Nicolet Elite

User's Manual
2
 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: Federal law (USA) restricts this device to use by or on the order of a
physician.

VIASYS Healthcare strives for continuous improvement. Please contact us if you

have comments or suggestions for improvements regarding our products or services.

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: [email protected]
www.viasyshealthcare.com

European Authorized Representative:

VIASYS Healthcare
Welton Road
Warwick, CV345PZ U.K.

© 2005 VIASYS Healthcare

M7-0775 Rev. I

3
Blank page.

4
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 Elite Problems 21
Service 23
Accessories 23
Limited Warranty 24
The purpose of this manual is to guide the user in the operation and care of the Elite. Every
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.

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 as with all medical instruments,
should be treated with care. While the Elite augments the user’s skills, it is not a substitute for
medical training and knowledge.
NOTE: The Elite provides the listener with information about the fetus and vascular conditions.
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.

5
PRODUCT DESCRIPTION
The Elite is a non-invasive hand-held Doppler with a speaker. The Elite has the following
special features that will enhance your product use:

On/Off: Recharge Indicator:

Pressing the On/Off button on the front panel
(Elite 100R & 200R)
of the unit turns on the Elite. The Elite is
The green light turns on to indicate that the unit is
turned off by again pressing the On/Off button.
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.

On Indicator:
(Elite 100 & 100R)
Green LED “On” indicator for
units without display.

Heart Rate/Low Battery Indicator (Elite Probe Connector:

200 & 200R): Disconnect the probe by holding the probe in one hand,
The digital display shows heart rate. The display grasping the connector at the bottom of the probe in the other
flashes when batteries are low. 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 Elite OR
PROBES IN THE PRESENCE OF FLAMMABLE OR EXPLOSIVE
GASES. DO NOT IMMERSE THE UNIT OR PROBES IN FLUIDS AND
DO NOT AUTOCLAVE.

6
 Probe Face:
Place 2 MHz, 3 MHz or 5 MHz probe flat on skin. There Louder
is no need to tip at various angles to detect fetal
heartbeat or blood flow in artery or vein. 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.

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

CAUTION:
device to Federal law
res
physician.use by or on the ord tricts this
er of a
CAUTION:
may be No part of
connected thi s equipme
to a tel nt
ephone sys
NICOLET tem.
VASCULAR
a division
of
5225 Verona VIASYS Healthcare
Madison, Rd., Bldg. 2
WI 53711-
1-800-525 449
-2519 USA 5

Battery Replacement:
To replace a battery, remove the battery compartment
door and remove the old battery. Carefully install the
Recharger new battery with the connector end as shown on the
label. Replace the battery compartment door.
(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.

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.
7
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
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 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 (Elite
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.

8
 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 (Elite100R & 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:
device to Federal law
restri
physicianuse by or on the order cts this
. of a
CAUTION:
may be No part of
connected this equip
to a telephone ment
NICOLET
VASCULAR system.
a division
of
5225 Veron VIASYS Healthcare
a
Madison, Rd., Bldg. 2
WI
1-800-525-25 53711-4495
19 USA

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.

9
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 Elite provides the listener with information about the fetus; however if there
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 Elite. Then
wipe the gel off the face of the probe. Return the probe to the top of the unit for protection.

10
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

Vessel
Coupling Gel

11
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.

12
 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 Elite will not be in use for an extended period. Do not expose to
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

13
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
NEMA # 1604A]
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 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
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 )
or
240VAC 50Hz @ 6VA (PN: PS-0028)
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

14
Ultrasound Output:
Acoustic Output Reporting Table
Transducer Model: Elite™ 2MHz Operating Mode: Continuous Wave (cw)
Application(s): Continuous Fetal Heart Monitoring
Acoustic MI ISPTA.3 ISPPA.3
Output (mW/cm2) (W/cm2)

Global Maximum Value .031 42.6 .043

p (MPa) .043
r.3
W (mW) 13.6 13.6
0
Associated f (MHz) 2.0 2.0 2.0
c
Acoustic Z (cm) 1.62 1.62 1.62
sp
Parameter Beam dimensions x (cm) 0.8 0.8
-6
y (cm) 0.4 0.4
-6
EBD Az. (cm) 0.79
Ele. (cm) 1.58

Acoustic Output Reporting Table

Transducer Model: Elite™ 3MHz Operating Mode: Continuous Wave (cw)
Application(s): Continuous Fetal Heart Monitoring
Acoustic MI ISPTA.3 ISPPA.3
Output (mW/cm2) (W/cm2)

Global Maximum Value .028 55.4 .055

p (MPa) .116
r.3
W (mW) 20.0 20.0
0
Associated f (MHz) 3.04 3.04 3.04
c
Acoustic Z (cm) 0.9 0.9 0.9
sp
Parameter Beam dimensions x (cm) 1.01 1.01
-6
y (cm) 0.85 0.85
-6
EBD Az. (cm) 1.02
Ele. (cm) 1.40

Acoustic Output Reporting Table

Transducer Model: Elite™ 5MHz Operating Mode: Continuous Wave (cw)
Application(s): Peripheral Vascular
Acoustic MI ISPTA.3 ISPPA.3
Output (mW/cm2) (W/cm2)

Global Maximum Value .029 114.7 .114

p (MPa) .068
r.3
W (mW) 35.0 35.0
0
Associated f (MHz) 5.45 5.45 5.45
c
Acoustic Z (cm) 0.4 0.4 0.4
sp
Parameter Beam dimensions x (cm) 1.13 1.13
-6
y (cm) 0.34 0.34
-6
EBD Az. (cm) 0.46
Ele. (cm) 1.24

