Introduction; Important Safety Notice; Indications For Use; Restricted Sale - Bayer MEDRAD Spectrics Solaris EP Manual De Instrucciones

Important Safety
Notice

Indications for Use

Restricted Sale

Trademarks

Disclaimers

1 Introduction

This manual applies to the Integrated Continuous Battery Charging System
for use with MEDRAD
®
MR Injection Systems. Read all of the information contained in this section.
Understanding the information will assist you in operating the device in a safe
manner.
The MEDRAD Spectris Solaris MR Injector System must be fitted with the
MEDRAD Spectris Solaris EP Power Upgrade in order to employ the
Integrated Continuous Battery Charging System.
This device is intended to be used by medical professionals with adequate
training and experience in magnetic resonance imaging (MRI) studies.
The system is intended for use with the MEDRAD Spectris Solaris and the
MEDRAD Spectris Solaris EP MR injection systems. This system is not to be
used in any means for which the device is not indicated.
Federal (USA) law restricts this device to sale by or on the order of a
physician.
Bayer, the Bayer Cross, MEDRAD, Spectris Solaris, MEDRAD Spectris
Solaris, and MEDRAD Spectris Solaris EP are trademarks owned by and/or
registered to Bayer in the U.S. and/or other countries.
External wiring and modifications disclaimers: Bayer disclaims liability for any
modifications or interfaces with other equipment which are not in conformity
with the specifications and information contained within this manual.
Anyone who connects additional equipment to the device or configures a
medical system is responsible that the system complies with the relevant
requirements of IEC 60601-1. An accessory or equipment connected to the
device must be certified to either IEC 60601-1 (Operator or Patient
Environment Use) or, outside the patient environment, the level of safety must
be equivalent to equipment complying with their respective IEC or ISO safety
standards, e.g. IEC 62368-1 or IEC 60950-1 (Operator Environment Use
Only), and must comply with the relevant requirements according to IEC
60601-1. Consult Bayer for any modifications to the equipment.
Spectris Solaris and MEDRAD
5
1 Introduction
Spectris Solaris EP
®