DGH 55 – Pachmate (English, 11/02/10)
Contents
1. Note In example 1 the Pachmate was pre configured to obtain 25 measurements with standard deviation enabled If standard deviation is disabled the display will look like example 2 See section V for configuration details Example 2 op Avg 25 540u 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 i e 25 measurements have been tak en when the Pachmate was pre configured to obtain 25 measurements no more measurements can be taken unless a measurement is 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 assist2. Use the A 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 12 10 11 12 13 14 DELAY TO STANDBY 1 0 min Use the A 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 A or V keys to select battery type Alkaline or Rechargeable Press the ENT key to confirm your selection and the display will then indicate CONTRAST Use the A 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 A 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 JL No Press A to save changes and return to measurement mode using new parameters or p
3. BIAS MEAS Enabled Enables or disables the display of the biased Mapping Disabled Disabled measurements AMOUNT OF BIAS 1 to 199 Selects the percentage used to calculate biased Mapping 100 measurements GOOD MEAS DELAY 1 0 to 9 5 Period of time before the unit will automatically Mapping 1 0 sec store the current measurement and advance to the next measurement position POOR APPL DELAY 1 0 to 9 5 Period of time after a poor applanation occurs Mapping 2 0 sec before the unit will automatically advance to the next measurement position BATTERY TYPE Alkaline Choose the type of battery being used NOTE Continuous Avg Rechargeable Rechargeable Use only Alkaline or NiMH Batteries Mapping CONTRAST 1 to 14 Adjusts display contrast for desired viewing Continuous Avg 7 Segments segments Mapping VOLUME 1 to 14 Adjusts alarm volume to desired level Continuous Avg 7 Segments segments Mapping 17 VI OBTAINING PACHYMETRY MEASUREMENTS The Pachmate 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 Pachmate 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 app
4. NOTE Key is used only when the unit is configured for the bilateral mode A V Keys Used to review measurements or to program options and numerical values presented on the display PWR Key Pressing this key turns the Pachmate on When the Pachmate is on pressing and holding this key turns the Pachmate off Also used in conjunction with the DEL key to enter the CalBox mode p gt 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 TECHNOLOGY INC DGH 59 Exton PA USA Pachymeter Figure III B DGH 55 Pachmate Back View a Battery Compartment Install batteries following label in compartment The unit serial number and battery orientation labels are located inside battery compartment DGH 55 SN YYYY XXXX AAA RO3 1 5v umM4 AAA RO3 1 5V UM4 Figure III C DGH 55 Pachmate Serial Number and Battery Orientation Label CAUTION The batteries should be removed if the device is not to be used for an extended period of time 2 Model Number Location of model number used to identify the unit 3 Classification and Attention Symbols A CE 0120 g This symbol indicates the degree of protection against electric shock The Pachmate is classified as type BF equipment This symbol cautions the operator to read the operating manual This mark indicates
5. has three modes Measurement Mode Unit will take a measurement when applanated to the cor nea In this mode display will indicate o Avg O On Std Dv 0 0 Standby Mode The unit will go into this mode if a measurement is not attempt ed within one minute from power up or a previous measurement The one minute factory default delay can be adjusted from 0 5 to 9 5 minutes by accessing the configuration menu as described in section V The display will stay active but a measurement cannot be obtained In this mode you can still access the configura tion 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 indicated o Avg O On 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 PWR key and the unit will perform an inter nal 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 10 V CONFIGURING THE PACHMATE Configuration Overview When shipped from the factory the Pachmate i
6. keys to select the desired display contrast Press the ENT key to confirm your selection and the display will then indicate VOLUME Use the A 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 A to save changes and return to measurement mode using new parameters or press Y 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 description 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 or ______sesesse__ _w_i_i_Uw _ Table 1 Parameters On The Configuration Menu And Associated Modes Parameter default value Range Description Associated Mode s OPERATIONA
