SULLIVAN Series Clinicians Manual June 1999

WARNINGS AND CAUTIONS...

1

THE SULLIVAN V SERIES...

4

ASSEMBLY...

7

PREPARING FOR USE...

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RESETTING THE HOUR METER SETTING THE TREATMENT PRESSURE LIMITING THE DELAY TIMER SETTING THE START PRESSURE

ELITE MODEL... SETTING THE REAL-TIME CLOCK SMARTSTART AUTOMATIC LEAK ADJUSTMENT DOWNLOADING COMPLIANCE DATA

STARTING TREATMENT... STOPPING GETTING UP

11 12 13 14 15 15 15 16 16 17 18 18

CALIBRATION...

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CLEANING AND MAINTENANCE...

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SERVICING...

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SELF TESTING (PLUS AND ELITE MODELS)

CONTENTS

CONTENTS

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TROUBLESHOOTING...

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WARNINGS RELATED TO TREATMENT...

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ACCESSORIES/SPARE PARTS...

29

SPECIFICATIONS...

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DEFINITIONS This manual contains special terms and icons that appear in the margins to draw the reader’s attention to specific and important information. WARNING

WARNINGS AND CAUTIONS

WARNINGS AND CAUTIONS

Alerts the user to possible injury.

! CAUTION

Alerts the user to possible equipment problems.

! NOTE

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An informative or helpful note.

Please read this manual carefully before use.

INDICATIONS The SULLIVAN V nasal CPAP systems are for the treatment of Obstructive Sleep Apnea (OSA) in adults.

CONTRAINDICATIONS Nasal CPAP therapy should be used with caution in subjects with the following conditions: •

Existing respiratory failure or insufficiency (such as, risk of increased work of breathing, due either to incomplete reversal of upper airway obstruction; or to breathing at high lung volume, leading to worsening respiratory failure; risk of rebreathing leading to worsening respiratory failure)

•

Pneumothorax or pneumomediastinum

•

Emphysematous bullae, or past history of pneumothorax (risk of pneumothorax)

•

Decompensated cardiac failure or hypotension, particularly if associated with intravascular volume depletion (risk of further hypotension or reduction in cardiac output)

•

Massive epistaxis or previous history of massive epistaxis (risk of recurrence)

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•

Pneumoencephalus, recent trauma or surgery (for example, pituitary or nasal) that may have produced cranio-nasopharyngeal fistula (risk of entry of air or other material into the cranial cavity)

•

Acute sinusitis, otitis media or perforated ear drum.

The clinician should assess on a case by case basis the relative risks and benefits of nasal CPAP therapy in such a subject. When assessing the relative risks and benefits, the clinician should understand that the SULLIVAN V series can deliver pressures up to 20 cm H2O. Also in the unlikely event of certain fault conditions, a maximum static pressure of 35 cm H2O is possible. If such a pressure could present risk to particular patients, then this device must not be used. For patients with limited respiratory capacity during sleep (for example, emphysema, reduced central drive, neuromuscular, chest wall or lung parenchymal disease, and similar conditions), the use of SmartStart feature may not be advisable; if the unit is stopped inadvertently by this feature (due to a leak, for example) the patient may not have strong enough breathing to restart the unit. WARNINGS

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•

THIS IS NOT A LIFE SUPPORT DEVICE. It may stop operating with a power interruption or if a fault occurs in the product.

•

Explosion Hazard - Do not use in the vicinity of flammable anesthetics.

•

The SULLIVAN V nasal CPAP systems must only be used with a suitable mask system as supplied by ResMed. ResMed mask systems have a number of special features which are not common to other CPAP mask systems.

•

A nasal mask should not be worn unless the machine is turned on and operating properly. The vent holes associated with the mask should never be blocked.

•

At low pressures, the flow through the exhalation ports may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur.

•

The air flow temperature for breathing produced by this device can be as much as 6°C (11°F) higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 32°C (90°F).

•

Do not open the flow generator case or attempt to adjust the unit.

OXYGEN USE WARNINGS

•

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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. •

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

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

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

WARNINGS AND CAUTIONS

NOTE

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THE SULLIVAN V SERIES LIGHTWEIGHT The SULLIVAN V Lightweight is the standard model of the series. It is equipped with a delay timer and international power supply.

PLUS The SULLIVAN V Plus has all the features of the Lightweight, and in addition has a carry bag, pressure display on the front panel and an hour meter on the underside.

ELITE

R210-352/2 K8

The SULLIVAN V Elite has all the features of the other models, and in addition has pressure feedback, compliance data recording and SmartStart.

