Whale PE-12-025 User manual
1.00
ENG This user manual includes detailed usage instructions for Portable
Ultrasound Diagnostic Scanner. Please read this manual before using
equipment.
Release Date
Rev Date
1.00 July 2017
The text of this manual was originally written, approved and published by the manufacturer in En-
glish.
This manual may not be reproduced, in whole or in part, without the written permission of Beijing
East Whale Imaging Technology Co., Ltd..
Rev 1.00 3
Contents
Contents
Contents .......................................................................................... 3
Chapter 1 - Introduction.................................................................. 9
1.1 Overview ...............................................................................................................11
1.2 Intended Use ........................................................................................................11
1.3 Contraindications...............................................................................................11
1.4 Configuration ......................................................................................................11
1.5 Attention...............................................................................................................12
1.6 Copyright ..............................................................................................................13
Chapter 2 - Safety.......................................................................... 15
2.1 Safety Introduction.............................................................................................17
2.2 Safety Hazard Alerts...........................................................................................17
2.3 Owner Responsibility .........................................................................................17
2.4 Regulatory Information ....................................................................................18
2.5 Safety Classification...........................................................................................18
2.6 Safety - Power Supply ........................................................................................18
2.6.1 Adapter...........................................................................................................18
2.6.2 Printer .............................................................................................................19
2.6.3 Cart .................................................................................................................. 19
2.7 Acoustic Output ..................................................................................................19
2.7.1 Acoustic Output Definition........................................................................19
2.7.2 Acoustic Output Display.............................................................................20
2.7.3 As Low As Reasonably Achievable (ALARA)...........................................20
2.7.4 Safety Statement..........................................................................................20
2.7.5 System Controls Affecting Acoustic Output...........................................20
2.8 Probe Safety .........................................................................................................21
2.8.1 Electrical Hazards.........................................................................................22
2.8.2 Mechanical Hazards....................................................................................23
2.8.3 Biological Hazards.......................................................................................23
2.9 Patient Safety.......................................................................................................23
2.9.1 Patient Identification ..................................................................................23
2.9.2 Diagnostic Information ..............................................................................24
2.10 Personnel And Equipment Safety ...................................................................24
2.10.1 Explosion Hazards .......................................................................................24
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4Portable Ultrasound Diagnostic Scanner User Manual
2.10.2 Electrical Hazards.........................................................................................25
2.10.3 Biological Hazards .......................................................................................25
2.10.4 Pacemaker Hazards.....................................................................................25
2.11 Electrical Safety ...................................................................................................26
2.12 Allergic Reaction .................................................................................................27
2.13 Electromagnetic Compatibility (EMC) ...........................................................27
2.13.1 Information on electromagnetic compatibility....................................27
Chapter 3 - Specifications ............................................................. 33
3.1 Power Supply .......................................................................................................35
3.2 Dimensions...........................................................................................................35
3.2.1 Console ...........................................................................................................35
3.3 Adapter..................................................................................................................36
3.4 Probe......................................................................................................................36
3.4.1 Supported Probes.........................................................................................36
3.4.2 Probe Orientation ........................................................................................38
3.4.3 Probe labeling...............................................................................................39
3.4.4 Probe Connection ........................................................................................39
3.5 Printers...................................................................................................................42
3.6 Replaceable Fuses...............................................................................................42
3.7 Operation Environment ....................................................................................42
3.7.1 Operate Room Condition ...........................................................................42
3.7.2 Environment Requirements.......................................................................43
3.7.3 Electromagnetic Interference....................................................................43
3.8 Transport and Storage Environment .............................................................43
Chapter 4 - Start-up....................................................................... 45
4.1 Positioning the unit ............................................................................................47
4.2 Unit Connection ..................................................................................................47
4.2.1 Check the voltage level ...............................................................................48
4.2.2 Connect the unit to the electrical outlet .................................................48
4.2.3 Battery.............................................................................................................49
