DeVilbiss DV57, DV5HH User manual

5 (1)

DV57 autoBilevel cpap series

EN DeVilbiss® IntelliPAP® Positive Airway Pressure Device

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

Made in the USA of US & Imported Parts. Instruction Guide.

 

Dispositivo de presión positiva en las vías respiratorias IntelliPAP®

ES

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.

Fabricado en EE. UU. de partes nacionales e importadas. Guía de instrucciones.

 

Appareil de ventilation spontanée en pression positive IntelliPAP®

FR

de DeVilbiss®

 

ATTENTION–Cet appareil ne peut être vendu que par un médecin ou sur ordonnance de ce dernier.

Fabriqué aux États-Unis avec des pièces des États-Unis et des pièces importées. Guide d’instructions.

DeVilbiss DV57, DV5HH User manual

Key Features

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DV57 / DV5HH

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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A-DV57

EN

ENGLISH................................................................................................

EN-3

ES

ESPAÑOL................................................................................................

ES-23

FR

FRANÇAIS..............................................................................................

FR-45

TABLE OF CONTENTS

Symbol Definitions.................................................................................................................................................

EN - 4

Important Safeguards............................................................................................................................................

EN - 4

Introduction............................................................................................................................................................

EN - 5

Intended Use................................................................................................................................................

EN - 5

Indications for Use.......................................................................................................................................

EN - 5

Contraindication...........................................................................................................................................

EN - 5

AutoBilevel Operating Diagram....................................................................................................................

EN - 5

Key Features..........................................................................................................................................................

EN - 6

IntelliPAP Device..........................................................................................................................................

EN - 6

Keypad.........................................................................................................................................................

EN - 6

Humidifier Cradle.........................................................................................................................................

EN - 6

Water Chamber............................................................................................................................................

EN - 6

Therapy Management System.....................................................................................................................

EN - 6

System Assembly...................................................................................................................................................

EN - 6

Without Heated Humidification.....................................................................................................................

EN - 6

With Heated Humidification..........................................................................................................................

EN - 6

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

EN - 6

Operation...............................................................................................................................................................

EN - 7

Start-Up........................................................................................................................................................

EN - 7

Controlling the Humidity...............................................................................................................................

EN - 7

SmartCode® and Adherence Score Information...........................................................................................

EN - 7

Using the SmartFlexFeature.....................................................................................................................

EN - 8

Using the Comfort Delay Feature................................................................................................................

EN - 8

Shut Down....................................................................................................................................................

EN - 9

Enable Menu List.........................................................................................................................................

EN - 9

Patient Messages..................................................................................................................................................

EN - 9

Reminders....................................................................................................................................................

EN - 9

Notifications..................................................................................................................................................

EN - 9

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

EN - 10

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

EN - 10

Battery Power...............................................................................................................................................

EN - 10

Supplemental Oxygen............................................................................................................................................

EN - 10

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

EN - 11

Maintenance...........................................................................................................................................................

EN - 11

Cleaning.................................................................................................................................................................

EN - 12

Troubleshooting.....................................................................................................................................................

EN - 13

Specifications.........................................................................................................................................................

EN - 14

Guidance and Manufacturer’s Declaration............................................................................................................

EN - 15

Advanced Control Menus.......................................................................................................................................

EN - 17

A-DV57

EN - 3

SYMBOL DEFINITIONS

 

 

 

 

 

 

 

Class II electrical protection-double insulated

 

 

 

 

Type BF equipment-applied part

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Data port input/output

 

 

 

 

Standby-turns blower on/off

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Next item on LCD display

 

Increase value on LCD display

 

 

Previous item on LCD display

 

Decrease value on LCD display

 

 

 

 

 

 

 

Attention, consult accompanying documents

 

 

 

 

Heat

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DC input: 12 VDC, center pin positive

 

 

 

 

100-240 VAC input 50/60 Hz

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Locked

 

 

Unlocked

 

 

 

 

 

 

 

IPX1 Drip-proof, vertical

 

 

 

 

Delay-starts the delay cycle

 

 

 

 

 

 

 

 

 

 

 

 

 

The device contains electrical and/or electronic equipment that must be recycled per EU Directive 2012/19/EU - Waste Electrical and Electronic Equipment (WEEE)

IMPORTANT SAFEGUARDS

READ ALL INSTRUCTIONS BEFORE USING THIS

DEVICE.

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 cabinet. 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.

Always remove the water chamber from the optional humidifier cradle before filling.

If water has spilled onto the humidifier cradle or it has been submerged into water, unplug power cord from power source immediately. Allow device to dry completely before use.

Never block air openings of the humidifier cradle or chamber. Do not insert objects into any openings or tubes.

For proper operation, place system on a flat, sturdy, level surface.

The optional humidifier is intended for single-patient use only.

If the system is placed on the floor, do not position it where it may be stepped on when getting out of bed.

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.

Never rinse or place the device in water. Never allow liquids to get into or around any of the ports, switches or air filter; 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.

EN - 4

A-DV57

Do not place the IntelliPAP where it can be knocked onto the floor or where the power cord may create a trip hazard.

Only the DeVilbiss DV5 series Heated Humidifier system is recommended for use with the IntelliPAP. Other humidifier systems may prevent the device from detecting snoring and may cause inappropriate pressure levels in the mask.

Empty and dry humidifier water chamber before transporting.

INTRODUCTION

Intended Use

The DeVilbiss IntelliPAP Model DV57 Series AutoBilevel CPAP is intended for use in treating OSA in spontaneously breathing patients 30 Kg (66 lbs) and above by means of application of positive air pressure. The device is to be used in home and clinical environments.

Indications For Use (Optional Heated Humidifier)

Use on the advice and prescription of a licensed physician to help relieve the symptoms of dryness of the throat, nasal passages and the mouth, which 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.

