DeVilbiss SleepCube DV53 Standard Plus CPAP, SleepCube DV54 AutoAdjust User Manual

DeVilbiss® SleepCube® Positive Airway Pressure Device
CAUTION–Federal (U.S.A.) law restricts this device to sale by, or on the order of a
physician.
Dispositivo de presión positiva en las vías respiratorias SleepCube® de DeVilbiss
®
PRECAUCIÓN: La ley federal de EE. UU. limita la venta de este dispositivo a
médicos o a personas que dispongan de la correspondiente orden médica.
Montaje efectuado en EE. UU. con piezas fabricadas en EE. UU. e importadas. Guía de instrucciones
Appareil de ventilation spontanée en pression positive SleepCube® de DeVilbiss
®
ATTENTION– En vertu de la loi fédérale américaine, cet appareil ne peut être
vendu que par un médecin ou sur ordonnance de ce dernier.
Assemblé aux États-Unis avec des pièces des États-Unis et des pièces importées. Guide d’instructions
ES
EN
FR
0044
DV53 Standard Plus CPAP Series
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tablE of contEntS
EN
ENGLISH ...................................................................................................... 2
ES
ESPAÑOL ..................................................................................................... 37
FR
FRANÇAIS .................................................................................................. 72
Table of ConTenTs
Symbol Definitions ............................................................................................................... 3
Important Safeguards ........................................................................................................... 3
Introduction
Intended Use/Indications for Use ................................................................................. 5
Contraindictions ............................................................................................................ 5
What Is Obstructive Sleep Apnea (OSA) ...................................................................... 5
How CPAP Therapy Works .......................................................................................... 6
Acclimating To Your Therapy ........................................................................................ 7
Benefits Of Your Therapy ............................................................................................. 7
Helpful Resources ......................................................................................................... 8
Key Features
Unpacking The Contents .............................................................................................. 9
SleepCube Device ......................................................................................................... 9
Keypad .......................................................................................................................... 9
System Assembly without Humidification ............................................................................ 10
Keypad and Display .............................................................................................................. 11
Operation
Start Up ......................................................................................................................... 11
Using The Comfort Delay Feature ............................................................................... 12
Using The SmartFlex Feature ....................................................................................... 12
Shut Down .................................................................................................................... 13
Advanced Menu Controls .................................................................................................... 13
Advanced Menu List ...................................................................................................... 14
SmartFlex Menu List ..................................................................................................... 16
SleepCube Enable Menu List ........................................................................................ 17
Blower Off Menu .......................................................................................................... 18
SmartCode and Adherence Score Information............................................................. 18
CPAP Patient Menu ....................................................................................................... 19
Quick View Menu Layout ............................................................................................. 20
Patient Messages .................................................................................................................. 21
Reminders ..................................................................................................................... 21
Notifications .................................................................................................................. 21
Travel Information ................................................................................................................ 22
SleepCube DC Operation .................................................................................................... 22
Battery Power ............................................................................................................... 22
Supplemental Oxygen .......................................................................................................... 23
Accessories/Replacement Items ........................................................................................... 24
Maintenance ......................................................................................................................... 25
Cleaning ............................................................................................................................... 26
Troubleshooting .................................................................................................................... 27
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Symbol DEfinitionS/ important SafEguarDS
Specifications ........................................................................................................................ 29
DeVilbiss Guidance and Manufacturer's Declaration ........................................................... 31
Declaration of Conformity ................................................................................................... 36
symbol DefiniTions
Class II electrical protection– double insulated
Type BF equipment– applied part
Data Port Input/Output Standby – turns the blower on or off
Next Item on LCD display
Increase value shown on LCD display
Previous Item on LCD display
Decrease value shown on LCD display
Attention - Consult Accompanying Documents
Heat
DC Input: 12 VDC, center pin is positive
100 – 240 Volts AC input 50/60 Hz
Locked
Unlocked
IPX1 Drip-Proof, Vertical
Delay – starts the delay cycle, if prescribed
This device contains electrical and/or electronic equipment that must be recycled per EC Directive 2002/96/EC - Waste Electrical and Electronic Equipment (WEEE)
IMPORTANT SAFEGUARDS
When using electrical products, basic safety precautions should always be followed. Read all instructions before using this device. Important information is highlighted by the following terms.
DANGER Urgent safety information for hazards that will cause serious injury or death. WARNING Important safety information for hazards that might cause serious injury. CAUTION Information for preventing damage to the product. NOTE Information to which you should pay special attention.
Please ReaD all insTRUCTions befoRe UsinG THis DeViCe.
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important SafEguarDS
SAVE THESE INSTRUCTIONS
DangEr
Electric Shock Hazard – Do not use while bathing.
Electric Shock Hazard – Do not immerse this device into water or any other liquid.
Electric Shock Hazard – Do not attempt to open or remove the enclosure. There are no user-serviceable internal components. If service is required, return the product to your home care provider. Opening or tampering with the product will void the warranty.
Warning
The DeVilbiss SleepCube® should be used only with masks recommended by DeVilbiss, your physician or respiratory therapist.
To avoid rebreathing of exhaled air, do not use a CPAP mask unless the device is turned on and providing a supply of air. Venting in the mask should never be blocked. When the device is turned on and providing a fresh supply of air, exhaled air is flushed out of the mask vent. However, when the device is not operating, exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation. This warning applies to most CPAP devices.
The DeVilbiss SleepCube is not a life support device and may stop operating with certain device faults or with a power failure. It is intended to be used on spontaneously breathing individuals weighing 66 lbs/30 Kg or greater.
To avoid electric shock, always unplug power cord from wall outlet power source when performing cleaning.
Use only accessories recommended by DeVilbiss.
The circular data port connector located on the back of the SleepCube is
used to attach accessories to the device. The connector must only be used with accessories approved for use by DeVilbiss. Do not attempt to attach any other device to this connector as it may damage the CPAP or the accessory device.
