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Chapter 2
Safety Information
The system can be used for continuous operation, but imaging duration for individual patients must not exceed 60 minutes. We recommend, however, that you turn off the system at the end of each workday.
Safety Information
This user guide contains cautions, warnings and other information about what you must do to ensure the safe and proper performance of the ultrasound system and the optional battery charger station (UA1247). You must also follow local government rules and guidelines at all times.
WARNING
Warnings contain information that is important for avoiding personal injury.
Caution:
Cautions contain information and instructions that must be followed to avoid damaging equipment, data, or software.
NOTE:
Notes contain information that you should be aware of.
Safety Symbols and Information on the Equipment
Table 2-1 contains brief explanations of the symbols and information used to label
the equipment. (Some labels in the table may appear on the transducer.)
BK Medical disclaims all responsibility for the operating safety, reliability and performance of the equipment if these symbols and warnings are disregarded in any way.
Symbol Name Description
Caution or Warning Consult accompanying user guides when you encounter this sign on the instrument, to avoid reducing its safety.
Consult instructions for use
Consult user guide or other instructions.
Pushing prohibited Do not use excessive force to push the system.
Excessive force when pushing over uneven surfaces can cause the system to overbalance and tip.
Manufacturer Legal manufacturer.
3D56
UL Classification for
Canada and US
UL requirements are met for special conditions.
Table 2-1. Symbols and information on the equipment.
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Symbol
LI-ION
Name
UL Recognized
Component for
Canada and US
Potential
Equalization
Description
UL recognizes this as part of a UL-approved apparatus.
Ground (earth)
Type BF
Type BF
Type B
Sealing
Standby
Terminal connected to the chassis. Should be connected to corresponding terminals on other equipment to eliminate potential differences.
Additional protective ground (earth).
•
•
BF: Isolated from ground.
Maximum patient leakage current under
Normal condition
≤
100
µ
A
Single-fault condition
≤
500
µ
A
BF, defibrillator-proof
•
•
B: Maximum patient leakage current under
Normal condition
≤
100
µ
A
Single-fault condition
≤
500
µ
A
Dust- and immersion-protected according to EN
60529 [1].
Symbol on ON/Standby button on back of scanner unit – used to turn system on and off.
Not watertight
ESD (electrostatic discharge)
Specified Radio
Equipment
WEEE waste
Plug may not be immersed (unless it is covered with a special watertight plug cover).
Do not touch pins in connectors with this symbol unless you follow ESD precautionary procedures.
(On remote control UA1237.) This equipment conforms to Japanese Radio Law regulations concerning frequency and power.
Within the EU, when you discard the equipment, you must send it to appropriate facilities for recovery and recycling.
Battery waste (On battery UA1225.) Dispose of used batteries properly. When you dispose of the batteries, you must follow national rules. Within the EU, you must send them to appropriate facilities for recovery and recycling.
China ROHS 25 Years
Lifetime
Environmentally Friendly Use Period for ROHS is 25 years.
Battery recycle (On battery UA1225.) Recycle used batteries properly.
Internally Powered (On the battery pack.) The text “Internally powered or
100V~, 60Hz / 100V-230V~, 50 Hz” indicates that the system can also use batteries as a power source.
Table 2-1. Symbols and information on the equipment. (continued)
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CE Marks on Electrical Devices
The European Union has introduced directives requiring b
marks on devices.
Non-medical devices marked with b
comply with relevant directives, for example
EEC Directive 2004/108/EC concerning Electromagnetic Compatibility.
BK Medical devices marked with b
or c
comply with EEC Council Directive
93/42/EEC of 14 June 1993 concerning Medical Devices. b
applies to Class I medical devices. c
applies to Classes Im, IIa, IIb and III. BK Medical defines classes assuming imaging duration for individual patients does not exceed 60 minutes.
General Safety Precautions
The ultrasound system is designed and tested in accordance with EN/IEC 60601-1
(Part 1: General requirements for safety)
(Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment)
. The ultrasound system and the optional battery charger station
(UA1247) comply with requirements for Class 1 (protective earth) and – for systems that include the mobile battery keyboard dock – internally powered devices of
EN/IEC 60601-1. They also comply with UL 60601-1 [4] and CSA C22.2 No.
601.1–M90 [5]. They fulfill the requirements for dust protection (IP20) for ordinary equipment specified in EN 60529 [1].
Caution:
Federal law in North America restricts this device to sale to, or on the order of, a physician.
Physicians only
Proper
Training
WARNING
GS-1
Before you attempt to use BK Medical equipment, you should be trained in ultrasonography or be under the supervision of someone who is trained in ultrasonography. You should also be thoroughly familiar with the safe operation of your ultrasound system: read all the user documentation that accompanies it.
In addition, if your system interacts with other equipment directly or indirectly, you need to be trained in making sure the interactions are both safe and secure.
No further training is required, but BK Medical offers training in how to use the system.
Consult your BK Medical representative for information.
Equipment failure
WARNING
GS-2
•
•
•
•
If at any time the system malfunctions, or the image is severely distorted or degraded, or you suspect in any way that the system is not functioning correctly:
Remove all transducers from contact with the patient.
Turn off the system. Unplug the system from the power source – and for systems that include the mobile battery keyboard dock, remove the batteries from the battery pack
– to make sure it cannot be used until the system has been checked.
Do not try to repair the system yourself.
Contact your BK Medical representative or hospital technician.
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Isolating the system
WARNING
GS-3
The power supply cord connects the equipment to the line voltage. To isolate the equipment, you must unplug the power supply cord from the power source, and for systems that include the mobile battery keyboard dock, remove the batteries from the battery pack. Do this before you try to make any repairs to the system.
Caution:
Do not spill liquids on the equipment.
Spilled liquids
Condensation
•
•
Caution:
Large variations in temperature or humidity may cause water to condense inside the system. If this happens, the system may fail to operate properly. Always let the system come to room temperature before you plug it in.
Wait at least 2 hours after the system has been subjected to major changes in temperature or humidity.
If there is visible evidence of condensation, wait at least 8 hours.
Before you use the equipment, make sure that all the safety requirements described in this chapter have been satisfied.
