Keeogo

Keeogo Safety & Performance Information

PERFORMANCE & EFFECTIVENESS

The majority of patients who use Keeogo have achieved improved clinical outcomes (i.e., sit-to-stand test, 6-minute walk test, timed up and go test) and the Keeogo has also been shown to be effective (i.e., increasing knee strength, enhancing stability/ balance, lowering pain).

Warnings

  • Users and Clinicians must read the user manuals before using or supervise the use of Keeogo.
  • The clinician/ patient should ensure that the patient fulfils the required profile – considering indications and contraindications of the Keeogo – prior to use.
  • If you do not have your user manual, contact customer support for replacement.
  • Training is mandatory for use of Keeogo. Reading the user manual is not a substitute for training by a B-Temia certified Health Professional.
  • Do not attempt to service or modify Keeogo or its accessories.
  • Keeogo should always be placed on top of clothing and should not have direct contact with the body surface.
  • Do not use Keeogo if it has been damaged or is missing parts. Contact customer support if you believe your Keeogo is missing parts or has been damaged.
  • Keeogo is customized for each user’s body and gait. Do not use another person’s Keeogo.
  • If you are injured while using Keeogo, please contact customer support immediately.

Potential Side Effects

The following side effects have been reported in association with exoskeletons:

  • Skin aliments: skin issues not specified, rash, skin peeling, skin abrasions, mild skin bleachable erythema at exoskeleton locations,
  • Lower limb soreness
  • Fear/ crying
  • Toenail breaking
  • Orthostatic hypertension
  • Fatigue in general,
  • Fatigue upper extremities
  • Low back pain,
  • Dizziness,
  • Knee hyperextension,
  • Pain,
  • Lower extremity numbness
  • Upper and lower extremity musculoskeletal issues,
  • Increased spasticity,
  • Neurological issues: issues not specified,
  • Spasticity
  • Visceral issue
  • falls,
  • bone fractures,
  • lower extremity numbness, and
  • urinary tract infection,
  • these may or may not be applicable to the Keeogo.

Keeogo clinical studies have reported the following side effects:

  • Skin afflictions (i.e., chaffing, soreness, skin abrasion)
  • Muscle pain
  • Knee/ankle pain
  • Over extension of knee (i.e., ‘twinge’ in knee)
  • Fatigue
  • Bruising
  • Falls
  • Spasticity and other neurological issues
  • Loss of balance