Pachette 3 (English, 12/03/10)
Contents
1. Enabled Disabled play BILATERAL MODE Enabled Enables or disables the Bilateral Mode which allows the unit to meas Continuous Avg Enabled Disabled ure and display results for both eyes Mapping AUTO SWTCH OD OS Enabled Enables or Disables the ability for the unit to after all measurements Continuous Avg Enabled Disabled are taken automatically switch to the other eye Mapping with Bilat eral Mode OD OS SWITCH DLY 1 to 9 5 Period of time after all measurements are taken before the unit will ContinuousAvg 4 0 sec automatically switch to the other eye Mapping with Bilat eral Mode NUMB OF MEAS 1 to 25 Selects the number of measurements to be obtained Continuous Avg 25 AUTO REP DELAY lt 50 to 950 Period of time between consecutive measurements while probe is ap Continuous Avg lt 50 msec planated to the cornea DELAY TO STANDBY 0 5 to 9 5 Period of time before unit switches from Measurement mode to Continuous Avg 1 0 min Standby mode Mapping NUMB OF POSN 1 to 33 Selects the number of positions to be measured Mapping 33 DISP BIAS MEAS Enabled Enables or disables the display of the biased measurements Mapping Disabled Disabled AMOUNT OF BIAS 1 to 199 Selects the percentage used to calculate biased measurements Mapping 100 GOOD MEAS DELAY 1 0 to 9 5 Period of time before the unit will automatically store the current Mapping 1 0 sec measurement and advance to the next measurement position P2. 1 Probe Cord Wrap Place to wrap the probe cord when not in use or during transport 2 Probe Connector The connector that mates to the connector on the probe cable 3 Tilt Stand Used to place unit in tilted position on a flat surface Back Of Unit REF DGH 555 PACHETTE 3 DGH TECHNOLOGY INC 110 SUMMIT DRIVE ml SUITE B EXTON PA 19341 YYYY USA 610 594 9100 CAUTION Federal U S A law restricts this device h r rder ofa physician Figure III D DGH 555 Pachette 3 Back Panel 1 Back Panel Label This label contains the model number and serial number for the unit It also provides contact information for DGH Technology Inc and the following classification and attention symbols This symbol indicates the degree of protection against electric shock The Pachette 3 is classified as type BF equipment N This symbol cautions the operator to read the operating manual This mark indicates that Notified Body 0120 SGS United Kingdom Ltd has 0120 certified the management system of DGH Technology Inc meets the re quirements of Directive 93 42 EEC Annex II excluding section 4 for ultra sonic pachymeters ef 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 dispo
3. occur to indi cate that a poor applanation has happened The message of POOR APPLANATION is also displayed for a time interval known as the Poor Applana tion Delay default 2 sec After this delay expires the display will advance to position 2 and two short beeps will occur to indicate that the unit is ready to take the next measurement Note The audible feedback is provided so that the operator can concentrate on probe tip alignment and positioning For instructions on changing the length of the Good Measurement and Poor Applanation delays see the beginning of this section If the message of POOR APLANATION keeps appearing on the display check to insure the probe tip actually touches the cornea and is perpendicular to the corneal surface 4 Whenever an acceptable measurement has been made the top line of the display will indicate the corneal thickness in microns All thickness measurements are based on a corneal velocity of 1640 m sec Simultaneously if enabled the bottom line of the display indicates a biased corneal thickness in microns that is based on surgical re 22 quirements as defined by the operator Refer to the beginning of this section for in structions on changing the percentage that determines the biased measurement All measurements can be reviewed on the display by using the or Y keys new measurement may be taken at any position by causing the appropriate position num ber to a
4. DGH 555 PACHETTE 3 ULTRASONIC PACHYMETER PACHETTE DGH 555 OPERATOR S MANUAL Equipment Manufactured By Authorized Representative DGH TECHNOLOGY INC EMERGO EUROPE 110 SUMMIT DRIVE Molenstraat 15 SUITE B EC REP 2513 BH The Hague EXTON PA 19341 The Netherlands Phone 31 70 345 8570 USA 610 594 9100 C 0120 555 INS OMENG Rev 2 L INTRODUCTION PRS 1 II FEATURES see 2 Il GENERAL DESCRIPTION Asa 3 IV PFOWER UPSEOUENCE ass 9 vV CONFIGURING THE PACHET TE Secese aaa pano aO n EoD S Sa A NS ESR ES Ea CEN SEENEN 11 V A Continuous Average Mode Factory Default Mode coooccccocccconccncoccnnoncnnnnncnnonocnnonccnonnnnnoncnnnns 11 VB MAPP Modes 14 VI OBTAINING PACHY METRY MEASUREMENTS cccsscccccscssccsccsessccceccccssccesscsscccescessccceccsessscees 19 VILA Obtaining Measurements With Continuous Average Mod e ccccccsecccceeeeceeseecenceeaeseseeneeeaes 19 VI B Obtaining Measurements With The Mapping Mode ooccccoccncoccnnonccnnnncnnonccnnoncnnononnnonccnonannnonnnnnns 21 VII PROBE OUALET Y ss 23 VIL VERIFYING PACHETTE 3 CALIBRATION ss 24 IX CARE AND MAINTENANCE vr 25 IX A Cleaning and Disinfecting Instruct10ns rrrororrnrnnornnnnrnvnnernvnnenvnnernrnnennnnernrnnennrnernnnnennnnssnnnnenene 25 IXB Transport and Storage CONAN a a a a 25 KE HETE TI a a aa 25 RD W a N E 26 FE AN 26 EDGE Tnstructions tor Chansins Batters sascha die saa td 26 A EE ER ENE 27 X IND
