DGH 55 Pachmate Operators Manual Rev 2

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TABLE OF CONTENTS I.

INTRODUCTION ... 1

II.

FEATURES... 2

III.

GENERAL DESCRIPTION ... 3

IV.

POWER-UP SEQUENCE ... 8

V.

CONFIGURING THE PACHMATE ... 10 V.A. V.B.

VI.

Continuous Average Mode (Factory Default Mode) ... 10 Mapping Mode ... 13

OBTAINING PACHYMETRY MEASUREMENTS ... 17 VI.A. VI.B.

Obtaining Measurements With Continuous Average Mode ... 17 Obtaining Measurements With The Mapping Mode ... 19

VII.

PROBE QUALITY ... 20

VIII.

VERIFYING PACHMATE CALIBRATION ... 21

IX.

CARE AND MAINTENANCE ... 22 IX.A. IX.B. IX.C. IX.D. IX.E. IX.F.

X.

Cleaning And Disinfecting Instructions ... 22 Transport and Storage Conditions ... 22 Operating Conditions ... 22 Warranty ... 23 Lifetime / Shelf-life ... 23 Service ... 23

INDICATIONS FOR USE, PRESCRIPTION DEVICE STATEMENT, PRECAUTIONS, INTENSITIES AND CAPABILITIES ... 25 X.A. X.B. X.C. X.D. X.E. X.F. X.G. X.H.

Indications For Use ... 25 Prescription Device ... 25 Tissue Exposure To Ultrasound Energy ... 25 Ultrasonic Intensities ... 25 Biometric Measurement Capabilities ... 26 Classification ... 26 Precautions ... 27 EMI / EMC Compliance ... 27

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LIST OF FIGURES Figure III-A DGH 55 Pachmate Front View. ... 3 Figure III-B DGH 55 Pachmate Back View. ... 5 Figure III-C DGH 55 Pachmate Serial Number and Battery Orientation Label ... 5 Figure III-D DGH 55 Pachmate Electronic CalBox ... 7

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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 corneal 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 patients. 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 discover how quickly and easily the Pachmate can be integrated into your practice.

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II.

FEATURES

The Pachmate is manufactured with high quality components that are designed and built using the latest technological concepts. The result is an advanced and powerful pachymeter 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 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.

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III. GENERAL DESCRIPTION Front View

Figure III-A DGH 55 Pachmate Front View.

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Detachable Probe Probe can be easily removed for cleaning or replacement.

2

LCD Display 16 x 2 character display used to present measurement data and/or configuration parameters 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.

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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.

4 6

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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). OS Key Press key to review or take measurements of the LEFT eye. NOTE: Key is used only when the unit is configured for the bilateral mode.

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/ Keys Used to review measurements or to program options and numerical values presented on the display.

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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.

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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.

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Back View 2

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3

Figure III-B DGH 55 Pachmate Back View.

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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 1.5V

RO3 UM4

+

+

AAA 1.5V

RO3 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.

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Classification and Attention Symbols This symbol indicates the degree of protection against electric shock. The Pachmate is classified as type BF equipment.

!

0120

This symbol cautions the operator to read the operating manual.

This mark indicates 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 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.

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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.

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 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

POWER

Model DGH 55

Figure III-D DGH 55 Pachmate Electronic CalBox

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IV. POWER-UP SEQUENCE 1.

Install two (2) AAA batteries (See inside battery compartment for battery orientation). 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 Instructions)

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 6.

F

When the power-up sequence is finished, the display will indicate: OD

Avg 0 = 0µ µ Std Dv = 0.0µ µ

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 description of the proper method for obtaining measurements. During use, the Pachmate 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: OD

Avg 0 = 0µ µ Std Dv = 0.0µ µ

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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 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 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 indicated: OD

Avg 0 = 0µ µ Std Dv = 0.0µ µ

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 internal test, display battery status, and then the display will indicate:

Clear All Meas? ↑ = Yes ↓ = No Press the

key to clear all measurements.

Press the

key to retrieve all measurements.

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V. CONFIGURING THE PACHMATE Configuration Overview When shipped from the factory, the Pachmate is ready to take corneal measurements. It is not necessary to setup or configure anything. However, the Pachmate has been designed 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 nonvolatile 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. 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 and the display will indicate:

OPERATIONAL MODE Continuous Avg 2.

Press ENT key to continue in Continuous Avg mode or press the or 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

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3.

Use the or keys to enable or disable standard deviation. Press the ENT key to confirm your selection and the display will then indicate:

BILATERAL MODE Enabled 4.

Use the or keys to enable or disable bilateral mode. Press the ENT key to confirm your selection and the display will then indicate:

AUTO SWITCH OD/OS Enabled 5.

Use the or 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 6.

Use the or 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 7.

Use the or 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 indicate:

AUTO REP DELAY <50 msec 8.

Use the or 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 selection and the display will then indicate:

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DELAY TO STANDBY 1.0 min 9.

