ResMed

Stellar 100 User Guide Feb 2011

User Guide

30 Pages

File Type: PDF

File Size: 5.06 MB

File Name: stellar_100_user_guide_feb_2011.pdf

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Page 1

Stellar™ 100 Invasive and noninvasive ventilator

User Guide English

Stellar™ 100 User Guide English

Contents Introduction... 1 Indications for use Contraindications Adverse effects

1 1 1

The Stellar 100 system... 2 Setting up the device... 3 Setting up the device for non-invasive use Attaching the H4i heated humidifier for non-invasive use Setting up the device for invasive use Attaching the pulse oximeter Adding supplemental oxygen Attaching antibacterial filters Using the device when mobile Using an external power supply unit

3 3 4 4 5 5 5 6

Using the Stellar 100... 6 Control panel LCD screen Operating functions Functional test Starting therapy Therapy settings Using mask-fit Stopping therapy Using the internal battery Use of the ResMed USB stick Turning off the device Optional device settings

6 6 7 8 9 9 10 10 10 10 11 11

Alarms... 12 Alarm display Muting alarms Setting the alarm volume Testing the alarm

12 13 13 13

Cleaning and maintenance... 13 Daily Weekly Monthly Replacing the air filter Disinfection Internal battery Maintenance reminder Servicing

13 13 14 14 14 14 14 14

Troubleshooting... 15 Technical specifications... 19 Guidance and manufacturer’s declaration – electromagnetic emissions and immunity Symbols

20 22

General warnings and cautions... 22 Limited warranty... 24

Introduction The Stellar 100 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (13kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnoea. The device is for non-invasive use, or invasive use with an uncuffed or deflated tracheostomy. Users of the device include patients and their caregivers, physicians, nurses, respiratory therapists and other clinical staff. Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

English

Indications for use

Contraindications The Stellar 100 is contraindicated in patients who are unable to endure more than brief interruptions in ventilation. The Stellar 100 is not a life support ventilator. If you have any of the following conditions, tell your doctor before using this device: • 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 • dehydration.

Adverse effects You should report unusual chest pain, severe headache or increased breathlessness to your prescribing physician. The following side effects may arise during the course of non-invasive ventilation with the device: • drying of the nose, mouth or throat • nosebleed • bloating • ear or sinus discomfort • eye irritation • skin rashes.

Introduction

The Stellar 100 system Handle

Oxygen inlet LCD screen Control panel

Air outlet Infrared connection for humidifier AC connection for H4i humidifier

Air filter cover

Oximetry connection Oxygen sensor connection Data communication ports DC power socket AC power socket Power-on/stand-by switch

The Stellar 100 comprises the following elements: • Stellar 100 device • Hypoallergenic air filter • AC power cord • Carry bag • 2 m air tubing • ResMed USB stick • Low pressure oxygen connector. The following optional accessories have been validated for use with the Stellar 100: • 3 m air tubing • SlimLine™ air tubing • Clear air tubing • H4i heated humidifier • Antibacterial filter • ResMed XPOD oximeter • Nonin™ pulse oximetry sensors • Mobility bag • ResMed leak port • Tubing wrap • Heat moisture exchanger filter.

WARNING The Stellar 100 should be used with air tubing and accessories recommended by ResMed. Connection of other air tubing or accessories could result in injury or damage to the device. ResMed regularly releases new products. Please check the catalogue of ventilation accessories on our website at www.resmed.com.

Setting up the device English

Setting up the device for non-invasive use

1 3 AC locking clip

AC power cord

Note: For stationary use, place the device on a flat surface near the head of your bed.

WARNING •

•

• •

The air filter cover protects the device in the event of accidental liquid spillage onto the device. Ensure that the air filter and air filter cover are fitted at all times. Make sure that all the air inlets at the rear of the device and under the device and vents at the masks or at the leak port are unobstructed. 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 inlets. Use only ResMed air tubing with this device. Different types of air tubing may alter the pressure you receive and reduce the effectiveness of your treatment. Do not use conductive or antistatic hoses or tubes. Do not leave long lengths of the air tubing or the cable for the finger pulse sensor around the top of your bed. It could twist around your head or neck while you are sleeping.

CAUTION •

Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord. • Make sure the area around the device is dry and clean. Note: ResMed recommends using the AC power cord supplied with the unit. If a replacement power cord is required, contact your ResMed service centre.