Mechanical Safety
Mechanical failure or unintended use of ultrasound equipment can result in physical injury to patients or operators.
Mechanical injury
WARNING
MS-1
•
•
Be careful to avoid the following potential sources of injury:
Parts of the body can be pinched by moveable parts of the equipment, such as the control panel.
Tilting the system can cause it to be unstable and injure someone.
Do not lean or sit on the control panel or any other part of the system. The control panel or monitor can break if subjected to heavy weights or impact.
All parts must be stable
WARNING
MS-2
When parts of the equipment can be mounted individually (for example, for use in an operating room) each part must be securely mounted to a stable support so that it does not tip, fall or come loose and injure someone.
Don’t drop the scanner unit
WARNING
MS-3
To avoid personal injury or damage to the system, if you handle the scanner unit by itself, make sure you have a firm grip so that you do not drop it. Note that it may be hot.
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Don’t push too hard
WARNING
MS-4
To avoid injury and equipment damage, do not push the system too hard, especially when you roll the system over an uneven surface. Applying excessive force near the top could cause the system to overbalance and tilt.
Explosion Hazards
Explosion hazards
WARNING
EH-1
The equipment is not designed to be used in potentially explosive environments. It should not be operated in the presence of flammable liquids or gases, or in oxygen-enriched atmospheres.
There is a possible explosion hazard if the equipment is used in the presence of flammable anesthetic. The system should be placed at least 25cm (10 inches) from the patient.
The ultrasound system contains a lithium battery. Never remove or replace this battery.
The lithium battery must not be removed except by a BK Medical service representative.
Electrical Safety
Do not use a power strip
WARNING
ES-1
•
•
Do not plug the equipment into an ordinary power strip. If the ground connection fails, this is dangerous because the total leakage current for all the connected equipment can exceed the limits
specified in EN/IEC 60601-1 [2]
(Part 1: General requirements for safety).
the impedance of the ground connection could exceed the limits specified in EN/IEC
60601-1.
Leakage current
WARNING
ES-2
When the equipment is used with 230V (and you believe the leakage current would be within the UL limit if you were using 120V), power to the equipment must come from an installation or supply unit with a center-tapped, 240V single-phase circuit. This will make sure that chassis leakage current during single fault condition fulfills the requirements specified in UL60601-1 [4] (limit of 300µA). If power is not supplied in the way specified,
the leakage current can be as high as 500µA, the limit specified in EN/IEC 60601-1 [2]
(Part
1: General requirements for safety).
Electrical shock
WARNING
ES-3
You risk electrical shock if you try to get inside the equipment (other than opening a cover to access connectors or batteries described in the user guide). Do not allow anyone but qualified service personnel to service the equipment.
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ESD Training
ESD
The ESD Symbol
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.
•
•
Caution:
Do not touch pins in connectors that have the ESD symbol . Do not connect anything to them unless you follow these ESD (electrostatic discharge) precautionary procedures:
Discharge your body to ground before you touch the pins with your hand or a tool. For example, touch an unpainted metal part of the system cover.
You can use a wrist strap connected to the additional protective ground or potential equalization terminal on the system if that is more convenient.
Interference
The Flex Focus 1202 Ultrasound System and the optional battery charger station
(UA1247) are suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Electrical Noise
Electrical noise
WARNING
EN-1
Electrical noise from nearby devices such as electrosurgical devices – or from devices that can transmit electrical noise to the AC line – may cause disturbances in ultrasound images.
This could increase the risk during diagnostic or interventional procedures.
Electromagnetic Interference
Medical electrical equipment requires special precautions regarding EMC
(electromagnetic compatibility) [6]. You must follow the instructions in this chapter
when you install the system and put it into service.
If the image is distorted, it may be necessary to position the system further from sources of electromagnetic interference or to install magnetic shielding.
Other equipment nearby
WARNING
EMC-1
Do not use this equipment adjacent to other equipment. If you must place it next to or stacked with other equipment, verify that it operates normally there and neither causes nor is affected by electromagnetic interference.
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EMC noise can reduce the usable image depth. Therefore, to avoid having to repeat an ultrasound examination, you must make sure beforehand that the ultrasound system can be used for the examination. Repeating an examination can be regarded as a potential risk that should be avoided, especially if the examination involves transducers used intracorporeally or transducers used for puncture.
RF (Radio Frequency) Interference
Portable and mobile RF (radio frequency) communication equipment can affect the system, but the system will remain safe and meet essential performance requirements.
An ultrasound system intentionally receives RF electromagnetic energy for the purpose of its operation. The transducers are very sensitive to frequencies within their signal frequency range (0.3MHz to 80MHz). Therefore RF equipment operating in this frequency range can affect the ultrasound image. However, if disturbances occur, they will appear as white lines in the ultrasound picture and cannot be confused with physiological signals.
Possible interference sources
Caution:
Other equipment may interfere with the system, even if that other equipment complies with CISPR (International Special Committee on Radio Interference) emission requirements.
Use specified equipment only
Caution:
If you use accessories, transducers or cables with the system, other than those specified, increased emission or decreased immunity of the system may result.
Installation
Installation safety requirement
WARNING
I-1
•
•
•
•
•
To ensure safe performance, a qualified electrician or hospital safety personnel must verify that the equipment is correctly installed and that it complies with the following safety requirements:
Use only the original power supply cord. In the USA, this is fitted with a hospital grade three-prong grounded power plug. Never try to remove or change the plug on the power supply cord.
All equipment must only be connected to a grounded AC power supply (or wall outlet) that meets EN/IEC/NEC requirements or applicable local regulations. The examination room’s grounding system should be checked regularly by a qualified electrician or hospital safety personnel.
Never use extension cords. The increased length of the cord will increase the resistance of the protective ground conductor and may increase the equipment’s leakage current beyond an acceptable level.
Keep power cords, sockets and plugs clean and dry at all times.
Make sure that the power supply cord cannot be accidentally disconnected from the power source or the equipment.
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Original power cords
If the original power cords are missing or damaged, you must order new ones from your local BK Medical representative.
Additional Protective Ground and Potential Equalization
An additional protective ground can be connected to the terminal underneath the control panel, see Fig 2-1.
