VIASYS Nicolet Elite User manual

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Nicolet Elite

User's Manual

Congratulations on your choice of the

Nicolet Elite

from VIASYS Healthcare

The

Elite

provides the features which have made VIASYS Healthcare a world leader

in Doppler technology: reliability, quality, sensitivity and value.

CAUTION:

physician.

VIASYS Healthcare strives for continuous improvement. Please contact us if you have comments or suggestions for improvements regarding our products or services.

Federal law (USA) restricts this device to use by or on the order of a

0344

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 www.viasyshealthcare.com

European Authorized Representative:

VIASYS Healthcare Welton Road Warwick, CV345PZ U.K.

M7-0775 Rev. I

Blank page.

TABLE OF CONTENTS

Section Page Number

Limitations 5 Product Description 6 Safety of Ultrasound 8 Contraindications 8 Operation 8 Care of the Instrument 8 General Hints 12 Care of the Instrument 13 Product Compatibility 14 Specifications 14 Electromagnetic Compatibility (EMC) 17 Troubleshooting Nicolet Service 23 Accessories 23 Limited Warranty 24

The purpose of this manual is to guide the user in the operation and care of the reasonable effort has been made to present accurate information. VIASYS Healthcare hereby disclaims and makes no warranty with respect to any diagnosis, clinical condition or interpretation made based on the information presented herein. Refer to the Limited Warranty at the end of this manual for the equipment warranty.

Elite

Problems 21

Elite

. Every

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 should be treated with care. While the medical training and knowledge.

NOTE: The Under poor signal conditions, the fetal heart sounds and readings may not be accurate. (Refer to the Troubleshooting section at the end of this manual for a description of sensitivity problems and solutions.) If there is any doubt about the fetal condition after using the Doppler, further investigation should be initiated immediately.

Elite

is designed to be reliable, but as with all medical instruments,

Elite

augments the user’s skills, it is not a substitute for

provides the listener with information about the fetus and vascular conditions.

PRODUCT DESCRIPTION

The

Elite

is a non-invasive hand-held Doppler with a speaker. The

special features that will enhance your product use:

Elite

has the following

On/Off:

Pressing the On/Off button on the front panel of the unit turns on the turned off by again pressing the On/Off button.

On Indicator:

(Elite 100 & 100R)

Green LED “On” indicator for units without display.

Heart Rate/Low Battery Indicator ( 200 & 200R):

The digital display shows heart rate. The display flashes when batteries are low.

Elite

. The

Elite

Recharge Indicator: (Elite 100R & 200R)

The green light turns on to indicate that the unit is recharging .

Headphone Connector:

To use optional headphones, plug connector into the hole on the edge of the unit. Main speaker will not be heard when headphones are plugged in.

Probe Connector:

Disconnect the probe by holding the probe in one hand, grasping the connector at the bottom of the probe in the other hand, firmly depressing the clear tab on the connector, and pulling the connector from the probe.

Warning

THE

Elite

IS NOT EXPLOSION PROOF. DO NOT USE THE PROBES IN THE PRESENCE OF FLAMMABLE OR EXPLOSIVE GASES. DO NOT IMMERSE THE UNIT OR PROBES IN FLUIDS AND DO NOT AUTOCLAVE.

Elite

Probe Face:

Place 2 MHz, 3 MHz or 5 MHz probe flat on skin. There is no need to tip at various angles to detect fetal heartbeat or blood flow in artery or vein.

Probe Face:

8MHz probe requires an approximate 45° angle for optimal results.

CAUTION:

device to use by or on the order of a physician.

CAUTION:

may be connected to a telephone system.

NICOLET VASCULAR a division of VIASYS Healthcare 5225 Verona Rd., Bldg. 2 Madison, WI 53711-4495 1-800-525-2519 USA

Louder

Volume control:

Volume is adjusted by sliding the “Volume” control button on the side of the unit. Slide the button up to make the sound louder. Slide the button down to make the sound quieter.

Federal law restricts this

No part of this equipment

Battery Replacement:

To replace a battery, remove the battery compartment door and remove the old battery. Carefully install the

Recharger (

Elite

100R & 200R):

Transformer/recharger unit plugs into main unit for recharging rechargeable batteries. The unit will not operate while the recharger is plugged in.

new battery with the connector end as shown on the label. Replace the battery compartment door.

Warning

USE ONLY RECHARGER AND RECHARGEABLE BATTERIES AS SPECIFIED BY VIASYS Healthcare. USE OF OTHER BATTERIES MAY CREATE A HAZARDOUS SITUATION AND VOID THE MANUFACTURERS WARRANTY.

