GORBEL safeGait 360, Instructions For Use Manual

Page 1: ...Instructions for Use...

Page 2: ...P O Box 593 Fishers NY 14453 0593 Phone 1 844 846 8744 E mail info safegait com www safegait com NOTICE TO USERS Read the entire Instructions for Use IFU before operating the system It is unsafe to us...

Page 3: ...rate 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 g...

Page 4: ...il 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...

Page 5: ...d 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 Custo...

Page 6: ...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 Troubleshoo...

Page 7: ...ows 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 sup...

Page 8: ...viding 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...

Page 9: ...ching the very end of the rail Loop configurations 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 i...

Page 10: ...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 EM...

Page 11: ...e 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...

Page 12: ...nd 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...

Page 13: ...s weight 175 lb 79 4 kg maximum Descent Limit Setting that defines a maximum amount of downward movement scaled 2 6 inches based on the patient s height Dynamic Fall Protection DFP Embedded software i...

Page 14: ...ient 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 p...

Page 15: ...trol 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...

Page 16: ...ad 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 c...

Page 17: ...el 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...

Page 18: ...application Doing so can negatively affect 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 Confirm that...

Page 19: ...gency 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...

Page 20: ...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 Cuf...

Page 21: ...an attachment point outer or inner that provides for the most vertical straight up and down position of the harness straps Standard connection of the harness is to the outermost attachment points Use...

Page 22: ...TIONING screen touch and hold the Spreader Bar Position up arrow to slowly raise the strap until there is an appropriate amount of tension on the patient harness shoulder straps NOTICE Ensure that the...

Page 23: ...ed while in the system from the centerline on the floor for various rail installation heights Patient Movement Table Rail Height ft Distance in Rail Height m Distance m Lateral max 9 20 2 75 0 50 10 2...

Page 24: ...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...

Page 25: ...ntrols related to the main section of the screen display along the bottom of the screen The BACK button is available on most Patient Management Software screens and allows you to return to the previou...

Page 26: ...ers For more information refer to the Settings section Logging In To Windows and SafeGait Note This procedure cannot be performed from the handheld remote control When the kiosk laptop is turned on fo...

Page 27: ...e and Password Touch LOGIN LOGIN Screen You will need to login as an Administrator to create new administrators and users Note Once a new administrator has been created log in as this administrator an...

Page 28: ...the procedures for managing patient records and selecting a patient for treatment Note The procedures in this section cannot be performed from the handheld remote control Note For information on how...

Page 29: ...eld 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 phy...

Page 30: ...mum BWS Warning Minimum BWS Warning NOTICE The minimum BWS allowed is reduced to 10 lbs but only for patients weighing less than 100 lbs If the patient weight is such that 20 of their weight is less t...

Page 31: ...g Patient area of the PATIENT SETUP screen type the patient s last name As you type a drop down list of patients that match your search criteria displays Choose an Existing Patient 3 Select the patien...

Page 32: ...ge Fields with an asterisk in them area required 7 Touch SAVE AND CONTINUE 8 Touch CONTINUE on the dashboard screen On the Confirm Patient Height and Weight screen confirm or reenter the patient s Hei...

Page 33: ...the patient s last name As you type a drop down list of patients that match your search criteria displays 3 Select the patient from the drop down list Choose an Existing Patient 4 From the Patient Das...

Page 34: ...T SETUP 2 In the Choose An Existing Patient area of the PATIENT SETUP screen type the patient s last name As you type a drop down list of patients that match your search criteria displays 3 Select the...

Page 35: ...ENT SETUP screen type the patient s last name As you type a drop down list of patients that match your search criteria displays 3 Select the patient from the drop down list Choose an Existing Patient...

Page 36: ...sary touch PATIENT SETUP 2 In the Choose An Existing Patient area of the PATIENT SETUP screen type the patient s last name As you type a drop down list of patients that match your search criteria disp...

Page 37: ...nsive list of tasks from which you can create a plan of care that is specific to individual patient requirements The plan of care can be used to create a schedule of tasks for a session Create a Plan...

Page 38: ...of Care This procedure allows you to edit the plan of care after you have selected a patient created a plan of care and then continued on with the session At this time the Today s Session screen disp...

Page 39: ...ait com 2 From the Create a Plan of Care screen select the additional tasks you wish to perform during this session or deselect the tasks you no longer wish to perform during this session 3 Touch SAVE...

Page 40: ...elect the other measurement Distance Select for gait tasks Repetitions Select for transfer tasks Measurements of Time Speed average Falls Prevented Average BWS and Number of Boosts are automatically a...

Page 41: ...e screen select one Custom Task Edit Custom Task Screen 2 Select Edit Custom Task 3 Edit the Custom Task Name or Measurement type Distance Select for gait tasks Repetitions Select for transfer tasks M...