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Please take some time to become familiar with the features of the SULLIVAN V flow generator. For details on the range of accessories available, see “Accessories/Spare parts” on page 29.

FRONT VIEW Flow generator

THE SULLIVAN V SERIES

THE FLOW GENERATOR

Mirage mask

Control panel

Carry handle Air outlet (with air tubing connector)

Air tube

REAR VIEW

Air inlet and filter Power plug

On/Off switch

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BOTTOM VIEW

Do not disassemble - risk of electrical shock. Refer servicing to qualified personnel. DANGER - Do not operate near anesthetics. Read Operating Manual before using.

Gefahr eines elektrischen Schocks - Gerät nicht auseinandernehmen. Wartung nur durch qualifiziertes Personal. GEFAHR - Nicht in der Nähe von Betäubungsmitteln benutzen. Benutzung nur auf Verschreibung eines Arztes.

Ne pas démonter - risque d'électrocution. S'adresser à un personnel technique qualifié pour le service. DANGER - Ne pas faire fonctionner en présenced'anesthésique. Lire le manuel d'utilisation avant emploi. No desmontar - Riesgo de descargas eléctricas. Solicitar el mantenimiento al personal técnico cualificado. PELIGRO - No manipular en presencia de anestésicos. Leer el manual de instrucciones antes de utilizar el equipo.

Foam pad

Non smontare - rischio di scossa elettrica. Indirizzarsi a personale tecnico qualificato per la manutenzione. PERICOLO - Non usare in presenza di anestetico. Leggere il manuale d'istruzioni attentamente prima dell'uso.

Tag inte isär - risk för elstöt. Reparation endast av kvalificerad person. FARA Använd inte nära bedövningsmedel. Läs bruksanvisningen före användandet. 110-240V ~ 50-60 Hz, 120 VA Made by ResMed Ltd, Sydney, Australia ResMed Corp, San Diego, USA ResMed (UK) Ltd, Abingdon, UK ResMed Asia Pacific Ltd, Sydney, Australia ResMed-Priess GmbH & Co KG, Moenchengladbach, Germany ResMed SA, Lyon, France ResMed Malaysia SDN BHD, Kuala Lumpur, Malaysia

LR76410

ACN 003 765 142 NRTL/C

Protected by: EP(DE,FR,GB) 0088761, JP 1697822, US 4944310, US 5199424, US5522382. C ResMed. SULLIVAN® is a trademark of ResMed Ltd.

Serial No. R210-305/4 C9

Hour meter (Plus and Elite only) Carry handle

Air outlet

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2 CAUTION

! NOTE

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Check that you have the following items: •

a SULLIVAN V flow generator unit

•

a power cord

•

a length of air tubing

•

an air tubing connector

•

a mask system (supplied separately).

ASSEMBLY

ASSEMBLY

Place the flow generator on a table near the head of the bed. Be careful to place it where it cannot be bumped, and where someone will not trip over the power cord. The flow generator may be placed on the floor beside or underneath the patient’s bed. However, you should ensure that the area is free from dust and clear of bedding, clothes or any other objects that could block the air inlet.

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Plug the power cord into the power socket at the rear of the flow generator.

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Plug the other end of the power cord into a power outlet.

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5 6

Assemble the mask system according to the user instructions supplied with the mask system.

Connect the air tubing connector to the air outlet of the flow generator. Connect one end of the air tubing firmly onto the connector and the other end to the mask system.

Air tubing connector

NOTE

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If the patient is using an axial swivel connector (supplied with the modular Mask Frame Kit, or available separately), connect this too. For further information, please refer to the user instructions supplied with the axial swivel. If you are connecting a humidifier, please refer to the instructions supplied with the humidifier. The Elite model will need to be set to Humidifier ON. See “Elite model” on page 15.

IMPORTANT

!

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•

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

•

Only use the same type of mask and air tubing as originally supplied with the flow generator. A different type of mask or tubing may alter the pressure the patient receives, therefore reducing the effectiveness of the treatment.

Turn on the power at the outlet and turn the flow generator switch to ON.

ASSEMBLY

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The flow generator is now assembled. To start treatment, see “Preparing for use” on page 11.

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Before the flow generator may be used by the patient, there are a number of settings that need to be made by the clinician.

NOTE:

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•

Reset the hour meter

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Set the treatment pressure

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Limit the delay times available

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Set the start pressure

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On the Elite model, you must also set the real-time clock and enable or disable SmartStart. See “Elite model” on page 15.

PREPARING FOR USE

PREPARING FOR USE

The UCU2 can be used to adjust the following settings: IPAP pressure, delay times available, start pressure. For further details, please refer to the UCU2 Clinical Manual.

