Omron HXA-GCUFF-MLA, HXA-GCUFF-SSLA, HXA-GCUFF-SLA, HXA-GCUFF-XLLA, HXA-GCUFF-LLA User Manual

SS (HXA-GCUFF-SSLA / HXA-GCUFF-SSLB) S (HXA-GCUFF-SLA / HXA-GCUFF-SLB) M (HXA-GCUFF-MLA / HXA-GCUFF-MLB) L (HXA-GCUFF-LLA / HXA-GCUFF-LLB) XL (HXA-GCUFF-XLLA / HXA-GCUFF-XLLB)

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

Production facility

OMRON (DALIAN) CO., LTD.

Dalian, CHINA

Subsidiary

OMRON HEALTHCARE UK LTD.

Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, U.K.

OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH

Gottlieb-Daimler-Strasse 10, 68165 Mannheim, GERMANY www.omron-medizintechnik.de

OMRON SANTÉ FRANCE SAS

14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE

This cuff fulfils the provisions of EC directive 93/42/EEC (Medical Device Directive).

IM-HXA-GCUFF-E-01-02/2013

5337486-1 AMade in China

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

· Read and understand “Notes on Safety” in these instructions, and the manual for the blood pressure monitor.

· The cuff has not been sterilized.

· Reusable.

· 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.

Notes on Safety

Warning

· 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:

- 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.

· 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.

(A)

Tube length :

SIZE

175 mm / 7 inches HXA-GCUFF-SSLA

HXA-GCUFF-SLA HXA-GCUFF-SLB

S M HXA-GCUFF-MLA HXA-GCUFF-MLB L HXA-GCUFF-LLA HXA-GCUFF-LLB

XL HXA-GCUFF-XLLA HXA-GCUFF-XLLB

Tube length : 1,000 mm / 39 inches

HXA-GCUFF-SSLB

Arm Circumference

12 - 18 17 - 22 22 - 32 32 - 42 42 - 50

(inch)(cm)

5 - 7 7 - 9

9 - 13 13 - 17 17 - 20

Caution

· 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.

· Do not use the cuff if it is damaged or has holes. It may burst during measurement.

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.

- 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 “ ” is directly over the brachial artery.

· The brachial artery is on the inner side of the patient’s upper arm.

3-3. Make sure that the “ ” is within the 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.

1 - 2 cm 1/2 - 1 inch

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

Usage environment Storage environment

Temperature: 5 – 40°C (41 – 104°F) Humidity: 15 – 85% RH (no condensation) Temperature: -20 – 60°C (-4 – 140°F) Humidity: 10 – 95% RH (no condensation)