BP AG120 - Blood pressure monitor MICROLIFE - Free user manual and instructions

USER MANUAL BP AG120 MICROLIFE

① Manometer
② Cuff
Pump ball
④ Adjustable deflation valve
(5) Stethoscope
⑥ Chest piece
⑦ Ear piece

Read the important information in these instructions for use before using this device. Follow the instructions for use for your safety and keep it for future reference.

Lot number

Keep dry

Manufacturer

Authorized representative in the European Union

Catalogue number

Serial number

(YYYY-MM-DD-SSS; year-month-day-serial number)

Caution

Humidity limitation for operating and storage

Temperature limitation for operating or storage

Medical device

Importer

Keep away from children of age 0-3

UDI

Unique Device Identifier

Model number

C€1639

CE Marking of Conformity

Introduction

Document scope:

Read the instructions for use thoroughly before using the device. The instructions for use contains important information - safe keep it for future reference.

Disclaimer:

Trademarks and trade names are those of their respective owners.

Table of contents

1. Important information

Device description

Contra-indications

Side effects

Cautions and warnings

Adverse events and reporting

2. Measurement preparation

Using the correct cuff

Checklist for taking a reliable measurement

3. Measurement operation

4. Device error and troubleshooting

5. Device maintenance and disposal

Cleaning

Cleaning the cuff

Storage

Calibration

Precaution

Service

Disposal

6. Guarantee

7. Specifications and compliance

Technical specifications

8. Supplement information for users and patients

How do I evaluate my blood pressure

1. Important information

Device description

Microlife BP AG1-20 aneroid sphygmomanometer is a non-automated, mechanical blood pressure measuring device which uses an inflation cuff around the upper arm. The cuff is inflated and deflated by a manual inflation bulb.

Intended use:

Aneroid Sphygmomanometer is a non-automated, mechanical blood-pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure.

Intended user:

Professional healthcare providers and individuals trained in the auscultatory blood pressure technique.

Intended patient:

The intended patients are over 18 years old.

Intended use environment and conditions:

This device is intended to be used in a professional healthcare environment and at home.

Indications:

Measurement of blood pressure.

Contra-indications

To avoid inaccurate measurements or injuries, do not use this device if the patient's condition meets the following contra-indications:

• Do not use with neonatal cuffs or neonate patients
• Do not take arm measurement on the side of a mastectomy or lymph node clearance
• Do not take measurement to patient with uncontrollable convulsion such as trembling or shivering, etc.
• Do not take measurement around upper arm with injuries (e.g. breached or compromised skin, open wound), foreign materials (e.g. needle of intravenous drip, blood vessel stent implant)

Side effects

• A device can lose calibration (become inaccurate) when it is jostled or bumped, leading to false readings
• Observers might have bias and terminal digit preference which lead to inaccurate readings

CAUTION

Cautions and warnings

Warning - before using the device

• Do not use this device if you think it is damaged or notice anything unusual.
• Do not use this device for purposes beyond described in this Instructions for Use. The manufacturer cannot be held liable for damage caused by incorrect application
• Keep the device away from children and people incapable of operating the device. Beware of the risks of accidental ingestion of small parts and of strangulation with the cables and tubes of this device and accessories.

Warning - during use

• Only pump up the cuff once fitted.
• Never inflate beyond 300mmHg .
• Do not use this device in a moving vehicle (for example in a car or on an aircraft).

Warning - after using the device

Do not wash the cuff in a washing machine or dishwasher.

Warning - maintenance

No modification to the device is permitted.

Caution - before using the device

• This device comprises sensitive components and must be treated with caution.
• Observe the storage and operating conditions described in the «Specifications and compliance» section.
  The cuffs are sensitive and must be handled with care.
• Read the further safety instructions in the individual sections of the instruction manual.

Caution - during use

It helps the user detect the Korotkoff sounds through a stethoscope for auscultation. The measurements and readings might be interfered by the noise around.

Caution - after using the device

Always deflate the cuff completely before storage.
- The measurement results given by this device is not a diagnosis. It is not replacing the need for the consultation of a physician, especially if not matching the patient's symptoms. Do not rely on the measurement result only, always consider other potentially occurring symptoms and the patient's feedback. Calling a doctor or an ambulance is advised if needed.

Caution - maintenance

The aneroid sphygmomanometer is recommended for frequent recalibration (at least every 6 months) or after mechanical impact (e.g. being dropped). Please contact your local Microlife-service to arrange the test.

Caution - protect from environmental conditions

• Protect the device from direct sunlight.
• Protect the device from extreme heat and cold.

Adverse events and reporting

In case of an adverse event, please contact your local Microlife distributor, the device authorized representative in the European Union/European Community, the device manufacturer, or the competent authority of the Member State.

2. Measurement preparation

Using the correct cuff

When choosing the correct size cuff the arm circumference should be measured at the centre of the upper arm. 22 - 32cm (8.75- 12.5 inches) should be the correct size for the majority of people.

Only use Microlife cuffs.

• Contact your local Microlife Service if the enclosed cuff ② does not fit.