7. press the Pachmate PWR key 3 Press the CalBox POWER key until the LED lights up 4 Observe that all Pachmate measurements are within 5um See user s manual for further details 5 Exit CalBox mode by pressing the CLR key Pachmate CalBox Figure III D DGH 55 Pachmate Electronic CalBox IV POWER UP SEQUENCE 1 Install two 2 AAA batteries See inside battery compartment for battery orienta tion 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 2 Verify that the detachable probe is properly mated in the probe rotator 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 IX A for Cleaning and Disinfecting In structions 3 Turn on the unit 4 The Pachmate performs an internal self test function 5 Unit will briefly display battery status as indicated Battery OK E SERRE RRERE F 6 When the power up sequence is finished the display will indicate o Avg O On Std Dv 0 0 The Pachmate 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 scription of the proper method for obtaining measurements During use the Pachmate is designed to conserve battery life Therefore the unit
8. rotates to allow the user to customize measurement position with detents at 30 45 60 75 90 degrees When not in use the probe can be rotated into the hand piece for protection while being transported or stored Probe is detachable and can be easily removed by the operator for cleaning or if necessary for replacement Ili GENERAL DESCRIPTION Front View Figure I A DGH 55 Pachmate Front View Detachable Probe Probe can be easily removed for cleaning or replacement LCD Display 16 x 2 character display used to present measurement data and or configuration pa rameters to the operator 3 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 4 CLR Key This key is used to erase all obtained measurements whenever it is desired to begin a new measurement sequence 5 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 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 lt Key Press key to review or take measurements of the LEFT eye
9. that Notified Body 0120 SGS United Kingdom Ltd has certified the management system of DGH Technology Inc meets the requirements of Directive 93 42 EEC Annex II excluding section 4 for ultrasonic pachymeters This symbol located on the DGH 55 indicates that the equipment consists of electronic assemblies and other components that may be subject to Di rectives 2002 96 EC 2003 108 EC and 2002 95 EC of the European par liament 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 lo cal regulations All electronic components and systems should be returned to Original Manufacturer for disposal Calibration Standard To check Pachmate calibration an electronic Calibration Verification Box CalBox below is 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 TECHNOLOGY INC Dh 1 With the Pachmate turned off disconnect the probe and then connect the CalBox cable to the Pachmate 2 Enter CalBox mode by pressing and holding the DEL key and then
10. under the supervision of a licensed physician X C Tissue Exposure To Ultrasound Energy The ultrasound energy emitted by the Pachmate 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 X D Ultrasonic Intensities The Pachmate has only one mode and ultrasonic intensity settings are not under the con trol of the operator Thus the values below are the values to be expected for a typical transducer Since the DGH 55 Pachmate 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 26 Output Summary Table T Model te od ot ea DGH2006DET 1 0 mW em eer 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 in 1985 and later incorporated into other internatio
11. DGH It is further understood that the cost of servicing replaceable and expandable items including parts and labor made in connection with the routine 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 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 T
12. DGH 55 PACHMATE HANDHELD PACHYMETER PacHMATE DGH 55 OPERATOR S MANUAL Equipment Manufactured By Authorized Representative DGH TECHNOLOGY INC EMERGO EUROPE 110 SUMMIT DRIVE Molenstraat 15 SUITEB ec REP 2513 BH The Hague EXTON PA 19341 The Netherlands Phone 31 70 345 8570 USA 610 594 9100 C 0120 55 INS OMENG Rev 2 I INTRODUCTION esesesesesneneneseresesnenenesesesesnenenesesesnsnenenesesesnsnenenesesesnsnenenesesesnsnenenesesesnsnenenesesesesnenenenener 1 II FEATURES Is 2 II GENERAL DESCRIPTION mesesoenesesereresnenenesereresnenenesesesnsnenenesesesesnenenesesesnsnenenesesesesnenenesesesesnenenenener 3 IV POWER UP SEQUENCE esevovevees 8 V CONFIGURING THE PACHMATE esesesessvneseseresesnensse 10 V A Continuous Average Mode Factory Default Mode 10 V B Mapping Mode a ssisisescccssiescuawaevsusccasavaxsnantuetaascsctascoiainasecacaccacacacassnaseveisicssscscasansnaveisisiceeaseees 13 VI OBTAINING PACHYMETRY MEASUREMENTS sesnesesereresevneneserereseenenesereseseenenesesesesnenenenener 17 VLA Obtaining Measurements With Continuous Average Mode enrnenrnenennnrvrrvrenenenenenesesersen 17 VIB Obtaining Measurements With The Mapping Mode esenevevevnvnenereneneneserrvserenereneneneseserser 19 VIL PROBE QUALITY seccccncccsccscssscsssssssecctstessssecedetusseseseceastutesnsnscessasossavecscssessssavocssssessssavecssssesosnavocoseses 20 VII VERIFYING PACHMATE CALIBRATION sses