5. DGH Technology Inc Changing Parameters On The Configuration Menu A complete list of all the possible parameters on the configuration menu is given in Table 1 The procedures below show how to activate the configuration menu and modify the parameters on the Pachette 3 V A Continuous Average Mode Factory Default Mode 1 Press the CFG key and the display will indicate OPERATIONAL MODE Continuous avg 2 Press ENT key to continue in Continuous Avg mode or press the or Y keys to change the operational mode from Continuous Avg to Mapping Refer to section V B to continue in Mapping Mode In Continuous Avg mode display will indicate 12 STD DEVIATION Enabled Use the or V keys to enable or disable standard deviation Press the ENT key to confirm your selection and the display will then indicate BILATERAL MODE Enabled Use the or V keys to enable or disable bilateral mode Press the ENT key to con firm your selection and the display will then indicate AUTO SWITCH OD OS Enabled Use the or V keys to enable or disable auto switch mode Press the ENT key to confirm your selection and the display will then indicate OD OS SWITCH DLY 4 0 sec Use the or Y keys to select the time in seconds that the unit will wait after completing measurements on one eye before switching to the other eye Press the ENT key to confirm your selection and the display will then indicate NUMB OF MEAS 25 Use the or V k
6. ICATIONS FOR USE PRESCRIPTION DEVICE STATEMENT PRECAUTIONS INTENSITIES AND CAPABIETTIES ass 29 KA aan FR VP 29 MBs Ferran Devi lead 29 XC Tissue Exposure Lo Ultrasound Emer Oy vase 29 XD Ultrasonicas An 29 Es Biometrie Measurement Capabilities asear casoni i ei iaa Oe ERE EA 30 Xo EA a a A 31 Pee A MN EN EE NN NS NE 31 SH EN EMC CNG 31 LIST OF FIGURES Pieure HRA DGH 555 Pachete S Front VEN adsense EE EAEE aan iniciadas 3 Feire 0 6 DET 555 Rachete gt BK VE Ne en 5 Freire HEC DOT 555 Fachete olde VIEW eee 6 Ersure HED DGH 555 Pachett 3 Back Panel a 7 Figure HLE DGH 555 Pachete Elcon Cal sind tcc clado 8 I INTRODUCTION Ultrasonic Pachymetry is an integral part of refractive corneal surgery as well as certain screening procedures that are a function of corneal thickness The DGH 555 Ultrasonic Pachymeter Pachette 3 is an ultrasonic pachymeter that uses echo spike techniques to measure the thickness of the cornea This is the recommended method for obtaining cor neal thickness measurements because 1t offers the following advantages Reproducibility High accuracy Ability to take measurements anywhere on the cornea Measurements are not dependent upon patient fixation Ease of use The corneal thickness measurement may then be used in many different ways including Lasik glaucoma screening and corneal edema check for extended wear contact lens pa tients The Pachette 3 was designed to provide a means of obtaining fas
7. OOR APPL DELAY 1 0 to 9 5 Period of time after a poor applanation occurs before the unit will Mapping 2 0 sec automatically advance to the next measurement position BATTERY TYPE Alkaline Choose the type of battery being used NOTE Use only Alkaline or Continuous Avg Rechargeable Rechargeable NiMH Batteries Mapping ON BACK LIGHT Selects backlight always on always off or normally on and then off in Continuous Avg OFF OFF in Standby BRIGHTNESS I to 14 Adjusts display brightness for desired viewing Continuous Avg 7 segments segments Mapping CONTRAST I to 14 Adjusts display contrast for desired viewing Continuous Avg 7 segments segments Mapping VOLUME I to 14 Adjusts alarm volume to desired level Continuous Avg 7 segments segments Mapping Off in Standby standby mode Mapping 19 VI OBTAINING PACHYMETRY MEASUREMENTS The Pachette 3 does not require an activation switch to obtain pachymetry measurements Instead measurements are automatically taken whenever the tip of the probe is properly applanated onto the cornea This feature allows the operator to concentrate on probe tip alignment and positioning In addition the Pachette 3 was designed in Continuous Aver age Mode to take multiple measurements very rapidly at a single location and display the total average Therefore as long as the probe is properly applanated onto the cornea the unit will continue taking measurements until a predetermined number of measu
8. WR key and the unit will perform an internal test display battery status and then the display will indicate Clear All Meas T Yes J No Press the A key to clear all measurements Press the V key to retrieve all measurements 11 V CONFIGURING THE PACHETTE 3 Configuration Overview When shipped from the factory the Pachette 3 is ready to take corneal measurements It 1s not necessary to setup or configure anything However the Pachette 3 has been de signed to allow the operator to modify certain default 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 pro cedure explains how to access the configuration menu and modify the default parameters The Pachette 3 was designed to obtain multiple corneal measurements at a single location and generate an average for those measurements In addition the mapping mode permits the operator to take a single measurement at different positions on the cornea With this mode enabled the Pachette 3 can be programmed to record measurements at a maximum of 33 different positions 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
