AAMI TIR23810 2012 RA 2015
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AAMI/ISO TIR23810: 2012/(R)2015 – Cardiovascular implants and artificial organs – Checklist for preoperative extracorporeal circulation equipment setup
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 30 |
Covers activities performed by perfusionists during equipment setup prior to cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), cardiopulmonary support (CPS), left or right heart bypass (LHB, RHB) and venovenous (VV) extracorporeal support for liver transplantation. These checklist items should be considered for assuring verification that the equipment, devices or systems have been set up correctly. This checklist is comprehensive by design and may be modified by each institution in order to conform to specific procedures or institutional practice.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR23810:2012/(R)2015, Cardiovascular implants and artificial organs – Checklist for preoperative extracorporeal circulation equipment setup |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 9 | Glossary of equivalent standards |
| 11 | Committee representation |
| 12 | Background of AAMI adoption of ISO/TS 23810:2012 |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Requirements 2.1 Patient information 2.1.1 Patient interviewed 2.1.2 Patient identity confirmed 2.1.3 Medical record number transcribed and verified 2.1.4 Allergies verified 2.1.5 Blood bank number verified |
| 16 | 2.1.6 Blood type, antibodies verified 2.1.7 Chart reviewed 2.1.8 Procedure verified 2.1.9 Instructions for use read 2.2 Sterility/cleanliness 2.2.1 Components checked for package integrity/expiration dates 2.2.2 Lot numbers 2.2.3 Equipment clean 2.2.4 Heat exchanger(s) leak-tested 2.2.5 Maintenance |
| 17 | 2.3 Pumps (all pumps, including arterial, and those used with subsystems such as vent[s], cardioplegia, and sucker[s]) 2.3.1 Electrical 2.3.1.1 Power cord connection secured 2.3.2 Batteries charged and functional 2.3.3 Speed controls operational 2.3.4 Rollers rotate freely 2.3.5 Pump head rotation smooth and quiet 2.3.6 Occlusion(s) set 2.3.7 Flow probe(s) in correct direction and calibrated |
| 18 | 2.3.8 Flow rate indicator correct for patient and/or tubing size 2.3.9 Holders secured 2.3.10 Servo-regulated connections tested 2.3.11 Coupling of centrifugal pump secured 2.3.12 Pumps functional 2.4 Cardioplegia 2.4.1 Solutions checked 2.4.2 Water-to-blood leaks absent 2.4.3 System debubbled 2.4.4 Leak-free after pressurization 2.5 Gas supply 2.5.1 Gas line connections secured 2.5.2 Source and appropriate connections of gas verified |
| 19 | 2.5.3 Flow meter/gas blender functional 2.5.4 Hoses leak-free 2.5.5 Gas exhaust unobstructed 2.5.6 Inhalational gas scavenge line functional 2.5.7 Gas sensor used 2.5.8 Operating pressures for gas sources verified 2.5.9 Gas filter checked 2.6 Vacuum supply 2.6.1 Vacuum line connections secured 2.6.2 Source and appropriate connections of vacuum supply verified 2.6.3 Operating pressures for vacuum sources verified 2.7 Components 2.7.1 Connections/stopcocks/caps secured |
| 20 | 2.7.2 Appropriate lines clamped and shunts closed 2.7.3 Tubing direction traced and verified as correct 2.7.4 No kinks noted 2.7.5 One-way valve(s) verified to be in correct direction 2.7.6 System debubbled 2.7.7 Confirmed as leak-free after pressurization 2.7.8 Patency of arterial line/cannula verified 2.8 Safety mechanisms 2.8.1 Alarms operational, audible and engaged 2.8.2 Arterial filter/bubble trap debubbled 2.8.3 Cardiotomy/hard-shell venous reservoir(s) vented 2.8.4 Venous line occluder(s) calibrated and tested |
| 21 | 2.8.5 Devices securely attached to console 2.8.6 Electromechanical arterial line occluder functioning 2.9 Assisted venous return 2.9.1 Cardiotomy positive pressure relief valve tested 2.9.2 Negative pressure-relief valve unobstructed 2.9.3 Vacuum regulator tested 2.9.4 Pump head and bypass tubing operational when using kinetic-assisted venous drainage 2.10 Monitoring 2.10.1 Temperature probes in place 2.10.2 Pressure transducers/monitors calibrated on proper scale(s) 2.10.3 In-line sensor(s) calibrated 2.10.4 Oxygen analyzer calibrated |
| 22 | 2.11 Anticoagulation 2.11.1 Heparin time and dose confirmed 2.11.2 Anticoagulation tested and reported 2.12 Temperature control 2.12.1 Water source(s) connected and functional 2.12.2 Temperature range(s) tested and functional 2.12.3 Water lines unobstructed 2.13 Supplies 2.13.1 Tubing clamps available 2.13.2 Drugs available and properly labeled 2.13.3 Solutions available 2.13.4 Blood products available 2.13.5 Sampling syringes/laboratory tubes and supplies available |
| 23 | 2.13.6 Inhalational anesthetic correct 2.13.7 Vaporizer operational and filled 2.14 Backup 2.14.1 Hand cranks available 2.14.2 Emergency lighting available 2.14.3 Backup full oxygen tank with flow meter available 2.14.4 Duplicate circuit components and hardware available 2.14.5 Ice available 2.15 Emergency reinitiation of bypass 2.15.1 Heparin time and dose confirmed 2.15.2 Components debubbled 2.15.3 Gas flow verified 2.15.4 Alarms re-established |
| 24 | 2.15.5 Water flow re-established 3 Documentation 3.1 Completion of the checklist 3.2 Retention of the checklist 3.3 Expiration date 3.4 Operator’s manuals 4 Devices or equipment not part of the extracorporeal circuit |
| 25 | Bibliography |
