SAMSUNG MEDISON HS40 (01) PDF Document

The safety classifications for the SAMSUNG MEDISON HS40 are as follows:

Type of protection against electric shocks: Class I

Degree of protection against electric shocks (when the patient is in physical contact): Type BF or type CF mounting

Degree of protection against the ingress of harmful liquids: General equipment

Degree of safety of use in the presence of flammable anesthetic agent mixed with air, oxygen, or nitrous oxide: Not suitable for use near flammable anesthetic agent mixed with air, oxygen, or nitrous oxide

Mode of operation: Continuous operation

The safety symbols used on the SAMSUNG MEDISON HS40 and in its manual indicate the following:

DANGER: Disregarding this instruction may result in death, serious injury, or other dangerous situations.

WARNING: Follow these instructions to prevent a serious accident or damage to property.

CAUTION: Follow these instructions to prevent minor accidents and damage to property.

NOTE: The accompanying information covers installation, operation, and maintenance procedures that require careful attention from the user, but have little chance of leading directly to a dangerous situation.

The policy for handling patient information on the SAMSUNG MEDISON HS40 is as follows:

Treatment of Patients’ Personal Information:

Patient Information (IDs, names, DOBs, images) must be managed carefully and solely for the purposes of repairs and demonstrations. It must not be used for unauthorized purposes, lost, revised, or shared with a third party.

Management on Demo and Trade Products:

Patient information stored on a product during use must be handled as the patient desires (e.g., deleted or backed up). When a demonstration is complete or a product is traded, patient information must be deleted if requested by the client.

Management on Repaired Hospital Products:

Before removing the product from a hospital for repairs, all patient information should be backed up to a storage device (like an external HDD) and given to the hospital. A patient privacy agreement should be signed before removing the product from the premises.

The main components are:

Front of the Product:

1. Monitor

2. Monitor arm

3. Touch Panel

4. Speaker

5. Control Panel & Handle

6. USB port

7. Probe holder

8. Lift & Lift Lever

9. ECG port

10. Outlet for internal peripheral devices

11. Probe port

12. CW Port

13. Wheel

14. Brake

15. Filter

Back of the Product:

1. Storage compartments

2. Ventilation

3. Cable holder

4. Rear panel

5. ID label

6. Power connection

The monitor of the SAMSUNG MEDISON HS40 displays ultrasound images, operation menus, and other information with the following layout:

1. Title Area: Displays patient information, hospital name, application, frame rate, depth, probe information, acoustic output information, and the current date and time.

2. Image Area: Displays ultrasound images. Image information, annotation, and measurement information are also displayed here.

3. Thumbnail Area: Shows images saved by pressing the Store button. Up to 4 single screens or 12 quad screens are shown. Clicking a thumbnail enlarges it for preview.

4. User Information and Status Information Area: Displays useful information such as current system status, image information, and selectable items.

5. User Key (User Defined Key) Area: Displays settings for User Defined Keys, including Set and Exit buttons. You can change the settings in Setup > Customize > Buttons.

You can move the control panel up and down only while pulling the lever located at the side of the control panel.

CAUTION:

Do not apply excessive force to the control panel.

Use the handles on the console when moving the product, not the control panel.

To ensure the safety of the system and probes, always connect or disconnect probes when the power is off.

1. Connect probes to the probe connectors on the front panel of the system. Up to four probes (five including CW) can be connected.

2. To disconnect, lift up the probe’s lockdown switch.

3. To connect, align the probe connector with the port.

4. Push down the probe’s lockdown switch to lock it in place.

NOTE: If a probe does not connect properly, check for and remove any foreign objects before trying again.

WARNINGS:

Electric shock may result if the system is not properly grounded. Connect to a “hospital grade” or “hospital only” grounded power outlet.

Never open the cover of the product. Hazardous voltages are present inside. All internal adjustments must be made by qualified service personnel.

Always check the product’s housing, cables, and plugs before use. Do not use if any part is damaged, cracked, or worn.

Always disconnect the system from the wall outlet before cleaning.

All patient contact devices (probes, ECG leads) must be removed from the patient before applying a high-voltage defibrillation pulse.

Avoid using the system near flammable anesthetic or oxidizing gases (N2O) due to the risk of explosion.

Do not use with HF surgical equipment, as it may damage the equipment and cause a fire risk.

