Omron HEM-CS19 User manual

5335066-0E_HEM-CS19-E_IM_M02_221021.pdf
Issue Date: 2022-09-09
IM-HEM-CS-CR-CL19-05-09/2022
5335066-0E
Warning
Do not attach the cuff to an arm on which
intravenous drip infusion or blood transfusion is
being performed.
OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 JAPAN
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK
www.omron-healthcare.com/distributors
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
www.omron-healthcare.com/distributors
OMRON SANTÉ FRANCE SAS
www.omron-healthcare.com/distributors
OMRON HEALTHCARE SINGAPORE PTE LTD.
www.omronhealthcare-ap.com
Subsidiaries
Asia Pacific HQ
EU-representative
Importer in EU
Manufacturer
Made in Japan
Importer in the
United Kingdom
and UK responsible
person
Small size adult arm cuff Model:HEM-CS19
Medium size adult arm cuff Model:HEM-CR19
Large size adult arm cuff Model:HEM-CL19
Read all of the instructions in the manual before you operate
the unit and keep the manual near the unit at all the times for
future reference. Refer to the manual of your Blood Pressure
Monitor.
Disclaimer
Our company assumes no responsibility for the following:
1. Failures, damage, or injuries due to maintenance or
repair work performed by other than our company or
a company that we specify.
2. Failures or damage to one of our product caused by a
product of another manufacturer not delivered by us.
3. Failures, damage, or injuries due to maintenance or
repair work using a repair part other than a part that
we specify.
4. Failures, damage, or injuries caused by failure to
observe the safety instructions and operational
procedures given in this manual.
5. Use of the product in conditions that do not conform
to the product usage conditions indicated in this
manual, including installation.
6. Failures, damage, or injuries due to modification or
inappropriate repair of the product.
7. Failures, damage, or injuries due to natural calamities
such as fire, earthquake, flooding, or lightning.
Principles
1. The contents of this manual are subject to change
without notice.
2. Considerable care has been taken in the preparation
of this manual. In the unlikely event that an error or
other problem is discovered in the manual, please
contact us.
3. Unauthorized reproduction of all or part of this manual
is prohibited. Use other than individual (corporate)
use without the permission of our company is
prohibited by copyright.
Trademark
Product brand names shown in this manual are likely to be
the trademark or registered trademark of the company
concerned.
Requests from OMRON
• Do not attach the cuff to a patient under the use of a
pump oxygenator.
• Do not inflate the cuff without attaching it to an arm.
• Do not use a damaged cuff.
Instruction Manual
Cuff, Blood Pressure
Intended Use
This item is used only for Non-Invasive Blood Pressure
Monitor HEM-907/HEM-9000AI.
Using Population
Legally certified medical experts, such as doctor, nurse and
ME.
Patient Population
It is used on adult patients only.
Environment
The instrument is used in a vascular laboratory, clinic,
hospital, doctor’s offices, and other medical facilities where
the non-invasive peripheral vascular test is conducted.
Precautions for use
Warnings and cautions described in the instruction manual
should be observed.

Arm circumference
17 - 22 cm
22 - 32 cm
32 - 42 cm
Size of the arm cuff
Small size adult arm cuff
Medium size adult arm cuff
Large size adult arm cuff
• Please report to the manufacturer and the competent authority
of the Member State in which you are established about any
serious incident that has occurred in relation to this device.
How to Apply the Arm Cuff
1. Select a cuff appropriate for the patient.
• Use a suitable cuff size.
Otherwise, incorrect measurement may result.
2. Securely connect the air tube.
When the air tube is extended with an additional air tube
of 1.0m or 1.3m, the entire length will be 1.2m or 1.5m
respectively.
3. Have the patient ready to wear an arm cuff.
• The arm cuff must be attached on the right upper arm.
• If the arm cuff is wrapped over a thick cloth or the
patient's sleeve is rolled up and pressure is applied on
the arm, an accurate measurement result will not be
obtained.
4. Have the patient rest the arm with
the palm facing up.
5. Place the cuff on the upper part of the arm.
Align the artery position mark
on the arm cuff with the artery
on the inner side of the upper arm.
6. The lower edge of the arm cuff must be placed 1 to 2 cm
above the inner side of elbow joint.
• If the arm cuff is not securely wrapped, patient may feel
numbness on the arm, or an accurate measurement
result will not be obtained.
• The cuff does not have to be wrapped aligning the
edges. Still correct measurement will be obtained.
7. Keep the arm with the cuff
attached at the level of the heart.
Specifications
Maintenance Procedures
To clean the cuff, use a damp cloth moistened with water,
diluted disinfectant alcohol or diluted neutral detergent.
,
Product production date is integrated in the Lot number, which is placed
on the product and/or sales package: the first 4 digits mean year of
production, the next 2 digits mean month of production and the last 2
digits mean day of production.
CE Marking
Symbols description
Small size
adult arm cuff
Medium size
adult arm cuff
Large size
adult arm cuff
HEM-CS19 HEM-CR19 HEM-CL19
17 - 22 cm 22 - 32 cm 32 - 42 cm
111 x 357 mm
Pressure: 0 to 299 mmHg
Pressure: ±3 mmHg
Class I
-20 to +60 °C, 10 to 95 % RH (non-condensing),
700 to 1060 hPa
+10 to +40 °C, 15 to 90 % RH (non-condensing),
700 to 1060 hPa
Cuff, instruction manual
1 year
146 x 517 mm 174 x 649 mm
LOT number
Medical device
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Range pointer and brachial artery alignment
position
Artery mark
Range indicator of arm circumferences to help
selection of the correct cuff size
Reference catalogue number
Date of manufacture
Need for the user to consult the instruction
manual
Arm circumference
Product description
Model
Arm circumference
Cuff dimensions
(approximately value)
Cuff pressure range
Accuracy
Classification
Operating conditions
Storage/Transport
conditions
Package contents
Durable period
(Service life),
Warranty
INDEX
UKCA Marking
Unique device identifier