Page 3 of 87 DGH 55B-INS-OMENG Rev: 3
Table of Contents
TABLE OF CONTENTS ............................................................................................................................................ 3
1. INTRODUCTION .............................................................................................................................................. 6
1.1 GENERAL DEVICE DESCRIPTION ...................................................................................................................... 6
1.2 DEVICE CLASSIFICATION ................................................................................................................................. 6
1.3 INDICATIONS FOR USE ..................................................................................................................................... 6
2. DESCRIPTION OF SYMBOLS ....................................................................................................................... 7
3. GENERAL CAUTIONS AND WARNINGS, PRESCRIPTION DEVICE STATEMENT AND
OPERATOR QUALIFICATIONS ................................................................................................................... 8
3.1 GENERAL CAUTIONS AND WARNINGS .............................................................................................................. 8
3.2 PRESCRIPTION DEVICE STATEMENT ................................................................................................................. 8
3.3 OPERATOR QUALIFICATIONS............................................................................................................................ 8
4. USE OF ULTRASOUND IN OPHTHALMIC MEASUREMENT ............................................................... 9
4.1 INTRODUCTION TO ULTRASOUND .................................................................................................................... 9
4.2 USING ULTRASOUND TO ASCERTAIN CORRECT PROBE ALIGNMENT ............................................................... 9
4.3 ULTRASONIC MEASUREMENT ........................................................................................................................ 10
4.4 PROPER APPLANATION FOR TAKING A MEASUREMENT ................................................................................. 11
5. ULTRASONIC EXPOSURE AND INTENSITIES ...................................................................................... 12
5.1 TISSUE EXPOSURE TO ULTRASOUND ENERGY ............................................................................................... 12
5.2 ULTRASONIC INTENSITIES .............................................................................................................................. 12
5.3 BIOMETRIC MEASUREMENT CAPABILITIES .................................................................................................... 13
6. PHYSICAL DESCRIPTION .......................................................................................................................... 14
6.1 FRONT VIEW .................................................................................................................................................. 14
6.2 BACK VIEW .................................................................................................................................................... 16
6.3 PROBE ............................................................................................................................................................ 17
6.4 CALIBRATION VERIFICATION BOX (CALBOX) ............................................................................................... 18
7. PROBE USE AND INDICATORS ................................................................................................................. 19
7.1 INSERTING AND REMOVING THE PROBE .......................................................................................................... 19
7.2 HOLDING THE DEVICE .................................................................................................................................... 20
7.3 ‘CHECK PROBE’ ERROR MESSAGE ................................................................................................................. 21
7.4 ‘PLUG IN PROBE’ ERROR MESSAGE ............................................................................................................... 21
7.5 ‘PQF FAILED’ ERROR MESSAGE .................................................................................................................... 21
8. VERIFYING PACHMATE 2 CALIBRATION ............................................................................................ 22
8.1 PROCEDURE FOR VERIFYING CALIBRATION ................................................................................................... 22
9. POWER MODES ............................................................................................................................................. 24
9.1 MEASUREMENT MODE ................................................................................................................................... 24
9.2 STANDBY MODE ............................................................................................................................................ 24
To Next Page
Loading...