Checklist for taking a reliable measurement

1. Avoid activity, eating or smoking immediately before the measurement.
2. Sit down on a back-supported chair and relax for 5 minutes. Keep your feet flat on the floor and do not cross your legs.
3. Always measure on the same arm (normally left). It is recommended that doctors perform double arm measurements on a patients first visit in order to determine which arm to measure in the future. The arm with the higher blood pressure should be measured.
4. Remove close-fitting garments from the upper arm. To avoid constriction, shirt sleeves should not be rolled up - they do not interfere with the cuff if they are laid flat.

5. Always ensure that the correct cuff size is used (marking on the cuff).

6. Fit the cuff closely, but not too tight.

7. Make sure that the cuff is positioned 1 - 2cm above the elbow.

The artery mark on the cuff (ca.3 cm long bar) must lie over the artery which runs down the inner side of the arm.
Support your arm so it is relaxed.
- Ensure that the cuff is at the same height as your heart.

1. Proper deflation rate is essential for an accurate reading. Practice and master a recommended deflation rate of 2-3 mmHg per second or a drop of 1-2 marks on the manometer (1) for each heartbeat.

3. Measurement operation

1. Place the chest piece ⑥ underneath the cuff ② or 1-2 cm below it. Make sure the chest piece is in contact with the skin and lies on the brachial artery.
2. Plug in the ear piece 7 and check, if the chest piece is placed correctly, so that the Korotkoff sounds appear the loudest.
3. Close the valve 4 on the pump ball ③ by turning the screw clockwise. Do not over-tighten.

4. Take the pump ball (3) in your free hand (the arm you are not using to measure) and pump up the cuff. Watch the pressure indicator on the manometer (1) and pump up to approx. 40mmHg higher than the expected systolic value (the upper value).

5. Inflate to 200mmHg if you are not sure about the expected value.

6. Open the valve 4 slowly by turning the screw counter clockwise whilst holding the stethoscope chest piece 6 on the brachial artery. Listen carefully as the cuff begins to deflate. Note the reading on the manometer 1 as soon as you hear a faint, rhythmic tapping or thumping sounds. This is the systolic blood pressure reading.

7. Allow the pressure to continue dropping at the same deflation rate. Note the reading on the manometer 1 as soon as the thumping sound stops. This is the diastolic blood pressure reading.
8. Deflate the cuff completely.
9. Repeat the measurement at least two further times and record your values, date and time immediately after finishing the measurements.
10. Remove the cuff and the stethoscope.

4. Device error and troubleshooting

If problems occur when using the device, the following points should be checked and if necessary, the corresponding measures are to be taken:

Description Potential	cause and remedy
The sound transmis-sion is poor, distorted or there is extraneous noise.	Check the ear pieces if they are dirty or cracked. If not, make sure you wear them properly. Check the tube if it is broken or twisted. Check the chest piece if there is any damage. Make sure the chest piece is in contact with the skin and lies on the brachial artery. Clean or replace any defective parts if found to avoid inaccurate reading.
The pressure does not rise although the pump ball ③ is pumping.	Make sure that the valve is closed. Make sure the cuff is properly connected to bulb and manometer. Check if the cuff, tube and/or bulb is leaking. Replace the defective parts if any.
The deflation rate can not be set to 2-3 mmHg/sec. by adjusting the valve ④.	Disassemble the valve from pump ball to check if there is any blockage in the airway of the valve. Clean the blockage and try again. If it still does not work, replace it to avoid inaccurate readings.
The manometer needle is not at 0 ± 3 mmHg at rest.	Make sure that the valve is completely open for zero check. If still more than 3 mmHg deviation, contact your dealer to recalibrate the manometer.

If you think the results are unusual, please read through the information in «Section 8.» carefully.

5. Device maintenance and disposal

Cleaning

Clean the device only with a soft, dry cloth.

Cleaning the cuff

Carefully remove spots on the cuff with a damp cloth and soapsuds.

Storage

When not in use:

Keep the device and accessories in a dry, cool place away from sunlight, with ambient conditions within the temperature and humidity ranges described in the «Technical specifications» section.

Calibration

We recommend this device is tested for accuracy every 6 months or after mechanical impact (e.g. being dropped). Please contact your local Microlife-Service to arrange the test (see foreword).

Precaution

The device and accessories can only be serviced (tested & calibrated) by trained personnel qualified for servicing Microlife products. DO NOT attempt to service or calibrate the device and accessories yourself.

Service

The device is not designed to be serviced by the user. Contact the device distributor for receiving service by qualified personnel authorized by the manufacturer.

Disposal

The device must be disposed in accordance with the locally applicable regulations, not with domestic or commercial waste.

6. Guarantee

This device is covered by a 2 year guarantee from the date of purchase. During this guarantee period, at our discretion, Microlife will repair or replace the defective product free of charge. Opening or altering the device invalidates the guarantee. The following items are excluded from the guarantee:

• Transport costs and risks of transport.
• Damage caused by incorrect application or non-compliance with the instructions for use.

