VIASYS Nicolet Elite User manual

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:

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: [phone]
Toll Free: [phone]
Fax: [phone]
Email: [e-mail]
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
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

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.

5

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

Elite

Recharge Indicator:
(Elite 100R & 200R)

is

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.

6

Elite

OR

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.

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

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.

8

Elite