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
Page 2

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
Page 3

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
Page 4

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
Page 5

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
Page 6

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
Page 7

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
Page 8

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
Page 9

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
Page 10