Advanced Circulatory ResQCRP ResQPOD ITD 16 Instruções de utilização

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Instructions For Use

the order of a licensed medical

practitioner.

CONTRAINDICATIONS

None known.

WARNINGS

Improper use of the ResQCPR System could cause serious injury to the patient and

ineffective chest compressions/decompressions. The ResQCPR System should only

be used by personnel who have been trained in its use.

Improper positioning of the ResQPUMP suction cup may result in possible

injury to the rib cage and/or internal organs, and may also result in suboptimal

circulation during ACD-CPR.

Do not use the ResQPUMP if the patient's chest is not large enough for the ResQPUMP

suction cup to provide adequate compressions/decompressions during use.

Moisture, gels, or other lubricating materials on the patient's chest should be removed

before applying the ResQPUMP. Failure to do so may result in sliding

of the suction cup on the chest, ineffective chest compressions/decompressions, and

possible injury to the rib cage or internal organs.

The ResQPUMP should not be used in patients who have had a recent

All users must read and fully understand these

sternotomy. Use of the ResQPUMP in patients with a recent sternotomy

ResQCPR System Instructions for Use (IFUs)

(within the past 6 months) has not been evaluated, but this may potentially cause

before using the ResQCPR System

serious injury.

or any of its components. The ResQCPR™

System includes the following components:

PRECAUTIONS

1. ResQPUMP

ACD-CPR Device

2. ResQPOD

ITD 16

The safety and effectiveness of CPR using the ResQCPR System have not been

assured when used to treat cardiac arrest in patients with drug/medication

USER INFORMATION: The use of other

overdose etiology.

medical equipment or drugs in conjunction

with cardiopulmonary resuscitation (CPR) may

If the patient has a return of spontaneous circulation (ROSC) (e.g. palpable pulse)

impact the effect of compressions/decompres-

during the resuscitation efforts, the ResQPOD should be immediately

sions. Consult the instructions for use for other

removed from the airway circuit and use of the ResQPUMP should be

equipment or drugs to assure that they are

discontinued. Failure to do so may cause shortness of breath, difficulty breathing and

used appropriately in conjunction with active

potential pulmonary edema if the patient begins to breathe spontaneously.

compression decompression CPR (ACD-CPR)

with an impedance threshold device (ITD) -

The ResQCPR System has not been studied in the setting of in-hospital cardiac arrest;

the ResQCPR System.

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-hospital

REQUIRED SKILLS: The ResQCPR System

cardiac arrest. Therefore, the safety may be different from the outcomes observed in

should be used only by persons with

the clinical trials of out-of-hospital cardiac arrest.

appropriate training, such as ambulance and

rescue personnel, or other medical staff who

Safety and effectiveness of the ResQCPR System in pregnant women and

have already completed a conventional CPR

children under the age of 18 have not been studied in clinical trials.

course (e.g. American Heart Association,

American Red Cross, or equivalent), and who

Safety and effectiveness of the ResQCPR System in the setting of traumatic

have been trained on use of the ResQCPR

injury (wounds resulting from sudden physical injury) have not been established.

System.

DETAILED INSTRUCTIONS RELATED TO THE USE OF THE RESQPUMP

Proper use of the ResQPUMP is shown in Figures 4 through 9.

RESQPUMP POSITIONING

Figure 4

The ResQPUMP's compression point is the same as for standard

manual CPR (Figure 4). Position the suction cup in the middle of the

sternum between the nipples (mid-nipple line). Make sure that the

edge of the suction cup does not extend below the xiphoid process,

as this could result in inadequate suction and/or rib injury.

RESCUER POSITION

Kneel close to the patient's side. For optimal position, shorter

Figure 5

rescuers may find it beneficial to be slightly elevated by kneeling on

padding. If the patient is in bed (with hard surface under torso), it

will be necessary to kneel next to the patient or stand on a platform

of sufficient height. Grasp the ResQPUMP's handle with both hands,

placing the heels of the hands near the gauge with wrists slightly

bent (Figure 5).

COMPRESSIONS WITH THE RESQPUMP

Compress the chest to the recommended depth (e.g. 2" or 5 cm),

observe the force required to achieve that depth, and then use that

force target as a guide. The amount of force required will vary

Figure 6

according to how compliant the chest is. Compress with shoulders

directly over the sternum, with arms outstretched and elbows locked

(Figure 6). Use the large thigh muscles to compress, bending at the

waist. Compress at a rate of 80/min and use the metronome to

guide the compression rate. Start and stop the metronome by

pressing the red button on the force gauge (Figure 7). Compress the

chest on one tone and lift on the other tone.

Note: The compression rate using the ResQPUMP

(80 compressions per minute) is different than the

current AHA-recommended rate of 100-120

Figure 7

compressions per minute for standard CPR.

