DGH TECHNOLOGY PACHETTE 500 Manual de usuario

DGH 500 (PACHETTE

™

)

ULTRASONIC PACHYMETER

OPERATOR’S MANUAL

TECHNOLOGY, INC.

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

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

Exton, PA 19341 Fax: (610) 594-0390

SYS.PA5 REV. 05/2000

TABLE OF CONTENTS

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

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

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

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

V. CONFIGURING THE PACHETTE™........................................................................................................8

VI. OBTAINING PACHYMETRY MEASUREMENTS ..............................................................................11

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

VIII. VERIFYING PACHETTE™CALIBRATION ........................................................................................15

IX. OPTIONAL FEATURES FOR THE PACHETTE™...............................................................................16

IX.A. Automatic Measurement Mode Option............................................................................................16

IX.B. Measurement Averaging Option ......................................................................................................18

IX.C. Printer Interface Option....................................................................................................................20

IX.D. Data Transfer Interface Option.........................................................................................................23

IX.E. Remote Control Interface Option.....................................................................................................25

X. CARE AND MAINTENANCE..................................................................................................................29

X.A. Cleaning Instructions........................................................................................................................29

X.B. Transport and Storage Conditions....................................................................................................29

X.C. Operating Conditions .......................................................................................................................29

X.D. Warranty...........................................................................................................................................30

X.E. Service..............................................................................................................................................30

XI. IMPORTANT NOTES ...............................................................................................................................32

XI.A. Prescription Device ..........................................................................................................................32

XI.B. Tissue Exposure To Ultrasound Energy...........................................................................................32

XI.C. Ultrasonic Intensities........................................................................................................................32

XI.D. Biometric Measurement Capabilities ...............................................................................................33

XI.E. Classification....................................................................................................................................33

XI.F. EMI / EMC Compliance (CE Units Only) .......................................................................................34

XII. APPENDIX A RS232C HARDWARE INTERFACE.....................................................................35

XIII. APPENDIX B DATA TRANSFER FORMAT...............................................................................38

XIV. APPENDIX C REMOTE CONTROL COMMANDS FORMAT ................................................39

LIST OF FIGURES

Figure III-A DGH 500 Front Panel Layout...........................................................................................................3

Figure III-B DGH 500 Back Panel Layout. ..........................................................................................................5

Figure III-C Electronic CALBOX.........................................................................................................................6

Figure XIII-A Format of data stream sent by Pachette™. ......................................................................................38

Figure XIV-A Format of remote control commands..............................................................................................39

Figure XIV-B Format of data responses to remote control commands..................................................................40

Figure XIV-C Status Byte Format..........................................................................................................................41

I. INTRODUCTION

Ultrasonic Pachymetry is an integral part of refractive corneal surgery. The DGH 500

(Pachette™) 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

After the corneal thickness has been obtained, the measurement may be used in different

ways. For example, the measurement may be used to determine the appropriate blade

depth when making partial thickness corneal incisions during radial keratotomy, or to

evaluate abnormalities in corneal function causing changes in the corneal thickness, or to

evaluate changes in corneal thickness due to various treatment modes including contact

lenses and various surgical treatments.

The Pachette™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™can be integrated into your practice.

II. FEATURES

The Pachette™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™.

Standard Features

•Simple to use. Turn on power and the Pachette™is ready to take measurements.

•Automatically stores up to 33 measurements.

•Simultaneously displays actual and biased measurements by position location.

•Large ½ inch LED character displays allow 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.

•Dual position foot switch for initiating measurements and memory storage.

•Personalized configuration. User-friendly front panel allows selection of number of

positions to be measured, speed of sound used to calculate corneal thickness, and type

and amount of bias based on incision depth factor.

•Configuration memory. Once personally configured for the operator, non-volatile

memory provides permanent storage of configuration data, even when the Pachette™

is turned off.

Optional Features

•Automatic measurement mode for operation without a foot switch.

•Measurement averaging of corneal positions designated by the operator.

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

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

•Remote control interface for operating the Pachette™from a personal computer.

