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DGH Pachette 2 Operator's Manual

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DGH Technology, Inc.
110 Summit Drive; Suite B
Exton, PA 19341
TECHNOLOGY, INC.
DGH 550 (PACHETTE 2)
ULTRASONIC PACHYMETER
OPERATOR'S MANUAL
www.pachymeter.com
www.dghkoi.com
SYS.PA52
REV. 06/2003
Sales: (800) 722-3883
Phone: (610) 594-9100
Fax:
(610) 594-0390

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  • Page 1 TECHNOLOGY, INC. DGH 550 (PACHETTE 2) ULTRASONIC PACHYMETER OPERATOR’S MANUAL SYS.PA52 REV. 06/2003 DGH Technology, Inc. Sales: (800) 722-3883 www.pachymeter.com 110 Summit Drive; Suite B Phone: (610) 594-9100 www.dghkoi.com Exton, PA 19341 Fax: (610) 594-0390...

  • Page 3: Table Of Contents

    CONFIGURING THE PACHETTE 2 ......................8 OBTAINING PACHYMETRY MEASUREMENTS ................12 VII. PROBE QUALITY .............................14 VIII. VERIFYING PACHETTE 2 CALIBRATION ..................15 OPTIONAL FEATURES FOR THE PACHETTE 2................16 IX.A. Mapping Mode Option ........................16 IX.B. FLAP Option ............................20 IX.C. Printer Interface Option........................20 IX.D. Data Transfer Interface Option......................24 IX.E.
  • Page 4 Figure III-B DGH 550 Back Panel..........................5 Figure III-C Electronic CalBox ............................6 Figure XII-A Wiring diagram for the SII DPU-414 printer interface cable..............36 Figure XII-B Wiring diagram for a typical PC interface cable.................36 Figure XIII-A Format of data stream sent by Pachette 2..................37...

  • Page 5: 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 550 (Pachette 2) 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: •...

  • Page 6: Features

    The following features are just a sample of the characteristics and capabilities of the Pachette 2. Standard Features • Simple to use. Turn on power and the Pachette 2 is ready to take measurements. • Automatic measurement mode for operation without a foot switch. •...

  • Page 7: General Description

    CLEAR ENTER PROBE IR PORT POWER Figure III-A DGH 550 Front Panel. LCD Display Large 16 x 2 character display used to present measurement data and/or configuration parameters to the operator. Keys Used to review measurements or to program options and numerical values presented on the display.
  • Page 8 Infrared port that can be used for wireless transfer of pachymetry data to another device that is IrDA compatible. (This feature is optional) Power switch Pressing “1” side of switch turns the Pachette 2 on. Pressing “0” side of switch turns the Pachette 2 off.

  • Page 9: Figure Iii-B Dgh 550 Back Panel

    250V MARKED 0.3A DGH 2003 DGH-550BPLCE Figure III-B DGH 550 Back Panel. Fuse Holder Location of AC input fuse(s). If a fuse needs replacing, always replace the fuse as marked. Model & Serial Numbers Location of model and serial numbers used to identify the unit CE Certification Marks These marks are used to identify CE certified units.

  • Page 10: Figure Iii-C Electronic Calbox

    100µm) All values are based on a corneal velocity of 1640m/s and should be within ±5µm. If any measurements are out of tolerance, contact DGH Technology, Inc. Important! Before taking any corneal measurements, re-connect the probe and exit the CalBox mode by...

  • Page 11: Power-Up Sequence

    Avg of Std Dev = 0.0u The Pachette 2 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.

  • Page 12: Configuring The Pachette 2

    It is not necessary to setup or configure anything. The operator only needs to connect the probe to the front panel and then apply power to the unit. However, the Pachette 2 has been designed to allow the operator to modify certain default parameters to tailor the instrument to meet one’s needs.
  • Page 13 STD DEVIATION Enabled Use the ↑ or ↓ keys to enable or disable standard deviation. Press the ENTER key to confirm your selection and the display will then indicate: NUMB OF MEAS Use the ↑ or ↓ keys to select the total number of measurements that you wish to obtain.
  • Page 14 Pachymetry measurements may now be taken. Refer to section VI for a detailed description of the proper method for obtaining measurements.
  • Page 15 Table 1 Parameters On The Configuration Menu And Associated Options Parameter Associated Range Description [ default value ] Option(s) Continuous Avg Selects how the Pachette 2 should operate. Continuous OPERATIONAL MODE Mapping Continuous Avg = multiple measurements at a single Avg with [ Continuous Avg ] Mapping location.

  • Page 16: Obtaining Pachymetry Measurements

    VI. OBTAINING PACHYMETRY MEASUREMENTS The Pachette 2 does not require a foot 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.
  • Page 17 Avg of 25 = 540u Std Dev = 0.3u Note: In example #1, the Pachette 2 was pre-configured to obtain 25 measurements with standard deviation enabled. See section V for configuration details. If standard deviation is disabled the display will look like example #2:...

  • Page 18: Probe Quality

    If the probe quality is satisfactory, the Pachette 2 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 be displayed on the front panel.

  • Page 19: Verifying Pachette 2 Calibration

    1. With the Pachette 2 turned off, connect the probe to the front panel. 2. Enter the CalBox mode by holding in the ↑ key and turning on the Pachette 2. 3. After power-up is completed, the display will indicate “CALBOX MODE” on the top line and “#1 = 0u”...

