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M y L a b

–

S A F E T Y A N D S T A N D A R D

3-1

3 - Devices Standards

Medical Device Directive

This system complies with the Medical Device Directive (MDD) 93/42/EEC,

according to which ESAOTE has classified this device as a Class IIa device.

Note for U.S. Customers

U.S. Federal Law restricts these devices to sale, distribution and use

by or on the order of a physician.

Medical Electrical Equipment Standard

As defined in EN60601-1 (IEC Standard 60601-1, Safety of Medical Electrical

Equipment),

MyLab

models are classified as Class I, with applied parts of type B or

BF (probes), and of Type CF (ECG).

These devices also comply with the EN 60601-2-37 (IEC 60601-2-37) “Particular

requirements for the safety of ultrasonic medical diagnostic and monitoring

equipment”.

Electromagnetic Compatibility

Each

MyLab

model complies with the EN60601-1-2 (Electromagnetic

Compatibility). Refer to the

MyLab

“Getting Started” manual for the

electromagnetic emissions classification of the devices and electromagnetic

immunity compliance levels.

Biocompatibility

The probe and electrode material that is in contact with patients, complies with the

applicable requirements of EN ISO 10993-1, according to their intended use. No

negative reactions to these materials have been reported.

Chapter

Содержание MyLab

Страница 1: ...ESAOTE SAFETY AND STANDARDS OPERATOR MANUAL Rev C September 2011 Doc 29B05EN03 ...

Страница 2: ...is chapter describes the situations that could affect the patient safety when an ultrasound system is used Chapter 3 Standards This chapter lists with which standards MyLab complies It also lists with which standards the peripherals connected to the device have to comply In this manual a WARNING pertains to possible injury to a patient and or the operator A CAUTION describes the precautions which ...

Страница 3: ...g with Video Display 1 5 Safety Symbols 1 5 2 Patient Safety 2 1 Electrical Safety 2 1 Electromagnetic Compatibility 2 2 Biocompatibility and Infection Control 2 2 Ultrasound Safety 2 3 Glossary and Definition of Terms 2 12 3 Devices Standards 3 1 Medical Device Directive 3 1 Medical Electrical Equipment Standard 3 1 Electromagnetic Compatibility 3 1 Biocompatibility 3 1 Standards Summary Table 3 ...

Страница 4: ......

Страница 5: ...evice Electrical Safety The equipment label placed on the rear panel specifies the device electrical requirements Incorrect connections to the main power may compromise the electrical safety of the system Warnings Electrical shock hazard Do not remove the system or the monitor cover Refer servicing and internal adjustments to qualified ESAOTE personnel only Always turn the equipment off before cle...

Страница 6: ...ight could require assistance during transportation The MyLab Getting Started manual details the weight and dimensions of your configuration MyLab products can be classified as portable and mobile Portable means that the system is equipped with a handle whose size and weight allow it to be used to carry the system The term portable is always used with this meaning in these manuals A mobile model o...

Страница 7: ...o the system and place the transducers in their cases a portable model should be packed in the original shipment case or other protective devices as available through ESAOTE during transportation for mobile systems make sure the cart wheels are blocked and the cart secured during transportation Explosive Hazard The equipment is not suitable for use in the presence of a flammable anesthetic mixture...

Страница 8: ...ndocavity and transesophageal transducers require specific cleaning and disinfecting procedures See the Transducers and Consumables manual for complete details on these procedures Repetitive Strain Injury Musculoskeletal disorders have been reported by the clinical literature1 as a result of repetitive scanning These musculoskeletal disorders are also described by the term Repetitive Strain Injury...

Страница 9: ...ter a long scanning session Safety Symbols The MyLab device uses the EN60601 1 safety symbols for medical electronic devices to classify a connection or to warn of any potential hazards On power Off power Type CF applied part suitable for cardiac application Type B applied part Type BF applied part Equipotentiality High Voltage This symbol generically means Attention Read carefully the appropriate...

Страница 10: ...M y L a b S A F E T Y A N D S T A N D A R D 1 6 ...

Страница 11: ... to install such devices Incorrect connections or use of peripherals with improper safety characteristics may compromise the electrical safety of the system MyLab models are not watertight and provides a class IP X 0 degree of protection to liquids do not expose the system to rain or moisture Avoid placing liquid containers on the system Remove probes and electrocardiography leads from patient con...

Страница 12: ...d manual may result in increased emission or decreased immunity of the system If an ultrasound system causes interference This can be identified by turning the system off and on with other devices the user could try to solve the problem by relocating the system increasing the separation from other devices powering the ultrasound system from an outlet different from the one of the interfering devic...

Страница 13: ...irements and recommendations established by the USA Food and Drug Administration and by the American Institute of Medicine and Biology MyLab is equipped with the Acoustic Output Display feature to provide the user with real time on line information on the actual power of the system The following sections describe the rationale of this methodology ESAOTE recommends the use of the ALARA principle se...

