Bardscan II Instructions For Use Ver 12

Bardscan®II User’s Guide

Table of Contents Explanation of Symbols ...2 Table of Contents ...3 Important Information...4 Installation...6 Scanning Procedure...7 Mode Selection ...8 Other Controls...9 Display Layout...10 Start Scanning ...12 Patient Details ...16 Manage Images ...19 Setup...21 Settings...22 General Device Care ...23 Cleaning ...25 Warnings and Precautions...27 Technical Issues ...28 Trouble Shooting...29 Warranty...30 Technical specifications of the scanner ...32

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Bardscan®II User’s Guide

Important Information Product Description The Bardscan®II Ultrasonic scanner is a battery operated, portable B-mode ultrasonic scanner, intended for the non-invasive measurement of urinary bladder volume. The scanner includes an 8.4” colour LCD screen to display cross sectional images of the bladder. A mechanical sector scanning transducer with a round crystal provides a symmetrical ultrasound beam, and gives high lateral and transverse resolution with high sensitivity and a low signal to noise ratio. The bladder volume is calculated automatically when the image is frozen, or it can be manually calculated by placing two or more points on the periphery of the bladder. The volume is then displayed on the screen. An inbuilt thermal printer can be used to print results.

Notice To All Operators Caution: United States Federal law restricts this device to use by or on the order of the Physician. The Bardscan®II should be used only by individuals who have been trained and authorised by their physician All operators should read this User’s Manual. Do not attempt to operate the Bardscan®II until all instructions and procedures in this manual have been read and thoroughly understood. Failure to comply with instructions may compromise the performance of the instrument. This is a class A product. The product is suitable for use in all establishments other than domestic. This product is allowed in domestic establishments under the jurisdiction of a health care professional (according to IEC60601-1-2 clause 36.201.1.8).

Biological Safety To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects. Ultrasound, however, should be used only by a medical professional when clinically indicated, using the lowest exposure times possible commensurate with clinical utility. The ultrasonic output power of the Bardscan®II is not user-adjustable and is limited to the minimum level necessary for effective performance. Data on acoustic output levels can be found in the Technical Specifications section.

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Bardscan®II User’s Guide Statement of Intended Use The Bardscan®II projects ultrasonic energy into the body of a patient to obtain an image of internal soft tissue structures. It is intended primarily to be used for general abdominal applications.

Cautions  Warning: Not intended for foetal use.  Warning: Not intended to be used on pregnant patients.  Warning: There is a possible explosion hazard if the Bardscan®II is used in the presence of flammable anaesthetics.  The Bardscan®II should not be used on a patient with open skin wounds.  Warning: Do not use the Bardscan®II on patients with active implants.

Ultrasound Coupling Gel Use an ultrasound coupling gel to prepare the probe for an exam. Certain ultrasound gels may be toxic to human reproductive cells. It is recommended that you check with the product’s manufacturer to determine appropriate use.

Agents and procedures that may damage the probes Use of any of the following procedures or products WILL VOID your probe warranty:  Acetone, Methanol, Denatured ethyl alcohol, Mineral oil, Iodine  Any lotions or gels containing perfume  Chlorine bleach disinfectant  Autoclaving Check with the ultrasound gel manufacturer regarding gel contents. If you have additional questions please contact your representative.

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Bardscan®II User’s Guide

Installation Components The Bardscan®II includes:  The scanner unit itself  Two removable rechargeable battery packs  An ultrasound probe  A stylus for the touch-screen  A mains cable and power pack  A container of ultrasound gel  A carry bag for all of the above

Figure 1 - Connectors

Connectors Connectors (from left to right): Item

Description

Qty

1

Battery

Removable rechargeable battery

1

2

On Switch

To turn on the unit

1

3

DC input socket For use only with the power pack provided

1

4

USB socket

For use only with memory sticks or external peripherals such as a keyboard or mouse.

1

5

Flash Card socket

For use only with a replacement flash card provided by Bard.

1

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Bardscan®II User’s Guide Contents Quantity

Part Number

Description

1

PA00251

Abdominal Probe

2

PA00284

Battery Pack

1

C01007

Power Supply

1

U0208

Acoustic Coupling Gel

1

PA00140

Carrying Case

1

PS00028

Touch-screen Stylus

1

PA00249

User Guide

1

PA00125A

UK Mains Lead

1

PA00262

Scanner unit

Scanning Procedure Startup Before the Bardscan®II is used it should be left to charge fully for 8 hours. Once it is fully charged, attach a probe and turn the unit on. From then on the battery charge level can be determined by the indicator at the bottom of the screen. The power on button is located on the back of the unit. After it is pressed once the unit will take approximately 1 minute to power-up. In normal use the unit should be shut down through the main menu.

