ROSC-U™ Frequently Asked Questions
The RMCC, a mechanical CPR device, provides consistent cardiopulmonary resuscitation in terms of number of compressions, and depth of compressions to give the patient improved circulation.
The RMCC provides compression depths up to 2.0 inches.
Most of the mechanical chest compression devices which were on the market were large, heavy, and difficult to set up and complicated to operate in the emergency settings of sudden cardiac arrest and resuscitation.
The RMCC was therefore developed with the goals of being light weight, small, easy to operate and fast to deploy. In addition to these advantages, the unique design of the Torso Restraint both fixes the unit to a patient securely but also increases its hemodynamic efficacy.
- 360 Circumferential Chest Compression
- Compact Size and Light Weight
- No Backboard Required
- Easy to Use, No Complicated Programming
- Can be Used Throughout Transport Minimizing CPR Interruptions
- Takes up Little Space for Storage
- Chest Compressor weighs Only 7.4 Pounds
- Uses Reliable Lithium Iron Phosphate Batteries
- Very Little Training Required of Personnel
- 10 Second Deployment Minimizes CPR Interruptions
- Low Cost of Ownership Compared to Competitive Products
- Very Quiet During Use
- One-Touch 30:2 Ratio of Compressions to Ventilations Feature with Visual “Alarm”
- Pause Compressions at a Touch of a Button
- Simple Compression Depth Selection Feature (Default, Mid and 2.0”)
Yes, the ROSC-U Miniaturized Chest Compressor has FDA 510(k) Clearance to Market.
Contact your distributor or the manufacturer for more detailed information.
There are 4 major components of the RMCC:
- The Compressor that contains a linear motor that drives the compressor pad to depress a patient’s chest.
- Battery Control Unit that contains the battery, illuminated power ON/OFF switch, Function Control Panel and Umbilical Power Cord connecting it to the Compressor. Note: The battery charger is a separate unit.
- The Torso Restraint is placed underneath and around the patient to firmly secure the compressor to the patient. Note: We have recently added an XL Size Torso Restraint for larger patients.
- The Stabilizer serves a dual purpose; providing a head rest and also securing the torso restraint to provide stability during continuous operation of the RMCC.
Yes, the torso restraint and stabilizer cover are single-use disposable components.
WARNING: Reuse of the single-use disposable components may result in harm to the patient. Reuse of these items, which may have become contaminated during its first use, may result in subsequent health deterioration of the patient due to contamination.
WARNING: Single use disposable components are not intended for reprocessing or sterilization.
WARNING: Treat the torso restraint and stabilizer cover as contaminated medical waste and dispose of accordingly.
The RMCC is used to perform mechanical external cardiac compressions, otherwise known as CPR (cardiopulmonary resuscitation) on adult patients (18+) who have acute, circulatory arrest and are clinically dead defined as the absence of spontaneous breathing, no pulse, and loss of consciousness.
Federal Law restricts this device to sale by or on the order of a physician.
The RMCC is intended for use on adults only.
The prescribing physician and your facility should make the final determination about when the RMCC is used. Always consult local protocol for the proper integration of the miniaturized chest compressor into your arrest management regime or regiment of care.
There are situations where CPR is not the appropriate method of intervention. Familiarity with accepted medical practices in your area is very important. Always consult local protocol for the proper integration of the miniaturized chest compressor into your arrest management regime or regiment of care.
DO NOT USE THE RMCC in the following cases:
- If there is no indication that chest compression is likely to help the patient.
The RMCC is not intended for pregnant patients.
The RMCC is not intended for patients with traumatic injury (wounds resulting from sudden physical injury or violence.
No. The current version of the American Heart Association Guidelines does not recommend the use of mechanical CPR on infants or children. The RMCC is intended for use on adults 18 or over.
The RMCC is powered by a unique rechargeable Lithium Iron Phosphate battery-powered control unit. The RMCC can only be operated with this Battery Control Unit and the charger provided.
CAUTION: Attempting to charge the RMCC with a non-approved charger could result in damage to the RMCC, its battery or to personnel.
The RMCC can run as long as 3 hours or more on one charge however recommended use is 30 minutes of run time with 30 minutes of rest thereafter.
NOTE: Runtimes may vary due to temperature and the length of time since the RMCC has been last charged.
NOTE: The RMCC must be charged after each use. Continual charging will not harm the Lithium Iron Phosphate battery.
The Battery Control Unit is sealed and can withstand humid conditions and light rain normally encountered outdoors. However, should the Battery Control Unit be immersed in water; the Battery Control Unit needs to be replaced!
Bruising, injury, vomiting, fractured or broken ribs, and soreness of the chest can be possible side effects of performing CPR①. Side effects of CPR are common and considered acceptable ramifications given that the alternative is clinical death. If the patient is resuscitated, all patients should be evaluated and assessed for post CPR related injuries.
