RESMED VPAP (01) PDF MANUAL


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PDF Content Summary: VPAPTM Adapt POSITIVE AIRWAY PRESSURE DEVICE H5iTM HEATED HUMIDIFIER Clinical Guide English Contents Welcome .....................................................................................................1 VPAP Adapt indications for use ............................................................ 1 VPAP Adapt contraindications .............................................................. 1 VPAP Adapt adverse effects ................................................................. 1 H5i indications for use ..........................................................................1 H5i contraindications ............................................................................ 1 VPAP Adapt at a glance ................................................................................2 Traveling with the VPAP Adapt.............................................................. 2 H5i at a glance ............................................................................................. 3 Traveling with the H5i ...........................................................................3 Operating information .................................................................................. 4 Modes of operation .............................................................................. 4 Leak Management – Vsync ...............................................................4 EPAP and Pressure Support ................................................................. 4 VPAP Adapt features .................................................................................... 5 Climate Control .................................................................................... 5 Sleep quality ......................................................................................... 6 Sleep quality ......................................................................................... 6 Setup ............................................................................................................7 Mask and tubing setup .........................................................................8 Filling the water tub ..................................................................................... 9 VPAP Adapt basics ..................................................................................... 10 Navigating the menus ................................................................................ 11 About the menus ....................................................................................... 11 Home menu ....................................................................................... 11 Changing settings via the Home menu .................................... 12 S9 Essentials ............................................................................ 12 Viewing the treatment screens ................................................ 13 Treatment screen parameters .................................................. 14 Setup menu ........................................................................................ 15 Patient Setup menu ................................................................. 15 Clinical Setup menu ................................................................. 15 Clinical setup menu parameters ............................................... 16 Info menu ........................................................................................... 18 Standard Info menu ................................................................. 18 Advanced Info menu ................................................................ 19 Clinical Info menu .................................................................... 19 Info menu parameters.............................................................. 20 Managing Climate Control ......................................................................... 21 Delivering therapy ...................................................................................... 22 Adding supplemental oxygen ............................................................. 22 i English ii Data management ..................................................................................... 23 SD card ............................................................................................... 23 Removing the card ............................................................................. 23 Inserting the card ............................................................................... 23 Analyzing the SD card data ................................................................24 Data storage ....................................................................................... 24 Data transmission adapters and modules .......................................... 24 Cleaning and maintenance ......................................................................... 25 Disassembling the water tub .............................................................25 Daily cleaning ..................................................................................... 25 Weekly ..............................................................................................25 Monthly .............................................................................................. 26 Maintenance checklist ........................................................................ 26 Reassembling and filling the water tub .............................................. 26 Replacing the air filter.........................................................................27 Antibacterial filters ............................................................................. 27 Technical specifications .............................................................................. 28 General technical specifications ......................................................... 28 VPAP Adapt technical specifications ..................................................29 H5i technical specifications ................................................................ 30 Air tubing technical specifications ...................................................... 30 Humidifier performance ..................................................................... 30 Pneumatic flow path .......................................................................... 31 Flow (maximum) at set pressures ......................................................31 Displayed values ................................................................................. 32 Warnings and cautions ............................................................................... 33 WARNINGS ........................................................................................33 CAUTIONS ..........................................................................................33 Welcome Thank you for choosing the VPAP Adapt or H5i. Before operating these devices, please read the entire Clinical and Information Guides. CAUTION In the US, Federal law restricts this device to sale by or on the order of a physician. VPAP Adapt indications for use The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use. VPAP Adapt contraindications ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea. Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing conditions: • severe bullous lung disease • pneumothorax or pneumomediastinum • pathologically low blood pressure, particularly if associated with intravascular volume depletion • dehydration • cerebrospinal fluid leak, recent cranial surgery, or trauma. VPAP Adapt 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 these devices: • drying of the nose, mouth, or throat • nosebleed • bloating • ear or sinus discomfort • eye irritation • skin rashes. H5i indications for use The H5i is indicated for the humidification of the air delivered from a CPAP or bilevel device. The H5i is for use only as recommended by a physician. The H5i is intended for single patient re-use in the home environment and re-use in a hospital/institutional environment. H5i contraindications The H5i is contraindicated for use with patients whose upper (supraglottic) airway has been bypassed. 1 English 2 SD card slot Module/Adapter port Air outlet VPAP Adapt at a glance The VPAP Adapt system comprises the following elements: • VPAP Adapt device • Air tubing • 90W power supply unit • S9 travel bag • SD card • S9 SD card protective folder. Optional components include: • H5i heated humidifier • Standard air tubing • SlimlineTM air tubing • 3m air tubing • ClimateLineTM heated air tubing • ClimateLineMAX TM heated air tubing • 30W power supply unit (does not support H5i) • Power Station II battery pack • DC/DC Converter 24V/90W • S9 Oximeter Adapter. Traveling with the VPAP Adapt When the patient travels with the VPAP Adapt only: • Advise the patient to pack the SlimLine or Standard air tubing as the ClimateLine or ClimateLineMAX heated air tubing is not designed to connect directly to the VPAP Adapt device. • Advise the patient to purchase and travel with the approved power cord for the region where they will be using the VPAP Adapt device. • ResMed confirms that the VPAP Adapt meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21, category M) for all phases of air travel.

DC power inlet Air filter

H5i at a glance The H5i system comprises the following elements: • H5i heated humidifier • H5i standard water tub • ClimateLine heated air tubing (if sold as a Climate Control Kit). Optional components include: • ClimateLineMAX heated air tubing • H5i cleanable water tub. Traveling with the H5i When moving or traveling with the H5i: • Ensure that the water tub is empty. • Disconnect the H5i from the VPAP Adapt by pressing the release button.

