Gilras GRU-6000 Ophthalmology Scanner User Manual

ULTRASONIC A/B SCANNER

FOR OPHTHALMOLOGY

GRU-6000

USER’S MANUAL

1

st

edition

Gilras,

FL, US

Contents

WARNINGS..................................................................................................................... 1

CAUTION........................................................................................................................ 2

INDICATORS ................................................................................................................. 3

1.

INTRODUCTION ....................................................................................................... 4

2.

SPECIFICATIONS ..................................................................................................... 5

2.1 Working Conditions ............................................................................................ 5

2.2 B Mode ............................................................................................................... 5

2.3 A Mode ............................................................................................................... 5

2.4 Safety .................................................................................................................. 6

3.

INSTALLATION......................................................................................................... 7

3.1 Packing List ........................................................................................................ 7

3.2 Main Parts of the Instrument............................................................................... 7

3.3 Environmental Requirements.............................................................................. 8

3.4 Connection.......................................................................................................... 8

3.5 Disassemble of Accessories/ Replacement of Consumables............................... 9

4.

OPERATION ............................................................................................................. 10

4.1 Keypad Description .......................................................................................... 10

4.2 B Mode ............................................................................................................. 12

4.3. A Mode ............................................................................................................ 15

4.4 Five-Point Marking Method ............................................................................. 17

4.5 IOL Calculation ................................................................................................ 20

4.6. Parameter Setup ............................................................................................... 22

4.7 Image Printing .................................................................................................. 23

5.

CLEANING, STERILIZATION AND MAINTENANCE OF

PROBE ................. 24

5.1 How to prevent Cross-Infection........................................................................ 24

5.2 Sterilization Procedure...................................................................................... 25

6.

MAINTENANCE AND TROUBLE

SHOOTING .................................................. 31

6.1 Maintenance of the Instrument ......................................................................... 31

6.2 Biometric Test................................................................................................... 31

6.3 Trouble Shooting .............................................................................................. 32

APPENDIX A SUPPORT INFORMATION ................................................................. 33

Warranty ................................................................................................................. 33

Accessories, Consumables and Supply Information............................................... 33

APPENDIX B T

HE ACOUSTIC OUTPUT INFORMATION

(IEC 1157)................................. 34

APPENDIX C G

UIDANCE AND MANUFACTURER

’

S DECLARATION

— EMC .................. 36

APPENDIX D: IOL FORMULA..................................................................................... 40

WARNINGS

The manufacturer won’t be responsible for any damage or injury caused by any failure of following the instructions in this manual.

The manufacturer reserves the right to modify equipment characteristics without previous notice under FDA Laws and MDD (93/42/EEC) Regulation.

The quality guarantee of GRU-6000 will be invalid if the equipment is opened (even partially), modified or repaired in any way by anyone who is not authorized by the manufacturer

-----------------------------

WARNING:

Do not make any modification to the device without authorization from Manufacture.

WARNING:

Federal (US) Law restricts that this device to sale by or on the order of a physician.

WARNING:

This device is not intended for fetal use.

WARNING:

Disconnect AC power before cleaning the case.

WARNING:

While plugging in the probe, make sure the red mark on the probe align with the red mark on the socket.

While plugging off the probe, please be sure you are pulling the connector in stead of the cable.

Do not scratch the surface of the probe.

Do not drop probes.

For any question, please contact the Manufacturer or Local Distributor:

Manufacturer: Gilras

Address: 9990 NW 14 ST Suite 105 Doral, FL 33172

Phone: +1-305-722-7321

Fax:+1- 786-664-3347

Email: [email protected]

1

CAUTION

HOW TO PREVENT CROSS-INFECTION:

Between uses on different patients the probes must be cleaned to prevent cross-infection.

Manufacturer advocates a preventive action and a cleaning procedure in Chapter 5:

CLEANING, STERILIZATION AND MAINTENANCE OF PROBE

---------------------------------

CAUTION:

The GRU-6000 IOL calculator will calculate negative IOL values if such is predicted by the data entered.

These are displayed with a minus sign (-). Do not ignore this sign.

CAUTION:

To preserve the equipment, avoid using any abrasive cleaner. If possible, clean spots before they dry.

----------------------------------

TISSUE EXPOSURE TO ULTRASOUND ENERGY:

The GRU-6000 unit is designed for use in ophthalmology only.

While the manufacturer is not aware of any reports of adverse effects from using ophthalmologic ultrasound scanner, even at FDA pre-enactment levels, no other use is intended or implied.

The system controls limit of the output energy within the parameters specified for its intended purpose. Please refer to APPENDIX B of User’s Manual.

No control of ultrasound energy is available to the user other than the duration of exposure, considering the current concern for possible unknown hazards, and despite the extremely low output intensities used in this ultrasound system.

The manufacturer recommends that patients exposure time during measurement be minimized.

2

INDICATORS

POWER IN

│

AC 100V~240V Power Input, 50/60Hz

Power On

〇 Power Off

FUSE Fuse socket, 100V~120V: 4A; or 200V~240V: 2A

Slow Blow Fuses, Dimension: 5x20 mm

VIDEO OUT Video Signal Output

①

Contrast Control

Brightness Control

Symbol of “Type B”

Refer to User’s Manual

Equipotentiality

CE mark

IPX7 The degree of protection against ingress of liquids

Note ①: Only for SONY/MITSUBISHI Video Printer and manufacturer’s image work station.

3

1. INTRODUCTION

GRU-6000 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging instrument specialized in ophthalmological diagnosis.

It consists of the main unit, 10MHz mechanical sector B-scan probe, 10MHz A-biometric probe, built-in video monitor and foldable keypad.

The product is used for ophthalmological ultrasonic diagnosis and measurement.

The product should be operated by experienced doctors.

Please read the manual carefully before installation and operation.

Contraindications:

Eyelid trauma and severe eye infection patients are prohibited to use B scan and cornea trauma, inflammation or infection patients are prohibited to use A-biometric scan.

Notes:

The instrument should be operated by trained doctors.