Contraindications

Do not use IntelliPAP system if your upper airway has been bypassed. 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 fluid leak, recent cranial surgery or trauma

AutoBilevel Operating Diagram

AutoBilevel is typically used for OSA patients with higher prescribed pressures.

A-DV57

EN - 5

Key Features (Page 2, Figures A-F)

DeVilbiss IntelliPAP Device

(Figures A and B)

Humidifier Cradle (Figure D)

1.

Keypad/LCD Display (see Figure C)

1.

Heater plate

2.

Air Supply Port on Back

2.

Heater power connector

3.

Air Supply Port on Bottom (for optional humidifier)

3.

Storage compartment for connector cover (on

4.

Air Supply Port Plug

 

bottom)

5.

Heater Power Connector (for optional humidifier)

4.

Air supply port inlet

6.

AC Power Connector

5.

Air supply port outlet

7.

DC Power Connector

6.

Flow generator release button

8.

Data Port

7.

Flow generator locking tabs

9.

Power Cord (appropriate to your wall outlet) (not

 

 

10.

shown)

Water Chamber (Figure E)

Air Inlet Filter Opening

1.

Chamber lid

11

Connector Cover (not shown)

2.

Chamber base

Keypad (Figure C)

3.

Heat transfer plate (on bottom)

1.

On/Off

4.

Sealing gasket

2.

Previous Item

5.

Water level indicators (front and sides)

3.

Next Item

6.

Chamber release latch

4.

Delay

7.

Chamber disassembly lever

5.

Decrease Value

Therapy Management System (Figure F)

6.

Increase Value

7.

Heater Power LED (for optional humidifier)

1.

SmartLink® (optional)

Ask your equipment provider for information about other

 

 

DeVilbiss masks, equipment, and accessories.

 

 

SYSTEM ASSEMBLY

Without Heated Humidification

1.Locate the air supply port and heater power 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 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.

NOTENever place the IntelliPAP system on a soft surface such as a bed or couch during operation.

With Heated Humidification

CAUTION–The height of the IntelliPAP must be lower than the mask when using a humidifier to prevent water from getting into mask.

1.If your system includes a humidifier, please follow steps in Figures 1-7.

a.Locate the heater power connector on the bottom of the device. Remove the connector cover and insert it into the storage opening in the bottom of the humidifier cradle.

b.Locate the air supply port at the bottom of the device. Remove the port plug and insert it into the air supply port in the back of the device.

c.Place device onto humidifier cradle and click into place.

d.Fill clean chamber to fill line with distilled water and insert into cradle. Note-Always use distilled water to avoid mineral buildup inside the chamber. Do not overfill.

KEYPAD AND DISPLAY

Basic CPAP Controls

Name

Symbol

Function

ON/OFF

 

The ON/OFF button starts and stops the flow 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.

 

 

The Delay button activates the comfort delay feature and only functions if this feature has been

DELAY

 

enabled. To understand how to set the parameters of this feature, please refer to the Using the

 

 

Comfort Delay Feature found on page EN - 9.

NOTE– The left and right arrow keys on the control panel provide access to menus for specific settings. Ask your homecare provider for more information.

EN - 6

A-DV57

OPERATION

1.Fully insert the power cord into the back of the device. Plug the other end of the power cord into the AC wall outlet.

2.Attach air supply tubing to air supply port in the back of the device.

3.Prepare the mask (supplied by your equipment provider) by referring to the mask’s instruction guide.

4.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 airflow. Use only the 22 mm diameter, smooth-bore, kink-resistant tubing supplied with this device or an air supply tubing recommended by your equipment provider.

Start-up

Put on your mask and press the ON/OFF button on the keypad 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.

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.

If your DeVilbiss IntelliPAP system includes a humidifier, its heater controls and status are displayed.

NOTE– If the display on your device is not similar to those listed above, refer to the section titled “Patient Messages” on page EN-9.

Controlling the Humidity (optional)

The heater setting can be adjusted within a range of 1 to 10. The optimum temperature setting is dependent on the ambient temperature and humidity of your room. If your room temperature is low and/or the relative humidity is high, then a lower temperature setting may be necessary to prevent excess condensation in the air supply tubing. If the room temperature is high and/or the relative humidity is low, then a higher temperature setting may be necessary for optimum comfort.

The heater setting of 1 results in a heater plate temperature of approximately 84°F (29°C). The heater setting of 10 results in a heater plate temperature of approximately 149°F (65°C).

NOTE–Always allow at least 10 minutes of cooling time after turning the device off before removing the water chamber from the humidifier cradle.

WARNING

Do not attempt to fill the humidifier while it is attached to the humidifier cradle. Damage to the humidifier cradle may occur.

CAUTION–Use only distilled water that is at room temperature. Do not add any medication or other additives to the water. CAUTION–For proper operation, ensure the flow generator is OFF before inserting humidifier chamber.

WARNING

Never touch the heater plate on the humidifier cradle. Never touch the heat transfer plate on the bottom of the water chamber. These plates can reach temperatures as high as 149°F (65°C) during operation.

Do not operate the heater if the water chamber is empty. The heater plate may be turned off using the keypad heater control when being used without water.

SmartCode and Adherence Score Information

Your homecare provider may contact you to retrieve SmartCode and Adherence Score information. To display the SmartCode, 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.

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.

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.

A-DV57

EN - 7

Generating Compliance Reports for Employer/Insurer/Physician

SmartCode reports satisfy most requirements for ongoing compliance/adherence information, and the software retains 1,023 days (2.8 years) of data. We recommend you work with your provider to establish a routine for clearing SmartCode data to ensure current usage information is available. Compliance meter should be cleared only after the required report is generated, submitted, and approved by the requestor. Once cleared, a new cycle of 2.8 years begins and the only source for the previous data will be the hard-copy reports.

NOTE-Only the provider has access to clear the meter.

Using The SmartFlex Feature in CPAP mode

Your IntelliPAP 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.