Air outlet Flip lid Release button ClimateLine/ ClimateLineMAX connection port Flip lid sealH5i water tub Latch Latch 3 English

4 Operating information This VPAP Adapt device uses internal pressure and flow sensors in the air path to respond reliably to patient flow rates even in the presence of most normal leaks in the patient circuit. Modes of operation The following table describes the operating modes available on the VPAP Adapt. Mode VPAP Adapt CPAP mode Treats obstructive sleep apnea where a fixed pressure not greater than 20 treatment cm H2O session. is set. Therapy is delivered at this pressure for the duration of the ✓ ASV mode Treats central sleep apnea and/or mixed apneas and periodic breathing by automatically adjusting the pressure support (PS). In ASV mode, the expiratory positive airway pressure (EPAP) is adjusted by the clinician to maintain upper airway patency, while Min PS and Max PS restricts the range of automatically adjusted pressure support. ✓ Leak Management – Vsync Vsync monitors and compensates for leak by continuously and automatically adjusting the baseline flow. This enables reliable triggering and cycling while maintaining the set pressures. EPAP and Pressure Support (ASV mode) EPAP can be adjusted to maintain upper airway patency. Pressure Support (PS) is defined as the difference between the peak pressure at the end of inspiration, and the minimum pressure at the end of expiration (ie, the amplitude of the pressure waveform delivered). The pressure support trigger points (Inspiration:Expiration and Expiration:Inspiration) are set automatically based on measurement of the patient respiratory flow. ASV mode automatically adjusts pressure support between Max PS and Min PS to keep the patient’s respiratory flow even. ResMed recommends maximum pressure support to be greater than or equal to 10 cm. Normal effort resumes Pressure cm H2O Respiratory airflow Normal effort Increased ventilation in response to apnea 25650 EPAP + Max PS EPAP + Min PS EPAP

VPAP Adapt features Climate Control VPAP Adapt devices, when used in conjunction with the H5i and ClimateLine/ClimateLineMAX heated air tubing, offer a feature called Climate Control. Climate Control enables the automatic delivery of a constant value of absolute humidity to the patient’s upper airway while protecting against rainout and allowing patients to select the air temperature that offers the most comfort for them. Rainout protection Rainout refers to the water or condensation that collects in the patient’s tubing or mask. Rainout is a common side effect of using a humidifier due to the humidified air cooling as it travels down the tubing and into the mask. Rainout occurs when relative humidity, which is a measure of the air’s capacity to hold water vapour, exceeds 100%. Climate Control protects the patient from rainout by maintaining a target relative humidity of 80% as well as maintaining the temperature of the air delivered to the patient without compromising the amount of absolute humidity delivered. Automatic constant humidity delivery For each temperature setting, the Climate Control system delivers a constant amount of water vapour, or absolute humidity, to the patient’s upper airway. The following table shows the target absolute humidity value that will be delivered to the mask for a selection of temperature settings. Temperature delivered to the mask Target absolute humidity at the mask, Body Temperature Pressure Saturated (BTPS) 60oF (16oC) 10 mg/L 68oF (20oC) 12 mg/L 75oF (24oC) 16 mg/L 80oF (27oC) 19 mg/L 86oF (30oC) 22 mg/L Automatic constant temperature delivery The temperature sensor located at the mask end of the ClimateLine/ClimateLineMAX heated air tube enables the system to automatically control the temperature of the air delivered to the patient. This ensures the temperature of the air delivered to the patient does not fall below the set minimum temperature, therefore maximizing breathing comfort for the patient. Automatic adjustment The H5i and ClimateLine/ClimateLineMAX heated tubing are controlled by the Climate Control algorithm to deliver constant humidity and temperature outputs. The system adjusts automatically to changes in: • ambient room temperature and humidity values • flow due to pressure changes • flow due to mask or mouth leak. 5 English 6 S9 Essentials S9 Essentials is designed to make device interaction and menu navigation easier for patients. If enabled, S9 Essentials disables the Info and Setup functionality so that patients can simply start and stop therapy and adjust ramp, humidification and Climate Control. S9 Essentials can be enabled via Clinical Setup > Options > Access. Sleep quality Designed to promote compliance, the Sleep Quality indicator allows the patient to actively engage in their own therapy by identifying leak, usage and AHI information. This information can be set to: • Usage—where only usage hours are displayed • On—where usage, leak and AHI information are displayed. Setup 1. Align your H5i with your VPAP Adapt and push them together until they click into place. 2. Connect the DC plug of the power supply unit to the rear of the VPAP Adapt. 3. Connect the power cord to the power supply unit. 4. Plug the other end of the power cord into the power outlet. 5. Connect one end of the air tubing firmly onto the air outlet. 6. Connect the assembled mask system to the free end of air tubing. Notes: • Always ensure that your VPAP Adapt and H5i are placed on a stable, level surface for proper operation. • Place the power supply unit away from the H5i to allow for adequate ventilation. 7 English 8 Mask and tubing setup • For more information on assembling the mask see the mask user guide. • If your patient is using a full face mask ensure that the “Full Face” setting is selected. If your patient is using a nasal pillows mask ensure that the “Pillows” setting is selected. If your patient is using a nasal mask ensure that the “Nasal” setting is selected with the exception of the Ultra Mirage mask which should use the “Nasal Ultra” setting. • For a complete list of recommended masks and their settings go to resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative. • The VPAP Adapt device is compatible with the following tubing: Tube Specifications Settings ClimateLine Length: Inner diameter: Heated 6’6” (2 m) 0.6” (15 mm) Automatically detected ClimateLineMAX Length: Inner diameter: Heated 6’3” (1.9 m) 0.75” (19 mm) Automatically detected SlimLine Length: Inner diameter: If using the SlimLine, Standard or 3 m tubing, adjust the tube setting in the Patient Setup or Clinical Setup menus. Standard Length: Inner diameter: 6’ (1.8 m) 0.6” (15 mm) 6’6” (2 m) 0.75” (19 mm) 3 m Length: Inner diameter: 9’10” (3 m) 0.75” (19 mm) Note: When using the SlimLine or ClimateLine above may not be reached if used with an antibacterial filter. 20 The cm device H2O, performance the device optimum must be performance checked prior to prescribing the SlimLine for use with an antibacterial filter. Filling the water tub 1. Slide the latch and lift open the flip lid. 2. Remove the water tub. 3. Fill the water tub (through the center hole) with distilled or deionized water up to the maximum water level mark (12.5 fl oz / 380 mL). 4. Return the water tub to the H5i. 5. Close the flip lid ensuring that it clicks into place. 9 English 10 VPAP Adapt basics LCD screen* Displays the menus, treatment screens and reminders. Start/Stop button Starts or stops treatment. Setup menu button** Key: Allows you to make changes to settings or Home exit from the menu. Humidity level Ramp Push dial Heated tube Turning the dial allows you to Climate Control scroll through the menu and change settings. Start/Stop Power Save mode (hold for 3 sec) Pushing the dial allows you to enter into a menu and confirm Push Dial your choice. Setup menu Info menu Advanced Info menu (hold for 3 sec) Clinical Setup menu (hold for 3 sec) Info menu button** Allows you to view your sleep statistics or exit from the menu. * Backlight—When treatment is being delivered, the backlight (including the Start/Stop button) automatically turns off after 30 seconds, otherwise it turns off after 3 minutes. ** The Info and Setup menus are disabled if S9 Essentials is enabled. Navigating the menus In general, to navigate the menus: to confirm your choice. The screen returns to blue. About the menus There are three menus that are designed to help you choose your options. They are: 1. Home menu—for day to day adjustments. 2. Info menu—provides sleep quality information. 3. Setup menu—where settings can be adjusted. Home menu The Home menu shows you and your patient what features are currently activated, and the accessories that are connected to the device. 1. Turn until the parameter you require is displayed in blue. 2. Press . The selection is highlighted in orange. Ramp—displayed when the Max Ramp function is activated in the Clinical Setup menu. Humidity Level—displayed when the H5i is connected. Climate Control—displayed when both the H5i and the ClimateLine/ClimateLineMAX heated air tube are connected and when Climate Control is activated in the Clinical Setup menu. Humidity Level and Heated Tube—displayed when both the H5i and the ClimateLine/ClimateLineMAX heated air tube are connected and when Climate Control is set to Manual in the Clinical Setup menu. until 3. Turn you see the setting that you require. 4. Press 11 English 12 Changing settings via the Home menu From the home menu, you can adjust or check the following features: . S9 Essentials When S9 Essentials is enabled, the patient can simply start and stop therapy, access mask fit and adjust ramp, humidification and Climate Control. Ramp Designed to make the beginning of treatment more comfortable for the patient, ramp time is the period during which the pressure increases from an initial pressure to the prescribed treatment pressure or minimum treatment pressure. Humidity level The patient can adjust their humidity level at any time to find the setting that is most comfortable for them. Climate Control When the ClimateLine/ClimateLineMAX heated air tubing is connected and Climate Control is enabled, the patient can adjust the air temperature to find the setting that is most comfortable for them. When set to Auto, Climate Control prevents rainout by maintaining 80% relative humidity in the delivered air. If Climate Control is set to Manual, Humidity Level and Heated Tube temperature can be set independently. Mask-fit Mask-fit is designed to help patients fit the mask properly. The mask-fit feature delivers treatment pressure for a three-minute period, prior to starting treatment. During this time, the mask can be adjusted to minimize leaks. To use mask-fit: 1. Fit the mask as described in the mask user guide. 2. Press for at least three seconds. One of the MASK FIT screens is displayed (as shown on the left). 3. If necessary, adjust the mask, mask cushion and headgear until there is a secure and comfortable fit. After three minutes, the pressure reverts to the set pressure and treatment will begin. You can end mask-fit at any time by pressing Viewing the treatment screens Depending on how the system has been configured, you will see one of the following screens when the device is running:

✓ Oximetry data via the oximeter adapter ✓ Standard VPAP Adapt without optional accessories

In ASV mode, the fixed lines on the pressure bar indicate the minimum and maximum pressures. In CPAP mode, only the set pressure is shown.

✓ H5i humidifier ✓ H5i humidifier ✓ ClimateLine/ClimateLineMAX heated air tube ✓ Climate Control – Auto ✓ H5i humidifier ✓ ClimateLine/ClimateLineMAX heated air tube ✓ Climate Control – Manual 13 English

14 Treatment screen parameters Parameter Modes Description CPAP ASV Treatment screen CPAP ✓ Shows the fixed treatment pressure. ASV ✓ Shows the treatment pressures. Ramp ✓ Orange icon shows that device is ramping up. Oxygen saturation (SpO2)* ✓ ✓ Measure of the saturation of blood hemoglobin with oxygen, expressed as a percentage (sampled every second). Leak ✓ ✓ Estimate of the total rate of air escaping due to mouth and unintentional mask leaks, expressed in L/min (5-breath moving average). Minute Ventilation (MV) ✓ ✓ Volume of air breathed in, or out within any 60-second period, expressed in L/min (5-breath moving average). Target minute ventilation (TgMV) ✓ Minute ventilation the device is attempting to achieve. Pressure support increases if the minute ventilation falls below the target, and decreases if it goes above the target. Pulse* ✓ ✓ Number of heart beats in a 60-second time frame (sampled every second). Respiratory rate (RR) ✓ ✓ Frequency of breathing, expressed as the number of breaths per minute (5-breath moving average). Tidal volume (Vt) ✓ ✓ Volume of air inspired or expired in one respiratory cycle (breath), expressed in mL (5-breath moving average). Pressure support (PS) ✓ Difference between the peak pressure at the end of inspiration and the minimum pressure at the end of expiration. * Only available via the oximeter adapter. .