Page 42: ...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 1...

Page 43: ...TIONING screen from Select a Patient or press BEGIN SESSION EXIT SESSION or JUST GO to continue 1 If necessary touch POSITIONING 2 From the Spreader Bar Position area of the POSITIONING screen touch a...

Page 44: ...herapy session to check the distance and adjust the harness or spreader bar straps as necessary to maintain the proper position A distance greater than dictated by the guide may result in reduced syst...

Page 45: ...collecting and logging performance measurements after creating a plan of care and positioning the actuator Today s Session Screen 1 From the Today s Session screen To Do column select a task MANAGE TA...

Page 46: ...tient Ready Screen TASK MONITORING Screen 2 Touch BEGIN TASK 3 From the Get Patient Ready confirmation screen touch BEGIN The purpose of this screen is to alert you that BWS is about to be applied The...

Page 47: ...AUTION 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 assist...

Page 48: ...to adjust the DFP SENSITIVITY setting for a task toggle the DFP SENSITIVITY bar located at the bottom right of the TASK MONITORING screen to the desired setting High Fall detection is triggered by a r...

Page 49: ...nt The Descent Limit can be deactivated during a task or reset in order to allow patients to perform tasks from a lower position such as the transfer task of sit to stand Even when the Descent Limit i...

Page 50: ...he actuator will move slightly to protect the patient and the device 10 RPE Entry To enable or disable the entry of the patient s rating of perceived exertion RPE upon completion of the task slide the...

Page 51: ...his session is reached the PATIENT GOALS turn green The following options are available while the patient is performing the task Adjust BWS Touch Boost located in the Body Weight Support area to provi...

Page 52: ...Use SG360 IFU 004 Rev B 12 Touch FINISH TASK Rating of Perceived Exertion RPE Scale Screen 13 If RPE ENTRY is enable from the Rating of Perceived Exertion RPE Scale screen select the value that corres...

Page 53: ...task can be repeated multiple times The number of times the task has been repeated is shown in parentheses under the Completed column 17 Once the next task is selected press BEGIN TASK to start it Tod...

Page 54: ...re information refer to the Positioning section 7 Attached the harness to the spreader bar For more information refer to the Patient Harness section 8 From the POSITIONING screen touch JUST GO Enter P...

Page 55: ...m after a prevented fall When a patient fall is prevented by the system the Falls Prevented screen displays and the actuator LED status light bar changes to either blinking yellow if fall detection wa...

Page 56: ...movement is allowed 1 If necessary secure the patient 2 From the Falls Prevented screen select whether to Record the fall using the Yes No radio buttons By default the Yes button is selected 3 Next se...

Page 57: ...ay s Session screen you will notice an alert that the previous task Horizontal Head Turns in the following screenshot was not completed 2 Click on the alert to resume the task 3 You will be presented...

Page 58: ...s Session screen touch FINISH SESSION Finish Session Screen 2 From the Finish Session screen touch REVIEW SAVE SESSION The session is ended and the Today s Session screen displays with the session per...

Page 59: ...button under the Notes text box A table of events will be shown 5 Use the touchscreen to scroll down should the list exceed the screen length 6 Alternatively a graphical timeline can be shown Press th...

Page 60: ...004 Rev B Table View of Events Timeline View of Events 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...

Page 61: ...the procedures for viewing and comparing the patient performance measurements that are captured and logged into the system in real time during the session These measurements can be viewed and compared...

Page 62: ...list Review Tasks 4 From the task screen select the session s to include in the report The task area is labeled with the current task for example Fast Speed 5 Select one of the following options HISTO...

Page 63: ...ed session HISTORICAL DATA Screen View by Task Single Task Data VIEW DASHBOARD Display bar graphs for each performance measurement associated with the selected task for each selected session HISTORICA...

Page 64: ...TORICAL DATA HISTORICAL DATA Screen Select a Patient Screen 2 If not patient is selected In the Select a Patient area of the HISTORICAL DATA screen touch SELECT PATIENT On the Select a Patient screen...

Page 65: ...pare Sessions Session Select Screen 4 From the Session Select screen select the session s to include in the report 5 Select one of the following options VIEW SESSION DETAILS Display the session data f...

Page 66: ...ev B VIEW DASHBOARD Display bar graphs for each performance measurement for each selected session Session Comparison Screen From this screen you can touch a bar graph to display a full screen bar grap...

Page 67: ...ifferent options are available depending on the selection Any number of sessions tasks can be exported Save to External Device Screen 3 In order to save the data an external storage device must be ins...

