BreatheX CPAP Device

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Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP DeviceUser ManualHoffman Laboratories, LLC.Chatsworth, CA 91311F-35

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Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsContentsINDICATIONS FOR USE . 7SAFETY INFORMATION . 7WARNINGS AND CAUTIONS . 7PRECAUTIONS FOR USE . 10INTRODUCTION . 11OVERVIEW . 11DEVICE DESCRIPTION . 12COMPONENTS . 12OPERATION . 14GETTING STARTED . 17CHARGING THE BATTERY . 17SELECTING AND ASSEMBLING THE MASK. 18ATTACHING THE TUBING AND MASK . 18POSITIONING OF THE BREATHEX DEVICE . 19CHANGING THE BATTERY . 20CHANGING THE SETTINGS . 22CONTROL PANEL . 22700-0002A

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsSETTING THE ALTITUDE COMPENSATION. 23TURNING RAMP ON/OFF . 24READING THE HOUR METER . 25USING THE BREATHEX DEVICE . 26CLEANING, MAINTENANCE, & STORAGE . 27GENERAL GUIDELINES . 27MASK . 27TUBING . 27OUTER CLOTH COVER . 27STORING THE BREATHEX DEVICE . 28AIR INLET FILTER . 28TROUBLESHOOTING . 29BREATHEX DEVICE SPECIFICATIONS . 32EMC STATEMENT. 34LIMITED WARRANTY . 36INDEX . 37ABOUT HOFFMAN LABS . 38REPLACEMENT PARTS 39

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Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideIndications for UseThe BreatheX device provides continuous positive airway pressure (CPAP)and is intended for the treatment of obstructive sleep apnea (OSA) inspontaneously breathing adults weighing at least 30 kg.NOTE: Federal law restricts this device to sale by or on the order of a physician.Safety InformationImportant! Before using the BreatheX CPAP device, carefully read this entiremanual, including the accessory directions for use as well as all precautionaryinformation.Warnings and CautionsThis manual will include warnings, cautions and notes throughout.A WARNING symbol indicates the possibility of serious injury to yourselfor others.A CAUTION symbol indicates the possibility of minor injury or damage tothe equipment.The following are warnings unless otherwise specified:-This device is not intended for life support.-The BreatheX device is a single patient use device; use only for your ownCPAP therapy as directed by your physician. Do not use this equipment untilyour sleep professional has set the pressure level.This CPAP system should be used only with CPAP masks recommended byyour physician or respiratory therapist. A mask should not be used unless theCPAP system is turned on and operating properly. The exhalation deviceshould never be blocked.Explanation of the Warning: CPAP systems are intended to be used withspecial masks with connectors which have vent holes or separate exhalation7

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsdevices to allow continuous flow of air out of the mask. When the CPAPmachine is turned on and functioning properly, new air from the CPAPmachine flushes the exhaled air out through the attached mask exhalationport. However, when the CPAP machine is not operating, enough fresh airwill not be provided through the mask, and exhaled air may be rebreathed.Rebreathing of exhaled air for longer than several minutes can in somecircumstances lead to suffocation. This warning applies to most models ofCPAP systems.-The BreatheX device should be used only with masks and connectors with asuitable exhalation port as recommended by Hoffman Laboratories, LLC, oryour sleep professional. A mask should not be used unless the CPAPmachine is turned on and operating properly.-At low CPAP pressures, the flow through the exhalation port(s) of the maskmay be inadequate to clear all exhaled gas from the tubing. Somerebreathing may occur.-Do not expose the battery to high temperatures (greater than 140ºF/60ºC)-Do not impact, pierce, crush or disassemble the battery. Dispose of thebattery thoughtfully, in compliance with local regulations, when battery isexhausted.-While wearing the device, you should NOT sleep facing down on the bed.-Keep the BreatheX device dry at all times. Do not use the unit where it cancome in contact with water.-This CPAP machine should be used only with tubing provided by HoffmanLaboratories or recommended by your sleep professional.-Contact your physician immediately if you experience problems such assinus drainage or discomfort, ear pain, daytime sleepiness, mood changes,memory lapse, nasal or airway dryness, irritability, or disturbance of yoursense of direction.-Do not smoke or use an open flame near a CPAP device.The following are cautions unless otherwise specified.8-Do not operate the unit without an air inlet filter installed.-Keep the air inlet clear at all times during operation.-Never insert any object into the air inlet, hoses, or mask.-Never operate the unit where the air inlet can be blocked.

