4. Error Messages and T roubleshooting
4.1 Error Messages
4.2 T r oubleshooti ng
5. Maintenance and S torage
5.1 Maintenance
T o protect yo ur devi ce from dam age, pleas e observe the follow ing:
• S tore the devi ce and the co mponents in a clean, safe
locat ion.
• Do not u se any ab rasive or volati le cleaner s.
• Do not wa sh the devic e and any components or im merse
them in wat er .
• Do not u se petrol, th inners or similar solvents to clean the
device.
• Use a soft and dry cloth , or a soft and moistene d cloth and
neutral soap to cl ean on the monitor and the arm cuff.
• Changes o r modifica tion not app roved b y the manu facturer
will void the user warranty . Do not disassem ble or attemp t to
repair the dev ice or co mponents. Cons ult your au thorised
OMRON retail outlet o r distributor .
Calibration and Servi ce
• The accur acy of this blood pres sure moni tor has been
careful ly tested an d is design ed for a long service li fe.
• It is gene rally recomme nded to hav e the dev ice inspec ted
every 2 years to ens ure correc t function ing and ac curacy .
Plea se co nsult your au thori sed OMRO N ret ail ou tlet or
distributo r .
5.2 Stor age
Keep the device in it s storage case when not in use.
1. Unplug th e air plu g from the ai r jack.
2. Gently fold the air tub e into the arm c uff.
Note: Do not bend or crease the air tube exce ssively .
3. Place th e monitor and the arm cu f f in the
storag e case.
Do not store the device in the following situations:
•If the dev ice is wet.
•Locations exp osed to extreme temperatures,
humidity , di rect sunlight, dust or corrosive
vapours.
•Locations exp osed to vibrations, shock s or
where it will be at an angle.
5.3 Optional Medi cal Accessorie s
(within the scope of EC Me dical Device Directive 93/42/EE C)
Using the Optional AC Adapter
1. Insert the AC adap ter plug
into the A C adapt er jack on
the rear side of the monito r .
2. Plug the AC adapter i nto an
electric al outlet .
T o disconnect the AC adapter , unplug the AC adapter from the electrical outlet
first and then remove the AC adapter plug f rom the monitor .
6. S pecifications
Notes:
• These specific ations are subject to c hange without notice.
• In the clinical v alidation study , the 5th phase was used on 85 s ubject s for
determination of diastolic blood pressure.
• This device has not been validated for u se on pregnant patients.
• This device fulfils the provisions of EC directive 93/42/EE C (Medical Device
Directive).
• This blood pressure monitor is designed according to t he European St andard
EN1060, Non-invasive sphygmomanomet ers Part 1: General Requirements and
Part 3: Supplementary requirem ents for electromec hanical blood pressure
measuring syst ems.
• This OMRON product is produced under the strict quality system of OMRON
HEAL T HCARE Co. Ltd. , Japan. The Core component for OMRON blood pressure
monitors, which is the Pressure Sensor , is produced in Jap an.
7. W arranty
Thank you for buying an OMRON product. This product is constructed of high
quality materials and great care has been t aken in its manufacturing. It i s designed
to give you every satisfaction, provided that it is properly operated and maint ained
as described in the instruction manual.
This product is guaranteed by OM RON for a period of 3 years after the date of
purchase. The pr oper construction, workm anship and materials of t his product is
guaranteed by OMRON. During this period of guarantee OMRON will, without
charge for labour or parts, repair or replace the def ect product or any defective
parts.
The guarantee does not cover any of t he following:
a. Tr ansport c osts and risks of transport.
b. Costs for repairs and / or defects resulting from re pairs done by unauthorised
persons.
c. Periodic ch eck-ups and maintenance.
d. Failure or w ear of optional parts or other attachments other than the m ain device
itself, unless explicitl y guaranteed above.
e. Costs arising due t o non-acceptance of a claim (those will b e charged for).
f. Damages of any kind including personal caused accident ally or from misuse.
g. Calibration service is not included within the guarantee.
h. Optional parts have a one (1) year warranty f rom date of purchase. Optional parts
include, but are not limited to the foll owing items: Cuff and Cuff T ube, AC Adapter .
