ROSC-U Mini Chest Compressor (RMCC) Model No. EMCC-201 ... IFU... · to assure that the equipment...

ROSC-U Mini Chest Compressor (RMCC) Model No. EMCC-201

INSTRUCTIONS FOR USE

Resuscitation International, LLC 17797 N Perimeter Dr. Suite #105

Scottsdale, AZ 85255 USA Tel: (480) 240 9495 Fax: (480) 419 8144

Email: [email protected] Website: www.resusintl.com

RMCC IFU – SPEC3002-092617

mailto:[email protected]

http://www.resusintl.com/

Instructions for Use

2 RMCC IFU – SPEC3002-092617

Page

Table of Contents .................................................................................................................... 2

Important User Information .................................................................................................... 3

General Warnings and Cautions ............................................................................................ 4

1.0 Introduction .................................................................................................................... 5 1.1 Indications for Use ................................................................................................... 5 1.2 Contraindications ..................................................................................................... 5 1.3 Device Description ................................................................................................... 5

1.3.1 System Components .................................................................................. 5 1.3.2 Electrical Power Source .............................................................................. 6 1.3.3 Connecting Compressor to Battery Control Unit ......................................... 6 1.3.4 User Controls .............................................................................................. 7 1.3.5 Annotation of Symbols ................................................................................ 9 1.3.6 Location of Symbols ................................................................................. 10

2.0 Set up and Operation ................................................................................................... 11 2.1 Preparing RMCC ................................................................................................... 11 2.2 Attaching RMCC .................................................................................................... 12 2.3 Operating RMCC ................................................................................................... 12 2.4 Interrupting Compressions ..................................................................................... 12 2.5 Ending Active Use of RMCC .................................................................................. 13 2.6 Preparing the RMCC for Its Next Use .................................................................... 13 2.7 Transporting the Patient......................................................................................... 13

3.0 Cleaning and Maintenance .......................................................................................... 14 3.1 Avoiding Contamination ......................................................................................... 14 3.2 General Cleaning ................................................................................................... 14 3.3 Maintenance .......................................................................................................... 14 3.4 Storage .................................................................................................................. 15 3.5 Service .................................................................................................................. 15

4.0 Technical Specifications .............................................................................................. 16 Table A Operating Specifications ........................................................................... 16

Table B Power Requirements ................................................................................ 16

Table C Environment Specifications Table ............................................................ 16

Table D Physical Specifications ............................................................................. 17

Table E Battery Physical Specifications ................................................................. 17

Table F Battery Environmental Specifications ........................................................ 17

Table 1 Electromagnetic Emissions ....................................................................... 18

Table 2 Electromagnetic Immunity ......................................................................... 19

Table 4 Electromagnetic Immunity Non-Life Supporting ……………………………. 20

Table 6 Recommended Separation RF Distances ……........................................... 21

Symbols ................................................................................................................................. 22

Troubleshooting Guide ......................................................................................................... 23

Ordering Information ............................................................................................................ 24

Inspection Checklist ............................................................................................................ 25


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IMPORTANT USER INFORMATION

All users must read and understand the entire Instructions For Use before operating the ROSC-U Miniature Chest Compressor (RMCC). The purpose of Instructions For Use is to explain the use, care, and user maintenance of RMCC and is not intended to teach cardiopulmonary resuscitation.

Instructions For Use should always be easily accessible to RMCC users.

Required skills

Personnel who intend to use RMCC must be trained in Basic Life Support and/or Advanced Life Support techniques. Resuscitation International LLC strongly recommends that RMCC only be operated by: emergency medical technicians, paramedics, nurses, physicians, police, fire rescue personnel, medical staff, and people who are certified to perform CPR according to the American Heart Association Guidelines for cardiopulmonary resuscitation, or equivalent. In addition, proper use of RMCC requires a thorough understanding of the product, appropriate training, and adequate practice with the device.

Disclaimer

Resuscitation International LLC assumes no responsibility for the use of RMCC by personnel that do not fulfill the requirements listed above.

