ResMed Astral Series User manual

Clinical guide
Clinical guide
English
278007 Astral 100_150_CG_cover_AMER_Eng_Spine.indd 2 16/06/2014 2:07:43 PM

278007 Astral 100_150_CG_cover_AMER_Eng_Spine.indd 3 16/06/2014 2:07:43 PM

Contents
Introduction............................................................................................................................. 1
Indications for use .............................................................................................................. 1
Contraindications ................................................................................................................ 2
Adverse effects .................................................................................................................. 2
General warnings and cautions........................................................................................... 2
The Astral system................................................................................................................... 4
The Astral device ................................................................................................................ 5
The Astral device interface ................................................................................................. 6
Touch screen ...................................................................................................................... 8
Information bar ................................................................................................................................... 9
Menu bar .......................................................................................................................................... 10
Bottom bar ........................................................................................................................................ 10
Main screen ...................................................................................................................................... 10
Pressure bar...................................................................................................................................... 11
Circuits and patient interfaces .......................................................................................... 11
Patient circuit accessories ................................................................................................ 12
Optional accessories......................................................................................................... 12
Power supplies ................................................................................................................................. 12
Astral Mobility bag ............................................................................................................................ 12
ResMed Hospital Trolley................................................................................................................... 12
Remote Alarm II................................................................................................................................ 13
Pulse oximeter .................................................................................................................................. 13
Astral Desktop Stand ........................................................................................................................ 13
Using the Astral device ........................................................................................................ 14
Connecting to mains power.............................................................................................. 14
Powering on the device ....................................................................................................14
Powering off the device.................................................................................................... 15
Accessing Clinical mode ................................................................................................... 15
Using the Setup Assistant ................................................................................................ 16
Starting and stopping ventilation ......................................................................................19
Locking and unlocking the touch screen .......................................................................... 19
Navigating the menus....................................................................................................... 20
Navigating the menus....................................................................................................................... 20
Monitors menu ................................................................................................................................ 21
Setup menu ..................................................................................................................................... 21
Alarms menu ................................................................................................................................... 22
Information menu ............................................................................................................................ 22
Programs .......................................................................................................................... 23
Working with programs .................................................................................................................... 23
Setting up a new program ................................................................................................................ 24
Adjusting patient settings ................................................................................................................. 26
Monitoring ventilation ....................................................................................................... 27
Device settings ................................................................................................................. 29
Adjusting device settings.................................................................................................................. 30

Assembling patient circuits................................................................................................. 31
Circuit options .................................................................................................................. 31
Circuit adapters ................................................................................................................ 32
Fitting the circuit adapter.................................................................................................. 33
Connecting a single limb circuit with intentional leak....................................................... 33
Connecting a single limb circuit for invasive use ..............................................................................35
Connecting a single limb circuit with expiratory valve...................................................... 36
Connecting a double limb circuit (Astral 150 only)............................................................ 38
Changing the circuit selection .......................................................................................... 39
Learn Circuit ..................................................................................................................... 39
Accessories........................................................................................................................... 42
Attaching patient circuit accessories................................................................................ 42
Attaching a humidifier ...................................................................................................... 42
Attaching a Heat Moisture Exchange (HME).................................................................... 43
Attaching an antibacterial filter ......................................................................................... 44
Adding supplemental oxygen ........................................................................................... 45
Attaching a nebulizer ........................................................................................................ 47
Attaching other accessories ............................................................................................. 48
Attaching a pulse oximeter ...............................................................................................................48
Attaching a remote alarm..................................................................................................................49
Astral Carry Bag................................................................................................................ 49
Traveling with the Astral device ....................................................................................... 50
Power .................................................................................................................................... 51
Connecting to mains power ............................................................................................. 51
Connecting to a ResMed Power Station (RPSII) .............................................................. 52
Connecting the Astral External Battery ............................................................................ 53
Using the External Battery ................................................................................................................53
Using the internal battery ................................................................................................. 54
Battery run time ................................................................................................................................55
Storing and recharging ......................................................................................................................55
Connecting to an external DC power source.................................................................... 56
Using the Astral device for the first time ........................................................................... 57
Ventilation modes ................................................................................................................ 58
(A)CV mode - Assisted volume-controlled ventilation....................................................... 59
P(A)CV mode - Assisted pressure-controlled ventilation .................................................. 60
P-SIMV - Pressure Synchronized Intermittent Mandatory Ventilation .............................. 62
V-SIMV - Volume Synchronized Intermittent Mandatory Ventilation ................................ 64
PS mode - Pressure support ............................................................................................ 66
(S)T mode - Spontaneous Ventilation with backup rate.................................................... 68
P(A)C mode ...................................................................................................................... 69
CPAP mode ...................................................................................................................... 70
Flow shape settings ......................................................................................................... 72