Figure 2 - On Switch

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Bardscan®II User’s Guide General scanning procedure Ensure that a liberal quantity of ultrasound gel is used in all examinations. The most accurate measurements will be obtained while the patient is resting quietly in a supine position. The blue button on the side of the probe toggles it from frozen to transverse scanning and back. It does not identify the orientation of the probe, instead that is indicated by the black dot on the probe, which corresponds to the dot on the screen.

Scanning Frequency For bladder scanning select the correct frequency for the patient to be examined: Patient

Bladder Depth

Frequency to be used

Adult

0-20cm

3.5 MHz

Child

0-12cm

5.0 MHz

Position the probe over the bladder, and gently press down and alter the angle of the probe to obtain the optimum image.

Figure 3- Abdominal Probe orientation marker (Above) and Freeze Button (Below)

After the Exam Check the battery after each use to ensure adequate charge is available for the next exam. It is recommended that you clean probes after each use, as they can be damaged by continual, long-term exposure to gel. If the scanner is not going to be used for some period of time then switch it off through the menu.

Mode Selection When the Bardscan®II is switched on it will start directly in scanning mode. A message will flash up on-screen during the start-up process inviting you to touching any point on the screen to enter the Setup screen. This accesses the touch-screen calibration and timedate control functions. Page 8 of 36

Bardscan®II User’s Guide

Other Controls Touchscreen Use either the stylus for accurate positioning or a finger to locate the item to be selected. For positioning calliper points for length or volumetric calculation it is preferable to use the stylus. Tap the screen gently to avoid causing any damage.

External Mouse or Keyboard If desired a standard USB keyboard or mouse can be connected to the Bardscan®II to replace the touch-screen or on-screen keyboard.

Remote Control An optional remote control can also be added to the system if desired, The USB wireless connector is stored inside the remote control. To remove it press the recessed square at the front of the controller. To replace it simply place it in the square slot and apply a light pressure. To use the remote control firstly ensure that the batteries are charged, and then plug the connector into a USB port on the Bardscan®II. Allow a few minutes for the software to recognise that it has been connected.

The remote control has four buttons, which have the following functions: Top:  Freeze Unfreeze Bottom:  Save Image Left:  Simple: Set for a larger bladder  Advanced: Increase scanning depth Right:  Simple: Set for a smaller bladder  Advanced: Decrease scanning depth

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Figure 4 - Remote Control

Bardscan®II User’s Guide

Display Layout Upper status bar shows:  Patient Name & ID at the top-left and Hospital Name at the top-right.

Figure 5 – Main Screen

Scan Control Down the left side of the display, the scan control buttons access:  Patient – To enter the Patient Management Screen (if selected in the Settings screen).  Scan – to begin a scan (the Sagittal Scan button becomes visible after a Transverse scan has been performed, if selected in the Settings screen).  Freeze – to freeze the image (replaces the Scan & Sagittal Scan buttons during scanning).  Volume - for bladder volume calculations. Only appears once you tap the screen of a frozen image to add a manual marker point.  Delete - to clear manual bladder volume calculations. Only appears once you tap the screen of a frozen image to add a manual marker point.  View Images - to load saved images or save them to a memory stick.  Save Image – to save the image into the memory - not visible if Auto-save image is selected in Settings screen).  Print - if not removed in the Settings screen. Page 10 of 36

Bardscan®II User’s Guide Ultrasound Image In the middle of the display is the ultrasound image.

Image Control Buttons Down the right side of the display, the image control buttons access:  Bladder Size (Scanning depth, as marked on scale on right side of scan).  Image Brightness (Resets to 0 when unit is turned off).  Image Contrast (Resets to 0 when unit is turned off).  Press the + and – buttons to adjust the setting appropriately.  As with the control buttons, these can be removed in the Settings screen.

Additional Control Buttons Situated below the ultrasound image these access:  Settings – controls appearance and setup of the Bardscan®II.  Exit – powers down the unit safely.  Adult or Child scanning (sets the probe frequency as appropriate for patient)

Lower Status Bar Across the bottom of the display, the lower status bar shows:  Instructions  Date & Time

Battery Status Below the ultrasound image is the battery status symbol, which indicates the amount of charge remaining in the battery. It is green when full, changing by degrees to red when empty.

