S8 Escape II POSITIVE AIRWAY PRESSURE DEVICE Clinical Guide English ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed Corp (US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA ResMed (UK) Ltd (EU Authorized Representative) 96 Milton Park Abingdon Oxfordshire OX14 4RY UK ResMed Offices Australia, Austria, Brazil, China, Finland, France, Germany, Hong Kong, India, Japan, Malaysia, Netherlands, New Zealand, Norway, Singapore, Spain, Sweden, Switzerland, UK, USA (see www.resmed.com for contact details). Protected by patents: US 5199424, US 5522382, US 6705315. Other patents pending. Protected by design registrations: AU 302180, AU 302181, AU 302182, AU 302183, AU 302184, AU 302185, AU 302186, CN 200430121212.2, CN 200430121213.7, CN 200430121211.8, CN 200430121214.1, CN 200430121215.6, CN 200430121216.0, CN 200430121217.5, EP 269436, HK 0412901.9, JP 1257662, JP 1257663, JP 1266956, JP 1266957, JP 1267270, JP 1267271, NZ 405614, NZ 406923, NZ 406924, NZ 406925, NZ 406926, NZ 406927, NZ 406928, US D544598, US D553228, US D557406, US D557407. Others pending. S8, S8 Escape, HumidAire 3i, Bubble Cushion and ResScan are trademarks of ResMed Ltd and Escape is registered in U.S. Patent and Trademark Office. 2008 ResMed Ltd. 338474/2 08 02
Contents S8 Escape II............................................. 1 Indications for Use 1 Contraindications 1 Adverse Effects 1 The S8 Escape II System................................... 2 Masks 2 Humidifiers 2 Data Management Products 2 Operating Information..................................... 3 System Setup 3 Delivering Therapy 5 Navigating the S8 Escape II Menus......................... 6 S8 Escape II Keypad and LCD 6 S8 Escape II menus 7 Setting Ramp Time 10 EPR 10 Reminder Menu 11 Calibration 13 S8 Data Management..................................... 15 Transmitting Data with the Data Card 17 S8 Adapters 18 Cleaning and Maintenance................................ 19 Daily 19 Weekly 19 Monthly 20 Replacing the Air Filter 20 Servicing 20 Troubleshooting.......................................... 21 System Specifications for S8 Escape II..................... 24 General Warnings and Cautions........................... 25
S8 Escape II Indications for Use The S8 Escape II CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients > 66 lb (30 kg). The S8 Escape II CPAP system is intended for home and hospital use. CAUTION In the US, Federal law restricts this device to sale by or on the order of a physician. Contraindications The S8 Escape II is not a life support device and may stop operating with power failure or certain fault conditions. It should not be used by patients who are dependent on continuous therapy. Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing conditions: severe bullous lung disease pneumothorax pathologically low blood pressure dehydration cerebrospinal fluid leak, recent cranial surgery, or trauma. Adverse Effects Patients should report unusual chest pain, severe headache or increased breathlessness to their prescribing physician. An acute upper respiratory tract infection may require temporary discontinuation of treatment. The following side-effects may arise during the course of therapy with the CPAP device: drying of the nose, mouth, or throat nosebleed bloating ear or sinus discomfort eye irritation skin rashes. S8 Escape II 1
The S8 Escape II System A complete S8 Escape II system comprises the following elements: S8 Escape II positive airway pressure device 2 m air tubing Power cord Carry bag. Carry handle Screen Keypad Data Card Module Air inlet Air outlet DC AC Optional components include: ResScan Data Card 3 m air tubing DC-12 converter. Masks Patients will also need a ResMed mask system (supplied separately). For information on using masks, see the relevant mask manual. Recommended masks are available on www.resmed.com on the Products page under Service & Support. WARNING Only ResMed mask systems are compatible for use with the S8 Escape II. Please refer to General Warnings and Cautions on page 25. Humidifiers A list of humidifiers compatible with ResMed devices can be found on www.resmed.com, on the Products page under Service & Support. Data Management Products The S8 Escape II will have a ResScan Data Card module attached. See S8 Data Management on page 15. The following data management products may be purchased separately. ResScan Data Card Serial adapter USB adapter and cable ResMed PC application. 2
Notes: Ensure that at least one module or adapter is connected to the S8 Escape II at all times. ResMed regularly releases new products. Please check our website at www.resmed.com. Operating Information The S8 Escape II delivers pressure within the range 4 to 20 cm H 2 O. To make the beginning of treatment more comfortable, you may set a ramp so the pressure starts low and gradually increases to full treatment pressure over the ramp time. System Setup WARNING Make sure the power cord and plug or adapter cable are in good condition and the equipment is not damaged. Only ResMed air tubing should be used with the device. A different type of air tubing may alter the pressure the patient receives, reducing the effectiveness of the treatment. Blocking the hose and/or air inlet of the device while in operation could lead to overheating of the device. In the clinical environment any personal computer that is used with your CPAP system must be at least 5 (1.5 m) away from, or at least 8 (2.5 m) above, the patient. It must also comply with the relevant test standard. For personal computers the international standard is IEC 60950 or equivalent. CAUTION Be careful to place the device where it cannot be bumped, and where no one will trip over the power cord. The S8 Escape II device may be placed on the floor beside or underneath the patient s bed. Ensure that the area is free from dust and clear of bedding, clothes, or any other objects that could block the air inlet. When calibrating the S8 Escape II or setting the treatment pressure, assemble the device as the patient would normally use it, and connect all accessories that are normally used. Operating Information 3
