SONEO Operating Manual Issue 4 May 2005

Operator Manual

Operator Manual

KONTRON MEDICAL S.A.S Zone d'Activités les Gâtines 52, rue Pierre Curie Boîte Postale 97 F – 78373 PLAISIR – FRANCE Telephone: +33 (0) 1 30 07 60 00 Telefax : +33 (0) 1 30 07 55 82

Internet : www.kontronmedical.com E-mail : [email protected]

Manufacturer according to 93/42/EEC

All rights reserved Technology upgrade is a continuous process at KONTRON MEDICAL. Hence, the specifications mentioned in this manual are subject to change without any prior notice. The contents in this manual are strictly not to be reproduced in any form, by any method, for any purpose.

Operator Manual

REGULATORY REQUIREMENT This product complies with regulatory requirements of the following European directive 93/42/CEE concerning medical devices.

Operator Manual

PREFACE To use the unit correctly and ensure a long operation life of the unit, it is most important to understand well the instructions, operation as well as its necessary maintenance. Please read the operator manual carefully before using it.

Even though the system is designed and manufactured with the safety of its operators and patients emphasized, be sure to read the following instructions to ensure a safe and reliable operation of the system:

a. The system should be operated by a qualified person, or let other person operate the unit under his guidance. b. This unit belongs to Type B, Class 1 of the IEC Standard. Be sure to use it correctly and safely according to the safety instruction specified in Section 1.5 Safety of the Operator Manual. c. Never try to remodel the unit. If remodeling is necessary, let us or our appointed agents do the work. d. The unit has been completely adjusted before delivery. Do not touch any adjustable parts that have been well fixed. e. Should any abnormality occur during operation, immediately shut off the power supply and contact our appointed contactor or us. f. The power cord of the unit should be connected to a power socket with ground terminal. The grounding wire should not be moved away. g. In case of connecting the unit with other manufacturer’s device either electrically or mechanically, make sure the device conform to IEC60601-1 standard and re-check the safety of electrical leakage of the system to avoid any possible hazard caused. h. The system is running with safety, however according to specialist’s promote, the working probe cannot be placed on an organ of a patient particularly the

Operator Manual

fetus for a long time. i. The ultrasound gel applied on the patient should be a qualified one.

This Operator manual may be different from that of your equipment due to the updated software for SONEO.

Operator Manual

TTA AB BLLE EO OFF C CO ON NTTE EN NTTS S

1.

GENERAL INFORMATION ...2

1.1 1.2 1.3 1.4 1.5 1.6

The characteristic of the products ...2 Application and Warning ...2 Ambient Conditions...2 Power Requirements ...3 Safety Classification...4 Safety Mark...6 2. STRUCTURE OF THE UNIT ...7 2.1 Main Unit Operation principle...7 2.2 The front panel of main unit ...8 2.3 The rear panel...9 2.4 Keyboard ...10 2.5 Probe ...20 2.6 Accessories ...20 2.7 Options ...20 3. SPECIFICATIONS ...21 3.1 Specification of main unit ...21 3.2 Probe Specification ...24 4. INSTALLATION AND VERIFICATION ...25 4.1 Preparations before turning on the system ...25 4.2 Inspection after power on...25 4.3 Performance verification ...25 5. OPERATION ...26 5.1 Preparation before turning on the system ...26 5.2 Operation Procedures after installation of the equipment ...28 5.3 Image Depiction ...28 5.4 Character input and measurement operation...33 5.5 Relocation of the equipment ...51 6. MAINTENANCE AND SERVICE ...52 6.1 Maintenance and service of probe ...52 6.2 Cleaning and disinfection...53 6.3 Maintenance ...53 6.4 Service...54 6.5 Service responsibility ...54 6.6 Service information ...54 AAPPPPEEN ND DIIXX AA ...55

