DGH PACHETTE 4 Manuel utilisateur

Page 1 of 92 DGH 555B-INS-OMENG Rev: 3

DGH 555B (PACHETTE 4)

ULTRASONIC PACHYMETER

OPERATOR’S MANUAL

For Use with Firmware v3.0.x

And DGH Connect Software v1.1.x

Equipment Manufactured By Authorized Representative

0120

Pachette

DGH 555B

Molenstraat 15

2513 BH, The H ague

The Netherlands

Phone: +31.70.345.8570

EC REP

EMERGO EUROPEDGH TECHNOLOGY, INC.

110 SUMMIT DRIVE

SUITE B

EXTON, PA 19341

USA (610) 594-9100

Molenstraat 15

2513 BH, The Hague

The Netherlands

Phone: +31.70.345.8570

EC REP

EMERGO EUROPEDGH TECHNOLOGY, INC.

110 SUMMIT DRIVE

SUITE B

EXTON, PA 19341

USA (610) 594-9100

Molenstraat 15

2513 BH, The Hague

The Netherlands

Phone: +31.70.345.8570

EC REP

EMERGO EUROPEDGH TECHNOLOGY, INC.

110 SUMMIT DRIVE

SUITE B

EXTON, PA 19341

USA (610) 594-9100

Prinsessegracht 20

2514 AP, The Hague

The Netherlands

Page 2 of 92 DGH 555B-INS-OMENG Rev: 3

Table of Contents

TABLE OF CONTENTS............................................................................................................................................2

1. INTRODUCTION, CLASSIFICATION AND INDICATIONS FOR USE..................................................5

1.1 GENERAL DEVICE DESCRIPTION ......................................................................................................................5

1.2 DEVICE CLASSIFICATION .................................................................................................................................5

1.3 INDICATIONS FOR USE .....................................................................................................................................5

2. DESCRIPTION OF SYMBOLS.......................................................................................................................6

3. GENERAL CAUTIONS AND WARNINGS, PRESCRIPTION DEVICE STATEMENT AND

OPERATOR QUALIFICATIONS...................................................................................................................7

3.1 GENERAL CAUTIONS AND WARNINGS..............................................................................................................7

3.2 PRESCRIPTION DEVICE STATEMENT.................................................................................................................7

3.3 OPERATOR QUALIFICATIONS............................................................................................................................7

4. USE OF ULTRASOUND IN OPHTHALMIC MEASUREMENT ...............................................................8

4.1 INTRODUCTION TO ULTRASOUND....................................................................................................................8

4.2 USING ULTRASOUND TO ASCERTAIN CORRECT PROBE ALIGNMENT ...............................................................8

4.3 ULTRASONIC MEASUREMENT ..........................................................................................................................9

4.4 PROPER APPLANATION FOR TAKING AMEASUREMENT.................................................................................10

5. ULTRASONIC EXPOSURE AND INTENSITIES ......................................................................................11

5.1 TISSUE EXPOSURE TO ULTRASOUND ENERGY ...............................................................................................11

5.2 ULTRASONIC INTENSITIES..............................................................................................................................11

5.3 BIOMETRIC MEASUREMENT CAPABILITIES ....................................................................................................12

6. PHYSICAL DESCRIPTION ..........................................................................................................................13

6.1 FRONT VIEW ..................................................................................................................................................13

6.2 BACK VIEW....................................................................................................................................................15

6.3 SIDE VIEW......................................................................................................................................................16

6.4 BACK OF UNIT (PROTECTIVE HOLSTER REMOVED).......................................................................................17

6.5 PROBE............................................................................................................................................................18

6.6 CALIBRATION VERIFICATION BOX (CALBOX) ...............................................................................................19

7. PROBE USE AND INDICATORS.................................................................................................................20

7.1 INSERTING AND REMOVING THE PROBE..........................................................................................................20

7.2 HOLDING THE PROBE .....................................................................................................................................21

7.3 ‘CHECK PROBE’ERROR MESSAGE .................................................................................................................22

7.4 ‘PLUG IN PROBE’ERROR MESSAGE ...............................................................................................................22

7.5 ‘PQF FAILED’ERROR MESSAGE....................................................................................................................22

8. VERIFYING PACHETTE 4 CALIBRATION .............................................................................................23

8.1 PROCEDURE FOR VERIFYING CALIBRATION...................................................................................................23