• Damage caused by accident or misuse.

• Packaging/storage material and instructions for use.

• Regular checks and maintenance (calibration).

The cuff is covered by a functional guarantee (bladder tightness) for 2 years.

Should guarantee service be required, please contact the dealer from where the product was purchased, or your local Microlife service. You may contact your local Microlife service through our website: www.microlife.com/support

Compensation is limited to the value of the product. The guarantee will be granted if the complete product is returned with the original invoice. Repair or replacement within guarantee does not prolong or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

7. Specifications and compliance

Technical specifications

Weight: ≤ 540g (including batteries)

Dimensions: 110 × 75 × 185 ~mm

Storage conditions: -20 - +70^ (-4 + +158^)

15 - 85% relative maximum humidity

Operating

conditions: 10 - 40^ / 50 - 104^

Measurement range: 0 - 300mmHg

Resolution: 2mmHg

Static accuracy: within ± 3mmHg

Air leakage: < ± 4mmHg / min

Expected service life: 2 years

Reference to

standards: EN ISO 81060-1 ANSI/AAMI 81060-1

Compliance information: device corresponds to the requirements of the standard for non-invasive sphygmomanometers EN ISO 81060-1:2012.

The stipulations of the EU Medical Device Regulation (EU)2017/ 745 for Class Im have been fulfilled.

8. Supplement information for users and patients

• Blood pressure is the pressure of the blood flowing in the arteries generated by the pumping of the heart. Two values, the systolic (upper) value and the diastolic (lower) value, are always measured.
• Permanently high blood pressure values can damage your health and must be treated by your doctor!
• Always discuss your values with your doctor and tell them if you have noticed anything unusual or feel unsure. Never rely on single blood pressure readings.
• There are several causes of excessively high blood pressure values. Your doctor will explain them in more detail and offer treatment where appropriate.
• Under no circumstances should you alter the dosages of drugs or initiate a treatment without consulting your doctor.
• Depending on physical exertion and condition, blood pressure is subject to wide fluctuations as the day progresses. You should therefore take your measurements in the same quiet conditions and when you feel relaxed! Take at least two readings every time (in the morning: before taking medications and eating / in the evening: before going to bed, bathing or taking medication) and average the measurements.
  It is quite normal for two measurements taken in quick succession to produce significantly different results.
• Deviations between measurements taken by your doctor or in the pharmacy and those taken at home are quite normal, as these situations are completely different.
• Several measurements provide much more reliable information about your blood pressure than just one single measurement.
• Leave a small break of 5 minutes between two measurements.
• If you are pregnant, you should monitor your blood pressure regularly as it can change drastically during this time.

How do I evaluate my blood pressure

Table for classifying home blood pressure values in adults in accordance with the international Guidelines (ESH, ESC, JSH). Data in mmHg.

Range Systolic Diastolic Recommendation
1. blood pressure normal	< 120 < 74 Self-check
2. blood pressure optimum	120 - 129	74 - 79 Self-check
3. blood pressure elevated	130 - 134	80 - 84 Self-check
4. blood pressure too high	135 - 159	85 - 99 Seek medical advice
5. blood pressure dangerously high	≥ 160 ≥ 100 Urgently	seek medical advice!

The higher value is the one that determines the evaluation. Example: a blood pressure value of 140/80 mmHg or a value of 130/90 mmHg indicates «blood pressure too high».

Microlife BP AG1-20

FR

stockage: Humidite relative 15 - 85% max.

Conditions

d'utilisation: 10 - 40^ / 50 - 104^

Plage de mesure: 0 - 300mmHg

Résolution: 2 mmHg

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OcToPOxKHO ydaJIte IaTHa C MaHKeTbI C NOMOuB BnaKHO TpIKN MblbHOB OBObl.

XpaHeHne

Korda He nconno3yetc:

XpaHNTe yCTpOInCTBO n AkCECCyapbI B CyXOM, pOxJIaDHOM, TEMHOM MeCTe, B YCIOBnIX, Ie Te TMNEpaTpya N BnaXHOCTb HaxoJITcB DnAHa3OHe, yKa3aHHOM B pa3dene «TexHnueckne xapaKTepeNCTNKI>.

KaJIIN6pOBka

Mby peKOMeHnyem npOBepaTb TOnHocTb np6opka KaKdIbe 6 Mecaybl n6o nocLe mexAHmecCKoro BO3deNCTBnA (HaNPIMep, NaDeHn). Iy npOBedeHnra TeTa o6paNTecb B MeCThbl cepBnCHbl ueHr Microlife (cM. BBeHeHne).

Mepa npedoctoopoxnoctn

YcTpoIcTBOn n akceccyapbI MOrTy 06CnyKuBaTbcra (TeCTnpoBAtbcr N KaJIbPoBaTbcra) TOnbKO OByeHHbIM nepcoHaON, KOTOpBn IMeet KbJIINΦNkAciuNo IJr O6CnyKuBaHn IpOdyKTOB Microlife. HE PbITaIATECb 06CnyKuBaTb IIn N KaJIbPoBaTb YcTpoIcTBOn n akceccyapbI cAmocToTepIbHo.

