Mcube Technology BIOCON900 Bladder Volume Measurement System User Manual
Mcube Technology Co.,Ltd Bladder Volume Measurement System
User manual
BioCon -900
Operator’s Manual
.
[for FCC]
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
FCC CAUTION
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
[for IC]
This device complies with Industry Canada’s licence-exempt RSSs. Operation is
subject to the following two conditions:
(1) This device may not cause interference; and
(2) This device must accept any interference, including interference that may cause
undesired operation of the device.
Le present appareil est conforme aux CNR d’Industrie Canada applicables aux
appareils radio exempts de licence. L’exploitation est autorisee aux deux conditions
suivantes :
1) l’appareil ne doit pas produire de brouillage;
2) l’utilisateur de l’appareil doit accepter tout brouillage radioelectrique subi, meme
si le brouillage est susceptible d’en compromettre le fonctionnement.
These limits are designed to provide reasonable protection against
i
This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to part 15 of the FCC Rules.
This equipment generates uses and can radiate radio frequency energy and,
if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:
* Reorient or relocate the receiving antenna.
* Increase the separation between the equipment and receiver.
* Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
* Consult the dealer or an experienced radio/TV technician for help.
harmful interference in a residential installation.
ii
BioCon-900
Bladder Volume Measurement System
Operator’s Manual
CAUTION : In the United States, federal Law restricts
this device to sale by or on the order of a physician.
“This product is not made with natural rubber latex.”
Copyright ⓒ 2015 by Mcube Technology Co.,Ltd. All rights reserved.
The information in this document is subject to change at any time without notice. No part of this
document may be reproduced or transmitted in any form or by any means, electronic or mechanical,
for any purpose, without the express written permission of Mcube Technology. Examples or images
in this document are fictitious and do not in any way represent real patient data. For up-to-date user
information, contact your local distributor or mcube@mcubetech.co.kr.
Non-Mcube Technology product names are the property of their respective owners.
iv
Contents
1 GENERAL INFORMATION ........................................................................................ 1
1.1 PRODUCT DESCRIPTION ............................................................................................................. 1
1.2 INTENDED USE .............................................................................................................................. 1
1.3 PRESCRIPTION STATEMENT ....................................................................................................... 1
1.4 SERVICE ......................................................................................................................................... 1
2 SAFETY INFORMATION ........................................................................................... 2
2.1 NOTICE TO ALL USERS ................................................................................................................ 2
2.2 CONTRAINDICATIONS .................................................................................................................. 2
2.3 BIOLOGICAL SAFETY ................................................................................................................... 2
2.4 ELECTRICAL SAFETY .................................................................................................................. 3
2.5 EQUIPMENT SAFETY .................................................................................................................... 5
2.6 SAFE HANDLING PROCEDURES FOR TRANSPORTER ........................................................... 6
3 INTRODUCTION ........................................................................................................ 7
3.1 PRODUCT FEATURES .................................................................................................................. 7
3.2 SYSTEM COMPONENTS ............................................................................................................... 8
3.3 OUTER APPEARANCE OF PROBE ............................................................................................ 10
3.4 OUTER APPEARANCE OF DOCKING STATION ....................................................................... 12
3.5 DISPLAY AND BUTTONS ............................................................................................................ 14
3.6 ICON DIRECTORY ....................................................................................................................... 15
4 SETUP ...................................................................................................................... 19
4.1. CHARGING BATTERY ................................................................................................................. 19
v
4.2. CHANGING A THERMAL PAPER ................................................................................................ 22
5 HOW TO USE .......................................................................................................... 23
5.1 CHECKUP BEFORE USE ............................................................................................................ 23
5.2 ACCURACY OF MEASUREMENT .............................................................................................. 24
5.3 PERFORM THE BLADDER VOLUME MEASUREMENT ............................................................ 24
5.4 SELECTING THE PATIENT TYPE ............................................................................................... 31
5.5 VERIFYING THE MEASUREMENT ............................................................................................. 32
5.6 PRINT OUT OF MEASUREMENT ................................................................................................ 34
5.7 READING BARCODES AND CAPTURING THE PATIENT INFORMATION .............................. 35
5.8 SAVING THE SCAN RESULT ...................................................................................................... 38
5.9 MISSING (UNSAVED) SCAN RESULT ........................................................................................ 39
5.10 HOME SCREEN ............................................................................................................................ 40
5.11 PRE-SCAN SCREEN .................................................................................................................... 41
5.12 NORMAL SCAN SCREEN ........................................................................................................... 42
5.13 SCAN RESULT SCREEN ............................................................................................................. 43
5.14 REVIEWING THE MEASUREMENT ( REVIEW SCREEN) ......................................................... 45
5.15 SETUP SCREEN .......................................................................................................................... 48
5.16 ADJUSTING THE DATE FORMAT ............................................................................................... 51
5.17 ADJUSTING THE DATE ............................................................................................................... 52
5.18 ADJUSTING THE TIME ................................................................................................................ 53
5.19 DISPLAY BRIGHTNESS............................................................................................................... 54
5.20 PRINT REPORT FORMAT ........................................................................................................... 55
5.21 PRE-SCAN SETTING ................................................................................................................... 57
5.22 BARCODE READER SETTING ................................................................................................... 58
5.23 CAPTURE SETTING .................................................................................................................... 59
5.24 DELETING ALL SAVED MEASUREMENTS ............................................................................... 60
5.25 BATTERY STATUS ....................................................................................................................... 61
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5.26 SLEEP MODE ............................................................................................................................... 62
5.27 SHUTDOWN MODE ..................................................................................................................... 64
5.28 DATA STORAGE .......................................................................................................................... 65
5.29 POPUP WINDOWS ....................................................................................................................... 66
5.30 UPLOADING SCAN RESULT ...................................................................................................... 67
5.31 RESET THE PROBE AND DOCKING STATION ......................................................................... 68
6 SOFTWARE (CUBEPRO) ........................................................................................ 69
6.1 GENERAL INFORMATION ........................................................................................................... 69
6.2 INTENDED USE ............................................................................................................................ 70
6.3 INSTALLING CUBEPRO SOFTWARE ........................................................................................ 71
6.4 UNINSTALLING SOFTWARE ...................................................................................................... 73
6.5 SETTING UP CUBEPRO .............................................................................................................. 74
6.6 RUN CUBEPRO ............................................................................................................................ 75
6.7 UPLOAD THE SCAN DATA ......................................................................................................... 76
7 TROUBLESHOOTING ............................................................................................. 86
7.1 TROUBLESHOOTING .................................................................................................................. 86
7.2 POPUP WINDOWS FOR MAINTENANCE .................................................................................. 87
8 MAINTENANCE ....................................................................................................... 88
8.1 CLEANING & DISINFECTION ..................................................................................................... 88
8.2 WEEKLY INSPECTION ................................................................................................................ 90
8.3 DISPOSAL .................................................................................................................................... 91
8.4 DEVICE REPAIR ........................................................................................................................... 91
8.5 CALIBRATION .............................................................................................................................. 92
8.6 CALIBRATION REMINDER .......................................................................................................... 95
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9 SPECIFICATIONS .................................................................................................... 96
9.1 ACOUSTIC OUTPUT TABLE ....................................................................................................... 96
9.2 DEFINITIONS AND SYMBOLS .................................................................................................... 98
9.3 ELECTROMAGNETIC COMPATIBILITY ................................................................................... 103
9.4 EXCESSIVE TEMPERATURE TEST RESULT .......................................................................... 110
9.5 SPECIFICATION OF COMPONENTS ........................................................................................ 110
9.6 ENVIRONMENTAL CONDITIONS .............................................................................................. 114
10 GLOSSARY............................................................................................................ 117
11 SYMBOL DIRECTORY .......................................................................................... 119
12 REFERENCES ....................................................................................................... 123
1
1 GENERAL INFORMATION
1.1 PRODUCT DESCRIPTION
CUBEScanTM BioCon-900 (bladder volume measurement system) is a safe and easy, non-invasive
system to measure the bladder volume. CUBEScanTM BioCon-900 is a B-mode instrument, hand-
held, wireless and battery-operated. A 3D-mechanical sector transducer provides cross–sectional
images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those
images and displays 12 scan planes on a screen. Furthermore, a live image of the bladder during
Pre-Scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a
personal computer running CubePro software via a wireless connection. CubePro allows the user to
print measurements, archive data and so on.
1.2 INTENDED USE
CUBEscanTM BioCon-900 projects ultrasound energy through the lower abdomen of a patient to
obtain images of bladder and calculate bladder volume.
1.3 PRESCRIPTION STATEMENT
Federal (United States) law restricts this system to sale by or on the order of a physician.
1.4 SERVICE
If you encounter difficulty with the system, please contact local distributers or Mcube Technology at
mcube@mcubetech.co.kr
2
2 SAFETY INFORMATION
2.1 NOTICE TO ALL USERS
This guide covers components, function, maintenance, storage, and precautions needed to use this
system. All users must read and thoroughly understand this entire guide prior to using the BioCon-900.
This section has information on safe use of the BioCon-900 (Electrical Safety, Battery Safety, EMC
(Electromagnetic Compatibility), Equipment Safety).
Complies with FDA performance standards for laser products except for deviations pursuant to Laser
Notice No. 50, dated June 24, 2007.
2.2 CONTRAINDICATIONS
WARNING
Do not use the BioCon-900 on following cases:
1) Fetal use or pregnant patients.
2) Patients with ascites.
3) Patients with open or damaged skin.
4) Wounds in the suprapubic region.
2.3 BIOLOGICAL SAFETY
To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects.
However, ultrasound should be used only by medical professionals when clinically indicated, using the
lowest possible exposure times possible commensurate with clinical utility. The ultrasonic output power of
3
BioCon-900 is limited to the minimum level necessary for performance effectively. Data on acoustic output
levels is listed in the Specifications chapter.
2.4 ELECTRICAL SAFETY
This system meets IEC 60601-1, Class I, Type BF isolated patient-applied parts safety requirements. This
system complies with the applicable medical equipment requirements published in the Canadian
Standards Association (CSA), European Harmonized Standards, and Underwriters Laboratories (UL)
safety standards.
To avoid the risk of electrical shock or injury, observe the following warninings and cautions.
WARNING
To avoid the risk of electric shock, this equipment must only be connected to a supply main with
theprotective earth. - Grounding reliability can only be achieved when equipment is connected to a
receptacle marked “Hospital Only” or “Hospital Grade” or the equivalent.
Do not operate the system in the presence of flammable gases or anesthetics.
Do not use the device with any defibrillator at the same time.
Do not use the device with any HF surgical equipment at the same time.
Disconnect the USB cable from the PC before cleaning the system.
Do not touch PC output connectors (eg.USB, port and others) and the patient at the same time.
Before using the system, inspect the enclosures, power cord and USB cable.
Do not use the system if these are damaged.
Do not use any probe that has been accidentally immersed in any liquid.
Charge the probe only with the docking station provided.
Only connect the docking station power supply to a mains supply rated at AC 100-240V and 50/60Hz.
