Omron Healthcare Blood Pressure Monitor HXA-GCUFF-MLA User's Manual
Contents
1. s arm or other body parts Only connect this cuff to the specified products Risk of accident 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 ultra2. 2cm 1 2 1 inch 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 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 SpO 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
3. ize 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 Usage Temperature 5 40 C 41 104 F environment Humidity 15 85 RH no condensation Storage Temperature 20 60 C 4 140 F environment Humidity 10 95 RH no condensation
4. omRON GS CUFF 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 Manufacturer OMRON HEALTHCARE Co Ltd taal 53 Kunotsubo Terado cho Muko Kyoto 617 0002 Japan EU Representative 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 ODG U K OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH Gottlieb Daimler Strasse 10 68165 Mannheim GERMANY www omron medizintechnik de OMRON SANT FRANCE SAS 14 rue de Lisbonne 93561 Rosny sous Bois Cedex FRANCE CE 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 A ARTERY D MAX RANGE MIN INDEX WARTERY LATEX FREE OCA OCE Oud Tube length Tube length Arm Circumference 175mm 7inches 1 000 mm 39 inches SS_ HXA GCUFF SSLA HXA GCUFF SSLB 12 18 5 7 S_ HXA GCUFF SLA HXA GCUFF SLB 17 22 7 9 M_ HXA GCUFF MLA HXA GCUFF MLB 22 32 9 13 L_ HXA GCUFF LLA HXA GCUFF LLB _ 32 42 13 17 XL_ HXA GCUFF XLLA HXA GCUFF XLLB 42 50 17 20 ee D o EE RTERY RANGE 1
5. violet 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 Attachment diagram Range indicator of arm circumferences to help selection of the correct cuff size Range pointer and brachial artery alignment position Does not contain natural rubber latex Caution CE mark Manufacturer s icon 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 INDEX ARTERY W 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 INDEX ARTERY W is within the PEESI range If outside the range there will be greater error in the blood pressure value In this case use the appropriate cuff s
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