Setup menu The Setup menu consists of: • Patient Setup menu—allows the patient to optimize comfort settings as well as make changes to the mask or tube type. • Clinical Setup menu—allows the clinician to set all parameters pertaining to the patient’s therapy. Patient Setup menu Only settings relevant to the patient are displayed in the Patient Setup menu. Depending on how the device has been customized via the Clinical Setup menu, the following screens can be viewed: Clinical Setup menu To access the Clinical Setup menu, press and hold the Setup button and push dial for three seconds. There are four screens available from the Clinical Setup menu as shown in ASV mode below: + Tube—only displayed if ClimateLine/ClimateLineMAX is not connected. If ClimateLine/ClimateLineMAX is attached, no setting is required. Climate Ctrl—only displayed if ClimateLine/ClimateLineMAX is connected and also set to PATIENT in the Clinical Setup menu. Mask—always available. Mask Fit—always available. Leak Alert—only displayed if set to PATIENT in the Clinical Setup menu. SmartStart—only displayed if set to PATIENT in the Clinical Setup menu. Settings Displays parameters directly affecting the patient’s therapy. Note: Clinical menus are identified by the yellow open lock shown in the top right corner. Where further options exist on a screen, the blue scroll bar down the right of the screen indicates your position within these options. Options Displays parameters affecting the patient’s comfort, therapy feedback and compliance reporting. Reminders Displays parameters for accessories requiring replacement. Configuration Displays general device setting and resetting options. 15 English

16 Clinical setup menu parameters Parameter Modes Default Range Description CPAP ASV Settings Mode ✓ ✓ ASV CPAP / ASV Sets the therapy mode available on the device. EPAP ✓ 5 cm H2O 4–15 0.2 increments cm cm HH2O 2O, Sets the pressure which will be delivered to the patient when the device is cycled into expiration. Max PS ✓ 15 cm H2O 8–16 cm H2O Sets the maximum pressure support delivered by the device. Min PS ✓ 3 cm H2O 3–6 cm H2O Sets the minimum pressure support delivered by the device. Max Ramp ✓ 45 minutes Off–45 minutes, 5-minute increments Limits the ramp time the patient may select. Start Pressure ✓ 4 cm H2O 4–Set pressure, 0.2 increments cm H2O Sets the pressure at the start of ramp, up to fixed treatment pressure. Set pressure ✓ 8 cm H2O 4–20 0.2 increments cm cm H2HO 2O, Sets the fixed treatment pressure. Circuit Mask type ✓ ✓ Full Face Full Face / Nasal / Pillows / Nasal Ultra Sets the type of mask used by the patient. Tube type ✓ ✓ SlimLine [Standard]* SlimLine / Standard / 3m Sets the type of air tubing used by the patient. AB filter ✓ ✓ No No / Yes Enables or disables antibacterial filter. Options Climate Control ✓ ✓ Auto Auto / Manual / Patient Sets the type of Climate Control. Sleep quality ✓ ✓ Usage [On]* On / Usage Sets Sleep Quality to Usage or On. SmartStart ✓ ✓ Off [On]* On / Off / Patient Enables or disables the SmartStart feature. Leak Alert ✓ ✓ Off Off / On Enables or disables the Leak Alert feature; when enabled, leaks >40L/min (0.7 L/s) for >20 sec result in an audible alert and a high leak message on the LCD. Also functions as a mask-off alert. *[Asia Pacific]

Parameter Modes Default Range Description CPAP ASV Access ✓ ✓ Full Full / Limited Enables or disables S9 Essentials—If set to Limited, the Info and Setup menu buttons are disabled. This means that the patient can simply start or stop therapy and adjust ramp, humidification or Climate Control. Combined button presses remain enabled. Date ✓ ✓ DD Mmm YYYY Sets the current date or time. If you set a new date or time that Time ✓ ✓ 00:00 (24 hr) occurs in the past then an ‘Invalid date/time, data exists for this period’ message is displayed. Before this change can be made, erase the compliance data – available under the Configuration menu. Reminders Mask ✓ ✓ 6 [12]* Seven-day increments (starting from the current set date) with a recurrence period of one to 24 months. A timed reminder to remind a patient when they need to replace their mask. Water tub ✓ ✓ 6 [Off]* A timed reminder to remind a patient when they need to replace their water tub. Tube ✓ ✓ 6 [Off]* A timed reminder to remind a patient when they need to replace their tubing. Filter ✓ ✓ 6 A timed reminder to remind a patient when to replace the air filter. SD card ✓ ✓ Off A timed reminder to remind a patient that they need to remove their SD card and return it to you, enabling you to establish compliance. Service ✓ ✓ Off [24]* A timed reminder to remind a patient when to return the device for service. Customised messages (Custom 1, Custom 2) ✓ ✓ Off Customised reminders, eg, to return equipment or to phone a particular person or number. Custom reminder text can be up to 16 characters long, via a PC application. See your PC application manual for more information. *[Asia Pacific] 17 English

18 Parameter Modes Default Range Description CPAP ASV Configuration Language ✓ ✓ English English / Français / Español / Português 简体中文 / 繁體中文 Sets the display language. Note: Not all languages are available in all regions. Restore factory defaults ✓ ✓ Yes / No Resets machine default settings (except for language, date and time). Erase data ✓ ✓ Yes / No Allows the clinician to erase all data stored in the unit and SD card (except for machine hours). Settings, date and time are not affected. Temperature units ✓ ✓ oF [oC]* oF / oC Sets temperature units. *[Asia Pacific] Reminder menu You can access reminders from the Clinical Menu > Options. From the REMINDERS screen, scroll down to the submenus to set a number of different types of messages. You can use the Reminder menu to alert a patient to specific events, such as when to replace their mask (shown on the left) or when to insert an SD card. When a reminder is due, a message is displayed on the LCD and remains while 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 will be displayed. Patients can clear each message by pressing any key (except the Start/Stop button). For a list of each of the reminders available and their default settings, see the table on the previous page. Info menu Designed to provide you with information about compliance, therapy and settings, the Info menu consists of: Standard Info menu; and Advanced Info menu. Standard Info menu From the Standard Info menu, patients can check their sleep quality, sleep report and service information. Sleep Quality—On When Sleep Quality is set to On (via Setup > Clinical Setup > Options), data on previous usage (up to 365 days of data), mask-fit and AHI can be viewed. Advanced Info menu +

