USER`S MANUAL RESMED


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1

R

ES

M

ED

U

SER

S

M

ANUAL

Reorder number: 308167/1 04 05

6/05/2004, 2:03 PM

308167r1.book Page 3 Friday, May 7, 2004 1:40 PM

Manufactured by:

ResMed Ltd

97 Waterloo Road North Ryde NSW 2113 Australia

Tel: +61 (2) 9886 5000 or 1 800 658 189 (toll free) Fax: +61 (2) 9878 0120 Email: [email protected]

Distributed by:

ResMed Corp

14040 Danielson Street Poway CA 92064-6857 USA

Tel: +1 (858) 746-2400 or 1-800-424-0737 (toll free) Fax: +1 (858) 746-2900 Email: [email protected]

US DESIGNATED AGENT:

ResMed Corp

EU AUTHORIZED REPRESENTATIVE:

ResMed (UK) Ltd

Internet:

www.resmed.com

Protected by patents: US 4944310, US 5199424, US 5522382, US 6705315. Other patents pending.

Protected by design registrations: AU 147283, AU 147335, AU 147336, AU 154957, CH 128.709, CH 128.710, CH

128.711, DE 40202007, DE 40202008, DE 40201723, DE 40202020, ES 153514, ES 153515, ES 153516, ES 153518,

ES 156136, FR 02 1407, GB 3001791, GB 3001819, GB 3001820, GB 3001821, JP 1164087, JP 1164265, JP 1164266,

JP 1164267, SE 75598, SE 75599, SE 75600, SE 75715, US D467335, US D468011, US D476077, US D477868, US

D487311. Other designs pending

S7, HumidAire 2i, Mirage, Protégé, and

Ultra Mirage are trademarks of ResMed Ltd.

© 2004 ResMed Ltd.

308167r1.book Page iii Friday, May 7, 2004 1:40 PM

C

ONTENTS

I

NTRODUCTION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

D

EFINITIONS

1

U

SER

/O

WNER

R

ESPONSIBILITY

1

M

EDICAL

I

NFORMATION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

W

HAT A

R

ES

M

ED

S7™ L

IGHTWEIGHT

U

NIT

I

S

F

OR

1

T

ELL

Y

OUR

D

OCTOR

I

F

...

W

ARNINGS

C

AUTIONS

2

3

T

HE

R

ES

M

ED

S7 L

IGHTWEIGHT

S

YSTEM

. . . . . . . . . . . . . . . . . . . . . . . . . 5

R

ES

M

ED

S7 L

IGHTWEIGHT

C

OMPONENTS

5

M

ASKS

6

H

UMIDIFIER

6

P

REPARING FOR

U

SE

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

S

ETTING

U

P

T

HE

R

ES

M

ED

S7 L

IGHTWEIGHT

9

F

EATURES OF THE

R

ES

M

ED

S7 L

IGHTWEIGHT

14

O

PERATING

I

NSTRUCTIONS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

S

TARTING

T

REATMENT

17

S

TOPPING

T

REATMENT

17

H

ELPFUL

H

INTS

18

C

LEANING AND

M

AINTENANCE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

D

AILY

19

W

EEKLY

19

P

ERIODICALLY

19

R

EPLACING THE

A

IR

F

ILTER

20

S

ERVICING

20

T

ROUBLESHOOTING

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

S

YSTEM

S

PECIFICATIONS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

L

IMITED

W

ARRANTY

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

I

NDEX

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 iii

iv

308167r1.book Page iv Friday, May 7, 2004 1:40 PM

308167r1.book Page 1 Friday, May 7, 2004 1:40 PM

I

NTRODUCTION

D

EFINITIONS

This manual contains special terms that appear in the text to draw your attention to specific and important information.

!

WARNING

Alerts you to possible injury.

!

CAUTION

Explains special measures for the safe and effective use of the device.

Note: Is an informative or helpful note.

U

SER

/O

WNER

R

ESPONSIBILITY

The user or owner of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from: operation which is not in accordance with the operating instructions supplied maintenance or modifications carried out unless in accordance with authorized instructions and by authorized persons.

Please read this manual carefully before use.

M

EDICAL

I

NFORMATION

W

HAT A

R

ES

M

ED

S7™ L

IGHTWEIGHT

U

NIT

I

S

F

OR

The

R

ES

M

ED

S7™ L

IGHTWEIGHT

system is intended for the treatment of adult patients with obstructive sleep apnea (OSA).

!

CAUTION

In the USA, federal law restricts this device to sale by or on the order of a physician.

T

ELL

Y

OUR

D

OCTOR

I

F

...

You must tell your doctor, and CPAP (continuous positive airway pressure) therapy must not be used, if you have any of the following conditions: pneumothorax or pneumomediastinum (air in the pleural cavity or mediastinum) severe heart failure, low blood pressure, or dehydration surgery to the brain, middle or inner ear, pituitary gland, or sinuses respiratory distress syndrome middle ear infection or perforated ear drum severe nosebleed.

