HandyScan - Degomed.com

Instructions for use HandyScan
Contents
1. Safety notes 45
2. Warnings 46
3. Description of the equipment 6
4. Preparatory measures 51
4.1 Charging the power pack 51
4.2 Configuration of the HandyScan 51
5. Operating the PRIMEDIC
HandyScan 52
6. Starting up the PRIMEDIC
HandyScan 56
7. Using the PRIMEDIC
HandyScan 64
8. Data management 70
9. Care and maintenance 74
9.1 General cleaning of the probe 74
9.2 Cleaning the scanner 74
9.3 Handling and maintenance 74
10. Disposal 74
11. Technical data, accessories, pictograms 75
11.1 Technical data of the PRIMEDIC
HandyScan 75
11.2 PRIMEDIC HandyScan Charger 76
11.3 Accessories
11.4 Pictograms
76
77
12. Guarantee conditions 78
13. Appendix 79
A1 Additional information 79
A2 Technical safety inspections 83
PRIMEDIC is a registered trademark of METRAX GmbH, Rottweil, Germany.
_________________
20289 / 09.03 / 002 43

Notes on the updated handbook:
HandyScan Instructions for use
In the supplement you will find a complete issue of the instructions for using the PRIMEDIC
HandyScan. All pages bear the same Issue Number: 20289 / 09.02 / 001.
Please note that the old pages should be replaced if this issue is updated.
USA: According to Federal Law in the USA, this equipment may only be used by a doctor or under the
instruction of a doctor.
Manufacturer: METRAX GmbH
Rheinwaldstrasse 22
D-78628 Rottweil
Germany
Tel.: +49 (0)741 257-0
Fax.: +49 (0)741 257-235
These instructions provide information about the PRIMEDIC HandyScan and its probes. The
directions explain the putting into service of the scanner, the instructions for use, technical data,
handling, storage and various probes. In these instructions, keys are designated with capital letters,
while concepts and/or lines from a menu are printed in bold type.
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Instructions for use HandyScan
1. Safety notes
The PRIMEDIC HandyScan which you have purchased has been developed in view of the
demanding requirements in emergency cases. Modern techniques based on our many years’
experience in the development and manufacture of ultrasonic equipment and combined with new,
shock-absorbing materials and new scientific findings will support you in an emergency when extreme
conditions of prehospital situations complicate the diagnostic that needs to be done particularly
quickly.
To enable the PRIMEDIC
HandyScan to function reliably and to your satisfaction, and in order to
avoid risks for either individuals or equipment, please observe the following points:
1. Every use of the PRIMEDIC
HandyScan assumes precise knowledge and observation of these
instructions.
2. The PRIMEDIC
HandyScan is only intended for and suited to applications named or described
in these instructions. Any other utilization may involve unrecognized risks and no attempt may
be made to utilize it otherwise than described.
3. The PRIMEDIC
HandyScan may only be operated by trained and authorized personnel.
Reading these instructions is no substitute for proper training.
4. Repairs, alterations, extensions to and the installation of the PRIMEDIC
HandyScan may only
be carried out by personnel authorized and trained by METRAX. The PRIMEDIC
HandyScan
has no components which can be repaired by the user.
5. The device may only be used with accessories, expendable materials and one-time articles
passed by a testing agency authorized to approve the safe operation of the equipment in its final
form, ready for use. This prerequisite is fulfilled by all original PRIMEDIC
accessories and
expendable items.
6. Before using the device, the user must check the operational safety and orderly condition of the
equipment.
7. Before being used, the device must be within the operating-temperature range. This applies, for
instance, to a HandyScan stored in an emergency vehicle in winter.
8. Do not operate the PRIMEDIC
HandyScan in the direct vicinity of sensitive devices (e.g.
measuring equipment) which are sensitive to magnetic fields or sources of strong interference,
as these may influence the functioning of the PRIMEDIC HandyScan. Keep your distance.
9. In order to avoid damage, the probe cable may not be wound into a coil with a diameter of less
than 9 cm.
10. When cleaning the probe you should first wipe off the transfer liquid with a soft cloth and then
carefully wipe the probe dry with a new, dry cloth. If more thorough cleaning is required, a soft
cloth in combination with a mild detergent or toilet soap and a little water may be used. When
running water is used, the probe should always be held pointing upwards with the cable
hanging down.
11. Avoid vibrations.
Additional regulations applicable to the Federal Republic of Germany:
12. This device meets the requirements of the German Medical Products Law
13.
(Medizinproduktengesetz – MPG) and is subject to the Regulations for Distributors of Medical
Products (Medizinprodukte-Betreiberverordnung – MPBetreibV).
In accordance with the Regulations for Distributors of Medical Products (MPBetreibV), the
device must be subjected to the regular inspections explained in Annex A6.
14. The Regulations for Distributors of Medical Products prescribe that a Medical Product Log-book
be kept for this device. Regular inspections of the device must be documented in this logbook.
For the other Member States of the European Community, the relevant national regulations for the
operation of medical products apply.
20289 / 09.03 / 002 45

2. Warnings
HandyScan Instructions for use
1. In order to exclude any risk of explosion, the device may not be used in proximity to combustible
anaesthetics.
2. In order to avoid the risk of electric shock, the device may not be opened. For maintenance,
contact a qualified service technician.
3. The use of components for this scanner which do not originate from Metrax GmbH may damage
those components originating from Metrax GmbH.
4. To avoid dangers or risks, the electrical installation should correspond to the local requirements
for a piece of equipment belonging to Class IIa, Type BF.
5. The manufacturer, the company setting up or installing the device and the importer is only
responsible for optimum safety, reliability and correct functioning of the installation: if fitting,
extension, readjustment, alteration or repair work is carried out by persons authorized to do such
work,
6. if the electrical installation in the room concerned corresponds to the IEC requirements,
7. if the product is used in accordance with the instructions.
8. Although a permanently installed pulse generator does not represent a risk to patients, it is
possible that the ultrasonic scanning apparatus may damage such a pulse generator if used
directly above the pulse generator.
9. Make sure that the device is not used in an environment where it will be subjected to powerful
electric or magnetic fields (e.g. close to a transformer).
10. The device should not be used in proximity to devices which generate high frequencies (e.g.
medical remote measuring devices or portable telephones). There is otherwise a risk of the
equipment causing incorrect operation or being influenced in a negative way.
11. Avoid installing the equipment close to a radiator or in direct sunlight. For optimum image
contrast, only TFT LCD monitors, correspondingly adjusted by the manufacturer, should be used
with the scanner.
12. If the probe is dropped, it must be thoroughly checked afterwards. Damage to the insulation
might give rise to a danger situation.
13. Detailed instructions on cleaning the probe will be found in Chapter 9.
14. The LCD monitor is fragile and should be treated with corresponding care.
15. Electromagnetic compatibility. The system fulfils the requirements of EN60601-1-2. This is a
Class IIa device.
16. A warning will be displayed if the internal temperature reaches or exceeds 60°C.
17. The system will be shut down if the temperature exceeds 70°C.
18. The probe ceases to vibrate if its temperature exceeds 42°C. A warning will then be displayed
on the screen.
19. The charging unit of the accumulator is not allowed to be plugged in the socket during the drive,
as e.g. the patient could be hurt at high speed in curves.
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Instructions for use HandyScan
3. Description of the device
3
1
6
10 9
Fig.: 1 Overall view of the PRIMEDIC HandyScan
1 Device
3 Keyboard
5 Cable wind-up
6 3.5/5.0 MHz or 5.0/7.5 MHz ultrasonic probe
8 Video output socket
9 Akupak charging socket
10 Akupak cover
20289 / 09.03 / 002 47
8
5

