Digital Color Doppler Palm Ultrasound System

Digital Color Doppler Palm Ultrasound System

Model
SonoEye P6

USER MANUAL
Direction: CHUM SonoEye-P6-001a
June.5th ,2020
Rev. 1.01

CHISON Medical Technologies Co., Ltd.

We reserve the right to make changes to this manual without prior notice.
 Digital Color Doppler Palm Ultrasound System

Regulatory Requirement

This product conforms to the essential requirements of the Medical Device

Directive93/42/EEC. Accessories without the CE mark are not guaranteed
to meet the Essential Requirements of the Medical Device Directive.

This manual is a reference for the SonoEye P6. Please verify that you are using the latest
revision of this document. If you need to know the latest revision, contact your distributor.
 Digital Color Doppler Palm Ultrasound System
TABLE OF CONTENTS
TABLE OF CONTENTS ................................................................................................................................................. 1
Chapter 1 Introduction................................................................................................................................................. 1
1.1 System Overview ............................................................................................................................................... 1
1.2 Contact Information.......................................................................................................................................... 1
Chapter 2 System Safety.............................................................................................................................................. 3
2.1 Safety Overview ................................................................................................................................................. 3
2.2 Electrical Safety ................................................................................................................................................. 4
2.3 Labels.................................................................................................................................................................. 7
2.3.1 Warning Symbols...................................................................................................................................... 7
2.3.2 Other Device Labels ................................................................................................................................. 9
2.4 Patient Environmental Devices ........................................................................................................................ 9
2.5 Biological Safety .............................................................................................................................................. 10
2.6 Scanning Patients and Education................................................................................................................... 11
2.6.1 Safe Scanning Guidelines ....................................................................................................................... 12
2.6.2 Understanding the MI/TI Display ......................................................................................................... 13
Chapter 3 Preparing the System for Use ............................................................................................................... 18
3.1 Site Requirement ............................................................................................................................................. 18
3.1.1 Operation Environmental Requirement ............................................................................................ 18
3.1.2 Electrical Requirements ...................................................................................................................... 18
3.2 Downloading and Installing the App ............................................................................................................. 18
3.3 System Specifications ...................................................................................................................................... 20
3.3.1 Console Overview ................................................................................................................................ 20
3.3.2 Physical Specifications ........................................................................................................................ 20
3.3.3 Image Modes ........................................................................................................................................ 20
3.3.4 Type....................................................................................................................................................... 20
3.3.5 System Configuration .......................................................................................................................... 21
3.4 System Positioning & Transporting............................................................................................................... 22
3.5 Powering the System ....................................................................................................................................... 23
3.5.1 Acclimation Time ................................................................................................................................. 23
3.5.2 Connecting the Electric Power ........................................................................................................... 23
3.6 The System ....................................................................................................................................................... 23
Chapter 4 Control Panel ............................................................................................................................................. 25
4.1 Overview of Display Area ............................................................................................................................... 25
4.2 Start a New Exam ............................................................................................................................................ 26
4.3 Probe ................................................................................................................................................................. 27
4.4 Switching Function .......................................................................................................................................... 28
4.5 Switching Mode ............................................................................................................................................... 28
4.6 Function Key Introduction ............................................................................................................................. 28
4.7 Image Parameter Area .................................................................................................................................... 30
4.8 Cine Control..................................................................................................................................................... 30
Chapter 5 Imaging........................................................................................................................................................ 31
5.1 Select Scan Mode ............................................................................................................................................. 31
5.1.1 System Identify ....................................................................................................................................... 31
5.1.2 Select Application ................................................................................................................................... 31
5.1.3 B mode ..................................................................................................................................................... 31
 Digital Color Doppler Palm Ultrasound System
5.1.4 FHI ........................................................................................................................................................... 31
5.1.5 B/M Mode ................................................................................................................................................ 31
5.1.6 CFM Mode .............................................................................................................................................. 31
5.1.7 PW mode ................................................................................................................................................. 32
5.1.8 B-Lines..................................................................................................................................................... 33
5.1.9 Biopsy Guide ........................................................................................................................................... 33
5.1.10 SonoNeedle ............................................................................................................................................ 33
5.1.11 SuperNeedle........................................................................................................................................... 34
5.1.12 SonoRemote........................................................................................................................................... 34
5.2 Functional Description of Parameter Adjustment ....................................................................................... 34
5.3 Parameter Adjustment in PW mode .............................................................................................................. 35
5.4 After Capturing the Image ............................................................................................................................. 35
5.4.1 Adding Annotation.................................................................................................................................. 35
5.4.2 Adding BodyMark .................................................................................................................................. 36
5.4.3 Adding Mark ........................................................................................................................................... 36
Chapter 6 Measurement and Calculation .............................................................................................................. 37
6.1 Measurement Methods.................................................................................................................................... 37
6.2 B Mode Measurement ..................................................................................................................................... 37
6.2.1 Vessel Measurement in B mode .......................................................................................................... 37
6.2.2 Abdomen Measurement in B mode .................................................................................................... 38
6.2.3 Cardiac Measurement in B mode ....................................................................................................... 38
6.3 B/M Mode Measurement ................................................................................................................................ 39
6.4 PW Mode Measurement ................................................................................................................................. 39
Chapter 7 Cine-Memory.............................................................................................................................................. 41
7.1 Image Storage .................................................................................................................................................. 41
7.2 Manual playback ............................................................................................................................................. 41
7.3 Automatic playback......................................................................................................................................... 41
7.4 Cine Save .......................................................................................................................................................... 41
Chapter 8 Side Menu ................................................................................................................................................... 42
8.1 Archive ............................................................................................................................................................. 42
8.2 EasyView .......................................................................................................................................................... 43
8.3 Report ............................................................................................................................................................... 45
8.4 Setting ............................................................................................................................................................... 45
8.4.1 General ................................................................................................................................................. 46
8.4.2 Language .............................................................................................................................................. 46
8.4.3 Button Configuration .......................................................................................................................... 47
8.4.4 Administrator ...................................................................................................................................... 47
8.4.5 Firmware Update................................................................................................................................. 47
8.4.6 Function Management ........................................................................................................................ 48
8.5 Tutorials ........................................................................................................................................................... 48
8.6 Demo ................................................................................................................................................................. 48
8.7 About ................................................................................................................................................................ 49
Chapter 9 System Maintenance ............................................................................................................................... 50
9.1 Cleaning............................................................................................................................................................ 50
9.2 System Maintenance........................................................................................................................................ 50
9.3 Safety Check .................................................................................................................................................... 51
 Digital Color Doppler Palm Ultrasound System
9.4 Troubleshooting ............................................................................................................................................... 51
9.5 Service Responsibility ..................................................................................................................................... 52
Chapter 10 System ...................................................................................................................................................... 53
10.1 General Description......................................................................................................................................... 53
10.2 Care and Maintenance .................................................................................................................................... 53
10.2.1 Inspecting Systems................................................................................................................................ 53
10.2.2 Cleaning and Disinfecting .................................................................................................................... 54
10.3 System Operation Instructions ....................................................................................................................... 59
10.4 Service Responsibility ..................................................................................................................................... 60
Appendix A: THE INFORMATION OF EC REPRESENTATIVE ........................................................................... 62
Appendix B: ACOUSTIC OUTPUT REPORT TABLE .............................................................................................. 63
Appendix C: TRANSDUCER MAXIMUM SURFACE TEMPERATURE .............................................................. 67
Appendix D: MEASUREMENT RESULTS SUMMARY ............................................................................................... 68
Appendix E: GUIDANCE AND MANUFACTURER’S DECLARATION ............................................................... 69
 Digital Color Doppler Palm Ultrasound System

Chapter 1 Introduction
This manual contains necessary information for safe system operation.

Read and understand all instructions in this manual before operating the system. Always keep this manual
with the equipment, and periodically review the procedures for operation and safety precautions.

1.1 System Overview

Indications for Use

SonoEye P6 Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in
B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated
for Cardiac, Abdomen, Lung.

SonoEye P6 Digital Color Doppler Palm Ultrasound System is intended for use in environments where
healthcare is provided by healthcare professionals.

Contraindication
The system is NOT intended for Ophthalmic use or any use that causes the acoustic beam to pass through
the eye.

1.2 Contact Information

For additional information or assistance, please contact your local distributor or the appropriate support
resource shown below:

CHISON website www.chison.com

Service Support CHISON Medical Technologies Co., Ltd.
Tel: 0086-400-8878-020; 0086-0510-85311707
Fax: 0086-0510-85310726
E-mail: [email protected]
Placing an Order CHISON Medical Technologies Co., Ltd.
Tel: 0086-0510-8531-0593/0937
Fax: 0086-0510-85310726
Email: [email protected]
Manufacturer CHISON Medical Technologies Co., Ltd.
No.228, Changjiang East Road, Block 51 and 53, Phase 5,
Shuofang Industrial Park, Xinwu District, Wuxi, Jiangsu, China
214142
No.9, Xinhuihuan Road, Xinwu District, Wuxi, Jiangsu, China 214028
US Agent Mr. Marco Mu, 2219 Rimland Drive,Suite 301,Bellingham, Barkley Villiage
Bellingham,Washington,98226, UNITED STATES
Phone: 360-3257028, Fax: 360-9253199, Email: us.agent@mid-
link.net MID-LINK INTERNATIONAL CO., LTD

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 Digital Color Doppler Palm Ultrasound System

CAUTION
Federal law restricts the device to sale by or on the order of a licensed practitioner or therapist.

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 Digital Color Doppler Palm Ultrasound System

Chapter 2 System Safety

2.1 Safety Overview

This section discusses measures to ensure the safety of both the operator and patient. To ensure the safety
of both operator and patient, please read the relevant details in this chapter carefully before operating this
system. Disregarding the warnings or violation of relevant rules may result in personal injury or even loss of
life for operator or patient.
Users should observe the following precautions:

 This system complies with Type BF general equipment, and the IEC standard. Please follow Chapter 1
“System Safety” in the user’s manual to use this system properly.

 Do not modify this system in any way. The system is prohibited to dismount. Necessary modifications
must be made only by the manufacturer or its designated agents.

 This system has been fully adjusted at the factory. Do not adjust any fixed adjustable parts.

 In the event of a malfunction, turn off the system immediately and inform the manufacturer or its
designated agents.

 Only connect this system, either electronically or mechanically, with devices that comply with the
EN60601-1 standard. Recheck the leakage current and other safety performance indices of the entire
system to avoid potential system damage caused by leakage from a current superposition.

 The system does not incorporate any specialized protective measures in the event it is configured with
high-frequency operation devices. The operator should use caution in these types of applications.

 The system should be installed only by personnel authorized by the manufacturer. Do not attempt to
install the system by yourself.

 Only an authorized service engineer may perform maintenance.

 Only a qualified operator, or someone under qualified supervision, should use the system.

