Hologic FluentPro Bedienungsanleitung Seite 100

Standard
Reference &
Symbol Symbol Number
EN ISO 15223-1
5.4.4
ISO 7000- 0434A
EN ISO 15223-1
5.4.5 and Annex B
ISO 7000-2725
FDA 21 CFR
801.109
ISO 7010-M002
ISO 7000, 2404
IEC 60417-6414
EN 50419
Directive
2012/19/EU
European Medical
Directive
93/42/EEC, Article
17 and Annex XII
European Medical
Device Regulation
2017/745, Annex V
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English
Fluent Pro Fluid Management System
Title of
Symbol Description of Symbol
Indicates that caution is
necessary when
operating the device or
control close to where
the symbol is placed, or
Caution that the current situation
needs operator
awareness or operator
action in order to avoid
undesirable
consequences
Indicates that natural
rubber latex was not
Product is not
used in the
made from
manufacturing of the
natural rubber
product, its container, or
latex
its
packaging.
Caution: Federal law
Prescription restricts this device to
use only sale by or on the order
of a physician
Refer to instruction
manual/ booklet.
To signify that the
IEC 60601-1
instruction
manual/booklet must be
read.
To indicate that the
Do not Stack items shall not be
vertically stacked.
To indicate that
WEEE; Waste
separate collection for
Electrical and
waste electric and
Electronic
electronic equipment
Equipment
(WEEE) is required.
Indicates the medical
device conforms to
European Medical
CE marking Directive 93/42/EEC
of conformity
and meets applicable
with notified
health, safety, and
body
environmental
identification
requirements. If the
number
mark is accompanied
by a number,
conformity is verified
by the indicated
notified body.
Supplementary Information
Standard
Reference &
Symbol Symbol Number
EN 15986 4.2,
Annex A and
Annex B
ISO 7000-2725
ISO 7000-2794
IEC 60417-5333
IEC 60529
IP21
IEC 60601-1
ISO 7000, 0623
EN ISO 15223-1,
5.1.2
Title of
Symbol Description of Symbol
Does not
Indicates the item does
contain
not contain phthalates
phthalates
(DEHP)
(DEHP)
To indicate the number
Packaging
of pieces in the
unit
package.
Identifies a type BF
Type BF
applied part complying
applied part
with IEC 60601-1
System is protected
Degrees of against solid objects of
protection 12.5mm or greater and
provided by protected against
enclosures vertically falling drops of
water condensation.
To indicate correct
This way up upright position of the
transport package.
Authorized
Indicates the
representativ
Authorized
e in the
representative in the
European
European Community.
Community
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