THE DOPPLER PROBE SHOULD ONLY BE APPLIED TO A PATIENT DURING THE BATTERY OPERATION. DO NOT APPLY THE DOPPLER PROBE TO A PATIENT WHEN THE UNIT IS PLUGGED INTO THE RECHARGER (ELITE 100R/200R MODELS). THE UNIT DOES NOT OPERATE WHILE CHARGING.

SAFETY OF ULTRASOUND

The American Institute of Ultrasound in Medicine (AIUM) has addressed the concerns relating to the safety of ultrasound and has issued the following statement as of March 1993:

Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the AIUM herein addresses the clinical safety of such use:

"No confirmed biological effects on patients or instrument operators caused by exposure at intensities typical of present diagnostic ultrasound instruments have ever been reported. Although the possibility exists that such biological effects may be identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any, that may be present.”

VIASYS Healthcare's policy is to always use as low an ultrasound power as practical. The level

Elite

of ultrasound power emitted by the would include minimizing the length of time that the patient is undergoing the ultrasound exposure.

is not adjustable. Prudent use on the operator’s part

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 intended for fetal use.

OPERATION

Remove the probe from the main unit by grasping the probe and pulling it straight up and away from the unit. Turn on the unit by pressing the On/Off button. All sections of the liquid crystal display ( 200 and 200R) will illuminate to ensure they are working properly.

1. Make sure the probe cable is connected at both the probe and the main unit.

2. Apply gel to the face of the probe and begin the Doppler examination.

3. Adjust the volume on the main unit as needed, by sliding the slider up to increase the volume or down to decrease the volume.

4. When finished with the exam, turn the unit off by pressing the On/Off button.

5. Refer to cleaning instructions to clean the probe.

Elite

6. To replace the battery, firmly push down on the battery door and slide the door off. Remove the existing battery. To replace with a new battery, align the battery as indicated on the battery door and in the diagram. Replace the battery door by sliding and snapping it in place.

7. To recharge the battery (

Elite

100R & 200R), turn the unit off by pressing the “On/ Off” button. Plug a VIASYS authorized recharger 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.

CAUTION:

Federal law restricts this

device to use by or on the order of a physician.

CAUTION:

No part of this equipment

may be connected to a telephone system.

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Warning

Replace batteries with VIASYS approved types only.

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 pregnancies and nearly 100% after 14 weeks.

The 3 MHz probe is designed to be used early in pregnancy. The 2 MHz waterproof probe is for use later in pregnancy in larger patients, or for use in water labors and/or deliveries.

The exam is most easily done with the patient supine, although it may also be accomplished in a sitting or standing position. Expose the abdomen and apply a generous amount of coupling gel to the face of the probe. It is important to maintain good coupling at all times with no air bubbles between the probe and the abdomen.

If preferred, start the examination using optional earphones for privacy. The key to the examination is to intercept the fetal heart with the beam from the probe. The beam travels in a relatively straight direction much like a flashlight beam.

In the first trimester, the best technique is to start with the probe on the midline of the abdomen and aimed downward behind the pubic bone. The probe should be moved very slowly to search the most likely areas. Because the fetal heart sounds are faint at this time, be careful not to scan too quickly or the sounds may be missed.

It is often 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: The is any doubt about fetal condition after using the Doppler, further investigation must be initiated immediately.

When you have completed the exam, press the On/Off button to turn off the wipe the gel off the face of the probe. Return the probe to the top of the unit for protection.

Elite

provides the listener with information about the fetus; however if there

Elite

. Then

Vascular Exams

A Doppler is very valuable for locating veins for injections or IVs, obtaining difficult to locate systolic blood pressures or listening to flow within a vessel.

Apply a liberal amount of gel to the vascular probe and gently place it on the skin, aligning it with the vessel. It is not necessary to press hard. If preferred, use optional headphones to eliminate the speaker sounds. If using the 5 MHz broadband 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 may be utilized to help distinguish a healthy vessel from a diseased one.

When you have completed the exam, press the On/Off button to turn off the

Elite

. Then

wipe the gel off the face of the probe. Return the probe to the top of the unit for protection.

5 MHz Probe

8 MHz Probe

Coupling Gel

Vessel

GENERAL HINTS

Use plenty of coupling gel. Ultrasound is almost completely stopped by any air or bubbles between the skin and the probe. Use the ultrasound gel liberally for best results.

Move the probe slowly. When searching for the fetal heart, a slow rocking and rotating motion will minimize noise and help avoid missing the heartbeat. Rest your hand on the patient to stabilize 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 approximate 45° angle for optimum results.

