Auto CPAP System Model 7410 Patient Operating Instructions
Contents
1. 11 A 7410 00C QXD 10 1 99 7 40 AM Page Troubleshooting Guide PROBLEM L Unit ches net tum m 2 Noair ows at of device wen it is tumad a 3 Air from device seems wam 4 Feeling thet the pressure is too high or too low i T POSSIBLE CAUSES Unit not connected to Live power source Fuse needs to be replaced Tnoorrect fuse was used Filter may be blocked by bris Intemal conponent has failed Filter may be blocked by debris Inlet vent may be blocked Roan air temperature has increased Teak in the systen Filter may be clogged Intemal omnet has failed Rap is active A INSTRUCTIONS Check to see if unit is plugged into a Live pwer source Contact your cealer for a new fuse Contact your cealer for a new fuse W ah or replae filter Contact your dealer W ah or replae filter Move the device away from the source of blockage Reduce roan air temperature Verify that the mesk is net allowirg air to lek and that there are no leaks in the hose Pressure check at zero flow W ah or plae the filter Contact your dealer Tum power OFF and then ON to deactivate rom 7410 00C QXD 10 1 99 7 40 AM PROBLI Gl M 5 Feelings of discomfort from the sensation of too much pressure 6 Air leeks aard the 7 Skin becares red where mask touches skin 8 Runny nose D Dryness of throat or nose 10 Nasal sinus ar ear pain2. This Limited W arranty gives you specific rights and you may also have other rights that vary firm state to state The tems of this Limited W arranty may not be varied by any person whether or not purporting to reoresent or act cm behalf of Respirmics To cotain service under this werrenty the ower of the APAP system must promptly notify Respironics of any defect in materials or workmanship and the serial number and date of purchase of the APAP system by calling the toll free number 800 345 6443 If Respironics determines that repair is required under this Limited W arranty Respirmics shall provide the ower with a Retum Authorization Number The owner must retum the APAP system or designated parts to Respinmics s factory or an authorized service center designated by Respirmics All items retumed must be properly packaged insured and shipped to Respirmics transportation charges prepaid The costs associated with the retum of the APAP system or carporent parts to Respironics for warranty services are not incluced in the Limited W arrarty Respircnics Tranqality and Encore areregistered trademarks of Respirmics Ix APAP is a treckmark of Respironics Inc Subject to US patent number 5 645 053 21 7410 00C QXD 10 1 99 7 40 AM Page 24 RESPIRONICS INC RESPIRONICS 1001 Murry Ridge Lane Deutschland SE Murrysville Pennsylvania Gewerbestrasse 17 15668 8550 USA 82211 Herrschi
3. 11 Retum of original symptans Page i SS POSSIBLE CAUSES Pressure from the APAP unit Mask is not fitting properly W rong size nasal mask Hadar too tight W rong size nasal mask General irritatim or allergic reaction to the mask material Reaction to air flow Inadeguate humidity Sinus infection or middle ear infectim APAP unit is nt reseanding 13 A INSTRUCTIONS While APAP may provide lower and more comfortable pressure an initial period of adjustment of up to two three weeks may be required Relax and take slow ceep breaths Tf discomfort amtinves after two to three cays omtact you physician Try agpin to fit the mask to your face If leks continues omtact your daler Contact your dealer Readjust the heacgear Contact your dealer Discontinue use and notify your physician Discontinue use and notify your physician Increase humidity or contact physician regarding the use of a hmidifier Discontinue use and notify your physician Have your dealer verify the proper gperetim of tre APAP uit 7410 00C QXD 10 1 99 7 40 AM Page 16 Maintenance Record Dates Notes Replaced Nasal Mask Replaced Headgear Replaced Hose Replaced Filter Checked APAP Pressure TS Xx Tg TS TSS Ss S5 Xx a TS ae ae ANS Xx PE Xx Xx oS SS SS See a 14 7410 00C QXD 10 1 99 7 40 AM Page 17 d Patient Checklist As you and your Hare Care Dealer go through the qoera