CAUTIONS:

The system is designed for 100-240VAC. Verify that any connected peripheral’s voltage rating matches the power cord’s rating.

Do not immerse cables in liquids. Cables are not waterproof.

Do not touch SIP/SOP (Signal Input/Output Part) and the patient simultaneously to avoid risk of electric shock from leakage current.

Use the auxiliary socket outlets (rated 100-240VAC, max 150VA total) only for supplying power to equipment intended to be part of the ultrasound system. Do not connect additional multiple-socket outlets or extension cords.

ALARA stands for “As Low As Reasonably Achievable.” It is the guiding principle for the safe use of diagnostic ultrasound. The goal is to keep ultrasound exposure as low as possible while still obtaining diagnostic-quality images, thereby minimizing potential ultrasonic bioeffects.

Applying ALARA on the SAMSUNG MEDISON HS40:

The operator is responsible for controlling the total energy transmitted to the patient by managing exposure time and system settings. Prudent use means limiting patient exposure to the lowest index reading for the shortest time necessary to achieve a good diagnosis.

System Controls for ALARA:

Direct Controls: These directly affect acoustic intensity.

– Application Selection: Choose the correct application for the exam (e.g., do not use peripheral vascular intensity levels for fetal exams).

– Output Power: Use the output control to select the lowest intensity level consistent with good image quality.

Indirect Controls: These have an indirect effect on acoustic intensity.

– Imaging Mode: Scanned modes (2D, Color) disperse energy, while unscanned modes (M-mode, Doppler) concentrate it. Understand the nature of the mode being used.

– Probe Selection: Higher frequency probes have greater attenuation, requiring higher output for deep scanning. Use a lower frequency probe for deeper scans if possible, rather than excessively increasing gain and output.

Receiver Controls: These do not affect output but improve image quality.

– Gain, TGC, Dynamic Range: Always optimize these receiver controls to improve image quality *before* increasing the output power.

Special caution is required when moving the SAMSUNG MEDISON HS40 to prevent product damage or personal injury.

Before Moving:

1. Check that the brakes on the wheels are unlocked.

2. Retract the monitor arm completely so it is secured in a stationary position.

3. Always use the handles on the console to move the product slowly.

Using the Foot Lock (Brakes):

Brakes are mounted to the wheels. To lock the brakes, press the bottom part of the brake with your foot. To unlock, press the part labeled OFF at the top of the brake. It is recommended to lock the brakes when using the product.

Precautions on Ramps:

WARNING: Be aware of the castors. Exercise caution when moving the product up or down ramps.

Always make sure the control panel is facing the direction of movement.

Leaving the cart unattended on an inclined surface may cause it to topple, even if the foot lock is engaged. Do not rest the product on ramps.

Follow these steps to unpack the SAMSUNG MEDISON HS40:

1. Open the box.

2. Remove the protective cover.

3. Take out the probe box and accessory box and store them in a safe place.

4. Unlock the brakes on the wheels.

5. Grab the rear handle on the product and move it to the desired installation location.

Release the Locking Mechanism:

Before use, the monitor arm must be unlocked. Pull down the locking mechanism on the center of the monitor arm to release the lock.

When installing the SAMSUNG MEDISON HS40, adhere to the following environmental conditions:

Optimal conditions are a temperature of 10-35°C and a humidity of 30-75%.

Avoid the following:

Placing the system near generators, X-ray machines, or broadcast cables, which may cause screen noise.

Sharing the power source with other electrical devices that may also produce noise.

Excess humidity.

Direct sunlight.

Excessive fluctuations in temperature.

Installing the product near a heating appliance.

Dusty and/or poorly ventilated locations.

Locations that are subject to vibration.

Locations where chemical substances or harmful gases are present.

The system’s tolerance for temperature and humidity during transport, storage, and operation is as follows:

Before powering on, ensure all probes and peripherals are connected to avoid patient injury or damage to the console.

Turning the Power On:

1. Press the On/Off button when the power is off. Booting will begin.

2. When booting is complete, the 2D mode screen will appear in End Exam status.

3. Before starting a diagnosis, you must register the patient information.

NOTE: If the power switch on the rear panel has been turned off, wait 10 seconds before turning the product back on. Do not press keyboard keys or buttons while the system is booting.

Shutting Down the System:

1. Press the On/Off button while the system is in use. A shutdown window will appear.

2. Click Shut Down on the screen to shut down the system, or click Cancel to cancel.

CAUTION:

To force a shutdown if the system does not turn off, press and hold the On/Off button for five seconds or longer.