 Do not use this system in the presence of flammable substances, otherwise an explosion may occur.

 Do not continuously scan the same part of a patient or expose the patient to prolonged scanning,
otherwise it may harm the patient.

 When using the system for ultrasound testing, use only qualified ultrasound gel that complies with
system standards.

 Do not unplug system when the system is in active operation. Always go to EXAM screen when you
need to remove the system.

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 Digital Color Doppler Palm Ultrasound System
 To prevent from arm or neck injury, the operator should not stay at the same position for too long during
patient scanning without taking break.

 Do not put the system near the liquid.

NOTE
*To dispose of this product properly, please call your local service department.

2.2 Electrical Safety

Type of protection against electric shock

 Class I Equipment
CLASS I EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only,
but includes a protective earth ground. This additional safety precaution prevents exposed metal parts from
becoming LIVE in the event of an insulation failure.

NOTE

The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential ENVIRONMENT (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
Degree of protection against electric shock
 Type BF Applied part (for Systems marked with BF symbol)
TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular
regard to allowable LEAKAGE CURRENT
BF: Isolation from ground; max. Patient leakage current: normal mode ≤100 µA, single fault condition≤500
µA
Level of protection against harmful ingress of water
 The IP Classification of System is Ordinary Equipment, immersed part is IPX7, the other part is IPX1.
Safety level when used in the presence of FLAMMABLE ANAESTHETIC MIXED WITH AIR (or WITH
OXYGEN or WITH NITROUS OXIDE):
The Equipment is not suitable for use in the environment with FLAMMABLE ANAESTHETIC MIXED WITH
AIR (or WITH OXYGEN or WITH NITROUS OXIDE)
Conduction Interference

NOTE
Image quality will effect by conducted disturbance. Please do not use the effected image. And put system in
a simpler electromagnetic compatibility environment to start working, if conducted disturbance occurred,
stop using it and change the position for acquiring a better image.
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 Digital Color Doppler Palm Ultrasound System
Mode of operation
 Continuous Operation
For maximum safety, always follow these guidelines:
 Do not remove or circumvent the grounding wire.
 Do not remove the protective covers on the system. These covers protect users from hazardous
voltages. Cabinet panels must remain in place while the system is in use. A qualified electronic
technician must make all internal replacements.
 Do not operate this system in the presence of flammable gases or anesthetics.
 All peripheral devices (unless certified as medical grade) that are connected to the system must be
powered through the electrical outlet through an optional isolation transformer.

Notice upon Installation of Product

Separation distance and effect from fixed radio communications equipment: 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 transmitter 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 ultrasound system is
used exceeds the applicable RF compliance level as stated in the immunity declaration, the ultrasound
system should be observed to verify normal operation. If abnormal operation is observed, additional
measures may be necessary, such as re-orienting or relocating the ultrasound system or using an RF
shielded examination room may be necessary.
 Use either power supply cords provided by or designated by CHISON. Products equipped with a power
source plug should be plugged into the fixed power socket which has the protective grounding
conductor. Never use any adaptor or converter to connect with a power source plug (e.g. three-prong-
to-two-prong converter).
 Locate the equipment as far away as possible from other electronic equipment.
 Be sure to use only the cables provided by or designated by CHISON. Connect these cables following
the installation procedures (e.g. wire power cables separately from signal cables).
 Lay out the main equipment and other peripherals following the installation procedures described in this
manual.

WARNING:
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of this medical system, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.

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 Digital Color Doppler Palm Ultrasound System
Notice against User Modification
The user should never modify this product.
User modifications may cause degradation in Electrical Safety. Modification of the product includes
changes in:
 Cables (length, material, wiring, etc.)
 System configuration/components

User modifications may cause degradation in EMC performance. Modification of the product includes
changes in:
 Cables (length, material, wiring, etc.)
 System installation/layout
 System configuration/components

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 Digital Color Doppler Palm Ultrasound System

2.3 Labels

Fig. 2-1: SonoEye P6 Label

2.3.1 Warning Symbols

Icon Meaning

Refer to instruction manual/booklet.

Caution, consult accompanying documents.

This symbol advises the reader to consult the accompanying documents for
important safety related information such as warnings and pre-cautions that
cannot be presented on the device itself.
The CE mark of Conformity indicates this equipment conforms to the Council
Directive 93/42/EEC.

Serial number of the device.

This symbol is accompanied by the name and the address of the manufacturer
and the manufacturing date of the device in the form YYYY-MM.
IPX7,IPX1 Protection against the effects of immersion
This label indicates immersed part.

Refer to instruction manual.

This symbol indicates that in the united states of America, Federal law restricts
the device to sale by or on the order of a licensed practitioner or therapist.

Icon Meaning

Refer to instruction manual/booklet.

Caution, consult accompanying documents.

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 Digital Color Doppler Palm Ultrasound System

This symbol advises the reader to consult the accompanying documents for
important safety related information such as warnings and pre-cautions that
cannot be presented on the device itself.
The CE mark of Conformity indicates this equipment conforms to the Council
Directive 93/42/EEC.

Serial number of the device.

This symbol is accompanied by the name and the address of the manufacturer
and the manufacturing date of the device in the form YYYY-MM.
IPX7,IPX1 Protection against the effects of immersion
This label indicates immersed part.

Refer to instruction manual.

This symbol indicates that in the united states of America, Federal law restricts
the device to sale by or on the order of a licensed practitioner or therapist.

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 Digital Color Doppler Palm Ultrasound System
2.3.2 Other Device Labels
The following table describes the purpose and location of safety labels and other important information
provided on the equipment.
Table 2-1: Symbol Icons

Icon Meaning
Identification • Manufacture’s name
and Rating
Plate • Serial number

Type-BF applied part

2.4 Patient Environmental Devices

 Front side: Power switch

 Freeze button, P button, + button, - button
Acceptable Devices

The Patient Environmental devices shown above are specified to be suitable for use within the PATIENT
ENVIRONMENT.
Anyone using the equipment must be able to recognize the ESD symbol and understand how to take the
necessary precautionary procedures, as described in the caution below:

ESD CAUTION:
Sensitive part in system has been labeled with anti-static label, please pay attention on electrostatic
protection.

CAUTION:
 DO NOT connect any device without approval by CHISON within the PATIENT ENVIRONMENT.

 DO NOT touch patient and devices without IEC/EN 60601-1 approval to avoid the leakage current risk
within the PATIENT ENVIRONMENT.

Unapproved Devices

CAUTION:
 DO NOT use unapproved devices.
 If devices are connected without the approval of CHISON, the warranty will be INVALID.
 The system can’t be used with HF surgical equipment, otherwise the burns to patient may occur.

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 Digital Color Doppler Palm Ultrasound System
Any device connected to this system must conform to one or more of the requirements listed below:

 IEC standard or equivalent standards appropriate to devices.

WARNING:
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this equipment and the other equipment should be observed
to verify that they are operating normally.

CAUTION: Unsafe operation or malfunction may result. Use only the accessories, options and
supplies approved or recommended in these instructions for use.

Peripheral used in the patient environment

The system has been verified for overall safety, compatibility and compliance with the printer which is
Mopria certified.

CAUTION
Printing quality may vary depending on the printer. If there is any quality problem, Chison will not be
responsible.
The system may also be used safely while connected to devices other than those recommended above if
the devices and their specifications, installation, and interconnection with the system conform to the
requirements of IEC/EN 60601-1-1.

The connection of equipment or transmission networks other than as specified in the user instructions can
result in an electric shock hazard or equipment malfunction. Substitute or alternate equipment and
connections require verification of compatibility and conformity to IEC/EN 60601-1-1 by the installer.

Equipment modifications and possible resulting malfunctions and electromagnetic interference are the
responsibility of the owner.

WARNING:
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity
of this equipment and result in improper operation.

2.5 Biological Safety

This product, as with all diagnostic ultrasound equipment, should be used only for valid reasons and should
be used both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low As
Reasonably Achievable) to produce diagnostically acceptable images. The AIUM offers the following
guidelines:
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 Digital Color Doppler Palm Ultrasound System

Clinical Safety Quoted from AIUM

Approved March 26, 1997

Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits
and recognized efficacy for medical diagnosis, including use during human pregnancy,
the American Institute of Ultrasound in Medicine herein addresses the clinical safety of
such use:

There are no confirmed biological effects on patients or instrument operators caused by

exposures from present diagnostic ultrasound instruments. Although the possibility
exists that such biological effects may be identified in the future, current data indicate
that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the
risks, if any that may be present.

Heating: Elevating tissue temperature during obstetrical examinations creates medical concerns. At the
embryo development stage, the rise in temperature and the length of time exposed to heat combine to
determine potential detrimental effects. Exercise caution particularly during Doppler/Color exams. The
Thermal Index (TI) provides a statistical estimate of the potential temperature elevation (in centigrade) of
tissue temperature. Three forms of TI are available: Soft Tissue Thermal Index (TIS), Bone Thermal Index
(TIB).

Soft Tissue Thermal Index (TIS). Used when imaging soft tissue only, it provides an estimate of potential
temperature increase in soft tissue.

Bone Thermal Index (TIB). Used when bone is near the focus of the image as in the third trimester OB
examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue.
Cavitation: Cavitation may occur when sound passes through an area that contains a cavity, such as a
gas bubble or air pocket (in the lung or intestine, for example). During the process of cavitation, the sound
wave may cause the bubble to contract or resonate. This oscillation may cause the bubbles to explode and
damage the tissue. The Mechanical Index (MI) has been created to help users accurately evaluate the
likelihood of cavitation and the related adverse effects.

MI recognizes the importance of non-thermal processes, cavitation in particular, and the Index is an attempt
to indicate the probability that they might occur within the tissue.

2.6 Scanning Patients and Education

The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility for the safe
use of this ultrasound system. Follow these usage guidelines for safe operation:

 In order to maintain proper cleanliness of the systems, always clean them between patients.

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 Digital Color Doppler Palm Ultrasound System
 Always use a disinfected sheath on all EV/ER systems during every exam.

 Continuously move the system, rather than staying in a single spot, to avoid elevated temperatures in
one part of the patient’s body.

 Move system away from the patient when not actively scanning.

 Understand the meaning of the TI, TIS, TIB and MI output display, as well as the relationship between
these parameters and the thermal/cavitation bioeffect to the tissue.

 Expose the patient to only the very lowest practical transmit power levels for the shortest possible time
to achieve a satisfactory diagnosis (ALARA - As Low As Reasonably Achievable).

2.6.1 Safe Scanning Guidelines

 Ultrasound should only be used for medical diagnosis and only by trained medical personnel.

 Diagnostic ultrasound procedures should be done only by personnel fully trained in the use of the
equipment, in the interpretation of the results and images, and in the safe use of ultrasound (including
education as to potential hazards).