RESETTING THE HOUR METER The Plus and Elite (and some Lightweight) models are equipped with an hour meter. The hour meter displays the total number of hours that the motor has been running, and may therefore be taken as an indication of compliance. The hour meter may be found on the underneath of the flow generator. See “Bottom View” on page 6. The hour meter should be reset to zero when the flow generator is given to a patient. NOTE

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NOTE

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You should reset the hour meter before setting the treatment pressure or start pressure. To reset the hour meter: 1.

Hold down the Start, 5 minute and 10 minute buttons while you turn on the main power switch at the rear of the flow generator. Keep the buttons pressed until the Start, 5 minute and 10 minute buttons illuminate.

2.

Press the Stop and 20 minute buttons together and release them. The motor will start running.

Do not press the Start, 5 minute or 10 minute buttons as this may interfere with the pressure calibration of the flow generator. If one of these buttons has been pressed by mistake, the pressure will need to be recalibrated. See “Calibration” on page 19. 3.

Press the 20 minute button to reset the hour meter.

4.

Press the Stop button to revert to normal operating mode, or turn the flow generator off.

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SETTING THE TREATMENT PRESSURE To set the treatment pressure, you will need a reference manometer with a range of 0-22 cm H2O in intervals of 0.1 cm, fitted with a sensor tube (3 or 2.5 mm internal diameter) and a standard Luer taper fitting.

NOTE:

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1.

Assemble the flow generator as the patient would normally use it complete with mask and air tubing, and connect all accessories (e.g. humidifier, filters, O2 etc.) that are normally used.

2.

Turn on the flow generator to allow the pressure transducer to warm up. The motor does not need to be running; if it does start running, press the Stop button to stop the flow. Let the flow generator warm up for 15 minutes

3.

Remove the plug from one of the access ports on the mask, and insert the Luer taper end of the sensor tube. The other end of the sensor tube should be fitted to the manometer. If you have a blind bubble, attach it to the mask. If you do not, or are using the Mirage Mask, you will need to block the opening of the mask with the palm of your hand (however, be careful not to block the mask vent).

4.

Turn the flow generator off. Hold down the Start and 20 minute buttons while you turn on the main power switch at the rear of the flow generator. Keep the buttons pressed until the Start and 20 minute buttons illuminate. The motor will start running and will build up to the current pressure setting.

5.

Read the pressure on the manometer. Adjust the pressure using the 5 minute (decrease pressure) and 10 minute (increase pressure) buttons until the manometer shows the desired pressure. If you wish to set the pressure to 10 cm H2O, press the Start button.

The hour meter on the underside of the flow generator will display the set pressure while in pressure setting mode. However, a manometer should be used when accurate pressure setting is required.

6.

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Press the Stop button to revert to normal operating mode. Remember to replace the plug in the access port of the mask.

0

Manometer 100

200

PREPARING FOR USE

.

300

Access port

Sensor tube

Figure 1 : Setting the Treatment Pressure

LIMITING THE DELAY TIMER The delay timer starts treatment very gently while the patient falls asleep, and slowly increases to full operating pressure over a selected time period. You can limit the delay times available to the patient. The delay times are 0 (none), 5 minutes, 10 minutes and 20 minutes.

NOTE:

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1.

Hold down the 5 minute and 10 minute buttons while you turn on the main power switch at the rear of the flow generator. Keep the buttons pressed until the Stop and Start buttons illuminate. Some other buttons may also light up.

2.

The lit buttons indicate which delay times are available. Press the 20 minute button to add delay times and the Start button to remove them.

3.

Press the Stop button to revert to normal operating mode.

Pressing a delay button which has been disabled will activate the next enabled delay. For example, if the 20 minute delay has been disabled, pressing the 20 minute delay button will activate the 10 minute delay. If all the time delays have been disabled, pressing any of the delay buttons will select Start.

SETTING THE START PRESSURE 13

The “Start pressure” is the pressure at which the flow generator starts when the delay timer is used. To set the Start pressure, you will need a reference manometer with a range of 0-22 cm H2O in intervals of 0.1 cm, fitted with a sensor tube (3 or 2.5 mm internal diameter) and a standard Luer taper fitting.

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1.

Assemble the flow generator as the patient would normally use it complete with mask and air tubing, and connect all accessories (e.g. humidifier, filters, O2 etc.) that are normally used.

2.

Turn on the flow generator to allow the pressure transducer to warm up. The motor does not need to be running; if it does start running, press the Stop button to stop the flow. Let the flow generator warm up for 15 minutes.

3.