Resuscitation International LLC does not accept liability for injury to personnel or damage to equipment that may result from misuse of the RMCC.

Under no circumstances shall Resuscitation International LLC be liable for incidental or consequential damage arising from use of RMCC.

The use of drugs or medical equipment in combination with external chest compressions may reduce the effectiveness of the compressions. Always refer to the Instructions For Use for other medical equipment to assure that the equipment is appropriate to use in conjunction with the mechanical chest compressions being performed by RMCC.

Side Effects:

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, the patient 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.

http://www.livestrong.com/article/75926-side-effects-cpr/


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GENERAL WARNINGS AND CAUTIONS

➢ Federal Law restricts ROSC-U Miniature Chest Compressor (RMCC) to sale by or on the order of a physician.

➢ RMCC is intended for use on adults only and only adult patients. ➢ RMCC is not intended for pregnant patients. ➢ The current version of the American Heart Association Guidelines does not recommend use of

mechanical CPR on infants and children. ➢ RMCC is not intended for patients with traumatic injury (wounds resulting from sudden physical

injury or violence). ➢ When CPR is indicated, manual CPR should start immediately and should not be postponed. ➢ RMCC must be used only in cases where manual CPR would normally be initiated. ➢ Personnel certified in manual CPR must always be present during the use of RMCC. ➢ If for any reason RMCC stops operation or mechanical problem occurs, immediately revert to

manual CPR. ➢ Do not leave the patient or device unattended while RMCC is in operation. ➢ RMCC must be attached to the battery pack prior to positioning the Chest Compressor on the

patient. Otherwise hazardous voltages could be applied to the patient from other equipment. ➢ If RMCC is not positioned correctly in relation to the sternum, there is an increased risk of

damage to internal organs, ribcage, and circulation may be compromised. ➢ During transport, regular checks of RMCC’s position on the patient should be performed. Failure

to properly position RMCC may cause injury to the patient. ➢ Straps or restraints used during transportation must not interfere with operation of RMCC. ➢ Do not attempt to charge RMCC with any other charger than the one provided with device.

Attempting to charge RMCC with a non-approved charger could result in damage to RMCC, its battery or to personnel.

➢ RMCC is designed for 30 minutes of use or less per deployment. ➢ Do not submerge RMCC in liquid or operate in water. ➢ Do not re-use single use disposable components. Reuse of these items, which may have become

contaminated during first use, may result in subsequent health deterioration of the patient due to contamination.

➢ Single use disposable components are not intended for reprocessing or sterilization. This could pose a risk of harm to the patient.

➢ Do not hold onto Chest Compressor longer than one minute as it may become hot during operation.


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1. INTRODUCTION

Important: Throughout set up and operation of RMCC, there should be two qualified personnel working as a team. This allows one person to immediately begin manual CPR while the additional person unpacks, sets up, and prepares RMCC for immediate use.

1.1 Indications for Use

To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

The current version of the American Heart Association Guidelines does not recommend the use of mechanical CPR on infants and children.

1.2 Contraindications

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 RMCC into your arrest management regime or regimen 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.

1.3 Device Description

The RMCC is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by a battery powered Control Unit.

The RMCC provides consistent CPR support for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques. A typical application of the device is shown in Figure 1.

1.3.1 System Components (The major components of the RMCC are shown in Figure 2.)

1. Compressor: contains the Motor that drives the Compressor Pad to compress a patient’s chest and the Umbilical Power Cord.

2. Battery Control Unit: contains a Battery, Power ON/OFF Rocker Switch, Function Control Panel, Connector for Umbilical Power Cord and Charger Port. Note: Battery charger is a separate unit.

3. Torso Restraint: is placed underneath and around patient’s back to firmly secure the Compressor to a patient.

4. Stabilizer: serves dual purpose; providing a head support and also attaches to Torso Restraint to provide stability during continuous operation of RMCC, especially during patient transport.

Figure 2. RMCC Components

Figure 1. ROSC-U Mini Chest Compressor (RMCC)


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1.3.2 Electrical Power Source

RMCC is powered by a unique rechargeable Lithium Iron Phosphate battery-powered Control Unit (Figure 1). RMCC can only be operated with this Battery Control Unit and Charger provided.