Interdependence of controls............................................................................................. 73
Dynamic settings limits .................................................................................................................... 73
Automatic reconfiguration of settings .............................................................................................. 73
Triggering and cycling ....................................................................................................... 74
Triggering with intentional leak circuits ............................................................................................ 75
Cycling with intentional leak circuits ................................................................................................. 75
Triggering with valve circuits ............................................................................................................ 76
Changing the Trigger Type................................................................................................................ 77
Cycling with valve circuits................................................................................................................. 78
Supplementary features ...................................................................................................... 79
Manual breath settings ..................................................................................................... 79
Sigh settings ..................................................................................................................... 81
Apnea Settings ................................................................................................................. 82
Control settings for Apnea ventilation .............................................................................................. 82
(A)CV Breath pattern......................................................................................................................... 83
P(A)CV breath pattern ....................................................................................................................... 83
Safety volume settings ..................................................................................................... 84
Mouthpiece settings......................................................................................................... 85
Alarms ................................................................................................................................... 87
Alarm priority .................................................................................................................... 88
Viewing the active alarms................................................................................................. 90
Muting alarms................................................................................................................... 90
Resetting alarms............................................................................................................... 91
Adjusting alarm settings ................................................................................................... 92
Testing the alarm sounders and indicators ....................................................................... 94
Testing the Remote Alarm................................................................................................ 95
Testing the alarms................................................................................................................ 96
Testing the power alarms ................................................................................................. 96
Testing the pressure alarms ............................................................................................. 97
Testing the ventilation monitoring alarms.........................................................................97
Testing the oximetry alarms ............................................................................................. 98
Testing the oxygen alarms................................................................................................ 98
Testing the breathing circuit alarms.................................................................................. 98
Alarm settings and conditions ............................................................................................ 99
Tidal volume alarms .......................................................................................................... 99
Minute volume alarms .................................................................................................... 100
Respiratory rate alarms................................................................................................... 100
Pressure alarms .............................................................................................................. 101
High pressure ................................................................................................................................. 101
Obstruction High pressure.............................................................................................................. 101
Low pressure .................................................................................................................................. 102
PEEP ............................................................................................................................................... 103
Breathing circuit alarms .................................................................................................. 103
High leak ......................................................................................................................................... 103
NV Mask ......................................................................................................................................... 103
Flow sensor not calibrated.............................................................................................................. 104
Circuit configuration alarms ............................................................................................................ 104
Oxygen alarms................................................................................................................ 104

Oximetry alarms ............................................................................................................. 104
SpO2 ...............................................................................................................................................105
Pulse rate ........................................................................................................................................105
Apnea alarm ................................................................................................................... 105
Ventilation stopped alarm............................................................................................... 105
Power alarms ................................................................................................................. 106
System alarms................................................................................................................ 106
Detecting circuit disconnection and de-cannulation....................................................... 107
Data management process ............................................................................................... 109
Data management summary.......................................................................................... 111
Cleaning and maintenance................................................................................................ 112
Single patient use........................................................................................................... 112
Weekly ............................................................................................................................................112
Monthly ...........................................................................................................................................112
Multi-patient use ............................................................................................................ 113
Replacing components................................................................................................... 114
Replacing the air filter .....................................................................................................................114
Replacing the expiratory flow sensor and antibacterial filter (Astral 150 only)................................115
Replacing the double limb adapter (expiratory valve)......................................................................116
Replacing the Oxygen sensor .........................................................................................................116
Replacing the internal battery .........................................................................................................117
Servicing......................................................................................................................... 118
Maintenance Timetable...................................................................................................................118
Internal Battery................................................................................................................................118
Device information .......................................................................................................................... 119
Additional considerations for hospital or healthcare facilities......................................... 119
Technical specifications..................................................................................................... 120
Monitoring ...................................................................................................................... 124
Time parameters .............................................................................................................................124
Volume and flow parameters ..........................................................................................................125
Pressure parameters.......................................................................................................................125
Other parameters............................................................................................................................126
Accuracy of controls....................................................................................................... 127
Measurement System and Accuracy ............................................................................. 129
Functional variants.......................................................................................................... 130
Guidance and Manufacturer’s Declaration Electromagnetic Emissions & Immunity ..... 130
Guidance and manufacturer’s declaration—electromagnetic emissions ........................................130
Guidance and manufacturer’s declaration – electromagnetic immunity ......................................... 131
Recommended separation distances between portable and
mobile RF communications equipment and the device ..................................................................133
Symbols.......................................................................................................................... 134
Standards compliance .................................................................................................... 135
Training and support....................................................................................................... 135
Alarm troubleshooting ...................................................................................................... 136
General troubleshooting ................................................................................................. 141

Recommendations for suctioning..................................................................................... 142
Limited warranty ................................................................................................................ 143
Appendix A: Definitions ..................................................................................................... 144
Ventilation settings definitions........................................................................................ 144
Measured and calculated parameter definitions............................................................. 146
Appendix B: Ventilation parameters................................................................................. 148
Ventilation Parameters summary table........................................................................... 148
Ventilation displayed parameters.................................................................................... 151
Supplementary Features................................................................................................. 152
Supplementary Features displayed parameters .............................................................154
Appendix C: Alarm parameters......................................................................................... 156
Alarm Parameters summary table .................................................................................. 156

Introduction
English 1
Introduction
The Astral device provides mechanical ventilation to both ventilation dependent and
non-dependent patients. It delivers pressure and volume ventilation through either a valve or
leak circuit, and is compatible with a range of accessories to support specific use cases.
The information in this guide applies to both the Astral 100 and the Astral 150 devices. Where
information applies to only one of these devices, that device will be specified.
WARNING
 Read the entire manual before using the Astral device.
 Use the Astral device only as directed by a physician or healthcare provider.
 Use the Astral device only for the intended use as described in this manual. Advice
contained in this manual does not supersede instructions given by the prescribing
physician.
 Install and configure the Astral device in accordance with the instructions provided in
this guide.
CAUTION
In the US, Federal law restricts this device to sale by or on the order of a physician.

Indications for use
The Astral device provides continuous or intermittent ventilatory support for patients weighing
more than 11 lb (5 kg) who require mechanical ventilation. The Astral device is intended to be
used in home, institution/hospital and portable applications for both invasive and non-invasive
ventilation.
CAUTION
The Astral device is not intended for use as an emergency transport ventilator.


Introduction
2
Contraindications
The Astral device is contraindicated in patients with the following pre-existing 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
 dehydration.

Adverse effects
Patients should report unusual chest pain, severe headache or increased breathlessness. The
following side effects may arise during use of the device:
 drying of the nose, mouth or throat
 nosebleed
 bloating
 ear or sinus discomfort
 eye irritations
 skin rashes.

General warnings and cautions
The following are general warnings and cautions. Further specific warnings, cautions and notes
appear next to the relevant instruction in the manual.
A warning alerts you to possible injury.

Introduction
English 3
WARNING
 If you notice any unexplained changes in the performance of the device, if it is making
unusual or harsh sounds, if the device or the power supply are dropped or mishandled
discontinue use and contact your healthcare provider.
 For ventilator-dependent patients, always have alternate ventilation equipment
available, such as a back-up ventilator, manual resuscitator or similar device. Failure to
do so may result in patient injury or death.
 The Astral device is a restricted medical device intended for use by qualified, trained
personnel under the direction of a physician.
 Ventilator-dependent patients should be continuously monitored by qualified
personnel or adequately trained carers. These personnel and carers must be capable of
taking the necessary corrective action in the event of a ventilator alarm or malfunction.
 The Astral device is not intended to be operated by persons (including children) with
reduced physical, sensory or mental capabilities without adequate supervision by a
person responsible for the patient's safety.
 The Astral device is not intended to be operated by patients unless they have been
given adequate instruction concerning the operation of the device by a person
responsible for the patient's safety.
 The Astral device must not be used in the vicinity of an MRI device.
 The effectiveness of ventilation and alarms should be verified including after any
ventilation or alarm setting change, any change in circuit configuration, or after a
change to co-therapy (eg, nebulization, oxygen flow).
 The Astral device and AC Power Supply can get hot during operation. To prevent
possible skin damage do not leave the Astral device or AC Power Supply in direct
contact with the patient for extended periods of time.