21
22
23
24
25
26
Fig. 2: Operating elements and monitor
HandyScan Instructions for use
20
20 Monitor high-resolution graphic LCD monitor for presenting the ultrasonic image and all
important device parameters.
21 Depth for changing the depth of the image.
22 FREEZE freezes the image displayed.
23 SET for activating and controlling the measuring point and for editing.
24 ESC. to leave the menu or to erase a measurement.
25 SEL. for calling up the main menu and for operating some it its functions.
26 This key is controlled via the software. It is used for various functions
depending on image mode or menu option.
27 ON/OFF On/Off switch
28 FOCUSFIELD These control keys adjust the overall depth of the ultrasonic image to an
acceptable level.
48 20289 / 09.03 / 002
27
28

Instructions for use HandyScan
31
Fig. 3: Ultrasonic probe
30 3.5/5.0 MHz or 5.0/7.5 MHz ultrasonic probe
31 Cable
32 Direction indicator
Mechanical sector
The mechanical scanning system offers several advantages over other scanning techniques. A round
crystal provides a symmetrical ultrasonic bundle, which guarantees a high, balanced resolution both
laterally and also in a transverse direction, while the size of the image guarantees a high degree of
sensitivity thanks to an excellent signal/interference ratio.
Fig.4: Wall fixation
32
Safety note:
If the unit will be put into the wall fixation, it must be attended that the display cover is closed. The
sonde is so adequate protected for dropping down.
20289 / 09.03 / 002 49
30

Two different models are available:
PRIMEDIC HandyScan
HandyScan Instructions for use
3.5/5.0 MHz probe
5.0/7.5 MHz probe
The PRIMEDIC
HandyScan has been specifically designed for rapid and safe use in emergency
situations. All functional units and operating elements are based on the following principles:
• clear arrangement of functional units
• reduction of functions to the absolute essentials
• logical operation guidance
• clear, self-explanatory operating elements
• ergonomic design
The PRIMEDIC
HandyScan can only be operated with the integrated Akupak.
The monitor is a high-resolution LCD graphic display which provides a high image contrast even under
problematic light conditions.
When not in use, the PRIMEDIC HandyScan can be placed in a wall holder. The console can be
secured to a wall or the inside of the emergency vehicle. The PRIMEDIC
HandyScan can, if need be,
be simply and quickly detached via a one-hand release. The wall holder has been tested in accordance
with EN1789.
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Instructions for use HandyScan
4. Preparatory measures
4.1 Charging the power pack
Before using the PRIMEDIC
HandyScan for the first time, the PRIMEDIC
Akupak must first be
charged.
CAUTION:
1. Insert the PRIMEDIC
Akupak into the HandyScan and plug into the socket.
2. AS soon as the power pack is nearly empty, a corresponding display will appear on the
screen. The power pack will then still have enough energy available for approx. 10
minutes.
Plug the charger into a mains wall socket and connect the HandyScan to the charging socket
provided. Charging begins automatically as soon as the device has been plugged in.
After the testing phase, charging commences (red display is permanently illuminated). When charging
is complete, the unit automatically switches to impulse trickle charge (green display is permanently
illuminated; red display goes out).
If the red display on the charger continues to light up after the testing phase (approx. 10 seconds) and
fails to switch to the permanent charge display, the Akupak is defective.
Important:
A power pack that is completely empty must be charged for at least 7 hours. Due to the physical
properties of the battery pack, a charging time that is too brief may cause the device to give a false
interpretation of the charge information. The charge display may erroneously indicate that the power
pack is full. Safe operation of the device may, under such circumstances, be jeopardized.
Important:
• Please do not open the power pack, do not attempt to incinerate, do not overheat or shortcircuit.
• Only re-charge with the charger supplied.
• Use the PRIMEDIC Akupak exclusively for the HandyScan
• Always re-charge at temperatures between 0 and 40°C.
• Power-pack storage temperature: -20 to +40°C
Safety note:
The charger may only be used in enclosed rooms. Remove the device from the socket if it is not
needed. Do not use the device if the housing or the mains plug are damaged. Do not open the device.
4.2 Configuration of the HandyScan
The PRIMEDIC HandyScan is factory-configured. In order to undertake individual settings, you can
alter certain parameters via the Setup menu. This configuration will be stored until new alterations are
made whether or not the Scanner is switched off or the Akupak changed.
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HandyScan Instructions for use
5. Operating the PRIMEDIC HandyScan
The operating menu begins with a hierarchical tree structure. The main menu is always displayed on
the left-hand side of the screen, overlapping the ultrasonic image. When a menu option is activated, the
second menu is superimposed on the main menu. The main menu remains partly visible. When an
option from the second menu is activated, this is overlapped by a third menu. The functions of the
various keys are described in the following:
SELECT
When only the ultrasonic image is visible on the screen, the SELECT key calls up the
main menu. When scrolling this menu with the cursor keys, with the arrow pointing
upwards and downwards, one of the menu options can be highlighted and activated
by pressing the SELECT key once again. This causes a further menu to be displayed
from which you can call up a menu option as described above by means of the
cursor keys. Repeated activation of the SELECT key will either:
■ call up a further menu window,
■ trigger a process, e.g. call up the calliper,
■ or program the menu option selected.
ESCAPE (Erase)
The ESCAPE key enables you to leave the menu last selected. This key permits the
selected menu to be removed from the display without activating a function of the
menus concerned. In a frozen image, the ESCAPE key is used to erase one
measurement after another.
SET
In several menus (grey-map editor) the SET key is used for editing. If no menus are
displayed, the SET key is used to activate and control the measuring point.
The direct operation keys
The direct operation keys are often used during an examination.
ON/OFF
This key permits the power supply to the HandyScan to be switched on and off.
FREEZE (stationary image)
The FREEZE key is used to freeze an image or to thaw it out. Thawing an image
automatically erases the measurements unless the function is otherwise
programmed.
This key is controlled via the software. It has various functions depending on image
mode or menu option.
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Instructions for use HandyScan
IMAGE DEPTH
CURSOR KEYS
Depth control
The IMAGE DEPTH key permits the displayed image depth to be altered. The upper
and the lower limit depends on the probe and the frequency. A lower frequency
permits the display of a greater image depth.
These keys can be used to alter the position of the cursor and of the calliper.
Depth adaptation
These control keys adjust the overall depth of the ultrasonic image to an appropriate
level.
The last valid level is stored in the non-volatile memory.
The screen
The screen is subdivided into the following sectors:
Status field
The status field shows the current mode/status of the scanner on the left-hand half of the screen, e.g.
FREEZE (F), REVERSE (R), DYNAMIC NOISE FILTER (DNF), FRAMERATE and DOUBLE
IMAGE.
Depth scale & focus points
A scale format indicates the depth displayed. It is possible to select the scale in cm or inch. To select
and program the scale in cm/inch. The current position of the focus point is indicated by an arrow.
20289 / 09.03 / 002 53