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 Never rinse or place the device in water. Never allow liquids to get into
or around any of the ports, switches or air lter; doing so will result in device damage. If this occurs, discontinue use and remove the power cord from the power source. Allow the device to completely dry before use.
 Do not place the SleepCube where it can be bumped onto the oor or
where the power cord may create a trip hazard.
 Only the DeVilbiss DV5 series Heated Humidier system is
recommended for use with the SleepCube. Other humidier systems may prevent the device from detecting snoring and may cause inappropriate pressure levels in the mask.
 Oxygen is a prescription gas and should only be administered under the
supervision of a physician.
inTRoDUCTion
Intended Use/Indications for Use
The DeVilbiss® SleepCube® Model DV5 Series is intended for use in treating obstructive sleep apnea in patients 66 lbs/30 kg and above.
Contraindication
Do not use SleepCube if your upper airway has been bypassed.
 Symptoms of dryness of the throat, nasal passages, and the mouth are common with
positive airway pressure therapy. This is especially true in dry climates and during the cold season when humidity in the air is typically lower than at other times. The SleepCube features an optional humidier system to help minimize these effects.
What Is Obstructive Sleep Apnea (OSA)?
Obstructive Sleep Apnea (OSA) is a breathing disorder that affects more than 22 million Americans – approximately 4% of middle-aged men and 2% of middle-aged women.
Physiological factors such as size of tonsils, shape of the nose, narrowing of the upper airway, or any combination of these can contribute to the potential for having OSA. During sleep, your airway can relax so much that it begins to collapse and becomes obstructed. Relaxation allows the tissue at the back of your throat to vibrate as you breathe causing snoring. But as your airway collapses more fully, it blocks your airflow and stops your breathing altogether. (In fact, the word “apnea” is derived from a Greek term meaning “without breath.”)
This stoppage occurs repeatedly throughout the night, each episode lasting from just a few seconds to more than a minute. As your blood oxygen level drops to dangerous levels, your
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central nervous system triggers a sudden gasp for breath, partially awakening you and preventing you from experiencing the sustained, deep sleep your body needs. As a result, it is common to feel fatigued, stressed and irritable the following day – a less-than-optimal and potentially dangerous condition in which to work, drive, and make decisions.
There are important medical concerns as well. OSA starves your heart, brain, and organs of life-sustaining oxygen. Over time, this deprivation can seriously impact your health potentially resulting in memory loss, impotence, hypertension, coronary disease, strokes, and heart attacks. Recent studies indicate that OSA has the same risk factor for heart disease as smoking, high cholesterol and alcohol, and estimate that as many as 38,000 people a year die from the effects of OSA.
Clearly, OSA is a serious medical condition that requires attention and treatment.
How CPAP Therapy Works
There are several treatments for OSA including surgery and CPAP therapy. However, CPAP therapy has proven very effective for most patients. CPAP stands for “continuous positive airway pressure” which is exactly what the DeVilbiss SleepCube device delivers to your upper airway, acting as an “air splint” to keep the passage open while you sleep.
This reduces or eliminates the obstruction, allowing you to enjoy the deep, refreshing, uninterrupted sleep you need. More importantly, your body will get the rest and oxygen it needs with more continuous, uninterrupted sleep – helping you avoid some of the serious health risks associated with OSA. And the SleepCube is designed to provide this therapy to you quietly and comfortably so that you can sleep through the night without distraction.
During an apneic episode the soft
palate collapses blocking the airway
Unobstructed Airway
Soft Palate
Uvula
Pharynx
Epiglottis
Tongue
Hard Palate
Nasal Cavity
Soft Palate
Uvula
Pharynx
Epiglottis
Tongue
Hard Palate
Nasal Cavity
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Acclimating To Your Therapy
Naturally anything new – including CPAP therapy – takes some getting used to. Having your mouth or nose (or both) covered by a mask may make you feel anxious or claustrophobic. Feeling the rush of air from your SleepCube may cause discomfort or concern. But don’t worry – every successful, long-term CPAP user began where you are today with the same reactions and concerns, and overcame them to enjoy the full benefits of their therapy.
Here are some steps to help you gradually ease into your therapy and overcome your anxieties:
1. Try attaching the mask to the CPAP unit, and switching the unit “On.” Practice breathing through the mask for one hour while watching television, reading, or performing some other sitting activity.
2. If you nap, use the CPAP during this time.
3. Use CPAP at least during the first initial 3-4 hours of nighttime sleep.
4. Use CPAP through an entire night of sleep.
Advance through the above steps one step at a time and progress to the next step as soon as you can carry out the current step without anxiety.
Benefits Of Your Therapy
As a DeVilbiss SleepCube user, you are on your way to living a happier, healthier life – a life free from the sleep disruptions and health risks associated with OSA. After you become acclimated to CPAP therapy, you may be surprised at how much better you feel, both physically and emotionally. CPAP therapy may give you the opportunity to finally experience the deep, restful sleep you’ve been missing out on. Many patients find they have more energy, better judgment, and improved concentration during the day. With effective therapy you’ll be less stressed, less irritable and more like your old self again, with a healthy, positive outlook on life. In fact, you may well wish you’d gotten your SleepCube sooner!
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Helpful Resources
As you begin your SleepCube therapy, remember: you’re not in this alone! You’re part of a large and growing network of CPAP users, and many resources are available to answer your questions, address your concerns, and help make your therapy as effective and effortless as possible.