If the system is unplugged or forcibly shut down while working, files may become corrupted, leading to system failure or data loss.

To safely cut off electrical power, set the main power switch at the rear of the product to the Off position after shutting down the system.

You can modify general system settings that do not have a direct bearing on imaging based on your needs.

1. On the touch screen, tap the Utility button, then tap the Setup button.

2. The Setup screen will appear. Select a tab that contains the items you want to configure. You can select a tab in one of two ways:

– Use the trackball to navigate and the Set button to select a tab.

– Tap the corresponding button on the touch screen.

3. Specify the settings for each item within the selected tab.

4. Save settings and exit. Click Exit on the main monitor or tap the Exit button on the touch screen to switch to Scan Mode.

If the Power Does Not Turn On:

This could be due to an unplugged power cord, a failed PSU, or a failed power socket.

1. Make sure the power cord is properly plugged in and the power switch is on.

2. Connect a different appliance to the power outlet to check if the outlet is working. If the appliance works, the system’s power connection part may have failed. If it doesn’t work, the outlet has failed.

3. Check if the system fan works. If it does, the problem is likely not with the main power connection. If the fan does not work, the PC Power has likely failed.

4. Check the output voltage of the PSU.

If the Power Does Not Turn Off:

This could be due to running software, a software error, or a failed PC Module/BE board.

1. Press and hold the Power button for at least 3 seconds to force a shutdown. Note: The power will not turn off if hardware (like a printer) is still working or if an OS error has occurred.

2. If the force shutdown does not work, the PC Module and/or BE board may have failed.

If the Power Turns Off by Itself:

This could be a defective Power Cord, PC Module, BE Board, Cable, Connector Pin, or PSU.

1. Make sure the power cord is properly plugged in and the power switch is on.

2. Test the power outlet with another appliance.

3. Check the LED status of the PSU.

4. If the issue persists, the PC Module, BE board, and/or PSU may have failed.

If Nothing Is Displayed on the Screen:

The HDMI Cable, monitor, or PC Module may be defective.

1. Check the status of the product with the printer output. If it prints, the main system is likely working.

2. Check the monitor connection cable to ensure it is secure.

3. If the problem persists, the monitor and/or PC Module may have failed. Inspect the PC Module, BE Board, or BP Board.

If the Screen is Discolored:

The Monitor and HDMI cable may have failed, or the Monitor and/or PC Module may have failed.

1. Check the status of the monitor connection cable.

2. If the cable is secure and the problem continues, the monitor and/or PC Module may have failed. Inspect the PC Module, BE Board, or BP Board.

An error during booting may be a temporary software issue or indicate product failure.

1. Force shut down the system and turn it back on in 1 or 2 minutes.

2. If the problem is not solved, note when the error message appears:

– If it appears when initiating Windows, the OS and/or PC parts may be defective.

– If it appears after displaying the product logo, the System Software and/or Ultrasound System part may be defective.

2D Mode: No IMAGE ECHO or IMAGE FORMAT

This could be due to poor contact between the probe and the product, or a failed BE Board or PSU.

1. Check that the contact between the probe and the system is secure.

2. Check the probe for a vibrating sound. If you can hear it, the PSU has likely failed.

3. If the problem persists, the BE Board has likely failed.

Lines (Noise) Appear in 2D Mode Image

This could be caused by power noise or a failure in the PSU or BF Board.

1. Check if the product is sharing its power outlet with another appliance, especially a motor or high-consumption device, as this can cause noise.

2. Plug the system into an outlet in a different room to see if the symptom persists. If the noise disappears, it was caused by power noise from the original outlet.

3. If the problem is not solved, the PSU or BF Board has likely failed.

M, C, PW, CW Mode Trouble

If you experience issues in M, Color, PW, or CW modes, the PSU, BF, and/or BE Board may be defective.

If you connect a removable device for the first time in Windows 7 and it forces a shutdown, the storage volume may not be recognized upon restart. This issue can be fixed by reinstalling the volume.

1. Launch Windows Explorer, enter “devmgmt.msc” into the address bar, and press Enter to start Device Manager.

2. In the device list, expand the “Storage Volumes” category.

3. Find and right-click on the “Unknown device” under “Storage Volumes” and select Uninstall.

4. In the Device Manager menu, click on Action, then select “Scan for hardware changes”.

Windows should now recognize and properly install the USB device.