The SmartFlex menu is available in CPAP mode and is a sub-menu that allows you to control various functions of your IntelliPAP. It is accessed by pressing the down button while “SmartFlex Menu” is shown on the Display.

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 OFF 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).

SmartFlex pressure relief can be operated Full Time or during the Delay Only. 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.

The device contains a SmartFlex disengagement feature. If a patient is experiencing a respiratory event while the CPAP is in the relief pressure mode, after a limited time the CPAP will shift to the prescription pressure and remain at this pressure until normal breathing resumes.

Using The Comfort Delay Feature

Your IntelliPAP 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 last few minutes of the specified delay time.

Note–When the delay comfort feature is activated, a message will flash 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 EN-21 for details.

Note–If you are unable to change the delay time, your provider has locked this setting. Refer to the keypad menu guide on page EN-21 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.

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 airflow you receive at the beginning of your therapy is the delay pressure prescribed by your physician when the device was setup. The airflow 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.

Comfort Delay Feature in AutoBilevel Mode

When you use the comfort delay feature while your IntelliPAP is operating in AutoBilevel mode, the airflow you receive at the beginning of your therapy is the delay pressure prescribed by your physician when the device was setup. The airflow

EN - 8

A-DV57

pressure will start at the delay pressure and gradually rise to the prescription setting. In AutoBilevel mode, the IPAP and EPAP pressures will gradually rise together until EPAP reaches the Min EPAP 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 Auto-OFF feature may have been disabled. In this case you must manually turn the device off.

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 “Enable Menu” is shown on the Display.

 

Display Example

 

 

Enable Menu Item Description

 

 

 

 

This option controls the Auto-OFF feature, which automatically stops the flow of air

 

Auto-OFF

 

 

 

 

after taking off the mask. The device will require at least 30 seconds to turn OFF

 

Enabled

 

 

 

 

 

depending on the kind of mask used. When Auto-OFF is enabled, Auto-ON is also

 

 

 

 

enabled. 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.

 

 

 

 

This option controls the Auto-ON feature, which automatically starts the flow of air

 

Auto-ON

 

 

 

 

after breathing once or twice into the mask. This is always enabled when Auto-OFF is

 

Enabled

 

 

 

 

 

enabled. 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.

 

 

 

 

 

 

 

 

 

This option controls the mask fit check feature. The air flow to your mask is

 

Mask Fit Check

 

 

 

 

 

constantly measured and if the amount of airflow exceeds 95 liters/minute for more

 

Enabled

 

 

 

 

 

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 Enable will keep the backlight dim during operation. Low backlight

 

Low Backlight

 

 

 

 

 

Disabled will turn the backlight OFF during operation.

 

Enabled

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pressing the up key exits the Enable menu.

 

Exit Menu

 

 

 

Press

 

 

 

 

 

 

 

 

 

 

 

 

 

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. 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 (Fig. F), 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 equipment 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 (Fig. F), which provides additional messages. Refer to the documentation that was provided with the SmartLink Module.

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 IntelliPAP 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

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EN - 9

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.

Mask Off – This message appears 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 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 equipment 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 8,500 ft (2,600 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 using the 12V DC cable. Alternatively you can power your IntelliPAP using a 12V DC stand alone battery with a DC battery clamp on adapter and 12V DC cable. All cables are available from your equipment provider (refer to Accessories/Replacement Items for the correct part numbers). The stand alone battery connection uses clamps that attach to the terminal connections of the battery.

NOTE–The heater for the IntelliPAP’s humidification system will not operate directly from a 12V DC power source. If you need humidification, non-heated humidification 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~.

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

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 off the oxygen source before turning off the IntelliPAP.

This device is not suitable for use in the presence of a flammable anesthetic mixture.

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 prescribed gas and should only be administered under the supervision of a physician.

The flow setting of the oxygen source must be specified by a physician.

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 homecare provider and connect it to the air supply 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.

EN - 10

A-DV57

2. If your mask is equipped with an oxygen port, your physician may request that you apply oxygen directly to your mask.

ACCESSORIES/REPLACEMENT ITEMS

Replacement Items

 

 

 

 

 

 

 

Air-inlet filter (4/pk)

DV51D-602

Heater connection cover

DV51D-605

Fine particle filter (4/pk)

DV51D-603

Oxygen adapter

7353D-601

Air supply tubing (6’)

DV51D-629

Carrying case

DV51D-610

Air supply plug

DV51D-604

Heated Humidifier

DV5HH

Humidifier Chamber

DV5C

Chamber Sealing Gasket

DV5C-614

Power Items

 

 

 

 

 

 

 

AC power cord (USA)

DV51D-606

AC power cord (Australia)

DV51D-609

AC power cord (UK)

DV51D-608

DC power cord

DV51D-619

AC power cord (EU)

DV51D-607

DC battery clamp-on adapter (requires DC

DV51D-696

 

 

Power Cord DV51D-619)

 

DeVilbiss Masks

 

 

 

 

 

 

 

FlexSet® Masks

 

Serenity® Masks

 

Large, Silicone

9354L

Large, Silicone

9352L

Medium, Silicone

9354D

Medium, Silicone

9352D

Small, Silicone

9354S

Small, Silicone

9352S

Large, Gel

9354GL

Large, Gel

9352GL

Medium, Gel

9354G

Medium, Gel

9352G

Small, Gel

9354GS

Small, Gel

9352GS

Large, ComfortTouchSilicone

9354LR

Large, ComfortTouch Silicone

9352LR

Medium, ComfortTouch Silicone

9354DR

Medium, ComfortTouch Silicone

9352DR

Small, ComfortTouch Silicone

9354SR

Small, ComfortTouch Silicone

9352SR

Large, ComfortTouch Gel

9354GLR

Large, ComfortTouch Gel

9352GLR

Medium, ComfortTouch Gel

9354GR

Medium, ComfortTouch Gel

9352GR

Small, ComfortTouch Gel

9354GSR

Small, ComfortTouch Gel

9352GSR

EasyFit® Nasal

Available in Silicone (S, M, L, XL), Gel (S, M, L) or SilkGel (S, M, L). Contact

 

your equipment provider

 

EasyFit Full Face

Available in Silicone (S, M, L, XL), Gel (S, M, L) or SilkGel (S, M, L). Contact

your equipment provider

 

 

 

MAINTENANCE

DANGER

Electric shock hazard-Do not attempt to open or remove the cabinet; there are no user-serviceable components inside. If service is required, contact your equipment provider for instructions on obtaining service. Opening or attempting to service your device will void the warranty.

