Patient Transport with the Automated Impella Controller
Contents
1. Patient Transport with the Automated Impella Controller OO CABIOMED Recovering hearts Saving lives TABLE OF CONTENTS PURPOSE OF THESE INSTRUCTIONS ccccctccscetstccstesecstesccstcsecssssecssvsecsenseesesecesessecsesecnsessensene 2 INDIGATION FOR USE 2 ln eui 2 ABOUT THE IMPELLA SYSTEM 222r norunt nans tantas adasa sedna na tnc acuit 3 PATIENT TRANSPORT WITH THE IMPELLA SYSTEM eene 3 Iinportant Considelatioris 8 3 9 UREHUER EHE ERE EEHEREH EUER EE REDE ERREUR ES 4 BETUIR EOS EMI CH seer errerereectrrrr 4 Transport with the Automated Impella Controller sss 5 Securing the Automated Impella Controller sss 5 TRANSFERRING SUPPORT FROM THE IMPELLA CONSOLE TO THE AUTOMATED IMPELLA CONTROLDLER 12223224 512a tun ta ianuis 6 Receiving Hospital Preparation c cccccecccsessesessesesesessesessesessesessesnssesessesseesnseesssesneeeenseeenseeenseeenees 6 How to SWItChiSUDDORE ucc a RR RH HEREDES 7 Patient Management Checklist ua cicer tete eec p cR ERR ERE EEEREN 7 TRANSFERRING SUPPORT FROM THE AUTOMATED IMPELLA CONTROLLER TO THE IMPELLA CONSOLE cocto reete paco Gees eerie eee hec rero cesi AEE 8 Receiving Hospital Prepaiati ieusnnsnsnmans nn n nnan n N tette tette re2. ductive Loop Systems in the Frequency Range 9 KHz to 30 MHz Part 1 Technical Characteristics and Test Methods EU ETSI EN300 330 2 V1 3 1 EMC amp ERM Short Range Devices V1 3 1 2006 04 SRD Radio Equipment in the Frequency Range 9 KHz to 25 MHz and Inductive Loop Systems in the Frequency Range 9 KHz to 30 MHz Part 2 EU ETSI EN 301 489 1 V1 7 1 Electromagnetic compatibility Issued 2007 04 01 and Radio spectrum Matters ERM Electromagnetic Compatibility EMC standard for radio equipment and services Part 1 Common Technical Requirements EU ETSI EN 301 489 3 V1 4 1 ERM amp EMC Standard for Radio Issued 2002 08 01 Equipment and Services Part 3 Specific Conditions for Short Range Devices SRD Operating on Frequencies between 9 KHz and 40 GHz Canada RSS 210 Low Power License Exempt Issue 7 June 2007 Radiocommunication Devices All Frequency A2 6 Bands Canada RSS GEN General Requirements and Information for Issue 2 June 2007 the Certification of Radiocommunication Equipment 12 User Manua EMC Tests and Standards IEC 60601 1 2 Harmonic current emissions Class A IEC 61000 3 2 Limitation of voltage fluctuations and flicker IEC 61000 3 3 Electromagnetic radiated field immunity IEC 61000 4 3 Electromagnetic conducted field immunity IEC 61000 4 6 Voltage dips and interruptions on AC power mains IEC 61000 4 11 Magnetic fields immunity IEC 61000 4 8 Electrically fast transients on AC power mai
3. er A Once the Impella Catheter is connected to the new 3 controller a message will appear on the screen asking you to confirm re starting the Impella Catheter at the previously set flow rate B Press OK within 10 seconds to confirm restarting the Confirm a catheter Patient Management Checklist Check each of the following once patient support has been transferred O Confirm Impella placement using echocardiography L1 Tighten the Tuohy bore on the Impella Catheter to prevent catheter migration Tighten all the way to the right L1 For patients supported with the Impella 2 5 Catheter attach a saline pressure bag pressurized to 350 mmHg to the red sidearm and complete the Transfer to Standard Configuration under the PURGE SYSTEM menu O Contact the local team or the 24 hour clinical support line 1 800 422 8666 with any questions or concerns Transport with the Automated Impella Controller 11 APPENDIX ELECTRICAL SAFETY TESTING EMI Conducted and Radiated Emissions Country or Test Description Test Standard Standard 60601 1 2 Radiated emissions CISPR 11 EN55011 30 1000 MHz Group 1 Class A 60601 1 2 Conducted emissions CISPR 11 EN55011 150 kHz 30 MHz Group 1 Class A US FCC 47CFR 15C Cert Title 47 CFR Part 15 Subpart C Intentional Radiator EU ETSI EN300 330 1 V1 5 1 EMC amp ERM SRD Radio Equip V1 5 1 2006 04 in the Frequency Range 9 KHz to 25 MHz and In
