Sytem Instruction Manual
48 Pages
Preview
Page 1
System Instruction Manual for use with Aerogen® Solo and Aerogen® Pro
www.aerogen.com
Contents Introduction
2
Intended Use
2
Set Up
5
System Contraindication and Warnings
8
Controls & Indicators
13
Accessories
14
Functional Test
22
Aerogen Solo Aerosol Flow Rate Calculation
23
Cleaning of the Aerogen USB Controller System
24
Troubleshooting
30
Warranty
31
Life Of Products
31
Specifications
32
Aerogen Solo Performance
33
Aerogen Pro Performance
34
Power
35
Symbols
36
Appendix 1: EMC Tables
37
Aerogen® USB Controller System Instruction Manual
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Introduction The Aerogen USB Controller System is: •• A portable medical device that is intended to aerosolise physicianprescribed medications for inhalation. •• Approved for use with USB ports on medical electrical equipment for the purposes of power only or the Aerogen USB Controller AC/DC Adapter. •• An alternative to the existing Aerogen® Pro and Aerogen® Pro-X Controllers.
Intended Use The Aerogen® Pro is a portable medical device for multiple patient uses that is intended to aerosolise physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment and on vent only in the homecare environment. The Aerogen Pro is suitable for use in adult, paediatric and neonate patients. The Aerogen® Solo belongs to the Aerogen Pro family, the Aerogen Solo nebuliser is a single patient use device intended for both intermittent and continuous nebulisation. It is intended to nebulise physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser. The Aerogen Solo is suitable for use with neonate, paediatric and adult patients. It is intended for on and off ventilation or other positive pressure breathing assistance in the hospital environment and on vent only in the homecare environment.
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Aerogen®
The Aerogen USB Controller can be used with Aerogen nebulisers as follows: Table 1. Intended Use Summary Intended Use Summary
Aerogen Solo Nebuliser
Aerogen Pro Nebuliser
Hospital - Ventilated patients Hospital -Spontaneously Breathing Patients Homecare - Ventilated patients Homecare - Spontaneously Breathing Patient 30 Minute Mode Operation 6 Hour Mode Operation
Aerogen® USB Controller System Instruction Manual
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Aerogen USB Controller System
Aerogen Solo
2
1
3
4
5
Figure 1. Aerogen USB Controller System (Items Provided)
1. Aerogen USB Controller 2. Aerogen Nebuliser (Aerogen Solo or Aerogen Pro) 3. T-Piece & Silicone Plug 4. Cable Management Clips 5. Aerogen USB Controller AC/DC Adapter Visit www.aerogen.com for full parts list.
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Aerogen®
Aerogen Pro
Set Up Read and study all instructions before using the Aerogen USB Controller. Perform a functional test of the Aerogen nebuliser prior to use as described in the Functional Test section of this manual (see page 22). 1
Connect the Aerogen Solo or Aerogen Pro nebuliser by firmly pushing into the T-piece.
2
Connect the Aerogen USB Controller to the nebuliser as shown.
3
Insert the nebuliser and the T-piece* in the breathing circuit. * Adult T-piece shown here. For full instruction on T-piece location see page 14 (T-Piece Accessories).
Aerogen® USB Controller System Instruction Manual
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Alternative Set Up: The Aerogen Solo can be placed on the dry side of the humidifier.
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Connect the Aerogen USB Controller into the USB Port. Note: The Aerogen USB Controller can only be operated from a USB port on any medical electrical equipment approved to IEC/EN 60601-1 or Aerogen USB Controller AC/DC Adapter.
5
Open the plug on the nebuliser and use a pre-filled ampoule or syringe to add medication to the nebuliser. Close the plug. Note: To avoid damage to the Aerogen Solo, do not use a syringe with a needle.
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Aerogen®
To operate in 30 Minute Mode press the On/Off button once.
6 1s
7
> 3s
30 Min.
30 Min.
6 Hr.
6 Hr.
USB Controller
USB Controller
To operate in 6 Hour Mode press the On/Off button from the off mode for >3 seconds. Note: Verify the correct mode of operation is selected.
Verify that aerosol is visible.