I

NTRODUCTION

1

308167r1.book Page 2 Friday, May 7, 2004 1:40 PM

2

W

ARNINGS

CPAP therapy should be used with caution if you have any of the following conditions:

• respiratory failure cavities or cysts in the lung (called bullae, and usually due to emphysema), or previous history of pneumothorax

• previous history of severe nosebleed sinus infection.

Tell your doctor if you have any of these conditions. Your doctor will advise you whether the likely benefits of CPAP therapy outweigh the expected risks.

Special care should be exercised if you are dehydrated, or may become dehydrated, for example as a result of fluid restriction or diuretic therapy (including changes in therapy).

Discontinue therapy and seek medical advice if, during therapy or when you start therapy each night, you feel faint or light-headed.

The following are general warnings that pertain to your use of a

R

ES

M

ED

S7

L

IGHTWEIGHT

unit. Specific warnings appear next to the relevant instructions in the manual.

This is NOT a life support device. It may stop operating with power failure or if a fault occurs in the unit.

The air flow for breathing produced by this device can be as much as 11 o

F (6 o

C) higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 90 o

F (32 o

C).

The R

ES

M

ED

S7 L

IGHTWEIGHT

unit should only be used with masks (and connectors)

*

recommended by ResMed, or by your physician or respiratory therapist. A mask should not be used unless the R

ES

M

ED

S7 L

IGHTWEIGHT unit is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked.

Explanation: The R

ES

M

ED

S7 L

IGHTWEIGHT

unit is intended to be used with special masks (or connectors)

*

which have vent holes 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 vent holes.

However, when the device is not operating, insufficient fresh air will be provided through the mask, and the exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation.

This applies to most models of CPAP devices.

The R

ES

M

ED

S7 L

IGHTWEIGHT

unit should only be connected to the components, humidifiers, or accessories specified in this manual. Connection of other items may result in injury, or damage to the R

ES

M

ED

S7 L

IGHTWEIGHT

unit.

At low pressures, the flow through the exhalation ports of your mask may not clear all exhaled gas from the tubing. Some rebreathing may occur.

This device is not intended for use with supplemental oxygen.

* Ports may be incorporated in the mask or in connectors that are near the mask.

308167r1.book Page 3 Friday, May 7, 2004 1:40 PM

Explosion hazard—do not use in the vicinity of flammable anesthetics.

Blocking the hose while in operation could lead to overheating of the device.

W

ARNINGS RELATED TO OXYGEN USE

!

WARNING

If oxygen is used with this device, the oxygen flow must be turned off when the device is not operating.

Explanation: when the device is not in operation and the oxygen flow is left on, oxygen delivered into the air delivery tubing may accumulate within the device enclosure and create a risk of fire. This applies to most types of CPAP machines.

Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.

Always ensure airflow is being generated by the device before the oxygen supply is turned on.

Always turn the oxygen supply off before stopping the airflow from the device.

Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on where the oxygen is introduced, the pressure settings, patient breathing pattern, mask selection, and leak rate.

W

ARNINGS RELATED TO TREATMENT

!

WARNING

If you stop your CPAP treatment, your sleep apnea will return.

Always consult your clinician if you expect to be in a situation where you cannot use your

R

ES

M

ED

S7 L

IGHTWEIGHT

unit.

If you are admitted to a hospital or prescribed any other form of medical treatment, always inform the medical staff that you are being treated with CPAP. It is also important to contact the clinician who is treating you for sleep apnea.

If you experience an infection of the upper respiratory tract, middle ear, or sinuses, contact your clinician before continuing your CPAP treatment. You may be advised to stop treatment until the infection has cleared. If you continue with treatment during an infection, be sure to clean your mask and tubing after every use.

C

AUTIONS

The following are general cautions. Specific cautions appear next to the relevant instructions in the manual.

Do not open the

R

ES

M

ED

S7 L

IGHTWEIGHT

case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorized service agent.

M

EDICAL

I

NFORMATION

3

4

308167r1.book Page 4 Friday, May 7, 2004 1:40 PM

P

OSSIBLE

S

IDE

E

FFECTS

The

R

ES

M

ED

S7 L

IGHTWEIGHT

flow generator helps you have a good night’s sleep.

However, you need to be aware of possible problems that may arise during CPAP treatment.

!

WARNING

Consult your clinician immediately if you experience any of the following symptoms during your CPAP treatment: headache middle ear or sinus discomfort chest pain dryness of the nose, mouth, or throat feeling bloated due to air swallowing air continually leaking out of the mouth while sleeping recurrence of any sleep apnea symptoms while on CPAP.

Skin irritation may occur from sensitivity to the mask materials or from excessively tight headgear straps. A correctly fitted mask and appropriately adjusted straps will often prevent skin irritation. If problems persist, contact your clinician for advice.

308167r1.book Page 5 Friday, May 7, 2004 1:40 PM

T

HE

R

ES

M

ED

S7 L

IGHTWEIGHT

S

YSTEM

R

ES

M

ED

S7 L

IGHTWEIGHT

C

OMPONENTS

Please identify and familiarize yourself with the following components of the

R

ES

M

ED

S7 L

IGHTWEIGHT

unit:

ResMed S7 Lightweight unit

Front view

LCD screen

Air outlet

Handle

Control panel

Removable front cap

Air tubing, 6’6" (2 m) Carry bag

A

CCESSORIES

The following accessories may be purchased separately.

