DeVilbiss DV55 Bilevel Series, DV56 Bilevel ST CPAP Series User Manual

EN

DeVilbiss® IntelliPAP™ Positive Airway Pressure

Device

CAUTION–Federal (U.S.A.) law restricts this device to sale by, or on the order of a

physician.

Assembled in USA of US & Imported Parts. Latex Free. Instruction Guide.

ES

Dispositivo de presión positiva en las vías respiratorias

IntelliPAP™ 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. UU.
Sin látex. Guía de instrucciones.

FR

Appareil de ventilation spontanée en pression positive

IntelliPAP™

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.
Sans latex. Guide d’instructions.

0044

DV55 Bilevel and DV56 Bilevel ST CPAP Series

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tAble of contents

EN

ENGLISH ............................................................................................................2

ES

ESPAÑOL .........................................................................................................33

FR

FRANÇAIS ......................................................................................................66

Table of ConTenTs

Symbol Definitions............................................................................................................... 3

Important Safeguards ........................................................................................................... 3

Introduction .......................................................................................................................... 5

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 ......................................................................................................................... 9

Unpacking The Contents .............................................................................................. 9

IntelliPAP Device ........................................................................................................... 9

Keypad .......................................................................................................................... 9

System Assembly without Humidification ............................................................................ 10

Keypad and Display .............................................................................................................. 10

Operation ............................................................................................................................. 11

Start Up ......................................................................................................................... 11

Using The Comfort Delay Feature ............................................................................... 11

Shut Down .................................................................................................................... 12

Advanced Menu Controls .................................................................................................... 12

Advanced Menu List ...................................................................................................... 13

IntelliPAP Enable Menu List .......................................................................................... 16

Bilevel Patient Menu...................................................................................................... 17

CPAP Patient Menu ....................................................................................................... 17

Patient Messages .................................................................................................................. 18

Reminders ..................................................................................................................... 18

Notifications .................................................................................................................. 18

IntelliPAP Travel Information ................................................................................................ 19

IntelliPAP DC Operation ...................................................................................................... 19

Battery Power ............................................................................................................... 19

Supplemental Oxygen .......................................................................................................... 20

Accessories/Replacement Items ........................................................................................... 21

Maintenance ......................................................................................................................... 22

Cleaning ................................................................................................................................ 23

Troubleshooting .................................................................................................................... 24

Specifications ........................................................................................................................ 26

DeVilbiss® Guidance and Manufacturer's Declaration ....................................................... 28

Warranty

........................................................................................................................... 32

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symbol Definition/
importAnt sAfeguArDs

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 in CPAP mode, if prescribed

– reduces pressure to lower pressure limit in Bilevel mode

The 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.

SAVE THESE INSTRUCTIONS

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importAnt sAfeguArDs

� 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 IntelliPAP™ 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 IntelliPAP 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.

CAUTION– The circular data port connector located on the back of the IntelliPAP 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.

CAUTION– 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.

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introDuction

CAUTION– Do not place the IntelliPAP where it can be bumped onto the oor or where the

power cord may create a trip hazard.

CAUTION– Only the DeVilbiss DV5 series Heated Humidier system is recommended for use

with the IntelliPAP. Other humidier systems may prevent the device from

detecting snoring and may cause inappropriate pressure levels in the mask.

CAUTION– Oxygen is a prescription gas and should only be administered under the

supervision of a physician.

inTRoDUCTion

Intended Use/Indications for Use

The DeVilbiss® IntelliPAP™ Model DV5 Series is intended for use in treating obstructive
sleep apnea in patients 66 lbs/30 kg and above.

Contraindications

Positive airway pressure therapy may be contraindicated in some patients with the following
pre-existing conditions:

• severe bullous lung disease

• pneumothorax or pneumomediastinum

• pathologically low blood pressure, particularly if associated with intravascular volume

depletion

• dehydration

• cerebrospinal uid leak, recent cranial surgery or trauma

NOTE–

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

IntelliPAP 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 airow and stops your breathing altogether.

(In fact, the word “apnea” is derived from a Greek term meaning “without breath.”)

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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
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 IntelliPAP 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 IntelliPAP 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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The DeVilbiss IntelliPAP Bilevel® system automatically switches between a higher pressure
(IPAP) and lower pressure (EPAP), prescribed by your doctor. The pressure changes follow
your breathing providing the higher pressure when you inhale and the lower pressure when
you exhale. Independent triggering and cycling sensitivity adjustments are provided to
ensure proper response to your specific breathing needs.

