Omron HBP-1300 manuale d’uso

Profe ssional Blood Pressur e Monitor HBP-1300 • Instruction Manual • Mode d’em ploi • Gebrauchsanweisung • Manuale di istruzion i • Manual de instrucciones • Gebruiksaanwijzing •             • Kullanm Klavuzu EN FR DE IT ES IM-HB P-13 00-E -01-0 2/20[...]

Content s Intr oduction Intend ed Use ........ ................. ........... ................. ........... ................. ........... ................. .... 1 Exemp tions ........... ........... ................. ........... ................. ........... ................. ........... .......... 1 Notes o n Safety ............... ................[...]

1 EN Introduction Intended Use Medical Purpos e The device is a digital m onitor intended for use in measuring blood pressure and pulse rate in adult and pediatric patient population with arm circumference ranging from 12 cm to 50 cm (from 5 inches to 20 inches). Intend ed User This device should be used by a medical prof essional. Pa tie n t Po pu[...]

2 Notes on Safe ty The warning signs and symbol exa mples indicated below are intended t o ensure safe us e of the product and prevent damage and injury to you and others. The signs and symbols are explained below . Safety Symbols used in this Inst ruction Manual Wa r n i n g Ind icates the matte rs in which dea th or severe bodily damage may arise[...]

3 EN W arnings and Cautions Usage warni ngs and cau tions Setup Wa r n i n g Caution Do not use t he cuff or AC adapt er to lif t the unit, it c an also caus e the unit to m alfunction. If the unit has brok en dow n, contact OMRON HEAL THCARE. Do not use in combination w ith a hyperbaric oxygen therapy device, or in an environment where combustible[...]

4 Before use / during use Wa r n i n g The unit complies with the EMC st anda rd (IEC60601-1-2). As such, it can be used simult aneously with multiple medical instrument s. However , if instruments t hat generate noise such as an electric scalpel or a microwave therapy device are near the unit, check the operation of the uni t during and after use [...]

5 EN Caution Before using the unit, verify that none of t he following apply to t he pati ent: - Poor peripheral circulation, noticeably low blood pressure, or low body temperature (there will be low blood f low to the measurement position) - The p atient uses an artificial heart and lung (there will be no pulse) -A n S p O 2 sensor and the c uf f [...]

6 Cleanin g Wa r n i n g Cauti on Maintena nce a nd insp ection Wa r n i n g When cleaning the unit, t urn off the power and disconnect the AC adapter from the unit. After cl eaning the unit, make sure it is completely dry before connecting to a power outlet. Do not spray , pour , or spill liquids into or on to the unit, acce ssories, connect ors, [...]

7 EN W arnings and c autions for safe measurem ent Recha rgeab le b atte ry Wa r n i n g Caution If battery fluid comes in contact with the eye, immediately flush with copious amounts of water . Do not rub. Seek m edical attention immediately . Do not use t he battery pack in any other device besides this unit . Do not throw into flame, disassemble[...]

8 Non-Inva sive Bloo d Pre ssure (NI BP) meas ure ment Wa r n i n g Cauti on If a cuf f is used on a pat ient with an inf ection, treat the cuff as medical waste, or disinfect before reuse. If frequently performing NIBP measurement using a cuf f over an extended period of time, periodically check the patient’ s circulation. In addition, wrap t he[...]

9 EN Note: Setup • Read and understand the manual for each optional accessory . This manual does not contain cautionary inf ormation for optional acces sory . • Exercise caution with the cables and arrange so t hat the pat ient does not become entangled or bound. Bef ore us e / du r in g use • Check the following af ter turning on the power: [...]

10 Using the Unit Component s of the Product Before using the unit, make sure that no accessories are missing and that the unit and accessories are not damaged. If an accessory is missing or there is damage, please contact OMRON HEAL THCARE. Main unit S tand ard Medi cal Accesso r ies • GS CUFF L (32 - 42 cm)/ M (22 - 32 cm) • AC ad apter Other[...]

11 EN Optiona l Medi cal Acce ssori es (within the scope of EC Medical Device Directive 93/42/EEC) * UK plug type AC AD APTER-UK 1600 (9994843-9) Caution Only O MRON G S CUFF can be us ed with this device. Features of the Produc t The OMRON HBP- 1300 is an af f ordable professional blood pressure unit that is clinical ly proven accurate and provide[...]