WARNING

Disconnect supply before servicing.

Pressure Accuracy–The IntelliPAP is designed to provide accurate pressure performance from the factory without additional calibration. No routine service is required provided the device is used in accordance with the manufacturer’s directions.

NOTE–Some countries require periodic servicing and calibration of this kind of medical device. Contact your equipment 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.

A-DV57

EN - 11

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 filter; doing so will result in product damage. If this occurs, do not use the device. Contact your equipment provider for service.

Device Cabinet

1.Unplug the IntelliPAP from the power source. Wipe the cabinet with a clean, damp cloth every few days to keep the cabinet dust free.

2.Allow the device to dry completely before plugging it into a power source.

Filters

Air-Inlet Filter

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 filter 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 equipment 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 fine particle filter is not installed first according to the directions, the life of the filter will be reduced requiring more frequent replacement.

Optional Heated Humidifier

Water Chamber Humidifier water chamber should be cleaned daily.

1.Press on the chamber release latch and pull out the water chamber from the cradle (Fig 4).

2.Separate the chamber halves by pressing forward on the chamber disassembly lever and lifting the lid of the chamber (Fig 9).

3.Remove the sealing gasket from the chamber lid (Fig 10).

4.Hand wash the parts in a solution of warm water and mild dishwashing detergent.

CAUTION–Do not use any solutions that contain bleach, chlorine, alcohol, scented oils or other aromatic-based ingredients to clean the humidifier components or tubing. These solutions may reduce the life of the product.

5.Allow the parts to dry before reassembly.

CAUTION–Inspect the gasket seal before each use to ensure that it is properly seated in the groove around the entire chamber.

NOTE– The disassembled chamber may also be washed once per week in a dishwasher on the delicate or glassware cycle, top shelf only.

Humidifier Cradle - The humidifier cradle should be cleaned as needed.

1.Turn off the heater and unplug from power source. Allow system to cool for at least 10 minutes.

2.Detach flow generator from the cradle; first remove water chamber then fully depress the flow generator release button to separate (Fig 4).

NOTE–Flow generator release button must be pressed completely to separate.

3. Use a soft, damp cloth to clean the surfaces of unit.

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.

EN - 12

A-DV57

TROUBLESHOOTING

WARNING

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.

Issue

Possible Cause

Remedy

Nothing shows on

1.

Device is not plugged in or the power cord

1a. Verify that power cord is firmly connected to

the display.

is not fully inserted.

the IntelliPAP and the power outlet.

 

 

 

1b. If you are using a DC power source, make

 

 

 

sure the cable connections are secure. Verify that

 

 

 

battery is charged.

 

2.

Optional Humidifier-The flow generator is

2.

Refer to assembly instructions (Fig. 1-7).

 

not fully seated on humidifier cradle.

 

 

 

3.

There is no outlet power.

3.

Locate a suitable functioning power source.

The IntelliPAP does

1.

The Auto-ON feature has been disabled.

1.

Use the ON/OFF button to start and stop

not start when

 

 

device.

breathing into the

2.

There is no power to the device.

2.

Verify that the power cord is firmly connected to

mask.

 

 

the device and the power outlet.

 

3.

Breath is not deep enough for the Auto-ON

3.

Breathe deeply in and out to start the device.

 

feature to detect.

 

 

 

4.

You are using a full face mask that has an

4. Auto-ON may not work because your exhaled

 

anti-asphyxia valve.

breath escapes through the open valve. Use the

 

 

 

ON/OFF button to start and stop the device.

 

5.

The air supply port plug is missing or not

5.

Make sure the air supply port plug is fully

 

fully inserted.

inserted into the unit.

 

6.

The humidifier chamber is not fully engaged

6.

Slide the humidifier chamber fully into the slot.

 

into the cradle or is missing.

Verify the latching lever snaps into place.

The airflow has

1.

The Auto-OFF feature has detected large

1.

Ensure you have a good mask fit; adjust mask

stopped

airflow because of loosely fitting mask.

and headgear.

unexpectedly

2.

During use, your mouth opens and you

2.

Contact equipment provider for a chin strap or

during use or

begin to mouth-breathe.

different mask to prevent mouth-breathing.

reports mask leak.

 

 

 

 

3.

The optional humidifier chamber is not fully

3.

Slide the humidifier chamber fully into cradle.

 

engaged or is missing.

Verify the release latch clicks into place.

 

4.

The air supply port plug is missing from the

4.

Ensure the air supply port plug is fully inserted

 

back of the CPAP or is not fully inserted.

into the back of the CPAP.

The display shows

An error has occurred in the device and

Contact your equipment provider for service.

a device fault.

requires servicing.

 

 

Apnea symptoms

1.

Air filter may be dirty.

1.

Clean or replace the air filter and relocate

have recurred.

 

 

device away from drapes or other dusty surfaces.

 

2.

Apnea condition has changed.

2.

Contact your physician or equipment provider.

Skin becomes

1.

Headgear is too tight or improperly

1.

Loosen headgear to reduce contact pressure

irritated where

adjusted.

on face.

mask contacts face.

2.

Your mask may not be sized properly or is

2.

Contact physician or equipment provider.

 

not the most appropriate shape for you.

 

 

Dryness of throat or

Inadequate humidity.