Attaching the H4i heated humidifier for non-invasive use The H4i heated humidifier attaches to the front of the Stellar 100 to provide heated humidification. The device automatically detects the presence of the humidifier. A humidifier is recommended at all times when stationary (except when mobile), especially for patients experiencing dryness of the nose, throat or mouth. For information on using the H4i, see your humidifier user guide.

WARNING • • •

Always place the H4i on a level surface below the level of the user to prevent the mask and tubing from filling with water. Make sure that the water chamber is empty and thoroughly dried before transporting the humidifier. The H4i heated humidifier is not intended for mobile use.

Setting up the device

Notes: • Effective humidification can be achieved up to 25 cm H2O. • The H4i is disabled when the device is not AC powered. • A tubing wrap can help if high humidification is causing water condensation within the tube.

Setting up the device for invasive use 2 ResMed leak port Antibacterial filter External humidifier*

HMEF* Catheter mount

Air tubing

AC locking clip AC power cord

When using this setup, select the mask type “Trach” in the Advanced settings of the Clinical settings menu. * A heat moisture exchange filter (HMEF) can be connected in place of an external humidifier. ResMed recommends using a circuit system with an impedance of maximum 2 cm H2O at 30 L/min, 5 cm H2O at 60 L/min and 16 cm H2O at 120 L/min.

WARNING • •

The HMEF has to be replaced regularly as specified in the manufacturer’s instructions of use. The H4i is contraindicated for invasive use. An external humidifier approved for invasive use is recommended according to EN ISO 8185.

Attaching the pulse oximeter

2 Use of a pulse oximeter may be recommended by your clinician.

Contraindication The pulse oximeter does not meet defibrillation-proof requirement per IEC 60601-1: 1990, clause 17.h.

Adding supplemental oxygen 2 Oxygen supply

English

Note: Up to 30 L/min at maximum oxygen pressure of 50 mbar can be added.

Press spring to release connection after use

Attach oxygen only to the specified oxygen connection of the device.

WARNING • • • •

Use only certified, clean oxygen sources. Oxygen flow must be turned off when the device is not operating, so that unused oxygen does not accumulate within the device and create a risk of fire. Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an open flame. Only use oxygen supply in well-ventilated rooms. The patient circuit and the oxygen source must be kept at a minimum distance of 2 m away from any sources of ignition (eg, electrical devices).

Attaching antibacterial filters

2 The use of an antibacterial filter may be recommended by your clinician. Antibacterial filters can be purchased separately from ResMed. Regularly check the filter for entry of moisture or other contaminants. The filter must be changed according to the manufacturer’s specifications. Always perform the Learn circuit function when changing filter types (see “Optional device settings” on page 11).

CAUTION Do not use the antibacterial filter with the H4i heated humidifier.

Using the device when mobile The mobility bag is intended for mobile use of the Stellar 100. It protects the device against dust and water. For longer mobile use, power the device using the ResMed Power Station II

Setting up the device

external power supply unit or other DC power supply that meets the required voltage and current specifications. For setup and correct use please read the User Guide of the mobility bag.

Using an external power supply unit You can operate the Stellar 100 with the ResMed Power Station II. The ResMed Power Station II is an external lithium ion battery that allows operation of the Stellar 100 where mains power is not available, and can also provide a power back-up in case of an unexpected disruption of the mains supply. For setup and correct use please read the ResMed Power Station II User Guide.

Using the Stellar 100 Control panel Mains power External power supply Internal battery

Monitoring menu

Setup menu

Alarm

Alarm mute button

Info menu

LCD screen Push dial (rotate/click)

Therapy LED Start/stop button

LEDs Therapy LED blue-on during treatment and flashes during mask fitting operation. The therapy LED can be disabled by the clinician. Alarm LED red/yellow-on during an alarm condition or during alarm testing. Power supply LEDs green-on when operating correctly. Internal Battery-when the internal battery is in use, the yellow light/LED is on. The LED flashes when the device is turned off and the battery is charging. Alarm mute LED yellow-on when the alarm mute button is pressed.

LCD screen The LCD screen displays the menus, monitoring screens and alarm status. To assist you in adjusting the device, the keypad and LCD are equipped with a backlight. The LCD backlight indicates when the device is turned on, when you press a key or an alarm occurs. The LCD backlight may be set to be on continually (see “Optional device settings” on page 11). If the backlight is set to Auto and no actions are performed for five minutes, the backlight dims.

