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17

ELITE - Electromagnetic Compatibility (EMC) Information

Portable and mobile RF communictions equipment can affect the ELITE. Install 
and operate the ELITE according to the EMC information presented on this page 
and the next 4 pages.

The ELITE has been tested for EMC emissions and immunity as a standalone 
instrument. Do not use the ELITE adjacent to or stacked with other electronic 
equipment. If adjacent or stacked use is necessary, the user should verify normal 
operation in the configuration.

Guidance and manufacturer’s declaration - electromagnetic emissions

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

Emissions Test

Compliance

Electromagnetic environment - guidance

RF emissions 

CISPR 11

Group 1

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

RF emissions 

CISPR 11

Class B

The ELITE 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.

Harmonic emissions 

IEC 61000-3-2

Not applicable

Voltage fluctuations / 
flicker emissions

IEC 61000-3-3

Complies

Summary of Contents for Nicolet Elite

Page 1: ...NicoletElite User s Manual ...

Page 2: ...2 ...

Page 3: ...he order of a physician VIASYS Healthcare strives for continuous improvement Please contact us if you havecommentsorsuggestionsforimprovementsregardingourproductsorservices The 0344 Mark identifies compliance with the Medical Device Directive 93 42 EEC VIASYS Healthcare Inc P O Box 44994 Madison WI 53744 Phone 608 441 2266 Toll Free 800 525 2519 Fax 608 441 2232 Email Vascular Info viasyshc com ww...

Page 4: ...4 Blank page ...

Page 5: ...his manual for the equipment warranty Caution The 5 MHz and 8MHz vascular probes are not intended for fetal use Warning This product is not intended for use on or around the eyes This product is not intended for use on non intact skin LIMITATIONS The theory of Doppler ultrasound is beyond the scope of this manual but is covered in many recent publications The Elite is designed to be reliable but a...

Page 6: ...on Recharge Indicator Elite 100R 200R The green light turns on to indicate that the unit is recharging HeartRate LowBatteryIndicator Elite 200 200R Thedigitaldisplayshowsheartrate Thedisplay flashes when batteries are low Probe Connector Disconnect the probe by holding the probe in one hand graspingtheconnectoratthebottomoftheprobeintheother hand firmly depressing the clear tab on the connector an...

Page 7: ...er recharger unit plugs into main unitforrechargingrechargeablebatteries The unit will not operate while the recharger is pluggedin Battery Replacement Toreplaceabattery removethebatterycompartment door and remove the old battery Carefully install the new battery with the connector end as shown on the label Replace the battery compartment door Warning USE ONLY RECHARGER AND RECHARGEABLE BATTERIES ...

Page 8: ...seaslowanultrasoundpoweraspractical Thelevel of ultrasound power emitted by the Elite is not adjustable Prudent use on the operator s part would include minimizing the length of time that the patient is undergoing the ultrasound exposure CONTRAINDICATIONS The Elite is not for invasive use not for use near or on non intact skin and not for use near the eyes The Elite 5 MHz and 8 MHz probes are not ...

Page 9: ...into the recharger jack Verify that the Recharge LED lights up Let the unit recharge for a minimum of 14 hours to fully charge the battery Obstetrical Exams Doppler ultrasound in an obstetrical application is used primarily to reassure the mother of the presence of fetal viability In some patients the fetal heart can be heard as early as 8 to 12 weeks It should be audible 95 of the time in 12 week...

Page 10: ...difficult to find the fetal heartbeat during the first trimester and this by itself is not a cause for alarm A full bladder may make finding the heartbeat a little easier The fetal heartbeat sounds like a galloping horse and is about twice the speed of the mother s heart rate The heart rate will be displayed on units with an LCD display The placental blood flow sounds more like a whirlwind NOTE Th...

Page 11: ...and probe no angling of the probe is necessary When using the 8 MHz probe use an approximate 45 angle for optimum results Arterial sounds pulsate with every heartbeat and venous sounds are spontaneous with respiration The sound a vein produces is similar to that of a windstorm Heart rate will be calculated and displayed on units with an LCD display These characteristic sounds are easily heard and ...

