1 - Intended Use
This device is intended to be used as a stress test device in a medical environment, primarily to create
reproducible stress tests and measuring the effect. With this device typically workload (watt) is
imposed.
The intended use is further enhanced to monitor:
- the diastolic and systolic blood pressure, and/or
- oxygen saturation of the blood, and/or
- pulse rate of the test subject,
when the measurement is executed with blood pressure and SpO2 measurement.
This device is designed for both manual control and external control by means of ergometry software,
external ECG and pulmonary equipment.
The device has to be operated under the supervision of well-trained medical specialists1 in the field of
use.
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.
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.
1These specialists hold a bachelor and/or master degree in the medical field, they can be sport
physicians, exercise physiologists, or (specialized) physical therapists.
2 - Precautions
Read all warnings posted on the device.
Inspect the device for worn or loose components prior to
use. Tighten / replace any loose or worn components prior to
use.
