GORBEL safeGait 360 User manual

Instructions for Use

GORBEL MEDICAL
ii SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B
Gorbel Medical
Physical Address: 600 Fishers Run, Victor, NY 14564
Mailing Address: P.O. Box 593, Fishers, NY 14453-0593
Phone: [phone]
E-mail: [email protected]
www.safegait.com
NOTICE TO USERS
Read the entire Instructions for Use (IFU) before operating the system. It is unsafe to use the system
without reading and comprehending the full contents of this manual
CAUTION: Do not operate this system if you have not been adequately trained in how to
use this device.

PREFACE
iii
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Preface
Purpose
This manual provides directions to help users safely and eectively operate the SafeGait 360° Balance
and Mobility Trainer. The manual also includes material such as indications for use, contraindications,
and troubleshooting information. It is assumed that the reader has a general knowledge of physical
therapy (PT) and balance and gait rehabilitation.
Help Information
Contact Gorbel Medical at 1-844-846-8744 or via e-mail at [email protected].

TABLE OF CONTENTS
iv SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B
Table of Contents
Gorbel Medical ii
NOTICE TO USERS ii
Preface iii
Purpose iii
Help Information iii
System Overview 1
System Description 1
Intended Use 1
Contraindications 1
System Components 2
Actuator 2
Ceiling-Mounted Rail 3
Strap 3
Spreader Bar / Spreader Bar Cover 4
Harness 4
Handheld Remote Control 5
Kiosk 5
Facility Power Panel 6
Router 6
NAS Device 6
Terminology 7
Actuator/Spreader Bar Positioning 7
Adjustable BWS 7
Assist 7
Boost 7
Descent Limit 7
Dynamic Fall Protection (DFP) 7
DFP Sensitivity Adjustment 7
Fall Detection 7
Horizontal Lock 7
Stop All 7
General Warnings and Precautions 8
Dangers 8
Precautions 8
Cleaning 10
Strap, Spreader Bar Cover and Harness 10
System Power 11
Overview 11
Power On the System 11
Power O the System 13

TABLE OF CONTENTS
v
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Perform an Emergency Stop 13
Patient Harness 14
Patient Harness Fitting 14
Securing the Patient in the Harness 14
Tracking Patient Movement 17
Strap Angle 17
Lateral Patient Movement 17
User Interface 18
Overview 18
Workow Menu 18
Kiosk vs. Handheld Remote 19
Permission Levels 20
Logging In To Windows and SafeGait 20
Patient Setup 22
Create a New Patient Record 22
View or Edit a Patient Record 25
Select a Patient 27
Patient Dashboard: Scheduling 28
Patient Dashboard: Repeat Last Session 29
Patient Dashboard: View Task Trends 30
Plan of Care 31
Overview 31
Create a Plan of Care 31
Edit a Plan of Care 32
Create a Task 34
Edit a Custom Task 35
Positioning and Horizontal Lock 36
Position the Actuator 36
Position the Spreader Bar 37
When the System is in Horizontal Lock 38
Tasks 39
Perform a Task from the Plan of Care 39
Perform a Task without Patient Information (Just Go) 47
Recover from a Prevented Fall 49
Stop the System in Case of Emergency or to Reposition the Patient 50
Resuming an Aborted Task 51
End the Session and Add Notes 52
Historical Data 55
View Patient Performance Measurements by Task 55
View Patient Performance Measurements by Session 58

TABLE OF CONTENTS
vi SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B
Save Patient Data to External Media 61
Settings 62
View a List of Users 62
Create a New User 63
Edit User Information 63
Disable a User 65
Enable a User 66
Edit System Settings 67
Edit Custom Tasks 68
Disable Custom Tasks 69
View Admin Reports 70
Maintenance 71
Overview 71
Before Each Use 71
Annually 73
Troubleshooting 74
Overview 74
Troubleshooting - Quick Reference 74
Troubleshooting - Corrective Action 75
Troubleshooting - Error Codes 76
Appendix 77
Appendix A: LED Status Light Bar 77
Appendix B: List of Symbols 78
Quick Reference Guide 79
Quick Reference - Task Monitoring 79
Index 80
Notations 82

