Impulse Dymanics OPTIMIZER Smart System

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SYMBOL

DESCRIPTION

Defibrillation-Proof Type BF

Applied Part

Produces Non-ionizing

Electromagnetic Radiation

Wand Power Indicator

Emergency Programming

Programming

Interrogation

Wand Signal Strength

Indicator

DC Power Input (charger

connection)

Serial data I/O port (for use

only by Impuls

e Dynamics

technical personnel)

IPG-Charger Coupling

Signal Strength Indicator

”Call Doctor” Indicator

Charger Start Button

Main Page

Default Chapter3
- Table of Contents3
Explanation of Symbols on Labels11
1 The Optimizer Smart System: an Overview15
- Description of the OPTIMIZER Smart IPG15
- OPTIMIZER Smart IPG Lead Connectors16
- OPTIMIZER Smart IPG Physical Characteristics16
- OPTIMIZER Smart IPG Battery17
- OPTIMIZER Smart IPG Rechargeable Battery Behavior17
- Extrapolated Battery Life18
- Extrapolated Battery Charge Longevity18
- User Profile and Training19
- Scientific Background about Heart Failure and CCM20
2 Indications21
3 Contraindications and Precautions22
4 Warnings22
- Prohibited Use22
- Potential Complications of Device Implantation22
- Handling24
- Storage and Handling24
- Packaging Information24
- Resterilization and Reuse25
- Cremation25
5 Cautions25
- Environmental Conditions25
- Electrocautery25
- RF Ablation26
- Diathermy (Medical "Short Wave" Induction Heating)26
- Defibrillation and Cardioversion26
- Radiation Therapy27
- Nuclear Magnetic Resonance (NMR), Magnetic Resonance Imaging (MRI)27
- Lithotripsy28
- Therapeutic Ultrasound28
- Transcutaneous Electrical Nerve Stimulation (TENS)28
- Home Appliances28
- Store Anti-Theft Systems/Airport Security Screening Systems29
- Industrial Machinery29
- Transmitting Devices29
- Cellular and Mobile Phones29
6 Potential Adverse Effects30
7 Device Implantation30
- General Considerations30
- Opening the Lead Sterile Package(S)31
- Opening the OPTIMIZER Smart Sterile Package31
- Verifying Lead Placement32
- Connecting the Implanted Leads to the OPTIMIZER Smart IPG32
- Dissection of the IPG Pocket33
- Inserting the OPTIMIZER Smart IPG and Closing the Pocket33
8 Device Explantation / Replacement33
9 Optimizer Smart Ipg: Functions and Programming Options34
- Operating Modes34
- CCM off Status35
- A/V Sensing35
- CCM Delivery Options36
- CCM Signal Delivery36
- CCM Inhibit Parameters38
  - Number of Beats for CCM Inhibition38
  - Conditions Causing Inhibition in Active OVO-LS-CCM Mode39
- Local Sensing39
- CCM Triggering Based on Local-Sense Events40
10 Omni Smart Programmer System42
- Description42
- Programmer Functions43
- Programmer Components43
- Interconnecting the Programmer Components for Operation44
- Programmer Wand44
- Charging the Battery of the OMNI II Programmer Tablet PC45
- Operating the OMNI Smart Programmer45
- Using the OMNI II Programmer Tablet PC Touch Screen46
- Buttons and Symbols on the OMNI II Programmer Tablet PC46
- OMNI II Programmer Tablet PC Battery Replacement46
- Routine Cleaning47
- Storage and Handling47
- Additional Notes47
11 Omni Smart Programmer System Software48
- Selection Screen48
- Basic Operation of the OMNI Smart Programmer Application50
12 The Omni Smart Programmer Screen52
- Title Bar53
- ECG Window53
- View Bar53
- ECG Statistics Bar57
- Main Tool Bar58
- Device Bar59
- Log Bar60
- Programming Bar60
- Parameter Conflict Bar61
- Task Bar61