1a. Add a DeVilbiss DV5 heated humidifier.

nose.

 

 

1b. Increase the heater setting on the humidifier.

Water condensation

1. Humidification is too high.

1.

Reduce humidifier heater setting.

collecting in the

 

 

 

 

hose causing a

2.

Room temperature fluctuates from higher to

2.

Increase room temperature.

gurgling sound.

lower levels through the night.

 

 

 

 

 

 

 

A-DV57

EN - 13

Issue

Possible Cause

Remedy

Air from flow

1.

Air filters are dirty.

1.

Clean filters.

generator seems to

 

 

 

 

2.

Air inlet port is blocked.

2.

Unblock air inlet.

be too warm.

 

 

 

 

3.

Room temperature is too high.

3.

Lower room temperature.

 

 

4.

Device is located near a heat source.

4.

Locate device away from heat source.

 

5.

Humidifier (optional) heater setting is too

5.

Lower heater setting.

 

high.

 

 

Nasal, sinus or ear

You may have a reaction to air flow pressure.

Discontinue use and contact physician.

pain, runny nose

 

 

 

 

 

 

 

 

 

Heater setting is

1.

The flow generator is not fully seated onto

1.

Ensure proper contact is made (Fig. 3).

not visible on

the humidifier cradle.

 

 

display

 

 

 

 

2.

Your CPAP device is not equipped with the

 

 

 

 

 

 

optional humidifier.

 

 

 

 

 

 

Bilevel changes

1.

Trigger Sensitivity is not set correctly.

1. Adjust the inspiratory and expiratory trigger

pressure too early

 

 

sensitivity to adjust triggering for the patient.

or too late (not

2.

Backup rate (time) is too high, the patient is

2.

Reduce Backup Rate setting.

following breathing)

breathing slower than the backup rate.

 

 

Specifications

CPAP

 

Size...........................................................................................................

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

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)

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 (2,600 m)

Storage & Transportation Temperature Range......................................................................

-40°F to +158°F (-40°C to 70°C)

Storage & Transportation Humidity Range...............................................................................

0% to 95% RH non-condensing

Maximum Limited Pressure...........................................................................................................

30 cmH2O under normal use

Sound Pressure Level (tested per ISO 17510)................................................................................................................

26 dBA

Sound Power Level..........................................................................................................................................................

38 dBA

SmartCode® Technology is protected under US patent 8649510

 

Humidifier

≥10 mgH2O/l air

Humidity Output (in the operating flow range):.................................................................................................

Size:......................................................................................................

2.6” H x 6.3” W x 8.4” D (6.6 cm x 16.0 cm x 21.3 cm)

Weight:.........................................................................................................................................................

1.75 lbs. (0.794 Kg)

Power Consumption:.....................................................................................................................................................

85 Watts

DV5HH Electrical Requirements.................................................................................................................

100-240VAC, 0.95 A

Heater Plate Thermal Cutout:..............................................................................................................................

305°F (152°C)

Power/Temperature Control:.......................................................................................

Setting of 1 (minimum) to 10 (maximum)

Heater Plate Temperature:................................................................................

84°F to 149°F (approx. 29°C to approx. 65°C)

Operating Temperature Range:....................................................................................................

41°F to 104°F (5°C to 40°C)

Operating Humidity Range:........................................................................................................

0 to 95% R.H. non-condensing

Operating Atmospheric Pressure Range:........................................................................................................

70.0 – 106.0 kPA

Filter Specifications

 

Standard Filter .........................................................................................................................................

> 3.0 micron particles

Optional Fine Particle Filter .....................................................................................................................

> 0.3 micron particles

EN - 14

A-DV57

Dynamic Short-Term Pressure Accuracy with and without DV5HH Humidifier (Per ISO 17510-1:2007)

 

 

 

Set Pressure

Pressure Accuracy

Waveform

Volume [mL]

Breath Rate [min-1]

[cmH2O]

[Pk-Pk cmH2O]

 

 

 

3.0

0.5

Sinusoidal

 

 

9.0

0.5

cycle with I:E =

500

10, 15, 20

14.0

1.0

1:1

 

 

 

 

 

 

20.0

1.0

 

 

 

25.0

1.0

Maximum Flow-Rate (per ISO 17510-1:2007)

 

Test Pressures

 

 

 

 

3.0 cmH2O

9.0 cmH2O

14.0 cmH2O

20.0 cmH2O

25.0 cmH2O

Measured pressure at the patient

3.0

8.9

13.0

19.0

24.0

connection port (cmH2O)

 

 

 

 

 

Average flow at the patient connection port

95.0

160.5

172.2

158.5

139.7

(l/min)

 

 

 

 

 

Long Term Static Pressure Accuracy ..................................................................................................................

 

 

 

 

+/- 0.5 cmH2O

Additional Specifications

 

 

 

 

 

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.......................................................................................

 

 

 

IPXI Drip-proof vertical

Mode of operation.....................................................................................................................................................

 

 

 

 

Continuous

Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

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.

NOTEThe 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

 

This device uses RF energy only for its internal function. Therefore, its RF

Group 1

emissions are very low and are not likely to cause any interference in nearby

CISPR 11

 

electronic equipment.

 

 

RF Emissions

Class B

 

Radiated and Conducted

 

CISPR 11

 

Emissions

This device is suitable for use in all establishments including domestic, and

 

Harmonics

Class A

those directly connected to the public low-voltage power supply network that

IEC 61000-3-2

supplies buildings used for domestic purposes.

 

Flicker

Complies

 

IEC 61000-3-3

 

 

 

A-DV57

EN - 15

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic

±6kV contact

±6kV contact

Floors should be wood, concrete or ceramic tile. If

Discharge (ESD)

floors are synthetic, the relative humidity should be at

±8kV air

±8kV air

IEC 61000-4-2

least 30%.