Decompression

COMPRESSION FORCE

LIFT

to 10 kgs

The red arrow tip indicates the force being applied (Figure 7).

The approximate amount of force required to compress the

Use enough

force to

COMPRESS

to 2" (5 cm) depth

chest two inches (5 cm) is as follows:

80/min

• 30 kg (≈ 65 lb) of force: soft/supple chest

• 30 - 40 kg (≈ 65 - 90 lb) of force: chest of medium/average

Compression

compliance (Figure 7)

• 50 kg (≈ 110 lb) of force: stiff/rigid chest

Once it has been determined how much force is required to

Figure 8

compress the chest to the appropriate depth, use that amount of

force as a guide for continued compressions.

DECOMPRESSIONS WITH THE RESQPUMP

To provide active decompression, use the large muscles in the thighs

to lift, bending at the waist (Figure 8).

DECOMPRESSION FORCE

Decompress (lift) the chest until the tip of the red arrow on the force

The ResQCPR™ System includes the following two components:

INDICATIONS FOR USE

1. ResQPUMP

ACD-CPR Device

The ResQCPR System is intended for use as

2. ResQPOD

ITD 16

a CPR adjunct to improve the likelihood of

survival in adult patients with non-traumatic

ResQCPR System Component:

cardiac arrest.

ResQPUMP ACD-CPR Device

DEVICE DESCRIPTION

The ResQPUMP ACD-CPR Device (hereafter

referred to as ResQPUMP) (Figure 1) is a

multi-use, hand-held device that includes a

suction cup for attachment to the patient's

chest (with clothing removed), and a handle

for the rescuer to hold onto.

The ResQPUMP enables the rescuer to perform active compression-

decompression cardiopulmonary resuscitation (ACD-CPR), which differs from

standard CPR. During ACD-CPR, the chest is actively re-expanded (decompressed) after each

compression; with standard CPR, the chest re-expands passively. The ResQPUMP design allows

the 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 cup

sticks to the chest and transfers the lifting force to the middle of the ribcage. Compression force

is transferred to the chest as in standard CPR via the device's piston. The handle includes a force

gauge that displays the forces exerted during both chest compression and decompression (chest

wall recoil). The ResQPUMP has a battery-powered metronome integrated into the handle to guide

the rescuer in the appropriate compression/decompression rate. The metronome emits two-tone

signals 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 of

time (50% duty cycle).

If suction difficulties occur, adjust the angle of the ResQPUMP on the chest to obtain an adequate

seal. 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 without

causing additional harm to the patient, as long as it does not distract from CPR quality.

ResQCPR System Component: ResQPOD ITD 16

INSPECTION PRIOR TO USE

Carefully inspect the ResQPOD in its package

before opening. Do not use if package is

opened or damaged, or if any defects are

noted.

HOW SUPPLIED

The ResQPOD ITD 16 is non-sterile and

intended for single patient use only. Dispose

of properly when use is completed.

DEVICE DESCRIPTION

The ResQPOD ITD 16 (hereafter referred to

as ResQPOD) (Figure 2) is a non-sterile, single

Figure 9

gauge registers -10 kg (≈ –20 lb) of force (Figure 9). This amount of upward

force must be exerted to fully achieve the benefits of active decompression.

Closely monitor the force gauge and suction cup seal during use. If the suction

cup dislodges, reposition it with the next compression; then, on the next

decompression, 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 compressing

and decompressing.

SUCTION CUP REMOVAL

Lift 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.

TROUBLESHOOTING

1. If suction difficulties occur, adjust the angle of the ResQPUMP on the chest to obtain an

adequate seal. 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 (with the metronome disabled) without causing additional harm to the

patient, 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 appears

that rib fractures have occurred, check to make sure the suction cup is properly positioned

and that compression depth is appropriate. The occurrence of rib fractures is not sufficient

reason to discontinue ACD-CPR.

3. If there are questions about whether the ResQPUMP is functioning properly, consider

discontinuing its use and perform standard manual CPR instead.

DETAILED INSTRUCTIONS RELATED TO THE USE OF THE RESQPOD ON

A FACEMASK

Figure 10

1. It is important to insert the ResQPOD into the ventilation circuit as soon as

chest compressions begin. In most cases this will involve placement on a

facemask; however, never delay the initiation of chest compressions while

waiting to place the ResQPOD.

2. The ResQPOD may be used on patients with or without an oral or nasal

airway.