Carrying the unit. Always check the probe to make sure it is completely seated in the holding clips. Never presume the probe is lodged tightly.

Care of the Instrument

Main Unit

Keep the instrument clean by wiping it periodically with a damp cloth and mild disinfectant cleaner. DO NOT immerse in fluids or use solvent cleaners.

Doppler Probes Caution: DO NOT USE organic cleaning agents or alcohol. DO NOT immerse the probes

in liquid. Only a probe specified as waterproof shall be immersed in water.

DO NOT drop or knock the probe against a hard surface. DO NOT pull on the transducer cable.

Note: The following steps are recommended for the cleaning and disinfecting of VIASYS probes before each use. The procedure renders clean probes which are neither sterile nor pyrogen free. When carried out according to standard clinical practice, it should help prevent the transfer of infectious agents, through the elimination of significant microbiological contamination between uses.

Regularly clean off the remains of the conductive gel. The probe should be wiped clean with a soft nonabrasive cloth or disposable wipe soaked in an aqueous disinfectant. Avoid aerosol preparations of 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 probe cable and associated connectors should be examined for any damage on a daily basis. DO NOT USE any probe which shows any signs of damage. The user should ensure that all probes are regularly tested for electrical safety.

If sterilization of the probes is desired, it can be done with cold gas sterilization (such as ethylene oxide at less than 140° F), or the Sterrad™ System. The user is responsible for verification of sterility. Follow the manufacturer’s instruction for your model.

Note: Only sterilize the probe with these methods. Do not sterilize the main unit in this manner.

Battery

Remove battery if the temperatures greater than 65°C (149°F).

Transport and Storage

Temperature: -20°C to 60°C Humidity: 15% to 90% (non-condensing) Pressure: 500 hPa to 1060 hPa

Elite

will not be in use for an extended period. Do not expose to

Product Compatibility

The

Elite was not designed to be compatible with other products. VIASYS Healthcare

recommends using only VIASYS approved accessories for use with the Elite.

Warning: No part of the

Elite

is to be connected to a telephone system.

Warning: This equipment is not intended for use with HF surgical equipment.

SPECIFICATIONS

Dimensions: 17cm x 7.5cm x 2.5cm (6.8” x 2.9” x 1.0”) Weight (with one probe): Approximately 0.25 kg (.60 lb.) Doppler Technology: Continuous Wave (CW) Unfocused. Battery Type: 9 volt alkaline or 9 volt rechargeable [IEC #6LR61 or

Operational Temperature: 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

Safety Standards: IEC 601-1 and IEC601-1-2 (if applicable and only when using

Classification: Internally Powered

Display Rate (BPM): 60-119 ± 2 for Vascular Probe

(If applicable) 60-199 ± 2 for OB Probe Recharger: Input: 120 VAC 60 Hz (PN: PS-0019 )

Output: 24VDC @ 65ma The maximum surface temperatures of the ultrasonic transducers when applied to the patient are as follows: 2 MHz: 24.6 degrees C 2 MHz waterproof: 23.5 deg. C 3 MHz: 24.4 deg. C 5 MHz: 27.6 deg. C 8 MHz: 27.7 deg. C

NEMA # 1604A]

Elite

100 Series

-3dB @ 391 Hz and 1.2 K for

the appropriate recharger) IEC 60601-2-37

Equipment, Type B

240VAC 50Hz @ 6VA (PN: PS-0028)

Elite

200 Series

Ultrasound Output:

Acoustic Output Reporting Table

Elite

Transducer Model: Application(s):

Associated f

Acoustic Z

Parameter Beam dimensions x

™ 2MHz Operating Mode: Continuous Wave (cw)

Continuous Fetal Heart Monitoring

Acoustic MI

Output (mW/cm

Global Maximum Value

r.3

EBD Az. (cm)

(MPa)

(mW)

(MHz)

(cm)

-6

(cm)

-6

Ele. (cm)

.031

SPTA.3

) (W/cm2)

42.6

SPPA.3

.043

13.6

2.0 2.0 2.0

1.62 1.62 1.62

0.8

0.4 0.4

0.79

1.58

Transducer Model:

Elite

™ 3MHz Operating Mode: Continuous Wave (cw)

Application(s): Continuous Fetal Heart Monitoring

Acoustic Output Reporting Table

Acoustic MI

Output (mW/cm

Global Maximum Value

-6

(MPa)

(mW)

(MHz)

(cm)

r.3

Associated f

Acoustic Z

Parameter Beam dimensions x

EBD Az. (cm)

Ele. (cm)

