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Evoke
SALUDA MEDICAL Evoke Manuals
Manuals and User Guides for SALUDA MEDICAL Evoke. We have
3
SALUDA MEDICAL Evoke manuals available for free PDF download: Clinical Manual, User Manual
SALUDA MEDICAL Evoke Clinical Manual (61 pages)
SCS System
Brand:
SALUDA MEDICAL
| Category:
Medical Equipment
| Size: 3.34 MB
Table of Contents
Table of Contents
2
Privacy Statement
3
1 Description
4
2 Indications for Use
5
3 Contraindications
5
4 Safety Information
5
Warnings
5
Precautions
7
Potential Risks
11
5 Intra-Operative Programming with the CI
12
Confirmation of Optimal Lead Placement
12
Confirmation of Proper Cls Connection
14
6 Post-Operative Procedures
14
Connecting an Ecls to Externalized Leads
14
7 Clinical Programming - Introduction
18
Clinical Interface (CI)
18
Clinical System Transceiver (Cst)
19
8 Clinical Programming - Using the Cpa
19
Programming Overview
19
T Ransceiver (Cst)
19
Connecting the CI to the Cst and Ecls/Cls
20
Set Stimulator Time
22
Retrieve or Set the Patient ID and Patient Zone
23
Measure Electrode Impedance
24
Set up Lead Orientation
25
Choose the Stimulation Electrodes Automatically
26
Start and Stop Stimulation
27
Set up Ecap Measurement
28
Set up Feedback Control (Fc) Therapy
30
Enable Feedback Control
31
Save a Program to the Stimulator
31
Interleaved Stimulation
33
Neurophysiological Measurements
36
9 Clinical Interface - Settings Guide
42
Stimulation Settings Menu
42
Measurement and Feedback Settings Menu
42
Electrode Selection Modes
43
Current Steering
43
Patient Perception
44
Cls Menu
45
Navigation Menu
46
Settings Menu
47
Error Display
48
10 Operation of Stimulator When Errors Occur
49
Out of Compliance
49
Reference Clock Error
49
Electrode Disconnected
50
Current at Maximum
50
Ert Clipping
50
11 Evoke Pocket Console and Evoke Charger
50
Pair Epc to Stimulator
50
Document Reference: ENG-UMAN
50
Clinical Studies - Set Treatment Arm
51
12 Evoke Charger
51
Safe Mode Error on Charger
51
13 Patient ID Card
52
14 Maintenance of the Evoke CI and Evoke Cst
52
Maintenance of the Evoke CI
52
Maintenance of the Evoke Cst
52
15 Specifications
53
Evoke CI
53
Evoke Cst
53
Evoke Pocket Console
54
Evoke Charger
54
Evoke Cls
55
Evoke Ecls
56
Evoke 12C Percutaneous Lead
56
16 Saluda Medical Evoke System Limited Warranty
57
Closed-Loop Stimulator
57
Leads
57
Externals
57
Claims
57
Limitations
58
17 Glossary and Symbols
59
Glossary
59
Symbols
60
18 Contact Us
61
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SALUDA MEDICAL Evoke Clinical Manual (56 pages)
SCS System
Brand:
SALUDA MEDICAL
| Category:
Medical Equipment
| Size: 3.53 MB
Table of Contents
Table of Contents
2
1 Description
4
The Concept of Feedback Control (Fc)
4
Evoke Closed Loop Stimulator (Cls)
4
Evoke External Closed Loop Stimulator (Ecls)
4
Evoke 12C Percutaneous Lead Kit, 60Cm and 90Cm
5
Evoke 12C Lead Extension Kit, 55Cm
5
Evoke Lead Adapter Kit
5
Evoke Pocket Console (Epc)
5
Evoke Charger
5
Evoke Clinical Interface (CI)
5
Evoke Clinical System Transceiver (Cst)
5
2 Package Contents
6
Evoke Clinical Interface (CI)
6
Evoke Clinical System Transceiver (Cst)
6
3 Indication for Use
6
4 Contraindications
6
5 Warnings and Precautions
6
Precautions
6
6 Introduction
8
Evoke Clinical Interface (CI)
8
Evoke Clinical System Transceiver (Cst)
9
7 Clinical Interface - General Programming Using the Cpa
9
Connecting the CI to the Cst and Ecls/Cls
9
Set Stimulator Time
12
