S9 VPAP™ Tx POSITIVE AIRWAY PRESSURE THERAPY DEVICE Clinical Guide English
S9 VPAP™ Tx POSITIVE AIRWAY PRESSURE THERAPY DEVICE Clinical Guide English
Contents General warnings and cautions...............................................................1 Welcome ................................................................................................2 S9 VPAP Tx indications for use........................................................2 S9 VPAP Tx contraindications..........................................................2 S9 VPAP Tx adverse effects.............................................................2 S9 VPAP Tx at a glance................
General warnings and cautions WARNINGS •• Read the entire manual before using the device. •• Use the device only as directed by the 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 physician.
Welcome The S9 VPAP Tx provides continuous positive airway pressure (CPAP) and bilevel therapy. The S9 VPAP Tx is a component of the S9 VPAP Tx Lab System. The S9 VPAP Tx Lab System provides remote PC control of a positive airway pressure therapy device (therapy device) capable of delivering multiple therapy modes. The system comprises: 1. S9 VPAP Tx or other compatible ResMed therapy device 2. Tx Link connection module 3. EasyCare Tx titration software.
S9 VPAP Tx at a glance Module/Adapter port DC power inlet Air filter Air outlet The S9 VPAP Tx system comprises the following elements: •• S9 VPAP Tx device •• H5i heated humidifier •• ClimateLine™ heated air tubing •• 90W power supply unit •• S9 travel bag •• S9 USB Adapter. Optional components include: •• Standard air tubing •• SlimLine™ air tubing •• ClimateLineMAX ™ heated air tubing •• 3 m air tubing •• Antibacterial filter.
Masks Mask systems recommended for use with the S9 VPAP Tx can be found at www.resmed.com. For information on using a mask refer to the mask user guide. For a complete list of recommended masks and their settings go to www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative. CAUTION Non-vented masks should not be used with the device. Supplemental oxygen Supplemental oxygen can be used with the S9 VPAP Tx.
Therapy modes The following table describes the therapy modes available on the S9 VPAP Tx. Therapy mode Description CPAP (Continuous Positive Airway Pressure) Delivers a fixed pressure with optional Expiratory Pressure Relief (EPR). EPR can improve patient comfort. AutoSet Delivers CPAP therapy with optional Expiratory Pressure Relief (EPR). Automatically adjusts the CPAP pressure in response to snore, flow limited breaths and apneas.
S9 VPAP Tx basics Info menu button LCD screen Start/Stop button Setup menu button Alarm mute button Alarm and therapy LEDs Push dial 6 Key Function Start/Stop button Starts or stops treatment. Power Save mode—hold for three seconds. Info menu button Allows you to view the device service information or to exit from the menu. Setup menu button Allows you to make changes to settings or to exit from the menu. Push dial Turning the dial allows you to scroll through the menu and change settings.
Setting up the S9 VPAP Tx Module/Adaptor Port 4 To Tx Link 5 6 8 1 3 7 2 WARNING •• 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. •• 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.
5. Connect the S9 VPAP Tx to the Tx Link via USB serial cable. 6. Plug the other end of the power cord into the power outlet. 7. Connect one end of the air tubing firmly onto the air outlet. 8. Connect the assembled mask system to the free end of air tubing. The S9 VPAP Tx does not use the SD Card function to store data. All necessary data is transferred via Tx Link and available through the EasyCare Tx software.
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.
Mask and air tubing settings Use the following settings below for each mask type: Mask type Settings Full Face Full Face Pillows Pillows Nasal Nasal (for Ultra Mirage mask, use ‘Nasal Ultra’) Pediatric Pediatric Notes: •• For more information on assembling the mask see the mask user guide. •• For a complete list of recommended masks and their settings go to www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative.
Navigating the menus In general, to navigate the menus: 1. Turn until the parameter you require is displayed in blue. . 2. Press The selection is highlighted in orange. 3. Turn until you see the setting that you require. 4. Press 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. These are: 1. Home menu—for day to day adjustments. 2. Setup menu—where settings can be adjusted. 3.
Changing settings via the Home menu From the Home menu, you can adjust or check the following features: Humidity level Humidity levels can be adjusted at any time to find the setting that is most comfortable for the patient. Climate Control When the ClimateLine or ClimateLineMAX heated air tubing is connected and Climate Control is enabled, the air temperature can be adjusted to find the setting that is most comfortable for the patient.
Viewing the treatment screens Depending on how the system has been configured and what mode has been selected, you will see one of the following example screens (shown in iVAPS mode below) when the device is running: 99 H5i humidifier 99 H5i humidifier 99 ClimateLine/ClimateLineMAX 99 Climate Control – Auto 99 H5i humidifier 99 ClimateLine/ClimateLineMAX 99 Climate Control – Manual 99 Therapy data To toggle between the treatment screens, press 99 Treatment with device trigger (Timed) and cycle (Timed,
Treatment screen parameters ASVAuto Leak ü ü ü ü ü ü ü ü ü ü 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) ü ü ü ü ü ü ü ü ü ü Volume of air breathed in, or out within any 60-second period, expressed in L/min (5-breath moving average). Target Minute Ventilation (TgMv) ü ü Minute ventilation the device is attempting to achieve.
Setup menu The Setup menu allows set up of all parameters pertaining to the patient’s therapy. Setup menu access To access Setup menu, press the Setup button. There are three screens available from the Setup menu as shown in iVAPS mode below: Settings Displays parameters directly affecting the patient’s therapy. Options Displays parameters affecting the patient’s comfort. Configuration Displays general device setting and resetting options.