Do not attempt to open the system components. This may cause serious injury to the operator or
patients. All services must be made by a qualified technician only.
4
CAUTION
The BioCon-900 has been tested and found to comply with the electromagnetic compatibility (EMC)
limits for medical systems to IEC 60601-1-2:2010. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. Medical systems must be
installed and operated according to the instruction in this manual. For more information, see the
Electromagnetic Compatibility section.
To maintain electromagnetic interference (EMI) within certified limits, the system must be used with the
cables, components, and accessories specified or supplied by Mcube Technology.
Medical electric devices can be affected by portable or mobile RF communication devices. Turn off any
portable or mobile RF device before operating your system.
Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon.
ESD is common in conditions of low humidity, which can be caused by heating or air conditioning.
Static shock is a discharge of electrical energy from a charged body to a lesser or non-charged body.
The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound
system. The following precautions can help reduce ESD: anti-static spray on carpet, anti-static spray on
linoleum, and anti-static mats.
Do not use the system if an error message appears on the display: note the error code; call Mcube
technology or your local distributor, shut down the system
When using the system with CubePro software, your computer must be minimally certified to
EN/IEC/CSA/UL60950 or 60101-1 standards. This configuration ensures that compliance to the EN/IEC
60601-1-1 standard is maintained. Anyone connecting additional equipment to the signal input port or
signal output port configures a medical system, and is therefore responsible for ensuring that the
system complies with EN/IEC60601-1-1. If you need assistance, contact your biomedical staff, Mcube
Technology, or your local distributor.
5
2.5 EQUIPMENT SAFETY
To protect your BioCon-900, and accessories, follow these warninings and cautions.
WARNING
No modification of this equipment is allowed.
Do not use the system if the head of probe is damaged.
To avoid the risk of excessive heating or damage to the device, use the device in a wall ventilated
environment.
Excess bending or twisting of cables can cause a failure or intermittent operation.
Shut down the device before disconnecting the docking station by unplugging the plug.
Do not use the system if there is evidence of leakage of internal liquids. Wash hands immediately
in warm, soapy water.
In the event that LCD is damaged, care should be taken to avoid contact with liquid crystal. Take
the urgent action indicated should any of the following situations arise:
- If liquid crystal comes in contact with your skin, clean the area with a cloth and then wash
thoroughly with soap and running water.
- If liquid crystal enters your eyes, flush the affected eye with clean water for at least 15 minutes
and then seek medical assistance.
- If liquid crystal is swallowed, rinse your mouth thoroughly with water. Drink large quantities of
water and induce vomiting, then seek medical assistance.
6
CAUTION
Use the system indoors only.
Do not use the system if it exhibits erratic or inconsistent behavior. Shut down the system and contact
Mcube Technology or your local distributor.
Do not spill liquid on the system.
2.6 SAFE HANDLING PROCEDURES FOR TRANSPORTER
Quarantine: Packages that are crushed, punctured or torn open to reveal contents should not be placed
into deployment. Such packages should be isolated until the shipper has been contacted, provides
disposition instructions and, if appropriate, arranges to have the product inspected and repacked.
Spoiled Product: In the event that damage to packaging results in damage to the battery causing
released electrolyte, the spill should be contained and the shipper should be contacted for instructions.
7
3 INTRODUCTION
3.1 PRODUCT FEATURES
CUBEScanTM BioCon-900 has two main components: the probe
and the docking station.
CUBEScanTM BioCon-900:
Hand-held, portable and lightweight
Measures bladder volume with ultrasound
Provides a live image of bladder
Takes scans and provides measurements in a short time
Allows for scan results and images to be transferred, reviewed
and printed using CubePro software
Easy to use: staff can easily learn to scan patients in a short
time
Battery-operated, wireless charging and wireless transmission
Barcode reading and information capture
Figure 1 BioCon-900
8
3.2 SYSTEM COMPONENTS
No.
Picture
Parts
Q’ty
Description
1
BioCon-900
(Probe)
1
Hand-held, wireless, battery-
operated, ultrasound volume
measurement system
2
Docking station
1
Use the docking station to charge
BioCon-900’s internal battery,
transfer data and print the
results. ,
3
Power cord
1
The type of power cord depends
on your country.
4
Thermal paper
For onboard printer
(57mm width)
5
Package CD
1
PC Software
6
Barcode & capture
module
Barcode &
capture module
Barcode reading and information
capture (optional)
9
6
USB Cable
1
USB 2.0: A - B type cable
7
-
Operator’s
manual
1
-
Users can replace only the following items below
-Thermal Paper, Gel
The other parts are not allowed for the users to disassemble or replace except the thermal paper and
gel. Please contact your local distributor or Mcube Technology.
Only use the ultrasonic gel approved by FDA, CE or biocompatible ultrasonic gel.
10
3.3 OUTER APPEARANCE OF PROBE
No.
Part
Function
1
LCD
screen
Displays bladder volume and other
information.
2
buttons
Variable function buttons(Contextual menu)
3
Scan
button
Press to take a scan and release
4
Probe
head
Generates, transmits and receives ultrasound
waves, producing a 3D image of bladder.
Type BF applied part
5
Reset
button
Press to reactive probe
6
Charge
indicator
Orange: Battery is charging. It lights off when
fully charged.
7
Stand-by
Indicator
Green: probe is ready for use.
Figure 2 Front-view of probe
11
No.
Part
Function
1
Ir
window
Ir window to transfer data to the docking
station
2
Safety
symbol
Safety symbols for Ir transmission and red
lights of barcode
3
Label
Note : Labels are subject to change without
prior notice
4
Barcode
read &
capture
module
Reads printed barcodes and captures
patient information.
Figure 3 Back-view of probe
12
3.4 OUTER APPEARANCE OF DOCKING STATION
Figure 5 Back-view of
docking station
Figure 4 Front-view of docking station
13
No.
Item
Function
1
Ir window
Communicates with the probe.
2
Printer
Thermal printer
3
Print button
Press to print the scan result
4
Reset button
Press to reactivate the docking station.
5
Error indicator
Indicates an error.
6
Charge indicator
Indicates charging status.
Blinking: Charging, On: Charging is completed.
7
Ready indicator
Indicates that the docking station is ready.
8
Power indicator
Indicates that power is supplied to the docking station.
9
Printer power indicator
Indicates that power is supplied to the printer.
10
Printer error indicator
Indicates a printer error.
11
Feed button
Roll(thermal) paper feed button
12
On/Off Switch
On/Off Switch
13
AC power inlet
AC power inlet
14
USB port
USB port
14
3.5 DISPLAY AND BUTTONS
The LCD screen displays the information for users and prompts that vary depending on the current
function. The four buttons below the main display have variable functions according to device mode. The
icons on the screen indicate the functions above each button. The button without an icon on the screen
has no function. The Home screen appears when the probe is turned on. It services as a starting point for
all the main functions of the device.
Figure 6 Main Display
No.
Description
1
Status Area which displays current date/time and
battery status
2
Main display Area which shows information
dependent on the each screen mode.
3
Menu Icon Area which shows menu icons
dependent on the current situation.
15
3.6 ICON DIRECTORY
The following icons may appear on the main display.
Patient Type Icons
Icons on the Home screen
Icon
Description
All other patients
A female who has not had a hysterectomy
A child with height less than 47 inches (120cm) and weight less than 55 lbs. (25kg).
Icon
Description
Missing data menu icon - Go to review the missing (unsaved) scan result.
Review menu icon - Go to the Review screen.
Setup menu icon - Go to the Setup screen.
The number of saved scan results / Maximum capacity storage is 50.
Battery status.
16
Icons on the Scan result screen & Review screen
Icon
Description
Urine volume icon - Measured urine volume.
Barcode icon - The scan result has a recorded barcode.
Capture icon - The scan result has a capture of patient information.
Saved icon -The scan result was saved.
P1
The 1st plane of 12 planes of the measurement (PX – The ordinal number of 12 planes)
Next plane menu icon - Shift the next plane of 12 planes of measurement.
Barcode menu icon - Read a barcode.
Save menu icon - Save the Scan result.
Home menu icon - Return to the Home screen.
Previously saved measurement menu icon
– Review the Previously saved measurements
Delete menu icon – Delete the currently displayed measurement
17
Icons on the Setup
Icon
Description
Date format (YY-MM-DD, DD-MM-YY,MM-DD-YY)
Date
Time (format : 24-hour)
Display brightness (0 to 100%, default= 50%))
Print report format
Sleep mode ( 0.5min, 1min,2min,3min,5min,off)
Pre-Scan On( ) / Off( )
Barcode reader On( ) / Off( )
Capture On( ) / Off( )
Delete all saved measurement.
Self-test
18
Phantom calibration
Move down a setting in the list
Move up a setting in the list.
Move right an item.
Select the option or perform the action.
Return to home screen.
Cancel the current function.
Exit the current function/or Return to the previous setting.
Perform the action.
Cease the action.
The function On
The function Off
19
4 SETUP
4.1. CHARGING BATTERY
CAUTION
The docking station and the power cord are not intended for patient contact. Ensure six feet (two meters)
is maintained between the patient and these components.
Immediately discontinue use of the battery, if the battery emits an unusual smell, feels hot, changes color
or shape, or appears abnormal in any other way. Contact Mcube Technology or your local distributors.
Risk of explosion, fire, or serious injury. The system is powered by a lithium-ion battery. Failure to note
the following instructions when handing the battery may result in serious injury.
- Never short-circuit the battery by either accidentally or intentionally bringing the battery terminals into
contact with any other conductive objects. This could cause serious injury or fire and could also
damage the battery and BioCon-900.
- Never expose the battery to abnormal shock, vibration, or pressure. The battery’s internal protective
covering could fail, causing it to overheat or ignite, resulting in caustic liquid leakage, explosion, or fire.
Avoid charging near fire or in the sunlight.
Do not use the docking station for other equipment.
WARNING
The battery must be replaced by the authorized service provider only.
Use only the provided docking station, and power cord to charge the battery for electric safety.
Do not disassemble, heat or dispose of the battery in fire.
Keep battery out of reach of children and in original sealed package.
Dispose of used batteries promptly according to local recycling or waste regulations.
20
Do not charge the battery with other chargers.
Long term storage: If you are not using BioCon-900 more than 3 months, remove the battery to prevent it
from discharging and store it in accordance with the recommended conditions, and charge the battery
every 6 months.
The probe is powered by a built-in lithium ion battery. The battery is charged by docking station and the
battery icon on the probe is always displayed, indicating the current capacity.
When you don’t use your probe, we recommend that you mount and store it in the docking station to
ensure that the probe is sufficiently charged. A battery has a protective circuit module which protects
battery from overcharging and over-discharging.
Figure 7 Probe-mounting
Figure 8 indicators of probe
Figure 9 indicators
of docking station
1) Plug the docking station into a wall outlet and turn the docking station on. The power indicator (3) and
the Ready indicator (4) on the docking station will light on in green.
2) Mount the probe on the docking station. Make sure that the upper part of probe reaches the wall of
21
docking station.