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 IntelliPAP 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 IntelliPAP 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 IntelliPAP sooner!

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Helpful Resources

As you begin your IntelliPAP 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: [phone]
Fax: [phone]
www.aasmnet.org

American College of Chest Physicians

3300 Dundee Rd
Northbrook, IL 60062-2348
Phone: [phone] or [phone]
Fax: [phone]
www.chestnet.org

The Sleep Apnoea Trust

12a Bakers Piece,
Kingston Blount
Oxon.
OX39 4SW
Tel: [phone]
www.sleepapnoea-trust.org

National Heart, Lung & Blood Institute
Information Center

P.O. Box 30105
Bethesda, MD 20824-0105
Phone: [phone]
Fax: [phone]
www.nhlbi.nih.gov

American Academy of Neurology

1080 Montreal Avenue
St. Paul, Minnesota 55116
Phone: [phone] or [phone]
Fax: [phone]
www.aan.com

American Sleep Apnea Association

1424 K Street NW, Suite 302
Washington, DC 20005
Phone: [phone]
Fax: [phone]
www.sleepapnea.org

National Center on Sleep Disorder
Research National Heart Lung & Blood
Institute (NIH)

6701 Rockledge Drive
Bethesda, MD 20892
Phone: [phone]
Fax: [phone]
www.nhlbi.nih.gov/sleep

National Sleep Foundation

1522 K Street, NW, Suite 500
Washington, DC 20005
Phone: [phone]
Fax: [phone]
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. IntelliPAP 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.

NOTE–

If you received a humidier with your IntelliPAP system,
please refer to the humidier’s instruction guide for

additional information.

DeVilbiss IntelliPAP 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

2. Previous Item

3. Next Item

4. Delay

5. Decrease Value

6. Increase Value

7. Heater Power LED (for 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

NOTE– 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 IntelliPAP
device. Ensure that each opening has the appropriate soft cover securely attached.

2. Place the IntelliPAP on a stable surface such as a nightstand or table. If you wish, you

may also place the device on the oor 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.

NOTE

– Never place the IntelliPAP system on a soft surface such as a bed or couch during

operation.

CAUTION– The height of the IntelliPAP 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.

NOTE

– 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.

KeyPaD anD DisPlay

Basic DeVilbiss IntelliPAP Controls

Name Symbol Function

ON/OFF

The ON/OFF button starts and stops the ow of air from the

device.

HEATER




If your IntelliPAP 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 11.

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operAtion

NOTE– The additional control buttons that you see on the IntelliPAP control panel provide

advanced controls for specic settings. Please refer to the ‘Advanced Menu Controls’
section on page 12 for more details.

oPeRaTion

Startup

To begin operation, verify that your IntelliPAP 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 airow OR
put on your CPAP mask and take a few breaths to turn on airow automatically. The

pressure in your mask will rise to the set pressure in about 10 seconds.

NOTE

– 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 IntelliPAP system includes a humidifier, its heater
controls and status are displayed as noted in the image.

NOTE–

If the display on your device is not similar to those listed above, refer
to the chapter section titled “Patient Messages” on page 18.

Using The Comfort Delay Feature

Your IntelliPAP has a comfort delay feature to help make it easier for you to fall asleep. The

airow will start at a low pressure and then gradually ramp-up to the prescribed setting over

the last few minutes of the specified delay time.

NOTE

– 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.

Delay Running
10 Minutes Left

OFF

P:10.0 ST

P:10.0 ST

Heat:Off

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ADVAnceD menu controls

NOTE– 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 is available in both IntelliPAP Standard and IntelliPAP Bilevel models, and in all
modes of operation.

Comfort Delay Feature In Standard CPAP Mode

When you use the comfort delay feature while your device is operating in CPAP mode, the

airow 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 airow pressure will drop to

the prescribed comfort delay pressure.

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 during the
first use.

Comfort Delay Feature in Bilevel Mode

When you use the comfort delay feature while your IntelliPAP is operating in Bilevel mode,

the airow you receive at the beginning of your therapy is the delay pressure prescribed by
your physician when the device was setup. The airow pressure will start at the delay

pressure and gradually rise to the prescription setting. In Bilevel mode, the IPAP and EPAP
pressures will gradually rise until they reach the prescription settings.

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.