Retrieve or Set the Patient ID and Patient Zone
13
Measure Electrode Impedance
14
Set up Lead Orientation
15
Programming Overview
16
Choose the Stimulation Electrodes Automatically
16
Start and Stop Stimulation
17
Set up Ecap Measurement
19
Set up Feedback Control (Fc) Therapy
20
Enable Feedback Control
21
Save a Program to the Stimulator
21
Interleaved Stimulation
24
8 Clinical Interface - Settings Guide
27
Stimulation Settings Menu
27
Measurement and Feedback Settings Menu
27
Electrode Selection Modes
28
Current Steering
28
Patient Perception
29
Patient Survey
30
Cls Menu
31
Navigation Menu
33
Settings Menu
33
Alert and Error Display
34
9 Intra-Operative Programming with the CI
35
Confirmation of Optimal Lead Placement
36
Confirmation of Proper Cls Connection
37
10 Post-Operative Programming Procedures
38
Connecting the Lead or Lead Extension to the Lead Adapter
38
Connect the Lead Adapter Cable to the Lead Adapter Extension
41
11 Operation of Stimulator When Errors Occur
42
Out of Compliance
42
Reference Clock Error
42
Electrode Disconnected
42
Current at Maximum
42
Ert Clipping
42
12 Evoke Pocket Console and Evoke Charger
43
Pair Epc to Stimulator
43
Evoke Charger
43
13 Patient Education and ID Card
44
14 Maintenance of the Evoke CI and Evoke Cst
44
Maintenance of the Evoke CI
44
Maintenance of the Evoke Cst
44
15 Disposal of Devices
44
16 Troubleshooting
45
17 Technical Specifications
48
Device Specifications
48
Wireless Communication
49
Electromagnetic Interference
50
18 Glossary and Symbols
53
Glossary
53
Symbols
54
19 Regulatory Statements
55
20 Contact Us
56
SALUDA MEDICAL Evoke User Manual (48 pages)
SCS System
Brand:
SALUDA MEDICAL
| Category:
Medical Equipment
| Size: 1.39 MB
Table of Contents
Table of Contents
2
1 Description
5
2 Indications and Contraindications
6
Indications for Use - What the Evoke System Is Used for
6
Contraindications - When the Evoke System Must Not be Used
6
3 Safety Information
6
Warnings
6
Precautions
9
Potential Risks or Side Effects
13
4 Temporary Trial Stimulation
13
Percutaneous Lead Placement Procedure
14
Programming the Temporary Trial System (Ecls)
14
How It Should Feel
14
Lead Removal and Next Steps
15
The Ecls
15
Using the Ecls
15
Ecls Battery
16
Stopping Stimulation from the Ecls
16
5 Fully Implantable Evoke System
17
Percutaneous Lead and Stimulator Implant Procedure
17
Programming
17
How It Should Feel
18
The CLS
18
Controlling the CLS
18
Charging the CLS Battery
18
Stopping Stimulation from the CLS
18
6 The Evoke Pocket Console (EPC)
19
EPC Audio Indicators
23
Switching Audio Indicators on and off
23
Changing the Battery in Your EPC
24
7 The Evoke Charger
24
Charging Your Evoke CLS Using the Evoke Charger
27
Charging Your Evoke Ecls Using the Evoke Charger
28
Charger Audio Indicators
28
Recharging Your Evoke Charger
28
8 Maintenance of EPC, Charger and Ecls
29
9 Disposal of Devices
29
10 Patient ID Card
29
11 Troubleshooting
30
12 Package Contents
33
13 Technical Specifications
33
Device Specifications
33
Evoke CLS
33
Evoke Ecls
35
Evoke 12C Percutaneous Lead (Includes Trial Leads)
36
Evoke 12C Lead Extension
37
Lead Adapter Kit
37
Evoke EPC
39
Evoke Charger
40
Wireless Communication
41
Quality of Service & Wireless Coexistence
41
Wireless Security
41
Electromagnetic Interference
42
Guidance and Manufacturer's Declarations
42
14 Glossary and Symbols
45
Glossary
45
Symbols
45
15 Regulatory Statements
47
16 Contact Us
47
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