technology Logo The Bluetooth Wireless Technology Logo will only appear on the front panel of the unit if the device has the optional Bluetooth module installed Page 13 of 92 DGH 555B INS OMENG Rev 0 4 PWR Key Pressing this key turns the Pachette 4 on When the Pachette 4 is on pressing and holding this key turns the Pachette 4 off Also used in conjunction with the DEL key to enter the CalBox mode 5 DEL Key Used to erase a single measurement from a group of measurements Also used in conjunction with the PWR key to enter the CalBox mode 6 CLR Key This key is used to show the clearing options of the device The user can clear all measurements OD measurements OS measurements patient information and paired devices Pressing and holding this key will display the date and time 7 ENT Key In measurement mode pressing key will display battery status In configuration mode the key is used to advance to the next configurabl
10. 65 15 DGH CONNECT SORTWA RE Se oa va dos arse e eeu 66 15 1 SOFTWARE REQUIREMENTS vz tire eec te EE EACH 66 15 2 INSTALLING THE SOEPWABE etti eR EU Ede EE ES 67 15 3 CONFIGURING THE SOFTWARE rnin e utu ue tee eset sessi sese sese 68 15 4 ADDING A DEVICE eerte eei iMd iE dc ME i 70 15 5 EXPORTING PATIENT INFORMATION TO THE PACHETTE 4 71 15 6 INITIATING MEASUREMENT TRANSFER USING THE PC SOFTWARE 73 15 7 INITIATING MEASUREMENT TRANSFER USING THE 4 eere eee 75 Page 3 of 92 DGH 555B INS OMENG Rev 0 16 CHANGING BATTERIES 78 16 1 REMOVING THE MOLDED RUBBER 78 16 2 CHANGING THE BATTERIES ieii inn 79 17 CARE AND MAINTENANNQE 5 eie eee eo vs one Rees 4 Fe ea ias ema e e IN eade DE Fe de Tuv eee eoo so Ce euo Seed 81 17 1 CLEANING AND DISINFECTING THE eee nnn nnn 81 17 2 GEEANING THE UNIT Reiner hum eedem RECO 82
11. are y the What To Clear menu Meas e The following selections affect the patient currently being measured Selecting Current Meas clears all measurements of both the left and right eye for the currently loaded patient o Selecting OD Current Meas clears all measurements of the right eye for the currently loaded patient o Selecting OS Current Meas clears all measurements of the left eye for the currently loaded patient Selecting Nothing Exit exits the menu without deleting anything e The other clearing options affect stored patient information or system configuration Selecting Patients clears all identifying information and all measurements for all patients Bluetooth option only o Selecting Paired Devices clears all paired devices from the device memory Bluetooth option only Page 42 of 92 DGH 555B INS OMENG Rev 0 12 3 Measurement in Mapping Mode NOTE Typically anesthetizing the patient s eye is necessary for obtaining a measurement 12 3 1 12 3 2 12 3 3 12 3 4 12 3 5 12 3 6 12 3 7 Perform the Power Up Sequence as described in Section 12 1 Press the CFG key to enter the Configuration Menu Press the ENT key repeatedly to navigate through the menu Confirm that Mapping Mode is selected in the Operational Mode menu See Section 11 3 Select a memory location to associate measurements with
12. 2 1 the device will only display the results for a few seconds before switching to the other eye for measurement e The example shows the right eye measurements Avg 25 indicates 25 successful 00 Avg 25 S40 measurements and the average of those Std Dw 03 measurements is 540 um The calculated standard deviation is 0 3u m e To scroll through each measurement press the Mea 1 50 or key The device will list the result of Std Dv 03 each measurement taken while showing the Standard Deviation on the bottom line Mea 2 533 u Std Dv Page 41 of 92 DGH 555B INS OMENG Rev 0 12 2 14 If a questionable measurement is found during review the operator can delete it To do this the operator presses the DEL key while viewing the measurement in question The Measurement Average and Standard Deviation will be automatically updated e The operator can take new measurements to replace those that were deleted or choose to accept the remaining measurements 12 2 15 Once both the OD and OS measurement groups are complete no more measurements can be taken for that eye unless the measurements of that group are cleared Or individual measurements are deleted as described in 12 2 14 12 2 16 If the device is operating in Multi Patient Mode the measurements will be automatically saved to memory 12 2 17 To clear all measurements for one or both eyes 2 press the CLR key The user will be prompted with
13. Confirm that it is turned On If not press the or Y key to enable Bluetooth See Section 14 1 Page 56 of 92 DGH 555B INS OMENG Rev 0 14 2 4 Press the ENT key two more times to navigate to ADD PRINTER Add PC Printer parameter Press the OD button to K initiate a scan The scan may take up to a minute can 14 2 5 The Pachette 4 will populate a list of all discovered iti sat Bluetooth devices Use the and V keys to scroll through list of available devices lt Add o NAME is the name of the device discovered is the list number of the device shown is the total number of devices discovered Up to 5 devices can be discovered at a time ReScan indicates that pressing the OS key will cause Pachette 4 to re scan for devices o Add indicates that pressing the OD key will cause the Pachette 4 to attempt to pair with the displayed device 14 2 6 With the desired device displayed select Add by pressing the OD key 14 2 7 4 Nan un d HAHE e device being paired to Use the ey to selec 2 E Yes when prompted Pair T Y H 14 2 8 The Pachette 4 will display a message indicating A that it is in the process of pairing It will then Pairing H Device prompt the user for the printer s Pin Code Please 14 2 9 The Pachette 4 will display Enter Pin Code and show a blinking black cursor Use the OS a
14. INS OMENG Rev 0 14 Configuring Bluetooth Connections Bluetooth wireless features can only be enabled if your device has an optional Bluetooth module installed Only Devices with a Bluetooth Wireless Technology Logo printed on the front in the bottom left hand corner have a module installed 14 1 Enabling Bluetooth 14 1 1 To turn on the Bluetooth wireless module press the CFG key then press the ENT one time to BLUETOOTH navigate to the Bluetooth parameter and set it to On On using the or Y key 14 1 2 Press the CFG key to exit the Configuration menu i Save Config 1 lt Ho and press the A key to select Yes when prompted to save the configuration The Pachette 4 will return to Measurement Mode 14 1 3 An icon will appear in the upper left hand corner to indicate that the Bluetooth module is enabled Mele 14 2 Pairing with a Bluetooth enabled printer The Pachette 4 can be paired directly to a Bluetooth enabled printer Once paired the operator can print measurements directly from the device without the need for a PC 14 2 1 Turn on the printer and put it in the discoverable mode Refer to the printer s user manual for instructions on using the printer s Bluetooth features 14 2 2 Turn on the Pachette 4 and enter the Configuration Menu by pressing the CFG key 14 2 3 Press the ENT key one time to navigate to the Bluetooth parameter
15. NOTE Single Patient Mode is available on all Pachette 4 devices however exporting measurements from the device is only available with Bluetooth module option installed By default every time the Pachette 4 is turned on it is in Single Patient Mode Single Patient Mode allows the user to start taking measurements immediately Single Patient Mode is indicated by a blank space on the lower left hand side of the screen o Avg 0 Op Std Dv 0 01 Once the user completes taking measurements for both the right and left eye the measurements must be cleared before a new measurement group can be initiated The device can only remember a single patient s measurements while operating Therefore it is necessary to either write down or export the measurements NOTE In Single Patient Mode the device can take either Continuous Averaging or Mapping measurements However if the Measurement Mode is changed it will clear the measurements for all patients stored in memory Page 28 of 92 DGH 555B INS OMENG Rev 0 SINGLE PATIENT MODE OPERATION ACTIVE MEMORY 1 In Single Patient Mode nothing is loaded into the Active Memory PERFORMS MEASUREMENTS 2 OD OS measurements and calculations are IN EITHER CONTINUOUS temporarily stored in the device s Active Memory AVERAGING OR MAPPING during the measurement sequence MODES 3 After OD and OS measurements are taken they must be cleared to start another se
16. P is the transmitter power in watts and d is the recommended separation distance The separation should include cables connected to the unit Interference may occur in the vicinity of equipment marked with the following symbol te Kp Conducted RF 3Vrms 150kHz Complies The DGH 555B Pachette 4 complies with requirements IEC 61000 4 6 to 80 2 V1 3Vrms however a separation distance from mobile RF communications should be maintained based on the following calculations EI where is the transmitter power in watts d is recommended separation distance The separation should include cables connected to the unit Electrical fast transient NA NA Not powered from mains IEC 61000 4 4 Surge IEC 61000 4 5 NA NA Power frequency magnetic NA NA Unit does not use magnetically sensitive field IEC 61000 4 8 components Voltage dips short NA NA Not power from mains interrupts and voltage variations on power supply input lines IEC 61000 4 11 Page 87 of 92 DGH 555B INS OMENG Rev 0 22 2 Wireless Radio Module Regulatory Compliance PAN1322 SPP Panasonic Bluetooth Qualification and Regulatory Certification ENWESB41A3KF Is Intended to be installed inside end user equipment ENWS5641A3KF Is Bluetoooth qualified and also FCC certfed and Industry Canada approved and conforms to RATTE European requirements and directives with the reference design described in Figure 3 Manufac
17. and the measurement 05 Posn 1 Heas Op The device can also be configured to display an operator defined measurement bias while in Mapping Measurement Mode See section 13 3 2 When biased measurements are enabled the screen will display which eye is being measured the mapping position number the actual 05 Pos 1 0 measurement and calculated biased measurement Biased Ou Pos 1 0 Biased With Mapping Measurement Mode enabled the Pachette 4 can be programmed to record from 1 to 33 unique measurement positions The illustration below shows 33 potential measurement points I 4 Fig 11 2 1 Potential Mapping Points Using multiple measurement points allows the user to the thicknesses of the cornea at various locations however the operator must keep track of which measurement belongs to each corneal position This can be achieved with the help of corneal thickness charts which are available upon request from DGH Technology Inc See section 13 3 for information on configuring Mapping parameters See section 12 3 for information on taking measurements in Mapping Measurement Mode Page 36 of 92 DGH 555B INS OMENG Rev 0 11 3 Changing Measurement Modes 11 3 1 Upon power up the Pachette 4 s Measurement Mode will be set to the last setting used factory default is Continuous Averaging 11 3 2 To check the Measurement Mode setting press the CFG key and
18. before advancing to the next measurement position Period of time in seconds after a poor applanation occurs before the unit will automatically advance to the next measurement position Period of time in minutes that the device will wait before automatically switching to Standby Mode The device is set to monitor voltages for alkaline batteries Rechargeable Off in Standby The device is set to monitor voltages for rechargeable batteries The back light will turn off in Standby Mode or when in the configuration menu Off The back light is always off On 1 to 14 segments 1 to 14 segments 1 to 14 segments The back light is always on Adjusts display brightness for desired viewing Adjusts display contrast for desired viewing Adjusts alarm volume to desired level Use the 1 or key to select either MMM DD YYYY or DD MMM YYYY The device will display the date in this format Page 49 of 92 Use the OD or OS keys to move the cursor left or right Use 7 or key to change the values This will set the date and time for the device Date and time must be reset after batteries are changed DGH 555B INS OMENG Rev 0 13 2 Parameters for Continuous Averaging Measurement Mode These are the Continuous Averaging Measurement Mode parameters that are accessible from the Configuration Menu The device must be set to Continuous Averaging to access these paramete
19. if in Mapping Mode and Disp Bias is enabled Only available if in Mapping Mode Only available if in Mapping Mode Always Available Always Available Always Available Always Available Always Available Always Available Always Available Parameter default value Disp Bias Meas Enabled Amount Of Bias 100 Good Meas Delay 1 0 sec Poor Appl Delay 2 0 sec Delay to Standby 1 0 min Battery Type Rechargeable Back Light Off in Standby Brightness 7 segments Contrast 7 segments Volume 7 segments Date Time Changing A Setting Press or key to enable or disable Press 7 or key to change the value Press or key to change the value Press or key to change the value Press or key to change the value Press 7 or key to change the value Press or key to change the value Press or key to change the value Press or key to change the value Press or key to change the value Press OS to Format Press OD to Set Disabled Result Description The device WILL NOT display measurement bias while in Mapping Mode Enabled 196 to 19996 1 0 to 9 5 1 0 to 9 5 0 5 to 9 5 Alkaline The device WILL display measurement bias while in Mapping Mode Selects the percentage to calculate biased measurements Period of time in seconds after a measurement that the device will display the result