9. Y keys to select the desired display brightness Press the ENT key to confirm your selection and the display will then indicate Use the or V keys to select the desired display contrast Press the ENT key to confirm your selection and the display will then indicate 14 14 15 16 Use the or V keys to select the desired alarm volume Press the ENT key to return to the beginning of the configuration mode or press the CFG key to exit the configuration mode If you did not make any changes the dis play will read Config Not Changed and return to measurement mode If you changed any parameter the display will indicate Save New Config T Yes J No Press to save changes and return to measurement mode using new parameters or press V to restore previous configuration and return to measurement mode Note You can press the CFG key at any time to exit the configuration mode Pachymetry measurements may now be taken Refer to section VI for a detailed de scription of the proper method for obtaining measurements V B Mapping Mode l Press the CFG key and the display will indicate OPERATIONAL MODE Continuous Avg Use the or V keys to change the operational mode from Continuous Avg to Map ping Press the ENT key to confirm your selection and the display will then indicate BILATERAL MODE Enabled Use the A or V keys to enable or disable bilateral mode Press the ENT key to con firm your selection and
10. connectors and then connect the CalBox cable to the Pachette 3 Enter the CalBox mode by pressing and holding the DEL key and then press the Pachette 3 PWR key Press the CalBox POWER key until the LED lights up and the Pachette 3 will begin taking measurements If the LED fails to light or goes out before the test sequence has completed or 1f POOR APPLANATION is displayed then replace the 9V alkaline battery If no measurements are taken within 2 2 minutes after the CalBox button is pressed the CalBox will automatically turn off Observe actual measurement values of 200um thru 1000um in steps of 100um All values are based on a corneal velocity of 1640m s and should be within 5um If any measurements are out of tolerance contact DGH Technology Inc Exit the CalBox mode by pressing the CLR key on the Pachette 3 Important You must exit CalBox mode before attempting corneal measurements 25 IX CARE AND MAINTENANCE IX A Cleaning and Disinfecting Instructions PROBE TIP Keep the probe tip clean and disinfected To prevent patient to patient infection after each patient wipe the probe with a Q tip soaked in 70 isopropyl alcohol and then im merse the probe tip for 10 minutes in 70 isopropyl alcohol The tip should be rinsed in sterile distilled water before using CAUTION The probe should NEVER be autoclaved or subjected to intense heat As a general rule the above cleaning instructions are sufficient t
11. eys to select the total number of measurements from I to 25 that you wish to obtain Press and release either key to change the current value slowly one number at a time or press and hold the key to scroll through the values more quickly Press the ENT key to confirm your selection and the display will then indi cate AUTO REP DELAY lt 50 msec 10 11 12 13 13 Use the or V keys to select the desired value for the auto repeat delay This is the period of time that the unit will wait between consecutive measurements while the probe is properly applanated to the cornea Press the ENT key to confirm your selec tion and the display will then indicate DELAY TO STANDBY 1 0 min Use the or V keys to select the desired value for the standby delay This is the period of time that the unit will wait before entering standby mode if no measure ments are attempted Press the ENT key to confirm your selection and the display will then indicate BATTERY TYPE Rechargeable Use the or V keys to select battery type Alkaline or Rechargeable Press the ENT key to confirm your selection and the display will then indicate BACK LIGHT OFF in Standby Use the or V keys to select the type of back light desired The choices are back light always on always off or normally on and then shutting off in Standby mode Press the ENT key to confirm your selection and the display will then indicate BRIGHTNESS Use the or
12. ill look like example 2 See section V for configuration details o Avg 25 540u Example 2 Mea 21 541u The top line of the display in example 1 and 2 shows the average of the 25 meas urements in microns All thickness measurements are based on a corneal velocity of 1640 m sec The bottom line of the display in example 1 shows the standard de viation of the 25 measurements The bottom line of the display in example 2 shows the thickness of Measurement 21 Note Once the measurement memory is filled 1 e 25 measurements have been tak en when the Pachette 3 was pre configured to obtain 25 measurements no more measurements can be taken unless a measurement 1s deleted or all measurements are cleared from memory To display and review each measurement and the standard deviation if enabled use the A or V keys If any measurement seems questionable to the operator it can be erased from memory by pressing the DEL key The standard deviation will be up dated with each deletion After the measurements have been reviewed the operator can take more measure ments to replace the ones that were deleted or just accept the ones that remain In either case the total average and standard deviation will be updated accordingly If the measurements are being used to assist in glaucoma screening the IOP Correc tion value can be displayed by pressing and holding the ENT key When the key is released the display will return to the previou
