GORBEL safeGait 360 Instructions For Use Manual

Brand: GORBEL

Model: safeGait 360

Type: Instructions For Use Manual

Instructions for Use

GORBEL MEDICAL

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: 1-844-846-8744

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

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

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

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

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

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

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

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

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

SafeGait 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

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

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

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

SafeGait 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

SYSTEM COMPONENTS

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

Handheld Remote Control

The handheld remote control can also be used to control the actuator.

It communicates with the actuator via the kiosk through an encrypted wire-

less signal.

The handheld remote control provides a subset of the controls provided on

the kiosk.

Handheld Remote Control

Kiosk

The kiosk contains the proprietary Patient Management Software

that manages patient data and controls the actuator. It provides

a user interface for inputting patient data, performing tasks, and

displaying patient performance measurements. You can interact with

the Patient Management Software via the touchscreen, onscreen

keyboard, or physical keyboard.

It communicates with the actuator, handheld remote control, and

NAS device via an encrypted wireless signal. The kiosk data is backed

up wirelessly to the NAS device.

The kiosk performs the same functions as the handheld remote

control.

Kiosk

SYSTEM COMPONENTS

SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B

Facility Power Panel

The facility power panel is mounted on a wall and connects to the

facility’s power system. It supplies 480 VAC to the actuator via the

ceiling-mounted rail. For additional information, refer to the System

Power section.

Facility Power Panel

Router

The router acts as the hub for the closed wireless network.

Router

NAS Device

The NAS device contains two hard drives that provide a mirrored backup of

the database.

NAS Device

TERMINOLOGY

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

Terminology

Actuator/Spreader Bar Positioning

Remote control of the actuator and spreader bar in order to facilitate connecting and disconnecting the

harness to and from the spreader bar.

Adjustable BWS

Therapist-controlled unloading of up to 50% of the patient’s body weight (175 lb. (79.4 kg) maximum).

Assist

Mode of operation: actuator provides an assistive lift while the patient moves in horizontal / vertical

directions.

Boost

Mode of operation that provides the patient with 10 seconds of 20% additional BWS, up to 50% of the

patient’s weight (175 lb. (79.4 kg) maximum).

Descent Limit

Setting that denes a maximum amount of downward movement (scaled 2-6 inches), based on the

patient’s height.

Dynamic Fall Protection (DFP)

Embedded software in the actuator that distinguishes between the patient’s intentional downward move-

ment (e.g., to sit) and when the patient is falling.

DFP Sensitivity Adjustment

Setting that allows the therapist to adjust fall protection sensitivity in order to accommodate patients

with varying levels of independence.

Fall Detection

Indication that a patient fall has been prevented.

Horizontal Lock

The actuator can be locked in place to prevent forward or backward movement along the rail, while

allowing the patient to move up and down, (vertically).

Stop All

Function that stops all horizontal and vertical movement of the actuator.

GENERAL WARNINGS AND PRECAUTIONS

SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B

General Warnings and Precautions

This section lists the general warnings and precautions that provide critical information

that should be reviewed before using the SafeGait 360° Balance and Mobility Trainer.

Dangers

To avoid the possibility of serious injury or death or other serious adverse reaction associated with the

use of the system:

• Do NOT touch the conductor bar inside the rail. This will result in serious injury or death.

Precautions

To avoid the possibility of injury or a problem with the system associated with its use:

• Do not operate this system if you have not been adequately trained in how to use this device.

• Using any accessories not provided by Gorbel Medical can result in injury.

• Do not use the system for any purpose other than the stated intended use.

• Ensure that all personnel using the system have a thorough understanding of the technical princi-

ples, clinical applications, and risks associated with physical rehabilitation procedures.

• Restrict the use of the system to personnel trained in physical rehabilitation procedures with this

system or to usage under the supervision of such personnel.

• Ensure that the patient’s correct weight has been entered before attaching the patient to the

system; an incorrect value may result in the patient receiving a higher or lower amount of BWS than

expected.

• Ensure that the patient’s correct height has been entered before attaching the patient to the system;

an incorrect value may result in the patient receiving a higher or lower amount of downward travel

than expected when the Descent Limit is activated and a fall is detected.

• Do not attach a patient who weighs more than 350 lb. (158.8 kg) to the system.

• Measure and t the harness to the patient carefully; a patient in discomfort might make certain

movements that put them at risk.

• Use care when assisting patients into and out of the harness; the patient can become tangled in the

straps and fall.

• Use care when attaching the patient harness to the spreader bar to reduce the risk of a fall.

• Do not use the system for patient transport (i.e., lifting the patient fully o the ground).

• Do not allow the patient to engage in an activity that (ascend high stairs, jumping) might cause him/

her to come in contact with the actuator.

• Do not touch the rail with your hands or any physical object; the system is powered by 480 VAC.

• Do not touch the actuator while the system is in operation.

• Handle the spreader bar with caution; specically, do not pull down then release the spreader bar.