The Monitor
HandyScan Instructions for use
Optimum image resolution
Focus adjustment and the number of echo lines per image influence the image resolution.
Focus
The focus of an ultrasonic image is subdivided into three planes:
1 Axial resolution
The resolution rectified with the help of the ultrasonic bundle
The axial resolution is determined by the frequency of the probe. The higher the frequency, the better
the axial resolution. The maximum penetration depth, however, declines.
2/3 Lateral and transverse resolution
The lateral resolution lies on the plane of the ultrasonic bundle, while the transverse resolution lies
vertically to the plane of the ultrasonic bundle. As mechanical probes make use of annular echo
converters, lateral and transverse resolution are identical. The AAS 3.5/5.0 MHz and 5.0/7.5 MHz
probes have optimised fixed focus.
Result sector (1)
The result sector shows the results of 1the
measurement.
Image sector (2)
The image is displayed in the image sector in
the middle of the screen.
2
Optimization of image presentation
Always try, in each case, to optimize the image with the help of the scanner’s overall depth control.
Video operation
The scanner makes digital grey-stage conversion possible. Grey-stage conversion is used, in some
applications, to make tissue structures visible. The scanner possesses three pre-programmed and two
user-programmable grey adjustments. The grey adjustments have an effect on the video grey stages
shortly before the video output to the LCD display.
Two grey adjustments can be programmed. The programming and execution of the gamma curves will
be explained in Chapter 6, STARTING UP.
Sector probes
The direction indicator on the handle of the probe serves as a direction indicator. In normal operation,
the groove corresponds to the left-hand side of the image displayed on the screen.
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Instructions for use HandyScan
Example menu structure:
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HandyScan Instructions for use
6. Starting up the PRIMEDIC HandyScan
Basic settings
■ Check the housing, the cable and the probe connection as well as the scanner for any
damage.
■ The scanner is used with a re-chargeable battery. Connect the Akupak to the socket provided
in the device and then insert the Akupak into the slot.
■ If a video printer or a video recorder are present, the video input of this device is to be
connected to the video output of the scanner.
Note:
Connect only CE-certified devices to the HandyScan.
■ In order to exclude all risks, the electrical installation must comply with local safety regulations.
Preparation of the examination environment
The scanner is supplied with current from the Akupak. If the scanner cannot be started, the cable
connections should by checked. If an additional piece of equipment such as a video printer should fail
to function, you should check the mains connection, the mains switch and the signal connection
display.
Should problems nevertheless occur when the HandyScan is switched on, please contact the
manufacturer of the equipment or the nearest dealer.
System and application settings
Basic settings are stored in memory when the device is switched off. When the scanner is switched on,
the programmed basic settings are called up.
Most system settings can be stored in the scanner’s non-volatile memory. The settings remain stored
after the scanner has been switched off. When the scanner is switched on again, the settings in the
non-volatile memory are called up.
The non-volatile settings of the PRIMEDIC
HandyScan comprise two different sectors. These are:
1. System settings
2. Application settings
Programming the "Application settings" is part of the normal system utilization. The only special point is
that the settings have to be stored before power is switched off. This procedure is often described as
"programming via example".
System settings
The system settings comprise all configurable scanner options, including the application settings. The
programmable system parameters include:
■ Watchdog function
■ Time and date
■ Time format and date format
■ Colour of text notes
■ Measuring-point settings
■ Macro command keys
■ All active menu-selection sectors
■ Measuring procedure
■ Measuring unit
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Instructions for use HandyScan
NOTE:
The system settings depend on the software version used in each case, and no guarantee can be given
with regard to software compatibility.
Application settings
Five application settings can be programmed per frequency.
Setting up / Configuring an application:
In order to add an application, please observe the following instructions:
1 . Set up a new application ('New application') if the application does not already exist. To name the
application, please type in a 7-figure name. In addition, an existing application can be renamed via
one of the menu functions. Otherwise, select an existing application.
2. Set the application preferences via normal scanner operation and by selecting all the options
required.
3. As soon as you are satisfied with the settings, save them in the non-volatile memory. Return to the
applications menu ('Applications') and select 'Edit'. A third menu will be displayed. Select 'Save
application'.
The system parameters stored as application settings are:
■ Probe designation
■ Grey setting
■ Speed in M-mode
■ Image depth
■ DNF (Dynamic Noise Filter)
■ Scanning angle
■ Image inversion
■ Dynamic sector
NOTE:
The application settings depend on the software version used in each case, and no guarantee can be
given with regard to software compatibility.
NOTE:
A maximum of five application settings can be programmed per frequency and per probe.
20289 / 09.03 / 002 57