4.2.4 Battery Replacement...................................................................................52
4.2.5 LED Lights.......................................................................................................52
4.2.6 Connect the peripheral/accessory ...........................................................53
4.2.7 Connect the digital printer.........................................................................55
4.2.8 Connect the video printer...........................................................................55
4.2.9 Connect the ECG...........................................................................................55
4.2.10 Connect the external monitor...................................................................56
4.2.11 Connect to the Wireless Local Area Networks.......................................56
4.2.12 Cart docking connection............................................................................57
4.3 Switch on/off the unit ........................................................................................60
Chapter 5 - Storage and Transportation ...................................... 63
5.1 Unit Transportation............................................................................................65
5.2 Related Symbols..................................................................................................66
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Contents
Chapter 6 - System Description..................................................... 69
6.1 Console..................................................................................................................71
6.2 Control Panel .......................................................................................................72
6.3 Main User Interface ............................................................................................81
6.4 Cart.........................................................................................................................83
6.4.1 Specifications................................................................................................84
6.4.2 The Cart’s Ports ............................................................................................. 85
6.4.3 Locking wheels .............................................................................................86
6.4.4 Cart Height Adjustment..............................................................................86
6.4.5 Portable Combination Lock.......................................................................88
Chapter 7 - System Operation....................................................... 93
7.1 Introduction .........................................................................................................95
7.2 Patient Management.........................................................................................95
7.2.1 Patient Information.....................................................................................96
7.2.2 Review...........................................................................................................105
7.2.3 Report............................................................................................................110
7.3 Probe/Application ............................................................................................115
7.4 Imaging Mode ...................................................................................................119
7.4.1 2D Mode .......................................................................................................119
7.4.2 Panoramic Imaging Mode.......................................................................122
7.4.3 M Mode.........................................................................................................125
7.4.4 Anatomical M-Mode .................................................................................128
7.4.5 CM Mode ......................................................................................................131
7.4.6 Color Mode ..................................................................................................133
7.4.7 Power Mode.................................................................................................137
7.4.8 DPDI Mode...................................................................................................140
7.4.9 Elastography Image Mode.......................................................................142
7.4.10 TVI Mode.......................................................................................................145
7.4.11 Strain Rate Imaging Mode.......................................................................148
7.4.12 Dual Live Mode ...........................................................................................151
7.4.13 PW Mode ......................................................................................................153
7.4.14 CW Mode......................................................................................................157
7.4.15 TVD Mode.....................................................................................................161
7.4.16 The Split Screen...........................................................................................165
7.4.17 The Quad Screen ........................................................................................167
7.5 Cine Loop ............................................................................................................168
7.5.1 Cine Storage Buffer....................................................................................169
7.5.2 Cine Loop Overview...................................................................................170
7.5.3 Cine Loop Main Menu Controls ..............................................................170
7.5.4 Cine Loop Other Controls.........................................................................171
7.5.5 View a cine loop..........................................................................................171
7.5.6 Store and view a cine file..........................................................................172
7.6 Zoom....................................................................................................................174
7.7 ECG .......................................................................................................................174
7.7.1 ECG Overview..............................................................................................175
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6Portable Ultrasound Diagnostic Scanner User Manual
7.7.2 ECG Controls............................................................................................... 176
7.7.3 Display the ECG curve .............................................................................. 176
7.7.4 Adjust the display of the ECG curve ...................................................... 176
7.8 Measurement.................................................................................................... 177
7.8.1 Measurement Overview .......................................................................... 177
7.8.2 General Measurement ............................................................................. 180
7.8.3 Special Measurement............................................................................... 188
7.8.4 Measurement Errors ................................................................................. 199
7.8.5 Measurement Result Table ..................................................................... 201