Acoustic Output Reporting Table

Transducer Model: Application(s): Peripheral Vascular

Associated f

Acoustic Z

Parameter Beam dimensions x

Elite

™ 5MHz Operating Mode: Continuous Wave (cw)

Acoustic MI

Output (mW/cm

Global Maximum Value

-6

(MPa)

(mW)

(MHz)

(cm)

r.3

EBD Az. (cm)

Ele. (cm)

.028

SPTA.3

) (W/cm2)

55.4

SPPA.3

.055

.116

20.0

3.04 3.04 3.04

0.9 0.9 0.9

1.01

0.85 0.85

1.02

1.40

.029

SPTA.3

) (W/cm2)

114.7

SPPA.3

.114

.068

35.0

5.45 5.45 5.45

0.4 0.4 0.4

1.13

0.34 0.34

0.46

1.24

Transducer Model: Application(s):

Associated f

Acoustic Z

Parameter Beam dimensions x

Elite

™ 8MHz Operating Mode: Continuous Wave (cw)

Peripheral Vascular

Acoustic MI

Output (mW/cm

Global Maximum Value

-6

(MPa)

(mW)

(MHz)

(cm)

(cm) (cm)

r.3

EBD Az. (cm)

Ele. (cm)

.033

.074

7.8 7.8 7.8

0.52

SPTA.3

) (W/cm2)

348

5.2

0.52

0.32

SPPA.3

.348

5.2

0.52

0.32

0.17 0.17

0.20

0.46

When in the presence of audible interference the heart rate display may be inaccurate.

- The derated spatial-peak, temporal-average intensity (milliwatts per square centimeter).

SPTA.3

- The derated spatial-peak, pulse-average intensity (milliwatts per square centimeter).

SPPA.3

MI - The Mechanical Index.

- The peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the value reported under

r.3

Acoustic Output Reporting Table

W f z x-6 & y-6- The -6dB beam dimensions in the x-y plane where z 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.

MI.

The total time-average ultrasonic power (milliwatts).

- The probe center frequency (MHz).

- The axial distance at which the reported parameter is measured (centimeters).

Measurement Uncertainties:

Power: +29%, -42% Pressure: +17%, -23% Intensity: +18%, -29%

is found (centimeters).

Frequency: +1%, -1%

Additional Information for IEC-1157

The output beam intensity I This transducer is intended for direct patient contact.

=48 mW/cm

The probe face has a liquid ingress level of IPX4.

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

RF emissions

CISPR 11

IEC 61000-3-2

Voltage fluctua tions / flicker emissions

IEC 61000-3-3

Group 1 The ELITE uses RF energy only for its internal function.

Class B The ELITE is suitable for use in all establishments other than

Not applicable

Complies

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions

ELITE

Recommended separation distances between portable and mobile RF communications equipment and the ELITE

The ELITE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ELITE can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ELITE as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum output

power of transmitter

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 frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies.

Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people.

Separation distance according to frequency of transmitter

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

ELITE

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

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

Immunity Test IEC 60601 Test

Electrostatic Discharge (ESD)

IEC 61000-4-2

6 kV contact

8 kV air

level

Compliance Electromagnetic

6 kV contact

8 kV air

Environm ent-

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be less than 30%.

Guidance

Electrical fast transient/ burst

IEC61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply lines

IEC 61000-4-11

Power Frequency (50/60 Hz)

IEC 61000-4-8

2 kV for power

+ supply lines

1 kV for input/

+ output lines

1 kV differential

+ mode

2 kV common

+ mode

< 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

3 A/m 3 A/m Power frequency

2 kV for power supply

+ lines

1 kV for input/output

+ lines

1 kV differential mode

2 kV common mode

< 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

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ELITE requires continued operation during power mains interruptions, it is recommended that the ELITE be powered from an Uninterruptable power supply or its battery.

magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

ELITE

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

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

Immunity

test IEC 60601

Conducted RF

IEC 610004-6

Radiated RF

IEC 61000-

4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

test level

Complianc

3 V/m

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the ELITE, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.17

d = 1.17 80 MHz to 800 MHz

d = 2.23 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)

Field Strengthens from fixed RF transmitters, as determined 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 absorption

and reflection from structures, objects and people.

ELITE

(a*) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ELITE is used exceeds the applicable RF compliance level above, the ELITE should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ELITE.

(b*) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Troubleshooting Elite Problems

Problem: Solution:

Unit will not turn on a. Battery is discharged. Replace battery or recharge for (All Models). several hours before use.

b. Unit does not operate while recharging, remove from the

recharger.

