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Summary of Contents for Medline HUDSON RCI Neptune ConchaSmart HUD42500
- Page 1 Neptune® Heated Humidifier with ConchaSmart® Technology Instructions for Use Mode d’emploi Instrucciones de uso Prescription device (USA) HUD42500 Dispositif sur ordonnance Non-Sterile (États-Unis) Non Stérile Dispositivo recetado No Estéril (EE. UU.)
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Page 2: Table Of Contents
Contents Introduction............................3 a. Intended Use b. Product Features c. Setup Diagrams Symbols..............................4 General Warnings, Cautions, and Contraindications..............5 Principles of Operations........................9 a. Neptune Basics b. Concha-Column Descriptions Specifications............................11 a. Hudson RCI Neptune Performance Characteristics b. Concha-Column Performance Characteristics c. General System Characteristics Controls and Indicators........................15 a. -
Page 3: Introduction
Introduction Intended Use The Hudson RCI® Neptune® (also referred to herein as ‘humidifier’) is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric and infant/neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson RCI heated-wire circuits. -
Page 4: Symbols
Symbols The following symbols are noted on the device and accessory labeling. (See Controls and Indicators section of this manual for descriptions of Front Panel and other Icons used in this manual) Symbols Definition Symbols Definition Manufacturer Refer to instruction manual Do Not Dispose in Landfill, Return to Manufacturer for Contains Phthalates. -
Page 5: General Warnings, Cautions, And Contraindications
Warning: Electrical Shock Hazard. No modification of the humidifier is allowed. Refer all servicing to Medline or authorized repair center. Use of the RS-232 service connector by anyone other than qualified, factory-trained personnel may damage the instrument and result in harm to the patient. - Page 6 than a ConchaSmart column with a Hudson RCI Neptune that has a low water sensor, the low water notification will not work. Warning: Some ventilators produce elevated gas temperatures at the patient inhalation port which can reduce the amount of absolute humidity in the circuit. Visually inspect for condensation droplets in the inspiratory circuit after one hour of operation, and periodically thereafter.
- Page 7 Warning: Do not add any attachments or accessories to the humidifier that are not listed in the instruction for use of the humidifier or accessory, or the humidifier might not function correctly affecting the quality of the therapy or injuring the patient. Warning: Use of the humidifier with equipment other than defined as part of intended use should be avoided because it could result in improper operation.
- Page 8 NOTE: The Neptune was designed to be used with only Hudson RCI water reservoirs which come prefilled with sterile water and are not refillable. See the current issue of the Hudson RCI Product Catalog or go to the Medline website (www.medline.com) for water reservoirs validated for use with the Hudson RCI Neptune Heated Humidifiers.
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Page 9: Neptune Basics
Principles of Operation Neptune Basics The Hudson RCI Neptune heated humidification system consists of: • Hudson RCI Neptune heated humidifier • Concha® Column humidifier cartridge (also referred to as ‘column’) • Concha sterile water reservoir (Available in 1650ml) • Hudson RCI Neptune dual-thermistor temperature probe •... - Page 10 Heated, humidified oxygen/air Dry oxygen/air mixture from mixture to patient flow source Saturated Wick CONCHA Prefilled. Disposable Sterile Water Reservoir Figure 3: Standard CONCHA-COLUMN Flow Diagram The Low-Compliance Concha-Column is recommended for applications requiring a more constant compressible volume and compliance, (see Figure 4). The Low-Compliance Concha-Column maintains a constant water level in the column resulting in a more stable compressible volume.
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Page 11: Specifications
Specifications Hudson RCI Neptune Performance Characteristics: • Patient Airway Temperature Ranges (Adjustable): Heated-Wire Circuit: 32-40°C Invasive Mode Non-heated Wire Circuit: 30-37°C Heated-Wire Circuit: 28-37°C Non-Invasive Mode Non-Heated-Wire Circuit: 28-37°C • Temperature Measurement Accuracy: +/- 2°C (uncertainty +/-0.2°C) Displayed measured gas patient airway temperature is measured by the temperature probe at or near the patient connection of the breathing circuit. -
Page 12: Concha-Column Performance Characteristics
Non-Invasive Mode > 12 mg/L at 37°C proximal airway temperatures when set zero gradient at the recommended Flow Rates listed above. • This mode should only be used when the patient airways ARE NOT bypassed. • Except in the event of an alarm or power failure. Concha-Column Performance Characteristics: Water Capacity: Standard... - Page 13 Auditory Medium Priority Alarm Signal Sound Pressure Range: 45 - 55 dBA (range based on radius of 1 meter or at the operator’s position) Noise Levels: The humidifier noise level under normal operation conditions shall be less than 50 dB measured 1 meter from the device, except while audible alarms are active.
