Teleflex ConchaTherm Neptune User Manual

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ConchaTherm

Neptune

Heated Humidifier

™

REF 425-00

User's Manual

88924-07 03/07

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Summary of Contents for Teleflex ConchaTherm Neptune

Page 1 ConchaTherm ® Neptune Heated Humidifier ™ REF 425-00 User’s Manual 88924-07 03/07...
Page 2: Table Of Contents
Symbols General Warnings and Cautions Principles of Operations a. ConchaTherm Basics b. Concha-Column Descriptions Specifications a. ConchaTherm Neptune Performance Characteristics b. Concha-Column Performance Characteristics c. General System Characteristics Controls and Indicators a. Front Panel Indicators b. Status Indicators c. Front Panel Controls Directions for Use a.
Page 3: Introduction
(non-heated wire) breathing circuits or compatible (21-volt) Hudson RCI heated-wire circuits. The ConchaTherm Neptune can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or non-flammable anesthesia gases to help maintain patient body temperature.
Page 4: Symbols
2. Symbols The following symbols are noted on the device labeling. (See Controls and Indicators section of this manual for descriptions of Front Panel and other Icons used in this manual) Symbol Description Manfacturer Name and Address Do Not Dispose in Landfill, Return to Manufacturer for Recycling DRIP-PROOF, a higher than ORDINARY level of protection from drips, leaks, and spills for Medical Devices.
Page 5: General Warnings And Cautions
3. General Warnings and Cautions Warning: For safe operation, only use Hudson RCI Branded Concha Columns, Water Reservoirs, Temperature Probes and 21-Volt Heated Wire Circuits, as listed in the Hudson RCI Product Catalog. Warning: Fire Hazard. Do not use the humidifier in the presence of flammable anesthetic gases. Warning: Burn Hazard.
Page 6 If device is used in areas outside the United States, ensure a Hospital Grade, grounded compatible power cord is utilized. Please call Teleflex Medical’s customer service to obtain Foreign Country power cord specification for your appli- cation.
Page 7: Principles Of Operations
(also referred to as ‘column’) • Concha sterile water reservoir • ConchaTherm Neptune dual thermistor probe • Hudson RCI Breathing circuit (non-heated wire breathing circuit or 21-volt heated-wire breathing circuit.) The servo-controlled heated humidifier continuously monitors the proximal airway temperature and regulates the heat supplied to the column by the heating element, and if used, the heated-wire circuit.
Page 8 Several factors increase the amount of fluid transfer: high peak pressure, lower breath rates, reduced water volume in reservoir, I/E ratios approaching 1:1.4, and square pressure waveforms. Note: The ConchaTherm Neptune requires the use of a dual temperature probe at all times.
Page 9: Specifications
5. Specifications ConchaTherm Neptune Performance Characteristics: Patient Airway Temperature Ranges (Adjustable): Invasive Mode Heated-Wire Circuit: 32-39 ºC Non-heated Wire Circuit: 30-37 ºC Non-Invasive Mode Heated-Wire Circuit: 30-37 ºC Non-Heated-Wire Circuit: 30-37 ºC Temperature Display: Three-digit, seven-segment LED High-Temperature Alarm Limit: 41.0°C typical Tracking Alarm: ±...
Page 10: Concha-Column Performance Characteristics
Concha-Column Performance Characteristics Water Capacity: Standard 193 ± 10 ml with full reservoir Low Compliance 40 ± 5 ml Comfort-Flo Low-Compliance: 40 ± 5 ml Minimal Compliance column: 40 ± 5 ml Column Compliance: Standard: 1.12 ml/cm H O with full reservoir 2.51 ml/cm H O with reservoir at “replace”...
Page 11 RF signals may cause erratic operation of this device. (See Tables, Appendix I) Standards: The ConchaTherm Neptune Heated Humidifier will be tested to and will comply with the following standards: UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety...
Page 12: Controls And Indicators
6. Controls and Indicators Figure 3: CONCHATHERM NEPTUNE Front Panel Indicators Front Panel Indicators Non-Invasive Mode - Icon illuminates when the humidifier is in the SUPRA-GLOTTIC or Non-Invasive Ventilation mode. Invasive Mode - Icon illuminates when the humidifier is in the SUB-GLOTTIC or Invasive or Intubated mode.
Page 13: Status Indicators