7.8.6 Measurement Units .................................................................................. 201
7.9 Worksheet.......................................................................................................... 202
7.10 Text...................................................................................................................... 204
7.10.1 Text Overview............................................................................................. 204
7.10.2 Insert a text ................................................................................................. 205
7.10.3 Move a text ................................................................................................. 205
7.10.4 Modify a text............................................................................................... 206
7.10.5 Delete a text................................................................................................ 206
7.11 Arrow .................................................................................................................. 207
7.11.1 Arrow Overview ......................................................................................... 207
7.11.2 Insert an arrow........................................................................................... 207
7.11.3 Move an arrow........................................................................................... 207
7.11.4 Delete an arrow ......................................................................................... 208
7.11.5 Rotate an arrow......................................................................................... 208
7.12 Body Mark.......................................................................................................... 208
7.12.1 Body Mark Overview ................................................................................ 209
7.12.2 Insert a body mark .................................................................................... 209
7.12.3 Modify a body mark.................................................................................. 210
7.12.4 Delete a body mark................................................................................... 210
7.12.5 Rotate the probe mark............................................................................. 210
7.13 Puncture Guide Line ........................................................................................ 211
7.14 Preset................................................................................................................... 211
7.14.1 System.......................................................................................................... 215
7.14.2 Exam............................................................................................................. 219
7.14.3 Meas/Text.................................................................................................... 223
7.14.4 Patient.......................................................................................................... 233
7.14.5 Network ....................................................................................................... 243
7.14.6 Peripheral.................................................................................................... 246
7.14.7 Service.......................................................................................................... 250
7.15 DICOM ................................................................................................................ 251
7.15.1 Dataflow...................................................................................................... 251
7.15.2 Stand-alone ultrasound unit scenario................................................. 257
7.15.3 A ultrasound unit and a DICOM server in a network........................ 258
7.15.4 DICOM JOB SPOOLER............................................................................... 266
Chapter 8 - User Maintenance .................................................... 269
8.1 System Care and Maintenance..................................................................... 271
8.1.1 Planned Maintenance.............................................................................. 271
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Contents
8.1.2 System Inspection ......................................................................................272
8.1.3 Unit Cleaning ..............................................................................................273
8.1.4 Static Electricity Interference Prevention..............................................275
8.2 Probe Care And Maintenance........................................................................275
8.2.1 Planned Maintenance...............................................................................275
8.2.2 Probe Inspection.........................................................................................276
8.2.3 Probe Cleaning and Disinfecting ...........................................................276
Chapter 9 - Components and Accessories .................................. 279
9.1 Components.......................................................................................................281
Appendix I - Labels and Nameplates ........................................... 283
i-1 Safety labels .......................................................................................................285
Appendix II - Acoustic Output Report Table ................................ 293
ii-1 Acoustic Output Report Table........................................................................295
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Rev 1.00 11
Overview Chapter 1 - Introduction
1.1 Overview
The Portable Ultrasound Diagnostic Scanner is a compact, high perfor-
mance portable digital ultrasound imaging system. The system is based on
the accumulated experience of the research department and clinical depart-
ment of Beijing East Whale Imaging Technology Co., Ltd.
The Portable Ultrasound Diagnostic Scanner provides image generation in
2D (B) Mode, M-Mode, Anatomical M Mode (AMM), Color Doppler, Power
Doppler, Elasticity Imaging (EI), Tissue Velocity Imaging (TVI), Strain Rate Im-
aging (SRI), Pulse Wave Doppler (PW), Continuous Wave Doppler (CW), and
Tissue Doppler imaging (TVD) mode.
The Portable Ultrasound Diagnostic Scanner allows optimal usage of all
scanning modes and probe types, throughout the full spectrum of operat-
ing frequencies and also provides users the flexibility of connecting to the
Internet and network system.
1.2 Intended Use
The Portable Ultrasound Diagnostic Scanner is intended for use by, or under
the direction of, a qualified physician or a clinician for ultrasound imaging
and analysis of Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology;
Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskel-
etal; Fetal; Intra-operative; Transvaginal.
1.3 Contraindications
The Portable Ultrasound Diagnostic Scanner is not intended for ophthalmic
use or any use that may result in acoustic beams passing thorough the eye.
1.4 Configuration
The type specification of Portable Ultrasound Diagnostic Scanner is P5/P7/
P9, and the standard configuration is illustrated as below:
Table 1-1: Standard Configuration
Configuration P5 P7 P9 Optional/Standard
Console YES YES YES Standard
Cart YES YES YES Optional
Adapter YES YES YES Standard
Probe (Model 1P4V) No No YES Standard
Probe (Model 2P4V) YES YES YES Standard
Chapter 1 - Introduction Attention
12 Portable Ultrasound Diagnostic Scanner User Manual
1.5 Attention
Federal (USA) law restricts this device to sale by or on the order of a physi-
cian.