American Academy of Sleep Medicine
One Westbrook Corporate Ctr, Ste 920 Westchester IL 60154 Phone: (708) 492-0390 Fax: (708) 492-0943 www.aasmnet.org
American College of Chest Physicians
3300 Dundee Rd Northbrook, IL 60062-2348 Phone: (847) 498-1400 or (800) 343-2227 Fax: (847) 498-5460 www.chestnet.org
The Sleep Apnoea Trust
12a Bakers Piece, Kingston Blount Oxon. OX39 4SW Tel: +44 845 60 60 685 www.sleepapnoea-trust.org
National Heart, Lung & Blood Institute Information Center
P.O. Box 30105 Bethesda, MD 20824-0105 Phone: (301) 592-8573 Fax: (240) 629-3246 www.nhlbi.nih.gov
American Academy of Neurology
1080 Montreal Avenue St. Paul, Minnesota 55116 Phone: (651) 695-2717 or (800) 879-1960 Fax: (651) 695-2791 www.aan.com
American Sleep Apnea Association
1424 K Street NW, Suite 302 Washington, DC 20005 Phone: (202) 293-3650 Fax: (202) 293-3656 www.sleepapnea.org
National Center on Sleep Disorder Research National Heart Lung & Blood Institute (NIH)
6701 Rockledge Drive Bethesda, MD 20892 Phone: (301) 435-0199 Fax: (301) 480-3451 www.nhlbi.nih.gov/sleep
National Sleep Foundation
1522 K Street, NW, Suite 500 Washington, DC 20005 Phone: (202) 347-3471 Fax: (202) 347-3472 www.sleepfoundation.org
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kEy fEaturES
Key feaTURes
Unpacking The Contents
The following items are included in your DeVilbiss SleepCube system:
1. SleepCube device 4. Carrying case 7. DVD
2. Spare filter pack 5. Air supply tubing
3. AC line cord 6. User manual
If any of the above items are missing, please contact your home care provider.
 If you received a humidier with your SleepCube
system, please refer to the humidier’s instruction guide for additional information.
DeVilbiss SleepCube Device
(Figures A and B)
1. Keypad/LCD Display (see Figure C)
2. Air Supply Port on Back
3. Air Supply Port on Bottom (for optional humidifier)
4. Air Supply Port Plug
5. Heater Power Connector (for optional humidifier)
6. AC Power Connector
7. DC Power Connector
8. Data Port
9. Power Cord (appropriate to your wall outlet) (not shown)
10. Air Inlet Filter Opening
11. Connector Cover (not shown)
Keypad (Figure C)
1. On/Off 5. Decrease Value
2. Previous Item 6. Increase Value
3. Next Item 7. Heater Power LED (for
4. Delay optional humidifier)
Ask your home care provider for information about other DeVilbiss masks, equipment, and accessories.
B
3
5
A
2
8
4
10
7
6
C
1
4
3
2
6
7
5
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SyStEm aSSEmbly
sysTem assembly wiTHoUT HUmiDifiCaTion
 If your system includes a humidier, please refer to the instructions provided with the
humidier for assembly and operation.
1. Locate the air supply port and heater accessory connector on the bottom of the SleepCube device. Ensure that each opening has the appropriate soft cover securely attached.
2. Place the SleepCube on a stable surface such as a nightstand or table. If you wish, you may also place the device on the floor at the bedside, being careful to place the unit where it won’t be kicked or stepped on. Ensure that the air inlet in the back of the device is not blocked by anything such as curtains or bedding.
 Never place the SleepCube system on a soft surface such as a bed or couch during
operation.
 The height of the SleepCube system must always be lower than the
interface mask when using a humidier to prevent water from getting into the CPAP mask.
3. Insert the power cord into the back of the device. Make sure the power cord is fully inserted into the connector. Plug the other end of the power cord into the AC wall outlet.
4. Attach the air supply tubing to the air supply interface in the back of the device.
5. Prepare the mask (supplied by your home care provider) by referring to the mask’s instruction guide.
6. Connect the air supply tubing to the mask.
 The air supply tubing supplied with the device is specially designed to prevent kinking
and allow you to receive optimal airow. Use only the 22 mm diameter, smooth-bore, kink-resistant tubing supplied with this device or an air supply tubing recommended by your home care provider.
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kEypaD anD DiSplay/ opEration
KeyPaD anD DisPlay
Basic DeVilbiss SleepCube Controls
Name Symbol Function
ON/OFF
The ON/OFF button starts and stops the flow of air from the device.
HEATER
 
If your SleepCube has a heater/ humidifier attached, these buttons adjust the heater setting. Increase the setting for more humidity and decrease the setting for less humidity.
DELAY
The Delay button activates the comfort delay feature and only functions if this feature has been enabled. To understand how to set the parameters of this feature, please refer to the Using the Comfort Delay Feature found on page 12.
 The additional control buttons that you see on the SleepCube control panel provide
advanced controls for specic settings. Please refer to the ‘Advanced Menu Controls’ section on page 13 for more details.
oPeRaTion
Startup
To begin operation, verify that your SleepCube is connected to a ‘live’ power source. When plugged in, the LCD display should appear as noted.
Put on your CPAP mask and press the ON/OFF button on the keypad to turn on airflow OR put on your CPAP mask and take a few breaths to turn on airflow automatically. The pressure in your mask will rise to the set pressure in about 10 seconds.
 If the device does not automatically start after taking 2-3 breaths, this feature may have
been disabled. If Auto ON/OFF is disabled, you must manually press the ON/OFF button to start and stop the device.
The keypad display shows the actual mask pressure while the device is in use. Because this is the actual pressure, the device pressure reading may vary slightly as you breathe. Your display should appear as noted.
If your DeVilbiss SleepCube system includes a humidifier, its heater controls and status are displayed as noted in the image.
 If the display on your device is not similar to those listed above, refer
to the chapter section titled “Patient Messages” on page 21.
OFF
P:10.0 CPAP
P:10.0 CPAP
Heat:Off
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opEration
Using The Comfort Delay Feature
Your SleepCube has a comfort delay feature to help make it easier for you to fall asleep. The airflow will start at a low pressure and then gradually ramp-up to the prescribed setting over the specified delay time.