To charge Control Unit’s battery, insert Charger’s AC power cord into any 120V AC outlet and plug the other cord (round barrel power connector) directly into recess on Battery Control Unit where Main Power Rocker Switch is located. The Light Emitting Diode (LED) on charger will light up Red indicating Battery is being charged. When this LED turns Green, the Battery is fully charged. Fully charging the Battery takes approximately 6 hours and fully charging a partially depleted battery will take less time, depending on the battery’s initial charge. Note: Charger automatically adjusts from 120V 60Hz to 220V 50Hz use when plugged into a 220V 50Hz electrical source.

CAUTION: You Must Recharge Battery Control Unit After Every Use.

CAUTION: Attempting to charge RMCC with a non-approved charger could result in damage

to RMCC, its battery or to personnel.

1.3.3 Connecting Compressor to Battery Control Unit

The Compressor of RMCC connects to the Battery Control Unit via a 6-foot Umbilical Power Cord. The Compressor and Battery Control Unit Should Not Remain Attached while in the Carrying Case. When reconnecting the Umbilical Power Cord Connector to the Battery Control Unit, it is imperative that the connectors be properly aligned.

Note: Umbilical Power Cord is permanently attached to Compressor.

CAUTION: DO NOT treat the Umbilical Power Cord like a handle! Doing so may damage the Umbilical Power Cord.

Connectors have a matching set of alignment keys (tang and slot) which assist to guide alignment of connectors. An alignment key can be seen in Figure 3 at the 12:00 position (viewing connector as a clock face). Use indented mark on surface of Battery Control Unit housing (above connector) to assist with aligning the two connectors. The black guide mark on Blue Ring on Power Cable Connector (Figure 3) aligns with mark on the housing.

Figure 3. Connector Alignment Keys

Battery Control Unit Key

Umbilical Power Cord Alignment Mark

Battery Control Unit Alignment Mark


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Once alignment keys have been properly aligned, use gentle but firm force to insert umbilical power cord’s connector into Battery Control Unit’s connector. The locking ring on cord’s connector should pass over the three retention tangs of Battery Control Unit’s connector. When connector is seated firmly, turn locking ring of Umbilical Cord approximately ¼ turn clockwise until a firm seating can be felt and a dull click heard (Figure 4).

Note: if resistance is encountered when attempting to make connection, the alignment keys may not be aligned or locking ring may need to be rotated slightly to pass over the 3 retention tangs.

1.3.4 User Controls

Controls for RMCC can be found on Battery Control Unit (Figure 5). These consist of a Main Power ON/OFF Rocker Switch (illuminated when ON) and a Function Control Panel (Figure 6). Main Power Rocker Switch must first be in the ON position (switch illuminated) before Function Control Panel can be operated. The membrane buttons on Function Control Panel are referenced ① through ④ and correspond to the numbered instructions below. CAUTION: Prior to using RMCC on a patient, ALWAYS insert the Charging Port Cover (Figure 7) in the Charging Port to protect it from debris and contaminants.

Figure 6. ON/OFF Rocker Switch & Function Control Panel

Figure 4. Connector Properly Seated

REF: Clockwise Rotation

Figure 7. Charging Port Cover

Figure 5. Battery Control Unit


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Main Power Switch, Function Control Panel Buttons and Functions by Button Reference Number

CAUTION: Before turning power ON or attempting to push any Buttons on Functional Control Panel, you must first have RMCC Compressor properly and securely attached to the patient (see Section 2.2 Attaching RMCC).

0. Main Power Rocker Switch: This switch is recessed and located on the side of Battery Control Unit.

Power OFF is indicated by ( O ) symbol and Power ON by ( ) symbol. Main Power Rocker Switch

will illuminate when Power ON symbol ( ) is firmly pressed with an audible click. Once Main Power Rocker Switch is ON and illuminated, Function Control Panel Buttons will illuminate and all six Green LED function lights will flash continuously in unison. RMCC is ready for use only after the six Green LED function lights have flashed two (2) times. Note: Main Power Rocker Switch must first be in ON position (switch illuminated) before RMCC can be operated.