To access the Advanced Info menu, press and hold the Info and Setup buttons for three seconds. This menu provides additional settings and sleep report information. Usage, Mask Fit and AHI are always displayed even when Sleep Quality is set to Usage. Clinical Info menu Accessed from the Clinical Setup menu, the Clinical Info menu provides the same screens as shown on the Advanced Info menu on the previous page but with lighter green background and with the unlock symbol. Sleep Quality—Usage When Sleep Quality is set to Usage, only the data on previous usage is displayed. Sleep Report For Sleep Report, only the period can be changed—other values are for display only. Service For Service information, the device run hours and software identifications are displayed 19 English 20 Info menu parameters Parameter Description Sleep Quality Displays the following information on last night’s usage, mask fit and AHI data. Period Time period displayed as Last night (last session). Usage Number of hours the device has been used during the last session. Mask Fit Indicates ‘Good’ if the 70th percentile leak is less than 24 L/min. AHI Apneas and hypopneas measured per hour for one day. An apnea is when the respiratory flow decreases by more than 75% for at least 10 sec. A hypopnea is when the respiratory flow decreases to 50% for at least 10 sec. The Apnea Index (AI) and Apnea Hypopnea Index (AHI) are calculated by dividing the total number of events that occurred by the total mask-on therapy period in hours. Sleep Report Displays additional therapy settings and compliance information (eg, Days used, Used Hrs). Period Sets time periods to a day, week, month (1, 3 or 6) and year to display available data. This period is the only parameter you can change in the Sleep Report—other parameters are for display only. Days Used Number of days the device has been used during the selected period or since the last compliance data was reset. Days>4hrs Number of days the device has been used for more than 4 hours during the selected period or since the last compliance data was reset. Avg. usage Average number of hours per day the device has been used during the selected period. Used Hrs Number of hours the device has been used during the selected period or since the last compliance data reset. Insp. pressure Average inspiratory pressure during the selected period (95th percentile for each day; average of the 95th percentile values for periods >1 day). Exp. pressure Average expiratory pressure during the selected period (95th percentile for each day; average of the 95th percentile values for periods >1 day). Leak Average of the 95th percentile values of leak during the selected period for days with usage only. Vt Average of the 50th percentile values of tidal volume during the selected period for days with usage only. RR Average of the 50th percentile values of respiratory rate during the selected period for days with usage only. MV Average of the 50th percentile values of minute ventilation during the selected period for days with usage only. AHI* Apnea-Hypopnea Index—average AHI during the selected period. AHI and AI are calculated for times of low leak only. Total AI* Apnea Index—average total AI during the selected period. *Central sleep apnea detection (CSAD) is not active in ASV mode. The ASV algorithm eliminates central apneas, provided the EPAP is sufficient to maintain an open airway. Therefore, any apneas reported by the device will be obstructive or indicative of a closed airway. Parameter Description View settings Displays parameter settings depending on therapy mode. Note: This screen displays the settings and options from the Clinical Setup menu. Service Displays the device run hours, software version and other component versions. Run hours Displays the total number of hours the device has been used including warm-up and cool-down times for the humidifier. It is not affected by the period selected. This is the only data item that is not reset when data is erased. SW Displays the current software version. BID Displays the boot loader ID. VID Displays the variant ID. RID Displays the regional variant ID. HID Displays the humidifier software ID. Managing Climate Control Designed to be ideal for most patients, Climate Control Auto enables the automatic delivery of a constant value of absolute humidity while protecting against rainout. To allow for increased flexibility, Climate Control can be turned to Manual in either the Patient Setup (when enabled) or the Clinical Setup menus. Setting Climate Control to Manual disables the automatic control of humidity and allows the patient to set humidity and temperature levels independently. However, rainout protection is not provided when Climate Control is set to manual. Mode Humidity Temperature Setting range Default settings Setting range Default settings Climate Control – Auto Humidity level Heated tube Off–6.0 (0.5 increments) 3 Off, 60oF–86oF (16oC–30oC) 80oF (27oC) * When the temperature setting is set to Off the tube will not heat the air, nor will the humidifier heat the water to add humidity to the air. 80oF (27oC) Climate Control – Manual Climate Control Constant absolute humidity (depending on temperature setting) – Off*, 60oF–86oF (16oC–30oC) 21 English 22 Delivering therapy Before initiating treatment with a VPAP Adapt, it is recommended that blood pressure is measured in all heart failure patients. In rare cases, blood pressure may fall on initiating positive air pressure treatment. Check the patient’s blood pressure before, during and after 10 minutes of therapy. 1. Make sure the power is connected. 2. Adjust the ramp time or humidification level if required. 3. Instruct the patient to fit their mask as described in the mask user guide. 4. To start therapy, instruct the patient to breathe into the mask and/or press . 5. Instruct the patient to lie down and arrange the air tubing so that it is free to move if they turn in their sleep. 6. To stop treatment at any time, instruct the patient to remove the mask and/or press If you enable SmartStart, the patient’s device will start automatically when the patient breathes into the mask and stop automatically when they remove their mask. Once therapy has started the treatment screen is displayed. In order to assist the heater plate in cooling, your VPAP Adapt device will continue to blow air for up to an hour after treatment has stopped. However, you can unplug the device from the power outlet at any time and allow the heater plate to cool without air flow, or press to enable Power Save mode. Note: If power is interrupted during treatment, the device automatically restarts therapy when power is restored. Adding supplemental oxygen Your VPAP Adapt device is designed to be compatible with up to 15 L/min of supplemental oxygen. At a fixed 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. Notes: • Adding oxygen may affect the delivered pressure, and the accuracy of the displayed leak and minute ventilation. • Before adding oxygen, familiarize yourself and your patient with the specific warnings relating to the use of supplemental oxygen. These can be found at the end of this guide. . all t.he o an ime is the ute he Data management The SD card may be used to monitor patient usage as well as treatment pressure, mask leak, and incidence of apneas and hypopneas. To assess the patient’s progress, data for the last session may be compared to values for the last week, the last month, the last three months, the last six months, and the last year. The device stores usage and summary data for up to 365 sessions. SD card The SD card allows VPAP Adapt devices to capture data. The VPAP Adapt Series comes with the SD card already inserted and ready to be used. Compliance data is also stored on the device, so if the card is lost, the data is not. You can also create new treatment settings and transfer them to the patient’s device via the SD card. VPAP Adapt device settings are written to the SD card. This allows a ResMed PC application to display actual device settings from the SD card instead of the default values. Removing the card Before removing the card, instruct the patient to disconnect the VPAP Adapt device from the power outlet. To remove the card, instruct the patient to: 2. 1. Push in the SD Remove the card to release card. it. 4. Send the protective folder back to you as instructed. Inserting the card 1. Remove the card from the protective folder. 2. Push the card into the VPAP Adapt device until it clicks. 3. The following message is briefly displayed: Reading SD card Notes: • For more information on removing and inserting the card refer to the S9 SD Card Protective Folder provided with the device. • Ask the patient to retain the S9 SD Card Protective Folder for future use. 3. Insert the card into the protective folder. 23 English 24 Analyzing the SD card data To analyze the data, use a ResMed PC application to transfer data and settings between a VPAP Adapt or an SD card and your personal computer. Refer to your PC application guide for more information about analyzing the information on returned SD cards. Data storage Designed to make data more easily available, the S9 SD card gives clinicians greater insight to patient therapy by making high resolution and detailed data available on the device. The amount of data stored on the SD card varies compared to the data stored on the device. Type of data VPAP Adapt device SD card Sampling rate Compliance and therapy summary and statistic 365 nights 365 nights data* Detailed data – 30 nights Apnea or hypopnea events (sec) Aperiodic Flow limitation (flat to round) 1/2 Hz Leak (L/sec) 1/2 Hz Minute ventilation (L/min) 1/2 Hz Pressure (cm H2O) 1/2 Hz Pulse rate (beats/min)** 1 Hz Snore (quiet to loud) 1/2 Hz Oxygen saturation (SpO2) (%)** 1 Hz High resolution flow and pressure data – 7 nights 25 Hz * The pressure and leak samples used to calculate the statistics data are averages over a one minute period. ** Information only available via the oximeter adapter. Data transmission adapters and modules The following data transmission adapters and modules are designed for use with VPAP Adapt devices. Note: For more information on setting up your S9 adapter or module refer to the relevant S9 adapter or module user guide. Device Method Description Type of data transferred Oximeter adapter Enables collection of oximetry data from an oximeter for storing data on the SD card inserted into the device. Oximetry data (oxygen saturation and pulse rate) Cleaning and maintenance You should regularly clean and maintain your device as described in this section. Disassembling the water tub 1. Slide the latch. 2. Lift open the flip lid. 3. Remove the water tub. 4. Discard any excess water from the water tub. 5. Unclip all four side latches. 6. Pull apart the tub lid and base. 1 2 3 4 5 6 Daily cleaning 1. Remove the air tubing by pulling the finger grips off the cuff. Hang it in a clean, dry place until next use. 2. Wash the disassembled tub lid and base in warm water using a mild detergent. 3. Rinse thoroughly in clean water and allow them to dry away from direct sunlight. Notes: • Do not hang the air tubing in direct sunlight as it may harden over time and eventually crack. • Do not wash the air tubing in a washing machine or dishwasher. Weekly 1. Remove the air tubing from the VPAP Adapt device 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. 25 English

