NURSE ROSIE RosieScan Bladder Scanner User manual

USER MANUAL
Bladder Scanner

Forward
Nurse Rosie Products, distributed by Life Systems, Inc. would like to thank you for your purchase of the
RosieScan™ Bladder Scanner. Please read this manual carefully before using the RosieScan. Familiarize
yourself with the features, methods of use, cautions and warnings, as well as any limitations of the
scanner. This manual should be kept in a safe, convenient place for future reference.
No part of this manual should be reprinted or reproduced without written consent from Life Systems
Inc., distributed by Life Systems Inc., maintains the right to modify the contents of this manual without
prior notice. If you have any questions about the information presented in this manual or about other
Nurse Rosie Products, distributed by Life Systems Inc., please contact us at:
Nurse Rosie Products / Life Systems Inc.
7320 Central Avenue
Savannah, Georgia 31406
www.nurserosie.com
800-841-1109
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Table of Contents
Table of Contents
1. Introduction .......................................................................................................................................... 6
1.1 General Description ...................................................................................................................... 6
1.2 Primary Components .................................................................................................................... 6
1.3 Intended Use................................................................................................................................. 6
1.4 Contraindication ........................................................................................................................... 7
1.5 Symbol Directory........................................................................................................................... 7
2. Product Specification ............................................................................................................................ 8
2.1 Main Technical Specifications....................................................................................................... 8
2.2 Accuracy Range............................................................................................................................. 8
2.3 Instructions for Environment Test ................................................................................................ 9
2.4 Sound Output................................................................................................................................ 9
3. System Overview....................................................................................................................................10
3.1 Primary Components .................................................................................................................. 10
3.1.1 Hardware Components....................................................................................................... 10
3.1.2 Embedded Software System ...............................................................................................10
3.2 Pictures and Descriptions ........................................................................................................... 11
3.3 Circuit Diagram and Part List ...................................................................................................... 13
4. Control Panel.......................................................................................................................................14
5. Optimal Conditions .............................................................................................................................15
5.1 For Use ..............................................................................................................................................15
5.2 For Storage........................................................................................................................................ 15
5.3 For Transportation ............................................................................................................................ 15
6. Installation .......................................................................................................................................... 16
6.1 Installation Instructions ..............................................................................................................16
7. Navigation ........................................................................................................................................... 18
7.1 Before Powering Up.................................................................................................................... 18
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7.2 Powering On................................................................................................................................ 18
7.3 Ready Screen............................................................................................................................... 19
7.4 System Reset Screen................................................................................................................... 21
7.4.1 Time .................................................................................................................................... 21
7.4.2 Date.....................................................................................................................................22
7.4.3 Print Images ........................................................................................................................22
7.4.4 Image Display: .....................................................................................................................22
7.4.5 Hospital ............................................................................................................................... 23
7.4.6 Alarm...................................................................................................................................23
7.4.7 Sound ..................................................................................................................................23
7.4.8 Volume Calibration .............................................................................................................24
7.5 The Scan Screen ..........................................................................................................................26
7.6 The Scan Results Screen..............................................................................................................28
7.7 Gray Scale Results Screen ...........................................................................................................29
7.8 The Save/Edit Screen ..................................................................................................................30
7.9 Browsing Historical Records........................................................................................................31
7.9.1 Deleting Stored Records .....................................................................................................32
7.9.2 Location Presentation .........................................................................................................32
7.10 Printing Results ........................................................................................................................... 34
7.11 Exporting Data to a PC ................................................................................................................34
7.12 Recharging the Battery ...............................................................................................................35
8. Clinical Application..............................................................................................................................37
8.1 Instructions for Use in a Clinical Setting .....................................................................................37
8.2 Images of Invalid Scan Results ....................................................................................................38
9. Transportation and Storage ................................................................................................................40
9.1 Transportation ............................................................................................................................ 40
9.2 Storage ........................................................................................................................................40
10. Maintenance and Service................................................................................................................ 41
10.1 Maintenance for Probe...............................................................................................................41
10.2 Main Unit Maintenance ..............................................................................................................41
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10.3 Service Guide .............................................................................................................................. 41
11. Troubleshooting.............................................................................................................................. 43
12. Quick Reference Guide ...................................................................................................................44
Appendix A.................................................................................................................................................. 45
Appendix B ..................................................................................................................................................48
B.1 Warnings .....................................................................................................................................48
B.2 Recharging and Discharging........................................................................................................ 48
B.3 Storage ........................................................................................................................................ 49
B.4 Transportation ............................................................................................................................ 49
B.5 Other Instructions....................................................................................................................... 49
Appendix C ..................................................................................................................................................50
C.1 Pre-Scan Image to the Left of Center.......................................................................................... 50
C.2 Pre-Scan Image to the Right of Center ....................................................................................... 51
Appendix D..................................................................................................................................................53
D.1 Electromagnetic Emissions ..............................................................................................................53
D.2 Electromagnetic Immunity.......................................................................................................... 54
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Introduction
1. Introduction
1.1 General Description
The RosieScan (“Device”) is a noninvasive ultrasound device used to measure urinary bladder volume.
