Do not operate this system if you have not been adequately trained in how to use this device. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
Preface Purpose This manual provides directions to help users safely and effectively 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.
Stop All General Warnings and Precautions Dangers Precautions cleaning Strap, Spreader Bar Cover and Harness system Power Overview Power On the System Power Off the System SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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Stop the System in Case of Emergency or to Reposition the Patient Resuming an Aborted Task End the Session and Add Notes Historical data View Patient Performance Measurements by Task View Patient Performance Measurements by Session Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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Troubleshooting - Error Codes appendix Appendix A: LED Status Light Bar Appendix B: List of Symbols Quick reference Guide Quick Reference - Task Monitoring Index Notations SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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 • Efficiency of care...
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 SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
(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. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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 SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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 Kiosk control. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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 SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
• 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 off the power switch located on the facility power panel. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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• 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 Cuffs must be attached to the harness torso during use. Contact Gorbel Medical at 1-844-846-8744 to order a replacement harness.
• 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.
PoWer 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 off under both normal and emergency conditions. Overview The facility power panel provides power to the ceiling-mounted rail, actuator, router, and NAS device.
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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. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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.
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(as opposed to a “V” angle) with their torso. Spreader Bar Attachment Points 4. Connect the spreader bar carabiners to the D-rings on the patient harness shoulder straps. Patient Harness to Spreader Bar Attachment Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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NoTIce: Ensure that the patient does not hold onto the harness shoulder straps while attached to the spreader bar. Doing so can affect the system’s response including triggering a “fall” or reducing reaction speed. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
4.25 0.77 4.50 0.82 caUTIoN: Positioning the patient outside of the area defined in the Patient Movement Table can result in premature wear on the strap, increasing the likelihood of injury. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
The Patient Management Software restricts you from accessing screens that violate the system workflow; for example, you cannot access the plan of care until you have selected a patient. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
• While one of the devices is in use, a Take coNTrol of aPPlIcaTIoN screen displays at the other device. • To move control from one device to the other, touch Take coNTrol of aPPlIcaTIoN. KIOSK IN USE Screen HANDHELD IN USE Screen Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
• Select a user. Your unit will have 3 options: Administrator, Backup, and Therapist. Tap/click on the Therapist icon. Windows® User Selection Screen • Enter your Windows login password. Windows® Login Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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This should be done to address safety and privacy concerns with having “default” accounts. Log Out Of the System Note: This procedure cannot be performed from the handheld remote control. Touch MENU > Log Out. The LOGIN screen displays. MENU Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
Note: For information on how to use the Just Go option, refer to the Tasks section. Create a New Patient Record 1. If necessary, touch PaTIeNT seTUP. PATIENT SETUP Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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The date field is automatically filled by the patient management software. Note: A drop-down calendar is provided for the dob field; however, it is recommended that you enter the dob from either the on-screen or physical keyboard in the format MM/DD/YYYY. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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BWS applied will be 10 lbs. (in the example shown above, BWS of 10 lbs. is 25% of body weight - therefore in this example body weight would be 40 lbs.). SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
Choose an Existing Patient 3. Select the patient from the drop-down list. 4. On the Patient dashboard page touch Patient details. 5. From the Patient Information screen, touch edIT INforMaTIoN. Patient Information Screen (Editable) Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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The patient record is updated, the Date field is set to the current day, and the Create a Plan of Care screen displays. Confirm Patient Height and Weight Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
Height and Weight. 6. Touch coNTINUe. If you reentered the patient’s height or weight, the patient record is updated. The Create a Plan of Care screen displays. Confirm Patient Height and Weight Screen Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