The potential equalization terminal underneath the control panel is connected to the system chassis. It can be connected to corresponding terminals on other equipment to eliminate potential differences. Do NOT use it for additional protective grounding.
Figure 2-1. The terminals for potential equalization and additional protective ground are underneath the control panel.
Connecting Other Equipment
For connection to other equipment, BK Medical systems have a communication protocol on top of TCP/IP
Connection guidelines
WARNING
C-1
Follow the guidelines in EN60601-1-1[7]
(Safety requirements for medical electrical systems)
when you connect the system to other equipment.
Network Connection
BK Medical’s range of ultrasound systems comply with the DICOM standard for handling, storing, printing and transmitting information in medical imaging.
DICOM includes a file format definition and a network communication protocol which facilitates the exchange of data between electronic medical systems.
For detailed information about:
•
network requirements
•
network configuration
•
workflow between devices
•
technical specifications
•
safety specifications
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see BK Medical’s DICOM conformance statement at http://www.bkmed.com/DICOM_en.htm
Network Security
Network guidelines
It is the responsibility of the on-site personnel or technician to maintain the ITnetwork and identify, analyze, evaluate and control new risks caused by a change in the network configuration.
If the applicable network connection does not meet the required characteristics of the
IT-network, the following hazardous situations may occur:
•
Corrupt patient data due to network errors, see Warning Exam-3 on page 27
•
System is unable to use the network due to faulty or overloaded network, see
•
System overloads the network causing other equipment to fail.
NOTE:
If your system interacts with other equipment directly or indirectly you must ensure that your network is properly dimensioned and that critical equipment is placed on a separate network. Otherwise you could risk overloading the network and your equipment failing.
Network Printing
For printing on network printers, BK Medical supports protocols PCL 5, PCL 6 and
PS (Post Script).
Connectors
PC connectors for connecting the system to other equipment such as approved printers and video equipment are located in the neck of the system. To access them, unscrew the screw on the bottom of the neck and remove the connector cover. See
Connector cover
Unscrew here to remove connector cover
Figure 2-2. Flex Focus connector cover.
Some connectors are used by the system. Do not use connectors that are not labelled
in Fig 2-3. For systems with a battery pack, the external power is plugged directly
into the battery pack on the system stand. The system is then connected to the power source through a connection from the battery pack to the 12 V plug in the neck (see
“Systems with battery pack” in Fig 2-3). Systems with a battery pack are delivered
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with a power cord in the neck; this is an auxiliary power source for an approved printer. When there is no printer on the system, the plug on the auxiliary power cord is stored in the empty space next to the 12 V outlet in the neck.
More information about the connectors is in Table 2-2. Information about the cables
DVI-I
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Systems
without
Power supply cord goes here
battery pack
Auxiliary power outlet - for approved printers only
Systems
with
battery pack
For systems without printer, auxiliary power cord plug
(for approved printers only) is placed here for future use
12 V from battery pack goes in to power the system here
Ground connector
Push tab to release fuses. Click new ones in place
Figure 2-3. Connectors in the neck of the Flex Focus system.
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Symbol
DVI-I
Connector
DVI-I
Composite/S-video In
Composite/S-video Out
Additional Information
Connector for auxiliary DVI or VGA monitor.
7-pin S-video connector (see Table 2-3 for
pin layout) that can be adapted to a
composite video input (see Table 2-4).
7-pin S-video connector (see Table 2-3 for
pin layout) that can be adapted to a composite video output
Audio In
Audio Out
4 USB 2.0 connectors, A-type 500mA current limit on each.
FireWire
TM
Not currently supported. For future use.
10/100/1000 Ethernet LAN: 10/100/1000 LAN connector, RJ45.
Table 2-2. Connectors in the neck of the Flex Focus system.
S-Video connector pin layout
7-pin S-video MINI-DIN Female
Table 2-3. S-video connector pin layout.
6
7
4
5
2
3
Pin Name
1 Y-GND
C-GND
Y
C
CVBS
Description
Luminance Ground
Chrominance Ground
Luminance
Chrominance
Composite Video
CVBS-GND Composite Video Ground
N.C.
No connection
DVI gives best image quality
Video Output
Although 4 different video output signal formats are available, the image quality is not the same for all of them.
To get the best image quality possible, connect your monitor or other video equipment using the output signal that gives the highest quality image. See the list below.
Output signal types (in order of quality, with digital DVI highest)
1
DVI - digital output that gives the best image quality.
2
VGA – this analog output from the DVI connector gives slightly poorer image quality than the digital DVI output.
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3
S-video – analog output
4
Composite – signal with the most loss of information
If you must use a cable that does not have a DVI connector, you may need to use an
adapter. Table 2-4 shows you which adapters can be used.
Cable Connectors
(in order of preference)
DVI-D
Adapter Flex Focus Connector
Not needed.
DVI-I
15-pin (VGA) DVI to VGA adapter (2 views)
DVI-I
4-pins (S-video)
Not needed
BNC (Composite) 7-pin S-video to Composite +
BNC (female) to Phone (male)
+
Phono RCA (Composite) 7-pin S-video to Composite
2 connectors
(S-video and composite)
(same view on both connectors)
7-pin S-video to
S-video/Composite
Table 2-4. Video connectors and adapters.
HistoScanning
1
The scanner units to be used with HistoScanning™ systems from AMD have an extra connector on the back of the monitor, in the upper left corner. It is used to take raw data, before it has been converted to an image on the monitor, out of the system
.
To use the Flex Focus for HistoScanning, you must have a HistoScanning license installed.
1. HistoScanning has not been market cleared by the FDA or licensed by Health Canada.
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Pull firmly to open, so you can attach the connecting cable
Figure 2-4. Connector for HistoScanning.
A cable (AO1385) is supplied to use with this connector.
Using the System with a Lithotriptor
Special considerations apply if you are using a lithotriptor with the system.
•
The lithotriptor must comply with the guidelines in EN 60601–1–1 [7]
(Safety requirements for medical electrical systems).
•
You must have a license installed to use a lithotriptor with the system.
•
You must always follow instructions in the manufacturer’s user guide for the lithotriptor.