Warm-up feature H4i

DC voltage*

Therapy mode

Internal battery

Patient mode Clinical mode

Title bar

English

Ramp time Program

ResMed USB stick Mains power

Current screen/number of screens within the menu

Settings Scroll bar

Therapy status bar *Only available when an external power supply unit is connected.

Operating functions Key

Function

Start/Stop

• Starts or stops treatment. • Extended hold for at least three seconds starts the maskfitting feature.

Alarm mute

• During therapy: Press once to mute an alarm. Press a second time to un-mute an alarm. If the problem is still present, the alarm will sound again after two minutes. See “Muting alarms” on page 13. • In stand-by mode: Extended hold for at least three seconds starts the alarm LED and alarm buzzer test.

Menu keys

Press the appropriate menu button (monitoring, setup, info) to enter and scroll through the relevant menu. The Monitoring menu comprises the following screens: treatment, monitoring of treatment settings, pressure/flow, minute ventilation/target alveolar ventilation, leak, tidal volume, synchronisation, oximetry (optional). On the Treatment screen you have several settings (see “Therapy settings” on page 9). In the Setup menu you will find the therapy and alarm settings of the Stellar 100. In the options sub menu you can change device settings (see “Optional device settings” on page 11). The Info menu allows you to view the following screens: Therapy statistics, used hours, events during device operation, reminder and device information.

Using the Stellar 100

Key

Function

Push dial

The Push dial acts as an enter/select button. Change between settings: Rotate the Push dial. The selected button is marked dark blue. Enabling a setting for change: Press the Push dial. The setting will be marked in orange. Change a setting: Rotate the Push dial to change the setting value. Confirm setting change: Press the Push dial within three seconds or setting change times out.

Functional test Make sure your device is functioning properly each time before starting therapy.

1 Check that the device is turned off. 2 Check condition of device and accessories. Inspect the device and all the provided accessories (eg, air tubing, mask, humidifier, antibacterial filter, oximetry, oxygen supply, ResMed leak port, catheter mount). If there are any visible defects, the system should not be used.

3 Check the patient circuit setup. Check the integrity of your patient circuit (device and provided accessories) according to the setup descriptions in this User Guide and that all connections are secure.

4 Turn on the device and test alarms. Press the power switch at the back of the device once to turn on the device. Check that the alarm sounds a test beep and the LEDs for the alarm signal and the alarm mute button flash. The device is ready for use when the treatment screen is displayed. If the display shows the Reminder page, follow the instructions, then press the Monitoring menu button to display the Treatment screen.

5 Check batteries. Disconnect the device from the mains and external battery (if in use) so that the device is powered by the internal battery. Check that the Battery use alarm is displayed and the battery LED is on. Note: If the charge state of the internal battery is too low, or if the battery is empty, an alarm occurs. See the Alarm troubleshooting section for further information. Reconnect the external battery (if in use) and check that the LED for the DC power supply is lit. The External DC power use alarm will be displayed and the alarm LED will light. Reconnect the device to the mains.

6 Check humidifier (if in use). Check that the warm-up feature is displayed in the Treatment screen. Start the warm-up feature. Check that the humidifier warm-up symbol is displayed on top of the screen.

7 Check oximeter (if in use). Attach the accessories according to the setup descriptions (see “Attaching the pulse oximeter” on page 4) and go to the Monitoring page in the Monitoring menu. Check that the values for SpO2 and Heart rate are displayed.

8 Check oxygen connection (if in use). If any problems occur, please read the troubleshooting section in this User Guide. Please also check other provided User Instructions of your accessories for troubleshooting information.

1 Turn on your device. 2 Fit your patient interface (mask or catheter mount) as described in the user instructions. 3 Lie down and arrange the air tubing so that it is free to move if you turn in your sleep or arrange the tubing so it is comfortable in your wheelchair.

4 To start treatment, press

or if the SmartStart/Stop function is enabled, simply breathe into your patient interface and treatment will begin.

English

Starting therapy

CAUTION The Clinical mode

is only for clinicians. If the device is operating in clinical mode

press the power switch to re-start the device in patient mode . Note: If the circuit configuration has changed, ensure that the Learn circuit function is performed before fitting your patient interface (see “Optional device settings” on page 11).