Page 68: ...r managing users and system settings The procedures in this section can only be performed by a user with the role of Admin Note These procedures cannot be performed from the handheld remote control Vi...

Page 69: ...Touch Users 4 On the Create New User screen enter the following information Last Name First Name Username Password 6 10 alpha and or numeric characters 5 Reenter the Password in the Confirm Password...

Page 70: ...er screen edit any of the following Last Name First Name Username and Role display on this screen however you cannot edit from this screen 6 To reset the user s password to the default touch RESET PAS...

Page 71: ...ouch DISABLE USER 6 On the Disable User confirmation screen touch YES 7 Touch SAVE The user is disabled The user can no longer log in to the system but their information is still stored on the system...

Page 72: ...bled 1 Touch MANAGE 2 Touch Users View Users 5 From the Edit User screen touch ENABLE USER 6 On the Enable User confirmation screen touch YES 7 Touch SAVE The user is enabled The user can log in to th...

Page 73: ...Edit System Settings 1 Touch MANAGE 2 Touch Settings 3 Touch Edit Settings Edit Settings Screen 4 On the Edit Settings screen change any of the following display settings Weight Height Distance Speed...

Page 74: ...G360 IFU 004 Rev B Edit Custom Tasks 1 Touch MANAGE 2 Touch Settings 3 Select a Task 4 Touch Edit Edit Custom Task Screen 5 On the Edit Custom Task screen change any of the following settings Name Mea...

Page 75: ...844 846 8744 E mail info safegait com Disable Custom Tasks 1 Touch MANAGE 2 Touch Settings 3 Select a Task 4 Touch Edit Edit Custom Task Screen 5 On the Edit Custom Task screen touch Disable Task 6 To...

Page 76: ...ttings 70 SafeGait 360 Balance and Mobility Trainer Instructions for Use SG360 IFU 004 Rev B View Admin Reports 1 Touch MANAGE 2 Touch Admin Reports Admin Reports Screen The admin reports are displaye...

Page 77: ...ld 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...

Page 78: ...ry Safegait EMBRACE Rehabilitation Harness Please refer to the SafeGait EMBRACE Instructions for Use IFU manual for detailed illustrations to reference component parts listed in the inspection items b...

Page 79: ...8744 E mail info safegait com Annually Contact Gorbel Medical to schedule a preventive maintenance appointment for the following Inspection and cleaning of the ceiling mounted rail Inspection of the S...

Page 80: ...prevented by the system the Falls Prevented screen displays and the actuator LED status light bar changes to either blinking yellow if fall detection was due to exceeding the DFP Sensitivity setting...

Page 81: ...isplays Verify that the fall was triggered by the patient exceeding the Descent Limit This condition is indicated by the LED status light bar blinking green From the FALLS DETECTED screen Record Fall...

Page 82: ...0118 The horizontal loadcell signal is not in neutral position when BWS is applied Center the patient directly under the actuator From the ERROR screen touch RESET Begin or resume task If error persis...

Page 83: ...owered up and in Stop mode waiting for network connection to the kiosk Blue System is ready and in a locked mode Green System is operational Actuator is moving during positioning or BWS is applied Gre...

Page 84: ...inor or moderate injury Lead Free RoHS Restriction of Hazardous Substances and WEEE Waste from Electric and Elec tronic Equipment Compliant Pinch Point Keep hands and fingers clear Temperature Limitat...

Page 85: ...Quick Reference Guide 79 Contact Gorbel Medical Phone 1 844 846 8744 E mail info safegait com Quick Reference Guide Quick Reference Task Monitoring...

Page 86: ...l 2 6 8 11 13 74 Falls prevented 34 35 49 50 53 74 79 H Handheld remote control 2 5 11 13 19 22 31 43 44 53 62 Harness 2 4 7 10 12 16 18 23 36 38 48 72 76 Historical data 18 54 58 61 Horizontal Lock 7...

Page 87: ...ettings 18 20 39 42 44 62 63 67 69 79 Single task data 57 Spreader bar 2 4 7 10 13 16 36 38 48 72 76 Stop all 7 45 50 51 74 79 Strap 2 4 8 10 12 14 18 37 38 42 49 71 73 76 79 T Task 1 5 8 9 13 17 22 2...

Page 88: ...Notations 82 SafeGait 360 Balance and Mobility Trainer Instructions for Use SG360 IFU 004 Rev B Notations A place to add notes by the users...

Page 89: ...Notations 83 Contact Gorbel Medical Phone 1 844 846 8744 E mail info safegait com...

Page 90: ...ait com Website www safegait com SG360 IFU 004 Rev B Gorbel Inc All rights reserved SafeGait 360 Balance and Mobility Trainer and Gorbel are registered trademarks of Gorbel Inc VELCRO is a registered...