EC REP
Medical Device & QA Services
76, Stockport Road
Timperley, Cheshire
WA15 7SN
United Kingdom
Tel: 44 161 870 6751
e-mail: [email protected]
0086
1.0
Introduction
2
1.1
Indications of Use
2
1.2
Contraindications
3
1.3
Warnings About FES
3
1.4
WalkAide Specific Warnings
4
1.5
Precautions
5
1.6
Regulatory Information
5
1.7
Adverse Reactions
6
1.8
Cautions
6
1.9
Glossary
6
2.0
Equipment
10
2.1
Clinician Kit
10
2.2
Patient Kit
11
2.3
Demo Kit
11
2.4
WalkAide/WalkLink Controls, Indicators & Alarms
12
2.5
WalkAide Bi-Flex Cuff
13
2.6
Electrode Replacement
14
2.7
WalkAide Cuff Disposable Liner
15
2.8
Symbols and Definitions
1
6
3.0
WalkAnalyst Software
16
3.1
Installation
16
3.2
WalkAnalyst Upgrades
17
3.3
Administration
17
3.4
Changing Clinical Preferences
18
3.5
Backup
18
4.0
WalkLink Configuration and Bluetooth Pairing
1
9
4.1
Configuring initial set-up process (Pairing)
1
9
5.0
Fitting Process
2
0
5.1
Pre-screening with the Peripheral Nerve Stimulator
20
5.2
Electrode Placements and System Preparations
22
5.3
Fitting a New Patient
25
5.4
Fitting a Returning Patient
25
5.5
Programming Options
26
5.5.1 Rapid+ Program
26
5.5.2 Standard Program
29
5.5.3 Adjustment
32
5.5.4 Recover Program
33
5.5.5 Transfer Program
33
5.6
Exercise Mode Settings
34
5.7
Wearing Schedule
35
5.8
Usage Log
36
6.0
Evaluation & Reporting
3
7
7.0
Use and Care of the WalkAide and Accessories
3
9
7.1
Care and Use of WalkAide Electrodes
39
8.0
Clinical Troubleshooting
4
0
8.1
Electrode Placement Best Practice
40
8.2
Manual Adjustment of the Stimulation Settings
41
8.3
Graph Analysis
46
8.4
Follow-Up and Re-Optimization
47
9.0
Technical Troubleshooting
4
9
9.1
WalkAide Troubleshooting
49
9.2
WalkLink Troubleshooting
51
9.3
Alternate Pairing Method
52
9.4
Bluetooth USB Troubleshooting
52
10.0
WalkAide User Manual
53
11.0
Technical Information
5
4
12.0
Contact Information
55