Страница 14: ...ration growth vibration and possible collapse of microbubbles within the tissue The occurrence of cavitation depends on a number of factors such as the ultrasonic pressure and frequency the ultrasonic field focused or unfocused pulsed or continuous the nature and state of the tissue and boundaries Mechanical bioeffects are a threshold phenomenon occurring only when a certain level of output is exc...

Страница 15: ...tor decides how much acoustic output to apply for obtaining diagnostically useful information for the patient the thermal and mechanical indices real time display is intended to provide information to the system operator throughout the examination so that exposure of the patient to ultrasound can be reasonably minimized while maximizing diagnostic information For systems with an output display the...

Страница 16: ...us after the beam has passed through soft tissue As with the Mechanical Index the thermal indices are relative indicator of temperature rise a higher value represents a higher temperature rise they indicate that the possibility for an increase in temperature exists and they provide a relative magnitude that can be used to implement ALARA Acoustic Output Display The acoustic output indices are disp...

Страница 17: ...play of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment publication Many of the assumptions used for measurements and calculation are conservative in nature The measured water tank values are derated using the conservative attenuation coefficient established by the standard 0 3 dB cm MHz Over estimation of actual in situ exposures is thus part of the calculation p...

Страница 18: ...ich directly affect the intensity direct controls 2 controls which indirectly affect the intensity indirect controls 3 controls which do not affect the intensity such as the gains and the processing curves Controls Which Directly Affect the Intensity This category includes two system controls the application selection which establishes the appropriate range of intensities see maximum output sectio...

Страница 19: ...ayed with 2D and the 2D is updated the system may show the latter mode MI and TI if available if higher The MI is primarily dependent on 2D settings i e the depth which will determine the 2D and color PRF and the transmit focal point The MI may also be increased by a decrease in the color PRF The TI may be increased by increasing the color CFM Increasing the color frame rate may increase the TI wh...

Страница 20: ... the system capabilities to preset the MyLab system to default each mode according to your needs or specific applications this will reduce the need for real time interactions and help to obtain useful images quickly thus reducing ultrasound exposure Start scanning with a low output level and optimize the focusing the gains and all other system adjustments if this is not adequate for diagnostic pur...

Страница 21: ...a conservative estimate of the actual temperature rise In PW Doppler the latter value is the primary parameter to consider for second or third trimesters pregnancies while the TIS is a more reliable indicator for earlier exams The general guidelines already expressed for the previous exams remain valid For Neonatal Head studies the MI and the TIB may be significant in imaging and CFM modes while t...

Страница 22: ...exp 0 23 a f z Id is the estimated in situ intensity at the tissue site Iw is the intensity measured in water at a distance z measured in cm a is the attenuation coefficient7 expressed in dB cm MHz f acoustic frequency in MHz of the ultrasound beam DefinitionofTerms The acoustic intensity generated by an ultrasound probe is usually described as follows The Spatial Peak Time Average Intensity is an...

Страница 23: ...ture by 1 C estimated on thermal models The peak rarefactional pressure pr in MPa is the temporal peak rarefactional pressure amplitude at a specified point The Pulse Intensity Integral PII is the time integral of instantaneous velocity for any specific point and for any specific pulse integrated over the time in which the envelope of acoustic pressure or the envelope of hydrophone signal for the ...

Страница 24: ...pth of ISPTAB 3 Bone at Surface TIC eq D W 40 0 Mechanical Index MI p z f r sp c 3 where pr 3 zsp is the peak rarefactional pressure in MPa derated by 0 3 dBcm 1MHz 1 to the point on the beam axis zsp where pulse intensity integral PII 3 is maximum and fc is the center frequency in MHz 8 The scanned mode or autoscanning is the electronic or mechanical steering of successive ultrasonic pulses or se...

Страница 25: ... power at source W01 mW Time average acoustic power at the source emitted from the central centimeter of the active aperture W 3 z mW Time average acoustic power derated to depth z X W mW cm Acoustic power per unit linear length for example of a linear array z cm Depth from the surface along the beam axis zbp cm Break point depth minimum depth for intensity measurements in the TIS unscanned models...

Страница 26: ...M y L a b S A F E T Y A N D S T A N D A R D 2 16 ...

Страница 27: ... applied parts of type B or BF probes and of Type CF ECG These devices also comply with the EN 60601 2 37 IEC 60601 2 37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment Electromagnetic Compatibility Each MyLab model complies with the EN60601 1 2 Electromagnetic Compatibility Refer to the MyLab Getting Started manual for the electromagnetic emissions...

Страница 28: ...ermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Acoustic Output MyLab acoustic output complies with the requirements of FDA Track 3 guidance Peripherals Standard Requirements When peripherals are connected to an ultrasound system they become part of a medical system Therefore they must comply with the below mentioned standards to maintain the overall system conformi...

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