13. in 1985 and later incorporated into other international Standards see Section 2 1 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 069x fx z I Xe where I is the estimated in situ intensity 1s the measured intensity in water at the focus of the transducer f is the ultrasonic frequency and z is the distance from the face of the probe to the transducer focus which 1s 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 X E Biometric Measurement Capabilities The following table shows the measurement range for the DGH 555 Ultrasonic Pachyme ter Pachette 3 Measurement Option Range um Accuracy Um Display Resolution um Standard Unit 200 1100 5 1 31 X F Classification According to the degree of protection against electric shock the Pachette 3 is classified as type BF equipment This classification is indicated by the symbol on the back of the unit X G Precautions Federal U S A law restricts this device to sale by or on the order of a physician Explosion hazard Do not use in the presence of flammable anesthetics gases or oxygen rich atm
14. indicate Std Dv 0 0u The Pachette 3 is now ready to take corneal measurements If any default parameters need to be modified refer to section V Otherwise refer to section VI for a detailed de 10 scription of the proper method for obtaining measurements During use the Pachette 3 is designed to conserve battery life Therefore the unit has three modes Measurement Mode Unit will take a measurement when applanated to the cornea In this mode display will indicate o Avg O Ou Std Dv 0 0u Standby Mode The unit will go into this mode if a measurement is not attempted within one minute from power up or a previous measurement The one minute facto ry default delay can be adjusted from 0 5 to 9 5 minutes by accessing the configuration menu as described in section VI The display will stay active but a measurement cannot be obtained In this mode you can still access the configuration menu and review all measurements When the unit enters this mode you will hear a beep and the display will have a flashing cursor in the bottom left corner as indicat ed o Avg 0 Ou E Std Dv 0 0u To return to measurement mode press the PWR key Sleep Mode If any key is not pressed for three minutes after the unit went into standby mode the unit will power down into Sleep Mode In this mode the display will go blank and the unit will appear to be off but all the measurements that were taken can still be retrieved Press the P
15. installed and the probe cord wrapped around the cord wrap on the protective holster with the probe seated in the pro tective cavity When necessary refer to section IX E for Instructions for Changing Batteries 1 oe ES A Remove the probe from the cavity by grasping the body of the probe at the access opening in the holster Do not pull on the probe cord to remove the probe as this can cause damage to the probe It is recommended that the probe be returned to the cavi ty for protection when transporting the Pachette 3 or when the unit is not being used Unwrap the probe cord The probe connector may be removed from the holster cavi ty by gently pulling on the probe cord at the connector strain relief Carefully align probe connector for proper mating orientation and insert into the opening on the right side of the holster Reference Figure IV C for connector orien tation 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 in jure the cornea Refer to section IX A for Cleaning and Disinfecting Instructions Flip tilt stand away from holster and place unit on flat surface in tilted position Turn on the unit The Pachette 3 performs an internal self test function Unit will briefly display battery status as indicated BATTERY OK E SERRE F When the power up sequence is finished the display will
16. iption device and is to be used only by or under the supervision of a licensed physician X C Tissue Exposure To Ultrasound Energy The ultrasound energy emitted by the Pachette 3 is low intensity and will have no ad verse 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 Achieva ble 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 sys tem activated except when making a measurement Do not make unnecessary measurements X D Ultrasonic Intensities The Pachette 3 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 555 Pachette 3 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 1s reported as shown in the Table be low 30 The appropriate Thermal Index is the Thermal Index for Soft Tissue TIS for the non scanning case with a beam aperature of less than 1 0 cm Output Summary Table Transducer Model DGH2006 1 0 mW cm dE re 0 0005 0 052 2 4 W cm aprt The acoustic output values given above are based on a presumed attenuation of ultra sound on tissue as developed by the U S Food and Drug Administration