Please read the manual carefully before installation and operation.

Please refer to Chapter 5 for CLEANING, STERILIZATION AND MAINTENANCE

OF PROBE to avoid cross-infection while using.

Unplug power supply before cleaning.

Other notice please refer to Chapter 6.

Manufacturer: Gilras

Address: 9990 NW 14 ST Suite 105 Doral, FL 33172

Phone: +1-305-722-7321

Fax:+1- 786-664-3347

Email: [email protected]

4

2. SPECIFICATIONS

2.1 Working Conditions

Environmental temperature: 5

C~40C, relative humidity not more than 80%.

Power supply: AC 100V~240V, 50/60 Hz.

2.2 B Mode

Ultrasonic frequency: 10MHz.

Scanning method: mechanical sector scan.

Gain control: 0~98dB.

Display mode: B, B+B, B+A, A.

Scanning scope: depth 34mm~60mm, scanning angle: 53º.

Resolution: axial

 0.2mm, lateral  0.4mm.

Accuracy of geometrical position: axial

 5%, lateral  10%.

Pixel capacity : 64 ×640×512×8 bits.

Number of image saved: 8.

Gray scale: 256.

Pre-image processing: frame even.

Post-image processing: 4 groups of curves (liner, logarithmic, exponential and S).

Electronic caliper: electronic cursor for multiple distance measurement,

accuracy not less than 0.25mm.

Area measurement: accuracy not less than 0.0625mm

2

.

Full screen text labeling.

Built-in Calendar & Clock: Mm-Dd-Yy, Hour-Min.

Patient information input: name, sex, age.

Continuous scanning will be stopped automatically to protect the probe if it is over 10 minutes.

30 minutes of power on but unused will lead to screen safeguard, which prolongs life of monitor. Press any key to recover.

2.3 A Mode

Ultrasonic frequency: 10MHz.

5

Measuring scope (AL): 16~40mm.

Total gain: 98dB, user adjustable gain scope: 0~55dB.

Measuring parameter: anterior chamber depth, lens thickness, vitreous length and axial

length.

Measuring mode: 5 (normal, aphakic, special, dense cataract, manual measuring).

Measuring method: contact.

IOL calculation: SRK-T, SRK-II, BINK-II, HOLLADAY, HOFFER-Q, HAIGIS. Any two calculations can be compared and displayed on the same screen.

Calculation of 8 groups’ average with standard deviation (S.D.).

50 groups of results saved permanently.

4 groups of IOL constants can be saved.

2.4 Safety

In accordance to IEC 60601-1 and IEC 1157 & IEC 60601-2-37.

6

3. INSTALLATION

3.1 Packing List

Please check the components in the package according to the following list.

* B Probe 1

* Foot Switch 1

* Power cord 1

* Fuse 2 (110V~120V: 4A; or 220V-240V:2A

Slow Blow Fuses, Dimension: 5x20 mm

)

* Test Object 1

* User’s Manual 1

3.2 Main Parts of the Instrument

The instrument consists of: main unit, 10MHz mechanical sector B probe, 10MHz A mode biometric probe, built-in video monitor and foldable keypad. The configuration is as follows:

Keyboard

Trackball

Monitor

Foot

Switch

A Probe

B Probe

Probe Holder

Probe Socket

Contrast control

Brightness control

Gain control

7

3.3 Environmental Requirements

The scanner should be operated in clean, dry and air-conditioned environment.

The power socket used must be with good grounding, otherwise it increases the risk of noise as well as creepage.

Do not use the equipment in locations subject to intense electric or magnetic fields. Avoid excessive shock (e.g. tooth drill) and direct sunlight.

The equipment should be placed on a stable worktable. Leave certain space around the instrument and avoid soft object below it for ventilation.

3.4 Connection

This is the rear panel of the main unit:

VIDEO OUT

FUSE

FOOTSWITCH

POWER

VGA

GROUNDING

POWER SUPPLY

SOCKET

Video Out: Video Output Socket Fuse: Fuse Socket

Footswitch: Footswitch Socket Power: Power Switch

1) Plug footswitch cable to FOOT SWITCH socket on the rear panel.

2) Plug power cable to the power socket on the rear panel and the other end to a properly grounded power supply socket.

3) Plug B probe into B-Probe socket on the right panel.

4) Plug A probe into A-Probe socket on the right panel.

Note: 1) While plugging the probe, make sure the red mark on the probe aligns with the red mark on the socket.

2) The probe should be placed in the probe holder. Do not put it on table or other supporters. Do not scratch the surface of the probe.

3) While unplugging the probe, please hold the connector. Do not pull the cable.

4) If the probe drops while using or moving, please check the surface and shell carefully.

If any of them is broken, then stop using it immediately and contact the manufacturer or local distributor for repairing.

8

5) If a video printer is available, connect the video cable to VIDEO IN of the printer, and the other end to VIDEO OUT on the rear panel of the main unit.

3.5 Disassemble of Accessories/ Replacement of Consumables

No part can be disassembled inside the main unit. Do not open the housing.

The probe and video printer should be disconnected from the main unit and put into its original package in case of moving.

Normal water-based high-molecule ultrasonic coupling gel for ultrasonic scanners is required to be used.

For replacement of printing paper, please refer to the User’s Manual of the printer.

The gel bottle is made of polythene, and the remaining gel is water-soluble. Heavy metal contents meet the requirements of cosmetic standard. The treatment of the empty bottle should conform to the local environmental protection regulations. It can be treated together with disposable plastics such as syringe.

9

4. OPERATION

In a usual measurement, it's better to let patient lie down and let his head close to the device (less than 1.2m). The operator should take a position convenient for reaching patient's head and operating the device.

4.1 Keypad Description

The instrument can be operated by keypad and soft keys on the screen. The keypad consists of alphabetic keys, numeric keys and functional keys. The soft keys are controlled by the trackball and its left and right key L and R .

4.1.1 Alphanumerical keys

Letter, Number The alphabetic and numeric keys are used to input characters in the place of the

cursor.