4. When using sugplerental oxygen with this system make sure that this APAP system is switched on before the oxygen source is turedc Wen you wish to stop using this APAP system tum of f the ayem flow first before tuming this APAP unit off A 7410 00C QXD 10 1 99 7 40 AM Page 6 2 3 4 5 G 7 15 16 T Oxygen quickly accelerates fire If you are using supplarental ac this APAP system as well as the oxygen source mst be keot away from heat or oe flame Smoking in the area of use must not oxur As with any electrical device cb net use this APAP unit ding an electrical stom Do not use this APAP unit with a portable electrical ertor CAUTICN indicates a condition that may lead to eguipment damage malfunction or inaccurate operation Do not use a rom humidifier within six feet of this unit Denmess may af fet dice parts Do not use attachments that are not recommended by Respironics This APAP system is to be used in the mner cescribed in this menal Never drp or insert any cojects into the comecting hose or air atles or inlets Coerating the unit with a dirty filter may kep the APAP unit frm working properly Do not use extension cords or electrical adapters At low pressures the flow through the exhalation port may not be enough to clear all of the exhaled gases As a result you may breathe in sore of the air that you have breathed at Do nct steriliz this unit from the h
5. pressures The Tranguility Auto qcperatim that omtinvally measures airflow ataratically adjusts therapy as you travel to dif feet elaatias Maintenance Changing the Filter The Trangiility Auto is sugolied with a reusable filter This filter can be removed from the reer of the unit by pulling it directly at of the filter receptacle The filter suld be washed thoroughly with a mild scap and water solution rinsed thoroughly with clear water and allowed to dry ampletely before use Retum the filter to the unit by pressing it against the filter receptacle and tucking the exhss into place An optimal disposeble filter is available for removal of smaller particles Check the condition of the filter prior to each use Cleaning The System The APAP unit should be cleared using a cloth misted with water and a mild scap solutim Caution Unplug the unit before cleaning it Do nct place the unit in wter Do not use alochol or other organic solvents to clean this unit Iet the unit dry completely before plugging it in or gpereting it Routine Maintenance Other than the cleaning detailed above no other maintenance is required by the user NOTE You should net attaret to con the unit s nclosure there are no user serviceable carponents inside Unauthorized tampering with the unit s enclosure or unauthorized servicirg will void the warrenty and could result in camage and or personal injury
6. 7410 00C QXD 10 1 99 7 40 AM Page 1 d The Respiraics Tranquility Auto is a medical device prescribed by a physician to assist breathing 7410 00C QXD 10 1 99 7 40 AM Page 2 d Table of Contents AC Fuse Traveling with your APAP System BG Opera ENEE EE Altitude Campensation Accessories 7410 00C QXD 10 1 99 Glossary of Symbols Symbol Description IN Attention consult accompanying documents such as manuals G before attarpting to use this APAP system O Power switch Off Disconnection fram the mains Power switch On Connection to the mains S Altemating current HA Ramp Ol Class II equigrent Dable insulated IPX1 Protected against vertically falling water 7 40 AM Page 3 Type BF agolied part Read thoroughly and understand this manual 7410 00C QXD 10 1 99 7 40 AM Page 4 d User Owner Responsibility This Respirmics APAP Autaratic Positive Airway Pressurg system and authorized accessories are designed to work as cescribed in this mmal You should not use parts thet have failed exhibit exessive wear are contaminated daed or otherwise inef fetie Read this entire mnal before using this APAP system The user amer of this system shall have the sole responsibility and liability for any injury to persons or dwe to property including this equipment resulting from L Operatim not in acoorcance with sugolied gperating instructions 2 Maintenance not in accordance wi
7. Aditimally this compact unit features an initial ramp a convenient handle amd an easily replaceable or washable filter Warnings and Cautions indicates a potentially harmful situation This is an atawtic positive airway pressure device and is intenced be used in the treatment of adult costructive slep area Do mt use this APAP unit in the preserve of flameble aesthetics Do not use the APAP unit around water in any way excect for wter amtained in a Respirmics Humidifier If this unit should core in contact with water unplug the unit This unit should never be tured cn and left unattended Never gperate this unit if the power cord or plug is ded Tf this unit has been drei or damaged amtact your distributor or Respironics at ance Adjusting the pressure without a physician s instruction could be hamful The APAP cevice should ly be used with a nasal interface or mask and patient circuit that are sugolied by Resoirmics Never ba any ciramstances use the nasal interface or patient circuit unless the Tranguility Auto is tumad m and erating properly 10 Do not block or costruct the vent hole located the front of the nasal mask or interface LL Make sure that all breathing connectims are properly secured D For 12 VDC qeration do not use any DC to AC inverter other than that sugolied or recommenced by Respirmics 13 Check and verify fuse rating before replacerent oO 0 HD Di F WY P 14