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocuments-BreatheX CPAP Device User’s GuideNever block the small vent openings in the mask or exhalation port. Thisensures that exhaled air is purged to prevent rebreathing of carbon dioxide(CO2).-The airflow for breathing produced by the BreatheX device can be as muchas 6 ºF (3 ºC) higher than the temperature of the room. Exercise caution ifthe room temperature is warmer than 90 ºF (32 ºC).-This device is not intended to be used as a pillow or to replace a pillow.-Risk of electrical shock. Do not disassemble the battery charger of theBreatheX device. Refer servicing to qualified personnel.-Keep the BreatheX device and accessories away from heaters and heatedsurfaces.-Never operate the device if it is damaged in any way. Refer to an authorizedservice center.-Contact your equipment provider if the device malfunctions in any way. Onlyqualified service personnel should service the BreatheX device.-Hoffman Laboratories offers no instructions for use of supplemental oxygenwith its CPAP device.-Hoffman Laboratories does not recommend this unit to be used with oxygen.-Hoffman Laboratories does not recommend this unit to be used with ahumidifier-Do not sterilize or apply disinfectant to the BreatheX device.-Recharge the BreatheX device using only a battery charger supplied byHoffman Laboratories.-When changing the battery, follow the instructions in this manual. Use only abattery specified by Hoffman Laboratories.-Discontinue the use of the BreatheX device if you experience skin irritation orother discomfort during use.-If you intend to use the BreatheX device at altitudes above 6000 ft (1830 m),contact your equipment provider. Your pressure settings may need to beadjusted-Patients with implanted biomedical electronic devices such as cardiacdemand pacemakers should consult their physician before using this CPAPdevice.9

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsPrecautions for UseThe BreatheX CPAP device should be used with caution if you have any of thefollowing conditions:10-Pneumothorax-Severe bullous lung disease-Pathologically low blood pressure-Dehydration-Cerebrospinal leak/recent cranial surgery or trauma

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideIntroductionOverviewContinuous positive airway pressure (CPAP) has become the first line oftreatment for obstructive sleep apnea (OSA). CPAP delivers a prescribed level ofpressurized air to the user and acts as an air splint to hold the upper airway openduring use. This therapy is safe and effective, and has been shown to improvesleep quality, daytime alertness, and quality of life.Learning how the device functions and how to properly fit the mask helps toensure maximum comfort and use. It is also important that you have access to asleep professional in case you have questions or concerns regarding treatment.The BreatheX CPAP device is an innovative product that allows more freedom ofmovement during use. The device is a battery operated CPAP unit, meaningthere is no power cord attached to the unit during treatment. The device usesonly a short tube between the CPAP unit and the mask, causing less pulling onthe mask than with a conventional longer hose. This can improve the mask fitand comfort, especially while you change positions during sleep.For further information about sleep disorders:American Sleep Apnea Association (ASAA)1424 K Street NW, Suite 302Washington, DC 20005Phone: (202) 293-3650Fax: (202) 293-3656www.sleepapnea.orgNational Sleep Foundation (NSF)1522 K Street, NW, Suite 500Washington, DC 20005Phone: (202) 347-3471Fax: (202) 347-3472www.sleepfoundation.org11

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsDevice DescriptionComponentsThe BreatheX CPAP device includes the following components:1. CPAP DeviceOffering a unique design and fit, the BreatheX device rests comfortablyover the user’s shoulders.This device is not intended to be used as a pillow or to replace a pillow.Support the head normally as you would during sleep.2. Tubing/Mask SystemThe mask and tubing connect to the device’s air outlet connector. Fordetailed information about the mask, refer to the manufacturer’sdocumentation.3. Air Outlet ConnectorThe air outlet connector connects the tubing to the CPAP unit.4. Battery ChargerThe battery charger is used to charge the CPAP unit’s battery from an ACoutlet when the device is not in use.The battery charger may be connected to a 12V DC source using acommercially available inverter.5. Carry BagA carry bag is provided with the BreatheX device.12

