ResQPUMP Instructions for Use

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ResQPUMP ACD-CPR Device

b

c

Metronome Handle Force Gauge

Suction Cup

d

e

f

g Decompression

15 10

kg

LIFT to 10 kgs

0 Use enough force to

COMPRESS

80/min

to 2” (5 cm) depth

30 40 50

Compression

h

i

j Decompression

15 10

kg

LIFT to 10 kgs

0 Use enough force to

COMPRESS

80/min

to 2” (5 cm) depth

30 40 50

Compression

k

l

m

Figure a: ResQPUMP ACD-CPR Device Metronome Handle Force Gauge

Suction Cup

ResQPUMP® ACD-CPR Device All users should read and fully understand these ResQPUMP® Active Compression Decompression Cardiopulmonary Resuscitation (ACD-CPR) Device Instructions for Use, and receive proper training prior to use. For guidance on using the ResQPUMP ACD-CPR Device in conjunction with the ResQPOD® ITD 16 (ResQCPR™ System), please see also the ResQPOD ITD 16 Instructions for Use and the ResQCPR System Caregiver Guide.

1.

INDICATIONS FOR USE

The ResQPUMP ACD-CPR Device is indicated for the treatment of adult patients with cardiac arrest (absence of effective pulse and respiration) to improve the overall efficiency of cardiopulmonary resuscitation (CPR) and the chances for short- and long-term survival. The device is intended to be used as an adjunct to the locally recommended protocols for basic cardiac life support.

2.

CONTRAINDICATIONS

None

3.

WARNINGS/PRECAUTIONS

• For use only by personnel adequately trained in ACD-CPR on ACD-compatible training manikins. Make sure that such personnel are made familiar with the contents of this manual. • Before starting chest compressions, always assess for absence of palpable pulse. • Use only on adult patients. • Never use on healthy, conscious persons for demonstration or training purposes. • Always switch between operators before getting tired, since decreased levels of compression depth and decompression lift, as well as decreased rate may otherwise occur. • Wipe excessive fluid away from the surface of the chest, if present, to avoid migration of the device during use. • If adequate suction cannot be achieved and becomes distracting, stop use of the device and use conventional manual or automated CPR. • Always check for correct function, visible damages and zero setting of the force gauge before placing the device ready for use. • Should not be used on patients who have had a recent (last 6 months) sternotomy. • If the patient has a return of spontaneous circulation (ROSC) (e.g. palpable pulse) during the resuscitation efforts, discontinue device use.

4.

DEVICE DESCRIPTION

The ResQPUMP ACD-CPR Device (hereafter referred to as ResQPUMP) (Figure a) is a multi-use, hand-held device that includes a suction cup for attachment to the patient’s chest, 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 conventional or automated 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

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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). This slightly slower rate allows for extra filling time for preload.

5.

INSTRUCTIONS FOR USE

Proper use of the ResQPUMP is shown in Figures b through h. 5.1

Device Positioning

The ResQPUMP’s compression point is the same as for standard manual CPR (Figure c). Position the suction cup in the middle of the sternum (clothing removed) between the nipples. 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. 5.2

Rescuer Positioning

Kneel close to the patient’s side. Shorter 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 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 d). 5.3

Compressions

Compress the chest to the recommended depth (e.g. 2” or 5 cm), observe the force gauge and note the force required to achieve that depth, and then use that force target as a guide. The amount of force required will vary according to how compliant the chest is. Compress with shoulders directly over the sternum, with arms straight (Figure e). 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 f). Compress the chest on one tone and lift on the other tone. The red arrow tip indicates the force being applied (Figure f). The approximate amount of force required to compress the chest two inches (5 cm) is as follows: • 30 kg of force: soft/supple chest • 30 - 40 kg of force: chest of medium/average compliance (Figure f) • 50 kg of force: stiff/rigid chest Once it has been determined how much force is required to compress the chest to the appropriate depth, use that amount of force as a guide for continued compressions. 5.4

Decompressions

To provide active decompression, keep arms straight and use the large muscles in the thighs to lift, bending at the waist (Figure g). Attempt to decompress (lift) the chest until the tip of the red arrow on the force gauge registers -10 kg of force (Figure h). 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 of lift. Use a 50% duty cycle, spending equal time compressing and decompressing. 5.5

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. 5.6

Other

1. Rotate ACD-CPR duties every two minutes (or more often) to avoid fatigue. 2. If the patient has a return of spontaneous circulation (ROSC), use of the ResQPUMP should be discontinued. If the patient re-arrests, resume ACD-CPR again immediately. 3. If suction difficulties occur, adjust the angle of the ResQPUMP on the chest to obtain an adequate seal. If you are not able to maintain suction with 10 kg of lift, then lift with less force on the next decompression. 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.

