Respironics 1116426 User Manual

DreamStation Go
Auto CPAP
CPAP
User manual
Table of contents
1. Safety Information .................................................................................. 1
Intended use ............................................................................................................................. 1
Warnings ....................................................................................................................................1
Contraindications ...................................................................................................................6
Safety Symbols Glossary ...................................................................................................... 6
2. System Overview .................................................................................. 10
System Contents .................................................................................................................... 10
Accessories ..............................................................................................................................10
System Diagram ......................................................................................................................11
3. Therapy Device ..................................................................................... 12
Where to Place Your Device ............................................................................................... 12
Supplying AC Power to Your Device ................................................................................. 12
Starting the Device ................................................................................................................ 13
Navigating the Device Screens .......................................................................................... 14
Therapy On Menu Navigation Settings ........................................................................... 15
Ramp Feature ................................................................................................................. 15
Therapy O Menu Navigation Settings ........................................................................... 16
My Info .............................................................................................................................. 16
My Comfort ...................................................................................................................... 17
My Device ........................................................................................................................18
My Support ...................................................................................................................... 19
Check Mask Fit .............................................................................................................. 20
Pairing Therapy Device to Bluetooth®-enabled Mobile Device ...................... 21
Device Pop-Up Messages ...................................................................................................22
4. Tubing ..................................................................................................... 25
Tubing Types ...........................................................................................................................25
Connecting the Tubing to Your Device ............................................................................25
Changing Your Tube Type ....................................................................................................26
Cleaning the Tubing ..............................................................................................................27
Tubing Device Pop-Up Messages .....................................................................................27
5. Filter ........................................................................................................28
Filter Types ..............................................................................................................................28
Installing or Replacing the Filter ...................................................................................... 29
Filter Device Pop-Up Messages ....................................................................................... 29
6. Accessories .......................................................................................... 30
Using the USB Port and the Micro USB Port ................................................................ 30
Using the microSD Card ....................................................................................................... 31
microSD card Device Pop-Up Messages ........................................................................32
7. Battery Pack .......................................................................................... 33
Indicators and Buttons on the Battery Pack .................................................................. 33
Preparing the Battery Pack for First Use and Recharging .........................................35
Attaching the Battery Pack to the Device ......................................................................35
Disconnecting the Battery Pack ........................................................................................37
8. Care and Maintenance ........................................................................38
Caring for the Therapy Device or Battery Pack .............................................................38
Caring for the Reusable Filter ............................................................................................38
9. Troubleshooting .................................................................................. 40
Tips and Tricks ....................................................................................................................... 40
Contacting Customer Service .............................................................................................42
10. Additional Notes.................................................................................43
Traveling with the System ...................................................................................................43
Airline Travel ...........................................................................................................................43
Altitude Compensation ........................................................................................................43
Adding Supplemental Oxygen...........................................................................................43
Service ......................................................................................................................................43
Additional Notices .................................................................................................................44
Specications..........................................................................................................................45
Disposal ................................................................................................................................... 48
EMC Information ................................................................................................................... 48
Limited warranty ......................................................................................... 52
1. Safety Information
Intended use
The Philips Respironics DreamStation Go systems deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs.). It is for use in the home or hospital/institutional environment.
Important
This device is to be used only on the instruction of a licensed physician. Your supplier will make the correct pressure settings according to your health care professional’s prescription.
Several accessories are available to make your Obstructive Sleep Apnea (OSA) treatment with the DreamStation Go system as convenient and comfortable as possible. To ensure that you receive the safe, eective therapy prescribed for you, use only Philips Respironics accessories.
Warnings
A warning indicates the possibility of injury to the user or operator.
Device usage This device is not intended for life support.
Personnel qualications
Operating and storage temperatures
Bacteria lter If the device is used by multiple persons in a hospital environment
This manual serves as a reference. The instructions in this manual are not intended to supersede your health care professional’s instructions regarding the use of the device.
The operator should read and understand this entire manual before using the device.
