Omron HBP-1300 manuale d’uso

Professional B l o o d Pressure Monitor HBP-1300 Instruction Manual T able of Contents Introduction Intended Use.............................................. 1 Exemptions ................................................ 1 Notes on Safety ......................................... 2 W arnings and Cautions .............................. 3 Using the U[...]

HBP-1300.book Page 0 Wednesday, March 7, 2012 9:28 AM[...]

1 Introduction Introduction Intended Use Medical Purp ose The devic e is a digit al monitor in tended for use in mea suring bloo d pressure an d pulse rate in adult an d pediatric p atient population w ith arm circum ference ra nging from 5 inc hes to 20 inche s (from 12 cm to 50 cm). Intended U ser This device should be us ed by a me dical profess[...]

2 Notes on Safe ty The warning signs and symbol examples indicated below are intended to en sure safe use of the product and prevent damage and injury to you and ot hers. The signs and sym bols are explained below . Safety Symbols used in this Instructi on Manual W arning Indicates t he matters in which deat h or severe bodily dama ge may arise as [...]

3 Introduction W arnings and Cautions Usage warnings an d cautions Setup Wa r ni n g Caution Do not use the cuff or AC adapter to lift the unit, it can also cause the unit to malfunction. If the unit has broken down, contact OM RON HEAL THCARE Customer Service. Do not use in combination with a hyperbaric o xygen therapy device, or in an environment[...]

4 Before use / dur ing use Wa r ni n g The unit complies with the EMC standard (IEC60601- 1-2). As such, it can be used simultaneously with multiple medical instruments. However , if instruments that generate noise such as an electric scalpel or a microwave therapy device are near t he unit, check the operation of the unit during and after use of t[...]

5 Introduction Caution Before using the unit, verify that none of the following apply to the patient: - Poor peripheral circulation, noticeably low blo od pressure, or low body temperature (there will be low blood flow to the measurement position) - The patient uses an artificial hear t and lung (there will be no pulse) -A n S p O 2 sensor and the [...]

6 Cleaning Wa r ni n g Caution Maintenance and inspection Wa r ni n g When cleaning the unit, turn off the power and disconnect the AC adapter from the unit. After cleaning the unit, make sure it is comp letely dry before conne cting to a power outlet. Do not spray , pou r , or spill liquids into or ont o the unit, accessories, connectors, buttons,[...]

7 Introduction W arn ings and cautions for safe measurement Optional rechargeable battery Wa r ni n g Caution If battery fluid comes in contact with the eye, imm ediately flush with copious amounts of water . Do not rub. Seek medical attention immediately . Do not use the optional battery pack in any other de vice besides this unit. Do not throw in[...]

8 Non-Invasive Blood Press ure (NI BP) measurement Wa r ni n g Caution If a cuff is used on a patient with an infection, treat the cuff as medical waste, or sterilize before reuse. If frequently performing NIBP measurement usin g a cuf f over an extended period of time, periodically check the patient's circulation. In addition, wrap the cuff a[...]

9 Introduction Note: Setup • Read and understand the manual for each optional accessory . This manual does not con t ain cautionary information for optional accessory . • Exercise caution with the cabl es and arrange so that the patient does not become entangled or bound. Before use / during use • Check the following after turning on the powe[...]

10 Using the Unit Component s of the Product Before using the unit, make sure that n o accessories are missing and that the unit and accessories are not damaged. If an accessory is missing or there is d amage, please cont act OMRON HEAL THCARE Customer Service. Main unit St andar d accessories Optional Acce ssories Instructio n Manual GS CUFF L and[...]

11 Using the Unit Caution Only OMRON GS CU FF can be used with this device. Features of the Product The OMRON HBP-1300 is an affordable professional bl ood pressure unit that is clinically proven accurate and provides fast, reliable results and is easy to use. Key features, benefits, look • 5 cuf fs a vailable - (SS: 5 to 7 inches, S: 7 to 9 inch[...]

12 Features / Funct ions of Unit Front and back o f unit Meaning of the Symbols 1 [ST ART/STOP ] button (Power ON/OFF) Power ON / Measure blood pres sure Press when the power is off to turn on the power an d st art blood pres sure measur ement. During inflation or measurement , press to stop. Power OFF Hold down at le ast 3 seconds to turn off the [...]

