ResMed S9 VPAP Tx manuale d’uso

S9 VP AP ™ Tx POSITIVE AIRW A Y PRESSURE THERAPY DEVICE Clinical Guide English[...]

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S9 VP AP ™ Tx POSITIVE AIRW A Y PRESSURE THERAPY DEVICE Clinical Guide English[...]

i English Contents General warnings and cautions ..............................................................1 W elcome ............................................................................................... 2 S9 VP AP Tx indications for use .......................................................2 S9 VP AP Tx contraindications ...........[...]

1 English General w ar nings and cautions W ARNINGS • Read the entire manual before using the device. • Use the device only as directed by the physician or healthcare pro vider . • Use the device only for the intended use as described in this manual. Advice contained in this manual should not supersede instructions gi ven by the ph ysician. ?[...]

2 W elcome The S9 VP AP Tx provides continuous positive airway pressure (CP AP) and bilevel therap y . The S9 VP AP Tx is a component of the S9 VP AP Tx Lab Sy stem. The S9 VP AP Tx Lab Sy stem provides remote PC control of a positive air w ay pressure therapy de vice (therapy de vice) capable of delivering multiple therapy modes. The sy stem compr[...]

3 English S9 VP AP Tx at a glance The S9 VP AP Tx system comprises the follo wing elements: • S9 VP AP Tx de vice • H5i heated humidifier • ClimateLine™ heated air tubing • 90W pow er supply unit • S9 trav el bag • S9 USB Adapter . Optional components include: • Standard air tubing • SlimLine ™ air tubing • ClimateLine MAX ™[...]

4 Masks Mask systems recommended f or use with the S9 VP AP Tx can be found at www .resmed.com. F or information on using a mask ref er to the mask user guide. F or a complete list of recommended masks and their settings go to www .resmed.com on the Products page under Service & Support . If y ou do not have internet access, please contact your[...]

5 English Therap y modes The f ollowing table describes the therapy modes available on the S9 VP AP Tx. Therap y mode Descr iption CP AP (Continuous Positive Airway Pressure) Delivers a fix ed pressure with optional Expirator y Pressure R elief (EPR). EPR can improve patient comf ort. AutoSet Deliv ers CP AP therapy with optional Expirator y P res[...]

6 Set ting up the S9 VP AP Tx W ARNING • Make sure the power cord and plug are in good condition and the equipment is not damaged. • Keep the power cord aw ay 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 nec k while they are sleeping. • Do[...]

7 English Set ting up the S9 VP AP Tx W ARNING • Make sure the power cord and plug are in good condition and the equipment is not damaged. • Keep the power cord aw ay 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 nec k while they are sleeping[...]

8 5. Connect the S9 VP AP Tx to the Tx Link via USB serial cable. 6. Plug the other end of the pow er 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 t ubing . The S9 VP AP Tx does not use the SD Card function to store data. All necessar y data [...]

9 English 1. Slide the latc h and lif t open the flip lid. 2. Remo ve the water t ub. 3. Fill the water t ub (through the center hole) with distilled or deionized water up to the maximum w ater lev el mark (12.5 fl oz / 380 mL). 4. Ret urn the water tub to the H5i. 5. Close the flip lid ensuring that it clic ks into place.[...]

10 Mask and air tubing set tings Use the follo wing settings belo w for eac h mask t ype: Mask type Settings Full F ace F ull Face Pillows Pillows Nasal Nasal (for Ultra Mirage mask, use ‘Nasal Ultra’) Pediatric P ediatric Notes: • F or more information on assembling the mask see the mask user guide. • F or a complete list of recommended ma[...]

11 English Navig ating the menus In general, to navigate the menus: 1. T urn until the parameter you require is display ed in blue. 2. Press . The selection is highlighted in orange. 3. T urn until you see the set ting that you require. 4. Press to confirm your c hoice. The screen returns to blue. About the menus There are three menus that are desi[...]

12 Changing set tings via the Home menu F rom the Home menu, you can adjust or c hec k the following f eatures: Humidity level Humidity levels can be adjusted at an y time to find the setting that is most comfortable for the patient. Climate Contr ol When the ClimateLine or ClimateLine MAX heated air tubing is connected and Climate Control is enabl[...]

13 English Viewing the tr eatment screens Depending on how the sy stem has been configured and what mode has been selected, you will see one of the follo wing example screens (shown in iV APS mode below) when the de vice is running: 9 H5i humidifier 9 H5i humidifier 9 ClimateLine/ClimateLine MAX 9 Climate Control – A uto 9 H5i humidifier 9 Climat[...]

14 T r eatment screen par ameters P arameter Modes Descr iption CPAP AutoSet VAuto S ST T PA C iVAPS ASV ASVAuto Leak 999999999 9 Estimate of the tot al rate of air escaping due to mouth and unintentional mask leaks, expressed in L/min (5-breath moving a verage). Minute V entilation (MV) 999999999 9 V olume of air breathed in, or out within any 60-[...]

15 English Setup menu The Set up menu allows set up of all parameters pertaining to the patient’ s therapy . Setup menu access To access Setup menu, press the Set up button. There are three screens a vailable from the Setup menu as shown in iV APS mode below: Settings Display s parameters directly aff ecting the patient’ s therapy . Options Dis[...]

16 Clinical setup menu par ameters * P arameter Modes Range Descr iption CPAP AutoSet VAuto S ST T PA C iVAPS ASV ASVAuto Settings Circuit Mask type 9999999999 F ull Face / Nasal / Pillows / Nasal Ultra / P ediatric Default: F ull Face Selects the type of mask used by the patient. T ube t ype 9999999999 SlimLine / Standard / 3 m Default: Standard S[...]