3. Attach the ResQPOD to the facemask. (Figure 10)

Figure 11

4. Obtaining and maintaining a tight facemask seal throughout

both chest compressions and ventilations is critical. To achieve

this, spread out the cushion of the mask. (Figure 11)

5. Use a two-handed technique to maintain proper airway positioning and

obtain 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); or

Figure 12

B. Forming a "C" with thumb and index finger.

6. Place the remaining fingers on the bony part of the lower jaw and lift the

lower jaw to the facemask. Do not push the facemask into the face to try

and obtain a seal.

7. Tilt the head back and continue to lift the lower jaw to the mask.

(Figure 13)

patient use, disposable impedance threshold device (ITD) that limits passive air entry into

the lungs during the chest wall recoil (decompression) phase of CPR, thereby

reducing intrathoracic pressure when rescuers are not providing a breath. Lowered intrathoracic

Figure 1: ResQPUMP ACD-CPR Device

pressure results in greater venous return (preload) which, in turn, results in greater cardiac output

on the subsequent compression. It is inserted into the airway circuit between the patient and

Metronome

the ventilation source, and can be used with either a facemask or advanced airway (e.g.

Handle

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 not

Force Gauge

restrict the patient's ability to exhale, nor the rescuer's ability to ventilate. The ResQPOD allows

the rescuer to provide periodic positive pressure ventilation while impeding passive inspiratory

gas exchange during the chest recoil phase. The ResQPOD ITD 16 includes a safety check

valve that allows inspiration at -16 cmH

Suction Cup

event that the patient begins to breathe independently while the device is in place within the

airway circuit. Timing assist lights provide guidance to the rescuer on the proper ventilation rate

for a patient with an advanced airway.

PERFORMING CPR USING THE RESQCPR SYSTEM

Before beginning CPR with the ResQCPR System

(ACD-CPR with an ITD; Figure 3), always assess

the patient according to local standards to assure

there are no signs of circulation (e.g. consciousness,

breathing, coughing, movement or pulse). Begin

performing CPR with the ResQCPR System as soon

as possible but do not delay manual chest

compressions while preparing the ResQCPR devices.

PERFORMING CPR USING THE RESQCPR

SYSTEM IN ADULTS

1. Assure that patient is pulseless and that

resuscitation is indicated.

2. Place ResQPUMP; turn on metronome and begin

performing compressions to appropriate depth

(e.g. 2" or 5 cm) depth at rate of 80/min (see

additional detailed instructions on the use of the ResQPUMP below).

3. Attach ResQPOD to facemask as soon as chest compressions begin; use a

2-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 one

second duration each until the chest rises.

Figure 2: ResQPOD ITD 16

5. Continue to provide a 30:2 compression to ventilation ratio until pulse returns or

Timing Assist Lights

advanced 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:

On/Off Switch for

Timing Assist Lights

• Confirm tube placement and secure with commercial tube restraint.

• Move the ResQPOD to the airway and turn on the timing assist lights.

Inspiratory

• Provide asynchronous ventilations; ventilate once (over one second until chest

Impedance

Regulator

rises) each time light flashes (10/min).

• Perform continuous chest compressions at 80/min. Do not pause compressions

Safety Check

for ventilations.

Valve

• Rotate ACD-CPR duties every two minutes to avoid fatigue.

7. If the patient has a return of spontaneous circulation (ROSC) the ResQPOD should

be immediately removed from the airway circuit and use of the ResQPUMP should be

discontinued. If the patient re-arrests, resume use of the ResQCPR System immediately.

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 to

perform continuous chest compressions and ventilate asynchronously with a

facemask, then the lights may be turned on and the rescuer should provide

a positive pressure ventilation on the upstroke of ACD-CPR every time the

light 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 the

rescuer who is performing chest compressions can reach over and

provide ventilations during the pause in chest compressions, while

the rescuer at the airway maintains a two-handed facemask seal.

(Figure 13)

12. The ResQPOD is disposable and intended for single patient use. Cross

contamination may occur if the device is used on multiple patients.

DETAILED INSTRUCTIONS RELATED TO USING RESQPOD ON AN ADVANCED

AIRWAY (E.G. ET TUBE):

Figure 14

1. Insert the advanced airway and confirm tube placement. Secure the tube

with a commercial tube restraint device. The use of tape to secure the tube

is not recommended.

2. Attach the ResQPOD to the top of the airway and attach the ventilation

source to the top of the ResQPOD (Figure 14); avoid interrupting CPR to

do this.

3. Turn on the timing assist lights. To activate, slide the ON/OFF switch to

the ON position.

4. Perform ResQCPR with continuous chest compressions (no pauses for

ventilations). Ventilate asynchronously when the timing lights flash (10/min)

and over proper duration (e.g. one second) until the chest rises.

Figure 15

5. If an end-tidal carbon dioxide detector is used, place it in the airway circuit

between 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.