HandyScan Instructions for use
Standard factory settings
In order to reset the HandyScan to the standard factory settings, use the menu option ‘Program /
Installation / Install default settings’. This reprograms the scanner’s original default settings. All
previously stored system and application settings are erased.
Program settings
The HandyScan can be programmed by the user. You can program the scanner for various
applications.
Call up the main menu onto the screen with the SELECT key.
Select Program
The Program menu consists of menu items which you can program as desired.
System settings
Select System settings.
The System settings menu appears on the screen:
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Instructions for use HandyScan
Watchdog
The scanner can be programmed so that it is either completely switched off or just the mechanical
probe (clock) is switched off if the device is not used within a certain period of time. This Watchdog
function is activated as follows: Call up the 'System settings' menu and select Watchdog.
The following menu appears on the screen:
Off: The scanner is neither switched to standby nor switched off completely.
Short: The scanner is switched off completely after approx. 1 min.
Normal: The scanner is switched off completely after approx. 10 min.
Long: The scanner is switched off completely after approx. ½ hour.
Clock: The scanner is switched to standby after approx. 6 min. A clock appears on
the screen.
Time & Date
Select Time or Date. A new menu is displayed:
or
In addition, a small alphanumerical keypad is displayed.
The time or date can now be changed by using the cursor and the Set key (confirmation).
Once the time and/or the date have been changed, the left-hand MACRO (ENTER) key must be
activated. The new time/date settings will now be saved. Accept the change by pressing „SELECT“.
Time and date are displayed at the top left of the screen.
Time format
The time format can be changed by activating Time format.
When Time format is selected, the following menu is displayed:
HH:MM:SS (display in 24-hour format)
HH:MM AM/PM (display in 12-hour format)
Select the desired Time format.
Date format
The date format can be changed by activating Date format.
Select the Date format desired. When Date format is selected, the following menu is displayed:
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HandyScan Instructions for use
Colour
Return to the System settings menu and select Colour. The following colours can be selected
for the calliper and the text displays on the image: White, Grey (light grey) or Dark grey.
Use as a criterion the average brightness of the structures to be displayed. If ultrasonic images on
which measurements are to be made appear too light, a darker cursor is easier to see.
Calliper settings
Return to the Program menu and select Calliper settings. The following menu appears on the
screen:
Length, Area/Circumference
Select Length, Area/Circumference method. Activate SELECT. The following menu appears on
the screen:
Via this menu you can determine whether you wish to perform the Length, Area/Circumference
method manually or automatically.
Manual
If Manual is selected, the cross is moved to the starting position of the measurement. Activate SET.
Move the calliper to the next position along the structure to be measured, and press SET again. Repeat
this procedure until you have drawn in a complete contour or the length of the structure.
Auto follow (automatic)
If Auto is selected, the cross is moved to the starting position of the measurement. Activate SET. Draw
the circumference of the structure or measure its length by moving the calliper.
Ellipse method
Select Ellipse method. The following menu appears on the screen:
In this menu you can determine whether you wish to measure the ellipse on the basis of axes or points.
Axes
If Axes is selected, an ellipse appears automatically as soon as the longitudinal axis has been plotted.
The ellipse can be re-positioned, its size altered and the ellipse rotated.
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Instructions for use HandyScan
Points
If Points is selected, an ellipse appears automatically as soon as five points have been plotted along the
structure to be measured.
Grey maps
Return to the Program menu and select Grey Maps. The following menu appears on the screen:
Select Grey Map 4 or Grey Map 5.
The following graph appears on the screen:
A grey map transforms an input signal into an output signal on the basis of a graph. On the graphic
presentation, the horizontal axis represents the signal received from the probe, a strong echo
producing a high amplitude and a weak echo producing a low amplitude. The scale runs from left, for
weak signal levels, to right, for strong levels. The vertical axis represents the grey level of the screen.
The scale runs from bottom (black) to top (white). Should no gamma correction be required, a straight
line from bottom left to top right must be plotted. On the image, weak echoes appear black and strong
echoes appear white. Reversal of the image is achieved by a straight line running from top left to
bottom right. These two straight lines are called linear graphs. For some applications, however, a nonlinear
graph is more suitable. The following section explains how such a graph is produced.
You can determine your own grey adjustments as follows:
■ Move the calliper with the cursor keys to the left-hand side of the field and position it where
the grey adjustment is to begin.
■ Activate SET. The calliper now changes into a white rectangle, whereby the white line is
immediately shifted.
■ Move the calliper slightly to the right, upwards or downwards, or to the level of the starting
point and activate SET again. A white rectangle appears and the white line changes again.
■ Repeat this procedure until you have determined the entire grey presentation (represented by
the white line).
■ When grey adjustment has been completed, activate the MACRO key to the left of the LCD
screen in order to save the grey adjustment setting.
The programmed graph can be changed as follows:
■ Position the calliper on the white rectangle and activate SET. The white rectangle will be
erased and the white line shifted.
In order to remove grey adjustment completely you must erase all the white rectangles as described
above. To activate your own grey setting, select Applications from the main menu. Then click on
Settings. Go to Grey Maps (grey adjustments) and select your own setting.
NOTE:
The grey adjustment can be programmed within an application.
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HandyScan Instructions for use
Macro
Return to the Program menu.
For every user the scanner offers four macro keys for the rapid implementation of preprogrammed
sequences:
In general, all sequences can be stored from one menu under a single key (macro). A macro is
programmed as follows:
Activate SELECT in order to call up the main menu. Select Program and press SELECT once more.
The Program menu now appears. Select Macro. Place the cursor on the macro command in the
Macro menu which you wish to program and press SELECT. A macro command that has already been
programmed is marked thus: ((Zeichen??)) . An empty window will appear at the bottom of the screen.
The options selected from the menu and which form part of the macro command will be shown in this
window. To permit selection of options from the normal menu structure, press SELECT in order to call
up the menu for macro programming.
Select Menu. The normal menu structure is now displayed.
A sequence can be programmed under a macro command. One sequence is, for instance, the option
Image Angle. With the help of a macro command programmed for altering the image angle, the latter
can be altered automatically.
Example: We wish to program the command MACRO 1 in order to change from one image
angle to another.
1. Press SELECT, slide the cursor to Program and press SELECT once more.
2. Now select Macro, then Macro 1, and press SELECT.
3. The programming window is now displayed.
4. Press, in the following order, SELECT, Menu, Applications, Settings and Image angle.
The last action appears in the window.
5. Then press SELECT and Save and Quit. From now on, the command Macro 1 will change
from one image angle to another.
Save and Quit
The option Save and Quit saves the required sequence as a macro and exits the Program
menu.
Quit
The option Quit exits the Program menu without saving the changes made.
Backspace
The option Backspace erases the last action. The cursor is moved one unit to the left.
Clear
The option Clear erases the entire content of the Program window.
Move
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Instructions for use HandyScan
The option Move links the Program window to the cursor keys to permit you to move it around
the screen and thus see the image underneath it.
Menu
The option Menu enables you to call up the main menu and to navigate to the sub-menus from
where you can call up macro actions.
Activating a macro command
In order to activate a macro command, press the 'Macro' key on the left-hand side of the keyboard. If all
macros have been programmed, the following menu is displayed:
Select the macro command for the desired action.
Installation
Return to the Program menu and select Installation. The lnstallation menu is displayed on the
screen:
Install default settings
Select Install default settings. The following menu is displayed:
Selecting Yes installs the factory default settings and simultaneously erases all settings
programmed by the user.
Main menu
Select Main menu. The following menu is displayed:
Place the cursor on the option to be displayed in the main menu or not, and then press SELECT.
Measurement unit
Select Measurement unit. A new menu is displayed:
At this point you can determine whether the scale on the screen should be displayed in cm or in
inches.
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HandyScan Instructions for use
7. Using the PRIMEDIC HandyScan
Measurements
General
The following keys are available for measurements:
SET key
The SET key freezes the image.
■ Initializes the measurement and generates the calliper.
■ Initializes measuring mode.
■ Fixes the calliper on the spot.
■ If you press the SET key repeatedly before touching the cursor keys, the option
Measurements will be selected.
In B mode, the following measurements can be made:
■ Distance
■ Length
■ Area/Circumference (manual or automatic)
■ Ellipse (volume)
■ Angle
In M mode, the following measurements can be made:
■ Heart frequency
■ Duration
■ Speed
■ Distance
Cursor keys
To position the calliper
Measurements
Five types of measurement are available for images from the B mode:
D(cm): Measurement of distance between two points
L(cm): Measurement of the length of a curve
A(cm 2
) and C(cm): Area/Circumference, manual or automatic
A(cm 2
), C(cm) and V(CM 3
): Area/Circumference, Volume, Ellipse method
Alpha (degrees): Angle measurement
The measurements can be called up with the SET key.
The measurements are arranged as follows: distance, length, area/circumference, ellipse and angle.
The measurement mode called up is displayed on the left of the screen.
Distance
■ The measurement of distance is done on the basis of a straight line between two points. Press
SET once or several times until distance measurement is displayed. The first calliper appears
on the screen.
■ Slide the calliper to the desired position.
■ Press the SET key to fix the position of the first calliper.
■ Press the cursor keys. A second calliper can now be moved to the second position. Do NOT
press SET again.
■ The distance is displayed on the left of the screen.
64 20289 / 09.03 / 002

Instructions for use HandyScan
Length (manual / auto follow)
■ Length measurement is carried out along a curved line. This can be done manually or
automatically. This type of measurement can be selected and programmed.
■ Press SET several times until length measurement is displayed. The first calliper appears on the
screen.
■ Slide the calliper to the desired position with the cursor keys.
■ Press the SET key to fix the position of the first calliper.
■ Then use the cursor keys to draw the outline of the structure. Depending on which
measurement type is active, the outline can be drawn in two ways:
1. Manually: the outline is produced by repeatedly pressing the SET key and by moving the
calliper with the tracker ball.
2. Auto follow (automatic): the outline is produced by locating the calliper on the correct
position. Press SET and produce an outline with the help of the cursor keys.
■ The result is displayed on the left-hand side of the screen.
Area / Circumference (manual / auto follow)
■ Area and circumference are measured simultaneously. Area/Circumference can be measured
manually or automatically. This type of measurement can be selected and programmed.
■ Press SET several times until the (first) Area/Circumference measurement is displayed on the
screen. The first calliper appears on the screen.
■ Slide the calliper to the desired position with the cursor keys.
■ Press the SET key to fix the position of the first calliper.
■ Then use the cursor keys to draw the outline of the structure. Depending on which
measurement type is active, the outline can be drawn in two ways:
1. Manually: the outline is produced by repeatedly pressing the SET key and by moving the
calliper with the tracker ball.
2. Auto follow (automatic): the circumference is produced by locating the calliper on the
correct position. Press SET and produce a circumference with the help of the cursor keys.
■ The result is displayed on the left-hand side of the screen.
Ellipse (Area / Circumference / Volume)
Area, Circumference and Volume can be measured simultaneously via the ellipse
method.
Two methods are available for measuring an ellipse:
1. on the basis of five points,
2. on the basis of the longitudinal axis.
To change the ellipse method: Select / Program / Calliper settings/ Ellipse method; then select
between Axes or Points. This change will be saved as system setting.
Method 1
Points
Press SET several times until Ellipse measurement is displayed on the screen. The first calliper appears
on the screen.
■ Slide the calliper to the desired position with the cursor keys.
■ Press the SET key to fix the position of the first calliper.
■ Then use the cursor keys to move the calliper to the next desired position. Press SET to fix the
second calliper.
■ Repeat this step until five points have been fixed.
■ Then an ellipse is automatically drawn on the basis of the five points.
■ The results are displayed on the left-hand side of the screen.
20289 / 09.03 / 002 65