Note: Clips are provided to assist with cable management.
Aerogen® USB Controller System Instruction Manual
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System Contraindication and Warnings Contraindication Do not use the Aerogen Solo nebuliser between the wye and a neonate patient. The total combined volume of the Aerogen Solo nebuliser, T-piece and/or HME may increase the dead-space to the extent that it adversely impacts the ventilatory parameters of the neonatal patient.
System Warnings Read and study all instructions before using the Aerogen USB Controller System. Only trained persons should operate the Aerogen USB Controller System, Aerogen Solo, Aerogen Pro and associated accessories. If this product is being used to treat a life threatening condition, a backup device is necessary. During use observe for correct functioning of the nebuliser by regularly verifying aerosol is visible and that no amber indicator lights are illuminated. Do not use a filter or heat-moisture exchanger (HME) between the nebuliser and patient airway. Only use with HME devices whose manufacturer’s instructions allow use with a nebuliser, and always follow the HME manufacturer’s instructions. Ensure that the total combined volume of nebuliser, T-piece with or without a HME is suitable for the tidal volume being delivered and does not increase dead space to the extent that it adversely impacts the ventilatory parameters of the patient. Always monitor the resistance to flow and excessive rain-out and change the HME device as per manufacturer’s instructions.
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Aerogen®
The Aerogen nebulisers, T-pieces and accessories are not sterile. The components and accessories of the Aerogen USB Controller System are not made with natural rubber latex. Only use physician-prescribed solutions that are approved for use with a general purpose nebuliser. Consult drug manufacturer’s instructions regarding suitability for nebulisation. Only use the Aerogen nebuliser technology with components specified in the instruction manuals. Use of the Aerogen nebuliser technology with components other than those specified in the Instruction Manual may result in increased emissions or decreased immunity of the nebuliser system. Do not place the Aerogen USB Controller in an incubator during use. To avoid exhaled medication affecting the ventilator, follow ventilator manufacturer’s recommendations for use of a bacterial filter in the expiratory limb of a breathing circuit. Do not use in the presence of flammable substances or flammable anaesthetic mixtures combined with air, oxygen or nitrous oxide. To avoid the risk of fire do not use to aerosolise alcohol-based medications, which can ignite in oxygen-enriched air and under high pressure. Do not modify this equipment without the authorisation of the manufacturer. Inspect all parts before use, and do not use if any parts are missing, cracked or damaged. In case of missing parts, malfunction or damage, contact your sales representative. Do not immerse or autoclave the Aerogen USB Controller or Aerogen USB Controller AC/DC Adapter. Do not microwave any parts. Aerogen® USB Controller System Instruction Manual
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Do not use or store outside of specified environmental conditions. Follow local laws and recycling plans regarding disposal or recycling of components and packaging. Do not use in the presence of devices generating high electromagnetic fields such as magnetic resonance imaging (MRI) equipment. The Aerogen USB Controller must be installed and put into service according to the EMC information provided in the Instruction Manual. Do not use the Aerogen USB Controller adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in this configuration. Portable and mobile radio frequency (“RF”) communication devices can disrupt medical electrical equipment. The Aerogen Solo is a single patient use device not to be used on more than one patient to prevent cross infection. Keep all cables tidy to avoid tripping or strangulation hazards and take particular care around children. Ensure that the Aerogen USB Controller cable is removed from the power supply host using the grip feature provided. Do not attempt to clean the device while in use. Do not obstruct the removal of the Aerogen USB Controller AC/DC Adapter from the mains. Do not store the Aerogen USB Controller System in a location where it is exposed to direct sunlight, extreme heat or cold, dust or moisture. Store out of reach of children.
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Aerogen®
Do not operate Aerogen USB Controller from USB ports on non-medical equipment. Condensate can collect and occlude ventilator circuits. Always position ventilator circuits so that fluid condensate drains away from the patient. Adult supervision is required when this product is used by children and individuals who require special assistance. To avoid damage to the Aerogen Palladium vibrating mesh technology: •• Do not apply undue pressure to the domed aperture plate in the centre of the nebuliser (Figure 2). •• Do not push out the Aerogen Vibronic® aerosol generator. •• Do not use a syringe with a needle to add medication. •• Do not use abrasive or sharp tools to clean the nebuliser. •• Prior to use, autoclave the Aerogen Pro and accessories according to specified directions and temperature given in the Cleaning, Disinfection and Sterilisation section of this Instruction Manual only. Any deviation from directions given in this Instruction Manual may cause damage to the nebuliser and render it inoperable.