• In an emergency, such as an electrical outage, immediately discontinue the current task, remove

the patient from the harness, move the patient away from the system, and then turn o the power

switch located on the facility power panel.

GENERAL WARNINGS AND PRECAUTIONS

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

• Connect the system to a main power system (general-purpose alternating-current (AC) electric

power supply) with an earthing or grounding system that provides a protective earth (PE) connection

to avoid the risk of electrical shock.

• Do not modify the system; in addition to the risks listed above, doing so voids the warranty.

• Do not attempt to service or repair the system.

• Do not use the system if maintenance is required.

• Do not use the system if the actuator is wet; for example, from a sprinkler system.

• If there is suspicion of electromagnetic interference from other electrical devices, shut down nearby

devices, one-by-one, to locate the source of the interference

• Ensure that the patient harness connected to the spreader bar is neither too narrow nor too wide;

the performance of the load sensors in the actuator might be adversely aected.

• Follow the IFU carefully to prevent movement of the patient with sharp, quick motions.

• Do not manually move the actuator along the track by pulling on the actuator strap.

• Do not perform jumping-based tasks.

◉ Patients might ascend beyond the upper limit of the device and might adversely aect system

functionality.

◉ This can cause the system to detect a fall due to the accelerated speed of the patient’s down-

ward movement.

• Do not use accessories that are not specied by the manufacturer.

• Therapists using the system should always practice standard guidelines for Environmental Infection

Control.

• Using a non-SafeGait spreader bar can result in injury.

• If there is a loss of communication between kiosk and actuator, this will be indicated by a ‘WHITE

LED’ on the status bar and an error message on the kiosk/handheld. If communication loss occurs

during a patient fall it could result in severe discomfort. If communication is not re-established

within two (2) minutes, then follow these steps: 1) Support the patient with assistance from other

sta if needed or other available equipment nearby. 2) Use the Positioning screen to introduce

‘slack’ on the Actuator Strap and Shoulder Straps while continuing to support patient. 3) Disconnect

Shoulder Straps from the Harness while patient is supported. 4) Get patient into safe position such

as chair or mat table. 5) Call Gorbel Medical support.

• Inspect the harness prior to each use. Do not use if the harness straps are torn or show signs of

wear, there is separation in the harness stitching, or the VELCRO® Brand attachments are unable

to adhere. Leg Cus must be attached to the harness torso during use. Contact Gorbel Medical at

1-844-846-8744 to order a replacement harness.

• Positioning the patient outside of the area dened in the Patient Movement Table can result in

premature wear on the strap, increasing the likelihood of injury.

• While positioning the actuator, ensure the patient is not in the path between current and desired

starting location of the actuator.

• Do not detach shoulder straps from the spreader bar while patient is being supported. This can lead

to patient injury.

• If the therapist observes that the applied BWS is noticeably more or less than the desired BWS the

patient may become understandably fatigued. In this situation, contact Gorbel Medical for assis-

tance.

CLEANING

SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B

• Improperly setting the Descent Limit can result in injury.

• Use of strap with excessive wear can lead to injury.

• Use of worn components can lead to injury. If any area found, discontinue using and contact Gorbel

Medical.

• Use of spreader bar with excessive play and/or lack of smooth rotation can lead to injury.

• Use of harness with any signs of damage or excessive wear can result in injury. Refer to the SafeGait

EMBRACE Instructions for Use (IFU) manual.

• Operating SafeGait while an error or warning code is indicated may result in injury. Contact Gorbel

Medical with an inquiry if any error or warning cannot be dismissed.

Cleaning

CAUTION: Therapists using the systems should always practice standard for Environ-

mental Infection Control.

Strap, Spreader Bar Cover and Harness

Cleaning Frequency: Facility infection control guidelines.

Cleaning Agent: Ethyl or isopropyl alcohol cleaning agent.

SYSTEM POWER

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

System Power

This section provides an overview of the SafeGait 360° Balance and

Mobility Trainer power components and procedures for powering the

system on and o under both normal and emergency conditions.

Overview

The facility power panel provides power to the ceiling-mounted rail,

actuator, router, and NAS device.

Facility Power Panel

Power On the System

1. At the facility power panel, press the green POWER ON button.

The POWER ON button lights up. After approximately one minute, the LED status light bar on the actuator

blinks white, indicating that the actuator is powering up and performing self-checks. When the LED status

light bar changes to solid white, the system has properly powered up and is in Stop mode, waiting for

network connection to the kiosk. Stop mode prevents the actuator from moving until it is disengaged by a

command from the kiosk or handheld remote control.

• Controls

1. EMERGENCY STOP

2. POWER ON

3. OFF

4. RESET

• Indicators:

◉ POWER ON (2)

SYSTEM POWER

SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B

2. If necessary, power on the router by pressing the POWER BUTTON LOCATED AT THE BACK OF THE

ROUTER.

The router powers up and established the closed wireless network. The LEDs (from left to right) are in the

following state:

◉ Power: Green.

