− Type of protection against electric shock: Class I
− Degree of protection against electric shock (when the patient is in physical
contact): Type BF or CF applied part
− Degree of protection against harmful ingress of water: Ordinary equipment
− Degree of safety of application in the presence of a flammable anesthetic
material with air or with oxygen or nitrous oxide: Equipment not suitable for
use in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide.
− Mode of operation: Continuous operation
■
Electromechanical safety standards met
− Medical Electrical Equipment, Part 1: General Requirements for Basic
Safety and Essential Performance IEC 60601-1:2005/A1:2012
− Medical Electrical Equipment, Part 1-2: General Requirements for Basic
Safety and Essential Performance - Collateral Standards: Electromagnetic
Compatibility - Requirements and Tests IEC 60601-1-2:2007
− Medical Electrical Equipment, Part 1-6: General Requirements for Basic
Safety and Essential Performance - Collateral Standards: Usability IEC 60601-1-6:2010
− Medical Electrical Equipment, Part 2-37: Particular Requirements for the
Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic
and Monitoring Equipment IEC 60601-2-37:2007
− Medical Electrical Equipment, Part 1: General Requirements for Safety IEC
60601-1:1988, A1:1991, A2:1995
− Medical Electrical Equipment, Part 1-1: General Requirements for Safety -
Collateral Standards: General Requirements for Medical Electrical Systems
IEC 60601-1-1:2000
− Medical Electrical Equipment, Part 1-2: General Requirements for Safety -
Collateral Standards: Electromagnetic Compatibility - Requirements and
Tests IEC 60601-1-2:2001, A1:2004
− Medical Electrical Equipment, Part 1-4: General Requirements for Safety -
Collateral Standards: Programmable Electrical Medical Systems IEC 60601-1-4:1996, A1:1999
− Medical Electrical Equipment, Part 2-37: Particular Requirements for the
Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic
and Monitoring Equipment IEC 60601-2-37:2001, A1:2004, A2:2005
− Medical Devices - Application of Risk Management ISO 14971:2007
− Medical Electrical Equipment, Part 1: General Requirements for Safety UL
60601-1:2003
− Medical Electrical Equipment - Part 1: General Requirements for Safety
CAN/CSA C22.2 No. 601.1-M90:1990, R2003, R2005
− Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing
ISO 10993-1: 2009
− Standard Means for Reporting the Acoustic Output of Medical Diagnostic
Ultrasonic Equipment IEC 61157:2007
■
Declarations
CSA mark with the indicators “C” and “US” means
that the product is certified for both the U.S. and
Canadian markets, to the applicable U.S. and
Canadian standards.
This is the manufacturer’s declaration of product
compliance with applicable EEC directive (s) and the
European notified body.
This is the manufacturer’s declaration of product
compliance with applicable EEC directive (s).
This is the GMP symbol for Korean Good
Manufacturing Practice quality system regulation.
Precautions for Use
Read this service manual to fam iliarize yourself thoroughly with repair procedures
and important safety information before attempting to service the product.
■ Refer to this service manual when you are servicing the product. Please
familiarize yourself with the safety precautions in 'Chapter 1. Safety' and
'Chapter 4. Maintenance' in particular.
■ This product is an ultrasound diagnosis device and cannot be used for other
purposes.
■ This product may only be serviced by a service engineer of Samsung Medison
or an authorized engineer. Samsung Medison is not responsible for any
problems caused by an unauthorized person servicing the product.
■ The manufacturer is not responsible for any damage to this product caused by
user carelessness and/or neglect.
■ The content of this service manual is subject to change without prior notice.
■ Products that are not manufactured by Samsung Medison are indicated with the
trademarks of their respective owners.
■ The following terms are used to highlight safety precautions that the user must
be aware of:
DANGER
WARNING
CAUTION
NOTE
Describes precautions necessary to prevent user hazards of great
urgency. Ignoring a DANGER warning will risk life-threatening
injury.
Used to indicate the presence of a hazard that can cause serious
personal injury, or substantial property damage.
Indicates the presence of a hazard that can cause equipment
damage.
A piece of information useful for installing, operating and
maintaining a system. Not related to any hazard.
Revision History
The revision history of this manual is as follows:
VERSION DATE REASON FOR CHANGE
v1.00.00 2015.07.07 Initial Release
V2.00.00 2016.09.22 Software upgrade / Parts change
If You Need Assistance
If you need any assistance with the equipment, please contact the Samsung
Medison Customer Service Department or your local vendor.