2 1 3 4 1 Connect the power cord to the socket on the rear of the S8 Escape II. 2 Plug the other end of the power cord or adapter cable into the power outlet. 3 Connect one end of the air tubing firmly onto the air outlet. 4 Connect the assembled mask system to the free end of air tubing. Refer to the relevant mask manual for assembly instructions. 4
Delivering Therapy WARNING A mask should not be used unless the S8 Escape II is turned on and operating properly. 1 Power on the S8 Escape II. The LCD will display the standby (Ramp) screen. 2 Ensure patient settings are correct. 3 To start therapy, press. Air will begin flowing slowly and will build up to the operating pressure in about 15 to 25 seconds. 4 Instruct the patient to fit the mask according to the mask user instructions. 5 Instruct the patient to lie down in bed. If desired, arrange the air tubing over the top of the headboard to reduce drag on the mask. WARNING Do not leave long lengths of air tubing around the top of the bed; they may twist around the patient's head or neck while sleeping. Blocking the hose while in operation could lead to overheating of the device. 6 Adjust the mask and headgear to achieve optimal fit. At the end of the ramp period, the LCD will look similar to the screen below: CPAP ----- 7 To stop therapy, remove the mask, and press. Using the S8 Escape II on an aircraft The S8 Escape II complies with US FCC Part 15, Class B requirements. Patients should consult the medical services department of their carrier if they intend to use their S8 Escape II on an aircraft. Note: Do not use the S8 Escape II while the aircraft is taking off or landing. Operating Information 5
Navigating the S8 Escape II Menus S8 Escape II Keypad and LCD The control panel of the S8 Escape II unit includes a keypad for navigating through the menus and delivering treatment (Figure 1). LCD screen Keypad Start/Stop key Figure 1: S8 Escape II CPAP Keypad and LCD The LCD is used to display the menus and other data. The arrows and the text on the bottom line of the LCD prompt the use of the keys within the menus. The keypad is used to navigate through the menus and start/stop treatment. The functions of the keys and quick key combinations are listed in Table 1. Both the LCD and keypad are backlit with power-up of the device. When you are navigating through the menus, the LCD backlight times out two minutes after your last menu choice. Once has been pressed to initiate treatment, the LCD backlight stays on for two minutes. The keypad remains illuminated to indicate that the device is on. Table 1: Keypad keys and their functions Key(s) Up key Down key Start/Stop Function(s) Navigates between items within the menu. Allows you to increase settings options. Navigates between items within the menu. Allows you to decrease settings options. Starts and stops treatment. Left Performs the function indicated by the guiding text displayed above it on the LCD (eg, change). 6
Key(s) Right Down + Right + Left + Down + Function(s) Performs the function indicated by the guiding text displayed above it on the LCD (eg, exit). Returns you to the standby screen from the Clinical menu screen. Extended hold (for at least three seconds) gives access to the Clinical Menu from the standby screen. Extended hold (for at least three seconds) gives access to the Reminder Menu from the standby screen. S8 Escape II menus Parameters in the patient and clinical menus are described in Table 2 on page 9. Patient Menu Enter the Patient Menu by pressing while in the standby (Ramp) screen. Figure 2 summarizes the Patient Menu screens. S8 ESCAPE II S8 PATIENT CLASSIC MENU S8 RAMP CLASSIC Menu 10min EPR LEVEL: 1 Change USED HRS: 960 USAGE: 120/180 Only displayed if clinician enabled LANG: Change ENGLISH SW: SX123456789 Figure 2: Screens in the Patient Menu Clinical Menu Enter the Clinical Menu from the standby screen by holding down + simultaneously for at least three seconds. Figure 3 summarizes the Clinical Menu screens. Navigating the S8 Escape II Menus 7
S8 ESCAPE II S8 S8 PATIENT CLASSIC MENU S8 RAMP CLASSIC MENU Menu 10min S8 CLINICAL CLASSICMENU EPR: RAMP ONLY Change EPR LEVEL: 1 Change EPR ACCESS:OFF Change EPR INHALE: MED Change RAMP: Change MAX RAMP: Change 20min 45min START CPAP: 4.0 Change CPAP: 9.0 Change CALIBRATE: 1:00 Change USED HRS: 960 USAGE: 120/180 ERASE:COMPLIANCE Reset LANG: Change ENGLISH TIME: 23:10 Change DATE: 2008-03-04 SN: 200312345678 SW: SX123456789 MOTOR HRS: 18250 Figure 3: Screens in the Clinical Menu 8