- Page 14 Reusable Temperature Probe e.g. HUD39590 Mounting Bracket e.g. HUD38610 See the current issue of the Hudson RCI Product Catalog or go to the Medline website (www.medline.com) for compatible circuits and accessories validated for use with the Hudson RCI Neptune Heated Humidifiers.
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Page 15: Controls And Indicators
Controls and Indicators Figure 5: Hudson RCI Neptune Front Panel Indicators Front Panel Indicators 1. Non-Invasive Mode - Icon illuminates when the humidifier is in the SUPRAGLOTTIC or Non-Invasive Ventilation mode. 2. Invasive Mode - Icon illuminates when the humidifier is in the SUBGLOTTIC or Invasive or Intubated mode. -
Page 16: Status Indicators
If this happens, turn the humidifier off and let it cool. If the condition persists, take the unit out of service and return to Medline for servicing. A solid red wrench will display in the set-up state if the unit is in Auto Settings mode, this indicates that the settings cannot be adjusted until the unit is taken out of Auto Settings mode. -
Page 17: Front Panel Controls
Figure 6: Hudson RCI Neptune Front Panel Controls Front Panel Controls a. Power ON/OFF - The button controls power to the humidifier. Press and hold to turn unit ON. Press and hold to turn unit OFF. When the unit is plugged in, but not turned on the button will fade on and off to indicate that the unit is in standby mode. -
Page 18: Directions For Use
1. Installation: Mount the humidifier to a pole, ventilator or rail system using the appropriate mounting bracket. Contact your Medline representative for available mounting brackets. Mounting instructions are supplied with the bracket. Warning: Fire Hazard: Do not use humidifier in the presence of flammable anesthetic gases. - Page 19 port and inspiratory limb of the breathing circuit to the right angled port. 5. Connect the dual thermistor probe: a. Insert the temperature probe plug into the jack at the lower front of the humidifier. b. Place the short-cabled probe at the column outlet and the long-cabled probe into the inspiratory side of the patient wye.
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Page 20: Automatic Operation
Note: If the humidifier detects an internal fault during the self-check, the icon will flash and an audible alarm will sound. If this happens, take the unit out of service and return to Medline for servicing. Note: The humidifier will begin to heat once settings are confirmed, or after 30 seconds if user does not confirm settings. - Page 21 3. Confirm Settings. The accept button will flash and the humidifier will automatically display the stored settings for mode (invasive or non-invasive) and patient airway temperature. When using a heated-wire circuit, the heated-wire and temperature gradient indicators will illuminate. Patient airway temperature and temperature gradient will default to the last used values for the present configuration (mode and breathing circuit type).
- Page 22 causing a bolus of hot air to be delivered to the patient. • Do not turn the humidifier ON without gas flow • Do not leave the humidifier ON without gas flow • Do not exit the pause mode without gas flow •...
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Page 23: User Adjustable Operation
Yellow Warning Indicator will illuminate, and an audible alarm will sound. If this happens, turn the humidifier OFF and let it cool. If the condition persists, take the unit out of service and return to Medline for servicing. User Adjustable Operation The Hudson RCI 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. - Page 24 respiratory rates and Concha-Column. 3. Temperature Gradient (only active if using heated-wire circuits) When using the Hudson RCI Neptune with heated-wire circuits, the temperature gradient may be adjusted to allow for the proximal patient airway temperature to be up to 3.0°C warmer or cooler than the temperature at the column outlet.
- Page 25 Figure 12: Negative Temperature Gradient, Display at -3.0°C. Note: A negative or decreased temperature gradient results in a higher relative humidity ( RH) at the proximal patient airway. Note: A negative temperature gradient increases the potential for rainout within the heated-wire circuit. Caution: The Hudson RCI Neptune is designed to deliver a minimum of 33 mg H2O/L at 37°C, under normal operating conditions.
- Page 26 To accept the new pause time, press the accept button or wait 30 seconds for unit to naturally return to warm-up and normal operation. The unit will return to warm-up and normal operation. 6. High Output Mode: (Compensates for Hot Inlet Gas Temperature) Some ventilators generate high internal temperatures during operation, therefore heating the gas that is delivered to the humidifier.
