Biocompatibility; Training Requirements - ACP OMNICYCLE ELITE User Manual

8
•
Traffic Jam - Varying the amount of force applied to the right and left pedals, the patient moves ("steers")
a car through traffic. The goal of the exercise is to drive the car without hitting and vehicles that appear
along the way. Overtaking or passing vehicles requires even distribution of forces applied to the right and
left pedals. An adjustable parameter called "Lane Preselection" enables the operator to select whether the
vehicles to be avoided will appear on the right, left, the center lane, or randomly. By selecting the
minimum level of difficulty, no other cars appear in adjacent lanes and the patient is simply required to
keep the car positioned in the center lane. The set resistance level remains constant regardless of the
pedaling speed.

Biocompatibility

•
All components and optional accessories of the Omnicycle
when using the device as intended, are designed to meet the biocompatibility requirements of the applicable
standards.

Training Requirements

Staff who have gained their skills and expertise by means of professional medical training, professional experience,
or by means of instruction/training by the manufacturer are deemed able to assess safety relevant regulations and
recognize potential risks.
•
Do not operate this device until the User Manual, has been carefully read and is understood.
•
Before you start the Omnicycle
Warnings and Precautions related to the safe use of the device.
•
Review and understand the section marked Operational Guidelines before operating the Omnicycle
•
Review and understand the proper use of the device controls and proper setup, features, and adjustment
requirements of the Omnicycle
•
A member of your ACP team will install and configure the device before training. ACP will conduct a train-the-
trainer style education process when the Omnicycle
•
During training:
Observe proper safety protocol by securing legs and arms sufficiently per user manual instructions
o
Start to exercise slowly
o
Increase to 70% of individual performance limit as you become more comfortable with the cycle
o
Avoid overstraining yourself
o
Patient Requirements
Patients are persons who have been instructed by staff on the correct and safe use of the Omnicycle
patient is responsible for the safe and correct use of the device.
COPYRIGHT 2010 - 2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
®
Elite exercise programs, consult the User Manual and understand the specific
®
Elite.
®
Elite is delivered.
OMNICYCLE
®
Elite, that the user might come in contact with
®
ELITE USER MANUAL
®
Elite.
®
Elite. The