A caution explains special measures for the safe and effective use of the device.
CAUTION
 Repairs and servicing should only be performed by an authorized ResMed service
representative.
 The airflow for breathing produced by the device can be as much as 42ºF (6ºC) higher
than the temperature of the room. Caution should be exercised if the room
temperature is warmer than 95ºF (35ºC).
 Do not expose the device to excessive force, dropping or shaking.

A note advises of special product features.
Notes:

 When using Astral for long term invasive ventilation in the home, due consideration should
be given to relevant practice guidelines such as the AARC Clinical Practice Guideline for
Long Term Invasive Mechanical Ventilation in the Home - 2007 Revision & Update
(www.rcjournal.com/cpgs/pdf/08.07.1056.pdf)

 For assistance and reporting of issues associated with the Astral device, contact your Health
Care Provider or authorized ResMed representative.

The Astral system
4
The Astral system
The Astral system comprises a number of components, including:
 Astral device with:
- hypoallergenic air inlet filter
- internal battery
 Power Supply Unit (PSU)
 AC Power cord
 Astral carry bag
 Single limb adapter
 Single limb leak adapter
 Double limb adapter (Astral 150)
 ResMed USB stick
 Astral User Guide
 Astral Clinical Guide CD.
Optional accessories are also available for use with the Astral device, and include:
 Remote Alarm II
 Astral External Battery
 Astral Mobility Bag
 ResMed Hospital Trolley
 ResMed HumiCare D900 Humidifier
 Pulse oximeter.
For a full list of accessories, see the Ventilation accessories guide on www.resmed.com on the
Products page under Service and Support. If you do not have internet access, please contact
your ResMed representative.

WARNING
Before using any accessory, always read the accompanying User Guide.


The Astral system
English 5
The Astral device
The following images describe the components of the Astral device.

The Astral system
6
Description
1Adapter port
Can be fitted with single limb adapter, single limb leak adapter or double limb adapter (Astral 150 only).
2Handle
3Inspiratory port (to patient)
Provides an outlet for pressurised air to be delivered to the patient via the patient circuit. Includes FiO2sensor
on the Astral 150. The FiO2sensor is an optional accessory on the Astral 100.
4Ethernet connector (service use only)
5USB connector (for download to ResScan)
6Mini USB connector (service use only)
7DC power inlet
8Device on/off push button
9SpO2Sensor connector
10 Remote alarm five pin connector
11 Low flow oxygen input (up to 30 L/min)
12 Air inlet (complete with hypoallergenic filter)

The Astral device interface
The interface of the Astral device comprises several different features described in the
following image.

The Astral system
English 7
Description
1Touch screen
2Power source indicators
AC (mains power supply)
DC (external battery or car accessory adapter)
Internal battery
3Therapy on/off indicator
Device ready
Constant green display when the device is turned on but not ventilating.
Device ventilating
Flashes blue when the device is ventilating and the Ventilation LED setting is 'ON'.
Otherwise is 'OFF'.
4Alarm mute/reset button
Illuminates when an alarm is triggered and flashes when the sound is muted.
5Alarm bar
Flashing red High priority alarm
Flashing yellow Medium priority alarm
Constant yellow Low priority alarm


The Astral system
8
Touch screen
The main method of interacting with the Astral device is via the touch screen. The display on
the touch screen changes according to the function being performed.