① Susan Robin (2010, January 24). Side Effects of CPR. Retrieved from http://www.livestrong.com/article/75926-side-effects-cpr/. Summary of Arkansas State University: Basic Life Support CPR and 123 CPR Inc: Complications of CPR.
All users must read and understand the entire instruction for use before operating the ROSC-U Miniature Chest Compressor (RMCC). The purpose of the instructions for use is to explain the use, care, and user maintenance of the RMCC and is not intended to teach cardiopulmonary resuscitation. Instructions for use should always be easily accessible to the users of RMCC
Personnel who intend to use the RMCC must be trained in Basic Life Support and/or Advanced Life Support techniques. Resuscitation International LLC strongly recommends that the RMCC only be operated by: emergency medical technicians, paramedics, nurses, physicians, police, fire rescue personnel, medical staff, and people who are certified according to the American Heart Association Guidelines for cardiopulmonary resuscitation, or equivalent. In addition, proper use of the RMCC requires a thorough understanding of the product, appropriate training, and adequate practice with the device.
The center of the compressor pad for the RMCC should be placed along an imaginary line connecting the nipples - approximately 3-4 cm/1.2 – 1.6 in (1-2 fingers) from the bottom of the sternal notch.
There are alignment indicator marks on both the Compressor housing and the mounting bracket (bottom of the Compressor that has the hooks) to assist with proper alignment on a patient’s chest. Use an imaginary line that connects the nipples on the patient with the alignment marks on the Compressor.
During transport, regular checks of the position of the RMCC on the patient should be performed.
The warranty period is 1 year from the time the customer receives the device.
The shelf life of the disposable components is 5 years from the manufacturing date.
The shelf life of the rechargeable Lithium Iron Phosphate Battery in the Battery Control Unit is 5 years.
Wipe all external surfaces of the RMCC, Battery Control Unit, Stabilizer, Carrying/Storage Case and related accessories to remove foreign matter after cleaning and disinfecting if necessary. Discard the single use items which are the torso restraint and the stabilizer cover.
The user must adhere to the CIDEX Solution Directions for Use since any modification will affect the safety and effectiveness of the disinfectant. It is recommended to follow the CIDEX directions for use supplied with the disinfectant bottle.
There are no user serviceable parts inside the RMCC and no calibrations or adjustments are needed for routine use. However, the general readiness and function of the system can, and should be evaluated on a regular basis.
Consideration should be given to the frequency of product use, storage conditions and knowledge of all product users to determine your local operator maintenance schedule.
If the RMCC is used more than once a week, daily inspection is appropriate.
If the RMCC is used less than once per week, a minimum of 1 weekly inspection is appropriate.
Inspect the RMCC in accordance with the inspection checklist provided with the instructions for use. Follow the recommended actions as appropriate.
Checklists are also provided to document these procedures. It is recommended that the user complete the checklists when these procedures are performed to provide a document trail to demonstrate that the proper recommended maintenance is being performed at the recommended/user determined intervals.
- Check that the device is clean.
- Check that the stabilizer is clean.
- Check that the umbilical power cord does not have any cracks or damage and fits securely to the Compressor.
- Check that the MAIN POWER ROCKER SWITCH is in the OFF position.
- Verify that a new torso restraint is in the carrying/storage bag.
- Verify that all major components are packed and ready for next use.
- Verify that the LED on the Charger is illuminated indicating the Unit is being charged.
- Check that the COMPRESSOR and BATTERY CONTROL UNIT are CONNECTED
Functional Check:
- Attach the RMCC to a test manikin as in Section 2.0 (Setup and Operation)
- Operate the RMCC for approximately 1 – 2 minutes.
- Check that it is operating normally.
The compression frequency is 100 ±1
Piston depth automatically sets to the default operating depth of 1 3/8 inches when the EMCC starts compressions, which is indicated by the first of the 3 LEDs above the yellow oval Piston Depth Set Button being ON. Pressing the Piston Depth Set Button once increases piston depth to medium depth of 1 11/16 inches (2 LED’s now ON) and pressing the Piston Depth Set Button again increases the depth to 2.0 inches (all 3 LED’s now ON).
Note: Once compressions have begun, in order to decrease piston compression depth and/or revert back to the default starting depth you must first stop compressions by pressing the Start/Stop Button. Then restart compressions by pressing the Start/Stop Button once more.
Careful storage of the RMCC is important. It should be stored in a location that is easily accessible and in a manner that does not allow dirt, debris, or moisture to get into the device or its accessories. It is recommended the RMCC be stored fully assembled in a Carrying bag/Storage Case ready for its next use.
For storage during normal transportation, a Carrying Bag/Storage Case offers maximum protection for the device. It provides convenient storage for the basic components of the system and allows quick access to the RMCC at an emergency site. The RMCC should remain plugged into an AC power outlet for continuous charging to be ready for its next use. There is a flap at one end of the Carrying Bag/Storage Case to allow access to the Battery Control Unit’s Charger Port for this purpose.
