SP-3000 Operator Manual Oct 2003

Important Precautions

•

i

Do not remove the cover of the instrument, or you may directly be exposed to high slectric voltage.

Referential Index: Brief Contents of this Manual: This Manual is composed of the following items 1.

Prior to use: Precautions and confirmations for the installation and usage of this instrument

2.

Names and functions of the components: Names and functions of this instrument

3.

Operating procedure: Necessary information for installing and using this instrument

4.

Technical information: Technical information of this instrument, which is convenient for the operation

5.

Maintenance and inspection: Replacement of spare parts for your routine work

6.

Troubleshooting: Counter measures for troubles

7.

Spare parts and option parts: Spare parts and option parts of this instrument

8.

Specifications: Spacifications of this instrument

9.

Index: Please refer to the index, as you need

ii

Symbols used in this manual The symbols used in this Manual represent the following meanings: • Precaution for an action that, if unheeded, may lead to or cause a serious injury or death.

• Warning for an action that, if unheeded, may lead to or cause an imminent injury or death with an extremely high possibility.

• Precaution for an action that, if unheeded, may lead to or cause a light or medium degree of injury or property damage.

• Special precaution that represents the corporate strategy directly or indirectly related to personal safety or property protection.

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Contents Important Precautions ... i Referential Index ... ii Brief Contents of this Manual ... ii Symbols used in this manual ... iii Contents ... iv 1 Prior to use ... 1-1 1.1

Operating precautions ... 1-1

1.2

Accesories ... 1-3

1.3

Symbol marks ... 1-4

1.4

Outline of the operation ... 1-5

2 Names and functions of the component ... 2-1 2.1

Front and right side view ... 2-1

2.2

Back and left sides view ... 2-3

3 Operating Procedure ... 3-1 3.1 Safety precautions ... 3-1 3.2 Preparation before use ... 3-2 3.2.1

How to connect accessories ... 3-2 a)

How to connect the probe holder ... 3-2

b)

How to connect the Pachyprobe ... 3-2

c)

How to change the Pachyprobe patterns (optional disposable tip probe) ... 3-3

d)

How to connect the power code ... 3-4

3.2.2

How to connect option parts ... 3-4 a)

3.3

How to insert and eject the memory card ... 3-4

Adjusting and setting ... 3-6

3.3.1

Turning power on and adjusting ... 3-6

3.3.2

Description of window ... 3-8 a)

SINGLE setting screen ... 3-8

b)

MAP setting screen ... 3-9

3.3.3

Front buttons ... 3-10 a)

Measure button ... 3-10

b)

SINGLE button ... 3-10

iv

c) 3.3.4

3.4

Setting of measureing conditions and registration of index ... 3-11 a)

Deleting measured data ... 3-11

b)

Calibration ... 3-11

c)

Entry of ID number / Name of Patient / sex / physician ... 3-12

d)

Setting of converted sound velocity and bias values ... 3-13

e)

Setting of eye to be measured ... 3-15

f)

Mode display ... 3-16

g)

Kinds of measured data to be displayed ... 3-17

h)

Bias display ... 3-18

i)

Display of date and time ... 3-18

Measurement ... 3-20

3.4.1

Description of the screen windows ... 3-21

3.4.2

Checking of performances ... 3-22

3.4.3

Preparation for measurement ... 3-23

3.4.4

Precautions for measurement ... 3-24

3.5

3.6

3.7

a)

Measuring methods ... 3-24

b)

Display of measured data ... 3-28

c)

Retaking of data ... 3-29

Saving, loading, and deleting of data ... 3-31 a)

Saving ... 3-31

b)

Loading ... 3-33

c)

Sorting ... 3-35

d)

Deleting ... 3-36

e)

Formatting of the memory card ... 3-38

Data difference display ... 3-39 a)

Setting of area ... 3-39

b)

Deleting of loaded data ... 3-40

c)

Display of difference between loaded data ... 3-41

Data communications ... 3-44

3.7.1 3.8

v

MAP button ... 3-10

Preparation and implementation of sending and receiving data ... 3-44

Printout ... 3-50

3.8.1

Printing procedure ... 3-50

3.8.2

Contents of printout ... 3-51 a)

Printout for SINGLE measurement ... 3-51

b)

Printout for MAP measurement ... 3-52

c)

Printout of displayed SINGLE difference ... 3-53

3.9

d)

Printout of displayed MAP difference ... 3-54

e)

Printout after sending data ... 3-55

Utilities ... 3-56

3.9.1

Description of the window ... 3-56 a)

Data Selection ... 3-57

b)

Sound setting ... 3-58

c)

Time and Data setting ... 3-59

d)

Print Mode setting ... 3-60

e)

Map Construction setting ... 3-61

f)

Cross Section setting ... 3-63

3.10 Memory Card ... 3-67 3.10.1

Specification of optional Memory Card ... 3-67

3.10.2

When the battery in the memory card should be replaced ... 3-67

a)

Displaying "No Battery!" message ... 3-67

b)

Displaying "Low Battery!" message ... 3-68

c)