26 Monthly 1. Wipe the exterior of the VPAP Adapt and H5i with a damp cloth and mild detergent. 2. Check the air filter for holes and blockage by dirt or dust. 3. Peel the flip lid seal from the flip lid and wash it in warm water using a mild detergent. Maintenance checklist ✓ Inspect the H5i water tub and flip lid seal for wear and deterioration. ✓ Replace the water tub if any component is leaking or has become cracked, cloudy or pitted. ✓ Replace the flip lid seal if cracked or torn. ✓ Clean white powder deposits in the water tub by using a solution of one part household vinegar to 10 parts water. Reassembling and filling the water tub 1. Place the tub lid back onto the base. 2. Clip all four side latches. 3. Fill the water tub with distilled or deionized water up to the maximum water level mark. Air 4. Return the water tub to the H5i. 5. Close the flip lid ensuring that it clicks into place. Ai

Replacing the air filter Replace the air filter every six months (or more often if necessary). 1. Remove the air filter cover from the back of the VPAP Adapt device. 2. Remove and discard the old filter. 3. Insert a new ResMed air filter ensuring that it is sitting flat in the air filter cover. 4. Replace the air filter cover. Notes: • Ensure the air filter and air filter cover are fitted at all times. • Do not wash the air filter. The air filter is not washable or reusable. Air filter cover Air filter The following filters are available for use with VPAP Adapt devices: Filter Efficiency Standard (ASMB 160) 88% at 7 micron Hypo-allergenic (Air Safety Electret100 – electrostatic filter) 89.8% at 0.5 micron, bacterial efficiency of 99.54%. Antibacterial filters Antibacterial filters increase resistance in the air circuit and may affect accuracy of displayed and delivered pressure, particularly at high flows. ResMed recommends using a filter with a low impedance (eg, less than 2 cm H2O at 60 L/min). 27 English 28 Technical specifications General technical specifications Power supply 90W power supply unit Input range: 100–240V; 50–60Hz; 115V, 400Hz nominal for aircraft use Typical power consumption: 70W (80VA) Maximum power consumption: 110W (120VA) 30W power supply unit Input range: 100–240V; 50–60Hz; 115V, 400Hz nominal for aircraft use Typical power consumption: 20W (40VA) Maximum power consumption: 36W (75VA) 90W DC/DC converter Nominal inputs: 12V, 24V Typical power consumption: 70W Maximum power consumption: 110W