Should guarantee ser vice be required please apply to the dealer whom the produ ct
was purchased from or an authorised OM RON distributor . For the address refer to
the product packaging / lit erature or to your specialised retailer .
If you have difficulties in finding OMRON customer services, c ont act us for
information.
www .omron-healthcare.com
Repair or replacement under the guarantee does not give rise to any extension or
renewal of the guarantee period.
The guarantee will be granted only if the complete product is returned together with
the original invoice / cash ticket issued to the consumer by the retailer .
Made in Vietnam
Error Display Cause Solution
Irregular heartbeats are
detected.
Remove the arm cuff. W ait 2 - 3
minutes and then take another
measurement. Repeat the steps
in section 3.3. If this error
continues to appear , contact
your physician.
Arm cuff is applied too loosely .
Apply the a rm cuff tighter .
Refer to section 3.1.
The batteries are low.
Y o u should replace the batteries
with new ones ahead of time.
Refer to section 2.1.
The batteries are ex hausted.
Y o u should replace the batteries
with new ones at once.
Refer to section 2.1.
Air plug disconnected.
Insert the p lug securely .
Refer to section 3.1.
Arm cuff is applied too loosely .
Apply the a rm cuff tighter .
Refer to section 3.1.
Air is leaking from the arm cuf f.
Replace the cuff with a new one.
Refer to section 5.3.
Movemen t during measurement
and the arm cuff has not been
inflated suffi ciently .
Repeat measurement. Remain
still and do not talk during
measurement.
Refer to section 3.3.
If “E2” appear s repeatedly ,
inflate the cuff manually until it is
30 to 40 m mHg above your
previous measur ement result.
Refer to section 3.3.
The arm cuff was inflated above
299 mmHg wh en inflating the
cuff manually .
Do not inflate the cuff above 299
mmHg .
Refer to section 3.3.
Movemen t during measurem ent.
Repeat measurement. Remain
still and do not talk during
measurement.
Refer to section 3.3.
Clothing is interfering with the
arm cuff.
Remove any clothing interfering
with the arm cuff.
Refer to section 3.1.
Device error .
Contact your OMRON r etail
outlet or distributor .
Proble m Cause Soluti on
The measurement
result is extremely
high (or low).
Arm cuff is applied t oo
loosely .
Apply the arm cuff tighter .
Refer to section 3.1.
Movement or talking during
measurement .
Remain still and do not talk
during measurement.
Refer to section 3.3.
Clothing is interfering wi th
the arm cuf f.
Remove any clothing
interfering with the arm cuff.
Refer to section 3.1.
Arm cuff pressure
does not rise.
The air con nector is not
securely connected into the
air jack.
Make sure that the air tube
is connected securely .
Refer to section 3.1.
Air is leaking from the arm
cuf f.
Replace the arm cuff with a
new one.
Refer to section 5.3.
Arm cuff deflates too
soon.
T
he arm cuff
is loose.
Apply the cuf f correct ly so
that it is firmly wrapped
around the arm.
Refer to section 3.1.
Cannot measure or
the results are too low
or too high.
The arm cuff has not been
inflated sufficiently .
Inflate the cuff so that it is 3 0
to 40 mmHg above your
previous measurement
result.
Refer to section 3.3.
Nothing happens
when you press the
buttons.
The batteries are empty .
Replace the batteries w ith
new ones.
Refer to section 2.1.
The batteries have been
inserted incorrectly .
Insert the batteries with the
correct ( +/-) polarity .
Refer to section 2.1.
Other problems.
• Press the ST AR T/STOP button and repeat
measurement.
• Replace the batteries with new ones.
If the problem continues, contact your OMRON r et ail outlet
or distributor .
Medium arm cuff Large arm cu ff AC adapter
Arm circum ference
22 - 32 cm
Arm circ umference
22 - 42 cm
CM2
9513256-6
(Model: HEM-C R24)
Easy Cuff L
991 1729-4
(Model: HEM-RML31)
Adapter S
9515336-9
Adapter UK
9983666-5
Product description Automatic Blood Pres sure Monitor
Mode l OMRON M2 (HEM-71 21-E)
Display LCD Digit al Display
Measurement
method
Oscillometric method
Measurement range Pressure: 0 t o 299 mmHg
Pulse: 40 to 18 0 beats/min.
