VITACON VitaScan PD Troubleshooting guide

VitaScan PD
Ultrasound Bladder Scanner
Version 1.0.3 | Date: 11th of December 2017.
User and Service Manual
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VitaScan PD
User and Service Manual
Ver/Rel. No Release Date Mod. By
Mod. Date
Rev, By
Relevant
Stakeholders
Rev, Dt.
Auth. By
Auth. Date Remark/Revision Details
1.0.0 25th- Jan -16
MW MW MW
Inial release
25th- Jan -16 25th- Jan -16 25th- Jan -16
1.0.1 24th- Apr -17
MW MW MW
Update specs, images, and screenshots
24th- Apr -17 24th- Apr -17 24th- Apr -17
1.0.2 6th-June-17
SW SW SW
Specicaon update page 7
06th-June-17 06th-June-17 06th-June-17
1.0.2 27-Sept-17
SW SW SW
Manufacturer informaon update
27 Sept-17 27 Sept-17 27 Sept-17
1.0.3 11-Dec-17
SW SW SW
Easy mode included
11-Dec-17 11-Dec-17 11-Dec-17
The Informaon contained in this user and service manual is proprietary to Vitacon. It is only used for convenience of our
customers. It may be changed in whole or in part without wrien noce. Any service work performed by persons who are
not authorized by Vitacon may void your warranty.
www.vitacon.com

Vitacon provides this publicaon as is
without warranty of any kind, either
expressed or implied, including but not
limited to the implied warranes of
merchantability or tness for any parcular
purpose. Further, Vitacon reserves the
right to revise this publicaon and to make
changes from me to me to the content
hereof, without obligaon to Vitacon
or its local representaves to nofy any
person of such revisions or changes. Some
jurisdicons do not allow disclaimers of
expressed or implied warranes in certain
transacons; therefore, this statement may
not apply to you.
In Europe:
Oce Address:
Vitacon AS
Vegamot 8B
7049 Trondheim Norway
E-mail: [email protected]
hp://www.vitacon.com
In North America:
Vitacon US
600 Twelve Oaks Center
Drive Suite 685, Wayzata,
MN 55391 USA
E-mail: [e-mail]
hp://www.vitacon.us
Manufacturer:
UAB Vitacon LT Naujoji
g. 12-525 Alitaus 62401
Lithuania
Copyright 2017.
All rights reserved.
PN: 6100-500
Vitacon warrants that the VitaScan PD
will substanally conform to published
specicaons and to the documentaon,
provided that it is used for the purpose for
which it was designed. Vitacon will, for a
period of twenty-four (24) months from
the date of purchase, replace or repair
any defecve device, if the fault is due
to a manufacturing defect. In no event
will Vitacon or its local representaves
be liable for direct, indirect, special,
incidental, or consequenal damages
arising out of the use of or inability to use
the VitaScan PD, even if advised of the
possibility of such damages. Vitacon or its
local representaves are not responsible
for any costs, loss of prots, loss of data,
or claims by third pares due to use of, or
inability to use the VitaScan PD. Neither
Vitacon nor its local representaves will
accept, nor be bound by any other form
of guarantee concerning the VitaScan
PD other than this guarantee. Some
jurisdicons do not allow disclaimers of
expressed or implied warranes in certain
transacons; therefore, this statement may
not apply to you.
VitaScan PD
User and Service Manual
Disclaimer
Contacting Vitacon:
Limited Warranty
www.vitacon.com