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Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsOperation6. On/Off ButtonThe On/Off button is a square black button located on the Control Panel.Pressing this button turns the device on or off.7. Set ButtonUse this button primarily for moving through menus and accessing the ramp,altitude compensation, and hour meter settings.8. Change ButtonThis button works in conjunction with the Set button and allows settings to beturned on/off.9. Battery Status Indicators (LED’s)The Battery Status Indicators display the current level of the battery charge: 3 LEDs 95% charge 2 LEDs 75% charge 1 LEDs 60% (or less) chargeNOTE: It is recommended that the device only be used when all 3 LEDs arelit.10. Low Battery AlarmThe device comes with a low battery alarm. If the battery charge is reducedsuch that only 10 minutes of operation are left on the charge, then an audiblealarm will sound. This alarm can be turned off by pressing the On/Off button.11. Charge PortThe battery charger plugs into the Charge Port to recharge the BreatheXdevicer. When the device is charging, the battery status will display on thecharger.NOTE: When you are charging the device, you cannot activate the On/Offbutton until the battery charger is unplugged from the Charge Port.14

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s Guide12. Air Inlet PortAir enters the CPAP unit through the air inlet port.13. Air Inlet FilterThe air inlet filter covers the air inlet port.15

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Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideGetting StartedRemove the BreatheX device from its packaging. Be sure all the components areincluded and carefully examine each component for any damage. Thecomponents consist of the following:-BreatheX CPAP unitTubingAir outlet connectorAC battery chargerCarry bagCharging the BatteryConnect the battery charger cord to the BreatheX device’s Charge Port and thenplug the other end of the battery charger into a wall outlet.Once the battery is charged, simply unplug the CPAP unit from the charger.It will take approximately 5 hours to fully charge the battery from a dischargedcondition. You should fully charge the battery before the first use.The battery should be recharged daily or after each use.When the battery is fully charged it will provide approximately 11 hours of use at10cm H2O pressure.During battery charging the indicator light on the charger will change from red toorange to green. A green indicator light indicates that the device is fully chargedand ready for use.17

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsWhen the device is turned on, the LEDs will light up and indicate the current levelof the battery charge-3 LEDs 95% charge-2 LEDs 75% charge-1 LEDs 60% (or less) chargeNOTE: While the battery is charging, the device cannot be turned onIt is recommended that the device only be used when all 3 LEDs are lit.If the battery charger light is not changing as indicated within the 5-hour period,the battery may need to be replaced.The device does have a low battery alarm. If the battery charge is reduced suchthat only 10 minutes of operation are left on the charge, then an audible alarmwill sound. This alarm can be turned off by pressing the On/Off button.The battery charger may be connected to a 12V DC source using a commerciallyavailable inverter.Selecting and Assembling the MaskYour sleep professional will supply a mask for use with the BreatheX device.Please use the mask according to the manufacturer’s instructions.Attaching the Tubing and MaskConnect the tubing to your mask, and then rotate the air outlet connector to thedesired position. The air outlet connector can accommodate a range of tubingpositions to make mask fit more comfortable and stable. The optimal position ofthe swivel joint should be determined during mask fitting. Ensure that the tubingis firmly connected to the mask and air outlet connector.18

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuidePositioning of the BreatheX DeviceYou have several options for positioning the BreatheX device using either the 8”tubing or 21” tubing, and you may choose whichever is most comfortable for you.We encourage you to try the BreatheX device in several positions to determinewhat works best for you.The device may be placed comfortably over your shoulders and closed at thefront with the fastener strap as shown below.With the 21” tubing, you may use the BreatheX device in a number ofpositions as suggested in the diagrams below.19

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsNOTE: The device was not designed to be used in place of a pillow. Your pillownormally used during sleeping should provide any needed head support. If youfind that the BreatheX device interferes with the support provided by your pillow,please consult your sleep professional.While wearing the device, you should NOT sleep facing down on the bed.Changing the BatteryThe BreatheX device allows you to replace the battery as required. The deviceshould be turned off before the battery is removed.Lift up the device’s outer cloth, pull out the battery pack, and insert the newbattery. To remove or insert the battery, use the tabs provided on the top andbottom of the battery box.You may also purchase additional batteries in order to operate the device formultiple evenings when it is not possible to recharge the batteries, for example ifyou intend to use the device on a camping trip.Do not expose the battery to high temperatures (greater than 140ºF/60ºC).Do not impact, pierce, crush or disassemble the battery.Recharge the BreatheX device using only a battery charger supplied by HoffmanLaboratories.20

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideWhen changing the battery, follow the instructions in this manual. Use only abattery specified by Hoffman Laboratories.DC inverters (120 watts minimum), enabling the charger to be used with a 12VDC outlet, are commercially available.The user may also purchase additional batteries in order to operate the devicefor multiple evenings when it is not possible to recharge the batteries, forexample if he or she intends to use the device on a camping trip.21