SYSTEM OVERVIEW
1
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System Overview
This section provides you with general information about
the SafeGait 360° Balance and Mobility Trainer.
System Description
The SafeGait 360° Balance and Mobility Trainer is an over-ground dynamic body weight support (BWS)
system designed to provide solutions to key challenges in the current physical rehabilitation market.
• Patient and therapist injury risk
• Eciency of care
• Data collection and comparison
Proven fall prevention technology enables you to perform one-on-one treatment without fear of injury
to yourself or the patient. You can create treatment programs that safely challenge patients with gait
or balance impairment. SafeGait allows you to collect and compare meaningful patient performance
measurements through user-friendly software.
Intended Use
This device is used to provide a safe means of treating gait and balance impairment in individuals after
injury or illness. The design incorporates a constant fall arrest feature that allows physical therapists
to work with patients up to 350 lbs of various abilities to practice intensive gait and balance activities
without the fear of falling. By altering the amount of body-weight support the complexity of the gait,
balance or transfer task can be modulated. This exibility will allow patients of diering abilities to
practice walking, perform balance tasks, sit-to stand and oor-to-stand maneuvers, or stairs in a safe and
controlled environment. The unloading mechanism will be mounted to an overhead track and physical
therapist input is controlled via a graphical user interface.
Contraindications
Prior to use, all patients shall be deemed medically stable and appropriate by a healthcare professional
who has been trained on the system. Patients with the following diagnoses or symptoms shall not use
the system:
• Weight greater than 350 lb. (158.8 kg)
• Unstable fractures
• When loading of the hip, pelvic, abdominal and chest regions is prohibited
• Fractured ribs
• Large disc bulge/rupture
• Lower Extremity contractures that preclude ambulation
• Patients who cannot tolerate a standing or upright position
• Severe osteoporosis
• Skin ulcers on the trunk or lower limbs
• Neoplastic, degenerative or vascular disorders of the spine or spinal cord

SYSTEM COMPONENTS
2SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B
System Components
System Components - Fig. 1
CAUTION: Using any accessories not provided by Gorbel Medical can result in injury.
Actuator
The actuator moves along the rail - aligned with the patient -
providing BWS and fall protection while collecting patient data, which
it transmits to the kiosk. A computer-controlled sensor maintains the
actuator’s location relative to the patient. A separate computer-con-
trolled sensor ensures that tension on the strap is kept at a desired
value.
Actuator
Actuator
Ceiling-Mounted Rail
Strap
Spreader Bar
Harness
(Harness Straps connect
to Spreader Bar)
360° Handheld Device
Other system
components included
(not shown here):
Kiosk, Facility Power
Panel, Router, NAS
device,

SYSTEM COMPONENTS
3
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Ceiling-Mounted Rail
The ceiling-mounted rail is attached overhead, typically to a support
beam. The rail denes the patient’s horizontal walking path. The track
includes straight and/or curved sections that can form various cong-
urations including straight, J-shaped, and loop (racetrack) shapes. The
actuator runs along the rail on a set of wheels and receives power via
an integrated conductor bar. The rail contains an end stop and a limit
switch that protect the actuator by preventing it from reaching the very
end of the rail. Loop congurations do not contain the end stop and
limit switch.
Ceiling-Mounted Rail
DANGER: Do NOT touch the conductor bar inside the rail. This will result in serious injury
or death.
Strap
The strap connects the actuator to the spreader bar. The software follows the
position of the strap, maintaining the position of the actuator relative to the
patient. The actuator responds to the load that is placed on the strap.
Strap
NOTICE: The system has an upper limit which limits the minimum distance between
the actuator cover and the end of the strap to three (3) inches. Facilities with a minimal
rail mounting height (top of rail, 8’ 8”) may be limited in treating certain taller patients
(maximum 6’ 2”) on the ground or elevated surfaces such as stairs or a treadmill.

SYSTEM COMPONENTS
4SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B
Spreader Bar / Spreader Bar Cover
The spreader bar connects the actuator strap to the patient
harness. The spreader bar has two sets of attachment points
to accommodate patients of varying body types.
The SafeGait 360 Balance and Mobility Trainer must be used
with the SafeGait 360 spreader bar.
Spreader Bar
CAUTION: Using a non-SafeGait spreader bar can result in injury.
Harness
The SafeGait EMBRACE Rehabilitation Harness is recommended for use with
the SafeGait 360° Balance and Mobility Trainer.
After it is placed onto the patient, the harness is connected to the spreader
bar. For additional information, refer to the SafeGait EMBRACE Rehabilita-
tion Harness Instructions for Use.
Harness