WARNING
LT-1
To avoid an inaccurate location of the crosshair cursor due to misalignment of recorded image and graphics, ensure the coordinate systems are synchronized.
Power Connections
Do
NOT
connect a lithotriptor to the auxiliary power outlet. Plug the system and the lithotriptor directly into independent wall power outlets.
Connecting the System to the Lithotriptor
Connect the lithotriptor to a USB connector on the system. If necessary, use a USB
RS-232 adapter cable.
Follow the connection instructions in the manufacturer’s user guide for the lithotriptor system. The connections must follow the guidelines given in EN 60601–
1–1 [7]
(Safety requirements for medical electrical systems)
.
EMC Requirements
To fulfill EMC requirements, cables attached to the system must be shielded and no longer than 5 m.
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Connector name
DVI-I
S-video/composite In
S-video/composite Out
Audio In
Audio Out
USB 1
USB 2
USB 3
USB 4
FW400
10/100/1000 Ethernet
HistoScanning/Research
Interface
Cable type
Dual link
S-video
S-video
Stereo, 3.5 mm jack
Stereo, 3.5 mm jack
USB, 2.0
USB, 2.0
USB, 2.0
USB, 2.0
FireWire
Network, CAT6E
MDR-26
Type and length
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 5 m
Shielded, 3 m
Table 2-5. List of cables used in testing for EMC compliance
Do not attach transducers and other accessories unless the user guide for the transducer or accessory states that it can be used with this system. Attaching other equipment may cause an increase in electromagnetic emissions or may cause the system to be more sensitive to electromagnetic interference.
Isolation of DICOM Network
The system must not be galvanically connected to a computer network (DICOM
®
) that has not been isolated. If the network is not isolated, the system must be connected via a network isolator DP0925.
Wireless Network (Wi-Fi)
1
The system can be connected to a wireless network for printing and archiving data.
This requires the optional wireless license for the system, and a Wi-Fi adapter that is supplied by BK Medical when you buy this option. The Wi-Fi adapter is inserted into
one of the USB connectors located in the neck of the system (see Fig 2-3 on page 16).
Caution:
Do not use a USB extension cable to connect a Wi-Fi adapter to the system. If you do, the wireless network may become unstable due to electromagnetic interference.
For information on how to install a license on the system, see Appendix C in the Flex
Focus 1202 Advanced User Guide (BB1946).
1. Wi-Fi on
flex
Focus
1202 systems has not been licensed by Health Canada.
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Connecting to a Wireless Network
You must establish a secure wireless network at your hospital, clinic or institution, including a password for the network, before you can use the system’s Wi-Fi for printing and archiving.
To use Wi-Fi on the system you need to install a license. When you have installed the license, a Wi-Fi logo is visible on the lower right of the main screen.
Figure 2-5. Position of the Wi-Fi symbol on the screen.
To connect to a wireless network, click the Wi-Fi logo, choose the appropriate network, and type in the password.
Weak vs.
strong signal
No wireless connection
Figure 2-6. Wi-Fi connection window.
You only have to type in a password the first time you connect to a specific network.
When you turn on the system an attempt is made to reconnect to the network that the system was connected to before it was turned off.
The bars in the Wi-Fi logo represents the signal strength. The more lit bars in the logo, the stronger the signal.
When the system is not connected to a wireless network, the Wi-Fi logo has a red ‘X’ over it.
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An advanced Wi-Fi setting option is available on the system using Windows configurations. Always follow the security procedures that have been established for your hospital, clinic or institution, as well as national guidelines. Contact your BK
Medical service representative for more information.
Additional characteristics
Frequency band
Data throughput
Latency
Integrity
Security characteristics
Spectrum management
2.412~2.4835 GHz
Max 150 Mbps
Depends on network setup
Full integrity of archiving operations
Support for WEP, WPA and WPA2 encryption.
Enterprise encryption (802.1x) requires assistance from an authorized BK Medical technician.
None required
When you transmit data over a wireless network, some special considerations apply.
In particular, the network connections must be set up correctly. See Warning GS-1 on page 9.
NOTE:
The system only supports one network at a time.
If the system loses connection with the network while transmitting (for example, because it is moved out of range of the network during a transmission), the pending data is stored temporarily and re-transmitted when the connection is re-established.
For information on saving and printing using the DICOM protocol, see the DICOM chapter in
Flex Focus 1202 Advanced User Guide
(BB1949).
Caution:
The network must be set up correctly so that data is sent to the correct location.
Otherwise data can be lost or accessed by unauthorized people.
Caution:
A safe encrypted protocol for data transmission, approved by the hospital, must be used. This is to prevent unauthorized people from getting access to the data.
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Medical Equipment
Power source
WARNING
ME-1
Follow the guidelines in EN 60601–1–1 [7]
(Safety requirements for medical electrical systems)
.
•
Equipment that complies with the requirements of EN/IEC 60601–1 [2]
(Part 1: General requirements for safety)
, UL 60601-1 [4] or CSA C22.2 No. 601.1–M90 [5] can be connected to the system, but one of the following conditions must be fulfilled:
Each piece of equipment is plugged directly into an independent wall power outlet.
•
or
The system and other equipment are plugged into an external common isolation transformer to control the leakage current during a ground connection fault.
If in doubt, contact your local BK Medical representative.
Printers and auxiliary power outlet
ON/Standby button does not turn off outlet
WARNING
ME-2
An approved printer, specified in the Product Data sheet, can be connected to the internal auxiliary power outlet on the system.
Do not use the auxiliary power outlet on the Flex Focus
1202 for any other equipment.
The auxiliary power outlet is still live even when the ON/Standby button on the system is turned off. To remove voltage from this outlet, you must unplug the power supply cord from the power source.
Non-Medical Equipment
WARNING
NME-1
Follow the guidelines in EN 60601–1–1 [7]
(Safety requirements for medical electrical systems)
.
If you connect non-medical equipment (instruments that do not comply with safety requirements for medical equipment, such as a video monitor, video recorder, endoscopic camera control unit or other documentation device), this equipment must be placed outside the patient environment (1.5m from the bed, for example). The equipment must fulfill the relevant EN standard or other applicable national or international standard.