8. arising from misuse abuse negligence or accicent or from repair maintenance adjustment modification or replacarent mace by anyone other than authorized Respironics Personnel and D To any darges for labor or expenses for making field replacement of warranted ost parts THIS LIMITED WARRANTY IS IN LIEU OF ANYAND ALLOTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE O THE EXTEN HAT STATE OR FEDERAL LAW PROHIBITS EXCLUSIONS OF IMPLIED WARRANTIES ANYSUCH IMPLIED WARRANTY IMPOSED BY LAW SHALLBE LIMITED TO A PERIOD OF NINETY 90 DAYS FROM THE DATE OF INITIAL PURCHASE FROM RESPIRONICS T 20 A 7410 00C QXD 10 1 99 7 40 AM Page 23 d Respircnics s responsibilities heeran r are limited to repair and plaet aly Resoirmics dell me no coligstims or Habilities in connection with the APAP system other than as provided herein including without limitation any and all doligatims and or lisbilities for alleged negligence or for strict ability In m eet shall Respironics be Liable of any incidartal or amsequential daneges either direct or contirgent NE Some states co not allow Limitations on how lang an implied warranty lasts so the above limitation may not apply to you
9. device thet is used to treat d tnrtiw sl lep qpa with air pressure that ere to meet daig Pes A device located in the Tramility Ato t hat measures the movement of air as it leaves the vie A device that n be used with the Trangility Ato to acd moisture to the air that you breathe while a the dies An electrical signal that may cause the Tranguility Auto to perform in a way that is net intended A computer located in the Trangiility Ato tht amtrols its actim A mask or similar way of directirg th ai r flow fron the Tranguility Auto to your nose A set of accessories that allow ay to be delivered alang with the APAP therapy A device located in the Tranguility Auto that measures the force of air that you receive 16 7410 00C QXD 10 1 99 7 40 AM Page 19 d Specifications APAP Pressure Approx 3 to 20 an H O W eidt 5 3 Ibs 2 4 ko Height 5 0 12 7 an Length 9 5 24 1 an W idh 7 75 19 7 am Electrical Requirements 100 120 200 240 VAC 50 60 Hz 75VA W arrerty 2 year limited Classification m FC Class II PA Type BF applied part IPX1 Protected against vertically falling water drip proof Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxice Continuous operation 17 7410 00C QXD 10 1 99 7 40 AM Page 20 Storage and Transport Temperature 2 C to O C Humidity 10 to 95 noncond
10. ed with the Oxygen Administration Kit Thread the oxyoen tubing thra the holes in the logos Attach the T adapter between the mask and the hose Attach as A of the tibing to the T ececter and the other ed 2 Oxygen Use Tum a the APAP unit so tht air flow will begin before tuming mn the flow of con ay When tuming the APAP unit ff always tum the ay flow of f firt ad to the axy n source Keel gesch Tea UA eg Im ett CTT mmm thn tre APAP unt UI NEVER TURN THE T APAPUNITON OR OFFWITH OXYGEN FLOWING INTO THE UNIT T A 7410 00C QXD 10 1 99 7 40 AM Page 12 d AC Fuse Tf tre APAP unit s power indicator ches not Light up wen the unit is plugged in rd tured on the fus may need to be replaced When replacing the fuse make sure that the power cord is not plugged into the electrical outlet Remove the power cord from the recectacle m the rear of the nit Reme the fuse holder by pressing the two tabs together and pulling at Tre fuse must be replaced with an identically vated fuse The comet fus isa TIAL 250V Amp 5mm x 20mm 250 Vat SloBlo After replacing the fuses in the fuse holder press the holder beck into the receptacle and replace the power cord Traveling With Your APAP System The Trangullity Ato will cperate o a n of voltages from 100 VAC to 240 VAC rd 50 or cycles You rot reed to switch from one voltage setting t