If the patient experiences ROSC – immediately discontinue using the RMCC in the same way you would discontinue manual CPR. Follow your medical direction and protocol.
Yes, follow your local protocols.
No, the RMCC consists of a number of metal parts which do not allow x-ray penetration.
Yes, due to the low profile of the Compressor and unique patient attachment the RMCC can be used in a Cath Lab.
No, the torso restraint and stabilizer cover are single-use disposable components.
WARNING: Reuse of the single-use disposable components may result in harm to the patient. Reuse of these items, which may have become contaminated during its first use, may result in subsequent health deterioration of the patient due to contamination.
WARNING: Single use disposable components are not intended for reprocessing or sterilization.
WARNING: Treat the torso restraint and stabilizer cover as contaminated medical waste and dispose of accordingly
The RMCC can be used in most encountered environmental temperatures.
Compressor |
|
Category |
Specifications |
Size (L x W x H) |
18.16 cm x 12.7.x cm 19.69 cm (7.15 in x 5.0 in x 7.75 in) |
Weight |
3.36 kg (7.4 lbs.) |
Battery Control Unit |
|
Size (L x W x H) |
25.4 cm x 15.24 cm x 22.86 cm (10.0 in x 6.0 in x 9.0 in) |
Weight |
4.22 kg (9.3 lbs.) |
Yes. The disposable components of the system are latex free.
Yes, one of the unique features about the RMCC is that it can be used during transport which cuts down on the number of times CPR is interrupted.
The RMCC can be used in conjunction with a transportation device such as a gurney, stair chair or a backboard during transport to hospital. However, care must be taken to ensure that the patient is properly strapped to the transportation device using locally-approved procedures for safe transport. For added safety and to insure that the compressor remains in a stable position, make sure the stabilizer is supporting the patient’s head and secure to the torso restraint with the Velcro strap whenever possible.
WARNING: Straps or restraints used for transportation purposes must not interfere with the operation of the RMCC. Specifically, straps across the patient’s chest may restrict the compression/ decompression of the chest. In general, strapping schemes must not alter the alignment of the patient to the RMCC. During transport, regular checks must be performed to insure that the RMCC is secured to the patient.
During transport, regular checks of the position of the RMCC on the patient should be performed.
If for any reason the RMCC stops operation or a mechanical problem occurs, immediately remove the RMCC from the patient and revert to manual CPR.
Do not leave the patient or the device unsupervised during operation.
Please contact the manufacturer for a list of distributors
Please contact the manufacturer for further details.
One of the goals in developing the RMCC was to make it simple and easy to use and deploy so that interruptions to CPR were minimized. The device can be put on a patient in less than 10 seconds with a minimal amount of practice.
The predicate device for the RMCC was the Weil Mini Mechanical Chest Compressor (MCC). The RMCC’s method of patient attachment and unique method of delivering chest compressions are very similar to that of the MCC. We feel that both clinical use and studies performed with the MCC would be analogous to that expected from the RMCC.
Two studies were presented at the AHA 2011 Science Sessions by Dr. Wanchun Tang, MD, FCCP, FCCM, FAHA, Professor, President, and Chief Scientific Officer of the Weil Institute of Critical Care Medicine
- Miniaturized Mechanical Chest Compression for Cardiopulmonary Resuscitation
- Miniaturized Chest Compressor Improves Neurological Recovery in a Porcine Cardiac Arrest Model
Resuscitation International is committed to training and in-servicing to assist your healthcare team, your facility and community experience positive outcomes. Please contact your distributor or the manufacturer for further details on training materials and schedules.
After purchase, a unique adaptive on-line training course may be made available to qualified users that are required to perform CPR at your facility. This course is intended for both in-servicing and as a refresher course to be used as deemed appropriate by your resident training authority.
Please contact your distributor or the manufacturer for further details or visit www.resusintl.com to view a demonstration of a ROSC-U working on a manikin.
Contact us for the MSRP for the ROSC-U™ Components.
Disposables are sold in a Disposables Pack that contains 10 packs each containing one Torso Restraint and one Stabilizer Head Cover. Your authorized distributor may make disposables available in smaller quantities.
Yes, there is a 2-Year Extended Warranty available for an additional cost. Ask your authorized distributor for details.
- ROSC-U System A03-01-000
- Disposables Pack of 10 A02-58-134
- ROSC-U Battery Control Unit Only A03-1B-000
- ROSC-U Compressor Only A03-1C-000
- Torso Restraint A02-57-134
- XL Torso Restraint A02-62-134
- Head Stabilizer A02-58-020
- Battery Charger A03-10-000
No, follow the instructions for cleaning found in number 20 of the FAQs.
No - CE is currently inactive.
Yes, the RMCC is Type B Equipment Defibrillator Proof.
The inspection checklist is provided with the Instructions for Use of the device. Please contact your distributor or the manufacturer to request additional copies.
The ROSC-U™ is $11,999.00 U.S. MSRP. Please contact us for your customized quote!