 When the delay comfort feature is activated, a message will ash on the display
periodically, indicating the amount of time remaining in the delay.
You can adjust the amount of time spent in comfort delay by using the advanced device controls. The Delay Time can be adjusted from 0 to 45 minutes in 5-minute increments. Refer to page 14 for details.
 If you are unable to change the delay time, your provider has locked this setting. Refer
to the keypad menu guide on page 14 for details.
Comfort Delay Feature In Standard CPAP Mode
When you use the comfort delay feature while your device is operating in CPAP mode, the airflow you receive at the beginning of your therapy is temporarily lowered to a pressure selected by your physician when the device was setup.
Press the delay button to activate the comfort delay feature. The airflow pressure will drop to the prescribed comfort delay pressure.
During the delay period, the pressure will gently rise to the pressure prescribed for your therapy. You may repeat the comfort delay by pressing the delay button again if you have not fallen asleep.
Using The SmartFlex Feature
Your SleepCube has a SmartFlex pressure relief feature to help make it easier for exhale against your prescribed pressure by lowering the pressure slightly when you exhale. The pressure returns to your prescribed pressure during inhale to maintain your therapy.
SmartFlex pressure relief includes three settings for exhale relief; 1, 2, and 3. (1 is the least amount of relief, 3 is the most amount of relief). Setting SmartFlex pressure relief to zero (0) turns the SmartFlex feature OFF.
The pressure waveform can also be adjusted independently for inhale and exhale to smooth the transition when SmartFlex pressure relief is active. The pressure waveform settings are SmartFlex-i (IRnd) and SmartFlex-e (ERnd) with settings from 0 to 5 in steps of 1 (0 is the least amount of smoothing, 5 is the most amount of smoothing).
P:10.0 FLX CPAP
Heat:Off
Delay Running 10 Minutes Left
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SmartFlex pressure relief can be operated Full Time, during the Delay Only or turned off. The display will show "FLX" in the top row of the default screen (between CPAP pressure and Mode) while SmartFlex pressure relief is operating.
When SmartFlex pressure relief is turned on Full Time, the pressure relief operates at all times when you are breathing on the device. When SmartFlex pressure relief is set to Delay Only, the pressure relief operates only during the Comfort Delay period and turns off after the delay period is finished. When SmartFlex pressure relief is turned OFF, the pressure relief does not operate.
Shut Down
Press the ON/OFF button to turn the device off. You may also simply remove your mask. After a few seconds the device will display the message “Mask Off. Please check mask fit.” If you do not put the mask on again the device will automatically turn off in about 20 seconds. Pressing any button will remove the message from the display.
 If the DeVilbiss SleepCube does not turn off automatically, the "Auto-OFF" feature may
have been disabled. In this case you must manually turn the device off.
aDVanCeD menU ConTRols
With the device on, press the “Next” or “Previous” buttons on the keypad to scroll through the items on the display. Not all of the features in the table below are available in all models; some are optional and some depend on what your physician and/or home care provider has selected. The table shows the items you may see, and describes the feature associated with each item. If you do not see some of these options, your model or configuration does not support them.
Name Symbol Function
PREVIOUS ITEM
Pressing this button displays the previous menu option.
NEXT ITEM
Pressing this button displays the next menu option.
SETTING CHANGE
 
These buttons allow you to adjust the setting that is shown on the display.
Please note that the values displayed are examples only.
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Advanced Menu List
Display Example Mode
Description
P: 5.0 CPAP
Heat:Off
All
This is the default screen when the SleepCube is turned on. The actual mask pressure and heater setting are shown. The displayed pressure may vary slightly while breathing. If the heater system is not connected, the heat setting will be blank.
Set Pressure
10.0 cmH2O
CPAP Mode
This is a prescription setting which controls the operating pressure.
Delay Time 45 minutes
All
Selectable delay time setting. Your provider has set the delay time.
Delay Pressure
5.0 cmH2O
CPAP Mode
This is a prescription setting which controls the operating pressure during the delay time.
Tubing Length
1.8 m (6 ft)
All
The standard tubing length supplied with the device is 6 feet (1.8 meters). However, you can adjust your SleepCube to accommodate an air supply tubing length of 10 feet (3.0 meters). Replacement tubing can be obtained through your home care provider (part numbers listed at the end of this manual).
SmartFlex Menu Press
All
Pressing the down key enters the SmartFlex menu. Refer to SmartFlex Menu section for details
Enable Menu Press
All
Pressing the down key enters the Enable menu. Refer to next section for Enable Menu details.
LCD Contrast Adj 50 %
All
This setting changes the contrast for the LCD display. This only needs to be adjusted if you find it difficult to see the display from your viewing angle.
Compliance Meter
123456.7 hours
All
The total number of hours (in 1/10 hour increments) that the SleepCube has been providing therapy.
Firmware Version V0.19 21/08/2009
All
Shows version of installed firmware.
Serial Number HD123456
All
Shows the serial number of the device.
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Display Example Mode
Description
Adherence Score 83% (25/30)
All
Shows the maximum adherence achieved for any period of thirty consecutive days of use within a ninety-day time frame. The score represents the percentage of days, within thirty consecutive days, where usage met or exceeded the ‘Usage Threshold.’
SmartCode 1-Day
F6CD-37F-357R
SmartCode 7-Day
3CCC-377D-7J7X
SmartCode 30-Day
DWY4-3DB7-DJ7L
SmartCode 90-Day
752TT-47DB-7DT7C
SmartCode Usage
ZDN-79FK-K7H
All
SmartCodeTM data is used for therapy management reporting; therapy information is encoded in a series of letters and numbers, and includes a special character for error checking to ensure accuracy. Use the UP arrow or DOWN arrow keys to change the SmartCode reporting period. There are five levels of SmartCode data – 1-day, 7-day, 30-day, 90-day and Usage. Use UP or DOWN button to change between levels.