Use the or 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 measurements are attempted. Press the ENT key to confirm your selection and the display will then indicate:

BATTERY TYPE Rechargeable 10. Use the or keys to select battery type, Alkaline or Rechargeable. Press the ENT key to confirm your selection and the display will then indicate:

CONTRAST

11. Use the or keys to select the desired display contrast. Press the ENT key to confirm your selection and the display will then indicate:

VOLUME

12. Use the

or

keys to select the desired alarm volume.

13. 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 display will read “Config Not Changed” and return to measurement mode. If you changed any parameter the display will indicate:

Save New Config? ↑ = Yes ↓ = No Press press

to save changes and return to measurement mode using new parameters, or to restore previous configuration and return to measurement mode.

Note: You can press the CFG key at any time to exit the configuration mode. 14. Pachymetry measurements may now be taken. Refer to section VI for a detailed description of the proper method for obtaining measurements.

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V.B. Mapping Mode 1.

Press the CFG key and the display will indicate:

OPERATIONAL MODE Continuous Avg 2.

Use the or keys to change the operational mode from Continuous Avg to Mapping. Press the ENT key to confirm your selection and the display will then indicate:

BILATERAL MODE Enabled 3.

Use the or keys to enable or disable bilateral mode. Press the ENT key to confirm your selection and the display will then indicate:

AUTO SWITCH OD/OS Enabled 4.

Use the or 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 or 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 or 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

or

keys to enable or disable the display of biased measurements (If you

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choose to disable this feature press ENT and go to step 9). Press ENT key to confirm your selection and the display will then indicate:

AMOUNT OF BIAS 100% 8.

Use the or 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 indicate:

GOOD MEAS DELAY 1.0 sec 9.

Use the or 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 10. Use the or 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 11. Use the or 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 measurements are attempted. Press the ENT key to confirm your selection and the display will then indicate:

BATTERY TYPE Rechargeable 12. Use the or keys to select battery type, Alkaline or Rechargeable. Press the ENT key to confirm your selection and the display will then indicate:

CONTRAST

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13. Use the or keys to select the desired display contrast. Press the ENT key to confirm your selection and the display will then indicate:

VOLUME

14. Use the

or

keys to select the desired alarm volume.

15. 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 display will read “Config Not Changed” and return to measurement mode. If you changed any parameter the display will indicate:

Save New Config? ↑ = Yes ↓ = No Press press

to save changes and return to measurement mode using new parameters, or to restore previous configuration and return to measurement mode.

Note: You can press the CFG key at any time to exit the configuration mode. 16. 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.

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Table 1 Parameters On The Configuration Menu And Associated Modes Parameter [ default value ]

Range

Description

OPERATIONAL MODE [ Continuous Avg ]

Continuous Avg Mapping

Selects how the Pachmate should operate. Continuous Avg = multiple measurements at a single location. Mapping = single measurement at different positions.

Continuous Avg, Mapping

STD. DEVIATION

Enabled Disabled

Enables or Disables the presentation of standard deviation on the display.

Continuous Avg

[Enabled]

Enables or disables the Bilateral Mode which allows the unit to measure and display results for both eyes.

Continuous Avg, Mapping

Enables or Disables the ability for the unit to, after all measurements are taken, automatically switch to the other eye.

Continuous Avg, Mapping with Bilateral Mode

BILATERAL MODE

Enabled

[ Enabled ]

Disabled

Associated Mode(s)

AUTO SWTCH OD/OS

Enabled

[ Enabled ]

Disabled

OD/OS SWITCH DLY

1 to 9.5

Period of time, after all measurements are taken, before the unit will automatically switch to the other eye.

Continuous Avg, Mapping with Bilateral Mode

1 to 25

Selects the number of measurements to be obtained.

Continuous Avg

[ 4.0 sec ] NUMB OF MEAS [ 25 ] AUTO REP DELAY [ <50 msec ]

<50 to 950

Period of time between consecutive measurements while probe is applanated to the cornea.

Continuous Avg

DELAY TO STANDBY

0.5 to 9.5

Period of time before unit switches from Measurement mode to Standby mode.

Continuous Avg. Mapping

1 to 33

Selects the number of positions to be measured.

Mapping

DISP BIAS MEAS Disabled

Enabled Disabled

Enables or disables the display of the biased measurements.

Mapping

AMOUNT OF BIAS

1 to 199

Selects the percentage used to calculate biased measurements.

Mapping

GOOD MEAS DELAY [ 1.0 sec ]

1.0 to 9.5

Period of time before the unit will automatically store the current measurement and advance to the next measurement position.

Mapping

POOR APPL DELAY

1.0 to 9.5

Period of time after a poor applanation occurs before the unit will automatically advance to the next measurement position

Mapping

Alkaline Rechargeable

Choose the type of battery being used. NOTE: Use only Alkaline or NiMH Batteries.

Continuous Avg, Mapping

Adjusts display contrast for desired viewing

Continuous Avg,

1.0 min NUMB OF POSN [ 33 ]

[ 100% ]

[ 2.0 sec ] BATTERY TYPE [Rechargeable] CONTRAST

1 to 14

[ 7 Segments ]

segments

VOLUME [ 7 Segments ]

1 to 14 segments

Mapping Adjusts alarm volume to desired level

Continuous Avg, Mapping

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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 Average 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 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: