Stellar 100 and 150 User Guide Oct 2011

Respiratory Care Solutions

Making quality of care easy

248549r1 Stellar 100 & 150 User Guide AMER Multi Cover.indd 4-5

Respiratory Care Solutions

Making quality of care easy

4/10/2011 1:28:55 PM

Stellar™ 100 Stellar™ 150 User Guide English

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

1 1 1

Stellar at a glance... 2 Patient interface Humidification Internal battery ResMed USB stick Use on an aircraft Mobile use

3 3 3 3 3 4

Setting up for noninvasive use... 4 Attaching the H4i heated humidifier for noninvasive use

5

Setting up for invasive use... 5 Working with other optional accessories... 7 Attaching the pulse oximeter Adding supplemental oxygen Starting therapy using oxygen Stopping therapy using oxygen Using the FiO2 monitoring sensor Attaching an antibacterial filter

7 7 8 8 8 9

Stellar basics... 10 About the control panel LCD screen

10 11

Starting therapy... 11 Performing a functional test Starting therapy Stopping therapy Turning off the power Working with alarms Tailoring treatment setup options Using mask-fit

11 12 12 13 13 14 14

Using the menus... 15 Setup menu... 16 Setup menu: Clinical Settings (Mask Type) Setup menu: Alarm Settings (Alarm Volume) Setup menu: Options Setup menu: Configuration Menu

Info menu

16 16 16 17

... 18

Event Summary Used Hours Device Information Reminders

18 18 18 18

Data management... 19

i

Cleaning and maintenance... 19 Daily Weekly Monthly Replacing the air filter Disinfection Multipatient use Servicing

19 20 20 20 20 21 21

Troubleshooting... 21 Alarm troubleshooting Other troubleshooting

21 24

Technical specifications... 26 Guidance and manufacturer’s declaration – electromagnetic emissions and immunity 28 Symbols 30

General warnings and cautions... 30 Limited warranty... 32

ii

Introduction Indications for use The Stellar 100/150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb/13 kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnea. The device is for noninvasive use, or invasive use with an uncuffed or deflated tracheostomy. Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

English

Read the entire manual before using the device. This User Guide is for a non-clinician user, and does not contain all the information provided in the Clinical Guide.

CAUTION US Federal law restricts this device to sale by or on the order of a physician.

Contraindications The Stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation. The Stellar 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. The use of the Stellar or pulse oximetry (including XPOD) is contraindicated in an MRI environment.

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 noninvasive ventilation with the device: • drying of the nose, mouth or throat • nosebleed • bloating • ear or sinus discomfort • eye irritation • skin rashes.

Introduction

1

Stellar at a glance Handle

H4i connector plug and AC connection

Air outlet Oxygen inlet

Infrared connection for humidifier

Air filter cover

XPOD pulse oximeter connection FiO2 sensor connection Data port for USB stick

DC power socket AC power socket Power-on/standby switch

Data port for direct PC connection

The Stellar comprises: • Stellar device • Hypoallergenic air filter • AC power cord • Carry bag • 6’ 6” (2 m) air tubing • ResMed USB stick • Low pressure oxygen connector. The following optional components are compatible with Stellar: • 9’ 10” (3 m) air tubing • SlimLine™ air tubing • Clear air tubing (disposable) • H4i™ heated humidifier • Antibacterial filter • Heat moisture exchanger filter (HMEF) • ResMed XPOD oximeter • Nonin™ pulse oximetry sensors • FiO2 monitoring kit (external cable, T-piece adapter) • FiO2 monitoring sensor • Stellar Mobility bag • ResMed leak port • Tubing wrap.

WARNING The Stellar should only 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.

2

ResMed regularly releases new products. Please check the catalogue of ventilation accessories on our website at www.resmed.com.

Both masks and tracheostomy tubes can be used with Stellar. To set the patient interface type go to the Setup menu, select Clinical Settings, then Advanced Settings. For information on using masks, see the mask manual. For a full list of compatible masks for this device, see the Mask/Device Compatibility List on www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative.

English

Patient interface

Humidification A humidifier is recommended especially for patients experiencing dryness of the nose, throat or mouth. For information on using a humidifier as part of: • noninvasive ventilation, see “Setting up for noninvasive use” on page 4. • invasive ventilation, see “Setting up for invasive use” on page 5.

Internal battery CAUTION The internal battery must be replaced every two years from the manufacturing date of the Stellar. Replacement of the internal battery should only be performed by an authorized service agent. Note: The battery duration depends on the state of charge, the environmental conditions, the condition and age of battery, the device settings and the patient circuit configuration. In case of a mains power 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 26). 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. Additionally the Internal battery use alarm will be displayed. Press the Alarm mute button to clear the alarm. To recharge the internal battery, connect the device to mains power. It can take up to three hours to fully recharge the internal battery, however this can vary depending on environmental conditions and if the device is in use.

Storing The internal battery has to be discharged and recharged every six months.

1

Remove the power cord while the Stellar 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. Note: If the device is stored for a longer period the internal battery should be at the charge level of approximately 50% to increase the durability.

ResMed USB stick A ResMed USB stick may be used with the device either to help the clinician to monitor your treatment or to provide you with updated device settings. For more information, see “Data management” on page 19.

Use on an aircraft ResMed confirms that the Stellar can be used during all phases of air travel without further testing or approval by the airline operator. See “Technical specifications” on page 26.

Stellar at a glance

3

Mobile use The Stellar Mobility bag allows the Stellar to be used in mobile situations, eg, in a wheelchair. For setup and correct use, see the Stellar Mobility Bag User Guide. For extended mobile use, the ResMed Power Station II external power supply unit can be used as an additional power source. Limitations apply to the use of oxygen with the Stellar Mobility Bag. For more information, contact your local ResMed representative.

Setting up for noninvasive use 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. Hoses or tubes must be nonconductive and antistatic. 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. Notes: • ResMed recommends using the AC power cord supplied with the unit. If a replacement power cord is required, contact your ResMed Service Center. • Place the device on a flat surface near the head of the bed.

2 3

4

5

1

AC power cord AC locking clip

1 2 3 4 5 6 7 4

Connect the power cord. Plug the free end of the power cord into a power outlet. Attach the H4i heated humidifier to the front of the Stellar. If the H4i is not in use, and if applicable, connect the antibacterial filter firmly onto the air outlet of the device (see “Attaching an antibacterial filter” on page 9). Connect one end of the air tubing firmly onto the air outlet of the H4i. Connect the mask system to the free end of the air tubing. Select the mask type (select Setup menu, then Clinical Settings, then Advanced Settings). Perform Learn Circuit (see “Setup menu: Options” on page 16).

Attaching the H4i heated humidifier for noninvasive use

WARNING • • • • •

Always place the H4i on a level surface below the level of the patient 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. Do not overfill the water chamber, as during use this will cause water to spill into the air circuit. For optimal accuracy and synchrony, perform Learn Circuit with a change of the circuit configuration, in particular when adding or removing high impedance components (eg, antibacterial filter, external humidifier, water trap, nasal pillow type mask or air tubing). See “Setup menu: Options” on page 16.

English

Use of the H4i heated humidifier may be recommended by your clinician. For information on using the H4i, see the H4i user guide.

CAUTION Check the air circuit for water condensation. Use a water trap or a tubing wrap if humidification is causing water condensation within the tube. Notes: • A humidifier increases resistance in the air circuit and may affect triggering and cycling, and accuracy of display and delivered pressures. Therefore perform the Learn Circuit function (see “Setup menu: Options” on page 16). The device adjusts the airflow resistance. • The heating feature of the H4i is disabled when the device is not mains powered.

Setting up for invasive use The Stellar can be used invasively only with the ResMed leak port and an uncuffed or deflated cuff tracheostomy tube.

WARNING • • •

When using a Heated Moisture Exchange Filter (HMEF), replace the HMEF regularly as specified in the instructions provided with the HMEF. The H4i is contraindicated for invasive use. An external humidifier approved for invasive use is recommended according to EN ISO 8185 with an absolute humidity of > 33 mg/L. For optimal accuracy and synchrony, perform Learn Circuit with a change of the circuit configuration, in particular when adding or removing high impedance components (eg, antibacterial filter, external humidifier, water trap, nasal pillow type mask or air tubing). See “Setup menu: Options” on page 16.

CAUTION When using a humidifier check the breathing system regularly for accumulated water. Note: When the mask type is set to Trach, the Non-Vented Mask alarm will be automatically enabled to alert you when the leak port has no vent holes or when the vent holes are blocked.

Setting up for invasive use

5

Leak Circuit configuration

Catheter mount** ResMed leak port

2

HMEF* Antibacterial filter

10

5

1 3

6 4

Air tubing External humidifier*

AC power cord AC locking clip

1 2 3 4

Connect the power cord.

5 6 7

Connect the air tubing to the external humidifier.

8 9

Perform Learn Circuit (see “Setup menu: Options” on page 16).

Plug the free end of the power cord into a power outlet. Connect the antibacterial filter firmly onto the air outlet of the device. Connect the external humidifier to the other side of the antibacterial filter. *If not using an external humidifier, the HMEF can be connected to the leak port (at step 9). Connect the leak port to the air tubing. Select the mask type Trach (select Setup menu, then Clinical Settings, then Advanced Settings). If an external humidifier is not being used, you can connect the HMEF to the leak port if necessary.