- If the unlocked symbol is shown, you are able to adjust this setting. If the locked symbol
is shown, this setting can only be adjusted by your provider.
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SmartFlex Menu List
The SmartFlex menu is available in all modes and is a sub-menu that allows you to control various functions of your SleepCube. It is accessed by pressing the down button while in this Advanced Menu.
Display Example Description
SmartFlex
3
This setting controls the amount of pressure relief. OFF = SmartFlex feature is OFF
1 = least amount of pressure relief 3 = most amount of pressure relief
SmartFlex Mode Full Time
This setting controls the SmartFlex operating mode.
Full Time means SmartFlex feature is always active Delay Only means SmartFlex feature is active only during the
pressure delay cycle.
SmartFlex IRnd
3
This setting controls the Inhale pressure waveform.
SmartFlex ERnd
3
This setting controls the Exhale pressure waveform.
Exit Menu Press
Pressing the up key exits the SmartFlex menu
- If the unlocked symbol is shown, you are able to adjust this setting. If the locked symbol
is shown, this setting can only be adjusted by your provider.
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SleepCube Enable Menu List
The Enable menu is available in all modes and is a sub-menu that allows you to control various functions of your SleepCube. It is accessed by pressing the down button while in this Advanced Menu.
Display Example Description
Auto-OFF Disabled
This option controls the Auto-OFF feature, which automatically stops the flow of air after taking off the mask. The device will require at least 30 seconds to turn OFF depending on the kind of mask used. When Auto-OFF is enabled, Auto-ON is also enabled.
Auto-ON Enabled
This option controls the Auto-ON feature, which automatically starts the flow of air after breathing once or twice into the mask. This is always enabled when Auto-OFF is enabled.
Mask Fit Check Enabled
This option controls the mask fit check feature. The air flow to your mask is constantly measured and if the amount of airflow exceeds 95 liters/minute for more than 10% of the time used, a notification will be created. This notification will be displayed the next time you use the SleepCube.
Low Backlight Enabled
This is a setting which controls the backlight. Low backlight Enable will keep the backlight dim during operation. Low backlight Disabled will turn the backlight OFF during operation.
Exit Menu Press
Pressing the up key exits the Enable menu.
 If the unlocked symbol is shown, you are able to adjust this setting. If the locked symbol
is shown, this setting can only be adjusted by your provider.
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Blower Off Menu
Compliance information can be viewed without turning the CPAP on. With the blower OFF (display shows OFF), press the left or right arrow keys on the keypad to scroll through the information.
Display Example Description
OFF
Blower OFF, the CPAP unit is plugged in to AC or DC power with the blower OFF.
Quick View Menu Press
Pressing the down key enters the Quick View menu. Refer to page 20 for Quick View Menu details.
 The “Quick View” menu is only shown if enabled from the
clinical menu.
Serial Number HD000005
Shows the serial number of the device.
Adherence Score 83% (25/30)
Shows the maximum adherence achieved for any period of thirty consecutive days of use within a ninety-day time frame. The score represents the percentage of days, within thirty consecutive days, where usage met or exceeded the ‘Usage Threshold.’
SmartCode 1-Day
F6CD-37F-357R
SmartCode 7-Day
3CCC-377D-7J7X
SmartCode 30-Day
DWY4-3DB7-DJ7L
SmartCode 90-Day
752TT-47DB-7DT7C
SmartCode Usage
ZDN-79FK-K7H
SmartCodeTM data is used for therapy management reporting; therapy information is encoded in a series of letters and numbers, and includes a special character for error checking to ensure accuracy. Use the UP arrow or DOWN arrow keys to change the SmartCode reporting period. There are five levels of SmartCode data – 1-day, 7-day, 30-day, 90-day and Usage. Use UP or DOWN button to change between levels.
SmartCode Data and Adherence Score Information
Your Healthcare provider may contact you to retrieve SmartCode data and Adherence Score information. To display the SmartCode data, press the LEFT arrow key once. Use the UP arrow or DOWN arrow keys to change the SmartCode reporting period. Press the LEFT arrow key again to display the Adherence Score.
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aDVancED mEnu controlS
DV53 Standard Plus Patient Menu Layout
The following chart shows by Mode each Display you will scroll through using the Next or Previous buttons on the keypad. Pressing the Down key at the Enable Menu Display will allow you to enter this submenu - then use Next or Previous buttons to scroll through it; press the Up button to return to main menu. Once the final Display is reached, pressing the Next button will return you to the first Display.
UP () BUTTON
RIGHT () LEFT () BUTTONS
Auto-ON Enabled
Auto-OFF Disabled
Exit Menu Press
Mask Fit Check Enabled
Low Backlight Enabled
MENU - CPAP Mode
 There are 5 levels of SmartCode data. Use UP
or DOWN key to change between levels.
RIGHT () LEFT () BUTTONS
SmartFlex Mode Full Time
SmartFlex
3
Exit Menu Press
SmartFlex IRnd
3
SmartFlex ERnd
3
DOWN () BUTTON
P:10.0 FLX CPAP
Heat:Off
Set Pressure
10.0 cmH2O
Delay Pressure
4.0 cmH2O
Delay Time 20 minutes
Enable Menu Press
SmartCode 1-Day
F6CD-37F-357R
Tubing Length
1.8 m (6 ft)
SmartFlex Menu Press
UP () BUTTON
Compliance Meter
123456.7 hours
Serial Number HD000005
Firmware Version V0.20 30/06/2010
LCD Contrast Adj 50 %
Adherence Score 83% (25/30)
DOWN () BUTTON
Heater setting shown if DV5HH is attached, FLX shown if SmartFlex feature is turned on.
