tiers 1-3 900 series patient manual - active forever · 2016-07-06 · tiers 1-3 900 series patient...
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CAUTION: USA Federal law restricts this device to sale by or on the order of a physician.
21148 Rev. E
RemRest™
Tiers 1-3 900 Series
Patient Manual
SIZE4.7" H X 8.6" W X 9.4" D11.9cm H x 21.8cm W x23.9cm D
WEIGHT<5lb 2.3kg
PRESSURE RANGE3.5 CMH2O TO 20 CMH2O
RAMP TIME5 TO 50 MINUTES
ELECTRICAL REQUIREMENTS100-240V~, 50/60 HZ or12 VDC, 40 Watts
OPERATING TEMPERATURERANGE41°F to 104°F ( 5°C to 40°C)
STORAGE ANDTRANSPORTATIONTEMPERATURE RANGE-4°F to 140°F (-20°C to 60°C)
STORAGE ANDTRANSPORTATION HUMIDITY RANGE 10% TO 95% RH non-condensing
SOUND LEVEL<30 dba (@10cmH2O, 1 meter from CPAP)
Specifications 2
Introduction 3
IEC Symbols 4
System Components 5
Instructions for Use 6
Save These Instructions 7
Accessories 15
RemRest Care 16
Troubleshooting 18
Travel Information 20
Safety 21
Warranty 22
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Table of Contents
Introduction
In 1993, the National Commission on SleepDisorders Research stated that as many as18 million Americans may have signs andsymptoms of Obstructive Sleep Apnea(OSA). OSA is a condition where the upperairway relaxes during sleep causing the airway to obstruct. Apnea is a word meaning “without breath.” People diagnosedwith OSA stop breathing repeatedly duringsleep which can result in extreme exhaustion and damage to vital organs.
HOW DOES THE REMREST HELP?The RemRest is a CPAP (Continuous PositiveAirway Pressure) device which providesconstant non-invasive air pressure to yourupper airway causing the airway to stayopen. In doing so, you are able to sleepwith no interruption allowing your body torest and regenerate. Small, adjustable,lightweight and quiet, the RemRest is ourcontribution to reaching your dreams.
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Equipment Classification with respect to protection from electric shock: Class II
Degree of protection from electric shock: Type BF
Degree of protection against ingress of liquids: Ordinary
Equipment not suitable for use in the presence of flammable anaesthetic mixturewith air or with nitrous oxide.
Mode of operation: Continuous
Attention, consult accompanying documents
Type BF equipment
Direct Current
Alternating Current
Disposal of electrical andelectronic equipment (WEEE)
Model number P/N
Serial number S/N
IEC Symbols
4 RemRest
REF
SN
System Components
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IMPORTANT SAFEGUARDSFollow all basic safety precautions. Pleaseread instructions before using. Precautionsare not limited to the safety informationprovided. Important information is highlighted as indicated:
WARNINGImportant safety information for hazardsthat might cause serious injury.
CAUTIONImportant information to prevent damageto the device.
NOTEInformation requiring special attention.
Instructions For Use
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Save These Instructions
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The RemRest system consists of a CPAP flowgenerator, tubing and a nasal interface.Other accessories may be used and areavailable as needed from your care provider.Comfortable fit is very important. Please discuss with your care provider to determinethe best nasal interface that will meet your needs.
WARNINGDo not under any circumstances plug anyvent holes on your mask. These are forproper exhaling and plugging them mightcause carbon dioxide buildup. This warningdoes not pertain to any capped holes on yourmask. These are for diagnostic purposes andmay remain plugged.
WARNINGThis CPAP unit should be used only withmasks (and connectors) recommended bythe manufacturer of the CPAP machine, your physician, or respiratory therapist. A maskshould not be used unless the CPAP is turnedon and operating properly.
