Advanced Circulatory ResQCRP ResQPUMP ACD-CPR Instructions For Use Manual
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ETCO2The ResQCPR™ System includes the following two components:1. ResQPUMP® ACD-CPR Device2. ResQPOD® ITD 16ResQCPR System Component:ResQPUMP ACD-CPR DeviceDEVICE DESCRIPTIONThe ResQPUMP ACD-CPR Device (hereafterreferred to as ResQPUMP) (Figure 1) is amulti-use, hand-held device that includes asuction cup for attachment to the patient’schest (with clothing removed), and a handlefor the rescuer to hold onto.The ResQPUMP enables the rescuer to perform active compression-decompression cardiopulmonary resuscitation (ACD-CPR), which differs fromstandard CPR. During ACD-CPR, the chest is actively re-expanded (decompressed) after eachcompression; with standard CPR, the chest re-expands passively. The ResQPUMP design allowsthe operator to use the same body position and compression technique as in standard CPR.Active chest decompression is achieved when the rescuer maintains a firm grip on the ResQPUMP,bends at the waist and pulls his or her body weight upwards after compression. The suction cupsticks to the chest and transfers the lifting force to the middle of the ribcage. Compression forceis transferred to the chest as in standard CPR via the device’s piston. The handle includes a forcegauge that displays the forces exerted during both chest compression and decompression (chestwall recoil). The ResQPUMP has a battery-powered metronome integrated into the handle to guidethe rescuer in the appropriate compression/decompression rate. The metronome emits two-tonesignals of the same duration, one low and one high pitch tone. The signal (set at 80/minute)guides the rescuer to compress and decompress at the appropriate rate and for equal amounts oftime (50% duty cycle).If suction difficulties occur, adjust the angle of the ResQPUMP on the chest to obtain an adequateseal. It may be necessary to shave hair from the middle of the chest to achieve good suction.NOTE: If suction difficulties persist, the ResQPUMP can still be used for compressions withoutcausing additional harm to the patient, as long as it does not distract from CPR quality.ResQCPR System Component: ResQPOD ITD 16Instructions For UseAll users must read and fully understand theseResQCPR System Instructions for Use (IFUs)before using the ResQCPR Systemor any of its components. The ResQCPR™System includes the following components:1. ResQPUMP® ACD-CPR Device2. ResQPOD® ITD 16USER INFORMATION: The use of othermedical equipment or drugs in conjunctionwith cardiopulmonary resuscitation (CPR) mayimpact the effect of compressions/decompres-sions. Consult the instructions for use for otherequipment or drugs to assure that they areused appropriately in conjunction with activecompression decompression CPR (ACD-CPR)with an impedance threshold device (ITD) -the ResQCPR System.REQUIRED SKILLS: The ResQCPR Systemshould be used only by persons withappropriate training, such as ambulance andrescue personnel, or other medical staff whohave already completed a conventional CPRcourse (e.g. American Heart Association,American Red Cross, or equivalent), and whohave been trained on use of the ResQCPRSystem.RX ONLYFederal Law (USA) restricts thisdevice system to sale by or onthe order of a licensed medicalpractitioner.CONTRAINDICATIONSNone known.WARNINGSImproper use of the ResQCPR System could cause serious injury to the patient andineffective chest compressions/decompressions. The ResQCPR System should onlybe used by personnel who have been trained in its use.Improper positioning of the ResQPUMP suction cup may result in possibleinjury to the rib cage and/or internal organs, and may also result in suboptimalcirculation during ACD-CPR.Do not use the ResQPUMP if the patient’s chest is not large enough for the ResQPUMPsuction cup to provide adequate compressions/decompressions during use.Moisture, gels, or other lubricating materials on the patient’s chest should be removedbefore applying the ResQPUMP. Failure to do so may result in slidingof the suction cup on the chest, ineffective chest compressions/decompressions, andpossible injury to the rib cage or internal organs.The ResQPUMP should not be used in patients who have had a recentsternotomy. Use of the ResQPUMP in patients with a recent sternotomy(within the past 6 months) has not been evaluated, but this may potentially causeserious injury.The safety and effectiveness of CPR using the ResQCPR System have