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4. 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. 5. If there are questions about whether the ResQPUMP is functioning properly, consider discontinuing its use and perform standard manual CPR instead. 6. To preserve battery life in the event it is inadvertently turned on, the metronome will automatically shut off after 10 minutes. Simply press the button to turn on again.

6.

FOLLOWING EACH USE

The ResQPUMP should be cleaned and disinfected after every use. 6.1

Cleaning

To clean the handle, wipe with a damp cloth and mild detergent. The suction cup may be replaced with a new suction cup or cleaned. Replacement suction cups are available from the manufacturer. 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. Do not spray water or cleaning solutions directly onto the handle. Doing so may cause permanent damage. 6.2

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® (follow manufacturer instructions for wetting times). Do not spray water or disinfectant solutions directly onto the handle. 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. 6.3

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. 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 - 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 i) 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 lownote beep is heard, or if no beep is heard, the device should be replaced as well. 6.4

Force Gauge Calibration

If the zero reading of the force gauge (Figure i) has drifted away from the zero line, the gauge should be readjusted prior to further use as follows: 1. Remove the suction cup by pulling it from the stem of the handle. 2. Use a Phillips screwdriver to loosen the screw at the top of the connection stem (Figure j) with a firm turn. Remove the nylon stem and washer located inside the stem (Figure k). 3. Insert a straight blade screwdriver (4 mm [1/8“] wide) in the threaded hole at the end of the spring/plunger assembly and catch the slot of the adjustment screw seated about 3 cm (1”) down inside the brass plunger (Figure k). 4. Loosen the screw. If there is excessive resistance, heat the screw slightly using a hairdryer to soften the locking resin (Figure l). 5. Loosen the screw and adjust it until the gauge is on the zero line (Figure i). Compress the spring a few times and check that the zero reading remains correct. Fine readjustment may be needed. If the screw was heated, wait until it cools to room temperature before proceeding to the next step. 6. Lock the screw by applying a drop of LOCTITE 242 locking fluid (or equivalent) to top edge of screw. Use a toothpick to ensure that the fluid is applied directly to the entire top edge of the screw. Wait ten minutes for the locking fluid to set.

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7. Reassemble in reverse order. Place the washer into the nylon stem as shown in Figure m. Apply a drop of locking fluid to the tip of the thread near the end of the screw. Push the screw up though the end of the stem and through the washer. 8. Finally, slip the spring/plunger on the handle down into the stem. Rotate the stem until the slot in the stem aligns with the rib in the handle and slips all the way into the handle, then tighten the screw. 9. Wait 24 hours before using the device to ensure that the locking resin obtains full strength. During this time, the ResQPUMP should be hung by the strap or left resting on the handle with the suction cup pointing up.

7.

TECHNICAL SPECIFICATIONS

Operating Specifications Force gauge compression range Force gauge decompression range

0 - 50 kg ± 15% 0 - 15 kg ± 15%

Metronome Function Signal pitches Sound level Rate

768 Hz (low) and 3070 Hz (high) ≥65 dB at distance of 0.5 m for sound source 80 per minute

Temperature Range Operation Storage

-18º to 50º C (0º to 122º F) -40º to 60º C (-40º to 140º F)

Dimensions Suction cup Height Weight

13.5 cm OD 17.0 cm 0.58 kg

Materials Suction cup and cushion pad Handle and support ring Connection stem Support ring Metal parts Battery

Silicone Polyamide (nylon), glass fiber reinforced Acetal polyoxymethylene Thermoplastic polyester elastomer Stainless steel and brass 3.6 V primary lithium-thionyl chloride

Battery life: Battery shelf life:

Minimum of 20 service hours Approximately 10 years

8.

ACCESSORIES AND REPLACEMENT COMPONENTS AVAILABLE

Reorder #

Description

12-0586-000

Suction Cup for ACD-CPR Device (replacement suction cup with support ring and compression cushion)

12-0935-000

ResQCPR Carrying Case (holds one ResQPUMP and two ResQPODs)

12-2116-000

ManiKIT (permits many CPR manikins to be adapted for ACD-CPR)

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9.