ETCO

ADDITIONAL INSTRUCTIONS:

1. If there is a return of spontaneous circulation (e.g. palpable pulse) and chest

compressions are no longer indicated, immediately remove the ResQPOD

from the airway circuit. Failure to do so may cause shortness of breath and

difficulty breathing. Support respirations as indicated.

2. Immediately replace the ResQPOD in the ventilation circuit if the patient

re-arrests and chest compressions are again indicated.

3. If vomit or secretions enter the ResQPOD, remove the ResQPOD from the

facemask or airway adjunct and use the ventilation source to clear the

material from the ResQPOD. Suction the patient as needed, then re-attach

the ResQPOD and resume use. Discontinue use of the

ResQPOD if it cannot be cleared or if positive pressure ventilation is

compromised in any way with the device in place.

NOTE: Signs and symptoms of improved

cerebral blood flow (e.g. eye opening,

gagging, spontaneous breathing, limb or

body movement) have been reported in

patients without a spontaneous pulse but

who are undergoing resuscitation with the

ResQCPR System. If these are noted, check

quickly to see if a spontaneous pulse has

returned. If the patient remains in cardiac

arrest, continue resuscitation with the

ResQCPR System and contact your medical

O. The check valve is a design safety feature in the

control authority or local protocol for

guidance on managing these signs and

symptoms in an arrested patient. If a

spontaneous pulse has returned, discontinue

the ResQCPR System and support ventilations

as indicated.

THE RESQCPR TEAM

Figure 3: Use of the ResQCPR System

It is highly recommended that rescuers work

in teams of 3 - 4 people. This enables one

person to perform ACD-CPR, one person

to hold the facemask in place with the

ResQPOD attached, and a third person to

manage the defibrillator and observe the

patient for signs of ROSC. In this team

scenario, the person compressing the chest

can stop after 30 compressions to provide

two positive pressure breaths (<5 seconds),

before resuming chest compressions. With

more personnel, two rescuers can manage

the airway.

ENSURING HIGH QUALITY CPR WITH

THE RESQCPR SYSTEM

• Check the ResQPUMP's force gauge at

regular intervals to ensure that the

appropriate forces needed to compress

and decompress are being delivered.

• Use the ResQPUMP's metronome as a

guide for compressing and decompressing

at the rate of 80/min. NOTE: This rate is

slightly slower than the rate recommended

for standard CPR in order to allow sufficient

time for blood return to the chest, and to

reduce rescuer fatigue.

• Rotate ACD-CPR duties every two minutes

to avoid fatigue.

• Once the patient has an advanced airway

placed, use the ResQPOD's timing assist

lights to guide the proper ventilation rate.

Ventilate over one second duration and do

not hyperventilate!

• Avoid unnecessary interruptions.

FOLLOWING EACH USE OF THE RESQCPR SYSTEM

The ResQPOD is intended for single patient use only and should be discarded after use. Failure to

do so may cause cross contamination between patients. The ResQPUMP should be cleaned and

disinfected after every use.

RESQPUMP CLEANING

To clean the handle, wipe with damp cloth and mild detergent. The suction cup may be replaced

with a new suction cup, or cleaned. To clean the suction cup, wash it with a mild detergent and

rinse with tap water.

Never immerse the handle in water or autoclave to clean. Doing so may cause

permanent damage.

RESQPUMP CHEMICAL DISINFECTION

The handle and suction cup may be chemically disinfected after washing. Wipe the cup and

handle with a bleach solution (5% chlorine, minimum) or Cavicide

instructions for wetting times). Wipe the handle with a dampened cloth to remove chemical

residue. Do NOT immerse the handle. The cup may be rinsed with water. Wipe with a clean

dry cloth and allow to air dry.

Hazards during disinfection. Always wear protective clothing during disinfection

of the ResQPUMP. Follow the handling instructions from the manufacturer of

the disinfectant.

NOTE: The cleaning procedure is sufficient after 'normal' soiling. If there are bodily fluids on the

ResQPUMP or if an infectious patient has been treated, the ResQPUMP should also be disinfected

as described above and the suction cup should be discarded and replaced.

RESQPUMP FUNCTION TESTING

Before placing the ResQPUMP into service and following each use, the following functional tests

should be performed:

1. Inspect the handle and suction cup for visible damage. Do not use the ResQPUMP if there is

obvious damage to the suction cup or handle. NOTE: Replacement suction cups are available

from 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 gauge

reading.

3. Pull up on the handle with approximately 10 to 15 kg of force, using the decompression

force gauge as a guide. Observe for a decreasing gauge reading and check for proper

suction. 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 NOT

read zero, see instructions for force gauge readjustment below.

5. Assess the metronome's battery level by pressing on the metronome button for more

than 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.

(follow manufacturer