3) As soon as the probe is mounted on the docking station, the beep and light indicators will work as below;
a) A short beep: the wireless connection for charging is completed.
b) The charge indicator (5) on the docking station will light on in green.
c) The charge indicator (2) on the probe will light on in orange.
4) The stand-by indicator (1) will be turn on when the probe is ready to use.
The main display (LCD) will go into sleep mode after designated idle time
You can turn the sleep mode off in the setup, if necessary.
The charge indicator (2) on the probe will be turn off after fully charged.
Press the power button ( ) until the probe goes into the sleep mode, if you want.
22
4.2. CHANGING A THERMAL PAPER
1) Open the printer lid.
2) Take out the empty bobbin.
3) With the printer paper in one hand, unroll a small length of the paper
and insert into the unit.
Be sure to insert the thermal paper in the correct orientation.
4) Make the printer lid completely closed and tear off any paper extending
from the printer.
When the system is operated in abnormal conditions (frozen system,
burning smell, etc), press the reset button with pen or turn the switch
off on the back of the docking station.
CAUTION
To avoid damaging the system, only use the thermal paper specified by Mcube Technology and only
print when the thermal paper is correctly loaded.
If the paper appears to be stuck in the printer, open the printer cover and clear the paper jam or contact
your local distributor or Mcube Technology.
23
5 HOW TO USE
5.1 CHECKUP BEFORE USE
Before using BioCon-900, make sure that users should be familiar with BioCon-900 and the part of
BioCon-900. If you are a new user of BioCon-900, we strongly recommend that you perform your first
bladder volume measurement on a patient with moderately full bladder using Pre-Scan. Pre-Scan helps
you detect the bladder and moderately full bladder can be easier to locate.
CAUTION
If the oil leaks from housing and fluid gets in contact with your eyes, skin or clothing, flush the affected
area immediately with clean water and seek medical attention or go see a doctor.
WARNING
If you use BioCon-900 in the presence of flammable anesthetics, explosion hazard exists.
Do not use the BioCon-900 on following cases:
1) Fetal use or pregnant patients.
2) Patients with ascites.
3) Patients with open or damaged skin.
4) Wounds in the suprapubic region.
24
5.2 ACCURACY OF MEASUREMENT
Following cases affect ultrasound transmission and accuracy of measurement.
When a patient has had supra-pubic or pelvic surgery
A patient with catheter in his or her bladder
A patient with scar, sutures, staples or incisions in his or her abdomen
Use of unsuitable ultrasound transmission gel
Air bubbles between probe head and the skin of the patient
An excessive obese patient
Use of the probe with an unclean probe head
Inappropriate patient position
5.3 PERFORM THE BLADDER VOLUME MEASUREMENT
5.3.1. SETTING UP
See “Accuracy of measurement” before use.
Check the probe’s battery has sufficient power through battery icon. If the battery has not been sufficiently
charged, recharge the battery before measurement.
Wipe the probe head gently with a soft cloth dampened in isopropyl alcohol to clean and disinfect the
probe.
5.3.2. MEASUREMENT OF BLADDER VOLUME
Pre-Scan: General 2D real-time ultrasound scanning. 2D ultrasound images are displayed continuously in
live image basis. This helps an operator locate bladder position and predicting the range of residual urine
to detect the bladder before normal scan.
25
Normal scan: Get 12-plane ultrasound images and calculate the residual urine in the bladder (3D
scanning).
1) Turn on the system
Press the power button ( ) shortly until the probe turns on. If the Pre-Scan was not on, only normal scan
performed.
2) Select patient type.
BioCon-900 supports three patient types.
Press the Patient type button ( ) repeatedly on the probe to select the patient type.
- All other patients
- A female who has not had a hysterectomy.
- A child with height less than 47 inches (120cm) and weight less than 55 lbs. (25kg).
3) Applying gel.
The patient should be lying in a supine position and lift up the patient garment exposing the abdominal
region from the pubis to the navel. Place an ample amount of gel without air bubbles to the probe head.
Place the probe 3~4cm above the pubic bone.
4) Aim toward bladder
Put the ultrasound probe on the patient’s abdomen and aim it to the location where the bladder is expected
to be.
26
When measuring the urine volume of a patient, sit or stand beside the right of the patient and grab the
probe with your right hand. At this point, press the scan button with your right hand thumb. Ensure the
head of the patient icon on the probe will point toward the head of the patient when you place the probe
head on the patient's abdomen.
Only use the ultrasonic gel approved by FDA, CE or biocompatible ultrasonic gel.
5) Find bladder with Pre-Scan
Press the Scan button to start “Pre-Scan” and start displaying the Pre-Scan image such as 2D ultrasonic
image on the screen.
27
The position where the bladder image is the largest and most centered is the optimal place to start the
normal scan process. To locate the bladder, keep the probe contacted the abdomen and tilt the probe
forward, backward, left and right.
The Pre-Scan is executed only when ‘PRESCAN’ setup is ‘ON’. When ‘PRESCAN’ is off, a normal scan
will be executed.
Locate the bladder along the centerline on the screen. It helps detect the optimal position during pre-scan.
6) Press the Scan button.
When you have located the bladder, as in the picture above, press the Scan button to start the Normal
scan and then, the progress bar on the screen will appear. It takes 3 seconds to complete the Normal scan
Hold the probe steady while scanning. Movement of the probe during scanning reduces the accuracy of
measurement. When you hear the beep, the scan is complete.
7) Check the scan results
View the scan result (bladder volume) displayed in milliliters (ml).
28
The Beaker icon shows the bladder volume. (1) shows the current volume and (2) shows the maximum
volume from multiple measurements for one patient. To verify the volume and check other 12 planes of
bladder, press the Next plane button ( ) on the probe repeatedly
8) Record a patient information with barcode read & capture module
If you don’t want to record any patient information, skip this step.
Move the aiming position to the center of the barcode and press the Barcode button ( ) with thumb. And
then a red light guide is emitted. Keep pressing the Barcode button ( ) and do not release until getting
barcodes. The barcode reader captures continuously and decodes for a good barcode scan. You will have
a good barcode with a short beep. And the barcode numbers will be displayed on the screen.
Move the aiming position to the objects and release the Capture button ( ) to capture the patient
information. It takes 3 seconds to capture the aimed object (patient information), so don’t move your probe
for 0.5 sec after releasing the button. You will have the captured object with short beep will be displayed on
the screen.
WARNING
“LASER RADIATION – AVOID DIRECT EXPOSURE TO BEAM”
Do not capture human being with the barcode read & capture module.
Recording barcodes and capturing patient information is not available, after the Scan result is saved.
29
And the Barcode icon ( ) and Capture icon ( ) will be displayed in the Review screen. When you are
not satisfied with your recording, you can make a new recording and the latest barcode and captured
patient information will be deleted.
Press the exit button ( ) to exit the Barcode and Capture screen.
<good>
<bad>
9) Save scan results
To save the scan results, press the Save button ( ) below the display and then a saved icon ( ) will
appear on the screen. You can save the scan result before barcode reading and/or capturing the patient
information. Recording the patient information is not available, after the scan result is saved.
10) Finish the measurement
After finishing scanning, take the probe away from the patient and then wipe the ultrasound gel off from the
patient and the probe.
30
11) Mount the probe on the docking station
Mount the probe on the docking station and the probe will display the scan result screen. At the same time,
the data of probe is communicated with the docking station. And the battery is recharged, if needed.
12) Print the measurement
Press the print button on the docking station.
31
5.4 SELECTING THE PATIENT TYPE
“All other patients” icon is firstly displayed, when the probe is turned on.
Press the Patient type button ( ) on the probe to select the patient type.
A button has three patient types. Press the button repeatedly to set the desired setup.
- All other patients
- A female who has not had a hysterectomy.
- A child with height less than 47 inches (120cm) and weight less than 55 lbs. (25kg).
Figure 10 selecting the patient type
32
5.5 VERIFYING THE MEASUREMENT
Press the Next plane button ( ) repeatedly to see all planes of bladder images on the Scan result screen,
if necessary. And then the aiming information (crosshair) will be rotated clockwise by 15° and displayed the
2nd&8th plane, 3rd&9th, 4th&10th, 5th&11th, 6th&12th plane of bladder in order. We strongly recommend that
perform the measurement one or more times, when a bladder image is incorrectly positioned in the plane.
Figure 11 Planes of measurement Figure 12 incorrectly positioned
33
In the aiming information on the Scan results screen, if the bladder is not in the crosshairs, it is strongly
recommended you re-aim and re-scan for accuracy.
To verify the scan result, the bladder contours of plane images.
Figure 13 How to re-aim
The crosshair helps how to re-aim and the guiding arrows show that the user will have to move or tilt the
probe for a more accurate scan.
34
5.6 PRINT OUT OF MEASUREMENT
The measurements can be printed via an onboard printer on the docking station. The currently displayed
measurement is printed.
Date, time, aiming info, bladder images and maximum bladder volume appear on the printout. The barcode
number (~XXXX) will be in the tag to prevent from leaking of recorded information, if the barcode is
recorded. You can handwrite patient information in the tag, if the barcode is not recorded. You can adjust
print report format in the setup screen.
Figure 14 Print out
Range & Value
Description
Raw Images
Print grayscale B-mode images ( 2
planes ) - Default
Volume Only
Volume only
Walls
Bladder outline only ( 2 planes )
All planes
All 12 planes with B-mode images
35
5.7 READING BARCODES AND CAPTURING THE PATIENT INFORMATION
Figure 15 barcode & Capture screen
No.
Description
1
Save icon
2
Barcode icon
3
Capture icon
4
Exit icon
WARNING
“LASER RADIATION – AVOID DIRECT EXPOSURE TO BEAM”
Do not capture human being with the barcode read & capture module.
Hold the probe with both hands tightly, when you read barcodes and capture patient information.
Recording barcodes and capturing patient information is not available, after the scan result is saved.
36
How to read a barcode
1) After scanning, move the aiming position to the center of the barcode and press the Barcode button
( ) on the Scan result screen with thumb.
2) A red light guide is emitted.
3) Keep pressing the button and do not release until getting a barcode.
4) The barcode reader captures continuously and decodes for a good barcode scan.
5) You will have a good barcode with a short beep. And the barcode numbers will be displayed on the
screen.
6) To save the barcode numbers, press the Save button( )
7) To exit the Barcode & capture screen, Press the Exit button( )
8) Barcode icon ( ) will be displayed in the Review screen, after the barcode reading is saved
successfully.
How to capture patient information
1) After scanning, move the aiming position to the objects and release the Capture button ( ) on the
Barcode & capture screen to capture the patient information.
2) It takes 3 seconds to captures patient information, so do not move the probe after releasing the Capture
button ( ) for 0.5 seconds.
3) You will have a good object with a short beep. And the captured patient information will be displayed on
the screen as well.
4) To save the captured patient information,press the Save button( )
37
5) To exit the Barcode & capture screen, press the Exit button( )
6) The Capture icon( ) will be displayed in the Review screen, after the captured patient information is
saved successfully.