R

ES

M

ED

S7 L

IGHTWEIGHT ACCESSORIES

Air tubing,

9’10" (3 m)

H

UMIDIFIER ACCESSORIES

(

H

UMID

A

IRE

and ResMed

P

ASSOVER

only)

Medium air tubing

21" (52 cm) for humidifier connection

Power cord

T

HE

R

ES

M

ED

S7 L

IGHTWEIGHT

S

YSTEM

5

308167r1.book Page 6 Friday, May 7, 2004 1:40 PM

M

ASKS

You will also need a

ResMed mask system (supplied separately).

The following ResMed mask systems are recommended for use with the

R

ES

M

ED

S7

L

IGHTWEIGHT

:

M

IRAGE

V

ISTA

M

ASK

U

LTRA

M

IRAGE

M

ASK

M

IRAGE®

M

ASK

P

ROTÉGÉ

™ M

ASK

M

IRAGE®

F

ULL

F

ACE

M

ASK

S

ERIES

2

M

IRAGE®

F

ULL

F

ACE

M

ASK

M

ODULAR

M

ASK

H

UMIDIFIER

A humidifier may be required if you are experiencing dryness of the nose, throat, or mouth. The

R

ES

M

ED

S7 L

IGHTWEIGHT

is compatible for use with the following humidifiers:

H

UMID

A

IRE

2i heated humidifier H

UMID

A

IRE

2iC passover humidifier

6

!

H

UMID

A

IRE

heated humidifier ResMed

P

ASSOVER

humidifier

WARNING

Only the HumidAire 2i, HumidAire 2iC, HumidAire heated humidifier, and the

ResMed Passover are compatible for use with the ResMed S7 Lightweight. Please

308167r1.book Page 7 Friday, May 7, 2004 1:40 PM refer to “Warnings” on page 2.

T

HE

R

ES

M

ED

S7 L

IGHTWEIGHT

S

YSTEM

7

8

308167r1.book Page 8 Friday, May 7, 2004 1:40 PM

308167r1.book Page 9 Friday, May 7, 2004 1:40 PM

P

REPARING FOR

U

SE

S

ETTING

U

P

T

HE

R

ES

M

ED

S7 L

IGHTWEIGHT

1

Place the

R

ES

M

ED

S7 L

IGHTWEIGHT

unit on a table near the head of your bed.

!

CAUTION

Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord.

Note: The ResMed S7 Lightweight unit may be placed on the floor beside or underneath your bed. Ensure that the area is free from dust and clear of bedding, clothes, or any other objects that could block the air inlet.

2

Connect the power cord to the socket at the rear of the flow generator. Plug the other end of the power cord into a power outlet.

!

WARNING

Make sure the power cord and plug are in good condition and the equipment is not damaged.

The air filter cover protects the device in the event of accidental liquid spillage onto the device. Ensure that the air filter and air filter cover are fitted at all times.

3

Connect one end of the air tubing firmly onto the air outlet of the unit.

!

WARNING

Only ResMed air tubing should be used with your flow generator. A different type of air tubing may alter the pressure you actually receive reducing the effectiveness of your treatment.

4

Assemble your mask system according to the mask user instructions.

P

REPARING FOR

U

SE

9

10

308167r1.book Page 10 Friday, May 7, 2004 1:40 PM

5

Connect your mask system to the free end of the air tubing.

The

R

ES

M

ED

S7 L

IGHTWEIGHT

is now ready for use. To start treatment, see

“Operating Instructions” on page 17.

H

UMIDIFIER

U

SE

Notes

The ResMed S7 Lightweight has no humidifier setting options.

The ResMed S7 Lightweight does not have the Warm-Up and cooling down features mentioned in the HumidAire 2i User’s Manual. When the HumidAire 2i is attached to the ResMed S7 Lightweight, you may begin therapy immediately.

H

UMID

A

IRE

2i

The

H

UMID

A

IRE

2i

attaches to the front of the

R

ES

M

ED

S7 L

IGHTWEIGHT

to provide heated humidification. No other accessories are required for its use

. Please refer to the HumidAire 2i User’s Manual for details.

308167r1.book Page 11 Friday, May 7, 2004 1:40 PM

H

UMID

A

IRE

2iC

The H

UMID

A

IRE

2iC attaches to the front of a R

ES

M

ED

S7 L

IGHTWEIGHT

unit to provide passover humidification. No other accessories are required for its use. Please refer to the HumidAire 2iC User’s Manual for details.

H

UMID

A

IRE AND

R

ES

M

ED

P

ASSOVER HUMIDIFIERS

Medium size 21" (52 cm) air tubing is a necessary accessory for connecting the

R

ES

M

ED

S7 L

IGHTWEIGHT

unit to the

H

UMID

A

IRE

and ResMed

P

ASSOVER

humidifiers.