Table of Contents 1
Table of Contents
Chapter 1. Safety
Purpose of Use ....................................................................................................................... 2
For detailed information on applicat ions and pr es ets, please refer to the
HS70A User Manual.
Restrictions
This product must not be used for ophthalmological applications, or any other use that involves the
ultrasound beam passing through the eye.
CAUTION
For information on the use or clinical application of this product, please
refer to the HS70A User Manual.
Chapter 1 Safety 1 - 3
Safety Information
Please read the following safety information before using this product. This provides explanation
about the ultrasound system, the probes, the recording devices, and any of the optional
equipment.
This product is intended for use by, or by the order of, and under the supervision of, a licensed
physician who is qualified for direct use of medical devices.
Prolonged use of three-dimensional ultrasound (3D, 4D) by an unqualified individual, such as to
produce a commemorative photograph or video of the fetus, may have an adverse effect on the
fetus.
Please use the 3D ultrasound diagnostic imaging system for appropriate purposes only, since
using it for non-diagnostic purposes such as recording videos of the fetus may adversely affect
the fetus.
Safety Symbols
The International Electro Technical Commission (IEC) has established a set of symbols for
medical electronic equipment, which classify a connection or warn of potential hazards. The
classifications and symbols are shown below.
Symbols Description
Warning: The accompanying information must be followed to prevent
serious accidents and/or dama ge to prop ert y.
Caution: The accompanying information helps to prevent minor
accidents and/or damage to property.
Refer to the user manual.
1 - 4 HS70A Service Manual
Symbols Description
Follow the user manual.
Caution: Risk of electric shock
Type BF applied part (Classification based on degree of protection
against electric hazard)
Defibrillation-proof type CF applied part (Classification based on
degree of protection against electric hazard)
Power on/off
Power on
V~
Power off
Product is partially powered on
Power off for part of the product
AC (alternating current) voltage source
Direct current voltage source
Dangerous voltage (Indicates dangerous voltages over 1000V AC or
1500V DC)
Protective earth (ground)
Equipotentiality
Data output port
Symbols Description
Chapter 1 Safety 1 - 5
Data input port
Data input/output port
Input port
Output port
Print remote output
Foot switch port
ECG port
USB port
Network port
IPX 1
IPX 7
IPX 8
Microphone port
Probe port
Dripping-proof device: Protected against vertically falling water
Immersion-proof device: Protected against the effects of temporary
immersion in water
Submersion-proof device: Protected against the effects of continuous
immersion in water
1 - 6 HS70A Service Manual
Symbols Description
Caution: Electrostatic sensitive devices (ESD)
Do not sit on the product.
Do not push the product.
Do not lean against the product.
Be mindful of the space. Do not place a finger, and or any part of your
body in the space.
LABEL
Phrases containing the words ‘warning’ and/or ‘caution’ are displayed on the product’s surface
in order to protect it.
Chapter 1 Safety 1 - 7
Electrical Safety
This equipment is categorized as a Class I device with Type BF or Type CF (ECG) applied parts.
Prevention of Electric Shock
In a hospital environment, dangerous electric current may occur as a result of the potential
difference between a contactable conductive part and connected equipment in treatment rooms.
The solution to the problem is consistent equipotential bonding. Medical equipment is connected
with connecting leads made up of sockets which are angled to the equipotential bonding
network in medical rooms.
[Figure 1.1 Equipotenti al B ond ing]
Additional equipment connected to medical electrical equipment must comply with the pertinent
IEC standards (e.g. IEC 60950/EN 60950 for data processing equipment, IEC 60601-1/EN
60601-1 for medical devices). Furthermore, all components of the product shall comply with the
requirements for medical electrical systems IEC 60601-1-1/EN 606 01-1-1. Any person
connecting additional equipment to the signal input and output ports of medical electrical
equipment must verify that the equipment complies with IEC 60601-1-1/EN 60601-1-1.
1 - 8 HS70A Service Manual
■ Electric shocks may result if this system, including all of its externally
mounted recording and monitoring devices, is not properly grounded.
■ Never open the cover of the product. Hazardously high voltage flows
through the product. All internal adjustments and replacements must
be made by a qualified Samsung Medison Customer Service
Department.
■ Always check the product's casing, cables, cords, and plugs for
damage before using the product. Disconnect and do not use the
power source if the face is cracked, chipped, torn, the housing is
damaged, or if the cable is abraded.