not beenassured when used to treat cardiac arrest in patients with drug/medicationoverdose etiology.If the patient has a return of spontaneous circulation (ROSC) (e.g. palpable pulse)during the resuscitation efforts, the ResQPOD should be immediatelyremoved from the airway circuit and use of the ResQPUMP should bediscontinued. Failure to do so may cause shortness of breath, difficulty breathing andpotential pulmonary edema if the patient begins to breathe spontaneously.The ResQCPR System has not been studied in the setting of in-hospital cardiac arrest;therefore, the safety and effectiveness of the device in this setting are unknown.Clinical outcomes when using the ResQCPR System in the setting of an in-hospitalcardiac arrest. Therefore, the safety may be different from the outcomes observed inthe clinical trials of out-of-hospital cardiac arrest.Safety and effectiveness of the ResQCPR System in pregnant women andchildren under the age of 18 have not been studied in clinical trials.Safety and effectiveness of the ResQCPR System in the setting of traumaticinjury (wounds resulting from sudden physical injury) have not been established.PRECAUTIONSFigure 1: ResQPUMP ACD-CPR DeviceMetronomeForce GaugeHandleSuction CupFigure 2: ResQPOD ITD 16On/Off Switch forTiming Assist LightsInspiratoryImpedanceRegulatorTiming Assist LightsSafety CheckValveINSPECTION PRIOR TO USECarefully inspect the ResQPOD in its packagebefore opening. Do not use if package isopened or damaged, or if any defects arenoted.HOW SUPPLIEDThe ResQPOD ITD 16 is non-sterile andintended for single patient use only. Disposeof properly when use is completed.DEVICE DESCRIPTIONThe ResQPOD ITD 16 (hereafter referred toas ResQPOD) (Figure 2) is a non-sterile, singlepatient use, disposable impedance threshold device (ITD) that limits passive air entry intothe lungs during the chest wall recoil (decompression) phase of CPR, therebyreducing intrathoracic pressure when rescuers are not providing a breath. Lowered intrathoracicpressure results in greater venous return (preload) which, in turn, results in greater cardiac outputon the subsequent compression. It is inserted into the airway circuit between the patient andthe ventilation source, and can be used with either a facemask or advanced airway (e.g.endotracheal [ET] tube). The ResQPOD may be used with standard ventilation sources (e.g.bag-valve or demand-valve resuscitators, rescuer’s mouth, automated ventilator). It does notrestrict the patient’s ability to exhale, nor the rescuer’s ability to ventilate. The ResQPOD allowsthe rescuer to provide periodic positive pressure ventilation while impeding passive inspiratorygas exchange during the chest recoil phase. The ResQPOD ITD 16 includes a safety checkvalve that allows inspiration at -16 cmH2O. The check valve is a design safety feature in theevent that the patient begins to breathe independently while the device is in place within theairway circuit. Timing assist lights provide guidance to the rescuer on the proper ventilation ratefor a patient with an advanced airway.PERFORMING CPR USING THE RESQCPR SYSTEMBefore beginning CPR with the ResQCPR System(ACD-CPR with an ITD; Figure 3), always assessthe patient according to local standards to assurethere are no signs of circulation (e.g. consciousness,breathing, coughing, movement or pulse). Beginperforming CPR with the ResQCPR System as soonas possible but do not delay manual chestcompressions while preparing the ResQCPR devices.PERFORMING CPR USING THE RESQCPRSYSTEM IN ADULTS1. Assure that patient is pulseless and thatresuscitation is indicated.2. Place ResQPUMP; turn on metronome and beginperforming compressions to appropriate depth(e.g. 2” or 5 cm) depth at rate of 80/min (seeadditional detailed instructions on the use of the ResQPUMP below).3. Attach ResQPOD to facemask as soon as chest compressions begin; use a2-handed technique to maintain a tight facemask seal and airway position(see additional detailed instructions on the use of the ResQPOD below).4. After 30 compressions, pause and administer two ventilations over onesecond duration each until the chest rises.5. Continue to provide a 30:2 compression to ventilation ratio until pulse returns oradvanced airway is placed. Rotate ACD-CPR duties every two minutes to avoid fatigue.6. Once an advanced airway (e.g. ET tube, supraglottic airway) is placed:• Confirm tube placement and secure with commercial tube restraint.• Move the ResQPOD to the airway and turn on the timing assist lights.