, , ,  Press them to input corresponding arrows in the place of the cursor.

 Backspace key. Press it to place the cursor one space back. At the same time the character will be erased.

SPACE Space key. To move the cursor to the right.

 Enter key. It is used to finish the current line and go to the next line, or finish the current item and go to the next one.

+ - To adjust the threshold of A-Scan measurement under A-Mode; while under IOL or

SETUP, can be used as just plus and minus.

4.1.2 Functional keys

B Press it to enter single B scan.

B+A Press it to enter B+ A mode.

B1 B2 Press them to enter double B scans and switch between images of B1 and B2.

A Press it to enter A mode automatic measurement or to refresh A-scanning and start a new

measurement.

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AUTO Automatic measuring key. Press it in the status of A automatic measurement, the

instrument will be shifted among NORM, APHA, SPEC and CATA.

NORM: NORMAL EYES

APHA: APHAKIC EYES

SPEC: SPECIAL EYES

CATA: DENSE CATARACT EYES

MANL Manual measuring key. Press it to enter manual measurement of A mode.

IOL Press it to enter IOL calculation mode where calculation parameters can be input. From

A-Mode to IOL, the average axial length can be automatically put in AL box; while if an appointed AL from 8 groups of results is necessary, press AL. Refer to AL below.

AL Press it under IOL mode, the axial length pointed by “

” line that is measured automatically in A mode can be input to AL box for IOL calculation.

CAL In IOL mode, press this key to calculate IOL after all constants are input correctly.

OS OD Indicate left or right eye which is displayed on the screen.



  Cursor control / function keys used to move the cursor and select functions.



  In B mode, press it to turn the image page up and down and save 8 pages, marked as P1-P8; in A mode, press it to display the curve of automatic measurement indicated by “

”;

In IOL mode, press it to retrieve the information of axial length, cornea curvature, etc.

FRZ/SCN Scan/Freeze control key. Press it, the instrument shifts from START SCAN to

FREEZE IMAGE or from FREEZE IMAGE to START SCAN. After 10 minutes of scanning,

it is frozen automatically to protect the probe.

4.1.3 Trackball

The trackball can be used to move the cursor on the screen. Press L to activate the functions where the cursor is; In B mode, press R to display or hide the functional menu on the right side of the screen.

4.1.4 Gain Control Knob

In B or A mode, the gain can be changed by adjusting this knob. Change of gain is displayed on the screen at the same time: GN = XX dB.

4.1.5 Foot Switch

In B mode or A mode, the foot switch has the same function as FRZ/SCN , i.e., controls the start-up of the probe. When it is started,

SCN

is on the screen: in B mode, the probe waves and the image is displayed dynamically; in A mode, the probe indicator is on. When it is

11

frozen,

FRZ

is on the screen: in B mode, the probe stops and the image is still; in A mode, the probe indicator is off.

4.2 B Mode

Mode Menu

Status

GN: Gain

OD/OS: right eye/ left eye

P1-P8: page number

Freeze/Scn

Probe Position

Scanned Image

Gray Scale

Ruler

Function Menu

Patient Information

Calendar & Clock

In mode menu, SB: single B mode; B1/B2: double B images; B+A/A+B: B mode and A mode, both B image and A waves displayed. Click the functional keys or the L key of the trackball to enter the corresponding work mode. The screen displays as following:

Single B Mode

B1 and B2 Mode

The upper one is B1 and the lower one is B2. Select one of them and active it, then you can scan, freeze, adjust the gain, label the eye and save.

12

4.2.1 Direction and Position Analysis

B+A Mode

Sample taking Line and A curve changes accordingly .

Top of Sector

Bottom of Sector

There is a white dot on one side of the probe end. This dot always corresponds to the upper part of the sector image. For instance, if the dot is above the eye, marked as “↑”, the image on the screen is the vertical section of that eye. The top of the sector corresponds to the upper part of the eye, and the bottom of the sector corresponds to the lower part of the eye.

Another example: if the dot is on the nose side of the right eye, marked as “→”, the image on the screen is the horizontal section of the eye. The top of the sector is the nose side of the eye, and the bottom of the sector is the temporal side of the eye.

Move the cursor with the trackball to the probe position marker, press L key, the marker will rotate clockwise; it rotates 45° every time it is pressed.

4.2.2 B Scan Steps

a) Select B mode. b) Input patient information at the bottom of the screen.

NAME: 13 digits of letters or numbers.

SEX: 6 digits of letters or numbers.

AGE: 3 digits of letters or numbers. c) Label the eye to be examined. Press OD key for right eye; press OS key for left eye. d) Let the patient lie on his/her back, slightly close the eyes. e) Put some acoustic gel on eyelid; gently place the B probe on the eyelid. f) Push down the footswitch or press FRZ/SCN , the probe starts scanning. The real time

13

ultrasonic sectional view of the eye will appear on the screen. g) Adjust the total gain knob to make the focus clear and get a satisfactory image. Push down the footswitch again or press FRZ/SCN to freeze the image. The collection of ultrasonic B image is completed.

Note: Adjustment of gain control is one of the key operations that affecting B mode image quality. For different conditions and diagnostic requirements, the gain adjustment is different. Make sure do not fix the gain, however it is also not the case that the larger the gain, the better the image.

h) Press the keys to save the current image and turn the page up and down.

Mark the image with P1 , … , P8 . 8 images can be saved at most.