Therapy settings Setting the mask type For information on using masks, see your mask user guide. For the latest available masks, see www.resmed.com. To set the mask type, go to the Settings menu, Clinical settings, Advanced settings.

WARNING Perform the Learn circuit function before the first use and each time any changes are made to the circuit. You must also check the correct setting of the patient interface. Failing to perform these actions may mean that under certain set pressures and combinations of air delivery components that alarms, eg, Leak alarm, fail to activate. Note: When the mask type is set to “Trach” or “Full Face” the Non-vented mask alarm is enabled.

Change settings in Treatment screen The treatment screen is displayed when the device is turned on. Depending on your configuration and settings, the functions set ramp, warm up humidifier or set program may be available (explanations see below). To change a setting proceed as follows:

1 From your treatment screen turn till the required setting is displayed in dark blue. 2 Press . The selection is highlighted in orange. 3 Turn until the setting you require is displayed. 4 Press within three seconds to confirm your choice or setting change times out. Ramp time Ramp time is a feature that can be enabled by your clinician by setting a maximum ramp time. Designed to make the beginning of treatment more comfortable, ramp time is the period during which the pressure increases from a low start pressure to the treatment pressure. Program Your clinician can set two programs with the therapy and alarm settings appropriate to your therapy and set the program availability on the treatment screen. Using the humidifier warm-up function The H4i heated humidifier will be automatically detected when the device is turned on. The treatment screen will give you the option to start warming up the humidifier prior to starting treatment. If the humidifier is heating, the related symbol is displayed at the top of the LCD screen. Note: The H4i can only be used when the device is connected to mains supply.

Using the Stellar 100

Using mask-fit You can use mask-fit to help you fit your mask properly. This feature delivers treatment pressure for a three-minute period, prior to starting treatment, during which you can check and adjust your mask-fit to minimise leaks.

1 Fit your mask as described in the mask user guide. 2 Hold down for at least three seconds until air pressure delivery starts. 3 If necessary, adjust your mask, mask cushion and headgear until you have a good mask fit. You can end mask-fit at any time by pressing . After three minutes, treatment will begin. Notes: • Press for at least three seconds during mask-fit to start the treatment immediately. The treatment screen will be displayed. • The mask-fitting feature is disabled when the mask type “Trach” is selected.

Stopping therapy To stop treatment at any time, remove your patient interface and press or if the SmartStart/Stop function is enabled, simply remove your mask. Notes: • The SmartStop function is disabled if the mask type “Full Face”, “Trach” or special alarms have been set by your clinician. The function is also disabled if the mask-fitting feature is running. • When the device is stopped and operating in standby mode with integrated humidifier it will continue to blow air gently to assist cooling of the heater plate. • Masks with high resistance (eg, pediatric masks) may cause the operation of the SmartStop feature to be restricted.

Using the internal battery In case of a mains disruption, the device will operate using the internal battery if there is no external battery connected to the device. The internal battery will operate for approximately two hours under normal conditions (see “Technical specifications” on page 19). The power status of the battery is displayed on top of the LCD screen. Check the battery status regularly while operating the device with the internal battery and connect the device in time to mains power or alternatively to the external battery. To recharge the internal battery, connect the Stellar 100 to mains power. It will take approximately three hours to fully recharge the internal battery, however this can vary depending on environmental conditions and if the device is in use. Note: The battery duration depends on the state of charge, the environmental conditions, the Stellar 100 settings and the patient circuit setup.

Use of the ResMed USB stick A ResMed USB stick may be used with the Stellar 100 either to help your clinician to monitor your treatment or to provide you with updates to your device settings. You can connect one ResMed USB stick to one of the data communication ports at the rear of the device. The Stellar 100 checks the USB stick and opens a dialogue for the data transfer. The various operations are described in the following table.

Function

Description

Read settings

The settings will be transfered from the connected ResMed USB stick to the Stellar 100.

Write settings / Write settings and loggings

The settings or the settings and loggings of the Stellar 100 will be saved on the connected ResMed USB stick.

Description

Cancel

Data transfer will be cancelled. You can also disconnect the ResMed USB stick to Cancel the action.

WARNING Only the ResMed USB stick is designed to be connected to the data communication port. Do not connect any other device to the data communication ports. Connecting other devices could result in injury, or damage to the Stellar 100 (see “General warnings and cautions” on page 22).