5. Select the tasks you want to perform on the selected data and click save. The tasks for that date have now been entered. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
6. On the Confirm Patient Height and Weight screen, confirm or reenter the patient’s Height and Weight. 7. Touch coNTINUe. The tasks from the last session will be repeated for the current session. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
5. If more than one task has been completed you can touch that task to view the trends. Touch Task Name. The task trends for a patients tasks are shown SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
2. From the create a Plan of care screen, select the tasks you wish to perform during this session. 3. Touch saVe aNd coNTINUe. The plan of care if created and the PosITIoNING screen displays. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
At this time, the Today’s session screen displays. Today’s Session Screen 1. From the Today’s session screen, touch MaNaGe Tasks. Create a Plan of Care Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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3. Touch saVe aNd coNTINUe. The plan of care is update and the PosITIoNING screen displays. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
The new task is created and the create a Plan of care screen displays, with the new task added to the custom column. The custom task becomes a permanent part of the facility’s Plan of Care options and cannot be deleted. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
◉ repetitions: Select for transfer tasks. Measurements of Time, speed (average), falls Prevented, average bWs, and Number of boosts are automatically added to the new task. 4. Touch saVe. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
NoTIce: Positioning the Actuator either in front of or behind the patient could lead to discomfort. caUTIoN: While positioning the actuator, ensure the patient is not in the path between current and desired starting location of the actuator. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
Depending on where you accessed the PosITIoNING screen from, Select a Patient or press beGIN sessIoN, eXIT sessIoN or JUsT Go to continue. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
Horizontal Locked state, if a fall is prevented, the actuator may move slightly, in order to protect both the patient (by reducing the impact of their fall) and the system. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
MaNaGe Tasks allows you to return to the create a Plan of care screen and adjust the selections. After making new selections, the PosITIoNING screen displays. You can use the MaNaGe Tasks function to reposition without changing tasks. After positioning, you are returned to the Today’s session screen. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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BWS is about to be applied. The actuator LED status light bar changes to green. BWS is applied. The Task MoNITorING screen displays. Get Patient Ready Screen TASK MONITORING Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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Goals for this session. Goals for the lasT sessIoN and fIrsT sessIoN display directly below the goals for this session. ◉ Touch seT aNd coNTINUe. Set Paint Goals Screen Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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Fall detection is triggered by a relatively high amount of downward speed on the strap; for patients with a mild level of impairment. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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USAGE TIP: Consider using the Descent Limit feature to safely demonstrate to the patient the way in which fall protection feels when it is engaged by having the patient bend at the knees until fall protection is activated. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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RPE ENTRY On/Off radio buttons when reaching for the Descent Limit On/Off radio buttons. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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NoTIce: Pressing reseT Task is NOT akin to repeating a task. If reseT Task is pressed, previous performance measurements are not retained. If you wish to repeat a task, follow steps 12-16 and select the same task. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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13. If rPe eNTry is enable, from the rating of Perceived exertion (rPe) Scale screen, select the value that corresponds to the patient’s rPe, the touch saVe aNd coNTINUe. REVIEW Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
You have the option to log performance measurements and assign them to an existing patient upon completion of the task. Before performing this procedure, you must know the patient’s height and weight. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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The TASK MONITORING screen displays. 10. Perform the task. For more information, refer to Perform a Task from the Plan of Care, Steps 6-12. Get Patient Ready Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
During a task, the user can choose whether or not to record the prevented fall into the system. This option is not available during JUsT Go. NoTIce: Ensure that the patient has completely regained his or her balance before clearing the Falls Prevented alert. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
Task MoNITorING screen. 1. Touch sToP all. The system stops. No movement is allowed. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
4. Press the resUMe button (where the Start Task button is normally located) to continue the task. All metrics should resume where they were left off. NoTIce: Once a different task is started, the aborted task cannot be resumed. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