 Operators should understand the likely influence of the machine controls, the operating mode (e.g. B-
mode, color Doppler imaging or spectral Doppler) and system frequency on thermal and cavitation
hazards.

 Select a low setting for each new patient. Output should only be increased during the examination if
penetration is still required to achieve a satisfactory result, and after the Gain control has been moved
to its maximum value.

 Maintain the shortest examination time necessary to produce a useful diagnostic result.

 Do not hold the system in a fixed position for any longer than is necessary. It should be removed from
the patient whenever there is no need for real-time imaging or spectral Doppler acquisition. The frozen
frame and Cine loop capabilities allow images to be reviewed and discussed without exposing the
patient to continuous scanning.

 Take particular care to reduce output and minimize exposure time of an embryo or fetus when the
temperature of the mother is already elevated.

 Take particular care to reduce the risk of thermal hazard during diagnostic ultrasound when exposing:
an embryo less than eight weeks after gestation; or the head, brain or spine of any fetus or neonate.

 Operators should continually monitor the on-screen thermal index (TI) and mechanical index (MI) values
and use control settings that keep these settings as low as possible while still achieving diagnostically
useful results. In obstetric examinations, TIS (soft tissue thermal index) should be monitored during
scans carried out in the first eight weeks after gestation, and TIB (bone thermal index) thereafter.

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 Digital Color Doppler Palm Ultrasound System
MI>0.3 There is a possibility of minor damage to neonatal lung or intestine. If such exposure is
necessary, reduce the exposure time as much as possible.

MI>0.7 There is a risk of cavitation if an ultrasound contrast agent containing gas micro-spheres is
being used. There is a theoretical risk of cavitation without the presence of ultrasound contrast agents. The
risk increases with MI values above this threshold.
TI>0.7 The overall exposure time of an embryo or fetus should be restricted in accordance with
Table 2-2 below as a reference:

Maximum exposure
TI
time (minutes)
0.7 60
1.0 30
1.5 15
2.0 4
2.5 1
Table 2-2 Maximum recommended exposure times for an embryo or fetus
 Non-diagnostic use of ultrasound equipment is not generally recommended. Examples of non-
diagnostic uses of ultrasound equipment include repeated scans for operator training, equipment
demonstration using normal subjects, and the production of souvenir pictures or videos of a fetus. For
equipment of which the safety indices are displayed over their full range of values, the TI should always
be less than 0.5 and the MI should always be less than 0.3. Avoid frequent repeated exposure of any
subject. Scans in the first trimester of pregnancy should not be carried out for the sole purpose of
producing souvenir videos or photographs, nor should their production involve increasing the exposure
levels or extending the scan times beyond those needed for clinical purposes.

 Diagnostic ultrasound has the potential for both false positive and false negative results. Misdiagnosis is
far more dangerous than any effect that might result from the ultrasound exposure. Therefore,
diagnostic ultrasound system should be performed only by those with sufficient training and education.

2.6.2 Understanding the MI/TI Display

Track-3 follows the Output Display Standard for systems that include fetal Doppler applications.
The acoustic output will not be evaluated on an application-specific basis, but the global
maximum de-rated Ispta must be ≤ 720 mW/cm2 and either the global maximum MI must be ≤
1.9 or the global maximum de-rated Ispta must be ≤ 190 W/cm2. An exception is for ophthalmic
use, in which case the TI = max (TIS_as) is not to exceed 1.0; Ispta.3 ≤50mW/cm2, and MI ≤ 0.23.
Track-3 gives the user the freedom to increase the output acoustic power for a specific exam, and
still limit output acoustic power within the global maximum de-rated Ispta≤ 720 mW/cm2 under an
Output Display Standard.

For any diagnostic ultrasonic systems, Track-3 provides an Output Indices Display Standard. The

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 Digital Color Doppler Palm Ultrasound System
diagnostic ultrasound systems and its operator’s manual contain the information regarding an
ALARA (As Low As Reasonably Achievable) education program for the clinical end-user and the
acoustic output indices, MI and TI. The MI describes the likelihood of cavitation, and the TI offers
the predicted maximum temperature rise in tissue as a result of the diagnostic examination. In
general, a temperature increase of 2.5°C must be present consistently at one spot for 2 hours to
cause fetal abnormalities. Avoiding a local temperature rise above 1°C should ensure that no
thermally induced biologic effect occurs. When referring to the TI for potential thermal effect, a TI
equal to 1 does not mean the temperature will rise 1 degree C. It only means an increased
potential for thermal effects can be expected as the TI increases. A high index does not mean that
bioeffects are occurring, but only that the potential exists and there is no consideration in the TI for
the scan duration, so minimizing the overall scan time will reduce the potential for effects. These
operator control and display features shift the safety responsibility from the manufacturer to the
user. So it is very important to have the Ultrasound systems display the acoustic output
indices correctly and the education of the user to interpret the value appropriately.
RF: (De-rating factor)
In Situ intensity and pressure cannot currently be measured. Therefore, the acoustic power
measurement is normally done in the water tank, and when soft tissue replaces water along the
ultrasound path, a decrease in intensity is expected. The fractional reduction in intensity caused by
attenuation is denoted by the de-rating factor (RF),
RF = 10 (-0.1 a f z)
Where a is the attenuation coefficient in dB cm-1 MHz-1, f is the transducer center frequency, and
z is the distance along the beam axis between the source and the point of interest.

De-rating factor RF for the various distances and frequencies with attenuation coefficient 0.3dB
cm-1 MHz-1 in homogeneous soft tissue is listed in the following table. An example is if the user
uses 7.5MHz frequency, the power will be attenuated by .0750 at 5cm, or 0.3x7.5x5=-11.25dB. The
De- rated Intensity is also referred to as ‘.3’ at the end (e.g. Ispta.3).

Distance Frequency(MHz)
(cm) 1 3 5 7.5
1 0.9332 0.8128 0.7080 0.5957
2 0.8710 0.6607 0.5012 0.3548
3 0.8128 0.5370 0.3548 0.2113
4 0.7586 0.4365 0.2512 0.1259
5 0.7080 0.3548 0.1778 0.0750
6 0.6607 0.2884 0.1259 0.0447
7 0.6166 0.2344 0.0891 0.0266
8 0.5754 0.1903 0.0631 0.0158

I’=I*RF Where I’ is the intensity in soft tissue, I is the time-averaged intensity measured in water.
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 Digital Color Doppler Palm Ultrasound System
Tissue Model:
Tissue temperature elevation depends on power, tissue type, beam width, and scanning mode. Six
models Tissue temperature elevation depends on power, tissue type, beam width, and scanning
mode. Six models are developed to mimic possible clinical situations.
Thermal Models Composition Mode Specification Application

2
1 TIS Soft tissue Unscanned Large aperture (>1cm ) Liver PW
2
2 TIS Soft tissue Unscanned Small aperture (<1cm ) Pencil System
3 TIS Soft tissue Scanned Evaluated at surface Breast color
4 TIB Soft tissue and bone Scanned Soft tissue at surface Muscle color
5 TIB Soft tissue and bone Unscanned Bone at focus Fetus head PW

Soft tissue:
Describes low fat content tissue that does not contain calcifications or large gas-filled spaces.
Scanned: (auto-scan)
Refers to the steering of successive burst through the field of view, e.g. B and CFM mode.
Unscanned:
Emission of ultrasonic pulses occurs along a single line of sight and is unchanged until the transducer is
moved to a new position. For instance, the PW mode.

TI:
TI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power required to raise tissue
temperature by 1°C (Wdeg), TI = W.3/Wdeg.
Three TIs corresponding to soft tissue (TIS) for abdominal; bone (TIB) for fetal and neonatal cephalic; have
been developed for applications in different exams.
An estimate of the acoustic power in milliwatts necessary to produce a 1°C temperature elevation in soft
tissue is:
Wdeg= 210/fc, for model 1 to4, where fc is the center frequency in MHz.

Wdeg= 40 K D for model 5 and 6, where K (beam shape factor) is 1.0, D is the aperture
diameter in cm at the depth of interest.

MI:
Cavitation is more likely to occur at high pressures and low frequencies in pulse ultrasound wave in the
tissue, which contains the bubble or air pocket (for instance, the lung, intestine, or scan with gas contrast
agents). The threshold under optimum conditions of pulsed ultrasound is predicted by the ration of the peak
pressure to the square root of the frequency.
MI = Pr’/ sqrt(fc)

Pr’ is the de-rated (0.3) peak rare-fractional pressure in Mpa at the point where PII is the maximum, and
fc is the center frequency in MHz. PII is the Pulse Intensity Integral that the total energy per unit area carried
by the wave during the time duration of the pulse. The peak rare- fractional pressure is measured in
hydrophone maximum negative voltage normalized by the hydrophone calibration parameter.
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 Digital Color Doppler Palm Ultrasound System
Display Guideline:
For different operation modes, different indices must be displayed. However, only one index needs to be
shown at a time. Display is not required if maximum MI is less than 1.0 for any setting of the operating mode,
or if maximum TI is less than 1.0 for any setting of the operating mode. For TI, if the TIS and TIB are both
greater than 1.0, the scanners need not be capable of displaying both indices simultaneously. If the index
falls below 0.4, no display is needed.
Display and Report in Different Mode
Located on the upper middle section of the system display monitor, the acoustic output display provides the
operator with real-time indication of acoustic levels being generated by the system.
Only display and report TIS or TIB and start from 0.4 if maximum TI > 1.0, display in increments of 0.2 for
values of indices of 2.0 or less, and 0.5 for values of indices greater than 2.0.
Below is a simple guideline for the user when TI exceeds one limit exposure time to 4(6-TI) minutes based
on the ‘National Council on Radiation Protection. Exposure Criteria for Medical Diagnostic Ultrasound: I.
Criteria Based on Thermal Mechanisms. Report No.113 1992’.

Operator Control Features:

The user should be aware that certain operator controls may affect the acoustic output. It is recommended
to use the default (or lowest) output power setting and compensate using Gain control to acquire an image.
Other than the output power setting in the soft-menu, which has the most direct impact on the power; the
PRF, image sector size, frame rate, depth, and focal position also slightly affect the output power. The
default setting is normally around 70% of the allowable power depending on the exam application mode.

Controls Affecting Acoustic Output

The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be influnced by certain
controls.
Direct: The Acoustic Output control has the most significant effect on Acoustic Output.
Indirect: Indirect effects may occur when adjusting controls. Controls that can influence MI and TI are
detailed under the Bioeffects portion of each control in the Optimizing the Image chapter.
Always observe the Acoustic Output display for possible effects.

Best practices while scanning

HINTS: Raise the Acoustic Output only after attempting image optimization with controls that have no
effect on Acoustic Output, such as Gain and STC.

WARNING: Be sure to have read and understood control explanations for each mode used before
attempting to adjust the Acoustic Output control or any control that can effect Acoustic Output.