English

Function

CAUTION Do not disconnect the ResMed USB stick while data transfer is in progress. Otherwise loss of data or incorrect data may result. The download time depends on the data volume. Note: Unknown files can get lost during data transfer.

Turning off the device 1 Turn off the oxygen flow if used. 2 Check that the device is in standby mode (no ventilation). 3 Press the power switch once and follow the instructions on the display. Note: To disconnect the device from the mains power pull out the power cord from the power socket.

Optional device settings The optional device settings are available from the Options menu and the Configuration submenu. Function

Description

Settings

Learn Circuit

The device is calibrated according to your air tubing system. Before performing the Learn circuit function, set up the circuit including accessories and patient interface (except catheter mount and HMEF for invasive use). The circuit must be unobstructed and left open to the air while performing the Learn circuit function. Notes: • The Learn circuit function has to be performed with every change of the circuit configuration. • Turn off the oxygen flow.

The function is enabled by pressing the Push dial.

SmartStart/ Stop™

If SmartStart/Stop is enabled by your clinician, the device will start automatically when you start breathing and will stop automatically when you take your mask off.1, 2

ON/OFF

Ramp Time

Pressure will be slowly increased to full operating pressure during the ramp time.

0 - Max ramp time (max. 45 minutes)

Using the Stellar 100

Function

Description

Settings

Selects the menu language.

Depends on regional configuration

Brightness3

Setting of the LCD backlight brightness.

20% - 100 %

Backlight3

Enables or disables the LCD backlight. If the AUTO setting is selected the backlight turns off after five minutes without any actions and turns on again if any button is pressed again or an alarm occurs.

ON/AUTO

Time3

Setting of the time.

Hours, minutes, seconds

Language

Setting of the date.

Day, month, year

Time format3

Setting of the time format.

24 h/12 h

Setting of the date format.

dd/mm/yyyy, mm/dd/yyyy

Date

Date format

To return to the Options screen press the Return button 1 2

If you select “Full Face” or “Trach” as the mask type, SmartStop is automatically disabled. SmartStop is automatically disabled when the Leak or Low minute ventilation alarm is set to ON because, if either of these conditions occur, SmartStop will stop treatment before the alarm signal is activated. Only displayed on the Configuration menu.

Alarms This device is fitted with alarms to alert you to changes that will affect your treatment.

WARNING This device is not intended to be used for vital signs monitoring. If vital signs monitoring is required, a dedicated device should be used for this purpose.

Alarm display The alarm LED lights during an alarm or the alarm test. Additionally an alarm message is shown on top of the LCD. High priority alarms are displayed in red, medium priority alarms in yellow and low priority alarms in turquoise. For further information about alarms see “Troubleshooting” on page 15. Your clinician has the option to set and to turn on or turn off the alarms. Press the settings menu key and switch to the alarm page to view the current settings. Alarm message

Alarm LED Alarm mute key

You can mute an alarm by pressing the Alarm Mute key once. When an alarm is muted the LED of the alarm mute key will light constantly. Pressing this key a second time will un-mute the alarm and the LED of the alarm mute key will go out. In case of a high or medium priority alarm the alarm will sound again after two minutes if the problem is still present. The alarm LED will remain on until the problem is solved. The top of the LCD will display the alarm message as long as the problem is present, except if the alarm mute key was pressed when a low priority alarm occured. If a high or medium priority alarm occured and the alarm mute key was pressed, the alarm mute symbol will be displayed on the LCD. When the alarm mute key is pressed during therapy for at least three seconds, specific alarm messages and the audible alarm will be temporarily reset.

English

Muting alarms

Setting the alarm volume To set the alarm volume, select the Settings menu, then Alarm settings. The alarm volume can be set to low, medium or high. After the set value has been confirmed, the alarm will sound and the alarm LED lights.

Testing the alarm When the device is turned on, the alarm LED and the alarm mute key LED will flash, and the alarm will beep to confirm that the alarm is working. If required, you can test the alarm manually by holding down the alarm mute button for at least three seconds when therapy is not running.

Cleaning and maintenance The cleaning and maintenance described in this section should be carried out regularly. This also helps to prevent the risk of cross contamination. Refer to your mask, humidifier and other accessories user guide for detailed instructions for care and maintenance.

WARNING •

•

Beware of electric shock. Do not immerse the device, pulse oximeter (if used) or power cord in water. Turn off the device, unplug the power cord from the power socket and the device before cleaning and be sure that it is dry before reconnecting. The mask system and air tubing are subject to normal wear and tear. Inspect them regularly for damage.