20. is sending to a PC If the device has already been pre configured to send to a PC press and hold the ENT key The Pachette 4 will attempt to send measurements Go to 15 7 5 If you are unsure if the device is pre configured check that the Pachette 4 is sending the records to the proper device To do this press the CFG key to enter the Configuration Menu and repeatedly press the ENT key to navigate to the Send Meas To menu 15 7 3 Use the and V keys to scroll through the saved A dap configurations SEND MEAS TO us P HAHE 5end o 15 name of the device that will receive the records o 5 is the list number of the device shown o is the total number of devices paired with the Pachette 4 Up to 5 devices can be paired at a time o Send indicates that pressing the OD key will cause the Pachette 4 to transmit measurements to the currently displayed device 15 7 4 With the desired device displayed press the OD key to select Send Page 75 of 92 DGH 555B INS OMENG Rev 0 15 7 5 The Pachette 4 will begin connecting to the and display the message Connecting To BT Device a NOTE If there no measurements stored in the device the Pachette 4 will not attempt to connect It will display the message No Measurements To Transfer 15 7 6 Once connected the Pachette 4 will display Bluetooth Connected and will transfer Bluetooth Connected measuremen
21. of 92 DGH 555B INS OMENG Rev 0 3 General Cautions and Warnings Prescription Device Statement and Operator Qualifications 3 General Cautions and Warnings 3 2 Prescription Device Statement 3 3 Operator Qualifications This DGH 555B is intended to be used by trained medical professionals The medical professional operating the DGH 555B must have a general knowledge of the use of ultrasonic medical devices Use of the DGH 555B requires adequate dexterity to position the probe safely The DGH 555B uses audio feedback to inform the operator of the scan status Page 7 of 92 DGH 555B INS OMENG Rev 0 4 Use Of Ultrasound In Ophthalmic Measurement 4 1 Introduction To Ultrasound Ultrasound offers a non invasive method to examine the interior of solid objects Ultrasonic pulses consist of sound waves of a frequency level too high to be heard by the human ear When a sound impulse strikes an interface some sound is reflected and some sound is transmitted Because some sound will pass through the surface and be reflected by the next surface complex structures can be examined with ultrasound When ultrasound penetrates an object with several interfaces the reflected ultrasound can be observed as a waveform with peaks that are related to the positions of the interfaces The DGH 555B transducer emits ultrasound pulses and detects ultrasound signals that have bee
22. one more time to navigate to Send SEHD MEARS TO a T Meas To parameter Use the and Y keys to HAHE Send scroll through the saved configurations 15 name of the device that will receive the records o 15 the list number of the device shown o 8 is the total number of devices paired with the Pachette 4 Up to 5 devices can be paired at a time o Send indicates that pressing the OD key will cause the Pachette 4 to transmit measurements to the currently displayed device 14 7 4 With the desired device displayed press the CFG 1 key The Pachette 4 will prompt for confirmation of the configuration change lim es la 9 14 7 5 Select Yes by pressing A key The Pachette 4 is now configured to send measurements to the selected device 14 8 Clearing A Single Paired Bluetooth Device Occasionally it may be necessary to clear a single Bluetooth pairing setting from the Pachette 4 s memory to allow connection to new devices 14 8 1 Enter the Configuration Menu by pressing the CFG key 14 8 2 Press the ENT key one time to navigate to the Bluetooth parameter Confirm that it is turned On If not press the or Y key to enable Bluetooth See Section 13 5 1 Page 64 of 92 DGH 555B INS OMENG Rev 0 14 8 3 Press the ENT two more times to navigate to Add PC Printer parameter Press the OD key to initiate ADD PC PRINTER scan Scan 14 8 4 The Pac
23. or select Single Patient Mode See Sections 10 1 and 10 2 Select the number of positions to be measured default is 33 measurements See Section 13 3 1 Press CFG key to exit Configuration Menu save 5 If changes have been made the Pachette 4 will T Yes lt prompt for confirmation of the configuration change Press the key to select Yes and save the configuration The Pachette 4 will return to Measurement Mode Page 43 of 92 DGH 555B INS OMENG Rev 0 12 3 8 Select the eye to be measured You can select either eye for measurement by pressing the OD or OS Posn 1 key The selected eye will be displayed in the upper Meas 0 left hand corner By default device is prepared to measure the RIGHT eye 05 Porn 1 Meas Op The devi Iso b fi d to displ i device can also be configured to display Posn 1 operator defined measurement bias while in Mapping Measurement Mode See sections Biased Ou 13 3 2 and 13 3 3 05 Posn 1 Biased 12 3 9 Have the patient visualize a fixation point 12 3 10 Confirm that the device is in Measurement Mode The blinking black cursor is not shown in the upper left hand corner 12 3 11 Gently position the probe tip on the cornea as described in section 4 4 The Pachette 4 will automatically take a single measurement when the probe is properly applanated e For each successful measurement taken the device will emit a quic
24. then repeatedly press the ENT key to OPERATIONAL scroll through the configuration options Scroll until Continuous Awg the Operational Mode menu is displayed OPERATIONAL MODE 11 3 3 Pressing the or Y key will switch between Continuous Awg Continuous Averaging or Mapping modes OPERATIONAL MODE Mapping 11 3 4 Press the CFG key when the preferred mode is displayed If changes have been made the device will display the Save New Config message Save Config T Yes 11 3 5 Press the key to select Yes to save the configuration e If there is data that is cleared the device will ALL MEAS CLEARED display the ALL MEAS CLEARED Config Saved message Config Saved e If there is no data to clear the device will display the Saving New Config message Saving Config e After the message is displayed the device will show the screen for the appropriate Measurement Mode Page 37 of 92 DGH 555B INS OMENG Rev 0 12 Taking Measurements The Pachette 4 is shipped from the factory preset to Continuous Averaging Measurement Mode The user can begin taking measurements immediately if this is the preferred mode The device is packaged with 2 AA batteries pre installed and the probe cord wrapped around the cord wrap on the protective holster with the probe seated in the protective cavity 12 1 Power Up Sequence 12 1 1 Remove the probe
25. 0 um pulse Acceptable Result 195 um 205 um Measurement 3 300 um pulse Acceptable Result 295 um 305 um Measurement 4 400 um pulse Acceptable Result 395 um 405 um Measurement 5 500 um pulse Acceptable Result 495 um 505 um Measurement 6 600 um pulse Acceptable Result 595 um 605 um Measurement 7 700 um pulse Acceptable Result 695 um 705 um Measurement 8 800 um pulse Acceptable Result 795 um 805 um Measurement 9 900 um pulse Acceptable Result 895 um 905 um Measurement 10 1000 um pulse Acceptable Result 995 um 1005 um Page 24 of 92 DGH 555B INS OMENG Rev 0 8 1 6 When all measurements are complete exit CalBox Mode by pressing the CLR key on the Pachette 4 8 1 7 The Pachette 4 will require confirmation to exit Exit Calbox Mode CalBox mode Press the key to select Yes t Yes Ho 8 1 8 Disconnect the CalBox by pulling the lead straight out 8 1 9 Reconnect the probe The Pachette 4 is now ready to take measurements Page 25 of 92 DGH 555B INS OMENG Rev 0 9 Power Modes During use the Pachette 4 is designed to automatically enter power saving modes to conserve battery life The user should be familiar with all modes before using the device 9 1 Measurement Mode Measurement Mode 15 when the device is at full power In Measurement Mode the de
26. 0390 Web www dghkoi com e When contacting DGH Technology Inc please make note of the model and serial number for the unit and probe See section 19 2 Service personnel use this to track the status of service calls 19 2 Viewing Model and Serial Number The model number and serial number are located on the back of the unit s plastic housing and can be viewed by removing the protective holster This information can also be viewed on the device display by pressing and holding the CFG key while the unit is on The probe serial number is engraved on the side of the probe Page 84 of 92 DGH 555B INS OMENG Rev 0 19 3 Warranty DGH Technology Inc DGH warrants each new DGH 555B and its accompanying accessories hereinafter called to be free from defects in material and workmanship for three 3 years from the date of delivery to the original purchaser This warranty is not applicable to any defect that is the result of an accident misuse mishandling neglect improper installation improper repair or improper modification by persons other than DGH This warranty does not apply if the Equipment has not been operated and maintained in accordance with the operating and maintenance manuals and instructions or bulletins issued in respect thereof by DGH It is further understood that the cost of servicing replaceable and expandable items including parts and labor made in connection with the rout
27. 1 2 While in the Configuration Menu each time that the ENT key is pressed the device will display the next editable parameter When the last parameter is reached and the ENT key is pressed the device will re start the list 13 1 3 To change a parameter setting use the or OS keys as indicated in the table below 13 1 4 After all necessary changes have been made press the CFG key again 13 1 5 If changes have been made the Save New 3 Config message will appear Select Yes or save Config as appropriate T7Yes Ho Page 47 of 92 DGH 555B INS OMENG Rev 0 The following table shows all device parameters in the order that they are displayed in the list NOTE Shaded parameters in this table are only available when certain settings are active e g Continuous Averaging parameters are only editable when Continuous Averaging is enabled Parameter Availability Always available Always available Only available if Bluetooth is enabled Only available if Bluetooth is enabled Only available if Bluetooth is enabled Always available Always available Only available if in Continuous Ave Mode Only available if in Continuous Ave Mode Only available if in Mapping Mode Configuration Menu Parameters Press the CFG key Press the ENT key repeatedly Press the CFG key again Parameter default value Select Patient Single Blueto
28. 17 3 TRANSPORT AND STORAGE CONDITIONS eee nnne rnt 82 17 4 OPERATING CONDITIONS eis 82 18 TROUBLESHOOTING GUIDE ui cccssscccssssscccsssccssssccccsssccscssscccssnsccscssseccccssccececsscsecssssccsesscaccsssececessnes 83 19 SER VICE 84 19 1 REPAIRS AND CUSTOMER e e 84 19 2 VIEWING MODEL AND SERIAL 84 19 3 WARRANTY 85 20 MANUFACTURED TECHNOLOGY INC ccssssccssssrcccsssccssssscccsssccscssccccscssccccssssccccssssees 85 21 AUTHORIZED EUROPEAN REPRESENTATIVE cscsccssssssscssssscccsssccssssscccsssccccssccccesssscscssseccccssssecs 86 22 REGULATORY COMPLIANCE sesscisscissssssccsdecseses decsdvessdestevocsevseneddeseidedscsdenscsesaccecsenseosdoesescs dbasisosstascdcnssasee 86 22 1 EMVEMC COMPLIANCE irt IUe Ie me UI 86 22 2 WIRELESS RADIO MODULE REGULATORY COMPLIANCE 88 Page 4 of 92 DGH 555B INS OMENG Rev 0 1 Introduc
29. 300 328 1 7 1 2006 10 For articic 3 2 Effective usc of spectrum albocaicd The technical contruction file is kept available at Panasonic Industrial Devices Europe GmbH Zeppelinstrasse 19 21337 Lueneburg Germany Issued on 31 of October 2012 Signed by the manufacturer Company name Panasonic Industrial Devices Eu Pgnasonic Indis visas Europe Signature 449 0 4121 299 0 Printed name Heino Kaebler Title Manager Wireless Connectivity Figure 12 Declaration of Conformity User s Manual 35 Revision 1 3 2013 06 14 Hardware Descrpton Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 Page 91 of 92 DGH 555B INS OMENG Rev 0 Panasonic E Bluetooth Qualification and Regulatory Certification 97 Bluetooth Qualified Design ID Panasonic has submited End Product Listing EPL for PAN1322 based on Intel eBMU piattform In the Qualified Product List of the Bluetooth SIG These EPL are referring the Bluetooth quartcaton of the SPP AT application running on the chip under QD ID 8021246 Manufacturers of Bluetooth devices Incorporating PAN1322 can reference the same QD ID number Biuetoof QD ID 6021245 PAN1322 SPP BT2 1 98 Industry Canada Certification PAN1322 complies with the regulatory requirements of Industry Canada IC license IC 2160 EBMU Manufacturers of moble fixed or portable devices incorporating this module are advised to clarify any regulatory questions and e
30. 5 6 Initiating measurement transfer using the PC software 15 6 1 Check that the Pachette 4 is placed in the correct Patient Mode fin Single Patient Mode only the single patient measurements will be retrieved by the computer e If in Multi Patient Mode all measurements in the patient memory locations will be retrieved by the computer Device 15 6 2 In the Device selection box choose which device the software is to receive measurements from 5558 p u 15 6 3 Press the Import Measurements button located at 7 the lower right hand corner of the table Gear Patients ExotPatents Import Measurements NOTE If there are no measurements stored in the device the software will display the message Measurements Exist for Selected Patient s 15 6 4 Once connected the Pachette 4 will display Bluetooth Connected and will transfer r measurements to the PC automatically 15 6 5 Once all files are transferred device will Bluetooth automatically disconnect and show the Bluetooth Disconnected Disconnected message Page 73 of 92 DGH 555B INS OMENG Rev 0 15 6 6 The Pachette 4 will display the message Erase Patients Sent Selecting Yes will clear all information of the patient s that was exported Erase Patients H 15 6 7 The software will automatically im