4. ller to a flat surface in the transport vehicle 3 The bed mount may be used as a loop through which to secure the straps Transport with the Automated Impella Controller 5 TRANSFERRING SUPPORT FROM THE IMPELLA CONSOLE TO THE AUTOMATED IMPELLA CONTROLLER If the sending hospital uses the Impella Console MPC follow these steps to switch support from the Impella Console to the Automated Impella Controller before transport This may require coordination with the receiving center to get the system to the sending hospital be f ore transport Receiving Hospital Preparation Gather the following items prior to switching support 1 Automated Impella Controller 2 White connector cable 3 Purge cassette 4 Purge solution recommended 20 dextrose with 50 IU mL of heparin User Manual How to Switch Support A Turn on the Automated Impella Controller B Open the purge cassette and spike a new bag of purge solution C Insert the purge cassette into the controller Prepare D Open the white connector cable and plug it into the controller A Disconnect the blue cable from the catheter B Connect the white cable to the catheter C Confirm re starting the catheter on the controller The Switch MPC system will still be purging the catheter at this point A Press PURGE SYSTEM on the controller and select Change Purge Fluid NOTE There may be purge alarms 3 on the console Co
5. ms life sustaining functions To use the system during transport you must understand and follow the Impella instructions for use The transport team should include one person fully trained in the use of the Automated Impella Controller and Impella Catheter FAA ADVISORY The Automated Impella Controller has been subjected to and passed the EMC EMI tests as specified in IEC 60601 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Refer to the Electrical Safety Testing Appendix in this manual for more information The Automated Impella Controller does not meet the requirements for conducted emissions of RTCA DO 160G section 21 4 and has not been tested for radiated emissions per RTCA DO 160G section 21 5 Abiomed recommends that air transport carriers follow the guidance FAA Advisory Circular AC No 91 21 1B Section 8 a of FAA Advisory Circular AC No 91 21 1B states Equipment tested and found to exceed the section 21 Category M emission levels are required to be evaluated in the operator s M PED selected model aircraft for electromagnetic interference EMI and radio frequency interference RFI All navigation communication engine and flight control systems will be operating in the selected aircraft during the evaluation User Manual ABOUT THE IMPELLA SYSTEM The Impella 2 5 5 0 and LD are intravascular microaxial blood pumps that support a patie
6. ns IEC 61000 4 4 Surge on AC power mains IEC 61000 4 5 Electrostatic discharge IEC 61000 4 2 Review of EMC identification markings and documents Section 6 Transport with the Automated Impella Controller 13 Automated Impella Controller Electrical Specifications Parameter Specification Temperature Operating 10 C to 40 C 50 F to 104 F Storage 15 C to 50 C 5 F to 122 F Relative humidity Operating 95 Storage 95 Atmospheric pressure Operating 8000 ft 750 hPa to 1000 ft 1050 hPa Storage 18 000 ft 500 hPa to 1000 ft 1050 hPa Dimensions Height 351 mm 13 8 in Width 443 mm 17 4 in Depth 236 mm 9 3 in Weight Maximum 11 8 kg 26 1 Ibs Maintenance and repair 12 months work must be performed by technicians interval authorized by Abiomed AC operation 100 230 V AC nominal 47 63 Hz 1 1 A Internal battery operation 14 4 V DC nominal lithium ion Characteristic values Max power consumption under load 120 VA 9 7 fuses 2 Amp 250 V 5 mm x 20 mm slow blow fuses Run time without AC power full charged batteries 60 minutes minimum charging duration of at least 5 hours Electrical system Installation in accordance with pertinent regulations is required for use in medical facilities eg VDE 0100 VDE 0107 or ICE stipulations Observe country specific regulations and national deviations OO CABIOMED Recovering hearts Saving lives Clinical suppo
7. nt s circulatory system The Impella Catheter is inserted through the femoral or axillary artery into the left ventricle or in the case of the LD surgically via the ascending aorta When properly positioned the Impella delivers blood from the inlet area which sits inside the left ventricle through the cannula to the outlet opening in the ascending aorta Users monitor the correct positioning and functioning of the Impella on the display screen of the Automated Impella Controller PATIENT TRANSPORT WITH THE IMPELLA SYSTEM Patients are placed on the Automated Impella Controller for either partial Impella 2 5 or full Impella 5 0 LD circulatory support for periods up to 6 hours If during this time a patient requires additional resources and specialized teams at another location eg a larger facility such as a transplant center the patient may be transferred safely to such a location using the Automated Impella Controller Maintaining optimal patient hemodynamic status and correct Impella position are two key factors in managing patients supported with the Impella System during transport Steps should be taken to eliminate or minimize any aspect of the transport that might adversely affect these two factors Abiomed encourages the establishment of a relationship between outlying centers SPOKE facilities and tertiary care centers HUB facilities Criteria for accepting patients into a program should be determined be