General Cleaning:

WARNING: Always turn off the system and disconnect the power cord before cleaning to avoid electric shock.

CAUTION: Do not spray detergent directly onto the exterior. Do not use chemicals like wax, benzene, alcohol, paint thinner, etc.

Console: Use a soft cloth lightly dampened with a mild soap to clean the exterior surfaces.

Monitor: Gently wipe the LCD surface with a soft, dry cloth.

Touch Screen: Wipe the LCD surface with a soft dry cloth. Ensure the screen is not contaminated by conductive substances like ultrasound gel, as this can degrade sensitivity. If contaminated, clean with a dry cloth and reboot the system.

Trackball:

1. Turn the trackball rim counterclockwise to remove it.

2. Wipe the trackball with a soft cloth.

3. Turn the trackball rim clockwise to reattach.

Cleaning Air Filters:

Clean the filter once every three months to prevent overheating.

1. Pull out the filter from under the front of the console.

2. Shake the filter to remove dust and wash it in a mild, soapy solution.

3. Dry the filter with a cloth, then air dry it completely in the shade. A wet filter can cause a malfunction.

4. Slide the filter back into the product.

After installation, inspect the device to verify that it works properly.

Basic Inspections:

Monitor: Check the screen for color, focus, dots, afterimage, stain, and blurriness.

Control Panel and LED Status: Press keys on the control panel to see if text appears correctly. Verify that keyboard LEDs turn on.

Body Mark Key: Check if the Body Marker image appears correctly and if selection works.

Indicator Key (Trackball): Check that the trackball works properly by rolling it up, down, left, and right.

Clear Key: Check that all text and measurements are cleared properly.

Zoom Function: Check the zoom function for proper action.

SonoView: Save images and Cine images in each mode. Check for errors while saving and verify that Backup & Restore functions work.

Measure: Check the operation of Distance, Caliper, Calc, etc.

Patient/End Exam: Enter Patient information and check that it displays correctly in Report, SonoView, etc. Make a measurement and press End Exam to verify it is erased.

Probe Key: Perform a Probe Change and check that it functions correctly.

Detailed Inspections (by Mode):

2D Mode:

– Perform a Phantom test to check for image errors.

– Check Freeze Cine actions (broken image, Auto Run, Trackball Cine).

– Check for image brightness changes when adjusting Gain and TGC.

– Perform Left/Right Flip, Up/Down Direction to check orientation changes.

– Check for changes in the image with changes in depth and focus.

Color Doppler Mode:

– Perform a Phantom test.

– Check for noise when moving or resizing the ROI Box.

– Adjust Scale up and down and check for frequency and blood flow speed range adjustments.

– Check if the Color Bar inverts with the Invert key.

– Move the Baseline up and down to check speed range positioning.

PW Spectral Doppler Mode:

– Perform a Phantom test.

– Change the Scale to check for velocity range changes.

– Move the Baseline to check spectrum range positioning.

– Check if the Doppler waveform inverts with the Invert key.

– Perform Auto Calc and check for correct line display and results.

The Service Mode is used for servicing the HS40, including updating software, backing up the system, and performing diagnostics.

How to Enter the Service Mode:

1. Press the Setup button on the alphanumeric keyboard.

2. Click the Service Mode button on the bottom left of the screen.

3. Ensure that the ‘Select User Level’ option is set to ‘Service Engineer’.

4. Enter the correct password into the Password box.

5. If the password is correct, you will enter the Service Mode.

Service Mode Functions:

Service Information: View hardware, software, and board version information.

Configuration:

– Clock: Change the date, time, and time zone of the Windows System.

– Keyboard/Region: Change keyboard type and system region.

– TCP/IP: Configure network settings (LAN, WLAN).

– Option: Manage licensed applications (install, uninstall).

– User Account: Reset user accounts.

– Printer: Manage printer settings and install drivers.

System:

– Upgrade Software: Install ultrasound software and check its patch version.

– System Serial Number: Change the system serial number of the software.

– Window Explorer: Access Windows Explorer.

– Install Recovery System: Reboot the system and enter the OS environment for software recovery.

Diagnostics:

– Control Panel Test: Test each button on the control panel.

– Keyboard Test: Test each button on the keyboard.

– Power On Self Test (POST): Perform a self-diagnosis of the PIST System.