VitaScan PD
User and Service Manual
Table of Contents
Tables of Contents......................................................................................................................................1
Introducon..................................................................................................................................................2
Important Informaon ...............................................................................................................................2
Indicaons for Use......................................................................................................................................3
Product Features.........................................................................................................................................3
Unpacking and Inspecon.........................................................................................................................3
Content of the packaging..........................................................................................................................4
Storage .........................................................................................................................................................4
Technical Specicaons ............................................................................................................................4
AC/DC Adaptor ..........................................................................................................................................5
Baery ..........................................................................................................................................................5
Product Upgrades and Updates ..............................................................................................................5
System Familiarizaon ...............................................................................................................................5
About the System Soware .................................................................................................................. 10
Electrical Safety ....................................................................................................................................... 10
Equipment Safety .................................................................................................................................... 11
Safety and Performance Summary ...................................................................................................... 11
Labeling Symbols .................................................................................................................................... 12
Applicable Standards/Approals............................................................................................................. 12
Applying the Ultrasound Gel ................................................................................................................ 13
Measuring Bladder Volume ................................................................................................................... 14
Regular Inspecons and Maintenance ............................................................................................... 14
Care, Cleaning and Disinfecng .......................................................................................................... 14
Powering up the System ....................................................................................................................... 14
Scan Operaon......................................................................................................................................... 15
Adjust result .............................................................................................................................................. 18
Setup........................................................................................................................................................... 19
Manufacturer ............................................................................................................................................ 20
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VitaScan PD
User and Service Manual
VitaScan PD - Ultrasound Bladder
Scanner
Real-me bladder scanning is a safe and
easy, non-invasive method to measure
bladder volume. Bladder scanning
measures ultrasonic reecons within
a paent’s body and dierenates the
urinary bladder from the surrounding
ssues.
The VitaScan PD is a B-mode ultrasound
instrument, portable and baery
operated, intended for the non-invasive
measurement of urinary bladder volume.
A mechanical sector scanning transducer
provides cross-seconal images of the
bladder from up to twenty-four scan
planes. Based on these images the
VitaScan PD automacally calculates the
esmated bladder volume in milliliters and
displays it on a screen.
VitaScan PD is applicable in many clinical
areas to determine bladder volume, me
for bladder emptying and detecon of
post-void residual volume (PVR).
A real-me image of the bladder during
pre-scan makes it easier to detect the
bladder before scanning.
Noce To All Operators:
The VitaScan PD should be used only by
individuals who have been trained and
authorized by a physician or the instuon
providing paent care. All operators
should read this manual prior to using
the VitaScan PD. Failure to comply with
these instrucons may compromise the
performance of the instrument and the
safety of the paent.
Biological Safety:
To date, exposure to pulsed diagnosc
ultrasound has not been shown to produce
adverse physiological eects. However,
ultrasound should be used only by medical
professionals when clinically indicated,
using the lowest exposure mes possible
commensurate with clinical ulity.
The ultrasound output power of the
VitaScan PD is not user-adjustable and is
limited to the minimum level necessary for
eecve performance. Data on acousc
output levels can be found in the secon
tled, “Technical Specicaons” in this
manual.
It is recommended that users read the
Health Canada Guidelines for the Safe
Use of Diagnosc Ultrasound before using
this, or any other diagnosc ultrasonic
device. (hp://www.hc-sc.gc.ca/ewh-
semt/alt_formats/hecs-sesc/pdf/pubs/
radiaon/01hecs-secs255/01hecs-
secs255-eng.pdf, note this link may
change over me).
Statement of Intended Use:
The VitaScan PD projects ultrasound
energy through the lower abdomen of the
paent to obtain an image of the bladder.
This image is used to determine bladder
volume noninvasively.
Contraindicaons
The VitaScan PD is not intended for fetal
use or pregnant paents.
Warning: Exposure to low power diagnosc ultrasound has not been shown to
produce adverse eects. However, medical professionals should use ultrasound
only when clinically indicated.
Warning: There is the hazard of possible explosion if the VitaScan PD
instrument is used in the presence of ammable anesthecs.
First me users We advise new operators to use the VitaScan PD on paents
with moderately full bladders, rather than inially aempng to locate nearly
empty bladders.
Introduction
Important Information
!
!
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VitaScan PD
User and Service Manual
Cauon:
The VitaScan PD should not be used on a
paent with open skin or wounds in the