13. L MODE Continuous Avg Selects how the Pachmate should operate Continuous Avg Continuous Avg Mapping Continuous Avg multiple measurements at a Mapping single location Mapping single measurement at different posi tions STD DEVIATION Enabled Enables or Disables the presentation of standard Continuous Avg Enabled Disabled deviation on the display BILATERAL MODE Enabled Enables or disables the Bilateral Mode which Continuous Avg Enabled Disabled allows the unit to measure and display results for Mapping both eyes AUTO SWTCH OD OS Enabled Enables or Disables the ability for the unit to after Continuous Avg Enabled Disabled all measurements are taken automatically switch Mapping with to the other eye Bilateral Mode OD OS SWITCH DLY 1t0 9 5 Period of time after all measurements are taken Continuous Avg 4 0 sec before the unit will automatically switch to the Mapping with other eye Bilateral Mode NUMB OF MEAS 1 to 25 Selects the number of measurements to be Continuous Avg 25 obtained AUTO REP DELAY lt 50 to 950 Period of time between consecutive measure Continuous Avg lt 50 msec ments while probe is applanated to the cornea DELAY TO STANDBY 0 5 to 9 5 Period of time before unit switches from Meas Continuous Avg 1 0 min urement mode to Standby mode Mapping NUMB OF POSN 1 to 33 Selects the number of positions to be measured Mapping 33 DISP
14. co Conducted RF 3Vrms 150kHz Complies The DGH 55 Pachmate complies with require IEC 61000 4 6 to 80MHz V1 3Vrms ments however a separation distance from mobile RF communications should be main tained based on the following calculations d Bg 1 where P is the transmitter power in watts and d is the recommended separation distance The separation should include cables connected to the unit Electrical fast NA NA Not powered from mains transient IEC 61000 4 4 Surge NA NA IEC 61000 4 5 Power frequen NA NA Unit does not use magnetically sensitive cy components magnetic field IEC 61000 4 8 Voltage dips NA NA Not power from mains short interrupts and voltage variations on power supply input lines IEC 61000 4 11
15. ervicing to qualified service personnel X H EMI EMC Compliance The Electro Magnetic Interference and Compatibility testing of the DGH 55 Handheld Pachymeter Pachmate 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 TEC 61000 4 2 1995 Electrostatic Discharge TEC 61000 4 3 1995 RF Susceptibility The system complied with the radiated and conducted immunity requirements throughout the test 28 Guidance and Manufacturer s Declaration Electromagnetic Emissions The DGH 55 Pachmate is intended for use in the electromagnetic environment specified below The cus tomer or the user of the DGH 55 Pachmate should assure that it is used in such an environment flicker emissions Emissions Test Compliance Electromagnetic environment guidance RF Emissions CISPR Group 1 The DGH 55 Pachmate uses RF energy only for its 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in near by electronic equipment RF Emission
16. esesesersvnenesesesesnenenesesesesnenenesssesesnenenssesesnsnenenenener 21 IX CARE AND MAINTENANCE eesesesneneserereresnenesesesesnsnenesesesesnsnensesesnsnensnsesesnsnenesesesesesnenssesesesnsnenene 22 IX A Cleaning And Disinfecting Instructions sesenrnevrvrerererenenennnerersrnerenenenenenessrsesenerenenenesesesser 22 IX B Transport and Storage Conditions nrenenerenrnrnrvrrrrrvrvrerenenenenesersrrenenenenenesererseserenenenenesesessen 22 IX C Operating Conditions oen 22 IX D Warranty f IX E Lifetime Shelf life IX F Service X INDICATIONS FOR USE PRESCRIPTION DEVICE STATEMENT PRECAUTIONS INTENSITIES AND CAPABILITIES sosnosereresernenesereresnsneneseseresnenenesesesesnenenesesesesnsnenesesesesnsnensnener 25 XA Indications For Uses cass X B Prescription DE ViCe 4 cesecssesecescsasaseaceseeeaeadddaciaaseasias eee NA eee eee ene eee X C Tissue Exposure To Ultrasound Energy se X D Ultrasonic Intensities r rnrrnononrvrvvrvrnonenevrsvererenenevvererenenenevrsreresenevevrersrasevevesssrevevenenessssesesene X E Biometric Measurement Capabilities roenrnnnrrrrrrnenerenenenrnerersrrererenenenenessrsrsesererenenenenesssser 26 X F Classification 26 X G Precautions X H EMI EMC Compliant 27 LIST OF FIGURES Figure III A DGH 55 Pachmate Front View ccccsssesesesesssseeesesesesesesesesesceeeeseseacaeaeeeseseeseseaeaeneeeeeeeeeeeeeeaeaes 3 Figure III B DGH 55 Pachmate Back View F
17. ge 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 it will require replacement PLUG IN PROBE This message occurs when 1 the detachable probe is not mated or is improperly mated to the rotator or 2 the probe is defective If the probe is found to be defective remove defective probe by holding the probe body and gently pulling straight out of rotator Cau tion Do not twist probe as this could damage connectors Properly align replacement probe to rotator and gently push in until properly seated POF 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 E for service 21 VIII VERIFYING PACHMATE CALIBRATION Pachymeter calibration is verified by using the electronic Calibration Verification Box CalBox that is supplied with the Pachmate see Figure III D 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 Calibrat