Accuracy Pressure: ±3 mm Hg
Pulse: ±5% of display reading
Infla tion Fuzzy-logic controlled by electric pump
Deflation Automatic press ure release valve
Memory 30 measurements
Rating DC6V 4W
Power sour ce 4 “AA” batteries 1.5V or optional AC adapter
(Adapter S-9515336-9, I NPUT AC100-240V 50/60Hz 0.12A)
(Adapter UK -
9983666-5
, INPUT A C100-240V 50/ 60Hz 15V A)
Battery life Approx. 1000 measurements (using new alkaline bat teries)
Applied part
= T ype BF
Protection against
electric shock
Internally powered ME equipment (When using only the
batteries)
= Class II ME equipment (Optional AC adapter)
Operating
temperature/
humi dity
+10 to +40°C / 30 to 85% RH
Storage
temperature/
humi dity/
air pressure
-20 to +60°C / 10 to 95% RH / 700 to 1060 hPa
IP classification IP 20
We ight Monitor: Approx. 250 g without batteries
Arm cuff: Approx. 130 g
Outer dimensions Monitor: A pprox. 103 (w) m m x 80 (h) mm x 129 (l) mm
Arm cuff: Approx. 145 mm x 466 mm
Cuff circumference 22 to 32 cm
Cuff/ T u be material Nylon, polyeste r , polyvinyl chloride
Package contents Monitor, arm cuff, instruction manual, storage case,
battery set, blood pressure pass
Important information regarding Electro Magn etic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular)
telephones, medical devices in use may be s usceptible to electromagnetic
interference from other devices. Electromagnetic interference may result in
incorrect operation of the medical devi ce and create a potentially unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with
the aim to prevent unsafe product situations, the E N60601-1-2:2007 standard has
been implemented. This standard def ines the levels of immunity to
electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
This medical device m anufactured by OMRON HEAL THCARE conforms to this
EN60601-1-2:2007 standard fo r both immunity and em issions.
Nevertheless, special pr ecautions need to be observed:
• Do n ot use mobile (cellular) telephones and other devices , which generate strong
electrical or electromagnetic fields, near the medical device. This may result i n
incorrect operation of the device and create a pot entially unsafe situation.
Recommendation is to keep a minimum distance of 7 m. V erif y correct operation
of the de vice in case the distance is shorter .
Further documentation in accordance with EN60601-1-2:2007 is available at
OMRON HEAL THCARE EUROPE at the address mentioned in this instruction
manual.
Documentation is also available at www.omron-healthcare.com
.
Corr ect Disp osal of This Pr oduct
(W aste Electrical & Electroni c Equipment)
This marking shown on the product or its literature, indicates that it
should not be dispos ed of, with other household was tes at the end
of its working life. T o prev ent possible harm t o the environment or
human health from uncontrolled waste disposal, please sep arate
this product from other types of wastes and rec ycle it responsibly to
promote the sustainable reuse of material resources.
Household users should contact either the ret ailer where they purchased this
product, or their local government of fice, for details of where and how they can
return this item for environmentally safe recycling.
Business users should contact their supplier and check the term s and conditions of
the purchase co ntract. This product should not be mixed with other commercial
wastes for disposal.
Manufacturer
OMRON HEAL THCARE Co., Ltd.
53, Kun otsubo, T e rado-cho , Muko, Kyoto ,
617-000 2 JAP AN
EU-representative
OMRON HEAL THCARE EUROPE B.V .
Scorpius 33, 21 32 LR Hoofd dorp, TH E NETHE RLANDS
www.omron-healt hcare.com
Prod uction f acility
OMRON HEAL THCARE MANUF ACTURING VIETNAM CO., LT D.
Binh Duo ng Province, VIE TNAM
Subs idiary
OMRON HEAL THCARE UK L TD.
Opal Drive, Fo x Milne, Milton Keynes, MK15 0DG , U.K.
OMRON MEDIZINTECHNIK HANDEL SGESELLSCHAFT mbH
Gottlieb-Da imler-S trasse 10 , 68165 M annheim, G ERMANY
www.omron-heal thcare.de
OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne , 93561 Ro sny-sous-Bois Cedex, FRANCE