9. POWER MODES.............................................................................................................................................26

9.1 MEASUREMENT MODE...................................................................................................................................26

9.2 STANDBY MODE ............................................................................................................................................26

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9.3 SLEEP MODE..................................................................................................................................................27

9.4 POWERING DOWN ..........................................................................................................................................27

9.5 CHECKING BATTERY POWER .........................................................................................................................27

10. PATIENT MODES ..........................................................................................................................................28

10.1 SINGLE PATIENT MODE.............................................................................................................................28

10.2 MULTI-PATIENT MODE .............................................................................................................................30

10.3 CHANGING PATIENT MODES .....................................................................................................................32

10.4 ADDING PATIENT IDENTIFICATION INFORMATION.....................................................................................33

10.5 CLEARING PATIENT INFORMATION............................................................................................................34

11. MEASUREMENT MODES............................................................................................................................35

11.1 CONTINUOUS AVERAGING MEASUREMENT MODE....................................................................................35

11.2 MAPPING MEASUREMENT MODE ..............................................................................................................36

11.3 CHANGING MEASUREMENT MODES ..........................................................................................................37

12. TAKING MEASUREMENTS ........................................................................................................................38

12.1 POWER UP SEQUENCE...............................................................................................................................38

12.2 MEASUREMENT IN CONTINUOUS AVERAGING MODE................................................................................40

12.3 MEASUREMENT IN MAPPING MODE ..........................................................................................................43

12.4 VIEWING DATE AND TIME.........................................................................................................................46

13. CONFIGURING THE PACHETTE 4...........................................................................................................47

13.1 ENTERING AND NAVIGATING THE CONFIGURATION MENU .......................................................................47

13.2 PARAMETERS FOR CONTINUOUS AVERAGING MEASUREMENT MODE.......................................................50

13.3 PARAMETERS FOR MAPPING MEASUREMENT MODE .................................................................................51

13.4 GENERAL DEVICE PARAMETERS ...............................................................................................................52

13.5 BLUETOOTH®PARAMETERS ......................................................................................................................54

14. CONFIGURING BLUETOOTH®CONNECTIONS ...................................................................................56

14.1 ENABLING BLUETOOTH®...........................................................................................................................56

14.2 PAIRING WITH A BLUETOOTH®ENABLED PRINTER ....................................................................................56

14.3 SENDING MEASUREMENTS TO A BLUETOOTH®ENABLED WIRELESS PRINTER ............................................58

14.4 PAIRING WITH A BLUETOOTH®ENABLED PC.............................................................................................59

14.5 ADDING COM PORTS................................................................................................................................62

14.6 SENDING AND RECEIVING INFORMATION VIA BLUETOOTH®CONNECTION TO A PC...................................63

14.7 RECALLING PAIRED DEVICE CONFIGURATION............................................................................................64

14.8 CLEARING ASINGLE PAIRED BLUETOOTH®DEVICE .................................................................................64

14.9 CLEARING ALL PAIRED BLUETOOTH®DEVICES........................................................................................65

15. DGH CONNECT SOFTWARE......................................................................................................................66

15.1 SOFTWARE REQUIREMENTS.......................................................................................................................66

15.2 INSTALLING THE SOFTWARE......................................................................................................................67

15.3 CONFIGURING THE SOFTWARE ..................................................................................................................68

15.4 ADDING A DEVICE .....................................................................................................................................70

15.5 EXPORTING PATIENT INFORMATION TO THE PACHETTE 4 .........................................................................71

15.6 INITIATING MEASUREMENT TRANSFER USING THE PC SOFTWARE. ............................................................73

15.7 INITIATING MEASUREMENT TRANSFER USING THE PACHETTE 4.................................................................75

Page 4 of 92 DGH 555B-INS-OMENG Rev: 3

16. CHANGING BATTERIES .............................................................................................................................78

16.1 REMOVING THE MOLDED RUBBER CASE.....................................................................................................78

16.2 CHANGING THE BATTERIES.......................................................................................................................79

17. CARE AND MAINTENANCE.......................................................................................................................81

17.1 CLEANING AND DISINFECTING THE PROBE................................................................................................81

17.2 CLEANING THE UNIT.................................................................................................................................82

17.3 TRANSPORT AND STORAGE CONDITIONS...................................................................................................82

17.4 OPERATING CONDITIONS...........................................................................................................................82

