Omron HEM-907 Instruction Manual

Instruction Manual
HEM-907
Small/Medium/Large size
adult arm cuff
S :HEM-CS19-PD
M :HEM-CR19-PD
L :HEM-CL19-PD
Manufacturer OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002
JAPAN
EU-representative OMRON HEALTHCARE EUROPE B.V.
Wegalaan 73, 2132 JD Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com
Importer in EU
Asia Pacific HQ OMRON HEALTHCARE SINGAPORE PTE LTD.
438B Alexandra Rd, #08-01/02
Alexandra Technopark, Singapore 119968
www.omronhealthcare-ap.com
Production OMRON HEALTHCARE Co., Ltd.
Mastsusaka Factory
Facility
1855-370, Kubo-cho, Matsusaka-shi, Mie, 515-8503
JAPAN
OMRON HEALTHCARE UK LTD.
Importer in the
United Kingdom Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK
and UK responsible
www.omron-healthcare.com/distributors
person
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Subsidiaries
www.omron-healthcare.com/distributors
OMRON SANTÉ FRANCE SAS
www.omron-healthcare.com/distributors
MADE IN JAPAN
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 products 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
prior 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.
Issue Date: 2024-02-08
IM-HXA-907-PDE-01-09/2023
3299311-1 A
Intended Use
Intended purpose
This cuff is intended to be used for a digital monitor that
measures blood pressure and pulse rate of adult patients.
Intended patients
Adult patient population
Intended users
Legally certified medical experts, such as doctor, nurse.
Limitation
Patient's arm circumference must be:
• HEM-CS19-PD: 17-22 cm
• HEM-CR19-PD: 22-32 cm
• HEM-CL19-PD: 32-42 cm
Type of use
This cuff is intended to be multiple patient multiple use.
The clinical features below can be obtained if this cuff is used
with specified OMRON blood pressure monitor.
• Clinical benefit
• Indication
• Contraindications
• Side effects
Clinical benefit
Patient's blood pressure can be measured non-invasively.
Indication
The device is used for healthy individuals and patients with
hypertension related diseases in medical professional environments
such as clinics, hospitals and physicians' office.
Contraindications
• DO NOT use this cuff on:
- An injured upper arm
- An upper arm under medical treatment
- An upper arm on which intravenous drip or a blood transfusion is
being performed
- An upper arm on which an SpO2 sensor, IBP catheter, or other
instrument is attached
- An upper arm with a shunt for hemodialysis
• DO NOT apply the arm cuff on your arm while on an intravenous drip
or blood transfusion.
• DO NOT use the device on infants, toddlers, children or persons who
cannot express themselves.
• 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.
Side effects
• Taking measurements more often than necessary may cause
bruising due to blood flow interference.
• Inflating to a higher pressure than necessary may result in bruising
of the arm where the cuff is applied.
• Stop using the device if the patient experiences skin irritation or
discomfort.
Indicates a potentially hazardous situation which, if not
Warning
avoided, could result in death or serious injury.
• Do not connect the air tube or cuff to the tubing of other devices
connected to the body.
• Do not use at extremely high temperature, high humidity, or high
altitude. Use only within the required ambient conditions.
• Properly connect the connectors
• Do not spray, pour, or spill liquids into or onto the cuff.
• If a cuff is used on some patients with an infection, treat the cuff as
medical waste. Otherwise, an infection may result.
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the
Precaution
user or patient, or cause damage to the equipment or
other property.
• Do not use thinner, benzene, or other solvents to wipe the cuff.
• Do not sterilize by autoclave or gas sterilization (EOG, formaldehyde
gas, high-concentration ozone, etc.).
• Use the appropriate cuff size to ensure correct measurements.
• Do not use the cuff if it is damaged or has holes.