  • Page 20: Optional Features For The Pachette 2

    IX. OPTIONAL FEATURES FOR THE PACHETTE 2 The Pachette 2 has been designed as an economical and easy to use instrument. A basic unit contains a variety of features that the operator will find useful when obtaining pachymetry measurements. To further enhance the functionality of the Pachette 2, DGH Technology, Inc.
  • Page 21 This can be achieved with the help of corneal thickness charts, which are available upon request from DGH Technology, Inc. Configuring The Mapping Mode Option A complete list of all configurable parameters for the mapping mode option is given in Table 2.
  • Page 22 Press ENTER to confirm your selection. At this point, the Pachette 2 will either exit the configuration menu or advance to the next configurable parameter. More parameters will only be available if other options have been installed.
  • Page 23 With the patient in supine position and visualizing a fixation spot on the ceiling, 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 2 will automatically attempt to take a measurement.

  • Page 24: Ix.b. Flap Option

    This option allows corneal measurements as thin as 95 microns to be obtained. When the FLAP option is installed, the Pachette 2 operates exactly the same way as it did without the option. The only difference is that the unit is now capable of taking thinner measurements.
  • Page 25 RS232C. Refer to appendix A for a technical description of the RS232C interface as it relates to the Pachette 2. Once the printer interface is installed, a serial printer and interface cable must also be purchased before a hardcopy of pachymetry data can be obtained.
  • Page 26 “Disabled” in step 4, and then press ENTER . Use the ↑ or ↓ keys, if necessary, to select a baud rate for the Pachette 2 that matches the baud rate of the printer (9600 is the default setting for the SII DPU- 414 printer).
  • Page 27 ON LINE button. Obtain pachymetry measurements as described in section VI. Initiate the printout by pressing the DATA XFER key on the Pachette 2 front panel. During the printout, the Pachette 2 display will indicate “PLEASE WAIT”.

  • Page 28: Ix.d. Data Transfer Interface Option

    PC, as well as what the operator intends to do with the data transferred from the Pachette 2. All information required by a programmer to determine the format of the data sent by the Pachette 2 is given in appendix B.
  • Page 29 “Disabled” in step 4, and then press ENTER . Use the ↑ or ↓ keys, if necessary, to select a baud rate for the Pachette 2 (9600 is the default setting) that matches the baud rate of the computer interface.

  • Page 30: Ix.e. Irda Interface Option

    COM port). Note: If the computer is to be mated to the Pachette 2 for extended periods of time, it is recommended that the “D-Type” connectors be secured to the computer and the Pachette 2 by using the (2) screws on each connector.

  • Page 31: Care And Maintenance

    Do not scratch or chip the conical probe tip, which makes contact with the cornea. X.B. Transport and Storage Conditions The Pachette 2 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.

  • Page 32: Warranty

    DGH does not, under any circumstances, assume any responsibility for the loss of time, inconvenience or other consequential damages, including but not limited to, loss or damage of personal property, or loss of revenue. DGH has neither assumed nor authorized any other person (including any distributor authorized to sell its Equipment) to assume for it any other liability in the connection with the sale of Equipment.
  • Page 33 When contacting us, please provide the model and serial number for the unit. These numbers are located on the back panel. DGH Technology, Inc. TECHNOLOGY, INC. 110 Summit Drive, Suite B Exton, PA 19341...

  • Page 34: Important Notes

    IMPORTANT NOTES XI.A. Prescription Device The Pachette 2 is a prescription device and is to be used only by or under the supervision of a licensed physician. XI.B. Tissue Exposure To Ultrasound Energy The ultrasound energy emitted by the Pachette 2 is low intensity and will have no adverse effects on the patient and/or operator.

  • Page 35: Xi.d. Biometric Measurement Capabilities

    ± 5 Extended Option 200 - 2000 XI.E. Classification According to the degree of protection against electric shock, the Pachette 2 is classified as type B equipment. On CE units this is indicated by the symbol on the back panel.

  • Page 36: Xi.f. Emi / Emc Compliance (Ce Units Only)

    XI.F. EMI / EMC Compliance (CE Units Only) The Electro Magnetic Interference and Compatibility testing of the DGH 550 Ultrasonic Pachymeter (Pachette 2) 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).
  • Page 37 IEC 61000-4-11:1994 Voltage Dips and Interrupts The system complied with the radiated and conducted immunity requirements throughout the test.

  • Page 38: Appendix Ars232C Hardware Interface

    Pachette 2. An RS232C standard serial interface is provided for the printer and data transfer options. A 25-pin D-Type female connector is located on the rear panel of the Pachette 2. This connector has the following pin out assignment.
  • Page 39 For reference, the wiring diagrams for both of these cables are given in Figure XII-A and Figure XII-B. Note: If a printer other than the SII DPU-414 is used with the Pachette 2, or if the Pachette 2 is interfaced to a personal computer that uses a non-standard RS232C port,...

  • Page 40: Figure Xii-A Wiring Diagram For The Sii Dpu-414 Printer Interface Cable

    DB 9 MALE FEMALE SGND PIN 6 PIN 4 DGH 550 SII DPU-414 SII DPU-414 PACHETTE 2 PRINTER CABLE PRINTER Figure XII-A Wiring diagram for the SII DPU-414 printer interface cable. DB 25 DB 25 FEMALE MALE FGND DB 9...

  • Page 41: Appendix Bdata Transfer Format

    When the data transfer interface is implemented, a specific data format is used to transfer data from the Pachette 2 to a personal computer. This appendix provides the necessary information for a programmer to interpret and utilize the data stream sent by the Pachette 2.

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Dgh 550

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