microlife ProBP 2400 Digital Blood Pressure Device Directions for Use

Introduction This directions for use manual is a comprehensive guide designed to help you understand the capabilities and operation of the ProBP 2400 digital blood pressure device. Read this manual thoroughly before attempting to setup, configure, use, troubleshoot, or maintain the device. Intended use The ProBP 2400 is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate and mean arterial pressure (MAP) for use in pediatric and adult populations with arm cuff circumference sizes ranging from 14 -52 cm. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia. The ProBP 2400 combines the advantages of an automatic blood pressure device and auscultatory sphygmomanometer. It is designed to provide convenient, accurate and reliable office blood pressure measurements according to guidelines of the European Society of Hypertension (ESH)1, American Heart Association (AHA)2, and World Health Organization (WHO)3 with the only modification that the ProBP2400 performs 3 repeated measurements always, regardless of the result of the first two measurements.

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Pregnancy Approximately 20% of women develop hypertension during pregnancy (Pre-eclampsia or Toxemia) which may affect pregnancy. Pre-eclampsia, can usually be recognized by a clear increase in blood pressure and high urine protein levels after 20 weeks of gestation. Since many oscillometric devices appeared to be unsuitable for use in pregnancy and Pre-eclampsia health care authorities require that blood pressure monitors used for this vulnerable patient group are specifically tested. The Welch Allyn ProBP 2400 digital blood pressure monitor has successfully passed this validation and therefore may be recommended for use during pregnancy and Pre-eclampsia.

1

Pickering TG, Hall JE, Appel LJ, et al. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the subcommittee of professional and public education of the american heart association council on high blood pressure research. Circulation 2005;111:697-716.

2

Whitworth JA. 2003 World Health Organization (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens 2003;21:1983-92.

3

O’Brien E, Asmar R, Beilin L, et al. Practice guidelines of the European Society of Hypertension for clinic, ambulatory and self blood pressure measurement. J Hypertens 2005;23:697-701. E, Asmar R, Beilin L, Imai Y, et al. European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure measurement. European Society of Hypertension Working Group on Blood Pressure Monitoring. J Hypertens 2005;23:697701.2003,21:1983-1992.

Welch Allyn ProBP 2400 digital blood pressure device

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Table of Contents Symbols ... 6

«Manual» Mode... 19-20

Warnings and cautions

« » Mode... 21

General warnings and cautions... 7-8

Special Functions

NIBP (non-invasive blood pressure) warnings and cautions... 9

MAP (Mean Arterial Pressure)... 22

Product description Name of parts and display... 10-11 Components and accessories... 12 Before using ProBP 2400 Attaching the power plug to the power adapter... 13

Irregular heartbeat detector in «1x» Mode... 22 Setting maximum inflation pressure... 23 Taking fewer than three measurements ... 24 Skipping the countdown time... 24 Setting measurement interval times in « » Mode... 25 Viewing the stored values... 26

Selecting Units of Measure... 14

Appendix

Selecting the correct cuff... 15

Rechargeable battery and power adapter ... 27

Fitting the cuff properly... 16-17

Troubleshooting... 28

Taking measurements in Single Reading (1x), Manual and Three Reading Average ( ) Mode «1x» Mode... 18

Welch Allyn ProBP 2400 digital blood pressure device

Error messages... 29-30 Safety, care, accuracy test and disposal... 31-34 Technical specifications... 35

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Symbols Documentation symbols



Control symbols

WARNING: The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death.

Power on/Power off

CAUTION: The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data.

Start/Stop Memory

Consult operating instructions/directions for use (DFU).Acopy of the DFU is available on this web site.Aprinted copy of the DFU can be ordered from WelchAllyn for delivery within 7 calendar days.

Adjust measurement interval times

Helpful notes.

Adjust maximum inflation pressure

Shipping, storing, and environment symbols Fragile; handle with care

Single Reading Mode

Recovery/Recyclable

Manual Mode

Recycle the product separate from other disposables

Three ReadingAverage Mode

Keep dry

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1x

General warnings and cautions Miscellaneous symbols Meets essential requirements of European Medical Device Directive 93/42/EEC

WARNING The information in this directions for use is a comprehensive guide to the operation of ProBP 2400. For best results, read this directions for use thoroughly before using the device.