Page 12: ...e the probe and to avoid unwanted motion and noise Maintain probe contact It is important to keep the entire probe face in contact with the skin surface Holding the probe in this manner allows you to obtain the best possible sounds Angling The 2 MHz 3 MHz and 5 MHz probes are designed to achieve optimum results without angling lay the probe face down against the skin The 8 MHz probe requires an ap...

Page 13: ...f disinfecting agents since they may contain alcohol or organic solvents The probe should then be wiped with a nonabrasive cloth moistened with water Clean dry probes should be packaged in clean bags covered trays or other suitable systems for storage and transport The probe assembly should be examined on a daily basis and inspected for cracks which allow the ingress of the conductive fluid The pr...

Page 14: ...rature 10 to 32 degrees C 50 to 90 degrees F Speaker 2 25 8 Ohms Audio Output 1 4 watt typical Headphones 8 Ohms mono 3 5mm Frequency Response 3dB 360 Hz and 1 2 K for Elite 100 Series 3dB 391 Hz and 1 2 K for Elite 200 Series Safety Standards IEC 601 1 and IEC601 1 2 if applicable and only when using the appropriate recharger IEC 60601 2 37 Classification Internally Powered Equipment Type B Displ...

Page 15: ...orting Table Transducer Model Elite 2MHz Operating Mode Continuous Wave cw Application s Continuous Fetal Heart Monitoring 031 42 6 043 043 13 6 13 6 2 0 2 0 2 0 1 62 1 62 1 62 0 8 0 8 0 4 0 4 0 79 1 58 028 55 4 055 116 20 0 20 0 3 04 3 04 3 04 0 9 0 9 0 9 1 01 1 01 0 85 0 85 1 02 1 40 Acoustic Output Reporting Table Transducer Model Elite 3MHz Operating Mode Continuous Wave cw Application s Conti...

Page 16: ... parameter is measured centimeters x 6 y 6 The 6dB beam dimensions in the x y plane where zsp is found centimeters EBD the entrance beam dimensions centimeters These dimensions are the same as the dimensions of the transmit crystal Operating Conditions There are no user controls which affect the ultrasound output Measurement Uncertainties Power 29 42 Pressure 17 23 Intensity 18 29 Frequency 1 1 Ad...

Page 17: ...E is intended for use in the electomagnetic environment specified below The customer or the user of the ELITE should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The ELITE uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in ...

Page 18: ...aration distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 80 MHz to 800 MHz d 1 17 800 MHz to 2 5 GHz d 2 23 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the f...

Page 19: ...ferential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 c...

Page 20: ...termined by an electromagnetic site survey a on the next page should be less than the compliance level in each frequency range b on the next page Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp...

Page 21: ... too young Wait a few weeks before trying the All Models test again b Use plenty of coupling gel c Try turning up the volume Weak or no blood flow signal detected a Use plenty of coupling gel All Models b Try turning up the volume c If using 8MHz vascular probe adjust angle of probe to optimize signal No fetal heart rate displayed with audible tones a Fetal heart rate is outside of display range E...

Page 22: ...flow sounds Reposition the probe Inaccurate fetal heart rate display a Thedetectedsignalismaternalormaternalmixedwithfetalsounds A Elite 200 200R maternal sound usually one half of the fetal sound may produce harmonics which are in the fetal range Reposition the probe to detect only fetal sounds b Excessive static Some probe movement patterns may cause erroneous heart rate displays Refer to the ab...

Page 23: ...number For service outside of the United States please contact the local representative from whom you purchased the unit Warranty It is important that you return the warranty card supplied with your Elite as soon as possible The specific warranty conditions and limitations were sent with your system Your Elite is protected by a limited warranty Accessories Description Catalog Number 2 MHz OB Probe...

Page 24: ...ranty shall not apply to any products repaired or altered by anyone not authorized in writing by VIASYS Healthcare VIASYS makes no warranty of the results to be obtained VIASYS s sole responsibility shall be to replace exchange or repair this product under the terms stated above and does not cover loss or damage from external causes such as but not limited to weather theft or abuse This warranty d...

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