Environmental conditions Operating temperature: +41oF to +95oF (+5oC to +35oC) Note: The airflow for breathing produced by this therapy device can be higher than the temperature of the room. Under extreme ambient temperature conditions (104oF/40oC) the device remains safe. Operating humidity:10–95% non-condensing Operating altitude: Sea level to 8,500’ (2,591 m) Storage and transport temperature: -4oF to +140oF (-20oC to +60oC) Storage and transport humidity: 10–95% non-condensing Electromagnetic compatibility Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2:2007, for residential, commercial, and light industry environments. It is recommended that mobile communication devices are kept at least 1 m away from the device. Information regarding the electromagnetic emissions and immunity of these ResMed devices can be found on resmed.com, on the Products page under Service and Support. Click on the PDF file for your language.

Aircraft use ResMed confirms that the VPAP Adapt meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21, category M) for all phases of air travel.

IEC 60601-1 classification Class II (double insulation), Type BF Measuring and display devices Pressure sensor: Internally located at device outlet, analog gauge pressure type, -5 to +45 cm H2O Flow sensor: Internally located at device inlet, digital mass flow type, -70 to +200 L/min

VPAP Adapt technical specifications Pressure and flow state Operating cm H2O (ASV) pressure range (measured at the mask): 4–20 cm H2O (CPAP); 4–25 Maximum single fault for > 6 sec; 40 cm H2O - steady if pressure state exceeded pressure: for 30 >1 cm sec H2O - if pressure exceeded Mode reading CPAP mode Set pressure: 4 to 20 cm H2O ASV mode EPAP: 4 to 15 cm H2O; Max PS: 8 to 16 cm H2O; Min PS: 3 to 6 cm H2O Sound: DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871:1996 Sound pressure level (CPAP mode) with SlimLine tube: 26 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 with Standard tube: 27 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 with either SlimLine tube or Standard tube and H5i: 28 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 Sound power level (CPAP mode) with SlimLine tube: 34 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 with Standard tube: 35 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 with either SlimLine tube or Standard tube and H5i: 36 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 Physical Dimensions (L x W x H): 6.0” x 5.5” x 3.4” (153 mm x 140 mm x 86 mm) Weight: 1.84 lb (835 g) Housing construction: Flame retardant engineering thermoplastic Air outlet: 22 mm conical air outlet (complies with ISO 5356-1:2004) Air filter Standard: Polyester non-woven fiber Hypoallergenic: Acrylic and polypropylene fibers in a polypropylene carrier Supplemental oxygen Recommended maximum supplemental oxygen flow: 15 L/min 29 English

30 H5i technical specifications Temperature Maximum heater plate temperature: 150°F (65°C) Temperature cut-out: 165°F (74°C) Maximum gas temperature at mask: ≤ 106°F (≤ 41°C) Physical Dimensions (L x W x H): 6.0” x 5.7” x 3.4” (153 mm x 145 mm x 86 mm) Weight (standard water tub): Docking station and unfilled water tub 1.52 lb (690 g) Weight (cleanable water tub): Docking station and unfilled water tub 1.74 lb (790 g) Water capacity: To maximum fill line 380 mL Material Docking station: Flame retardant engineering thermoplastic, aluminium Cleanable water tub: Injection molded plastic, stainless steel and silicone seal Standard water tub: Injection molded plastic, aluminium and elastomer seal Air tubing technical specifications Air tubing Length Inner diameter Material ClimateLine 6’6” (2.0 m) 0.6” (15 mm) Flexible plastic and electrical components ClimateLineMAX 6’3” (1.9 m) 0.75” (19 mm) Flexible plastic and electrical components SlimLine 6’ (1.8 m) 0.6” (15 mm) Flexible plastic Standard 6’6” (2.0 m) 0.75” (19 mm) Flexible plastic 3m 9’10” (3.0 m) 0.75” (19 mm) Flexible plastic Heated tubing temperature cut-out: ≤ 106°F (≤ 41°C) Notes: • The manufacturer reserves the right to change these specifications without notice. • The temperature and relative humidity settings displayed for Climate Control are not measured values. • Check with the service provider before using the SlimLine air tubing with devices other than the S9 or H5i. • The electrical connector end of the heated air tubing is only compatible with the H5i air outlet and should not be fitted to the device or mask. Humidifier performance The following settings have been tested at 71.6°F (22°C) ambient temperature: CPAP mask pressure cm H2O RH output % Setting 3 Setting 6 Nominal system output AH1, BTPS2 Setting 3 Setting 6 4 90 100 10 18 10 95 100 11.5 21 20 95 100 11 18 25 100 100 12 13.5 1 AH - Absolute Humidity in mg/L. 2 BTPS - Body Temperature Pressure Saturated.

