Respironics C-Flex M Series Manual de usuario

M Series with C-Flex™

e REMstar® Auto M Series with C-Flex™ system is covered by one or more of the following patents:

5,148,802; 5,313,937; 5,433,193; 5,632,269; 5,803,065; 6,029,664; 6,305,374; 6,539,940, 5,535,738;

5,794,615; 6,105,575; 6,609,517; 6,629,527; 6,622,724; 6,564,797; 6,427,689; 5,645,035; 6,286,508;

6,550,478; 6,752,150, and 6,932,084. Other patents pending. REMstar, Whisper Swivel, Encore Pro, and

Encore Pro SmartCard are trademarks of Respironics, Inc. NOTE: e C-Flex trademark is used under

license.

IMPORTANT! Fill in the information below when you receive the REMstar

Auto M Series system.

Serial No.: _______________________________ (located on the bottom of the device)

System Prescribed for: __________________________________________

Date of Purchase or Rental: ______________________________________

Pressure Setting: _____ cm H2O

Mask Type: __________________________________________________

Mask Size: ___________________________________________________

If you have any questions concerning the system, contact:

 t )PNF$BSF$PNQBOZ@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@@

Telephone Number: _________________________________________

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Telephone Number: _________________________________________

tRespironics, Inc.

1001 Murry Ridge Lane

Murrysville, Pennsylvania

15668-8550 USA

Customer Service

Telephone Number: 1-724-387-4000

 t 3FTQJSPOJDT%FVUTDIMBOE

Gewerbestrasse 17

82211 Herrsching Germany

Customer Service

Telephone Number: +49 8152 93060

iREMSTAR AUTO M SERIES USER MANUAL

TABLE OF CONTENTS

Chapter 1: Introduction ..................................................................................................................1-1

1.1 System Contents........................................................................................................1-1

1.2 Intended Use...............................................................................................................1-2

1.3 Warnings, Cautions, and Contraindications.....................................................1-2

1.3.1 Warnings...........................................................................................................1-2

1.3.2 Cautions............................................................................................................1-4

1.3.3 Contraindications..........................................................................................1-4

1.4 System Overview.......................................................................................................1-5

1.4.1 Breathing Circuit Overview........................................................................1-6

1.5 Glossary.........................................................................................................................1-7

1.6 Symbol Key ..................................................................................................................1-8

1.7 How to Contact Respironics ..................................................................................1-8

Chapter 2: Device Controls and Displays .................................................................................2-1

2.1 Controls and Displays ..............................................................................................2-1

2.1.1 Control Panel Inactivity...............................................................................2-2

2.2 Rear Panel.....................................................................................................................2-2

Chapter 3: Setup................................................................................................................................3-1

3.1 Installing the Air Filters............................................................................................3-1

3.2 Where to Place the Device......................................................................................3-2

3.3 Connecting the Breathing Circuit .......................................................................3-2

3.4 Supplying Power to the Device............................................................................3-4

3.4.1 Using AC Power .............................................................................................3-4

3.4.2 Using DC Power .............................................................................................3-5

3.5 Complete Assembly Example ...............................................................................3-6

Chapter 4: Device Operation ........................................................................................................4-1

4.1 Available Therapies...................................................................................................4-1

4.2 Starting the Device ...................................................................................................4-1

ii REMSTAR AUTO M SERIES USER MANUAL

4.3 Using the Ramp and C-Flex Features..................................................................4-3

4.3.1 Ramp Feature..................................................................................................4-3

4.3.2 C-Flex Comfort Feature ...............................................................................4-3

4.3.2.1 C-Flex Enabled....................................................................................4-3

4.3.2.2 C-Flex Locked...................................................................................... 4-4

4.3.2.3 C-Flex Disabled ..................................................................................4-4

4.4 Changing the Device Settings ..............................................................................4-4

4.4.1 Navigating the Display Screens................................................................4-5

4.4.1.1 Viewing Data on the Patient Data Screens...............................4-5

4.4.1.2 Viewing and Modifying Patient Setup Screens ...................... 4-7

4.5 Completing the FOSQ Questionnaire ................................................................4-9

4.6 Patient Reminder Screen ......................................................................................4-10

Chapter 5: Device Alerts and Troubleshooting......................................................................5-1

5.1 Device Alerts ............................................................................................................... 5-1