11. ensing Atmospheric Pressure 790 523mm Hg Operating Temperature 5 C to 40 C Humidity 10 to 95 noncondensing Atmospheric Pressure 790 523mm Hg Hectromagnetic Compatibility The Tranguility Auto model 7410 is designed to camply with EN 60601 1 2 1995 Electromagnetic Compatibility Requirements and Tests Moe the APAP unit away from other electronic euimet if you suspect the electronic equiprent is interfering with the cperatim of te APAP Yau should also move the APAP if it qos to be interfering with the qoeratic of other electrmic euimet 18 7410 00C QXD 10 1 99 7 40 AM Page 21 d Accessories Respironics of fers a full lire of accessories and plaet parts for use with the Tranguility Ato These accessories inclu our nasal masks available in dif ferent sizes aide support the Nasal Seal several styles of Haber anda chin strap Also available are high grace disposable filters and reolacerents for the starcard filter a hmidifier and an oxygen acininistration kit and the DC to AC Inverter Contact your Hare Care Dealer in orcer to dotain these accessories 19 7410 00C QXD 10 1 99 7 40 AM Page 22 d Limited Warranty Respironics Inc Respirmics warrants each new and use APAP system Model 7410 hereinafter referred as APAP system or Unit to be free from fects in material or workmenship for a period of twenty four 24 months from the initial date of purchase fran Respirmics For the purpose of th
12. interface in orcer to use this system FANYOF THESE COMPONENTS ARE MISSING OR DAMAGI Fl Gl D CONTACT RESPIRONICS AT ONCE 7410 00C QXD 10 1 99 7 40 AM Page 8 d Initial Use L Before each use inspect this unit for any sions of damage failure or wom parts Contact Respirmics or your Hare Care Dealer immediately to replace these parts Also dek to se if thee is ay misu in th area of this APAP unit ad dek the air inlets and outlets for any blockage or the presence of any dust or dirt If you find moisture dry the area thoromhly before use Rave any blockage and or dust or dirt from the air inlets or atles before each use Do not use a room hmidifier within six feet of this APAP unt 2 Plate the APAP unit in a den dry place reer an electrical atlet mt aombtrolled by a wall switch Do net use extension coms or electrical adapters Place this unit in an uoricht positim m a nightstand or cther suitable surface with the front facing you Positim ths APAP unit so that the vents are never blocked Never allow the APAP unit to be placed on a table or nichtstard that cannet safely spat the APAP unit For example cb net use a table or nightstand without good support that will tum oer if it is accidentally bumped 3 Comect the pwr cord to the AC power comector m the rear of the unit After checking to be sure that the Power switch is in the F position plug the cther edd of the power cord into the electrica
13. is Limited W arranty the initial cate of purchase frm Respirmics shall be the date of himet fron Respirmics to the initial ower of record Should the Unit be cefective in material or workmanship during the tem of this Limited W arranty Respironics at its gptim will repair or replace the defective system or carponent parts Replacarent units and or parts cb not carry a new werranty and shall only be warranted for the unexpired portion of the original Limited W araty Specifically excluded fram this Limited W arranty are ancillary items including but not limited to tubing filters nasal masks and headgear This Limited W arranty ches nct cover the APAP system or any compot part thereof i which is not gperated in accordance with the gperating instructicns contained in the Patient Marval as arenced from tine to time by Respironics or ii which is not maintained in accordance with the all aplicable service manuals regardless of whether such maintenance is designated as required or recommended maintenance This Limited W arranty shall be void and not aly A Tftre APAP system is not installed and omrected in accorchnce with the instructims fumished by Respironics B If the serial moter or letter idartificatim of the Unit or any coyponert part thereof has been altered cefaced or removed or if purchaser amt pae a bill of sale or other evicerce to verify the initial purdhase of the Unit C To defects