When the battery is ending of its life ... 3-68

3.10.3

Load the saved memory card data by Windows PC ... 3-69

a)

Windows95/98 ... 3-69

b)

WindowsMe ... 3-70

c)

Windows2000 ... 3-70

3.10.4

Taking the memory card out of the Personal Computer ... 3-71

a)

Windows95/98/Me ... 3-71

b)

Windows2000 ... 3-71

3.11 Turning power off ... 3-72 4 Technical Information ... 4-1 4.1

Pachymetry calculation method and function ... 4-1

4.2

Checking of the software version ... 4-2

4.3

Acoustic Output ... 4-3

5 Inspection and Maintenance ... 5-1 5.1

Warranty ... 5-1

5.2

How to replace the fuse ... 5-2

5.3

Routine maintenance ... 5-3

5.3.1

Maintenance of the probes ... 5-3 a)

Cleaning ... 5-3

b)

Disinfection ... 5-3

vi

5.3.2

Maintenance of the main body ... 5-4

5.4

Replacing the paper for built-in printer ... 5-5

5.5

Storing ... 5-6

5.6

Precautions for disposing of instrument packing materials ... 5-7

6 Troubleshooting ... 6-1 7 Spare parts and Option parts ... 7-1 7.1

Spare Parts ... 7-1

7.2

Option Parts ... 7-2

8 Spacifications ... 8-1 8.1

8.1.1

Pachymetry function ... 8-1

8.1.2

Main unit ... 8-2

8.1.3

Power source ... 8-2

8.2

Energy and other consumptions ... 8-3

8.2.1

Influence of ultrasound energy on human body ... 8-3

8.2.2

Ultrasound energy ... 8-3

8.2.3

Electromagnetic compatibility ... 8-5

8.3

vii

Specifications ... 8-1

Noise ... 8-10

1.Prior to use Make sure that there is no other equipment in the surrounding of the present instrument that generates an intensive magnetic field. An intensive magnetic field may cause this instrument with noises to subsequently disorder the functions of this instrument. Do not place any object on this instrument. For your correct and safe operation of the instrument, please be sure to read this Operator Manual before using this instrument. Do not use this instrument by any operating procedure other than specified in this Manual.

1.1

Operating precautions

•

No other person than skilled person is allowed to use this instrument

•

Give caution for the following items when installing the instrument.

- Install the instrument in a place where it is free from water or chemicals. - Install the instrument in a place where it is free of direct sunbeam, high temparature, excessive moisture or any adverse influences with dusty, salty or sulfic air. - Install the instrument level in a stable place, which is free of inclination, vibration and shock. - Do not install the instrument in a place in which chemicals are stored or which may generate any gas. - Care shall be taken on the frequency and voltage of power source and a permissible electric current (or consumptive electric power). - Make sure of the power source conditions (such as electric discharges and polatiry) - Connect the grounding properly, which may otherwise cause an electric shock.

1-1

•

Give caution to the following items, before using the instrument. - Inspect the contact condition of the switch, polary and dial setting and make sure that the instrument functions properly. - Make sure that all the cords and cables have been connected safely and securely. - Make sure that the grounding has been connected to the instrument properly. - Sufficient care must be taken not to use the instrument in combination with other equipment that may cause erroneous diagnosis or danger. - Recheck the part to which the patient is connected directly.

•

Care must be taken on the following items while using the instrument. - Always watch the instrument and the patient closely and make sure that they have no abnormal condition.

- Should any abnormal condition be found with the instrument or the patient, immediately stop the instrument operation in such a manner that the safety for patient can be secured, or take the appropriate countermeasures.

- Care must also be taken not to cause the instrument to touch the patient. •

Care must be taken on the following items after using this equipment. - For disconnecting the cords, do not apply such an undue force as pulling off the cord with hand.

- For storing the instrument, follow "5.5 Storing" mentioned in the latter part of this Manual.

- For storing the probes, accessories, and cords, clean them and store them at the same place.

- Be sure to keep the instrument clean, so it will be ready for its reuse. •

When the instrument is disordered, do not give your repair yourself, but consult with Tomey Representative for check and/or repair.

•

Do not give any functional and design change to the instrument.

•

Give your periodical inspection to the instrument, parts and components.

•

When reusing the instrument after leaving it unused for a while, check to make sure that it functions properly and safely.

1-2

1.2

Accessories

After unpacking the shipment, make sure that the following items have been received without damages. Should any of the following items be found missing or damaged, ask your local Tomey Distributors or Representatives. The packaging containers and cushion materials should not be disposed but maintained, since they may be necessary when moving or transporting the instrument.

*Main unit of the Ultrasonic Pachymeter SP-3000 ... 1 *3P plug power source cord ... 1 *Pachymeter test piece ... 1 *Printer Paper ... 1 *Dust cover ... 1 *Fuses ... 2 *Operator Manual (This booklet) ... 1

1-3

1.3

Symbol marks [

]

Contrast adjusting volume

[MEMORY CARD]

Memory card slot

[

]

On side of the power source switch

[

]

Off side of the power source switch

[

]

Communication cable connecting terminal

[

]

Maintenance terminal and switch

[

]

Fuses.