18. he 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 Pachmate Standard Features Simple to use Turn on power and the Pachmate 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 allows easy visibility Proven measurement algorithm which yields accurate reproducible measurements in a fraction of a second Ultra Portable Handheld battery operated lightweight and will fit easily into any lab coat or pocket Operator feedback Audible signal indicates when a valid measurement is complete Personalized configuration 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 Pachmate is turned off and the batteries are removed Built in IOP Correction Calculation capabilities to assist in glaucoma screening Detachable probe
19. he shelf life lifetime indicated for this device is 10 years IX F 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 24 model and serial number for the unit The model number is located on the back of the unit The serial number is located in the battery compartment This information can also be viewed on the display by pressing and holding the CFG key Manufactured By DGH TECHNOLOGY INC TECHNOLOGY INC 110 SUMMIT DRIVE i J SUMEB p 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 25 X INDICATIONS FOR USE PRESCRIPTION DEVICE STATEMENT PRECAUTIONS INTENSITIES AND CAPABILITIES X A Indications For Use The DGH 55 Handheld Pachymeter Pachmate is a handheld battery operated ultrason ic device that is used in the ophthalmic field for measuring the thickness of the human cornea X B Prescription Device The Pachmate is a prescription device and is to be used only by or
20. igure III C DGH 55 Pachmate Serial Number and Battery Orientation Label enrnononrvrrrvrvrerenenennnererner 5 Figure III D DGH 55 Pachmate Electronic CalBox c cccessssssssssssesesesesesesescececeseseseseneseseeceseseseaeaeneeeeneeseaeaeae 7 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 55 Handheld Pachymeter Pachmate 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 it 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 Pachmate was designed to provide a means of obtaining fast accurate corneal thickness measurements with a handheld battery operated instrument that is simple to use economical and ultra portable We invite you to read this manual carefully to dis cover how quickly and easily the Pachmate can be integrated into your practice I FEATURES The Pachmate is manufactured with high quality components that are designed and built using t
21. 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 previous screen Note The programmed correction values are based on a reference corneal thickness 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 To begin a new measurement sequence press the CLR key to erase all measure ments and re initialize the Pachmate Measurements are also erased from memory whenever the unit is turned off 19 VI B Obtaining Measurements With The Mapping Mode 1 Perform the Power Up Sequence as described in section IV 2 Rotate probe to desired position 3 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 Pachmate will automatically attempt to take a measurement 4 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 I sec After the delay expires the measurement will be stored the display will ad
22. ing CAUTION The probe should NEVER be autoclaved or subjected to intense heat As a gen eral rule the above cleaning instructions are sufficient to disinfect the probe in ordinary use Do not scratch or chip the conical probe tip which makes contact with the cornea IX B Transport and Storage Conditions The Pachmate 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 Pachmate should be operated between temperatures of 18 C to 40 C 23 IX D Warranty DGH Technology Inc DGH warrants each new DGH 55 and its accompanying acces sories 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 is not applicable to any defect that is the result of an accident misuse mis handling 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
23. ion 1 With the Pachmate turned off disconnect the probe by holding the probe body and gently pulling straight out of rotator Caution Do not twist probe as this could damage connectors and then connect the CalBox cable to the Pachmate Enter the CalBox mode by pressing and holding the DEL key and then press the Pachmate PWR key Press the CalBox POWER key until the LED lights up and the Pachmate will begin taking measurements If the LED fails to light or goes out before the test sequence has completed or if POOR APPLANATION is displayed then replace the 9V alkaline battery If no measurements are taken within 22 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 Pachmate Important You must exit CalBox mode before attempting corneal measurements 22 IX CARE AND MAINTENANCE IX A Cleaning And Disinfecting Instructions 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 us
24. lanated onto the cornea the unit will continue taking measurements until a predetermined number of measurements 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 Rotate the probe to the desired position 4 With the patient visualizing a fixation point position the tip of the probe onto the cornea Once the probe tip is aligned properly the Pachmate 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 5 For each measurement that is 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 OD Measurement Group Completed and then the display will look like the example below 18 Example 1 op Avg 25 540u Std Dev 0 3u