12 Features / Functions of Unit Front an d back of un it Meanin g of t he Sy mbols 1 [ST A RT/STOP ] butto n (Pow er ON /OFF) Power ON / Measure blood pressure Pres s when the p ower is of f to tur n on th e power and st art blood pre ssure measur ement. During infla tion or measu rement, press to stop. Powe r OFF Hold down at least 3 sec onds to t[...]

13 EN LCD Display * O nly when the battery is inst alled. 1 SYS Displays sys tolic bloo d pressure . 2 DIA Displays diast o lic blood pres sure. 3 Pulse Displays the pulse rate. 4 Puls e synchronizatio n icon Flashes in syn chroniz ation wit h the pulse duri ng measur ement. 5 Irre gular pul se wave icon Light s in the meas urement result dis play [...]

14 Inst a lling the Battery Pac k Cauti on Do not short the positive and negative terminals of the battery pack with a wire or other metal object. If battery fluid comes into cont ac t with t he skin or clothes, immediately rinse with wat er . 1. Make su re the AC adap ter has been d isconn ected . 2. Remove the two screws from the top of the rear [...]

15 EN Battery ch arging Battery lev el Connecting the AC Adapter AC power V erify that the power out let supplies the specified voltage and frequenc y (100 - 240 V AC, 50/60 Hz). Connect the AC adapter to the DC jack on the unit and the power outlet. Note: When the ba tt ery pack is i nst alle d If there is no pr oblem with the f ollowing. - A C ad[...]

16 Syste m Settings The syst em settings are divided into t wo modes, “ Menu Mode” and “Ut ility Mode”. Menu Mode “Menu Mo de” al low s yo u to co nfig ure t he “I niti al In flatio n Pr ess ure V alue ” an d “Au sculta tion Mode ” set tin gs. 1. Press the [MODE] butt on. The “Initial Inflation Pressure V a lue” setting scre[...]

17 EN Utility Mode “Utility M ode” a llows y ou to con figure th e “Auto Powe r Off” and “Pr essure Accurac y Confir mation ” setting. 1. Con fir m tha t th e d evi ce i s swit ched o f f. If the power i s on, hold down t he [ST ART/STOP] button for at least 3 seconds t o turn of f the power . 2. Hold down the [MODE] butto n until the ?[...]

18 Non-Invasive Blood Press ure (NIBP) Measurement Non-Invasi ve Pressure Measur ement Principle s Oscillometric method The beat in t he pulsation generated by the contraction of the heart is captured as t he pressure inside the cuff to measure the blood pressure. If t he cuff wrapped around t he upper arm is pressurized suf ficiently , the blood f[...]

19 EN Cuff Selection and Connection Selectin g the cuff Caution • D o not us e the cuff if it is da maged or has ho les. • U se the appropriate cu ff size to ensur e correct m easurements. If a cuff that is too larg e is used, the measured blood press ure value tends to be lower t han the actual blood pressure . If a cuf f that is too small is [...]

20 Applying the Cuff to the Patient 1. Wrap on a bare arm or over thin clothing. Wrap t he cuff on a bare arm or over thin clothi n g . Thick clothing o r a rolled up sleeve will cause inaccurate blood pressure measu rements. The device can be used on either the right or left arm. 2. A lign the ar tery mark “I NDEX AR TER Y” with the br achial [...]

21 EN Caution Make sure the cuff is wrapped in the correct arm position an d is at the same he ight as the h eart. A dif ference of 10 cm (4 inches) in hei ght may cause a variation in the blood pres sure value of up to 7 - 8 mmHg. Note: • I f meas urement is dif fic ult due to arrhyt hmia, use a di f feren t blood pressure measure ment met hod. [...]

22 Irregula r pulse w ave detect ion function If the pulse wav e interval becom es irregular dur ing measurem ent, the irregular puls e wave det ection icon will light to notify you. Body m ovemen t detectio n function If body m ovement is d etected during measure ment, deflation st ops for 5 seco nds. T he irregular pulse wave icon appears in the [...]

23 EN S topping the Meas urement T o stop measurement while measurement is in progress, press [ST ART/STOP] button. Displayi ng Last Reading The previous meas urement value (systolic blood pressure, diastolic blood pres sure, and pulse rat e) and whether or not an irregular pulse wave was det ected can be displayed. In t he case of auscultation mea[...]