06cnyxmbaHne

YcTpoNCTBO He npEHa3HaueHO nla 06CnyKnBaHnnoIOnb3OBATeJIem.CBxKntEc b dncTpnbIOtopom yctpoNCTBa,HTo6bl Nony

YtB o6cIyXuBaHne y KBaIIuΦuIupoBaHHoro nepcoHa,OnyUeHHoro npou3BOuTeJem.

YTNJN3aun

YCTPOINCTBO HEO6XODIMO yTNIN3NPOBAbTB COOTBETCTBNN C MeCTHbIMN INPIMEHIMbIMN INPABnAMN, 3aIpeUaTcR yTNIN3NPOBAbTB BmecTe C 6blTOBbIMN INN KOMMepueckMN OTXODAMN.

6. rapaHTnA

Ha npnbop pacnpoctpaehetc rapaHTnB TeeyHne 2 net c daTbI npno6pehen. B TeeyHne 3TOrO rapaHTnHO repnoDa, no Hauemy ycmOTpeHHo, Microlife 6ecnnaTHO OTpemOHnpyET nIN 3aMeHNT HeCNpABhI pOdyKT.

BckpbTne nIN n3MeHHeNe yCTpoCTBa aHHyInpye rapaHTnIO. CneNyUoNne NYKTBi NCKJIouChEhBi n3 rapaHTmI:

• TpaHCnOpTHbIe IOBpeJdeHn I pUckn, CBraHHbIe C TpaHCnopTOM.
  NoBpeXdEHHa, BbI3BaHHbIe HEnpaBnIbHbIM npImHeHEm HnHecO6NIODeHMe HNCTpyKcN No npImeHInIO.
• NOBpeXdEHHa, BbI3BaHHbIe HeCuaCTHbIM Cnyaem IIN HnPaBUNJbHbIM INcIOJIb3OBAHHeM.
• YnakOBka n HNCTpyKuIN No npImeHeHInIO.
• PerjIyIe IpoBepKn 06cIyKuBaHne (kaIb6pOBKa). Ha MaHXeTy pacIPOCTpaHReTc rapaHTna (repMeTuHOCb BO3dyUHoro KNaHa) Ha 2 roJa.

EcnI Tpe6yeTc rapaHTnHoe 06CnyKuBaHne, 6paTntecb B MeCTHyIO CnyK6y IopDepKkMicrolife. Bbl MoKeTe CBra3aTbc C MeCThBIM CepBnCOM Microlife uepe3 haw caT: www.microlife.ru/support

IpaANTn6ydt npedoctabHe,ecnTOBap 6ydt BO3bpaueH ceJIHKOM COpINHaJIbHbIM YeKOM INI rapaHTnHbIM TaIOHOm. PemOH Tn 3aMeHa B pAMkax rapaHTnHE npOJNeBaET n He BOCCTaHaBJIbAeT ChauJa rapaHTnHbIM cPOK. OpNInCeKe IpeTeH3nn N npaba Notpe6nteJe He orpAHneHbI 3ToI rapaHTnei.

7.CneuФkaun co6JIIODeHne Tpe6OBaHn

Texnueckne xapaKtepncnK

Macca: ≤ 540 g(r) (Вклоча батеи).

Pa3mepbl:110x75x185MM

YcnoBnaXpaHeHnN-20+70°C(-4+158°F)

TpaHcnpTpObKn: 15-85%MaKcImaJIbHa

OTHOCHTeJIbHaB BJIaXHOCTb

yCIOBn

npmeHn: 口 + 10^ do +40^

Dnana3OH

n3MepeHn:0-300 MM pT.CT.

MHHMaJIbHbI WAr

HdNkaun:2MMpT.CT.

Ctatauecka B npedeJax ± 3 mm Hg

TOUHOCTb: (MM pT.CT.)

YTeUka BO3dyxa: <±4 MM pT. CT./MnH

Oxuaembicpok

cnyxbj:2net

COOTBETCTBNE

CTaHdapTaM: EN ISO 81060-1 ANSI/AAMI 81060-1

HhopmaunOco6HoeHN Tpe6oAHn: yCTPOCTBO COOTBETCTByET Tpe6oAHnM CTaHapTa dIe HENHBA3NBbIX CmHOMaHOMetpoB EN ISO 81060-1:2012.

IIOJXeHn, OINCAHbIe B DInpeKTNBe EC OMeINuHNcknx yCtpoiCTbax (EC)2017/745 dnn KNaCCa Im, co6NIOHebl.