17. ire replacement PLUG IN PROBE 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 de fective probe by holding the probe connector and gently pulling straight out of the unit Caution Do not twist probe as this could damage connectors Properly align replace ment probe connector and gently push in until properly seated PQF FAILED This message usually indicates a hardware failure occurred within the unit and the unit must be returned for repair See page 24 section IX F for service 24 VII VERIFYING PACHETTE 3 CALIBRATION Pachymeter calibration is verified by using the electronic Calibration Verification Box CalBox that is supplied with the Pachette 3 see Figure III E It is important to realize that the CalBox does not calibrate the pachymeter The CalBox generates a sequence of precise predetermined thicknesses that can be measured by the pachymeter The values of these thicknesses have been purposely selected to span the full measurement range of the unit Therefore by measuring these predetermined thicknesses the operator can quickly verify that the pachymeter is properly calibrated Procedure For Verifying Calibration l With the Pachette 3 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
18. it the configuration mode If you did not make any changes the dis play will read Config Not Changed and return to measurement mode If you changed any parameter the display will indicate Save New Config T Yes J No Press to save changes and return to measurement mode using new parameters or press V to restore previous configuration and return to measurement mode Note You can press the CFG key at any time to exit the configuration mode Pachymetry measurements may now be taken Refer to section VI for a detailed de scription of the proper method for obtaining measurements Note When changing operational modes Continuous Avg to Mapping or Mapping to Continuous Avg mode any measurements obtained in the previous mode will be deleted before the selected mode becomes active This is necessary because the two operational modes are very different and measurements from the previous mode would have no relevance if carried over to the new mode 18 Table 1 Parameters On The Configuration Menu And Associated Modes Parameter ance D scriotion Associated default value 8 P Mode s OPERATIONAL MODE Continuous Avg Selects how the Pachette 3 should operate Continuous Avg Continuous Avg Mapping Continuous Avg multiple measurements at a single location Mapping Mapping single measurement at different positions STD DEVIATION Enabled Enables or Disables the presentation of standard deviation on the dis Continuous Avg
19. ment The DGH 555 Pachette 3 is suitable for use in all establishments including Harmonic emissions NA domestic establishments and those directly connected to the public low IEC 61000 3 2 voltage power supply network power supply that supplies buildings used for domestic purposes Voltage fluctuations flicker NA Fs M Guidance and Manufacturer s Declaration Electromagnetic Immunity The DGH 555 Pachette 3 is intended for use in the electromagnetic environment specified below The customer or the user of the DGH 555 Pachette 3 should assure that it is used in such an environment Immunity test ge ES ala 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 555 Pachette 3 complies with requirements however IEC 61000 4 3 to 2 5GHz E1 3V m a separation distance from mobile RF communications should be maintained based on the following calculations d ENG 80MHz 800MHz 1 d 800MHz 2 5GHz 1 where P is the transmitter power in watts and d is the recom mended separation distance The separation should include cables connected to the unit Interference may occur in the vicinity of equipment marked with the following symbol a Conducted RF 3Vrms 150kHz Complies The DGH 555 Pache
20. nfiguration User friendly keypad allows selection of number of measurements to be obtained and selection of delay time between measurements Configuration memory Once personally configured for the operator non volatile memory provides permanent storage of configuration data even when the Pachette 3 is turned off and the batteries are removed Built in IOP Correction Calculation capabilities to assist in glaucoma screening Unit comes in a protective holster with a built in tilt stand for easy viewing When not in use the probe cord can be wrapped up and probe can be stored in the cus tom molded holster cavity for protection while being transported or stored Probe is detachable and can be easily removed by the operator for cleaning or if nec essary for replacement li GENERAL DESCRIPTION Front View ULTRASONIC PACHYMETER PACHETTE I JUDO 00 GE Q w Figure III A DGH 555 Pachette 3 Front View A LCD Display 16 x 2 character display used to present measurement data and or configuration pa rameters to the operator 2 Probe Clips Two clips molded into the protective case to place probe between cases 3 PWR Key Pressing this key turns the Pachette 3 on When the Pachette 3 is on pressing and holding this key turns the Pachette 3 off Also used in conjunction with the DEL key to enter the CalBox mode 3 DEL Key Used to erase a single measurement from a group of meas