CAUTION The device cannot be sterilised.

Daily Disconnect the air tubing from the device (and humidifier, if used) and hang it in a clean, dry place until next use.

CAUTION Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack.

Weekly 1 Remove the air tubing from the device and the patient interface. 2 Wash the air tubing in warm water using mild detergent. 3 Rinse thoroughly, hang and allow to dry. 4 Reconnect the air tubing to the air outlet and patient interface. CAUTION Do not use bleach, chlorine, alcohol or aromatic-based solutions (including all scented oils), moisturising or antibacterial soaps to clean the air tubing or the device. These solutions may cause hardening and reduce the life of the product.

Cleaning and maintenance

Monthly 1 Wipe the exterior of the device and the pulse oximeter (if used) with a damp cloth and mild detergent.

2 Check the air filter to check if it is blocked by dirt or contains holes.

Replacing the air filter Replace the air filter every six months (or more often if necessary).

1 Remove the air filter cover from the back of the device. 2 Remove and discard the old air filter. 3 Insert a new air filter. 4 Refit the air filter cover. WARNING Do not wash the air filter. The air filter is not washable or reusable.

Disinfection Disinfection of your device helps to prevent the risk of cross contamination. Disinfect the exterior of the device, and especially the air outlet, with a damp cloth and a disinfection solution (eg, Microzid).

Internal battery The internal battery of your device has to be discharged and recharged every six months.

1 Remove the power cord while the Stellar 100 is providing therapy and let the device operate with the internal battery to a charge level of 50%.

2 Reconnect the power cord to the mains power while the device is operating. The internal battery will be recharged.

CAUTION The internal battery must be replaced after two years. Replacement of the internal battery should only be performed by an authorised agent. Under no circumstances should you attempt to replace the internal battery yourself.

Maintenance reminder Your device informs you about the following maintenance events that are set by your clinician: Replace mask, call provider, replace filter, service due, custom reminder. If an event occurs, it will be shown on the Reminder screen right after the device is turned on. Once the maintenance issue has been dealt with, you have to confirm this to reset the reminder date.

Servicing This product should be inspected by an authorised ResMed service centre five years from the date of manufacture. Prior to this, the device is intended to provide safe and reliable operation provided that it is operated and maintained in accordance with the instructions provided by ResMed. Applicable ResMed warranty details are provided with the device at the time of original supply. Of course, as with all electrical devices, if any irregularity becomes apparent, you should exercise caution and have the device inspected by an authorised ResMed service centre.

CAUTION Inspection and repair should only be performed by an authorised agent. Under no circumstances should you attempt to open, service or repair the device yourself.

Troubleshooting Problem / possible cause

Solution

LCD turns off. The device stops delivering air pressure Power failure.

LCD:

Remove the mask or the catheter mount from the tracheotomy tube until power is restored.

English

If there is a problem, try the following suggestions. If a problem cannot be solved, contact your equipment supplier or ResMed. Do not attempt to open the device.

Internal Battery Empty! (Alarm)

The voltage capacity is below 15%.The device is powered by the internal battery for maximum 2 minutes.

Connect the device to mains power. Note: In case of a total power failure, the current settings will be stored and restored when the device is powered again.

LCD: System Failure! [X] (Alarm) The device could stop delivering air pressure Component failure.

LCD:

Over Pressure! (Alarm)

The device generates a pressure that is too high. Treatment will be stopped.

LCD:

Therapy could be stopped automatically. Ensure the ambient temperature conditions are within the specified operating range. If the problem persists within the specified operating conditions please return the device for servicing.

High Pressure! (Alarm)

Mask pressure exceeds alarm setting level. LCD:

1. Check the airpath for any blockages. 2. Remove the blockages. 3. Stop treatment. 4. Re-start treatment.

High Temperature! [X] (Alarm)

The temperature inside the device is too high.

LCD:

1. Turn off the device. 2. Check that the air tubing is connected properly. 3. Turn on the device again. 4. Re-start treatment.

Blocked Tube! (Alarm)

Airpath is blocked.

LCD:

1. Turn off the device. 2. Turn on the device again. 3. Re-start treatment.

1. Stop treatment. 2. Re-start treatment.

Low Pressure! (Alarm)

• Mask pressure has dropped below the alarm setting level. • Mask is removed while SmartStop has been disabled.