8.Дононтельнанинфорmaцядпяпльб3OBaTeNei n Naци entOB

• AptepnabHoe daBHe Hne -3To daBHe He KPOB, noDaBaEmoCepDcEM B apTePN. Bcerda n3MepraTc Da 3NaueHna, CnCTOJIuYeCKoe (BepxHe) daBHeHne n dnaCTOJIuYeCKoe (HHKHe) daBHeHne.
  B cnyuae noctoHH NOBbIweHHoro apTepeNaIbHO rDaJIeHnBa Hm Heo6xOdmo 6paNTbcK BpaCy, YTO6bl npedynpeDHT pa3BNTne ocNoXHeHn.
  Bcerda coo6aaine Bpauy o BaWiem daBneHn n coo6aaiTe emy/ei, ecn Bbl 3amEtINu YTO-HbUdb Heo6bIuHoe nn yBCTBye THeYBepeHHocTb. HnkOrda He noJaraTeCb Ha pe3yIbTaT ODHokpArHorO n3MepeHnaApTePnAIBHO rDaBJeHn.

CyueCTbyeT HeckoIbKO npuHH Bo3HKnHOBeHn BblcOKoro apTeepaIbHOr DaBHeHn. BaI neuaIIN BpaV paCCkAeT O Hx 60Jee nOpO6Ho IpeIIOXHT noXODJaUeJeUeHne.
Hn np KaKnx 06cToTbCTBax He MeHnTe Do3npOBky JekapCTB H He 3aHMaIteCb CamOJeHEm 6e3 KOHCyIb-Taun Baawero NeaUero Bpaua.
B 3aBnCIMOCtN OT fHn3uecknx Harpy3OK N BaWero COCTOHN, apTePnAIBHOe DaBHeHne NOBepXeHO 3HaunTeNbHbIM KOEN-6aHNM B TeUeHne Dn. PoTOMy KaxDbI pa3, npExde Yem n3MepeTb DaBHeHne, Heo6xOdHMo oBeCneYtB cNoKoHyO obctahOBky n paccna6ntbc! Notpe6yeTcH He MEeE DBx N3MepeHn (Ytpom Do eDbl N npEma JekapCTB IN Beuepom nepei CHOM, npInrTneM BoHbIX npOeDyp IN npEeMOM JekapCTB) dIra ONpeDeJIeHn CpeHero 3HaueHn.
CobepueHHo HopMaIbHo,ecn npn DByx N3MepeHnx NoPdNoIyueHhble pe3yNbTaTb6dyT OTNuaTbcra dpYrOT dpya.
PacxoxdHmMeJype3yNbTaTAMnI3MepHm,noJyehHbIMN BpaOM NIN B aNTKe, IN pe3yNbTaTAMn, noJyehHbIMN BDOMaUHnx YcIOBnX, TaKke RaJIOTcBIOJIHe HOpMaJIbHbIMN, NOCKOJIbKy CNTyaCmN, B KOTOpbIX npoBOJrTcN 3MepHn, COBepHHO pa3NJuHbI.
HeckoIbko n3MepeHn o6ecneuBAIOr ropa3do 6oJee HaJeKHyIO INΦopMaζIHO 6 apTePnaJIbHOM daBJeHn, Yem OJHO n3MepeHne.
CdaIaIte He6oJIbwoI nepepbIB 5 MmHyT MeKdy DByMa H3MepeHnMaM.
Bo Bpem 6epemHeHocn CneJeT TuaTeNbHO CneIuTb3a apTePnaBbIM DaBHeHEm, NCKOJIbKy Ha npOTJKeHm 3TOrO nepNoDa OHO MOKeT CyueCTBeHHo MeHrTbc!

Kak onpeDenbapTrepaNAbHoe daBneHne

Tablua dIa KIaccnФkaun 3NaueHn apTepaJbHO daBHeHn B3PocNoTo YeNoBeKa B COOTBeTCTBm C MeKdyHapOdHbIM peKoMeHdaUmaESh, ESC, JSH DaHHbIe npuBeJeHb I B mmHg (MM pt.ct.)

YHnKaJIeH nIeHTnΦnKaTOp Ha n3dJIeNTo

Mодeн homeр

CE1639 CE MapKnpoBka 3a cboTBetCTBne

BbBeHeHne

06xBaT Ha DOKyMeHTa:

Ipooyete BHNMaTeJHNO HNCTpyKunnte 3a ynoTpe6a, npdi da n3n03BaTe n3deJeJIneto. NHCtpyKunnte 3a ynoTpe6a cbDbpKata BaxHa INHOpMaUra - na3eTe r3a 6bDeuN cnpaBKn.

OTka3 OTROBOPHOCT:

TbproBCKNTe MapKu TbproBCKNTe HAMMeHOBaHna Ca Ha CbOT-BETHNTE IM CO6CTBeHnI.

CbDbPkaHnE

1. Baxha InhOpmaun

OnncnHeHa n3denneto

IpoTnBONOKa3aHn

CtpanuHn epeKtn

Yka3aHn 3a BHMaHne n npedynpeXdHn

HexeNaHc6bntnI DOKnaDaHe

U3non3BaHe Na noXoJaMaHweT

CnncbK C Bbnpocn, rapaHTnpaU N3BbPwBaHe Ha HAdEJHO 3MepBaHe

3.ОперацязИЗмерВанe

1. Ppewka Ha n3denneto n OTCpaHraBaHe Ha Hn3npaBHOCTN

5.ПодрьжkaиИЗХБьрЯнеHaИЗДелпЕТО

TouncBaHe

NouchteBaHeHaMaHWeTa

CbXpaHeHne

Kanibpnpahe

PpeDn3HaMpaK

O6cJyKbaHe

Денихаре

6.「rapaHnua

7.CneuФнkaunm n cbotbetCTBnE

Texnueckn cneuΦnkaun

8.Доьннгелнаифорmaцязnotpe6ntin naeHTN

Kak da onpeedja KpbBHOTo MHaHrahe?

