ResMed BILEVEL Adaptive Servo Ventilator User Guide

ResMed BILEVEL Adaptive Servo Ventilator

Please ensure that you read any specific references in this user guide that apply to your product type. Use the following list to identify your product type:

• Bilevel – VPAP™ ST-A devices
• Adaptive Servo Ventilator (ASV) – AutoSet CS™

This manual is specific to your device. Do not use with other devices. Information for clinicians is available in the clinical guide.

Indications for Use

Your device is intended for home and hospital use.

Bilevel

Your bilevel ventilator device is intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnoea (OSA).

Adaptive Servo Ventilator (ASV)

Your adaptive servo ventilator device is intended to stabilize the ventilation of adult patients exhibiting Cheyne-Stokes Respiration (CSR), or central sleep apnoea (CSA) associated with congestive heart failure, with or without upper airway obstruction. It is also intended for the treatment of patients with obstructive sleep apnoea (OSA).

Contraindications

Positive airway pressure may be contraindicated in some patients with the following  conditions:

• pneumothorax or pneumomediastinum
• pathologically low blood pressure, particularly if associated with intravascular volume depletion
• cerebrospinal fluid leak, recent cranial surgery or trauma
• severe bullous lung disease

Adverse Effects
You should report unusual chest pain, severe headache or increased breathlessness to your prescribing physician. An acute upper respiratory tract infection may require temporary discontinuation of treatment.
The following side effects may arise during the course of therapy with the device:

• drying of the nose, mouth or throat
• bloating
• ear or sinus discomfort
• eye irritation
• skin rashes nosebleed.

Masks and Humidifiers
Recommended masks and humidifiers are available from your place of purchase. For information on using your mask or humidifier, refer to the user guide supplied with your mask or humidifier.
Setting up your Device
Refer to illustration A on page 1.

1. There are two sockets at the rear of your device. Insert the power cord into the top socket and push the locking clip (a) down to hold the cord in place.
2. Plug the other end into a power outlet.
3. Connect the air tubing to the air outlet of the device.

ASV only: To attach the pressure sensor tube (b) to the device, screw the Luer connector (c) onto the socket (d) on the side of the device. Ensure all components have been correctly assembled and check for any split or damaged parts.
ASV air tubing is assembled as follows (refer to illustration B on page 1):
(1) Proximal cuff; (2) Air tubing; (3) Pressure sensor tube; (4) Tube clip; (5) Luer connector.
2. Connect the assembled mask system to the free end of the air tubing.

ASV only: Attach the mask to the end of the air tubing with the proximal cuff (e).

WARNING

• Make sure the power cord and plug are in good condition and the equipment is not
• Only ResMed air tubing should be used with the A different type of air tubing may alter the pressure you actually receive and reduce the effectiveness of your treatment.
• Blocking the tubing and/or air inlet of the device while in operation could lead to overheating of the
• Use care when handling the air Be particularly careful when attaching the Luer connector to the device. If you kink or excessively twist the sensor tube, it may affect the protection offered by the mask pressure alarm system.

CAUTION

• Be careful to place the device where it cannot be bumped, and where no one will trip over the power
• If you put the device on the floor, make sure the area is free from dust and clear of bedding, clothes or other objects that could block the air
• Make sure the area around the device is dry and clean. Take care when using liquids around the

Device Control Panel

Refer to the control panel (illustrations C and D on page 1) that best matches your device.

Your  control panel may have the following items:

(1)  Start/Stop; (2) LCD screen; (3) Up and Down keys; (4) Enter key; (5) Exit key; (6) Left key; (7) Right key; (8) Alarm Mute; (9) LEDs; (10) QuickView.

Starting Treatment

1. Turn the main power switch at the back of the unit to on ( I ).
2. Lie down and arrange the air tubing so that it is free to move if you turn in your

ASV only: Select your mask type and run Learn Circuit.

To start treatment, press . (If SmartStart™/Stop is enabled on your device, breathing into your mask should start therapy automatically.)
Fit your mask as described in the mask user instructions.

WARNING

A mask should not be used unless the device is turned on and operating properly.

CAUTION

Do not leave long lengths of air tubing around the top of your bed. They could twist around your head or neck while you are sleeping.
Stopping Treatment
To stop treatment at any time, remove your mask and press or, if your device has SmartStart/Stop enabled, simply remove your mask and treatment will end.