Figure 2. Aerogen Palladium Vibrating Mesh Technology
Aerogen® USB Controller System Instruction Manual
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Use of the Aerogen Solo and T-piece during the administration of volatile anaesthetics may result in adverse effects on the constituent plastics. Do not use with volatile anaesthetics unless known to be compatible. Aerogen have determined that, using anaesthetic ventilators, the following volatile anaesthetic agents are compatible under the stated conditions below:
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Anaesthetic Agent
Proprietary Name
Maximum Percentage of Anaesthetic
Maximum Duration of Exposure
Isoflurane
FORANE®
3.5 %
12 hours
Sevoflurane
SEVOFLURANE®
8%
12 hours
Desflurane
SUPRANE®
10 %
12 hours
Aerogen®
Controls & Indicators
30 Minute Mode Indicator light 30 Min. 6 Hr.
6 Hour Mode Indicator light On/Off Control USB Controller
Figure 3. Aerogen USB Controller Controls & Indicators Table 2. Aerogen USB Controller Controls & Indicators Control / Indicator
Function
30 Min. Indicator
• Green = 30 Minute nebulisation cycle on. • Amber = Nebuliser disconnect. • Aerogen USB Controller automatically powers off after 30 minutes have elapsed.
6 Hr. Indicator
• Green = 6 Hour nebulisation cycle on. • Amber = Nebuliser disconnect. • Aerogen USB Controller automatically powers off after 6 hours have elapsed.
Error Indicator
• 30 Minute and 6 Hour Indicators flash amber alternatively twice = Internal error condition. Aerogen USB Controller automatically powers off.
On/Off Power Button
• To operate in 30 Minute Mode press the On/Off button once. • To operate in 6 Hour mode press and hold the On/Off button for greater than 3 seconds. • Pressing during nebulisation turns off power to the nebuliser.
Aerogen® USB Controller System Instruction Manual
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Accessories T-Pieces - Connection To A Breathing Circuit Adult & Paediatric Circuit For adult and paediatric patients, connect the nebuliser with T-piece into the inspiratory limb of the breathing circuit before the patient Y.
Neonate Circuit Connect the nebuliser with the paediatric T-piece and the neonate adapters approximately 30 cm (12 in.) back from the patient Y. Alternatively connect the nebuliser with the Neonate T-piece 30cm (12 in.) back from the patient Y.
Dry Side of the Humidifier The Aerogen Solo can be placed on the dry side of the humidifier as shown. The Aerogen Solo can be used with a nasal interface in this configuration. The Aerogen Pro is not recommended for use on the dry side of the humidifier.
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Aerogen®
Between the Wye and Endotracheal Tube The Aerogen Solo can be placed between the wye and endotracheal tube as shown. The Aerogen Solo can be used with a Heat and Moisture Exchange Device (HME) which may contain a filter.
Between the HME and Endotracheal Tube Only a HME approved for use with a nebuliser should be used in this configuration (as shown). Follow the HME manufacturer instructions regarding use with a nebuliser. Ensure the total combined volume of nebuliser, T-Piece with or without a HME is suitable for the tidal volume being delivered. Do not use a nebuliser between the wye and neonate patient. Please refer to contraindication on page 8. See Table 5 for T-piece volumes.
Note: Always perform a leak test of the breathing circuit after inserting or removing the nebuliser. Follow ventilator manufacturer instructions for performing a leak test. For additional T-piece Adapters visit www.aerogen.com for full parts list.
Aerogen® USB Controller System Instruction Manual
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Connection To A Face Mask - Mouthpiece (Hospital Use Only) Face Mask Mask kits, which include a vented elbow and mask elbow, are available separately (visit www.aerogen.com for full parts list). Note: When using a mask, connect the vented elbow, mask elbow and mask to the nebuliser by firmly pushing the parts together. Rotate the vented elbow to suit the position of the patient.