1.BaxhaHnΦopMaun

OncanHe Ha n3dneTo

AheponndnT cFmMOMaHometbP Microlife BP AG1-20 e HeabTomatn3npaHO, MexAHuHO n3dJIne 3a n3MepBaHe Ha KpbBHOtO HJraHe, KOEtO n3No3Ba MaHwET 3a pa3NyBaHe OKoI OropHaTa Yact Ha pbkata. MaHwETbT ce pa3NyBa n Cnada ot PbHa nomna 3a HaNyBaHe.

IpeHa3HaueHHe:

AheponHnT CpHrMOMaHOMeTp e HeaBTOMaN3npaH, MexaHnueH anapaT 3a KpbBHO HaJraHe, KOITo Ce N3No13Ba 3a HnprKOTO n3MepBaHe (HenHBa3NBHO) INOKa3BaHETo Ha apTePnaHOTO KpbBHO HaJraHe.

UeBn noTpe6nteHn:

PpoecnoHaJIHIOCTaBcNtHa 3IpaBHO O6CnyKBaHe N IInuA, oByeHN BTEXHKaTa 3a ayckyIITaUNHa KpbBbHOTo HAnrahe.

ZeeneBn naunent:

LcJIeBnTe naunEnT ca Ha Bb3pact Na 18 roDHH.

PpeBndeHa cpea n ycNoBna 3a n3noN3BaHe:

ToBa n3dennne e npedHa3hauheo 3a n3no13BaHe B npocno-HaHnHa 3npabHb CpeDa N y Doma.

Noka3aHnA:

I3mepBaHe Ha KpbBHOTo HAnraHe.

IpoTHBONOKa3AHn

3a da n36erHete HeToCHn n3MepBaHn IIN HapaHbAHn,He n3non3BaIte TOBa n3dJIne, Ako CbCToHnEto Ha naCHeTA OTROBapra Ha cNeDHnte npOTUBONOKa3AHn:

He n3no13BaITe C HeoHaTaJIH MAnIeTn IIN npu HOBOpOJeH naueHTN
He n3BbPbBaIte n3MepBaHe Ha pBkata OT cTpaHaTa, KbTeTo ca 6nIN n3BbPbBaHn MacTeKTOMn INN OTCpaHraBe Ha JIMΦHN Bb3NJ
He n3BbPWBaIte n3MepBaHe Ha naIeHCT HeKoHTpOIpPyEMn KOHByLCmN, KaTO TpeIepeHe, BTPncAHe n dp.

He n3BpWbaIte n3MepBaHe OKO NO rOpHaTa YAcT Ha pKaTa, aKo TAm mMa HapaHbAHHa (HaNp. HapaHeHa NnYyBpeDeHa KOKa, OTBoPeHa paHa), yJxN MaTePnaJI (HaNp. INrJa 3a INHTpaBeHO3HO KAnKOBO BInBaHe, INmIIaHT Ha CTeHT 3a KpbBOHOceH CbD)

CtpaHnUH n epeKtn

• Ⅲdenneto moKe da 3ary6n kaIb6pupaHe (da cTahe HeToH0), KOrato 6bDe 6bChato nn ydapeHo, KoTe 6n doBeJIO do rpeuHn nokaahna
  IpoBexJaUHTe N3MepBaHTo Jnua MoKe Da IMaT npNCTpactnI IN pEiNoHTaHn 3a 3AkpbTJBAHe NIN N3NOJ3BaHe Ha KpaHInTe UnpPn PnP erNCTpupaHa HcTOHOCHTne, KOeTo 6n DOBeno Do HeTOHNoKa3AHn

BHIMAHHE

Yka3aHn 3a BnHaHne n npdeynpeKdHn

Ppeynpexdene -npen n3no3BaHe Ha n3deJeTeO

He n3no13BaIte TOBa yCTpoIcTBO, aKO cMraTate, ye e NOBpe-DeHO uIN 3a6JIeXKeTe HeIO HeoBuHaHNo.
He n3no13BaIte TOBa n3dJIeNne 3a CEENn n3BbH ONnCaHNTE B Te3n INHcTpyKUm 3a yNoTpe6a. PpOn3BOJNTeJIrT He HOCn OTROBOPHOCT 3a UETn, pPunHEnH O T HEPaBUNHO pPnIOXeHne
- Na3ete anapata daney ot deca n xopa, KOHTo He MORaT da pa6oTc Hero. B3emete noi BHIMAHne pncKOBeTe OT cnuyauHNOIbuahe Ha MaNKu Yactn 3aDywaBaHe C Ka6eJIITE u Tpb6nte Ha To3n anapat N HerOBIne npHaADNkXHocTN.

