Chison ECO 6 User manual

Digital Color Doppler Ultrasound System
Model
ECO 6
V1.2
Sep 12, 2017
OPERATION MANUAL
Direction: 57-00594-00
CHISON Medical Technologies Co., Ltd.
We reserve the rights to make changes to this manual without prior notice.
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ECO 6 Digital Color Doppler Ultrasound System
Regulatory Requirement
This product conforms to the essential requirements of the
Medical Device Directive 93/42/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 ECO 6. Please verify that you are using the latest
revision of this document. If you need the latest revision, contact your distributor.
NOTE:
Important
1. No part of this manual may be reduced, modified, copied or reprinted, in whole or in part,
without written permission from CHISON.
2. The contents of this manual are subject to change without prior notice and without our legal
obligation.
3. Before operating the system, please read and understand this manual. After reading, keep this
manual in an easily accessible place. If you have any question or doubt, please contact CHISON's
authorized service engineer.
4. CHISON’s Warranty only cover material and parts costs for repairing, but do not cover any
labor cost or onsite service cost at end user's side.
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ECO 6 Digital Color Doppler Ultrasound System
NOTE:
Important information
1. It is the customer’s responsibility to maintain and manage the system after
delivery.
2. The warranty does not cover the following items, even during the warranty period:
a) Damage or loss due to misuse or abuse with system and probes, for example,
drop the probe, the liquid or the metal part fall into the system.
b) Damage or loss caused by Acts of God such as fires, earthquakes, floods,
lightning, etc.
c) Damage or loss caused by failure to meet the specified conditions for this
system, such as inadequate power supply, improper installation or environmental
conditions.
d) Damage or loss caused by non-approved transportation by CHISON.
e) Damage or loss due to use the system outside the region where the system was
originally sold.
f) Damage or loss involving the system purchased from a source other than
CHISON or its authorized agents.
3. Do not make changes or modifications to the software or hardware of this system
and probes.
4. During operate the system, if user has any doubt, difficulty or any unclear, please
contact CHISON's authorized service engineer immediately. Please describe the
situation clearly to solve the question in time. Before solve the question, please don’t
operate the system.
5. This system shall not be used by persons other than fully qualified and certified
medical personnel.
6. It is prohibited to use the device for fetal sex examination, except for necessary
medical needs. The device can only be sold to qualified medical institutions or doctors.
The users shall fully understand and master the devices before operating. The users
shall have got the qualification, and shall comply with the local laws and regulations,
the local religion and customs, etc.
7. The System modified or repaired by people other than CHISON’s qualified service
engineers, CHISON shall not be liable for the system.
8. The purpose of this system is to provide physicians with data for clinical diagnosis.
It is the physician’s responsibility for diagnostic procedures. CHISON shall not be
liable for the results of diagnostic procedures
9. This manual contains warnings regarding foreseeable potential dangers, but user
shall always be alert to dangers other than those indicated as well. CHISON shall not
be liable for damage or loss that results from negligence or from ignoring the
precautions and operating instructions described in this operation manual.
10. Due to negligence not following operation manual, CHISON shall not be liable
for the results.
11. Each time before and after ultrasound examination, please check the probe
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ECO 6 Digital Color Doppler Ultrasound System
surface, probe cable and sheath whether they are abnormal, such as cracking, peeling
and deformation. Also check whether the lens is strongly fixed. Abnormal probes may
cause electric shock and injure the patient. Once any abnormal, user must stop using
and contact CHISON's authorized service engineer.
12. If the probe is dropped or scratched by hard part, please stop using the probe
immediately. And contact CHISON's authorized service engineer to make sure the
safety and effectiveness is in good condition before use.
13. If there is any liquid or metal to enter to the system, please power off the system
and stop using it immediately. Please first contact CHISON’s authorized service
engineer to make sure it’s safe before restart using it.
14. Please don't use solvents (such as paint thinner, benzine, or alcohol) or abrasive
cleansers for cleaning the system (including monitor and probes, etc). It may corrode
the system and probes.
15. While the system or probe is over life time, please refer to operation manual
section 9.4
16. Important data must be backed up on external memory media. CHISON shall not
be liable for loss of data stored in the memory of this system caused by operator error
or accidents.