21. o disinfect the probe in ordinary use Do not scratch or chip the conical probe tip which makes contact with the cor nea UNIT The unit s plastic housing and protective holster can be cleaned using a mild soap and water IX B Transport and Storage Conditions The Pachette 3 is capable while packed for transport or storage of being exposed for a period not exceeding 15 weeks to environmental conditions not outside the following ranges 1 An ambient temperature range of 40 C to 70 C 2 A relative humidity range of 10 to 100 including condensation 3 An atmospheric pressure range of 500 hPa to 1060 hPa IX C Operating Conditions The Pachette 3 should be operated between temperatures of 18 C to 40 C 26 IX D Warranty DGH Technology Inc DGH warrants each new DGH 555 and its accompanying ac cessories hereinafter called Equipment to be free from defects in material and workmanship for twelve 12 months from the date of delivery to the original purchaser This warranty 1s 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 1f the Equipment has not been op erated 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
22. osphere Electrical shock hazard Do not open Refer servicing to qualified service personnel X H EMI EMC Compliance The Electro Magnetic Interference and Compatibility testing of the DGH 555 Ultrasonic Pachymeter Pachette 3 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 throughout the test 32 Guidance and Manufacturer s Declaration Electromagnetic Emissions The DGH 555 Pachette 3 is intended for use in the electromagnetic environment specified below The customer or the user of the DGH 555 Pachette 3 should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF Emissions CISPR 11 The DGH 555 Pachette 3 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 equip
23. ppear on the display and then retaking the new measurement Any measurement that is suspect may also be erased by pressing the DEL key All measurements remain in memory until the CLR key is pressed or the Pachette 3 is turned off Press CLR key to erase all measurements and re initialize the Pachette 3 for a new measurement sequence starting at position 1 23 Vil PROBE QUALITY Whenever the Pachette 3 is initialized a self test is automatically performed that checks the quality of the ultrasonic probe Ultrasonic waves are emitted from the piezoelectric element in the transducer housing and transmitted through the plastic cone return sig nal echo is created when the ultrasonic waves pass through the end of the plastic cone into free air This echo signal is received by the piezoelectric element and then amplified and measured within the unit The magnitude of the echo signal 1s compared to the mag nitude of the echo signal when the unit was originally calibrated at the factory If the probe quality is satisfactory the Pachette 3 is ready to take measurements and the operator is unaware that the self test has occurred However if the probe quality is not satisfactory one of the following messages will appear on the display CHECK PROBE This message usually means the tip of the probe is wet However if drying the tip of the probe fails to make this message go away then the probe may have degraded to the point that 1t will requ
24. rements have been reached This number can be selected by the operator before beginning the measurement sequence The following procedure may be used to obtain pachymetry measurements VI A Obtaining Measurements With Continuous Average Mode 1 Perform the Power Up Sequence as described in section IV 2 Select the number of measurements to be obtained by accessing the configuration menu as described in section V 3 With the patient visualizing a fixation point position the tip of the probe onto the cornea Once the probe tip is aligned properly the Pachette 3 will automatically begin to take a series of measurements If a measurement is not obtained within 3 seconds a long beep will occur and the display will indicate POOR APPLANATION If the message of POOR APPLANATION keeps appearing check to insure the probe tip actually touches the cornea and is perpendicular to the corneal surface 4 For each measurement that 1s obtained a short beep will occur to indicate that the measurement has been stored in memory After all measurements have been taken two long beeps will occur the display will briefly indicate 20 oo Measurement Group Completed and then the display will look like example 1 o Avg 25 540u Example 1 Std Dev 0 3u Note In example 1 the Pachette 3 was pre configured to obtain 25 measurements with standard deviation enabled If standard deviation is disabled the display w
25. s screen Note The programmed correction values are based on a reference corneal thickness 21 of 545um and are modified from the work of Doughty and Zamen The correction values are derived from a chart from the Review of Ophthalmology July 2002 Leon Herndon MD Duke University Glaucoma Service Pages 88 89 90 A copy of this chart is included with every unit 8 To begin a new measurement sequence press the CLR key to erase all measure ments and re initialize the Pachette 3 Measurements are also erased from memory whenever the unit is turned off VI B Obtaining Measurements With The Mapping Mode 1 Perform the Power Up Sequence as described in section IV 2 With the patient visualizing a fixation point position the tip of the probe onto the cornea at the location the operator has defined as position 1 Once the probe tip is aligned properly the Pachette 3 will automatically attempt to take a measurement 3 When a measurement is obtained a short beep will occur to indicate that the measurement has been displayed The measurement is shown on the top line of the display for a time interval known as the Good Measurement Delay default 1 sec After the delay expires the measurement will be stored the display will ad vance to position 2 and two short beeps will occur to indicate that the unit is ready to take the next measurement If a measurement is not obtained within 3 seconds a long beep will