Description
1Clinical mode access button
Locked Unlocked
2Manual breath button
only shown if enabled
3Information bar
4Internal battery indicator
5Lock touch screen button
6Menu bar
7Bottom bar
8Start/Stop ventilation button
9Main screen
10 Sub-menus
11 Pressure bar


The Astral system
English 9
Information bar
The Information bar is displayed at the top of the touch screen. The Information bar displays the
operating status of the device, including patient type, current circuit configuration, programs,
information messages, ventilation status, alarms and power status.
Description
Patient type – Adult
Patient type – Pediatric
Circuit type – Single limb with intentional leak
Circuit type – Single limb with expiratory valve
Circuit type – Double limb
P1
(A)CV
Program number and ventilation mode in use
Multiple alarms are active simultaneously. The highest priority active alarm is displayed first.
Message
window
Will display alarms or information. Image above shows device in Standby. (Displayed when the device is
powered on but not ventilating). Date and time will be displayed when the device is ventilating and there
are no active alarms.
Information messages are displayed in blue text. If the device Alert tone setting is 'On', you will be alerted
to new information messages by a single beep.


The Astral system
10
Menu bar
The Menu bar provides access to the four main menus in the Astral device.
Monitors menu
View real-time patient data in either waveform or monitoring formats including pressure, flow, leak,
tidal volume, synchronization and oximetry.
Setup menu
Configure and view ventilation therapy and device settings.
Alarms menu
Configure and view alarms including alarm volume.
Information summary menu
View therapy statistics, used hours, events, reminder and device information.

Bottom bar
The Bottom bar changes with the function of the device.
It can display buttons to Stop or Start ventilation and Apply or Cancel functions. It can also
display real-time readings.

Main screen
The Main screen displays the monitoring data, ventilation and device controls. Each function is
accessed through the various menus and tabs.


The Astral system
English 11
Pressure bar
The Pressure bar displays real-time therapy data while the Astral device is ventilating.
Patient pressure is shown as a bar graph. Peak inspiratory pressure is shown as a numerical
value and watermark. Spontaneously triggering and cycling is indicated by and .
The example below displays the pressure bar when a patient is spontaneously breathing.
Description
1Peak inspiratory pressure (PIP) value
2Spontaneous cycled breath marker—indicates patient-cycled breath
3Peak inspiratory pressure marker
4Current pressure
5Positive end expiratory pressure (PEEP) setting
6Spontaneous triggered breath marker—indicates patient-triggered breath

Circuits and patient interfaces
The following circuits are available for use with the Astral device.
 Single limb circuit with intentional leak (provides a leak compensated estimate of patient
flow and exhaled tidal volume)
 Single limb circuit with expiratory valve
 Double limb circuit (exhaled gas returns to the device for monitoring). (Astral 150 only)
The Astral device is compatible with the following invasive and non-invasive patient interfaces:
Invasive
 endotracheal tubes
 tracheostomy tubes
Noninvasive
 vented and non-vented masks
 mouthpiece.
WARNING
When using a noninvasive interface, the measurement of patient exhaled gas volume may
be affected by leak.


The Astral system
12
Patient circuit accessories
The following patient circuit accessories are available for use with the Astral device:
 Humidifier
 Heat Moisture Exchange (HME)
 Antibacterial filter
For information on attaching and using patient circuit accessories, see Attaching patient circuit
accessories (see page 42).

Optional accessories
WARNING
The Astral device should only be used with accessories recommended by ResMed.
Connection of other accessories could result in patient injury or damage to the device.
The Astral device is compatible with a range of accessories as follows:
 ResMed External Battery
 Astral DC adapter
 Astral Mobility Bag
 ResMed Hospital Trolley
 ResMed Remote Alarm II
 Pulse Oximeter
 Astral Desktop stand.

Power supplies
In addition to the internal battery and mains power sources, the Astral device can be powered
from the following sources:
 ResMed External Battery
 Astral DC adapter.

Astral Mobility bag
The Astral Mobility Bag offers extra protection to the Astral device and enables patients to easily
transport the device while ventilating. The bag may be carried by hand, worn as a backpack or
attached to a wheelchair.
The bag holds the Astral device, optional battery pack and an Astral power supply unit.

ResMed Hospital Trolley
The ResMed Hospital Trolley is designed to hold and move compatible ResMed ventilators and
accessories between points of therapy in the hospital and limited care facilities. For further
information, see the Hospital Trolley user guide.
