User's Manual
Table Of Contents
- SWORD Health User Manual
- Getting to know SWORD Phoenix
- 1 - Introduction
- 2 - Indications, Contraindications and Adverse Events
- 3 - Candidate Selection
- 4 - Components
- 5 - Digital Therapist Kits
- 6 - Setup
- 7 - Motion Trackers
- 8 - Patient’s Card
- 9 - Straps
- Phoenix Portal
- 10 - Create a User Account
- 11 - Accessing the Portal
- 12 - Getting to Know the Portal
- 13 - Patient List
- 14 - Add a New Patient
- 15 - Patient Screen
- 16 - Prescription
- 17 - Prescribe a Session
- 18 - Set Exercise Difficulty Level
- 19 - Patient Results
- 20 - Patient Profile
- 21 - Overview
- 22 - Daily Summary
- 23 - Send Messages
- 24 - Settings
- Digital Therapist
- 25 - Turn On the Digital Therapist
- Support
- Technical specifications
- 34. Service and inspections
- 35. Regulatory Statements
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35. REGULATORY STATEMENTS
1 - OWNERSHIP
SWORD Phoenix® including all the components and documents that are included in the kits, are
the sole property of SWORD Health, S.A..
2 - INTENDED USE
SWORD Phoenix is a Medical Device intended to provide physical therapy. The information of the
movement of body parts is gathered and used to give real time feedback on patient’s performance.
The physical therapy may be performed at home but must be oriented by a physical therapist.
3 - SIDEEFFECTS AND CONTRAINDICATIONS
The device is contra-indicated for hemodynamic instability or other serious medical condition
limiting physical rehabilitation; hyper-acute stroke patients; pain or deformity limiting the
movement of target joints; respiratory and/or cardiovascular disease contraindicating mild to
moderate exercise; skin lesions or any continuity solution in the area where the motion trackers
would need to be place. SWORD Health has exercised great diligence in selecting the materials for
SWORD Phoenix. Nevertheless, there is always a small chance that some materials may lead to
allergic reactions in individuals under exceptional circumstances.
4 - LIABILITY
In no event will SWORD Health be liable to the misuse or lack of the SWORD Phoenix, including
negligence or any other use not described in this document. Whilst being a motor rehabilitation
tool, the use of the SWORD Phoenix does not automatically guarantee patient improvement.
5 - WARRANTIES, RISKS, AND DAMAGE TO SWORD PHOENIX
SWORD Health, S.A. will be responsible for the deployment of SWORD Phoenix in the clinical
facility. After the deployment, the responsibility of SWORD Health, S.A. is limited to the
maintenance of the software and to the repair or replacement of equipment and/or non-conform
components. SWORD Health, S.A. reserves the right to refuse warranty coverage, and will not be
responsible for repairing or replacing any device or component nonconforming or defective under
this warranty if any of the supplied parts is altered, tampered with, not maintained and/or not used
as specified in the User Manual; or presents non-compliance or defect has resulted from any
technical service or equipment maintenance executed by personnel not authorized by SWORD
Health, S.A..
6 - INTELLECTUAL PROPERTY RIGHTS
The “intellectual property” rights are the exclusive property of SWORD Health, S.A.. These include
all the intellectual property and/or industrial property rights/and or rights about software or
hardware owned by SWORD Health, S.A. and/or related with the activity of SWORD Health, inter
alia, relating to SWORD Phoenix or any other product, technological solution, technical