Method 2
HandyScan Instructions for use
Axes
Press SET several times until Ellipse measurement is displayed. The first calliper appears on the screen.
■ Slide the calliper to the desired position with the cursor keys.
■ Press the SET key to fix the position of the first calliper.
■ Then draw a straight line along the longitudinal axis of the structure.
■ Press the SET key to fix the position of the second calliper.
■ An ellipse of small area is then drawn automatically.
■ Alter the area of the ellipse with the help of the cursor keys.
■ The result is displayed on the left-hand side of the screen.
The position, size and rotation of the ellipse can be changed by pressing the SET key again. A
pictogram showing whether the position, size or rotation is controlled by tracker ball is shown for a few
seconds in the left-hand corner of the screen.
Angle
Press SET several times until Angle measurement is displayed. The first calliper appears on the screen.
■ Slide the calliper with the cursor keys to the position at which you wish to measure the angle.
■ Draw a straight line along one of the lines enclosing the angle.
■ Press the SET key to fix the position of this line.
■ Rotate the tracker ball. A second line appears. Position this line along the other line enclosing
the angle.
■ The result is displayed on the left-hand side of the screen.
Measurement in the M mode
In the M mode, the SET key is used for the following measurements:
Duration T(s)
Heart frequency Hr(b/m)
Distance D(cm)
Speed V(cm/s)
Press SET to show the measurements in the M mode on the right-hand side of the image. The calliper
appears on the image in the M mode.
NOTE:
The heart frequency is measured and displayed after two heart cycles have been completed.
■ As soon as the mitral, aortal or pulmonary valve is displayed, the opening speed of the
valve can be measured:
■ Position the calliper just before the valve opens.
■ Press SET to fix the first calliper.
■ Press one of the cursor keys. A second calliper can now be positioned at the first peak
of the valve movement.
■ The opening speed is calculated automatically and displayed on the left of the screen.
Main menu
As already explained in the introduction to this handbook, the scanner makes use of an extensive 'Pull-
Down' menu structure. These menus are described in combination with the option concerned.
Image modes
Select the option Image modes to display a second menu:
66 20289 / 09.03 / 002

Instructions for use HandyScan
B mode
The HandyScan is started in the B mode Single image live. When B mode is selected, the device
always switches to B mode Single image live.
The active image can be frozen with the FREEZE key.
The word FREEZE is highlighted in the status field when an image has been frozen.
B+B Mode
When B+B mode is selected, a double B image appears on the screen. If the scanner is already in
double-image mode, the same option is used to transfer the live image from the left-hand image to the
right-hand one and vice-versa.
A highlighted 'B' shows whether the left-hand or the right-hand image is activated.
B+M Mode
Select B+M mode. On the left-hand side of the screen, an image in B mode is displayed and, on the
right, an image in M mode.
With the mechanical sector probe, either B mode is active and M mode is frozen, or B mode is frozen
and M mode is active.
If the scanner is already in B+M mode, this option is used for switching between B mode and M mode.
On the M image, the distance between two dotted, vertical lines corresponds to one second. The
complete “swipe” time across the entire screen width is displayed in the status field as:
Swp: ... s
The M image swipe speed can be altered. Select from the main menu, one after the other, Applications,
Settings and M mode speed.
A bar now appears at the bottom of the screen. Use the cursor keys to select an M-mode speed and
press 'Select' to save the speed.
The selection line for M mode can be positioned with the help of the cursor keys.
Then select B mode to return to the individual B-mode image.
M Mode
Select M mode in order to display the M image across the entire screen width.
On the M image, the distance between two dotted, vertical lines corresponds to one second. The
complete “swipe” time across the entire screen width is displayed in the status field as:
Swp: ... s
The M-image swipe speed can be altered as described above.
Zoom
While the scanner is displaying a single live image in B mode, activation of Zoom generates a rectangle
on the screen, the zoom field. This rectangle represents the size of the zoomed image, and can be
moved around with the help of the cursor keys. The size of the zoom field can be altered via the depth
key.
The position of the zoomed image can still be altered via the cursor keys.
Now press the arrow key to the left of the screen in order to retain the zoomed image. Press this key
again in order to return to the normal B-mode image.
Macros
Press the Macros option in order to display a second menu if macro commands have been
programmed. Only the programmed macro commands appear in the macro menu. To program a
macro command, see Chapter 6.
Specials
For explanations, see Specials Measuring Pack as well as the Chapter ‘Specials’ in this handbook.
20289 / 09.03 / 002 67

HandyScan Instructions for use
Applications
Select the option Applications in order to display a second menu on the screen.
Selecting the application
Select the option Select application in order to view the connected frequencies and the
applications programmed per frequency. Use the cursor keys to select one of the frequencies or
applications. Press Select to log the system onto the selected frequency or application.
Settings
Select the option Settings in order to display the following menu.
Upside down
The command Upside down reverses the image vertically. Activating the option again
returns the image to its normal orientation.
Reverse
The command Reverse switches the horizontal orientation of the image. Activating the option
again returns the image to its normal orientation.
Image Angle
Each sector probe has two or more scanning angles, which can be selected by activating Image
angle.
DNF (Dynamic Noise Filter)
This option switches the DNF (Dynamic Noise Filter) on or off.
Dynamic range
Selecting Dynamic range displays a horizontal command bar. With the cursor keys, the dynamic
range on the 'input' side can be tuned to the current application. Please note that the overall image
depth may have to be readjusted after the dynamic range has been set.
M-mode speed
When M-mode speed has been selected, a control bar appears at the bottom of the screen. The Mimage
running speed can be selected with the tracker ball. As soon as the desired speed has been
reached, press SELECT to save it. Five speeds are available.
Grey Maps
The HandyScan makes digital grey stage conversion possible. Three pre-programmed and two userprogrammable
grey-stage adjustments are available. The grey adjustments have an effect on the video
grey stages just before the video output to the screen. Grey adjustments can be changed as soon as
the image has been frozen.
Select the option Grey maps in order to select the best grey setting for the current application.
See Chapter 6 on how to program the grey settings.
68 20289 / 09.03 / 002