1

Fill the

H

UMID

A

IRE

or

P

ASSOVER

with water as described in the humidifier manual.

2

HumidAire Users Place the filled water chamber inside the H

UMID

A

IRE

. Connect the medium 21" (52 cm) air tubing to the left connector port, and the long air tubing

6’6" or 9’10" (2 m to 3 m) to the right connector port on the humidifier. Close the

H

UMID

A

IRE

lid.

ResMed Passover Users Connect the medium 21in (52 cm) air tubing to the left connector port, and the long air tubing 6’6" or 9’10" (2 m to 3 m) to the right connector port on the humidifier.

Medium (21in) air tubing

HumidAire

Long air tubing

Medium (21in) air tubing

ResMed Passover

Long air tubing

P

REPARING FOR

U

SE

11

308167r1.book Page 12 Friday, May 7, 2004 1:40 PM

3

Place the

R

ES

M

ED

S7 L

IGHTWEIGHT

on top of the

H

UMID

A

IRE

or

P

ASSOVER

. Do not place the

R

ES

M

ED

S7 L

IGHTWEIGHT

unit underneath the humidifier. (This is to avoid water spilling into the unit.)

HumidAire ResMed Passover

4

HumidAire Users Connect the free end of the medium air tubing to the air outlet of the

R

ES

M

ED

S7 L

IGHTWEIGHT

.

ResMed Passover Users Connect the free end of the medium air tubing to the air outlet of the R

ES

M

ED

S7 L

IGHTWEIGHT

.

HumidAire ResMed Passover

5

Connect the mask system to the free end of the long air tubing. The final assembly should look like this:

12

HumidAire ResMed Passover

6

HumidAire Users Plug the

H

UMID

A

IRE

power cord into a power outlet and turn the power on.

308167r1.book Page 13 Friday, May 7, 2004 1:40 PM

7

Connect the power cord to the socket at the rear of the

R

ES

M

ED

S7 L

IGHTWEIGHT

.

Plug the other end of the power cord into a power outlet and turn the power on.

!

WARNING

Make sure that the power cord and plug are in good condition and the equipment is not damaged.

8

The R

ES

M

ED

S7 L

IGHTWEIGHT

is now ready for use with the H

UMID

A

IRE

or ResMed

P

ASSOVER

.

A

LTITUDE

C

OMPENSATION

Changes in altitude will affect the pressure delivered by the

R

ES

M

ED

S7 L

IGHTWEIGHT

.

The device has a feature which compensates for these changes in altitude.

As you move or travel with the R

ES

M

ED

S7 L

IGHTWEIGHT

to areas of different altitudes, you will need to adjust the altitude compensation setting in the device. To change the altitude compensation setting, see “Using the Menus” on page 14.

There are three altitude settings to choose from:

Altitude Settings

0–2000 ft

2001–4000 ft

4001–7000 ft

(0–610 m)

(611–1219 m)

(1220–2134 m)

For example, if you are at an altitude of 3107 ft (947 m), your altitude compensation setting would be 2001–4000 ft (611–1219 m), as 3107 ft falls within that range.

Note: If you are above 7000 ft (2134 m), consider consulting your clinician.

P

REPARING FOR

U

SE

13

14

308167r1.book Page 14 Friday, May 7, 2004 1:40 PM

F

EATURES OF THE

R

ES

M

ED

S7 L

IGHTWEIGHT

LCD S

CREEN AND

K

EYPAD

The control panel of the

R

ES

M

ED

S7 L

IGHTWEIGHT

includes an LCD screen and keypad.

Left key

Up/down key

Start/S top

LCD screen

Right key

Front Key

The R

ES

M

ED

S7 L

IGHTWEIGHT

keypad has the following keys:

Key

Front

Function

• Starts or stops treatment

Start/Stop

Up/Down

• Allows you to scroll through the ResMed S7 L

IGHTWEIGHT

menus and setting options.

Left

Right

• Performs the function indicated by the guiding text displayed above it on the LCD screen. Guiding text includes menu,

change,

and apply.

• Performs the function indicated by the guiding text displayed above it on the LCD screen. Guiding text includes exit and

cancel

.

To assist you in adjusting the

R

ES

M

ED

S7 L

IGHTWEIGHT

the keypad is equipped with a backlight. The keypad is backlit with power-up of the unit. Under normal operation, the keypad remains illuminated to indicate that the device is ON.

U

SING THE

M

ENUS

The ResMed

S7 L

IGHTWEIGHT

unit provides a set of functions which are arranged in menus. Via the LCD screen, the menus allow you to view and change the settings for a particular function. You can access the menus when the Ramp screen is displayed.

After the Welcome Screen appears and device self-checks are complete, the Ramp screen appears. In the Ramp screen, you can immediately set a ramp time. Ramp time is the period during which the pressure increases from a low comfortable pressure to

308167r1.book Page 15 Friday, May 7, 2004 1:40 PM

• the prescribed treatment pressure. Ramp time can be altered in 5 minute increments

(from 0min to a maximum ramp time set by your clinician) by using the Up/Down key.