• Provide asynchronous ventilations; ventilate once (over one second until chestrises) each time light flashes (10/min).• Perform continuous chest compressions at 80/min. Do not pause compressionsfor ventilations.• Rotate ACD-CPR duties every two minutes to avoid fatigue.7. If the patient has a return of spontaneous circulation (ROSC) the ResQPOD shouldbe immediately removed from the airway circuit and use of the ResQPUMP should bediscontinued. If the patient re-arrests, resume use of the ResQCPR System immediately.Figure 3: Use of the ResQCPR SystemNOTE: Signs and symptoms of improvedcerebral blood flow (e.g. eye opening,gagging, spontaneous breathing, limb orbody movement) have been reported inpatients without a spontaneous pulse butwho are undergoing resuscitation with theResQCPR System. If these are noted, checkquickly to see if a spontaneous pulse hasreturned. If the patient remains in cardiacarrest, continue resuscitation with theResQCPR System and contact your medicalcontrol authority or local protocol forguidance on managing these signs andsymptoms in an arrested patient. If aspontaneous pulse has returned, discontinuethe ResQCPR System and support ventilationsas indicated.THE RESQCPR TEAMIt is highly recommended that rescuers workin teams of 3 - 4 people. This enables oneperson to perform ACD-CPR, one personto hold the facemask in place with theResQPOD attached, and a third person tomanage the defibrillator and observe thepatient for signs of ROSC. In this teamscenario, the person compressing the chestcan stop after 30 compressions to providetwo positive pressure breaths (<5 seconds),before resuming chest compressions. Withmore personnel, two rescuers can managethe airway.ENSURING HIGH QUALITY CPR WITHTHE RESQCPR SYSTEM• Check the ResQPUMP’s force gauge atregular intervals to ensure that theappropriate forces needed to compressand decompress are being delivered.• Use the ResQPUMP’s metronome as aguide for compressing and decompressingat the rate of 80/min. NOTE: This rate isslightly slower than the rate recommendedfor standard CPR in order to allow sufficienttime for blood return to the chest, and toreduce rescuer fatigue.• Rotate ACD-CPR duties every two minutesto avoid fatigue.• Once the patient has an advanced airwayplaced, use the ResQPOD’s timing assistlights to guide the proper ventilation rate.Ventilate over one second duration and donot hyperventilate!• Avoid unnecessary interruptions.DETAILED INSTRUCTIONS RELATED TO THE USE OF THE RESQPUMPProper use of the ResQPUMP is shown in Figures 4 through 9.RESQPUMP POSITIONINGThe ResQPUMP’s compression point is the same as for standardmanual CPR (Figure 4). Position the suction cup in the middle of thesternum between the nipples (mid-nipple line). Make sure that theedge of the suction cup does not extend below the xiphoid process,as this could result in inadequate suction and/or rib injury.RESCUER POSITIONKneel close to the patient’s side. For optimal position, shorterrescuers may find it beneficial to be slightly elevated by kneeling onpadding. If the patient is in bed (with hard surface under torso), itwill be necessary to kneel next to the patient or stand on a platformof sufficient height. Grasp the ResQPUMP’s handle with both hands,placing the heels of the hands near the gauge with wrists slightlybent (Figure 5).COMPRESSIONS WITH THE RESQPUMPCompress the chest to the recommended depth (e.g. 2” or 5 cm),observe the force required to achieve that depth, and then use thatforce target as a guide. The amount of force required will varyaccording to how compliant the chest is. Compress with shouldersdirectly over the sternum, with arms outstretched and elbows locked(Figure 6). Use the large thigh muscles to compress, bending at thewaist. Compress at a rate of 80/min and use the metronome toguide the compression rate. Start and stop the metronome bypressing the red button on the force gauge (Figure 7). Compress thechest on one tone and lift on the other tone.Note: The compression rate using the ResQPUMP(80 compressions per minute) is different than thecurrent AHA-recommended rate of 100-120compressions per minute for standard CPR.COMPRESSION FORCEThe red arrow tip indicates the force being applied (Figure 7).The approximate amount of force required to compress thechest two inches (5 cm) is as follows:• 30 kg (≈ 65 lb) of force: soft/supple chest• 30 - 40 kg (≈ 65 - 90 lb) of force: chest of medium/averagecompliance (Figure 7)• 50 kg (≈ 110 lb) of force: stiff/rigid chestOnce it has been determined how much force is required tocompress the chest to the appropriate depth, use that amount offorce as a guide for continued compressions.DECOMPRESSIONS WITH THE RESQPUMPTo provide active decompression, use the large muscles in the thighsto lift, bending at the waist (Figure 8).DECOMPRESSION FORCEDecompress (lift) the chest until the tip of the red arrow on the forceFigure 4Figure 5gauge registers -10 kg (≈ –20 lb) of force (Figure 9). This amount of upwardforce must be exerted to fully achieve the benefits of active decompression.Closely monitor the force gauge and suction cup seal during use. If the suctioncup dislodges, reposition it with the next compression; then, on the nextdecompression, lift until just before the suction cup releases but do not exceed-10 kg (≈ -20 lb) of lift. Use a 50% duty cycle, spending equal time compressingand decompressing.SUCTION CUP REMOVALLift up an edge of the suction cup lip to release the vacuum under the cup.This will free the cup from the patient’s chest.Figure 6Figure 7DecompressionCompression300kg4015105080/minLIFT to 10 kgsUse enoughforce toCOMPRESSto 2” (5 cm) depthFigure 8Figure 9TROUBLESHOOTING1. If suction difficulties occur, adjust the angle of the ResQPUMP on the chest to obtain anadequate seal. It may be necessary to shave hair from the middle of the chest to achievegood suction. NOTE: If suction difficulties persist, the ResQPUMP can still be used forcompressions (with the metronome disabled) without causing additional harm to thepatient, as long as it does not distract from CPR quality.2. Rib fractures can occur with any method of CPR, even if performed correctly. If it appearsthat rib fractures have occurred, check to make sure the suction cup is properly positionedand that compression depth is appropriate. The occurrence of rib fractures is not sufficientreason to discontinue ACD-CPR.3. If there are questions about whether the ResQPUMP is functioning properly, considerdiscontinuing its use and perform standard manual CPR instead.DETAILED INSTRUCTIONS RELATED TO THE USE OF THE RESQPOD ONA FACEMASK1. It is important to insert the ResQPOD into the ventilation circuit as soon aschest compressions begin. In most cases this will involve placement on afacemask; however, never delay the initiation of chest compressions whilewaiting to place the ResQPOD.2.The ResQPOD may be used on patients with or without an oral or nasalairway.3. Attach the ResQPOD to the facemask. (Figure 10)4. Obtaining and maintaining a tight facemask seal throughoutboth chest compressions and ventilations is critical. To achievethis, spread out the cushion of the mask. (Figure 11)5. Use a two-handed technique to maintain proper airway positioning andobtain a tight facemask seal. Place the facemask onto the patient,covering the nose and mouth. Obtain a tight facemask seal by either:A. Using the thumb and base of the palm (Figure 12); orB. Forming a “C” with thumb and index finger.6. Place the remaining fingers on the bony part of the lower jaw and lift thelower jaw to the facemask. Do not push the facemask into the face to tryand obtain a seal.7. Tilt the head back and continue to lift the lower jaw to the mask.(Figure 13)8. Attach the ventilation source to the top of the ResQPOD.9. DO NOT turn on timing assist lights. If rescue personnel elect toperform continuous chest compressions and ventilate asynchronously with afacemask, then the lights may be turned on and the rescuer should providea positive pressure ventilation on the upstroke of ACD-CPR every time thelight flashes.10. Administer ResQCPR using the proper compression to ventilation ratio(e.g. 30:2) and the proper ventilation duration (e.g. one second).11. If there is only one rescuer available to manage the airway, then therescuer who is performing chest compressions can reach over andprovide ventilations during the pause in chest compressions, whilethe rescuer at the airway maintains a two-handed facemask seal.