Introduction
Ch. 1
TRACKMASTER
8
TMX428 Owner’s Manual
317-160-284 Rev 6
February 2021
Contraindications:
Acute myocardial infarction within 2 to 3 days
Unstable angina not previously stabilized by medical therapy
Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
Symptomatic severe aortic stenosis
Uncontrolled symptomatic heart failure
Acute pulmonary embolus or pulmonary infarction
Severe pulmonary hypertension
Acute myocarditis or pericarditis or endocarditis
Acute aortic dissection
High-grade AV blocks
Severe hypertension (SBP greater than 200 mm Hg, DBP greater than 110 mm Hg, or
both)
Inability to exercise given extreme obesity or other physical/mental impairment
Regulatory and Safety Information
This section provides information about the safe use and regulatory compliance of this system.
Familiarize yourself with this information, and read and understand all instructions before
attempting to use this system. The system was designed and manufactured to the appropriate
medical regulations and controls.
The purchaser is solely responsible for the training, instruction, supervision and safety of all users
of the TRACKMASTER® treadmill, and to use it as intended by the manufacturer. This device is
intended to be used as a motion appliance to facilitate cardiac or VO2 medical evaluation.
NOTE:
Disregarding the safety information provided in this manual is considered abnormal use
of this system and could result in injury, loss of data, and void any existing product warranties.
Reporting of serious incident
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient is
established.
•
To report to manufacturer:
Email: tmservice@full-vision.com
•
Please provide the following information:
•
The model number of the device as stated on its identification plate
affixed on the device
•
The serial number of the device
•
Date of incident
•
Description of incident, including any patient or user impact/injury
•
Your contact information (facility, address, contact name, title, and
telephone number)
Summary of Contents for TRACK MASTER TMX428
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