•
One of the following conditions must be fulfilled:
The system and other equipment are plugged into an external common isolation transformer to control the leakage current during a ground connection fault.
•
or
The system is grounded with an additional safety ground connection (see “Additional
Protective Ground and Potential Equalization” on page 14).
If in doubt, contact your local BK Medical representative.
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Battery Support System
If you use a battery pack to supply power to the system, be sure to read the battery support chapter of this user guide.
Also observe the following warnings for both the battery pack and the optional battery charger station (UA1247):
WARNING
BS-1
To ensure proper ventilation and avoid overheating, keep both ends of the battery pack
(or optional battery charger station (UA1247)) clear.
WARNING
BS-2
To prevent damage to the equipment, use only the UA1225 battery set – check the number on the battery set before you insert it into the battery pack or recharge in the optional battery charger station (UA1247).
Battery disposal
WARNING
BS-3
The batteries in the battery pack (or optional battery charger station (UA1247)) may present a risk of fire or chemical burn if mistreated. Do not disassemble, heat above the manufacturer’s maximum temperature limit, or incinerate. Replace battery with the
UA1225 battery set only. Use of another battery may present a risk of fire or explosion.
When you dispose of the batteries, you must follow national rules. Within the EU, you must send them to appropriate facilities for recovery and recycling.
WARNING
BS-4
Dispose of used batteries properly. Keep away from children. Do not disassemble and do not dispose of in fire.
Information Printed on the Battery (UA1225)
The following information, including Warning BS-5 below, is printed on one side of the battery (UA1225).
WARNING
BS-5
Charge only with a SMBUS complaint level 2 or 3 charger. Do not heat above 80°C. Do not open battery, dispose of in fire or short circuit – may ignite, explode, leak or get hot causing personal injury. Replace battery with same part number only. Use of another battery may present a risk of fire or explosion. Keep away from children.
<100Wh Lithium ion rechargeable battery. 0% Hg, 0% Cd, 0%Pb. For optimal performance use BK Medical equipment for charging. Must be recycled or disposed of properly. Recycle facilities may not be available in all areas. Charge before use.
To re-purchase contact your local BK Medical representative. Can be found on www.bkmed.com
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If the System Will Not Start
The batteries supplied for use with the system are called
smart batteries
, which means they have built-in safety features to prevent overloading. If, for unknown reasons, the batteries are overloaded and the safety feature is triggered, you may not be able to start the system, even if it is plugged in to a power source.
To reset the batteries:
1
Unplug the system.
2
Open the door on the battery pack.
3
Pull out all 4 batteries approximately 1 cm so they are no longer connected inside the battery pack.
4
Wait approximately 1 minute.
5
Plug in the system.
6
Make sure that the fan is started.
7
Push all batteries into place and close the battery pack door.
This procedure resets the safety feature and should resolve the issue. If the problem persists (for example, the fan does not start), contact your BK Medical representative.
Touch Screen
NOTE:
This information applies to the Flex Focus 700 (order no. 1202-3) with touch screen.
When using sterile covers available in some hospitals and clinics, make sure only the area with keyboard and screen controls are covered. No cover is necessary on the image area of the touch screen because it is not touch sensitive.
WARNING
TS-1
To avoid misdiagnosis of an image, make sure the touch screen is clean before use.
Touch screen must be clean
Remote Control
If you use a wireless remote control UA1237 with the system, be sure to read the remote control chapter of this user guide.
The remote control uses short wave radio waves to communicate with the system.
WARNING
RC-1
The remote control is active at a distance of at least 10 meters from the system, even if the system is in a different room.
Caution:
The remote control can be disrupted by other equipment operating at the same frequency of 2.5 GHz.
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This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1
This device may not cause harmful interference, and
2
This device must accept any interference received, including interference that may cause undesired operation.
Computer Security
When the Flex Focus is connected to a hospital network, BK Medical does not take any responsibility for computer viruses from the network that may infect the Flex
Focus.
Caution:
You must perform a virus check on any external storage medium (USB device or
DVD) to make sure that it is virus-free before you connect it to the system.
Check external media
Service and Repair
Authorized personnel
WARNING
SR-1
Service and repair of BK Medical electromedical equipment must be carried out only by the manufacturer or its authorized representatives. BK Medical reserves the right to disclaim all responsibility, including but not limited to responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties.
After service or repairs have been carried out, a qualified electrician or hospital technician should verify the safety of all equipment.
Transducers
Electrical shock
WARNING
T-1
The transducer sockets contain terminals with 5V. Do not touch the patient while you are touching an uncovered socket.
Type B transducers
WARNING
T-2
When using Type B (non-isolated) transducers, carefully check all electrical equipment within the patient area. Also, consider using additional protective grounding.
Electrical burns
WARNING
T-3
Do not leave transducers in contact with the patient when using HF electrosurgical equipment.
BK Medical transducers fulfill EMC requirements when they are outside as well as inside the patient’s body.
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Surface temperature on array
Creutzfeldt-
Jakob disease
¨
WARNING
T-4
Do not turn the transducer on and allow it to scan into mid-air without ultrasound gel applied to the surface of the array. Doing so may cause the surface temperature on the array to heat up to 27 °C above room temperature (measured according to EN 60601–2–
Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
)). To avoid this, freeze the image when the transducer is not used for imaging.
¨
WARNING
C-J-1
Do not use a transducer for neurosurgical applications if the patient is suspected of having
Creutzfeldt-Jakob disease. If a neurosurgical transducer has been used on a patient suspected of or diagnosed as being Creutzfeldt-Jakob positive, the transducer must be destroyed, following approved procedures for your hospital.
During an Examination
Checking the Date
Before you start imaging, verify that the date and time displayed on the monitor are correct.
Date
WARNING
Exam-1
An incorrect date or time will make documentation of the image incorrect and may also cause some calculated values to be incorrect.
Patient ID required
WARNING
Exam-2
You must enter a new patient ID before you image a new patient. Otherwise the documentation will not contain the correct patient identification, and you will not be able to capture images and clips. We recommend that you enter the complete name of the patient.