When you are not satisfied with your recording, you can make a new recording and the latest barcode
numbers and captured patient information will be deleted. You can save the measurement by pressing the
Save button ( ), when you are satisfied with the recordings.
Figure 16 Recorded
barcode numbers
Figure 17 Captured
patient information
Figure 18 Barcode & Capture icon
38
5.8 SAVING THE SCAN RESULT
You can save the currently displayed Scan result on the Scan result screen. And also Missing scan result
can be saved after fetching the Missing scan result.
Press the Save button ( ) to save the Scan result. The Saved icon ( ) appears on the screen after the
Scan result is saved successfully.
Figure 19 Saving the scan result
39
5.9 MISSING (UNSAVED) SCAN RESULT
If you did not save the Scan result and return to the Home screen, the Missing (unsaved) scan result icon
( ) will appear on the Home screen. Press the Missing scan result button ( ) to fetch the missing scan
result. Then the Missing scan result screen will appear.
Recoding a new barcode or capturing patient information is not available for Missing scan results.
The performances below will make the Missing scan result icon disappear.
1) Fetch and save the Missing scan result.
2) A new Normal scan is performed.
Figure 20 Home screen with Missing scan result
40
5.10 HOME SCREEN
Turn the probe on and the Home screen will appear. It shows the main functions of the probe. The buttons
below the display allow you to select patient type, go to the Review screen and go to the Setup screen.
Figure 21 Home screen
No.
Description
1
Date & Time
2
Model name
3
Number of saved data
4
Patient type icons ( )
5
Review menu icon
6
Setup menu icon
7
Battery status
41
5.11 PRE-SCAN SCREEN
Pre-Scan- 2D ultrasound images are displayed continuously in live image basis.
This helps an operator locate bladder position and predicting the range of residual urine.
And also the centerline is provided during Pre-Scan. Locate the bladder along the centerline on the screen.
It helps detect the optimal position during Pre-Scan.
The Pre-Scan is executed only
when ‘PRESCAN’ setup is ‘ON’.
When ‘PRESCAN’ is off, a normal
scan will be executed.
Figure 22 Pre-Scan screen
No.
Description
1
Centerline
2
Max detection depth to measure
a child’s bladder volume
3
Press the rotation button ( ) repeatedly to rotate the Pre-
Scan display between 3 display modes.
(default, -90°, +90° display modes)
4
Cease the Pre-Scan and return to the Home screen.
Press the Cease button( ) in all 3 modes
42
5.12 NORMAL SCAN SCREEN
Normal scan - Get 12-plane ultrasound images and calculate the residual urine in the bladder (3D
scanning). It takes 3 sec to complete the Normal scan.
As bladder volume is calculated, the progress bar increases until the scan is completed.
Figure 23 Normal scan screen
43
5.13 SCAN RESULT SCREEN
The Scan result screen appears automatically when a normal 3D measurement is complete. The aiming
information (crosshair) helps you verify the Scan result. The menu buttons below the display allow you to
review other planes of the same measurement, read barcodes, save the measurement, and return to the
Home screen.
Figure 24 Scan result screen before saving
No.
Description
1
Date & Time
2
Aiming information(Crosshair)
3
Measured date & time
4
Capture icon if any image is captured.
5
The first plane of 12 planes
6
Next plane menu icon
7
Barcode menu icon
8
Save menu icon
9
Home menu icon
10
Barcode icon and part of the barcode if
barcode is recorded.
11
Patient type icon( )
12
Maximum volume from multiple measurement
13
Current volume from multiple measurement
14
Battery status
44
Description of button
Press the Menu buttons below the display.
Next plane menu icon ( ) – Shifts the next plane of the measurement.
Press the Next plan button repeatedly to shift the next plane.
Home menu icon ( ) - Returns to the Home screen.
Barcode menu icon ( ) – Reads a barcode and goes to the Barcode & capture screen.
Save menu icon( ) – Saves the scan result
If there is no recorded barcode and/or capture, the
barcode and capture icons will not appear.
Press the Save button ( ) to save the scan result. The
saved icon appears after the scan result is saved
successfully.
Figure 25 Not-recorded
barcode & capture
45
5.14 REVIEWING THE MEASUREMENT ( REVIEW SCREEN)
The Review screen will be displayed when you press the Review button ( ) on the Home screen. The
Review screen shows the bladder volume, ultrasound images and other saved information with the
selected measurement (saved scan result). While reviewing the measurement, the menu buttons below the
display allow you to review other planes of the same measurement, review to the previous saved
measurement, delete the current reviewing measurement and return to the Home screen.
The maximum storage capacity of measurement cannot exceed 50. in the header, right side on
the display shows the chronological order of saved measurements and the total number of saved
measurements. For example, 3/49 is the 3rd saved measurement, and 49 measurements are totally saved.
Once the probe in sleep mode is mounted on the docking station, the probe is turned on and the lastly
saved measurement will be displayed. The currently displayed screen will keep the displayed screen on
after mounting on the docking station.(eg. Setup screen, Review screen )
DESCRIPTION OF BUTTON
Press the Menu buttons below the display.
Next plane menu icon ( ) – Shifts the next plane of the measurement.
Press the Next plan button repeatedly to shift the next plane.
Home menu icon ( ) - Returns to the Home screen.
Previously saved measurement menu icon ( ) – Goes to the previously saved measurements.
Delete menu icon ( ) – Delete the current reviewing measurement.
46
Figure 26 Review screen
No.
Description
1
Aiming information(Crosshair)
2
Date & Time
3
Capture icon shows that Captured patient
information is saved
4
1st plane of 12 planes
5
Bladder outline
6
Centerline (helps detect the optimal position)
7
Next plane menu icon
8
Previously saved measurement menu icon
9
Delete menu icon
10
Home menu icon
11
7th plane of 12 planes
12
Barcode Icon shows that the barcode is saved
13
Saved barcode number
14
Patient type icon ( )
15
Chronological order of saved measurements
47
You can print the currently displayed measurement by pressing the print button on the docking station.
Reading a barcode and capturing the patient information are not available on the Review screen.
Transfer the saved measurement to your PC running CubePro via docking station to review the recorded
barcode numbers and captures. In the Review screen only the part of the barcode will be displayed (the
last four digits). The rest digits of the barcode are concealed by two tilde symbols to protect the patient
information. Only you can see the saved barcode after uploading to the PC.
DELETING THE CURRENT SCAN RESULT
Press the Deletion button ( ) and a confirm popup window ( ) will appear.
And press the Selection button ( ) to delete the scan result or press the Cancel button ( ) to cancel.
Figure 27 shifting planes
Figure 28 Previous
measurement
Figure 29 Popup window
deleting scan result
48
5.15 SETUP SCREEN
Press the Setup button ( ) on the Home screen.
In the Setup screen the left column shows the setup menus and the right column shows the setup values.
The setup menu icon which has an outer line (eg. ) is the currently focused menu.
1) Use the Move-down or up button ( , ) to move to the desired menu by pressing the buttons, until the
desired menu is highlighted with a green outer line.
2) To select the setup value of the desired menu, press the Selection button ( ). The green underline
below the setup value will be displayed (eg. ).
3) To adjust the setup values, use the Move-down or up button ( , ) and Move-right button ( ). Press
the Select button ( ) to finish adjusting the setup.
Icon
Description
Date format (YY-MM-DD, DD-MM-YY,MM-DD-YY)
Date
Time (format : 24-hour)
Display brightness (0 to 100%, default= 50%))
49
Print report format
Raw Images : Print grayscale B-mode images ( 2 planes )
Walls : Bladder outline only ( 2 planes )
All planes : All 12 planes with B-mode images
Volume only
Sleep mode ( 0.5min,1min,2min,3min,5min,off)
Pre-Scan On( ) / Off( )
Barcode reader On( ) / Off( )
Capture On( ) / Off( )
Delete all saved measurement.
Self-test : Perform ( ) & the latest calibration date on the right
Phantom calibration : Perform ( ) & the latest calibration date on the right
Move to next Setup Menu or show next setup value.
Move to previous Setup Menu or show previous setup value.
50
Move to the next setup item.
Select the menu, select the setup value or perform the action.
Home menu icon
Cancel icon – cancel the current function.
Exit icon – Exit from current setup and return to the previous setup.
Play icon - Perform the action.
Stop icon – Stop the action.
Turn-on icon
Turn-off icon
51
5.16 ADJUSTING THE DATE FORMAT
Date format: YY/MM/DD, MM/DD/YY, DD/MM/YY
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Press the Selection button ( ) to select the Date format menu ( ) with a green outline.
3) A green underline will appear.
4) Use the Move-down or up button ( , ) to adjust the date format.
5) Press the Selection button ( ) again to adjust the date format. Or return to the previous date format by
pressing the exit button ( ) to return to the previous setup.
Figure 30 Date format setup
52
5.17 ADJUSTING THE DATE
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Use the Move-down button ( ) and select the Date menu ( ) by pressing the Selection button ( ).
3) A green underline will appear.
4) Use the Move-down ( ), Move-up button ( ) and Move-right button ( ) to adjust the date.
5) Press the Selection button ( ) to finish adjusting the date.
Figure 31 Date setup
53
5.18 ADJUSTING THE TIME
A 24-hour clock provided only.
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Use the Move-down button ( ) and select the Time menu ( ) with by pressing the Selection button
().
3) A green underline will appear.
4) Use the Move-down ( ), Move-up button ( ) and Move-right button ( ) to adjust the time.
5) Press the Selection button ( ) to finish adjusting the time.
Figure 32 Time setup
54
5.19 DISPLAY BRIGHTNESS
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Use the Move-down button ( ) and select the Brightness menu ( ) by pressing the Selection button
().
3) A green underline will appear.
4) Use the Move-down and up button ( , ) to adjust the brightness. Or press the Exit button ( ) to
return to the previous setup.
5) Press the Selection button ( ) to finish adjusting the brightness
Figure 33 Brightness setup
55
5.20 PRINT REPORT FORMAT
There are 4 print report formats of bladder on the printout.
Raw Images : Print grayscale B-mode images ( 2 planes ) : default
Walls : Bladder outline only ( 2 planes )
All planes : All 12 planes with B-mode images
Volume only
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Use the Move-down button ( ) and select the Print report format menu ( ) by pressing the
Selection button ( ).
3) The green underline will appear.
4) Use the Move-down and up button ( , ) to adjust the print report format. Or press the Exit button
( ) to exit.
5) Press the Selection button ( ) to finish adjusting the print report format.
56
Figure 34 Print report format setup
57
5.21 PRE-SCAN SETTING
See “Pre-Scan screen”. Refer to the figures below when you turn the Pre-Scan off.
And you can turn the Pre-Scan on in reverse order.
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Use the Move-down button ( ) and select the Pre-Scan menu ( ) by pressing the Selection button
( ).
3) A green underline will appear.
4) Use the Move-down and up button ( , ) to turn the Pre-Scan on( )or off( ) or Press the Exit button
( ) to return to the previous setup.
5) Press the Selection button ( ) to finish setting the Pre-Scan.