Clinical setup menu parameters* Description ASVAuto ASV iVAPS Range PAC T ST S VAuto AutoSet Modes CPAP Parameter Settings Circuit Mask type ü ü ü ü ü ü ü ü ü ü Full Face / Nasal / Pillows / Nasal Ultra / Pediatric Default: Full Face Selects the type of mask used by the patient. Tube type ü ü ü ü ü ü ü ü ü ü SlimLine / Standard / 3 m Default: Standard Shows the type of air tubing used by the patient.
EPAP ü ü ü ü ü ü Range Description 3–25 cm H2O** Default: 4 cm H2O Sets the pressure which will be delivered to the patient when the device is cycled into expiration. Dependent on IPAP. ASVAuto ASV iVAPS PAC T ST S VAuto AutoSet Modes CPAP Parameter Min PS ü ü ü 0–20 cm H2O Default: 4 cm H2O Minimum pressure support in iVAPS mode. Dependent on EPAP. Max PS ü ü ü 0–28 cm H2O Default: 20 cm H2O Maximum pressure support in iVAPS mode. Dependent on EPAP and Min PS.
EasyBreathe (US Only) ü Range Description On / Off Default: On Enables Easy-Breathe comfort feature. ASVAuto ASV iVAPS PAC T ST S VAuto AutoSet Modes CPAP Parameter Max Pressure ü Min–20 cm H2O, 0.2 cm H2O increments Default: 20 cm H2O Sets the upper limit of treatment pressure. Min Pressure ü 4–Max cm H2O, 0.2 cm H2O increments Default: 4 cm H2O Sets the lower limit of treatment pressure. Min EPAP ü 4–15 cm H2O Default: 4 cm H2O Sets the minimum EPAP delivered by the device.
Info menu Service Displays the device run hours, software version and other component versions. Parameter Description Run hours Displays the total number of hours the device has been used including warm-up and cool-down times for the humidifier. SW Displays the current software version. BID Displays the boot loader ID. VID Displays the variant ID. AID Displays the alarm software 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 the Setup menu. Setting Climate Control to Manual disables the automatic control of humidity and allows humidity and temperature levels to be set independently.
Delivering therapy WARNING Blocking the air tubing and/or air inlet of the device while in operation could lead to overheating of the device. CAUTION 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. The following procedure describes the steps required to start therapy at the patient’s bedside using the S9 VPAP Tx.
Adding supplemental oxygen WARNING •• Explosion hazard—do not use in the vicinity of flammable anesthetics. •• 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.
Cleaning and maintenance Regular cleaning should be carried out on the S9 VPAP Tx. Clean the exterior of the device with a damp cloth and mild detergent. Reprocessing the H5i and air tubing between patients The H5i and air tubing should be reprocessed when used between patients. Cleaning and disinfection instructions are available from the ResMed website, www.resmed.com under Products and Service & Support. If you do not have internet access, please contact your ResMed representative.
Working with alarms The S9 VPAP Tx is fitted with an alarm module that continuously monitors both therapy and device conditions. Alarms are only activated when therapy is running. An alarm condition can be indicated by an audible sound, a flashing yellow LED or a message on the screen. Note: The alarms should be tested after final system setup to ensure the alarms work as required. Alarms menu The alarms pre-set for the device are: •• Power fail •• Blocked tube* •• System fault (system error).
Troubleshooting If there is a problem, try the following suggestions. If the problem cannot be solved, contact your equipment supplier or ResMed. Do not attempt to open the device. Problem/Possible cause Solution No display Power is not connected. Ensure the power cord is connected and the power outlet (if available) is on. The DC plug is partially inserted into the back of the device or inserted too slowly. Fully insert the DC plug. The S9 VPAP Tx and H5i are not connected correctly.
Problem/Possible cause Solution Air filter is blocked. Replace your air filter. Disconnect the power cord and then reconnect it to restart the device. Air tubing is blocked. Check your air tubing and remove any blockages. Disconnect the power cord and then reconnect it to restart the device. Humidity level setting is too high, resulting in accumulation of water in the air tubing. Turn the humidity level setting down and empty the water from the air tubing.
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) 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 air flow for breathing produced by this therapy device can be higher tha
Sound: DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871:1996 Sound pressure level (CPAP mode) with SlimLine air tubing: 26 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 with Standard air tubing: 27 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 with either SlimLine or Standard air tubing and H5i: 28 dBA with uncertainty of 2 dBA as measured according to ISO 17510-1:2007 Sound power level (CPAP mode) with SlimLine air tubing: 34
Flow (maximum) at set pressures The following are measured at the end of the specified air tubing: Pressure cm H2O S9 VPAP Tx and standard air tubing, L/min S9 VPAP Tx, H5i and standard air tubing, L/min S9 VPAP Tx and SlimLine, L/min S9 VPAP Tx, H5i and ClimateLine, L/min 4 8 12 16 20 25 200 200 200 200 190 180 170 170 170 170 170 161 195 190 184 175 168 144 170 170 170 170 161 125 Displayed values Value Range Display resolution 3–30 cm H2O 0.
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Limited warranty ResMed Ltd (hereafter ‘ResMed’) warrants that your ResMed product shall be free from defects in material and workmanship from the date of purchase for the period specified below.
258189/2 2013-02 S9 VPAP Tx CLINICAL GLO MULTI Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. Distributed by: ResMed Corp 9001 ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK. Spectrum Center Boulevard San Diego CA 92123 USA. See www.resmed.com for other ResMed locations worldwide. For patent information, see www.resmed.com/ip. S9, H5i, ClimateLine, SlimLine, SmartStart, TiControl and VPAP are trademarks of ResMed Ltd.