13 Using the Unit LCD Display * O nly when the optional battery is installed. 1 SYS Displays systolic bl ood pressu re. 2 DIA Displays diast olic blood pressure. 3 Pulse Displays the pulse r ate. 4 Pulse synchroniz ation icon Flashes in syn chronization with the pulse du ring measurement. 5 Irregular pu lse wave icon Lights in the measure ment resu[...]

14 Inst alling the Op tional Battery Pack Caution Do not short the positive and negative terminals of the optional battery pack with a wire or other metal object. If battery fluid comes into contact with t he skin or clothes, immediately rinse with water . 1. Make sure the AC adapt er has been disconnecte d. 2. Remo ve the two screws from the top o[...]

15 Using the Unit Battery charging Battery level Connecting the AC Adapt er AC power V erify that the power outle t supplies the specified voltage and frequency (100 - 240 V AC, 50/60 Hz). Connect the AC adapter to the DC ja ck on the unit and the power outlet. Note: When the optional battery p ack is installe d If there is no problem with the foll[...]

16 System Settings The system settings are divided into two modes, "Menu Mode" and "Utility Mode". Menu Mode "Menu Mode" allows you to configure the "Initial Infl ation Pressure V alue" and "Auscultation Mode" settings. 1. Press the [MODE] button. The "Initial Inflation Pressure V alue" se[...]

17 System Settings Utility Mode "Utility Mode" allows you to con figure the "Auto Po wer Of f" and "Pressure Accuracy Confirmation" setting. 1. Confirm that t he device is s witched off. 2. Hold down the [MODE] button until the "Auto Power Off" setting screen appears. The "Initial Inflation Pressure V al[...]

18 Non-Invasive Blood Pressure (NIBP) Measurement Non-Invasive Pressure Measur ement Principles Oscillometric method The beat in the pulsation generated by the contracti on of the heart is captured as the pressure inside the cuff to measure the blood pressure. If the cuff wrapped around the upper arm is pressurized sufficiently , the blood flo w st[...]

19 Non-Invasive Blood Pressure (NIBP) Measurement Cuff Selection and Connection Selecting the cuff Caution • Do not use the cuf f if it is damage d or has holes. • Use the appropriate cuff size to ensure correct measurements. If too large a cuf f is used, the measured blood pressure value tends to be lower than the actual blood pressure. If too[...]

20 Applying th e Cuff to the Patient 1. Wrap on a bare arm or over thin clothing. Wrap the cuff on a bare arm or over thin clothing. Thick clothing or a roll ed up sleeve will cause inaccurate blood pressure measurements. The device can be used on either the right or left arm. 2. Align the artery mark "INDEX ARTER Y" with the brachial art[...]

21 Non-Invasive Blood Pressure (NIBP) Measurement Caution Make sure the cuff is wrapped in the correct ar m position and is at the same height as the heart. A difference of 4 inches (10 cm) in height ma y caus e a variation in the blood pressure value of up to 7 - 8 mmHg. Note: • If measurement is difficult due to arrhythmia, use a different bloo[...]

22 Irregular pulse wave detection func tion If the pulse wave interval becomes irregular duri ng measure ment, the irregular pulse wave detection icon will light to notify you. Body movement de tection function If body movement is detected during measurement, def lation stops for 5 seconds. T he irregular pulse wave icon appears in the measurement [...]

23 Non-Invasive Blood Pressure (NIBP) Measurement Stopping t he Measurement T o stop measurement while measurement is in progress, press [ST A R T/STOP] button. Displaying Last Reading The previous measurement value (systolic blood pressur e, diasto lic blood pressure, and pulse rate) and whether or not an irregular pulse w ave was detect ed can be[...]

24 Maintenance Maintenance Inspectio n and Safety Management The HBP-1300 must be maintained to ensure functionality and to secure the safety of patients and operators. Daily checks and maintenance should be performed by the operator . (page 25) In addition, qualified personnel are necessary to maintain the performance and the safety , and to condu[...]

25 Maintenance Check before Use Before conducting safety checks, be sure to impl ement the items in the "Device Maintenance" and "Accessory Care" sections. (page 24) Before turn ing on the power Before turning on the power , check for the following External appearance ■ The device or accessories are not defo rmed due to fallin[...]

26 T roubleshooting The power does no t turn on Cause Soluti on If the unit i s being powered by the batte ry , the bat tery is not installe d or the charge is deple ted. Insert battery or replace with a new battery (page 14). Internal p art failure Disconnec t the AC adap ter , remove the ba ttery , and contact OMRON H EAL THCARE Custo mer Service[...]

27 Maintenance Abnormal measure ment value Cause / solut ion The causes belo w are possible. Check t he p atient by palpatio n and then repeat measuremen t. • Body movemen t (chills or other trembl ing) • Arrhythmia. • Noise in th e cuff - A ne arby person touched th e p atient. - Car diac massage was being perf ormed. The measurement value i[...]

28 List of Error Codes The alarm lamp flashes when a medium-priority alarm occur s , and lights steadily when a low-priority alarm occurs. T o clear an alarm, press any button. ■ If a low-priority alarm and a medium-priority alarm occur at the same time, t he medium-priority alarm is displayed. If the alarms are the same priority level, the erro [...]

29 Maintenance Other problems Disposal Description As there is a risk of environmental pollution, foll ow your applicable Federal, state and local legal regulations regarding disposal or recyc ling of this equipment and batteries. The main constituents of each part are listed in the table below . As there is a risk of infectio n, do not recycle pat[...]

30 Limited W arranty Y our OMRON HBP-1300 Professional Blood Pressure M onitor , excluding the arm cuf fs is warranted to be free from defects in materials and workmanship appearing within 2 year s from the date of purchase, when used in accordance w ith the instru ctions provided with the unit. The arm cuffs are warranted to be free from defects i[...]

31 S pecificat ions Specifications Factory Defa ult Settings Factory default settings and backup are as shown below . Backup : Setting is retained even if the power is interrupted. : Reverts to factory default setting if the power is turned off. Specifications Main unit Setting Pressur e V a lue Settings Fa ctory Settin g Backup Initial Inf lation [...]

32 Power supply Environment al Conditions Non-Invasive Blo od Pressure (NIBP) * Co mp ariso n with auscult ation method performed by a trained professional. DIA determined by the auscultation method is "K5". AC adapter Input voltage rang e: AC 100 V to 240 V Rated Current : 1.6 A Frequency: 50/60 Hz Output voltage rang e: DC 6 V ±5% Opti[...]

33 S pecificat ions Manufacturer' s Declaration The HBP-1300 is intended for use in the el ectromagnetic envir onment specified below . The customer or the user of the HBP-1300 should assure th at it is used in such an environment. Electromagnetic Emissions: (IEC60601-1-2) Electromagnetic Immunity: (IEC60601-1-2) Emission T est Complianc e Ele[...]

34 Immunity test IEC60601-1-2 test level IEC60601-1-2 test level Electromagnetic environment - guidance Conducted RF IEC 61000-4- 6 Radiated RF IEC 61000-4- 3 3 V rms 150 kHz to 80 MHz 80% AM (2Hz) 3 V rms 80 MHz to 2.5 GHz 80% AM (2Hz) 3 V rms 3 V/m Portab le and mobile RF communicati ons equipment sho uld be used no closer to any part of the HBP-[...]

35 S pecificat ions Note: POTENTIAL FOR RADIO / TELEVISION INTERFERENCE (for U.S.A. only) This product has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to prov ide reasonable protection against harmf ul interference in a residential installation. The pr[...]

36 Recommended Separation Distances: Recommended separation distance between portab le and mobile RF communications eq uipment and the HBP-130 0 The HBP-1300 is intended for use in an electromagneti c environment in whi ch radiated RF disturb ances are controlled. The custo mer or the user of the HBP-1300 c an help pr event elect romagnetic i n te [...]

HBP-1300.book Page 37 Wed nesday, March 7, 2012 9:28 AM[...]

Manufactured by OMRON HEAL THCARE Co., Ltd. Distributed by OMRON HEAL THCARE, INC. 1925 West Field Court, Lake Forest, IL 60045, USA Made in China. © 2012 OMRON HEAL T HCARE, INC. For Customer Service Call T oll Free 1-877-216-1336 HBP-1300.book Page 38 Wed nesday, March 7, 2012 9:28 AM[...]