14. l atlet 7410 00C QXD 10 1 99 7 40 AM Page 9 4 Atad the APAP Foss to the Air Atlet Port cm the fiot of the APAP unt D Attach the Nasal Mask to the other ed of the APAP Hose G Refer to the Nasal Mask Instruction for infometim cn preparing the interface and making adjustments Do not block the hole bias flow port located at the base of the Mask 7 Tumtte APAP uit m using the Power switch located cm the cause air to begin flowing through the hose amd mask Power Ramp 8 Place the Nasal Mask mand adjust it to get rid of any leaks while maintaining comfort The pressure that you are receiving should allow you to locate and eliminate most leks Ler ty D As you beste in you will find thet the airflow will increase sligtly Tre unit s pressure cortroller adjusts to amstantly deliver the set pressure OS A 7410 00C QXD 10 1 99 7 40 AM Page 10 d 10 The Ramp button cm the front of the APAP unit may be used to redee the pressure to a lower level so that you o to slep easier f your physician has prescribed a higher starting pressure then you may not notice a recuctim in pressure when pressing the rap htta After the pressure is mie it will slowly increase to higher level over a fifteen minute period At the ed of this period the APAP unit will sense your breathing and change the pressure to meet your neees IL You may press the Ramp buttm a
15. ng Germany 9128 E 577 7410 00 JEM 9 27 99
16. o anther You will reed to use a plug acbpter in some locatios in orcer to comect the pwer cord into the available wall atlet When traveling by airplane cb not check your APAP system as baggage because it may be damaged Always carry this manual with your APAP system when you travel both for reference and for the notice that this is a medical device that requires regular use This notice may be helpful in dealing with Customs agents DC Operation Cperating the APAP system from a DC power source will require the use of a Respirmics DC to AC Inverter Part Number 7304 When connecting the DC to AC Inverter tm te APAP system Power switch OFF Cnet the AC power cord to the AC receptacile of the Inverter Then plug the DC to AC Imerter into a cigarette lighter type camsctor as fard in cars trucks boats etc Under nomal ganditians this unit will typically draw less than 3 meres The maximm draw for the inverter is listed in the DC to AC Inverter manual For 10 hours of DC to AC Imerter use this unit will typically oam less than 30 Amp hours 10 A 7410 00C QXD 10 1 99 7 40 AM Page 13 d Altitude Compensation The Trangulity Ato unit features a pressure transducer that measures pressure delivered to you and a microprocessor that makes the needed adjustnents if you travel to a dif feet elaatim The mit will autaratically adjust the blower speed to campensate for the new elevatim and deliver the prescribed
17. ose Be aware that irterference with the gperatim of this device can oxur from external sources Even though this device comtains methods and techniques that can provide protection from extemal sources of interference you should take the following precaution Keep the device at least three feet awy frm all electrical appliances such as TV sts electric blankets air comiticrers cordless telechones and cellular telechones The airflow for breathing produced by the APAP can be as mich as 1 8F 1 0 C higher than the tenperature of the rom Exercise caution if the roam temperature is wamer than YF 20 CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PHYSICIAN THIS APAP UNIT SHOULD BE USED ONLY UNDER THE SUPERVISION OFA LICENSED PHYSICIAN 7410 00C QXD 10 1 99 7 40 AM Page 7 d Set up and Use Unpacking and Inspection When you get your APAP system carefully gpen the box and unpack the system making sure that you have the following amporents and that nothing agpears to be ces Accessories are not incluc d in this basic package and can be obd separately Incluced with this system is the following L Tveo litv Auto Model 7410 nasal APAP uit AC Power Cord Carrying Case 2 3 Six foot Hose 4 5 Patient Cperating Instructions You will need a Nasal Interface Nasal Mask or other type of
18. t a latter time to start a new rap 12 In the moming or uhenever you wish to stop using the unit you can switch the unit off by switching the Power switch to the F position and removing the Nasal Mask Routine Use Regular use of the Tranguility Auto System irvolves a simple brief routine that is tailed here L Switch the Power switch to the ON position The Power indicator light will come Airflow will be felt coming at of the hose and mask The pressure will increase to a level that can be used to check your mask for leaks 2 Place the Nasal Mask with the Headgear and Hose attached on and adjust the Heacbear straps as needed Check the mask for any leaks and adjust as nesced 3 Ya may nw press the bam button to mae the pressure as you fall asleep If you do not wish to reduce the pressure you ney keep the pressure at this leel util the APAP unit begins to seek the pressure that you reed 4 If the Hose becomes disconnected from either the Nasal Mask or the APAP unit the unit may op into a Flow Limit m In this m the pressure will be led to prevent any damage to the unit Wen the corecticn is reestablished the pressure will etum to the level set by the Hore Care Dealer D Tf you reed to ot wp during the night tum the Power switch to the F position and remove the Mask When you wish to start using the APAP unit again replace the Nasal Interface and Heacbear and tum the unit ON Make sure to check for leaks as yo