Figure 35 Pre-Scan On/Off setting
58
5.22 BARCODE READER SETTING
See “READING A BARCODE AND CAPTURING THE PATIENT INFORMATION”.
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Use the Move-down button ( ) and select the Barcode menu ( ) by pressing the Selection button
( ).
3) A green underline will appear.
4) Use the Move-down and up button ( , ) to turn the Barcode on ( ) or off ( ).
5) Press the Selection button ( ) to finish setting the Barcode.
Figure 36 Barcode setting
59
5.23 CAPTURE SETTING
See “READING A BARCODE AND CAPTURING THE PATIENT INFORMATION”.
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Use the Move-down button ( ) and select the Capture menu ( ) by pressing the Selection button
( ).
3) A green underline will appear.
4) Use the Move-down and up button ( , ) to turn the Capture on ( ) or off ( ).
5) Press the Selection button ( ) to finish setting the Capture.
Figure 37 Capture setting
60
5.24 DELETING ALL SAVED MEASUREMENTS
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Press the Home button ( )
to return to the Home screen, if you want.
2) Use the Move-down button ( ) and select the Delete menu ( ) by pressing the Selection button ( ).
3) A green underline will appear.
4) Use the Move-down and up button ( , ) and select the Selection menu ( ) or Cancel menu ( ).
5) Press the Selection button ( ) to delete all saved measurements.
6) And a popup window ( ) to confirm will appear before deletion.
7) Press the Selection button ( ) to delete or press the Cancel button ( ) to cancel.
8) See the Home screen whether all saved measurements were deleted.
Figure 38 Deleting all saved measurements
61
5.25 BATTERY STATUS
A fully charged battery
A battery about 80% charged.
A battery about 60% charged
A battery about 40% charged
A battery nearly depleted
Recharge the battery immediately
When the battery is nearly depleted, a popup window will appear and need to be recharged.
To conserve battery power, the probe goes into sleep mode by shutting itself down automatically when
not in use. You can adjust the time to go into sleep mode in the setup. See “SLEEP MODE”.
It takes approximately 6 hours for the discharged battery to fully charge.
Fully charged battery can provide approximately 1,500 normal scans.
Contact your local distributor when the fully charged battery does not allow normal scan for 10min.
Figure 39 Popup window
- Needs to be recharged
62
5.26 SLEEP MODE
Simply the probe can go into sleep mode by pressing the power button ( ) for 2~3 seconds, when a
measurement is finished.
To preserve battery power, the probe goes into sleep mode by shutting itself down automatically when not
in use. You can set the time to go into sleep mode in the setup. However, if a battery needs to be
recharged immediately, a popup window will appear shortly and goes into sleep mode. We strongly
recommend that you should recharge the battery immediately. See “Charging Battery”
Press the power button ( ) shortly to wake the probe from sleep mode.
A time setting to go into sleep mode: 0.5min, 1min, 2min, 3min, 5min and Off ( )
1) Press the Setup button ( ) on the Home screen to open the Setup screen. Or press the Home button
( ) to return to the Home screen.
2) Use the Move-down button ( ) and select the Sleep mode menu ( ) by pressing the Selection button
( ).
Figure 40 Popup window
- Goes into sleep mode
63
3) A green underline will appear.
4) Use the Move-down and up button ( , ) to adjust the time to go to sleep mode. Or Press the Exit
button ( ) to return to the previous setup. You can select the Sleep mode-off ( ), if you want.
5) Press the Selection button ( ) to finish adjusting the time to go into sleep mode.
Figure 41 Time setting of Sleep mode
64
5.27 SHUTDOWN MODE
Shutdown mode - The probe draws little power when it is gone into sleep mode. To preserve battery power,
the probe will be shut down in approximately 24 hours after going into sleep mode, if there is no activity.
However, if you do not plan to use the probe for more than a week, you should shut the probe down
completely to prevent it from discharging completely.
1) First press the power button ( , 2). And then press the scan button (1) in a second, while keeping the
power button ( ) pressed.
2) A popup window will appear.
Figure 42 Popup window for shutdown mode
3) Select the OK menu ( ) to shut down BioCon-900 or select the Cancel menu ( ) to cancel the action.
4) Press the power button (1) shortly to turn the probe on.
65
5.28 DATA STORAGE
The data storage of measurements appears on the Home screen.
N/50 -> N: Number of currently saved measurement / 50: Maximum number of saved measurements
The blue bar increases as the number of saved measurement increases.
And the blue bar will be changed to red, when the number of saved measurement exceeds 45.
When the memory is full, a user saves a new measurement, the oldest measurement is automatically
deleted.
Figure 43 Data storage on Home screen
66
5.29 POPUP WINDOWS
windows
Description
Confirm message: “Are you sure you want to delete this saved scan result?”
Confirm message: “Are you sure you want to delete all saved measurements?”
Confirm message: shutdown mode – To prevent the probe from discharging.
“Are you sure you want to go into shutdown mode?”
Alert message: The battery is nearly depleted and needs to be recharged.
Alert message: The battery needs to be recharged immediately, so the probe
goes to sleep mode soon by shutting itself down
67
5.30 UPLOADING SCAN RESULT
To upload saved scan results after measurements,
1) Turn on the docking station and check the Ready indicator is on in the docking station.
2) Confirm that the docking Station and the PC is connected via USB cable.
3) If probe is in shutdown mode, turn the Probe on and go to the Review screen. And mount the probe
on the docking Station properly.
4) If probe is on, go to the Review screen. And mount the probe on the docking Station properly.
5) If probe is in sleep mode, mount the probe on the docking Station properly. When the probe is
mounted on the docking station, the probe wakes up from sleep mode and will display the Review
screen with the last saved measurement.
6) Now the probe is ready to transfer the saved data to the PC.
7) For next steps, see “SOFTWARE(CubePro)”.
Make sure that the green Ready indicator (1) is on. If the Ready indicator does not light on, contact
Mcube Technology or your local distributor.
Figure 44 Probe mounting for uploading scan results
68
5.31 RESET THE PROBE AND DOCKING STATION
A reset clears any pending state in the system, in a controlled manner.
Figure 45 Resetting system
When the system is in abnormal conditions (frozen system, burning smell, etc.), press the reset button with
a pen or stylus. And then press the power button to turn on the probe and/or docking Station again.
69
6 SOFTWARE (CubePro)
Skip this part if you do not have or use the CubePro software.
6.1 GENERAL INFORMATION
Copyright ⓒ 2009-2015 Mcube Technology Co., Ltd. All rights reserved.
The contents of this manual are the property of Mcube Technology Co., Ltd. Any reproduction in whole or in
part is strictly prohibited.
This manual correctly describes the software and its functions at the time of publishing of the CD-ROM.
However, as modifications may have been carried out since the production of this manual, the device
package may contain one or more addenda to the manual. This manual including any such addenda must
be read, before using the software.
The following situations void any guarantee(s) and obligations of Mcube Technology:
The software is not used according to the enclosed manuals and other accompanying documentation.
The software is installed or modified by persons other than Mcube Technology certified service
technicians
This Operator Manual covers the basics of installing CubePro software and using the upload function
between the BioCon-900 and a PC.
70
CAUTION
Computer connection:
When connecting the BioCon-900 to a computer, the computer must be certified to EN/IEC/CSA/UL 60950
or 60101-1 standard to maintain the device’s compliance to EN/IEC/CSA/UL 60601-1-1 standard.
Transmission of data:
When transmitting data to or from a computer, make sure that the BioCon-900, any accessories, and the
computer are at least 3.8 meters or 12.5 feet away from the patient
Disconnect the USB cable from the PC before cleaning the system.
Do not touch PC output connectors (eg.USB, port and others) and the patient at the same time.
Before using the system, inspect the enclosures, power cord and USB cable
6.2 INTENDED USE
This software is intended to transfer and review the data from BioCon-900. The overview of the features
controlled by this software is as follows:
Uploading of the data saved in the BioCon-900 via the Docking station.
Review of the data uploaded from the BioCon-900 to the PC.
Printing of the data uploaded via the local printer or network printer.
Image printing (JPG, PDF) of the data uploaded.
71
6.3 INSTALLING CUBEPRO SOFTWARE
Insert the software CD into the CD-ROM drive. Double-click “Setup_CubePro_V2.0.msi” file in the CD.
And then click “Next”.
Select an installation folder. If you want to change the folder, click “Browse”. It is recommended to install in
the default directory (folder).
And then click “Next”.
Figure 46 Initial screen for installation
Figure 47 Selecting installation folder
72
Click “Next” and you will see the installing progress bar as follows:
Figure 48 Confirm installation
Figure 49 Installing
73
CubePro is installed successfully. Click “Close” to exit.
Figure 50 Installation compete
6.4 UNINSTALLING SOFTWARE
“Control panel” “Add or Remove Programs” in Control panel Remove the CubePro
74
6.5 SETTING UP CUBEPRO
Click from Menu bar Setup CubePro Setup
Figure 51 CubePro setup
“Hospital Name” Hospital/Clinic name
“Department Name” Department name
“Scan Data Folder Path”
Select a folder to store uploaded data from BioCon-
900
“Output Data Folder Path”
Select a folder to store PDF or JPG output files.
“Number of Output Data Image”
Select the number of ultrasound image planes on the
output data.
“Date Format”
Select the date format.
75
6.6 RUN CUBEPRO
After a successful installation CubePro icon will appear on your desktop.
Run the CubePro.exe file and the title bar shows [USB: Not Connected]
Figure 52 Running CubePro
After the docking station and your PC are connected using USB cable, the title bar shows [USB:
Connected].
Figure 53 Title bar : USB connected
76
6.7 UPLOAD THE SCAN DATA
Click “file” from the menu bar.
Figure 54 File from menu bar
“Open” Open the data stored in the PC.
Figure 55 Popup message -" No connection"
When BioCon-900 is not mounted properly and IrDA is not working, the message will appear.
77
1) Upload Saved Data List
a) Connect the docking station with the PC using the USB cable.
b) Turn the probe on and press the Review button ( ) to go to the Review screen
c) Mount the probe on the docking station.
d) Run CubePro in your PC.
e) Check that the title bar shows [USB: Connected].
f) Click “file” from the menu bar and then click “Upload Saved Data List” from file menu.
g) The data list in the BioCon-900 is uploaded, and “BioCon-900 File List” is displayed
Figure 56 File list
78
Figure 57 Selecting files
- “Save”, ”Open” and “Delete” are not activated when No data was selected.
- “Total data” is displayed at the bottom left corner.
- Maximum 20 data is displayed in a page.
- Click “<” button to go to the previous page, or click “>” button to go to the next page.
- Maximum 40 data is uploaded from internal memory at a time.
“File Name” the name of data file
“STATE” PC uploading progress (completed: “SAVED”)
“DATE” the date of data
79
“Time” the time of data
One or more selected data makes “Save”, ”Open” and “Delete” activate.
“Save” button Upload the data to the PC from BioCon-900 and store the uploaded
data in the PC.
“Open” button Open files in the stored in the PC through “Save” function.
“Delete” Delete the data from BioCon-900.
After deletion, the data list is updated.