18. TROUBLESHOOTING GUIDE ....................................................................................................................83

19. SERVICE..........................................................................................................................................................84

19.1 REPAIRS AND CUSTOMER SUPPORT...........................................................................................................84

19.2 VIEWING MODEL AND SERIAL NUMBER....................................................................................................84

19.3 WARRANTY...............................................................................................................................................85

20. MANUFACTURED BY DGH TECHNOLOGY, INC. ................................................................................85

21. AUTHORIZED EUROPEAN REPRESENTATIVE....................................................................................86

22. REGULATORY COMPLIANCE ..................................................................................................................86

22.1 EMI/EMC COMPLIANCE...........................................................................................................................86

22.2 WIRELESS RADIO MODULE REGULATORY COMPLIANCE ..........................................................................88

Page 5 of 92 DGH 555B-INS-OMENG Rev: 3

1. Introduction, Classification and Indications For Use

1.1 General Device Description

The DGH 555B Ultrasonic Pachymeter (Pachette 4) is a portable, battery operated, ultrasonic

device that is used in the ophthalmic field for measuring the thickness of the human cornea.

Cornea thickness measurements are used in the preoperative evaluation of laser vision correction

procedures, and for the evaluation of glaucoma. The DGH 555B is also used as a diagnostic tool

in a variety of clinical situations including the general assessment of corneal health related to

pathologies and in evaluating corneal swelling following surgery or injury.

The general principle of operation of the DGH 555B Ultrasonic Pachymeter (Pachette 4) is as

follows: The tip of the ultrasonic transducer (probe) is placed in contact with the patient’s cornea

which automatically initiates a measurement cycle. At the start of the measurement cycle, the

electronic circuit board transmits voltage pulses to the ultrasonic transducer (probe). The

piezoelectric element in the transducer converts these voltage pulses into ultrasonic energy,

sending a pulse of a high frequency sound waves (20MHz damped to 13MHz) through the eye,

and reflected pulses (echos) are received back to the transducer and are converted to voltage

pulses. The first echo to be received comes from the anterior corneal surface. If an echo spike

from the anterior corneal surface is received within an anticipated time window, the DGH 555B

then prepares to receive an echo spike from the posterior corneal surface. Only anterior and

posterior echo spikes that fall within specified voltage limits that ensure that the probe tip is

perpendicular to the cornea surface are accepted for processing. The time interval between the

accepted anterior and posterior echo spikes represents the thickness of the cornea. The time

interval is converted to a corresponding distance, or thickness, based on the acoustic velocity

through the cornea, and is displayed on the 16 x 2 LCD in units of microns.

1.2 Device Classification

Device: System, Imaging, Pulsed Echo, Ultrasonic Device: Diagnostic Ultrasonic Transducer

Panel: Radiology Panel: Radiology

Product Code: IYO Product Code: ITX

Device Class: II Device Class: II

Regulation Number: 21 CFR 892.1560 Regulation Number: 21 CFR 892.1570

1.3 Indications For Use

The DGH 555B Ultrasonic Pachymeter (Pachette 4) is a portable, battery operated, ultrasonic

device that is used in the ophthalmic field for measuring the thickness of the human cornea.

Page 6 of 92 DGH 555B-INS-OMENG Rev: 3

2. Description of Symbols

This symbol indicates a potentially hazardous situation which, if not avoided, could cause

injury or harm to the equipment, operator or patient.

This symbol indicates the type BF classification and is located on the front and back of

the unit.

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 555B 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.

This symbol instructs the operator to read the operating manual.

This symbol indicates that DGH Technology, Inc. is the manufacturer of the DGH 555B

Pachette 4 device. The YYYY under the symbol indicates the year the device was

manufactured.

This symbol indicates that Emergo Europe is the European Authorized

Representative for this device.

This symbol indicates that the model number of this device is DGH 555B.

This symbol indicates the serial number of the device. YYYY indicates

the year of manufacture and XXXX indicates the unit number.

012 0

EC REP

yyyy

REF

Page 7 of 92 DGH 555B-INS-OMENG Rev: 3

3. General Cautions and Warnings, Prescription Device

Statement and Operator Qualifications

3.1 General Cautions and Warnings

WARNING: EXPLOSION HAZARD. Do not use in the presence of flammable

anesthetics, gases or in oxygen-rich atmosphere.