5.2 Troubleshooting.........................................................................................................5-4

Chapter 6: Accessories .................................................................................................................... 6-1

6.1 Adding a Humidier ................................................................................................. 6-1

6.2 Using the SmartCard ..............................................................................................6-1

6.3 Adding Supplemental Oxygen.............................................................................6-2

Chapter 7: Cleaning and Maintenance......................................................................................7-1

7.1 Cleaning the Device ................................................................................................. 7-1

7.2 Cleaning or Replacing the Filters......................................................................... 7-1

7.3 Cleaning the Tubing ................................................................................................. 7-2

7.4 Service ...........................................................................................................................7-2

7.5 Traveling with the System ......................................................................................7-2

7.5.1 International Travel.......................................................................................7-2

Chapter 8: Specications................................................................................................................ 8-1

Appendix A: EMC Information......................................................................................................A-1

1-1REMSTAR AUTO M SERIES USER MANUAL

CHAPTER 1: INTRODUCTION

is chapter provides information on:

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1.1 SYSTEM CONTENTS

Your REMstar Auto M Series system includes the following items:

Device

Flexible Tubing

Reusable Gray Foam

Filter

Disposable Ultra-ne

Filter

Power Supply

AC Power Cord

Carrying Case

User Manual

Flex

FIGURE 1–1 SYSTEM CONTENTS

Note: If your system includes a humidier, you will receive additional items with your

package. See the instructions included with your humidier for more informa-

tion.

Note: If any of the above items are missing, contact your home care provider.

1-2 REMSTAR AUTO M SERIES USER MANUAL

1.2 INTENDED USE

e Respironics REMstar Auto M Series system is a CPAP (Continuous Positive Airway Pressure)

device designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing

patients weighing >30 kg.

e device is to be used only on the instruction of a licensed physician. e system can deliver

CPAP therapy or Auto-CPAP therapy, both with and without C-Flex. Your home care provider

will make the correct pressure settings according to your health care professional’s prescription.

When set in the Auto-CPAP therapy, the system will monitor your breathing as you sleep and

automatically adjust the pressure to meet your needs. When in CPAP therapy, the system will

deliver a continuous, set pressure during the night.

Several accessories are available to make your OSA treatment with the REMstar Auto M Series

system as convenient and comfortable as possible. To ensure that you receive the safe,

eﬀective therapy prescribed for you, use only Respironics accessories.

1.3 WARNINGS, CAUTIONS, AND CONTRAINDICATIONS

1.3.1 WARNINGS

A warning indicates the possibility of injury to the user or the operator.

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sede the health care professional’s instructions regarding the use of the device.

tThe operator should read and understand this entire manual before using the device.

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te device should be used only with masks and connectors recommended by Respironics

or with those recommended by the health care professional or respiratory therapist. A mask

should not be used unless the device is turned on and operating properly. e exhalation

port(s) associated with the mask should never be blocked.

Explanation of the Warning: e device is intended to be used with special masks or con-

nectors that have exhalation ports to allow continuous ﬂow of air out of the mask. When the

device is turned on and functioning properly, new air from the device ﬂushes the exhaled air

out through the mask exhalation port. However, when the device is not operating, enough

fresh air will not be provided through the mask, and exhaled air may be rebreathed.

As with most CPAP devices, at low CPAP pressures, some exhaled gas (CO2) may remain in

the mask and be rebreathed.

1-3REMSTAR AUTO M SERIES USER MANUAL

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in use.

Explanation of the Warning: When the device is not in operation and the oxygen ﬂow is left

on, oxygen delivered into the tubing may accumulate within the device’s enclosure. Oxygen

accumulated in the device enclosure will create a risk of ﬁre.

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of an open ﬂame.

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with the patient circuit. Failure to use the pressure valve could result in a ﬁre hazard.

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with oxygen or air, or in the presence of nitrous oxide.

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tions can increase the temperature of the air coming out of the device.

tContact your health care professional if symptoms of sleep apnea recur.

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usual or harsh sounds, if the device or the power supply are dropped or mishandled, if water

is spilled into the enclosure, or if the enclosure is broken, discontinue use and contact your

home care provider.

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only. Unauthorized service could cause injury, invalidate the warranty, or result in costly

damage.

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Discontinue use and replace if damaged.

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in any ﬂuids.