Table 2: Parameters in the Patient and Clinical Menus Parameter EPR EPR Level a EPR Access EPR Inhale Ramp a Max Ramp Start CPAP CPAP Calibrate Used Hrs a Usage a,b Erase Language a Time Date SN SW a Motor Hours Description Sets EPR to occur all the time, during ramping only, or never. Sets the EPR value. Enables or disables patient view of, and ability to change, the EPR level. Sets the inhalation type as either Medium or Fast. Selects the Ramp time. (Available in standby mode.) Sets the maximum ramp time the patient can select. Sets the pressure at the start of the ramp time up to fixed treatment pressure. Sets the fixed treatment pressure. Adjusts the measured pressure at the manometer to match the set CPAP pressure. Use if there is a differential of greater than 0.5 cm H 2 O between the set CPAP pressure and the measured pressure. Changing the calibration will change the pressure gain displayed on the LCD. Entering the Calibrate screen will start airflow. ing this screen will stop airflow. See Calibration on page 13. Displays the total number of treatment hours. (View only.) The number of used sessions greater than 1 minute in length over the number of days elapsed since the first used day. Resets the used hours and used days. The language in which menus and settings are displayed on the LCD. Sets the current time. Displays the current date. Displays the serial number of the device. Displays the current software version. Displays the total number of hours the S8 Escape II motor has been running, to a maximum of 18,250 hours. a. Available on both the Patient Menu and the Clinical Menu. b. More detailed data is available via your PC application. Refer to the S8 Escape II Quick Set-up Guide for details of factory settings. Navigating the S8 Escape II Menus 9
Setting Ramp Time EPR If the patient has difficulty falling asleep with full pressure, select a ramp time. The pressure will slowly increase to full operating pressure over the selected ramp time. The Ramp Time screen is displayed after the standby (Ramp) screen, and is also available in the Clinical Menu. The clinician also sets a Maximum Ramp time; the patient may select any value up to the set maximum. When ramping begins the LCD will display the word RAMPING with the current pressure indicated as dashes. Table 3 describes the range of set pressures that the dashes represent. Table 3: Pressure range indicators on S8 LCD No. of dashes Pressure range (cm H 2 O) 2 Set Pressure 4.0 and < 5.0 3 Set Pressure 5.0 and < 7.0 4 Set Pressure 7.0 and < 9.0 5 Set Pressure 9.0 and < 11.0 6 Set Pressure 11.0 and < 13.0 7 Set Pressure 13.0 and < 15.0 8 Set Pressure 15.0 and < 17.0 9 Set Pressure 17.0 and < 19.0 10 Set Pressure 19.0 and = 20.0 During treatment, you can select EPR. EPR is designed to maintain optimal CPAP treatment for the patient during inhalation and reduce the delivered mask pressure during exhalation. The desired result of EPR is to decrease the pressure the patient must breathe out against, making the overall CPAP therapy more comfortable. The features of EPR are: You can select an EPR pressure drop level of 1, 2, or 3 cm H 2 O. You can set EPR to be off, delivered only during ramping, or delivered throughout therapy. There are two inhalation comfort levels; medium and fast. Pressure drop is limited, to avoid sub-optimal treatment (maximum drop is 3cm H 2 O). When EPR is enabled, the delivered pressure will not drop below a minimum pressure of 4 cm H 2 O, even if, for example, the set pressure is 6 cm H 2 O and the EPR level is 3. Clinicians can restrict a patient s access to their EPR level. 10
Reminder Menu You can use the Reminder menu to set a number of reminders to alert the patient to specific events; for example, when to replace their mask, when to insert a Data Card (if their device is Data Card enabled) and so on. When a reminder is due, a message is displayed on the LCD and remains whenever the device is not delivering therapy. The backlight on the LCD flashes when a message is displayed. If more than one reminder for a patient is scheduled for the same date, all scheduled reminders are displayed during that day. A patient can clear a message by pressing (or inserting a Data Card, in the case of the Data Card reminder). The default setting for all reminders is that they are disabled. Enter the Reminder Menu from the standby screen by pressing + for at least three seconds. To move through the menu, see Navigating the S8 Escape II Menus on page 6. Figure 4 summarizes the Reminder Menu screens on page 12. Replace mask You can set a timed reminder to remind a patient when they need to replace their mask. The patient can press (OK) to remove the message from the LCD. Call Provider You can set a timed reminder for your patient to phone you at a certain time; for example, to discuss how their therapy is going. The patient can press (OK) to remove the message from the LCD. Insert Card You can set a timed reminder on the S8 Escape II to remind the patient that they need to insert a Data Card to transfer their data. This enables you to establish compliance. The patient should actually insert the Data Card in order to clear the message from the LCD. (They can also press (OK) to remove the message.) Replace filter You can set a timed reminder to remind your patient when to replace the air filter. The patient can press (OK) to remove the message from the LCD. Service Due You can set a timed reminder to remind your patient when to return the device for service. The patient can press (OK) to remove the message from the LCD. Navigating the S8 Escape II Menus 11