Ppeynpecknne - no Bpeme Ha ynoTpe6a

• TomnaiTe MaHweta cMo KOraTo e NoCTaBeH Do6pe Ha pBkata.
  Hnkora He He HanaomnBaIte Ha300 MM XnBaueh CTbI6.
  He n3no13BaIte anapaTa B DnBKeIc ce npEBo3HO cpeIcTBO (HapnpMeB Kona nn camonet).

PpeynpexkdeHne - cJe n3non3BaHe Ha n3denneto

He nepete MaHweta B nepaIIHa IIcBdOMnHa MaIHa.

PpeynpekdeHne-noaPbXka

He ce pa3peuaba HnKaBa MoNΦnKaZna Ha yCTpoIcTBOTO.

BHHMaHHe - npEiN3noJ3BaHe Ha n3DeJIeNeTo

ToBa n3dennie CbIbpxKa YyBCTBNTENH KOMNOHEHTN C Hero Tp6Ba Da ce pa60TN BHNMaTeNo.

Cb5nIpaBaaTe ycIOBnaTa 3a cbxpaHHeHne np6Ota, onncAHn B pa3deJ «CneunikauuN CbOTBeTCTBNE».
MaHJETIe ca YyBCTBNTENn TpA6Ba da ce 6opabn BnmaTeJIHO C Tx.
- HanpaBeTe cnpaBka c DonbJHnHTeHnHTe INcTpyKuIN 3a 6e30-nachOCT B OTdeHNHTe pa3dEIn Ha pBkoBOdCTBOTO C INHCTpyKUIN.

BHHMaHHe - no BpeMe Ha ynoTpe6a

Toba nomara Ha notpe6ntela da OKpne TOHOBeTe Ha KopoTkoB ue3 CTeTOckON 3a ayCKyNTaCnur. N3MePbAHnra T n OTHTaHnra MoKe da 6bDat NOBInrHn OT Wyma HAOKOJIO.

BHMaHHe - cneI n3nOJ3BaHe Ha n3dJeHneTo

CbXpaHraBaIe MaHWeTa KaTo N3nycheTe HAnbJInHO Bb3dyxa OTHero.
Pe3yIITaTbT OIN3MepBaHETO,DAeHOT TOBA yCTpOCTBO He e dnaarHO3a.ToHHe 3aMeHRe HEO6XoDMOCCTTA O KOHCyIITaCnA C nekap,ocobEHO aKO He cBcTBcTcBA Ha CmMTOMITE Ha NaUeHTa. He pa3HTaTe cAmO Ha pe3yIITaT O IN3MepBaHETO, BnHaRn B3emaIte PpeBnD n DpyrN oTEHuaNHO pOraBbauCe CmNTOMn, KaKTo N O6paTHa T Bp3Ka OT NaueHTA.Ako e Heo6xOIMO, Ce npenOpbYBa NOBkBaHETO Ha Jekap nn JInneKeKa.

BHMaHne-noDpBxka

3a aHepoHNn cFmOMaHOMeTbp ce npenopbUba yeCTO NOBTOPO KaIN6pnpAne (noHe Ha BCEK 6 Meceua) nIu CneMexAHnHO B3DeiCtBne (Hanp. cNeI uNpyckaHe). CbPKeTe Ce C MecTHnE cepBn3 Ha Microlife, 3a da opraHn3nPate Tecta.

BHHMaHHe - npedna3Ba OT BnHHeTo Ha OKoHnHaTa cpea

• Na3eTe N3dJIeIeTO OT pRJa CJIbHYeBa CBETJInHa.
• Na3eTe n3denneto OT npekomepHa tonnHa n CTyD.

HexeNaHcBbHTnI DOKnaBaHe

B cnyaHa hHexeJanaHO cb6ntne Ce CbbpKeTe C Baunia MeCTeH dIcTpN6byTop Ha Microlife, yIbIhOMoUeHH IpeIcTAbNTeHa n3deJIIneto B EbponeIckn CbO3/EbponeIckata ObuHocT, pOn3- BODHTeHa H3deJIIneto IIN KOMNETEHnOprAH Ha DbPkaBaTa qNeHka.

cbxpaheHHe: 15-85%OTHOCTeJIHaMaKcIMaJIHa BnaXHOCT

Pa6oTHn yCNoBn: 10-40°C/50-104°F

06xBaT Ha

m3MePbaHe:0-300MMKINBauehCTbI6

Pa3dJIeNTeHa

CnOCo6HocT:2MMXNBauehCTbπ6

CtAnuHa ToUHcT: pAMKInTe Ha ± 3 mmHg

N3TNUaHe Ha

Bb3dyxa: <±4MMKINBAueHCTbJI6/MNH.