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsChanging the SettingsControl PanelLocated on top of the CPAP device, the Control Panel lets you turn the deviceOn/Off and, using a combination of buttons, change the settings, as well asreview battery charge status.When the device is turned on the LCD will show the current software version, thealtitude compensation setting, the ramp setting and usage hours, and will cyclethrough these settings 3 times. The LCD will then go blank.Use the main display to change the settingsNOTE: The display options will only appear when the device is powered on.NOTE: When the device is being charged, it cannot be turned on/off. The batterycharger must be disconnected from the device’s Charge Port before operatingthe device.22

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideSetting the Altitude CompensationThe Altitude Compensation should be set to the Off option if the CPAP device isto be used at altitudes from 0-3000 ft (914m). For altitudes between 3000 feet(914m) and 6000 feet (1830m), the Altitude Compensation should be On. If youintend to use the BreatheX device at altitudes above 6000 ft (1830 m), contactyour equipment provider.1. Turn the device on by pressing the On/Off button. The LCD will scrollthrough the altitude compensation, ramp and hour settings; the LCD will thenturn off.2. At any time after turning the device on, press and hold the Set button for 3seconds until Alt Comp is displayed (airflow will stop at this time).3. To change the option, press the Change button.4. To save this option, press the Set button 3 times, which will then turn on theairflow, scroll through the settings, and turn off the LCD. The device is thenready to use.23

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsTurning Ramp On/OffThe ramp feature allows your treatment to start at a lower pressure than theprescribed pressure. The pressure will increase to the prescribed pressure over a15-minute time period.241.Turn the device on by pressing the On/Off button. The LCD will scrollthrough the altitude compensation, ramp and usage hours settings. TheLCD will then turn off.2.At any time after turning the device on, press and hold the Set button for 3seconds until Alt Comp is displayed (airflow will stop at this time).3.Press the Set button once until the Ramp option is displayed.4.To change the option, press the Change button.5.To save this setting, press the Set button twice, which will then turn on theairflow and scroll through the settings. The device is then ready for use.

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideReading the Hour MeterThe hour meter will display total use time, information that may be requested byyour sleep professional.As the LCD cycles when the device is turned on, the usage hours will bedisplayed. If you need to see the detail again, either turn the device off and onagain, or follow these instructions.1. Turn the device on by pressing the On/Off button. The LCD will scrollthrough the altitude compensation, ramp and usage hours settings; the LCDwill then turn off.2. At any time after turning the device on, press and hold the Set button for 3seconds until Alt Comp is displayed (airflow will stop at this time).3. Press the Set button twice until the Usage Hours option is displayed.4. After reading usage hours, press the Set button once, which will then turn onthe airflow and scroll through the settings. The device is then ready for use.25

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsUsing the BreatheX DeviceWhen you are ready to start treatment, be sure your mask and device arecomfortably positioned, and press the On/Off button to start delivering the airpressure. If you are using the ramp option and need to restart it, just press theOn/Off button twice. The device will turn off and on again.If you need to get up during the night, you do not need to disconnect the mask ordevice.Diagram of person in bed with device on.26

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideCleaning, Maintenance, & StorageGeneral GuidelinesTo prolong the life of your BreatheX device, be sure to properly clean and store itaccording to the following guidelines.MaskIt is recommended that you clean and store the mask according to the maskmanufacturer’s instructions.TubingWash the tubing daily in warm water and a mild detergent, such as unscentedPalmolive. Rinse the tubing thoroughly with cold water and allow the tubing to airdry out of direct sunlight before re-use. . The tubing should be inspected aftereach cleaning, and the tubing should be replaced if it contains cracks,tears, orextensive discoloration.Do not use bleach, chlorine, alcohol, aromatic based solutions, moisturizing orantibacterial soap, or scented oils to clean the tubing. These solutions may causedamage and/or reduce the life of the product.Outer Cloth CoverTo change or wash the BreatheX device’s outer cloth cover, first remove the airoutlet connector by turning its locking screw one-half turn anticlockwise andremoving the air outlet connector. Then unzip and remove the cover.The outer cover should be hand washed in lukewarm water with a standarddetergent, such as Tide, rinsed in cold water and dried flat, out of direct sunlight.The outer cover should be washed at least once a week.NOTE: The inner cover and contents should not be removed or washed.27