Explanation of the Warning: This CPAP unit isintended to be used with special masks (or connectors) which have vent holes to allow continuous flow of air out of the mask. Whenthe CPAP unit is turned on and functioningproperly, new air from the CPAP machineflushes the exhaled air out through the maskvent hole. However, when the CPAP machineis not operating, enough fresh air will not beprovided through the mask, and exhaled airmay be rebreathed. Rebreathing of exhaled
air for longer than several minutes can insome circumstances lead to suffocation.This warning applies to most models ofCPAP units.
CAUTIONAt low CPAP pressures, the flow through theexhalation port may be inadequate to clearall exhaled gas from the tubing. Somerebreathing may occur. This warning appliesto devices with rebreathing testing whichdemonstrates that rebreathing may occur atlow pressures within the operating pressure range of the device.
CAUTIONThe air flow for breathing produced by thisdevice can be as much as 4°F higher thanthe temperature of the room. Cautionshould be exercised if the room temperatureis warmer than 90°F. (This caution appliesto devices in which the temperature of theoutput of the device is more than 3°F aboveambient under typical test conditions.)
REMREST TUBING SET-UPSmooth-bore tubing is designed to deliverair pressure to your nasal interface. Attachone end of your tubing to the RemRest air outlet. The other end of the tubing is usedfor the nasal interface. See diagram onpage 5. When humidifier or oxygen equipment is used with the RemRest system, please follow the user instructionsprovided with the humidifier or oxygenequipment to set up the system. For bestresults, it is recommended you use theRemRest Heated Humidifier with this device.
WARNINGThis device is not suitablefor use in the presence ofa flammable anaesthetic mixture with air or withnitrous oxide.
WARNINGThis is not intended for use as a life supporting or life sustaining device.It is intended for use on spontaneously breathing adults.
WARNINGAll settings of yourRemRest are to be adjusted by authorizedpersonnel. Settings are theresult of physician supervised diagnosis andmust not be changedwithout physician authorization.
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RemRest Flow Generator Operation• Place the RemRest device on a flat, sturdy
surface with the back of the unit awayfrom heating vents, radiators, curtainsand other objects that could restrict airintake.
• Secure the mask, connect the tubing, andprepare any accessories you might useprior to operation of the RemRest device.
It is recommended that the device be leftplugged in when not in use. This is especiallyhelpful for Tier 2 and 3. Tier 2 does not havea battery and therefore only “remembers”plugged in time with regards to time usedand time plugged in. Tier 3 has an internalbattery and therefore will “remember” all ofits times without being plugged in. However,it will save the battery if the unit remainsplugged in when not being used, i.e. duringthe day.
RemRest Tier 1There are two options to provide power tothe CPAP: AC or DC power.
1. For AC Power, plug one end of the ACpower cord into the AC inlet plug locatedon the back of the RemRest device. Plugthe other end into the wall socket. Go toStep 3.
2. If using the DC power cord with autoadapter for operation of the RemRest in amotor vehicle or recreational vehicle,insert the plug into the DC jack located onthe back of the CPAP and plug the otherend into the vehicle’s 12V DC outlet.
NOTEThe device will draw asmall amount of powerwhen plugged in but not “On”.
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3. The two green lights (on/off light andramp light) will turn on for two secondsthen will remain off until the motor/bloweris turned on and/or the ramp function isturned on. If the ramp function was usedthe last time the device was operated,then the ramp light will stay on.
4. To turn on a Tier 1 device, press theon/off button. The on/off light will turn onand the CPAP device will accelerate to its prescription air pressure setting. If theramp function is turned on (the ramp lightis on), then the CPAP device will reach theprescription air pressure setting accordingto the preset ramp time.
Your physician may have prescribed aspecific ramp time. In this case, donot attempt to adjust the ramp setting or operating the unit withoutthe ramp function turned on withoutconsulting your physician.