1. Start/Stop Button: Default setting on Start/Stop Button is OFF. Push the Red Start/Stop Button once to Start Compressions on the patient. The LED directly above Start/Stop Button, as well as the first LED above the Piston Depth Set Button, illuminates simultaneously indicating RMCC is performing compressions. Note: The first few compressions are partial strokes due to device calibration (adjusting to patient’s anatomy) and are appropriate for proper function of device. Pressing Start/Stop Button again will Stop Compressions on the patient. Depth setting will then default back to initial default operating depth.

2. Piston Depth Set Button: After starting compressions you may want to increase the depth of the piston’s compression greater than that of default setting. Piston depth automatically sets to default operating depth when RMCC starts compressions, which is indicated by the first of three LEDs above the yellow oval Piston Depth Set Button being ON. Pressing Piston Depth Set Button once increases piston depth to medium depth (two LEDs now ON) and pressing Piston Depth Set Button again increases to maximum depth (all three LEDs now ON). Note: Once compressions have begun, in order to decrease piston compression depth and/or revert back to default starting depth you must first stop compressions by pressing Start/Stop Button. To restart compressions, press Start/Stop Button once more.

3. Pause/Resume Compressions Button: This is a dual function button. Pressing Pause/Resume Compressions Button once Pauses (Stops) Compressions on the patient’s chest (LED above button is now ON) and pressing Pause/Resume Compressions Button again Resumes (Starts) Compressions on the patient’s chest (LED above is now OFF) while retaining previously set piston depth setting.

4. 30:2 Compressions to Ventilations Button (optional function): RMCC has a built-in program to allow a continuous cycle of 30 compressions followed by an automatic pause for three seconds allowing the patient to receive 2 ventilations and then automatically restarting another 30 compressions and so on. Approximately 3 seconds prior to each pause for ventilations, a visual “alarm” will alert the user when each pause is about to start by the blinking of the Green LED above the 30:2 Button. To run 30:2 program, push 30:2 Compressions to Ventilations Button once (LED above the button is now ON). To disable this function press 30:2 Compressions to Ventilations Button again (LED above the button is now OFF). Note: The 30:2 Compressions to Ventilations Button is an optional function and default operation is OFF when first initiating compressions with Start/Stop Button.

CAUTION: Be sure to follow your local protocol before activating this optional function.

Note: Additional Battery Control Units can be purchased separately. Contact your distributor.


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1.3.5 Annotation of Symbols

Symbols Description

Caution: please refer to user manual. All users must read the manual completely before using the RMCC on patients.

Type B Equipment Defibrillator Proof

Use battery charger K2C24V2AG only

Guide for alignment of chest compressor to an imaginary line that connects the nipples (one mark on either side).

NOTE: This position is important to the efficacy of the RMCC.

IP21

Protected against falling water drops

Temperature Limits for Storage and Transport

Humidity Limits for storage and transport.

Pressure limits for storage and transport.


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1.3.6 Location of Symbols (Figure 7)

Figure 7. Locations of Symbols


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2.0 SET UP AND OPERATION

RMCC system is delivered fully assembled with Compressor, Battery Control Unit with Umbilical Power Cord, Charger, Stabilizer, and Torso Restraint. Before setting up and using RMCC, there are several important precautions that must be observed at all times.

1. RMCC is intended for use on adults and only on adult patients.

2. Manual CPR should be started on a patient immediately upon arrival. If manual chest compressions have already been started, immediately unpack and set up RMCC for use.

3. RMCC is not intended for patients with traumatic injury (wounds resulting from sudden physical injury or violence).

4. RMCC must be used only in cases where manual CPR would normally be initiated. Personnel certified in manual CPR must always be present during the operation of the RMCC.

2.1 Preparing RMCC

• Place Carrying/Storage Case on ground (Figure 8).