See Figure 1 for a summary of the

R

ES

M

ED

S7 L

IGHTWEIGHT

menus.

To access the

R

ES

M

ED

S7 L

IGHTWEIGHT

menus:

Press the Left key (menu) while the Ramp screen is displayed.

To scroll through items within a menu:

Press the Up/Down key

To change a setting option for a function:

1. Press the Left key (change)

2. Press the Up/Down key until the desired setting option appears.

3. Press the

Left key (apply) to select the setting option.

To exit without changing options:

Press the

Right key (cancel)

To exit out of a menu or submenu:

Press the

Right key (exit)

RAMP: 10min menu

ResMed S7 Lightweight

Ramp screen

ALT: 0-2000ft change exit

USED HRS: 8888

exit

Figure 1: ResMed S7 Lightweight Menu Series

M

ENU

F

UNCTIONS

The

R

ES

M

ED

S7 L

IGHTWEIGHT

menu functions are summarized in Table 1 with a brief description of what each function does and the available setting options. To access these functions see “Using the Menus” on page 14.

S

ETTINGS

M

ENU

The Settings Menu allows you to view and change certain operating features of the

R

ES

M

ED

S7 L

IGHTWEIGHT

unit.

P

REPARING FOR

U

SE

15

16

308167r1.book Page 16 Friday, May 7, 2004 1:40 PM

Table 1: Settings Menu Functions

Function

Altitude

(Compensation)

Function Description

Sets the altitude compensation range.

Used hours Displays the total number of treatment hours.

Setting Options

0–2000 ft (0–610 m),

2001–4000 ft (611–1219 m),

4001–7000 ft (1220–2134 m)

(View only)

308167r1.book Page 17 Friday, May 7, 2004 1:40 PM

O

PERATING

I

NSTRUCTIONS

S

TARTING

T

REATMENT

The

R

ES

M

ED

S7 L

IGHTWEIGHT

unit should be assembled beside your bed with the air tubing and mask system connected. See “Setting Up The ResMed S7 Lightweight” on page 9.

1

Turn the main power switch at the back of the unit to on

(I).

When the

R

ES

M

ED

S7 L

IGHTWEIGHT

is turned on, the software version is displayed on the LCD screen. The Ramp screen then appears.

2

Fit your mask as described in the mask user instructions.

3

Lie down and arrange the air tubing so that it is free to move if you turn in your sleep.

!

CAUTION

Do not leave long lengths of air tubing around the top of your bed. It could twist around your head or neck while you are sleeping.

Make sure the area around the flow generator is dry and clean. It should also be clear of bedding, clothes, and other potential blockages.

4

To start treatment, press the

Front key.

If a ramp time is selected, the LCD will display the word RAMPING with set pressure indicated as dashes. At the end of the ramping period the LCD will display CPAP.

After starting treatment, the LCD will look similar to one of the screens below.

CPAP

– – – – – –

RAMPING

– – –

The dashes represent the set pressure, where each dash is approximately equivalent to 2 cm H

2 pressure.

O pressure. For example, 6 dashes represents approximately 12 cm H

2

O

S

TOPPING

T

REATMENT

To stop treatment at any time, remove your mask and press the Front key.

O

PERATING

I

NSTRUCTIONS

17

18

308167r1.book Page 18 Friday, May 7, 2004 1:40 PM

H

ELPFUL

H

INTS

S

TARTING OUT

F

IRST

U

SE

When you first use your

R

ES

M

ED

S7 L

IGHTWEIGHT

unit, you may feel uncomfortable breathing against the air flow. This is normal. You will continue to breathe normally while you sleep. Take time to adjust to this new sensation. Taking a few deep breaths may help.

G

ETTING

U

P

If you need to get up during the night, remove your mask and turn the flow generator off. Always remember to put your mask on and turn your flow generator on when you return to bed.

M

OUTH

L

EAKS

If using a nasal mask, try to keep your mouth closed during treatment. Air leaks from your mouth can decrease the effectiveness of your treatment. If mouth leaks are a problem, a full face mask or chin strap may help. Contact your clinician or equipment supplier for further details.

M

ASK

F

ITTING

The flow generator delivers the most effective treatment when the mask is well fitted and comfortable. Treatment can be affected by leaks, so it is important to eliminate any leaks that may arise.

If you have problems trying to get a comfortable mask fit, contact your sleep clinic or equipment supplier. You may benefit from a different size or style of mask.

Before wearing your mask, wash your face to remove excess facial oils. This will allow a better fit and prolong the life of the mask cushion.

N

ASAL

I

RRITATION

D

RYNESS

You may experience dryness of the nose, mouth, and/or throat during the course of treatment, especially during winter. In many cases, a humidifier may resolve this discomfort. Contact your clinician for advice.

R

UNNY OR

B

LOCKED

N

OSE

You may experience sneezing and/or a runny or blocked nose during the first few weeks of treatment. In many cases, nasal irritation can be resolved with a humidifier.

Consult your clinican for advice.

