1 - Intended Use
This device is intended to be used as a stress test device in a medical environment. The main goal of
the use of the devices is to create reproducible stress tests. With cycling ergometers typically workload
(watt) is imposed. With treadmills typically speed (km/h) and inclination (% grade) are imposed. This
product is designed both for manual operation and for control by external ECG-, pulmonary
equipment. Most likely this device will be used in conjunction with another medical device to obtain
other important physiological data, allowing a physician to evaluate a test subjects physical status.
The product may also be used for rehabilitation or active aging therapy. As such the intended use of
the device solely cannot be defined specifically.
The device has to be operated under the supervision of well-trained medical specialists (bachelor
and/or master degree in the medical field) in the field of use. This can be sport physicians, exercise
physiologists, (specialized) physical therapists or personal trainers. All users should read the IFU
(available in corresponding language) and should have knowledge and/or experience of exercise
protocols, contra indications for exercise test, knowledge of stop criteria and cleaning of the device.
When the medical device is executed with blood pressure measurement and/or SpO2 measurement
the intended use of the combination is extended with monitoring the diastolic and systolic blood
pressure and/or oxygen saturation of the blood as well as pulse rate of the subject.
The maintenance and service of the medical device has to be done by a well-trained service engineer
who is working for a Lode distributor and is specifically trained regarding the MD by the International
Service Coordinator of Lode.
2 - Validity
This manual covers all Katana Sport versions starting with the following article numbers:
9349xx | : S/N 20130001 and higher
Date of first issue: October 2015