8. ntinue with the purge fluid change to complete the transfer Check the alarms once the transfer has been completed w Complete the purge fluid change making sure to flush the Prime purge tubing C Disconnect the old purge tubing D Connect the new purge tubing Patient Management Checklist Check each of the following once patient support has been transferred O Confirm Impella placement using echocardiography L1 Tighten the Tuohy bore on the Impella Catheter to prevent catheter migration Tighten all the way to the right L1 For patients supported with the Impella 2 5 Catheter attach a saline pressure bag pressurized to 350 mmHg to the red sidearm and complete the Transfer to Standard Configuration under the PURGE SYSTEM menu O Contact the local team or the 24 hour clinical support line 1 800 422 8666 with any questions or concerns Transport with the Automated Impella Controller TRANSFERRING SUPPORT FROM THE AUTOMATED IMPELLA CONTROLLER TO THE IMPELLA CONSOLE If the receiving hospital uses the Impella Console MPC follow these steps to transition from the Automated Impella Controller to the Impella Console after transport Receiving Hospital Preparation Gather the following items prior to switching support jl Cc mo A W N Impella Console system Console infusion pump and Impella Power Supply on cart Blue connector cable Grey pressure t
9. ransducer cable Infusion pump tubing CM Set Purge solution recommended 2096 dextrose with 50 IU mL of heparin User Manual How to Switch Support A Turn on the Impella Console B Set up the infusion pump and tubing C Connect the gray pressure transducer cable to the 1 CM Set and the Impella Console D Plug the blue cable into the console E Press PURGE SYSTEM on the Automated Impella Prepare Controller select Change Purge Fluid and complete the procedure to bolus the purge system Do NOT flush the purge fluid from the cassette A Disconnect the purge cassette tubing Purge System Open alarm will sound 2 B Connect the new purge tubing and start the infusion C Disconnect the white cable from the Impella Catheter Switch D Connect the blue cable to the Impella Catheter Console a message will appear on the screen asking you to confirm re starting the Impella Catheter at the 3 A Once the Impella Catheter is connected to the Impella previously set performance level B Press OK within 10 seconds to confirm restarting the Confirm a catheter Patient Management Checklist Check each of the following once patient support has been transferred O Confirm Impella placement using echocardiography L1 Tighten the Tuohy bore on the Impella Catheter to prevent catheter migration Tighten all the way to the right L1 For patients supported with the Impella 2 5 Catheter a
10. rt 24 hours per day 7 days a week 1 800 422 8666 US 49 0 1805 2246633 EU www abiomed com T Abiomed Inc Abiomed Europe GmbH 22 Cherry Hill Drive Neuenhofer Weg 3 Danvers Massachusetts 01923 USA 52074 Aachen Germany Voice 978 777 5410 Voice 49 241 8860 0 Facsimile 978 777 8411 Facsimile 49 241 8860 111 Email marketing abiomed com Email europe abiomed com 2011 Abiomed Inc All rights reserved The ABIOMED logo and ABIOMED are registered trademarks of Abiomed Inc in the U S A and certain foreign countries Recovering hearts Saving lives is a trademark of Abiomed Inc Impella is a registered trademark of Abiomed Europe GmbH a wholly owned subsidiary of Abiomed Inc in the U S A and certain foreign countries December 2011 HCS PM 1211 0267 0 C 0086
11. sport time is expected to include more than 60 minutes during which the system will be disconnected from AC power arrangements should be made to use a vehicle with a built in DC to AC power inverter 4 User Manual Transport with the Automated Impella Controller 1 Unplug the Automated Impella Controller from AC power Rotate the T knobs to unlock the controller from the cart Lift the controller off the cart using the blue handle KR UJ N Place the controller on a flat surface seat bench shelf or stretcher or hang the controller on the end of the stretcher using the bed mount 5 Remove the purge solution from the IV pole on the cart and place it on the IV pole of the stretcher or transport vehicle 6 Secure the controller If the controller is left unsecured it can become a dangerous projectile inside the transport vehicle or aircraft Securing the Automated Impella Controller Options for securing the Impella System during transport will vary by transport provider Transport providers should take into consideration their particular vehicle stretcher design and accessory mounting options when planning to transport a patient supported by the Impella System 1 The Automated Impella Controller has a bed mount on the back of the housing that may be used to hang the controller on the stretcher while the patient is transported inside the hospital 2 Straps may be used to secure the Automated Impella Contro