suprapubic region.
• The manual measurement funcon
should be used on paents with
catheters, as a catheter can reect
ultrasound signals that can lead to an
inaccurate volume measurement.
• User care with suprapubic/pelvic
surgery paents, Scar ssue, incisions,
sutures, and staples aect ultrasound
transmission and reecon.
• Accuracy may be aected for paents
with ascites or free oang uid in the
peritoneum.
Indicaons for Use
This manual is directed toward the reader
who is familiar with Ultrasound techniques.
Sonography training and clinical procedures
are not included here. This manual is
not intended as training material for the
principles of ultrasound, anatomy, scanning
techniques, or applicaons. You should be
familiar with all of these before aempng to
read this manual or using the device.
Product Features
• Real-me 3D Ultrasound Bladder
Scanner.
• Automac Urinary Bladder volume
calculaon in large digits
• Storage of ultrasound images
• Simple, intuive soware with Touch-
Screen support
• Large for storage of Paent Records
and Images
• Touch Screen
• USB port to save on external memory
device
• Integrated carry handle
• Baery operated
Unpacking and Inspecon
There are no special unpacking instrucons,
but be careful not to damage the instrument
when unpacking it. When unpacking the
VitaScan PD to check for damage during
shipment:
• Inspect the shipping carton for damage.
If the shipping carton is damaged,
carefully connue unpacking the
instrument and note any dents and
scratches on the VitaScan PD. Save the
damaged shipping carton and packing
material for the carrier’s inspecon and
contact the respecve carrier. If there is
any damage to the scanner equipment,
contact Vitacon.
• If there is no shipping damage, connue
removing the VitaScan PD from the
shipping case. Save the box and packing
materials; they will be needed when
returning the VitaScan PD to Vitacon
for recalibraon or future service.
• Verify that all items listed on the
packing list have been received and are
in good condion.
!
Note:
This box contains specically designed inserts to ensure safe shipment of the VitaScan PD.
Save these for future shipment of the unit for service or calibraon.
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VitaScan PD
User and Service Manual
The content of the packaging:
This box contains specically designed inserts to ensure safe shipment of the VitaScan PD.
Save these for future shipment of the unit for service or calibraon.
• VitaScan PD, VitaScan LT ultrasound probe and probe holder.
• USB Memory sck with User & Service Manual, cercates and applicaon notes
• VitaScan PD console
• VitaScan LT Ultrasound probe
• Thermal Printer
• User Manual
• Power cord
Storage
If the system is to be stored, pack it in the original container, and keep it in an environment
free of corrosive material, uctuaons in temperature and humidity, and vibraon and shock.
Storage Requirements:
Storage temperature from -30°C to 50°C
Relave humidity of 20% to 90% @ 30°C, non-condensing
Atmospheric pressure from 700 hPa to 1060 hPa
As with most electronic equipment, the unit should be operated in a dry area within normal
temperature limits (+10°C to +45°C, 10% - 80% humidity).
Dispose of electronic waste:
VitaScan PD complies with the WEEE Direcve (2002/96/EC) marking requirements.
The axed label indicates that you must not discard this Medical Electric Equipment in
domesc household waste. Product category: With reference to the equipment types in
WEEE direcve annex IA, this product is classed as category 8 “Medical Devices”. To return
unwanted products, contact Vitacon at the address menoned at the front of this manual or
your local VitaScan distributor.
Technical Specicaons
• Display type........................................................................................LCD Touchscreen Display
• Input method............................................................................................................. Touchscreen
• Volume range ............................................................................................................. 0 – 1000 ml
• Accuracy..................................................................................... +/- 10 % of reading, +/- 20 ml
• Frequency ....................................................................................................................... 2.35 MHz
• Acousc Output .............................................................MI max: 0.38, Power: 0.25 mW/cm²
• Thermal Index – TI ...............................................................................................................< 0.02
• Scanning method.........................................................................................Sector, 180 degrees
• Rotaon posions......................................................................6, 12 or 24 rotang posions
• Sweep angle ...............................................................................................................110 degrees
• Max detecon depth.................................................................................100, 160 or 230 mm
• Max probe temperature.................................................35°C @ 22°C ambient temperature
• IP rang .....................................................................................................................................IPX1
• Input Voltage ....................................................................................100 ~ 240VAC, 50 ~ 60Hz
• Dimension............................................(D x W x H) 7.5 x 29.5 x 21 cm - 3.0 x 11.6 x 8.3 in
• Weight .................................................................................................................... 2.0 kg - 4.4 lbs
• Operang condions...............................+10°C to + 45°C, 10 % - 80 % relave humidity
• Storage temperature...........................................................................................-30°C to +50°C
¹ Accuracy referred to measurements on Vitacon Phantoms only.
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VitaScan PD
User and Service Manual
AC/DC Adaptor
Input
Input range 100-240VAC
Frequency 50 - 60Hz
Input current 0.7- 0.35A
Output
Maximum Power 25W
Nominal output 15V DC
Output current Max 1.66A
Table 0-0 Baery Specicaons
Product Upgrades and Updates
Vitacon may oer soware upgrades and new features that may improve system
performance. User and Service Manual updates, explaining the eects of upgrades and new
features on system performance, will accompany the upgrades.
Number Item Specicaons
1Rated Capacity (minimum) 7500mAH with 0.2C Charging &
0.2C Discharging
2Nominal Capacity 75000mAH with 0.2C Charging
& 0.2C Discharging
3 Normal Voltage 11.1V
4Open circuit voltage when shipped 11.40V - 11.85V
5Charge ending voltage 12.60V
6Discharge ending voltage 9.0V
7Charge current 0.4 C
8Charging me 2.0 – 2.5 hours
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VitaScan PD
User and Service Manual
1 Touch Display
2 Ultrasound prob
3 ON/OFF buon
VitaScan PD
System Familiarizaon Introducon
The VitaScan PD is an Ultrasound Urinary Bladder Scanner System. The VitaScan PD consists
of an inbuilt LCD Display with Touch Screen input and ulizes a VitaScan LT Ultrasound
Probe.
Front View
The front view of the VitaScan PD is as shown in the gure below:
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3