Use the minimum necessary acoustic output to get the best diagnostic image or measurement during an
examination. Begin the exam with the system that provides an optimum focal depth and penetration.
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 Digital Color Doppler Palm Ultrasound System
Acoustic Output Default Levels
In order to assure that an exam does not start at a high output level, the system initiates scanning at a
reduced default output level. This reduced level is preset programmable and depends upon the exam icon
and system selected. It takes effect when the system is powered on or New Patient is selected. To modify
acoustic output, adjust the Power Output level on the Soft Menu.

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 Digital Color Doppler Palm Ultrasound System

Chapter 3 Preparing the System for Use

3.1 Site Requirement

3.1.1 Operation Environmental Requirement

The following environmental conditions are within system tolerances for operation:
Strong radiation sources or powerful electromagnetic waves (e.g. electro-magnetic waves from radio
broadcasting) may result in image ghosting or noise. The system should be isolated from such radiation
sources or electromagnetic waves.

Environment
Operation Transportation & Storage
Parameter
Temperature 10℃～38℃ -10℃～50℃

Relative Humidity 30%～75% ≤80%，non-condensing

Atmosphere Pressure 700hPa～1060hPa 700hPa～1060hPa

NOTE: While the temperature of environment is between 0 ℃ to 38 ℃ , the system can work
continuously in normal. If the temperature of environment is over 38 ℃ , the system can detect the
temperature and stop working while overheating.
3.1.2 Electrical Requirements
Power Requirements：DC 5V
Power Consumption：≤10VA
Voltage Fluctuation：±5%

WARNING: Maintain a fluctuation range of less than ±10% of voltage labeling on

rear panel of the system, otherwise the system may be damaged.

3.2 Downloading and Installing the App

Downloading the App
Use a computer to obtain the.apk installation package from Chison and move it to a mobile device
Installing the App
1. Select the file which ended by .apk to install APP.
2. After installation, press the icon to enter the interface.

Giving App Access to Shared Device Storage

App uses shared device storage for the patient database and to access your device's camera for QR code
scanning.
Some versions of the Android operating system require that you specify that an app is allowed access to

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 Digital Color Doppler Palm Ultrasound System
shared device storage. If your device prompts you to allow App to access photos, media, or files on your
device, touch Allow. If you touch Deny, you cannot use App until you give access to shared device storage
in the Android App Permissions settings.

Updating the App

Use a computer to obtain the.apk update package from Chison and move it to the mobile device. Select the
update package to install APP.

Turning the System On and Off

1. Power on:

Press for 3 seconds to turn on the system. The blue light is on while the system is on.

2.Poweroff:

Press for 3 seconds to shut down the system.

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 Digital Color Doppler Palm Ultrasound System

3.3 System Specifications

3.3.1 Console Overview

SonoEyeP6 system:

Fig. 3-1 a: Console Overview

Fig. 3-2: Firmware Front View for SonoEyeP6 system

From left to right: Freeze Button，P，- & + (They can be set as None, Freeze/Unfreeze, Gain+, Gain-,
Depth+, Depth- and Save Image )

3.3.2 Physical Specifications

Dimensions of main unit (approx.): 64mm（Width）*172mm（Height）*24mm（Depth）

3.3.3 Image Modes

 B mode
 B/M mode
 Color Flow Map mode
 PulsedWave Doppler mode

3.3.4 Type
 SonoEye P6 4.0MHz-8.0MHz/6.0MHz-10.0MHz Micro-convex Array

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 Digital Color Doppler Palm Ultrasound System
3.3.5 System Configuration

Function SonoEye P6

B mode √
B/M mode Option
PW mode Option
CFM mode Option
FHI Option
Type-C cable √
Identify probe √
Switch exam mode √
Gain √
Depth √
STC √
Focus √
Zoom √
Adjust sample Gate location Option
Adjust size of sample Gate horizontal Option
Adjust size of sample Gate vertical Option
Adjust PW sample gate Option
Compound √
Frequency Scaling √
Freeze/Unfreeze √
B-distance √
B-Circumference √
B-Area √
B-Volume √
B/M-Distance Option
B/M-Time Option
B/M-HR Option
PW-Velocity Option
PW-Time Option
Vessel measure package Option
Abdomen measure package Option
Cardiac measure package Option
Lung measurement Option
General report Option

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 Digital Color Doppler Palm Ultrasound System
Vessel report Option
Abdomen report Option
Cardiac report Option
Lung report Option
English Interface √
Multi-language Interface Option
Auto vascular tracking Option
Instant AIO √
Biopsy Guide Option
SonoNeedle Option
SuperNeedle Option
SonoRemote Option
Save Cine √
Save Image √
Cine Loop Option
Annotation Option
Bodymark Option
Mark Option
Patient management Option
Voice/Angle/Baseline on PW Option
Content in interference:
Image area(Probe type, frequency, probe direction, Image depth
and depth ruler, gray scale ruler, color power ruler, cine loop ruler, √
focus position, AIO, A.P., battery condition)
Title area:(menu, switch probe, product logo, patient ID, End exam )
Physical key √
Setting √
Archives √
Tutorials √
EasyView √
Demo √
About √
“√” : Standard

3.4 System Positioning & Transporting

Moving the System

When moving or transporting the system, take the precautions described below to ensure maximum safety
for personnel, the system and other equipment.

Before Moving the System

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 Digital Color Doppler Palm Ultrasound System
Completely switch off the system.

NOTE
To prevent damage to the cable, DO NOT pull excessively on the cable or sharply bend the
cable while wrapping it.
 Store all systems in their original cases or wrap them in soft cloth or foam to prevent damage.
 Replace gel and other essential accessories in the appropriate storage case.
 Ensure that no loose items are left.

When Moving the System

 Take extra care when you move the system long distances.
 Use extra care when crossing door or elevator thresholds.

Caution
 Walk slowly and carefully when moving the system.
 Be sure the pathway is clear.
 Do not let the system strike walls or doorframe.
Transporting the System
After preparing the system as described above, take the following additional precautions:
 Before transporting, place the system in its original storage carton.
 Drive carefully to prevent damage from vibration. Avoid unpaved roads, excessive speeds, and erratic
stops or starts.

3.5 Powering the System

3.5.1 Acclimation Time

After being transported, the unit requires one hour for each 2.5 ºC increment if its temperature is below 10
ºC or above 38 ºC.
3.5.2 Connecting the Electric Power
After making sure the power supply on displayer is normal status, and the voltage type is matched to the
power requirement indicated on the label of system, then connect the connector with displayer.

3.6 The System

Caution
Before connecting the system, please carefully check the system lens, system cable and system connector
to see whether there is anything abnormal, such as cracks, falls off. Abnormal system is not allowed to
connect to the system; otherwise there is possibility of electricity shock.
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 Digital Color Doppler Palm Ultrasound System
 Connect the connector from the SonoEyeP6 system to displayer.

Caution
 The system can only be disconnected with displayer while the power supply is off to prevent damage to
the system.
 If system is not correctly or completely connected with displayer, this may cause mis-operation, e.g. the
system cannot be recognized, mis-recognized, or the system may drop off from the main unit and be
damaged.

Deactivating the System

Disconnect the connector from displayer to deactivate the system.

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 Digital Color Doppler Palm Ultrasound System

Chapter 4 Control Panel

4.1 Overview of Display Area

Fig 4.1a Display Interface

1. Side Menu 2. Application 3. Parameters control

4. Center Line 5. Full Screen 6. B/M mode
7. PW mode 8. CFM mode 9. Freeze
10. Logo 11. Patient information 12. End Exam
13. Connection status 14. Image parameter area 15. Focal indicator

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 Digital Color Doppler Palm Ultrasound System
4.2 Start a New Exam

Press to end the current exam, and start a new patient.

To add patient information:

1. On the imaging display, touch the ID number.

2. On the patient Info display, type the patient information.

3. Click the [Save] button.

Patient Information:
MRN Medical Record Number
ID Patient ID
Date Date of the study
First Name Input patient’s First Name
Middle Name Input patient’s Middle Name
Last Name Input patient’s Last Name
Sex Select the patient’s sex
Age Set the patient’s age, the system will automatically calculate the patient’s birthday
Birth Set the patient’s birthday, the system will automatically calculate the patient’s age
Height Input the patient’s height
Weight Input the patient’s weight

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 Digital Color Doppler Palm Ultrasound System

4.3 Probe

Press to display current probe preset. Choose the desired preset to start an exam.

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 Digital Color Doppler Palm Ultrasound System

4.4 Switching Function

Slide the top left along the buttons to show Freq.

4.5 Switching Mode

Available imaging modes are B, CFM, PW, B/M Mode.

4.6 Function Key Introduction

Button Name Function
Freeze Touch this icon to freeze the current image

Preset Press this button to select preset.

AIO Press this button to optimize current image.

Auto vascular Press this key to help user identify artery and
tracking vein in current image automatically.

Freq. Press this button in phantom preset to adjust the

Freq.

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 Digital Color Doppler Palm Ultrasound System
Image save Press this key to save image

Cine save Press this key to save cine

B Mode Press this key to enter B mode.

B/M Mode Press this key to enter B/M mode.

CFM Mode Press C to enter CFM Mode.

PW Mode Press PW to enter PW Mode.

Side Menu
Press to enter the side menu list.

Full Screen Press the key to turn on the full screen function.

Measure Press this key to enter measurement.

Ellipse Press this key to start ellipse measurement.

Distance Press this key to start distance measurement.

Mark Press this button and the user can select the
content to add in current exam interface.

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 Digital Color Doppler Palm Ultrasound System
Annotation Press this button to add annotation in current
exam interface.

Arrow Press this button to add arrow in current exam

interface.

BodyMark Press this button to add body mark in current

exam interface.

Clear Press this button to clear all the content that user
have added in current exam interface.

4.7 Image Parameter Area

Display information about Patient ID, Frequency, time, current exam and etc.

4.8 Cine Control

No. Item Description

<1> Starts Cine playback.

Stops Cine playback.

<2> Press and slide on the processing bar to view frames.

<3> Current/Total The number corresponds to the current frame and total frame.

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 Digital Color Doppler Palm Ultrasound System

Chapter 5 Imaging
This chapter will introduce image display modes and the operation of image control and adjustment.

5.1 Select Scan Mode

5.1.1 System Identify

The App will identify the system automatically while system is connected.
5.1.2 Select Application
Click icon, the examination interface will pop-up, according to the type of probe to select corresponding
application. Press it to enter into expected exam.

Start App to enter Compound Image automatically.

There are five image display modes: B mode, B/M mode, CFM mode, FHI and PW mode. Theycan be
shifted by the mode icon.

5.1.3 B mode
Click [B] icon to display single B mode image. B mode is the basic operating mode for two-dimensional
scanning and diagnosis.

