VPAP II & II ST - CPAP Discount Store
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1. amp II ST USER S MANUAL RESMED amp II ST USER S MANUAL R ler number 218043 2 02 02 Manufactured by ResMed Ltd 97 Waterloo Road North Ryde NSW 2113 Australia Tel 61 2 9886 5000 or 1 800 658 189 toll free Fax 61 2 9878 0120 Email reception O resmed com au Distributed by ResMed Corp Danielson Street Poway CA 92064 6857 USA Tel 1 858 746 2400 1 800 424 0737 toll free Fax 1 858 746 2900 Email usreception resmed com ResMed UK Limited 67b Milton Park Abingdon Oxfordshire OX14 4RX UK Tel 44 1235 862 997 Fax 44 1235 831 336 Email reception O resmed co uk ResMed Asia Pacific Ltd 97 Waterloo Road North Ryde NSW 2113 Australia Tel 61 2 9886 5000 or 1 800 991 900 toll free Fax 61 2 9889 1471 Email reception O resmed com au ResMed NZ Ltd PO Box 51 048 Pakuranga Auckland New Zealand Tel 64 25 737 633 Fax 64 9 239 0193 Email reception O resmed co nz ResMed GmbH amp Co KG Rudolfstra e 10 D 41068 M nchengladbach Deutschland Tel 49 0 2161 3521 0 49 0 180 22 22 668 Kunden Service Center 0 06 Anruf 49 0 180 22 66 888 Technische Service Line 0 06 Anruf Fax 49 0 2161 3521 299 Email reception resmed de ResMed SA Parc de la Bandonni re 2 rue Maurice Audibert 69800 Saint Priest France T l 33 0 4 37 251 251 Fax 33 0 4 37 251 260 Email reception O resmed fr ResMed Sweden AB Industrigatan 2 S 461 37 Trollh ttan2. CONTENTS WARNINGS amp CAUTIONS WARNING CAUTION NOTE This manual contains special terms and icons which appear the margins to draw the reader s attention to specific and important information Alerts the user to possible injury Alerts the user to possible equipment problems An informative or helpful note Please read this manual carefully before use This manual is intended for the user only For clinical information please refer to the Clinician s Manual for this product USER OWNER RESPONSIBILITY INDICATIONS The user or owner of this system shall be liable for any injury or property damage resulting from operation not in accordance with the instructions supplied or maintenance modifications carried out by unauthorized persons The VPAP IT is intended for the treatment of obstructive sleep apnea OSA in adult patients 2 66 Ib or 30 kg CONTRAINDICATIONS The VPAP II and VPAP II ST should not be used in cases of severe respiratory failure where intubation is judged to be immediately necessary VPAP therapy should be used with caution in the following cases e Existing respiratory failure e Emphysematous bullae pneumothorax pneumomediastinum or past history of the above indicating risk of pneumothorax or further baro trauma e Decompensated cardiac failure or hypotension particularly if associated with intravascular volume depletion e Massive epistaxis or risk of recurrence i
3. Sverige Tel 46 520 420 110 Fax 46 520 397 15 Email reception O resmed se ResMed Singapore Pte Ltd 57 Ubi Ave 1 07 09 Ubi Centre Singapore Tel 65 284 7177 Fax 65 284 7787 Email reception resmed com sg ResMed Malaysia Sdn Bhd Suite E 10 20 Plaza Mon t Kiara No 2 Jalan 1 70C Mon t Kiara 50480 Kuala Lumpur Malaysia Tel 60 3 6201 7177 Fax 60 3 6201 2177 Email reception O resmed com my US DESIGNATED AGENT ResMed Corp EU AUTHORISED REPRESENTATIVE ResMed UK Ltd Internet http www resmed com Protected by EP DE FR GB 0088761 JP 1697822 US 4944310 US 5199424 US 5522382 Other patents pending Copyright subsists in ResMed products SULLIVAN VPAP AutoSet AutoView Bubble Cushion Bubble Mask HumidAire Mirage ResCap SCAN SmartStart and Ultra Mirage are trademarks of ResMed Ltd Copyright ResMed Ltd 2002 All rights reserved CONTENTS WARNINGS amp CAUTIONS secrete ee wg hs 22133 a STEP ON e EE OTHER REQUIRED COMPONENTS OPTIONAL ACCESSORIES STEP 2 ASSEMBLY SAX anne FO RARER d STEP 3 STARTING TREATMENT ALARM CANCEL BUTTON Rep SCREEN aac EEN A AA Se Sar oe eae ae ae ae aac Sas Spee CLEANING amp MAINTENANCE 4 204 SERVICING TROUBLESHOOTING 222626224241 EN WARNINGS RELATED TO TREATMENT 244 442 4424 04 05 ead ea OPP Me IATA IN re E
4. Wipe the inside and outside of the mask and cushion with a clean damp cloth Hang them up to dry in the shade not in the sun as the tubing may harden and crack over time Handwash the mask and air tubing with pure soap Do not use moisturizing deodorizing fragranced or antibacterial soaps Refer to the mask user instructions for further information Handwash the headgear with pure soap and drip dry out of direct sunlight Check the mask outlets for blockages PERIODICALLY WARNING CAUTIONS The exterior of the flow generator should be cleaned with a slightly damp cloth and mild detergent Beware of electric shock Do not immerse the flow generator or power cord in water Always unplug the flow generator before cleaning and be sure that it is dry before plugging it back in Do not use bleach chlorine alcohol or aromatic based solutions scented oils moisturizing deodorizing fragranced or antibacterial soaps to clean the VPAP or the mask system as these may damage or otherwise reduce the life of the product The mask and air tubing are subject to normal wear and tear Inspect them regularly for damage CLEANING amp MAINTENANCE 15 16 REPLACING THE AIR FILTER STRIP The air filter strips should be replaced approximately every six months or more often if they becomes noticeably dirty To remove the air filters slide out the air filter cover Instructions on replacing the air filter stri