80
Click “Save” and it shows you a progress bar with percent saved.
When finished, “SAVED” is displayed.
Figure 58 Uploading state
After all data selected are uploaded, “Delete” Dialog box is displayed on the screen. If you want to delete
all data in the BioCon-900 which has been uploaded to the PC, click “OK” button, or if you want to keep
data in the BioCon-900, click “Cancel” button.
To delete the data in the BioCon-900 without uploading, follow below steps.
- Select the data in the “BioCon-900 File List” dialog to delete by clicking the checkbox.
- Click “Delete” push button and click “OK” button in the “Delete” Dialog box.
81
2) Upload Current Image(data)
a) Connect the docking station with the PC using the USB cable.
b) Turn the probe on and press the review button ( ) to go to the Review screen
c) Display the data saved in the BioCon-900 to be uploaded.
d) Run CubePro in your PC
e) Check that the title bar shows [USB: Connected]
f) Click “File” from the menu bar and then click “Upload Current Image” from file menu.
g) Uploaded current data is displayed on the PC.
BioCon-900 should be “Scan Result screen” or “Review screen” to upload current data.
Figure 59 Screen after uploading current data
82
To update patient information:
Enter the new patient information (Patient name, tag, age and comments).
It is essential to enter the tag for a file name.
“Save” button is activated, if any patient information is entered. After that, click “Save” button.
Figure 60 update patient information
83
If the patient type is child, enter the age in years or months.
Figure 61 Modification of child age type
84
Output the data
Select the output format.
- “Printer”: the data will be printed out through the network printer.
- “JPG and PDF”: the data will be saved in the format.
Click the Direct Output: the data will be printed out or “Successfully, JPG (PDF) was saved” will be popped
up.
Output folder is the designated folder where the PDF and JPG outputs are saved. The output folder is
designated when installing CubePro.
Figure 62 Control of output data
85
3) Number of output images
You can set the number of image planes to be output in a setup menu: All, Two, or None.
Figure 63 Output images
86
7 TROUBLESHOOTING
7.1 TROUBLESHOOTING
Error message
Description
Actions
FPGA configuration
error
Contact your local distributor or Mcube Technology.
System information error
Contact your local distributor or Mcube Technology.
Angle motor error
Contact your local distributor or Mcube Technology.
Plane motor error
Contact your local distributor or Mcube Technology..
High temperature error
Contact your local distributor or Mcube Technology.
87
Low temperature error
Contact your local distributor or Mcube Technology.
Data deletion error
Contact your local distributor or Mcube Technology.
7.2 POPUP WINDOWS FOR MAINTENANCE
popup
Description
Indicates that the temperature of oil inside the probe is below 10°C. So the
thermostat inside probe makes the oil warm and the temperature of oil rises
above 10°C.
The following popup windows appear during the progress of warming oil. When
finished, press the button ( ) to return to the home screen.
Warming oil lasts for 3 minutes. And then a new error code will appear, if the
temperature of oil inside the probe remains below 10°C.
(during warming oil) (when finished)
88
8 MAINTENANCE
8.1 CLEANING & DISINFECTION
CAUTION
- Incorrect cleaning or disinfecting of any part of the system can cause permanent damage.
- Do not use solvents such as thinner or benzene, or abrasive cleaner on any part of the system.
- Do not use Cidex Plus or Metricide Plus 30 to disinfect the device. Cidex Plus or Metricide Plus 30 will
damage the plastic enclosure during the disinfecting. This will be considered abused and will void the
warranty.
- Do not subject the system to any method of sterilization.
- Availability of cleaning, disinfection, and sterilization products varies by country and Mcube Technology is
not able to test all products in every market.
- Do not immerse the probe except the probe head, when cleaning and disinfecting.
- Do not immerse the docking station, when cleaning and disinfecting.
Cleaning
1) Cleaning outer case (housing) of the system
a) Air dry or towel dry with a soft, clean cloth.
b) Wipe the main body 1~2 times using soft cloth dampened with isopropyl alcohol or any other
appropriate hospital cleaning solution to 1000 ppm. Do not allow liquids to leak into the device while
cleaning.
c) Dry the device completely with a clean and soft cloth before using.
89
2) Cleaning the probe
Since the surface of the probe affects the result of data, users should keep as follows:
a) Air dry or towel dry with a soft, clean cloth.
b) Before using the device, you have to wipe out the probe cap cleanly 4~5 times with soft cloth which
was dampened with isopropyl alcohol or an appropriate hospital cleaning agent to 1000ppm. Then
you can use the device after drying with a dry, clean cloth.
c) Remove the residual gel on the probe’s surface after scanning finished.
Disinfection
1) Disinfection of the probe head
a) Clean the Probe prior to disinfection.
b) Dampen a soft cloth with disinfected solution listed in the table below.
c) Wipe the probe with a dampened cloth.
d) Air dry or towel dry with a soft, clean cloth.
e) Inspect the Probe for any damage such as cracks.
Disinfectants Lists for the Probe disinfection
Use any glutaraldehyde based disinfectant to disinfect the Probe. Following table lists compatible
disinfectants.
Disinfection Solutions
Type
Country of Origin
Manufacturer
Cidex
Liquid
USA
Johnson & Johnson
Cidex 7
Liquid
USA
Johnson & Johnson
Metricide 14
Liquid
USA
Metrex Research Inc.
Metricide 28
Liquid
USA
Metrex Research Inc.
90
Chlor-Clean (max 1000ppm)
Liquid
England
Guest Medical LTD
Trigene
Wipes
England
Medichem international
CAUTION
Do not use Cidex Plus, Metricide Plus 30, aOxivir® Tb, Oxivir® Five 16 Concentrate, Oxivir® Tb Wipes
at dilution to disinfect the device. Those solutions will damage the plastic enclosure. This will be
considered abused and will void the warranty.
Deep Cleaning
If either the outer case of the probe or docking station becomes contaminated with faeces, urine or blood
or any other dangerous bacteria, it is advised to clean with a cleaning agent to 10000 ppm such as Chlor-
Clean 4.5g Haz Tabs, following the Chlor-Clean manufacturer’s dilution instructions. Following this the
following must be carried out “that after surfaces have been disinfected for about 15 minutes the area
should be washed off with a fresh water dampened soft, clean cloth and dried carefully afterwards”. Failure
to follow these instructions could lead to damage of the plastic outer casing of both the reader unit and the
probe and will be considered as abuse and will void the warranty.
8.2 WEEKLY INSPECTION
a) Thoroughly inspect the probe and the docking station, if it has any cracks or leakage.
b) Inspect the power cord for any damage.
c) When scanning, check out any abnormal noise emanating from the probe head.
91
8.3 DISPOSAL
The device and accessories may contain environmentally hazardous materials (mineral oil, lead, battery
pack, etc.). When they have reached the end of its useful service life, return them to the Mcube Technology,
or follow your local regulations for hazardous waste disposal.
8.4 DEVICE REPAIR
.
Faults not described in section “7. Troubleshooting” are intended to be serviced by a certified technician.
When any troubles unlisted in section 7 occur, contact an authorized service provider or Mcube Technology.
92
8.5 CALIBRATION
BioCon-900 must be calibrated every 12 months to ensure accurate measurements. Calibrating ensures
accurate alignment of BioCon-900’s internal system. You can take scan, even if calibration is not
performed by the designated date. But measurement can be compromised.
CAUTION
Calibrate BioCon-900 when the battery has over 60% of charge.
There are two methods for the calibration. The phantom calibration process is as follows;
Phantom Calibration
1. Place the CubeScan phantom on a flat surface.
And open the cover of the phantom.
2. Drop about 5ml water or more on the center
surface of the phantom
3. Place the holder on the top of the CubeScan
phantom. Check if the holder is in a stable and
flat position.
4. Put the probe head into the probe holder
firmly.
93
5. Turn the probe on and press the Setup button ( ) below the display on the home screen.
6. Use the Move-down button ( ) and select phantom calibration button ( ) by pressing the
Selection button ( ).
7. Select the Action button ( ) to perform the calibration. You can cease the Phantom calibration
with the Cease button ( )
8. The calibration progress icon and bar will appear, when the calibration is started. And the
progress bar will show the calibration is progressed. It takes about 3min to complete the
calibration. When the calibration is completed, 100% is displayed.
Press the Selection button ( ) to return to the home screen and calibration date will be
updated. Press the cancel button ( ) to cancel the last calibration and calibration date will not
be updated.
Figure 64 Phantom calibration screen
94
Self-test
1. Put the probe on the docking station for Self-test.
2.Turn the probe on and press the Setup button ( ) below the display on the home screen.
3. Use the Move-down button ( ) and select Self-test button ( ) by pressing the Selection button
().
4. Select the Action button ( ) to perform the calibration. You can cease the Self-test with the
Cease button ( )
5. Self-test progress icon and bar will appear, when the calibration is started. And the progress bar
will show the calibration is progressed. It takes about 3min to complete the calibration. When the
calibration is completed, 100% is displayed.
Press the Selection button ( ) to return to the home screen and calibration date will be
updated. Press the cancel button ( ) to cancel the last calibration and calibration date will not
be updated.
Figure 65 Self-test screen
95
8.6 CALIBRATION REMINDER
1) Calibration reminder popup window
Calibration reminder popup window appears on the Top screen under the conditions as follows:
- After 1 year since the last calibration
Press the Selection button ( ) to return to the home screen. And the Calibration reminder popup will
disappear.
2) Calibration reminder icon
The Calibration reminder icon ( ) will be displayed on the Home screen after the Calibration reminder
popup disappears. When Phantom calibration is succeeds, the last calibration date is updated and the
calibration reminder icon ( ) will disappear.
Figure 66 Calibration reminder icon on Home screen
96
9 SPECIFICATIONS
9.1 ACOUSTIC OUTPUT TABLE
Transducer Model: BioCon-900 Transducer Operating Mode: B-mode
TIS
TIB
Index Label
MI
scan
non-scan
non-
TIC
Aaprt>1
scan
Global Maximum Index Value:
0.268
0.179
(a)
(a)
(b)
(b)
IEC FDA Units
pra pr.3 (MPa)
0.39
P Wo (mW)
-1.299
#
#
#
min of [P zsIta,zs [W.3(z1),ITA.3(z1)]
#
zs z1 (cm)
#
Associated
zbp zbp (cm)
#
Acoustic
zb zsp (cm)
#
Parameter
z at max. I zsp (cm)
deq(zb) deq(zsp) (cm)
#
fawf fc (MHz)
2.08
2.08
#
#
#
#
WARNING
ALARA principle (As Low As Reasonably Achievable) should be employed for all medical ultrasound
exposure.
Users can not adjust the acoustic output energy of the BioCon-900. And the output level is below than
the levels which were referred in AIUM remarks in 1992 and there were no reported biological effects
under the level. However, to minimize exposure, measurements should be kept as short as possible.
Refer to the acoustic output section for more information.