31. 555B then prepares to receive an echo spike from the posterior corneal surface Only anterior and posterior echo spikes that fall within specified voltage limits that ensure that the probe tip is perpendicular to the cornea surface are accepted for processing The time interval between the accepted anterior and posterior echo spikes represents the thickness of the cornea The time interval is converted to a corresponding distance or thickness based on the acoustic velocity through the cornea and is displayed on the 16 x 2 LCD in units of microns 12 Device Classification Device System Imaging Pulsed Echo Ultrasonic Device Diagnostic Ultrasonic Transducer Panel Radiology Panel Radiology Product Code IYO Product Code ITX Device Class II Device Class II Regulation Number 21 CFR 892 1560 Regulation Number 21 CFR 892 1570 13 Indications For Use The DGH 555B Ultrasonic Pachymeter Pachette 4 is a portable battery operated ultrasonic device that is used in the ophthalmic field for measuring the thickness of the human cornea Page 5 of 92 DGH 555B INS OMENG Rev 0 2 Description of Symbols This symbol indicates a potentially hazardous situation which if not avoided could cause injury or harm to the equipment operator or patient This symbol indicates the type BF classification and is located on the front and back of the unit This mark indicates that Notified Body 0120 SGS United Kingdom L
32. 58 AHHH Page 71 of 92 DGH 555B INS OMENG Rev 0 15 5 2 Input the patient Last Name First Name Patient ID number D O B and gender in the table To do this select the field you wish to edit and begin typing Last Name First Name Patient ID 008 1 Smith Abraham 10231 Jan 01 1971 Male n nean e There are 20 numbered rows for inputting patient information When imported the Pachette 4 will store this information in a similarly numbered patient location 15 5 3 When all of the patient information is entered press the Export Patients button located at the Clear Patients Export Patients lower right hand corner of the table Import Measurements 15 5 4 The Pachette 4 will briefly display a message Bluetooth Connected and beep when it has started receiving files It will display Bluetooth Disconnected and beep when all files have been received 15 5 5 After the files have been received press the CFG key on the Pachette 4 The device will display the ra T Select Patient menu Press the A or V key to scroll through the patient files e Pressing the OD or OS key while a patient s SELECT name is displayed will show additional 10251 identifying information for that patient SELECT PRTIEHT POT Jan 01 1971 SELECT PRTIEHT P 1 Hale Page 72 of 92 DGH 555B INS OMENG Rev 0 1
33. 5B INS OMENG Rev 0 21 Authorized European Representative EMERGO EUROPE Molenstraat 15 EC 2513 BH The Hague The Netherlands Phone 31 70 345 8570 22 Regulatory Compliance 22 1 EMI EMC Compliance The Electro Magnetic Interference and Compatibility testing of the DGH 555B Ultrasonic Pachymeter Pachette 4 was performed to determine compliance with emissions and immunity requirements set forth by the European Community under the requirements of the EMC Directive 89 336 EEC Test for radiated emissions was performed Test was performed according to EN55011 1998 Radiated Emissions The system complied with the radiated emissions requirements throughout the test Tests for radiated and conducted immunity were performed per EN60601 1 1 2 2002 requirements Tests were performed according to IEC 61000 4 2 1995 Electrostatic Discharge IEC 61000 4 3 1995 RF Susceptibility The system complied with the radiated and conducted immunity requirements through out the test Page 86 of 92 DGH 555B INS OMENG Rev 0 Guidance Manufacturer s Declaration Electromagnetic Emissions The DGH 555B Pachette 4 is intended for use in the electromagnetic environment specified below The customer or the user of the DGH 555B Pachette 4 should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF Emissions CISPR 11 Group 1 The DG
34. Configuration Menu by pressing the CFG key Press the ENT key repeatedly to navigate through the menu See section 13 1 13 5 1 Bluetooth default On determines if the Bluetooth module is enabled or disabled This BLUETOOTH must be set to On to connect devices or transfer On files Press the A or V key to change the value e When the Bluetooth wireless module is enabled a logo will appear in the upper left hand corner 13 5 2 Send Meas To determines which device the Pachette 4 will transmit records to If there are no SEHD MEAS TO 0 0 devices paired with the Pachette 4 the screen will Hone display e Ifthe Pachette 4 is paired to one or more MEAS TO s m devices the screen will display HAHE Send 15 name of the device that will receive the records 15 the list number of the device shown o 8 is the total number of devices paired with the Pachette 4 Up to 5 devices can be paired at a time o Send indicates that pressing the OD key will cause the Pachette 4 to transmit measurements to the currently displayed device 13 5 3 When Add PC Printer is displayed the device is in Bluetooth discoverable mode This is a ADD PC PRINTER necessary mode for pairing Bluetooth devices See section 14 for information on device pairing Page 54 of 92 DGH 555B INS OMENG Rev 0 13 5 4 Printer Config determines what
35. H 555B Pachette 4 uses RF energy only for it s internal function Therefore it s RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The DGH 555B Pachette 4 is suitable for use in all establishments Harmonic emissions NA including domestic establishments and those directly connected to the IEC 61000 3 2 public low voltage power supply network power supply that supplies buildings used for domestic purposes Voltage fluctuations flicker NA emissions Guidance and Manufacturer s Declaration Electromagnetic Immunity The DGH 555B Pachette 4 is intended for use in the electromagnetic environment specified below The customer or the user of the DGH 555B Pachette 4 should assure that it is used in such an environment A IEC60601 test Compliance Immunity test level level Electromagnetic environment guidance Electrostatic discharge 6kV Contact Complies Floors should be wood concrete or ceramic tile If floors are ESD IEC 61000 4 2 8kV Air covered with synthetic material the relative humidity should be at least 30 Radiated RF 3 V m 80MHz Complies The DGH 555B Pachette 4 complies with requirements IEC 61000 4 3 to 2 5GHz E1 3V m however a separation distance from mobile RF communications should be maintained based on the following calculations d 80M Hz 800M Hz 1 d 800M Hz 2 5GHz 1 where
36. Windows and the Pachette 4 will display a message indicating that the process was completed e After pairing newer versions of Windows will automatically configure COM Ports This may be indicated by a Driver Software Installation message Older versions of Windows may require the user to manually configure COM Ports see section 14 5 14 4 12 Press the CFG key on the Pachette 4 to exit the Pairing configuration menu Completed Page 61 of 92 DGH 555B INS OMENG Rev 0 14 5 Adding Ports NOTE Newer version of Windows automatically configure COM Ports when a device is paired however the user may need to manually configure COM Ports in older versions of Windows This process may vary depending on the hardware and software installed in the system NOTE Depending on the software the terms Serial Port and COM Port may be used interchangeably 14 5 1 These steps are to be performed after the device has been paired with the PC See section 14 4 for information on pairing to the PC 14 5 2 Navigate to the Windows Control Panel by going to the Start menu and click on the Control Panel item Find the Bluetooth Settings item and click it to open the dialog box e Illustration shows the Windows XP Start Menu Start menu will vary by operating system 14 5 3 In the Bluetooth Settings window there will typically be a tab indicating COM Por
37. asurement Mode is changed only Patient ID info is maintained 1 The operator may input patient ID information on a Windows PC 2 The patient ID information is transmitted to the device and filed in the corresponding number P01 P20 3 Patient ID information is not necessary for measurement It is an option provided for the convenience of the user 4 After measurements are taken the device can send results back to the PC or directly to a Bluetooth enabled printer Fig 10 2 1 Multi Patient Mode Page 31 of 92 DGH 555B INS OMENG Rev 0 10 3 Changing Patient Modes 10 3 1 By default the Pachette 4 is in Single Patient Mode upon power up To confirm that the device is in Single Patient Mode press the CFG key and the device will display the Select Patient screen with Single selected SELECT PATIENT Single If Single Patient Mode is preferred press the CFG key to exit the menu 10 3 2 Pressing the key will scroll through Select Patient menu Available patient locations are indicated by a number 1 20 on the bottom left hand side of the screen e Ifthe patient location is empty there will be a No Data message e If the patient location contains recorded measurements there will be a Meas Only message e Ifthe location contains patient ID information See 15 5 for instruction on entering patient ID the device will show the patient na
38. avigate to Settings File Settings Hp Settings p COM Settings TY Add Devices 14 5 7 In the COM Settings dialog box click Add Devices button The Incoming Port and Outgoing Port should be pM automatically selected Confirm that the COM Ports il selected match the port numbers that were added in the Outgoing Pots Bluetooth Settings menu Por Nanc 5558 0 DGH 5558 0 If the Incoming Port is incorrect change it using drop down menu Clear Devices Add Devices 14 6 Sending and receiving information via Bluetooth connection to a PC The Pachette 4 is capable of transmitting measurements and patient information via Bluetooth wireless connections However the Pachette 4 can only interact with PCs using the DGH Connect Software Refer to section 15 for instructions on sending receiving and printing reports using the DGH Connect Software on a PC Page 63 of 92 DGH 555B INS OMENG Rev 0 14 7 Recalling paired device configuration The Pachette 4 will store pairing configurations for up to 5 devices This allows for quick pairing at a later time To recall a paired device 14 7 1 Enter the Configuration Menu by pressing the CFG key 14 7 2 Press the ENT key one time to navigate to the Bluetooth parameter Confirm that it is turned On If not press the or V key to enable Bluetooth See Section 13 5 1 14 7 3 Press the ENT
39. back of the rubber pad 16 1 5 With the bottom edge of the unit still making contact with the flat surface press with both thumbs until the unit is free of the holster 16 1 6 Once the top edge is free pull the holster off of the device 16 2 Changing the Batteries 16 2 1 Slide open the battery door to gain access to the batteries 16 2 2 Remove the discharged batteries and install new batteries following the orientation shown in the battery compartment Page 79 of 92 DGH 555B INS OMENG Rev 0 16 2 3 Re insert the device into the holster by placing the left side of the Pachette 4 into the holster first and then pressing the right side down into the holster 16 2 4 Verify that the round opening is aligned with the probe connector of the Pachette 4 16 2 5 Re connect the probe by pushing it straight into the connector DO NOT TWIST THE PROBE CONNECTOR 16 2 6 Power up the unit by pressing the PWR key You BATTERY will be prompted to identify the type of batteries ALK RCH used Select the appropriate type t We e You will receive a message indicating that the time and date must be reset See section 13 4 7 TIME AND DATE MUST BE RESET Page 80 of 92 DGH 555B INS OMENG Rev 0 17 Care and Maintenance 17 1 Cleaning and Disinfecting the Probe Keep the probe tip clean and disinfected to prevent patient to patient infection After each patient wipe t
40. been saved to the PC One both or none of these options be selected at same time V Auto Open f Auto Print is enabled the report s will automatically be sent to the default system printer when imported e If Auto Open is enabled the report s will automatically be opened using the viewer for the appropriate file type 15 3 5 Date Format default MMM DD Y Y Y Y determines how the date Date Format will be displayed MMM DD YYYY e Ifthe date format is changed in the Connect Software the DD MMM YYYY Pachette 4 will set to match it the next time records are sent from the PC to the Pachette 4 Page 69 of 92 DGH 555B INS OMENG Rev 0 15 3 6 Automatically Start At Login default Enabled determines if the software automatically starts when a user logs in to the computer 15 3 7 Show Connection Status default Disabled will open a box that shows connection status between the PC and Pachette 4 15 4 Adding a device After the device has been paired with the PC it can be selected for use from within the DGH Connect software NOTE The Pachette 4 must be paired with the PC and COM Ports must be created before it can communicate with the DGH Connect Software See section 14 4 and 14 5 15 4 1 Adding a device can be done by clicking the Add Devices button under the Device selection box or by going to Settings COM Settings at the top o