Emergency Alarm Indicator will flash and an audible alarm will sound. If this hap- pens, turn the heater off and let it cool. If the condition persists, take the unit out of service and return to Teleflex Medical for servicing. Temperature Gradient Indicator - Indicates the temperature gradient set point. Indicator is active when using a heated wire circuit and will be illuminated during “Set-up”...
Page 14: Front Panel Controls
Figure 4: CONCHATHERM NEPTUNE Front Panel Controls Front Panel Controls Power ON/OFF - The button controls power to the humidifier. Press and hold to turn unit ON. Press and hold to turn unit OFF. Mode Selector - This key selects the operating mode (Invasive or Non-Invasive).
Page 15: Directions For Use
7. Directions for Use Read this entire section, including all warnings and cautions, before operating the ConchaTherm Neptune. See the “Applications” section for tips on using the ConchaTherm Neptune in specific clini- cal situations. System Setup Installation: Mount the humidifier to a pole, ventilator or rail system using the appropriate mounting bracket.
Page 16 Warning: When using Hudson RCI Heated-Wire Circuits: • Observe the minimum minute volumes recommended in this manual. • Do not cover the circuit with sheets, blankets, towels, clothing or other materials. • Do not apply excessive tension to the heated-wire harness — DO NOT "MILK" TUBING.
Page 17: Automatic Operation
RESERVOIR CONCHA COLUMN BOTTLE HEATED WIRE (BLUE) INSPIRATORY PLACE PATIENT AIRWAY TEMPERATURE PROBE HERE CONCHA HEATED HUMIDIFIER TO PATIENT HEATED WIRE CABLE (BLUE) HEATED WIRE CABLE (YELLOW) DUAL TEMPERATURE PROBE Figure 6: The CONCHATHERM NEPTUNE System Using a Heated-wire Circuit...
Page 18 EXPIRATORY (YELLOW) (NOT USED) TEMPERATURE PROBE Figure 7: The CONCHATHERM NEPTUNE System for the Comfort-Flo Cannula Warm-Up. During warm-up, the °C will flash and the LED display will show the actual proximal patient airway temperature. Warm-Up ends when the patient airway temperature reaches within 2°C of the set airway temperature.
Page 19 After warm-up, the humidifier will convert to normal operation. Figure 8 shows a typical display for the ConchaTherm Neptune during normal operation. Figure 8: CONCHATHERM NEPTUNE - Normal Operation Using a Dual Heated-Wire Circuit Warning: Maintain adequate gas flow through the column and breathing circuit. This will prevent overheating the column and circuit.
Page 20 Priority Alarm Indicator will flash and an audible alarm will sound. If this hap- pens, turn the humidifier OFF and let it cool. If the condition persists, take the unit out of service and return to Teleflex Medical for servicing.
Page 21: User Adjustable Operation
User Adjustable Operation The ConchaTherm Neptune will arrive with the following factory default settings: invasive mode, patient airway temperature 37.0° C, temperature gradient 0° C, and pause interval 30 minutes. All of these parameters may be adjusted by the clinician.
Page 22 LED when viewing the “set” parameters. The ConchaTherm Neptune will arrive from the factory with the column-to-patient tempera- ture gradient set at 0 ºC. A temperature gradient of 0 ºC allows the temperature of the gas, and therefore, the relative humidity (RH) of the gas, to be constant throughout the length of the heated-wire circuit.
Page 23 30 mg H O/L of delivered gas at 30 ºC. The ConchaTherm Neptune is designed to advise the user of low- humidity conditions (when the humidifier is in the Invasive mode and the set airway temperature and gradient result in a column temperature equal to or less than 31 ºC).
Page 24 As a result less water vapor is created. To compensate for this situation, the ConchaTherm Neptune features a High Output Mode (see figure 12). This mode allows the humidifier to respond to high incoming gas temperatures by increasing the column-to-patient temperature gradient.
Page 25 Figure 13: High Output Examples Automatic Gradient Adjustment The ConchaTherm Neptune is intended to heat and humidify respiratory gases at a proximal patient airway temperature selected by the clinician. In addition, the ConchaTherm Neptune will allow the use of heated-wire circuits to minimize the condensation or "rainout" within the circuit.
Page 26: Other Operating Features
Incompatible Heated-Wire Circuits The ConchaTherm Neptune was designed to detect incompatible heated-wire resistance. If an incompatible resistance heated-wire is detected, the heated-wire arrows will flash red, a priority alarm will be activated and the unit will not warm-up.
