MCube Europe Ltd
PTS Linkton Plam Bladder Scanner Operating Manual V3.1
Operating Manual
54 Pages
Preview
Page 1
Operating Manual Palm Bladder Scanner -PBS V3.1-
MCube Europe Ltd - Old Sarum - Salisbury-SP4 6EB
Operating Manual 2-
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
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To ensure you use this device correctly and safely, please read this manual before use.
Safety notices 1. This device is equipped with a special rechargeable lithium aggregation battery. It has a power supply carrying capacity of 6300 mAh. It can be (re)charged by an AC adapter and a mobile charger with an AC 220V ± 10% and 50/60 Hz input. Auxiliary power supply socket should only be connected on recommendation by PTS Linkton. Do not use any other charger or different voltage. 2. Regularly check the device power supply: if the power voltage is low the device will not work normally. The device will self check on start up. The screen will display: "Battery test ……Ok". When the setup procedure is finished the battery capacity is shown at the top of the screen in the right pictogram. (status bar) Recharge the battery or use a spare battery of the same capacity when the power supply is insufficient to operate. 3. Before switching on: • connect the battery and close the cover of the battery cavity • tightly fix the probe to the main unit
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
-1-
4. Always ensure that there are no heavy objects on the device especially the LCD screen. 5. Do not leave the device unattended when switched on. 6. After use, always turn off the power supply. 7. Do not drop the device or probe. The manufacturer cannot take any responsibility for such damage. The crystal of the probe is especially vulnerable and may break on impact if dropped. 8. Stop using the device immediately if any of the following abnormalities occur; • the device produces abnormal noise • the device emits smoke • over exposure of the brightness of the screen. • short circuit of the unit 9. If AC-adapter is damaged, please contact manufacturer for replacement or purchase a new adapter with standard GB9706.1-2007. Its output parameter must accord with article no 2.9 in Chapter 2 (see page - 9 -). To use an adapter which does not meet the requirements is dangerous.
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
-2-
Caution • installation must be implemented by a qualified person • device operators must be trained and qualified • the repair of the device must be carried out by PTS-Linkton technicians or trained medical service engineers • Avoid strong interference from other electromagnetic instruments • Adjust time set before operation • The system will be shut down automatically if no further operation follows within 10 minutes
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
-3-
Contents Chapter 1
General
page - 7 -
1.1
Features
-7-
1.2
Applications
-8-
1.3
Relevant marks
-8-
1.4
Environmental test requirement
-8-
Chapter 2
Technical specifications
-9-
Chapter 3
System principles
- 11 -
3.1
General principles
- 11 -
3.1.1
Brief introduction of PBS
- 11 - 11 -
3.1.2
System components
- 12 -
3.1.3
Hardware components
- 12 -
3.1.4
Embedded software system
- 13 -
3.2
Device diagram
- 15 -
Chapter 4
Keyboard control
- 19 -
4.1
Keyboard
- 19 -
4.2
Keyboard explanation
- 19 -
Chapter 5
Environmental requirements
- 20 -
5.1
Environmental requirements for use
- 20 -
5.2
Requirements for device storage
- 20 -
5.3
Transportation requirements
- 21 -
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
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Chapter 6
Installation
- 22 -
6.1
Unpacking and control
- 22 -
6.2
Device installation
- 22 -
6.2.1
Battery installation
- 22 -
6.2.2
Probe installation
- 22 -
Chapter 7
Device operation
- 23 -
7.1
Preparation before switch on the device
- 23 -
7.2
Switching on the device
- 23 -
7.2.1
Explanation of check screen
- 24 -
7.2.2
Function keys
- 24 -
7.3
Main screen of system
- 25 -
7.3.1
Explanation of illustrations of status bar
- 25 -
7.3.2
Operation with main interface of system
- 26 -
(Ready screen) 7.4
Scan screen
- 26 -
7.4.1
Pre-scan (mode) screen
- 26 -
7.4.2
Scan (mode) screen
- 27 -
7.5
Scan result screen
- 27 -
7.5.1
Grey-scale screen
- 28 -
7.5.2
Grey scale screen (with red line outline)
- 29 -
7.6
Arrow Guiding Location System
- 30 -
7.7
Edit and / or save screen
- 32 -
7.8
History screen
- 33 -
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
-5-
7.9
System reset / install screen
- 35 -
7.10
Print scanned result
- 41 -
7.11
Export data from your device to your PC
- 41 -
7.12
Printer
- 43 -
7.13
Battery (re)charging
- 44 -
Chapter 8
Transportation and storage
- 45 -
8.1
Transportation
- 45 -
8.2
Storage
- 45 -
Chapter 9
Maintenance and service guidance
- 46 -
9.1
Probe maintenance
- 46 -
9.2
Device maintenance
- 47 -
9.3
Service guide
- 47 –
Appendix 1
Caution for Polymer Lithium-ion battery
- 48 -
Appendix 2
Note for testing the PBS (on a phantom)
- 51 -
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
-6-
Chapter 1 General
1.1 Features The Palm Bladder Scanner PBS V3.1 ultrasound system is a portable non invasive electronic device for measuring the bladder volume. It is small, light weight and has a large TFT LCD screen display. The device consists of an ultrasonic probe and a data processing system. It has a Real-Time Pre-Scan function for an accurate bladder location. It has an additional help function for finding the bladder; the Arrow Guiding Location System (AGLS). The colour display (TFT LCD) has 600 x 480 pixels; its measured results can be printed out using a thermal printer or stored in a built-in flash-disk. The measurement records which are stored on the flash-disk can be sent to a computer through a USB cable interface. The device is battery powered. The device is built strictly in accordance with the national standard GB9706.1-2007 "Medical electrical equipment Part 1: General requirements for safety" in its design and manufacture. The whole process of design, production and sale is controlled by ISO13485:2003QMS. The internal power supply the device has protection type: class 1, to prevent the risk of electric shock and type: B for charging. Its performance is stable and reliable. The device has a CE-mark.
