Instructions for Use
Resting & Stress ECG with seca
ct330/331 and seca diagnostic 5.9
1.1.2 Laws and regulations applicable to the product
Strict compliance with the safety instructions protects against personal
injury and property damage during device operation. These Instructions
for Use are designed to accompany the product and must be kept ready
to hand close to the device. As either the
operator or user of this device
you should have read and understood the Instructions for Use, in
particular the safety instructions.
Should serious incidents occur in connection with the product, they must
be reported by the user and/or patient to the manufacturer and the
competent authority of the member state in which the user and/or patient
is established.
This system is designed in accordance with Regulation (EU) 2017/745
on medical devices, Medical Device Regulation (MDR), Class IIa and
corresponds to protection class I or II, depending on the power supply
unit, or it is a device with an internal power supply, type BF or CF in
accordance with DIN EN 60601-1. Other devices that are part of the
system must comply with the standard for information technology
equipment (DIN EN 62368) or the standard for electromedical devices
(DIN EN 60601-1).
The electrical installations in the rooms in which the system is used must
meet the requirements of the applicable safety standards.
For users outside the Federal Republic of Germany, the respective
national accident prevention measures, regulations and requirements
apply.
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