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Notices

Defibtech, L.L.C. shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use of
this material.

Information in this document is subject to change without notice. Names and data
used in the examples are fictitious unless otherwise noted.

Limited Warranty

The “Limited Warranty” shipped with Defibtech ACC products serves as the sole
and exclusive warranty provided by Defibtech, L.L.C., with respect to the products
contained herein.

Copyright

Copyright © 2019 Defibtech, L.L.C.

All rights reserved. Copyright questions should be directed to Defibtech. For contact
information, refer to Chapter 10 of this manual.

Patents

For patent information, see www.defibtech.com/patents.

CAUTION

Federal Law (USA) restricts this device

to sale by or on the order of a physician.

RAC-E1510EN-DN

3

Issued: 2019-06-19

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Содержание RMU-1000

Страница 1: ...User Manual Defibtech RMU 1000 Automated Chest Compression System ELECTRONIC DISTRIBUTION RAC E1510EN DN...

Страница 2: ......

Страница 3: ...ranty The Limited Warranty shipped with Defibtech ACC products serves as the sole and exclusive warranty provided by Defibtech L L C with respect to the products contained herein Copyright Copyright 2...

Страница 4: ...ent Wrist Straps to the Frame 19 3 6 The Compression Module 21 3 7 Installing and Removing the Patient Interface Pad 23 3 8 Installing and Removing the Battery Pack 23 3 9 Charging the Battery Pack 24...

Страница 5: ...ack 47 6 3 External AC Adapter 47 6 4 Stabilization Strap 48 6 5 Patient Wrist Straps 48 6 6 USB Cable 48 6 7 Battery Pack Charging Station 48 6 8 Tactical Case 49 7 Technical Specifications 51 7 1 De...

Страница 6: ...RAC E1510EN DN 6...

Страница 7: ...e ACC system The Frame is placed over the patient and snaps into the Backboard with self locking latches The Compression Module mounts into the Frame and contains the user interface a replaceable Batt...

Страница 8: ...1 2 The Defibtech RMU 1000 ACC 7 6 3 4 5 1 2 13 12 14 15 8 9 10 11 RAC E1510EN DN 8...

Страница 9: ...ace that the Frame attaches to 8 Backboard Latches One on each side of the Frame the Backboard Latch is the mechanism that secures the Frame to the Backboard 9 Stabilization Strap Connectors One on ea...

Страница 10: ...aison Committee on Resuscitation ILCOR states the following side effects of CPR Rib fractures and other injuries are common but acceptable consequences of CPR given the alternative of death from cardi...

Страница 11: ...raining in accordance with resuscitation guidelines as required by local state provincial and or national regulations e g American Heart Association European Council of Resuscitation Thorough knowledg...

Страница 12: ...RAC E1510EN DN 12...

Страница 13: ...other liquids Immersion in fluids may result in fire or explosion Do not sterilize the RMU 1000 ACC or its accessories Do not let fluids get into the RMU 1000 Compression Module Avoid spilling fluids...

Страница 14: ...oon as possible The Patient Wrist Straps are designed only for use with Defibtech RMU 1000 Automated Chest Compression Systems Do not apply to other items such as a stretcher or bedside rails Do not u...

Страница 15: ...l power source The Battery Pack must always be installed to operate the ACC from external power Without the Battery Pack the ACC will flash the warning indicator and will not perform compressions The...

Страница 16: ...o it is ready to go for use Store the Compression Module with a fully charged Battery Pack installed and a Patient Interface Pad attached to the Piston It is recommended to maintain a charged spare Ba...

Страница 17: ...uptions Perform manual compressions whenever possible Run Continuous Run with Breaths 1 4 5 Place Backboard under patient and expose chest Adjust Piston height until it touches the patient s chest Sta...

Страница 18: ...ving parts on the Backboard Attachment Points Attachment Points 3 4 The Frame The Frame holds the Compression Module It attaches to the Backboard and is used to maintain the Compression Module s posit...

Страница 19: ...the ACC As shown in the above left illustration each Patient Wrist Strap is comprised of two main strap sections a Frame Strap that attaches to the ACC s Frame and an Forearm Strap that wraps around...

