Vector Gait & Safety System Safety Information

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 weight to enable the patient to practice walking with less than his or her full body weight.

Contraindications

Prior to use, all patients need to be deemed medically stable and appropriate by a trained healthcare professional. Patients with the following diagnoses, symptoms, or findings should not use the Vector Elite system:

  • Body weight more than 500 lbs. (227 kgs.)
  • 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 the harness as they can get tangled and fall.
  • Follow instructions carefully to prevent pulling or jerking the patient in the equipment.
  • Carefully measure and fit the harness to the patient. Incorrect sizing may cause discomfort and/or injury.
  • Use care when attaching the patient harness to the spreader bar. If not attached correctly, the patient may fall.
  • When using a multi-trolley configured system on the same track, leave a safe distance between patients to prevent collision injury or injury from a patient fall.
  • In a multi-trolley configured system, while using the manual controls, avoid driving the Vector Elite trolley into the other trolley on the same track.
  • Before starting a training session with a multi-trolley configured system, make sure the correct computer and remote control are being used with the correct Vector Elite trolley. The incorrect computer or remote control will not operate the trolley. The remote control and computer are configured to only operate the trolley with which they are paired.
  • Ensure that the handheld is operating and communicating with the appropriate computer before starting a training session.

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 less than 30 lbs. (13 kgs.) or more than 500 lbs. (227 kgs.) in the Vector Gait & Safety System.
  • Do not exceed recommended weight limits or otherwise misuse the equipment. 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 Vector 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.
  • Modifying the Vector Elite system equipment voids 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 Vector Elite trolley has become wet (e.g., from 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.
  • Manually moving the trolley along the track by pulling on the Support Rope, could damage the Vector Elite system.
  • The Vector Gait & Safety System may only be operated by a trained health care professional.
  • The use of accessories not specified by the manufacturer may result in injury and/or increased emissions, 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 the Vector Gait & Safety System, it is recommended to shut down the electrical devices nearby, one by one, to locate the possible interference source.
  • Due to potential confusion about which computer is being used with which patient, a clinician should not operate multiple computers at the same time.
  • The Vector PC and Remote Control network configurations should not be modified without direction from Bioness Support, including changing network connection or connection to the Internet. Modification of the network can void the warranty and may affect equipment performance.
  • The Vector PC and Remote Control should be used by trained healthcare professionals only outside of the patient environment and are to be used for operation of the Vector system only. Any modification to the operating systems, software, or configuration can void the warranty and may
    affect equipment performance.
  • The Vector PC and database are secured using a username and password. Each user of the Vector system should keep the password secure and ensure that the system is not left unattended.