Do not use this device if the room temperature is warmer than 95˚ F (35˚ C) because the temperature of the airow may exceed 109˚ F (43˚ C). This could cause thermal irritation or injury to the patient’s airway.
Do not use the device while positioned in a warm place, such as direct sunlight or near a heating appliance. These conditions can increase the temperature of the airow and could cause thermal irritation or injury to the patient’s airway.
(such as rental devices), a low-resistance, main ow bacteria lter should be installed in-line between the device and the circuit tubing to prevent contamination.
If the device is used on multiple users, discard and replace the bacteria lter each time the device is used on a dierent person.
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1. Safety Information
Patient circuits and tubing
The device should be used only with masks and connectors recommended by Philips Respironics or with those recommended by the health care professional or respiratory therapist. A mask should not be used unless the device is turned on and operating properly. The exhalation port(s) associated with the mask should never be blocked. Explanation of the Warning: The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous ow of air out of the mask. When the device is turned on and functioning properly, new air from the device ushes the exhaled air out through the mask exhalation port. However, when the device is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed.
If you are using a full face mask (a mask covering both your mouth and your nose), the mask must be equipped with a safety (entrainment) valve.
Do not pull or stretch the tubing. This could result in circuit leaks.
Inspect the tubing for damage or wear. Discard and replace the tubing as necessary.
Improperly functioning device
If you notice any unexplained changes in the performance of the device, if it is making unusual sounds, if water is spilled into the enclosure, or if the enclosure is cracked or broken, discontinue use and contact your supplier.
Power cord Route the power cord to the outlet in a way that will prevent the cord
from being tripped over or interfered with by chairs or other furniture.
This device is activated when the power cord is connected.
Use only power cords supplied by Philips Respironics for this device. Use of power cords not supplied by Philips Respironics may cause overheating or damage to the device.
To avoid strangulation hazards, ensure that all cords connected to the device and battery pack are properly routed.
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1. Safety Information
Accessories Do not use any accessories, detachable parts, and materials
not recommended by Philips Respironics. Incompatible parts or accessories can result in degraded performance.
The USB charging port is designed only for use in charging a mobile device, such as a cell phone. Ensure there are no additional accessories attached to the mobile device while connected to this charging port.
Use of accessories, transducers and cables other than those specied or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Oxygen When using oxygen with this system, the oxygen supply must comply
with local regulations for medical oxygen.
Do not connect the device to an unregulated or high pressure oxygen source.
When using oxygen with this system, a Philips Respironics pressure valve must be placed in-line with the patient circuit between the device and the oxygen source. The pressure valve helps to prevent the back ow of oxygen from the patient circuit into the device when the unit is o. Failure to use the pressure valve could result in a re hazard.
Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open ame.
Do not use the device in the presence of a ammable anesthetic mixture in combination with oxygen or air, in the presence of nitrous oxide, or in an oxygen-enriched environment.
Do not use the device near a source of toxic or harmful vapors.
When using oxygen with this system, turn the device on before turning on the oxygen. Turn the oxygen o before turning the device o. This will prevent oxygen accumulation in the device. Explanation of the Warning: When the device is not in operation and the oxygen ow is left on, oxygen delivered into the tubing may accumulate within the device’s enclosure. Oxygen accumulated in the device enclosure will create a risk of re.
EMC Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation.
The Health Industry Manufacturers Association recommends that a minimum separation of six inches be maintained between a wireless phone and a pacemaker to avoid potential interference with the pacemaker. The DreamStation Go on-board Bluetooth communication should be considered a wireless phone in this regard.
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1. Safety Information
Care and Maintenance
Choking This device contains small parts which could result in a choking
Nebulization Nebulization or humidication can increase the resistance of
General Contact your health care professional if symptoms of sleep apnea
Periodically inspect electrical cords, cables, tubing, and accessories for damage or signs of wear. Discontinue use and replace if damaged.
Repairs and adjustments must be performed by Philips Respironics­authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly device damage. Contact your supplier for maintenance.