Only professional personnel are allowed to use this device.
Electronic waste must not be discarded as unsorted municipal waste, and
must be collected separately according to local regulations. Please contact
an authorized representative of the manufacturer or an authorized waste
management company for information concerning the decommissioning of
equipment.
The MANUFACTURER will make available on request circuit diagrams, com-
ponent part lists, descriptions, calibration instructions, or other information
that will assist SERVICE PERSONNEL to repair those parts of ME EQUIPMENT
that are designated by the MANUFACTURER as repairable by SERVICE PER-
SONNEL.
To ensure safe and correct operation, please read and understand all instruc-
tions in the User’s Manual before attempting to use the Portable Ultrasound
Diagnostic Scanner. Keep the manual with the equipment at all times. Peri-
odically review the procedure for operation and safety precautions.
Never modify this product, including system components, software, cables,
and so on. User modification may cause safety hazards and degradation in
system performance. All modification must be accomplished by the Service
Engineer from Whale or others authorized by Whale.
Probe (Model 3P8V) No YES YES Standard
Probe (Model 2C5V) YES YES YES Standard
Probe (Model 4EC9V) YES YES YES Standard
Probe (Model 12L5V) YES YES YES Standard
ECG Lead YES YES YES Optional
Digital Graphic Printer
(Printer A)
YES YES YES Optional
Video Copy Processor
(Printer B)
YES YES YES Optional
Table 1-1: Standard Configuration
Configuration P5 P7 P9 Optional/Standard
WARNING
To avoid the risk of electric shock, this equipment must be connected
to a grounded power source..
Rev 1.00 13
Copyright Chapter 1 - Introduction
The equipment is not suitable for use in the presence of flammable anes-
thetic mixture with air or with Oxygen or Nitrous Oxide.
Devices that intrinsically transmit radio waves such as cellular phones, radio
transceivers, mobile radio transmitters, radio-controlled toys, and so on,
should not be used near the unit, it could cause the unit to malfunction.
1.6 Copyright
The contents of this system’s hardware and related documents are protected
under all intellectual proper rights.
Without the advanced written permission or agreement, any unit, individual
or institution shall not in any form or means remove or copy any part of this
manual.
This manual is exclusively for the operation, repair, and maintenance of the -
Portable Ultrasound Diagnostic Scanner. Beijing East Whale Imaging Tech-
nology Company owns the copyright of this non-publicly published manual,
and has the right to use it as confidential data.
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Rev 1.00 17
Safety Introduction Chapter 2 - Safety
2.1 Safety Introduction
This chapter describes the important safety measures which should be tak-
en before operating the Portable Ultrasound Diagnostic Scanner. Proce-
dures for simple care and maintenance of the unit are also described. The
information contained in this chapter is intended to familiarize the user with
the hazards associated with the use of unit, and to alert them to the extent
to which injury and damage may occur if the precautions are not taken. Us-
ers are obligated to familiarize themselves with these safety considerations
and to avoid conditions that could result in injury or damage.
2.2 Safety Hazard Alerts
Pay attention to all areas of this manual marked with this symbol .
2.3 Owner Responsibility
It is the responsibility of the owner to ensure that anyone operating the sys-
tem reads and understands this section of the manual. However, there is no
implication that the act of reading this manual renders the reader qualified
to operate, inspect, test, align, calibrate, troubleshoot, repair or modify the
system. The owner should make certain to have only authorized and quali-
fied Whale service personnel undertake the installation, maintenance, trou-
bleshooting, calibration, and repair of the equipment.
The owner of the Portable Ultrasound Diagnostic Scanner should ensure
that only properly trained, fully qualified personnel are authorized to oper-
ate the system. Before authorizing anyone to operate the system, it should
be verified that the person has read, and fully understands, the operating in-
Table 2-1: Safety Hazard Aler ts
Alert Circumstances for Use
Indicates an imminently hazardous situation that, if not
avoided, could result in serious injury or death.
Indicates a potentially hazardous situation that, if not avoided,
could result in serious injury or death.
Indicates a potentially hazardous situation that, if not avoided,
may result in minor or moderate injury, equipment damage or
loss of data.
Indicates important information necessary for users to under-
stand.