- Page 27 When High Output Mode is active, the gradient icon will flash. When normal temperature gradient is active, the gradient icon will be continuously illuminated. Temperature Gradient in HI Mode With Patient Temp set at 39 Deg and Gradient to -4 Deg Column Temp Column Temp would be at 43 Deg and Patient Temp at 39 Deg Patient Temp...
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Page 28: Other Operating Features
when using auto setting mode with a conventional or heated wire circuit in non-invasive mode. • Press the to accept. • Turn unit off. Activating and Deactivating Auto Settings Mode: • While the unit is in stand-by mode (the unit is off but plugged in), press and hold the console button for 5 seconds. -
Page 29: Applications
Applications The Hudson RCI Neptune heated humidification system is designed to heat and humidify respiratory gases delivered to adult, pediatric, and infant patients. The following information is offered regarding the use of the humidifier in specific applications. The Hudson RCI Neptune has been tested to operate with ventilators designed to support neonatal, pediatrics, and adult patients using commonly applied ventilation modalities. - Page 30 Warm or Cool Environments Operating the humidifier in environments near the extremes of its operating environment temperature range may result in alarms as the unit attempts to control the airway temperature as it is affected by heat transfers along the circuit path. The Hudson RCI Neptune works best at a room temperature of 22 to 26°C (72 to 79°F).
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Page 31: Troubleshooting And Maintenance
If either one of these alarm conditions does not occur, remove the humidifier from service and contact the Medline Customer Service Department at 1-800-633-5463. In addition, the following method can also be used at any point in time to verify alarm system functionality. - Page 32 System Alarm Alarm What is displayed What is clinician Clears Delay heat control Condition Priority when it happens? action to remedy? when: response Unit failed Yellow warning on. Power down and N/A (must Software turns < 1 second self-diagnostic (Service) Wrench flashes.
- Page 33 Heated Wire Yellow warning Restore original Valid current None </=5 Change on. Inspiratory or heated wire heated wire seconds Warning, expiratory flashes red configuration. configuration Inspiratory (if issue). or valid new and/ or Patient temp indicator heated wire Expiratory green. configuration Numerical display with Accept...
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Page 34: Symptoms And Corrective Actions
Blown internal fuse Return the unit for service. Unit not heating. • Internal malfunction, usually accompanied by a service alarm. Return the humidifier to Medline for service. Proximal patient airway temperature will not set below 32°C or above 40°C in the Invasive mode or with Heated-Wire circuit in use. -
Page 35: Routine Checks
Program desired settings for proximal airway temperature, gradient and pause time. Press accept button to return unit to warm-up and normal operation. If problem persists after reprogramming, return to Medline for service. Sudden power failure. • Power button inadvertently pushed, causing loss of power, or power cord inadvertently removed from humidifier. -
Page 36: Cleaning
The Hudson RCI Neptune has no user serviceable components inside and requires no annual calibrations. Component part lists and circuit diagrams are confidential and not commercially available. Please contact the Medline Customer Service Department at 1-800-633-5463 if you have special needs or questions with this policy. -
Page 37: Limited Warranty Statement
(1) year from the date of purchase. Medline, at its option, will at no charge either repair the Product (with new or reconditioned parts) or replace it (with new or reconditioned Product), during the warranty period provided that it is returned in accordance with the terms of this warranty. - Page 38 Product or interferes with Medline’s normal warranty inspection and testing of the Product to verify any warranty claim. Product that has the serial number removed or made illegible. Freight and insurance costs to the service center.
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Page 39: Appendix
Appendix Guidance and manufacturer’s declaration - electromagnetic immunity The Hudson RCI Neptune Humidifier is intended for use in the electromagnetic environment specified below. The customer or the user of the Hudson RCI Neptune Humidifier should assure that it is used in such an environment. Electromagnetic environment Immunity test IEC 60601 test level... - Page 40 Guidance and manufacturer’s declaration - electromagnetic immunity The Hudson RCI Neptune Humidifier is intended for use in the electromagnetic environment specified below. The customer or the user of the Hudson RCI Neptune Humidifier should assure that it is used in such an environment. Electromagnetic Immunity test IEC 60601 test level...
- Page 41 22mm, 15mm, and 10mm inner diameter heated wire breathing circuits up to 6 feet 6 inches (78 inches) in length www.medline.com Medline Industries, LP. Product of Mexico, Packaged in Mexico 1-800-MEDLINE V1 RK23145 HNL02785 Hudson RCI, Comfort FLO, Concha, Conchatherm, Concha-Column, ConchaSmart and Neptune are registered trademarks of Medline Industries, LP.
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