T

RAVELLING WITH THE

R

ES

M

ED

S7 L

IGHTWEIGHT

I

NTERNATIONAL

U

SE

Your R

ES

M

ED

S7 L

IGHTWEIGHT

flow generator has an internal power adapter that enables it to operate in other countries. It will operate on power supplies of 100–240V and 50–60Hz. No special adjustment is necessary, but you may need a plug adapter for the power outlet.

308167r1.book Page 19 Friday, May 7, 2004 1:40 PM

C

LEANING AND

M

AINTENANCE

You should regularly carry out the cleaning and maintenance described in this section.

D

AILY

1. Disconnect the air tubing and hang it in a clean, dry place until next use. Do not hang the air tubing in direct sunlight as it may harden and crack over time.

2. Clean the mask according to the mask user instructions.

3. If you are using a humidifier, clean it according to the instructions in the manual.

W

EEKLY

1. Remove the air tubing from the

R

ES

M

ED

S7 L

IGHTWEIGHT

unit and the mask.

2. Wash the mask system according to the instructions supplied with it.

3. Wash the air tubing in warm water using mild detergent. Rinse thoroughly, hang and allow to dry.

4. Before next use, assemble the mask and headgear according to the mask user instructions.

5. Reconnect the air tubing to the air outlet and mask.

!

CAUTION

Do not use bleach, chlorine-, alcohol- or aromatic-based solutions (including all scented oils), moisturizing, or antibacterial soaps to clean the cushion, mask, air tubing, or the ResMed S7 Lightweight. These solutions may cause hardening and reduce the life of the product.

Do not wash or dry the mask frame at a temperature above 176 o

F (80

Exposure to higher temperatures may reduce the life of the product.

o

C).

Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack.

P

ERIODICALLY

1. The mask and air tubing are subject to normal wear and tear. Inspect them regularly for damage.

2. Clean the exterior of the flow generator with a damp cloth and mild detergent.

3. Inspect the air filter to check if it is blocked by dirt or contains holes. See

“Replacing the Air Filter” on page 20.

!

WARNING

Beware of electric shock. Do not immerse the flow generator or power cord in water. Always unplug the flow generator before cleaning and be sure that it is dry before reconnecting.

C

LEANING AND

M

AINTENANCE

19

20

308167r1.book Page 20 Friday, May 7, 2004 1:40 PM

!

CAUTION

Do not attempt to open the ResMed S7 Lightweight. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorized service agent.

R

EPLACING THE

A

IR

F

ILTER

Inspect the air filter every month to check if it is blocked by dirt or contains holes. With normal use of a

R

ES

M

ED

S7 L

IGHTWEIGHT

unit, the air filter needs to be replaced every six months (or more often if your unit is in a dusty environment). To replace the air filter:

1. Remove the air filter cover at the back of the

R

ES

M

ED

S7 L

IGHTWEIGHT

.

Air filter cover

2. Remove and discard the old air filter.

3. Insert a new filter with the blue tinted side facing out from the unit.

4. Replace the air filter cover.

!

WARNING

Do not wash the air filter. The air filter is not washable or reusable.

Note: The air filter should be inspected once a month.

S

ERVICING

Your R

ES

M

ED

S7 L

IGHTWEIGHT

flow generator will give you years of trouble-free operation.

The flow generator should not require regular servicing if it is maintained according to the instructions in this manual. If you feel that your unit is not performing properly, see

“Troubleshooting” on page 21.

!

CAUTION

Inspection and repair should only be perfomed by an authorized service agent.

Under no circumstances should you attempt to service or repair the flow generator yourself.

308167r1.book Page 21 Friday, May 7, 2004 1:40 PM

T

ROUBLESHOOTING

If there is a problem, try the following suggestions. If the problem cannot be solved, contact your equipment supplier or ResMed. Do not attempt to open the unit.

Problem

No display.

Insufficient air delivered from the ResMed S7

Lightweight.

Excessive air delivered from the ResMed S7 Lightweight.

Displays error message:

Exx

(where

xx

defines an error code)

Possible Cause

Power not connected or switch at back is not on.

Ramp Time is in use.

Air filter is dirty.

Air tubing is kinked or punctured.

Air tubing not connected properly.

Mask and headgear not positioned correctly.

Cap(s) missing from access port(s) on mask.

Altitude compensation setting is incorrect.

Pressure required for treatment may have changed.

Altitude compensation setting is incorrect.

Component failure.

Solution

Ensure the power cable is connected and that the switch at the back of the unit is in the ON position.

Wait for air pressure to build up.

Replace air filter.

Straighten or replace tubing.

Check air tubing.

Adjust position of mask and headgear.

Replace cap(s).

Adjust altitude compensation setting to the correct altitude range.

See your clinician to adjust the pressure.

Adjust altitude compensation setting to the correct altitude range.

Return your ResMed S7

Lightweight for servicing.

