SynCardia Freedom

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SynCardia Systems, LLC

Freedom® Driver System Operator Manual Page 2 of 170

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Table of Contents3
Device Description9
Figure 1-1 - 50Cc or 70Cc TAH-T with the Freedom Driver System9
Figure 1-2 - the Syncardia 70Cc TAH-T and 50Cc TAH-T10
Figure 1-3 - Freedom Driver with Attached Power Adaptor and Drivelines Connected to the Cannulae of a TAH-T11
Figure 1-4 Exploded View of the Freedom Driver System16
Figure 1-5 - Primary Freedom Driver with Attached Power Adaptor and Two Inserted Onboard Batteries17
Figure 1-6 - Backup Freedom Driver with Attached Power Adaptor and Inserted Dummy Battery20
Figure 1-7 - Power Adaptor21
Figure 1-8 - Onboard Battery22
Figure 1-9 - Hospital AC Power Supply23
Figure 1-10 - Home AC Power Supply24
Figure 1-11 - AC Power Supply and Cord25
Figure 1-12 - Car Charger26
Figure 1-13 - Battery Charger26
Figure 1-14 - Dummy Battery28
Figure 1-15 - Filter Pack, Screwdriver and Screws29
Figure 1-16 - Patient Tool Kit30
Figure 1-17 - Shoulder Bag31
Figure 1-18 - Backpack31
Figure 1-19 - Shoulder Bag with Rain Cover33
Figure 1-20 - Backpack with Rain Cover33
Figure 1-21 - Accessory Bag34
Figure 1-22 - Pelican Case34
Figure 1-23 - Clinician Tool Kit35
Figure 1-24 - Connector Kit36
Indications for Use39
Table 2-1 - Key Adverse Event Comparison Stable PMSS to Freedom In-Hospital Cohort41
Table 2-2 - Adverse Event Comparison Stable PMSS to Freedom In-Hospital Experience43
Table 2-3 - Adverse Event Comparison Stable PMSS to Cumulative Freedom Experience46
Table 2-4 - Freedom Adverse Event Comparison In-Hospital to Out-Of-Hospital50
Table 2-5 - Adverse Event Comparison Freedom Experience High Volume Sites to Low Volume Sites53
Contraindications57
Warnings59
Precautions and Recommendations63
Operating Instructions65
Figure 6-1 - Unplugging the Power Adaptor from the Freedom Driver69
Figure 6-2 - Removing the Power Adaptor from the Freedom Driver70
Figure 6-3 - Plugging the Green Connector into the Green Power Adaptor Receptacle71
Figure 6-4 - Connection to External Power Via the AC Power Supply71
Figure 6-5 - Removing the Green Connector from the Green Power Adaptor Receptacle76
Figure 6-6 - Battery Fuel Gauge78
Figure 6-7 Correct Onboard Battery Insertion into Battery Well79
Figure 6-8 - Battery Charger and Bays80
Figure 6-9 - Connect AC Power Supply and Battery Charger80
Figure 6-10 - Driver LCD Screen82
Preparing the Freedom Driver for Patient Use85
Table 7-1 - Normotensive Settings - Patient Simulator87
Figure 7-1 - Driveline Caps88
Figure 7-2 - Beat Rate Setting Dial on the Back of the Freedom Driver89
List of Symbols93
Table 8-1 -Symbols Used in the Freedom Driver System93
Freedom Driver Operating Cautions95
Visual and Audible Alarms99
Figure 10-1 - Illuminated Flashing Yellow Battery Alarm Light99
Figure 10-2 - Illuminated Flashing Red Temperature Alarm Light102
Figure 10-3 - Illuminated Solid Red Fault Alarm Light103
Switch from Primary Freedom Driver to Backup Freedom Driver107
Figure 11-1 - Freedom Drivelines Connected to Cannulae Via the CPC Connectors110
Figure 11-2 - Cutting the Wire Tie with the Wire Cutter Tool111
Figure 11-3 - Disconnecting the Drivelines from the Cannulae112
Figure 11-4 - Connecting the Drivelines to the Cannulae112
Figure 11-5 - Inserting Wire Tie under Metal Release Button of CPC Connector113
Switch from CSS Console to Primary Freedom Driver115
Figure 12-1 - Inserting Wire Tie under Metal Release Button of CPC Connector116
Figure 12-2 - Wire Ties Around CSS Hose Barb Connectors117
Figure 12-3 - Metal Hose Barb Connectors Loosened, but Still Connected, to the Cannulae118
Figure 12-4 - Inserting the Freedom Drivelines into the Cannulae118
Figure 12-5 - Securing Cannulae to CPC Connectors with Wire Ties119
Figure 12-6 - Cut Driveline Tubing120
Figure 12-7 - Male CPC Connector120
Figure 12-8 - Female CPC Connector120
Figure 12-9 - Driveline End Comparison121
Figure 12-10 - Modified CSS Console Driveline121
Switch from Freedom Driver to CSS Console123
Figure 13-1 - Connection of Driver Connectors to Cannulae124
Figure 13-2 - Cutting the Wire Tie with the Wire Cutter Tool124
Figure 13-3 - Disconnecting Freedom Drivelines from the Cannulae126
Figure 13-4 - Connecting the Modified CSS Console Drivelines to the Cannulae126
Figure 13-5 - Inserting Wire Tie under Metal Release Button of CPC Connector127
Switch from CSS Console with Modified Drivelines to Freedom Driver129
Figure 14-1 - Connection of Modified CSS Console Driveline to Cannulae130
Figure 14-2 - Cutting the Wire Tie with the Wire Cutter Tool131
Figure 14-3 - Disconnecting Modified CSS Console Drivelines from the Cannulae132
Figure 14-4 - Connecting the Freedom Drivelines to the Cannulae132
Figure 14-5 - Inserting Wire Tie under Metal Release Button of CPC Connector133
Switch from Companion 2 Driver to Freedom Driver135
Figure 15-1 - Companion Drivelines Connected to Cannulae Via the CPC Connectors137
Figure 15-2 - Cutting the Wire Tie with the Wire Cutter Tool138
Figure 15-3 - Disconnecting the Companion Drivelines from the Cannulae139
Figure 15-4 - Connecting the Freedom Drivelines to the Cannulae139
Figure 15-5 - Inserting Wire Tie under Metal Release Button of CPC Connector140
Switch from Freedom Driver to a Companion 2 Driver141
Figure 16-1 - Freedom Drivelines Connected to Cannulae Via the CPC Connectors142
Figure 16-2 - Cutting the Wire Tie with the Wire Cutter Tool143
Figure 16-3 - Disconnecting the Freedom Drivelines from the Cannulae144
Figure 16-4 - Connecting the Companion Drivelines to the Cannulae144
Figure 16-5 - Inserting Wire Tie under Metal Release Button of CPC Connector145
Equipment Maintenance and Care147
Figure 17-1 - Filter Cover148
Freedom Driver System Specifications153
Table 18-1 - Declaration Concerning General Safety Standards for the Freedom Driver153
Table 18-2 - Declaration Concerning General Safety Standards for the Battery Charger155
Table 18-3 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions156
Table 18-4 - Declaration and Guidance Concerning Electromagnetic Immunity for the Freedom Battery Charger for IEC 60601-1-2157
Table 18-5 - Declaration and Guidance Concerning Electromagnetic Immunity for the Freedom Battery Charger for IEC 60601158
Table 18-6 - Input / Output Characteristics160
Table 18-7 - IP Rating Classification162

SynCardia Freedom - Page 2

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