ON/OFFLIGHT RAMP
LIGHT
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5. If the ramp function is not already set,simply pushing the ramp button on oncethe unit is running will not start the rampfunction. To initiate the ramp function:• If the device motor is running, turn off
the device by pushing on/off button(ramp light and on/off light turn off)
• Push the ramp button on (ramp lightturn on)
• Turn ON the device by pushing on/offbutton (ramp light and on/off light on).The CPAP will start at the prescribed lowsetting and accelerate through the ramptime to prescribed pressure setting.
6. To turn off the ramp function: While theunit is running, push the ramp ON/OFFbutton. The ramp light will go out and theunit will go to the prescription pressuresetting. When the device is turned onagain, the RemRest will accelerate to the prescription setting without the ramp.
7. Turn OFF the device (ramp light andon/off light turn off) by pressing theON/OFF button.
RemRest Tier 2 & Tier 3
There are two options to provide power tothe CPAP: AC or DC power.
1. For AC Power, plug one end of the ACpower cord into the AC inlet plug locatedon the back of the RemRest device. Plugthe other end into the wall socket. Go toStep 3.
2. If using the DC power cord with autoadapter for operation of the RemRest in a
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motor vehicle or recreational vehicle,insert the plug into the DC jack located onthe back of the CPAP and plug the otherend into the vehicle’s 12V DC outlet.
3. The green light (on/off light) will turn onfor two seconds then will remain off untilthe motor/blower is turned on. The LCDwill also turn on completely (as shown inSymbols Definition section on page 13)for 2 seconds and will then switch to display the prescription pressure. The display will illuminate and show the pressure setting and icons based on thelast settings saved. If the ramp functionwas used the last time the device wasoperated, then the ramp icon will be illuminated on the LCD indicating theramp mode is still active. The display willshow the prescription pressure setting incmH2O. The PRES icon will be on.
NOTE: For Tier 3 only, the TIME icon on theLCD may be flashing. See the AUTO MASKCHANGE section on page 15.
ON/OFFLIGHT
NOTERunning the RemRest offyour vehicle battery (12V DC) without theengine running may drainthe battery.
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SYMBOLDEFINITIONS
LOW Used in technician/dealer mode only
HI Used in technician/dealer mode only
TIME Used in the technician/dealer mode only
USE Used in the technician/dealer mode only
RAMP Icon will flash during ramp setting orwill stay on once ramp is set and theramp mode is in use
RUN The display will show the time the motor/blower has been running. May only be reset in the dealer/technician mode
PRES The display will show the prescription pressure setting
HUMD Not currently available.
4
4. To turn on the device, press the on/offbutton. The on/off light will turn on andthe CPAP device will accelerate to its prescription air pressure setting.• If the ramp function is not turned on,
then the Ramp icon will not be shownon the LCD and the prescription willbe shown.
• If the ramp function is turned on,then the RemRest will reach the prescription air pressure settingaccording to the preset ramp time.
• In the ramp mode, the display willshow the increasing pressure until the prescription pressure is reached.
Your physician may have prescribed a specific ramp time. In this case, do notattempt to adjust the ramp setting or operating the unit without the ramp function turned on without consulting your physician.5. If the ramp function is not already set,
changing the ramp setting to “ON” whilethe CPAP device is running will not startthe ramp function. To initiate the rampfunction:• Press the mode button once, the
ramp icon should flash.• Press the up arrow or down
arrow to toggle the setting on and off.The display will show ON or OFF toindicate whether the ramp function ison or off.
• If the device motor/blower is running,turn OFF the device.
• Turn ON the device. The CPAP will startat the prescribed low setting and accelerate through the ramp time tothe prescribed pressure setting.
6. To view the total running time of themotor/blower, press the mode button asecond time or until the TIME icon is on. The running time in hours willshow on the display. Press mode againto return the display to the prescribedpressure setting.
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A wide variety of accessories such asmasks, headgear, tubing, and humidifiersare available from evo and can be purchased through your local care provider.Instructions on how to assemble the purchased accessories will be found in theaccessory package.