During each scan, the RosieScan creates a three-dimensional image of the bladder. This image is then
used to automatically calculate and display the urinary bladder volume. The results of the scan may be
stored internally, printed using the on-board thermal printer or transferred to an external computer
using a USB connection.
The RosieScan can be programmed to make calculations based on a male, female or pediatric bladder
before each scan. The RosieScan can store up to 100 patient I.D.s and measurements. When the
memory is full the results may be transferred to an external computer and the on board memory can be
cleared.
1.2 Primary Components
The RosieScan consists of a Main Unit, Probe (standard frequency 2.6MHz), two Batteries, a USB cable,
Adapter and Charger.
1.3 Intended Use
The device is intended to provide a noninvasive means of measuring urinary bladder volume by a
licensed medical professional. All users must read this entire manual prior to using the RosieScan.
Failure to comply with these instructions may compromise the performance of the device and the
accuracy of its measurements.
Immediately after unpacking your new RosieScan, refer to the parts list below to ensure that all parts
are included in your package. Also verify that the user’s manual, maintenance document and all
accessories are included.
RosieScan Packing List
No.
Name of Parts
Quantity
1
Main Unit
1
2
Probe
1
3
Adapter
1
4
Charger
1
5
Battery
2
6
USB Cable
1
7
Cross Screwdriver
1
8
Certificate
1
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If any parts are missing please contact Life Systems using the contact information listed in the
Foreword.
Check to ensure that all components are connected properly and free of defect before turning on the
RosieScan. Do not use if any component is missing or damaged. Cease use immediately and contact
customer service if the RosieScan appears to be functioning abnormally in any way. Examples include,
but are not limited to the screen becoming abnormally bright, strange or unusual sounds coming from
the device or the sudden smell of fumes or smoke. The RosieScan must be calibrated before its initial
use and should not be used in close proximity to other electrical devices or high-frequency operational
equipment.
Make sure to turn the RosieScan off after every use. Do not leave the RosieScan unattended while it is
turned on or in use. Remove the batteries and place them in an easily accessible location before the
RosieScan is transported or stored for an extended period of time.
1.4 Contraindication
The device is not suitable for those who have an abdomen wound or skin disease.
1.5 Symbol Directory
Symbol
Indicates
Symbol
Indicates
USB screen
Class II device
Probe B-type application
Indicate arrow of battery insert
direction
Be away from liquid intrusion
Open the battery buckle
Check the documents enclosed in the
device
Lock the battery buckle
DC
Switch indicator
AC
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Product Specifications
2. Product Specification
2.1 Main Technical Specifications
1Transducer: 2.6MHz
2Probe: Mechanical Sector Scanning
3Detect depth : ≥140 mm;
4Host power supply: internal battery
5Battery: Voltage 7.4V (standard value), capacity: ≥4200mAh Charge the batteries for 3.5-4
hours for full charge. Fully charged batteries will provide 4 hours of sustained use
6Charger : Input voltage : AC 220V±10%
， 50±1HZ ；
7Output voltage for adapter: 9.0V
；
Output voltage for charger: 8.5V
；
8Output screen: USB for data storage and software upgrade
9Readings displayed: scan results, present location and ultrasound image
10 Measured result: scan results are automatically measured and displayed.
11 Case management options: Store, browse and export
12 Max. measurement: 999ml;
13 Measurement accuracy: 0ml≤V≤999ml, ±15%
；
14 Storage capacity: 100 cases
15 Device dimensions: 310x260x50mm
；
16 Net weight: about 2.1 KG 。 (4.62 LBS)
2.2 Accuracy Range
Accurate results are contingent upon proper use of device.