97
Dim of Aaprt
X (cm)
4.991
#
#
#
#
Y (cm)
4.271
#
#
#
#
td PD (µsec)
1.23
prr PRF (Hz)
320
Other
pr at max. Ipi pr@PIImax (MPa)
2.70
Information
deq at max. Ipi deq@PIImax (cm)
#
Focal Length
FLX (cm)
6
#
#
#
FLY (cm)
6
#
#
#
I at max. MI IPA.3@MImax (W/cm2)
Operating
Frequency
2 and
3.4
Control
Conditions
…
Notes:
(a) This index is not required for this operating mode; see section 4.1.3.1 of NEMA Standard UD-3.
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value is not reported
for the reason listed.
Acoustic Measurement Precision and Uncertainty
All entries in the below table have been obtained at the same operating conditions that produce the
maximum index value. The measurement precision and uncertainty values are determined by repeated
98
measurements.
Parameter
Precision
(% of standard deviation)
Uncertainty
(95%)
pr.3
6.0%
+/- 24%
Wo
8.2%
+/- 32%
fc
5.2%
+/- 15%
9.2 DEFINITIONS AND SYMBOLS
MI
the Mechanical Index
TISscan
the Soft Tissue Thermal Index in an auto-scanning mode
TISnon-scan
the Soft Tissue Thermal Index in a non-auto-scanning mode.
TIB
the Bone Thermal Index.
TIC
the Cranial Thermal Index.
Aaprt
the area of the active aperture (square centimeters).
pr.3
the derated peak rarefractional pressure associated with the transmit pattern giving
rise to the value reported under MI (megapascals)
Wo
For TIB and TIC: time average acoustic power at the source, in milliwatts. (Also see
the definitions for W01 and W01x1 that follow.)
For TIS scan, Wo = Wo1 + Wo1x1
For TIS non–scan, Wo = Wo1x1
Wo1: For scanning modes and/or scanning components of combinational modes:
time average acoustic power at the source, per cm, in milliwatts. This is the acoustic
power emitted from the central 1–cm length, in the scan direction, of the aperture
corresponding to the scanned pulses.
99
Wo1x1: For non–scanning modes and/or non–scanning components of
combinational modes: time average acoustic power at the source, per cm2, in
milliwatts. This is the acoustic power emitted from the central 1 cm2 of the active non–
scanned aperture through which the highest acoustic power is being transmitted.
W.3(z1)
the derated ultrasonic power at axial distance z1 (milliwatts).
ITA.3(z1)
the derated spatial-peak, temporal-average intensity at axial distance z1 (milliwatts per
square centimeter).
z1
the axial distance corresponding to the location of max[min(W.3(z), ITA.3(z) x 1 cm2)],
where z = zbp (centimeters).
zbp
(centimeters).
zsp
For MI, the axial distance at which pr.3 is measured
for TIB, the axial distance at which TIB is a maximum (i.e., zsp = zB.3)
(centimeters).
deq(z)
the equivalent beam diameter as a function of axial distance z, and is equal to
o/ITA(z))]0.5 where ITA(z) is the temporal-average intensity as a function of z
(centimeters).
fc
is the center frequency (MHz). For MI, fc is the center frequency associated with the
transmit pattern giving rise to the maximum reported value of MI. For TI, for
combined modes involving transmit patterns of unequal center frequency, fc is defined
as the overall range of center frequencies of the respective transmit patterns.
Dim. of Aaprt
the active aperture dimensions for the azimuthal and elevational planes (centimeters).
PD
the pulse duration (microseconds) associated with the transmit pattern giving rise to
the reported value of MI.
PRF
the pulse repetition frequency associated with the transmit pattern giving rise to the
reported value of MI (Hz).
1.69 Aaprt
100
pr@PIImax
the peak rarefactional pressure at the point where the free field, spatial-peak pulse
intensity integral is a maximum (megapascals). See Section 6.2.4.1 of the Output
Display Standard, entitled "Measurement Methodology for Mechanical and Thermal
Indices".
deq@PIImax
the equivalent beam diameter at the point where the free field, spatial-peak pulse
intensity integral is a maximum (centimeters). See Section 6.2.5.1 of the Output
Display Standard, entitled "Measurement Methodology for Mechanical and Thermal
Indices".
FL
the focal length, or azimuthal and elevational lengths, if different (centimeters).
IPA.3@MImax
the derated pulse average intensity at the point of maximum reported MI (Watts per
square centimeter).
p_
MPa
The Peak Rarefactional Acoustic Pressure is the maximum of the
modulus of the negative instantaneous acoustic pressure expressed as
a positive number.
ISPTA
mW/cm2
The maximum value of the temporal average derived intensity in an
acoustic field. For systems in combined operating mode, the time
interval over which the temporal average is taken is sufficient to include
any period during which scanning may not be taking place.
System settingsa
User selectable system settings which may include Application, SV and
Focal Length.
Ip
mm
This is the distance from the transducer output face to the point of
maximum pulse-pressure-squared integral (or max mean square
acoustic pressure for continuous pressure for CW)
101
wpb6 (||)
mm
This is the -6dB pulse beam width in the beam axis (X) at the point of
max pulse-pressure-squared integral (or max mean square acoustic
pressure for continuous pressure for CW). If the beam widths in X and
Y differ than less than 10%, there is no need to specify both. For
scanning modes, the beam-widths shall correspond to the central scan
line only.
wpb6 (_|_)
mm
This is the -6dB pulse beam width in the elevational axis (Y) at the point
of max pulse-pressure-squared integral (or max mean square acoustic
pressure for continuous pressure for CW). If the beam widths in X and
Y differ than less than 10%, there is no need to specify both. For
scanning modes, the beam-widths shall correspond to the central scan
line only.
Prr
kHz
Pulse Repetition Rate is the rate of successive pulses or tone bursts
and applies to single element non-scanning systems and automatic
scanning systems.
Srr
Hz
Scan Repetition Rate is the rate of the same identical point of
successive frames, sectors, or scans and applies to automatic scanning
systems (modes) only.
Output beam
dimensionsb
mm
Output beam dimensions are the dimensions of the ultrasound beam (-
6dB pulse beam width) in a specified direction normal to the beam
alignment axis and at the transducer output face. In scanning modes,
these shall refer to the center scan line only.
Fawf
MHz
The Arithmetic-mean Acoustic Working Frequency is the arithmetic
mean of the frequencies f1 and f2 at which the amplitude of the
spectrum of the acoustic signal first becomes 3dB lower than the peak
amplitude.
102
APFc
%
Acoustic Power-up Fraction is the ratio of the peak rarefactional
acoustic pressure when the system is in Power-up mode to the
maximum value of the peak rarefactional acoustic pressure for any
system settings of a specified mode of operation. This ratio is
determined from measurements made at the position which yields the
maximum pulse-pressure-squared integral (or maximum mean square
acoustic pressure for CW)
AIFd
%
Acoustic Power-up Fraction is the ratio of the peak rarefactional
acoustic pressure when the system is in Initialization mode to the
maximum value of the peak rarefactional acoustic pressure for any
system settings of a specified mode of operation. This ratio is
determined from measurements made at the position which yields the
maximum pulse-pressure-squared integral (or maximum mean square
acoustic pressure for CW)
Maximum
powere
mW
This is the Maximum Temporal Average power output. For scanning
modes, this shall be the total power output of all the acoustic pulses.
Iob
mW/cm2
Output Beam Intensity is the temporal-average power output divided by
the output beam area
Power-up mode
With the probe connected cycle power on the system. Write down the
mode to which the system powers up. Usually, it is “B” mode.
Initialization
mode
Write down “N/Af “ where it denotes “system settings do not change on
new patient entry”
Acoustic output
freeze
Write down “YES “ if the system is supplied with an output freeze
facility.
103
Itt
mm
Transducer to Transducer output face distance is the distance along the
beam alignment axis between the surface containing the active face of
the transducer or elements and the transducer output face (usually the
lens thickness)
Its
mm
Transducer Standoff distance is the shortest distance between the
transducer output face and the patient entry plane. The term “contact” is
used to connate direct contact between the transducer output face and
the patient.
Inclusive modes
Make a note of the Inclusive Modes for this particular declaration which
are not being declared separately.
9.3 ELECTROMAGNETIC COMPATIBILITY
1) Electromagnetic emissions
Guidance Manufacturer’s declaration - electromagnetic emissions
The BioCon-900 is intended for use in the electromagnetic environment specified below. The customer
or the user of the BioCon-900 should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF Emissions
CISPR 11
Group 1
The BioCon-900 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment
104
RF Emissions
CISPR 11
Class A
The BioCon-900 is suitable for use in all establishments, other
than domestic and those directly connected to the public low-
voltage power supply network that supplies buildings used for
domestic purposes
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Complies
2) Electromagnetic Immunity
Guidance Manufacturer’s declaration - electromagnetic immunity
The BioCon-900 is intended for use in the electromagnetic environment specified below. The customer or
the user of the BioCon-900 should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic environment
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV Contact
±8kV air
±6kV Contact
±8kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
105
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power
supply lines
± 1kV for
input/output lines
±2kV for power
supply lines
± 1kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1kV differential
mode
±2kV common
mode
±1kV differential
mode
±2kV common mode
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips,
short
interruptions and
voltage
variations
on power supply
input lines
IEC 61000-4-11
<5% Uт
(>95% dip in Uт)
for 0.5cycle
40% Uт
(60% dip in Uт )
for 5 cycles
70% Uт
(30% dip in Uт)
for 25 cycles
<5% Uт
(<95% dip in Uт )
for 5 sec
<5% Uт
(>95% dip in Uт)
for 0.5cycle
40% Uт
(60% dip in Uт )
for 5 cycles
70% Uт
(30% dip in Uт)
for 25 cycles
<5% Uт
(<95% dip in Uт )
for 5 sec
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the BioCon-900 requires
continued operation during power mains
interruptions, it is recommended that the
BioCon-900 ultrasound system be powered
from an uninterruptible power supply or a
battery.
106
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
NOTE: Uт is the a.c. mains voltage prior to application of the test level.
107
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80MHz
3 V/m
80MHz to
2.5GHz
3 V
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the BioCon-900,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1,2√ 𝐏
d = 1,2√ 𝐏 80 MHz to 800 MHz
d = 2,3√ 𝐏 800 MHz to 2,5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol :
108
NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the BioCon-900 is used exceeds the applicable RF compliance level above, the
BioCon-900 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the BioCon-900.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.
3) Recommended separation distance
Recommended Separation Distances between Portable and Mobile RF communications
equipment and the BioCon-900
The BioCon-900 is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of BioCon-900 is can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and BioCon-900 as recommended below, according to the maximum output power of the
communications equipment.