T

ROUBLESHOOTING

21

22

308167r1.book Page 22 Friday, May 7, 2004 1:40 PM

308167r1.book Page 23 Friday, May 7, 2004 1:40 PM

S

YSTEM

S

PECIFICATIONS

Performance

Operating pressure range: 4 to 20 cm H

2

O

Dimensions (L x W x H): 10.6" x 9.1" x 5.6"

Weight: 4.6 lb.

Power Supply

Input range 100–240 V, 50–60 Hz, < 120 VA (maximum power consumption)

Actual power consumption will vary, depending on factors such as the use of accessories, height above sea level, and ambient temperature. Power consumption values for typical treatment conditions (using a breathing machine set to 0.5 L and 15 breaths/min with 6’6" air tubing and a modular mask) are given in the following table.

Device

ResMed S7 Lightweight

Pressure

(cm H

2

O)

5

10

15

20

Power

(VA)

20

24

29

35

Housing Construction: Flame retardant engineering thermoplastic

Environmental Conditions

Operating Temperature: +41°F (+5°C) to +104°F (+40°C)

Operating Humidity: 10%–95% non-condensing

Storage and Transport Temperature: -4°F (-20°C) to +140°F (+60°C)

Storage and Transport Humidity: 10%–95% non-condensing

Electromagnetic Compatibility: Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for residential, commercial, and light industry environments. For further details, see

“Guidance and Manufacturer’s Declaration - Electromagnetic Emissions and Immunity” on page 25.

Air Filter: Two-layered, powder-bonded, polyester non-woven fiber

Air Tubing: Flexible plastic, 6’6" (2 m) length

IEC 60601-1 Classifications: Class II (double insulation), Type CF

Note: The manufacturer reserves the right to change these specifications without notice.

S

YSTEM

S

PECIFICATIONS

23

24

308167r1.book Page 24 Friday, May 7, 2004 1:40 PM

G

LOSSARY OF

S

YMBOLS

Attention, consult accompanying documents

Class II equipment

Type CF equipment

Drip Proof

Start/Stop

Start/Stop

F

LOW

/P

RESSURE

C

HARACTERISTICS

70

60

50

40

30

20

10

0

0 5 10 15

Pressure (cm H

2

O)

20 25

Vista/Mirage/Protégé

Modular

Mirage Full Face Mask/Mirage Full Face Mask Series 2

Ultra Mirage

308167r1.book Page 25 Friday, May 7, 2004 1:40 PM

G

UIDANCE AND

M

ANUFACTURER

S

D

ECLARATION

- E

LECTROMAGNETIC

E

MISSIONS

AND

I

MMUNITY

Guidance and manufacturer’s declaration – electromagnetic emissions

The ResMed S7 Lightweight is intended for use in the electromagnetic environment specified below. The customer or the user of the ResMed S7 Lightweight should assure that it is used in such an environment.

Emissions test Compliance

Electromagnetic environment - guidance

RF emissions CISPR11 Group 1 The ResMed S7 Lightweight uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Harmonic Emissions

IEC 61000-3-2

Class B

Class A

The ResMed S7 Lightweight is suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage network that supplies buildings used for domestic purposes.

Voltage Fluctuations/Flicker

Emissions IEC 61000-3-3

Complies

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document.

Warnings

: The ResMed S7 Lightweight should not be used adjacent to or stacked with other equipment.

If adjacent or stacked use is necessary, the ResMed S7 Lightweight should be observed to verify normal operation in the configuration in which it will be used.

The use of accessories (eg Humidifiers) other than those specified in this manual is not recommended.

They may result in increased emissions or immunity of the ResMed S7 Lightweight.

S

YSTEM

S

PECIFICATIONS

25

26

308167r1.book Page 26 Friday, May 7, 2004 1:40 PM

Guidance and manufacturer’s declaration – electromagnetic immunity

The ResMed S7 Lightweight is intended for use in the electromagnetic environment specified below. The customer or the user of the ResMed S7 Lightweight should assure that it is used in such an environment.

Immunity test

IEC60601-1-2 test level

Compliance level

Electromagnetic environment –guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/burst

IEC 61000-4-4

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

±2 kV

Not Applicable

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

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

Surge

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines.

IEC 61000-4-11

Power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

±2 kV for power supply lines

±1 kV for input/ output lines

±1 kV differential mode

±2 kV common mode

<5% Ut

(>95% dip in Ut) for 0.5 cycle

40% Ut

(60% dip in Ut) for 5 cycles

70% Ut

(30% dip in Ut) for 25 cycles

<5% Ut

(>95%dip in Ut) for 5 sec

3 A/m

±1 kV differential mode

±2 kV common mode

< 12V

(>95% dip in 240V) for 0.5 cycle

96V

(60% dip in 240V) for 5 cycles

168V

(30% dip in 240V) for 25 cycles

<12V

(>95%dip in 240V) for 5 sec

3 A/m

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

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

If the user of the ResMed S7

Lightweight requires continued operation during power mains interruptions, it is recommended that the

ResMed S7 Lightweight be powered from an uninterruptible power source

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

NOTE: Ut is the a.c. mains voltage prior to application of the test level.