– Built in Self Test (BIST): Perform a self-diagnosis of the BIST System.

– Monitor Test: Test the color sense and brightness of the monitor.

Backup and Restore:

– Backup: Back up user data files to an external storage device.

– Restore: Restore a selected user data file from a backup.

– Log Backup: Copy all system logs and DB files to an external storage device.

Before starting, ensure the system is powered off and you are using appropriate antistatic gear.

1. Remove Front Case: Remove 2 screws at the bottom and 2 screws in the front of the Front Case, then detach the Front Case.

2. Detach PSA Board: Remove 10 screws and detach the PSA (Probe Select Assembly) Board.

3. Detach BE Module: First, detach the BF (Beamformer) Board. Then, remove 8 screws and the Cover, and detach the BE (Back End) Module.

4. Detach ADM: Remove 4 screws from the ADM Case and 6 screws from the Rear Case. Then, remove 1 Power Connector and 1 screw, and pull the ADM towards you to detach it.

5. Detach Fan Module: Remove 2 screws at the bottom of the Front Side and pull the Fan Module towards you. After detaching it, disconnect the Power Cable Connector.

Ensure the system is powered off and you are using antistatic protection before proceeding.

1. Remove Rear Module: Remove 8 screws and detach the Rear Cover. Then, remove 4 screws and detach the Rear Module.

2. Detach HDD: Remove 2 screws and disconnect 2 connectors, then detach the HDD.

Follow these steps to disassemble the control panel:

1. Remove Top Plate: Remove 4 screws and carefully detach the 2 pieces of the top plate cover. Then, remove 7 screws from the bottom right side and 7 screws from the bottom left side. Lift up the top plate of the CP Panel. While lifting, disconnect 4 connectors and then detach the top plate completely.

2. Disassemble Touch Panel: Remove 1 screw and 2 connectors at the bottom of the CP Panel and disconnect the cable. Then, remove 2 more screws and carefully detach the Touch Panel from the CP Panel without scratching it.

3. Disassemble Track Ball: Remove 2 screws and 1 connector from the Track Ball, and detach the Track Ball.

4. Disassemble Speaker: First, remove 4 screws fixing the speaker in place and detach the speaker module halfway. Then, remove 2 connectors and detach the speaker completely.

All probes must be cleaned before being disinfected after each use.

WARNING: Always use protective eyewear and gloves. Inspect the probe for damage after cleaning/disinfecting.

Cleaning the Probe:

1. Disconnect the probe from the system.

2. Remove and properly dispose of any biopsy guide, needle, and sheath.

3. Use a soft cloth lightly dampened with mild soap or a compatible cleaning solution to remove all particulate matter and bodily fluids from the probe and cable.

4. Rinse with water to remove any soap and cleaning residue (up to the immersion point).

5. Wipe with a clean, dry soft cloth.

Disinfecting the Probe with a Fluid Disinfectant:

CAUTION: Using a non-recommended disinfectant can damage the probe and void the warranty. Do not immerse probes for longer than one hour, unless they are sterilizable.

1. Follow the instructions on the disinfectant label for mixing, use, and disposal.

2. Immerse the probe into the disinfectant according to the immersion diagram for your probe type.

3. Follow the instructions for the required immersion time. Do not exceed the maximum duration.

4. After immersion, rinse the probe with sterile water.

5. Air dry the probe and store it properly (e.g., in a sterile bag) to prevent re-contamination.

WARNING: Only use government-approved needles. Do not attempt to use the biopsy kit until you have read all instructions. Ensure the probe and needle guide are securely attached.

Biopsy Procedure Steps:

1. Prepare the patient for the examination.

2. Install the sheath and the biopsy kit onto the probe.

3. Set the system controls for the biopsy procedure, which will display a needle guideline on the screen.

4. Scan the patient and adjust so the target location is within the needle guideline.

5. Insert the needle into the needle guide and perform the puncture, sliding the needle along the groove until it intercepts the target visible on the screen.

6. Once the examination location is reached, remove the needle from the guide.

7. Detach the needle guide, adapter, and sheath from the probe.

8. Discard all disposable items properly.

Assembling a Stainless Steel Biopsy Kit:

1. Place a sheath over the probe’s handle.

2. Mount the biopsy adapter onto the probe, aligning it with any fluting on the probe’s surface.

3. Install the needle into the needle guide to start the exam.