• Unpack Compressor, Torso Restraint and Stabilizer (Figure 9). It is suggested that Battery Control Unit remain in Carrying/Storage Case.

• Make sure to securely attach the Compressor to the Battery Control Unit via Umbilical Power Cord per Section 1.3.3 Connecting Compressor to Battery Control Unit. When handling ROSC-U™ DO NOT treat the Umbilical Power Cord like a handle! Doing so may damage the Umbilical Power Cord.

NOTE: When stored, Compressor and Battery Control Unit Should Not Remain Connected to each other.

• Ensure Main Power Switch on Battery Control Unit is in the ON position which is indicated by it being illuminated (Figures 5 & 6).

CAUTION: You must Fully Charge Battery Control Unit (approximately 6 hours) using only the supplied Charging Unit before attempting to use RMCC for the first time.

Figure 8. Carrying/Storage Case Figure 9. Unpacking


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2.2 Attaching RMCC

• Roll patient on his/her side and slip Torso Restraint under patient’s back (Figure 10).

• Position center of Compressor along an imaginary line connecting the nipples approximately 3-4 cm/1.2-1.6 in (1-2 fingers) from bottom of sternum notch (Figure 11).

• Wrap Torso Restraint around patient and secure Compressor to patient’s body (Figure 12) by firmly pulling fabric ends of Torso Restraint fully out (creating tension) then down onto patient’s chest.

2.3 Operating the RMCC

• Verify that RMCC is properly positioned and secured on the patient (Figure 12).

• Turn the power ON using the Main Green Power Rocker Switch (it will illuminate).

• Start compressions by pushing the Red Power Button (Figure 13).

• If desired, adjust piston depth beyond default depth using the Yellow Piston Depth Set Button.

• Pause/Restart compressions by pushing the Green Run/Pause Button.

Warning: Should RMCC appear not to be properly secured to the patient, immediately stop compressions and make appropriate adjustments.

2.4 Interrupting Compressions

When RMCC is used in conjunction with defibrillators or with other therapeutic devices that must monitor an ECG signal, interruption of compression cycles may be required to avoid ECG motion artifact associated with mechanical chest compressions. To temporarily interrupt RMCC’s active operation, push Green Run/Pause Button once. To restart RMCC, follow procedures in Section 2.3 Operating RMCC.

Figure 10. Placement of Torso Restraint

Figure 12.

Warning: It is important to properly position compressor on the chest. Incorrect positioning diminishes the quality of compressions and more importantly, injury to the patient may occur.

Figure 13.

Figure 11. Positioning of Chest Compressor


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2.5 Ending Active Use of RMCC

When resuscitation effort is terminated, push Red Power ON/OFF button to stop compression cycles and then turn Main ON/OFF Power Rocker Switch to OFF position.

• Disconnect Torso Restraint from Compressor.

• Remove Compressor from patient’s chest.

• We strongly recommend keeping Torso Restraint in place in case patient re-arrests until all treatment on the patient is concluded.

2.6 Preparing RMCC for its Next Use

• Discard and replace Torso Restraint and Stabilizer cover. Torso Restraint and Stabilizer cover are single-use, disposable components.

NOTE: Reuse of single-use, disposable components may result in harm to the patient. Reuse of these items, which may have become contaminated during the first use, may result in subsequent health deterioration of the patient due to contamination.

NOTE: Single-use, disposable components are not intended for reprocessing or sterilization.

NOTE: Treat Torso Restraint and Stabilizer cover as contaminated medical waste and dispose of accordingly.

• Clean Compressor before next use. Refer to Section 3.0 Cleaning and Maintenance.

• Plug Battery Charger into Battery Control Unit. Then plug Charger into a 120V AC outlet to fully charge Battery Control Unit so it is ready for its next use.

2.7 Transporting the Patient

RMCC can be used in conjunction with a transportation device such as a gurney or a backboard during transport to hospital. However, care must be taken to ensure that the patient is properly strapped to transportation device using locally-approved procedures for safe transport. For added safety and to ensure compressor remains in a stable position, make sure Stabilizer is supporting the patient’s head and secured to Torso Restraint with the Velcro strap (Figures 14 & 15).