1. Check that the air tubing is connected properly. 2. Stop treatment. 3. Re-start treatment.

Troubleshooting

Problem / possible cause LCD:

Circuit disconnected! (Alarm)

The air tubing is not connected properly to the humidifier or the device.

LCD:

Contact your clinician.

High Leak! (Alarm)

High mask leak for more than 20 seconds. LCD:

Contact your clinician.

Low Respiratory Rate!, High Respiratory Rate! (Alarm)

The respiratory rate level has dropped below or has exceeded the alarm setting level. LCD:

1. Check that the air tubing is connected properly to the humidifier or the device. 2. Re-start treatment.

Low Minute Ventilation! (Alarm)

Minute ventilation level has dropped below the alarm setting level. LCD:

Solution

Adjust the mask to minimise leak (see “Using mask-fit” on page 10).

Non-Vented Mask! (Alarm)

Note: The non-vented mask alarm activates within 30 seconds of using therapy with a non-vented mask or invasive ventilation without a leak port (for exhalation).

• Connection of a non-vented mask. • Mask expiratory flow port (vent) may be blocked. • ResMed leak port is missing or flow ports (vent) are blocked.

LCD:

Apnoea! (Alarm)

The device detects an apnoea. LCD:

H4i cannot be used for treatment pressures exceeding 25 cm H2O. Contact your clinician.

Keypad Failure! (Alarm)

One of the keys was held down for more than 10 seconds or got stuck.

Check if the finger sensor or the XPOD is attached properly to the finger and connection to the pulse oximeter respectively the device is proper.

Pressure too high for H4i! (Alarm)

The device delivers an over pressure with connected H4i humidifier. LCD:

Contact your clinician.

SpO2 finger sensor failure!, Xpod oximeter disconnected! (Alarm)

The finger sensor or the pulse oximeter is not connected properly or delivers faulty values. LCD:

Connect the device to mains power.

Low SpO2! (Alarm)

The oxygen saturation of the blood is too low. LCD:

Breathe normally to disable the alarm.

Internal Battery Low! (Alarm)

The voltage capacity of the internal battery is below 30%. LCD:

• Ensure your mask has an expiratory flow port (vent). • Ensure your mask expiratory flow ports (vents) are not blocked. • Ensure the leak port is installed and that the flow ports (vent) are not blocked. • Contact your clinician.

1. Stop treatment. 2. Re-start treatment.

Problem / possible cause

Attention High Temp! [X] (Alarm)

The temperature inside the device is high.

LCD:

Internal Battery Use! (Alarm)

The device is using the internal battery.

LCD:

Ensure the ambient temperature conditions are within the specified operating range. If the alarm remains enabled stop treatment then re-start treatment. If the problem persists within the specified operating conditions please return the device for servicing.

English

LCD:

Solution

Check if the power cord is properly connected to the device and the power socket.

External DC Power Use! (Alarm)

The device loses (accidental or intentional) mains power and switches to external DC power.

Check if the power cord is properly connected to the device.

No display Power not connected.

Ensure the power cord is connected and press the switch at the back of the device once.

Treatment pressure seems low Ramp time is in use.

Wait for air pressure to build up.

Air filter is dirty.

Replace air filter.

Air tubing is kinked or punctured.

Straighten or replace tubing.

Air tubing is not connected properly.

Check air tubing connection.

Mask and headgear not positioned correctly.

Adjust position of mask and headgear.

Plug(s) missing from access port(s) on mask.

Replace plug(s).

Pressure required for treatment may have changed.

See your clinician to adjust the pressure.

There is a large impedance (eg, antibacterial filter) in the air circuit.

Perfom the Learn circuit function.

Humidifier control dial set too high, resulting in accumulation of water in the air tubing.

Turn humidifier control down and empty the water from the air tubing.

The device does not start when you breathe into the patient interface SmartStart/Stop not on.

Consult your clinician.

Breath is not deep enough to trigger SmartStart.

Take a deep breath in and out through the patient interface.

There is excessive leak.

Adjust position of mask and headgear.

Plug(s) may be missing from access port(s) on mask.

Replace plug(s).

Air tubing is not connected properly.

Connect firmly at both ends.

Air tubing is kinked or punctured.

Straighten or replace.

Troubleshooting

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