AUTO MASK CHANGEFor Tier 3 only, the TIME icon on theLCD will flash after 90 days. Please contactyour care provider for further assistancewith obtaining a new mask.
Accessories
7. To view the “data code”, push and holdthe MODE button for three seconds, acode will show up on the display for fiveseconds and the on/off light will flash.No other icons will turn on. After fiveseconds, the display will return to theprescribed pressure setting and theon/off light will stop flashing.
8. Turn OFF the device (the on/off light willturn off and the motor/blower will stoprunning). The display will remain on, ifthe device remains plugged in.
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REMREST CLEANINGTo clean the RemRest device, turn OFF theunit and unplug it from the power source.Using a damp cloth, wipe the unit cleanmaking sure no liquids enter the deviceitself. Allow the unit to completely dry priorto using.
REMREST INLET FILTERThe RemRest filter is located on the back ofthe device and is reusable. To make sureyour device continues to provide optimumperformance, check your filter weekly andclean the filter once per month (or sooner if dirty).
To clean the filter, remove the filter fromthe unit and wash it in warm water untilthe water runs clear. Allow the filter tocompletely air dry. Once the filter is dry,return it to its housing.
RemRest Care
WARNINGMake sure to unplug thedevice from the wall outletor DC power source beforecleaning as failure to do somay cause electric shock.
CAUTIONNever place or submergethis unit under water orplace near a water sourceof any kind. Do not allowliquids to enter into thisdevice. Doing so mayresult in device damage.
CAUTIONDo not clean RemRestdevice with alcohol oralcohol based products.
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MASKS, NASAL INTERFACES,TUBING AND HEADGEARConsult the user instructions provided withthe accessories to determine the recommended cleaning method. Otherwise,these items may be washed as needed. To clean, remove the tubing and headgearfrom the nasal interfaces. Using a solutionof warm water and mild dishwashing detergent such as Dawn™, wash each itemindividually, rinse with clean, warm tapwater and allow the accessory to air drybefore using. Hang the tubing vertically toallow the water to drain and dry completely.
CAUTIONDo not place masks, tubing, headgear orother nasal interfaces in the dishwasher.Some automatic dishwashing soaps containingredients which may damage these items.Alcohol or alcohol based cleaners may also damage these accessories.
SYSTEM SERVICEDo not attempt to open or remove theouter covers of the CPAP as there are nouser-serviceable internal components. Donot attempt to repair this unit on your ownas this may cause further damage and willvoid the warranty. If service is required,have your care provider return this deviceto an authorized evo service center.
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Problem Possible Causes RemediesUnit wi not run Unit not p ugged into a P ug unit into a “ ive” out et
“ ive” out et
Power cord not connected Firm y attach AC or DC cord proper y
No air comes out whi e Air fi ter is p ugged C ean or rep ace the fi terthe unit is on
Air in et is b ocked Remove obstruction orreposition the unit so thein et is not b ocked.
F exib e hose not connected Connect f exib e hose to to device. device.
Unit p ugged in but device Verify the “green” ight is not turned on on; if not, push the on/off
button
Symptoms of Obstructive Air fi ter is p ugged C ean or rep ace the fi ter, S eep Apnea have remove any possib ereoccurred obstructions or reposition
the device
Incorrect pressure setting Contact your care provider
Your Obstructive S eep Apnea Contact your physician, youconditions have changed may need to be retested
Dry or sore eyes The mask or nasa interface are Readjust your mask, nasaeaking or headgear adjustment interface or headgear. If is causing a eak prob em persists, contact
your dea er or care provider
Troubleshooting
Problem Possible Causes Remedies
Irritated skin where Headgear is too tight Loosen the headgearmask meets the face
Poor mask fit Contact your dealer
Allergic reaction to mask Try a different material or material use a barrier between
the mask and face.Contact your dealer and physician
Cold nose Room temperature is too Raise the room cold air cools as it travels temperature and placethrough the tubing tubing under covers to
reduce loss of heat
Nasal, sinus, ear pain Nasal reaction to air flow, Discontinue use.or runny nose sinus infection or nasal Contact your doctor.