Verify patient ID
WARNING
Exam-3
Verify that the patient name and ID are correct.
Type number displayed must match number on transducer
Verifying the Transducer Type
WARNING
Exam-4
Before you start to image, verify that the type number on the transducer matches the number displayed on the monitor. In case of any inconsistency, stop imaging, turn off the system, and contact your local BK Medical representative.
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Measurements
Pay careful attention when you position cursors to make measurements on a scanned image or on a Doppler curve.
Polygon measuring tool
WARNING
M-1
When you use the polygon measuring tool, if the sides of the polygon intersect (as in forming a curve like a figure eight, for example), the area calculation is incorrect. In this case, the calculated area of the polygon is the area of the bigger loop minus the area of the smaller loop.
Using
Doppler curves
WARNING
M-2
Drawings of Doppler curves, manual and automatic, are meant as tools for positioning cursors so that measurements based on the curves can be calculated automatically. The system has no facilities for checking whether the automatic measurements are reasonable. Curves drawn on very noisy spectra may lead to misplacement of measurement cursors. Make sure that measurement cursors are positioned so that the results are reasonable. If they are not, you must adjust the position of the cursors manually.
Nuchal translucency
Nuchal Translucency
Caution:
You must be adequately trained before you attempt to make nuchal translucency measurements.
VFI – Vector Flow Imaging
Artifacts
WARNING
VFI-1
Before you turn on VFI, check the B-mode image to make sure there are no artifacts visible in the blood vessel. If there are strong artifacts in the B-mode image, the arrows in VFI may be pulled to point in a more axial direction (toward or away from the transducer), especially in low flow situations with correspondingly low PRF. These artifacts will not affect the color mode (CFM) image, so it is important to check in B-mode.
Arrow aliasing
WARNING
VFI-2
Check to make sure the VFI arrows are not aliasing before you activate the assisted
Doppler gate placement. Otherwise, the Doppler gate will not be positioned correctly.
Diameter markers
WARNING
VFI-3
Check to make sure that the diameter markers correspond to the inner vessel wall and that the connecting line between the markers is perpendicular to the direction of the vessel.
Otherwise, the real-time volume flow measurement may not be precise.
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Doppler gate large enough
WARNING
VFI-4
Check to make sure that the Doppler gate covers the entire vessel. Otherwise, the realtime volume flow measurement may not be precise.
Doppler gate over only one vessel
WARNING
VFI-5
Check to make sure that the Doppler gate only covers one vessel. Otherwise, the real-time volume flow measurement may not be precise.
Doppler spectrum aliasing
WARNING
VFI-6
Check to make sure that the Doppler spectrum does not alias. Otherwise, the real-time volume flow measurement may not be precise.
Puncture and Brachytherapy
Verify transducer type number
WARNING
P-1
Before you start to image, verify that the type number of the transducer matches the number displayed on the monitor. If they do not match, the puncture line on the monitor may not correspond to the true puncture path in the tissue. In case of any inconsistency, stop imaging, turn off the system, and contact your local BK Medical representative.
Verify puncture guide type number
WARNING
P-2
Verify that the type number of the puncture guide displayed on the monitor corresponds to the puncture guide that you are actually using. If the number is incorrect, the puncture line on the monitor may not correspond to the true puncture path in the tissue.
Watch the needle tip
Offset changes
WARNING
P-4
The puncture line on the image is an indication of the expected needle path. The needle tip echo should be monitored at all times so any deviation from the desired path can be corrected.
NOTE:
If the image depth is set very low (to see tissue close to the transducer with high magnification), the needle tip echo can be outside the displayed image area. To see the needle tip in this case, zoom out so the full needle path is visible or pan the image to the side (to keep the high magnification).
WARNING
P-3
Changes you make to the offset of a programmable puncture guide or brachy matrix will affect ALL programmable puncture guides and brachy matrixes. This could lead to incorrect puncture lines or matrix positions for a different guide than the one you wanted to change.
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Verify matrix type and coordinates
Brachytherapy and Prostate Transperineal Biopsy
WARNING
B-1
Verify that the matrix type and coordinates displayed on the monitor agree with the actual matrix template you are using.
Verify userdefined matrix
WARNING
B-2
If you create a user-defined matrix, it is your responsibility to verify that the matrix that appears on the monitor corresponds to the physical matrix you are using.
Verify matrix alignment
WARNING
B-3
Before you use the matrix for seed implantation or biopsy, check the matrix offset value to verify that it corresponds with the chosen matrix. Then check the matrix alignment. See
Care, Cleaning & Safety
for instructions.
3D
3D measurements
Pay particular care to the following safety issues when operating the 3D system.
WARNING
3D-1
Measurements obtained with the 3D system and used in diagnosis must be carefully and thoughtfully performed to ensure accurate quantitative assessment. Before you perform a calculation, make sure that all necessary calibrations and measurements are made.
If you suspect that the 3D system’s calibration is inaccurate (that is, the measurements are not as expected), contact your local BK Medical service representative to check and confirm the system’s proper operation.
Untracked freehand
WARNING
3D-2
You cannot make accurate measurements on a 3D data set acquired using the untracked freehand method.
If you start to make a measurement on a 3D data set acquired using the untracked freehand method, the following warning appears on the monitor:
Warning on monitor
Symbol Description
Measurement will not be accurate.
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PiP must not cover important information
Picture in Picture
WARNING
PIP-1
When you use Picture in Picture, do not cover critical information (such as TI or MI) on the monitor. Make sure that all important information will appear if you print or save the ultrasound image.
Acoustic Output
General
Medical research has yet to prove whether or not ultrasound causes biological effects. Therefore, prudent use considerations require you to follow certain
guidelines; see EN60601-2-37 [3]
(Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment).
Prudent Use
Exposure level
WARNING
AO-1
Always keep the exposure level (the acoustic output level and the exposure time) as low as possible.
•
Image patients only when clinical reasons make it necessary.
•
Keep exposure time as short as possible.
•
Be careful to prepare the patient correctly so that you get the best possible image.
•
Start imaging at a low acoustic output level (see “Thermal and Mechanical
Indices” on page 32) and increase the level only as much as necessary to obtain
a satisfactory image.