17 English P arameter Modes Range Descr iption CPAP AutoSet VAuto S ST T PA C iVAPS ASV ASVAuto EP AP 999999 3–25 cm H 2 O** Default: 4 cm H 2 O Sets the pressure whic h will be delivered to the patient when the device is cy cled into expiration. Dependent on IP AP . Min PS 999 0–20 cm H 2 O Default: 4 cm H 2 O Minimum pressure support in iV AP[...]

18 P arameter Modes Range Descr iption CPAP AutoSet VAuto S ST T PA C iVAPS ASV ASVAuto Easy- Breathe (US Only) 9 On / Of f Default: On Enables Easy-Breathe comf ort f eature. Max Pressure 9 Min–20 cm H 2 O, 0.2 cm H 2 O increments Default: 20 cm H 2 O Sets the upper limit of treatment pressure. Min Pressure 9 4–Max cm H 2 O, 0.2 cm H 2 O incre[...]

19 English Info menu Service Display s the device run hours, sof tware version and other component versions. P arameter Descr iption Run hours Display s the total number of hours the device has been used including warm-up and cool-down times f or the humidifier . SW Displays the cur rent sof t w are version. BID Displays the boot loader ID . VID D[...]

20 Managing Climate Contr ol Designed to be ideal for most patients, Climate Control Auto enables the automatic delivery of a const ant value of absolute humidity while protecting against rainout. T o allow for increased fle xibility , Climate Control can be turned to Manual in the Set up menu. Set ting Climate Control to Manual disables the automa[...]

21 English Deliver ing therap y W ARNING Bloc king the air tubing and/or air inlet of the device while in operation could lead to overheating of the device. CA UTION Make sure the area around the device is dry and clean and clear of bedding, clothes or other objects that could bloc k the air inlet or cover the power supply unit. The f ollowing proc[...]

22 Adding supplemental o xyg en W ARNING • 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 o xygen supply is turned on. Always turn the o[...]

23 English Cleaning and maintenance Regular cleaning should be carried out on the S9 VP AP Tx. Clean the exterior of the de vice with a damp cloth and mild detergent. Reprocessing the H5i and air t ubing between patients The H5i and air t ubing should be reprocessed when used bet w een patients. Cleaning and disinf ection instructions are a vailabl[...]

24 W or king with alar ms The S9 VP AP Tx is fit ted with an alarm module that continuously monitors both therapy and device conditions. Alarms are only activ ated when therapy is running. An alarm condition can be indicated b y an audible sound, a flashing yello w LED or a message on the screen. Note: The alarms should be tested af ter final syste[...]

25 English T r oubleshooting If there is a problem, tr y the f ollowing suggestions. If the problem cannot be solv ed, cont act your equipment supplier or ResMed. Do not at tempt to open the device. Problem/P ossible cause Solution No display P ower is not connected. Ensure the pow er cord is connected and the power outlet (if av ailable) is on. Th[...]

26 Problem/P ossible cause Solution Air filter is bloc ked. Replace y our air filter . Disconnect the power cord and then reconnect it to restart the device. Air tubing is bloc ked. Chec k your air tubing and remo ve any bloc kages. Disconnect the pow er cord and then reconnect it to rest art the device. Humidity level set ting is too high, resul[...]

27 English T echnical specifications General t echnical specifications P ower supply 90W power supply unit Input range: 1 0 0–240V ; 50–60Hz; 1 15V , 40 0Hz nominal f or aircraft use T ypical power consumption: 70W (80V A) Maximum pow er consumption: 1 1 0W (1 20VA) 90W DC/DC conver ter Nominal inputs: 1 2V , 24V T ypical power consumption: 7[...]

28 Sound: DECLARED DUAL -NUMBER NOISE EMISSION V ALUES in accordance with ISO 4871:1 996 Sound pressur e level (CP AP mode) with SlimLine air tubing: 26 dB A with uncert ainty of 2 dBA as measured according to ISO1 751 0-1:20 07 with Standard air tubing: 27 dB A with uncert ainty of 2 dBA as measured according to ISO1 751 0-1:20 07 with eithe[...]

29 English Flow (maximum) at set pr essures The f ollowing are measured at the end of the specified air tubing: Pressur e cm H 2 O S9 VP AP Tx and standard air tubing, L/min S9 VP AP Tx, H5i and standard air tubing, L/min S9 VP AP Tx and SlimLine, L/min S9 VP AP Tx, H5i and ClimateLine, L/min 4 200 17 0 19 5 17 0 8 200 17 0 19 0 17 0 12 200 17 0 18[...]

30 Symbols The f ollowing symbols may appear on y our product or pac kaging . Caution; R ead instructions before use; Protection against insertion of fingers and against vertically dripping w ater; T ype BF equipment; Class II equipment; Start/Stop; Manufact urer; European Authorised Representative; European R oHS; Batc h code; Catalogue number; Se[...]

31 English Limited w ar ranty ResMed Ltd (hereaf ter ‘ResMed’) warrants that y our ResMed product shall be free from defects in material and workmanship from the date of purc hase for the period specified below . Product W arr anty period Mask systems (including mask frame, cushion, headgear and t ubing)—excluding single-use devices 90 day s [...]

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Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. Distributed by: ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA. ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK. See www .resmed.com for other ResMed locations worldwide. For patent information, see www .resmed.com/ip. S9, H5i, Cl[...]