5.1.4 FHI
Press [Freq.] button to open its sub-menu, select the expected frequency to optimize current image. Press
[Freq.] again to exit FHI selection menu. FHI is used for improving SNR (Signal to Noise Ratio) and remitting
pseudo morphism on current image. Thus, the image quality is improved by this function.
5.1.5 B/M Mode
B/M-mode is used to determine patterns of motion for objects within the ultrasound beam.
Click [M] icon to enter B/M ready mode, then move the M-line to enter B/M mode. B/M mode is fit for heart
scanning and measurement.

5.1.6 CFM Mode

Color Flow Map is a technique for imaging blood flow by displaying flow data such as velocity and direction
on B mode image. Based on Doppler Effect, normally the blood flow moving toward the probe scan direction
is marked in red, while blood flow moving away from probe scan direction is marked in blue. Touch [C] icon,
screen only displays color mode operation interface.

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 Digital Color Doppler Palm Ultrasound System

Fig. 5-1CFM Mode

5.1.7 PW mode
Intended Use:
Doppler is intended to provide measurement data concerning the velocity of moving tissues and fluids.
PW Doppler lets you examine blood flow data selectively from a small region called the Sample
Volume.
The X axis represents time while the Y axis represents velocity in either a forward or reverse direction.
PW Doppler is typically used for displaying the speed, direction, and spectral content of blood flow at
selected anatomical sites.
PW Doppler can be combined with B-mode for quickly selecting the anatomical site for PW Doppler
examination. The site where PW Doppler data is derived appears graphically on the B-mode image
(Sample Volume Gate). The Sample Volume Gate can be moved anywhere within B-mode image.
PW mode Exam Procedure:
 Connect the appropriate system, leaving the systems in their respective holders.

 Position the patient for the examination.

 Press ID number and enter the appropriate patient data.

 Select the application and system to be used.

 Locate the anatomy to be examined. Get a good B-mode image. Press C- icon to help locate the

vessel you wish to examine.

 Press PW- icon to display the sample volume cursor and gate.

 Position or re-size the sample volume gate by moving the slide left, right, up and down.

 Press PW- icon to display PW Doppler spectrum and the system operates in combined B+Doppler

mode. The Doppler signal is heard through the speakers.

 Optimize the PW Doppler spectrum, as necessary.

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 Digital Color Doppler Palm Ultrasound System
 Press the corresponding button to transfer the exam mode between real time B-mode with Doppler
mode (with audio).
 Sample along the whole length of the vessel. Ensure that the system is parallel to flow. Listen, then

look, when positioning the sample volume cursor.

 Perform measurements and calculations, as necessary.
 Record results with your recording devices.

 Press to resume imaging.

 Repeat the above procedure until all relevant flow sites have been examined.

 Replace the system in its respective holder.

5.1.8 B-Lines
Select the Lung preset to start an exam, press the lung icon on the left side while freeze image. The
analysis data of lung will display on the right bottom corner which include B-Lines, mean pleural
thickness, maximum pleural thickness, minimum pleural thickness, standard deviation on pleural and
diffuse.
 Edit pleural line:
Press the Edit icon on the left of image, press the image with single finger and blue line display, move
the blue line with finger to edit pleural line.
 Add B-Lines:
Press Add icon on the left of image, a yellow line displayed, press it and move it to the target position
and release finger to add B-lines.
 Delete B-Lines:
Press the existed B-Lines with single push to active current B-Lines, press the Delete icon on the left of
image area to delete current B-Lines.
 Lung Report:
After finishing all operation on lung, press the Report key onside menu, select images on current exam
and compare exam to start lung analysis, and result will display below the image.

5.1.9 Biopsy Guide

Press Biopsy Guide icon and the guide line displays. Press the icon again to exit Biopsy Guide.
 Adjust Biopsy Guide Line:
Press the Biopsy Guide line and slide it to adjust the guide line.
 Adjust Biopsy Guide Angle:
Press the Biopsy Guide line, the angle icon displayed, press to slide it to adjust the Biopsy Guide angle.

5.1.10 SonoNeedle
Select SonoNeedle in B mode, the system will recognize and mark the needle position and needle trajectory
automatically.

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 Digital Color Doppler Palm Ultrasound System
5.1.11 SuperNeedle
SuperNeedle is to balance the B mode image. Select SuperNeedle, the user can optimize image by
adjusting angles.

5.1.12 SonoRemote
SonoRemote enables remote real-time ultrasound diagnosis.
Install SonoRemote on PC and open it, check the network connection. The SonoRemote will register an
account automatically when you first log into it. After registration, each time you open it, SonoRemote will log
in your account automatically.
Check the network connection on system, click SonoRemote icon to open it. The SonoRemote will register
an account automatically when you first log into it. After registration, each time you open it, SonoRemote will
log in your account automatically.
Input the ID of answer terminal on originate and start a call. System will receive the signal and connect with
originate terminal. If the connection is successful, the camera on the original terminal will automatically turn
on. The ultrasound screen and camera screen will be displayed on the PC. Before connecting, users can set
up video, microphone and speakers on the original terminal. The video data on the originate terminal will be
displayed on the answering terminal. Before connecting, the user can set the video, microphone and
speaker on the answering terminal.

Note: When the network connection of either originate or answer is disconnected automatically, it will
be automatically reconnected.

5.2 Functional Description of Parameter Adjustment

1. Gain
To adjust the Gain:
Swipe left, right in arbitrary place of screen.
Press the Gain button and slide the block to adjust the Gain.
2. Depth
To adjust the Depth:
Swipe up and down in the image area to adjust the depth.
3. Frequency

Click to choose Frequency. The range of the frequency depends on different probes.
4. Focus position
Press and hold the target position of the ruler, the focus will automatically jump to the position.
5. Zoom
 Touch the screen with two fingers and slide it outward to adjust the zoom position.

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 Digital Color Doppler Palm Ultrasound System

6. Sample Gate
In the real-time state of CFM mode, press the blood flow sampling gate and move it to adjust the
position.
In the real-time state of CFM mode, press and hold the lower left corner of the blood flow sampling
gate. After the adjustment mark appears, slide left and right to adjust the horizontal size of the blood
flow sampling gate, and slide up and down to adjust the vertical size of the blood flow sampling gate.

5.3 Parameter Adjustment in PW mode

1. PW Gain
At real-time state, slide left or right in spectrum area to adjust the size of doppler gain, adjustment
range from 0~255, the smallest value of adjustment is 1.
2. Voice
At real-time state, press the display device sound keys to adjust the voice.
3. Angle
At real-time state, press the angle icon to adjust the angle.
4. PW Sample Gate
At real-time state, use two fingers to slide it outward to adjust the size of sample gate.
At real-time state, press the sample gate and move it to adjust the location.
5. Baseline
At real-time state, press the baseline and move it to up and down to adjust the location.

5.4 After Capturing the Image

5.4.1 Adding Annotation

Annotation can be added to an ultrasound image to bring attention, notate or communicate information
observed during the examination. You can add annotations to: zoomed image, cine review image and frozen
image.

WARNING: You must ensure that the entered annotations are correct. Incorrect annotations may
cause misdiagnosis!

Operation:

1. Freeze image and slide the menu list to select .

2. The submenu appears, press . “︱”is displayed in image area and the soft icon board appeared in
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 Digital Color Doppler Palm Ultrasound System
the bottom of screen.
3. After the user inputs the annotation, press it with a single finger to move it to target position.
4. To edit existed annotation, press and hold it, the soft icon board appears, the user can re-input annotation.

5.4.2 Adding BodyMark

Operation:

1. Freeze image and slide the menu list to select .

2. The submenu appears, press . The body mark list displays, select the body mark in desired
application. The body mark displays in image area.
3. Slide the blue dot to adjust the probe direction.
4. To move the body mark, press it and move it to target position.

5.4.3 Adding Mark

Operation:

1. Freeze image and slide the menu list to select .

2. The submenu appears, press . The mark displays in image area.

3. Slide the blue dot to adjust the mark direction.
4. To move the mark, press it and move it to target position.

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 Digital Color Doppler Palm Ultrasound System

Chapter 6 Measurement and Calculation

6.1 Measurement Methods
The system contains Distance, Ellipse.
1. Distance
Measurement steps:
 Click the『Distance』icon under the measurement menu to enter into measurement.
 Click the B image area; it will display a segment with two “+” icon. One of the “+” is active, you
can move it by dragging your finger to fit the one point of the line.
 After measurement, the result will appear on the exam interface.
 Repeat the above step to start a new measurement, press can delete the current
measurement result.

 Press can delete all the measurements.

2. Ellipse
Measurement steps:
 Click the [Ellipse] icon under the measure menu to enter into measurement.
 Click in the B image area，it will display an ellipse with four “+” icon, you can move the “+” by
dragging your finger on B image area to fit it’s position.
 After measurement, the result will appear on the exam interface.
 Repeat the above step to start a new measurement, press can delete the current
measurement result.

 Press can delete all the measurements.

6.2 B Mode Measurement

Press B to enter the B mode and press measure to start measurement.

1. Distance
Distance measurement is the same as section 6.1.
2. Area
Area measurement is the same as section 6.1.
3. Circumference
Circumference measurement is the same as section 6.1.
4. Volume
Volume measurement is the same as section 6.1.