Warning: Straps or restraints used for transportation purposes must not interfere with operation of RMCC. Specifically, straps across the patient’s chest may restrict compression/decompression of the chest. In general, strapping schemes must not alter the alignment of the RMCC to the patient. During transport, regular checks must be performed to ensure RMCC is secured to the patient (Section 2.2).

Figure 14. Stabilizer and Transporting Figure 15. Stabilizer

Stabilizer


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3.0 CLEANING AND MAINTAINENCE

Always store RMCC in a clean, dry place. When cleaning RMCC, make certain Charging Port Cover is in place to prevent fluid or contaminants from entering Battery Control Unit.

3.1 Avoid Contamination

Avoid exposing Compressor and Battery Control Unit to any contaminants.

3.2 General Cleaning

Wipe all external surfaces of RMCC, Battery Control Unit, Stabilizer, Carrying/Storage Case and related accessories to remove foreign matter after cleaning and disinfecting if necessary. Discard Torso Restraint and Stabilizer cover which are single-use items.

User must adhere to CIDEX Solution Directions for Use since any modification will affect safety and effectiveness of disinfectant. It is recommended to follow CIDEX directions for use supplied with disinfectant bottle.

3.3 Maintenance

There are no user serviceable parts inside RMCC and no calibrations or adjustments are needed for routine use. However, general readiness and function of the system can and should be evaluated on a regular basis.

Consideration should be given to frequency of product use, storage conditions and knowledge of all product users to determine your local operator maintenance schedule.

• If RMCC is used more than once a week, daily inspection is appropriate.

• If RMCC is used less than once a week, a minimum of weekly inspections is appropriate.

Inspect RMCC in accordance with Inspection Checklist provided. It is recommended to 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.

After completing Inspection Checklist (page 24) - sign, date, and file it.

• Check that device is clean.

• Check that stabilizer is clean.

• Confirm umbilical power cord does not have cracks or damage and fits securely to Compressor.

• Check that MAIN POWER ROCKER SWITCH is in the OFF position.

• Verify that a new Torso Restraint is in Carrying/Storage Case.

• Verify that all major components are packed and ready for next use.

• Verify that LED on Charger is illuminated indicating Unit is being charged.

• Check that COMPRESSOR and BATTERY CONTROL UNIT are CONNECTED.

Functional Check:

• Attach RMCC to a test manikin as in Section 2.0 Setup and Operation.

• Operate RMCC for approximately 1 – 2 minutes.

• Check that RMCC is operating normally.


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3.4 Storage

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 that RMCC be fully assembled in Carrying/Storage Case and plugged into a 120V AC outlet for charging (the battery cannot be overcharged). For storage during normal transportation, the Carrying/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. It is highly recommended that the Compressor and Battery Control Unit Should Not Remain Attached while in the Carrying Case.

CAUTION: Due to the nature of the Lithium Iron Phosphate battery housed inside Battery Control Unit, certain precautions must be observed:

1. Battery Control Unit is not to be stored in a depleted or completely discharged condition.

Note: A fully charged battery would be indicated by LED on Charger changing from Red to Green.

2. Battery Control Unit should be recharged after each use. Charging Battery Control Unit may take up to 6 hours. In most cases, the time to fully charge Battery Control Unit will be significantly less.

3. If Battery Control Unit is not used and not plugged into a wall outlet for longer than 6 months, the Battery Control Unit needs a full maintenance charge of no less than 6 hours.

4. Battery Control Unit is not to be stored at temperatures below -4° F (-20 C) or above 140° F (60 C).

Note: If Battery Control Unit is stored at -4° F (-20 C) to 32° F (0 C), battery output can be affected by as much as 30%.

5. If Battery Control Unit is stored in freezing temperatures and then used, it can temporally reduce run time of battery to drive Compressor.

WARNING: Battery Control Unit needs to be replaced if it is immersed in water.

3.5 Service

• Warranty period on RMCC System is 1 (one) year.