NOTE

– If the DeVilbiss IntelliPAP does not turn off automatically, the AutoOFF 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. Also, some features are only available in Bilevel Mode or with the DeVilbiss

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ADVAnceD menu controls

SmartLink™ Therapy Management Module – these are noted in the ‘Mode’ column below. 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.

Advanced Menu List

Display Example

Mode

Description

P: 5.0 ST

Heat:Off

All

This is the default screen when the IntelliPAP 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.

P:10.0 S–T RR:15
I/E: 1:1.0 (50%)

All
Bilevel
Modes

Real time info screen, top row shows measured
pressure (P), Trigger source (Spontaneous or
Timed), breath state (dash in center of top row
goes high during inhale and low during exhale).
Bottom row shows I:E ratio and % inhale.

LK:123 S–S EV:AS
MV:123.4 VT:1234

All
Bilevel
Modes

Real time info screen, top row shows Leak rate
(LK), Trigger source (Spontaneous or Timed),
breath state (dash in center of top row goes high
during inhale and low during exhale), Event
Markers (EV), Bottom row shows Minute Volume
(MV) and Tidal Volume (VT)

IPAP

10.0 cmH2O r 5.0

All
Bilevel
Modes

This is a prescription setting which controls the
pressure during inhale, this also shows the pressure
delta (5.0 in example) between inhale and exhale
pressure settings

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ADVAnceD menu controls

Display Example

Mode

Description

EPAP

5.0 cmH2O r 5.0

All
Bilevel
Modes

This is a prescription setting which controls the
pressure during exhale, this also shows the
pressure delta (5.0 in example) between inhale and
exhale pressure settings

Delay Time 
45 minutes

All

Selectable delay time setting. Your provider has set
the delay time. 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.

Delay Pressure

5.0 cmH2O

CPAP
Mode

This is a prescription setting which controls the
operating pressure during the delay time.

IPAP Rounding 
0 (1234 ms)

All
Bilevel
Modes

This is a setting which controls the comfort
rounding when switching to IPAP pressure, settings
are 0 thru 5 also shows measured rise time of the
last breath in milliseconds.

EPAP Rounding 
0 (1234 ms)

All
Bilevel
Modes

This is a setting which controls the comfort
rounding when switching to EPAP pressure,
settings are 0 thru 5 also shows measured rise time
of the last breath in milliseconds.

Insp. Trigger 
5

Bilevel
S & ST
Modes

This is a setting which controls the sensitivity of the
inspiratory trigger, can be set from 1 to 10, 1 is
most sensitive, 10 is least sensitive.

Exp. Trigger 
5

Bilevel
S & ST
Modes

This is a setting which controls the sensitivity of the
expiratory trigger, can be set from 1 to 10, 1 is
most sensitive, 10 is least sensitive.

Backup Rate
15 BPM

Bilevel

ST & T

Modes

This is a setting which affects the backup pressure
cycle rate. A new breath will be triggered if the
patient’s breathing is slower than this setting.

I/E Ratio
1 : 1.0 (50%)

Bilevel

ST & T

Modes

This is a setting which affects the back up pressure
cycle rate. This is the ratio of the inhale to exhale
time and is expressed as 1:X. A new exhale will be
triggered by the Bilevel if the patient’s breathing is
slower than this setting, also linked to Backup
Rate. % inhale is shown in parenthesis.

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 IntelliPAP 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).

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ADVAnceD menu controls

Display Example

Mode

Description

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 IntelliPAP has been providing
therapy. (while breathing hours)

Hourmeter

123456.7 hours

All

The total number of hours (in 1/10 hour
increments) that the IntelliPAP has been in
operation.

Firmware Version
V0.11 21/08/2009

All

Shows version of installed firmware.

Serial Number
KD123456

All

Shows the serial number of the device.

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
G201-0Y7-6GPH

All

SmartCodeTM 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.

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ADVAnceD menu controls

Intellipap 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 IntelliPAP. It is accessed by pressing the down button while in this
Advanced Menu.

Display Example Description

Auto-OFF 
Enabled

This option controls the Auto-OFF feature, which

automatically stops the ow 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 ow 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 t check feature. The air ow

to your mask is constantly measured and if the amount of

airow 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 IntelliPAP.

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.

17

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ADVAnceD menu controls

DV55/DV56 Bilevel Patient
Menu Layout

The following charts 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.