6.2.1 Vessel Measurement in B mode

IMT(Auto):Press CALC icon to enter Vascular measurement, click IMT(Auto) icon, the sampling frame
appears in image area. Use a finger to slide on the top right or left corner to adjust location, press image
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 Digital Color Doppler Palm Ultrasound System
area to finish measurement. The measurement results display on result area.
Meas. item mark unit Meas. Method and calc. formula
name
Max cm Refer to Auto IMT in 6.2.1
Min
IMT(Auto)
Mean
Std
A Out cm 2 Refer to “Ellipse” measurement in 6.1

StA% A In cm 2 Refer to “Ellipse” measurement in 6.1

StA% % StA%=（A Out-A In）/ A Out*100%

D Out cm Refer to “Distance” measurement in 6.1

StD% D In cm Refer to “Distance” measurement in 6.1

StD% % StD%=（D Out-D In）/ D Out*100%

6.2.2 Abdomen Measurement in B mode

Meas. item mark unit Meas. Method and calc. formula
name
CBD CBD cm Refer to “Distance” measurement in 6.1
GB Wall GB Wall cm Refer to “Distance” measurement in 6.1
Liver Length Liver Length cm Refer to “Distance” measurement in 6.1
Length cm Refer to “Distance” measurement in 6.1
Spleen Width cm Refer to “Distance” measurement in 6.1
Height cm Refer to “Distance” measurement in 6.1
Length cm Refer to “Distance” measurement in 6.1
Renal Vol. Width cm Refer to “Distance” measurement in 6.1
Height cm Refer to “Distance” measurement in 6.1
Length cm Refer to “Distance” measurement in 6.1
GB Volume Width cm Refer to “Distance” measurement in 6.1
Height cm (3.14159265/6) * Length * Height * Width
IVC Ins cm Refer to “Distance” measurement in 6.1
IVC
IVCExp cm Refer to “Distance” measurement in 6.1

6.2.3 Cardiac Measurement in B mode

Meas. item mark unit Meas. Method and calc. formula
name
IVSd IVSd cm Refer to “Distance” measurement in 6.1
LVIDd LVIDd cm Refer to “Distance” measurement in 6.1
LVPWd LVPWd cm Refer to “Distance” measurement in 6.1
IVSs IVSs cm Refer to “Distance” measurement in 6.1
LVIDs LVIDs cm Refer to “Distance” measurement in 6.1
LVPWs LVPWs cm Refer to “Distance” measurement in 6.1
3
EDV EDV ml (7*LVIDd /1000)/(2.4+(LVIDd/10))
3
ESV ESV ml (7*LVIDd /1000)/(2.4+(LVIDd/10))
SV SV ml EDV-ESV
CO CO L/min HR*SV/1000
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 Digital Color Doppler Palm Ultrasound System
EF EF % 100*SV/EDV
FS FS % 100*（LVIDd-LVIDs）/LVIDd
SI SI SV/BSA
CI CI CO/BSA
ml
EDV(A2C/A4C)

ml
ESV(A2C/A4C)

SV SV ml EDV-ESV
CO CO L/min HR*SV/1000
EF EF % 100*SV/EDV
SI SI SV/BSA
CI CI CO/BSA
IVC Ins IVC Ins cm Refer to “Distance” measurement in 6.1
IVC Exp IVC Exp cm Refer to “Distance” measurement in 6.1
LVOT Diam LVOT Diam cm Refer to “Distance” measurement in 6.1
LVOT Area LVOT Area cm 2 Refer to “Ellipse” measurement in 6.1
AV Diam AV Diam cm Refer to “Distance” measurement in 6.1
AV Area AV Area cm 2 Refer to “Ellipse” measurement in 6.1

6.3 B/M Mode Measurement

1. Distance
This feature allows the measurement of the distance between two points. It is a measurement between the
two horizontal lines that lean on the two cursors. The position of the vertical time line does not affect the
distance measurement.
Distance measurement is the same as distance measurement in B mode.

2. Time
Time is the measurement between the two vertical time lines created by two cursors. The position of the
horizontal distance line does not affect time measurements.

3. HR
HR is the measurement between the two vertical lines that are created by two cursors in beat per minute
(BPM). The position of the horizontal distance line does not affect HR.

6.4 PW Mode Measurement

1. Velocity
Press Freeze after finish the scan, select the velocity in menu, the blue “+” displayed on the screen, move it
to desired position to start measurement. The result will display on image area and result area. Repeat the
above steps to start new measurement.
2. Time
Press Freeze after finish the scan, select the time in menu, there are two blue “+” displayed on the screen,
39
 Digital Color Doppler Palm Ultrasound System
move it to desired position to start measurement. The result will display on image area and result area.
Repeat the above steps to start a new measurement.

40
 Digital Color Doppler Palm Ultrasound System

Chapter 7 Cine-Memory
This chapter introduces the theory of saving images in Cine-Memory and the operation of image playback in
Cine-Memory.
7.1 Image Storage
Images in B-mode can be stored in Cine-Memory at the unit of frame in time sequence. If the storage is full
of images, when storing a latest new frame image, the first saved frame image will be removed out of Cine-
Memory. Therefore, there are always the latest images in the storage. All the images in Cine-Memory can be
played back manually or automatically.

Fig 7-1 Movie playback bar diagram

7.2 Manual playback

After clicking the button to freeze the image, the movie playback bar pops up. At this time, slide to
right in image area to display the images in ascending order of frames, that is, the same order as the images
are stored, otherwise frames are displayed in descending order.

7.3 Automatic playback

Press Freeze and click to start automatic playback.

7.4 Cine Save

Press Freeze and click to save current cine.

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 Digital Color Doppler Palm Ultrasound System

Chapter 8 Side Menu

The setting function is used to set the system’s startup operating environment, state and configuration
parameters of each exam mode. The settings are stored in system's memory and are not lost when the
power is turned off.

8.1 Archive

Press on the top left corner of the screen, select archive to enter the archive management.

42
 Digital Color Doppler Palm Ultrasound System

Press on the top right corner of the screen, user can manage archive according to ID, MRN and
Name.

Select archive:Press archive and hold it, the current archive is selected.

: Select all archives.

: Press it to delete selected archive.

Press selected archive to enter EasyView.

8.2 EasyView
Press EasyView to check the patient information, saved images and cines.

43
 Digital Color Doppler Palm Ultrasound System

Press on the top right corner of the displayer, the user can set the image preview mode.

Press an image and hold it to select the current image, the frame of image will turn to blue.

44
 Digital Color Doppler Palm Ultrasound System

: Press this button to send selected image to external media device.

: Press this button to select all images.

: Press this button to delete selected image.

8.3 Report
Select the report from side menu, press “<” on the top left corner to return to the exam interference.

Press on the top right corner to select the report type, the General, Vessel, Abdomen, Cardiac and
Lung can be selected.

8.4 Setting
Press the setting button to enter the setting interface.

45
 Digital Color Doppler Palm Ultrasound System

8.4.1 General
Set STC display and ID display on system.

8.4.2 Language
Press language to select the needed language. The system supports English, Chinese and Deutsch.

46
 Digital Color Doppler Palm Ultrasound System

8.4.3 Button Configuration

Select the button configuration to set the key function.
Button Function
“+”
None/Freeze, Unfreeze/Gain+/ Gain-/Depth+/Depth-/Save Image
“-”
“P”

8.4.4 Administrator
Click the Administrator to manage accounts.

8.4.5 Firmware Update

Select firmware update to upgrade system software version.

47
 Digital Color Doppler Palm Ultrasound System

8.4.6 Function Management

Select function management to manage system functions.

8.5 Tutorials
The first time you enter the app, it displays tutorials to familiarize you with the features of the system. You

can view the Tutorials at any time. Press and select tutorials to enter it, there is a short video to help
you learn the system.

8.6 Demo
Click Demo to enter it, the user can view the exam images and cines.

48
 Digital Color Doppler Palm Ultrasound System

Exit Demo: press anywhere on screen, then press “<” on the top left corner to exit demo.

8.7 About
Press About to check the current software version.

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 Digital Color Doppler Palm Ultrasound System

Chapter 9 System Maintenance

9.1 Cleaning

Caution
Before cleaning any part of the system, please make sure that the system is turned off and the power cord is
disconnected from the power supply socket. Otherwise there will be danger of electricity shock.
Cleaning method:
Please use a piece of soft and dry cloth to clean the system. If there’s some dirty difficult to be cleaned,
please use wet cloth to clean system, and then use dry cloth to wipe off the water on the system.

Caution
Please don’t use organic solvent to clean the system; otherwise it will damage the system surface.
Please never allow any liquid get inside the system or system, otherwise it will damage the system and
cause electronic short.
If the system connector is required to be cleaned, please contact our authorized agent in your country in
advance. Any cleaning by unauthorized person may result in system malfunction or affect its features.

9.2 System Maintenance

According to the purposes, the system is used on the surface of patient body.

Caution
No matter which type of examination is performed, please always try to reduce the unnecessary radiation of
ultrasound wave to the patient during the ultrasound examination.

Caution
1. System can only be used by professional doctor who has received professional training of ultrasound.
2. It is forbidden to sterilize and disinfect system by high pressure. If it needs to be used in sterilized
occasion, please use a sterilized disposable system cover on the system.
3. Please avoid drop off or hitting the system by anything.
4. Don’t scratch the system surface while using it.
5. Please use the authorized ultrasound gel during scanning. Using un-authorized gel may cause scratch
or damage to system surface.
6. Please keep the system clean and dry.

7. Please don’t use or preserve the system where it is over 50℃.

8. Please carefully check the system surface before using. If there is any abnormal phenomenon (eg.
50
 Digital Color Doppler Palm Ultrasound System
there’s a leakage on the system surface), please stop using the system immediately and contact our
authorized agent in your country as soon as possible. If you don’t know the contact number of your
authorized agent, please contact us by detail contact information at the end of this chapter.
System maintenance
Please take good care of the system. Collision and dropping is strongly prohibited.
Please use the ultrasound gel which is acknowledged by the manufacture of the unit. We recommend
AQUASONIC Gel made by R. P. Kincheloe Company in USA.
Plug and unplug of system in real-time is strongly prohibited.
Clean the system:
1) System tip
Cleaning: Use a sponge or soft cloth to remove gently the dirt and gel on system tip.
2) Connector, Cable, other part of the system tip must not be soaked in a solution. Simply clean it using a
soft cloth moistened with alcohol and then dry it.
Aeration and let the system become dry in normal temperature.
Please strictly keep the system away from the paint thinner, ethylene oxide, other organic solvent, etc
Please keep the system inside the system case when it is not in use.
Dipping the system into any liquid is strongly prohibited.

Caution
Please immediately stop using the system and system if there is any broken phenomenon on the electricity
cable or the system transducer. Otherwise there will be a danger of the electricity shock.

9.3 Safety Check

To ensure the system work normally, please make a maintenance plan, check the safety of the system
periodically. If there is any abnormal phenomenon with the machine, please contact our authorized agent in
your country as soon as possible.
If there is no image or menu on the screen or other phenomenon appears after switching on the machine,
please do troubleshooting first according to the following check list. If the trouble is still not solved, please
contact our authorized agent in your country as soon as possible.

9.4 Troubleshooting
According to the most frequently occurred errors and system messages, the list of possible causes and
relevant solutions is attached as below:

Errors & Messages Possible Cause Solution

Power-indicating lamp is Type C cord may not be Please contact with Sales
not lit When user turn on connected, or may not be well office, service department
the system. connected with the displayer. and distributor.

51
 Digital Color Doppler Palm Ultrasound System
Power indicating lamp is lit The restart time interval after Wait 1 minute after power
When turn on the system, shutdown is too short off and then power on.
but no images on displayer.

Menu bar displays on the Transmission frequency, gain Adjust the transmission
screen but no scanning or STC control is not set frequency, gain or STC
image. properly. control.
System is connected Ensure the system is
improperly. connecting correctly
The system is in frozen status Defreeze the system by
pressing the FREEZE
icon.
Image quality is abnormal Examination mode is not Adjust image post-
correct. processing settings or set
The image post-processing it to default.
setting is abnormal.

The system is not working Internal circuit protection Restart system

properly

9.5 Service Responsibility

If users install, use and maintain the system fully according to CHISON’s installation manual, operation
manual and service manual, then SonoEyeP6 main unit has a life time of 5 years,
The warranty of the system after ex-work is as the time in the warranty card.
The system is a precise electronic system. Standard maintenance must be performed by CHISON’s
authorized service engineer during the life time of the product.