5. persist e air continually leaking out of the mouth while sleeping recurrence of any sleep apnea symptoms while on VPAP Do not stop your VPAP treatment without the approval of your clinician Always consult your clinician if you expect to be in a situation where you cannot use your VPAP for more than a few days If you are admitted to a hospital or prescribed any other form of medical treatment always inform the medical staff that you are being treated with VPAP It is also important to contact the clinician who is following your VPAP treatment If you experience an infection of the upper respiratory tract middle ear or sinus contact your clinician before continuing your VPAP treatment You may be advised to stop treatment until the infection has cleared If you continue with treatment during an infection it is advisable to wash your mask and tubing more often Skin irritation may occur from sensitivity to the materials in the mask or from too much tension in the headgear straps A correctly fitted mask and optimum tension in the straps will often prevent skin irritation If problems persist contact your clinician for advice WARNINGS RELATED TO TREATMENT 21 SPECIFICATIONS FLOW GENERATOR SULLIVAN VPAP II amp 11 ST Dimensions H x W x L 5 7 x 9 5 x 13 8 in 142 x 240 x 350 mm Weight 7 7 lb 3 5 kg Power Supply Input range 110 240 V 50 60 Hz 200 VA voltage is auto selecting Storage Temperature 4 to 14
6. 0 F 20 to 60 C Operating Temperature 41 to 104 F 5 to 40 C Operating Humidity 15 to 95 CYCLING VPAP II ST ONLY Breaths Per Minute BPM 5 to 30 Breathing Rate Accuracy 1 Inspiratory to Expiratory Ratio 1 9 to 1 0 1 10 to 90 of breath period DYNAMIC PRESSURE AND FLOW CHARACTERISTICS AIR OUTLET Pressure Flow range IPAP 2 cmH O to 25 cmH O at 130 L min measured at the end of standard 2m air tubing 2 cmH20 to 25 cmH20O at 130 L min measured at the end of standard 2m air tubing Pressure Calibration Accuracy 1 cmH O of the indicated control setting To fit standard 22mm tapered connection PRESSURE MEASUREMENT Internally mounted pressure transducer FLOW MEASUREMENT Internally mounted flow transducer SPECIFICATIONS 23 24 IEC 601 1 CLASSIFICATIONS ZN Class II Type CF Read Operating Manual before use Lire le manuel d utilisation avant emploi Class II double insulated Classe II double isolation Type CF Applied Part Partie appliqu e du type CF PRESSURE FLOW CHARACTERISTICS FOR MASKS NOTE Pressure cmH20 20 25 30 35 40 45 50 55 Flow L min Mirage Full Face is Modular Standard Disposable Nasal Ultra Mirage 60 65 The manufacturer reserves the right to change these specifications without notice
7. Delay Timer you will need to press a Delay Timer button to start treatment However the flow generator will still stop automatically NOTES To stop treatment simply press the Start Stop button and remove your mask If SmartStart is enabled the flow generator will stop automatically when you remove your mask If the Mask Alarm is enabled the M icon appears on the LCD screen SmartStart will not stop the flow generator automatically when you remove your mask The mask alarm will activate Use the Start Stop bution to turn the flow generator off before removing your mask Some masks or mask valve combinations may affect the operation of the SmartStart feature If SmartStart does not trigger the operation of the flow generator start the flow generator by pressing the Start Stop bution ALARM CANCEL BUTTON The VPAP is equipped with an alarm to warn you when you are not receiving correct treatment The alarm will activate e if the detects a high mask leak and if the Mask Alarm option has been enabled by your clinician e when excessively high temperatures cause the to overheat and switch from your prescribed bilevel treatment pressures to a single constant pressure MASK ALARM If your clinician has activated the Mask Alarm feature the Mask Alarm will activate if it detects a high mask leak or if your mask has become totally dislodged from your face The VPAP will illuminate an indicator light sound a buz