41. e parameter Pressing and holding this key will send measurements to a PC Printer only available with Bluetooth option installed 8 CFG Key Used to enter and exit the configuration mode Also used to display the unit model number serial number software version and option number when the key is pressed and held 9 OS Key Press key to review or take measurements of the LEFT eye 10 Y Keys Used to review measurements or to program options and numerical values presented on the display 11 OD Key Press key to review or take measurements of the RIGHT eye Also used while in the configuration menu to confirm some device parameters 12 Device Labels Refer to Section 2 for descriptions of device classification and attention symbols Page 14 of 92 DGH 555B INS OMENG Rev 0 6 2 Back View 2 3 Fig 6 2 1 The DGH 555B Pachette 4 Back View 1 Probe Holder Used to hold or store probe when not in use or during transport 2 Probe Connector Holder Used to hold or store probe connector when not in use or during transport 3 Tilt Stand Used to place the unit in a tilted position while on a flat surface Page 15 of 92 DGH 555B INS OMENG Rev 0 6 3 Side View Fig 6 3 1 The DGH 555B Pachette 4 Side View 1 Probe Clips Two clips molded into the protective case to place the probe between patients 2 Probe Cord Wrap Place to wrap the probe cord when not in use or during transport 3 Probe Connecto
42. eption which can be determined by tuming the equipment and on the user is encouraged to try to correct the Interference by 1 or more of the following measures Reorient or relocate antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from fat to which e recetver is connected Consult the dealer or an experienced radio or television technician for heip 93 FCC Wireless Notice This product radio frequency energy but the radiated output power of this device Is far below the FCC radio trequency exposure limits Nevertheless the device should be used In such a manner that the potential for human contact win the antenna during normal operation 15 minimized To meet the FCC s RF exposure rules and regulations The system antenna used for fnis transmitter must not be co Hocated or operating conjunction with any oiner antenna or transmitter The system antenna used for this module must not exceed 4 dEl Users and Installers must be provided with antenna instaliaton instructions and transmitter operating conditions for satistying RF exposure compliance please refer to Figure 10 User s Manual 32 Revision 1 3 2013 06 14 Hardware Description Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 Page 88 of 92 DGH 555B INS OMENG Rev 0 PAN1322 SPP Panasonic E Blustooth Qualification and Regulatory Certification I
43. f possible place 1 322 in the RS center of main PCB 8 7 v 8 v gt z 8 Lj 8 All dimensions Use a Ground plane in the area surrounding the PAN1322 module wherever possible Figure 10 Cutout Drawing Manufacturers of mobile or portable devices Incorporating this module are advised to clarify any regulatory questions and to nave their complete product tested and approved for compliance 9 4 FCC Interference Statement This device complies with Part 15 of Rules Operation Is subject to the folowing two conditons 1 This device may not cause interference User s Manual Revision 1 3 2013 08 14 Hardware Description Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 Page 89 of 92 DGH 555B INS OMENG Rev 0 Panasonic Bluetooth Qualification and Regulatory Certification 2 This device must accept any interference received Including interference tat may cause undesired operation 95 FCC Identifier FCC ID T7VEBMU 9 6 European R amp TTE Declaration of Conformity Hereby Panasonic industrial Devices Europe GmbH declares that the Bluetooth module ENWES841A3KF Is In compliance win the essential requirements and other relevant provisions of Directive 1999 S EC As a result of the conformity assessment procedure described in Annex of the Directive 1999 S EC the end customer equipment shouid be labelled as follow
44. f the window 15 4 2 Click the Add Devices button from the main page or from the Settings dialog box Page 70 of 92 Device Add Devices File Settings Help D COM Settings Device v Add Devices 77779 Cancel ok DGH 555B INS OMENG Rev 0 Search for Devices 15 4 3 The software will prompt you to check that the device is powered on and paired Confirm that the Pachette 4 is on and click OK 15 4 4 The software will automatically find paired devices and add them to the list of devices Device 5558 4257 MT gt Outgoing Ports Port Device Name DGH 5558 5558 Gear Devices Add Devices cancel 1 NOTE From Settings dialog box user has option to assign a unique name in Name field This is to assist the user in distinguishing between units 15 5 Exporting Patient Information to the Pachette 4 The DGH Connect Software is designed to allow the user to quickly input patient identification information into the Pachette 4 The following steps explain how to send patient identification information to the Pachette 4 15 5 1 In the Device selection box choose which device is to receive the patient files 55
45. from the cavity by grasping the body of the probe at the access opening in the holster e tis recommended that the probe be returned to the cavity for protection when transporting the Pachette 4 or when the unit is not being used 12 1 2 Unwrap the probe cord The probe connector may be removed from the holster cavity by gently pulling on the probe cord at the connector strain relief 12 1 3 Carefully align probe connector for proper mating orientation and insert into the opening on the right side of the holster See section 7 1 for connector orientation 12 1 4 Gently press probe into opening until probe is properly mated Inspect the probe tip to verify it is clean and free of any nicks scratches or any other defect that could injure the cornea Refer to section 17 1 for Cleaning and Disinfecting Instructions 12 1 5 Flip tilt stand away from holster and place unit on flat surface in tilted position 12 1 6 Turn on the unit Page 38 of 92 DGH 555B INS OMENG Rev 0 12 1 7 The Pachette 4 performs an internal self test function 12 1 8 The unit will briefly display battery status as Battery OK indicated indicated SERRE 12 1 9 When the power up sequence is finished the device 00 Avg 0 0 automatically enters Measurement Mode The Std Ov 0 0 device will start in the last Measurement Mode ME selected when powered off The factory default is Continuous Averaging Measurement Mode 12 1 10 The Pachette 4
46. ftware See section 14 regarding Bluetooth connectivity and section 15 regarding the use of DGH Connect Software Page 33 of 92 DGH 555B INS OMENG Rev 0 10 5 Clearing Patient Information 10 5 1 Press the CLR key The user will be prompted with TO CLEAR the What To Clear menu All Current Heas Use the Aor V key to scroll through the clearing options Press the ENT key to select an option e The following selections affect the patient currently being measured Selecting Current Meas clears all measurements of both the left and right eye for the currently loaded patient o Selecting OD Current Meas clears all measurements of the right eye for the currently loaded patient o Selecting OS Current Meas clears all measurements of the left eye for the currently loaded patient Selecting Nothing Exit exits the menu without deleting anything e The other clearing options affect stored patient information or system configuration o Selecting Patients clears all identifying information and all measurements for all patients Bluetooth option only o Selecting Paired Devices clears all paired devices from the device memory Bluetooth option only Page 34 of 92 DGH 555B INS OMENG Rev 0 11 Measurement Modes The Pachette 4 allows the user to select the preferred Measurement Mode The device will either use Continuous Averaging or Mapping conf
47. h icon in the notification area _ Cm w e Depending on the version of the operating system or the Bluetooth software installed the Bluetooth Settings dialog box may appear differently Click the Apply button then the OK button Turn on the Pachette 4 and enter the Configuration Menu by pressing the CFG key Press the ENT key one time to navigate to the Bluetooth parameter Confirm that it is turned On If not press the key to enable Bluetooth See section 13 5 1 Press the ENT key two times to navigate to Add PC Printer parameter This screen indicates that ADD PC PRIHTER the device is discoverable Press the OD key to scan initiate a scan Once the scan is complete use the or Y key to scroll through the available devices With the PC HAHE you wish to pair with displayed select Add lt Add Ifthe PC to be paired is not listed press OS key to re scan Page 60 of 92 DGH 555B INS OMENG Rev 0 14 4 8 Both the Pachette 4 and Windows will display screen requiring confirmation of a passkey 14 4 9 When Windows displays passkey select Yes and click the Next button e The passkey must be accepted on both devices within 30 seconds or a timeout error is produced 14 4 10 When the Pachette 4 displays the passkey press the A key to accept 14 4 11 Pairing is now complete Both
48. have Powering Down been no key presses When entering Sleep Mode the Pachette 4 will display a Powering Down message After the Powering Down message the display will go blank and the unit will appear to be off but all the measurements that were taken can still be retrieved To bring the device out of Sleep Mode press the PWR key B The unit will perform an internal test and display batter a PIS F will show empty measurement screen If there are active Clear All Meas measurements the Pachette 4 will display If there are no currently active measurements the device SST e Press the A key to clear all measurements Press the V key to retrieve all measurements e After exiting Sleep Mode the device will return to Measurement Mode 9 4 Powering Down The unit is powered down by pressing and holding the PWR key The device will emit a beep and turn off NOTE If the device is powered down by the user only measurements in memory will be stored See sections 10 1 and 10 2 for information on memory 9 5 Checking Battery Power Battery power will be displayed every time the device is powered on Battery power can also be checked at any time Battery by quickly pressing the ENT key BEEBBENEBEB Page 27 of 92 DGH 555B INS OMENG Rev 0 10 Patient Modes 10 1 Single Patient Mode
49. he probe with a Q tip soaked in 70 isopropyl alcohol and then immerse the probe tip the clear cone for 10 minutes in 70 isopropyl alcohol The tip should be rinsed in sterile distilled water before using The following disinfectants were found to be compatible with the probe tip material Disinfectant Concentration Tested 10 20 Isopropyl Alcohol and 1 5 Ethylene Glycol Monobutyl Ether e 10 20 Isopropyl Alcohol 1 5 Ethylene Glycol Monobutyl Ether Cidex 2 55 w w Glutaraldehyde Cidex OPA 6 2 by w w Ortho Phthalaldehyde 1 2 benzenedicarboxaldehyde Isopropyl Alcohol 70 v v Isopropyl Alcohol Household Bleach 0 6 w w Sodium Hypochlorite Hydrogen Peroxide 3 w w H202 Milton 2 w w Sodium Hypochlorite The concentrations listed in this table are the specific concentrations that were tested by DGH to ensure compatibility with the probe tip material DGH does not endorse or recommend the concentrations listed in the table above Page 81 of 92 DGH 555B INS OMENG Rev 0 17 2 Cleaning The Unit The unit s plastic housing and protective holster can be cleaned using a mild soap and water 17 3 Transport and Storage Conditions The Pachette 4 is capable while packed for transport or storage of being exposed for a period not exceeding 15 weeks to environmental conditions not o
50. hette 4 will populate a list of all discovered HAHEH af EL Bluetooth devices Use the A and V keys to scroll through the list of available devices If the lt Paired device is paired with Pachmate 2 the message Paired will be displayed 14 8 5 Press the OD key The device will show the name S of the paired device and give the option to remove Remove it Press the key to select yes The device pairing has been removed 14 8 6 Press the CFG key to return to Measurement Mode 14 9 Clearing All Paired Bluetooth Devices Occasionally it may be necessary to clear Bluetooth pairing settings from the Pachette 4 s memory to allow connection to new devices 14 9 1 Press the CLR key The user will be prompted with the What To Clear menu Use the A or V key to scroll through the clearing options until Paired Devices is displayed CLEAR Paired Devices 14 9 2 With Paired Devices displayed press the ENT PAIRED DEVICES key The Pachette 4 will clear all Bluetooth rz CLERRED devices pairing information from memory and display the Paired Devices List Cleared message 14 9 3 The Pachette 4 will return to Measurement Mode Page 65 of 92 DGH 555B INS OMENG Rev 0 15 DGH Connect Software The DGH Connect Software is an application that allows the operator to use a Windows based PC to communicate with DGH devices This s
51. iguration when reporting measurements It is important to note that switching between Continuous Averaging or Mapping will clear ALL measurements this includes patient information stored in Non Volatile Memory 11 1 Continuous Averaging Measurement Mode The Pachette 4 s factory default Measurement Mode option is Continuous Averaging In this mode the device 00 Awg 0 0 takes 25 corneal measurements in rapid succession at a ctd Dv 0 0 single location and generates an average from those gt measurements The device allows user to program how many measurements are taken from 1 to 25 as well as the 05 Avg 0 Ou period of time between consecutive measurements default Std 0 00 is 50msec While in Continuous Averaging Measurement Mode the screen will display which eye is being measured the measurements and standard deviation See section 13 2 for information on configuring Continuous Averaging parameters See section 12 2 for information on taking measurements in Continuous Averaging Measurement Mode Page 35 of 92 DGH 555B INS OMENG Rev 0 11 2 Mapping Measurement Mode The Pachette 4 s other Measurement Mode option is Mapping Mode In this mode the operator is able to take a 1 single measurement not averaged at various positions on Meas 0 the cornea While in Mapping Measurement Mode the screen will display which eye is being measured the mapping position number