CAUTION: When the above life time is expired, the effectiveness and safety of
system and transducers maybe greatly affected, so it’s NOT suggested to continue
using the system and transducers even the system and transducers seem work
properly. But if user still wants to continue using the system and transducers, user
should first contact CHISON service center at CHISON headquarter to arrange the
necessary safety check and calibration by CHISON’s authorized service engineer. If
CHISON headquarter service center provides the calibration certificate for the related
system or transducer, then user could continue use the system or transducers according
to the calibration certificate. However, if CHISON headquarter service center concludes
that the system or transducer is no longer complied to the safety and effectiveness
standard, then user should immediately stop using the system or transducer. User
understands that such check and calibration cost will be born by the user.
Systems and transducers keep on using after the life time may also be difficult to repair
and maintain, so it’s suggested to renew the product after the life time.

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 Digital Color Doppler Palm Ultrasound System

Chapter 10 System

10.1 General Description

Transducer
Scanhead (Lens)

Fig.6-1:Convex Probe Overview

The system provides high spatial and contrast ultrasound imaging of frequencies from 4.0MHz to 8.0MHz.
These systems operate by pulsing sound waves into the body and listening to the returning echoes to
produce high-resolution brightness mode, and a real time display.

10.2 Care and Maintenance

The system is designed to be durable and dependable. These precision instruments should be inspected
daily and handled with care. Please observe the following precautions:
 Do not drop the transducer on hard surface. This can damage the transducer elements and compromise
the electrical safety of the transducer.
 Avoid kinking or pinching the transducer cable.
 Use only approved ultrasonic coupling gels.
 Follow the instructions for cleaning and disinfecting that come with each system.

10.2.1 Inspecting Systems

Before and after each use, inspect carefully the system’s lens, cable, casing, and connector. Look for any
damage that would allow liquid to enter the system. If any damage is suspected, do not use the system until
it has been inspected and repaired/replaced by an authorized Service Representative.

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 Digital Color Doppler Palm Ultrasound System
NOTE
Keep a log of all system maintenance, along with a picture of any system malfunction.

WARNING
The systems are designed to be used only with this ultrasound system. Use of these systems
on any other device or a non-qualified device may cause electrical shock or damage on the
system/transducer.

10.2.2 Cleaning and Disinfecting

This section provides information and instructions for properly cleaning and disinfecting the system.
Following these instructions will also help to avoid damaging the system during cleaning and disinfection.
After each exam, clean and disinfect the system.

CAUTION: Prevent any fluid from entering electrical or metal portions of the cable’s connector
during the cleaning and disinfecting process. Damage due to fluid in these areas may result.

 Scrub the system as needed using a soft sponge, gauze, or cloth to remove all visible residue from
the system surface.
 Use a soft cloth to clean the cable and the user section of the system with the cleaning disinfectant
liquid. Make sure that the surface of the system and cable is wetted thoroughly with the cleaning-disinfectant.
 Allow system to air dry completely.

54
 Digital Color Doppler Palm Ultrasound System

Recommended materials for cleaning and disinfecting transducer

Qualified Active Ingredients Time
Solution Origin Purpose
Use
Isopropyl NA
alcohol/Didecyl
WIP'ANIOS FRA Wipe Disinfection
dimethyl ammonium
chlorides
80% Ethanol（Using clean Ethanol Clean or NA
Any Wipe
cloth soak the liquid） Disinfection
70% Isopropyl alcohol Isopropyl alcohol NA
Clean or
（Using clean cloth soak Any Wipe
Disinfection
the liquid）
Sodium NA
Clinell Sporicidal Wipes GBR Wipe Percarbonate Citric Disinfection
Acid
peraceticacid,Hydro NA
mikrozid PAA wipes DEU Wipe genperoxid, Acetic Disinfection
acid
Quaternary NA
Universal wipes GBR Wipe Disinfection
ammonium
EP NA
perform classic wipes EP DEU Wipe Disinfection

CAUTION
These transducers are not designed to withstand heat sterilization methods. Exposure to
temperatures in excess of 60 º C will cause permanent damage. The transducers are not
designed to be totally submerged in fluid, as permanent damage will result if the entire
transducer is submerged.

System Safety

Handling precautions
Ultrasound systems are highly sensitive medical instruments that can easily be damaged by improper
handling. Use care when handling and protect from damage when not in use. DO NOT use a damaged or
defective system. Failure to follow these precautions can result in serious injury and equipment damage.

Electrical shock hazard:

The system is driven with electrical energy that can injure the patient or user if live internal parts are
contacted by conductive solution:
 DO NOT immerse the system and the system connector into any liquid.
 Prior to each use, visually inspect the system lens for cracks, cuts, tears, and other signs of physical
damage. DO NOT use a system that appears to be damaged until you verify functional and safe
performance. You need to perform a more thorough inspection, including the cable, strain relief, and

55
 Digital Color Doppler Palm Ultrasound System
connector, each time you clean the system.
Electrical leakage checks should be performed on a routine basis by CHISON Service or qualified hospital personnel.
Mechanical hazard:
A defective system or excess force can cause patient injury or system damage:
 Inspect systems for sharp edges or rough surfaces that may injure sensitive tissue.
 DO NOT apply excessive force to the system connector when inserting into the system port.
Special handling instructions

Using protective sheaths

The use of market cleared system sheaths is recommended for clinical applications. Reference FDA March
29, 1991 "Medical Alert on Latex Products".

Protective sheaths may be required to minimize disease transmission. System sheaths are available for use
with all clinical situations where infection is a concern.
DO NOT use pre-lubricated condoms as a sheath. In some cases, they can damage the system. Lubricants
in these condoms may not be compatible with system construction.
Devices containing latex may cause severe allergic reaction in latex sensitive individuals. Refer to FDA’s
March 29, 1991 Medical Alert on latex products.
DO NOT use an expired system sheath. Before using a sheath, verify if it has expired.

System handling and infection control:

This information is intended to increase user awareness of the risks of disease transmission associated with
using this equipment and provide guidance in making decisions directly affecting the safety of the patient as
well as the equipment user.

Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the patient by direct
physical contact.
Depending on the type of examination, this contact occurs with a variety of tissues ranging from intact skin in
a routine exam to recirculating blood in a surgical procedure. The level of risk of infection varies greatly with
the type of contact.

One of the most effective ways to prevent transmission between patients is with single use or disposable
devices. However, ultrasound transducers are complex and expensive devices that must be reused
between patients. It is very important, therefore, to minimize the risk of disease transmission by using
barriers and through proper processing between patients.

Risk of Infection
56
 Digital Color Doppler Palm Ultrasound System
ALWAYS clean and disinfect the system between patients to the level appropriate for the type of
examination and use FDA-cleared system sheaths where appropriate.

Adequate cleaning and disinfection are necessary to prevent disease transmission. It is the responsibility of
the equipment user to verify and maintain the effectiveness of the infection control procedures in use.

System Cleaning process:

DO disconnect the system from the displayer prior to cleaning/disinfecting the system. Failure to do so could
damage the system.

Perform Cleaning system after each use

 Disconnect the system and remove all coupling gel from the system by wiping with a soft cloth and
rinsing with flowing water.
 Wash the system with mild soap in lukewarm water. Scrub the system as needed using a soft sponge,
gauze, or cloth to remove all visible residue from the system surface. Prolonged soaking or scrubbing
with a soft bristle brush (such as a toothbrush) may be necessary if material has dried onto the system
surface.

WARNING
To avoid electrical shock, always turn off the system and disconnect the system before cleaning the
system.

CAUTION
Take extra care when handling the lens face of the system. The lens face is especially sensitive
and can easily be damaged by rough handling. NEVER use excessive force when cleaning the
lens face.
 Rinse the system with enough clean potable water to remove all visible soap residue.
 Air dry or dry with a soft cloth.

CAUTION
To minimize the risk of infection from blood-borne pathogens, you must handle the system and
all disposables that have contacted blood, other potentially infectious materials, mucous
membranes, and non-intact skin in accordance with infection control procedures. You must
wear protective gloves when handling potentially infectious material. Use a face shield and
gown if there is a risk of splashing or splatter.

Disinfecting the systems:

57
 Digital Color Doppler Palm Ultrasound System
After each use, please disinfect the systems. Ultrasound systems can be disinfected using liquid chemical
germicides. The level of disinfection is directly related to the duration of contact with the germicide.
Increased contact time produces a higher level of disinfection.

In order for liquid chemical germicides to be effective, all visible residue must be removed during the
cleaning process. Thoroughly clean the system, as described earlier before attempting disinfection.

You MUST disconnect the system from the displayer prior to cleaning/disinfecting the system. Failure to do
so could damage the system.

DO NOT soak systems in liquid chemical germicide. Soaking may cause system damage and early failure of
the enclosure, resulting in possible electric shock hazard.
 Prepare the germicide solution according to the manufacturer's instructions. Be sure to follow all
precautions for storage, use and disposal. The transducer is not designed to be totally submerged in
fluid. Permanent damage will result if the entire transducer is submerged.
 Place the cleaned and dried system in contact with the germicide for the time specified by the germicide
manufacturer.
Ultrasound transducers can easily be damaged by improper handling and by contact with certain chemicals.
Failure to follow these precautions can result in serious injury and equipment damage.
 Avoid mechanical shock or impact to the transducer and do not apply excessive bending or pulling force
to the cable.
 Transducer damage can result from contact with inappropriate coupling or cleaning agents:
• Do not soak or saturate transducers with solutions containing alcohol, bleach, ammonium
chloride compounds or hydrogen peroxide.
• Avoid contact with solutions or coupling gels containing mineral oil or lanolin.
• Avoid temperatures above 60°C. Under no circumstances should the transducer be subjected
to heat sterilization method. Exposure to temperatures above 60º C will cause permanent
damage to the transducer.
 Inspect the system prior to use for damage or degeneration to the housing, strain relief, lens and seal.
Do not use a damaged or defective system.

Coupling gels
DO NOT use gels (lubricants) that are not recommended. They may damage the system and void the
warranty. AQUASONIC Gel made by R. P. Kincheloe Company in USA is recommended.

In order to assure optimal transmission of energy between the patient and system, a conductive gel must be
applied liberally to the patient where scanning will be performed.

58
 Digital Color Doppler Palm Ultrasound System
DO NOT apply gel to the eyes. If there is gel contact to the eye, flush eye thoroughly with water.

Coupling gels should not contain the following ingredients as they are known to cause system damage:
 Methanol, ethanol, is opropanol, or any other alcohol-based product.
 Mineral oil
 Iodine
 Lotions
 Lanolin
 Aloe Vera
 Olive Oil
 Methyl or Ethyl Parabens (para hydroxybenzoic acid)
 Dimethylsilicone

Planned maintenance
The following maintenance plan is suggested for the system and systems to ensure optimum operation and
safety.
Daily: inspect the systems
After each use: clean the system, disinfect the system.
As necessary: inspect the system, clean the system, disinfect the system.

