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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 affected.

•

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 affect 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 specified 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

staff 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 Cuffs 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 defined 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.

Содержание safeGait 360

Страница 1: ...Instructions for Use...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

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