17. Please put this operation manual with the system to ensure operator and manager
can reach it at any time.
18. LCD display screen may have some dark or light dots, it is normal for the LCD. It
does not mean that LCD screen is defective.
Caution: It is prohibited to use the device for fetal sex examination, except for necessary
medical needs. The device can only be sold to qualified medical institutions or doctors. The users
shall fully understand and master the devices before operating. The users shall have got the
qualification, and shall comply with the local laws and regulations, the local religion and customs,
etc.
Caution: The users should read the operation manual carefully before operating the devices.
Turning on the device means the users have read the operation manual and accept the listed
cautions, warnings, and notes in the manuals. If the users disagree and cannot accept the cautions,
the users can ask for returning the device.
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ECO 6 Digital Color Doppler Ultrasound System
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Content
Chapter 1 Introduction..............................................................................................................................1
1.1 System Overview......................................................................................................................1
1.2 Contact Information ................................................................................................................1
Chapter 2 System Safety...........................................................................................................................2
2.1 Safety Overview........................................................................................................................2
2.2 Electrical Safety........................................................................................................................3
2.3 Label..........................................................................................................................................5
2.3.1 Warning Symbols............................................................................................................5
2.4 Patient Environmental Devices...............................................................................................6
2.5 Biological Safety.......................................................................................................................8
2.6 Scanning Patients and Education ...........................................................................................9
2.6.1 Safe Scanning Guidelines ...............................................................................................9
2.6.2 Understanding the MI/TI Display.................................................................................11
2.7 Battery Handling Instructions ..............................................................................................14
Chapter 3 System Introduction...............................................................................................................16
3.1 Consol Overview.....................................................................................................................16
3.2 Physical Specification.............................................................................................................16
3.3 System View in Different Views............................................................................................17
3.4 Function Introduction............................................................................................................18
3.4.1 Image Modes.................................................................................................................18
3.4.2 Accessories....................................................................................................................19
3.5 Installation Procedures..........................................................................................................20
3.5.1 Environment Condition.................................................................................................20
3.5.2 Powering the System.....................................................................................................23
3.5.3 Probe Installation ..........................................................................................................23
3.5.4 Accessories Installation.................................................................................................24
Chapter 4 Control Panel .........................................................................................................................25
4.1 Keyboard Appearance...........................................................................................................25
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4.2 Alphanumeric Keyboard.......................................................................................................25
4.3 Function Keys/Knob ..............................................................................................................26
4.4 Parameter Control key ..........................................................................................................28
4.5 STC..........................................................................................................................................28
4.6 Central Control ......................................................................................................................28
4.7 Information Area Indicating Machine Status......................................................................29
4.7.1 Indicator Light ..............................................................................................................29
Chapter 5 Operation and Exam Mode ....................................................................................................31
5.1 Preparing the System for Use................................................................................................31
5.1.1 The Device Inspection ..................................................................................................31
5.1.2 Power On ......................................................................................................................31
5.2 Choose Exam Mode................................................................................................................31
5.2.1 The Probe Identification................................................................................................31
5.2.2 Mode Selection .............................................................................................................31
5.3 Patient Data Entry .................................................................................................................32
5.4 Image Interface Display.........................................................................................................33
5.5 Display Mode..........................................................................................................................33
5.5.1 B Mode .........................................................................................................................33
5.5.2 B/B Mode......................................................................................................................33
5.5.3 4B Mode .......................................................................................................................33
5.5.4 B/M Mode.....................................................................................................................34
5.5.5 M Mode ........................................................................................................................34
5.5.6 CFM Mode....................................................................................................................34
5.5.7 B/BC Mode...................................................................................................................35
5.5.8 CPA (PD) Mode............................................................................................................35
5.5.9 DPD Mode....................................................................................................................35
5.5.10 CW Mode....................................................................................................................35
5.5.11 TDI Mode....................................................................................................................35
5.5.12 B steer.........................................................................................................................35
5.5.13 Trapezoidal Mode .......................................................................................................35
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5.5.14 Biospy and Super Needle............................................................................................36
5.5.15 PW Mode....................................................................................................................36
5.6 B Image Adjustment ..............................................................................................................37
5.6.1 Parameters Adiustment .................................................................................................37
5.6.2 B Menu Adjustment ......................................................................................................38
5.63 Accessories.....................................................................................................................40
5.7 CFM Image Adjustment........................................................................................................40