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aDVancED mEnu controlS
DV53 Standard Plus Quick View Menu Layout
The Quick View Menu shows a summary of information which is reported in the SmartCode data. Information in the Quick View includes: Number of days used more than 4 hours (or can be set to 5 hours by clinician), AHI (Apnea/Hypopnea Index), High Leak percent (percent of time at leak >95 L/m), and Daily Usage (average hours per day used). Each parameter can be viewed in any of four time periods, 1 day, 7 days, 30 days and 90 days.
The following chart shows the Quick View information that is available on your CPAP display if viewing this information has been enabled by your provider. The Quick View menu shows a summary of your SmartCode data for 1, 7, 30, and 90 day periods. Each of the time periods contains info for "Number of Days > x hrs", Apnea Hypopnea Index (AHI), High Leak % (>95 L/m) and Average Daily Hours of while breathing use.
Diagram of CPAP displays
Days 4H 1d 1/ 1 (100%)
AHI 1d
31.5+
High Leak 1d 31+%
Daily Usage 1d
9.3+ hours
Exit Menu Press
Days 4H 7d 7/ 7 (100%)
AHI 7d
31.5+
High Leak 7d 31+%
Daily Usage 7d
9.3+ hours
Days 4H 30d 30/30 (100%)
AHI 30d
31.5+
High Leak 30d 31+%
Daily Usage 30d
9.3+ hours
Days 4H 90d 90/90 (100%)
AHI 90d
31.5+
High Leak 90d 31+%
Daily Usage 90d
9.3+ hours
UP () DOWN () buttons
RIGHT () LEFT () buttons
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patiEnt mESSagES
PaTienT messaGes
Your SleepCube will alert you of issues that may require some action on your part in order to make your therapy more effective. These messages are displayed when the device is turned on, either by pressing the ON/OFF button or by breathing into the mask. You can press any key or button to clear the message from the display, but the SleepCube will operate normally even if the message is not cleared.
Two kinds of messages are displayed: Reminders and Notifications.
Reminders
Reminders alert you when parts of your system need to be replaced. Some components of your system wear over time and, if not replaced, may compromise your therapy. If you see a message on the display that is not listed below, you may have the optional DeVilbiss SmartLink™ Module attached to your device, which provides additional messages. Refer to the documentation that was provided with the SmartLink Module.
Clean Filter – The filter should be checked every 10 days for signs of dirt or wear so that it can be cleaned as needed. This message helps to remind you to check it regularly.
Notifications
Notifications identify conditions in your SleepCube that may require action by you or your home care provider in order to maintain a high level of therapy. If you see a message on the display that is not listed below, you may have the optional DeVilbiss SmartLink Module attached to your device, which provides additional messages. Refer to the documentation that was provided with the SmartLink Module.
The values displayed are examples only.
Delay Running xx Minutes Left – While a comfort delay session is active, this message is flashed on the display every 5 seconds to let you know how much time is left in the delay.
Mask Leak – This message means the SleepCube has detected a large amount of airflow during therapy for at least 10% of the time during your previous use session. This notification is displayed when the device is turned on. If this message is displayed, put on the mask and adjust the headgear to ensure the mask is properly fitted to your face. Follow the mask manufacturer’s directions for adjusting the mask and headgear for proper fitting.
Delay Running 10 Minutes Left
Clean Filter
Mask leak = 25 % Check Fit.
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traVEl/Dc opEration
Mask Off – This message appears whenever a high airflow condition occurs. High airflow is normally due to a poor mask fit or a removed mask. Check for leak around the mask seal and make adjustments as necessary according to the mask manufacturer’s instructions. This message will be displayed until the high airflow problem is corrected. If the high airflow condition persists for about 20 seconds, the device will automatically turn off (if AutoOFF is enabled).
Device Fault – If a device fault message is displayed, refer to Troubleshooting for instructions.
sleePCUbe TRaVel infoRmaTion
International Power Changes
Your DeVilbiss SleepCube is equipped with a universal power supply. This means that it is automatically capable of accepting line voltages of 100 to 240V~ 50/60Hz. You do not need to make any adjustments to the device if you are traveling to another country where the line voltage is different than your domestic line voltage. Simply contact your home care provider for the correct style power cord for the region in which you will be traveling (refer to Accessories/Replacement Items for the correct part number).
Altitude
Your SleepCube automatically compensates for changes in altitude between sea level and 9000 ft (2750 m). You do not need to make adjustments to the device for changes in altitude.
sleePCUbe DC oPeRaTion
Battery Power
Your SleepCube can be operated from a 12V DC power source in a motor home, boat or other recreational vehicle. The power source can be used with a 12V DC accessory cable or a 12 V DC stand-alone battery. Both parts are available from your home care provider (refer to Accessories/Replacement Items for the correct part numbers). Both accessory cables are required for stand-alone battery operation. The stand-alone battery connection uses clamps that attach to the terminal connections of the battery.
 The heater for the SleepCube’s humidication system will not operate directly from a
12V DC power source. If you need humidication, non-heated humidication is still available. Alternately, instead of connecting12V DC power directly to the SleepCube, you can pass the DC power through an inverter that will deliver AC power to the system. This will allow the heater to function. The power rating of the inverter must be at least 200 watts @ 110V~ / 400 watts @ 220V~.
Device Fault E07 Call Provider
Mask Off. Please check mask fit.
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SupplEmEntal oxygEn
 The SleepCube will automatically switch power sources between AC and 12V DC if
both sources are available. If your unit is connected to both AC and 12V DC power sources, it will operate on AC power as long as AC power is present, and automatically switch to 12V DC power if AC power is lost. When AC power is restored, it will return to the AC source. You do not need to reset or adjust any settings when the power source switches, but remember that your heater will not operate on 12V DC.
sUPPlemenTal oXyGen
Supplemental oxygen is sometimes prescribed in addition to CPAP for treatment of Obstructive Sleep Apnea. If your physician prescribed oxygen for your sleep therapy, you can add the oxygen in one of two ways:
1. Obtain the optional oxygen adapter (part #7353D-601) from your home care provider and connect it to the outlet port on the SleepCube. Connect one end of the air supply tubing to the open end of the adapter and the other end of the air supply tubing to the mask.