■ Always disconnect the system from the wall outlet prior to cleaning it.
WARNING
■ All patient contact devices, such as probes and ECG leads, must be
removed from the patient prior to the application of a high voltage
defibrillation pulse.
■ The use of flammable anesthetic gas or oxidizing gases (N2O) should
be avoided. Doing so may cause an explosion.
■ Avoid placing the system where it is likely to be difficult to operate, or
disconnect.
■ Do not use HF surgical equipment with the system. Any malfunctions
in the HF surgical equipment may result in burns to the patient.
■ The system must only be connected to a supply mains with protective
earth to avoid risk of electric shock.
CAUTION
Chapter 1 Safety 1 - 9
■ The system has been designed for 100-240VAC; you should select the
input voltage of any connected printer and VCR. Prior to connecting a
peripheral power cord, verify that the voltage indicated on the power
cord matches the voltage rating of the peripheral device.
■ An isolation transformer protects the system from power surges. This
continues to operate when the system is on standby.
■ Do not immerse the cable in liquids. Cables are not waterproof.
■ Make sure that the inside of the system is not exposed to or flooded
with liquids. In such cases, fire, electric shock, injury, or damage to the
product may occur.
■The auxiliary socket outlets installed on this system are rated 100-
240VAC, with a maximum total load of 150VA. Only use these outlets
for supplying power to equipment that is intended to be part of the
ultrasound system. Do not connect additional multiple-socket outlets or
extension cords to the system.
■Do not connect any peripheral devices not listed in this manual to the
auxiliary socket outlets of the system. It may cause an electrical hazard.
■Do not touch SIP/SOP and the patient simultaneously. There is a risk of
electric shock from current leakage.
1 - 10 HS70A Service Manual
ECG-Related Information
■ This product does not support ECG monitoring. Therefore, it will not
recognize incompatible ECG signa ls.
■ Do not use the ECG electrodes of HF surgical equipment. Any
malfunctions in the HF surgical equipment may result in burns to the
WARNING
patient.
■Do not use ECG electrodes during cardiac pacemaker procedures or
other electrical stimulators.
■Do not use ECG leads and electrodes in an operating room.
ESD
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring
phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by
heating or air conditioning. The static shock, or ESD, is a discharge of the electrical energy
buildup from a charged individual to a lesser or uncharged individual or object. An ESD occurs
when an individual with an electrical ener gy build-up comes in to contact with conductive objects
such as metal doorknobs, file cabinets, computer equipment, and even other individuals.
■ The level of electrical energy discharged from a system user or a patient
to an ultrasound system can be significant enough to cause damage to
the system or probes.
■ Always perform the pre-ESD preventive procedures before using
connectors marked with the ESD warning label.
CAUTION
- Apply anti-static spray to carpets or linoleum.
- Use anti-static mats.
- Ground the product to the patient table or bed.
■It is highly recommended that the user be given training on ESD-related
warning symbols and preventive procedures.
Chapter 1 Safety 1 - 11
EMI
This product complies with EMI (Electromagnetic Interference) standards. However, using the
system inside an electromagnetic field can lower the quality of ultrasound images and even
damage the product.
If this occurs often, Samsung Medison suggests a review of the environment in which the
system is being used, to identify possible sources of radiated emissions. These emissions could
be from other electrical devices used within the same room or an adjacent room.
Communication devices, such as cellular phones and pagers, can cause these emissions. The
existence of radios, TVs, or microwave transmission equipment nearby can also cause
interference.
CAUTION
In cases where EMI is c ausing disturbances, it m ay be necessary to relocate
the system.
1 - 12 HS70A Service Manual
EMC
Testing of the EMC (Electromagnetic Compatibility) of this system has been performed
according to the international standard for EMC with medical devices (IEC 60601-1-2). This IEC
standard was adopted in Europe as the Europea n nor m (EN 60601-1-2).
▐ Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions
This product is intended for use in the electromagnetic environment specified below. The
customer or the user of this product should assure that it is used in such an environment.
Emission Test Compliance Electromagnetic environment guidance
The Ultrasound System uses RF energy only for its
RF Emission
CISPR 11
Group 1
internal function. Theref ore, it s RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
RF Emission
CISPR 11
Harmonic Emission
IEC 61000-3-2
FlickerEmission
IEC 61000-3-3
Class A
Class A
Complies
The Ultrasound System is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Chapter 1 Safety 1 - 13
▐Approved Cables, Probes a nd Peripherals for EMC
Cable
Cables connected to this product may affect its emissions.