4.2.3 Functional Menu

In B mode, press the R key of the trackball to show the functional menu; press any key again to hide it. Select the functions with the trackball’s L key. a) ZOOM Depth control key. To change the scanning scope. 6 depths are available to be adjusted. They are showed on the right upper screen as:

DEPTH = 34 mm

DEPTH = 39 mm

DEPTH = 45 mm

DEPTH = 50 mm

DEPTH = 56 mm

DEPTH = 60 mm

Press

  to adjust the depth. It is effective after the scanning is activated. b) PROC Gray scale control and Post-image processing key. Press

  keys to select the post image processing mode: linear (LINE), logarithmic (LOG CURVE), exponential (EXP CURVE) and S (S CURVE). c) TEXT Full screen text labeling key. Move the cursor with the L key of the trackball and enter the text to label the image. d) DIST Distance Measuring key. Select DIST and activate double cursor distance measuring status, a “+” appears on the screen. Move the “+” to the position where you want to start measuring, then press the L key of the trackball, the current “+” will be locked. Move the trackball again, another “+” is shown up. Move it to the terminal of measuring and press L key again to complete the measurement. The distance between two “+” will appear on the screen. The unit is “mm”. If another measurement is needed, repeat the above procedure.

14

e) AREA Area measuring key. Press L key to fix a start point and draw the outline of an area with the trackball. Press L key again to get the area measurement result.

Multiple measurements can be made and the unit is mm

2

. f) CLRS To clear all the labels and measuring results on the image. g) NEW New patient. Clear the previous patient’s information, temporarily save ultrasonic B images and get prepared for the next examination. h) EXIT To exit functional menu.

4.3. A Mode

Ultrasonic A Biometry is used to measure the anterior chamber depth, lens thickness, vitreous length and to calculate the axial length according to these measurements. To ensure the accuracy, the ultrasound should go into the eye from the vertex of the cornea as close as possible, and superpose with the axis.

Auto and manual modes can be selected for the measurement. Auto mode is suitable for normal, aphakic, dense cataract and other conditions, where the velocity of ultrasound is known.

For contact method, A probe is contacted with the cornea vertex directly. This method is simple and easy to control. But the cornea can be injured and slightly distorted, therefore affecting the results. So the operator should operate very carefully and not press the cornea. The contact method applies to both the auto and manual mode.

When A Scan is selected, it enters the following screen.

NORM Normal Eye, Auto

APHA Aphakic, Auto

15

CATA Dense Auto

MANL Manual

COR Thickness of Cornea

AC Anterior Chamber Depth

LENS Thickness of Lens

AL Axial Length

AV Average Measuring Result

SD Standard Deviation

4.3.1 Auto Measuring Steps

(1) Press A to enter A scan auto measuring mode (NORM).

(2) Select the type of eye among NORM, APHA, SPEC, CATA.

(3) Let the patient lie on his/her back and open both eyes. Anaesthetize the eye to be measured.

(4) Sterilize the front part of A probe with chloramphenicol eyedrop.

(5) Push down the footswitch or press the FRZ/SCN to start scanning.

* Let the patient stare at the probe and put the probe on the cornea vertex gently.

(6) Adjust the gain control to get the satisfactory wave.

(7) When you hear a series of beep sound, the result comes out and is displayed on the screen. If the beeps are not heard, move the probe slightly until beeps heard and the measuring is completed. Measuring is undertaken one by one automatically until eight groups of data are achieved or it can be stopped when FRZ/SCN is pressed to freeze the image. Eight groups of data can be achieved from each patient at most, and the operator decides how many groups of data are needed.

Note: Since auto measuring result is calculated by averaging multiple operations, the operator needs to handle the probe gently and stably. The image can be frozen and the probe be taken away only after the beeps stop and the result appears on the screen.

Check the results & Delete unreliable data: If the measuring results are obviously

unreliable, delete them. Press keys to move the cursor “

” to the line that needs to be deleted and click DEL with the trackball’s L key. The next line moves up and average value is recalculated.

16

Cornea

Front of the lens

Back of the lens

Retina

A wave with contact method

Please delete the results in the following situations: a) Position marker does not correspond with the top of the wave. b) The retina wave is not sharp. c) There is a big difference between the measuring and the average.

(8) Label the eye. OS for left eye; OD for right eye.

(9) Clear the current result and start a new measurement. Repress A key or click

NEW with L key of the trackball.

4.3.2 Manual Measuring Steps

In some circumstances, it is difficult to get the result by automatic biometry or patients have difficulties to cooperation with the operator. In these cases, manual biometry is selected; otherwise, it is not preferred. Press MANL to enter manual measurement.

Operating steps are similar to the automatic measurement. Press FRZ/SCN to start scanning, adjust gain control and get a satisfactory wave. Press FRZ/SCN to freeze the wave, mark and measure it with the trackball. The operation refer to Five-Point Marking Method in chapter 4.4.

Manually measured mark

Manually Measured Waves

4.4 Five-Point Marking Method

When a bundle of ultrasounic goes through optic axial, we can get ultrasonic reflex from five different layers (Figure One), including: (1) cornea vertex; (2) back of cornea; (3) front of lens; (4) back of lens; (5) retina

17

Figure One

Due to the specialty of eye structure, ultrasonic velocity becomes different when going through different tissues as follows:

Velocity of cornea： Vcor = 1620 m/s (1) – (2)

Velocity of anterior chamber： Vac = 1532 m/s (2) –(3)

Velocity of lens： Vlen = 1641 m/s (3) – (4)

Velocity of vitreous： Vvitr = 1532 m/s (4)—(5)

Axial length: AL = Vcor * (t2-t1) + Vac*(t3-t2) + Vlen *(t4-t3) + Vvitr *(t5-t4). (1.1)

As long as the five special points can be marked precisely, we can then figure out accurate axial length according to (1.1). This is what we called Five-Point Marking method for axial length measurement.

4.4.1 Use of Five-Point marking method under B+A mode for axial length measurement

(1) Press B+A key to enter B+A mode, see Figure Two.

(2) Scan the eyeball, then freeze it once satisfied image is obtained;

(3) Move trackball, press >>> area on screen with L key of the trackball, then enter Five-Point marking stage;

(4) Move the cursor to A curve at the bottom of the screen, press L key of the trackball to mark the five points;

Note: GRU-6000 has only contact mode for A measurement, it is hard to recognize vertex

and back of cornea, so points (1) and (2) should both be put on (1). Vertex and back of cornea can be recognized seperately on A measurement when immersion mode is available.

(5) After marking the 5 th

point, the result of axial length will be shown on top of the screen.