Pneumatic flow path VPAP Adapt H5i Mask Inlet filter Blower Tube Flow (maximum) at set pressures The following are measured at the end of the specified tubing: Pressure cm H2O VPAP and VPAP, H5i and VPAP and VPAP, H5i and Standard air tube Standard air SlimLine air tube, ClimateLine L/min tube, L/min heated air tube, L/min L/min 4 200 170 195 170 8 200 170 190 170 12 200 170 184 170 16 200 170 175 170 20 190 170 168 161 25 180 161 144 125 31 English

32 Displayed values Value Range Display resolution Pressure sensor at air outlet Mask pressure 4–20 4–25 cm cm HH22O O (CPAP); (ASV) 0.1 cm H2O Flow derived values Leak 0–200 L/min 1 L/min Tidal volume 0–4000 mL 1 mL Respiratory rate 0–50 BPM 1 BPM Minute ventilation 0–30 L/min 0.1 L/min Value Accuracy1 Pressure measurement1 Mask pressure ±0.5 cm H2O (+ 4% of measured value) Flow derived measurements1 Leak2 ±12 L/min or 20% of reading, whichever is greater, at 0 to 60 L/min Tidal volume2,3 ±20% Respiratory rate2,3 ±1.0 BPM Minute ventilation2,3 ±20% 1 Results are expressed at ATPD (Ambient Temperature and Pressure, Dry) 2 Accuracy may be reduced by the presence of leaks, supplemental oxygen, tidal volumes <100 mL or minute ventilation <3 L/min. 3 Measurement accuracy verified as per ISO 10651-6:2004 for Home Care Ventilatory Support Devices (Figure 101 and Table 101) using nominal ResMed mask vent flows.

Warnings and cautions WARNINGS • Read the entire manual before using the device. • Before putting patients on ASV, each patient should be assessed for heart failure. In case of signs and symptoms of heart failure an objective assessment of LVEF should be performed. • Use the device only as directed by your physician or healthcare provider. • Use the device only for the intended use as described in this manual. Advice contained in this manual should not supersede instructions given by the prescribing physician. • If you notice any unexplained changes in the performance of the device, if it is making unusual or harsh sounds, if the device or the power supply are dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, discontinue use and contact your ResMed Service Center. • Beware of electrocution. Do not immerse the device, humidifier, power supply or power cord in water. In the event of a spill, disconnect the device from the power supply and let the parts dry. Always unplug the device before cleaning and make sure that all parts are dry before plugging in the device. • Explosion hazard—do not use in the vicinity of flammable anesthetics. • Make sure the power cord and plug are in good condition and the equipment is not damaged. • Keep the power cord away from hot surfaces. • The device should only be used with masks (and connectors1) recommended by ResMed, or by a physician or respiratory therapist. A mask should not be used unless the device is turned on. Once the mask is fitted, ensure that the device is blowing air. The vent hole or holes associated with the mask should never be blocked. Explanation: The device 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 or bilevel devices. • Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an open flame. • Always ensure that the device is turned on and airflow generated before the oxygen supply is turned on. Always turn the oxygen supply off before the device is turned off, so that unused oxygen does not accumulate within the device enclosure and create a risk of fire. • Do not operate the H5i if it is not working properly or if any part of the device or H5i has been dropped or damaged. • Do not leave long lengths of air tubing around the top of the patient’s bed. It could twist around the patient’s head or neck while they are sleeping. • Do not use electrically conductive or antistatic air tubings. • Do not use the air tubing if there are any visible signs of damage. • Only ResMed air tubing and accessories should be used with the device. A different type of air tubing or accessory may alter the pressure you actually receive, reducing the effectiveness of the treatment. • Only use the ResMed 90W or 30W power supply unit. Use the 90W power supply unit to power the system comprising the device, H5i, air tubing, DC/DC converter and battery pack. The 30W power supply unit is designed to power the device only and recommended for traveling. • Only ResMed products are designed to be connected to the module connector port. Connecting other devices could damage the device. • Blocking the air tubing and/or air inlet of the device while in operation could lead to overheating of the device. CAUTIONS • Do not open the device enclosure. There are no user serviceable parts inside. Repairs and servicing should only be performed by an authorised ResMed service agent. • Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturising or antibacterial soaps or scented oils to clean the device, humidifier or air tubing. These solutions may cause damage and reduce the life of these products. 1 Ports may be incorporated into the mask or in connectors that are near the mask. 33 English 34 • Incorrect system setup may result in incorrect mask pressure reading. Ensure the system is correctly set up. • Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord. • Make sure the area around the device is dry and clean and clear of bedding, clothes or other objects that could block the air inlet or cover the power supply unit. • Ensure that the device is protected against water if used outdoors. Enclose the device in the S9 travel bag for transport. • The H5i should only be used with tubing or accessories recommended by ResMed. Connection of other delivery tubes or accessories could result in injury, or damage to the device. • Do not open the H5i enclosure. There are no user serviceable parts inside. Repairs and servicing should only be performed by an authorised ResMed service agent. • Do not overfill the water tub as water may enter the device and air tubing. • Do not use any additives (eg, scented oils and perfumes). These may reduce the humidification output of the H5i and/or cause deterioration of the water tub materials. • Take care when handling the H5i as the water/water tub may be hot. Allow 10 minutes for the heater plate and any excess water to cool. • The H5i should only be connected or disconnected when the water tub is empty. • Make sure that the water tub is empty before transporting the H5i. • Do not operate the H5i on an aircraft as water may enter the device and air tubing during turbulence. • Always place the H5i on a level surface below the level of the user to prevent the mask and tubing from filling with water. • If liquids are inadvertently spilled into or on the H5i, unplug the device from the power outlet. Disconnect the H5i from the device and allow it to drain and dry before re-using. 3681064/2 2018-05 S9 VPAP Adapt H5i CLINICAL AMER ENG Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. See resmed.com for other ResMed locations worldwide. S9, H5i, ClimateLine, SlimLine, SmartStart, TiControl and VPAP are trademarks of ResMed Ltd. S9, ClimateLine, SlimLine, SmartStart and VPAP are registered in U.S. Patent and Trademark Office. © 2018 ResMed Ltd. Global leaders in sleep and respiratory medicine resmed.com


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