308167r1.book Page 27 Friday, May 7, 2004 1:40 PM

Guidance and manufacturer’s declaration – electromagnetic immunity

The ResMed S7 Lightweight is intended for use in the electromagnetic environment specified below. The customer or the user of the ResMed S7 Lightweight should assure that it is used in such an environment.

Immunity test

IEC60601-1-2 test level

Compliance level

Electromagnetic environment – guidance

3 Vrms

Portable and mobile RF communications equipment should be used no closer to any part of the ResMed S7 Lightweight, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.17 √P Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

10 V/m

80 MHz to 2.5 GHz

10 V/m d = 0.35 √P 80 MHz to 800 MHz d = 0.70 √P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.

b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800MHz, 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.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ResMed S7 Lightweight is used exceeds the applicable RF compliance level above, the ResMed S7 Lightweight should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ResMed S7 Lightweight.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

R000-303/6 03 08

S

YSTEM

S

PECIFICATIONS

27

28

308167r1.book Page 28 Friday, May 7, 2004 1:40 PM

Recommended separation distances between portable and mobile RF communications equipment and the ResMed S7 Lightweight

The ResMed S7 Lightweight is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the ResMed S7 Lightweight can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ResMed S7 Lightweight as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter m

Rated maximum output power of transmitter

W

0.01

0.1

150kHz to 80MHz d = 1.17 √P

0.17

0.37

80 MHz to 800 MHz d = 0.35 √P

0.04

0.11

800MHz to 2.5 GHz d = 0.35 √P

0.04

0.11

1

10

1.17

3.69

0.35

1.11

0.35

1.11

100 11.70

3.50

3.50

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined 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.

308167r1.book Page 29 Friday, May 7, 2004 1:40 PM

L

IMITED

W

ARRANTY

ResMed warrants that your ResMed product shall be free from defects in material and workmanship for the period specified below from the date of purchase by the initial consumer.

Product

AutoSet CS™ flow generator, ResMed humidifiers, ResControl™,

ResLink™.

CPAP (continuous positive airway pressure), APAP (automatic positive airway pressure), bilevel, and AutoSet CS™2 flow generators.

Accessories, mask systems (including mask frame, cushion, headgear and tubing). Excludes single-use devices.

Warranty Period

1 Year

2 Years

90 Days

Note: Some models are not available in all regions.

If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components. This Limited Warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product; b) repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs; c) any damage or contamination due to cigarette, pipe, cigar or other smoke; d) any damage caused by water being spilled on or into the flow generator. Any product repaired or replaced under warranty will be returned, freight prepaid, to the dealer designated by the consumer. The cost of transporting the product to an authorized service organization will be borne by the consumer.

This warranty is in lieu of all other express or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.

ResMed shall not be responsible for any incidental or consequential damages claimed to have occurred as a result of the sale, installation or use of any ResMed product.

Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from region to region.

For further information on your warranty rights, contact your local ResMed dealer or

ResMed office.

L

IMITED

W

ARRANTY

29

30

308167r1.book Page 30 Friday, May 7, 2004 1:40 PM

308167r1.book Page 31 Friday, May 7, 2004 1:40 PM

I

NDEX

A accessories 5

Air Filter 20

,

23

Air Tubing 23

Altitude Compensation 13

Altitude Settings 13

B

Back-light, Keypad 14

C

Cleaning and Maintenance 19

Cleaning Periodically 19

Components 5

D

Daily Cleaning 19

Definitions 1

Dimensions 23

Dryness 18

E

Electromagnetic Compatibility 23

Environmental Conditions 23

Error Messages 21

F

Features of the ResMed S7 Lightweight

14

First Use 18

Flow/Pressure Characteristics 24

Front Key 14

G

Getting Up 18

Glossary of Symbols 24

H

Helpful Hints

18

Housing Construction 23

HumidAire 11

HumidAire 2i 10

HumidAire 2iC 11

Humidifier 6

,

10

Humidifier Use 10

I

IEC 60601-1 Classifications 23

International Use 18

K

Keys, functions 14

L

LCD Screen and Keypad

14

Left Key 14

M

Mask Fitting 18

Masks 6

Medical Information 1

Menu 15

Menu Functions 15

Menus, using the ResMed S7 Lightweight

14

Mouth Leaks 18

N

Nasal Irritation 18

O

Operating Instructions 17

P

Performance

23

Power Supply 23

Preparing for Use 9

R

Ramp screen 14 time 14

Replacing the Air Filter 20

ResMed Passover humidifier 11

Responsibility, user/owner 1

Right Key 14

Runny or Blocked Nose 18

S

Servicing 20

Servicing Menu 17

Setting Up 9

Settings Menu 15

Side Effects 4

Starting Treatment 17

Stopping Treatment 17

System Specifications 23

31

32

308167r1.book Page 32 Friday, May 7, 2004 1:40 PM

T

Travelling 18

Troubleshooting 21

U

Up/Down Key

14

User/Owner Responsibility 1

Using the Menus 14

W

Warnings Related to Oxygen Use 3

Warnings Related to Treatment 3

Weekly Cleaning 19

Weight 23

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