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User and Service Manual
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1 VESA mount - 75 x 75 mm
2 Probe holder mount
3 Thermal printer
4 DC Power Inlet – 15V
Back View
The back view of the VitaScan PD is as shown in the gure below:
1
2
3
4

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User and Service Manual
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1 Power On/O switch
2 Thermal printer
Le Side View
The le side view of the VitaScan PD is as shown in the gure below:
1
2

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User and Service Manual
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1 USB port for external USB memory sck
2 USB port for VitaScan LT probe
3 Probe holder
Right Side View
The right side view of the VitaScan PD is as shown in the gure below:
1
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VitaScan PD
User and Service Manual
About the System Soware
Vitacon will provide soware updates on micro SD card. Typically, the new soware provides
new capabilies.
Electrical Safety
This system meets EN60601-1, Class I and Type BF isolated paent-applied parts safety
requirements. This system complies with the applicable medical equipment requirements
published in the European Norm Harmonized Standards, Underwriters Laboratories (UL) and
the Canadian Standards Associaon (CSA).
For maximum safety observe the following warnings and cauons:
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Warning:
To avoid the risk of electrical shock or injury,
do not open the system enclosure.
All internal replacements must be made by a
qualied technician.
To avoid the risk of injury, do not operate the
system in the presence of ammable gasses
or anesthecs.
To avoid the risk of electrical shock, use only
properly grounded equipment.
Shock hazards exist if the power supply is
not properly grounded. Grounding reliability
can only be achieved when equipment is
connected to a receptacle marked “Hospital
Only” or “Hospital Grade” or the equivalent.
The grounding wire must not be removed
or defeated. Connect equipotenal ground
terminal whenever integrity of the external
protecve earth conductor arrangement is in
doubt.
To avoid the risk of electrical shock, before
using the VitaScan PD, inspect the housing,
cable, and probe. Do not use the VitaScan
PD if these are damaged.
To avoid the risk of electrical shock, always
disconnect the power inlet before cleaning
the system.
To avoid the risk of electrical shock, do
not use any transducer that has been
accidentally immersed in any liquid, or has
been immersed in any liquid for cleaning or
any other purpose.
To avoid the risk of electrical shock, do not
touch USB port or Ethernet port and the
paent at the same me.
Cauon:
Although your system has been
manufactured in compliance with
exisng EMC/EMI requirements
(EN60601-1-2), use of the system in the
presence of an electromagnec eld can
cause degradaon of the ultrasound image. If
this occurs oen, Vitacon suggests a review
of the system environment. Idenfy and
remove the possible sources of the emissions
or move your system.
Medical Electric Equipment can be aected
by portable or mobile RF communicaon
devices. Turn OFF any portable or mobile RF
device before operang your system.
Electrostac discharge (ESD), or stac shock,
is a naturally occurring phenomenon. ESD is
common in condions of low humidity, which
can be caused by heang or air condioning.
Stac shock is a discharge of electrical
energy from a charged body to a lesser or
non-charged body. The degree of discharge
can be signicant enough to cause damage
to a transducer or an ultrasound system. The
following precauons can help reduce ESD:
an-stac spray on carpets, an-stac spray
on linoleum, and an-stac mats.
Do not use the system if an error message
appears on the display: note the error code;
turn o the system; call Vitacon or your local
representave.
! !