Instructions for use HandyScan
Edit
Select the option Edit to display the following menu:
New application
When 'New Application’ is selected, a horizontal bar and an alphanumerical keypad are displayed.
Select the letters with the cursor keys and then press the SET key to store them on the horizontal bar. A
maximum of seven characters can be input.
Save application
Select the option Save application as soon as you have generated a new application and
reprogrammed it as described above.
Save application as
Select the option Save application as if you have reprogrammed the application as described above but
have not allocated a name to it.
A horizontal bar and an alphanumerical keypad are displayed on the screen.
Select the letters with the cursor keys and then press the SET key to store them on the horizontal bar. A
maximum of seven characters can be input.
Rename application
When Rename application is selected, a horizontal bar with the name of an application and an
alphanumerical keypad are displayed on the screen.
Overwrite the existing name of the application using the cursor keys. Select a letter and then press the
SET key in order to display it on the horizontal bar.
Delete application
Select the option Delete application to display a menu with all programmed applications. Select the
application to be deleted and press Select.
Program
Select the option Program to display a second menu. The menu Program offers options which the user
can program him- or herself (see Chapter 6).
About the Scanner
Select the option About the scanner to display a second menu.
This menu contains details intended for the maintenance technician, e.g. series number and date of
manufacture.
Scroll down the page with the cursor keys in order to display the foetal age tables installed.
20289 / 09.03 / 002 69

8. Data management
HandyScan Instructions for use
The position of the zoomed image can be further altered with the cursor keys. Now press the arrow key
on the left-hand side of the screen to save the zoomed image. Press the same key again to return to the
normal image in B mode.
Macros
Select the item "Macros" and a second menu is displayed on the screen if macros have
been programmed. The macro menu only shows the macros which have been programmed.
Specials
The package "Specials measurement" is described in the Chapter "Specials" in this handbook.
Save/Recall image
Select the item "Save/Recall image" and a further menu appears on the screen.
Save image
Select this item and the following menu appears:
Save image.
Recall image.
Image to disk.
Image from disk.
Delete from disk.
Format disk.
Image 1
Image 2
Image 3
Image 4
Select one of the four images under which you wish to save the frozen, i.e. fixed image, and press
"Select".
The following modes can be stored in the permanent memory: B, B+B, B+M, M.
Recall image
Select "Recall image" and the following menu will be displayed.
Select one of the saved images and press "Select".
NOTE: If no images have been saved, the text in this menu will be displayed in white.
Image to disk
This item only appears if an additional memory flash card is installed in the scanner.
Select this item and the fixed image will be stored on the memory card. The following modes can be
stored on diskette: B-mode image, B+B-mode image, B+M-mode image, M-mode image + the Report
page.
Image from disk
This item only appears if an additional scanner memory flash card is installed.
Select this item and a further menu is displayed. Depending how many images are stored there and on
which date they were stored, the menu may look like this. [DIR] 26_01_02 refers to an image
directory which was generated on 26 th
January in the year 2002. If one of these directories is selected,
a menu with all the images saved on this date will be displayed.
Image 1
Image 2
Image 3
Image 4
[DIR] 26–01–02
[DIR] 28–01–02
[DIR] 14–02–02
[DIR] 20–03–02
70 20289 / 09.03 / 002

Instructions for use HandyScan
An example of one such menu is shown below:
B_103022.BMP: this means an image in B mode, saved at 10.30.22 a.m. BB104500.BMP: means an
image in B+B mode, saved at 10.45.00 a.m. BM110500.BMP: means an image in B+M mode, saved
at 11.05.00 a.m.
M_111545.BMP: means an image in M mode, saved at 11.15.45 a.m.
R_113050.BMP: means a report page, saved at 11.30.50 a.m.
Delete from disk
This item only appears if an additional scanner memory flash card is installed.
Select this item and a further menu is displayed. Select this item and a further menu is displayed.
Depending how many images are stored there and on which date they were stored, the menu may
look like this. [DIR] 26_01_02 refers to an image directory which was generated on 26 th
January in
the year 2002. If one of these directories is selected, a menu with all the images saved on this date will
be displayed.
The following is an example of such a menu.
B_103022.BMP
BB104500.BMP
BM110500.BMP
M_111545.BMP
R_113050.BMP
[DIR] 26–01–02
[DIR] 28–01–02
[DIR] 14–02–02
[DIR] 20–03–02
B_103022.BMP
BB104500.BMP
BM110500.BMP
M_111545.BMP
R_113050.BMP
Select the image that you wish to delete and press "Select". Should you wish to delete several images
simultaneously, proceed as follows. Use the cursor keys to locate the image you wish to delete with the
cursor and press "SET". The image is now designated with the symbol . Move the cursor to the next
image you wish to delete and press SET once more. As soon as you have marked all the images which
are to be deleted, press "Select".
Format disk
Select this item to format the flash card. All images saved to it will be deleted.
NOTE: The HandyScan Communication Package permits images to be transferred from the
HandyScan to a PC. Talk to your Metrax area representative or with Metrax GmbH direct if you wish to
receive this package. The HandyScan Communication Package contains instructions which will show
you how to install the package and how to transfer images to your PC.
Text
Three lines of text can be input at the bottom of the display.
Select the item "Text"; the following menu will then be displayed.
Enter text
Select this item and the following menu will then appear. Select Header 1, 2 or 3 in order to input
information such as the patient’s identity, hospital or doctor. The header can consist of 15 characters.
Select Line 1, 2 or 3 in order to input text at the bottom right-hand side of the screen, in agreement
with the programmed header. If, for instance, Header 1 is the patient’s identity, Line 1 should include
the name or the number of the patient. The text for Line 1, 2 or 3 can consist of 25 characters.
Enter text
Hide text
20289 / 09.03 / 002 71

HandyScan Instructions for use
Line 1
Line 2
Line 3
Header 1
Header 2
Header 3
Hide Text
Select this item if you wish to hide lines of text at the bottom of the screen. In order to make lines of
text visible again, select the item "Text" from the main menu. A further menu is displayed. Select
"Expose Text" and the lines of text will re-appear on the screen.
Applications
Select the item "Applications"; a second menu will then appear on the screen.
Select application
Activate the item "Select application"; an overview of the active frequencies and programmed
applications per frequency will be displayed. Use the cursor keys to move the cursor to one of the
frequencies or applications. Press "Select" and the system will switch to the frequency or application
selected.
Settings
Activate the item "Settings" and the following menu will then be displayed on the screen.
Upside down
If you select "Upside down", the image will be stood on its head. If this item is selected again, the
original state of the image displayed will be restored.
Reverse
If you select "Reverse", the image shown will be replaced by the previous one. If you select this item
again, the original state of the image displayed will be restored.
Image angle
Every sector probe has two or more scanning angles selection of which is done via "Image angle".
Select applications
Settings
Edit
Upside down
Reverse
Image angle
DNF
Dynamic range
M-mode speed
Grey maps
DNF (Dynamic Noise Filter)
Selecting this item turns the dynamic noise filter on or off.
Dynamic range
When "Dynamic range" is selected, a horizontal control bar appears. By means of the cursor
keys, the dynamic range of “reception” can be tuned to the current application. Please note that the
overall image amplification may have to be re-adjusted when a new dynamic range setting has been
selected.
M-mode speed
Select "M-mode speed"; a bar will then appear at the bottom of the screen. Use the mouse to select
M-mode speed. As soon as you have selected the desired speed, press SELECT to program this speed.
A total of five speeds are available.
72 20289 / 09.03 / 002