Auto-OFF 
Enabled

Auto-ON 
Enabled

Low Backlight
Enabled

Exit Menu
Press 

Mask Fit Check
Enabled

MENU - CPAP Mode

P:10.0 CPAP

Heat:5

Set Pressure

10.0 cmH2O

Delay Pressure

5.0 cmH2O

Compliance Meter

123456.7 hours

Serial Number
KD123456

Hourmeter

123456.7 hours

Firmware Version
V0.11 21/08/2009

LCD Contrast Adj
50%

Delay Time 
10 minutes

Enable Menu
Press 

SmartCode 1-Day
G201-0Y7-6GPH

Tubing Length 

1.8 m (6 ft)

Adherence Score
83% (25/30)

MENU - Bilevel Mode

P:10.0 ST

Heat:Off

Compliance Meter

123456.7 hours

Serial Number
KD123456

Hourmeter

123456.7 hours

Firmware Version
V0.11 21/08/2009

LCD Contrast Adj
50%

Auto-OFF 
Enabled

Auto-ON 
Enabled

Low Backlight
Enabled

Enable Menu
Press 

Tubing Length 

3.0 m (10 ft)

Exit Menu
Press 

Delay Time 
45 minutes

SmartCode 1-Day
FZA4-99D-D6WH

Adherence Score
70% (21/30)

NOTE: Mode can read S,

T or ST

P:10.0 S–T RR:15
I/E: 1:1.0 (50%)

LK:123 S–S EV:AS
MV:123.4 VT:1234

IPAP

10.0 cmH2O r 5.0

EPAP

5.0 cmH2O r 5.0

Delay Pressure

5.0 cmH2O

Exp. Trigger 

5

Backup Rate
15 BPM

I/E Ratio
1 : 1.0 (50%)

Insp. Trigger 

5

EPAP Rounding 
0 (1234 ms)

IPAP Rounding 
0 (1234 ms)

Mask Fit Check
Enabled

Bilevel S & ST Modes Only

Bilevel S & ST Modes Only

Bilevel ST & T Modes Only

Bilevel ST & T Modes Only

P:10.0 S–T RR:15
I/E: 1:1.0 (50%)

LK:123 S–S EV:AS
MV:123.4 VT:1234

NOTE: There are 5 levels of

SmartCode. Use up  or down
 key to change between levels.

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pAtient messAges

PaTienT messaGes

Your IntelliPAP 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 IntelliPAP 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 IntelliPAP 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.

NOTE-The values displayed are examples only.

Delay Running xx Minutes Left – While a comfort delay session

is active, this message is ashed on the display every 5 seconds to

let you know how much time is left in the delay.
Mask Leak – This message means the IntelliPAP has detected a

large amount of airow 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. Available on Bilevel
models.

Mask Off – This message appears whenever a high airow
condition occurs. High airow is normally due to a poor mask t or

Mask Off. Please
check mask fit.

Delay Running
10 Minutes Left

Clean Filter

Mask leak =
25 % Check Fit.

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trAVel/Dc operAtion

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 airow problem is corrected. If the high airow condition persists for at least 30

seconds, the device will automatically turn off (if Auto-OFF is enabled).
Device Fault – If a device fault message is displayed, refer to

Troubleshooting for instructions.

inTelliPaP TRaVel infoRmaTion

International Power Changes

Your DeVilbiss IntelliPAP 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 IntelliPAP automatically compensates for changes in altitude between sea level and
8500 ft (2600 m). You do not need to make adjustments to the device for changes in
altitude.

inTelliPaP DC oPeRaTion

Battery Power

Your IntelliPAP 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. A battery rated for 20
Amp Hours will power the CPAP at 14 cmH

2

O for 2 nights.

NOTE– The heater for the IntelliPAP’s humidication system will not operate directly from a

12V DC power source. If you need humidication, passover humidication is still
available. Alternately, instead of connecting12V DC power directly to the IntelliPAP, 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

20

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supplementAl oXygen

NOTE– The IntelliPAP 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 IntelliPAP. 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 IntelliPAP before turning on the oxygen source. Turn the
oxygen source off before turning off the IntelliPAP.

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
IntelliPAP if the device is not in use. If the IntelliPAP is not being used, turn off the
oxygen flow.

CAUTION– Oxygen is a prescription gas and should only be administered under the

supervision of a physician.

CAUTION–The ow setting of the oxygen source must be specied by a physician.