10 Connect the catheter mount. ** The leak port or the HMEF can be connected to standardized tracheostomy interfaces including connector pieces like catheter mounts. The catheter mount and the external humidifier are not part of the ResMed component.

6

Working with other optional accessories English

Attaching the pulse oximeter

1

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.

1 2

Connect the plug of the finger pulse sensor to the plug of the pulse oximeter. Connect the plug of the pulse oximeter at the rear of the device. To view the oximetry values, from the Monitoring menu, select Monitoring.

Adding supplemental oxygen Oxygen may be prescribed by your clinician. Note: Up to 30 L/min at maximum oxygen pressure of 50 mbar (0.73 psi) can be added.

WARNING • • •

• • •

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. Use only certified, clean oxygen sources. ResMed strongly recommends adding oxygen into Stellar’s oxygen inlet at the rear of the device. Entraining oxygen elsewhere, ie into the breathing system via a side port or at the mask, has potential to impair triggering and accuracy of therapy/monitoring and alarms (eg, High Leak alarm, Non-vented mask alarm). If used in this way, therapy and alarm operation must be verified each time oxygen flow is adjusted. 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 breathing system and the oxygen source must be kept at a minimum distance of 6’ 6” (2 m) away from any sources of ignition (eg, electrical devices). Oxygen must not be used while the device is being operated within the mobility bag.

Working with other optional accessories

7

2 1

Oxygen supply

1

2

Press spring to release connection after use

Starting therapy using oxygen 1 2 3 4

Fit the oxygen connector to the oxygen inlet of the device. Attach the other end of the oxygen supply tubing to the oxygen supply. Press

to start treatment.

Turn on oxygen.

Stopping therapy using oxygen 1 2

Turn off oxygen. Press

to stop treatment.

Using the FiO2 monitoring sensor Use of the FiO2 monitoring sensor may be recommended by your clinician.

CAUTION Do not use the FiO2 monitoring sensor with the H4i humidifier.

Preparing to use a new sensor

1 2 3

Before use, leave the FiO2 monitoring sensor open to the air for 15 minutes. Attach a new FiO2 monitoring sensor (as shown below). Perform the sensor calibration (see “Setup menu” on page 16). Note: The FiO2 monitoring sensor must be replaced every 12 months.

3 1 8

5 2 4

Connecting a sensor Connect the air tubing to the T-piece adapter. Connect the FiO2 monitoring sensor to the T-piece adapter. Connect the adapter to the air outlet of the device. Connect one end of the cable to the FiO2 monitoring sensor. Connect the other end of the cable to the rear of the device.

English

1 2 3 4 5 6

Start calibration (see “Setup menu: Options” on page 16). This should be repeated periodically at the recommendation of your clinician.

Attaching an antibacterial filter The use of an antibacterial filter may be recommended by your clinician. One antibacterial filter-product code 24966-can be purchased separately from ResMed. Regularly check the filter for entry of moisture or other contaminants. The filter must be replaced according to the manufacturer‘s specifications. Note: ResMed recommends using a filter with a low impedance (less than 2 cm H2O at 60 L/min, eg, PALL BB 50 filter).

WARNING Do not use the antibacterial filter (product code 24966) with the H4i.

1

1 2 3 4

2

Fit the antibacterial filter to the air outlet of the device. Attach the air tubing to the other side of the filter. Attach the mask system to the free end of the air tubing. Perform the Learn Circuit function (see “Setup menu: Options” on page 16). From the Setup menu, select Options. This enables the device to compensate for the impedance introduced by the filters.

Working with other optional accessories

9

Stellar basics About the control panel Mains Power LED

LCD Screen

On when operating on mains power. External power supply LED

On when external battery is connected. Internal battery LED

On when internal battery is in use. Flashes when device is turned off and battery is charging.

Setup menu

Alarm LED

Info menu

Monitoring menu

Red or yellow during an alarm or during alarm testing.

Push dial (rotate/

click)

Alarm mute button LED

On when

is pressed.

Therapy LED

On during treatment. Flashes during maskfitting operation.

Start/stop button

10

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 “Working with 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.

Push dial

Turning the dial allows you to scroll through the menu and change settings. Pushing the dial allows you to enter into a menu or confirm your choice.

LCD screen The LCD screen displays the menus, monitoring screens and alarm status.

ResMed USB stick Mains power External power supply Internal battery Title bar

Ramp time Program Therapy mode

English

Warm-up feature H4i

Patient mode or Clinical mode Current screen/number of screens within the menu

Settings Scroll bar

Therapy status bar

Starting therapy Performing a functional test Make sure your device is functioning properly each time before starting therapy. If any problems occur, see “Troubleshooting” on page 21. Please also check other provided User Instructions for troubleshooting information.