Note: Velocity between points can be set up in SETUP menu (press SPEC, input velocity of cornea, lens and vitreous, then click on SAVE).

18

4.4.2 Use of Five-Point marking method under A mode for axial length measurement

(1) Press A to enter A mode;

(2) Choose measuring mode: (NORM, APHA, SPEC, CATA);

(3) Place A probe onto patient’s cornea, start foot switch and undertake an automatic measurement;

(4) When standard deviation, S.D, is not clinically satisfied, Five-Point marking can be corrected.

(a) Press key to see A scan waves, remark the ones are not satisfied;

(b) Move trackball, press >>> area on screen with L key, then enter Five-Point marking stage;

(c) Move the cursor to A curve at the bottom of the screen, press L key of the trackball to mark the five points, (if it is hard to recognize vertex and back of cornea, points (1) and (2) can both be put on (1));

(d) After marking the 5 th

point, the measurement result, average of axial length and S.D will all be recaculated according to the new marking. See Figure Three.

Note: Velocities under different measuring modes:

NORM (Normal):

Velocity of cornea: Vcor = 1620 m/s (1) – (2)

Velocity of anterior chamber: Vac = 1532 m/s (2) –(3)

Velocity of lens: Vlen = 1641 m/s (3) – (4)

Velocity of vitreous: Vvitr = 1532 m/s (4)—(5)

CATA (dense cataract):

Velocity of cornea: Vcor = 1620 m/s (1) – (2)

Velocity of anterior chamber: Vac = 1532 m/s (2) –(3)

Velocity of lens: Vlen = 1629 m/s (3) – (4)

19

in SETUP menu.

After reset the velocities, press <<< under A mode, the results will be recalculated accordingly.

+ - can be used to adjust the threshold of A-scan measurement.

Velocity of vitreous: Vvitr = 1532 m/s (4)—(5)

Velocities under modes of SPEC (special), MANL (manual), APHA (aphakic) can be set up

4.5 IOL Calculation

4.5.1 Velocity of Setup

The velocity refers to the spread velocity of the ultrasound within the eye. This instrument has four eye modes: NORM (normal), APHA (aphakic), SPEC (special) and CATA (dense cataract). The parameters are as follows:

Unit：m/s

1532 Anterior Chamber V(AC)

Lens V(LEN)

1532

1641

-

-

1532*

PMMA：2718

**

Acrylic：1946

Silicone：1050

1532* Vitreous Body V(VITR) 1532

*：To modify the velocity in the parameter setup function, refer to 4.6.

**：Provided by IOL manufacturer.

1629

1532

4.5.2 Constants in different Formulae

6 groups of IOL calculation formulae are provided: SRK_II, SRK_T, BINK_II,

HOLLADAY, HOFFER_Q, HAIGIS. Different constants are used for different formula, recorded as A or ACD or SF, which are provided by IOL manufacturers. They can be modified and saved in the parameter SETUP function. For details, refer to 4.6.

BINK-II and HOFFER-Q use ACD, i.e., the desired anterior chamber depth constant. ACD can also be calculated from constant A:

ACD = [((A × 0.5663) - 65.60) + 3.595] / 0.9704

or ACD = (SF + 3.595) / 0.9704

HOLLADAY uses SF，can also be calculated from constant A：

SF = (A × 0.5663) - 65.60

or SF = (ACD × 0.9704) - 3.595

20

The shift from A to SF is completed automatically after constant A is entered.

SRK-II and SRK-T use A, can be calculated from the following formula:

A = (SF + 65.60) / 0.5663

or A = 109.49 + (1.71358 × ACD)

HAIGIS uses three constants: a0, a1, a2, can be calculated from A： a0 ＝ (0.62467 × A) - 72.434 a1 ＝ 0.40 a2 ＝ 0.10

4.5.3 IOL Calculation Steps

a) Press IOL to enter the calculation mode. b) Select formula with the L key of the trackball. c) Enter correct parameters.

AL = Axial Length

K1, K2 = Keratometry

DR = desired Refraction

When calculation mode is entered, the average of axial length calculated is put in AL.

Press AL key to input the axial length from the line where the cursor “

” is located.

Move the cursor “_” with arrow key and enter key to input numbers required. d) Modify and save constants A or ACD in the parameter SETUP function. See 4.6.

*

IOL type needs to be selected for formula BINK-II: anterior or poserior. Click ANTI or POST with L key of the trackball.

*Anterior chamber depth AC needs to be input for formula HAIGIS. The automatically calculated average anterior chamber depth is put in AC in calculation status. Press AL key, the anterior chamber length from the line where the cursor “

” is located is input. If it is required to enter manually, move cursor “_” to AC and enter the numbers. e) Enter patient informaiton, label the eye. f) Press CAL the calculation will be completed and listed on the screen.

DEM

Diopter of emmetropia, (D)

DAM

Diopter of ametropia (D)

IOL Diopter of IOL (D)

21

REFR

Refraction after implant (D)

Each group of AL, K1, K2, REFR, etc. can be calculated by different formulae in order to be compared with each other . g) The parameters and measured results can be saved as a record by click SAVE with L key of the trackball. “REC= XX” is showed at the right upper corner of the screen. To review the records, press . 50 records can be saved in total.

4.6. Parameter Setup

Click MENU on the left upper corner of the screen with the L key of the trackball, select SETUP to enter.

Move the cursor “_” with arrow key and enter key to enter the number where the “_” is.

Click on IOL CONST with L of the trackball and setup IOL constants: A and ACD.

There are two groups: LEFT and RIGHT, for left and right side IOL calculation respectively.

The number after CURRENT tells which group is active. DR is desired refraction after surgery.

The constants setup by the manufacturer are:

LEFT 1 A = 115.3 ACD = 3.39

RIGHT 1 A = 116.6 ACD = 4.15

LEFT 2 A = 117.9 ACD = 4.91

RIGHT 2 A = 118.7 ACD = 5.37

CURRENT 1

Click on SPEC with L key of the trackball to set the velocity. When aphakic

(APHA) or special (SEPC) eyes are measured, the velocity in the anterior chamber, lens and vitreous body can be set manually. For the velocity in IOL, consult the manufacturer.