8. around the flow generator is clean dust free and clear of bedding clothes and any other potential blockages STEP 3 STARTING TREATMENT START STOP DELAY TIMER SMARTSTART A Start the flow generator in one of the following ways SULLIVAN VP II MODE 5 5 10 20 IPAP 10 0 lt IPAP max 2 0 T MIN T TEL Start Stop 5 10 20 Alarm Cancel RESMED button Delay Timer buttons button VPAPII REsSMED Figure 2 Control panel of the II Press the Start Stop button to start the air flow The air will begin flowing slowly and build up to pressure in 10 15 seconds OR If you have difficulty falling asleep with full pressure you can use the Delay Timer The airflow will start very gently while you fall asleep and slowly increase to full operating pressure over a selected time period You can select a delay time of 5 10 or 20 minutes Choose a delay time and press the corresponding button The air will start to flow automatically There is no need to push the Start Stop button If you have not yet fallen asleep after the delay period you may press one of the Delay Timer buttons again OR This feature is set by your clinician If SmartStart is enabled the hand icon will appear on the LCD screen see LCD Screen on page 11 The flow generator will automatically start when you breathe into the mask and stop when you remove it If you want to use the
9. ask humidifier combination interfering with SmartStart triggering Excessive leak SmartStart not enabled A does not appear on the LCD screen e a deep breath and out through the mask e Use Start Stop button e Adjust position of mask and headgear Plugs may be missing from ports on mask replace them Air tubing not connected properly connect air tubing firmly at both ends e Air tubing kinked or punctured straighten or replace air tubing e Use Start Stop button Air leaking around nose and eyes e Nasal cushion not fitted properly onto mask frame e Mask and headgear straps not positioned correctly e Plugs missing from mask ports e Nasal cushion torn or distorted e Incorrect mask size e Fit cushion properly e Adjust position of mask and headgear tighter is not always better Replace plugs Replace cushion Obtain correct sized mask 17 18 Problem SmartStart is enabled but the flow generator does not stop automatically when you remove your mask Possible cause e Mask or mask humidifier combination interfering with SmartStart triggering Mask Alarm enabled M appears on the LCD screen e SmartStart not enabled does not appear on the LCD screen e Humidifier used but the Humidifier option has not been enabled 9 does not appear on the LCD screen e Incompatible humidifier or mask system being used Flow generator incorrectly calib
10. duces two humidifier models that will humidify the air flow to relieve the symptoms Contact your clinician for advice MASK FITTING The Mirage mask does not need to be tightly fastened The VPAP delivers the most effective treatment when the mask is well balanced and comfortable without being pulled tight A minor leak around the lower part of the face is preferable to overtightening the mask However any air leaks blowing near the eyes should be eliminated as they may cause eye irritation If you have continuing problems trying to get a comfortable mask fit do not hesitate to contact your sleep clinic or HELPFUL HINTS 13 14 equipment supplier They may be able to modify the cushion or mask or they may suggest an alternative size or style from the wide range available RUNNY BLOCKED NOSE You may experience sneezing and a runny or blocked nose during the first few weeks of VPAP treatment which may need treatment with a humidifier or nasal spray Consult your clinician for advice INTERNATIONAL USE Your VPAP flow generator is equipped with a universal input power supply enabling it to operate in other countries It will operate on 110 240 V and 50 60 Hz No special adjustment is necessary but you may need an adaptor for the power outlet Always remember to pack the detachable power cord For more information contact your equipment supplier CLEANING amp MAINTENANCE DAILY WEEKLY Disconnect the air tubing and mask
11. e turned off when the device is not operating Explanation When the device is not in operation and the oxygen flow is left on oxygen delivered into the ventilator tubing may accumulate within the device enclosure and create a risk of fire Always turn the flow generator on before the oxygen Always turn the oxygen off before the flow generator Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame At a fixed flow rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on the pressure settings patient breathing pattern mask selection and leak rate STEP 1 UNPACKING Check that you have the following items B VPAP II or IIST flow generator O 8 PPH 7 Carry bag Air tube Power cord STEP 1 UNPACKING OTHER REQUIRED COMPONENTS You will also need a ResMed mask system which is supplied separately VPAP flow generators are compatible with the following mask systems Mirage Mask Mirage Ultra Mirage Mask Modular Mask Full Face Mask WARNING Use only mask systems as recommended and supplied by ResMed Other mask i systems may not be compatible OPTIONAL ACCESSORIES HumidAire heated Passover humidifier humidifier WARNING Only ResMed humidifiers are compatible for use with VPAP flow generators Do not i use any other humidifier systems STEP 2 ASSEMBLY 1 CAUTION Place the flow gene