S8 ESCAPE II S8 S8 PATIENT CLASSIC CLASSIC MENU S8 RAMP CLASSIC Menu MENU 10min S8 REMINDER CLASSIC MENU MASK: 2008-10-30 Change MASK RECUR: 6mth Change CALL: 2008-10-30 Change CALL RECUR: OFF Change CARD: 2008-10-30 Change CARD RECUR: OFF Change FILT: 2008-10-30 Change FILT RECUR: 6mth Change SERV: 2009-10-30 Change SERV RECUR:24mth Change Figure 4: Screens in the Reminder Menu 12
Table 4 shows the options and default settings for the types of reminders in the Reminder Menu. Table 4: Reminder type options and default settings Type of reminder Default setting a Options b Recurrence period Replace mask (MASK) OFF 7-day increments, starting from current date Call provider (CALL) OFF 7-day increments, starting from current date Insert Card (CARD) OFF 7-day increments, starting from current date Change filter (FILT) OFF 7-day increments, starting from current date Service due (SERV) OFF 7-day increments, starting from current date 1 24 months 1 24 months 1 24 months 1 24 months 1 24 months Setting Reminder Recurrence You can set each reminder to keep reoccuring at a specific time period, starting from the date set for the original reminder. You can set the recurrence time period from 1 to 24 months. (Each month in the recurrence time period is equal to 30 days.) You have to set a date for a specific reminder before its recurrence time period will take effect. For example, if you set a MASK (replace mask) reminder for 16 June 2008, the patient will see that reminder on 16 June 2008. If you have also set a MASK RECUR reminder for six months, the mask reminder will occur again six months (180 days) from the date the reminder is acknowledged by the patient. The mask reminder will continue to recur at six-monthly intervals unless you change the recurrence period, or set the mask reminder to OFF. Calibration a. OFF means that the date set for the reminder is today s date or earlier. b. If you have used a PC application to set a reminder date, and you later change that date using the S8 Escape II Reminder Menu, you can only change it in 7-day increments. The S8 Escape II is factory calibrated before delivery and will not require periodic calibration for home use. If there has been a change in altitude within a given altitude compensation range, or a change in circuit configuration, we recommend you check the calibration and adjust as required. Note: Some countries require all medical equipment to have a periodic service and calibration. Please check the regulations in your country. Navigating the S8 Escape II Menus 13
Quick Check To check the calibration of the S8 Escape II: 1. In the Clinical Menu, set the CPAP pressure setting to 12 cm H 2 O. 2. Measure the pressure at the mask using an accurate manometer. If the delivered pressure is less than 11.5 cm H 2 O or more than 12.5 cm H 2 O, you may need to recalibrate the device. Adjusting the Calibration To calibrate the S8 Escape II you will need a reference manometer with a range of 0 to 22 cm H 2 O in intervals of 0.1 cm H 2 O, fitted with a sensor tube 0.098 to 0.118 (2.5 mm to 3 mm) internal diameter and a standard Luer taper fitting. 1. Assemble the S8 Escape II as the patient would normally use it, complete with air tubing and the mask system. Connect all accessories (humidifier, filters, etc) that are normally used. 2. Turn on the S8 Escape II to allow the device to warm up. If the motor does not start running, press to start the airflow. Let the device warm up for 15 minutes. 3. While the device is warming up, remove the plug from one of the access ports on the mask, and attach 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 Cushion, attach it to the mask. 4. When the motor has been running for 15 minutes, press to stop the airflow. 5. Access the Clinical Menu from the S8 Escape II screen by holding down + simultaneously for at least three seconds. 6. Scroll to the CPAP menu. 7. Press to change the pressure setting. Use and to set the pressure to 12 cm H 2 O. Press to apply this pressure. 8. Scroll to the Calibrate screen. Press (Change) to change the calibration setting. The airflow will start. If you are not using a blind Bubble Cushion, you can use the patient's normal mask and block the opening of the mask with the palm of your hand (however, be careful not to block the mask exhalation vent). 9. Read the pressure on the manometer. Use or to change the pressure until the manometer reads 12 ± 0.2 cm H 2 O. Note: You will notice that the pressure gain increases when is pressed and decreases when is pressed. 10.Press (Change) to apply this pressure. The airflow will stop. 14