 

 

 

 

Electrical Fast

 

 

Mains power quality should be that of a typical

Transient/burst

±2kV on AC Mains

±2kV on AC Mains

commercial or hospital environment.

IEC 61000-4-4

 

 

 

 

 

 

Surge

±1kV Differential

±1kV Differential

Mains power quality should be that of a typical

IEC 61000-4-5

±2kV Common

±2kV Common

commercial or hospital environment.

 

>95% Dip for

>95% Dip for

 

 

Voltage dips, short

0.5 Cycle

0.5 Cycle

Mains power quality should be that of a typical

interruptions and

60% Dip for

60% Dip for

commercial or hospital environment. If the user of this

voltage variations

5 Cycles

5 Cycles

device requires continued operation during power

on power supply

30% Dip for

30% Dip for

mains interruptions, it is recommended that the device

input lines

25 Cycles

25 Cycles

be powered from an uninterruptible power supply or

IEC 61000-4-11

>95% Dip for

>95% Dip for

battery.

 

 

5 Seconds

5 Seconds

 

 

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Power Frequency

3A/m

3A/m

Power frequency magnetic fields should be that of a

50/60Hz Magnetic

typical location in a typical commercial or hospital

Field IEC 61000-4-8

 

 

environment.

 

 

 

 

Portable and mobile RF communications equipment

Conducted RF

3 Vrms from

V1 = 3 Vrms

should be separated from the device by no less than

the recommended separation distances calculated/

IEC 61000-4-6

150 kHz to 80 MHz

 

listed below:

 

 

 

 

D=(3.5/V1)√P

 

 

 

 

 

 

 

 

 

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

Radiated RF

3 V/m

E1 = 3V/m

is the recommended separation distance in meters.

Field strengths from fixed transmitters, as determined

IEC 61000-4-3

80 MHz to 2.5 GHz

 

by an electromagnetic site survey, should be less than

 

 

 

 

 

 

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 reflection from structures, objects, and people.

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and this device. This device and system are NOT

Life-Supporting

This device is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the device as recommended below, according to the maximum output power of the communications equipment.

Maximum Output

Recommended Separation Distances for the device (meters)

150 kHz to 80 MHz

80 to 800MHz

800 MHz to 2.5 GHz

Power (Watts)

D=(1.1667)√P

D=(1.1667)√P

D=(2.3333)√P

 

 

 

 

0.01

0.11667

0.11667

0.23333

0.1

0.36894

0.36894

0.73785

1

1.1667

1.1667

2.3333

10

3.6894

3.6894

7.3785

100

11.667

11.667

23.333

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 reflection from structures, objects, and people.

EN - 16

A-DV57

Advanced Menu Controls

With the device on, press the “Next” or “Previous” buttons on the keypad to scroll through the items on the display.

Name

Symbol

Function

PREVIOUS ITEM

k

Pressing this button displays the previous menu option.

NEXT ITEM

j

Pressing this button displays the next menu option.

SETTING CHANGE

h

These buttons allow you to adjust the setting that is shown on the display.

 

i

 

Please note that the values displayed are examples only.

Patient Menu Layout

 

CPAP Mode

 

 

 

 

 

 

 

 

 

The following charts show by Mode each Display

 

 

 

 

 

 

 

 

 

 

 

you will scroll through using the Next or Previous

 

P:10.0 FLX

CPAP

 

 

 

Heater setting shown if DV5HH is

 

 

 

Heat:5

 

 

 

 

attached, FLX shown if SmartFlex

buttons on the keypad. Pressing the Down key at

 

 

 

 

 

 

 

 

 

 

 

feature is turned on.

 

 

the Enable Menu Display will allow you to enter

 

P:10.0 S–T RR:15

 

 

 

 

 

 

 

 

this submenu - then use Next or Previous buttons

 

I/E: 1:1.0 (50%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SmartFlex 3

 

 

to scroll through it; press the Up button to return to

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LK:123 S–S EV:AS

 

 

 

 

 

 

 

main menu. Once the final Display is reached,

 

MV:123.4 VT:1234

 

 

 

 

 

 

 

 

pressing the Next button will return you to the first

 

 

 

 

 

 

 

 

SmartFlex Mode

 

 

 

 

 

 

 

 

 

 

Full-Time

 

 

 

 

 

 

 

BUTTON

 

 

 

 

 

 

 

 

 

 

 

Display.

 

Set Pressure

 

 

 

 

 

 

 

Note-If the unlocked symbol is shown, you are

 

10.0 cmH2O

 

 

 

 

SmartFlex IRnd

 

 

able to adjust this setting. If the locked symbol is

 

 

 

 

 

()

 

3

 

 

 

Delay Time

 

 

 

 

 

 

 

shown, this setting can only be adjusted by your

 

 

 

DOWN

 

 

 

 

 

20 minutes

 

 

 

 

SmartFlex ERnd

 

 

provider.

 

 

 

 

 

 

3

 

 

 

 

Delay Pressure

 

 

 

 

 

 

 

 

 

 

 

4.0 cmH2O

 

 

 

 

 

 

Exit Menu

 

 

 

 

 

 

 

 

 

 

 

Press

 

 

RIGHT () LEFT () BUTTONS

NOTE: There are 5 levels of SmartCode. Use up p or down key to change between levels.

Tubing Length

 

1.8 m (6 ft)

 

 

 

SmartFlex Menu

 

Press

 

 

 

Enable Menu

 

Press

 

 

 

LCD Contrast Adj

 

50%

 

 

 

Compliance Meter

 

123456.7 hours

 

 

 

Firmware Version

 

V0.01 30/11/2010

 

 

 

Serial Number

 

MD000005

 

 

 

Adherence Score

 

83% (25/30)

 

SmartCode 1-Day

B6CD-37F-35M2

UP () BUTTON

 

 

DOWN () BUTTON

 

 

 

 

 

 

 

 

Auto-OFF

 

 

 

 

Disabled

 

 

 

 

 

 

 

 

 

Auto-ON

 

 

BUTTON

 

Enabled

 

 

 

 

 

 

Mask Fit Check

 

 

)

 

Enabled

 

 

UP (

 

 

 

 

 

 

 

 

 

Low Backlight

 

 

 

 

Enabled

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exit Menu

 

 

 

 

Press

 

 

 

 

 

 

 

RIGHT () LEFT () BUTTONS

A-DV57

EN - 17

Bilevel S Mode

 

 

 

 

 

 

 

Heater setting shown if DV5HH

 

 

 

P:10.0

S

 

 

 

 

 

Heat:Off

 

 

 

is attached.

