Bioness Vector Elite User manual

Manufacturer:
Bioness Inc
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone] or 661.362.4850
Email: [email protected]
Website: www.bioness.com
European Authorized Representative:
NESS Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, The Netherlands
Telephone: [phone]
Email: [email protected]
Website: www.bioness.com
612-00624-001 Rev. A
06/2013
Vector Gait and Safety SystemTM, Bioness, the Bioness Logo®, and LiveOn® are registered trademarks of Bioness Inc. in
the United States or other countries | www.bioness.com
©2013 Bioness Inc.
All Rights Reserved
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or
any computer language, in any form or by any third party, without the prior written permission of Bioness Inc.
Disclaimer
Bioness Inc and its affiliates shall not be liable for any injury or damage suffered by any person, either directly or indirectly, as a result
of the unauthorized use or repair of Bioness Inc products. Bioness Inc and its affiliates do not accept any responsibility for any damage
caused to its products, either directly or indirectly, as a result of use and/or repair by unauthorized personnel.

Clinician's Guide

List of Symbols
Warning
Caution
Consult Instructions for Use
Re-Order Number
Manufacturer
SN Serial Number
European Authorized Representative
Temperature Limitation
Humidity Limitation
Atmospheric Pressure Limitation
This product must not be disposed of with other household waste
Keep Dry
BF Applied Part
Complies with the European Union Medical Device Directive

Table of Contents
Chapter 1: Introduction ........................................................................................................ 1
Device Description .......................................................................................................................................1
Chapter 2: Warnings and Cautions ....................................................................................... 3
Intended Use ............................................................................................................................................... 3
Contraindications .........................................................................................................................................3
Precautions ..................................................................................................................................................3
Warnings .....................................................................................................................................................3
Chapter 3: Patient Harness Fitting ....................................................................................... 5
Selecting a Harness Size ............................................................................................................................5
Donning a Patient Harness ..........................................................................................................................5
Chapter 4: Starting the Vector Elite System and Software ................................................... 7
Turning the system on and off ......................................................................................................................7
Launching the Vector Gait and Safety Software ...........................................................................................8
Chapter 5: Patient Training Menu ...................................................................................... 11
Creating a New Patient Account ................................................................................................................ 11
Opening an Existing Patient Account .........................................................................................................12
Training Session Screen ............................................................................................................................13
Manual Control ...........................................................................................................................................14
Attaching a Patient Harness to the Spreader Bar .......................................................................................14
Training Controls ........................................................................................................................................16
Trolley Tracking ...................................................................................................................................16
Dynamic Body Weight Support ............................................................................................................17
Dynamic Unloading ..............................................................................................................................17
Fall Limit ...............................................................................................................................................18
Session Status Section ...............................................................................................................................18
Starting a Training Session .........................................................................................................................18
Fall Limit Detection .....................................................................................................................................20
Stopping a Training Session .......................................................................................................................21
Emergency Stop and Emergency Lower Buttons .......................................................................................21
Session Summary Screen ..........................................................................................................................22

Vector Elite Time Out Feature ....................................................................................................................23
Chapter 6: Manual Controls, Summaries, and Reference Material Menus .......................... 25
Manual Control Menu .................................................................................................................................25
Patient Summaries Menu ...........................................................................................................................26
Reference Material Library Menu ...............................................................................................................29
Chapter 7: Vector Elite Remote Control ............................................................................ 31
Remote Control Software Navigation .........................................................................................................31
Manual Control Screen ...............................................................................................................................32
Training Controls Screen ............................................................................................................................33
Session Status Screen ...............................................................................................................................34
Take Control Screen ................................................................................................................................... 35
Using the Remote Control for a Patient Training Session ......................................................................... 37
Using the Remote Control to Operate System without Patient Data ........................................................ 38
Chapter 8: Vector Elite Software Administrator Menu ........................................................ 41
Accessing the Administrator Menu .............................................................................................................39
Patient Database .................................................................................................................................41
Add User ..............................................................................................................................................41
Backup and Restore Database Menu ..................................................................................................42
Chapter 9: Service and Maintenance .................................................................................. 45
Chapter 10: Technical Specifications ................................................................................. 47

1
Chapter
1
Chapter 1 - Introduction
Introduction
Introduction of Vector Gait and Safety System™
The Vector Elite is a body weight support system designed to accelerate physical rehabilitation of
patients with severe gait or balance impairment. The system provides dynamic body weight support
and trolley tracking, enabling the patient to practice gait and balance training with less than a full body
weight. When using the Vector Elite System a computer controlled motor keeps the trolley at a desired
location relative to the patient, and a separate computer controlled motor ensures that the rope tension
is kept at a desired value. The patient may walk along a predetermined path or on a treadmill. The
system receives control signals through an encrypted WiFi signal from a PC or remote control.
Figure 1-1: Vector Elite Trolley
Device Description:
The Vector Elite System consists of a mechanical track, a power rail, a power station, a motorized trolley
with rope, a spreader bar, PC computer with proprietary software and an optional remote control.
Mechanical Track and Power Rail
The mechanical track is mounted overhead, typically attached to a support beam, floor or truss, and
the trolley runs along the track. The mechanical track defines the horizontal aspect of the walking path
of the patient. The track includes straight and curved portions that form a closed loop track.
Mechanical Track
Trolley Rope
Spreader Bar
Vector Elite Trolley
Power Rail

