GE TONOPORT V Operator's Manual page 4

General Information
 The product TONOPORT V bears the CE marking
CE 0482 (notified body MEDCERT GmbH)
indicating its compliance with the provisions of the
Council Directive 93/42/EEC about medical devices
(including amendment 2007/47/EC) and fulfills the
essential requirements of Annex I of this directive. It
has an internal power source and is an MDD class
IIa device. The device fulfills the requirements of the
Directive 2011/65/EU of the European Parliament
and of the Council.
 It has a type BF applied part.
 The product fulfills the requirements of the standard
EN/IEC 60601-1 "Medical Electrical Equipment, Part
1: General Requirements for Basic Safety and
Essential Performance" as well as the electromagnetic
immunity requirements of the standard EN/IEC
60601-1-2 "Medical electrical equipment – Collateral
standard: Electromagnetic compatibility –
Requirements and tests" and applicable amendments.
 The radio-interference emitted by this product is
within the limits specified in CISPR11/EN 55011,
class B.
 The CE marking covers only the accessories listed in
the "Order Information" chapter.
 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 which are of particular
importance in the operation of the equipment.
4
General Information
 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 Healthcare will provide a detailed
Service Manual.
 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, the
hazard may result in minor injury and/or product/
property damage.
 To ensure patient safety and interference-free
operation and to guarantee the specified measuring
accuracy, we recommend only original equipment
accessories as available through GE Healthcare
distribution. The user is responsible for the
application of accessories from other manufacturers.
TONOPORT V
Danger
Warning
Caution
2001589-085 Revision G