Returning/Shipping Systems and Repair Parts

Transportation dept. and our policy require that equipment returned for service MUST be clean and free of
blood and other infectious substances.
When you return a system for service, you need to clean and disinfect the system prior to packing and
shipping the equipment.
Ensure that you follow system cleaning and disinfection instructions provided in this Manual.
This ensures that employees in the transportation industry as well as the people who receive the package
are protected from any risk.

10.3 System Operation Instructions

For details on connecting, activating, deactivating, disconnecting, transporting and storing the systems, see
Chapter 3.

Scanning the Patient

In order to assure optimal transmission of energy between the patient and system, a conductive gel must be

59
 Digital Color Doppler Palm Ultrasound System
applied liberally to the patient where scanning will be performed.
After the examination is complete, follow the cleaning and disinfecting procedures as appropriate.

10.4 Service Responsibility

The system is a precise electronic system. Only an authorized service contractor should replace defective
parts. Failures caused by unauthorized service are not the responsibility of the manufacturer.

60
 Digital Color Doppler Palm Ultrasound System
REFERENCE:

1) 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 Manufacturers
Association, Rosslyn, VA; 2004a.
2) Implementation of the Principle of As Reasonably Achievable (ALARA) for Medical and Dental
Personnel, National Council on Radiation Protection and Measurements (NCRP), report NO.107,
December 31,1990
3) FDA Center for Devices and radiological Health (CDRH), 510(K) Guidance for Diagnostic
Ultrasound and Fetal Doppler Ultrasound Medical Devices, September 8 1989 draft
4) FDA/CDRH,510(K) Diagnostic Ultrasound Guidance Update of 1991, April 26, 1991 draft
5) Biological Effects of Ultrasound: Mechanisms and Clinical Implications, NCRP Report No. 74,
December 30,1983
6) Exposure Criteria for Medical Diagnostic Ultrasound: I. Criteria Based on Thermal Mechanisms,
NCRP Report No.113, June 1,1992
7) Bioeffects Considerations for the safety of Diagnostic Ultrasound, Journal of Ultrasound in Medicine,
AIUM, September1988
8) Geneva Report on Safety and Standardization in Medical Ultrasound, WFUMB, May 1990 Medical
Ultrasound Safety, AIUM, 1994
9) Medical Electrical Equipment standard IEC 60601-1, IEC60601-1-2, IEC 60601-2-37
10) Diagnostic Ultrasound Physics and Equipment, edit by P. R. Hoskins, in 2003

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 Digital Color Doppler Palm Ultrasound System

Appendix A: THE INFORMATION OF EC REPRESENTATIVE

Shanghai International Holding Corp. GmbH (Europe)
Add: Eiffestrasse 80, 20537 Hamburg,Germany
Tel: +49-40-2513175
Fax:+49-40-255726
DimdiNo.:DE/0000040627
E-mail: [email protected]

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 Digital Color Doppler Palm Ultrasound System

Appendix B: ACOUSTIC OUTPUT REPORT TABLE

Transducer Model: SonoEyeP6
Operation Mode: B
TIS TIB
Index Label MI At Below At Below TIC
Surface Surface Surface Surface
Maximum Index Value 1.05 0.11 0.11 0.25
Index component Value 0.11 0.11 0.11 0.11
pr.α at
(MPa) 1.58
ZMI
P (mW) 10.02 10.02 12.62
P1*1 (mW) 10.02 10.02
Acoustic Zs (cm) 2.15
Parameters
Zb (cm) 2.15
ZMI (cm) 2.15
Zpii.α (cm) 2.15
fawf (MHz) 2.25 2.25 2.25 2.22
prr (Hz) -
srr (Hz) 18.94
npss NA 1.00
Ipa.α at 2
(W/cm ) 79.17
Zpii.α
Other
Information Ispta.α at
2
Zpii.α or (mW/cm ) 0.79
Zsii.α

Ispta at 2
(mW/cm ) 0.82
ZpiiorZsii
pr at Zpii (MPa) 1.79

Focus (cm) 3.00 3.00 3.00 3.00

Operating Depth (cm) 16.00 16.00 16.00 16.00
control
conditions Freq MHz 2.00 2.00 2.00 2.00
PRF HZ - - - -

63
 Digital Color Doppler Palm Ultrasound System
Transducer Model: SonoEyeP6
Operation Mode: B+M
TIS TIB
Index Label MI At Below At Below TIC
Surface Surface Surface Surface
Maximum Index Value 1.12 0.26 0.58 0.36
Index component Value 0.26 0.18 0.26 0.58
pr.α at
(MPa) 1.65
ZMI
P (mW) 20.12 20.12 20.12
P1*1 (mW) 14.58 14.58
Acoustic Zs (cm) 1.52
Parameters
Zb (cm) 2.22
ZMI (cm) 2.05
Zpii.α (cm) 2.05
fawf (MHz) 2.16 2.16 2.16 2.16
prr (Hz) 346
srr (Hz) -
npss NA 1.00
Ipa.α at 2
(W/cm ) 80.46
Zpii.α
Other
Information Ispta.α at
2
Zpii.α or (mW/cm ) 8.77
Zsii.α

Ispta at 2
(mW/cm ) 8.89
ZpiiorZsii
pr at
(MPa) 1.75
Zpii

Focus (cm) 3.00 3.00 3.00 3.00

Operating Depth (cm) 16.00 16.00 16.00 16.00
control
conditions Freq MHz 2.00 2.00 2.00 2.00
PRF HZ - - - -

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 Digital Color Doppler Palm Ultrasound System
Transducer Model: SonoEyeP6
Operation Mode:B+CFM
TIS TIB
Index Label MI At Below At Below TIC
Surface Surface Surface Surface
Maximum Index Value 0.88 0.22 0.22 0.50
Index component Value 0.22 0.22 0.22 0.22
pr.α at
(MPa) 1.39
ZMI
P (mW) 24.21 24.21 28.90
P1*1 (mW) 18.68 18.68
Acoustic Zs (cm) 3.20
Parameters
Zb (cm) 3.20
ZMI (cm) 2.60
Zpii.α (cm) 2.60
fawf (MHz) 2.51 2.48 2.48 2.38
prr (Hz) -
srr (Hz) 6.49
npss NA 8.00
Ipa.α at 2
(W/cm ) 94.79
Zpii.α
Other
Information Ispta.α at
2
Zpii.α or (mW/cm ) 0.50
Zsii.α

Ispta at 2
(mW/cm ) 0.51
ZpiiorZsii
pr at Zpii (MPa) 1.73

Focus (cm) 3.00 3.00 3.00 5.00

Operating Depth (cm) 16.00 16.00 16.00 16.00
control
conditions Freq MHz 3.00 3.00 3.00 3.00
PRF HZ - - - -

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 Digital Color Doppler Palm Ultrasound System
Transducer Model: SonoEyeP6
Operation Mode:PW
TIS TIB
Index Label MI At Below At Below TIC
Surface Surface Surface Surface
Maximum Index Value 0.63 0.20 0.74 0.38
Index component Value 0.15 0.20 0.16 0.74
pr.α at
(MPa) 1.00
ZMI
P (mW) 21.79 18.92 22.59
P1*1 (mW) 12.61 14.60
Acoustic Zs (cm) 1.40
Parameters
Zb (cm) 3.20
ZMI (cm) 3.05
Zpii.α (cm) 3.05
fawf (MHz) 2.48 2.47 2.50 2.45
prr (Hz) 2000
srr (Hz) -
npss NA 1.00
Ipa.α at 2
(W/cm ) 40.29
Zpii.α
Other
Information Ispta.α at
2
Zpii.α or (mW/cm ) 109.67
Zsii.α

Ispta at 2
(mW/cm ) 213.87
ZpiiorZsii
pr at Zpii (MPa) 1.22

Focus (cm) 4.00 11.00 4.00 7.00

Operating Depth (cm) 16.00 16.00 16.00 16.00
control
conditions Freq MHz 3.00 3.00 3.00 3.00
PRF HZ 2000 2000 2000 2000

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Appendix C: TRANSDUCER MAXIMUM SURFACE TEMPERATURE

Maximum surface temperature(℃) Maximum surface

Transducer model Contacting human-tissue mimicking temperature(℃)
material Suspending in air
SonoEyeP6 <37.6 <31.4

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Appendix D: MEASUREMENT RESULTS SUMMARY

Measurement Useful Range Accuracy

Distance Image area <±5%
Circumference: Image area <±5%
trace method, ellipse method
Area: Image area <±10%
trace method, ellipse method
Volume Image area <±5%
Angle Image area <±5%

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Appendix E: GUIDANCE AND MANUFACTURER’S DECLARATION

1. Guidance and manufacturer’s declaration – electromagnetic emissions

SonoEye is intended for use in the electromagnetic environment specified below. The
customer or the user of SonoEye Series should assure that it is used in such an
environment.

Emissions test Compliance Electromagnetic

environment – guidance

RF emissions Group 1 SonoEye uses RF energy

only for its internal function.
CISPR 11 Therefore, its RF emissions
are very low and are not
likely to cause any
interference in nearby
electronic equipment.

RF emissions Class A SonoEye is suitable for use

in all professional
CISPR 11 healthcare environments,
like physicians, offices,
dental offices and those not
directly connected to the
public low-voltage power
supply net work

that supplies buildings used

for professional medical
purposes.

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2. Guidance and manufacturer’s declaration – electromagnetic immunity

The SonoEye is intended for use in the electromagnetic environment the SonoEye should
assure that it is used in such an environment.

Immunity test IEC 60601 Compliance level Electromagnetic

test level environment –
guidance

Electrostatic ±8 kV contact ±8 kV contact Floors should be wood,

discharge ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV, concrete or ceramic tile.
(ESD) ±15kV air ±15kV air If floors are covered with
IEC 61000-4-2 synthetic material, the
relative humidity should
be at least 30 %.
Power 30 A/m 30 A/m Power frequency
frequency magnetic fields should
frequency be at levels
(50/60 Hz) characteristic of a
magnetic field typical location in a
IEC 61000-4-8 typical
commercial or hospital
Radiated RF EM 3V/M 3V/M Radiated RF EM fields
fields IEC61000-4-3 should be at levels
80MHz-2.7GHz 80MHz-2.7GHz characteristic of a
typical location in a
typical
80%AM at 1KHz 80%AM at 1KHz commercial or hospital
environment.
Proximity fields from Proximity fields from RF
RF wireless wireless
communications See teble 9 See table 9 communications
equipment equipment should be at
levels characteristic of a
IEC 61000-4-3 typical location in a
typical
commercial or hospital
environment.

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