12. f previous occurrence e Pneumoencephalus recent trauma or surgery that may have caused cranio nasopharyngeal fistula risk of entry of air into cranial cavity WARNINGS amp CAUTIONS WARNINGS OXYGEN USE WARNING NOTE Acute sinusitis otitis media or perforated ear drum Explosion hazard do not use in the vicinity of flammable anesthetics THIS IS NOT A LIFE SUPPORT DEVICE It may stop operating with power interruption or if a fault occurs in the product Use only mask systems as recommended and supplied by ResMed Other mask systems may not be compatible In the USA Federal law restricts this device to sale by or on the order of a physician The mask should be worn only when the machine is turned on and operating properly Explanation exhaled air is flushed out of the vents when the machine is operating If the unit is not operating exhaled air will be rebreathed The vent holes on the mask should never be blocked At low pressures the flow through the exhalation ports may be inadequate to clear all exhaled gases Some rebreathing may occur The airflow for breathing may be as much as 11 F 6 C higher than room temperature Caution should be exercised if the room temperature is higher than 95 F 35 C Do not drop or insert any objects into the air tubing or air outlet Do not open the flow generator case or attempt to adjust the unit If oxygen is used with this device the oxygen flow must b
13. on when cool Cool the room if possible but do not direct the source of cold air toward the flow generator TROUBLESHOOTING Remove blockage Remove blockage Insufficient air flow delivered from the flow generator e Delay Timer is in use e Air filter strips are dirty e Air tubing is kinked or punctured e Air tubing is not connected properly e Plugs missing from the mask ports Wait for air pressure to build up gradually or press the Start Stop button to start immediately If this is uncomfortable see your clinician to have the start pressure increased Replace air filter strips e Straighten or replace air tubing eCheck and tighten both ends of the air tubing Replace plugs 19 WARNINGS RELATED TO TREATMENT WARNING The flow generator is designed to help you have a good night s sleep However you need to be aware of possible problems that may arise during the course of VPAP treatment If you experience any of the following symptoms during your VPAP treatment consult your clinician immediately e headache e middle ear or sinus discomfort e chest pain e dryness of the nose mouth or throat The use of a humidifier may help Your clinician or equipment supplier can advise you on the humidifiers available e feeling slightly bloated This is usually the result of swallowing air while you are awake Using the Delay Timer may help but consult your clinician if the symptoms
14. ps are supplied with the new filters Figure 4 Removing the air filter cover NOTE Hypoallergenic filter strips are also available from ResMed to provide a higher O level of filtration from airborne particles such as molds and pollens CAUTION The air filter strips are not washable or reusable SERVICING The flow generator is designed to give you years of trouble free operation It will not require regular servicing provided that you clean and maintain it according to the instructions in this manual If you feel that your unit is not performing properly see Troubleshooting on page 17 If it is still not working properly consult your equipment supplier or take it to an authorized service agent CAUTION Inspection and repair should only be performed by an authorized service agent i Under no circumstances should you attempt to service or repair the unit yourself TROUBLESHOOTING Problem Flow generator does not start when you press the Start Stop or Delay Timer button and the LCD screen is blank Possible cause e Power cord is not connected properly Flow generator is not switched on Power outlet may be faulty Solution TROUBLESHOOTING eCheck both ends of the power cord Switch on main switch at rear of unit e Try another power outlet SmartStart is enabled but flow does not start when you begin breathing in the mask Breath is not deep enough to trigger SmartStart e Mask or m
