The Nicolet Elite® is a non-invasive, hand-held Doppler device designed for obstetrical and vascular examinations, providing audio and visual feedback. It is manufactured by VIASYS Healthcare, a company specializing in Doppler technology.
Function Description:
The Elite Doppler is used to detect fetal heartbeats and assess blood flow in arteries and veins. It provides real-time audio of the Doppler sounds through an integrated speaker or optional headphones. For models with an LCD display (Elite 200 and 200R), it also calculates and displays the heart rate in beats per minute (BPM). The device is intended for use by or on the order of a physician.
For obstetrical exams, the Elite helps reassure mothers of fetal viability by detecting the fetal heartbeat. The 3 MHz probe is recommended for early pregnancy (8-12 weeks), while the 2 MHz waterproof probe is suitable for later pregnancy, larger patients, or use during water labors/deliveries. Fetal heart sounds are described as a "galloping horse" and are approximately twice the speed of the mother's heart rate. Placental blood flow sounds like a "whirlwind."
For vascular exams, the Elite is valuable for locating veins for injections or IVs, obtaining difficult-to-locate systolic blood pressures, and listening to flow within a vessel. Arterial sounds pulsate with each heartbeat, and venous sounds are spontaneous with respiration, similar to a "windstorm." These characteristic sounds help distinguish healthy vessels from diseased ones.
Important Technical 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 (0.60 lb.)
- Doppler Technology: Continuous Wave (CW) Unfocused.
- Battery Type: 9-volt alkaline or 9-volt rechargeable (IEC #6LR61 or NEMA # 1604A). Rechargeable models (Elite 100R & 200R) include a recharger unit.
- Operational Temperature: 10 to 32 degrees C (50 to 90 degrees F).
- Speaker: 2.25", 8 Ohms, 1/4 watt typical audio output.
- Headphones: 8 Ohms, mono 3.5mm connector. When headphones are plugged in, the main speaker is muted.
- Frequency Response:
- Elite 100 Series: -3dB @ 360 Hz and 1.2 KHz
- Elite 200 Series: -3dB @ 391 Hz and 1.2 KHz
- 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) (Elite 200 & 200R):
- Vascular Probe: 60-119 ± 2 BPM
- OB Probe: 60-199 ± 2 BPM
- Recharger Input (Elite 100R & 200R):
- 120 VAC 60 Hz (PN: PS-0019)
- 240VAC 50Hz @ 6VA (PN: PS-0028)
- Output: 24VDC @ 65ma
- Probe Frequencies: Available probes include 2 MHz, 3 MHz, 5 MHz, and 8 MHz.
- Maximum Surface Temperatures of Ultrasonic Transducers:
- 2 MHz: 24.6 degrees C
- 2 MHz waterproof: 23.5 degrees C
- 3 MHz: 24.4 degrees C
- 5 MHz: 27.6 degrees C
- 8 MHz: 27.7 degrees C
- Ultrasound Output (Acoustic Output Reporting Table): Detailed tables are provided for 2 MHz, 3 MHz, 5 MHz, and 8 MHz probes, including Mechanical Index (MI), Spatial-Peak Temporal-Average Intensity (ISPTA.3), Spatial-Peak Pulse-Average Intensity (ISPPA.3), peak rarefactional pressure (Pr.3), total time-average ultrasonic power (Wo), probe center frequency (fo), axial distance (Zsp), and beam dimensions (X-6, Y-6, EBD).
- EMC Information: The device is tested for EMC emissions and immunity, compliant with CISPR 11 (Group 1, Class B), IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-11, and IEC 61000-4-8. It is designed for use in typical commercial or hospital environments.
Usage Features:
- On/Off Button: A single button on the front panel turns the unit on and off.
- Volume Control: A slider button on the side of the unit adjusts the speaker volume (up for louder, down for quieter).
- Probe Connector: Probes are connected to the main unit via a secure connector with a clear tab that must be depressed to disconnect.
- Recharge Indicator (Elite 100R & 200R): A green light indicates when the unit is recharging. The unit will not operate while plugged into the recharger.
- On Indicator (Elite 100 & 100R): A green LED indicates the unit is on for models without a display.
- Heart Rate/Low Battery Indicator (Elite 200 & 200R): The digital display shows heart rate and flashes when batteries are low.
- Probe Application:
- 2 MHz, 3 MHz, and 5 MHz probes are placed flat on the skin.
- 8 MHz probes require an approximate 45° angle for optimal results.
- Coupling Gel: Liberal use of ultrasound gel is crucial for optimal sound transmission, as air bubbles between the skin and probe can block ultrasound.
- Slow Movement: Moving the probe slowly, with a rocking and rotating motion, minimizes noise and helps locate signals.
- Maintain Probe Contact: Keeping the entire probe face in contact with the skin surface ensures the best possible sounds.
- Headphone Use: Optional headphones can be plugged into a dedicated connector on the unit's edge for private listening.
Maintenance Features:
- Main Unit Cleaning: Wipe periodically with a damp cloth and mild disinfectant cleaner. Do NOT immerse in fluids or use solvent cleaners.
- Doppler Probe Cleaning:
- Wipe clean with a soft nonabrasive cloth or disposable wipe soaked in an aqueous disinfectant. Avoid organic cleaning agents, alcohol, and aerosol preparations.
- Wipe with a nonabrasive cloth moistened with water.
- Store in clean bags or covered trays.
- Inspect daily for cracks or damage to the probe assembly and cable. Do NOT use damaged probes.
- Only waterproof probes can be immersed in water.
- Sterilization: Probes can be sterilized using cold gas sterilization (ethylene oxide at less than 140°F) or the Sterrad™ System. The user is responsible for verifying sterility and following manufacturer instructions. The main unit cannot be sterilized this way.
- Battery Replacement: To replace the 9V battery, remove the battery compartment door, install the new battery as shown on the label, and replace the door. Use only VIASYS Healthcare approved batteries and rechargers.
- Long-Term Storage: Remove the 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 Conditions:
- Temperature: -20°C to 60°C
- Humidity: 15% to 90% (non-condensing)
- Pressure: 500 hPa to 1060 hPa
- Carrying the Unit: Always ensure the probe is completely seated in the holding clips.
Safety Warnings:
- The Elite is not explosion-proof; do not use it or probes in the presence of flammable or explosive gases.
- Do not immerse the unit or probes in fluids (except waterproof probes in water) and do not autoclave.
- The 5 MHz and 8 MHz vascular probes are not intended for fetal use.
- This product is not intended for use on or around the eyes or on non-intact skin.
- 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.
- Do not connect any part of the Elite to a telephone system.
- This equipment is not intended for use with HF surgical equipment.
- When in the presence of audible interference, the heart rate display may be inaccurate.
Troubleshooting:
The manual provides solutions for common issues such as the unit not turning on (check battery, recharger connection), low battery (recharge or replace), no audio signal (check headphones, probe connection), static (use ample gel, reduce volume), weak or no signal (fetus too young, use ample gel, turn up volume, adjust 8MHz probe angle), no heart rate displayed (outside range, reposition probe), and inaccurate heart rate (maternal sounds, static, harmonics).
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