issue V8.3E from
01.07.2019
4
The DT80 vacuum system is a medical product according to guideline 93/42/EWG. It is
designed for operation with common ECG devices and offers improved safe ECG diagnostics
combined with increased economical efficiency.
The DT80 vacuum system suits for ECGs in rest as well as under physical exercise. Owing to
the secure fixing of the electrodes it is especially advantageous in ergometry.
The DT80 vacuum system is well suited for the practicing physician for “regular” use in
maximal 5 Exercise ECG or 20 Resting ECG per day. The system is not designed for high-use
ECG practice and continuous operation.
The vacuum electrodes are to be used according to standard measurement procedures. They are
fixed to the patient's body by means of a defined vacuum.
The DT80 vacuum system is qualified for ECG diagnostics of adults, teenagers and children
from the age of about 7 years (depending on body size).
Note
The DT80 vacuum system is dedicated only for using in hospital and in medical practice.
The DT80 vacuum system is not designed for continuous cardiac and circulatory monitoring
and emergency medicine.
The DT80 vacuum system is designed for temporary applications.
These operating instructions are considered to be a constituent of the device and are to be kept
therewith.
Exact observance of the operating instructions is a prerequisite for the proper operation of the
device and thus for the operator's safety.
Compliance with the safety instructions provides protection against injury and prevents undue
operation of the device.
Each user of this device or each person concerned with installation, maintenance, testing or
repair of the device should have completely read and understood these operating instructions
before they start working.
Appropriate juridical regulations of the MPG and the MPBetreibV are to be kept.
1. DT80 vacuum system