RegulatoryAffairs Representative

WARNING The device is intended for use only in environments with clinician supervision.

Type BF applied parts

WARNING The device is designed for medical clinician use.Although this directions for use may illustrate medical spot-check techniques, only a trained clinician should use this device.

Manufacturer

WARNING The device is not intended for use during patient transport. WARNING Fire and explosion hazard. Do not operate the device in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen enriched environments. WARNING Every three months, inspect the blood pressure cuff and other accessories for fraying or other damage. Replace as necessary. WARNING Inaccurate measurement risk. Do not use the device on patients who are connected to heart/lung machines. WARNING Electric shock hazard. Do not open the device or attempt repairs. There are no user-serviceable parts inside ProBP 2400 other than battery replacement. Only perform routine cleaning and maintenance procedures specifically described in this directions for use. Inspection and servicing of internal parts shall only be performed by qualified service personnel. WARNING The device complies with applicable domestic and international standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices.As a precaution, avoid using the device in close proximity to other equipment.

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WARNING WelchAllyn is not responsible for the integrity of any mounting installation. WelchAllyn recommends that customers contact their Biomedical Engineering Department or maintenance service to ensure professional installation for safety and reliability of any mounting accessory. WARNING The device may not function properly if dropped or damaged. Do not use the device if you notice any signs of damage. Qualified service personnel must check any device that is dropped or damaged for proper operation before putting the device back into use. WARNING Defective batteries can damage the device. If the battery shows any signs of damage, leakage, or cracking, it must be replaced immediately, and only with a battery recommended for or supplied with the device. WARNING Improper disposal of batteries may create an explosion or contamination hazard. Never dispose of batteries in refuse containers. Do not dispose of the battery in fire.Always recycle batteries according to local regulations. WARNING Improper handling of the battery can lead to heat generation, smoke, bursting, or fire. WARNING Do not disassemble, modify, or solder the battery. WARNING For proper patient electrical isolation and battery charging, use only the provided external power supply to charge the device. WARNING Electric shock hazard. Before cleaning the device, disconnect the power cord from the power source and the device. WARNING Take care to prevent water or other fluid from entering any connectors on the device. Should this occur, dry the connectors with warm air. Check the accuracy of all operating functions. 8

Avoid simultaneously connecting patients to the device and high frequency surgical equipment. CAUTION The device is not heat-resistant. Do not autoclave. CAUTION Use the device within stated operating temperature ranges. The device will not meet performance specifications if used outside these temperatures ranges. CAUTIONAlways unplug the external power source from the outlet before moving the device to a new location. CAUTION Use only WelchAllyn approved accessories. Use of unapproved accessories with the device can affect patient and operator safety, and can reduce product performance and accuracy. CAUTION Federal law restricts this device to sale by or on the order of a physician or licensed health care provider

NIBP (non-invasive blood pressure) warnings and cautions WARNING ProBP 2400 is not intended to measure blood pressure on children younger than 3 years of age.

CAUTION If the blood pressure cuff is not at heart level, note the difference in reading due to the hydrostatic effect.

WARNING Do not compress the blood pressure hose or cuff. This may cause system errors or patient safety risks to occur.

CAUTION Proper blood pressure cuff size and placement is essential to the accuracy of the blood pressure determination. See Blood pressure cuff selection for sizing information.

WARNING Inaccurate measurement risk. Do not use the device on patients who are experiencing convulsions or tremors. WARNING Use only blood pressure cuffs and hoses listed as approved accessories to ensure safe and accurate of blood pressure measurements. WARNING Patient injury risk. When several blood pressure measurements are taken on the same patient, regularly check the cuff site and extremity for possible ischemia, purpura, and/or neuropathy. WARNING Do not allow a blood pressure cuff to remain on the patient more than 5 minutes when inflated above 15 mmHg. Excessive cuff tightness may cause venous congestion, peripheral nerve injury, discoloration of the limb, and patient distress.