5.8 PW / CW Image Adjustment.................................................................................................41
5.8.1 Parameters in PW Mode ...............................................................................................41
5.8.2 Parameters in CW Mode...............................................................................................42
5.9 M Image Menu & Parameters Adjustment .........................................................................43
5.10 CPA/DPD/TDI Image Adjustment .....................................................................................43
5.10.1 CPA & DPD Parameter and Menu Adjustment...........................................................43
5.10.2 TDI Image Adjustment................................................................................................44
5.11 Full Screen Show..................................................................................................................45
5.12 Edit Comment.......................................................................................................................45
5.12.1 Overview.....................................................................................................................45
5.12.2 Input Characters..........................................................................................................45
5.12.3 Input Comment Library Characters ............................................................................46
5.12.4 Edit Quick Comments.................................................................................................46
5.12.5 Input Quick Comments...............................................................................................46
5.12.6 Move Comments.........................................................................................................46
5.12.7 Edit Comments ...........................................................................................................46
5.12.8 Delete Comments........................................................................................................46
5.12.9 Set the Position of Default Comment..........................................................................47
5.13 Set Body Mark......................................................................................................................47
5.13.1 General Description ....................................................................................................47
5.13.2 Body Mark Operation .................................................................................................51
5.14 Image and Cine Disposition.................................................................................................51
5.14.1 The Principle of Cine Storage.....................................................................................51
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5.14.2 Manual Loop...............................................................................................................52
5.14.3 Automatic Loop ..........................................................................................................52
5.14.4 Save and Recall Image................................................................................................52
5.14.5 Save and Recall Cine ..................................................................................................52
5.14.6 Delete images..............................................................................................................52
5.14.7 Send images................................................................................................................52
5.15 Image Browse .......................................................................................................................53
5.16 Archive Management...........................................................................................................53
5.17 Report....................................................................................................................................54
5.18 DICOM .................................................................................................................................56
5.18.1 DICOM Worklist.........................................................................................................56
5.18.2 DICOM Storage..........................................................................................................56
5.18.3 DICOM Print ..............................................................................................................57
5.18.4 DICOM SR .................................................................................................................57
Chapter 6 Measurement and Calculation................................................................................................58
6.1 Keyboard for Measurement..................................................................................................58
6.1.1 Trackball .......................................................................................................................58
6.1.2 [ENTER].......................................................................................................................58
6.1.3 [UPDATE] ....................................................................................................................58
6.1.4 [DEL]............................................................................................................................59
6.1.5 [Change] .......................................................................................................................59
6.1.6 [Exit].............................................................................................................................59
6.1.7 Parameters control button .............................................................................................59
6.2 B Mode general Measurement methods...............................................................................59
6.2.1 Meas. Distance..............................................................................................................59
6.2.2 Ellipse ...........................................................................................................................59
6.2.3 Trace .............................................................................................................................60
6.2.4 Histogram......................................................................................................................60
6.2.5 Profile ...........................................................................................................................61
6.3 B Fast Measurement ..............................................................................................................61
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6.4 B General Measurement........................................................................................................62
6.5 ABD Measurement.................................................................................................................63
6.6 OB Measurement ...................................................................................................................65
6.6.1 Twins Measurement......................................................................................................67
6.6.2 EDD (estimated date of delivery) Estimation ...............................................................67
6.6.3 Growth curves...............................................................................................................67
6.7 Pediatric Measurement..........................................................................................................68
6.7.1 HIPAngle......................................................................................................................68
6.8 GYN Measurement ................................................................................................................69
6.9 Small Parts Measurement .....................................................................................................69
6.10 B Mode Vessel Measurement ..............................................................................................70
6.11 Urology Measurement..........................................................................................................70
6.12 Cardiac Measurement..........................................................................................................71
6.13 Normal Measurement in M, B/M mode .............................................................................74
6.13.1 Distance ......................................................................................................................74
6.13.2 Time............................................................................................................................74
6.13.3 Heart rate.....................................................................................................................75
6.13.4 Velocity.......................................................................................................................75
6.14 General Measurement in M mode ......................................................................................75
6.15 M Abdomen Measurement..................................................................................................75
6.16 M OB Measurement.............................................................................................................76
6.17 M GYN Measurement..........................................................................................................76