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Operator Manual

1. GENERAL INFORMATION 1.1 The characteristic of the products SONEO is an electronic linear/convex ultrasound scanner with an advanced built-in digital scan converter (DSC) and a full range of multi-frequency probes from 2.5MHz to 10MHz. Take the C2-5S4 probe as an example. The center frequency of C2-5S4 is 3.5MHz and it can be converted to 2.5MHz, 3.0MHz and 5.0MHz. SONEO consists of a 10” non-interlaced monitor with larger ultrasound imaging and a backlit keyboard. The backlit keyboard allows the operator to view clearly the character on the keyboard even in a dark room. Besides, some keys will become brighter when activated. It is compatible with a video printer and equipped with a RS-232 interface for storage and handling of the image via a computer. SONEO is a full-featured and easy-operated ultrasound scanner. 1.2 Application and Warning With a varied selection of probes, SONEO can be used for examination of abdominal organs, OBS/GYN (including vagina), cardiac and thyroid gland etc. in a polymorphous hospital.

WARNING The SONEO is not applicable for ophthalmology or any examination that ultrasound beam would penetrate through eye.

1.3 Ambient Conditions This unit must be used on the following environmental conditions to ensure a safe and correct operation:

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Operation condition

Storage condition

Ambient Temperature:

5～40℃

-40℃～55℃

Relative Humidity:

≤80%

≤95%

700~1600hPa

700~1600hPa

Atmospheric Pressure:

If the operation temperature and humidity are beyond the ranges above, no correct ultrasonic images are ensured.

NOTE In case of storing the unit for a long time, the ventilation of the storage place must be considered.

Strong radiation sources or electromagnetic waves, from broadcast & TV station for instance, may cause the unit to display an image overlapped or noise. Keep the unit away from the disturbance sources. Do not place anything on the top of main unit. After use of the unit, be sure to turn off the power switch and protect the unit with the accessory dust proof cover. Whenever the unit is not used, keep the cover on since the unit is sensitive to dust. 1.4 Power Requirements The power requirements for the unit are as specified as below. Never use this unit when power supply does not meet the requirements, or the unit may possibly be damaged. Power Voltage for the Main Unit The power voltage for the main unit should be in accordance with the specification on the rear panel of the unit. The voltage fluctuation of power supply to the unit should be within the limits of ±10%. Otherwise, the unit is likely to be damaged.

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Operator Manual

Power voltage: 110V~/220V~ Frequency of the Power Supply: 50Hz/60Hz Apparent Impedance of Power Supply: 0.5Ω or less Grounding Connect the power supply after the additional protective ground connector is connected to the special ground device.

WARNING The user should wait for at least 20 seconds before switching the unit on again after power off.

1.5 Safety Classification a. This system is designed and manufactured in accordance with the Safety Requirements of IEC. To operate the unit correctly and safely, observe the following instructions: The safety protection of electronic shock is classified in Ⅰclass Type B. The safety protection of deleterious fluid is classified in IPX0. The unit should not be used in a flammable atmosphere. The unit can be operating continuously more than 8 hours. This unit needs a protective grounding device. When using it, be sure to earth it with the additional grounding device. Do not use the unit where no ground terminal is available b. Data of Acoustic Output:

X

X

MI 1.0

5-2MHz, C2-5S4 Convex Array ISPTA.3(B) ISPTA.3(M) ISPPA.3 108.45 7.16 41.1

MI

10-5MHz, L5-10S5 Linear Array ISPPA.3 ISPTA.3(B)

0.66

176.0

6.35

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ISPTA.3(B/M) 46.41

Operator Manual

c. Adverse Effects and Precautions The SONEO, same as other diagnostic ultrasound system in the market, should be used only for clinically appropriate reasons, for the shortest period of time and at power settings as low as reasonably achievable (ALARA). The American Institute of Ultrasound in Medicine (AIUM) principle of As Low As Reasonably Achievable (ALARA) is recommended during selection of the output of ultrasound power. Try not to aim probe at the same spot in tissue for a long period of time unless it is really necessary for diagnostic purpose. This system generates acoustic power that is below pre-enactment level, which is generally considered to be safe for the respective applications. The value of ISPTA.3 under M-mode and B/M-Mode is larger than the ISPTA.3 under B-mode. The value of ISPTA.3 is the maximum when only focus M is selected. However the difference between the values of ISPTA.3 for each focus is no so much. Multi-frequency Each probe has three frequencies, including the center frequency, high frequency and low frequency. The acoustic output is decreasing from low frequency, center frequency to high frequency.