Using the Menus

Key Functions
Up and Down keys: Scrolls through menus and setting options. Enter key: Enters menus; changes options; applies settings. Exit key: Exits menu or setting.
Left key: Enters menus; changes options; applies settings. Right key: Exits menu; cancels operation.
Menu Settings
Some menu items may not be available on your model.
Ramp: Period during which the device increases from a low pressure to the prescribed treatment pressure.
Learn Circuit: Allows the device to ‘learn’ what pressure it needs to build in to its calculations, based on the components in the system. Select every time you add or remove a component.
Mask: Selects your mask type.
Tube Length: Selects the length of air tubing.
Humidifier: Selects the type of humidifier used with your device. SmartStart/Stop: Turns the SmartStart/Stop function on or off. Leak Alert/Mask Alarm: If enabled, sounds an alarm when a high mask leak is detected.
Alarm Vol/Test: Sets the alarm volume and tests the alarm. Backlight: Sets LCD backlight to permanently on (ON) or to turn off after two minutes if no key is pressed (AUTO).
Clock: Sets the time and date.
Language: Selects the LCD display language.
Low PS: LOW PS is displayed if your clinician has enabled the Insufficient Pressure Support alarm.
Alarms
To mute an alarm, press the Alarm Mute key once.
Power failure is indicated by the LCD turning off and:

•  two alternating continuous tones and a red flashing LED, or

• a single intermittent tone and yellow flashing LED.
  The alarm will stop if you press the Alarm Mute key or after two minutes or when power is restored.
  A single intermittent tone and yellow flashing LED will alert you to the following alarm conditions. Follow the steps below to resolve.

•  If any of the following messages appear on your LCD screen: PRESSURE ERROR
  IPAP LOWER ALARM
  SENSOR ERROR
  SYSTEM ERROR
  return your device to your place of purchase.

• If any of the following messages appear on your LCD screen: CHECK TUBE
  LOW PRES ALARM
  LOW PRESSURE
  (1) check that the air tubing and pressure sensor tube (ASV only) are connected properly; (2) turn the device off and on again at the power switch and, if the alarm persists, return to your place of purchase.

• If any of the following messages appear on your LCD screen:
  LOW PS
  LOW MV
  (1) treatment stops; (2) turn power off; (3) check that the air tubing and pressure sensor tube (ASV only) are connected properly and not obstructed; (4) turn the device on again; (5)(ASV only) perform Air Circuit Learn functions; (6) try using the device one more time and, if the alarm persists, return to your place of purchase.

• If the following message appears on your LCD screen:
  FLOW BLOCKED
  (1) treatment stops; (2) turn power off; (3) check and remove any blockage in the air circuit; (4) turn the device on again; (5) try using the device one more time and, if the alarm persists, return to your place of purchase.

• If the following message appears on your LCD screen:
  HIGH LEAK
  adjust the mask to minimise leak.

• If the following message appears on your LCD screen: NVENT ALARM
  NO MASK VENT
  ensure your mask vent holes are not blocked and, if the alarm persists, contact your place of purchase.

ResLink™
The ResLink is an optional accessory that records data during your therapy so your clinician can observe your progress and adjust settings if necessary. For full details on using the ResLink, refer to the ResLink user guide.

Using a Battery to Power the Device

Information regarding suitable DC and battery power supplies for your device can be found on www.resmed.com on the Products page under Service & Support > Ventilation Accessories.
Adding Supplemental Oxygen
Up to 15 L/min of oxygen can be added at the mask or at an oxygen connector between the device (or integrated humidifer) and the air tubing while still providing safe and effective therapy.
WARNING
When oxygen is added, always ensure that you verify the correct operation of triggering and cycling, and activation of mask alarm when enabled.
Using an Antibacterial Filter
If supplied by your clinician, antibacterial filters can be used with your device. Fit the antibacterial filter to the air outlet of the device (or integrated humidifier). Follow the manufacturer’s recommendation on the replacement schedule.

Cleaning and Maintenance

Daily:
Disconnect the air tubing and hang it in a clean, dry place until next use.
Weekly:

1. Remove the air tubing and wash it in warm water and mild detergent. Rinse thoroughly, hang and allow to dry.
2. Before next use, reassemble the mask and headgear.
3. Reconnect the air tubing

Monthly:

1. Clean the exterior of the device with a damp cloth.
2. Check the air filter for holes and blockage by dirt. Replace it every six months, or more often in a dusty environment.
3. Check for any split or damaged components.
   For information on cleaning your mask or humidifier, refer to the user guide supplied with your mask or humidifier.

WARNING
Beware of electric shock. Do not immerse the device or power cord in water. Always unplug the device before cleaning and make sure it is dry before reconnecting.

CAUTION

• Do not hang the air tubing in direct sunlight as it may harden over time and eventually crack.
• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean the air tubing or the device. These solutions may cause hardening and reduce the life of the product.

Changing the Air Filter

1. Disconnect the power cord and air tubing.
2. Remove the air filter from the air inlet at the back of the device.
3. Put the new air filter into the air inlet with the blue side facing out from the device.