V(A) : velocity in anterior chamber (m/s)

22

V(L) : velocity in lens (m/s)

V(V) : velocity in vitreous body (m/s)

After setup, press SAVE to save permanently. The parameters will be effective when the instrument is turned on next time.

Click TIME with L key of the trackball to set the time. The format is mm-dd-yy, hh-mm with 24-hour system. Click TIME again to save.

4.7 Image Printing

If a video printer is available, all images and characters on the screen can be printed by simply pressing PRINT key on the printer. Please read the user’s manual of the printer for details.

23

5. CLEANING, STERILIZATION AND MAINTENANCE OF PROBE

5.1 How to prevent Cross-Infection

The surface of the probe must be always clean, which can be cleaned with soft tissue after each use.

Front part of the probe may be washed with distilled water, physiological saline water, alcohol, chloramphenicol eye drop or Cidex liquid disinfectant, which are usually found in hospitals. Other FDA-cleared disinfectants may also be used.

The probe can be immersed.

Do not immerse the connector.

Do not autoclave the probes.

After cleaning, rinse the end of the probe thoroughly with clean water to remove all traces of the liquid used.

Follow the instruction on the label of commercial disinfectants.

The surface should then be dried with lint-free cloth.

24

5.2 Sterilization Procedure

PREPARATION OF DECONTAMINATION AGENTS

A) DECONTAMINATION-PREDISINFECION

-Proteolytic enzyme based agents (2 possibilities)

1-0. 5% Alkazyme solution in water (20g sachet)

Pour in 1L of warm water an unopened Wait 1 minute Fill up with 4L warm tap

(25 – 30

C) from the tap sachet water and stir

The Alkazyme solution can be used for 8 days if kept in a sealed flask. The solution can also be made up in a

4L recipient using distilled water fill up the soaking tray from there.

OR:

2-0. 5% Aniozyme solution in water (25g sachet):

Pour 1L of warm water an unopened Wait a minute Fill up with 4L warm tap

((25 – 30

C) from the tap sachet water and stir

The Aniozyme solution lasts 1 day in a sealed flask.

B) DISINFECTION AGENT

1- 5% Alkacide solution in water:

5L flask of distilled water Pour the Alkacide on the flask Stir

The Alkacide solution will keep for 8 days in a sealed flask:

Fill soaking tray (500ml) when disinfection is necessary.

C) RENEWING CONTENTS OF SOAKING TRAYS

For frequent use, the contents of the trays should be replaced at the beginning of the morning and at the beginning of the afternoon.

Wait 10 minutes after the last decontamination before emptying out the Alkazyme or Aniozyme solutions.

STANDARD PROTOCOL

25

Reminder:

-disconnect the probes from the machines. Machines must be turned off first.

-Avoid any contact between liquids and the electrical connectors at the ends of probes

Sector scan B type probe A scan type probe

A) Decontamination-Predisinfection

1°Immerse the first 5 cm maximum in a 1°Immerse the probe and the cable solution of either Alkazyme or Aniozyme for except for the connector in a solution

5 to 15 minutes depending on the perceived of either Alkazyme or Aniozyme for 5 level of risk. to 15 minutes depending on the perceived

level of risk.

2°Clean the end of the probe in the chosen 2°Clean the probe and the cable in the solution for 1 minute using the brush. Chosen solution for 1 minute using the

brush.

Dry

3°Clean the rest of the probe body and the cables using a swab ligtly dampened with the same solutin. Do not wet the connectors.

B) Rinsing

4°Rinse the end of the probe in demineralized 3°Rinse the probe and the cable in or distilled water. Do not wet the connectors. demineralized or distilled water.

Do not wet the connectors.

Sector-scan B type probe A scan type probe

26

C) Disinfecion

5°Dip the probe up to A maximun of 5 cm in 4°Dip the probe and the cable in the the Alkacide solution for 5 to 20 minutes Alkacide solution for 5 to 20 minutes depending on the estimated level of risk. depending on the estimated level of risk

Do not wet the connectors. Do not wet the connectors.

Dry

6°Clean the probe body and the cable that were not soaked using a wipe lightly dampened with the Alkacide solution.

Keep the connectors dry.

D) Rinsing

7°Rinse the end of the probe with 5°Rinse the end of the probe with demineralized or distilled water. demineralized or distilled water.

Keep the connectors dry. Keep the connectors dry.

E) Drying

Sterile compress

Sterile compress

8°Dry with a sterile compress or a single 6°Dry with a sterile compress or a single use dry wipe if the rinsing water was sterile. use dry wipe if the rinsing water was sterile.

9°The B probe is ready for use. 7°The B probe is ready for use.

27

PROTOCOL FOR HIGH RISK PATIENTS

Reminder:

-disconnect the probes from the machines. Machines must be turned off first.

-avoid any contact between liquids and the electrical connectors at the end of the probe.

Sector-scan B type A scan type probe

A)Decontamination -Predisinfection

1°Immerse the first 5 cm maximum in a 1°Immerse the probe and the cable (except solution of either Alkazyme or Aniozyme for for the connector) in a solution of either

5 to 15 minutes depending on the percreived Alkazyme or Aniozyme for 5 to 15 minutes level of risk. depending on the perceived level of risk.

2°Clean the end of the probe in the chosen 2°Clean the probe and the cable in the solution for 1 minute using the brush. Chosen solution for 1 minute using the brush

Dry

3°Clean the rest of the probe body and the cables using a swab ligtly dampened with the same solution.

Do not wet the connector.

B) Rinsing

4°Rinse the end of the probe in 3°Rinse the probe and the cable in

demineralized or distilled water. Demineralized or distilled water.

Do not wet the connectors. Do not wet the connector.