If you do not want to save the session data, touch dIscard sessIoN. This option ends the session and returns you to the PaTIeNT seTUP screen. Finish Session Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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8. Use the touchscreen to scroll sideways should the timeline exceed the screen width. 9. Press the back button to stop viewing events and return to the Today’s session screen. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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10. If you do not wish to review historical data with the patient, touch saVe & loG oUT PaTIeNT. The PATIENT SETUP screen displays. For information on reviewing historical data with the patient, refer to the Historical Data section. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
These measurements can be viewed and compared by specific tasks or full session. View Patient Performance Measurements by Task 1. Touch HIsTorIcal daTa. HISTORICAL DATA Screen Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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The task area is labeled with the current task; for example, Fast Speed. 5. Select one of the following options: HISTORICAL DATA Screen (Session List) SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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◉ From this screen, you can touch a bar graph to display a full-screen bar graph for a single performance measurement. HISTORICAL DATA Screen (View by Task > Dashboard > Single Performance Measurement) Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
As you type, a drop-down list of patients that match your search criteria displays. ◉ Select the patient from the drop-down list. ◉ Touch ok. Select a Patient Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
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5. Select one of the following options: ◉ VIEW SESSION DETAILS: Display the session data for the selected task, with the option to view the data for any selected session. Session Data Screen Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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◉ From this screen, you can touch a bar graph to display a full-screen bar graph for a single performance measure- ment. Session Comparison Screen (Single Performance Measurement) SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
The filename can be changed by clicking on the filename box and editing it. 4. To export, click on saVe. It will take a few moments for the file to be exported. Wait until complete to remove the external storage device. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
Note: These procedures cannot be performed from the handheld remote control. View a List of Users 1. Touch MaNaGe. A list of management functions appears: Users, Tasks, Settings, Admin Reports, System (Admin role only). MANAGE Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
◉ Therapist: Permission to perform all system operations. 7. Touch saVe aNd coNTINUe. The new user is added to the system. Create a New User Screen Edit User Information 1. Touch MaNaGe. 2. Touch Users. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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6. To reset the user’s password to the default, touch reseT PassWord. 7. Touch saVe. The user’s information is updated. End User Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
The user is disabled. The user can no longer log in to the system but their information is still stored on the system. In the View Users area of the MANAGE screen, their username is displayed in strikethrough text. Edit User Screen Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
The user is enabled. The user can log in to the system. In the View Users area of the MANAGE screen, their user- name is no longer displayed in strikethrough text. Edit User Screen SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
4. On the edit settings screen, change any of the following display settings: ◉ Weight ◉ Height ◉ Distance ◉ Speed 5. Change the default dfP sensitivity. 6. Touch saVe. The system settings are updated. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
5. On the edit custom Task screen, change any of the following settings: º Name º Measurement § Distance § Repetitions 6. Touch saVe. The custom task has been updated. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
This section describes the SafeGait 360° Balance and Mobility Trainer maintenance requirements. Overview Annual preventative maintenance should be performed by a certified Gorbel Medical technician. Please contact Gorbel Medical to schedule this service. Before Each Use Inspect the following components for damage or excessive wear. If any is found, discontinue using and contact Gorbel Medical.
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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. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
MaINTeNaNce Annually Contact Gorbel Medical to schedule a preventive maintenance appointment for the following: • Inspection and cleaning of the ceiling-mounted rail • Inspection of the SafeGait 360 Actuator • Replacement of the Actuator Strap Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
The the stop, resume the task, resume POSITIONING screen. system continues to provide the session, or return to the POSI- static BWS. TIONING screen. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
• The falls deTecTed screen MoNITorING screen, to the reMoVe displays. setting. - or - Reset the task and set the Descent Limit with the patient in a seated posi- tion. Perform the task. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
Gorbel® caUTIoN: 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. SafeGait 360° Balance and Mobility Trainer | Instructions for Use | SG360-IFU-004 Rev B...
A fall has been detected, due to exceeding the Descent Limit. (blinking) yellow A fall has been detected, due to exceed the DFP Sensitivity setting. (blinking) yellow A warning has been issued. A fault in the system has been detected. Contact Gorbel Medical | Phone: 1-844-846-8744 | E-mail: info@safegait.com...
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