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsStoring the BreatheX DeviceStore the device in a cool dry place, away from temperature extremes andhumidity.Keep the entire unit out of direct sunlight and heat as they may cause theproduct to deteriorate.Air Inlet FilterTo prolong the life of the BreatheX device, the disposable air inlet filter needs tobe replaced periodically, preferably every month. If the device is frequentlyexposed to dust, change the filter more frequently.Open the mesh compartment on the left side of the device and remove the filter.Then replace with a new filter and close the compartment.To prevent damaging the device or rendering the filter inoperable, do not washthe filter strip. Also, in humid environments, fungi could grow inside the filter. Besure to inspect and replace the filter according to the instructions.28

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideTroubleshootingProblemPossible CauseActionDevice will not operate.Batteries discharged.Check battery status LEDs andrecharge if necessary.Sore or inflamed skinunder the maskBattery charger is stillconnected to device andis charging.Disconnect charger fromdevice.Mask is applied too tight.Adjust the mask for a looser fit.Reaction to maskmaterialDevice operates for tooshort a time (not a fullnight’s sleep).Contact your sleep professionalfor other mask choices.Batteries are not chargedsufficiently.Be sure to charge batteries aminimum of 4 hours after eachuse.Battery life is depleted byuse.Contact your service provider toreplace the battery.Battery Charger indicatorlight does not changefrom red to orange togreen.Battery life is depleted byuse.Contact your service provider toreplace the battery.Battery Status Indicators(LEDs) do not all light upafter system has beenfully charged.Battery life is depleted byuse.Contact your service provider toreplace the battery.29

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsProblemPossible CauseActionSystem fault indicationon main displayMask and tubing are notproperly connected.Make sure mask and tubing areproperly attached, and recyclepower button. If the problem stillpersists, contact your servicecenter about repair of your unit.Unit has internalmalfunction.The device is deliveringair that is too warm.The room temperature istoo high.The air inlet filter may bedirty. The air inlet isclogged.The device is notdelivering the correctpressure.The ramp is activated.It is being used ataltitude.Discomfort that is due toa feeling that thepressure is too highSet pressure of BreatheXdevice.Contact your service centerabout repair.Lower the thermostat for theroom. Make sure the BreatheXr is away from any heat source.Clean or replace the filter asdescribed in this manual’s AirInlet Filter section. Move anylinen, bedding or clothing awayfrom the BreatheX device.Check whether the rampfunction is on. Refer to thismanual’s Turning Ramp On/Offsection.Need to set the altitudecompensation setting.Adapting to the nasal pressurecan take a while. Try using theramp function. This will slowlyincrease the pressure over aperiod of 15 minutes.If the pressure is not suitablefor you, contact your sleepprofessional.30

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideProblemPossible CauseActionAudible alarm issoundingBattery has reached astate of charge which is10 minutes or less.Pressing On/Off button will turnoff alarm and the unit. Thedevice should then be put onHoffman supplied charger tofully charge unit.31

Click Here & UpgradeExpanded FeaturesUnlimited PagesPDFBreatheX CPAP Device User’s GuideCompleteDocumentsBreatheX Device SpecificationsThe following are specifications for the BreatheX CPAP device:BreatheX Device PerformancePressure range5 cmH2O to 12 cmH2O adjustable byincrements of 0.5 cm H2OMaximum achievable pressure at thepatient connection port under single faultcondition30 cmH2ORamp time0 or 15 minutes – selectableSound level measured in accordance withISO 17510-1:200131 dBAMaximum sound level31 dBA at 10 cmH2OOperating Period11 hours with operation at 10 cm H2OPhysical CharacteristicsDimension (W x H x L)14 x 12 x 4 inches (35.6 x 30.5 x 10 cm)Weight4 lbs (1.8 kg)Transport and Storage ConditionsTemperature Range-20 C to 60 C (- 4 F to 140 F)Relative HumidityUp to 95% without condensationAtmospheric pressure range500 hPa to 1060 hPa(1 hecto-Pascal 1cmH2O)32

Click Here & UpgradePDFCompleteExpanded FeaturesUnlimited PagesDocumentsBreatheX CPAP Device User’s GuideConditions of UseTemperature 5 C to 38 C ( 41 F to 100

manual, including the accessory directions for use as well as all precautionary information. Warnings and Cautions This manual will include warnings, cautions and notes throughout. A WARNING symbol indicates the possibility of serious injury to yourself or others. A CAUTION symbol indicates the possibility of minor injury or damage to the .

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instruction method where learners of different levels form small groups and work together towards a specific objective. Learners take the responsibility of their own learning and of those in the group so the success of one member is a success of all members. Piaget (1932, in Webb, 2009: 3) argues that cognitive conflict leads to higher levels of reasoning and learning. When a student notices a .