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VIASYS Nicolet Elite User Manual Download Page 24

24

LIMITED WARRANTY

This warranty is in lieu of all other warranties, expressed or implied.

In the U.S.A., VIASYS Healthcare warrants this 

Elite

 against defects in materials or

workmanship as follows:

Parts – 

VIASYS Healthcare will repair or replace parts for a period of five (5) years after date

of original purchase with no charge for parts.

*

  VIASYS Healthcare reserves the right to

determine whether a unit should be repaired, replaced or exchanged.

* 

Please note: Waterproof probes carry 1 (one) year parts and 1 (year) labor warranty only.

Labor – 

VIASYS Healthcare will repair, replace or exchange the 

Elite

 

with no labor charge

for a period of one (1) year after date of original shipment when it is shipped to an authorized
service center. Transportation and insurance to the service center are to be prepaid by the
purchaser. This applies to units shipped to the U.S. and Canada only.

Limitations – This product is to be used for the intended and labeled indications
presented in this manual. 

This warranty 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 does not

apply to batteries, shipping case or other accessories, or to damage from shipping,
tampering, misuse or negligence. 

Preventative maintenance, the refinishing or replacement

of any cosmetic defect or deterioration, or the replacement of batteries unless damaged by
a component failure, is not covered by this warranty. VIASYS will not be responsible for any
loss, damage or injury resulting from delay in rendering service under this warranty. VIASYS
HEALTHCARE SHALL NOT BE RESPONSIBLE FOR ANY SECONDARY CHARGES OR
CONSEQUENTIAL DAMAGES FROM ANY BREACH OF ANY WARRANTY, EXPRESSED
OR IMPLIED. Since some states do not allow the exclusion or limitation of consequential
damages, some of this limitation may not apply to you. This warranty gives you specific legal
rights which vary from state to state.

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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