Do not attempt to modify the device or battery pack in any way.
Periodically check battery pack charge status and recharge if depleted.
To avoid electrical shock, always unplug the power cord from the wall outlet before caring for the device. DO NOT immerse the device in any uids.
Do not submerge the battery pack in water or any other liquid.
hazard.
breathing system lters and the operator must monitor the breathing system lter frequently for increased resistance and blockage to ensure the delivery of the therapeutic pressure.
recur.
Cautions
A caution indicates the possibility of damage to the device.
US Federal Caution
EMC Medical electrical equipment needs special precautions regarding
Mobile RF Communications
Device usage Before operating the device, ensure that both end caps are attached
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U.S. federal law restricts this device to sale by or on the order of a physician.
EMC and needs to be installed according to EMC information. Contact your supplier regarding EMC installation information.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
whenever any of the accessories such as the battery pack is not installed.
Ensure that the therapy device is properly secured if it is being used in a portable environment.
1. Safety Information
Electrostatic Discharge (ESD)
Pins of connectors shall not be touched and connections shall not be made without special precautions. Precautionary procedures include methods to prevent build-up of electrostatic charge (e.g., air conditioning, humidication, conductive oor coverings, non-synthetic clothing), discharging one’s body to the frame of the equipment or system or to earth. It is recommended that all individuals that will handle this device understand these precautionary procedures at a minimum as part of their training.
Condensation Condensation may damage the device. If the device has been
exposed to either very hot or very cold temperatures, allow it to adjust to room temperature (operating temperature) before starting therapy. Do not operate the device outside of the operating temperature range shown in the Specications section later in this manual.
Filters A properly installed, undamaged Philips Respironics reusable lter or
disposable, ne lter is required for proper operation.
Clogged inlet lters may cause high operating temperatures that may aect device performance. Regularly examine the inlet lters as needed for integrity and to check for accumulated debris.
Never install a wet lter into the device. You must ensure sucient drying time for the rinsed lter.
Make sure the air inlet holes on the side of the device are not blocked by bedding, curtains, or other items. Air must ow freely around the device for the system to work properly.
Battery Pack Do not expose the battery pack to extreme temperatures (see the
Specications section for temperature specications). If the battery pack becomes very hot or very cold, allow it to come to room temperature before using.
There are no user-serviceable parts inside of the battery pack; therefore, do not attempt to disassemble or repair it.
Extension cords Do not use extension cords with this device.
Device placement
Do not place the device in or on any container that can collect or hold water.
Do not place the device directly onto carpet, fabric, or other ammable materials.
Tobacco use Tobacco smoke may cause tar build-up within the device, which may
result in the device malfunctioning.
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1. Safety Information
Contraindications
When assessing the relative risks and benets of using this equipment, the clinician should understand that this device can deliver pressures up to 20 cm H2O. In the event of certain fault conditions, a maximum pressure of 40 cm H2O is possible. Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients:
• Bullous Lung Disease
• Pathologically Low Blood Pressure
• Bypassed Upper Airway
• Pneumothorax
• Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure. Caution should be used when prescribing CPAP for susceptible patients such as those with: cerebral spinal uid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus. (Chest 1989; 96:1425-1426)
The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection. Not for use with patients whose upper airways are bypassed. Contact your health care professional if you have any questions concerning your therapy.
Safety Symbols Glossary
The following symbols may appear on the device and accessories:
Symbol Title and Meaning Reference
Operator’s manual; operating instructions Consult instructions for use.
Approved for airline use. RTCA/DO-160G section
AC power (Alternating current) Indicates on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.
Separate collection for electrical and electronic equipment.
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IEC 60878 ISO 7000-1641 Symbol 5.4.3, ISO 15223-1
21, category M
IEC 60417-5032
EC Directive 2012/19/ EU
1. Safety Information
Symbol Title and Meaning Reference
Li Ion Battery -
Bluetooth® symbol Indicates the device has Bluetooth capabilities.