1 2

Turn off the device by pressing the power switch

3

Check the circuit configuration. Check the integrity of the circuit configuration (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 check 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 (visual indicator) 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 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 on page 21 for further information.

at the back of the device.

Check condition of device and accessories. Inspect the device and all the provided accessories. If there are any visible defects, the system should not be used.

Reconnect the external battery (if in use) and check that the LED for the external 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 H4i heated 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.

Starting therapy

11

Warm-up humidifier

You can use the warm-up feature to pre-heat the water in the humidifier prior to starting treatment. The humidifier will be automatically detected when the device is turned on. The Treatment screen provides the option to start warming the humidifier. If the humidifier is heating, the related symbol is displayed at the top of the LCD screen. For more information, see the H4i User Guide. Note: The H4i in heating mode can only be used when the device is connected to mains supply.

7

Check the FiO2 monitoring sensor (if in use). Start the FiO2 sensor calibration. Select Setup menu, then Options (see “Setup menu: Options” on page 16). Follow the instructions on the display.

8

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

9

Check oxygen connection (if in use). Attach the accessories according to the setup descriptions (see “Adding supplemental oxygen” on page 7).

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

.

1 2

Fit your patient interface (mask or catheter mount) as described in the user instructions.

3

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

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.

Stopping therapy You can stop therapy at any time, simply remove the patient interface and press to stop airflow or if SmartStart/Stop is enabled, simply remove the patient interface, and treatment will stop automatically. Notes: • SmartStop may not work if Full face or Trach is selected as mask type; the High Leak alarm or the Low Min Vent alarm is enabled; “Confirm Therapy Stop“ is enabled; or the mask-fitting feature is running. • When the device is stopped and operating in standby mode with an integrated humidifier connected, it will continue to blow air gently to assist cooling of the humidifier’s heater plate. • Masks with high resistance (eg, pediatric masks) may cause the operation of the SmartStop feature to be restricted. • When using with oxygen, turn off oxygen flow before stopping therapy.

12

Turning off the power Stop the therapy. Press the power switch at the back of the device 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.

English

1 2

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

Alarm LED

Alarm mute key

Alarm messages are displayed along the top of the screen. High priority alarms are displayed in red, medium priority alarms in yellow and low priority alarms in light blue. The Alarm LED lights red during high priority alarms and yellow during medium and low priority alarms. The alarm volume can be set Low, Medium or High. From the Setup menu, select Alarm Settings. After the set value has been confirmed, the alarm will sound and the alarm LED lights. Alarm settings, see “Setup menu: Alarm Settings (Alarm Volume)” on page 16. You can mute an alarm by pressing once. By pressing the Alarm mute key again, the alarm sounds again. When an alarm is muted, the Alarm mute key LED will light constantly. For a high or medium priority alarm, if after two minutes the problem is still present, the alarm will sound again. Any active low priority alarm will be permanently muted and the Internal Battery Use alarm will be cleared until the alarm condition is fulfilled again.

Starting therapy

13

Tailoring treatment setup options Setting Ramp 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. See “Setup menu: Options” on page 16.

Programs Program

If the Clinician has selected both, ie, dual, you can choose the program to use on the Treatment screen. If only a single program is selected, the option does not display.

Using mask-fit You can use mask-fit to help you fit your mask properly. This feature delivers constant treatment pressure for a three-minute period, prior to starting treatment, during which you can check and adjust your mask-fit to minimise leaks. The mask-fit pressure is the set CPAP or EPAP pressure or 10 cm H2O, whichever is greater.

1 2 3

14

Put the mask on according to the mask user guide. Hold down

for at least three seconds until pressure delivery starts.

If necessary adjust the mask, mask cushion and headgear until you have a good mask fit. After three minutes treatment will begin. Mask-fit can be stopped at any time by pressing . Notes: • Press for at least three seconds during mask-fit to start the treatment immediately. • The mask-fitting feature is disabled when the mask type Trach is selected.

The device has three menus (Monitoring, Setup, Info) accessed by the equivalent buttons on the right of the LCD screen. In each menu there are screens that display settings, device or therapy information. MONITORING

Treatment

SETUP

INFO

Clinical Settings

Event Summary

Monitoring

Pressure / Flow

English

Using the menus

Leak

Alarm Settings

Min Vent/Resp Rate or MV/Va (iVAPS Mode)

Minute Ventilation

Tidal Volume

Options

Respiratory Rate

Leak

I:E Ratio Tidal Volume Pressure Support Synchronisation AHI Oximetry SpO2

Used Hours

Device Information

Reminder

Note: iVAPS mode is only available in Stellar 150.

Using the menus

15