• Contact your distributor or the manufacturer for maintenance in case of malfunctions.

• Under no circumstances should housing cover of RMCC be removed. There are no user serviceable parts inside.

• Only Authorized Technicians may repair device.

• Use original package, when returning device. For this purpose, retain the shipping package and padding in which RMCC was delivered.


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4.0 TECHNICAL SPECIFICATIONS

RMCC is to be used on adults with chest circumference of 78 - 130 cm / 30.7 - 51.1 in.

Table A Operating Specifications

Category Specifications

Chest Displacement (Piston Depth Set)

1. 35 mm / 1.375 in .05

2. 42.5 mm / 1.675 in .14

3. 51 mm / 2.0 in .12

Compression Rate 100 Compressions/min 1

Compression Duty Cycle 50 5%

Compression Modes (operator selectable)

• 30:2 (30 compressions followed by a 3 second pause for 2 ventilations)

• Continuous Compressions

Rated Duty Cycle 30 minute activation followed by 60 minute rest.

Table B Power Requirements


Compressor Power Source 24V DC 2.0A from the Supplied Battery Control Unit

Power Consumption 2.0A

Table C Environmental Specifications Operation Transport and Storage Tables

Operation


Operating Temperature -20 to 40o C / -4 to 104o F

Relative Humidity 5% to 98%, non-condensing

Atmospheric Pressure 700 hPa to 1060 hPa

Storage


Storage Temperature -20 to 60o C / -4 to 140o F

Charging Temperature 0 to 40o C / 32 to 104o F

Relative Humidity 5% to 65%, non-condensing

Atmospheric Pressure 700 hPa to 1060 hPa

WARNING: Default depth is set at minimum depth which may not reach 1.5 inches of compression depth. Press Depth Selection Button Twice to set depth at 2.0 inches.


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Table D Physical Specifications

Compressor B02-01-00C


Size (L x W x H) 18.16 cm x 12.7 cm x 19.69 cm (7.15 in x 5.0 in x 7.75 in)

Weight 3.36 kg (7.4 lbs.)

Battery Control Unit B02-01-00B


Weight 4.22 kg (9.3 lbs.)

Table E Battery Physical Specifications



Weight 2.5 kg / 5.51 lbs

Type Lithium Iron Phosphate

Capacity (nominal) 9.6 Ah

Battery Voltage (average) 25.6V

Initial Battery Runtime 3.0 Hours

Maximum Battery Charge Time No Maximum

Required Interval for Battery Replacement

Recommended to replace battery every 3 years or after 1,500 uses of 10 minutes or more

Table F Battery Environmental Specifications


Operating Temperature -20 to 40o C / -4 to 104o F

Charge Temperature -20 to 40o C / -4 to 104o F

Storage Temperature -20 to 60o C / -4 to 140o F

Compliance

• UNDOT 38.3 Tested

• RoHS Compliant

• UL 2054 Certified

• IEC 62133 Certified


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EMI Compatibility (tables provided by independent test organization)


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SYMBOLS

The following symbols are used on the RMCC and/or in the accompanying documentation.

SYMBOL MEANING

Caution, consult accompanying documents.

Single use only. Do not re-use.

Serial Number.

Model number.

Dispose in accordance with institution or local government

environmental regulations.

Manufacturer.

EC Representative

Resuscitation International, LLC

17797 N Perimeter Dr. Suite #105 Scottsdale, AZ 85255 USA

EC REP

EC Representative:

MDSS GmbH

Schiffgraben 41

30175 Hannover

Germany

Phone (+49)-511-6262 8630

FAX (+49)-511-6262 8633

EC REP

0086


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ROSC-U™ Trouble Shooting Guide

Observed Situation User Action

Compressions Won't Start or

Compressions Cease

• Confirm Umbilical Power Cord is properly attached to the Battery Control Unit.

• Turn Main Power Rocker Switch OFF, wait a few seconds and turn Power ON,

start compressions.

• Wait for the 6 Green LEDs to Flash at least 2 times for Software Initialization to

occur, start compressions.