Page 27: Applications
The following information is offered regarding the use of the humidifier in specific applications. The ConchaTherm Neptune has been tested to operate with ventilators designed to support neonatal, pediatric, and adult patients using commonly applied ventilation modalities. These ventilators may incorporate some or all of the following performance characteristics: •...
Page 28 The ConchaTherm Neptune works best at a room temperature of 22 to 26 °C (72 to 78 °F). Evaluate the circuit, circuit length, room temperature and other factors before placing the...
Page 29: Troubleshooting And Maintenance
9. Troubleshooting and Maintenance ALARMS The ConchaTherm Neptune has two alarms conditions: priority and cautionary. Priority alarms are indicated by a red status light and an audible alarm. Clinician involvement is required to reset a priority alarm. To reset a priority alarm, turn the unit’s power OFF, correct the alarm condition and turn the unit’s power ON.
Page 30: Symptoms And Corrective Actions
AIRWAY TEMP (Patient Temp Indicator Flashes Green): • Airway temperature >41ºC, power is disconnected to humidifier and wires, power returns when temp falls back below 40.5ºC and alarm will deactivate, check temperature setting for ambient and/or ventilator conditions • Patient Temp > +/- 2ºC from set point after warm-up is complete (°C stops flashing), check for proper usage for current ambient and ventilatory conditions.
Page 31: Routine Checks
Temperature probe not properly connected to humidifier. • Turn unit off for 60 seconds. Properly connect the temperature probe to the humidifier and turn unit back on. Unit displaying “Service” icon and alarm condition. • Remove the humidifier from use. Humidifier does not retain user defined settings.
Page 32: Cleaning
Two, 250 V ~, 4 amp, 5 x 20mm time delayed Service and Repairs The ConchaTherm Neptune has no user serviceable components inside and requires no annual cali- brations. Component part lists and circuit diagrams are confidential and not commercially available.
Page 33 Repair of leased heaters: A Teleflex Medical customer service representative will assist you in obtaining a replacement heater for your ConchaTherm Neptune. User-performed repairs of leased heaters should not be attempted. Such repairs shall be considered user caused damage and may result in the cancellation of the lease.
Page 34: Limited Warranty Statement
Product. Teleflex cannot be respon- sible in any way for any ancillary equipment not furnished by Teleflex, which is attached to or used in connection with the Product. Because each system, which may use the Product, is unique, Teleflex disclaims liability for range, coverage, or operation of the system as a whole under this warranty.
Page 35 Shipping Address 4024 Stirrup Creek Drive Durham, North Carolina 27703 Telephone: (919) 544-8000; (866) 246-6990 Fax (919) 361-4081 Made in Mexico 88924-07 03/07 © 2007, Teleflex Incorporated Hudson RCI, Concha, Conchatherm, and Concha-Column are registered trademarks of Teleflex Medical Incorporated.
Page 36: Electromagnetic Emissions Table
Recommended separation distances between portable and mobile RF communications equipment and the CONCHATHERM NEPTUNE Humidifier. The CONCHATHERM NEPTUNE Humidifier is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CONCHATHERM NEPTUNE...
Page 37 Guidance and manufacturer's declaration - electromagnetic immunity The CONCHATHERM NEPTUNE Humidifier is intended for use in the electromagnetic environment specified below. The customer or the user of the CONCHATHERM NEPTUNE Humidifier should assure that it is used in such an environment.
Page 38 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electro- magnetic site survey should be considered. If the measured field strength in the location in which the CONCHATHERM NEPTUNE Humidifier is used exceeds the applicable RF compliance level above, the CONCHATHERM NEPTUNE Humidifier should be observed to verify normal operation.
Page 39 Guidance and manufacturer's declaration - electromagnetic emissions The CONCHATHERM NEPTUNE Humidifier is intended for use in the electromagnetic environment specified below. The customer or the user of the CONCHATHERM NEPTUNE Humidifier should assure that it is used in such an environment.

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425-00