15. rated Solution e Use Start Stop button e SmartStart will not stop the flow automatically when the mask alarm is enabled use the Start Stop button e Use Start Stop button Your clinician must enable the Humidifier option if you want to use a humidifier and SmartStart feature Use only equipment recommended and supplied by ResMed Return to supplier for calibration Mask Alarm is enabled but alarm does not activate when the mask is removed during treatment e Incompatible humidifier or mask system being used e Humidifier used but Humidifier option has not been enabled a does not appear on the LCD screen Use only equipment as recommended and supplied by ResMed Your clinician must enable the Humidifier option if you want to use a humidifier and Mask Alarm feature Problem Flow generator delivers a single pressure instead of alternating between the two set pressures and pressure indicator displays a constant level Possible cause Rapid breathing and a room temperature above 95 F 35 C have caused the motor to overheat e Blocked air filter has caused overheating e Blocked air inlet Solution eIf you are comfortable with the constant pressure let it run The motor will cool down after about 15 minutes and resume normal operation If the single pressure is uncomfortable stop the unit by pressing the Start Stop button and allow it to cool You may resume normal operati
16. rator on a table near the head of your bed Be careful to not place it where it can be bumped over or where someone may trip over the power cord 2 Plug the power cord into the power socket at the back of the flow generator Plug the other end of the power cord into an AC wall outlet Assemble your mask system Please refer to the mask system user instructions If you are using a humidifier please refer to the connection instructions in the user s manual supplied with the humidifier STEP 2 SSEMBLY Connect one end of the air tubing to the outlet on the flow generator Connect the other end to your mask system LLL U LL L 11 Turn the power switch on D Your system is now assembled To start treatment see Step 3 Starting treatment on page 7 STEP 3 STARTING TREATMENT 1 You should have assembled the flow generator and connected the air tubing see Step 2 Assembly on page 5 Assemble your mask as described in the mask system user instructions and put it on CAUTION Lie down and arrange the air tubing so that it is free to move if you turn in your sleep this configuration not possible with Mirage mask Figure 1 Arranging the air tube Do not leave long lengths of air tubing around the top of your bed they could twist around your head or neck while sleeping e Make sure the area
17. ure 3 Example of settings shown on the LCD screen NOTE The items appearing on the LCD screen will vary depending upon the settings amp made by your clinician LCD SCREEN 11 HELPFUL HINTS FIRST USE When you use your VPAP flow generator for the first time you may feel an unusual sense of pressure when breathing Even though the flow generator reduces the pressure when you breathe out you may still need to consciously push out when breathing This is normal and will occur automatically while you sleep Take your time to adjust to this new sensation Taking a few deep breaths may help MOUTH LEAKS GETTING UP Try to keep your mouth closed as air leaks from your mouth can be unpleasant If you wake up during the night the sensation of a mouth leak can be alarming You should close your mouth and try to go back to sleep Using the Delay Timer may also help See Delay Timer on page 8 If mouth leaks continue to be a problem for you talk to your clinician about ResMed s Mirage Full Face Mask which is designed to prevent mouth leaks If you get up during the night remember to remove your mask Always remember to replace the mask when you return to bed and turn the flow generator on again See Step 3 Starting treatment on page 7 DRYNESS Some people experience dryness of the nose mouth and throat during the course of VPAP treatment especially during winter A humidifier may be the best solution ResMed pro
18. zer and display MASK OFF ALARM on the LCD screen To stop the alarm press the Alarm Cancel button or eliminate the cause of the leak To eliminate the leak reposition the mask on your face and or check that the air tubing is connected properly to the mask and the flow generator OVERHEATING In rare circumstances when the room temperature is above 95 F 35 C and you have been breathing rapidly and there are large pressure changes the air pump in the flow generator may overheat The alarm will activate and display O HEAT ALARM on the LCD screen You can cancel the alarm by pressing the Alarm Cancel button If the air pump does overheat the VPAP will deliver a single constant pressure for about 15 minutes to allow the pump to cool When cool the pump will automatically return to normal operation If you prefer press the Start Stop button and remove your mask Allow the flow generator to cool for about 15 minutes then resume your normal treatment STEP 3 STARTING TREATMENT LCD SCREEN The LCD screen will show the settings made by your clinician You cannot modify any of the items shown on the display SULLIVAN MODE 5 10 0 8 0 Treatment IPAP max 2 0 settings Es MIN Humidifier option SmartStart E N M Mask Alarm enabled enabled EI Settings lock Pressure indicator settings cannot RESMED Message panel 5 VPAPII BAR be changed RESMED Fig
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