IP22 Drip proof equipment
Protection against ingress of solid foreign objects
12.5 mm diameter. Protection against ingress of water with harmful eects dripping (15° tilted).
Non-ionizing electromagnetic radiation Indicates that the equipment includes RF transmitters.
Caution, consult accompanying documents. IEC 60878
Prescription device Caution: U. S. federal law restricts this device to sale by or on the order of a physician.
Electrostatic sensitive devices (ESD warning symbol) Attention – Observe precautions for handling electrostatic sensitive devices.
Serial connection Identies a connector for a serial data connection.
Class II equipment (Double Insulated) To identify equipment meeting the safety requirements specied for Class II equipment.
Keep away from sunlight Indicates the medical device needs protection from light sources.
Type BF applied part To identify a type BF applied part complying with IEC 60601-1.
-
-
IEC 60878 IEC 60417-5140
Symbol 5.1.2, ISO 15223-1
-
IEC 60878 IEC 60417-5134
IEC 60878 IEC 60417-5850
IEC 60878 IEC 60417-5172
IEC 60878 ISO 7000-0624 Symbol 5.3.2, ISO 15223-1
IEC 60878 IEC 60417-5333
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1. Safety Information
Symbol Title and Meaning Reference
Do not disassemble. -
For indoor use only Equipment is designed primarily for indoor use.
Manufacturer Indicates the medical device manufacturer.
Date of manufacture Indicates the date when the medical device was manufactured.
Reorder number Indicated the manufacturer’s catalogue number so the medical device can be identied.
Serial number Identify the manufacturer’s serial number for the medical device.
Keep dry Indicates the medical device that needs to be protected from moisture.
Fragile, handle with care Indicates the medical device can be broken or damaged if not handled carefully.
Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed.
Temperature limit Indicates the storage temperature limits to which the medical device can be safely exposed.
IEC 60878 IEC 60417-5957
IEC 60878 ISO 7000-3082 Symbol 5.1.1, ISO 15223­1
IEC 60878 ISO 7000-2497 Symbol 5.1.3, ISO 15223-1
ISO 7000-2493 Symbol 5.1.6, ISO 15223-1
IEC 60878 ISO 7000-2498 Symbol 5.1.7, ISO 15223-1
IEC 60878 ISO 7000-0626 Symbol 5.3.4, ISO 15223-1
IEC 60878 ISO 7000-0621 Symbol 5.3.1, ISO 15223-1
IEC 60878 ISO 7000-2620 Symbol 5.3.8, ISO 15223-1
IEC 60878 ISO 7000-0632 Symbol 5.3.7, ISO 15223-1
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1. Safety Information
ISO 7000:2014, Graphical symbols for use on equipment – Registered symbols
ISO 7010:2011+A1:2012+A2:2012+A3:2012+A4:2013+A5:2014+A6:2014, Graphical symbols -­Safety colours and safety signs -- Registered safety signs (not currently FDA recognized)
EN 15986:2011, Symbols for medical devices containing phthalates (not currently FDA recognized)
ISO 15223-1:2012, Medical devices—Symbols to be used with medical devices labels ­General requirements
IEC 60417:2002 DB, Graphical symbols for use on equipment
IEC/TR 60878:2015, Graphical symbols for electrical equipment in medical practice
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2. System Overview
The DreamStation Go CPAP is a Continuous Positive Airway Pressure therapy device designed for the treatment of Obstructive Sleep Apnea (OSA). Your supplier will choose the appropriate pressure settings for you.
Several accessories are also available for use with your device. Contact your supplier to purchase any accessories not included with your system.
System Contents
Your DreamStation Go system may include the following items:
• Device • microSD Card (optional)
• User Manual • Disposable Fine Filter (optional)
• Reusable Filter • Battery Pack (optional)
• 12 mm Micro-exible Tubing
(12 Typ e)
• 6 ft. (1.83 m) Power Cord
Note
If any of these items are missing, contact your supplier.