Explanation Narrative
Bladder volume accuracy
±25%（60ml≦V≦150）
±15%（150ml≦V≦999）
Bladder volume range 0-999ml
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2.3 Instructions for Environment Test
The environmental testing for the device should be in accordance with requirements of GB/T
14710-2009 (Medical electrical equipment environmental requirement and test method)
2.4 Sound Output
The device is in accordance with GB16846-2008 and the announcement exemption for the public in
chapter 6 of Requirement of medical ultrasound diagnosis device for its sound output (see Figure 2-
1).
Transducer frequency: 2.6MHz
Device is in accordance with requirements of GB9706.9-2008 -< Part 2-37 in Medical electrical
equipment : 51.2aa),dd) in requirements for particular safety of ultrasound diagnostic and monitoring
equipment> . Exempted from showing MI, TI. MI <1 TI<1
Fig 2-1 Technical Datasheet for
Level of Sound Output
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System Overview
3. System Overview
3.1 Primary Components
The system consists of two parts --hardware circuit and embedded software.
3.1.1 Hardware Components
The hardware circuit consists of an embedded micro-controller system, B-mode transducer, B-
mode signal processing module, B-mode signal A/D conversion module, Step-motor driving module,
LED display system, print system, keyboard input, high speed USB screen and the power/battery
management system. Its composition is shown in Figure. 3-1:
3.1.2 Embedded Software System
The embedded software system is fully designed according to the hardware structure to allow for
better stability, ease of use and a friendly user screen. The software modules include B-mode
ultrasonic-image data acquisition, image edge identification, step-motor drive control, LED drive,
graphical menu display, printing, power management and USB data communication. Its components
are shown in Figure 3-2.
Figure 3-1
Hardware Configuration
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3.2 Pictures and Descriptions
The RosieScan consists of a main unit, ultrasonic probe and external thermal printer.
1. RosieScan see Figure 3-3
Figure3-2
Software Module Block
Diagram
Figure 3-3
Device
1. LED Display
2. Control Panel
3. Printer
4. Power Light
5. Probe
6. Screen Buckle
7. Printer Cover
1
2
3
4
5
6
7
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2. Probe and USB Port see Figure 3-4
3. 3D Probe see Figure 3-5
2
1
Figure 3-4
Ports
1. Probe Port
2. USB Port
Figure 3-5
Ports
1. Probe Cable
2. USB Plug
3. Probe Perspective Window
1
2
3
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4. Battery Box see Figure 3-6
3.3 Circuit Diagram and Part List
Please contact Life Systems Inc. for circuit diagram, parts list and any other information pertaining to
maintenance or repairs. THE USER SHOULD NOT DISASSEMBLE OR TRY TO REPAIR THIS DEVICE.
Figure 3-6
Battery Box
1. Battery
1
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Control Panel
4. Control Panel
Figure 4-1
Control Panel
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Optimal Conditions
5. Optimal Conditions
5.1 For Use
1. Temperature range: +41～+105 F；
2. Relative humidity: ≤70%；
3. Atmospheric pressure: 700～1060 hPa；
4. Power supply of charger: AC 220V±10%，50Hz±1Hz；
5. Keep device away from strong electrical fields, strong magnetic fields and high-voltage
equipment.
6. Use the socket from an independent power supply.
7. Images on the display may appear faded if viewed in bright rooms.The device should be used in
rooms that are clean, and pollution free. Loud noises may result in inaccurate readings.
5.2 For Storage
1. Temperature range: 23F～104F,
2. Relative humidity ≤ 80%
3. Scope of atmospheric pressure: 700 hPa～1060 hPa
5.3 For Transportation
1. Temperature range:. 14 F～131 F
2. Relative humidity ≤ 80%
3. Scope of atmosphere pressure: 700 hPa～1060 hPa
Note: The battery should be removed before the device is transported.