6.18 M Mode Cardiac Measurement..........................................................................................76
6.19 M Urology Measurement.....................................................................................................78
6.20 M Small Parts Measurement...............................................................................................78
6.21 M Pediatric Measurement...................................................................................................78
6.22 PW mode measurement methods........................................................................................78
6.22.1 Velocity.......................................................................................................................79
6.22.2 Time............................................................................................................................79
6.22.3 HR...............................................................................................................................79
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6.22.4 Auto Trace...................................................................................................................79
6.22.5 Manual Trace ..............................................................................................................79
6.23 PW Fast Measurement.........................................................................................................79
6.24 PW Genearl Measurement ..................................................................................................81
6.25 PW Abdomen Measurement ...............................................................................................83
6.26 PW OB Measurement..........................................................................................................84
6.27 PW GYN Measurement.......................................................................................................84
6.28 PW Cardiology Measurement.............................................................................................85
6.29 PW Vascular Measurement.................................................................................................90
6.30 PW Urology Measurement..................................................................................................91
6.31 PW Small parts Measurement ............................................................................................91
6.32 PW Pediatric Measurement ................................................................................................91
Chapter 7 Preset......................................................................................................................................92
7.1 General setting........................................................................................................................92
7.2 Measurement..........................................................................................................................93
7.2.1 General measurement setting........................................................................................93
7.2.2 Measurement formula setting........................................................................................95
7.3 Comment...............................................................................................................................102
7.3.1 Comment Library........................................................................................................102
7.3.2 Edit Comment.............................................................................................................103
7.3.3 Comment and Arrow Option.......................................................................................103
7.4 Body marks...........................................................................................................................104
7.4.1 Body Marks Library....................................................................................................104
7.4.2 Bodymark edition .......................................................................................................104
7.4.3 BodyMark Option.......................................................................................................105
7.5 Exam Mode...........................................................................................................................105
7.5.1 Exam Mode Edit .........................................................................................................105
7.5.2 Exam Mode Selection.................................................................................................105
7.5.3 ExamMode config.......................................................................................................106
7.5.4 Image Freeze Config...................................................................................................107
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7.6 Keyboard...............................................................................................................................108
7.7 DICOM .................................................................................................................................109
7.7.1 Add/Edit DICOM Function.........................................................................................110
7.8 NET Work ............................................................................................................................110
7.9 System ...................................................................................................................................111
7.9.1 System information..................................................................................................... 111
7.9.2 Update......................................................................................................................... 111
7.9.3 Function Setting.......................................................................................................... 111
7.9.4 Installment setting....................................................................................................... 111
7.9.5 Video VGA .................................................................................................................112
7.9.6 Hardware function ......................................................................................................112
7.9.7 System Maintenance...................................................................................................112
7.9.8 USB Video Printer Option ..........................................................................................112
Chapter 8 System Maintenance............................................................................................................113
8.1 Machine Cleaning.................................................................................................................113
8.2 Probe Maintenance ..............................................................................................................113
8.3 Safety Check.........................................................................................................................114
8.4 Malfunction Check...............................................................................................................115
Chapter 9 Probes...................................................................................................................................116
9.1 General Description .............................................................................................................116
9.2 Care and Maintenance.........................................................................................................116
9.2.1 Inspecting Probes........................................................................................................116
9.2.2 Cleaning and Disinfecting...........................................................................................117
9.3 Probe Operation Instructions..............................................................................................125
9.3.1 Scanning the Patient....................................................................................................125
9.3.2 Operating Transvaginal probe.....................................................................................125
9.3.3 Cleaning and Disinfecting TV and TR Probes............................................................126
9.4 Service Responsibility ..........................................................................................................127
Appendix A: The Information of EC Representative ...........................................................................129
Appendix B: Acoustic Output Report Table.........................................................................................130
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Appendix C: Guidance and Manufacturer’s Declaration......................................................................179
Appendix D: Measurement Results Summary......................................................................................183
Appendix E: Display Accuracy and Acoustic Measurement Uncertainties..........................................184
Appendix F: Transducer Maximum Surface Temperature....................................................................185
Appendix G: Procedures of set network sharing in ECO series ...........................................................186
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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 keeping this manual
with the equipment, and periodically review the procedures for operation and safety precautions.