2Clinician's Guide
The power rail is also mounted overhead, and runs parallel to the mechanical track. The power rail
delivers electricity to the Elite trolley.
Power Station
The power station is mounted to a wall and plugs into an outlet. It converts electrical power from the
building to a predetermined power level, which is supplied to the trolley through the power rail. The
power station also contains an electrical isolation transformer, as a safety feature of the system.
Elite Trolley
The Elite Trolley consists of two motors and a rope that attaches to the spreader bar. When using the
Vector Elite System a computer controlled motor keeps the trolley at a desired location relative to the
patient, and a separate computer controlled motor ensures that the rope tension is kept at a desired
value. The trolley moves along the entire length of the track.
Spreader Bar
The spreader bar is a device that enables the attachment of a patient harness to the trolley rope. The
spreader bar attaches to a patient harness at two points. On each side of the spreader bar there are
three holes built to accommodate patients of different widths.
PC
The touch screen PC contains the software that controls the Vector Elite System and manages the
secure patient database. The Vector Gait and Safety System Software is password protected and
communicates with the trolley through an encrypted WiFi signal.
Remote Control
The remote control is an optional accessory that may be used to control the System once a training
session has begun. This accessory is not necessary to operate the Vector Elite System. The remote
control uses an Android Operating System with a Vector Gait and Safety System Application and
communicates with the trolley through an encrypted WiFi signal.

Chapter
3
Warnings and Cautions
Intended Use
The Vector Elite System is a body weight support system designed to accelerate physical rehabilitation
of patients with severe gait and/or balance impairment. The system unloads a programmed amount
of the patient’s weight thus enabling the patient to practice walking with less than a full body weight.
Contraindications
Prior to use all patients need to be deemed medically stable and appropriate by a Vector Gait and
Safety System trained healthcare professional. Patients with the following diagnoses or symptoms
should not use the Vector Base System:
• Patients that weigh more than 400 lbs (181.4 kg)
• Unstable fractures
• Halo neck supports
• Uncontrolled hypertension
• Uncontrolled diabetes
• Severe osteoporosis
Precautions
• Pulling down on the spreader bar and then letting go could cause injury; use with caution.
• For correct usage, ensure that the patient harness connection to the spreader bar is not too
narrow or too wide.
• Use care when assisting patients into/out of a harness as they can get tangled and fall.
• Follow instructions carefully to prevent pulling or jerking of the patient in the equipment.
• Carefully measure and fit a harness to the patient. Incorrect sizing may cause discomfort
and/or injury to the patient.
• Use care when attaching a patient harness to the spreader bar. If not attached correctly,
there is a risk of the patient falling.
Warnings
• Incorrect patient data entry or incorrect patient retrieval may cause the patient to fall and/or
serious injury.
• Do not place a patient that weighs more than 400 lbs (181.4kg) in the Vector Gait and
Safety System.
Chapter 2 - Warnings and Cautions
2

4Clinician's Guide
• Do not exceed recommended weight limits or otherwise misuse the equipment as the
equipment can dislocate and fall causing serious injury.
• Do not lift the patient too high or have the patient ascend/descend high stairs where they
might be injured from the trolley.
• Do not touch the motorized Elite trolley during a training session. The trolley contains
moving parts that could cause injury if touched.
•
In an emergency such as an electrical outage, stop exercise immediately to avoid injury and
turn off the power switch located on the power station.
• Do not attempt to service or repair the Vector Elite System or electrocution may occur.
• Do not modify the Vector Elite System equipment; doing so would void the warranty.
• Do not use the Vector Elite System if maintenance is required; serious injury may occur.
• In the event of power failure, carefully remove patient from the harness and step away from
the equipment.
• Do not use equipment if the Elite trolley has become wet (e.g. with sprinklers) as there is a
risk of electrocution. Servicing is required before the equipment may be used.
• To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
• The Vector Elite System is not intended for patient transport. Using the system as a
transport could cause serious patient injury.
• Do not manually move the trolley along the track by pulling on the trolley rope this could
damage the Vector Elite System.
• The Vector Gait and Safety System may only be operated by a trained healthcare professional.
•
The use of accessories not specified by the manufacturer may result in increased emissions
by, or decreased immunity of the equipment, affecting its performance.
• There is a possibility of electromagnetic interference with other devices. When there is
suspicion of possible EMC interference to Vector Gait and Safety System, it is recommended
to shut down the electrical devices nearby, one-by-one, to locate the possible interference
source.