25. measurement 6 All measurements can be reviewed on the display by using the A or V keys A new measurement may be taken at any position by causing the appropriate position num ber to appear on the display and then retaking the new measurement Any measurement that is suspect may also be erased by pressing the DEL key 7 All measurements remain in memory until the CLR key is pressed or the Pachmate is turned off Press CLR key to erase all measurements and re initialize the Pach mate for a new measurement sequence starting at position 1 20 Vil PROBE QUALITY Whenever the Pachmate 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 A 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 is 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 Pachmate 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 messa
26. nal 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 I xe where I 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 the face of the probe to the 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 X E Biometric Measurement Capabilities The following table shows the measurement range for the DGH 55 Handheld Pachymeter Pachmate Measurement Option Range um Accuracy um Display Resolution um Standard Unit 200 1100 5 1 X F Classification According to the degree of protection against electric shock the Pachmate is classified as type BF equipment This classification is indicated by the symbol on the back of the unit 27 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 atmosphere Electrical shock hazard Do not open Refer s
27. nd the display will indicate OPERATIONAL MODE Continuous Avg 2 Press ENT key to continue in Continuous Avg mode or press the A or V 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 STD DEVIATION Enabled 11 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 A 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 A or V 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 A or V keys to select the total number of measurements from 1 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
28. ou 14 10 11 12 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 biased measurement Press ENT key to confirm your selection and the display will then in dicate GOOD MEAS DELAY 1 0 sec Use the A or V keys to select the time in seconds that the unit will wait before 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 A or V keys to select 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 A 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 CONTRAST 13 14 15 16 15 Use the A or V
29. ress 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 description of the proper method for obtaining measurements 13 V B Mapping Mode 1 Press the CFG key and the display will indicate OPERATIONAL MODE Continuous Avg 2 Use the A 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 3 Use the A 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 4 Use the A 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 5 Use the A or V 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 6 Use the A 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 7 Use the A or V keys to enable or disable the display of biased measurements If y
30. s CISPR Class B The DGH 55 Pachmate is suitable for use in all estab 11 lishments including domestic establishments and those Harmonic emissions NA directly connected to the public low voltage power sup ply network power supply that supplies buildings used IEC 61000 3 2 gt for domestic purposes Voltage fluctuations NA 29 Guidance and Manufacturer s Declaration Electromagnetic Immunity The DGH 55 Pachmate is intended for use in the electromagnetic environment specified below The cus tomer or the user of the DGH 55 Pachmate should assure that it is used in such an environment Immunity test IEC60601 test Compliance Electromagnetic environment guidance level level Electrostatic 6kV Contact Complies Floors should be wood concrete or ceramic discharge ESD 8KV Air tile If floors are covered with synthetic material IEC 61000 4 2 the relative humidity should be at least 30 Radiated RF 3 V m 80MHz Complies The DGH 55 Pachmate complies with require IEC 61000 4 3 to 2 5GHz E1 3V m ments however a separation distance from mobile RF communications should be main tained based on the following calculations d Big 80MHz 800MHz 1 d FAG 800MHz 2 5GHz 1 where 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
31. s ready to take corneal measurements It is not necessary to setup or configure anything However the Pachmate 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 Pachmate 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 Pachmate 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 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 Pachmate V A Continuous Average Mode Factory Default Mode 1 Press the CFG key a
32. 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 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 5 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 quirements as defined by the operator Refer to the beginning of this section for instructions on changing the percentage that determines the biased
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