 

 

 

 

 

 

 

 

 

 

 

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 Time

 

 

 

 

 

 

 

20 minutes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Delay Pressure

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.0 cmH2O

 

 

 

 

BUTTONS

 

3 (1234 ms)

 

 

 

 

 

 

 

IPAP Rounding

 

 

 

 

()

 

 

 

 

 

 

 

 

 

 

 

 

LEFT

 

EPAP Rounding

 

 

 

 

 

3 (1234 ms)

 

 

 

 

()

 

 

 

 

 

 

RIGHT

 

Insp. Trigger

 

 

 

 

 

5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exp. Trigger

 

 

 

 

 

 

 

5

 

 

 

 

Tubing Length

 

3.0 m (10 ft)

 

 

 

Enable Menu

 

Press

 

LCD Contrast Adj

50%

Compliance Meter 123456.7 hours

Firmware Version

V0.01 30/11/2010

Serial Number

MD000005

Adherence Score

70% (21/30)

SmartCode 1-Day

B6CD-37F-35M2

 

 

 

 

 

Auto-OFF

 

 

 

Disabled

 

BUTTONS)(

 

Mask Fit Check

 

 

Auto-ON

 

 

 

Enabled

 

 

 

 

 

LEFT

 

Enabled

 

 

 

 

 

 

 

()

 

Low Backlight

 

 

Enabled

 

RIGHT

 

 

 

 

Exit Menu

 

 

 

Press

 

 

NOTE: There are 5 levels of SmartCode. Use up p or down key to change between levels.

AutoBilevel Mode

 

 

 

 

 

 

 

P:10.0

Auto S

 

 

 

Heat:Off

 

 

 

 

 

 

 

 

P:10.0 S–T RR:15

 

 

 

I/E: 1:1.0 (50%)

 

 

 

 

 

 

 

 

 

LK:123 S–S EV:AS

 

 

 

MV:123.4 VT:1234

 

 

 

 

 

 

 

 

Max IPAP

 

 

 

 

10.0 cmH2O

 

 

 

 

 

 

 

 

 

Min EPAP

 

 

 

 

5.0 cmH2O

 

 

 

 

 

 

 

 

 

Pressure Support

 

 

 

5.0 cmH2O

 

 

 

 

 

 

 

 

 

Delay Time

 

 

 

 

20 minutes

 

 

 

 

 

 

 

 

 

 

 

BUTTONS)

 

Delay Pressure

 

 

 

4.0 cmH2O

 

 

 

 

 

 

 

(

 

IPAP Rounding

 

 

 

3 (1234 ms)

 

 

)LEFT

 

 

 

 

 

 

 

(

 

EPAP Rounding

 

 

 

3 (1234 ms)

 

 

RIGHT

 

 

 

 

 

 

 

 

 

Insp. Trigger

 

 

 

 

5

 

 

 

 

 

 

 

 

 

Exp. Trigger

 

 

 

 

5

 

 

 

 

 

 

 

 

 

Tubing Length

 

 

 

 

3.0 m (10 ft)

 

 

 

 

 

 

 

 

 

Enable Menu

 

 

 

 

Press

 

 

 

 

 

 

 

 

LCD Contrast Adj

 

 

 

50%

 

 

 

 

 

 

 

 

Compliance Meter

 

 

 

123456.7 hours

 

 

 

 

 

 

 

 

 

Firmware Version

 

 

 

V0.01 30/11/2010

 

 

 

 

 

 

 

 

Serial Number

 

 

 

 

MD000005

 

 

 

 

 

 

 

 

 

Adherence Score

 

 

 

70% (21/30)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SmartCode

1-Day

 

 

 

B6CD-37F-35M2

 

 

 

 

 

 

Auto-OFF

 

Disabled

 

 

 

Auto-ON

 

Enabled

 

Mask Fit Check

Enabled

Low Backlight

Enabled

Exit Menu

Press

RIGHT () LEFT () BUTTONS

EN - 18

A-DV57

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

Display Example

 

SmartFlex

 

 

 

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SmartFlex Mode

 

 

 

 

Full Time

 

 

 

 

 

 

 

 

 

 

 

 

 

SmartFlex IRnd

 

 

 

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SmartFlex ERnd

 

 

 

 

3

 

 

 

 

 

 

 

 

 

Exit Menu

 

 

 

 

Press

 

 

 

 

 

 

 

 

Description

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

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. This setting controls the Inhale pressure waveform.

This setting controls the Exhale pressure waveform.

Pressing the up key exits the SmartFlex menu

Blower Off Menus

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

OFF

Quick View Menu

Press

Serial Number

MD000005

Adherence Score

83% (25/30)

SmartCode 1-Day

B6CD-37F-35M2

SmartCode 7-Day

9CCC-377D-7JMV

SmartCode 30-Day

EWY4-3DB7-DJM1

SmartCode 90-Day

C52TT-47DB-7DTMJ

SmartCode Usage

ZDN-79FK-KMN

Description

Blower OFF, the CPAP unit is plugged in to AC or DC power with the blower OFF.

Pressing the down key enters the Quick View menu. Refer to page EN-20 for Quick View Menu details. Note: The “Quick View” menu is only shown if enabled from the clinical menu.

Shows the serial number of the device.