52. ime The Pachette 4 can display the time and date on the screen to assist the operator in recording when measurements are taken 12 4 1 Press and hold the CLR key until the Time Date Time HH HH 55 IPH screen is displayed Date 99 12 4 2 The Time Date screen will be displayed until the operator presses the CLR key again The device will return to Measurement Mode e The user can configure how the date will be displayed See section 13 4 7 12 4 3 If the user is using a Bluetooth enabled device to receive patient reports the Time and Date will be recorded with the measurements Page 46 of 92 DGH 555B INS OMENG Rev 0 13 Configuring the Pachette 4 When shipped from the factory the Pachette 4 is ready to take corneal measurements No additional setup or configuration is necessary However the Pachette 4 has been designed to allow the operator to modify certain parameters to tailor the instrument to meet one s needs Once modified these parameters are permanently stored in non volatile memory and are automatically recalled each time the unit is powered up To change a parameter the operator must access the configuration menu The following procedure explains how to access the configuration menu and modify the default parameters 13 1 Entering and Navigating the Configuration Menu 13 1 1 To enter the Configuration Menu press the CFG Key The screen will display iiu 13
53. ine maintenance services as described in such Operator s Manual is not covered under this warranty and is the responsibility of the purchaser This warranty is strictly limited to replacement or repair of the part that is found to be defective in material and workmanship At the option of DGH said part shall be replaced or repaired free of charge F O B our factory by DGH DGH reserves the right to make changes in the design and material of Equipment without incurring any obligations to incorporate such changes in Equipment already completed on the effective date of any such change or changes This is the only warranty of this product and is expressly in lieu of all other warranties expressed or implied by law or otherwise including any implied warranties of merchantability and of fitness for a particular purpose Without regard to the alleged defect DGH does not under any circumstances assume any responsibility for the loss of time inconvenience or other consequential damages including but not limited to loss or damage of personal property or loss of revenue DGH has neither assumed nor authorized any other person including any distributor authorized to sell its Equipment to assume for it any other liability in the connection with the sale of Equipment 20 Manufactured By DGH Technology Inc DGH TECHNOLOGY INC 110 SUMMIT DRIVE SUITE B p EXTON PA 19341 USA 610 594 9100 Page 85 of 92 DGH 55
54. information is sent to the Bluetooth enabled printer There are 3 fields that determine what is being sent Press the or Y key tO patient Info will be change the field printed if Add Patient set to Yes Device Info always printed Measurement Info always printed All measurements taken for OD will be printed if Add All Meas set to Yes OD Results always printed All measurements taken for OS will be printed if Add Meas set to Yes OS Results always rinted Lines for hand written notes will be printed if Add Notes set to Yes e Add Patient default Yes field determines if patient name ID number date of birth and PRINTER CONFIG gender are included on the printed measurement report Press the OD key to switch between Yes Add Patient Y and No If Add Patient is enabled but no patient identifying information is entered blank lines will be printed for hand written notes e Add Notes default No determines if the PRINTER CONFIG printed measurement report will include an area Add Hotes gt for the operator s hand written comments Press the OD key to switch between Yes and No e Add All Meas default No determines if each PRINTER CONFIG measurement taken during Continuous Averaging Mode is printed or only the average and standard deviation Press the OD key to switch between Yes and No Add All Meas gt Page 55 of 92 DGH 555B
55. is now ready to take corneal measurements If any default parameters need to be modified refer to section 13 Otherwise refer to sections 12 2 and 12 3 for detailed descriptions of the proper methods for obtaining measurements Page 39 of 92 DGH 555B INS OMENG Rev 0 12 2 Measurement in Continuous Averaging Mode NOTE Typically anesthetizing the patient s eye is necessary for obtaining a measurement 12 2 1 12 2 2 12 2 3 12 2 4 12 2 5 12 2 6 12 2 7 12 2 8 12 2 9 Perform the Power Up Sequence as described in Section 12 1 Press the CFG key to enter the Configuration Menu Press the ENT key repeatedly to navigate through the menu Confirm that Continuous Averaging Mode is selected in the Operational Mode menu See Section 11 3 Select a memory location to associate measurements with or select Single Patient Mode See Sections 10 1 and 10 2 Select the number of measurements to be obtained default is 25 measurements See Section 13 2 2 Press the CFG key to exit the Configuration Menu If changes have been made the Pachette 4 will prompt for confirmation of the configuration change Save Hew Config f2Yes Ho Press the key to select Yes and save the configuration The Pachette 4 will return to Measurement Mode Select the eye to be measured You can select either 00 Avg 0 u eye for measurement by pressing the OD or OS Std Dw 0 0 key The selected e
56. k beep e If the device is not able to obtain a POOR measurement within 3 seconds the device will APPLANATION emit a long beep and the Poor Applanation message will be displayed e Ifthe Poor Applanation message is displayed attempt to reposition the probe tip for proper applanation Once the probe tip is in proper alignment the device will continue measurement Page 44 of 92 DGH 555B INS OMENG Rev 0 12 3 12 After each successful measurement the device will i show the result on the display for a short time Posn 1 Good Measurement Delay default 2 seconds Meas 98 e During this time either wait for two short beeps before re applanating the probe at the next mapping position or Re applanate at the same point to re measure that mapping position 12 3 13 The device will emit two short beeps when it is ready to take the measurement at the next mapping position Reposition the probe and re applanate at the next position to be mapped 12 3 14 Continue measuring all positions until all necessary measurements have been taken 12 3 15 The device DOES NOT indicate when all measurements have been taken instead it will go o 1 back to measurement for position number 1 Meas 540 e scroll through each measurement press the or Y key The device will list the position number and list the thickness measurement Heas 540 u below 12 3 16 If a questionab
57. k the I Agree to the License terms and conditions box on the bottom left hand side of the window The Next button will appear highlighted Click the Next button The software will list all necessary prerequisite programs The installer will then install the remaining prerequisites Microsoft System CLR Types for SQL Server 2012 e Microsoft Report Viewer 2012 Runtime Click the Install button and the software will complete installation Once installation is complete click the icon created on the desktop to start the program Page 67 of 92 DGH 555B INS OMENG Rev 0 15 3 Configuring the Software Once the software has been installed and the Pachette 4 has been paired with the PC See section 14 4 the DGH Connect software is ready to use The operator determines how the patient records are imported Below is a screenshot that shows the DGH Connect Software with no patients added NOTE The Pachette 4 must be paired with the PC and COM Ports must be created before it can communicate with the DGH Connect Software See section 14 4 and 14 5 Connect File Settings Device Report Import Location Report Format Report Options Y C Users User Desktop Pachymetry Reports 9 PDF 7 Auto Print Add Devices Change DOC V Auto Open Date Format MMM DD YYYY DD MMM YYYY V Automatically Start at Login Show Connection Stat
58. le measurement is found during review the operator can delete it To do this the operator presses the DEL key while viewing the measurement in question e The operator can take new measurements to replace those that were deleted or choose to accept the remaining measurements 12 3 17 If the device is operating in Multi Patient Mode the measurements will be automatically saved to memory Page 45 of 92 DGH 555B INS OMENG Rev 0 12 3 18 To clear all measurements for one or both eyes gt press the CLR key The user will be prompted with TO CLEAR the What To Clear menu All Current Meas e The following selections affect the patient currently being measured Selecting Current Meas clears all measurements of both the left and right eye for the currently loaded patient o Selecting OD Current Meas clears all measurements of the right eye for the currently loaded patient Selecting OS Current Meas clears all measurements of the left eye for the currently loaded patient o Selecting Nothing Exit exits the menu without deleting anything e The other clearing options affect stored patient information or system configuration o Selecting All Patients clears all identifying information and all measurements for all patients Bluetooth option only Selecting Paired Devices clears all paired devices from the device memory Bluetooth option only 12 4 Viewing Date and T
59. ly turn off Page 23 of 92 DGH 555B INS OMENG Rev 0 8 1 5 Refer to the following table that corresponds with your unit If the Pachette 4 is a Standard Unit refer to Table 8 1 5a The device will show calibration measurements of 200um through 1000um in steps of 100um If the Pachette 4 is a Flap Option Unit refer to Table 8 1 5b The device will show calibration measurements of 100 um through 1000 um in steps of 100 um values are based on a corneal velocity of 1640 m sec and should be within Sum of the measurement pulse Table 8 1 5a Standard Pachette 4 Measurement Range Chart Measurement 1 200 um pulse Acceptable Result 195 um 205 um Measurement 2 300 um pulse Acceptable Result 295 um 305 um Measurement 3 400 um pulse Acceptable Result 395 um 405 um Measurement 4 500 um pulse Acceptable Result 495 505 um Measurement 5 600 um pulse Acceptable Result 595 um 605 um Measurement 6 700 um pulse Acceptable Result 695 um 705 um Measurement 7 800 um pulse Acceptable Result 795 um 805 um Measurement 8 900 um pulse Acceptable Result 895 um 905 um Measurement 9 1000 um pulse Acceptable Result 995 um 1005 um Table 8 1 5b Flap Option Pachette 4 Measurement Range Chart Measurement 1 100 um pulse Acceptable Result 95 um 105 um Measurement 2 20
60. me By pressing the OD or OS key while the patient s name is displayed other identifying information will be displayed Page 32 of 92 SELECT PRTIEHT 1 Ho Daka SELECT PO Heas Only SELECT PRTIEHT Doe SELECT PATIENT POS 03 1973 SELECT PATIENT POS 30453 SELECT PRTIEHT FOS Hale DGH 555B INS OMENG Rev 0 10 3 3 10 3 4 10 3 5 10 3 6 To select a patient location press the CFG key when the desired location number is displayed The device will then enter Measurement Mode and 0D Avg 0 0 u show a number in the bottom left hand corner of Std Dw 0 0 the screen The device is now ready to record wv Un measurements to the location After taking measurements See section 12 for measurement instructions press the CFG key to enter the Configuration Menu The Pachette 4 records the information to the specified location in Non Volatile Memory once the CFG key is pressed To select a different patient location or Single Patient Mode press the orY key to scroll through the Select Patient menu Press the CFG key again to make the selection 10 4 Adding Patient Identification Information The Pachette 4 will store a single patient s name ID number date of birth and gender in each patient location Patient ID information is entered by connecting the Pachette 4 to a computer using the optional Bluetooth connection and utilizing the DGH Connect So
61. n reflected back The time delay between the echoes is used to calculate distances between surfaces in the eye NOTE Ultrasound cannot travel through air because air is not dense enough for the high frequency waves to propagate Ultrasonic measurements must therefore be performed by direct contact or through a denser medium such as water 4 2 Using Ultrasound To Ascertain Correct Probe Alignment Sound travels in straight lines so the direction of reflected sound is based solely on its angle of incidence Sound hitting an interface perpendicularly will reflect back along the same path that it approached Figure 4 2 1 Sound hitting an interface at an angle will reflect at an angle away from the source Figure 4 2 2 The transmitted sound will continue on at a lesser amplitude because of reflected energy lost at the interface When reflected ultrasound is shown as a two dimensional waveform the peaks are related to the positions of the interfaces By comparing the relative height intensity of the peaks one can determine the angle at which the sound is striking it Steadily diminishing peaks are an indicator that the ultrasound is not perpendicular to the interfaces Page 8 of 92 DGH 555B INS OMENG Rev 0 Fig 4 2 1 Sound hitting an interface perpendicularly Fig 4 2 2 Sound hitting an interface at an angle Using these properties of ultrasound the alignment of an ultrasound beam thr