Saving Images The Bardscan®II can be set to automatically save any image where a volume has been calculated. Up to 250 images will be stored in the memory. A warning message will pop-up when the memory is full, allowing you to set the newest to overwrite the oldest.

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Bardscan®II User’s Guide

Start Scanning On the main screen, press Scan or the freeze button on the probe to begin scanning.

Figure 6 – Transverse Scan orientation

Place the probe on the patient with the black orientation marker pointing to their right-hand-side (a Transverse scan).

Figure 7 – Scanning Screen

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Bardscan®II User’s Guide Adjust the location of the probe so that the displayed bladder is positioned as near the middle as possible in the scanned image. Use the Size control at the upper right of the screen to ensure that all of the bladder is visible, and that it is as large as possible on-screen Adjust the location and angle of the probe so that the largest possible cross section of the bladder is displayed. Hold the probe steady and press the freeze button on the probe or the Freeze button on-screen to freeze the image on the display.

Figure 8 – Scanned Image

The Bardscan®II will automatically attempt to find the edge of the bladder, mark it, and calculate the volume from that, displaying it at the top right of the screen. A single transverse scan may be used to calculate the bladder volume, or for a more accurate bi-planar volume both a transverse scan and a sagittal scan may be used (see page 15).

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Bardscan®II User’s Guide Manual Bladder Volume Calculation If you wish to adjust the automatic volume then you can do so as follows: Place at least two bladder outline points on the periphery of the bladder image by tapping the screen in the appropriate locations. Volume & Delete buttons will appear once you have tapped the screen. The Delete button can be used to remove points you wish to alter, or they can be selected and dragged on-screen with the stylus.

Figure 9 – Manual Volume

Press the Volume button to re-calculate the volume. The volume will be displayed on the frozen image display in the top right corner of the image. If the bladder image is not clear enough for an accurate calculation an error message will be given instead. Please try again. If no bladder is visible then the bladder is nearly empty and the volume may be assumed to be <10ml. Bladders of less than 50 millilitres are not usually considered significant, but this may depend on the guidelines within your organisation. Check these before making a determination.

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Bardscan®II User’s Guide Transverse and Sagittal Scanning For a truly accurate bladder volume scan it is recommended that you perform both a Transverse scan and a Sagittal scan. Scan and freeze a transverse bladder image as indicated in the previous section. Place the bladder outline points and calculate the bladder volume as described in the previous section. Press Sagittal Scan and rotate the probe 90° from the previous transverse scan bladder image, so that the black orientation marker is pointed towards the head of the patient.

Figure 10 –Sagittal Scan

Adjust the location of the probe so that the largest possible cross section of the bladder is displayed. Place the outline points on the sagittal image. Press the Volume button to calculate the volume. The volume will be displayed on the frozen image display. This value will be calculated from the data from both transverse and the sagittal images. If you do not calculate a transverse volume before a sagittal one you will receive an error message. Repeat the process from the transverse scan.

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Bardscan®II User’s Guide

Patient Details The Bardscan®II acts as a patient database being able to save details of Patient Name, ID Number & Gender along with ultrasound images and test results. Patient details should be entered before any scanning is commenced so that scanned images can be easily saved against an existing patient record. The active patient name is displayed on the main screen at the top left of the display along with the patient’s ID Number. Any scanned images saved will be assigned to the active patient. To enter the Patient screen press the Patient button.

Figure 11 - Manage Patients

Entering Patient Details An on screen qwerty keyboard is displayed to allow patient details to be entered. Alternatively, an external USB keyboard may be connected if preferred. Select the First Name field in the centre of the screen. A cursor will appear there. Type in the patient’s forename. Continue to enter Last Name and ID in the same manner after selecting the appropriate field. The First Name and ID fields will accept up to fourteen characters each. The Last Name field can contain a maximum of twenty two characters. Highlight either Male or Female in the bottom box to select the appropriate gender. Save the entries by pressing Save. Page 16 of 36

Bardscan®II User’s Guide The patient’s details now appear in the database and can be recalled at any time for reference or editing. If you wish to return to the main screen without either entering or selecting a patient, press Cancel.