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 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.

A-DV57

EN - 19

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

30d

 

Days ≥ 4H

90d

 

 

Days ≥ 4H

1d

 

Days ≥ 4H

7d

 

1/ 1 (100%)

 

 

7/ 7 (100%)

 

 

30/30 (100%)

 

 

90/90 (100%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AHI

1d

 

AHI

7d

 

AHI

30d

 

AHI

90d

 

 

31.5+

 

 

31.5+

 

 

31.5+

 

 

31.5+

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

High Leak

1d

 

High Leak

7d

 

High Leak

30d

 

High Leak

90d

 

 

31+%

 

 

31+%

 

 

31+%

 

 

31+%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Daily Usage

1d

 

Daily Usage

7d

 

Daily Usage

30d

 

Daily Usage

90d

 

 

9.3+ hours

 

 

9.3+ hours

 

 

9.3+ hours

 

 

9.3+ hours

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exit Menu

 

 

 

 

UP () DOWN () buttons

 

 

 

 

Press

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

RIGHT () LEFT () buttons

definitions

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 certain modes or with the DeVilbiss 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.

Please note that the values displayed are examples only.

 

Display Example

Description

Mode

 

 

 

 

Blower OFF, the CPAP unit is plugged in to AC or DC power with the

All

 

OFF

 

 

 

 

 

 

blower OFF.

 

 

 

 

 

 

 

 

 

Quick View Menu

 

 

Pressing the down key enters the Quick View menu. Refer to page

All

 

Press

 

 

EN-20 for Quick View Menu details. Note: The “Quick View” menu is

 

 

 

 

only shown if enabled from the clinical menu.

 

 

 

 

 

 

 

P: 5.0

Auto S

 

This is the default screen when the device is turned on. The actual mask

All

 

 

pressure and heater setting are shown. The displayed pressure may

 

 

Heat:Off

 

 

 

 

 

 

vary slightly while breathing. If the heater system is not connected, the

 

 

 

 

 

heat setting will be blank.

 

 

 

 

 

 

 

P:10.0 ST RR:15

 

 

 

Real time info screen, top row shows measured pressure (P), Trigger

All

 

I/E: 1:1.0 (50%)

 

 

 

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 SS EV:AS

 

 

 

Real time info screen, top row shows Leak rate (LK), Trigger source

All

 

MV:123.4 VT:1234

 

 

 

(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)

 

 

 

 

 

 

 

EN - 20

A-DV57

Display Example

Max IPAP 15.0 cmH2O

Min EPAP

5.0 cmH2O

Pressure Support

5.0 cmH2O

IPAP

10.0 cmH2O r 5.0

EPAP

5.0 cmH2O r 5.0

Set Pressure 10.0 cmH2O

Delay Time

 

20 minutes

 

 

 

Delay Pressure

 

4.0 cmH2O

 

 

 

IPAP Rounding

 

3 (1234 ms)

 

 

 

EPAP Rounding

 

3 (1234 ms)

 

 

 

Insp. Trigger

 

5

 

 

 

Exp. Trigger

 

5

 

 

 

Tubing Length

 

1.8 m (6 ft)

 

 

 

SmartFlex Menu

 

Press

 

 

 

Enable Menu

 

Press

 

 

 

LCD Contrast Adj

 

50 %

 

 

 

Compliance Meter

 

123456.7 hours

 

Description

Mode

Maximum IPAP pressure level that will be administered. Range: (Min

AutoBilevel

EPAP + Pressure Support) - 25.0 cm H2O, increments of 0.5 cm H2O.

Mode

 

 

 

Minimum EPAP pressure level that will be administered. Range: 3.0 cm

AutoBilevel

H20 - (max IPAP - Pressure Support), increments of 0.5 cm H2O

Mode

 

 

 

 

Difference between IPAP and EPAP Pressure. Range: 0 - (Max IPAP -

AutoBilevel

Min EPAP), 12 cm H2O max, increments of 0.5 cm H2O

Mode

 

 

 

 

This is a prescription setting which controls the pressure during inhale,

Bilevel S

 

this also shows the pressure delta (5.0 in example) between inhale and

Modes

 

exhale pressure settings

 

 

This is a prescription setting which controls the pressure during exhale,

Bilevel S

 

this also shows the pressure delta (5.0 in example) between inhale and

Modes

 

exhale pressure settings

 

 

This is a prescription setting which controls the operating pressure.

CPAP Mode

 

 

 

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

All

 

 

 

This is a prescription setting which controls the operating pressure

All

during the delay time.

 

 

 

 

 

 

This is a setting which controls the comfort rounding when switching to

All

 

IPAP pressure, settings are 0 thru 5 also shows measured rise time of

Bilevel

 

the last breath in milliseconds.

Modes

 

This is a setting which controls the comfort rounding when switching to

All

 

EPAP pressure, settings are 0 thru 5 also shows measured rise time of

Bilevel

 

the last breath in milliseconds.

Modes

 

This is a setting which controls the sensitivity of the inspiratory trigger,

All

 

can be set from 1 to 10, 1 is most sensitive, 10 is least sensitive.

Bilevel

 

 

 

Modes

 

 

This is a setting which controls the sensitivity of the expiratory trigger,

All

 

can be set from 1 to 10, 1 is most sensitive, 10 is least sensitive.

Bilevel

 

 

 

Modes

 

 

The standard tubing length supplied with the device is 6 feet (1.8

All

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).

 

Pressing the down key enters the SmartFlex menu. Refer to SmartFlex

CPAP Mode

Menu section for details

 

 

 

 

Pressing the down key enters the Enable menu. Refer to next section for

All

Enable Menu details.

 

 

 

 

This setting changes the contrast for the LCD display. This only needs to

All

be adjusted if you find it difficult to see the display from your viewing

 

angle.

 

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

All

has been providing therapy.

 

 

 

 

 

A-DV57

EN - 21

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