2. If your mask is equipped with an oxygen port, your physician may request that you apply oxygen directly to your mask.
Warning-oxygEn uSE
Oxygen supports combustion. To avoid possible physical injury, do not smoke while using this device with supplemental oxygen. Do not use this device near hot objects, volatile substances or sources of open flames.
Always turn on the SleepCube before turning on the oxygen source. Turn the oxygen source off before turning off the SleepCube.
This device is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen, or nitrous oxide.
At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration will vary depending on the pressure setting, patient breathing pattern, mask selection, and leak rate. This warning applies to most types of CPAP devices.
Never allow the oxygen source to run continuously while connected to the SleepCube if the device is not in use. If the SleepCube is not being used, turn off the oxygen flow.
 Oxygen is a prescription gas and should only be administered under the
supervision of a physician.
The ow setting of the oxygen source must be specied by a physician.
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accESSoriES/rEplacEmEnt
itEmS
aCCessoRies/RePlaCemenT iTems
Replacement Items
Air-inlet filter (4/pk) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-602
Optional fine particle filter (4/pk) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-603
Air supply tubing (6') . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-629
Air supply plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-604
Heater connection cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-605
Oxygen adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7353D-601
Carrying case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-610
Power Items
AC power cords
USA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-606
Europe, except U.K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-607
U.K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-608
Australia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-609
DC power cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-619
DC battery clamp-on adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DV51D-696
DC Battery clamp-on adapter requires DC power cord DV51D-619.
Masks Recommended For Use With The DeVilbiss SleepCube:
DeVilbiss FlexSet® Masks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9354 Series
DeVilbiss Serenity
®
Masks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9352 Series
Optional Heated Humidifier
DeVilbiss Heated Humidifier (cradle and chamber) . . . . . . . . . . . . . . . . . . . . . . . . . .DV5HH
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maintEnancE
sleePCUbe mainTenanCe
DangEr
Electric shock hazard – Do not attempt to open or remove the enclosure; there are no user-serviceable components inside. If service is required, contact your home care provider for instructions on obtaining service of your device. Opening or attempting to service your device will void the warranty.
Warning
If the operation of the device appears to deviate from normal operation or begins to produce unusual sounds, discontinue use and contact your home care provider for assistance.
If the device has been dropped, verify functionality of the device. If the device does not function or the enclosure is damaged, discontinue use and contact your provider.
If the device does not appear to be functioning properly refer to the Troubleshooting section for instructions.
Pressure Accuracy–The SleepCube is designed to provide accurate pressure performance
from the factory without additional calibration. No routine service is required for a period of 2 years of use, provided the device is used in accordance with the manufacturer’s directions. After 2 years the device should be inspected.
 Some countries require periodic servicing and calibration of this kind of medical
device. Contact your home care provider for further information.
Standard Air-Inlet Filter–Check the filter every 10 days and clean it if necessary. Replace the filter every 6 months or sooner if it is damaged. The standard filter is designed to filter particles larger than 3.0 microns in size. The SleepCube MUST have the standard filter in place during operation.
Optional Fine Particle Filter–Check the filter every 10 days, and replace it if it is dirty or damaged; otherwise replace the filter every 30 days. The optional fine particle filter is designed to filter particles as small as 0.3 microns in size and larger.
Filter Maintenance–Refer to Cleaning for instructions.
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clEaning
sleePCUbe CleaninG
Warning
To avoid electric shock, always unplug the power cord from the wall outlet power source before cleaning.
 Never rinse or place the device in water. Never allow liquids to get into
or around any of the ports, switches or air lter; doing so will result in product damage. If this occurs, do not use the device. Contact your home care provider for service.
Device Cabinet
1. Unplug the SleepCube from the power source. Wipe the enclosure with a clean, damp cloth every few days to keep the enclosure dust free.
2. Allow the device to dry completely before plugging it into a power source.
Filters
Air-Inlet Filter (Standard)
1. The air-inlet filter should be checked every 10 days and cleaned as necessary. The filter is located in the rear of the device.
 Proper lter function is important for the operation of the device and to
protect the device from damage.
2. To clean, remove the dark outer foam filter from the frame.
3. Wash the filter in a solution of warm water and dishwashing detergent, and rinse with water. Allow the filter to dry completely. If the filter (part #DV51D-602) is damaged, contact your home care provider for a replacement.
4. Ensure the filter is completely dry before installation and use.
Fine Particle Filter (Optional)
1. If you have an optional fine particle filter (part #DV51D-603), inspect this filter and replace it if it shows signs of dirt or damage. Do not wash.
2. Install the fine particle filter behind the standard filter.
 If the ne particle lter is not installed rst according to the directions, the life of the
lter will be reduced requiring more frequent replacement.
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troublEShooting
Tubing
The air supply tubing should be cleaned daily. Remove the tubing from the device and mask. Use a mild detergent and water to clean the inside of the tubing. Rinse the tubing and allow to air dry.
Mask and Headgear
Clean the mask and headgear according to the manufacturer’s instructions.
TRoUblesHooTinG
DangEr
Electric Shock Hazard - Do not remove the device cabinet; there are no user-serviceable internal components. The cabinet should only be removed by a qualified DeVilbiss provider.
If you are having trouble with the operation of your DeVilbiss SleepCube, please refer to the table below for a list of problems with possible causes and remedies. If you are unable to resolve the problem by following the instructions, contact your home care provider for assistance.
Problem Probable Cause Remedy
Nothing shows
on the display.
1. Device is not plugged in or the power cord is not fully inserted.
2. There is no outlet power.
1a. Verify that power cord is firmly
connected to the SleepCube and the power outlet.