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User and Service Manual
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Equipment Safety
To protect your ultrasound system, scanner and accessories follow these precauons.
Cauon:
• To avoid the risk of excessive heang or
damage to the system, use the system
in a well-venlated environment.
• If the operang environmental
temperature exceeds 25°C, limit scans
to 5 minutes and allow a 10 minute
cooling period between scans.
• Excessive bending or twisng of cables
can cause a failure or intermient
operaon.
• Do not submerge the VitaScan PD
in any soluon, follow the cleaning
instrucons.
• To avoid damaging the power supply,
verify the power supply input is within
the correct voltage range.
• Do not short the USB or Ethernet
terminals.
• Always charge the baery before using
the system, to avoid the risk of the
system turning o while in use.
• Incorrect cleaning or disinfecng
of any part of the system can cause
permanent damage.
• Do not use solvents such as thinner or
benzene, or abrasive cleaners on any
part of the system.
• Do not spill liquid on the system.
• Do not use the system if it exhibits
errac or inconsistent behavior. Turn
O the power of the system and call
Customer Service.
• Do not dispose of the baery in re.
• Immediately disconnue use of the
baery if, while using, charging or
storing the baery, the baery emits an
unusual smell, feels hot, changes color
or shape, or appears abnormal in any
other way. Contact a customer service
representave if any of these problems
are observed.
• Do not use the VitaScan PD if probe
head or cable is damaged.
• Do not use the VitaScan PD if there is
evidence of leakage of internal liquids.
Wash hands immediately in warm,
soapy water. Consult the MSDS on
Polypropylene Glycol for addional
informaon/precauons.
• To avoid the risk of electrical shock, do
not use any VitaScan PD that has been
immersed in liquid.Note:
Safety and Performance Summary
Safety and Performance Summary
The VitaScan PD computes the volume of
the urinary bladder based upon twenty-four
cross-seconal ultrasound images (or less).
For maximum accuracy, be sure to hold the
Scan head moonless while scanning.
The most accurate measurements are
obtained when the paent rests quietly in
the supine posion.
Accuracy is compromised if the user does
not obtain an opmal, repeatable image.
Errors in usage tend to result in the
underesmaon of bladder volume, except in
cases where the Scan head is moved during
scanning. In this case, the measurement may
overesmate the paent’s bladder volume.
The paent being scanned should not have a
catheter in his/her bladder. This could create
micro bubbles in the bladder, which aect
the accuracy of the measurement.
Do not use the VitaScan PD on paents
with open skin or wounds in the suprapubic
region.
Use care when scanning suprapubic and
pelvic surgery paents. Scar ssue, surgical
incisions, sutures, and staples can aect
ultrasound transmission and reecon.

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User and Service Manual
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Warning
There is a possible hazard of explosion if the VitaScan PD is used in the presence of
ammable anesthecs.
Labeling Symbols
!
!
CE mark – Noed body no.2274 Warning, consult
accompanying documents
Read the documentaon
Ultrasound radiaon
Drip proof
Alternang current input
Test Agency Cercaon Mark –
North America
BF type (Body Floang)
WEEE - Waste Electrical and
Electronic Equipment
Applicable Standards/Approvals
The VitaScan PD Bladder Monitor conforms with following standards:
CSA C22.2 NO 60601-1-08: Medical electrical equipment – Part 1: General requirements for
basic safety and essenal performance
IEC 60601-1 Medical Electrical Equipment - Part 1: General requirements for safety, 1988:
A1 1991-11, A2 1995
CSA C22.2 NO. 60601-1-2A-03 (R2006) [EN 60601-1-2 (2001) + A1 (2006)]: Medical
electrical equipment – Part 1-2: General requirements for safety – Collateral standard:
Electromagnec compability – Requirements and tests
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essenal performance
IEC 60601-1-2 ed. 4.0 Medical electrical equipment - Part 1-2: General requirements for
basic safety and essenal performance - Collateral Standard: Electromagnec disturbances -
Requirements and tests
EN 60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements for
basic safety and essenal performance - Collateral standard: Electromagnec compability -
Requirements and tests
IEC 60601-2-37, Medical Electrical Equipment, Part 2-37: Parcular Requirements for the
basic safety and essenal performance of ultrasonic equipment, Ed. 2.0, 2007-08
ISO 14971:2007 Medical devices – Applicaon of risk management to medical devices
US FDA 510(k) market approval: K121689