•
If you switch from an application requiring high acoustic output levels (see
“Functions Affecting Acoustic Output” on page 33), to one that requires lower
levels (fetal imaging, for example), be sure to reset the levels before you image.
(For example, start in B-mode.)
•
Take into account all the types of tissue that may be affected. For example, when imaging a breast, it may be appropriate to monitor the TI in bone rather than in soft tissue because the ribs will be subjected to ultrasound.
Appropriate transducer
WARNING
AO-2
Always use the transducer best suited to the examination.
Acoustic output data for transducers used with the system are given in the Technical
Data (BZ2100) that accompanies this user guide. The uncertainty level for each parameter is also listed. For definitions of the parameters, refer to the Food and Drug
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32
Chapter 2
Administration (FDA) Guide [8] as well as EN 60601-2-37 [3]
(Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment)
and AIUM/NEMA standards [9,10].
The routes (or tracks) available for clearance by the FDA are well-defined. Track 3 is for diagnostic ultrasound systems that follow the Output Display Standard [10].
Under Track 3, acoustic output will not be evaluated on an application-specific basis, but the maximum derated Spatial Peak–Temporal Average Intensity (I
SPTA
) must be
≤
720mW/cm
2
, the maximum Mechanical Index (MI) must be
≤
1.9, and the maximum Thermal Index (TI) must be
≤
6. All BK Medical transducers for use with the Flex Focus 1202 Ultrasound System are Track 3.
Monitor Display
The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all imaging modes.
Thermal and Mechanical Indices
The MI and TI indices are intended to allow users to implement the ALARA [11, 12]
(As Low As Reasonably Achievable) principle using an indicator related to a potential bioeffect.
The full details of the indices are given in references EN60601-2-37 [3] and
AIUM/NEMA standard [10], but the formulas are given below.
MI Formula
MI
=
P
( f z sp c
)
-----------------------where the variables are defined in the table below.
Variable Definition
P r0.3
(z sp
) Peak Rarefactional Pressure (MPa), derated by 0.3dB/cm·MHz, measured at z sp the point on the beam axis where pulse intensity integral (PII
0.3
) is maximum
, f c measured center frequency (in MHz)
TI Formula
TI =
W
-------------
W d eg where the variables are defined in the table below.
Variable Definition
W
0
W deg time-averaged acoustic power of the source or other power parameter (W) estimated power necessary to raise the temperature of the target tissue one degree Celsius (W/°C)
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Blood perfusion and
TI
Fever
As a rule of thumb, the Thermal Index (TI) indicates the highest expected temperature increase in degrees Celsius. It is based on an average level of blood perfusion. The displayed TI may underestimate the temperature rise in poorly perfused tissues; you must take this into account when deciding on the maximum TI you will allow. Conversely, in areas with a rich perfusion of blood the temperature increase will be less than the displayed TI indicates.
A temperature increase of one degree Celsius increase in a patient with fever may cause complications in certain circumstances; it may be safer to delay the investigation.
Acoustic Output Measurement
I formula
All values are measured in water according to the EN 60601-2-37 [3] and
AIUM/NEMA display standards [9, 10]. For some of the acoustic parameters, an estimated in situ derated value is given. This is derived assuming a tissue attenuation of 0.3 dB/(cm·MHz) when the estimated in situ derated value (I) is described by the following equation:
I = I w exp
(
–
0,069fz
) where the variables are defined in the table below.
Variable Definition
I
W f z
Intensity in water at the position where I is maximum transducer frequency (in MHz) distance (in cm) from the transducer face to the position where I is maximum
It should be stressed that the in situ values given are only applicable when there is attenuating tissue between the transducer face and the focal point.
Fetal imaging
Possibility of Adverse Effects
Although it is believed that diagnostic ultrasound causes no significant biological
effects in mammalian tissue [3, 10], the user should be aware of the hypothetical
possibilities of adverse effects [11, 13, 14].
Current scientific and clinical concern over possible adverse effects is particularly focused on fetal ultrasound imaging. It is due to the increased sensitivity of mammalian cells and organs at this phase of their development and the fact that such a risk could have profound implications on public health. If you use high acoustic
output levels for some reason (see “Functions Affecting Acoustic Output”, below),
be sure to return to B-mode alone and turn down the power level before you do any fetal imaging.
Functions Affecting Acoustic Output
The system has a control function that ensures that neither the I
SPTA
nor MI nor TI value exceeds the maximum allowable value. When necessary, the system will reduce the output voltage and/or PRF (pulse repetition frequency) to the transducer to comply with requirements.
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Some of the system functions can affect the acoustic output, as listed here.
(Instructions for using these functions are given in the relevant sections of this user guide.)
•
Sizing functions such as ROI (region of interest) – in general, smaller size results in higher acoustic intensity because the pulse repetition frequency (PRF) is higher or the ultrasound beam is more strongly focused.
•
Focus – in general, strongly focusing the beam makes the acoustic intensity higher.
•
Frame rate – higher frame rate results in higher acoustic intensity.
•
Range – increasing the Doppler range increases the acoustic intensity by increasing the PRF.
•
CFM Resolution – higher resolution increases the acoustic output.
•
Color box size – narrowing the color box generally increases the acoustic output within it.
The user can set a Thermal Index limit. This will provide an upper limit for acoustic output.
Default Acoustic Output
Fetal imaging
After the system has been turned off, the transducers will start in the default setup when the system is turned on again. The default setup may be factory-defined or defined by the user.
The factory-defined default setup values of acoustic output for each transducer are listed in the Technical Data (BZ2100).
These setups have been optimized to give the best compromise between low acoustic output and enough power to obtain the image features as quickly as possible. This is part of the ALARA principle. The factory default setup for all transducers is B-Mode to ensure the lowest acoustic output when you start imaging.
When you enter a new patient ID, by default the transducer setup will be reset to the factory setup.
When you use transducers intended for fetal imaging, it is important to make sure that the default settings are appropriate and to reset to the default setting before imaging a new patient.
Clinical Measurements: Ranges and Accuracies
This section states the accuracies for measurements made using the BK Medical range of ultrasound systems. A table containing accuracies for specific transducers can be found in the Technical Data (BZ2100) that accompanies this user guide.
