Instructions for Use
Intended Use
Medical Purpose
This product is an upper arm cuff for OMRON non-invasive blood pressure monitors.
Intended User
This product is to be used by doctors, nurses, technicians, or other medical professionals.
Patient Population
This device is intended for use on adults and children.
Environment
The instrument is designed for use in physicians’ offices, hospitals, clinics and other medical
facilities.
Precautions for Use
SS (HXA-GCUFF-SSLA / HXA-GCUFF-SSLB)
(HXA-GCUFF-SLA / HXA-GCUFF-SLB)
M (HXA-GCUFF-MLA / HXA-GCUFF-MLB)
(HXA-GCUFF-LLA / HXA-GCUFF-LLB)
S
L
XL (HXA-GCUFF-XLLA / HXA-GCUFF-XLLB)
· Read and understand “Notes on Safety” in these instructions, and the manual for the blood pressure
monitor.
· The cuff has not been sterilized.
· Reusable.
OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 Japan
· This product is a consumable supply item. It will be replaced free of charge only if found to be
damaged or defective when the package is opened.
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
Production facility
OMRON (DALIAN) CO., LTD.
Dalian, CHINA
Notes on Safety
Warning
Subsidiary
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, U.K.
· Do not bend cuff tube during inflation and deflation, particularly after a change of body position.
· Do not wrap the cuff on the following parts:
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Gottlieb-Daimler-Strasse 10, 68165 Mannheim, GERMANY
- An upper arm on which intravenous drip or a blood transfusion is being performed.
- An upper arm on which SpO2 sensor, IBP catheter, or other instrument is attached.
- An upper arm with a shunt for hemodialysis.
· If frequently performing NIBP measurement using a cuff over an extended period of time,
periodically check the patient’s circulation. In addition, wrap the cuff as indicated in the
cautionary points.
OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE
· Ensure that the cuff tube does not become wrapped around the patient’s arm or other body parts.
· Only connect this cuff to the specified products. Risk of accident.
This cuff fulfils the provisions of EC directive 93/42/EEC (Medical Device Directive).
IM-HXA-GCUFF-E-01-02/2013
Made in China
5337486-1 A
Caution
(A)
· If a doctor has indicated that the patient has hemorrhagic diathesis or hypercoagulability, check
the condition of the arm after measurement.
· Make sure the connections are tight. An air leak will prevent correct measurement.
· Use the appropriate cuff size to ensure correct measurements. If too large a cuff is used, the
measured blood pressure value tends to be lower than the actual blood pressure. If too small a cuff
is used, the measured blood pressure value tends to be higher.
· Do not sterilize by autoclave, ultraviolet irradiation, radiation, gas sterilization (EOG,
formaldehyde gas, high concentration ozone, etc.). In addition do not clean or sterilize using a
method other than that indicated in “Cleaning and Storage” directions, and do not wash. The cuff
may become deformed and correct measurement will not be possible.
· Do not store in a location where corrosive gas is generated. The cuff may become deformed and
correct measurement will not be possible.
· Do not allow any liquids inside the cuff. If a liquid gets in the cuff, dry the inside well. If used
with even a slight amount of liquid in the cuff, the liquid may enter the monitor to which the cuff
is connected and cause the monitor to malfunction.
· Do not inflate the cuff when it is not wrapped on the upper arm. This may damage the cuff.
· Do not leave in direct sunlight or ultraviolet light. This may damage the cuff and cause it to
deteriorate.
· The cuff is a consumable product. If it becomes damaged, replace it. Correct measurement may
not be possible with a damaged cuff.
1.
Arm Circumference
Tube length :
175 mm / 7 inches
Tube length :
1,000 mm / 39 inches
SIZE
(cm)
(inch)
5 - 7
· Do not use the cuff if it is damaged or has holes. It may burst during measurement.
SS HXA-GCUFF-SSLA HXA-GCUFF-SSLB 12 - 18
7 - 9
S
M
HXA-GCUFF-SLA HXA-GCUFF-SLB 17 - 22
HXA-GCUFF-MLA HXA-GCUFF-MLB
HXA-GCUFF-LLA HXA-GCUFF-LLB 32 - 42
9 - 13
13 - 17
17 - 20
22 - 32
L
42 - 50
XL HXA-GCUFF-XLLA HXA-GCUFF-XLLB
2.
Description of icons (Fig. A)
1 Attachment diagram
2 Range indicator of arm circumferences to help selection of the correct cuff size.
3 Range pointer and brachial artery alignment position
4 Does not contain natural rubber latex
5 Caution
6 CE mark
7 Manufacturer’s icon
8 Refer to manual
How to Use the Cuff
1. Select the cuff size that is appropriate for the circumference.
· There are two cuff tube lengths.
3.
- 175 mm / 7 inches (HXA-GCUFF-**LA)
- 1,000 mm / 39 inches (HXA-GCUFF-**LB)
For cuff tube lengths that can be connected, see the manual for the blood pressure monitor.
2. Connect the cuff to the blood pressure monitor or cuff hose, and lock clockwise.
· If a cuff hose is used, use an OMRON specified hose.
3-1. Make sure the cuff tube is not bent.
· The cuff tube should be on the peripheral side.
3-2. Wrap the cuff so that the
· The brachial artery is on the inner side of the patient’s upper arm.
3-3. Make sure that the ” is within the
“
” is directly over the brachial artery.
“
range.
· If outside the range, there will be greater error in the blood pressure value. In this case, use
the appropriate cuff size.
· Attach the cuff so that the bottom edge is 1 - 2 cm (1/2 - 1 inch) from the inner side of the
elbow joint.
· The cuff should be wrapped to a tightness that roughly allows two fingers to be inserted
under the cuff.
4. During measurement, keep the brachial artery on which the cuff is wrapped at the same height
as the right atrium of the heart.
Cleaning and Storage
· Wipe clean on the surface of the cuff with a cloth moistened with a 70 v/v% dilution of isopropyl
alcohol, or a 80 v/v% or less dilution of disinfection ethanol (ethyl alcohol).
· For disposal, have a company that specializes in medical waste disposal dispose of the cuff.
· Usage environment / storage environment
1 - 2 cm
1/2 - 1 inch
Temperature: 5 – 40°C (41 – 104°F)
Usage
Humidity: 15 – 85% RH (no condensation)
Temperature: -20 – 60°C (-4 – 140°F)
Humidity: 10 – 95% RH (no condensation)
environment
Storage
environment
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