Instructions for use HandyScan
Grey Maps
The HandyScan offers digital grey stage conversion. Three pre-programmed and two userprogrammable
grey stages are available. The grey adjustments have an effect on the video grey stages
just before the video output to the screen. Grey adjustments can be changed as soon as the image has
been frozen. Select “Grey maps” in order to select the preferred grey setting for the current application.
Edit
Activate the item EDIT and the following menu will appear on the screen.
New application
Select this item and a horizontal bar plus an alphanumerical keypad appear on the screen. Select the
letters with the cursor keys and then press the SET key to input them on the horizontal bar. A
maximum of seven characters can be input.
Save application
Select this item as soon as you have input a new application and the application settings have been
reprogrammed as described above.
New application
Save application
Save application as
Rename application
Delete application
Save application
Select the option Save application as soon as you have generated a new application and
reprogrammed it as described above.
Save application as
Select this option if you have reprogrammed the application as described above but still have to type in
a name to it. A horizontal bar and an alphanumerical keypad are displayed on the screen.
Select the letters with the cursor keys and then press the SET key to store them on the horizontal bar. A
maximum of seven characters can be input.
Rename application
A horizontal bar with the name of an application and an alphanumerical keypad are displayed on the
screen. Overwrite the existing name of the application using the cursor keys. Select a letter and then
press the SET key in order to display it on the horizontal bar.
Delete application
Select this option and a menu with all programmed applications appears on the screen. Select the
application to be deleted and press “Select”.
Program
Select the option “Program” to display a second menu. The menu Program offers options which the
user can program him- or herself.
About the Scanner
Select the option “About the scanner” to display a second menu.
This menu contains details intended for the maintenance technician, e.g. series number and date of
latest software update.
20289 / 09.03 / 002 73

9. Care and maintenance
9.1 General cleaning of the probe
HandyScan Instructions for use
When cleaning the probe you should first wipe off the transfer liquid with a soft cloth and then carefully
wipe the probe dry with a new, dry cloth.
If the probe is very dirty, proceed as follows:
■ Clean the probe by hand with water or with water and a mild cleaning agent. Use a soft, damp
cloth. Do not use abrasive cleaning swabs.
■ When running water is used, the probe should always be held pointing upwards with the cable
hanging down.
■ Rub the probe dry with a cloth.
■ Disinfect the probe with Cidex tm activated dialdehyde solution in accordance with the
manufacturer’s instructions.
■ Disinfect the probe carefully with a cloth that contains a little alcohol solution. Never dip the
probe straight into a solution of alcohol.
Store the cleaned and disinfected probes in the probe holder, on the scanner or in the original
container.
NOTE:
For cleaning and intensive disinfection, the following basic precautionary measures should always be
observed:
■ Do NOT dip the probe into alcohol. Alcohol is virtually ineffective in the case of certain
organisms.
■ When cleaning the probe with water and soap, DO NOT use an abrasive cleaning swab. Use a
soft cloth.
9.2 Cleaning the scanner
■ Carefully rub the scanner dry with a cloth.
■ If the scanner is very dirty, proceed as follows:
o Carefully wipe the scanner down with a damp cloth.
o Rub the scanner dry with a cloth.
o Carefully disinfect the scanner with a cloth that contains a little alcohol solution.
Never dip the probe straight into a solution of alcohol.
9.3 Maintenance
Although the scanner has been manufactured with the greatest care out of high-quality materials,
maintenance is required at regular intervals in order to ensure that the device operates perfectly at all
times.
■ Remove dust with a dry cloth or a dry brush. You may use a little water with a mild cleaning
agent. Do not use aggressive detergents.
■ Check whether the fan of the device is operating correctly.
10. Disposal
74 20289 / 09.03 / 002

Instructions for use HandyScan
11. Technical Data, accessories, pictograms
11.1 Technical Data PRIMEDIC HandyScan
Nominal supply voltage: see rating plate
Power consumption: 12 VA
Video OUT:
General data:
Video output, designed for video recordings or printing
options. 1 V(p-p), 75 Ohm.
Scanning method: Mechanical sector
Display modes: B mode, B mode + M mode, M mode, B+B
Probe frequency: 3.5/5.0 and 5.0/7.5 MHz
Max. image depth: 20 cm
Scan converter: Completely digital, 512 x 512 x 8 Bit
Postprocessing: 5 gamma correction graphs
Measuring point: Control via microprocessor, multifunctional measuring
system, measures distance, length, area, circumference,
angle, duration, volume and speed.
Display format: Standard CCIR or EIA Video, 5-inch TFT LCD
Accumulator: 12 Volt rechargeable, min. 5 hours of continuous operation
Safety:
Classification: Within the compass of regulations for Class IIA, Type BF in
accordance with IEC 601-1, medical product of Class II,
hand-held devices
Identification: 0123
The device is a medical product and corresponds to EC
guideline 93/42/EWG (93)
Ambient conditions: Temperatures between 8-40°C, humidity up to 90% (20°C)
General storage conditions: Temperatures between 0-50°C
Dimensions: 19 x 15.5 x 11.5 cm (W x D x H)
Weight: approx. 2.2 kg incl. Akupak and probe
System precision: Diameter, length, circumference and the corresponding
calculations (e.g. GSD diameter) with precision greater
than 95% area and corresponding calculations with
precision greater than 90% volume and weight are
estimated values.
NOTE:
If the device is stored at temperatures below 8°C, the probe oil in the mechanical sector should be
given sufficient time to warm up before the scanner is switched on.
20289 / 09.03 / 002 75

HandyScan Instructions for use
NOTE:
The use of accessories which do not meet the safety requirements of this device may lead to a
reduction in the safety level of the final system.
Please bear the following in mind when making your selection:
■ Use of accessories in the proximity of the patient
■ Proof that the safety test to which the accessory is subjected has been carried out in accordance
with the national standard concerned on the basis of IEC 601 – 1/IEC950 or IEC 601-1-1.
Adaptable dynamic range: 40 dB to 60 dB
Max. image rate: 30 images/sec.
Image angles: 30°, 60°, 80°
Connection: Bi-directional infrared port
Grey shades: 256
Energy supply from exchangeable
power pack: Akupak 12V DC, 4.4 Ah, NiMh
The right to make technical changes is reserved.
Extent of supply: Article No.
PRIMEDIC
HandyScan 3.5/5.0 MHz
consisting of:
96305
1 PRIMEDIC
HandyScan 3.5/5.0 MHz
1 PRIMEDIC
Akupak 20325
1 Instructions for use 20289
1 PRIMEDIC power-pack charger 20394
1 Shoulder strap 20375
1 Tube of Sonogel (250 g) 14224
1 Medical Product Logbook 13084
11.2 PRIMEDIC HandyScan Charger
Input voltage: 230 V AC
Output current: 700 mA
Capacity range: 500 – 5000 mAh
11.3 Accessories
Article No.
Bag with storage pockets ?????
Shoulder strap ?????
Tube of Sonogel (250 g) 14224
PRIMEDIC Akupak 20325
Further accessories, see separate list of accessories and prices.
76 20289 / 09.03 / 002

Instructions for use HandyScan
11.4 Pictograms
The following pictograms are used on the device:
Rating plate:
IPX3
Protection class II
Protected against rain and splashes of water
Observe instructions for use!
Protection degree BF
20289 / 09.03 / 002 77