26. sed of as normal domestic refuse In order to prevent environmental risks or endanger ments 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 elec tronic components and systems should be returned to Orignal Manufacturer for disposal 2 Battery Door This door provides access to the battery compartment Calibration Standard To check Pachette 3 calibration an electronic Calibration Verification Box CalBox below 1s used to simulate the thickness of the cornea Instructions for using the CalBox are given in section VIII and they are also printed on the CalBox label It is recommended that calibration verification be performed at least once a day dd TECHNOLOGY INC 1 With the Pachette 3 turned off disconnect the probe and then connect the CalBox cable to the Pachette 3 2 Enter CalBox mode by holding in the DEL key and turning on the Pachette 3 3 Press the CalBox POWER key until the LED lights up 4 Observe that all Pachette 3 measurements are within 5um See user s manual for further details 5 Exit CalBox mode by pressing the CLR key PACHETTE 3 Model CalBox DGH 555 Figure III E DGH 555 Pachette 3 Electronic CalBox IV POWER UP SEQUENCE NOTE The Pachette 3 is shipped with 2 AA batteries
27. servicing replaceable and expandable items including parts and labor made in connection with the routine maintenance services as described in such Operator s Manual 1s 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 de fective 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 merchant ability 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 incon venience 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 IX E Lifetime Shelf life The shelf life lifetime indicated for this de
28. t accurate corneal thickness measurements with a battery operated instrument that is simple to use econom ical and ultra portable We invite you to read this manual carefully to discover how quickly and easily the Pachette 3 can be integrated into your practice 2 II FEATURES The Pachette 3 is manufactured with high quality components that are designed and built using the latest technological concepts The result is an advanced and powerful pachyme ter that offers practicality and reliability The following features are just a sample of the characteristics and capabilities of the Pachette 3 Standard Features Simple to use Turn on power and the Pachette 3 is ready to take measurements Automatic measurement mode for operation without an activation switch Rapidly obtains and stores up to 25 measurements at a single location Displays the current measurement the average and the standard deviation of all measurements taken Mapping mode for obtaining and storing up to 33 actual and biased corneal mapped measurements 16 x 2 LCD character display with LED backlighting allows easy visibility Proven measurement algorithm which yields accurate reproducible measurements in a fraction of a second Ultra Portable Battery operated lightweight and can be easily transported from of fice to hospital in its custom carrying case Operator feedback Audible signal indicates when a valid measurement is complete Personalized co
29. tall the probe and follow the power up sequence in section IV IX G 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 instru ment as described in the manual However if you feel there is a problem with the unit or a probe please contact the Cus tomer Service Department at the address below DGH Technology Inc can also be contacted via our website at www dghkoi com When contacting us please provide the model and serial number for the unit 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 hol ster This information can also be viewed on the display by pressing and holding the CFG key 28 Manufactured by DGH TECHNOLOGY ING 110 SUMMIT DRIVE TECHNOLOGY INC a DGH EE EXTON PA 19341 USA 610 594 9100 Authorized European Representative EMERGO EUROPE Molenstraat 15 EC 2513 BH The Hague The Netherlands Phone 31 70 345 8570 29 X INDICATIONS FOR USE PRESCRIPTION DEVICE STATEMENT PRECAUTIONS INTENSITIES AND CAPABILITIES X A Indications For Use The DGH 555 Ultrasonic Pachymeter Pachette 3 is a portable battery operated ultra sonic device that is used in the ophthalmic field for measuring the thickness of the human cornea X B Prescription Device The Pachette 3 is a prescr