12. ttach a saline pressure bag pressurized to 350 mmHg to the red sidearm O Contact the local team or the 24 hour clinical support line 1 800 422 8666 with any questions or concerns Transport with the Automated Impella Controller 9 TRANSFERRING SUPPORT FROM THE AUTOMATED IMPELLA CONTROLLER TO A NEW AUTOMATED IMPELLA CONTROLLER If the receiving hospital uses the Automated Impella Controller follow these steps to transition from the sending hospital s Automated Impella Controller to the new Automated Impella Controller after transport Receiving Hospital Preparation Gather the following items prior to switching support 1 Automated Impella Controller from receiving hospital 10 User Manual How to Switch Support A Confirm that the new controller is powered on and ready B Press PURGE SYSTEM on the original controller select Change Purge Fluid and complete the procedure to bolus the purge system Do NOT flush the purge fluid from the cassette Prepare C Disconnect the yellow luer connector from the Impella Catheter to release the pressure in the purge cassette A Transfer the purge cassette and purge solution from the original controller to the new controller B Reconnect the yellow luer connector to the Impella Catheter C Remove the white connector cable from the original Switch controller and plug it into the catheter plug on the front of the new controll
13. ttet ttis 8 Howto Switch SUP PON uses eee eene nene ne n RARE RR Rd 9 Patient Management Checklist scssscrsscssscesssscssssessssescesessesossssescacessasessaccnsascnsasensascasassssassssaseseaies 9 TRANSFERRING SUPPORT FROM THE AUTOMATED IMPELLA CONTROLLER TO A NEW AUTOMATED IMPELLA CONTROLLER cscssceseeseeseeeeeeeeeeeeeseeeeesseeseneaeease 10 Receiving Hospital PTeDatdtloli 2 rrr ERREUR REA ERE o 10 HOWEO SWITCH SUD PONE 2993516 EIE III ER RERO URN RENE URERE LER L ERU RERLRER UON U NER L RENTRER THERE 11 Patient Management Ch ckllsl e c a m HU RR 11 APPENDIX ELECTRICAL SAFETY TESTING eeeeeeneenennnnnnnnnnnnnnnnnnnnnnnnnn 12 PURPOSE OF THESE INSTRUCTIONS These instructions are designed for healthcare professionals to facilitate the safe transport of patients supported with the Automated Impella Controller from one medical facility to another This manual contains clinical and technical information to guide healthcare professionals before during and after transport INDICATION FOR USE The Automated Impella Controller and Impella Catheters have been cleared by the FDA for hospital to hospital transport via ambulance helicopter or fixed wing aircraft The Automated Impella Controller is qualified for safe use by healthcare professionals to facilitate the transport of patients supported by the Impella Systems from one medical facility to another The Impella System perfor
14. tween hospitals in advance of the need for a transfer Transport with the Automated Impella Controller Important Considerations 1 Planning is critical to success Abiomed representatives can help with planning for transport They can be contacted 24 hours a day at 1 800 422 8666 2 Abiomed recommends that air transport carriers follow the guidance FAA Advisory Circular AC No 91 21 1B 3 The Automated Impella Controller should be fully charged prior to transport Keep the controller connected to AC power or an AC inverter whenever possible 4 Do not stress the connector cable from the controller to the Impella Catheter Such tension could move the catheter out of correct position and compromise patient circulatory support 5 Carefully monitor purge pressures during changes in altitude 6 The controller should be positioned to allow easy access to the display screen and soft buttons to view alarms and make any necessary changes 7 Maintain ACTs between 160 and 180 or at the level recommended by the physician responsible for the patient 8 If possible place the controller and the red Impella plug at the level of the patient s heart during transport 9 Decrease the flow rate if CPR is necessary Battery Operation The Automated Impella Controller is designed to operate for at least 60 minutes on battery power Transport teams should take this into consideration when planning the transport If the total tran
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