WARNING During calibration, you may not be able to calibrate the S8 Escape II for all patients under extreme conditions (eg, high set pressures and high altitudes). This is because the delivered pressure will reach a peak and will not increase any further, even though the pressure gain may be increasing. In this case, we advise that you do not increase the pressure gain once the pressure has peaked; otherwise the pressure may be too high if operated at lower altitudes. S8 Data Management Before issuing the Data Card, make sure that it has been labeled with the patient s ID and is correctly addressed. Refer to Using the Protective Folder on page 16 for more details. Check that the patient knows: why they are being issued with a Data Card when and how they must use the Data Card how to insert, remove and return the Data Card where to look for information (the Troubleshooting section of the User s Manual for their S8 device) if the data transfer does not work as expected. Labeling the Data Card We strongly advise that you write the name of the patient on the Data Card to prevent any mix-up of patient data. A space is provided on the Data Card for this purpose. Each Data Card is reusable. If you are issuing an existing Data Card to a new patient, make sure that the card is labeled with the new patient s ID. Use the space provided on the Data Card label when issuing a new card. Notes: When reusing a Data Card, make sure that you use a label that does not cover more than the name area on the Data Card, and is not more than 0.06 (0.15 mm) thick. If the label is larger than this, the patient may not be able to insert the Data Card into the Data Card module on their S8 Escape II. If you reuse a Data Card that already has a label on it, remove the old label before attaching a new one. Supplying the Data Card You can monitor a patient s treatment with the Data Card and protective folder supplied with their device. The patient can return the card to you when they have copied their data onto it. If you are mailing the Data Card, you need to advise the patient when the card is being mailed out to them. Ensure that the patient knows that they must remove their Data Card from the device when they have finished copying data to it. Leaving the Data Card in the device during therapy will not result in additional data being copied to the card. If a patient needs to copy additional data to the Dard Card, they will need to insert the card again. S8 Data Management 15
If you want a patient to update the settings in their S8 Escape II, you can load the new settings on to a Data Card and either give or mail them the card. The patient can return the card to you when they have applied the settings on their S8 device. The information on the card will allow you to assess whether the patient s settings have been changed as expected. Notes The Data Card should be stored in its protective folder when not in use. Use a postal envelope to mail the protective folder and its contents to the patient. Using the Protective Folder The protective folder should always be used to store the Data Card and for mailing. The protective folder contains all the necessary instructions for a patient to copy data or update their settings (as shown in Figure 5). Dear patient, please follow the directions as marked below. FR Cher/Chère patient(e), veuillez suivre les instructions ci-dessous. ES Estimado paciente, tenga a bien seguir las instrucciones que se indican a continuación. PT Caro paciente, siga as instruções abaixo indicadas. COPY DATA COPIEZ LES DONNEES COPIADO DE DATOS COPIAR DADOS FR ES PT 1 2 3 4 FR CARTE INSEREE Patientez SVP ES TARJ. INSERTADA Espere PT CARTAO INSERI Aguarde p.f. FR ES PT COPIE TERMINEE Retirez carte COPIA COMPLETA Quitar tarjeta COPIA COMPLET Retirar cartão Instructions for copying data 5 Return by mail FR Retournez par courrier ES Devolver por correo PT Devolva o cartão por correio Return by person FR Retournez la carte personnellement ES Devolver en persona PT Devolva o cartão pessoalmente Keep the card FR Gardez la carte ES Conservar la tarjeta PT Fique com o cartão Indicate what you want the patient to do Data Card goes here UPDATE SETTINGS METTEZ LES REGLAGES A JOUR ACTUALIZACIÓ N DE LA CONFIGURACIÓN ACTUALIZAR PARÂMETROS FR ES PT 1 2 3 4 FR ES PT CARTE INSEREE Patientez SVP TARJ. INSERTADA Espere CARTAO INSERI Aguarde p.f. FR ES PT CHARG.REUSSI Retirez carte CONFIG CORRECTA Quitar tarjeta PARAMET SUCESSO Retirar cartão Instructions for updating settings If messages differ, see your manual. Use Data Card as per above before returning. FR Si les messages affichés sont différents, référez-vous à votre manuel. Utilisez la carte de données conformément aux instructions ci-dessus avant de la retourner. ES Si los mensajes son distintos, consulte el manual. Antes de devolverla, utilice la tarjeta tal como se indica. PT Se as mensagens forem diferentes, consulte o seu manual. Use o cartão de dados tal como é descrito acima antes de o devolver. Figure 5: Data Card s protective folder 16
Transmitting Data with the Data Card Copying Data onto a Data Card If you want a patient to give you their compliance data, you need to tell them how to copy data onto their Data Card. This information is also supplied in the patient s User Guide. 1. Ensure the S8 Escape II is switched on and displaying the standby (Ramp) screen. 2. Insert the Data Card (arrow facing up) into the Data Card Module until it stops. Copying of data starts automatically. The Card Inserted Please Wait message is displayed on the LCD while data is copied to the Data Card. Copying takes approximately five seconds. The Copy Complete Remove Card message is displayed on the LCD when copying has finished. 3. Remove the Data Card by gripping the end of the Data Card and pulling it out. The Data Card should be stored in its protective folder when not in use. 4. If mailing the Data Card to a patient, use a postal envelope to send the Data Card in its protective folder. Updating Settings on the S8 Escape II You can create new treatment settings and transfer them to a Data Card via your ResMed PC application. A patient can then use the Data Card to update the settings in their S8 Escape II. If you mail the Data Card to the patient, send it in the protective folder. If you need the Data Card sent back to you for verification, use a postal envelope to mail the protective folder and its contents to the patient. Instruct the patient to carry out the following steps to update settings on their S8 Escape II. This information is also supplied in the patient s User Guide. 