Remove the plug from one of the access ports on the mask, and insert the Luer taper end of the sensor tube. The other end of the sensor tube should be fitted to the manometer. If you have a blind bubble, attach it to the mask. If you do not, or are using the Mirage Mask, you will need to block the opening of the mask with the palm of your hand (however, be careful not to block the mask vent.)

4.

Turn the flow generator off. Hold down the 5 minute and 20 minute buttons while you turn on the main power switch at the rear of the flow generator. Keep the buttons pressed until the 5 minute and 20 minute buttons illuminate. The motor will start running and will build up to the current Start pressure setting.

5.

Read the pressure on the manometer. Adjust the Start pressure using the 5 minute (decrease pressure) and 10 minute (increase pressure) buttons until the manometer shows the desired Start pressure. If you wish to set the Start pressure to 4.0 cm H2O, press the Start button.

6.

Press the Stop button to revert to normal operating mode.

SETTING THE REAL-TIME CLOCK The real-time clock is used to determine compliance, and must be set before the flow generator is given to the patient. To set the clock: 1.

Hold down the Start and 5 minute buttons while you turn on the main power switch at the rear of the flow generator. Keep the buttons pressed until the Start and 5 minute buttons illuminate.

2.

The hour meter on the underside of the flow generator will display the currently set time. Press the 5 minute button to change the hours and press the Start button to change the minutes.

3.

Press the Stop button to revert to normal operating mode, or turn the power off.

4.

The clock battery has a 5 year life span. If you are using the flow generator to monitor patient compliance, be sure to contact your supplier to have the battery replaced before the end of the battery life span.

ELITE MODEL

ELITE MODEL

SMARTSTART When SmartStart is enabled the flow generator will automatically start when the patient breathes into the mask, and automatically stop when they remove the mask. To enable SmartStart: 1.

Hold down the Start, 5 minute and 20 minute buttons while you turn on the main power switch at the rear of the flow generator. Keep the buttons pressed until the pressure display lights come on.

2.

Press the Start button to enable/disable SmartStart. If the Start button is lit, then SmartStart is enabled. If the Start button is not lit, then SmartStart is disabled.

3.

If the patient is using a humidifier, then the humidifier setting must be set to ON. Press the 20 minute button to set the humidifier setting. If the 20 minute button is lit, then the humidifer setting is ON. If the 20 minute button is not lit, then the humidifer setting is OFF.

4.

Press the Stop button to revert to normal operating mode, or turn the power off.

AUTOMATIC LEAK ADJUSTMENT 15

The Elite model uses a pressure sensor to accurately determine the treatment pressure at the patient’s mask. If a leak should occur, the flow generator will increase the air flow slightly to maintain the treatment pressure at the set level.

DOWNLOADING COMPLIANCE DATA The Elite model records up to 200 nights of patient compliance data that can be downloaded for review and print-out. Data may also be downloaded via modem. Please refer to your compliance software manual for details.

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The flow generator should be assembled beside the patient’s bed with the air tubing and mask system connected. (See “Assembly” on page 7.)

STARTING TREATMENT

STARTING TREATMENT

Have the patient lie down in bed and put the mask on. Arrange the air tube so that it is free to move if they turn in their sleep.

* this configuration is not possible with the Mirage mask CAUTION

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Do not leave long lengths of air tubing around the top of the bed that could twist around the patient’s head or neck while sleeping.

Start the flow generator in one of three ways:

Stop button

Start button

5

10

20

Delay timer buttons

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START BUTTON Press the Start button to start the air flow. The air will begin flowing slowly and build up to full operating pressure in about 10 - 15 seconds.

DELAY TIMER If the patient has difficulty falling asleep with full pressure, they can use the Delay timer. The airflow will start very gently while they fall asleep, and slowly increase to full operating pressure over a selected time period. They can select a delay time of 5, 10 or 20 minutes (unless you have disabled some of the delay times). Choose a delay time and press the corresponding button. The air will start to flow automatically. There is no need to push the Start button. If you the patient has not yet fallen asleep after the delay period, they may press one of the delay buttons again.

SMARTSTART (ELITE ONLY) When SmartStart is enabled the flow generator will automatically start when the patient breathes into the mask, and stop when they remove it. If the patient wants to use the Delay timer, they will need to press a delay button to start treatment. However, the flow generator will still stop automatically. SmartStart can only be enabled by the clinician. See “Elite model” on page 15.

STOPPING The patient may stop treatment at any time by pressing the Stop button. If they have the Elite model and SmartStart is enabled, they can simply remove their mask, and treatment will stop automatically.

GETTING UP If the patient needs to get up during the night, they must remove their mask and turn the flow generator off. The patient should be reminded to replace their mask when they return to bed and turn the flow generator on again.

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