Chapter
5
Patient Harness Fitting
The Vector Elite System is used with a patient harness. The sizing chart and fitting instructions
in this chapter are for the Maine Anti-Gravity Systems patient harness and are for demonstration
purposes only. Instructions for other patient harness devices may vary, please refer to device label
for further information.
Selecting a Harness Size
It is important to make sure that the proper size harness is selected for a patient to ensure safety and
effectiveness while using the Vector Base System. Refer to Table 3-1 for harness sizing.
Harness Size Waist Size 1Harness Color Code
X-Small 24”-28” (60 cm - 71 cm) Gray
Small 28”-32” (71 cm - 81 cm) Yellow
Medium 32”-36” (81 cm - 91 cm) Red
Double Medium 34”-38” (91 cm - 96 cm) Purple
Large 36”-40” (96 cm - 101 cm) Blue
X-Large 40”-44” (101 cm - 111 cm) Green
2X-Large 44”-48” (111 cm - 121 cm) White
3X-Large 48”-52” (121 cm - 132 cm) Orange
4X-Large 52”56” (132 cm - 142 cm) Brown
5X-Large 56”-60” (142 cm - 152 cm) Pink
1 Waist Size is determined by measuring 2 in (5 cm) below the umbilicus (belly button) tightly around the torso.
Table 3-1: Maine Anti-Gravity Systems Patient Harness Sizing Chart.
Donning a Patient Harness
CAUTION: Inspect the harness prior to use. Do not use if harness straps are torn, if there is
separation in the harness stitching, or if the Velcro is unable to adhere. Contact Bioness.
1. Detach all Velcro attachments to open the vest.
2. Make sure the patient is in a secured position.
3. Have the patient put their arms through the shoulder straps to put on the vest. The open side of
the vest will face the front.
4. Secure the lower abdominal support first by attaching the Velcro. Make sure the support is as
tight as possible.
5. Next secure the upper abdominal support by attaching the Velcro. Note: This is the middle
support with the netting material on the back.
6. Securely attach the top torso support.
Chapter 3 - Patient Harness Fitting
3

6Clinician's Guide
7. Tighten side straps on lower abdominal support.
8. If necessary adjust side vertical straps.
9. Wrap leg supports around the upper thigh and secure the Velcro.
10. If necessary adjust side vertical straps attached to the leg supports.
11. Adjust shoulder straps to the desired length.
Figure 3-1: Maine Anti-Gravity Systems Patient Harness Features.
Shoulder Straps
Lower Abdominal Support
Upper Abdominal Support
Top Torso Support
Side Straps
Side Vertical Straps
Side Vertical Leg Straps
Leg Supports
D-Ring

Chapter
7
Starting the Vector Elite System and Software
Turning the system on and off
1. Turn the power switch, located on the wall mounted power station, to the on position. See
Figure 4-1.
2. A green light will appear on the power station. The Elite Trolley will initialize and after
approximately 90 seconds a green light on the posterior of the trolley body will appear indicating
that the power is on and the system started properly.
3. After the power has been turned on, turn on the touch screen PC and log into the Windows
operating system.
Figure 4-1: Power Switch
Note: The power may be left on between training sessions. Turn the power off if the system is not
expected to be used for an extended period of time (e.g. several hours). To turn the system off flip the
power switch on the power station to the off position.
4
Chapter 4 - Starting the Vector Elite System and Software

8Clinician's Guide
Launching the Vector Gait and Safety Software
1. To launch the Vector Elite Software click on the icon labeled “Vector Gait and Safety System”
located on the computer screen.
2. The Login screen will appear, enter in your username and password. Click on the green arrow
to login and proceed to the Main Menu. See Figure 4-2.
Note: Login username will be set up when the administrator creates new user accounts.
Figure 4-2: Login Screen
3. After logging into the software the Main Menu screen will appear. See Figure 4-3. There are
four menu options to choose from on the Main Menu screen:
• Patient Training Menu – This option is to access the patient database, create a new patient
account and start a training session.
• Manual Control Menu – This option allows the clinician to control the Vector Elite Trolley
manually without needing to select a patient account.
• Summaries Menu – This option allows the clinician to view a patient’s training history data.
•
Reference Library Menu- This is the location of training videos of examples of patients using
the product and of the Vector Elite Clinician’s Guide.
Note: Log-out arrow is used to return to the login screen. Use after a session has ended.
Note: You can always quit the Vector Elite software any time by simply clicking on the ‘X’ mark in the
upper right hand side of the screen.

