GE eBike with Control Terminal PC Operator's Manual page 40

General Information
The product eBike with Control Terminal PC bears
the CE marking CE-0459 (notified body GMED)
indicating its compliance with the provisions of the
Council Directive 93/42/EEC about medical devices
and fulfills the essential requirements of Annex I of
this directive. It is an MDD class IIa product.
The device fulfills the requirements of standard EN
60601-1 "Medical Electrical Equipment, Part 1:
General Requirements for Safety" as well as the
interference protection requirements of standard EN
60601-1-2 "Electromagnetic Compatibility – Medical
Electrical Devices".
The device is in radio-interference protection class B
in accordance with CISPR11/EN 55011.
The CE marking covers only the accessories listed in
the "Order Information" chapter.
The information given in this manual reflects
firmware version FW 1.0.
This manual is an integral part of the equipment. It
should be available to the equipment operator at all
times. Close observance of the information given in
the manual is a prerequisite for proper equipment
performance and correct operation and ensures
patient and operator safety. Please note that
information pertinent to several chapters is given
only once. Therefore, carefully read the manual
once in its entirety.
The symbol means: consult accompanying
documents. It indicates points that are of particular
importance in the operation of the equipment.
If unauthorized personnel opens the control terminal,
damaging the calibration sticker, any warranty claim
shall become void.
This manual reflects the equipment specifications and
applicable safety standards valid at the time of
printing. All rights are reserved for devices, circuits,
techniques, software programs, and names appearing
in this manual.
On request GE Medical Systems Information
Technologies will provide a detailed Service Manual.
The ergoline quality management system complies
with the standards DIN EN ISO 9001 and EN 46001.
4
General Information
The safety information given in this manual is
classified as follows:
indicates an imminent hazard. If not avoided, the
hazard will result in death or serious injury.
indicates a hazard. If not avoided, the hazard can
result in death or serious injury.
indicates a potential hazard. If not avoided, this
hazard may result in minor personal injury or
product/property damage.
To ensure patient safety and interference-free
operation and to guarantee the specified measuring
accuracy, we recommend using only original GE
Medical Systems Information Technologies
accessories. The user is responsible if accessories
from other manufacturers are used.
GE Medical Systems Information Technologies is
responsible for the effects on safety, reliability, and
performance of the device, only if
– assembly operations, extensions, readjustments,
modifications, or repairs are carried out by GE
Medical Systems Information Technologies or by
persons authorized by GE Medical Systems
Information Technologies,
– the device is used in accordance with the
instructions given in this manual.
eBike with Control Terminal PC
Danger
Warning
Caution
2018112-001 Revision B