Power LED flashes ( Heart rate display flashes (

Main unit recharge light does not come on a. Verify that the wall transformer is plugged in and that the (

Elite 100R, 200R). wall outlet has power.

Main unit is on, but no audio signal is present a. Headphones interrupt the internal speakers, remove the (All Models). headphones.

Static a. Use an ample supply of ultrasonic coupling gel. Hold the (All Models). probe steady once a signal has been detected.

Weak or no fetal signal detected a. Fetus is too young. Wait a few weeks before trying the (All Models). test again.

Weak or no blood flow signal detected a. Use plenty of coupling gel. (All Models). b. Try turning up the volume.

No fetal heart rate displayed with audible tones a. Fetal heart rate is outside of display range.

(

Elite

200, 200R). See Specifications Section.

No vascular heart rate is displayed with a. Heart rate range is outside of display range. audible tones (

Unit shuts off during use. a. The unit shuts off after approximately 3 minutes if not in (

Elite

200, 200R) use. Large signals are used to reset the power-off-timer.

(All Models) b. Battery is low. Replace or recharge.

Inaccurate vascular heart rate a. Certain flow waveforms contain large display ( 200R). harmonics which can cause heart rate doubling.

Elite

100, 100R). a. Main unit battery is low and should be

Elite

200, 200R) replaced or recharged.

b. Verify that the cable from the wall transformer is plugged

into the unit.

b. Probe is not plugged in.

b. Some coupling agents, such as baby oil, maycause extra

static.

c. Reduce the volume level.

b. Use plenty of coupling gel.

c. Try turning up the volume.

c. If using 8MHz vascular probe, adjust angle of

probe to optimize signal.

b. The detected signal is blood flow or placental flow. The

characteristics of placental flow sounds produce a smooth Doppler envelope. A very smooth envelope will not correlate well, so no rate is displayed. Reposition the probe.

Elite

200, 200R). See Specifications Section.

Faint signals may not reset the timer.

Elite

200,

Unstable fetal heart rate display a. Fetus is too young. Wait a few weeks before trying the test

Elite

200, 200R). trying the test again, or try a manual method for determining heart

(

Inaccurate fetal heart rate display a. The detected signal is maternal or maternal mixed with fetal sounds. A (

Elite 200, 200R). maternal sound, usually one half of the fetal sound, may produce

Audible hum or feedback with a. Replace or recharge battery. no signal present.

rate.

b. Fetus is moving. Wait a few minutes to see if the fetus

settles down.

c. Excessive static. Some probe movement patterns may

cause erroneous heart rate displays. Refer to the above section on static for recommendations.

d. Probe is detecting blood flow sounds. Reposition the probe.

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 above section on static for recommendations.

c. Fetal heart rate is out of the display range. Harmonics may cause

doubling of the displayed fetal heart rate.

Service

Service information and assistance is available on the Elite by phoning VIASYS Healthcare at (800) 525-2519, or (608) 441-2266. Fax (608) 441-2242 or visit our web site at www.viasyshealthcare.com.

If you need to return the unit for repair, contact VIASYS Healthcare Technical Service first to obtain a Repair Authorization # (RMA). Package the product carefully (in its original container, if possible) and send it to:

Attn: Service Department VIASYS Healthcare 2920 Commerce Park Drive Madison, WI 53719

Ship the product, insured, via US mail or United Parcel Service.

Include a note indicating the problem, the name of a contact person and their phone number.

For service outside of the United States, please contact the local representative from whom you purchased the unit.

Elite

Warranty: It is important that you return the warranty card supplied with your possible.The specific warranty conditions and limitations were sent with your system. Your is protected by a limited warranty.

as soon as

Elite

Accessories

Description Catalog

Number

2 MHz OB Probe N200 3 MHz OB Probe N300 5 MHz Vascular Probe N500 8 MHz Vascular Probe N800 2 MHz Waterproof OB Probe NW20 12 2 oz. Ultrasound Gel Tubes A100 12 0.25 liter Ultrasound Gel Bottles A120

Description Catalog

Walkman-style Headset A210 Soft-sided Padded Carrying Case A420 9 Volt Alkaline Battery

Elite

100;

Elite

(

9 Volt NiMH Battery

(

Elite

100R;

Replacement Recharger

Elite

100R;

(

200) C623

Elite

200R) C622

Elite

200R) C640

Number

LIMITED WARRANTY

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

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

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.

Elite

against defects in materials or

Elite with no labor charge

VIASYS Nicolet Elite User manual

Specifications and Main Features

Frequently Asked Questions

User Manual