24 Maintenance Maintenance In spection and Safe ty Management The HBP-1300 must be maintained to ensure func tionality and to secure the saf ety of patien t s and operators. Daily checks and maintenance should be per formed b y the operator . (page 25) In addition, qualified personnel are necessary to maint ain the performance and the sa fety , and[...]

25 EN Check be fore Use Before cond ucting safety checks, be su re to imple ment the items in the “Cleaning of the D evice” and “A ccessory Care” sect ions. (page 24) Before turning on t he power Before t urning on the power , check f or the following External appear ance Q The device or accessories are not deformed due to falling or other [...]

26 T roubleshooting The power do es not turn on Cause S olutio n If the un it is being powered by the bat tery , the batte ry is not ins ta lled or the charge is depl eted. Insert ba ttery or replace with a ne w batter y (page 14 ). Inte rnal part f ailu re Discon nect the AC ad apter , remo ve t he b attery , and conta ct OMRON HE AL THCAR E. • [...]

27 EN Abnormal measurement value Cause / solu tion The causes below are possi ble. Chec k th e pat ient by pa lp ation and th en repeat measure ment. • Body movement (chil ls or oth er tremblin g) • Arrhythmia. • Noi se in the c uff - A nearb y pe rson touc hed t he p atient. - Cardiac mass age was bei ng performed. The meas urement va lue is[...]

28 List of Error Codes The alarm lamp flashes when a medi um-priority alarm occur s, and light s steadily when a l ow-priority alarm occurs. T o clear an alarm, press any button. Q If a low-priority alarm and a medium -priority alarm occur at the sam e time, the medium-priority alarm is displayed. If the alarms are the same priority level, the erro[...]

29 EN Other problem s Disposal Descriptio n As there is a risk of environmental pollution, follow y our applicable national and local legal regula tions regarding dispos al or recy cling of this equipment and batteries. The main constituents of each p a rt are li sted in the t able below . As there is a risk of inf ection, do not recycle patient at[...]

30 S peci ficat ions Factory Default Settings Factory default settings and backup are as shown below . Backup : Setting i s retained even i f the power is interrupted. : Reverts t o factory default setting if the power i s turned off. T echnica l Specifications: HBP-130 0 Main unit Power sup ply Sett ing Pr ess ure V al ue Setti ngs Factory Se ttin[...]

31 EN Environme ntal Conditions Non-Invas ive Blood Pressure (NI B P) * C omparison with auscultation method performed by a trained prof essional. DIA determined by the auscultation method is “K5”. Note: S pecifications m ay be c hanged without prior notice. This blood pressure monitor fulfils the requirements of the EC directive 93/42/EEC (Med[...]

32 Important information regarding Elec tro Magnet ic Compatibility (EMC ) With the increased number of electronic devices such as PC’ s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrec t operation of t he medical de [...]

33 EN Manufacturer ’ s Declarat ion The HBP -1300 is inte nded for use in the electromag netic environm ent specified below . The cust omer or the user of the HBP- 1300 should ass ure that it is used in such an environment . Electromagnetic E missions: (IEC6 0601-1-2) Electromagnetic I mmunity: (IEC6 0601-1-2) Emissi on T est Compliance Elec trom[...]

34 Immunity test IEC60601-1-2 test level Compliance level Electromagneti c environment - guidance Conduct ed RF IEC 61000-4 -6 Radiat ed RF IEC 61000-4 -3 3 V rms 150 kHz to 80 MH z 80% A M ( 2H z) 3V / m 80 MH z to 2.5 GH z 80% A M ( 2H z) 3 V rms 3 V/m Port able and mobile RF communicat ions equipmen t shoul d be used no close r to any p art of t[...]

35 EN Recomm ended Separation Distances: Recommended separation dist anc e between port able and mobile RF commun ications equipment and the HBP-1300 The HBP- 1300 is intend ed for u se in an elec troma gnetic en v ironme nt in whic h radia ted RF dis turban ces are co ntrolled . The customer or the user of the HBP-1 300 can help preve nt elec trom[...]

Made in C hina Manufacturer OMRON HEAL THCA RE Co., Lt d. 53, Kunotsubo, T era do-cho, Muko, Kyoto, 617-0002 JAP AN EU-rep resent ative OMRON HE AL THCARE EUROPE B .V . Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS www .omron-healthcare. com Product ion facility OMRON (DALIAN) CO., L TD. Dalian, CHINA S ubs id ia ry OMRON HEAL THCA RE UK L TD. Op[...]