62. nd OD keys to move the cursor left and right Use the A and keys to change the value Enter Pin Code 1000 1 e The necessary Pin Code is provided with the printer Typically the manufacturer will include the Pin Code in the user documentation Page 57 of 92 DGH 555B INS OMENG Rev 0 14 2 10 Enter the Pin Code for the selected printer Enter Pin Code press the ENT key 14 2 11 A message will appear to indicate that the devices Pairin have been properly paired 9 Completed e The Pachette 4 may briefly display the messages Bluetooth Connected then Bluetooth Bluetooth Disconnected The pairing is still Connected complete The devices will re connect automatically when measurements are sent to the printer Bluetooth Disconnected 14 2 12 The Pachette 4 has now saved the pairing to Save Config memory Press the CFG key to exit the H Configuration Menu The Pachette 4 will prompt t ES 0 for confirmation of the configuration change 14 2 13 Press the A key to select Yes and save the configuration The Pachette 4 will return to Measurement Mode 14 3 Sending measurements to a Bluetooth enabled wireless printer 14 3 1 Press the CFG key to enter the Configuration Menu PRINTER CONFIG and navigate to the Printer Config menu by E repeatedly pressing the ENT key Add Patient Y 14 3 2 Confirm that the desired fields are set to be included in the printed report See sec
63. nd left eye When measurement is complete the user presses the CFG key and all results are recorded and can be retrieved at a later time The user can also use the DGH Connect Software See section 15 to enter patient identification information before taking measurements NOTE In Multi Patient Mode the device can take either Continuous Averaging or Mapping measurements However if the Measurement Mode is changed it will clear the measurements for all patients stored in memory Page 30 of 92 DGH 555B INS OMENG Rev 0 MULTI PATIENT MODE OPERATION 1 tn Multi Patient Mode a number 1 20 is loaded into the Active Memory while taking ACTIVE MEMORY measurements Patient ID information is not required to load a number PERFORMS MEASUREMENTS IN EITHER CONTINUOUS 2 OD OS Measurements and Calculations are AVERAGING OR MAPPING temporarily stored in the device s Active Memory MODES during the measurement sequence 3 When the measurement sequence is complete the results can be stored in Non Volatile Memory 4 Measurements and patient ID information can be reviewed and or deleted at a later time by recalling the number P01 P20 Non Volatile Memory is not affected by power state Information is stored if power is on or off with or without batteries CHANGING MEASUREMENT MODE WILL CLEAR ALL MEASUREMENTS STORED IN MEMORY The Measurement Mode determines how patient records are stored If the Me
64. nsure compilance for SAR and or RF exposure limis Users can obtain Canadian Information on RF exposure and compliance from www Ic gc ca This device has been designed to operate wit the buik in antenna It is not allowed to alter antenna or connecting an extemal antenna to the module The bulit In antenna used for this transmitter must not be collocated or operating conjunction with cther antenna or transmitter 3 3 Label Design of the Host Product R is recommended to Inciude the following information on the host product label Contains transmitter Module ID T7VEBMU IC 216QEBMU 3 10 Regulatory Test House The test house used by Panasonic the Bluetooth and Regutatory approvals for the module PAN1322 Eurofins Product Service GmbH Sitorkower Str 38c D 15526 Reichenwalde b Berlin GERMANY 49 33631 853 0 Fax 449 33631 868 650 WWwWW eurofns com User s Manual 36 Revision 1 3 2013 06 14 Hardware Descripton Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 Page 92 of 92 DGH 555B INS OMENG Rev 0
65. of the backlight Press the or Y key to change the value Page 52 of 92 DGH 555B INS OMENG Rev 0 13 4 5 Contrast default 7 bars determines the contrast of CONTRAST the screen Press the A or V key to change the value 13 4 6 Volume default 7 bars determines the volume of VOLUME audible signals alarms Press the key to change the value 13 4 7 Time Date allows the user to set the time and date and choose the date format Press the OS key to TIME DATE adjust the date format Press the OD key to set the Format Sel 5 time e Press the OS key to enter the Date Format default MMM DD Y Y Y sub menu Press the DRTE F RHRT or Y key to change the value The date can MMM dd yyyy display as either MMM DD YYYY or DD MMM YYYY e Press the OD key to enter the Time Date sub menu While in this sub menu there will be a 55 PH blinking black cursor Use the OD and OS keys Date HHH dd uuy to move the cursor left and right Press the or V key to change the value in each field Page 53 of 92 DGH 555B INS OMENG Rev 0 13 5 Bluetooth Parameters These are the Bluetooth operation parameters If the Pachette 4 has a Bluetooth module installed they will be accessible when the Bluetooth parameter is enabled Only Devices with a Bluetooth Wireless Technology Logo printed on the front have a module installed NOTE To access these parameters enter the
66. oftware will interact with Pachette 4 and Pachmate 2 devices To utilize DGH Connect the PC must first be paired with the Pachette 4 For information on pairing refer to section 14 4 15 1 Software Requirements 15 1 1 System Requirements e Processor 32 bit or 64 bit 2 GHz e Memory 2 GB RAM e Hard Drive 1 GB minimum 100 GB recommended e Ports USB 2 0 e Display 1024 x 768 resolution e Peripherals Mouse or Touchpad Keyboard e Bluetooth Radio v2 1 or later Software is compatible with USB Bluetooth adapters dongles for desktop systems 15 1 2 Compatible Operating Systems Microsoft Windows XP Service Pack 3 or higher 32 bit Microsoft Windows Vista Service Pack 2 or higher 32 bit or 64 bit Microsoft Windows 7 32 bit or 64 bit Microsoft Windows 8 8 1 32 bit or 64 bit Page 66 of 92 DGH 555B INS OMENG Rev 0 15 2 Installing the software 15 2 1 15 2 2 15 2 3 15 2 4 15 2 5 15 2 6 15 2 7 15 2 8 Insert the USB flash drive and allow the computer to initiate the installation program The installer will check if the system has the NET Framework v4 0 If the PC does not have this software installed a dialog box will prompt for installation After the NET Framework v4 0 has been installed a dialog box will open indicating showing an installation directory DGH Connect Confirm the installation directory or set a custom directory Chec
67. onnect Software to input patient information and retrieve measurement reports 14 4 1 Navigate to the Windows Control Panel by going to the Start menu and type Control Panel in the search bar The Start menu will list the Control Panel item Click the list item to open the Control Panel Find the Bluetooth Settings item and click it to open the dialog box e Depending on the version of the operating system the Start Menu may appear differently Page 59 of 92 DGH 555B INS OMENG Rev 0 14 4 2 14 4 3 14 4 4 14 4 5 14 4 6 14 4 7 In Bluetooth Settings under the Options tab enable the following features Options COM Pos Hardware Share FIM Discovery Allow Bluetooth devices to find this computer e Check the box for Allow Bluetooth devices to find this computer Ay To protect your privacy select this check box only when you want a Bluetooth device to find this computer Connections V Allow Bluetooth devices to connect to this computer e Check the box for Allow Bluetooth devices to V Alert me when a new Bluetooth device wants to connect connect to this computer V Show the Bluetooth icon in the notification area Turn off the Bluetooth adapter e Check the box for Alert me when a new Bluetooth device wants to connect Change settings for a Bluetooth enabled device Restore Defaults e Check the box for Show the Bluetoot
68. or service information Page 22 of 92 POF FAILED DGH 555B INS OMENG Rev 0 8 Verifying Pachette 4 Calibration Pachymeter calibration is verified by using the electronic Calibration Verification Box CalBox that is supplied with the Pachette 4 see section 6 6 The CalBox does not calibrate the pachymeter it generates a sequence of precise predetermined pulses that are measured by the pachymeter The user must confirm that each measurement generated by the CalBox falls within the acceptable range see 8 1 5 8 1 Procedure For Verifying Calibration 8 1 1 With Pachette 4 turned off disconnect the probe by holding the connector and gently pulling straight out of the unit Caution Do not twist probe as this could damage connectors 8 1 2 Connect the CalBox to the Pachette 4 by inserting CalBox lead into the probe connector 8 1 3 Enter the CalBox mode by pressing and holding the Pachette 4 s DEL key and then press the PWR key 8 1 4 Press and hold the CalBox START key until the green LED on the CalBox lights up and the Pachette 4 will begin taking measurements e Ifthe LED fails to light or turns off before the test sequence is complete or if the Poor Applanation message is displayed the CalBox 9v alkaline battery needs to be replaced e If measurements are taken within 2 6 minutes after the CalBox START button has been pressed the CalBox will automatical
69. oth On Send Meas To Add PC Printer Printer Config Operational Mode Continuous Ave Auto Switch OD OS Enabled Numb Of Meas 25 Auto Rep Delay lt 50 Numb of Posn 33 Changing A Setting Press or key to Single Enter the Configuration Menu Navigate down the Parameters List Exit the Configuration Menu Result Description The device will clear measurements when the user initiates a new measurement cycle navigate through patient files P1 to P20 Press or key to turn Bluetooth Each number indicates a memory location Patient measurements will be stored in non volatile memory The Bluetooth module is turned off module on or off Press or key to switch between linked devices Press OD to send data Will display up to 5 linked devices Not Scanning Press OD key to initiate a scan Scanning Press 1 or key to lt Add Patient switch between The Bluetooth module is turned on The user selects the device using 7 or keys When the OD button is pressed the device sends the data While the Add PC Printer menu is visible the device will be discovered when scanned by other Bluetooth enabled devices When the OD key is pressed the device is actively scanning for other Bluetooth enabled devices When Yes is displayed patient information will be included on the printout printer config options Then pre
70. ough the eye can be determined Proper alignment is crucial to the accuracy of measurements 43 Ultrasonic Measurement The speed of sound increases in denser materials Liquids or substances containing large amounts of water conduct ultrasound very well air does not conduct ultrasound Using the relationship between the density of a material and the speed of sound ophthalmic pachymeters obtain distances in the eye by performing a two step process First a pulse of sound is timed as it travels through the cornea reflects off the back of the cornea and returns to the transducer Second the thickness is calculated based on the travel time and the speed of sound through the eye distance velocity x time 2 All thickness measurements are based on a corneal velocity of 1640 m sec Page 9 of 92 DGH 555B INS OMENG Rev 0 4 4 Proper Applanation for Taking A Measurement Proper applanation is necessary for obtaining an accurate measurement Proper applanation occurs when the flat tip of the probe comes into full contact with the cornea perpendicular to the cornea surface The user must ensure that pressure against the cornea is minimized The diagram below illustrates correct and incorrect alignment of the probe tip to the cornea 1 and 2 CORRECT The probe IS perpendicular to the corneal surface 3 and 4 INCORRECT The probe IS NOT perpendicular to the corneal surface Fig 4 4 1 Correct and Incorrect Applana
71. port patient Report Import Location records and save them to the directory indicated in C Users User Desktop Pachymetry Reports the Report Import Location box Change If Auto Open is enabled the software will open each patient record in its own window e If Auto Print is enabled the software will print all patient records from default system printer 15 6 8 To open the patient reports that have been imported go to the Settings File Open Report The software will open a window that shows all patient records that have been imported 15 6 9 The report will show all measurement and patient Name Abraham Smith Pachymetry Report information PDF reports cannot be edited DOC Rum M reports can be edited using a word processing lt c program OD Average um 509 OS Average um 513 Std Dev um 0 7 Std Dev am 0 9 Page 74 of 92 DGH 555B INS OMENG Rev 0 15 7 Initiating measurement transfer using the Pachette 4 15 7 1 Check that the Pachette 4 is placed in the correct Patient Mode fin Single Patient Mode only the single patient measurements will be retrieved by the computer e If in Multi Patient Mode all measurements in the patient memory locations will be retrieved by the computer 15 7 2 Check that the device
72. r The connector that mates to the connector on the probe cable 4 Tilt Stand Used to place unit in tilted position on a flat surface Page 16 of 92 DGH 555B INS OMENG Rev 0 6 4 Back Of Unit Protective Holster Removed Pachene 4 Su vero DGH TECHNOLOGY INC Lp REF DGH 555B SN TECHNOLOGY INC ec rer 110 SUMMIT DRIVE ud SUITE B o EXTON PA 19341 The Netherlands YYYY USA 610 594 9100 13170348 7229 Doc 5558 LAB BKPNL1 Rev 0 C Contains Transmitter Module FCCID T7VEBMU IC 2160EBMU CAUTION Federal U S A law restricts this device by oronthe order of a physician 2 DANGER Explosion hazard Do notuse in presence of flammable anesthetics gases oxygen rich atmosphere e CAUTION Electrical shock hazard Do not open LS 3 Refer servicing to qualified service personnel 0120 Doc 5558 LAB BKPNL2 Rev 0 Fig 6 4 1 The DGH 555B Pachette 4 Back View with protective holster removed 1 Unit Identification Label This label contains the model number and serial number for the unit It also provides contact information for DGH Technology Inc 2 Classification and Attention Label This label contains classification and attention symbols Refer to Section 2 for descriptions of device classification and attention symbols