9
Chapter 4 - Starting the Vector Elite System and Software
Figure 4-3: Main Menu Screen
Patient
Training
Summaries
Manual
Control
Reference
Material
Library
Log Out

10 Clinician's Guide

Chapter
11
Patient Training Menu
This menu is used to create a new patient account, access the patient database and start a training
session.
Caution: Incorrect patient data entry or incorrect patient retrieval may cause the patient to fall
and/or serious injury.
Creating a New Patient Account
1. From the Main Menu screen click on the Patient Training Icon. See Figure 4-3. This will open
the Patient Menu Screen. See Figure 5-1.
2. Fill in the required patient data fields located in the top part of the screen. Some data fields will
have a drop down menu. See Figure 5-1. Required fields have an asterix (*) next to it.
Note: Verify that all information has been correctly entered.
3. Click on the Save Icon to save the patient data and create a new patient account. See Figure 5-1.
Note: The Save Icon will not be available until all required fields are filled.
4. Click on the Start Training button to start the patient training session. See Figure 5-1.
Note: The Starting Training button will not be available until a patient is selected.
Figure 5-1: Patient Menu Screen
Chapter 5: Patient Training Menu
5
Save
Start
Training

12 Clinician's Guide
Opening an Existing Patient Account
1. From the Main Menu screen click on the Patient Training Icon. See Figure 4-3. This will open
the Patient Menu Screen.
2. The screen will display patients currently in the database under “Known Patients”.
3. Select patient from list shown on the screen by clicking on the patient’s name highlighting that
row. Use the scroll up/down if there are more patients that fit in one screen or start typing in the
patient’s name in the blank fields above the list. The database will filter and display only the
names that match the typed information. See Figure 5-2.
4. Once the patient has been selected the data fields will automatically be filled in with the
patient’s information. At this time if appropriate the patient’s information can be edited by
clicking the Edit button. All patient data fields can be cleared by clicking the Clear button. See
Figure 5-3.
5. Click on the Start Training Button to open the Training Session Screen. See Figure 5-3.
Figure 5-2: Filtered Patient Menu
A

13
Chapter 5: Patient Training Menu
Figure 5-3: Selecting a Patient
Training Session Screen
The Training Session screen is divided into 3 sections: Manual Controls, Training Controls, and Session
Status. See Figure 5-4.
Figure 5-4: Training Session Screen
Edit
Start
Training
Clear

14 Clinician's Guide
Manual Controls
Warning: The Vector Elite System is not intended for patient transport. Using the system as a
transport could cause serious patient injury.
When the Training Session screen opens only the Manual Controls section is enabled. See Figure 5-4.
The Manual Control section allows the user to winch the rope up and down and to move the trolley
along the track in either direction. See Table 5-1.
Manual Control Button Definition
When pressed this button will continue to winch up the trolley
rope with spreader bar attached until the button is released.
When pressed this button will continue to winch down the trolley
rope with spreader bar attached until the button is released.
When pressed this button will continue to move the trolley along
the track in the direction indicated until the button is released.
Reference the trolley icon to determine the direction of the
movement.
When pressed this button will continue to move the trolley along
the track in the direction indicated until the button is released.
Reference the trolley icon to determine the direction of the
movement.
When pressed this button will move the trolley 18 inches (45.7
cm) along the track in the direction indicatedand then stop.
Reference the trolley icon to determine the direction of the
movement.
When pressed this button will move the trolley 18 inches (45.7
cm) along the track in the direction indicated and then stop.
Reference the trolley icon to determine the direction of the
movement.
Table 5-1: Manual Control Button Definitions
The Manual Control buttons are used to position the trolley along the track, lower the trolley rope in
order to connect the patient harness to the spreader bar, and winch up the trolley rope to the desired
tension for the patient harness straps.
Attaching a Patient Harness to the Spreader Bar
After a patient harness has been securely placed and adjusted on the patient, the harness will need
to be attached to the spreader bar.
1. Make sure the patient is in a secured position.
2. Use the Manual Control Winch Down button to lower the rope with spreader bar attached.

15
Chapter 5: Patient Training Menu
3. The spreader bar provides three attachment points to attach a patient harness. The selection
of the attachment point depends on the width of the patient. Connect the patient harness to the
outermost attachment points for wide patients, and to the innermost points for narrow patients.
See Figure 5-5.
4. Connect the spreader bar carabiners to the D-rings on the patient harness shoulder straps.
Check to make sure connection is secure.
5. Use the Manual Control Winch Up button to slowly raise the trolley rope until there is tension in
the rope and patient harness shoulder straps.
Figure 5-5: Spreader Bar attachment points
Note: When using the Manual Control buttons with a patient attached to the spreader bar, make sure
to inform the patient that they are about to be moved.
Attachment points for narrow patients
Attachment points for wide patients