Страница 20: ...tion 2 After the Frame Strap has been inserted through the Frame Strap Loop pull the end of the Frame Strap in the opposite direction so that the Frame Strap is tightly wrapped around the ACC Frame as...

Страница 21: ...of the ACC system including the User Control Panel the Battery Pack and the Compression Piston It easily attaches to the Frame and locks into place for operation User Control Panel Patient Interface...

Страница 22: ...the Frame at which point it should rest in the Frame Rotate the Module in either direction until it is in line with the Frame and snaps to lock into place When properly attached the Compression Module...

Страница 23: ...status of the Battery Pack on the Compression Module s Battery Pack indicator for approximately three seconds Ship Mode Battery Packs are shipped from the factory at less than 30 charge capacity in a...

Страница 24: ...ection 6 7 for details To connect the AC Adapter to the ACC insert the AC adapter plug into the Compression Module s external power input jack as shown in the center illustration above As the jack is...

Страница 25: ...nal power Otherwise charge Battery Pack as soon as possible Red bar fast flashing Battery Pack not installed Install a charged Battery Pack Battery Pack is in ship mode Transfer Battery Pack from ship...

Страница 26: ...been completed to set up your RMU 1000 ACC follow this procedure to perform an initial test of the unit 1 Turn the unit on by pressing the ON OFF button for at least one second 2 Verify that piston is...

Страница 27: ...the case Always leave a fully charged Battery Pack inserted in the Compression Module when storing Release the Frame from the Backboard by pressing the Backboard release levers and lifting the Frame f...

Страница 28: ...RAC E1510EN DN 28...

Страница 29: ...se are Place Backboard under patient Attach Frame to Backboard Attach Compression Module to Frame Press ON OFF button for at least one second to turn ON Adjust piston height Press Run button to perfor...

Страница 30: ...g to the compressions with breaths protocol and pauses for the operator to give rescue breaths A reminder chirp and flashing LED occur during the 3 compressions prior to the ventilation pause Pause Bu...

Страница 31: ...two rescuer scenario STEP 1 Confirm that the patient is unresponsive and not breathing Remove clothing from the patient s chest and begin manual CPR immediately STEP 2 Open the Carrying Case and remov...

Страница 32: ...ntinue manual CPR compressions Do not use the ACC if the Frame cannot be latched to the backboard STEP 7 Remove Compression Module from case Check to make sure a Patient Interface Pad is installed If...

Страница 33: ...e with the nipples Note that the compression target point is the same location as that used for manual compressions according to resuscitation guidelines Rajab T et al Technique for chest compressions...

Страница 34: ...oo small Remove Frame and continue with manual CPR compressions STEP 3 Once the Piston is properly adjusted start compressions in accordance with your emergency response protocol by pushing the Run Co...

Страница 35: ...When Battery Pack indicator shows one red segment replace Battery Pack as soon as possible or apply external power WARNING Do not leave the ACC running while unattended Patient injury may result if t...

Страница 36: ...ing the strap clips into the Frame s Stabilization Strap Connectors until they click into place The Stabilization Strap s length can be adjusted using the self adhesive Velcro that holds both strap cl...

Страница 37: ...Straps be affixed to the ACC Frame using the instructions shown in Section 3 5 prior to a rescue and that the Frame be stored in the ACC s Carrying Case with the Patient Wrist Straps already attached...

Страница 38: ...prevent potential injury Repeat the above two steps to secure patient s other arm to the ACC s Frame WARNING Observe the patient s arms during use Do not leave a patient unattended when using the ACC...

Страница 39: ...he other hand to support the lower torso by grasping the patient s leg belt or pants After the patient is safely on the stretcher transport equipment check that the RMU 1000 ACC and the Piston have no...

Страница 40: ...n install the spare Battery Pack Wait for the Pause LED indicator to illuminate Re start compressions by pushing the Pause button again or one of the Run buttons Note If the Battery Pack change takes...