15
 Acoustic Output Reporting Table
Transducer Model: Elite ™ 8MHz Operating Mode: Continuous Wave (cw)
Application(s): Peripheral Vascular
Acoustic MI ISPTA.3 ISPPA.3
Output (mW/cm2) (W/cm2)

Global Maximum Value .033 348 .348

p (MPa) .074
r.3
W (mW) 5.2 5.2
0
Associated f (MHz) 7.8 7.8 7.8
c
Acoustic Z (cm) 0.52 0.52 0.52
sp
Parameter Beam dimensions x (cm) 0.32 0.32
-6
y (cm) 0.17 0.17
-6
EBD Az. (cm) 0.20
Ele. (cm) 0.46

When in the presence of audible interference the heart rate display may be inaccurate.
ISPTA.3 - The derated spatial-peak, temporal-average intensity (milliwatts per square centimeter).
ISPPA.3 - The derated spatial-peak, pulse-average intensity (milliwatts per square centimeter).
MI - The Mechanical Index.
pr.3 - The peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the value reported under
MI.
W0 - The total time-average ultrasonic power (milliwatts).
fc - The probe center frequency (MHz).
zsp - The axial distance at which the reported 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%
Additional Information for IEC-1157
The output beam intensity Iob=48 mW/cm2
This transducer is intended for direct patient contact.
The probe face has a liquid ingress level of IPX4.

16
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 Group 1 The ELITE uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions Class B The ELITE is suitable for use in all establishments other than
CISPR 11 domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
Harmonic emissions Not applicable purposes.
IEC 61000-3-2
Voltage fluctuations / Complies
flicker emissions
IEC 61000-3-3

17
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.

Separation distance according to frequency of transmitter

Rated Maximum output m
power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W
d = 1.17 d = 1.17 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 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.

18
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 Compliance Electromagnetic
level Environment-
Guidance
Electrostatic Discharge +6 kV contact +6 kV contact Floors should be wood,
(ESD) concrete or ceramic tile.
If floors are covered
+8 kV air +8 kV air
with synthetic material,
IEC 61000-4-2
the relative humidity
should be less than 30%.

Electrical fast transient/ +2 kV for power +2 kV for power supply Mains power quality
burst supply lines lines should be that of a
typical commercial or
hospital environment.
IEC61000-4-4 +1 kV for input/ +1 kV for input/output
output lines lines

Surge +1 kV differential +1 kV differential mode Mains power quality

mode should be that of a
typical commercial or
IEC 61000-4-5 +2 kV common mode
hospital environment.
+2 kV common
mode

Voltage dips, short < 5% UT < 5% UT Mains power quality

interruptions and voltage (>95% dip in UT) (>95% dip in UT) for should be that of a
variations on power supply for 0.5 cycle 0.5 cycle typical commercial or
lines hospital environment. If
40% UT
the user of the ELITE
40% UT (60% dip in UT) for 5 requires continued
IEC 61000-4-11 cycles
(60% dip in UT) for operation during power
5 cycles 70% UT mains interruptions, it is
70% UT (30% dip in UT) for 25 recommended that the
cycles ELITE be powered from
(30% dip in UT) for
an Uninterruptable
25 cycles <5% UT
power supply or its
<5% UT (>95% dip in UT) for 5 battery.
(>95% dip in UT) sec
for 5 sec
Power Frequency (50/60 3 A/m 3 A/m Power frequency
Hz) magnetic fields should
be at levels
characteristic of a
IEC 61000-4-8
typical location in a
typical commercial or
hospital environment.

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

19
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 Complianc Electromagnetic environment – guidance
test level e
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
Conducted 3 Vrms 150 3V
RF kHz to 80
IEC 61000- MHz d = 1.17 80 MHz to 800 MHz
4-6
3 V/m
3 V/m 80 MHz
to 2.5 GHz
Radiated RF d = 2.23 800 MHz to 2.5 GHz
IEC 61000- where P is the maximum output power rating of the
4-3 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 re-
orienting or relocating the ELITE.
(b*) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

20
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 (Elite 100, 100R). a. Main unit battery is low and should be
Heart rate display flashes (Elite 200, 200R) replaced or recharged.
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.
b. Verify that the cable from the wall transformer is plugged
into the unit.
Main unit is on, but no audio signal is present a. Headphones interrupt the internal speakers, remove the
(All Models). headphones.
b. Probe is not plugged in.
Static a. Use an ample supply of ultrasonic coupling gel. Hold the
(All Models). probe steady once a signal has been detected.
b. Some coupling agents, such as baby oil, maycause extra
static.
c. Reduce the volume level.
Weak or no fetal signal detected a. Fetus is 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.
(Elite 200, 200R). See Specifications Section.
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.
No vascular heart rate is displayed with a. Heart rate range is outside of display range.
audible tones (Elite 200, 200R). See Specifications Section.
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.
Faint signals may not reset the timer.
(All Models) b. Battery is low. Replace or recharge.
Inaccurate vascular heart rate a. Certain flow waveforms contain large display (Elite 200,
200R). harmonics which can cause heart rate doubling.

21
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
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.
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
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.
Audible hum or feedback with a. Replace or recharge battery.
no signal present.

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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.
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 Description Catalog
Number Number
2 MHz OB Probe N200 Walkman-style Headset A210
3 MHz OB Probe N300 Soft-sided Padded Carrying Case A420
5 MHz Vascular Probe N500 9 Volt Alkaline Battery
8 MHz Vascular Probe N800 (Elite 100; Elite 200) C623
2 MHz Waterproof OB Probe NW20 9 Volt NiMH Battery
12 2 oz. Ultrasound Gel Tubes A100 (Elite 100R; Elite 200R) C622
12 0.25 liter Ultrasound Gel Bottles A120 Replacement Recharger
(Elite 100R; Elite 200R) C640

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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.

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