CAUTION The blood pressure cuff must be properly positioned to ensure blood pressure accuracy and patient safety. Wrapping the cuff too loosely (preventing proper inflation) may result in inaccurate blood pressure readings. CAUTION The patients should be comfortably seated, legs uncrossed, feet flat on the floor, back and arm supported. The middle of the cuff should be at the level of the heart. CAUTION Recommend the patients to sit down and relax for at least 5 minutes prior to the measurement and not talk during the measurement procedure.

WARNING Patient injury risk. Never install Luer Lock connectors on WelchAllyn blood pressure tubing. Using these connectors on blood pressure cuff tubing creates the risk of mistakenly connecting this tubing to a patient’s intravenous line and introducing air into the patient’s circulatory system. WARNING NIBP measurements may be inaccurate in the presence of excessive motion artefact. Minimize extremity and cuff motion during blood pressure readings. WARNING The position and physiologic condition of the subject can affect a blood pressure reading.

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Product description Name of parts On/Off Switch Power Adapter Socket Battery Compartment

Cuff Socket Recharge Indicator Display M Button (Memory) Mode Switch Start/Stop Button

10

3 sec.

1x

3x

3 sec.

Display Power Power Low LowBattery Battery Mode Selection: Mode Selection: SingleReading, Reading, Single Manual, Three ReadingAverage Average Manual, Three Reading Unit ofofMeasure Unit Measure

Maximum InflationPressure Pressure Maximum Inflation Rest/CountDown Down Rest/Count Auto Inflation Auto Inflation Memory Memory

1x

mmHg kPa 34.7 260 32.0 240 29.3 220 26.7 200 24.0 180 21.3 160 18.7 140 AUTO AUTO M1 M2 M3

M 3x

Welch Allyn ProBP 2400 digital blood pressure device

Systolic SystolicValue Value

3x SYS

Diastolic Value Diastolic Value

DIA Mean Arterial Pressure Mean Arterial Pressure PAM MAP

Irregular Hear BeatBeat (IHB) (IHB) Irregular Heart Pulse Rate Pulse Rate / MIN

Pulse Detected Pulse Detected

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ProBP 2400 components and accessories 1 X Power Adapter 4 X Power Plugs (US, Europe, UK, Australia)

1 X ProBP 2400

(Input: 100-240V~50/60Hz 0.5A Output: +7.5V 1.5A)

3 sec. 1x

3x

3 sec.

Welch Allyn ProBPTM 2400

digital blood pressure device

Directions for use Version 1.01 English, , Deutsch, Español, Português, Français, Italiano, Nederlands, Dansk, Norsk, Svenska, Suomi, Русский, Polski, Türkçe, 한국어

Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C.

2400 le ProBP ff ReusabPressure Cu Blood

Distributed by Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153

ADULT m 22-32c

Microlife AG Espenstrasse 139 9443 Widnau, Switzerland

NOTES: 1. USE CMYK COLOR MODE AND WHITE FLOOD FOR PRINTING ONTO THE CD/DVD SURFACE. 2. THE CD SHAPE LINES ARE FOR REFERENCE ONLY AND SHOULD NOT BE PRINTED.

1 X Adult (22cm~32cm) 1 X Large adult (32cm~42cm)

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3. THE TITLE TEXT IS C-58, M-17, Y-0, K-46, EQUAL TO PMS 5405C DARK BLUE.

1 X CD Directions For Use 4. INFORMATION TEXT COLOR IS BLACK IN CMYK VALUES C-50, M-50, Y-50, K-100.

5. WELCH ALLYN WORDMARK IS GREEN C-100, M-0, Y-91, K-6, AND BLUE C-100, M-72, Y-0, K-38. 6. UNIVERS FONTS IN BOLD AND REGULAR ARE USED. LANGUAGE FONT IS ARIAL UNICODE MS REGULAR. FONT TYPE, ATTRIBUTES, AND COLOR SHALL BE CLEARLY LEGIBLE.