1b. If you are using a DC power
source make sure the cable connections are secure. Verify that your battery is charged.
2. Locate a suitable functioning power source.
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troublEShooting
Problem Probable Cause Remedy
The SleepCube does not start when breathing into the mask.
1. The Auto-ON feature has been disabled.
2. There is no power to the device.
3. Breath is not deep enough for the Auto-ON feature to detect.
4. You are using a full face mask that has an anti-asphyxia valve.
5. The air supply port plug is missing or not fully inserted.
6. The humidifier chamber is not fully engaged into the cradle or is missing.
1. Use the ON/OFF button to start and stop the device.
2. Verify that the power cord is firmly connected to the device and the power outlet.
3. Breathe deeply in and out to start the SleepCube
4. Auto-ON may not work because your exhaled breath escapes through the open valve. Use the ON/OFF button to start and stop the device.
5. Make sure the air supply port plug is fully inserted into the unit.
6. Slide the humidifier chamber fully into the slot. Verify the latching lever snaps into place.
The airflow has stopped unexpected during use.
1. The Auto-OFF feature has detected large airflow because of loosely fitting mask.
2. During use your mouth opens and you begin to mouth breathe.
1. Ensure you have a good mask fit; adjust the mask and headgear as needed.
2. Contact your home care provider for a chin strap or different mask which will help prevent mouth breathing.
If problem is not resolved with above remedies, disable Auto-OFF feature in Advanced Menu options.
The display shows a device fault.
An error has occurred in the device and requires servicing.
Contact your home care provider for service.
Symptoms of OSA have recurred.
1. Air filter may be occluded.
2. Sleep apnea condition has changed.
1. Clean or replace the air filter and relocate device away from drapes and other dusty surfaces.
2. Contact your physician.
Your skin becomes irritated where the mask touches your face.
1. Headgear is too tight or improperly adjusted.
2. Your mask may not be properly sized or is not the most appropriate shape for you.
1. Loosen the headgear to reduce the contact pressure on your face.
2. Contact your physician or home care provider.
Dryness of throat or nose.
Inadequate humidity. 1. Add a DeVilbiss DV5 Heated
Humidifier.
2. Increase the heater setting on the
humidifier.
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SpEcificationS
Problem Probable Cause Remedy
Condensation of water is collecting in the hose causing a gurgling noise.
1. Your humidification setting is too high.
2. The room temperature fluctuates from higher to lower levels through the night.
Reduce the humidifier heater setting and/or increase the temperature of the room.
Air from flow generator seems to be too warm.
1. The air filter(s) is/are dirty.
2. The air inlet port is blocked.
3. The room temperature is too high.
4. The SleepCube is located near a heater.
1. Refer to the Cleaning section for instructions on filter maintenance.
2. Unblock the air inlet.
3. Reduce the room temperature.
4. Locate the device away from the heat source so the air being drawn into the device is at room temperature.
If the problem persists contact your home care provider.
Nasal, sinus or ear pain, possibly with runny nose.
You may have a reaction to air flow pressure.
Discontinue use and contact your physician.
sPeCifiCaTions
Size . . . . . . . . . . . . . . . . . . . . . . . . 10.7 cm x 16.5 cm x 17.5 cm (4.2” H x 6.5” W x 6.9” D)
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.22 kg (2.7 lbs.)
Electrical Requirements AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100-240V~, 50/60 Hz
Electrical Requirements DC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.4 - 15 VDC, 5 Amps
Maximum Power Consumption . . . . . . . . . . . . . . . . . . 65 watts max from AC power source
(flow generator only)
Pressure Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20 cmH2O
Operating Temperature Range. . . . . . . . . . . . . . . . . . . . . . . . . . .5°C to 40°C (41°F to 104°F)
Operating Humidity Range. . . . . . . . . . . . . . . . . . . . . . . . . . 0% to 95% RH non-condensing
Operating Atmospheric Conditions . . . . . . . . . . . . . . . . . . . .Sea level to 9,000 feet (2743 m)
Storage & Transportation Temperature Range. . . . . . . . . . .-40°C to +70°C (-40°F to 158°F)
Storage & Transportation Humidity Range. . . . . . . . . . . . . . 0% to 95% RH non-condensing
Maximum Limited Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 cmH2O under normal use
Sound Pressure Level (tested per ISO 17510-1:2007) . . . . . . . . . . . . . . . . . . . . . . . . 26 dBA
Sound Power Level (tested per ISO 17510-1:2007) . . . . . . . . . . . . . . . . . . . . . . . . . . 38 dBA
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SpEcificationS
Filter Specifications
Standard Filter > 3.0 micron particles Optional Fine Particle Filter > 0.3 micron particles
Maximum Flowrate (per ISO 17510-1:2007)
Test Pressures
3.0 cmH20 7.0 cmH20 12.0 cmH20 16.0 cmH20 20.0 cmH20
Measured pressure at the patient connection port (cmH20)
2.9 6.4 11.0 15.0 19.0
Average flow at the patient connection port (l/min)
83.8 126.8 137.4 130.0 113.8
Long Term Static Pressure Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +/- 0.5 cmH2O
Dynamic Short-Term Pressure Accuracy with and without DV5HH Humidifier
(per ISO 17510-1:2007)
Waveform
Volume
[mL]
Breath Rate
[min-1]
Set Pressure
[cmH2O]
Pressure Accuracy
[Pk-Pk cmH2O]
Sinusoidal cycle with I:E = 1:1
500 10, 15, 20
3.0 0.5
7.0 0.5
12.0 1.0
16.0 1.0
20.0 1.0
Equipment classification with respect to protection from electric shock . . . . . . . . . . .Class II
Degree of protection from electric shock . . . . . . . . . . . . . . . . . . . . . . . Type BF Applied Part
Degree of protection against ingress of liquids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IPX1
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Mode of operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous
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