RATED MAXIMUM
OUTPUT
POWER OF
SEPARATION DISTANCE ACCORDING TO FREQUENCY OF
TRANSMITTER (m)
150 kHz to 80 MH
80 MHz to 800 MHz
800 MHz to 2.5 GHz
109
TRANSMITTER
(W)
d = 1,2√ 𝐏
d = 1,2√ 𝐏
d = 2,3√ 𝐏
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
4) Components conformance to standards
EMC standards for accessory
Accessory
Max length
docking station
3.8 m(12.5ft)
110
9.4 EXCESSIVE TEMPERATURE TEST RESULT
Transducer type →
External use
Test to be applied ↓
Simulated use test
Temperature rise
The ambient temperature : 22.8 ℃
The temperature rise to: 24.6 ℃
Still air test
(no gel)
Temperature rise
The ambient temperature : 23.1 ℃
The temperature rise to: 25.5 ℃
9.5 SPECIFICATION OF COMPONENTS
Probe
Item
Features
Bladder Volume Range
0 - 999ml
*Accuracy
±15%,±15ml (0 - 999ml)
(According to the scanning instruction, and scanning on a Mcube Technology
tissue-equivalent bladder phantom.)
Scan time
Less than 3 sec
111
Power
MC-BA-01 (Lithium-ion rechargeable battery)
- Nominal Voltage: 3.6v
- Nominal capacity:5200mAh
Charging time: less than 6 hours
- Charged by the docking station
**Number of scanning : approximately 1500 scans.
- For a new battery module fully charged.
- Tested under Mcube Technology’s test conditions.
Display
TFT-LCD
2.4 inch
Format : 240 X RGB X 320 Stripe
External Interface
IrDA
Patient ID Input
1D/2D Barcode
Image capture
User Interface
- Icons
- 5 buttons
Water Resistance
Rated at IPX3
112
Probe Head
-Transducer : Diameter: 14mm
-Sector scan
-Dual frequency (2MHz, 3.4MHz)
-B-mode scan image
-Scan angle : 120°
-Penetration depth(normal patient): 23cm
-Applied part: Probe Cap
-Type BF equipment
Mode of Operation
- Continuous operation
Weight
490g with battery
docking station
Item
Features
Use
Indoor
Input Voltage
AC 100- 240V
Input Frequency
50/60Hz
Input Current
1A/60-80VA
Output
Wireless Power Transfer Charger
- BioCon-900 only
Insulation
Class I with protective earth
113
Thermal Printer
Built in(57mm width)
External Interface
USB 2.0
IrDA
Water Resistance
IPX0 Ordinary equipment
Mode of Operation
Continuous operation.
Weight
1190g
*Accuracy:
- According to the scanning instruction, and scanning on a Mcube Technology tissue-equivalent
bladder phantom.
**Number of scanning
- For a new battery module fully charged
- Tested under Mcube Technology’s test conditions
114
9.6 ENVIRONMENTAL CONDITIONS
CAUTION
Do not place the heavy object on the device. The device can be damaged.
Keep away from the humid or dusty place.
Use the device indoors only under the environmental conditions.
For additional protection of the device during a lightning storm, or when it is left unattended and unused
for long periods of time, unplug it from the wall outlet.
The immediate use of the probe which has been stored under 10℃ without warming may damage the
probe. So take it into a room where the temperature is over 10℃ and let BioCon-900 warm up for a
while. And then when the temperature of probe is over 10℃ you may use it.
If you are not using BioCon-900 more than 3 months, remove the battery to prevent it from discharging
and store it in accordance with the recommended conditions, and charge the battery every 6 months.
Contact your local distributor or Mcube Technology, when you need to remove or replace the battery
WARNING
Do not leave this device in places subject to extremely high temperatures such as a sealed vehicle or
in direct sunlight. This can cause a fire.
Do not place the device on an unstable surface. This can cause the device to fall or tip over and
cause injury.
115
9.6.1 PROBE
Operating conditions
Condition
Description
Use
Indoor
Ambient temperature range
+10 - +40℃ (+50 - +104℉)
Relative humidity
+30% - +75% non-condensing
Atmospheric pressure range
+700hPa - +1060hPa
Storage and transport conditions
Condition
Description
Use
Indoor
Ambient temperature range
-10 - +20℃ (+14 - +68℉) ≤ 1 Year
-10 - +45℃ (+14 - +113℉) ≤ 3 Month
-10 - +60℃ (+14 - +140℉) ≤ 1Month
Relative humidity
+20% - +80% non-condensing
Atmospheric pressure range
+600hPa - +1060hPa
116
9.6.2 DOCKING STATION
Operating conditions
Condition
Description
Use
Indoor
Ambient temperature range
+10 - +40℃ (+50 - +104℉)
Relative humidity
+30% - +75% non-condensing
Atmospheric pressure range
+700hPa - +1060hPa
Storage and transport conditions
Condition
Description
Use
Indoor
Ambient temperature range
-10 - +60℃ (+14 - +140℉)
Relative humidity
+20% - +80% non-condensing
Atmospheric pressure range
+600hPa - +1060hPa
117
10 GLOSSARY
B-Mode
A kind of ultrasound imaging mode. Displays the brightness information corresponding to
the amplitude of the signal.
Probe
The main device with the LCD display.
Contextual
menu
The menu displayed in the bottom of LCD based on the system state.
Session
The process a user starts to scan on the Top screen and returns to the Top screen
again.
Transducer
Device that transforms one form of energy into another form of energy. Ultrasound
transducer transforms electric energy into acoustic energy and vice versa. Transducer in
this guide means ultrasound transducer.
Pre-Scan
General 2D real-time ultrasound scanning. 2D ultrasound images are displayed
continuously in live image basis.
This helps an operator locate bladder position and predicting the range of residual urine.
Normal scan
Get 12-plane ultrasound images and calculate the residual urine in the bladder (3D
scanning).
Home screen
Appears when BioCon-900 is turned on.
Pre-Scan
screen
Appears when the user presses the Scan button on the probe to locate the bladder.
Normal scan
screen
Appears when the user presses the Scan button on the probe during Pre-Scan. The
bladder volume is calculated during Normal scan.
Scan result
screen
Appears when a Normal scan is completed. It displays calculated bladder volume,
patient type and aiming info and so on.
118
Review
screen
Appears to allow users to review the saved measurement.
Setup screen
Start screen for adjusting Date format, Date and Time, Display brightness, Print report
format and sleep mode. And for turning Pre-Scan on/off, Barcode reader on/off, and
Capture on/off. And for deletion of all saved measurement, and doing the Self-test, and
Phantom calibration
Self-test
Displays Self-test progress and results.
Phantom-
calibration
Displays phantom-calibration progress and results.
119
11 SYMBOL DIRECTORY
Symbol
Description
CE marked in accordance with
the Medical Device Directive
Type BF patient applied part
(IEC 60601-1) protection against electric shock.
(B= Body, F= Floating applied part)
Collect separately from other household waste
(See European Commission Directive 2002/96/EEC.(WEEE))
Refer to local regulations for disposal.
Manufactured date
Manufacturer
Authorized representative in the European community
120
Serial number
Catalog(Part) number
DC jack connector and DC input voltage
IPX3
Degree of protection against harmful ingress of water as detailed in the
IEC 60529:IPX3 - Protected against spraying water
Fragile
This Way Up
Use no hook
Keep dry
121
Temperature limitation
Humidity
limitation
Atmospheric pressure limitation
Do not use blades to open
Rx only
Statement of prescription
Caution
Operating instructions
122
Underwriters Laboratories Certification Mark
MEDICAL EQUIPMENT+
(ANSI/AAMI ES60601-1 AMD 1 MEDICAL ELECTRICAL EQUIPMENT - PART 1:
GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL
PERFORMANCE, AMENDMENTS - Edition 1 - Issue Date 2012/08/20
CAN/CSA C22.2 NO. 60601-1:14 MEDICAL ELECTRICAL EQUIPMENT. PT. 1,
GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL
PERFORMANCE - Edition 3 - Issue Date 2014/01/01)
Tested to Federal Communications Commission requirements
WARNING; Laser radiation, Do not stare into beam class2, Laser product
Stand-by
123
12 REFERENCES
AIUM: Medical Ultrasound Safety, American Institute of Ultrasound in Medicine, Laurel, MD, 1994.
AIUM: Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How
Manufactures Should Specify Acoustic Output Data, Revision 1, American Institute of Ultrasound in
Medicine, Laurel, MD, 2008.
AIUM/NEMA: Standard For Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment, Revision 2. NEMA Standards Publication UD 3-2004; American Institute
of Ultrasound in Medicine, Laurel, MD; National Electrical Association, Rosslyn, VA; 2004a.
AIUM/NEMA: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3.
NEMA Standards Publication UD 2-2004; American Institute of Ultrasound in Medicine, Laurel, MD;
National Electrical Association, Rosslyn, VA; 2004b.
Health Canada: “Guidelines for the safe use of diagnostic ultrasound,” Cat. H46-2/01-255E, Ministry of
Public Works and Government Services Canada, 2001.
IEC: IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety, International
Electrotechnical Commission, 2004.
UL 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety, Underwriter
Laboratories Inc, 2003.
CSA C22.2 No. 601.1B-90, Medical Electrical Equipment – Part 1: General Requirements for Safety,
124
Canadian Standards Association, 2006.
IEC: IEC 60601-2-37, Medical electrical equipment – Part 2-37: Particular requirements for the safety of
ultrasonic medical diagnostic and monitoring equipment, International Electrotechnical Commission, 2007.
ISO: ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, 2003.
FDA Guidance: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers, 2008
FDA Guidance: General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002.
IEC: IEC 61157, Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic
equipment, International Electrotechnical Commission, 2007.
MDD 93/42/EEC, Medical Device, Office for the Official Publications of the European Communities, 2003.
Woo Sung Hong, Sun Young Ham, Tong-Wook Kim, Jeong-Seok Seo, Sang-Kuk Yang. Usefulness of a
Sonographic Bladder Scan for Uroflowmetry and the Evaluation of the Anxiety Level Associated with
Uroflowmetry. The Korean Journal of Urology 2007:48(06):633-637
Chung B, Lee T, Yang J H. The Diagnostic Value of Portable Bladder Volume Measurement (BVMS) with
Real Bladder Image in the Measurement of Bladder Volume According to the Different Angling of
Transducer. The Korean Journal of Urology 2006:47(06):1320-1326
Bodker B, Lose G. Postoperative urinary retention in gynecologic patients. Int Urogenecol J Pelvic Floor
Dsyfunct 2003;14:94-97
125
McNaughton-Collins M, Barry MJ. Managing patients with lower urinary tract symptoms suggestive of
benign prostatic hyperplasia. Am J Med 2005;118:1331-9
BioCon-900
Manufacturer
Mcube Technology Co., Ltd.
#803, 123, Bonghwasan-ro,
Jungnang-gu, Seoul, Korea
Tel.: +82-2-3421-7780
Fax.: +82-2-3421-7076
E-mail: mcube@mcubetech.co.kr
Web site: www.mcubetech.co.kr
Revision Date : Mar.04.2016
MUM-BioCon-900EN(Rev.1.0.1)
U.S. Distributor
Medline Industries, Inc.
One Medline Place
Mundelein, Illinois, 60060 USA
Tel: 1-800-MEDLINE
Website: www.medline.com
DongBang Acuprime
1 Forrest Units, Hennock Road East,
Marsh Barton, Exeter
EX2 8RU, U.K
Tel: +44 1392 829500
Fax: +44 1392 823232
Local Distributor