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User and Service Manual
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Applying the Ultrasound Gel
Palpate the paent’s symphysis pubis (pubic bone) and apply the Gel immediately superior to
the paent’s symphysis pubis, as shown in images below. Or apply the Gel around the dome
of the Probe. Smooth the gel out and remove any air bubbles, which may block ultrasound
transmission.
Using Ultrasound Gel Pad:
Somemes it may be convenient to use ultrasound transmission Gel pad. The Gel pad is an
easy-to-use coupling medium.
To apply the ultrasound Gel Pad, peel back the foil lid of the individual gel pad package,
exposing the gel pad.

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User and Service Manual
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Measuring Bladder Volume
Palpate the paent’s symphysis pubis and place the Scanhead midline on the paent’s
abdomen, approximately 4 cm (1.5 inches) superior to the symphysis pubis, as shown in
images below.
• Aim the Scanhead so the ultrasound is projected toward the expected locaon of
the bladder. For most paents, this means aiming the p of the Scanhead toward the
paent’s coccyx.
• Press and release the scan buon, located on the Scanhead.
• Locate the bladder.
• Press and release the scan buon and hold the Scanhead steady throughout the scan.
Note:
While scanning, avoid making any changes in the posion, angle or pressure of the Scanhead.
Regular Inspecons and Maintenance
VitaScan PD is a Medical Electric Equipment and therefore needs special precauons
regarding EMC. VitaScan PD needs to be installed and put into service according to the EMC
informaon provided in the accompanying documents.
Vitacon recommends that the VitaScan PD be cered by an authorized VitaScan PD Service
Center once a year. Cercaon service includes a comprehensive inspecon and tesng of
the instrument, to ensure accurate measurement performance. For more informaon, please
contact your VitaScan PD Service Center or your local VitaScan distributor.
Weekly Inspecons:
Once a week, you should inspect the Scanhead and cable for physical faults or cracks. Cracks
that allow the leakage or ingress of uid may aect the safety and/or the performance of
the instrument. Any apparent faults or cracks must be referred to your authorized VitaScan
Service Center or your local VitaScan distributor.

VitaScan PD
User and Service Manual
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Figure 0-1 Home Screen
• Tap on the screen, to navigate through the screen.
• Tap Woman or Man opon
• For Woman tap Hysterectomy if needed
• Tap Scan Depth opon
• Tap Start to start Prescan and locate the bladder.
• Tap Restart to start a new scan
• Tap Setup to enter setup menu
Scan Operaon
To make a measurement, press the Start buon in the Home Screen. The Prescan displayed
as shown below.

VitaScan PD
User and Service Manual
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www.vitacon.com
Scan Operaon
To make a measurement, press the Start buon in the Home Screen. The Prescan displayed
as shown below.
Figure 0-2 PreScan
• Tap SCAN to start scanning of the whole bladder.
• Tap Restart to stop pre-scan.
• Tap Icon to colorize the detected area.

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User and Service Manual
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Scan Operaon
To make a measurement, press the Start buon in the Home Screen. The Prescan displayed
as shown below.
Figure 0-3 Result
• Tap Start to do a new scan
• Tap Clear/Restart to clear screen
• Tap Print to print result
• Tap Save to save result to USB memory sck. (Only enabled when USB-memory sck is
connected)
• Tap Adjust to adjust result. (Adjustment might be needed if bladder edge is not detected
properly)