1.1 System Overview
Indications for Use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for
evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testicle, thyroid);
Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal Conventional & Superficial; Transrectal and
Transvaginal.
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:[phone]
Fax: [phone]
E-mail: [email protected].cn
Placing an Order
CHISON Medical Technologies Co., Ltd.
Tel: [phone]
Fax: [phone]
Email: [email protected].cn
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
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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.
Do not modify this system in any way. 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.
The power cable of the system should only be connected to a grounded power socket. Do not remove the
ground cable for any reason.
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 probe when the system is in active operation. Always go to EXAM screen when need to
remove the probe.
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 liquid on top of the main unit.
NOTE
*The system has built-in screen saver to avoid the tic mark on the display. It is not recommended to constantly
turn on and off the unit.
*To dispose of this product properly, please call your local service department.
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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 mains supply shall be cut off after disconnecting the power line and the net power.
Degree of protection against electric shock
Type BFApplied part (for Probes marked with BF symbol)
TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular
regard to allowable LEAKAGE CURRENT
Level of protection against harmful ingress of water
Parts of probe likely to come into contact with operator or patient meet the requirements of drip-proof
equipment (IPX1)
Parts of probe intended to be immersed in normal use meet the requirements of watertight equipment (IPX7)
The IP Classification of System is Ordinary Equipment (IPX0)
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)
Mode of operation
Continuous Operation
For maximum safety, always follow these guidelines:
Proper grounding of the system is critical to avoid electrical shock. For protection, ground the chassis with
a three-wire cable and plug, and plug the system into a hospital-grade, three-hole outlet.
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.
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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 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.
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
Securing system parts (cover open/close, cover screwing)
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2.3 Label
Fig. 1 Real panel label
2.3.1 Warning Symbols
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.
Dangerous electric voltage. Unplug the main
plug before opening the system!
Do not use the following devices near this
equipment: cellular phone, radio receiver, and mobile
radio transmitter, radio controlled toy, etc. Use of
these devices near this equipment could cause this
equipment to perform outside the published
specifications. Keep power to these devices turned off
when near this equipment.
Be careful of static.
WASTE OF ELECTRICALAND
ELECTRONIC EQUIPMENT (WEEE): This symbol
is used for Environment Protection, it indicates that
the waste of electrical and electronic equipment must
not be disposed as unsorted waste and must be
collected separately. Please contact your local
Authority or distributor of the manufacturer for
The CE mark of Conformity indicates this
equipment conforms with the Council Directive
93/42/EEC
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information concerning the decommissioning of your
equipment.
AUTHORIZED REPRESENTATIVE
IN THE EUROPEAN COMMUNITY: This symbol is
accompanied by the name and the address of the
authorized representative in the European
Community.
Type-BF applied part
This symbol is followed by the serial
number of the device.
MANUFACTURER: This symbol is
accompanied by the name and the address of the
manufacturer.
Power On/off.
CAUTION: This Power Switch cannot isolate Mains
Supply completely.
Refer to instruction manual/booklet.
The “Alternating current” symbol indicates
that the equipment is suitable for alternating current
only.
Rx only
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.
This symbol is followed by the manufacturing date of
the device in the formYYYY-MM.
CORRECT: The correct connection of the battery
connector
WRONG: The wrong connection of the battery
connector
Direct current
To indicate on the rating plate that the equipment is
suitable for direct current only; to identify relevant
terminals.
2.4 Patient Environmental Devices
Left side:
1 LAN port
1 VGA port: External monitor
2 USB ports
1 Footswitch port
1 Power in port
Rear panel:
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2 Probe ports
1 USB port
1 Video out port
1 Remote port
Acceptable Devices
The Patient Environmental devices shown above are specified to be suitable for use within the PATIENT
ENVIRONMENT.
CAUTION:
DO NOT connect any probes or accessories 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.
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.
The devices shall be connected to PROTECTIVE EARTH (GROUND).
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 following on-board
image recording devices:
B/W video printer: SONY UP-X898MD
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.
Adapter is considered as a part of ME equipment
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 by the installer. Equipment
modifications and possible resulting malfunctions and electromagnetic interference are the responsibility of the
owner.
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