congestion
Dryness/burning in Room temperature too high Decrease roomthroat temperature
Insufficient room humidity Increase room humidity. If problem persists,contact your dealerregarding humidificationdevices
Tier 2 & 3 Only: Green The internal data codeLight starts to blink must be read by the (3 seconds on/1 technician. Contact yoursecond off) dealer for further
instruction
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20 RemRest
A carry bag is provided with the RemRestsystem and is suitable for carrying the unitand most accessories you might have. Thisbag is to be used as carry-on luggageonly. Damage might occur to the unit ifchecked as regular luggage.
RemRest is suitable for operation in most electrical power environments ranging from 100 to 240 Volts of alternating current(VAC), 50 and 60 Hertz or 12V DC whenusing the DC power cord. Appropriate international plug adapter(s) may need tobe used and they differ from country tocountry. The adapter(s) may be purchasedin most retail and/or travel stores. Besidesthe plug adapter, no further changes tothe machine are necessary.
Travel Information
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Safety
ELECTROMAGNETIC SUSCEPTIBILITYThis device meets therequirements of IEC 60601-1-2 which describesrequirements for electromagnetic compatibility (EMC) ofmedical devices. Thisincludes immunity toradio frequency electricfields and electrostatic discharge, in addition tothe other applicablerequirements of the standard. Compliance withEMC standards does notmean a device has totalimmunity; certain devices(cellular phones, pagers,etc.) can interrupt operation if they are usednear medical equipment.
WARNINGThis unit is shipped with adust cover on the DB9 connector. This cap shouldbe left on except whenthe connector is in use.
WARNINGThis device is not suitablefor use in the presence ofa flammable anaesthetic mixture with air or withnitrous oxide.
OXYGEN SAFETYOxygen is a prescription drug and shouldonly be administered under the supervisionof a physician.
Oxygen supports combustion. To avoid possible physical injury do not smoke orplace the device near any heat source whileusing your CPAP with oxygen.
WARNINGIf oxygen is used with this CPAP machine,the oxygen flow must be turned off whenthe CPAP machine is not operating.
Explanation of the warning: When the CPAPdevice is not in operation and the oxygenflow is left on, oxygen delivered into theventilator tubing may accumulate within theCPAP machine enclosure. Oxygen accumulated in the CPAP machine enclosurewill create a risk of fire. This warning appliesto most types of CPAP machines.
NOTEAt a fixed flow rate of supplemental oxygenflow, the inhaled oxygen concentration willvary, depending on the pressure settings,patient breathing pattern, mask selection,and leak flow rate. This warning applies tomost types of CPAP machines.
NOTEThere is no other expresswarranty. Implied warranties, including thoseof merchantability and fitness for a particular purpose, are limited to theduration of the express limited warranty and to theextent permitted by lawand all implied warrantiesare excluded. This warrantydoes not cover providing a loaner device, compensating for costsincurred for device rental,or labor costs incurred inrepairing or replacingdefective part(s).
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Warranty
ELECTRICAL SAFETYDo not submerse this product in waterunder any circumstances.
Place this product away from the reach ofchildren.
FOLLOW ALL BASIC SAFETY PRECAUTIONS. PRECAUTIONS ARE NOT LIMITED TO THE SAFETY INFORMATION PROVIDED.
evo warrants the RemRest to be free fromdefective workmanship and materials for a period of 3 years from the date of purchase. Check with your care provider for more details. This warranty is limited to the care provider. Any defective part or assembly will be repaired or replaced, atthe sole discretion and determination ofevo if the unit has not been misused or tampered with during the warranty period.Normal maintenance items and disposable components as outlined in this manual arenot covered by this warranty. Shippingcharges, if any, shall be paid by the purchaser.
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Notes
EC REP
MDSS GmbHSchiffgraben 4130175 Hannover, Germany