1. With the device in standby (Ramp) mode, insert the Data Card into the slot on the Data Card module. Updating will start automatically. The Card Inserted Please Wait message will appear on the LCD while updating is in progress. Updating takes approximately five seconds. The Settings Success Remove Card message is displayed on the LCD if the settings were updated successfully. Note: This message only appears once. If you re-insert the Data Card after you have updated your settings, this message is not displayed. 2. Remove the Data Card from the device. 3. Store the Data Card in its protective folder when not in use. When you create a Data Card with therapy settings you can specify the serial number of the device on which the settings need to be updated. This prevents the settings from being applied on the wrong device. Refer to your PC application manual for more details. WARNING Advise the patient to contact you immediately if they are using the Data Card to update the settings on their device and the Settings Success message does not appear. S8 Data Management 17
Analyzing the Data Card Use a ResMed PC application to transfer data and settings between an S8 Escape II or a Data Card and your personal computer. Refer to the user guide for your PC application for more information about analysing the information on returned Data Cards. S8 Adapters S8 adapters are designed for use with the ResMed S8 series of devices, to transfer data between the device and a personal computer. They slot onto the device in place of the Data Card Module. Two adapters are available: Serial adapter, which uses a standard serial cable USB adapter (supplied with a USB cable). Data Card Module Serial adapter USB adapter WARNINGS Only use S8 adapters as specified in this manual. S8 adapters are specifically designed for use with ResMed S8 devices. Attach the S8 serial or USB adapter to a ResMed S8 device to create a serial or USB port. You can then connect a cable that enables transfer of data between the device and a personal computer. CAUTION If a cable is not attached when the S8 adapter is attached to an S8 device, either attach the adapter s protective cover or remove the adapter and replace it with the Data Card module. This is to prevent damage to the S8 adapter. Attaching an S8 adapter Notes: Ensure that a module or an adapter is attached to the S8 device at all times. Remove the existing module from the S8 device if the serial or USB adapter is required. The device should be turned off when removing a module and attaching the serial adapter. 18
1. Unplug the device from the wall. 2. Remove the module currently attached to the S8 device. 3. Press and hold down the button on the adapter, while pushing it onto the device. 4. Connect one end of the cable to the adapter, and the other end to the computer. Removing an S8 adapter Note: The device should be turned off when removing an adapter and attaching a module. 1. Press and hold down the button on the adapter, while pulling it off the S8 device. 2. Attach another module to the S8 device according to the instructions for that module. See the manual for your PC application for information about downloading data to your computer. Cleaning and Maintenance Daily Patients should regularly carry out the cleaning and maintenance described in this section. Refer to the related mask and humidifier (if used) manuals for detailed instructions regarding the care of those devices. WARNING Beware of electric shock. Do not immerse the unit or power cord in water. Always unplug the unit before cleaning and be sure it is dry before plugging back in. The mask system and air tubing are subject to normal wear and tear. Inspect them regularly for damage. CAUTION Do not hang the air tubing in direct sunlight as it may harden over time and eventually crack. Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturising or antibacterial soaps or scented oils to clean the air tubing or the S8 Escape II. These solutions may cause hardening and reduce the life of the product. Weekly Disconnect the air tubing and hang it in a clean, dry place until next use. 1. Remove the air tubing from the S8 Escape II and the mask. 2. Wash the air tubing in warm water using mild detergent. 3. Rinse thoroughly, hang, and allow to dry. 4. Before next use, reconnect the air tubing to the air outlet and mask. Cleaning and Maintenance 19