(Figure 13)12. The ResQPOD is disposable and intended for single patient use. Crosscontamination may occur if the device is used on multiple patients.1. Insert the advanced airway and confirm tube placement. Secure the tubewith a commercial tube restraint device. The use of tape to secure the tubeis not recommended.2. Attach the ResQPOD to the top of the airway and attach the ventilationsource to the top of the ResQPOD (Figure 14); avoid interrupting CPR todo this.3. Turn on the timing assist lights. To activate, slide the ON/OFF switch tothe ON position.4. Perform ResQCPR with continuous chest compressions (no pauses forventilations). Ventilate asynchronously when the timing lights flash (10/min)and over proper duration (e.g. one second) until the chest rises.5. If an end-tidal carbon dioxide detector is used, place it in the airway circuitbetween the ResQPOD and the ventilation source. (Figure 15)6. If there is desire to administer medications via the advanced airway,remove the ResQPOD and administer medications directly into the tube,then re-connect ResQPOD and resume use.ADDITIONAL INSTRUCTIONS:1. If there is a return of spontaneous circulation (e.g. palpable pulse) and chestcompressions are no longer indicated, immediately remove the ResQPODfrom the airway circuit. Failure to do so may cause shortness of breath anddifficulty breathing. Support respirations as indicated.2. Immediately replace the ResQPOD in the ventilation circuit if the patientre-arrests and chest compressions are again indicated.3. If vomit or secretions enter the ResQPOD, remove the ResQPOD from thefacemask or airway adjunct and use the ventilation source to clear thematerial from the ResQPOD. Suction the patient as needed, then re-attachthe ResQPOD and resume use. Discontinue use of theResQPOD if it cannot be cleared or if positive pressure ventilation iscompromised in any way with the device in place.Figure 10Figure 11Figure 12Figure 13DETAILED INSTRUCTIONS RELATED TO USING RESQPOD ON AN ADVANCEDAIRWAY (E.G. ET TUBE):Figure 14Figure 15FOLLOWING EACH USE OF THE RESQCPR SYSTEMThe ResQPOD is intended for single patient use only and should be discarded after use. Failure todo so may cause cross contamination between patients. The ResQPUMP should be cleaned anddisinfected after every use.RESQPUMP CLEANINGTo clean the handle, wipe with damp cloth and mild detergent. The suction cup may be replacedwith a new suction cup, or cleaned. To clean the suction cup, wash it with a mild detergent andrinse with tap water.Never immerse the handle in water or autoclave to clean. Doing so may causepermanent damage.RESQPUMP CHEMICAL DISINFECTIONThe handle and suction cup may be chemically disinfected after washing. Wipe the cup andhandle with a bleach solution (5% chlorine, minimum) or Cavicide® (follow manufacturerinstructions for wetting times). Wipe the handle with a dampened cloth to remove chemicalresidue. Do NOT immerse the handle. The cup may be rinsed with water. Wipe with a cleandry cloth and allow to air dry.Hazards during disinfection. Always wear protective clothing during disinfectionof the ResQPUMP. Follow the handling instructions from the manufacturer ofthe disinfectant.NOTE: The cleaning procedure is sufficient after ‘normal’ soiling. If there are bodily fluids on theResQPUMP or if an infectious patient has been treated, the ResQPUMP should also be disinfectedas described above and the suction cup should be discarded and replaced.RESQPUMP FUNCTION TESTINGBefore placing the ResQPUMP into service and following each use, the following functional testsshould be performed:1. Inspect the handle and suction cup for visible damage. Do not use the ResQPUMP if there isobvious damage to the suction cup or handle. NOTE: Replacement suction cups are availablefrom the manufacturer.2. Compress the ResQPUMP against a smooth hard surface with approximately 50 kg of force,using the force gauge on the ResQPUMP as a guide. Observe for an increasing gaugereading.3. Pull up on the handle with approximately 10 to 15 kg of force, using the decompressionforce gauge as a guide. Observe for a decreasing gauge reading and check for propersuction. The gauge should move smoothly within the compression and decompression ranges.4. Ensure that the force gauge reads zero (Figure 16) when no force is applied. If it does NOTread zero, see instructions for force gauge readjustment below.5. Assess the metronome’s battery level by pressing on the metronome button for morethan three seconds. If the battery is okay, first, a long high-note beep will be heard,followed by three short beeps. If one long low-note beep is heard, or if no beep is heard,the device should be replaced as well.INDICATIONS FOR USEThe ResQCPR System is intended for use asa CPR adjunct to improve the likelihood ofsurvival in adult patients with non-traumaticcardiac arrest.1 2 3 4 56 7 8 9 |
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