Use Instructions

SpiroSphere
®
ECG Instructions for Use
Page 109/136
Version 02.02 • 04AUG2022
General Safety Precautions
The Instructions for Use describes the present state of the device/system,
including software and accessories, with regard to the fundamental requirements of the
MDD 93/42/EEC and MDR (EU) 2017/745.
Exact adherence to the instructions issued is a prerequisite for perfect and intended
functioning of ERT instruments.
The Instructions for Use is regarded as part of the instrument, and should always be kept
on hand.
Deviation from Intended Use
Any non-observance of the procedures (such as preparation for a measurement
and methods, disinfection procedures, use of accessories and replacement
parts etc.) described in the Instructions for Use results in a deviation from
intended use.
In case of a deviation from intended use, the operator/user has to supply proof
of meeting all corresponding fundamental requirements.
The operator/user is responsible for performing the conformity assessment
correctly and is also completely liable for defective products - i.e. the operator/
user is liable for his/her modication of the medical product.
ERT only guarantees for the safety, reliability and functionality of the instrument if
- installation, extension, modications, and repairs are exclusively carried out by
personnel authorized for these tasks by ERT.
- the room in which the equipment is operated complies with the country-specic
installation standard.
- the unit can be plugged into a socket with protective conductor system.
- the ambient conditions at the place of installation are suitable for the unit.
- the unit is used according to the Instructions for Use.
Unpack your medical device. Please check if the unit is damaged. If so, do not use it and
return it for a replacement.
Patient Safety according to EN 6611
This medical device safely insulates the subject from the mains power supply as required in
the safety regulations on leakage current according to EN 60601-1, Type BF. Nevertheless, a
subject environment must be dened. The subject has to keep a distance of at least 1.5 m from all
open interfaces and connectors of the SpiroSphere Main Unit to avoid any contact with electrical
voltage.
The physician/operator must not touch any voltage-carrying parts (e.g. USB Plug, Ethernet Plug)
and the subject at the same time.