Monthly 1. Clean the exterior of the S8 Escape II with a damp cloth and mild liquid soap. 2. Check the air filter for holes and blockage by dirt or dust. Replace it every six months, or more often in a dusty environment (see Replacing the Air Filter on page 20). Replacing the Air Filter WARNING Do not wash the air filter. The air filter is not washable or reusable. The air filter cover protects the device in the event of accidental liquid spillage onto the device. Ensure the air filter and air filter cover are fitted at all times. 1. Remove the air filter cover at the back of the S8 Escape II. 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 device. 4. Replace the air filter cover. Inspect the air filter every month to check if it is blocked by dirt or contains holes. With normal use of an S8 Escape II, the air filter needs to be replaced every six months (or more often if your device is in a dusty environment). Servicing CAUTION Do not attempt to open the S8 Escape II case. There are no user serviceable parts inside. Inspection and repair should only be performed by an authorised agent. Under no circumstances should you attempt to service or repair the S8 Escape II yourself. 20 This product (S8 Escape II) should be inspected by an authorized ResMed Service Center five years from the date of manufacture. Prior to this, the device is intended to provide safe and reliable operation provided that it is operated and maintained in accordance with the instructions provided by ResMed. Applicable ResMed warranty details are provided with the device at the time of original supply. Of course, as with all electrical devices, if any irregularity becomes apparent, you should exercise caution and have the device inspected by an Authorized ResMed Service Center. If you feel that the S8 Escape II is not performing properly, see Troubleshooting on page 21.
Troubleshooting No display CAUTION If the problem cannot be solved, contact your equipment supplier or ResMed. Do not attempt to open the S8 Escape II case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorised service agent. Problem/Possible Cause Solution Power is not connected. Ensure the power cable is connected and the power switch (if available) is on. Treatment pressure seems low Ramp Time is in use. Air filter is dirty. Air tubing is kinked or punctured. Air tubing is not connected properly. Mask and headgear are not positioned correctly. Caps are missing from access port on mask. Pressure required for treatment may have changed. Wait for air pressure to build up or change ramp time. Replace air filter. Straighten or replace tubing. Check air tubing. Adjust position of mask and headgear. Replace caps. Calibrate pressure. Displays error message: Exxxx Call Service (where xxxx defines an error) or MOTOR FAULT Call Service or UPLOAD LANGUAGES Call Service or DATA LOST Call Service Component failure. Call service. Date or time in data files is wrong Date or time on S8 Escape II device is wrong. Correct the current time on the device. The date can only be changed via the PC application. Troubleshooting 21
Problem/Possible Cause Solution The Data Card is returned without the expected patient data Data Card was not inserted correctly. Data Card was only partly inserted. The card is not a ResScan Data Card. Check that the patient is inserting the Data Card into the Data Card module with the arrow facing up, while the S8 Escape II is powered and not delivering therapy (in standby mode). Check that the patient is inserting the Data Card as far as it will go into the slot on the Data Card module. Check that the card used is a ResScan Data Card. The following message is displayed on the LCD after the patient inserts a Data Card: Card Error Remove Card Data Card is not inserted correctly. The card is not a ResScan Data Card. If this message occurs repeatedly even when the Data Card is inserted correctly, there may be a physical card fault on the Data Card. Check that the patient is inserting the Data Card into the Data Card module with the arrow facing up, while the S8 Escape II is switched on and not delivering therapy (standby mode). Check that the card used is a ResScan Data Card. Issue a new Data Card to the patient. The following message is displayed on the LCD after the patient tries to update the settings using the Data Card: Settings Invalid Remove Card The identification details on the Data Card do not match the identification details on the device the patient is trying to update. Check that the identification details on the Data Card are correct. (See the clinician s manual for your PC application for instructions.) The following message is displayed on the LCD after the patient tries to update the settings using the Data Card: Settings Error Remove Card There is an unrecoverable data error on the Data Card. Use the appropriate PC application to reprogram the settings on a new Data Card and issue it to the patient. 22
Problem/Possible Cause Solution The following message is NOT displayed on the LCD after the patient tries to update the settings using the Data Card: Settings Success Remove Card The settings were not updated. The message only appears the first time a Data Card is inserted into a device to update settings. The patient may have missed seeing the message. To check whether the settings have actually been applied: Ask the patient whether the therapy they are receiving feels different. Check the settings data written on the Data Card from the S8 Escape II to see if they are correct (refer to your PC application clinician s manual for more information). If the settings data on the Data Card matches the intended settings the device has been programmed successfully. After settings have been updated using the Data Card, if the patient doesn t feel any difference in therapy and/or the settings are not correct Data Card given to patient did not contain settings because the patient received the wrong card. The Data Card was removed before settings were copied to the S8 Escape II. Data