SALUDA MEDICAL Evoke SCS System Manuals

Manuals and User Guides for SALUDA MEDICAL Evoke SCS System. We have 3 SALUDA MEDICAL Evoke SCS System manuals available for free PDF download: Clinical Manual, User Manual, Surgical Manual

SALUDA MEDICAL Evoke SCS System Clinical Manual

SALUDA MEDICAL Evoke SCS System Clinical Manual (101 pages)

Brand: SALUDA MEDICAL | Category: Medical Equipment | Size: 3 MB

Table of Contents

Table of Contents
2
Description
5
The Concept of ECAP-Controlled Closed-Loop SCS
5
Stimulation Features
5
Measurement Features
6
System Components
8
Indication for Use
10
Contraindications
10
Safety Information
10
Precautions
10
Introduction
12
Evoke Clinical Interface (CI)
12
Evoke Clinical System Transceiver (Cst)
12
Clinical Interface - General Programming Using the Cpa
13
Connecting the CI to the Cst and Ecls/Cls
13
Set Stimulator Time
15
Check Stimulator Battery Voltage
16
Retrieve or Set the Patient ID and Patient Zone
16
Measure Electrode Impedances
18
Set up Lead Orientation
19
Programming Overview
20
Choose the Stimulation Electrodes Automatically
20
Start and Stop Stimulation with Closed-Loop Disabled
21
Set up Ecap Measurement
23
Set up Closed-Loop Stimulation
29
Set Appropriate Limits and Increments
30
Enable Closed-Loop Stimulation
31
Start and Stop Stimulation with Closed-Loop Enabled
33
Save a Program to the Stimulator
34
Create a New Program or Use Programming Features and Settings
36
Disconnect from the Stimulator and Close the Cpa
36
Clinical Interface - Programming Features
37
Stimulation Waveform
37
Clearcap
38
Current Steering
39
Measurement Electrode Scan
40
Interleaved Stimulation
45
Activation Plot Levels
49
Data Files
50
Neurophysiological Measurements
51
Additional Impedance Measurements
57
Patient Survey
57
Clinical Interface - Settings Guide
59
Stimulation Settings Menu
59
Measurement and Feedback Settings Menu
60
Electrode Selection Modes
61
Cls Menu
62
Navigation Menu
65
Settings Screen
65
Alert and Error Display
68
Intra-Operative Programming with the CI
70
Connect the Intraoperative Cable to the Ecls
70
Confirm Optimal Lead Placement
71
Confirm Cls Connection
72
Post-Operative Programming Procedures
73
Prepare the Ecls for the Trial Stimulation Period
73
Connect the Lead or Lead Extension to the Lead Adapter
73
Connect the Lead Adapter to the Ecls
75
Place the Ecls into the Case
76
Charge the Ecls Battery
76
Secure the Ecls for the Trial Stimulation Period
77
Behaviour of the Stimulator When Alerts Occur
77
Out of Compliance
77
Reference Clock Error
78
Electrode Disconnected
78
Current at Maximum
78
Clipping
78
Evoke Patient Controller
79
Pair Epc to Stimulator
79
Evoke Charger
80
Stimulation During Charging
80
Patient Education and ID Card
81
Maintenance of the Evoke CI and Evoke Cst
82
Maintenance of the Evoke CI
82
Maintenance of the Evoke Cst
82
Updating the Evoke CI Software
82
Disposal of Devices
83
Troubleshooting
83
Package Contents
87
Technical Specifications
87
Device Specifications
87
Wireless Communication
89
Electromagnetic Interference
89
Federal Communications Commission (Fcc)
93
Glossary
94
Symbols
99
Contact Us
101

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SALUDA MEDICAL Evoke SCS System User Manual

SALUDA MEDICAL Evoke SCS System User Manual (53 pages)

Brand: SALUDA MEDICAL | Category: Medical Equipment | Size: 1 MB

Table of Contents

Table of Contents
2
Description
4
Indications for Use - What the Evoke System Is Used for
5
Contraindications - When the Evoke System Must Not be Used
5
Safety Information
5
Warnings
5
Precautions
8
Potential Risks or Side Effects
12
Temporary Trial Stimulation
13
Percutaneous Lead Placement Procedure
13
Programming the External Closed-Loop Stimulator (Ecls)
14
How It Should Feel
14
Lead or Lead Extension Removal and Next Steps
14
The Ecls
15
Fully Implantable Evoke System
20
Percutaneous Lead and Stimulator Implant Procedure
20
Programming
20
How It Should Feel
20
The CLS
21
The Evoke Pocket Console (EPC)
22
EPC Buttons and Indicators
23
EPC Audio Indicators
25
Changing the Battery in Your EPC
26
The Evoke Charger
27
Charger Buttons and Indicators
27
Charging Your Evoke CLS Using the Evoke Charger
30
Charger Audio Indicators
31
Recharging Your Evoke Charger
31
The Evoke Accessory Belt
32
Wearing the Ecls with the Accessory Belt
32
Wearing the Charger Coil with the Accessory Belt
33
Maintenance of EPC, Charger and Ecls
34
Disposal of Devices
34
Patient ID Card
34
Troubleshooting
35
Package Contents
38
Technical Specifications
38
Device Specifications
38
Wireless Communication
45
Electromagnetic Interference
46
Glossary
50
Symbols
51
Contact Us
53

SALUDA MEDICAL Evoke SCS System Surgical Manual

SALUDA MEDICAL Evoke SCS System Surgical Manual (40 pages)

Brand: SALUDA MEDICAL | Category: Medical Equipment | Size: 1 MB

Table of Contents

Table of Contents
2
1 Description

4
2 Intended Use

5
3 Contraindications

5
4 Safety Information

6
- Warnings
  6
- Precautions
  8
- Potential Risks
  10
5 Percutaneous Lead Implant Procedure

12
- Overview
  12
- Percutaneous Lead Placement
  12
6 Anchor the Lead

15
7 Lead Tunneling and Cls Implant Procedure

17
8 Trial with a Temporary Percutaneous Lead

22
9 Revision, Replacement and Explant Surgery

22
- Open the Component Sites
  23
- Percutaneous Leads
  23
- Cls
  23
10 Intra-Operative Testing

24
11 Sterilization

30
12 Patient ID Card

30
13 Maintenance of the Evoke™ Ecls

30
14 Package Contents

31
15 Specification

33
- Evoke™ CLS
  33
- Evoke™ Ecls
  34
- Evoke ™ 12C Percutaneous Lead ( Includes Trial Leads )
  35
- Surgical Accessories
  35
- Evoke™ CI Specifications
  37
- Evoke™ CST Specifications
  37
16 Glossary and Symbols

38
- Glossary
  38
- Symbols
  39
17 Contact Us

40

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