◉ DSL (digital subscriber line): O (The router has no DSL connection).

◉ Internet: O (The router has no internet connection).

◉ Wireless: Solid blue.

◉ USB (Universal Serial Bus): O.

3. Power on the kiosk by pressing the power button at the top right of the tablet. Conrm that

the kiosk is charged prior to starting a session. If the kiosk is not fully charged and loses power

during a session, the connection to the actuator will be lost and need to be reestablished by

connecting to an outlet power source and pressing the power button.

The status indicator, located to the right of the touch pad, turns on. After the operating system boots, the

Windows login screen is displayed. Login as the “therapist” user with your provided credentials. After

logging in, the Windows® operating system desktop displays briey until the SafeGait Patient Management

Software starts. After running diagnostics, the LOGIN screen displays.

NOTICE: Use the kiosk to access only the application. Doing so can negatively aect the

SafeGait application.

4. Power on the handheld remote control by pressing the power button located at the top of the

right side of the device. Conrm that the handheld remote control is charged prior to starting a

session. If the handheld remote is not fully charged and loses power during a session, the device

will turn o and control will automatically be transferred to the kiosk.

5. Launch the SafeGait Patient Management Software on the handheld remote control by touching

the SafeGait icon.

CAUTION: If there is a loss of communication between kiosk and actuator, this will be

indicated by a ‘WHITE LED’ on the status bar and an error message on the kiosk/hand-

held. If communication loss occurs during a patient fall it could result in severe discom-

fort. If communication is not re-established within two (2) minutes, then follow these

steps: 1) Support the patient with assistance from other sta if needed or other available

equipment nearby. 2) Use the Positioning screen to introduce ‘slack’ on the Actuator

Strap and Shoulder Straps while continuing to support patient. 3) Disconnect Shoulder

Straps from the Harness while patient is supported. 4) Get patient into safe position such

as chair or mat table. 5) Call Gorbel Medical support.

The system can remain powered on between therapy sessions. Depending on the facility’s energy conser-

vation policy, most system components can remain powered on for an extended period of time.

SYSTEM POWER

Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: [email protected]

Power Off the System

Note: This procedure cannot be performed from the handheld remote control.

1. At the kiosk, touch MENU > Shut Down.

2. When the Shutdown System conrmation screen displays, touch YES.

The actuator LED status light bar changes to white. The kiosk powers o.

3. At the facility power panel, press the red OFF button.

The green POWER ON indicator turns o. The actuator LED status light bar turns o.

In order to conserve energy, turn the power o if the system is not expected to be used for an extended

period of time.

Perform an Emergency Stop

At the facility power panel, or at the remote location, (optional remote Emergency Stop) press the red

EMERGENCY STOP button.

All power is removed from the ceiling-mounted rail and actuator. The actuator is locked into position. If a

patient is attached to the spreader bar, the system continues to provide static BWS.

Release the Emergency Stop by turning the button clockwise until it ‘pops’ out into its original position.

Pressing the Reset Button on the front of the Power Panel will return the safety relay to its ready state.

Press the Power On button then to return power to the system.

NOTICE: In an emergency, such as an electrical outage, immediately discontinue the

current task, remove the patient from the harness, move the patient away from the

system, and then press the OFF button located on the facility power panel.

PATIENT HARNESS

SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B

Patient Harness

This section provides information on the harness and spreader bar. It describes the

procedures for placing the patient into the harness and attaching the harness to

the spreader bar, as well as guidelines for maintaining and cleaning the harness.

Patient Harness Fitting

The SafeGait 360° Balance and Mobility Trainer is used with a patient harness. The SafeGait EMBRACE

Rehabilitation Harness is recommended for use with the SafeGait 360° Balance and Mobility Trainer.

Refer to the SafeGait EMBRACE Instructions for Use for a sizing chart and tting instructions.

Securing the Patient in the Harness

CAUTION: Inspect the harness prior to each use. Do not use if the harness straps are

torn or show signs of wear, there is separation in the harness stitching, or the VELCRO®

Brand attachments are unable to adhere. Leg Cus must be attached to the harness

torso during use. Contact Gorbel Medical at 1-844-846-8744 to order a replacement

harness.

1. Attach the Spreader Bar to the Actuator Strap

The spreader bar is the connection point between the actuator strap and the harness. Attach the

spreader bar to the actuator strap rst and then connect the patient harness to the spreader bar.

Once attached to the actuator strap, the spreader bar may remain connected between patient

sessions.

Spreader Bar to Actuator Strap Attachment

2. Attach the Patient Harness to the Spreader Bar

After the harness has been securely placed on the patient and adjusted, the harness needs to be

attached to the spreader bar.

◉ Ensure that the patient is in a secure position.

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GORBEL safeGait 360 Instructions For Use Manual

Brand: GORBEL

Model: safeGait 360

Type: Instructions For Use Manual

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GORBEL safeGait 360 Instructions For Use Manual

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