A

RELEASE TO PRODUCTION

VER

DESCRIPTION OF CHANGE

D*

CHANGE NUMBER/APVD

D* SEE SAP DIR FOR CHANGE NUMBER, APPROVER NAME AND DATE OF APPROVAL

SCALE : 1:1

TITLE: AW, CD LABEL, DFU, PROBP 3400, ML 1.03 DRAWING NO: PART NO. 408263 103701

DESCRIPTION CD, DFU, PROBP 2400, ML 1.01 DFU, PROBP 2400

SHEET 1 OF 1 DRW BY: Microlife DATE: 2014-12-24

Initial set up Attaching the power plug to the power adapter

Select a proper power plug and attach to the power adapter as shown below.

Charge the battery completely

When using for the first time, charge the battery until the recharge indicator on the device turns to green.

 Refer to page 27 for the section of “Using a power adapter“.  Refer to page 27 for the section “Rechargeable Battery“ Welch Allyn ProBP 2400 digital blood pressure device

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Initial set up (cont.)

Selecting units of measure 1) Make sure the device is switched off. 2) Press and hold the M Button and then turn on the power with the On/Off Switch. 3) Release the M Button when backlight illuminates. 4) Press the Start/Stop Button to select the preferred pressure unit (mmHg or kPa). 5) Press M Button to confirm the selection.

Units

MAP or PAM

1

mmHg

MAP

2

mmHg

PAM

3

kPa

MAP

 Factory default setting

 MAP is the abbreviation of Mean Arterial Pressure.  PAM or MAP is chosen depending on language preference. 14

Before using the device Selecting the correct cuff

Child

A variety of different cuff sizes are available. Adult and Large Adult cuffs are provided with the device. Use the cuff marker to select the cuff size that best matches the circumference of the patient’s upper arm.

Reusable ProBP 2400 Blood Pressure Cuff CHILD 14-22cm

LATEX

!

www.welchallyn.com

Adult Reusable ProBP 2400 Blood Pressure Cuff ADULT 22-32cm

LATEX

!

www.welchallyn.com LATEX

Cuff Size

Circumference (cm)

Circumference (inch)

Child

14 - 22

5.5 - 8.7

PVC

DEHP

Large Adult Reusable ProBP 2400 Blood Pressure Cuff LARGE ADULT 32-42cm

LATEX

!

Adult

22 - 32

8.7 - 12.6

Large Adult

32 - 42

12.6 - 16.5

Large Adult Long

32 - 52

12.6 - 20.5

 Each cuff is provided with 130 cm air tube.  Use only cuffs provided by Welch Allyn!  Contact Welch Allyn or its authorized distributor to purchase

www.welchallyn.com

LATEX

DEHP

Large Adult Long

Reusable ProBP 2400 Blood Pressure Cuff LARGE ADULT LONG 32-52cm

PVC

LATEX

!

www.welchallyn.com

 Adult and Large Adult cuffs are included as standard accessories.

cuffs.

Welch Allyn ProBP 2400 digital blood pressure device

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Before using the device (cont.)

Fitting the cuff properly

3) Wrap and tighten the cuff around the arm.

1) Place the cuff over the upper arm so that the air tube and artery mark arrow point towards the lower arm. The artery mark on the cuff must be placed over the brachial artery. 2) Lay the cuff on the arm. Make sure that the lower edge of the cuff lies approximately 2 to 3 cm ( ¾ to 1 inch) above the elbow.

(3/4 to 1 inch)

AD

22

2-3 cm

m

m

-32c

R Bloeus od able Pre Pro UL ss BP ure 2 T Cu 400 -3 ff 2c

U

AD

16

22

0 40 P2 f oB Cuf e Prsure sablPres Reu od Blo LT

4) Leave free space with the size of 2 fingers between the arm of the patient and the cuff. Excessive tightness may cause venous congestion and discoloration of the limb. If the cuff is wrapped too loosely, it cannot be inflated properly and the measured values may be inaccurate. Remove all clothing covering or constricting the measurement arm. Clothing may interfere with measurement accuracy.