73. r Appl Delay default 2 0 sec is the amount of time that the device will wait before advancing to POOR APPL DELAY the next mapping point after a poor applanation It 2 0 sec can be adjusted from 1 0 sec to 9 5 sec Press the or key to change the value 13 4 General Device Parameters These are the general device parameters that are accessible from the Configuration Menu They are accessible at any time NOTE To access these parameters enter the Configuration Menu by pressing the CFG key Press the ENT key repeatedly to navigate through the menu See section 13 1 13 4 1 Delay To Standby default 1 0 min is the amount of time that the device will wait before going into DELAY STANDBY Standby Mode It can be adjusted from 0 5 min to 1 0 min 9 5 min Press the A or V key to change the value 13 4 2 Battery Type should be selected to match the batteries installed in the device If the device detects BATTERY TYPE that the batteries have been removed a prompt will Rech arge able require the user to set the battery type accordingly see section 16 2 6 Press the or Y key to change the value 13 4 3 Back Light default Off in Standby determines BACK LIGHT how the backlight of the screen will function It can be set always On always Off or Off in Standby OFF in Standby mode Press the A or key to change the value 13 4 4 Brightness default 7 bars determines the brightness
74. ries of measurements Clearing measurements from Active Memory does not affect Non Volatile Memory NON VOLATILE MEMORY Non Volatile Memory is not affected by power state Information is stored if power is on or off with or without batteries LJ CHANGING MEASUREMENT MODE WILL CLEAR ALL MEASUREMENTS STORED IN MEMORY The Measurement Mode determines how patient records are stored If the Measurement Mode is changed only Patient ID OD OS INFO info is maintained 1 After measurements are taken the results lt A Se SE ems can be sent back to the PC or directly to a Bluetooth enabled printer Single Patient Mode is always available however information can only be transferred to a PC if the device has a Bluetooth module installed Fig 10 1 1 Single Patient Mode Page 29 of 92 DGH 555B INS OMENG Rev 0 10 2 Multi Patient Mode NOTE Use of Multi Patient Mode is only available with a Bluetooth enabled device This includes transferring data and storing data in memory Multi Patient Mode allows the user to access the memory 0 0 of the device for storing patient measurements Multi 00 0 Patient mode is indicated by a number 1 20 being Std 0 01 displayed in bottom left hand corner of screen The memory is capable of storing information for 20 patients The user selects a number 1 P20 and takes measurements for the right a
75. robe tip 2 Auto Rep Delay configuration Replace probe Contact DGH Technology See section 19 2 Adjust configuration See section 13 2 3 Cannot send files to PC printer 1 Bluetooth not enabled 2 Devices not paired 3 COM settings incorrect 1 Enable Bluetooth module See section 14 1 2 Pair devices See section 14 2 and 14 4 3 Adjust COM settings See section 15 5 3 Remote Device Not Found error message when attempting to send measurements to the software Pairing not established Pair devices then add device to the software s device list See section 14 4 and 15 4 Cannot find correct device on the Pachette 4 when trying to export print measurements Pairing not established Clear all pairing and re pair with preferred device See section 14 9 regarding clearing See section 14 3 and 14 4 regarding pairing Page 83 of 92 DGH 555B INS OMENG Rev 0 19 Service If you are having problems with this unit please refer to the appropriate sections of this manual Most service calls result from a misinterpretation of the operation of the instrument as described in the manual 19 1 Repairs and Customer Support If you feel there is a problem with the unit or a probe please contact the Customer Service Department at DGH Technology Inc 110 Summit Drive Suite B Exton PA 19341 Phone 610 594 9100 Fax 610 594
76. rs NOTE To access these parameters enter the Configuration Menu by pressing the CFG key Press the ENT key repeatedly to navigate through the menu See section 13 1 13 2 1 Auto Switch default enabled can be enabled or disabled for Continuous Averaging Mode With AUTO SHITCH 00705 Auto Switch enabled device will automatically Enabled switch eyes after a 4 second delay when a measurement group is complete Press the or Y key to change the configuration 13 2 2 Numb of Meas default 25 is the number of measurements that the unit will use to calculate the OF MEAS measurement average and standard deviation of a 05 measurement point in Continuous Averaging Measurement Mode It can be adjusted from to 25 Press the A or V key to change the value 13 2 3 Auto Rep Delay default 50 msec is the period of time in milliseconds that the device will wait AUTO REP DELAY between consecutive measurements while the probe lt 0 msec is applanated to the cornea in Continuous Averaging Measurement Mode It can be adjusted from 50 msec to 950msec Press the A or V key to change the value Page 50 of 92 DGH 555B INS OMENG Rev 0 13 3 Parameters for Mapping Measurement Mode These are the Mapping Measurement Mode parameters that are accessible from the Configuration Menu The device must be set to Mapping to access these parameters NOTE To access
77. s Figure 11 Equipment Label 1322 In the specified reference design can be used In the following countries ireland Italy Latvia Lithuania Luxembourg Mata Poland Portugal Sioverta Spain Sweden The Netnertands the United Kingdom Switzerland and Norway User s Manual 34 Revision 1 3 2013 06 14 Hardware Image from Panasonic Corporation PAN1322 SPP User Manual Rev 1 3 Page 90 of 92 DGH 555B INS OMENG Rev 0 Panasonic ENW89841A3KF Bluetooth Qualification and Regulatory Certification Declaration of Conformity DoC 1999 5 EC We Panasonic Devices Europe GmbH Wireless Connectivity Power Electron amp cs RAD Center Zeoppelinstrasse 19 21337 Loeneburg Germany declare under our sole responsibility that the product of equipment Bluetooth Module Brand name PANI321 1322 1312 Model name EN W8981LK4CF ENW8981OKSCE ENWHNSS41 ASKF ENWHSSSATCSKE to which this declaration relates is in compliance with all the applicable essential requirements and other provisions of the European Council Directive 1999 5 8 Radio and Telecommentcations Terminal Equipenent Directive The conformity assessment procedure used for this declaration is Annex IV of this Directive Product compliance has been demonstrated cn the basis of EN 50371 2002 11 EN 301 489 1 V1 9 1 2011 04 z
78. s half circle with a small hole in it Page 20 of 92 DGH 555B INS OMENG Rev 0 7 1 2 The connectors are designed to go together WITHOUT twisting When inserting or removing the probe slide the connectors together without twisting 7 2 Holding the Probe While handling the probe try to avoid contact with the probe tip clear plastic cone so as to avoid contamination Touching the probe tip with ungloved hands may leave a residue that will cause the device to return an error message when self testing See section 7 3 Page 21 of 92 DGH 555B INS OMENG Rev 0 7 3 Check Probe Error Message This message typically indicates an error generated by the probe tip being wet Dry the tip and cycle the device power off then back on If drying the tip of the probe does not resolve the error then the probe may have degraded to the point that it will require replacement CHECK PROBE 7 4 Plug In Probe Error Message This message occurs when 1 the detachable probe is not mated or is improperly mated to the unit or 2 the probe is defective If the probe is found to be defective remove defective probe by holding the probe connector and gently pulling straight out of the unit PROBE PLUG IH 7 5 PQF Failed Error Message This message usually indicates a hardware failure occurred within the unit and the unit must be returned for repair See section 19 1 f
79. ss Add Notes When Yes is displayed operator notes will be included on the printout the OD key to select what to include Press key to Continuous switch between Ave When Yes is displayed all measurements will be included on the printout The device is in Continuous Averaging Mode Continuous Ave and Mappin Mapping pping Press or key to Disabled enable or disable The device is in Mapping mode The device WILL NOT automatically switch eyes when measurements are finished for an eye in Continuous Averaging Mode Auto Switch Enabled Press 7 or key to change the value Press or key to change the value Press key to change the value Page 48 of 92 The device WILL automatically switch eyes when measurements are finished for an eye in Continuous Averaging Mode The device will take this number of measurements at single position The period of time in milliseconds between measurements while the probe is applanated to the cornea Selects the number of positions to be measured for each eye One measurement per position DGH 555B INS OMENG Rev 0 Configuration Menu Parameters Press the CFG key Press the ENT key repeatedly Press the CFG key again Enter the Configuration Menu Navigate down the Parameters List Exit the Configuration Menu Parameter Availability Only available if in Mapping Mode Only available
80. t Communications Port or Serial Port settings Select this tab 14 5 4 The Connect software needs an Inbound and Outbound port to operate If either is missing add the appropriate port e Adding ports menu will vary depending on the software installed Page 62 of 92 L My Documents ap 8 56 3 z H 2 E 8 3 27 My Pictures DGH Connect e My Music qs My Computer Windows Media Player Set Program Access ar Defaults Provide Cg Printers and Faxes Windows Messenger account Help and Support GO and Settings Transfer gt Search ard 17 Run All Programs gt Log Off Turn Off Computer 2 start My Bluetooth Places 8GB DRIVE General Accessibility PIM Interface Share Communications Port Networking Diagnostics lt The computer is using the COM serial ports below To determine whether you need COM port read the documentation that came with your Bluetooth device COM Port Direction Name Outbound Bluetooth Serial Port 2 COM11 Inbound Bluetooth Serial Port Add Inbound Add Outbound Delete 555B INS OMENG Rev 0 14 5 5 After the COM Ports have been set start the DGH Connect software If the software has not yet been installed install it section 15 and then complete the final steps 14 5 6 In the DGH Connect software n
81. td has certified the C management system of DGH Technology Inc meets the requirements of Directive 0120 93 42 EEC Annex II excluding section 4 for ultrasonic pachymeters This symbol located on the DGH 555 indicates that the equipment consists of electronic assemblies and other components that may be subject to Directives 2002 96 EC 2003 108 EC and 2002 95 EC of the European parliament which advises that electrical and electronic devices must not be disposed of as normal domestic refuse In order to prevent environmental risks or endangerments by non professional disposal the disposal of this product including any accessories must comply with valid practices as outlined in Directives 2002 96 EC 2003 108 EC and 2002 95 EC and local regulations All electronic components and systems should be returned to Original Manufacturer for disposal This symbol instructs the operator to read the operating manual This symbol indicates that DGH Technology Inc is the manufacturer of the DGH 555B Pachette 4 device The YYYY under the symbol indicates the year the device was yyyy manufactured This symbol indicates that Emergo Europe is the European Authorized ner Representative for this device REF This symbol indicates that the model number of this device is 555B SN This symbol indicates the serial number of the device YY YY indicates the year of manufacture and XXXX indicates the unit number Page 6
82. these parameters enter the Configuration Menu by pressing the CFG key Press the ENT key repeatedly to navigate through the menu See section 13 1 13 3 1 Numb of Posn default is 33 is the number of positions where the device will take single HUME OF POSH measurements It can be adjusted from 1 to 33 33 Press the A or V key to change the value 13 3 2 Disp Bias Meas default disabled enables or disables if the device will display a measurement DISP BIAS MEAS bias with each measurement taken during Mapping Disabled Measurement Mode Press the or key to change the configuration 13 3 3 Amount Of Bias default 100 determines the amount of bias used in calculating the measurement AMOUNT OF BIAS bias in Mapping Measurement Mode This 1002 parameter is available if the device is configured to display measurement bias It can be adjusted from 1 to 199 Press the or Y key to change the value e The amount of bias is applied to all patients stored in the device memory If the amount of bias is changed the device will re calculate all bias measurements for all stored patients 13 3 4 Good Meas Delay default 1 0 sec is the amount of time that the device will wait before advancing to 5000 MEAS DELAY the next mapping point after a measurement is 1 0 sec taken It can be adjusted from 1 0 sec to 9 5 sec Press the A or V key to change the value Page 51 of 92 DGH 555B INS OMENG Rev 0 13 3 5 Poo