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
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1.2 Applications The device is used for measurement of human bladder volume. The device measures bladder volume in a non invasive way for easy clinical examination. The device must not be used on burns, or scar tissue.
1.3 Relevant marks USB interface
Class II equipment
Probe
B-mode application part
Printer
IPX4
Prevent splashing water
Prompt sound
Attention to refer random files!
Alarm
DC
Battery
AC
1.4 Environmental test requirement The environmental conditions for the device conform to the requirements of GB/T 14710-1993 standard of Registered Product for Medical Equipment. More environmental requirements in chapter 5 page - 20 -
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
-8-
Chapter 2 Technical specifications
2.1
Transducer freq: 2.6MHz
2.2
Scan method: Mechanical scan
2.3
Sway angle: 120°± 2°
2.4
Rotating angle: 180°± 2°
2.5
Scan depth: ≤140 mm
2.6
Display screen: 8.0 inches / 20.32 cm TFT colour LCD
2.7
Power supply for the device: internal battery of 6300mAh capacity
2.8
Battery control: capacity indicator and alarm for lower power
2.9
Recharge device: power adapter: Input voltage:
～220V±10%;
output voltage:
7.4V ± 0.1V
2.10
USB interface: for saving data and upgrade software
2.11
Serial interface: for printer
2.12
Printer: prints micro characters, graphic and image, measured volume in ml. and edited patient ID.
2.13
Screen display: 4 cross-section ultrasound images , measurement result, real-time date, time and hospital name
2.14
Patient record: memory for 100 data (records), including all scanned pictures (12 pictures per patient)
2.15
Patient ID: 8 digits
2.16
Max. measurement: 999ml
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
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2.17
Measurement difference: ± 25%（when volume value ≤ 150ml） Measurement difference: ± 15%（when volume value＞150ml）
2.18
Selection of measurement location: A grey scale and black and white window will give you clear information of the bladder position during pre-scan function, prior to measuring
2.19
Measurement method: After pre-scan, the measurement will be automatically shown after the “ scan” key is pressed once more.
2.20
Gender selection: for male and female
2.21
Language of interface: English
2.22
Dimensions (Shell size): 320 x 180 x 65 mm
2.23
Weight: 1.8 kg
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 10 -
Chapter 3 System principles
3.1 General principles 3.1.1 Brief introduction about the PBS The PBS is a medical device which operates with B-mode ultrasound technology, a very high performance and ultra-modern computer technology. The device consists of a unit and is connected to a probe. During the pre-scan function, it easily and quickly detects the bladder area, the shape of the bladder, the difference between the tissues by B-mode ultrasound technology. The signal is processed and displayed on the TFT LCD screen; so you see the angle of scanning, how much of the bladder has been scanned; whether total or partial scanning has occurred and performance in grey scale or in black and white. After identifying the bladder, the scan button is pressed again and the calculated volume of the scanned bladder is displayed in a view seconds. In general: the device shows very quickly the location and measurement result in ml. and gives the user the information needed.
After scanning the results are displayed in 4 planes (4 out of 12 planes) which are coloured with a red line, to verify that the whole bladder has been scanned.
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 11 -
3.1.2 System components The PBS consists of three parts; the hardware circuit, the embedded software and the device housing (shell). This manual only includes the programming of hardware circuit and the embedded software. The hardware circuit is designed to allow for possible heat release (cooling possibility) of the housing (device shell). Also the hardware circuit and housing have effective electromagnetic compatibility and anti-interference shielding.
3.1.3 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, TFT LCD display system, print system, keyboard input, high speed USB interface, and a power/battery management system. Their composition is as follows: (see next page).
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 12 -
Fig. 3-1: hardware framework
3.1.4 Embedded software system For stability and ease of operation, the embedded software system is specifically for the hardware structure. The software modules mainly include B-mode ultrasonic-image data acquisition, image edge identification, step-motor drive control, LCD drive, graphical menu display, printing, power/battery management and USB data communication. Its components are shown in Fig. 3-2 next page.
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 13 -
Fig. 3-2: software modules structure
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 14 -
3.2
Device diagram
The PBS V3.1 consists of a mainframe, ultrasonic probe and external thermal printer.
1. The mainframe: the first screen after the device is switched on
1 3 4 5
2
7
6
Fig. 3-3: mainframe
1
Indicator lights
2
LCD screen
3
7
Operating Manual
operating keys
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 15 -
1
2 Probe connection
3 PC connection
Printer connection
Fig. 3-4: side view of the device
2. Probe:
Fig. 3-5: probe
scan key
probe transducer
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 16 -
3. Battery cavity
battery box
battery socket
Fig. 3-6: battery cavity
4. Back view of device battery cover
screw bolts for probe socket
battery cover lock
bolts for battery cover
Fig. 3-7: back cover of device
Operating Manual
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 17 -
5. Battery placement
battery
Operating Manual
Fig. 3-8: battery placement
Palm Bladder Scanner PBS V3.1
MCube Europe Ltd. Salisbury - SP46EB v.01.10
- 18 -