Страница 41: ...external power source are not available and the ACC stops compressions remove the unit from the patient and begin manual compressions immediately 4 8 Other Therapies The ACC may be used in conjunction...

Страница 42: ...t Interface Pad Remove and clean the Stabilization Strap The Patient Wrist Straps may be removed for cleaning purposes or if they need to be replaced see Section 5 2 To remove the Patient Wrist Straps...

Страница 43: ...ncluding Patient Interface Pad s AC Adapter Stabilization Strap and Patient Wrist Straps Make sure a Patient Interface Pad is installed on the Compression Module Make sure at least one unused Patient...

Страница 44: ...sible location In general the unit should be stored in clean dry and moderate temperature conditions Make sure that the environmental conditions of the storage location are within the ranges detailed...

Страница 45: ...for ordering information see Section 3 8 for installation instructions Battery Pack Indicators on Battery Pack do not illuminate after button on Battery Pack is pressed Battery Pack is in ship mode Tr...

Страница 46: ...m should there be any further questions 5 7 Service The RMU 1000 ACC contains no user serviceable parts Defibtech recommends periodic maintenance every 18 months of use After approximately 200 hours o...

Страница 47: ...rface Pad is a user replaceable single use component that provides the interface between the piston and the patient s chest Top Bottom 6 2 Battery Pack The Battery Pack provides a replaceable primary...

Страница 48: ...on Module to be connected to a personal computer and for ACC data retrieval and event reporting when used in conjunction with utility software available at www defibtech com The ACC s USB port is loca...

Страница 49: ...pact Tactical Case is available as an optional accessory For more information visit www defibtech com or contact Defibtech or your authorized distributor see Chapter 10 Contacts 6 R MU 1000 ACC Access...

Страница 50: ...RAC E1510EN DN 50...

Страница 51: ...inches 5 3 cm 0 3 cm from Start Position nominal patient Compression frequency 101 1 compressions per minute Compression duty cycle 50 5 Compression modes Continuous compressions Compressions with bre...

Страница 52: ...r displays a replace Battery Pack condition 300 charge discharge cycles Battery Pack operating temperature 0 40 C 32 104 F ambient Charging temperature 0 40 C 32 104 F ambient Storage temperature 0 40...

Страница 53: ...ts and hazardous substances the accumulation of which could pose serious risk for the environment and human health It is for this reason that local administrations provide regulations which encourage...

Страница 54: ...RAC E1510EN DN 54...

Страница 55: ...e Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 8 kV contact 15 kV air There are no special requirements with respect to electrostatic discharge Electrical fast transient burst IEC 6...

Страница 56: ...pagation is affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to...

Страница 57: ...m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer...

Страница 58: ...part of the RMU 1000 ACC including cables than necessary WARNING The RMU 1000 ACC should not be used adjacent to other equipment and that if adjacent the RMU 1000 ACC should be observed to verify nor...

Страница 59: ...ths Pause Button Stops compressions when running or resumes compressions when paused Warning Indicator Flashes to alert the user that the ACC has determined that there is a problem Warning Mute Button...

Страница 60: ...e or crush X X X X Y Y Y Y Follow proper disposal procedures Meets the requirements of the European Medical Device Directive Y Y Y Y Operational temperature limitation Y Y Y Y Use by yyyy mm dd Y Y Y...

Страница 61: ...ge requirements See environmental requirements on packaging EC REP Authorized European Representative EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague The Netherlands Not made with natural rubber la...

Страница 62: ...fication UDI information NOTE Sample shown at left is for visual reference purposes only actual UDI information specific to this device appears on a physical label affixed to the unit s components and...

Страница 63: ...te 201 Guilford CT 06437 USA Tel 1 866 333 4241 Toll free within North America 1 203 453 4507 Fax 1 203 453 6657 Email sales defibtech com Sales reporting defibtech com Medical Device Reporting servic...

Страница 64: ...RAC E1510EN DN 64...

Страница 65: ...ment the replacement at a minimum shall reflect the prorated time remaining for the Product based on the remaining WARRANTY PERIOD In the case of a credit the credit shall be the prorated value of the...

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