III. GENERAL DESCRIPTION

Front Panel

ULTRASONIC PACHYMETER

PQT

CLEAR

PROBE

POWER

PACHETTE

POSITION

CTUAL DATA

BIASED DATA

TECHNOLOGY, INC.

41 2 3 5

6 7

PQT / Clear Switch

PQT – Performs a Probe Quality Test when pressed and released. Used to

initiate the main configuration mode when pressed and held.

Clear – Used to clear all measurements from memory and re-initiate measurements

at position 1 when pressed and released. If the printer interface option is installed, a

print out will also be initiated. Used to initiate the velocity configuration mode when

pressed and held.

/ Switch

Used to program options and numerical values presented on the displays.

Position Display

A 2-character LED display used to correlate a given measurement with a

specific location on the cornea. It is the operator’s responsibility to maintain a record

Figure III-A DGH 500 Front Panel Layout.

of the position number to the actual corneal location. This record may be maintained

on a chart such as the “Cornel Thickness Chart” supplied with each Pachette™. This

display is also used to present setup information to the operator when configuring

the Pachette™.

Actual Data Display

A 4-character LED display used to present corneal thickness measurements to

the operator. All measurements are given in microns (µm) and are based on a

corneal velocity of 1640m/s unless the operator changes the velocity. This display is

also used to present setup information to the operator when configuring the

Pachette™.

Power Switch

Pressing “1” side of switch turns the Pachette™on. Pressing “0” side of switch

turns the Pachette™off.

Probe Interface

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

Biased Data Display

A 4-character LED display used to present biased corneal measurements to the

operator. All biased measurements are given in microns (µm) and are based on a

corneal velocity of 1640m/s unless the operator changes the velocity. The bias can

be either a percentage (1-199%) of the actual measurement or a fixed offset (±1-

199µm). This display is also used to present setup information to the operator when

configuring the Pachette™.

Back Panel

Pachette

Model-DGH 500

SN-3048

110 SUMMIT DRIVE

SUITE B

EXTON, PA 19341

USA (610) 594-9100

FOR PROFESSIONAL USE ONLY.

DANGER:

EXPLOSION HAZARD. DO NOT USE IN PRESENCE OF FLAMMABLE

ANESTHETICS, GASES OR OXYGEN-RICH ATMOSPHERE.

DGH 1999 DGH-500BPLCE

INPUT

100-240V~

50/60Hz

0.3A

REPLACE

FUSES

MARKED

T0.5A

250V

0459

12 34

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.

Foot Pedal Interface

Phone jack that accepts the phone plug attached to the end of the foot pedal cable.

CE Certification Marks

These marks are used to identify CE certified units. (CE certification is optional)

Figure III-B DGH 500 Back Panel Layout.

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.

TECHNOLOGY, INC.

DGH 500 PACHETTE™CALIBRATION BOX

OPERATING INSTRUCTIONS

1. With Pachette turned off, connect probe to front panel.

2. Enter the Demo mode by holding in the switch and

turning on the Pachette.

3. Afterpower-upiscompleted,thedisplaywillindicate:

Positon = 1 Actual Data = 0 Biased Data = 0

4. Disconnect probe and connect CalBox to the Pachette.

5. PressCalBoxbuttonuntilpowerLEDlights.

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

sequence is completed, or if “POORAPPL” is displayed,

replacethe9Valkalinebattery.

If no measurements are taken within 2½ minutes after

the CalBox button is pressed, the CalBoxwill turnoff.

6. If“Auto Mode” is enabled, the Pachete willbegin taking

measurements. If “Auto Mode” is not enabled, then use

thefootpedaltotakemeasurements.

7. Observe actual measurement values of 200

8. Before taking any corneal measurements,

re-connect the probe and exit the Demo mode by

pressing andthenpress .

Important!

CLEAR PQT

µm thru

1000µm in steps of 100µm. (ALKunits start at 100µm)

All values are based on a corneal velocity of 1640m/s

and should be within ± 5µm. If any measurements are

outoftolerance,contactDGHTechnology,Inc.

Figure III-C Electronic CALBOX

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