LIMITED WARRANTY

Subject to the terms, conditions and limitations contained herein, ZOLL Medical warrants only to the ultimate user of the product that ZOLL Medical’s products will not fail to operate in accordance with their specifications due to defects in material or workmanship during the time period listed below. The foregoing period is sometimes referred to as the “original warranty period.” The foregoing limited warranty does not apply to any part, portion, or component of any product which is manufactured by a third-party (“Third-Party Component”). The time period for the warranty begins on the date of delivery of the product to the first purchaser and continues for 12 months. THE LIMITED WARRANTY SET FORTH IN THE FOREGOING PARAGRAPH, IS THE SOLE AND EXCLUSIVE WARRANTY WITH RESPECT TO ZOLL MEDICAL’S PRODUCTS. ZOLL MEDICAL MAKES NO OTHER EXPRESS WARRANTY OF ANY KIND OR NATURE AS TO THE PRODUCTS OR THEIR PERFORMANCE EXCEPT FOR THOSE LIMITED WARRANTIES EXPRESSLY SET FORTH IN THE FOREGOING PARAGRAPH AND EXCEPT THEREFORE, SPECIFICALLY DISCLAIMS ANY AND ALL REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE CONCERNING THE PRODUCTS, INCLUDING, BUT NOT LIMITED TO, ANY REPRESENTATION OR WARRANTY THAT THE PRODUCTS COMPLY WITH ANY LAW, OR THAT ANY PARTICULAR RESULT WILL BE OBTAINED BY USING THE PRODUCTS. ZOLL MEDICAL MAKES NO WARRANTIES WITH RESPECT TO ANY THIRD PARTY COMPONENT AND ZOLL MEDICAL SPECIFICALLY SELLS SUCH THIRD-PARTY COMPONENTS “AS IS” WITHOUT ANY WARRANTY. FURTHER, ZOLL MEDICAL MAKES NO IMPLIED WARRANTY OF ANY KIND OR NATURE WITH RESPECT TO ITS PRODUCTS OR ANY THIRD-PARTY COMPONENT AND SPECIFICALLY DISCLAIMERS ANY AND ALL IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, ANY AND ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR COMPLIANCE WITH ANY FEDERAL, STATE OR LOCAL LAW, RULE OR REGULATION. IN ADDITION, ZOLL MEDICAL EXPRESSLY DISCLAIMS TO THE FULLEST EXTENT ALLOWED BY LAW, RULE OR REGULATION ANY WARRANTY PROVIDED UNDER ANY LAW. The limited warranties set forth above shall be null and void if (a) any alterations or modifications are made to a product, (b) a product is not maintained in strict compliance with the maintenance requirements set forth in the maintenance manual for such product or otherwise provided by ZOLL Medical, (c) any repairs are made to a product which are not authorized by ZOLL Medical in writing, (d) any failure of a product to comply with the above limited warranty is not reported to ZOLL Medical in writing within thirty (30) days of the date such failure first occurs, (e) a product is operated after the failure of any warranty first occurs, (f) a product is used for any purpose other than for the purpose for which it was manufactured, (g) a product is not operated in strict compliance with the terms and conditions set forth in any operating manual, notice or other statement accompanying the product, (h) a product is abused or damaged, (i) purchaser fails to deliver the product to ZOLL Medical for inspection and testing if requested by ZOLL Medical or purchaser disposes of the product or any part or component on or before the thirtieth (30th) day after sending a written claim under the warranty to ZOLL Medical, (j) such failure of the limited warranty results from a failure of any third party component, or (k) a product is not stored or handled as directed in writing by ZOLL Medical. The sole and exclusive remedy for any failure of any product to comply with the limited warranty set forth above or any other warranty imposed upon ZOLL Medical by Law, if any, shall, at the election of ZOLL Medical, in its sole discretion, be either (a) the repair or replacement of the product or component which failed to comply with such warranty or (b) the refund of the purchase price of the product. Except as provided below, any repair or replacement shall carry the same warranty as the original product but only for the remainder of the original warranty period. Purchaser’s exclusive remedy with respect to any claim arising out of or as a result of third-party component shall be against the third-party manufacturer. Any and all claims under the above limited warranty shall be made to ZOLL Medical only in writing and not later than thirty (30) days after the date the product first fails to comply with the above limited warranty but in no event later than the expiration of the original warranty period with respect to which the claim is being made. Any claim under the above limited warranty made after such period for making a claim shall be null and void. After receiving written notice of the warranty claim, ZOLL Medical shall determine whether to (a) repair or replace the product or part or (b) refund the purchase price of the product. ZOLL Medical may require purchaser to return any Product or component thereof which purchaser claims to be defective to ZOLL Medical at purchaser’s cost for inspection as a condition to any claim under the above limited warranty. No product or part may be returned to ZOLL Medical without ZOLL Medical’s prior written authorization. If a product which is returned is determined by ZOLL Medical in its sole discretion not to have failed to comply with the limited warranty, purchaser shall pay costs of removal, repair and/or replacement for such product. If a product that is returned is determined by ZOLL Medical in its sole discretion to have failed to comply with the limited warranty, ZOLL Medical shall pay for all repair and/or replacement costs for such product (or refund the purchase price if so elected by ZOLL Medical) and ZOLL Medical shall reimburse purchaser for the reasonable costs of shipping the product or component to purchaser. ResQPOD and ResQPUMP are registered trademarks of ZOLL Medical. These products and their use are protected by one or more of the following patents listed at www.zoll.com/patents.

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