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Acessories/
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') ...............................................7351D-616

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

NOTE- DC Battery clamp-on adapter (Requires DC power cord DV51D-619).

Masks Recommended For Use With The DeVilbiss IntelliPAP:

DeVilbiss FlexSet® Mask.................................................9354D

DeVilbiss FlexSet

®

Shallow Mask .......................................... 9354S

DeVilbiss FlexSet

®

Gel Mask .............................................9354G

DeVilbiss FlexSet

®

Gel Shallow ..........................................9354GS

DeVilbiss Serenity

®

Mask ................................................9352D

DeVilbiss Serenity

®

Shallow Mask ......................................... 9352S

DeVilbiss Serenity

®

Gel Mask.............................................9352G

DeVilbiss Serenity

®

Gel Shallow..........................................9352GS

Optional Heated Humidifier

DeVilbiss Heated Humidifier (cradle and chamber) ..........................DV5HH

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mAintenAnce

inTelliPaP 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 IntelliPAP 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.

NOTE– 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 IntelliPAP 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

inTelliPaP CleaninG

� WArning

To avoid electric shock, always unplug the power cord from the wall outlet
power source before cleaning.

CAUTION– 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 IntelliPAP 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.

CAUTION– 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.

NOTE– 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.

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.

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troublesHooting

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 IntelliPAP, 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 IntelliPAP 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.

The IntelliPAP
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 IntelliPAP

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.

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troublesHooting

Problem Probable Cause Remedy

The airow has

stopped
unexpected
during use.

1. The Auto-OFF feature has

detected large airow 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.

Condensation of
water is
collecting in the
hose causing a
gurgling noise.

1. Your humidification setting is
too high.

2. The room temperature

uctuates from higher to

lower levels through the
night.

Reduce the humidifier heater setting
and/or increase the temperature of the
room.

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specificAtions

Problem Probable Cause Remedy

Air from ow

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 IntelliPAP 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

ow pressure.

Discontinue use and contact your
physician.

Bilevel changes
pressure too
early or too late
(not following
breathing)

1. Trigger Sensitivity is not set
correctly

2. Backup rate (time) is too
high, the patient is breathing
slower than the backup rate

1. Adjust the inspiratory and expiratory
trigger sensitivity to adjust triggering
for the patient

2. Reduce Backup Rate setting

Bilevel changes
pressure too
early or too late
(not following
breathing)

1. Trigger Sensitivity is not set
correctly

2. Backup rate (time) is too
high, the patient is breathing
slower than the backup rate

1. Adjust the inspiratory and expiratory
trigger sensitivity to adjust triggering
for the patient

2. Reduce Backup Rate setting

sPeCifiCaTions

Size ........................ 4.2” H x 6.5” W x 6.9” D (10.7 cm x 16.5 cm x 17.5 cm)

Weight ......................................................2.7 lbs. (1.22 kg)

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)

Bilevel Pressure Range .............................................3-25 cmH2O

Operating Temperature Range...........................41°F to 104°F (5°C to 40°C)

Operating Humidity Range.......................... 0% to 95% RH non-condensing

Operating Atmospheric Conditions ....................Sea level to 8,500 feet (2600 m)

Storage & Transportation Temperature Range...........-40°F to 158°F (-40°C to +70°C)

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specificAtions

Storage & Transportation Humidity Range.............. 0% to 95% RH non-condensing

Maximum Limited Pressure ............................30 cmH

2

O under normal use

Sound Level (tested per ISO 17510) ...................................... 26 dBA

Filter Specifications

Standard Filter > 3.0 micron particles
Optional Fine Particle Filter > 0.3 micron particles

Max Flow Rates

154 L/m @ 8.5 cmH2O (1/3 max pressure)
180 L/m @ 16.5 cmH

2

O (2/3 max pressure)

181 L/m @ 25 cmH

2

O (max pressure)

Pressure Accuracy .............................................................................................. ± 1.0 cmH

2

O

Pressure Swings

(cmH2O peak to peak at 500mL tidal volume, sine wave profile)

Breaths per minute 10 15 20

@ 8 cmH

2

O

0.5 0.5 0.5

@ 10 cmH

2

O

1.0 1.0 1.0

@ 17 cmH

2

O

1.0 1.0 1.0

@ 25 cmH

2

O

1.0 1.0 1.0

Warranty .......................................................................................................Three-year limited

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

Clinical Specifications for Digital Outputs

Mask Pressure ..........................................0 to 25.5 cmH2O ± 0.5

Patient Flow .....................................-127 to +127 L/min ± 10 L/min

Leak Flow..........................................0 to +127 L/min ± 10 L/min

Tidal Volume ....................................0 to 1023 mL ± 30% of reading

28

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guiDAnce & mAnufActurer's

DeclArAtion

DeVilbiss® GUiDanCe anD manUfaCTUReR's
DeClaRaTion

� WArning

Medical Electrical Equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the Electromagnetic
Compatibility [EMC] information provided in the accompanying documents.