Card given to patient did not contain settings because programming of settings did not complete. Data Card was not inserted correctly. The card is not a ResScan Data Card. Use the appropriate PC application to reprogram the Data Card with the settings, and reissue it to the patient. Check that the patient does not remove the Data Card before the Settings Success Remove Card message appears on the LCD. Use the appropriate PC application to reprogram the Data Card with the settings, making sure that programming completes. Re-issue the card to the patient. Check that the patient is inserting the Data Card fully into the Data Card slot with the arrow facing up, while the S8 Escape II is switched on and not delivering therapy (standby mode). Check that the card used is a ResScan Data Card. Troubleshooting 23
System Specifications for S8 Escape II. Operating pressure range Dimensions (H x W x D) Weight 4 to 20 cm H 2 O 4.6 x 6.5 x 5.7 (112 mm x 164 mm x 145 mm) 2.9lb (1.3 kg) Power Supply Input range for S8 Escape II with HumidAire 3i:100 240V, 50/60Hz; 110V, 400Hz; 2.5A < 140VA (110W) (maximum power consumption). Instantaneous peak power consumption <340VA. Refer to the DC-12 converter instructions for DC ratings. Only use the ResMed DC-12 converter for DC input. Typical power consumption at 20 cm H 2 0 is 34VA or 20W. Air Filter Two-layered, powder-bonded, polyester non-woven fiber Air Tubing Flexible plastic, 6 6 (2 m) Air Outlet The 22 mm conical outlet complies with EN 1281-1 IEC 60601-1 Class II (double insulation), Type CF Classifications Noise Level Radiated sound pressure is measured at <30dBA at 10 cm H 2 O and 3 3.36 (1 m) according to ISO17510-1. Supplemental Oxygen Recommended maximum supplemental oxygen flow: 4 L/min Housing Construction Flame retardant engineering thermoplastic Operating +41ºF to +95ºF (+5ºC to +35ºC) Temperature Operating Humidity 10% 95% non-condensing Storage and Transport -4ºF to +140ºF (-20ºC to +60ºC) Temperature Storage and Transport 10% 95% non-condensing Humidity Operating Altitude Sea level to 8500 (2591 m) Electromagnetic Compatibility Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for residential, commercial, and light industry environments. Note: The manufacturer reserves the right to change these specifications without notice. Symbols which appear on the device Attention, consult accompanying documents; Drip proof; Type CF equipment; Dangerous voltage; Class II equipment; Start/Stop. 24
General Warnings and Cautions Warnings Read the entire manual before using the S8 Escape II. Advice contained in this manual should not supersede instructions given by the prescribing physician. A patient should not connect a device to the data communication port unless instructed to do so by their health care provider or physician. Only ResMed products are designed to be connected to the data communication port. Connecting other devices could result in injury, or damage to the device. The S8 Escape II should only be used with masks (and connectors) 1 recommended by ResMed, or by a physician or respiratory therapist. A mask should not be used unless the device is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked. Explanation: The S8 Escape II is intended to be used with special masks (or connectors) 1 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. In the event of power failure or machine malfunction, remove the mask. The S8 Escape II can be set to deliver pressures up to 20 cm H 2 O. In the unlikely event of certain fault conditions, pressures up to 30 cm H 2 O are possible. If oxygen is used with this device, the oxygen flow must be turned off when the device is not operating. If the oxygen has been left on, turn off the device, then wait 30 minutes before turning on the device again. Explanation: When the CPAP device is not in operation and the oxygen flow is left on, oxygen delivered into the air delivery tubing may accumulate within the CPAP machine enclosure and create a risk of fire. This applies to most types of CPAP machines. Oxygen supports combustion. Oxygen should not be used while you are 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. 1 Ports may be incorporated into the mask or in connectors that are near the mask. General Warnings and Cautions 25
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. Do not use the S8 Escape II if there are obvious external defects or unexplained changes in performance. Do not open the S8 Escape II case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorized service agent. Explosion hazard do not use in the vicinity of flammable anaesthetics. Cautions 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. The air flow for breathing produced by this device can be as much as 11ºF (6ºC) higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 90ºF (32ºC). When data transfers have been completed using the PC application, always replace the serial cover on the serial connector, or replace the serial adaptor with a Data Card module. When AC mains power (100 240V AC) is not available, always use a ResMed DC-12 converter. (The DC-12 converter is available as an optional accessory. It is not supplied with all models.) The Data Card module is designed for use with specific ResMed devices. Note: The above are general warnings and cautions. Specific warnings, cautions, and notes appear with the relevant instructions in the manual. 26