WARNING: ELECTRICAL SHOCK HAZARD. Do not open the unit. Refer servicing to

qualified service personnel.

3.2 Prescription Device Statement

WARNING: The DGH 555B (Pachette 4) is a prescription device and is only to be used

by, or under the supervision of, a licensed physician.

3.3 Operator Qualifications

This DGH 555B is intended to be used by trained medical professionals. The medical

professional operating the DGH 555B must have a general knowledge of the use of ultrasonic

medical devices. Use of the DGH 555B requires adequate dexterity to position the probe safely.

The DGH 555B uses audio feedback to inform the operator of the scan status.

Page 8 of 92 DGH 555B-INS-OMENG Rev: 3

4. Use Of Ultrasound In Ophthalmic Measurement

4.1 Introduction To Ultrasound

Ultrasound offers a non-invasive method to examine the interior of solid objects. Ultrasonic

pulses consist of sound waves of a frequency level too high to be heard by the human ear. When

a sound impulse strikes an interface, some sound is reflected, and some sound is transmitted.

Because some sound will pass through the surface and be reflected by the next surface, complex

structures can be examined with ultrasound. When ultrasound penetrates an object with several

interfaces, the reflected ultrasound can be observed as a waveform with peaks that are related to

the positions of the interfaces.

The DGH 555B transducer emits ultrasound pulses and detects ultrasound signals that have been

reflected back. The time delay between the echoes is used to calculate distances between

surfaces in the eye.

NOTE: Ultrasound cannot travel through air because air is not dense enough for the high

frequency waves to propagate. Ultrasonic measurements must therefore be performed by direct

contact or through a denser medium such as water.

4.2 Using Ultrasound To Ascertain Correct Probe Alignment

Sound travels in straight lines, so the direction of reflected sound is based solely on its angle of

incidence. Sound hitting an interface perpendicularly will reflect back along the same path that it

approached (Figure 4.2.1). Sound hitting an interface at an angle will reflect at an angle away

from the source (Figure 4.2.2). The transmitted sound will continue on at a lesser amplitude

because of reflected energy lost at the interface.

When reflected ultrasound is shown as a two-dimensional waveform, the peaks are related to the

positions of the interfaces. By comparing the relative height (intensity) of the peaks, one can

determine the angle at which the sound is striking it. Steadily diminishing peaks are an indicator

that the ultrasound is not perpendicular to the interfaces

Page 9 of 92 DGH 555B-INS-OMENG Rev: 3

Fig 4.2.1: Sound hitting an interface perpendicularly. Fig 4.2.2: Sound hitting an interface at an angle

Using these properties of ultrasound, the alignment of an ultrasound beam through the eye can be

determined. Proper alignment is crucial to the accuracy of measurements.

4.3 Ultrasonic Measurement

The speed of sound increases in denser materials. Liquids or substances containing large

amounts of water conduct ultrasound very well; air does not conduct ultrasound. Using the

relationship between the density of a material and the speed of sound, ophthalmic pachymeters

obtain distances in the eye by performing a two-step process.

First, a pulse of sound is timed as it travels through the cornea, reflects off the back of the

cornea, and returns to the transducer.

Second, the thickness is calculated based on the travel time and the speed of sound through the

eye:

distance = velocity × time

All thickness measurements are based on a corneal velocity of 1640 m/sec.

Page 10 of 92 DGH 555B-INS-OMENG Rev: 3

4.4 Proper Applanation for Taking A Measurement

Proper applanation is necessary for obtaining an accurate measurement. Proper applanation

occurs when the flat tip of the probe comes into full contact with the cornea perpendicular to the

cornea surface. The user must ensure that pressure against the cornea is minimized.

The diagram below illustrates correct and incorrect alignment of the probe tip to the cornea.

1 and 2: CORRECT: The probe IS perpendicular to the corneal surface.

3 and 4: INCORRECT: The probe IS NOT perpendicular to the corneal surface.

Fig 4.4.1 Correct and Incorrect Applanation

While in Measurement Mode, the Pachette 4 will automatically take a measurement whenever

the tip of the probe is properly applanated to the cornea.

WARNING: Moving or realigning the probe tip while it is in contact with the cornea or

applying pressure while measuring the cornea may cause damage to the cornea. When

changing position or alignment of the probe, it is necessary to disengage contact, reorient

and then gently re-applanate.

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