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1.6 Safety Mark The user should observe the operating procedure in this Operator Manual and the relative warning message to ensure the safety of the unit. Following is the interpretation of the mark on the unit.：

Characteristic

Name Equalization potential terminal Caution

Type B

Damage for electric shock

Description To eliminate the phasic mistake, the terminal linking to the unit cover should connect to the corresponding terminal of other equipment. Please refer to the relative explanation in the Operator Manual when you find this label on the unit or any document. It is labeled for the safety assurance of the unit. Type B equipment (IEC 60601-1)

Terminals at the High voltage

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Operator Manual

2. STRUCTURE OF THE UNIT 2.1 Main Unit Operation principle The block diagram of SONEO is shown in Fig. 2-1. Following the main unit operation principle: a. The CPU (Central Processing Unit) in the main CPU module reads the instruction from the key operation on the keyboard and issue control commands to the ultrasonic transmitter/receiver according to the instructions. b. The ultrasonic transmitter/receiver sends ultrasonic transmitting signal to the ultrasonic probe. c. The electrical signals are converted into ultrasonic signals by the transducer in ultrasonic probe, and are able to propagate in a patient’s body. d. The ultrasonic waves reflected from a patient’s body are then converted into the electrical signal by the transducer. e. The echo signals are sent to the ultrasonic transmitter/receiver, where the signals are amplified, compressed and detected. f. The detected signals are analog signals. The digital scan converter (DSC) converts them to digital signals, and further writes into a frame memory. The signals in the frame memory are read by means of television timing signals and then are converted into analog signals once again and displayed as an ultrasonic image on the monitor screen, Some image processing function, such as freezing, frame averaging, interpolation and gray scale mapping, is also realized by DSC. g. The 10” monitor receives the non-interlaced compounded video signal and display on the CRT.

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Pr obe A

Moni t or Pusl e T/ R

DSC

Aux. CPU Syst em

Mai n CPU Syst em

Pr obe B

Power Syst em Oper at i on Panel RS- 232C VI DEO I

VI DEO I I

Foot Swi t ch

Fig 2-1 The block diagram of SONEO

2.2 The front panel of main unit Fig 2-2 shows you the scheme of the front panel. The numbers on the front panel represent: 1. 10” monitor 2. Nameplate 3. Brightness Control knob The brightness of the monitor will increase when the knob is turned clockwise. 4. Contrast Control Knob The contrast will increase when the knob is turned clockwise. 5. Power Switch Turn on and off the power supply of the unit.

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1 2

3

4

5

Fig 2-2 Front Panel

2.3 The rear panel Fig 2-3 shows you the scheme of rear panel. 2

1

12

13 3

4 11 5

10 9

8

Fig 2-3

7

Real Panel

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6

Operator Manual

1. Probe Connector A 2. Probe Connector B 3. Video output interface for non-interlaced signal 4. Video output interface for interlaced signal 5. Video printer Connector 6. Connector for Foot Switch (Freeze and unfreeze) 7. RS-232 Port 8. Fan for heat-sinking 9. Power connector 10. Grounding terminal 11. Fuse 12. Warning label 13. Label 2.4 Keyboard Fig 2-4 shows you the picture of keyboard.

● B-mode Selection keys a) B-mode full screen image will be displayed by pressing the

key.

b) The active B mode image of dual B mode will be displayed on the left half of the screen by pressing the

key. Press the

key, the active B mode image is

displayed on the right half of the screen and the image on the left side will freeze.

● M-mode Selection keys Press the

key to display M-mode and B-mode images simultaneously. The left

part on the screen is B-mode image. The sampling beam position, which can be changed by operating the trackball, decides the sampling position of M-mode image on the right part of the screen.