30. the display will then indicate 15 AUTO SWITCH OD OS Enabled Use the or Y keys to enable or disable auto switch mode Press the ENT key to confirm your selection and the display will then indicate OD OS SWITCH DLY 4 0 sec Use the or Y keys to select the time in seconds that the unit will wait after completing measurements on one eye before switching to the other eye Press the ENT key to confirm your selection and the display will then indicate NUMB OF POSN 33 Use the or V keys to select the number of positions that will be measured Press ENT key to confirm your selection and the display will then indicate DISP BIAS MEAS Disabled Use the or V keys to enable or disable the display of biased measurements If you choose to disable this feature press ENT and go to step 9 Press ENT key to con firm your selection and the display will then indicate AMOUNT OF BIAS 100 Use the or V keys to select the percentage that will be used to calculate the bi ased measurement Press ENT key to confirm your selection and the display will then indicate GOOD MEAS DELAY 1 0 sec Use the A or V keys to select the time in seconds that the unit will wait before 16 10 11 12 13 14 storing the current measurement and advancing to the next measurement position Press ENT key to confirm your selection and the display will then indicate POOR APPL DELAY 2 0 sec Use the or V keys to select
31. the time in seconds that the unit will wait after a poor applanation before advancing to the next measurement position Press ENT key to confirm your selection and the display will then indicate DELAY TO STANDBY 1 0 min Use the or Y keys to select the desired value for the standby delay This is the period of time that the unit will wait before entering standby mode if no measure ments are attempted Press the ENT key to confirm your selection and the display will then indicate BATTERY TYPE Rechargeable Use the or V keys to select battery type Alkaline or Rechargeable Press the ENT key to confirm your selection and the display will then indicate BACK LIGHT OFF in Standby Use the or V keys to select the type of back light desired The choices are back light always on always off or normally on and then shutting off in Standby mode Press the ENT key to confirm your selection and the display will then indicate BRIGHTNESS Use the or V keys to select the desired display brightness Press the ENT key to confirm your selection and the display will then indicate 15 16 17 18 17 CONTRAST Use the or V keys to select the desired display contrast Press the ENT key to confirm your selection and the display will then indicate VOLUME Use the or V keys to select the desired alarm volume Press the ENT key to return to the beginning of the configuration mode or press the CFG key to ex
32. tte 3 complies with requirements however IEC 61000 4 6 to 80MHz V1 3Vrms a separation distance from mobile RF communications should be maintained based on the following calculations d ar 1 where P is the transmitter power in watts and d is the recom mended separation distance The separation should include cables connected to the unit Electrical fast transient IEC NA NA Not powered from mains 61000 4 4 Power frequency magnetic NA NA Unit does not use magnetically sensitive field IEC 61000 4 8 components Voltage dips short inter NA NA Not power from mains rupts and voltage variations on power supply input lines IEC 61000 4 11
33. urements Also used in conjunction with the PWR key to enter the CalBox mode CLR Key This key is used to erase all obtained measurements whenever it is desired to begin a new measurement sequence ENT Key In measurement mode pressing key will display battery status In configuration mode the key is used to advance to the next configurable parameter The key is also used to display the IOP correction calculation when the key is pressed and held Continuous Avg mode only 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 OS Key Press key to review or take measurements of the LEFT eye NOTE Key is used on ly when the unit is configured for the bilateral mode V Keys Used to review measurements or to program options and numerical values presented on the display OD Key Press key to review or take measurements of the RIGHT eye NOTE Key is used only when the unit is configured for the bilateral mode Back View Figure III B DGH 555 Pachette 3 Back View G 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 unit in tilted position on a flat surface 6 Side View Figure III C DGH 555 Pachette 3 Side View
34. vice is 10 years IX F Instructions for Changing Batteries 1 Remove the protective holster as follows Detach the probe entirely from the Pachette 3 and place in a safe place being careful to avoid any surface that could scratch or 4 27 damage the probe tip Next place the Pachette 3 face down on a clean flat surface Lift the top of the unit off the flat surface by reaching under the unit and grasping the left front top of the holster with 3 fingers of the left hand Place the left thumb on the rectangular molded pad on the outer surface of the cord wrap Position the right hand fingers and thumb at the same locations on the right side of the unit With the bottom edge of the unit still making contact with the flat surface press with both thumbs until the plastic case snaps out of the holster Slide open the battery door to gain access to the batteries Remove the discharged bat teries and install new batteries following the orientation shown in the battery compartment Important Use only Alkaline or NiMH batteries The first time the unit is powered up after installing batteries you will be prompted to identify the type of batteries used Re insert the plastic case into the protective holster by placing the left side of the case into the holster first and then pressing the right side of the plastic case into the hol ster Verify that the round opening on the holster lines up with the probe connector on the plastic case Ins
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