Sector-scan B type probe A scan type probe

28

C) Inactivation

5°Immerse the first 5 cm maximum in a 6 4°Immerse the probe and the cable chlorometric degree solution of sodium (except for the connector) in a 6 hypochloride for 60 min at 20

℃

ensuring the chlorometric degree solution connectors are kept dry . hypochloride for 60 min at 20

℃

ensuring the connectors are kept dry.

Dry

6°Clean the probe body and the cable that were not soaked using a wipe lightly dampened with the Alkacide solution.

D) Rinsing

7°Rinse the end of the probe with demineralized 5°Rinse the probe and the cable with or distilled water. demineralized or distilled water.

E) Disinfection

8° Dip the probe up to a maximum of 5 cm in the 6° Dry with a sterile compress or a

Alkacide solution for 15 min. single use dry if the rinsing water

was sterile.

Dry

9°Clean the probe body and the cable that were not soaked using a wipe lightly dampened with the Alkacide solution . keep the connectors dry.

Sector-scan B type probe A scan type probe

F)Rinsing

29

10° Rinse the end of the probe with demineralized 7° Rinse the end of the probe with or distilled water. demineralized or distilled water.

keep the connectors dry.

G) Drying

Sterile compress

Sterile compress

11°Dry with a sterile compress or a single 8°Dry with a sterile compress or a single use dry wipe if the rinsing water was sterile. use dry wipe if the rinsing water was

sterile.

12°The B probe is ready for use . 9°The A probe is ready for use.

30

6. MAINTENANCE AND TROUBLE SHOOTING

6.1 Maintenance of the Instrument

* Main power socket must be with good grounding.

* The main unit should not be used for a long time, normally not more than 4 hours continuously. While no measurement is done, the instrument should be in the state of freezing.

* Avoid collision and falling of the probe. Keep the top surface of the probe clean.

* None corrosive detergent is allowed to clean the housing. Avoid water and liquid get into the housing and external keyboard. Only a mild detergent may be used with soft cloth.

* In humid area and season, if the instrument is not used for a long time, it should be power-on for two hours per month.

* Don’t shake and fall off the instrument when moving.

* All parts should be put into the original package in case of moving, especially the probe.

Therefore, the original package should be kept properly.

6.2 Biometric Test

There is a test object available with each equipement which imitates four acoustical reflect interfaces of human eyes and used to test the biometric measuring.

Fill the object with distilled water. Be sure that there is no air bubble in the water. Gently place A probe onto the highest stage perpendicularly in the object (see left drawing). Press A to enter

A-scan and MANL to enter manual mode. Click on FRZ/SCN to start scanning; move the probe gently, adjust the gain properly to make the start wave and 3 reflected waves clear and sharp as shown in the figure below.

At this time, press AUTO key, the result will be seen automatically.

Keep the position of the probe, press A and then FRZ/SCN , the test can be restarted.

If the measuring results are repeatable, it means A-biometric scan is working properly.

31

Start wave Reflected wave

6.3 Trouble Shooting

1) Light indicator of the power supply is not on and the instrument doesn’t work.

― Check if the power supply plug and socket are well connected.

―

Unplug the power and check if the fuse is burnt out.

The fuse is 4A Fuse (110V-120V) or 2A Fuse (220V-240V). Be always sure to use the same standard product.

2) Main unit is working, but the monitor is not active or not displayed correctly.

―

Check if the probe is well connected.

If above operation is not effective, please don’t open the housing without authorization.

Contact the supplier immediately. Explain the problems in detail for proper and in time support.

The scanner is a high-tech product designed elaborately. Only qualified trained engineers are authorized to repair the instrument. We are not responsible for problems caused by any kind of unauthorized repair.

If required, we can provide the complete maintenance and repair manual to the authorized qualified engineers of service stations.

32

APPENDIX A SUPPORT INFORMATION

Warranty

1. The product has a warranty of one year from the date of purchasing, on the premise that it is used in accordance with this Manual.

2. If the instrument does not work properly, please contact the warrantor immediately.

3. Following repairs are charged within warranty period:

(1) Problems caused by accidents and man-made damages.

(2) Damages caused by unauthorized repair;

(3) Damages caused by inappropriate operation.

4. We provide continuous maintenance and repair after warranty period with certain charges.

Accessories, Consumables and Supply Information

For purchasing of consumable probe, printing paper and acoustic gel, please contact the local distributor or manufacturer.

33

APPENDIX B The acoustic output information (IEC 1157)

Mode

A B

The acoustic output information a) Maximum power (mW) 19 7.3 b) P- (MPa) 4.3 3.2 c) Iob (mW/cm

2 d) I spta

(mW/cm

2

1.6 e) System settings Console mode: manual Console mode: manual f) Lp (mm) 12 24 g) W pb6

(‖) (mm)

(⊥) (mm)

2.53

2.60

1.68

0.74 h) prr (KHz) 6.250 srr (Hz) Not applicable i) Output beam diamensions (cm

2

) 0.196

Not applicable

22.32

0.636 j) f awf

(MHz) k) APF (%) l) Power-up mode m) AIF (%) n) Initialization mode

9

100%

B-mode Freeze

100%

A-mode

8.5

0%

B-mode Freeze

100%

B-mode o) Acoustic output freeze p) Ltt (mm)

No

1

Yes

1 q) Lts (mm) Contact mode: Contact

Immersion mode:

2～5

注： 1）The definition of the the acoustic output information, see IEC 1157

Contact

34

The acoustic output report (IEC60601-2-37)