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Connections should not be made to these connectors unless ESD precautionary procedures

are used. Precautionary procedures include methods to prevent build-up of electrostatic

discharge (e.g., air conditioning, humidiﬁcation, conductive ﬂoor coverings, non-synthetic

clothing), discharging one’s body to the frame of the equipment or system or to earth or a

large metal object, and bonding oneself by means of a wrist strap to the equipment or system

or to earth.

1-4 REMSTAR AUTO M SERIES USER MANUAL

1.3.2 CAUTIONS

A Caution indicates the possibility of damage to the device.

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to room temperature before starting therapy. Condensation may damage the device.

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malfunctioning.

Note: Additional warnings, cautions, and notes are located throughout this manual.

1.3.3 CONTRAINDICATIONS

When assessing the relative risks and beneﬁts of using this equipment, the clinician should

understand that this device can deliver pressures up to 20 cm H2O. In the event of certain fault

conditions, a maximum pressure of 30 cm H2O is possible. Studies have shown that the following

pre-existing conditions may contraindicate the use of CPAP therapy for some patients:

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sure. Caution should be used when prescribing CPAP for susceptible patients such as those

with: cerebral spinal ﬂuid (CSF) leaks, abnormalities of the cribriform plate, prior history of

head trauma, and/or pneumocephalus. (Chest 1989; 96:1425-1426)

e use of positive airway pressure therapy may be temporarily contraindicated if you exhibit

signs of a sinus or middle ear infection. Not for use with patients whose upper airways are by-

passed. Contact your physician if you have any questions concerning your therapy.

1-5REMSTAR AUTO M SERIES USER MANUAL

1.4 SYSTEM OVERVIEW

e REMstar Auto M Series device, shown in Figure 1–2, is a CPAP (Continuous Positive Air-

way Pressure) device designed for the treatment of Obstructive Sleep Apnea (OSA). It can deliver

CPAP therapy or Auto-CPAP therapy.

When prescribed for you, the device provides several special features to help make your therapy

more comfortable. e ramp function allows you to lower the pressure when you are trying to fall

asleep. e air pressure will gradually increase until your prescription pressure is reached. You also

have the option of not using the ramp feature at all.

Additionally, the C-Flex comfort feature provides you with pressure relief when you exhale during

therapy.

Several accessories are also available for use with your REMstar Auto M Series device. Contact

your home care provider to purchase any accessories not included with your system.

FIGURE 1–2 REMSTAR AUTO M SERIES DEVICE

Figure 1–3 illustrates many of the device features, described in the table below.

Ramp Button Start/Stop

Button C-Flex

Button Power Inlet

Filter Area

Air Outlet

Accessory

Module

Medical

Equipment Note

(on bottom)

Display Screen

(under door)

lex

FIGURE 1–3 REMSTAR AUTO M SERIES SYSTEM OVERVIEW

1-6 REMSTAR AUTO M SERIES USER MANUAL

DEVICE FEATURE DESCRIPTION

Accessory Module If applicable, insert the optional accessory card here.

Air Outlet Connect the exible tubing here.

C-Flex Button This button allows you to change the C-Flex comfort set-

ting, if C-Flex is prescribed for you. See Chapter 4 for more

information about C-Flex.

Display Screen Shows therapy settings, patient data, instructions, and error

messages.

Filter Area A reusable, gray foam lter must be placed in the lter

area to screen out normal household dust and pollens. An

optional, white ultra-ne lter can also be used for more

complete ltration of very ne particles.

Medical Equipment Note For ease at airport security stations, there is a note on the

bottom of the device stating that it is medical equipment.

It may help if you also take this manual with you when you

travel.

Power Inlet Connect the power cord here.

Ramp Button This button starts or restarts the ramp cycle.

Start/Stop Button This button starts or stops the airow.

1.4.1 BREATHING CIRCUIT OVERVIEW

e patient breathing circuit, shown in Figure 1–4, consists of the following:

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nose and mouth, depending on which interface has been prescribed for you

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Circuit

Tubing

Exhalation

Device

Patient Interface

(Typical)

Circuit with Separate

Exhalation Device

Circuit with Mask with

Integrated Exhalation Port

Flexible

Tubing

Connector

Mask's

Connector

Exhalation

Port

FIGURE 1–4 TYPICAL BREATHING CIRCUITS

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