19. th authorized maintenance instructions 3 Maintenance by anyone other than a factory authorized service reoresentative 4 Modification of the system or accessories or 5 Use of damaged or unauthorized carponents or accessories The Scope of this Manual This manual will show you how to gperate the Respironics Tranguility Auto Model 7410 nasal APAP system to provice positive pressure to the breathing passages Read thoroughly and understand this manual before attempting to use this system Introduction Nasal CPAP devices produce mall aarts of air pressure that is delivered using anasal mask This pressure coms the breathing passages to prevent blockages and to allow nmal breathing The Trangullity Auto system provides various levels of pressure The pressure delivered at any tine is based m your needs Tre APAP system makes receated measurements and tests of air flow and pressure to provide autaretic adjustment of the therapy The pressure is controlled by a microprocessor that menitors flow and a pressure transducer to provide accuracy and comfort and adjust to changes in elevation The Tranguility Auto M l 7410 system frm Respironics is a medical device that incluoss a microprocessor The microprocessor 2 7410 00C QXD 10 1 99 7 40 AM Page 5 receives informatio fron a flow sensor and pressure transducer and processes this infometim in orcer to adjust the blower to deliver the pressure that you require
20. tion of your APAP system make sure that you thoroughly understand the following Why your physician has prescribed the APAP syst The importance of using your APAP System each and every night How to properly connect the Hose to the device and to the Nasal Mask How to put on the Nasal Mask and Hadar to achieve a good fit The importance of not blocking te Ne Vet m t APAP unit How to operate the Ramp feature How to care for the Nasal Mask Headgear and Hose How to clean and or replace the filter How to check the gperatim of the nasal APAP unt What to if symptans of dostructive sleep apnea reappear What to do if you experience any ear mse or sins pain Annual Inspection Tt is recomended that a routine inspectim of the masal APAP system be performed at least once each year This service should Ich L Visually inspecting for any me 2 Replacing the filter 3 Verifying the pressure setting 4 Checking the comiticn of the Mask and Headgear Contact your authorized dealer for further information 15 A 7410 00C QXD 10 1 99 7 40 AM Glossary of Terms Page 18 W arcs in this glossary are italicized in their first use in the nial Anesthetics APAP Flow Sensor Humidifier Tnterfer ence Micrgprocessor Nasal Interface Oxygen Administratim Kit Pressure Transducer A dng th is used to control pain A
21. u have done previously If you wake up you may press the Ranp buttm to lover the pressure In the moming or when you are through using the unit tum the Power switch F and remove the Mask 7 The nasal mask headgear and hose should be removed fron the system for cleaning A 7410 00C QXD 10 1 99 Humidifier Use 7 40 AM Page 11 S An gptioal Humidifier is available through Respironics for use with the system The Hmidifier is a reservoir that fits under yor unit When properly filled with distilled wter it ads moisture to the airflow and mie masal dryness ard irritation Do not leave wter in the Humidifier when the hose is disconnected mall arounts of water may be blown out of the Humidifier if the blower accidentally cares m Follow the instructions included with the Humidifier regarding cleaning CONTACT YOUR DEALER FOR FURTHER INFORMATION Using Oxygen W ith This Systm Tt is important that you read understand and carefully follow these instructions regarding the use of oxygen with your Tranquility Auto syst CAUTION Oxygen is ayan the APAP sysi must not occur 1 Set up Attach the oxygen cam a prescription gas and should be used only under the super visioydirectim of a licensed physician While using tem and oxygen source must be keot away fra heat and open flare Smoking by anyone in the presence of Co tubing to the hose using the logos includ
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