•If the Main Power Rocker Switch is not illuminated, charge the Control Unit.

• If Green LED over the Pause/Resume Compressions Button ③ is illuminated,

Unit is in Pause Mode. Push Button ③ to Resume Compressions.

• Confirm Battery Control Unit has been fully charged. Charger's LED will change

from RED to GREEN when fully charged.

• Ensure Locking Collar on the Charger Cord has been properly screwed onto the

Battery Control Unit's Charging Port to insure proper electrical contact during

battery charging. Charge Battery Control Unit with Locking Collar in place.

Compressions Stop After Only a

Few Compressions (all 6 LEDs

Flash in Unison on Control Panel)

• Check Torso Restraint tightness. ROSC-U™ automatically detects Overload

Conditions which Stops Function and Shuts Down. Loosen Torso Restraint fit

slightly and Restart Compressions.

Functional Control Panel Does Not

Light Up

• Confirm Umbilical Power Cord properly attached to the Battery Control Unit.

•If Main Power Rocker Switch on Battery Control Unit is not illuminated, charge

Battery Control Unit.

•Ensure Battery Control Unit has been fully charged, Charger's LED will change

from RED to GREEN.

Compressions Seem to be

Irregular

• Initial compressions are irregular as the device is calibrating.

•If the Green LED over the illuminated, 30:2 Function has been activated. Press

the 30:2 Button ④ to resume compressions without the ventillation pauses.

• Ensure Torso Restraint is properly attached and Compressor is snug,, indicating

a tight fit on patient's chest.

Can't Reduce Compression Depth • Start/Stop Compressions Button ① must be pushed first in order to reset Piston

Depth to the Default setting. Press Piston Depth Set Button ② once more to set

Piston Depth to mid-depth).


24 RMCC IFU – SPEC3002-092617

For ordering information, please refer to the part ID and description below:

Part ID Description

A02-55-135 ROSC-U™ Head Stabilizer

A02-58-134 ROSC-U™ 10Pk (Torso Restraint, Stabilizer Cover, and 1 Stabilizer)

A02-60-134 ROSC-U™ 5Pk (XL-Torso Restraint, Stabilizer Cover, and 1 Stabilizer)

A03-01-000 ROSC-U™ Miniature Chest Compressor System

A03-10-000 ROSC-U™ Battery (K2) Charger ONLY

A03-1B-000 ROSC-U™ Battery Control Unit ONLY

A03-1C-000 ROSC-U™ Compressor Assembly ONLY

A03-PB-000 ROSC-U™ Carrying/Storage Case ONLY

A03-WB-000 ROSC-U™ Wheeled/Storage Case ONLY

R45-21810 Quick Reference Guide RS021

R45-21811 Instructions for Use Booklet

For International distributors, please follow the link: http://www.resusintl.com/distributors

For customer related enquiries, complaints, technical support, please call 1.480.240.9495 or e-mail:

[email protected]

http://www.resusintl.com/distributors


25 RMCC IFU – SPEC3002-092617

Inspection Checklist - Use this checklist as required according to Section 3.3. File the completed checklist. Copying this sheet is permitted.

Date: Signature:

Action / Procedure Problems Corrective Actions/Remarks

Check that device is clean.

Check that stabilizer is clean.

Check that umbilical power cord does not have any cracks or damage and fits securely to Compressor.

Check that MAIN POWER ROCKER SWITCH is in the OFF position.

Check that compressor pad is intact.

Verify that a new Torso Restraint is in Carrying/Storage Case.

Verify that all major components are packed and ready for next use.

Verify that LED on Charger is illuminated indicating Unit is being charged.

Functional Check

Attach RMCC to a test manikin as in Section 2.0 Setup and Operation.

Operate RMCC for approximately 1–2 minutes. Check that the Battery Control Unit is connected to charger and it is plugged into a 120V AC outlet.

Check that RMCC is operating normally.

ROSC-U Mini Chest Compressor (RMCC) Model No. EMCC-201 ... IFU... · to assure that the equipment...

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