Portable and Mobile RF Communications Equipment can affect Medical
Electrical Equipment.

The equipment or system should not be used adjacent to or stacked with
other equipment and that if adjacent or stacked use is necessary, the
equipment or system should be observed to verify normal operation in the
configuration in which it will be used.

NOTE– The EMC tables and other guidelines provide information to the customer or user that

is essential in determining the suitability of the Equipment or System for the
Electromagnetic Environment of use, and in managing the Electromagnetic
Environment of use to permit the Equipment or System to perform its intended use

without disturbing other Equipment and Systems or non-medical electrical equipment.

Guidance and Manufacturer’s Declaration – Emissions All Equipment and
Systems

This device is intended for use in the electromagnetic environment specified below. The
customer or user of this device should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Enforcement – Guidance

RF Emissions
CISPR 11

Group 1

This device uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.

RF Emissions
CISPR 11

Class B
Radiated and
Conducted Emissions

This device is suitable for use in all
establishments including domestic, and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.

Harmonics
IEC 61000-3-2

Class A

Flicker
IEC 61000-3-3

Complies

29

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guiDAnce & mAnufActurer's
DeclArAtion

Guidance and Manufacturer’s Declaration – Emissions All Equipment and
Systems

This device is intended for use in the electromagnetic environment specified below. The
customer or user of this device should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test
Level

Compliance
Level

Electromagnetic Environment ­Guidance

Electrostatic
Discharge
(ESD)
IEC 61000-4-2

±6kV contact

±8kV air

±6kV contact

±8kV air

Floors should be wood, concrete or

ceramic tile. If oors are synthetic,

the relative humidity should be at
least 30%.

Electrical Fast
Transient/burst
IEC 61000-4-4

±2kV on AC
Mains

±2kV on AC
Mains

Mains power quality should be that
of a typical commercial or hospital
environment.

Surge
IEC 61000-4-5

±1kV
Differential

±2kV
Common

±1kV
Differential

±2kV
Common

Mains power quality should be that
of a typical commercial or hospital
environment.

Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11

>95% Dip for

0.5 Cycle
60% Dip for

5 Cycles
30% Dip for

25 Cycles
>95% Dip for

5 Seconds

>95% Dip for

0.5 Cycle
60% Dip for

5 Cycles
30% Dip for

25 Cycles
>95% Dip for

5 Seconds

Mains power quality should be that
of a typical commercial or hospital
environment. If the user of this
device requires continued operation
during power mains interruptions, it
is recommended that the device be
powered from an uninterruptible
power supply or battery.

30

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guiDAnce & mAnufActurer's

DeclArAtion

Guidance and Manufacturer’s Declaration – Emissions All Equipment and
Systems

This device is intended for use in the electromagnetic environment specified below. The
customer or user of this device should assure that it is used in such an environment.

Immunity Test

IEC 60601
Test Level

Compliance
Level Electromagnetic Environment - Guidance

Power
Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8

3A/m 3A/m

Power frequency magnetic fields should be
that of a typical location in a typical
commercial or hospital environment.

Conducted RF
IEC 61000-4-6

3 Vrms
from
150 kHz to
80 MHz

V1 = 3
Vrms

Portable and mobile RF communications
equipment should be separated from the
device by no less than the recommended
separation distances calculated/listed
below:

D=(3.5/V1)√

P

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to

2.5 GHz

E1 = 3V/m

D=(3.5/E1)√

P

80 to 800 MHz

D=(7/E1)√

P

800 MHz to 2.5 GHz

Where P is the maximum power rating in
watts and D is the recommended
separation distance in meters.
Field strengths from fixed transmitters, as
determined by an electromagnetic site
survey, should be less that the compliance
levels (V1 and E1).
Interference may occur in the vicinity of
equipment containing a transmitter.

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reection from structures, objects, and people.