Refer to the table below for recommended cable types and lengths:
Cable Type Length
VGA Shielded Normal
RS232C Shielded Normal
USB Shielded Normal
LAN(RJ45) Twisted pair Any
S-Video Shielded Normal
Foot Switch Shielded 2.99m
B/W printer Unshielded Coaxial Normal
MIC Unshielded Any
Printer Remote Unshielded Any
Audio R.L Shielded Normal
VHS Shielded Normal
ECG AUX input Shielded < 3m
Parallel Shielded Normal
Probe
The image probe used with this product may affect its emission. The probe listed in
‘Chapter 5. Probes’when used with this product, have been tested to comply with the
group1 Class A emission as required by International Standard CISPR 11.
Peripherals
Peripherals used with this product may affect its emissions.
CAUTION
WARNING
When connecting other customer-supplied accessories to the
system, it is the user’s responsibility to ensure the electromagnetic
compatibility of the system.
The use of cables, probes, and peripherals other than those
specified, may result in increased emissions or decreased immunity
of the Ultrasound System.
1 - 14 HS70A Service Manual
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
IEC 60601 Test
Level
±6KV contact
±8KV air
±2KV
for power supply lines
±1KV
for input/output lines
±1KV differential mode
±2KV common mode
<5% Uт
(>95% dip in Uт)
40% Uт
(60% dip in Uт)
70% Uт
(30% dip in Uт)
<5% Uт
(<95% dip in Uт)
for 0.5 cycles
for 5 cycles
for 25 cycles
for 5 s
Compliance level
±6KV contact
±8KV air
±2KV
for power supply lines
±1KV
for input/output lines
±1KV differential mode
±2KV common mode
<5%Uт for 0.5 cycles
(>95% dip in Uт)
40% Uт
(60% dip in Uт)
70% Uт
(30% dip in Uт)
<5%Uт
(<95% dip in Uт)
for 5 cycles
for 25 cycles
for 5 s
Electromagnetic
environment guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
this product requires
continued operation during
power mains interruptions, it
is recommended that this
product be powered from an
uninterruptible power supply
or a battery.
If the user of
Power frequency
magnetic field
(50/60Hz)
IEC 61000-4-8
Note: Uт is the AC mains voltage, prior to application of the test level.
3A/m 3A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial or hospital
environment.
Chapter 1 Safety 1 - 15
Where
Note 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
Immunity T est
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601 Test
Level
3Vrms
150kHz
~ 80MHz
3V/m
80MHz
~ 2.5GHz
Compliance
level
3V
3V/m
Electromagnetic environment guidance
Portable and mobile RF communications
equipment should be used no clo ser to any
part of the Ultrasound System, including
cables, than the recommended separation
distance. This is calculated using the equation
applicable to the frequency of the transmitter.
Recommended separation di stanc e
80MHz to 800MHz
800MHz to 2.5GHz
P is the transmitter’s maximum output
power rating in watts (W) according to the
transmitter’s manufacturer, and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
b
Note 1) At 80MHz and 800MHz, the higher frequency range applies.
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio, (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be
predicted with accuracy.
electromagnetic site survey should be con sid ered.
To assess the electromagnetic environment due to fixed RF transmitters, an
If the measured field strength, in the loc a tion in
which the Ultrasound System is used, exceeds the applicable RF compliance level above, the
Ultrasound System should be observed to verify normal operation.
If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Ultrasound
System or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
b
IOver the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
1 - 16 HS70A Service Manual
For transmitters rated at a maximum output power not listed above, the recommended separation
in meters (m) can be estimated using the equation applicable to the frequency of the
▐ Recommended Separation Distances between This Product
and RF Communications Equipment
This product is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of this product can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and this product. These distances are
recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
W
0.01
0.1
1
10
100
distance d
transmitter, where p is the maximum output power rating of the transmitter in watts (W), according to
the transmitter’s manufacturer.
NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
Separation distance, according to frequency of transmitter m
150kHz ~ 80MHz
0.12 0.12 0.23
0.38 0.38 0.73
1.2 1.2 2.3
3.8 3.8 7.3
12 12 23
80MHz ~ 800MHz
800MHz ~ 2.5GHz
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