Accessing details for an existing patient If the patient has been previously entered into the database, their name will appear in a drop-down list in a section labelled Select Patient in the middle of the Patient Details screen. Scroll to the patient you wish to select and highlight their name. The First Name, Last Name and ID number will appear in the appropriate boxes. Press OK to make them the active patient.

Figure 12 – Select Patient

Editing details for an existing patient If a mistake is made in entering the patient’s details, it can be corrected from the Patient Details screen using the Edit Details button. Highlight and overtype the incorrect information and press the Save button to save the updated details to the database. NOTE: If the ID number is edited, a completely new record will be created using the first and last names but containing the new ID number. This new record will have no scan or test information. Also, it should be noted that you are unable to merge two or more patients’ results into one record.

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Bardscan®II User’s Guide Erasing a Patient If a patient record is no longer required it can be erased from the database by using the Delete Patient button. WARNING: It should be noted that this action will result in the loss of any records (e.g. scan images & test results) associated with the patient being deleted and they CANNOT be recovered.

Figure 13 – Load Patient data

Loading Patient Data To load a list of patient data from a memory stick insert it into the USB port at the rear of the Bardscan®II and select Load Patient List from USB stick from the Manage Patients screen. The E: drive will be accessed automatically. If the appropriate text file is not found you will be offered the opportunity to browse for it. Select it and then press OK to add the relevant entries to the patient database on the unit. To create a list of patient data use a program such as Microsoft Word and enter the First Name, Last Name, ID and Gender. Each should be separated by a comma, and each patient should be on a new line. Save the file as a plain text file called Patients (Patients.txt). Page 18 of 36

Bardscan®II User’s Guide

Manage Images The Manage Images dialogue is used to select saved images to view, to print images and also to copy to a computer saved images with a USB memory stick storage device. Select View Images to enter it. To view the selected image at full size click the View button. To return to the Manage Images screen press End View. To move up and down in the list of images use the arrow buttons.

Figure 14 – Manage Images

The large buttons with up and down arrows to the right of the list of saved images can be used to navigate up and down respectively in the image list. Alternatively, select the desired image by clicking on the relevant line in the image list.

Printing Images Press Thermal printer to send the selected image to the thermal printer.

Deleting Images To delete the selected image click the Delete button and then click the Yes button in response to the Are you sure you want to delete the selected image confirmation dialog. A total of 250 images will be stored by the Bardscan®II.

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Bardscan®II User’s Guide Saving Images Images may be saved to a USB memory stick plugged into the device. To save a single image to the memory stick ensure that the Selected Image radio button is checked then click the Save button. A save dialogue will be presented with the root directory of the memory stick pre-selected as the Save in directory. Click Save in the dialogue to save the selected image to that directory, or if required use the save dialog to navigate to an alternative directory before saving the image.

Figure 15 – Save Images

To save all the images listed ensure that the All Images button is checked, and then click the Save button. A Save Images dialogue will be presented with the root directory of the memory stick pre-selected as the Save in directory. Click OK in the dialogue to save all the images to that directory, or if required use the Save Images dialogue to navigate to an alternative directory before saving the images. Most commonly available USB memory sticks can be used to save images, however the device has been tested using the SanDisk® Cruzer® Micro USB flash. We recommend that this USB memory stick is inserted at start up.

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Bardscan®II User’s Guide

Setup To enter the setup screen press the screen during the start-up procedure. A message instructing you when to do so will flash up on-screen.

Date/Time If the device date or time requires altering then click on the Set Date/Time button. The date/time properties can then be adjusted using the Date/Time Control Panel dialogue. Once the adjustments to the date/time have been made then click the OK button to affect the changes.

Figure 16 – Setup Screen

Touchscreen Calibration Periodically the touchscreen will require calibrating as over time in response to grime on the screen the point at where the cursor is displayed will not coincide with the point where the touchscreen is touched. To perform the calibration procedure click the Touchscreen Calibration button. Then click on the Standard Calibration button in the Calibrate Tab of the Penmount Control Panel dialogue. As accurately as possible touch the red diamonds (the location of which is indicated by blue arrows) that are displayed on the screen.

Figure 17 – TimeDate Setup

If the screen is significantly out of calibration then you can connect a USB mouse to enter this mode, but you must physically touch the screen to calibrate it. Press Save Changes to exit the Setup screen and keep the new settings. Page 21 of 36

Figure 18 – Touchscreen Calibration