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