Impulse Dymanics OPTIMIZER Smart System - Explanation of Symbols on Labels

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EXPLANATION OF SYMBOLS ON LABELS

SYMBOL

DESCRIPTION

Manufacturer

Date of Manufacture

Consult instructions for use.

Caution, consult

accompanying documents

Transport Temperature

Limits

Sterilized with Ethylene

Oxide

Use By

Do Not Reuse

Part Number

Lot Number

Serial Number

Open Here

Torque Wrench

Port Plug

Do Not Use if Package is

Damaged

Class II

Type BF Applied Part

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 - Explanation of Symbols on Labels

Table of Contents