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The measurement accuracies are based on the assumption of “ideal” tissue, that is, a tissue characterized by a sound velocity of 1540 m/s. When making clinical measurements with ultrasound, errors may arise which are not taken into account in this section. For example,
•
The sound velocity may vary from approximately 1450 m/s in fatty tissue to
1585 m/s in muscle. This can, in simple cases, give rise to errors of up to 6% for linear measurements. This inaccuracy may be further increased by refraction occurring at tissue boundaries.
•
The user can introduce errors when using approximate formulas, when positioning the system’s calipers with respect to the ultrasound image and when outlining structures in the image.
•
The ellipsoid volume approximation, described in this user guide, is only applicable when the cross section of the structure being studied approximates an ellipse (the circle being a special ellipse), and when the structure is roughly symmetrical about the selected axis of rotation
NOTE:
The choice of the axis of rotation is important for the calculation of the volume. A vertical axis gives a different volume than a horizontal axis.
The minimum requirement is that the cross section outlined by the user should be convex. If the user draws a non-convex outline, an inaccuracy is introduced which is not taken into account in this section. In this case, the system calculates and displays the convex hull of the figure, that is, the smallest convex figure containing the non-
convex figure outlined by the user (see Fig 2-7). The system bases the calculation of
the ellipsoid volume on the convex hull.
Figure 2-7. The dotted line indicates the convex hull of the non-convex figure.
Measuring volume using a stepping method produces an approximation caused by the finite number of steps in the measurement. The user must always try to assess how large an inaccuracy is introduced by the selected step size, that is, the distance between organ cross sections.
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Geometric Measurements
Volume accuracy
Distance and area accuracy
2D Measurements
The geometric measurements performed by BK Medical ultrasound systems are distance, perimeter, area and ellipsoid volume. The accuracy of these measurements is influenced by the following factors:
•
Transducer geometry
•
Rounding of results
•
Resolution of digital image memory
3D Measurements
The 3D volume is found by summing the marked area in the individual slices and multiplying by a factor that includes the distance between the slices and their relative orientation.
To obtain the accuracies listed in the table in the Technical Data (BZ2100), you must ensure that the calculation is based on contributions from at least 10 slices for very regular shapes and more for irregular shapes. It must also be possible to discriminate the boundary of the object from the surrounding tissue.
The volume accuracy in the table is given as a percentage of the captured 3D volume starting with the first slice and ending with the last slice that intersects the object of interest.
If the 2D ROI (region of interest) is set to be much larger than the object, the accuracy as a percentage of the object volume can be much worse (higher percent).
NOTE:
To ensure that the accuracy of your volume measurement is as high as possible, make sure that the object you are interested in fills the region of interest as much as possible.
The accuracy of a distance measurement on a 3D image will never be better than 6%; the accuracy of an area measurement on a 3D image will never be better than 6%.
In the table in the Technical Data (BZ2100), the overall measurement accuracy for a full range measurement is given in the right-hand column for each measurement. The footnote below the table states the digital image resolution.
Time Measurements
In M-mode and spectral Doppler mode, data is displayed along a time axis. It is possible to measure time differences. The accuracy for a time difference measurement is
•
Rounded to the nearest: 0.01s
•
Accuracy: 0.01 x
t
where
t
is the full time scale of the image field.
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Doppler Measurements
In measuring blood flow velocity it is assumed that the measured power spectral distribution of the Doppler signal equals the blood cell velocity distribution.
The measurement accuracy of blood flow velocity is heavily dependent on the angle
θ
between the ultrasound beam and the velocity vector of the blood cells. The velocity accuracies given in the Technical Data (BZ2100) are valid for
θ
= 55
°
. To find the percentage accuracy for other angles, multiply the stated accuracy by
cos
– cos cos
(
θ
θ
+
1,8
)
×
100
+
0,5
If the blood velocity exceeds the selected velocity range, aliasing occurs, corresponding to an overload condition of the measurement system.
References
[1] EN 60529:1991+A1:2000.
Specification for degrees of protection provided by enclosures
(IP code).
[2] EN/IEC 60601-1:1990+A1:1993+A2:1995+A13:1996
Medical electrical equipment. Part
1: General requirements for safety.
EN/IEC 60601-1:2006 3rd Ed.
Medical electrical equipment. Part 1: General requirements for basic safety and essential performance
.
[3] EN 60601-2-37:2001+A1:2005
+A2:2005 Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
EN 60601-2-37:2008
Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
[4] UL 60601-1:2003
Medical Electrical Equipment – Part 1. General Requirements for Safety.
[5] CSA C22.2 No. 601.1–M90
Medical Electrical Equipment – Part 1. General Requirements for safety.
[6] EN 60601-1-2:2001 + A1:2006
Medical electrical equipment - Part 1-2: General requirements for safety. Collateral standard: Electromagnetic Compatibility-Requirements and tests.
EN 60601-1-2:2007
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic Compatibility-Requirements and tests.
[7] EN 60601–1–1:2001
Medical electrical equipment –Part 1-1: General requirements for safety. Collateral standard: Safety requirements for medical electrical systems.
[8]
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.
FDA Center for Devices and Radiological Health. September 2008.
[9]
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
AIUM/NEMA. 2004.
[10]
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment.
AIUM/NEMA. 2004.
[11]
Medical Ultrasound Safety.
Second edition. AIUM. 2009.
[12]
ALARA Training Program.
Ultrasound III Training. BK Medical. 1993.
[13] Bioeffects considerations for the safety of diagnostic ultrasound.
Journal of Ultrasound in
Medicine
, Vol. 7, No. 9 (supplement). September 1988.
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37
[14]
The safety of diagnostic ultrasound.
The British Institute of Radiology. 1987.
AIUM: American Institute of Ultrasound in Medicine
CSA: Canadian Standards Association
EN: European Standards
FDA: Food and Drug Administration (USA)
IEC: International Electrotechnical Commission
NEC: National Electrical Code
NEMA: National Electrical Manufacturers Association
UL: Underwriters Laboratories Inc., USA
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