OchKaBAn cpoK Ha

ekpnoataa:2rOdHH

PpenpaTka KbM

CTaHapTn: EN ISO 81060-1 ANSI/AAMI 81060-1

HOpMaun3a CbOTBeCTBHe: N3deJIneTO OTROBapHa
N3NCBAHnTa Ha CTAanpTa 3a HeINBa3NBn CfIMOMaHometpn EN ISO 81060-1:2012.

Pa3nope6nte Ha PernaMeHTa Ha EC 3a MeduHcN u3dEHH (EC) 2017/745 3a Knac Im ca u3nblHeH.

8.ДоиьнHTeJIHa HnΦopMaцЯ 3a nOtpe6nteIи naunEHTN

KpbBHO haJrahe Hapuame HaJraHeTo HA KpbBta, IpemnHabaanda ppe3 aPtepnte, Koeto ce 6pa3yBa OT NOMNEHATA DeHocT Ha cbpueTo. BUnHarCe n3MepBat DBe cToHocTn, CnCTOnHa (BnCoka) cToHOCr N dnaactOnHa (HnCKa) cToHocT.
Ako nocToaHNO mATE BUCOKO KpbBHO HAnraHe,TOBa MoKe Da yBpeN 3dpabeTo BN N Tp86Ba Da ce o6bphete 3a NOMoUs KbM Jekapn
BnHaN O6cbKdAte CToHocHTe C Baunna Jekap m My cbo6- 7aBaIte, ako 3a6eJeknte Heo Heo6uauHO nIN Ce NoyBCTBaTe HecnryPHn. Hkora He pa3uTaNTE Ha eDhOKpaTHO n3MepeHNTe CToHocTN.
CbIeCTByBat HAKOIO npuHn 3a npeKaJIeHOBUCOK cToHocTN Ha KpbBHOHaJraHe. BauT nekap Tn o6rHi no-noDp6Ho n ige npdnoKn neueHne, koraTo e Heo6xOIMO.

• ПпнкakBNO6CTOBa He Tp86Ba Da npomeHTe do3npobkata Ha lekapCTbata cn nIN da 3anoyBate leueHne 6e3 KOHCyntaunc Baunr lekap.
  B 3aBNCIMOCT OT Φm3nueCKOTO HaTOBapBaHne n CbCTOHRHe KpbBHO THaJraHe TbPnI rOJeMn KOe6aHnB PAMKtE Ha DeHc. CneDobATEHNO Tp86Ba Da npabNTe N3MepBaHnTa cn pR eHNu cBsu Tnxu yCNoBnN u Korato Ce YyBCTBaTe cnoKoHn! IpaBeTe NOHe DBe OTHTaHn BCEKn PtTc(yTpHn: npdN npiem Ha JekapCTBa n XpaHe/Beepe: npdi JraHe, Kbnahe nn npiem Ha JekapCTBa) n OcepeHraBaTe N3MepBaHnTa.
  HopmaJHO eIBe I3MepBaHn, HAnpaBEni CKopo eHOb CneI Dpyro, Da NOKaKAT DoCTa pa3NJuHn pe3yNTaTn.
  OTKIOHEHnB CTOHOCHTHe Ha N3MepBaHnTa, HAnpabeHn OT Jekapra Bn INB aNTeKaTa, IN Te3n HApabeHn BkBUn Ca HanbIHO HopMaJIHn, TbN KaTO yCNOBnTa, pN KOnTO ca HanpaBeHn, ca HanbIHO pa3NIuHN.
  HrkOIO n3MepBaHnO OcIpyBaT MHOr NO-HaEckHa HΦopMaun 3a BaSeTO KpbBHO HaJraHe, OTKOJIKOTO CAMo EHO EDINHNO I3MepBaHe.
• HanpaBeMaIka nay3a 5 MInHyTm MekJy DBe N3MepBaHn.
• Ako Cte 6peMeHHa, Tp8Ba peoBHO Da n3MepBaTe KpbBHOTo CN HAnraHe, TbKATO TO MOKe Da CE npOMeHr IpaCTuHOrnpes To3n NepNo.

Kak da onpeedna KpbBHOTo MN HaJrahe?

Tabnca 3a KnaCnΦnIpaHne Ha NImpeHnte B DomaHn YcIOBnCTOHOCTN Ha KpbBHOTo HAIraHe PnBb3pAcTHN, B CbOTBeTCTBnE C MExdyHapOnHte MeTOOnueckn IpeOpbKn (ESH, ESC, JSH). DaHHnte ca B mmHg.

The device must be disposed in accordance with the locally applicable regulations, not with domestic or commercial waste.

6. Garantia

J 6 J
Microlife 150.

1. b x

品

S J 120 120

i

S BCD = S COD + S BDO - S BOC

j 1 j 5

j 1

:

jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia

（）

2g j 1j g j 1 (j j

210 1

1234567890

auii jdi j 1 (g g) 2

a_6^3 = 256

01 01 01

J. mmHg (ESH, ESC, JSH)

aai jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia jia

EN1SO 81060-1:2012

S (EU)2017/745 8

用A

3.4138

J 8

4.

（）（）

y

1

Gg 500000000000000000000000000000000000000000000000000000000000

Hg 1