DANGER
WARNING
CAUTION
Notes
Chapter 2 - Safety Regulatory Information
18 Portable Ultrasound Diagnostic Scanner User Manual
structions contained in this manual. It is advisable to maintain a list of autho-
rized operators.
Should the system fail to operate correctly, or if the unit does not respond to
the commands described in this manual, the operator should contact the
nearest Whale Service Office.
2.4 Regulatory Information
AAMI/ANSI ES60601-1:2005/A2：2010/CAN/CSA-C22.2 No. 60601-1:
2008
EN60601-1：2006/AC: 2010
IEC 60601-1-2:2007
IEC 60601-2-37：2007/ EN 60601-2-37:2008
NEMA UD 2-2004 (R2009)
IEC 62359：2010
AAMI / ANSI / ISO 10993-5:2009/(R) 2014
AAMI / ANSI / ISO 10993-5:2009/(R) 2014
2.5 Safety Classification
Type of protection against electric shock
Class I Equipment
Degree of protection against electric shock
Probes: BF applied parts
ECG: BF applied parts
Continuous Operation
System in Ordinary Equipment (IPX0)
Probe (IPX7)
2.6 Safety - Power Supply
2.6.1 Adapter
Input Rated: 100-240V~, 50/60 Hz, 1.8 A
Output: 19V DC 7.89A
Rev 1.00 19
Acoustic Output Chapter 2 - Safety
2.6.2 Printer
Digital Graphic Printer (Printer A)
Model: UPD897
Input: 100-240V~ 50/60Hz 1.5-0.8A
Video Copy Processor (Printer B)
Model: P93C
Input: 100-240V~ 50/60Hz 0.8A
2.6.3 Cart
Input Rated: 100-240V~, 50/60 Hz
2.7 Acoustic Output
2.7.1 Acoustic Output Definition
Mechanical Index (MI)
MI is the estimated likelihood of tissue damage due to cavitation. The abso-
lute maximum limit of the MI is 1.9 as set by the FDA 510(k) guidance of
1997.
Thermal Index (TI)
TI is an estimate of the temperature increase of soft tissue or bone. There are
three thermal index categories:
TIS: soft tissue thermal index. The main TI category. Used for applica-
tions that doesn’t image bone.
TIC: cranial bone thermal index (bone located close to the surface).
Used for transcranial application.
TIB: bone thermal index (bone located in a focal region). Used for fetal
application.
WARNING
Connect the power supply of the printer to the respective power recep-
tacle on the Cart. Do not power the printer from other power supply
sources.
Chapter 2 - Safety Acoustic Output
20 Portable Ultrasound Diagnostic Scanner User Manual
2.7.2 Acoustic Output Display
In the top area of the Main User Interface, two fields are allocated for the dis-
play of TI &MI values is shown below:
The Portable Ultrasound Diagnostic Scanner chooses the correct category
based on mode of operation and chosen application, and presents only one
TI to the operator. It is therefore important that the operator chooses the
right application.
2.7.3 As Low As Reasonably Achievable (ALARA)
Ultrasound procedures should be performed using output levels and expo-
sure times as low as reasonably achievable while acquiring clinical informa-
tion.
Training
During each ultrasound examination the user is expected to weigh the med-
ical benefit of the diagnostic information that would be obtained against
the risk of potential harmful effects. Once an optimal image is achieved, the
need for increasing acoustic output or prolonging the exposure can’t be jus-
tified. It is recommended that all users receive proper training in applica-
tions before performing them in a clinical setting. Contact the Whale
Ultrasound sales representative for training assistance.
2.7.4 Safety Statement
Although no harmful biological effects have been demonstrated for ultra-
sound frequencies, intensities and exposure times used in examination with
the Portable Ultrasound Diagnostic Scanner, it is recommended to use the
lowest acoustic output settings that will produce diagnostically acceptable
information.
2.7.5 System Controls Affecting Acoustic Output
The operation controls that directly affect the acoustic output are discussed
in the Acoustic Output Data Tables in the Reference Manual. These tables
show the highest possible acoustic intensity for a given mode, obtainable
Figure 2-1: The display of MI and TI on the screen
1MI 2 TI
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