Mouthpiece When using a standard ISO 22 mm mouthpiece, connect the nebuliser to the T-piece as shown, and connect the T-piece to the mouthpiece by pushing the parts firmly together. Note: To ensure correct nebulisation, maintain the nebuliser in a vertical orientation.
Use With A Nasal Interface The Aerogen Solo can be used on/off ventilator with a nasal interface when configured with a humidifier.
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Aerogen®
Aerogen® Ultra (Hospital Use Only) The Aerogen Ultra is an accessory specific to the Aerogen Solo nebuliser. It facilitates intermittent and continuous nebulisation and optional supply of supplemental oxygen to paediatric and adult patients via mouthpiece. The device can alternatively be used with the I-Guard™ Aerosol Mask, as supplied. It is a single patient use device which is qualified for 20 intermittent use treatments (at a rate of four 3 mL doses per day over 5 days) or 3 hours of continuous use. Optimal aerosol delivery is achieved with valved mouthpiece or valved aerosol face mask with low/no oxygen flow. Inspect for device integrity and correct valve placement prior to use.
Mouthpiece Face Mask
Aerogen Ultra Aerogen Solo
Oxygen Tubing
Figure 4. Assembly of Aerogen Ultra
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1. Insert Aerogen Solo nebuliser firmly into Aerogen Ultra in orientation shown in Figure 4. 2. If supplemental oxygen is required, firmly attach oxygen tubing to Aerogen Ultra. Note: Oxygen flow rate should be set between 1-6 LPM. 3. If a face mask is required, remove mouthpiece and attach face mask to Aerogen Ultra. Note: When using an open face mask, a minimum oxygen flow of 1 LPM is required. 4. Add medication to Aerogen Solo. 5. Connect cable to Aerogen Solo and power on controller. 6. Introduce Aerogen Ultra to patient and observe aerosol flow to ensure correct operation. 7. Remove excess rainout from the Aerogen Ultra periodically (hourly with continuous nebulisation). 8. To ensure optimum performance of the Aerogen Ultra, remove any residue by rinsing through with sterile water, shake off excess and allow to air dry. Warnings • •
• • • •
Do not use with a closed face mask. When using with an open face mask, always use supplemental oxygen flow of 1-6 LPM. Performance of the Aerogen Ultra may vary depending upon the type of drug and Aerogen Ultra configuration used. Do not exceed recommended oxygen flow for system. Ensure oxygen connection port or tubing is not occluded. Do not use Aerogen Ultra without a mouthpiece or face mask. Visually check Aerogen Ultra post-rinsing to ensure that valves have not become dislodged. Do not cover Aerogen Ultra valves during use. Do not use Aerogen Ultra in conjunction with the Aerogen Pro. Do not autoclave any component of the kit. Ensure tubing is safely orientated to prevent strangulation hazard.
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Aerogen®
• • • • •
Continuous Nebulization Tube Set (Hospital Use Only) The Aerogen Continuous Nebulization Tube Set is an accessory specific to the Aerogen Solo nebuliser which enables safe continuous infusion of liquid medication for aerosolisation. Note: Place the syringe cap on the syringe after it is filled with medication. Tethered Silicone Plug Tubing (Nebuliser End) Syringe Cap
A
Tubing Syringe
Tubing (Syringe End)
Figure 5. Continuous Nebulization Tube Set
1. Ensure the Aerogen Solo nebuliser is firmly fitted into the Aerogen Solo T-piece in the breathing circuit. 2. Remove the syringe cap from the medication-filled syringe. 3. Attach the syringe end of the tubing onto the syringe. 4. Prime the tubing until the medication reaches end of tubing (Point A) Note: The tubing priming volume is maximum 3.65 mL. 5. Unplug the tethered silicone plug from the Aerogen Solo nebuliser, but do not remove it from the nebuliser. 6. Screw the nebuliser end of the tubing onto the top of the nebuliser. Aerogen® USB Controller System Instruction Manual
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