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Operator Manual

Press

key to display the full M-mode image.

● M-mode Sweep Speed Selection key Press

key repeatedly, and you can select four sweep speeds: 8s/f, 4s/f,

2s/f and 1s/f.

● Image Magnification Selection keys (a) Magnification factor increases by pressing

key.

Magnification factor decreases by pressing

key.

(b) Press

key repeating, the magnification factor will be changed from ×

0.8→×1.0→ ×1.2→ ×1.5→×1.7 → ×2.0.

● Image Vertical shift keys The image will be shifted up or down vertically about 2 mm by each press when the image is in B mode and the magnification factor is >1.0.

Fig 2-4 Keyboard

● Focus Selection keys - 11 -

Operator Manual

The focus is corresponding to a required position in the depth direction, which can be selected by the following operation. The focus selected is displayed on the right side of the screen. : Select the focus in ear field, i.e., focus in less-depth portion. Select the focus in middle field, i.e., focus in intermediate portion. Select the focus in far field, i.e., focus in deep portion. Select the focus in extra-far field, i.e., focus in deeper portion.

NOTE a) Only one focus can be selected in M or B/M mode.

b) Multi-step focusing can be selected in B-mode and adjacent focus should be selected simultaneously,

and

for instance, or else the image may have

horizontal straps with discontinuous darkness. ●

Image Processing key Press (1) CORRM

key to enter into Image Processing Menu Change correlated coefficient

To select an extent of frame correlation, there are four correlation factors for selection. When you select a correlation factor form CORR0 to CORR3, a corresponding indication is displayed on the left side of screen. (2) ENHCM

Image Edge Enhancement

By pressing the key, four kinds of edge enhancement can be selected. (3) GREYM

Grayscale Curve Selection key

There are 4 grayscale curves (γ correction) for selection. A corresponding indication is shown on the screen. (4) P/N M

Image Positive-Negative Reverse Key

To reverse the display of image between positive and negative. The key is initially set for negative image display (black background and white characters) - 12 -

Operator Manual

(5) L/R M

Image Left-Right Reverse key

Pressing the key can change scanning direction of ultrasonic beam to reverse the image between left and right. (6) U/D M

Image Upside/downside Reverse Key

The image can be upside-down by pressing this key. The near field is initially set on the upside when power on. This function is subject to trans-vaginal probe only. The Item can be selected by pressing down the corresponding number key or by moving the trackball to highlight the item. To activate the function, pressing key or

key。Press

the item after selected. Press

key repeatedly to alter the parameter of key to retreat from the alteration.

● Frequency selection key Press

Key to convert the working frequency of the probe. There are four

frequencies available for selection for each probe. The working frequency will correspondingly be display on the right side of the monitor.

● Probe Selection key Press

key to select the desired probe. The model and the frequency of

the probe will be displayed on the left side of the screen. Message “NO PROBE” will appear on the screen and the image will be frozen when no probe connects to the selected probe connector. NOTE Probe A will be automatically selected when SONEO power on. Probe B will be initially selected if no probe connects to Probe A when the system turn on.

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Operator Manual

● Freeze key Freeze key is to freeze or unfreeze the image. The character inputted and image acquired will remain unchanged when frozen. The screen will be renewed after unfrozen.

● Cine loop Control key To playback the single frame, please press down frozen. Under single B-mode, press

when the image is

key to Cine loop the frame

continuously. Under M-mode continuous Cine loop is not available. Press “U” to change the speed of Cine loop. Four different kinds of speed are available. In single frame loop under B-mode, the number of frame can be selected by moving the trackball. In M-mode, single frame can be selected by choosing different time slice with trackball. key will be unable when one of PROCESS, OB, MEAS or BODY key is activated.

● Body Mark Control Key Press

key to enter into the Body Mark Menu shown as below:

BODY

Enter the selection of Body Mark

MOROP

Move and turn over the Probe Mark

OFFBY

Remove the Body Mark

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