DGH Pachette 2 User manual

TECHNOLOGY, INC.

DGH 550 (PACHETTE 2)

ULTRASONIC PACHYMETER

OPERATOR’S MANUAL

SYS.PA52 REV. 06/2003

DGH Technology, Inc. Sales: (800) 722-3883

110 Summit Drive; Suite B www.pachymeter.com Phone: (610) 594-9100

Exton, PA 19341 www.dghkoi.com Fax: (610) 594-0390

TABLE OF CONTENTS

I. INTRODUCTION.........................................................................................................................................1

II. FEATURES ...................................................................................................................................................2

III. GENERAL DESCRIPTION ........................................................................................................................3

IV. POWER-UP SEQUENCE............................................................................................................................7

V. CONFIGURING THE PACHETTE 2........................................................................................................8

VI. OBTAINING PACHYMETRY MEASUREMENTS ..............................................................................12

VII. PROBE QUALITY .....................................................................................................................................14

VIII. VERIFYING PACHETTE 2 CALIBRATION ........................................................................................15

IX. 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. IrDA Interface Option......................................................................................................................26

X. CARE AND MAINTENANCE..................................................................................................................27

X.A. Cleaning Instructions........................................................................................................................27

X.B. Transport and Storage Conditions....................................................................................................27

X.C. Operating Conditions .......................................................................................................................27

X.D. Warranty...........................................................................................................................................28

X.E. Service..............................................................................................................................................28

XI. IMPORTANT NOTES ...............................................................................................................................30

XI.A. Prescription Device ..........................................................................................................................30

XI.B. Tissue Exposure To Ultrasound Energy...........................................................................................30

XI.C. Ultrasonic Intensities........................................................................................................................30

XI.D. Biometric Measurement Capabilities ...............................................................................................31

XI.E. Classification....................................................................................................................................31

XI.F. EMI / EMC Compliance (CE Units Only) .......................................................................................32

XII. APPENDIX A RS232C HARDWARE INTERFACE...........................................................34

XIII. APPENDIX B DATA TRANSFER FORMAT......................................................................37

LIST OF FIGURES

Figure III-A DGH 550 Front Panel. ............................................................................................................................3

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

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 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:

• 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 and glaucoma screening, Lasik flap measurement, corneal edema

check for extended wear contact lens patients, and pre-operative data for intrastromal

ring implantation and radial/arcuate keratotomy.

The Pachette 2 was designed to provide a means of obtaining fast, accurate, corneal

thickness measurements with an 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 Pachette 2 can be integrated into your practice.

II. FEATURES

The Pachette 2 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 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.

• Rapidly obtains and stores up to 50 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.

• Large 16 x 2 LCD character display allows easy visibility from a distance over a

large viewing angle and in all lighting conditions.

• Proven measurement algorithm which yields accurate, reproducible measurements

in a fraction of a second.

• Ultra-Portable. Compact and light weight to allow easy transfer from the office to

the hospital. Adjustable tilt stand/handle for ease of viewing.

• Operator feedback. Audible signal indicates when a valid measurement is complete.

• Personalized configuration. User-friendly front panel 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

2 is turned off.

Optional Features

• FLAP option for measuring Lasik flaps as thin as 95 microns.

• Printer interface for sending pachymetry data to a serial printer.

• Data transfer interface for sending pachymetry data to a personal computer.

• IrDA interface for sending pachymetry data to other IrDA compatible devices.

III. GENERAL DESCRIPTION

Front Panel

TECHNOLOGY, INC.

ULTRASONIC PACHYMETER

PACHETTE

PROBE POWER

DELETE

MEAS

CLEAR

DATA

XFER

CONFIG

ENTER

41 2 3 5 6

IR PORT

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. The key is also used to enter the CalBox mode which

permits the operator to verify calibration of the pachymeter.

“CLEAR” Key

This key is used to erase all obtained measurements whenever it is desired to

begin a new measurement sequence. Also used to exit the CalBox mode or to exit

the configuration menu.

“DELETE MEAS” Key

Used to erase a single measurement from a group of measurements.

“DATA XFER” Key

When a data transfer option is installed, this key is used to transfer

pachymetry data to a printer or a computer.

“CONFIG/ENTER” Key

This key is used to activate the configuration menu for the purpose of

changing configuration parameters. After the menu has been activated, the /

keys can be used to select the desired value for the current configuration

parameter. Parameters values are then chosen by pressing ENTER.

Probe Connector

Front panel connector which mates to the connector on the Probe cable.

Infrared Port

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.

Back Panel

FOR PROFESSIONAL USE ONLY.

EXPLOSION HAZARD. DO NOT USE IN PRESENCE OF FLAMMABLE

ANESTHETICS, GASES OR OXYGEN-RICH ATMOSPHERE.

DANGER:

PACHETTE

110 SUMMIT DRIVE

SUITE B

EXTON, PA 19341

USA (610) 594-9100

DGH 2003 DGH-550BPLCE

INPUT

100-240V~

50/60Hz

0.3A

REPLACE

FUSES

MARKED

T0.5A

250V

Model-DGH 550

SN-XXXXX

0459

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. (CE certification is optional)

Calibration Standard

To check Pachymeter calibration, an electronic 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.

TECHNOL OGY, INC.

DGH 550 CALIBRATION BOX

OPERATING INSTRUCTIONS

1. With the turned off, connect the probe to

the front panel.

2. Enter the CalBox mode by holding in the switch

and turning on the .

3. After power-up is completed, the display will indicate

“CALBOX MODE” on the top line and #1 = 0u” on the

bottom line.

4. Disconnect the probe and connect the CalBox to the

5. Press the CalBox button until the power LED lights, and

the will begin taking measurements.

If the LED fails to light or goes out before the test

sequence i s complet ed, or if “P O OR APPLANATION” is

displayed, replace the 9V alkaline battery.

If no measurements are taken within 2½ minutes after

the C alBox button is pressed , the CalBox will turn off.

6. Observe actual measurement values of 200

7. Before ta king any corneal measurements,

re-connect the probe and exit the CalBox mode by

pressing .

Pachette 2

“

Important!

CLEAR

µm thru

1000µm in steps of 100µm. (Unitswith FLAP option start

at 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.

PACHETTE

Figure III-C Electronic CalBox

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