Technical Specifications

• Operating pressure range
  2 to 30 cm H2O (Bilevel) 4 to 20 cm H2O  (ASV)

• Power supply
  Input range 100–240V, 50/60Hz; 100V, 400Hz (VPAP ST-A  with QuickNav only) ASV: 60VA VPAP: 2.2A

• Operating temperature
  +5°C  to +35°C

• Operating humidity
  10–95% non-condensing

• Storage and Transport Temperature
  -20°C  to +60°C

• Storage and Transport Humidity
  10–95% non-condensing

• Atmospheric pressure range
  1013 hPa (sea level) to 700 hPa (2,591 m) (Bilevel)
  1060 hPa (sea level) to 680 hPa (2,591 m) (ASV)

Additional Information
Additional technical specifications and information can be found in the device-specific user guide on www.resmed.com on the Products page under Service & Support.
Electromagnetic Compatibility
Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for residential, commercial and light industry environments. The electromagnetic compatibility tables for these ResMed devices can be found
on www.resmed.com on the Products page under Service & Support. Click on the PDF file for your device.
Aircraft Use
Please consult ResMed and the medical services department of your carrier if you intend to use your device on an aircraft.
The manufacturer reserves the right to change these specifications without notice.
Symbols that may Appear on the Product

Environmental Information

This device should be disposed of separately, not as unsorted municipal waste. To dispose of your device, you should use appropriate collection, reuse and recycling systems available in your region. The use of these collection, reuse and recycling systems is designed to reduce pressure
on natural resources and prevent hazardous substances from damaging the environment. If you need information on these disposal systems, please contact your local waste administration. The crossed-bin symbol invites you to use these disposal systems. If you require information on collection and disposal of your ResMed device please contact your ResMed office, local distributor or go to www.resmed.com/environment.
General Warnings and Cautions
Warnings

• Read the entire guide before using the device.

• The device is NOT a life support ventilator and may stop operating with power failure or in the unlikely event of certain fault conditions.

• Advice contained in this guide should not supersede instructions given by the prescribing physician.

• A patient should not connect a device to the data communication port unless instructed to do so by their health care provider or physician. Only ResMed products are designed to be connected to the data communication port. Connecting other devices could result in injury, or damage to the device.
  (Data communication ports are not available on all devices.)

• The device should be used with masks (and connectors)* recommended by ResMed, or by a physician or respiratory therapist. A mask should not be used unless the device is

• In the event of power failure or machine malfunction, remove the mask.

• In certain fault conditions, pressures up to 40 cm H2O are possible.

• If oxygen is used with this device, the oxygen flow must be turned off when the device is not operating. If oxygen has been left on, turn off the device, then wait 30 minutes before turning on the device again.
  Explanation: When the device is not in operation and the oxygen flow is left on, oxygen delivered into the air delivery tubing may accumulate within the device enclosure and create a risk of fire. This applies to most types of positive airway pressure devices.

• Oxygen supports combustion. Oxygen should not be used while you are smoking or in the presence of an open flame.

• Always ensure airflow is being generated by the device before the oxygen supply is turned on.

• Always turn the oxygen supply off before stopping the airflow from the device.
  Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on where the oxygen is introduced, the pressure settings, patient breathing pattern, mask selection, and leak rate.

• Do not use the device if there are obvious external defects, unexplained changes in performance or unusual noises.

• Do not open the device case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorised service agent.

• Explosion hazard – do not use in the vicinity of flammable anaesthetics.

• The device should not be used with anaesthetised patients.

• The device should not be connected to both AC and DC power sources simultaneously (unless otherwise specified by ResMed).

• In the clinical environment any PC that is used with the device must be at least 1.5 m away from, or at least 2.5 m above the patient. It must also comply with IEC 60950 or equivalent.

Cautions

1. At low pressures, the flow through the exhalation ports of your mask may not clear all exhaled gas from the tubing. Some rebreathing may occur.
2. The air temperature for breathing produced by this device can be as much as 6ºC higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 32ºC.
3. Do not remove any attached accessories while power is connected to your device.

Note: The above are general warnings and cautions. Specific warnings, cautions, and notes appear with the relevant instructions in this user guide.

Servicing

The device should be inspected by an authorised ResMed service centre five years from the date of manufacture. Before this, the device is intended to provide safe and reliable operation if it is operated and maintained according to the instructions provided by ResMed. Warranty details are provided with the device at the time of original supply. As with all electrical devices, if any irregularity becomes apparent, you should have the device inspected by an authorised ResMed service centre.
Limited Warranty
ResMed warrants that your ResMed device shall be free from defects in material and workmanship for a period of two years from the date of purchase by the initial consumer. This warranty is not transferable.
If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components. This Limited Warranty does not cover:

• any damage caused as a result of improper use, abuse, modification or alteration of the product;
•  repairs carried out by any service organisation that has not been expressly authorised by ResMed to perform such repairs;
• any damage or contamination due to cigarette, pipe, cigar or other smoke;
•  any damage caused by water being spilled on or into the product.

Warranty is void on product sold, or resold, outside the region of original purchase. Warranty claims on defective product must be made by the initial consumer at the point of purchase.
This warranty is in lieu of all other express or implied warranties, including any implied warranty of merchantability or fitness
for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.
ResMed shall not be responsible for any incidental or consequential damages claimed to have occurred as a result
of the sale, installation or use of any ResMed product. Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from region to region. For further information on your warranty rights, contact your local ResMed dealer or ResMed office.

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Environmental policy - ResMed

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