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Installation
6. Installation
6.1 Installation Instructions
1. Put the device on a soft, flat surface.
2. Turn the main unit over so the bottom is facing up
3. To ensure that the battery is being installed correctly, confirm that the arrow on the unit
corresponds with the arrow on the battery.
4. Slide the battery lock into the unlocked position and hold. See Figure 6-1
5. Insert the battery into the battery slot while holding the battery lock in the unlocked position.
6. Then slide the battery lock into the locked position.
7. When the battery is successfully installed it will resemble Figure 6-2. The arrow on the battery is
pointing directly at the arrow on the main unit.
Figure 6-1
1. Batter Lock
1
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Note: The device must be switched off before removing the battery.
8. To remove the battery, put the device on a soft, flat surface. Move the battery lock to the
unlocked position, and then slowly pull the battery out of the unit.
9. To install the probe, find the red dots on the main unit port and on the plug at the end of the
probe cord. See Figure 6-3. Align the two red dots and then plug the probe into the main unit.
See Figure 6-4.
Note: Do not scratch the surface of the probe. This will result in inaccurate readings. Only the probe
supplied by the original manufacturer may be used with this device. Please contact Life Systems, Inc.
in the event a replacement probe is needed.
Figure 6-2
Back view of main unit
with battery in place
Figure 6-3
Probe Installation
Figure 6-4
Probe Installed
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Navigation
7. Navigation
7.1 Before Powering Up
1. Confirm that that battery is properly installed and locked
2. Confirm that the probe is properly installed
3. Confirm that the device is tightly secured on the stand (if applicable).
7.2 Powering On
To turn on the device, press the “POWER” key. Once turned on, the device will automatically check
the battery level, printer, probe connection, memory capacity and screen. The screen show in Figure
7-1 will display after the device is turn on
Note: Once the device self-checks successfully, the system will enter its main system screen. If any of
the items fails during self-checking, an alarm will alert you. If the alarm sounds, press direction key
before entering the main system. If the printer fails, it will not influence your measurements
Self-check displays:
Battery Checking.…..OK This means your battery is good and connected properly.
Probe Checking……..OK This means the probe is connected correctly and ready to use.
Printer Checking…….OK This means the printer is ready to print.
Storage…………………..100% Percent represents the remaining storage space.
Note: If “Disconnect” is displayed instead of “OK” next to the probe-checking, remove and reconnect
the probe. If “Disconnect” is still displayed, check the probe cord and contact Life Systems, Inc.
Figure 7-1
Power On Screen
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At the bottom right corner of the power on screen there will be two functional keys: and .
The functional key displays when self-checking fails, so touch the key or press the
directional key on the control panel to enter “Ready” screen of system. You may touch with
stylist pen or press Power button on the control panel to turn off the device.
Note: The system will automatically power down if you do not press

key on the control panel
within 20 seconds of a self-check failure.
7.3 Ready Screen
Once RosieScan is finished self- checking the Ready screen will display on the monitor, see Figure 7-2.
Figure 7-2
Ready Screen
1. Status Bar
2. Scan Mode
3. Touch Screen
Navigation Keys
1
2
3
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On the top of the Ready screen you will see a Status bar. The icons below may change depending on the
device’s self-check results. Please consult the Figure 7-3 for the meaning of each icon. Please contact
Life Systems Inc. if you have any questions.
Icon
USB Probe Printer Prompt Alarm Battery
Normal or
successful
connection
Problem or no
connection
You will find two sets of navigation keys – one set on the Ready screen and one set on the control panel.
See Figure 7-4 and 7-5.
•Press key on the right or touch on the Ready screen to delete the max tested
volume without switching off the device;
•Press key on the left or touch to browse previously saved readings
•Press key or touch to to select gender. Select the icon for male, the for
female and the icon for Pediatric. Pediatric mode is only effective to measure volumes that
are less than 100 ml.
Figure 7-3 Status Bar and Instructions
Figure 7-4
Ready Screen
Figure 7-5
Control Panel
Figure 7-4 and 7-5
Navigation Keys
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