- Status Bar68
13 Interrogation68
- Communicating with the Implanted OPTIMIZER Smart IPG68
- Interrogating the OPTIMIZER Smart IPG69
14 Modifying Parameter Values69
- Parameter Color Convention70
- Parameter Conflicts70
15 Programming71
- Programming the OPTIMIZER Smart IPG71
- Cancel and Undo Functions71
  - Cancel72
  - Undo72
16 Using Standards72
- Opening a Standard File73
- Saving a Standard File73
17 Loading and Exporting Information73
- Loading Log Files73
- Exporting Data73
18 Log and Ecg Recording74
- Log74
- ECG Recording74
19 Emergency Programming75
- Emergency Programming When the Programmer Is off75
- Emergency Programming When the Programmer Is on76
20 Magnet Mode76
21 Resetting the Optimizer Smart Ipg77
22 Initiating CCM Delivery77
- Operating Mode Options77
- CCM Signal Delivery Options78
23 Marker Events80
- Turning Markers on80
- Turning Markers off80
- Sensed Events80
- CCM Train Delivery81
- CCM Inhibit Conditions in Active OVO-LS-CCM Mode81
- CCM Signal Delivery State81
- Log Browser Window81
24 CCM Schedule82
25 Active Ovo-Ls-CCM Mode83
- Deactivated Parameters in Active OVO-LS-CCM Mode83
- Parameter Modifications in Active OVO-LS-CCM Mode84
- Marker Events in Active OVO-LS-CCM Mode85
26 Statistics85
- Loading Statistics86
  - Statistics Tabs86
  - Statistics Buttons87
- Resetting Device Counters88
27 Measuring Lead Impedances88
28 Setting the Clocks on the Optimizer Smart Ipg and Omni Smart Programmer89
- Reading the OPTIMIZER Smart IPG Time89
- Setting the OPTIMIZER Smart IPG Real Time Clock90
- Setting the OMNI Smart Programmer Clock91
29 Optimizer Smart Ipg Alarms Reported to the Optimizer Mini Charger91
- Minimum Target Percentage for CCM Delivery91
- Maximum Lead Displacement92
30 Local Sense (Ls) Scan93
31 Remote Operation95
- Connecting the OMNI Smart Programmer to a Wired Ethernet Network96
- Connecting the OMNI Smart Programmer to a Wireless Network96
  - OMNI Smart Wireless Network Configuration96
  - OMNI Smart Wireless Network Configuration Commands98
- OMNI Smart Operation Modes98
  - OMNI Smart Startup Modes98
  - OMNI Smart Master/Slave Modes99
- OMNI II Programmer Client Window100
  - Connecting the OMNI Smart Programmer to the Remote Server100
  - Show OMNI II Programmer Client Window101
- Starting a Remote Session with the OMNI Smart Programmer101
- Ending an OMNI Smart Programmer Remote Session103
- Sending a Chat Message Using the OMNI Smart Programmer103
- OMNI II Log Upload/Download103
32 Bluetooth Printer105
- Description105
- Printer Charging105
- Set Bluetooth106
- Set Default Printer107
33 Log File Manager107
34 Optimizer Mini Charger109
- Description109
  - Charger System Components109
- Charger Features110
- Charging Method: Transcutaneous Energy Transfer110
- Charger Operation111
- Frequency of Charging Sessions112
- Numerical Codes113
- Cleaning114
- Maintenance115
- Storage and Handling115
- Disposal115
35 Service and Warranty115
- Limited Warranty Information115
- Mandatory Battery Charging116
- Physical Characteristics117
- Battery117
Appendix I117
- Current Consumption118
- Safe Mode118
- Programmable Parameters118
- Factory Settings120
- Emergency Programming122
- Electromagnetic Interference Information (Table 1 of 6)124
Appendix II124
- Electromagnetic Interference Information (Table 2 of 6)125
Appendix III129

Impulse Dymanics OPTIMIZER Smart System - Page 12

Table of Contents