[PACHY PROBE]

1-4

Pachy probe connecting terminal.

1.4

Outline of the operation This instrument is designed as an ophthalmic diagnosis instrument which provides the functions which acquires cornea thickness, by using ultrasonic waves which are transmitted from the ultrasonic oscillator enclosed in the probe.

Acoustic output is switch off after measurement.

This instrument measures the time from the echo for corneal epithelium to corneal endothelium, with which the length of the tissues is calculated by applying the sound velocity for conversation as set.

This instrument provides with the automatic measuring function and the sound monitoring function for the pachymetory function.

This instrument also saves measured data, corneal radius of curvatures data and so on in the memory card. The instrument is also capable of displaying a difference of each corneal thickness.

1-5

This page is left intentionally blank.

1-6

2.Names and functions of the component 2.1

Front and right side view. (7) (6)

(1) (8)

(5) (4) (2)

(3)

(9)

(1) Monitor Display/Touch panel Data are displayed and the buttons are used for operation.

(2) Probe Holder Pachyprobe is held in the holder.

(3) Pachyprobe connection terminal. Pachyprobe is connected to the terminal.

(4) Power source indicator Lights up when the power switch is on.

(5) MEASURE front button Turn to measurement display.

(6) SINGLE front button Turn to single setting display.

(7) MAP front button Turn to MAP setting display.

(8) Memory Card Slot The memory card is inserted into this part.

(9) Built-in Printer Print out the result of measurement.

2-1

2.2

Back and left side view. (5)

(4)

(2) (1) (7)

(6)

(3)

(1) Serial communication cable terminal Used to connect the serial communication terminal

(2) Power source cord terminal Used to connect the 3-Pin plug power source cord.

(3) Fuse Holder Fuses are inserted in these holders.

(4) Power Switch Turn the main power ON/OFF.

(5) Contrast adjuster Used for adjusting the contrast of the monitor.

(6) 3-pin plug power source cord. Connects to the AC 3-pin plug power source receptacle.

(7) TOMEY Service Switch This switch is used for maintenance only. Service person, autholized by TOMEY can use this.

2-2

3.Operating Procedure 3.1 Safety Precautions

•

The Pachyprobe must be disinfected before it is used.

•

Do not use the probe, if its eye contacting part is damaged, which otherwise does not only allow an accurate diagnosis, but may also harm the eyelid or the ccornea.

•

This instrument is exclusively designed for the purpose of opthalmic diagnosis and measurement, therefore, it must not be used for any purposes other than for opthalmic purpose.

•

The connection terminals of this instrument must not be used for any purposes other than specified, which otherwise causes to malfunction the

Cautions

instrument

The protection cap should be used for the probe and put it on a probe holder when you do not use a probe.

3-1

3.2 Preparation before use 3.2.1

How to connect the accessories a) How to connect the probe holder (1)

(2)

Insert the claws (1) of the probe holder into the probe holder inserting holes (2) located on the right side of the main unit, by sliding the holder downward along the holes. Care is to be given not to disorder the position of the holder, and place the holder in position by adsjusting its upper and lower sides.

b) How to connect the Pachyprobe

(1)

(2)

The direction of the connector for Pachyprobe is specified. Insert the connector into the terminal until it makes "Click" sound. Insert the Pachyprobe(1) into the Pachyprobe connection terminal(2) located on the front side of the main unit.

3-2

c) How to change the Pachyprobe patterns.(Optional disposable tip probe) (2)

1) (1)

This optional Pachyprobe is consisted by "Inner probe(1)" "Case(2)" "Hold ring(3)" and "Disposable tip(4)"

2)

You can select 2 patterns shape of Pachyprobe. And you select its shape following your purpose.

(3)

(4)

How to change the pattern of probe. Please make sure not to involve air bubble in disposable tip. Air bubble may be cause of inaccurate measurement.

1) (1)

Attach "Case" and "Hold ring" on "Inner probe" with proper order.

(2)

2)

Attach a Ultrasonic gel on the top of "Inner probe".

3)

Put "Disposable tip" on the top of probe and make sure not to involve air bubble.

(4) (3)

(How to change pattern) 1)

Remove "Disposable tip", "Hold ring" and "Case" with proper order.

2)

Change the "Case" following your purpose.

3)

Attach another "Case" and "Hold ring" on "Inner probe" with proper order.

4)

Attach a Ultrasonic gel on the top of "Inner probe".

5)

Put "Disposable tip" on the top of probe and make sure not to involve air bubble.

3-3

d) How to connect the power code

securely insert the connector in specified direction without looseness.

(2)

Insert the connector (1) of the power cord into the terminal (2) of power cord located on the rear side of the main unit. All of 3-pin in the plug must be connected.

U A B

(1)

3.2.2

How to connect option parts. a) How to insert and eject the memory card. When using the memory card for the first time, after unpacking, load the battery as specified in the operator manual. Next, format the memory card by the formatting function of the SP-3000. Since the memory card may be sprung out of the slot, press the ejection button by holding memory catrd.

3-4