Accessories
The following accessories are available for your DreamStation Go system:
• 6 ft. (1.83 m) Serial
Communication Cable (with ferrites)
• Small Travel Kit • Medium Travel Kit
• 15 mm Standard Tubing
(15 Type)
• Bacteria Filter • Pressure Valve (for use with
Note
Your mobile device charging cable should not be longer than 6 ft (1.83 m).
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• 10 ft. (3.04 m) Power Cord
• 22 mm Performance Tubing (22 Type)
supplemental oxygen)
System Diagram
2
1
4
2. System Overview
3
9
5
6
8
10
7
The gure above illustrates some of the device features, described in the following table.
# Feature Description
1
2 Display Touchscreen This is the User Interface for the therapy device.
3 Ambient Light Sensor
4 Air Outlet Port Connect the tubing here.
5 Serial Connector Access the serial connector here. 6 AC Power Inlet Connect the power cord here.
7 Battery Pack Access
8 microSD Card Access the microSD card here.
9 Mobile Charging Port
10 Filter Access Access the lter here.
Therapy on/o button
11
Starts and stops the airow for therapy.
Detects room light levels and adjusts brightness of the display screen.
This end cap slides o for access to the battery pack connection.
Access the USB charging port here for mobile device usage.
3. Therapy Device
Where to Place Your Device
Place the device on a rm, at surface somewhere within easy reach of where you will use it. The device should sit at a level lower than your sleeping position. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners).
Note
When positioning the device, make sure that the power cable is accessible because removing power is the only way to turn o the device.
Supplying AC Power to Your Device
Complete the following steps to operate the device by plugging the AC power cord into an electrical outlet.
1. Plug the power cord connector into the power inlet on the back of the device.
2. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch.
3. Make sure that all connections are secure.
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3. Therapy Device
Starting the Device
1. Ensure power is supplied to the device. Tap anywhere on the display screen to wake up the device.
1
2
# Feature
1 Therapy on/o button
2 Display Touchscreen
2. Put on your mask assembly. Refer to the instructions supplied with the mask.
3. Tap the therapy button on top of the device to turn on airow and begin thera­py. The current delivered pressure will display on the screen. The therapy button is
only for therapy.
4. A small amount of mask leak is normal and acceptable. Correct large amount of mask leaks or eye irritation by adjusting your mask headgear. See the instructions provided with your mask for more information, or refer to the Check Mask Fit sec­tion.
5. Tap the therapy button again to turn o the therapy. To turn o therapy when the display screen is o, place and hold a nger on the display screen for three sec­onds. Alternatively, tap anywhere on the display screen to wake up the display and then tap the therapy button to turn o therapy.
Notes
• If you are using the device in a bed with a headboard, try placing the tubing over the headboard. This may reduce tension on the mask.
• During therapy, if there is a power loss, the device will return to the home screen once power is restored. You may resume therapy as needed.
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3. Therapy Device
Navigating the Device Screens
The User Interface (UI) on this device allows you to adjust the device settings and view information about your therapy. The UI consists of the display screen and the touch panel. Swipe left or right on the touch panel to scroll through the menu options on the display screen.
To adjust a setting:
1. Swipe the touchscreen until you nd your desired menu option.
2. Tap the desired menu option.
3. Swipe the touchscreen until you nd the sub-menu option and tap to select that setting.
4. Swipe the touchscreen to change the setting.
5. Tap the icon or tap the up arrow in the upper left corner of the display to save the setting, and return to the previous menu option.
Notes
• The swipe icon on any screen indicates to swipe the display left or right to perform an action.
• The tap icon on any screen indicates to press the display to perform an action.
• Tapping the down arrow on the display when the down arrow appears on any screen will take you to a sub-menu with more menu options. Tapping the up arrow when the up arrow appears on any sub-menu will return you back to the main menu.
• The screens shown throughout this manual are examples for reference only. Actual screens may vary based upon device model and supplier settings.
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