12. Guarantee conditions
HandyScan Instructions for use
As the manufacturer of this device, Metrax guarantees it for two years from the purchase date
onwards. Within this time, Metrax will remedy, free of charge, defects in this equipment attributable to
defective materials or manufacture. Remedying such defects shall comprise, at the discretion of Metrax,
either repair or exchange. Repairs under guarantee shall not provide grounds for extending the original
guarantee period.
Claims under this guarantee, including legal claims concerning defects, shall not be valid in the case of
insignificant limitation of usability, natural wear and tear or damage, subsequent to the transfer of risk,
resulting from incorrect or careless treatment, excessive strain or as a result of unusual external
influences which are not envisaged by the contract. The same applies if alterations or maintenance
work have been carried out inexpertly either by the purchaser or by some third party.
Any other claims on Metrax are excluded unless such claims are founded on deliberate intent or gross
negligence or compelling legal liability standards.
Claims concerning defects made by the purchaser against the seller (dealer) are not affected by this
guarantee.
Should a claim under guarantee be made, please send the device with proof of purchase (e.g. invoice)
to your dealer or to Metrax, stating your name and your address.
On expiry of the guarantee period, the Metrax customer-service staff will still be at your service!
78 20289 / 09.03 / 002

Instructions for use HandyScan
13. Appendix
A1 Additional information:
The PRIMEDIC
HandyScan is equipped either with a 3.5/5.0 MHz probe or a 5.0/7.5 MHz probe.
Range of applications
The following section explains the application field of the probes:
Probe frequency in MHz Clinical application
3.5/5.0 A F
5.0/7.5 A F S
A Abdominal, F Foetal, S Small organs
Warnings and precautionary measures
Fundamental precautionary measures concerning the probes
Always observe these fundamental precautionary measures:
■ Check the probe regularly for signs of damage.
■ Do NOT use the probe in a damaged condition.
■ If the probe has been dropped or has struck another object, the equipment should NOT
continue to be used until a maintenance technician has checked it.
■ Avoid extreme twisting or bending of the probe cable. If the probe casing has been damaged
or if cracks have appeared in the cable, electrical safety can no longer be guaranteed.
■ Switch the system off before cleaning and disinfecting.
■ In the case of endo-rectal examinations, use a condom to protect probe and cable.
Substances and manipulations which can damage the probes.
Certain substances and manipulations cause damage to the probe. The following incorrect
manipulations or unsuitable substances will void the guarantee for the probe.
Substances which contain the following chemicals will damage the probe:
■ Acetone
■ Methanol
■ Denatured ethyl alcohol
■ Mineral oil
■ Iodine
■ Lotions or gels containing perfume
With regard to the composition of the gel, please agree this with the manufacturer. Should you have
any further questions, please contact your dealer.
The following incorrect manipulations lead to damage:
■ Autoclave cleaning
■ Dipping the probe in chlorine bleach
NOTE:
Intensive disinfection of the probes should only be carried out with the recommended antiseptics.
Other methods are not permissible as they may damage the probes.
Clinical applications
Depending on the probe connected, your scanner can be used for a wide range of clinical applications.
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An overview follows:
HandyScan Instructions for use
Notes for clinical use
In the case of abdominal ultrasonic examination with the probes, the frequency to be used depends on
the structure of the organ to be investigated:
Organ at a depth of: Frequency to be used:
0 - 20 cm 3.5 MHz
0 - 12 cm 5.0 MHz
0 - 6 cm 7.5 MHz
Abdominal application
Depending on the organ or structure to be scanned, use a probe with a frequency of 3.5 MHz, 5.0 MHz
or 7.5 MHz.
Others
To use the probe correctly, you require the following additional items:
■ Disinfection solution (only use recommended brand)
■ Transfer liquid
This section Others provides you with brief information on these additional items and, in some cases,
their suppliers. The additives may also be available from dealers not listed. The manufacturer permits
no other products than those approved by him for servicing the system. The use of other products will
void the service guarantee. Experience has, namely, shown that only our own products contribute
towards the retention of the system’s properties and conformity with the requirements of our service
guarantee.
Transfer liquid
Use the transfer liquid to prepare the probe for examinations. Certain ultrasonic gels are toxic to human
fertility cells. Obtain information from the product manufacturer concerning the correct use of the
product. For additional information on transfer liquids, also read the section entitled 'Substances and
manipulations which may damage the probes’.
Probes for the HandyScan
1 3.5/5.0 MHz mechanical sector (410047)
2 5.0/7.5 MHz mechanical sector (410048)
80 20289 / 09.03 / 002

Instructions for use HandyScan
Details of the acoustic output of the 3.5/5.0 MHz mechanical sector
Parameters B Mode
M Mode
P_
W0 max.
1.2
W0 max.
1.2
Ispt 2.8 34.3
System settings
5.0 MHz
min. scanning angle
min. scanning depth
5.0 MHz
LP 53.8 53.8
W (II) pb6 2.4 2.4
W (_I_) pb6 2.4 2.4
Prr 1708 1000
Srr
Dimensions
28 -
Output bundle
520,6
283.5
Area [mm²]
Ø, [mm],
[0]
19.35
19.0
Fawf 3.2 3.2
Acoustic fraction Power-up[%] 100 100
Acoustic fraction Initialisation
[%]
0 0
Maximum performance [mW] 2.6 1.5
I [mW/cm2] ob 0,6 0,5
Power-up mode B B
Initialisation mode B B
Acoustic output freezing Yes Yes
L [mm] tt 7.29 7.29
L [mm] ts
Inclusive mode
CONTACT CONTACT
20289 / 09.03 / 002 81

HandyScan Instructions for use
Details of the acoustic output of the 3.5/5.0 MHz mechanical sector
Parameters B Mode
W 0 max.
M Mode
W 0 max.
P_ 1.2 1.2
I spt 1.7 24.6
System settings
Frequency
Focus point
Scanning angle
Scanning depth
2d performance output
B-B mode
TIF*
HQM**
5.0 MHz
1.0
Minimum
Minimum
-
-
-
-
5.0 MHz
1.0
Minimum
Minimum
-
-
-
-
L P 49.8 49.8
W pb6 (II) 1.8 1.8
W pb6 (_I_) 1.8 1.8
Prr 1708 1000
Srr 28 -
Dimensions
Output bundle
Area [mm²]
Ø, [mm],
321.3
16.35
201.1
16.0
[0]
Fawf 4.1 4.1
Acoustic fraction Power-up[%] 100 -
Acoustic fraction Initialisation
[%]
1.1 0.7
Maximum performance [mW] 1.1 0.7
I [mW/cm²] ob 0.4 0.3
Power-up mode B B
Initialization B B
Acoustic output freezing Yes Yes
L [mm] tt 5.84 5.84
L [mm] ts
Inclusive mode
* Overall image focus
* High-quality mode
CONTACT CONTACT
82 20289 / 09.03 / 002

Instructions for use HandyScan
A2 Technical Safety Inspections
In accordance with Paragraph 6 (Technical Safety Inspections) of the Regulations for Distributors of
Medical Products (Medizinprodukte-Betreiberverordnung – MPBetreibV), the user is obliged to have
regular inspections carried out. METRAX prescribe that these inspections in accordance with
MPBetreibV, Paragraph 6, be carried out at 24-month intervals.
The technical safety inspections may only be entrusted to persons whose training, knowledge and
experience gained from their practical activities enable them to carry out these inspections properly
and who can carry out their inspection activities without instructions.
If the technical safety inspection reveals faults which could endanger patients, employees or third
parties, the operator is obliged in accordance with MPBetreibV, Paragraph 3, to inform the responsible
authorities without delay.
The following data is to be entered in the Medical Product Logbook prescribed by Paragraph 7 of the
MPBetreibV:
• Date and time the work was carried out
• Name of the person or company carrying out the work, and
• the measures carried out.
The responsibility of METRAX only extends to the details given in these instructions. This applies, in
particular, to new settings, maintenance and alterations to the device.
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