Acoustic output reporting table（A-Probe）

Index lable MI

TIS

Non-scan

Scan

A aprt

≤1cm

2

A aprt

＞1cm

2

TIB

Non-scan

TIC

Maximum index value

Associated acoustic parameters

1.01

— — — — —

P ra

P mW

Min. of〔P a

(z s

), I zpta

, a

(z s

) mW

Z s

cm

Z bp

Z b

Z at max. I pi, a d

cm eq f awf

cm

(Z b

) cm

Dim of A aprt

cm

9.0

X cm

Y cm t d

μ s

0.12

Other information

I

P r

at max. I pi d eq pa

,

at max. I pi

a

cm at max. MI

Operating control conditions

W/cm

2

3.1

176

No Operating control of acoustic output

Acoustic output reporting table（B-Probe）

Index lable MI

Scan

TIS

Non-scan

A aprt

≤1cm

2

A aprt

＞1cm

2

TIB

Non-scan

TIC

Maximum index value 0.56

—— —— —— —— —

Associated acoustic parameters

P ra

P mW

Min. of〔P a

(z s

), I zpta

, a

(z s

) mW

Z s

cm

Z bp

Z b

cm

cm

Z at max. I pi, a d eq f awf

(Z b

cm

) cm

8.3

X cm

Dim of A aprt Y cm t d

μ s

0.16

Other information

P r

at max. I pi d eq

I pa

at max. I

， pi

2.3

cm a at max. MI

W/cm

2

45

Operating control conditions

No Operating control of acoustic output

35

APPENDIX C Guidance and manufacturer’s declaration —

EMC

Guidance and manufacturer’s declaration - electromagnetic emissions

The GRU-6000 ULTRASONIC A/B SCAN FOR OPHTHALMOLOGY is intended for use in the electromagnetic environment specified below. The customer or the user of the GRU-6000 should assure that it is used in such an environment.

Emissions test compliance Electromagnetic environment-guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Group 1

Class A

The GRU-6000 uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The GRU-6000 is suitable for use in all establishments, other than domestic establishment and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Class A

Complies

36

Guidance and manufacturer’s declaration - electromagnetic immunity

The GRU-6000 ULTRASONIC A/B SCAN FOR OPHTHALMOLOGY is intended for use in the electromagnetic environment specified below. The customer or the user of the GRU-6000 should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment-guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrostatic fast transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

±

±

± 2 kV for power supply lines

± 1 kV for input/output lines

±

±

6 kV contact

8 kV air

1 kV differential mode

2 kV common mode

±

±

±

±

6 kV contact

8 kV air

2 kV for power supply lines

1 kV for input/output lines

±

1 kV differential mode

±

2 kV common mode

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

＜ 5% U

40% U

T

70%U

T

T

(＞95% dip in U for 0.5 cycle

(60% dip in U

T for 5 cycles

(30% dip in U

T for 25 cycles

)

)

T

)

＜ 5% U

(＞95% dip in U for 0.5 cycle

40% U

70%U

T

T

(60% dip in U

T for 5 cycles

T

(30% dip in U

T for 25 cycles

)

)

T

)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the

GRU-6000 requires continued operation during power mains interruptions, it is recommended that the GRU-6000 be powered from an uninterruptible power supply or a battery.

＜ 5% U

(＞95% dip in U for 5 s

T

T

)

＜ 5% U

T for 5 s

(＞95% dip in U

T

)

Power frequency

(50/60Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m

Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: U

T

is the a.c. mains voltage prior to application of the test level.

37

Guidance and manufacturer’s declaration-electromagnetic immunity

The GRU-6000 ULTRASONIC A/B SCAN FOR OPHTHALMOLOGY is intended for use in the electromagnetic environment specified below. The customer or the user of the GRU-6000 should assure that it is used in such an environment.

Immunity test

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

IEC 60601 test level

3 Vrms

150kHz to 80MHz

3 V/m

80MHz to 2.5GHz

Compliance level

1 Vrms

3 V/m

Electromagnetic environment-guidance

Portable and mobile RF communications equipment should be used no closer to any part of the GRU-6000, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance d = 3.5

√

P d = 1.2

√

P 80MHz to 800MHz d = 2.3

√

P 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer and d is the recommended separation distance in metres

(m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the GRU-6000 is used exceeds the applicable RF compliance level above, the

GRU-6000 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the GRU-6000. b

Over the frequency range 150KHz to 80 MHz, field strengths should be less than 1 V/m.

38

Recommended separation distances between portable and mobile RF communications equipment and the GRU-6000 ULTRASONIC A/B SCAN FOR OPHTHALMOLOGY

The GRU-6000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the GRU-6000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile

RF communications equipment (transmitters) and the GRU-6000 as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

Rated maximum output power of transmitter w

150kHz to 80MHz m

80MHz to 800MHz 800Mhz to 2.5GHz d = 1.2

√

P d = 1.2

√

P d = 2.3

√

P

0.01 0.35 0.12 0.23

0.1 0.11 0.38 0.73

1 3.5 1.2 2.3

10 11 3.8 7.3

100 35 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (m) according to the transmitter manufacturer.

NOTE 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

39

APPENDIX D: IOL FORMULA

Six formulae are used in GRU-6000, they are:

SRK-II

SRK-T

BINKHOST-II

HOLLADAY

HOFFER-Q

HAIGIS

Please refer to REFERENCES for further information.

REFERENCES:

HAIGIS W: Biometrie, in: Augenärztliche Untersuchungsmethoden, Straub W, Kroll P, Küchle HJ

(Hrsg), F.Enke Verlag Stuttgart, 255-304, 1995

RETZLAFF J: A new intraocular lens calculation formula, Am Intra-Ocular Implant Soc J 6:148-152,

1980

RETZLAFF J, SANDERS DR, KRAFF MC: Development of the SRK/T intraocular lens implant power calculation formula. J Cataract Refract Surg 16 (3):333-340, 1990

SANDERS DR, KRAFF MC: Improvement of intraocular lens power calculation using empirical data,

Am Intra-Ocular Implant Soc J 6: 263-267, 1980

SANDERS DR, RETZLAFF J, KRAFF MC: Comparison of the SRK II formula and other second generation formulas. J Cataract Refract Surg 14: 136-141, 1988

HOFFER KJ: The effect of axial length on posterior chamber lens and posterior capsule position.

Current Concepts Ophthalmic Surg, 1:20-22, 1984

HOLLADAY JT, PRAGER TC, CHANDLER TY, MUSGROVE KH, LEWIS JW, RUIZ RS: A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg, 14:17-24, 1988

40