83. tion While in Measurement Mode the Pachette 4 will automatically take a measurement whenever the tip of the probe is properly applanated to the cornea Page 10 of 92 DGH 555B INS OMENG Rev 0 5 Ultrasonic Exposure And Intensities 51 Tissue Exposure To Ultrasound Energy The ultrasound energy emitted by the Pachette 4 is low intensity and will have no adverse effects on the patient and or operator However the operator is still cautioned to perform examinations using the principle of ALARA As Low As Reasonably Achievable All examinations should be done so that the patient receives as little ultrasound radiation as possible Do not hold the probe against the eye or other tissue with the system activated except when making a measurement Do not make unnecessary measurements 5 2 Ultrasonic Intensities The Pachette 4 has only one mode and ultrasonic intensity settings are not under the control of the operator Thus the values below are the values to be expected for a typical transducer Since the DGH 555B Pachette 4 is not capable of exceeding either a TI of 1 0 or an MI of 1 0 in any operating mode the output of the system is reported as shown in the Table below The appropriate Thermal Index is the Thermal Index for Soft Tissue TIS for the non scanning case with a beam aperture of less than 1 0 cm Output Summary Table Transducer Model used with DGH TI Value MI
84. tion 13 5 4 for detailed instructions regarding printed fields 14 3 3 Exit the Configuration Menu by pressing the CFG key If changes have been made the Pachette 4 Save Hew Config will prompt for confirmation of the configuration t Yes change Page 58 of 92 DGH 555B INS OMENG Rev 0 14 3 4 Press the key to select Yes and save the configuration The Pachette 4 will return to Measurement Mode 14 3 5 Press and hold the ENT key until the Pachette 4 Connecting displays the Connecting to BT Device Printing BT device will begin automatically e When printing in Single Patient Mode only the Single Patient information will be printed The measurements will be retained until cleared by the user or until Measurement Mode or Patient Mode is changed When printing in Multi Patient Mode all patient measurements in Non Volatile Memory will be printed The measurements will be retained until cleared by the user or until the Measurement Mode is changed 14 3 6 The Pachette 4 will store the printer configuration This allows the user to print from this device directly at any time by pressing and holding the ENT key 14 4 Pairing with a Bluetooth enabled PC The Pachette 4 can be paired with PCs that are equipped with Bluetooth wireless technology This can be via integrated Bluetooth modules or USB adapters dongles Once the Pachette 4 is properly paired with the PC the operator can use the DGH C
85. tion Classification and Indications For Use 11 General Device Description The DGH 555B Ultrasonic Pachymeter Pachette 4 is a portable battery operated ultrasonic device that is used in the ophthalmic field for measuring the thickness of the human cornea Cornea thickness measurements are used in the preoperative evaluation of laser vision correction procedures and for the evaluation of glaucoma The DGH 555B is also used as a diagnostic tool in a variety of clinical situations including the general assessment of corneal health related to pathologies and in evaluating corneal swelling following surgery or injury The general principle of operation of the DGH 555B Ultrasonic Pachymeter Pachette 4 is as follows The tip of the ultrasonic transducer probe is placed in contact with the patient s cornea which automatically initiates a measurement cycle At the start of the measurement cycle the electronic circuit board transmits voltage pulses to the ultrasonic transducer probe The piezoelectric element in the transducer converts these voltage pulses into ultrasonic energy sending a pulse of a high frequency sound waves 20MHz damped to 13MHz through the eye and reflected pulses echos are received back to the transducer and are converted to voltage pulses The first echo to be received comes from the anterior corneal surface If an echo spike from the anterior corneal surface is received within an anticipated time window the DGH
86. ts to the PC automatically NOTE If the incorrect incoming COM Port is selected the Pachette 4 will not be able to initiate measurement transfer To correct this error Incoming Port 15 7 6a Select Settings COM Settings 15 7 6b When the Settings dialog box opens change the port by going to the Incoming Port selection box and choosing a different COM Port from the list The computer will automatically save the new COM Port aa a configuration Incoming Port 15 7 6c If this error occurs again select another COM coms Port and attempt another import oos 15 7 7 all files are transferred the device will Bluetooth automatically disconnect and show the Bluetooth Disconnected Disconnected message Page 76 of 92 DGH 555B INS OMENG Rev 0 15 7 8 The Pachette 4 will display the message Erase Erase Patients Patients Sent Selecting Yes will clear all 2 2 information of the patient s that was exported sent fj H 15 7 9 The patient reports will be stored in the Report Report Import Location Import Location that is listed in Connect CAUsers User Desktop Pachymetry Reports Software If Auto Open is enabled the software will open each patient record in its own window e If Auto Print is enabled the software will print all patient records from
87. turers of mobile fixed or portable devices incorporating this device are advised to ciartty any regulatory questions and to have their complete product tested and approved for compilance FCC or other when applicable When using ofer antennas a ciass 11 permissive change 15 required for FCC approval The normal procedure is to first provide a technical test report showing fat 4 15 not exceeded and to continue working wih a reguiatory test house to tnalize the approval for a new antenna implementation There are no parts In ENWS9841A3KF that can be modified by the user except modifications of the device BD data and loading of SW patches Any changes or modifications made to this device that are not expressly approved by Panasonic may void the user s authority to operate the equipment 9 2 FCC Class B Digital Devices Regulatory Notice This equipment has been tested and found to comply with the limits for Ciass B digital device pursuant to Part 15 of the Rules These limits are designed to provide reasonable protection against harmful interference In a residential instalation This equipment generates uses and can radiate radio frequency energy and not installed and used In accordance with the instructions may cause harmful Interference to radio communications However there 15 no guarantee that Interference will not occur in a particular Installation If this equipment does cause harmful interference to radio or television rec
88. us 15 3 1 The Device selection box allows the user to select which DGH Bluetooth enabled device to interact with The Device box will list all devices that are associated with the DGH Connect Software by showing the model number and serial number Device 5558 4455 devices are shown in the list it is necessary to add the device to the software s memory See section 15 4 for information on adding the device To check the serial number of the Pachette 4 press and hold the CFG key Page 68 of 92 DGH 555B INS OMENG Rev 0 Report Import Location C Users User Desktop Pachymetry Reports 15 3 2 The Report Import Location box allows the user to select where records will be stored when imported from the Pachette 4 Change e Pressing the Change button will open a dialog box that allows the user to select a custom import location 15 3 3 Report Format default PDF controls how the report will be imported Format from the device Only one format can be selected at a time E If setto PDF the report will be imported to the Report Import Location as an un editable PDF file If set to DOC the report will be imported to the Report Import Location as an editable DOC file 15 3 4 Report Options default Auto Open enabled control how the report will Report Options be processed once it has
89. user s manual for further details Ti 5 Exit CalBox mode by pressing the CLR key Pachere Model CalBox DGH 555B 558 LAB CALBX Rov 0 Fig 6 6 1 The DGH 555B Pachette 4 Electronic CalBox Page 19 of 92 DGH 555B INS OMENG Rev 0 7 Probe Use and Indicators The Pachette 4 s removable probe contains a piezo electric element within its transducer housing See section 6 5 This element creates an ultrasonic pulse main bang that is channeled through the clear plastic cone and focused to the point of measurement The pulse exits the cone and creates a return signal echo as it passes through the cornea The piezo electric element receives the return signal echo and the Pachette 4 analyzes the magnitude of the return signal echo in order to calculate corneal thickness Correct use and maintenance of the probe is essential for collecting accurate measurements The operator must ensure that the probe is properly cleaned and connected so that the device can perform a probe self test The Pachette 4 automatically performs a self test to check the functionality of the probe This test is done every time the device is put into Measurement Mode Typically the operator will be unaware that a self test is occurring however the operator must know how to react if an error message is produced 7 1 Inserting and Removing the probe 7 1 4 Align the probe connector prong to fit into Pachette 4 The prong i
90. utside the following ranges An ambient temperature range of 40 C to 70 C A relative humidity range of 10 to 100 including condensation An atmospheric pressure range of 500 hPa to 1060 hPa 17 4 Operating Conditions The Pachette 4 should be operated between temperatures of 18 C 64 4 F to 40 104 F Page 82 of 92 DGH 555B INS OMENG Rev 0 18 Troubleshooting Guide PROBLEM ERROR MESSAGE POTENTIAL CAUSE SOLUTION Device will not turn on Dead batteries Replace batteries See section 16 Device screen is blank In Sleep Mode Press the PWR button See section 9 3 Screen is on but will not take In Standby Mode indicated Press the PWR button measurement by blinking black cursor in upper left hand corner See section 9 2 Plug In Probe Message on screen Probe is wet or has a residue on it Dry probe See section Error Reference source not found and 7 4 Check Probe message on startup Probe is wet or has a residue on it Dry probe See section Error Reference source not found and 7 3 Will not initiate CalBox mode While device is off hold down the DEL key and press the PWR key Device starts in CalBox mode See section 8 Black boxes across the top half of the screen 1 Bad battery contact 2 Dead batteries 1 Clean battery contacts 2 Replace batteries See section 16 Slow measurement cycle 1 Dented scratched p
91. vice 15 energizing the probe When the probe is properly applanated See section 4 4 to the cornea in Measurement Mode the unit will detect contact and automatically take a measurement Measurement Mode can take either Continuous Averaging measurements or Mapping measurements When Measurement Mode is set to Continuous Averaging the device will display o Avg 0 u Std Dw 0 0 e When Measurement Mode is set to Mapping the Posn 1 device will display Meas E 0 u 9 2 Standby Mode This is when the device is not energizing the probe The unit automatically goes into Standby Mode if there has been no attempt at measurement for one minute The device will not be able to detect corneal contact in Standby Mode Standby Mode is indicated by a beep and flashing cursor in the upper left hand corner of the display While in Standby 00 Awg 0 Mode the display will stay on and you will be able to view Std Dw 0 01 measurements and access configuration menu You will not be able to take a measurement in Standby Mode To exit Standby Mode press the PWR key this will put the unit back into Measurement Mode The 1 minute delay can be adjusted from 0 5 to 9 5 minutes by accessing the configuration menu as described in section 13 4 1 Page 26 of 92 DGH 555B INS OMENG Rev 0 9 3 Sleep Mode The device will automatically enter Sleep Mode if it has been in Standby Mode for three minutes and there
92. ye will be displayed in upper left hand corner By default the device is prepared to measure RIGHT eye Awg 0 Ou Std Dv 0 01 Have patient visualize a fixation point 12 2 10 Confirm that the device is in Measurement Mode The blinking black cursor is not shown in the upper left hand corner Page 40 of 92 DGH 555B INS OMENG Rev 0 12 2 11 Gently position the probe tip on the cornea as described in section 4 4 The Pachette 4 will automatically begin the measurement cycle when the probe is properly applanated e The device will emit a quick beep for each successful measurement e If the device is not able to obtain a POOR measurement within 3 seconds the device will emit a long beep and the Poor Applanation APPLANATION message will be displayed e Ifthe Poor Applanation message is displayed attempt to reposition the probe tip for proper applanation Once the probe tip is in proper alignment the device will continue measurement 12 2 12 Once the device has collected the required number 00 Measurement of measurements the device will emit two long Group Completed beeps and display the Measurement Group Completed message 05 Measurement Group Completed 12 2 13 The device will display the measurement average and standard deviation of the eye measured To scroll through individual measurements press the e If Auto Switching is enabled See 13

DGH 555B – Pachette 4 (English, 01/06/15)

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DGH 555B &ndash; Pachette 4 (English, 01/06/15)

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DGH 555B – Pachette 4 (English, 01/06/15)