28
6. Technical Data
•
This device fulfils the provisions of EC directive 93/42/EEC (Medical
Device Directive).
•
This blood pressure monitor is designed according to the European
• This OMRON product is produced under the strict quality syste
m of
OMRON HEALTHCARE Co. Ltd., Japan. The Core component for
OMRON blood pressure monitors, which is the Pressure Sensor, is
produced in Japan.
S
tandard E
N
1060
,
Non
invasive sph
y
gmomanometers
P
art 1:
General
R
e
qu
irements and
P
art 3:
S
upplementar
y
re
q
uirements for
electromechanical blood pressure measuring s
y
stems.
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as
P
C’s and mobile (cellular) telephones
,
medical devices in use ma
y
be susceptible to electromagnetic interference from other devices.
Electromagnetic interference ma
y
result in incorrect operation of the medical device and create a
potentiall
y
unsafe situation.
Medical devices should also not interfere
w
ith other devices.
In order to regulate the re
q
uirements for EMC (Electro Magnetic Compatibilit
y
)
w
ith the aim to
prevent unsafe product situations
,
the E
N
60601-1-2:2007 standard has been implemented. This
standard defines the levels of immunit
y
to electromagnetic interferences as
w
ell as maximum levels
of electromagnetic emissions for medical devices.
This medical device manufactured b
y
O
M
RON
conforms to this E
N
60601-1-2:2007
standard for both immunit
y
and emissions.
Ne
vertheless
,
special precautions need to be observed:
•
Do not use mobile (cellular) telephones and other devices
, wh
ich generate strong electrical or
electromagnetic fields
,
near the medical device. This ma
y
result in incorrect operation of the unit
and create a potentiall
y
unsafe situation.
Re
commendation is to keep a minimum distance of 7 m.
Verif
y
correct operation of the device in case the distance is shorter.
EUROPE
at the address mentioned in this instruction manual.
Documentation is also available at
www
.omron-healthcare.com
.
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)
This marking s
how
n on the product or its literature
,
indicates that it should not be
disposed of
,
w
ith other household
wa
stes at the end of its
work
ing life. To prevent
possible harm to the environment or human health from uncontrolled
wa
ste disposal
,
please separate this product from other t
y
pes of
and re
cy
cle it responsibl
y
to
promote the sustainable reuse of material resources.
Hou
sehold users should contact either the retailer
w
here the
y
purchased this product
,
or their local
government office
,
for details of
wh
ere and ho
w
the
y
can return this item for environmentall
y
safe
recyclin
g.
Business users should contact their supplier and check the terms and conditions of the purchase
contract. This product should not be mixed
wi
th other commercial
wa
stes for disposal.
HEM-7221-C1_C_M.book Page 28 Monday, November 22, 2010 1:19 PM
wa
stes
HEALTHCARE
Further documentation in accordance with EN60601-1-2:2007 is available at OMRON HEALTHCARE