5) Cuffs that do not fit properly may lead to inaccurate readings. Use a different size cuff if the range index at the end of the cuff does not fall into the range specified by the range stripes.

 The range index of the cuff should fall into this range.

Reusable ProBP 2400 Blood Pressure Cuff ADULT 22-32cm

LATEX

!

www.welchallyn.com

Welch Allyn ProBP 2400 digital blood pressure device

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Taking measurements in 1x, Manual and Turn on the power

Turn on the device by pressing the On/Off Switch at the back of the device to the ON position.

Connect the cuff to the device

Connect the cuff to the device by inserting the cuff connector into the cuff connector socket.

Mode

Set maximum inflation pressure

Select desired maximum inflation pressure or "AUTO".

Refer to page 22 for the section of “Set maximum inflation pressure“

3 sec.

1x

3x

1x

1x

3x

3 sec.

3x

Select an operation mode

1x

There are three measurement modes that can be used. Slide the switch to select 1x (standard single measurement), Manual or Mode (automatic three reading average). 18

3x

«1x» Mode (standard single measurement)

Select «1x» Mode then press the «Start/Stop» Button to perform a single blood pressure measurement. The measurement reading is displayed and saved after the measurement.

1x

3x

1x

Welch Allyn ProBP 2400 digital blood pressure device

3x

1x

3x

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«Manual» Mode

Mode (cont.)

When maximum inflation pressure is reached, the ProBP 2400 will automatically begin linear deflation at a rate of 3mmHg/sec.

AD

AD

R Bloeusa od ble

Pre Pro AD ULT ss BP ure 2 22 Cu 400 -3 ff 2cm

20

22

cm

R Bloeusa od ble Pre Pr UL ss oBP ure 2 T Cu 400 -32 ff

22

m

Select «Manual» Mode if auscultatory blood pressure measurement is preferred above using the oscillometric method. In «Manual» Mode, the device serves only as a pressure gauge. No oscillometric measurements will be taken. The user can hear the systolic and diastolic Korotkoff sounds by means of a stethoscope placed over the Brachial artery.

Start inflation – Press the Start/Stop Button to start inflation of the cuff.

Re Bloous ab d le Pr Pr es oB UL su P T re 24 Cu 00 -3 ff 2c

Taking measurements in 1x, Manual and

Re-inflate –Push and Hold the M Button during deflation to re-inflate for as long as the button is held up to a max of 299mmHg. Release the button to continue deflation. Exceeding 299mmHg will result in an immediate release of cuff pressure and a 'HI' Error message.

When the cuff pressure reaches 20mmHg during the deflation cycle, the remaining pressure is vented and the ProBP 2400 goes into the Stand by mode. Push the «Start/Stop» at any time to start fast deflation and set the ProBP 2400 to Stand by. Take note – Take note of the systolic and diastolic values in the same manner as performed with sphygmomanometer measurements. Set to ‘Stand by’ – The device can be set to ‘‘Stand by” by pressing the «Start/Stop» Button without turning off the power. The device will automatically switch to ‘Stand by’ if there is no operation for one minute. 1x

3x

1x

3x

« » Mode (automatic three reading average)

Select « » Mode then press the «Start/Stop» Button to perform automatic triple blood pressure measurements to determine a three reading average. The countdown time before the first measurement is set at 60 seconds. The interval times between measurements is user adjustable to 15, 30, 45 or 60 seconds. The average measurement reading is displayed and saved after the measurements are complete.

1x

3x

60 sec.

1

2

15, 30, 45, or 60 sec.

15, 30, 45, or 60 sec.

3

The user can manually select up measurement interval times Stand by

of 15, 30, 45 or 60 seconds in Mode. (Please refer to special functions section page 21 “Setting measurement interval times”).

The 60 second wait period before the first measurement is not

adjustable but may be bypassed by pressing the Start/Stop Button a second time. This will start the first reading immediately.

Welch Allyn ProBP 2400 digital blood pressure device

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