Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Directions for use Software Version A01, Model 2000-A
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iii Contents Introduction ............................................................................................. 1 Intended use/Indications for use .......................................................................... 1 Contraindications ................................................................................................. 1 Symbols ............................................................................................................... 2 About warnings and cautions ..........
iv Contents Welch Allyn ProBP™ 2000 Digital Blood Pressure Device
1 Introduction Readings taken by the device are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This Directions for use contains important safety and care information and provides stepby-step instructions for using the device. Read the manual thoroughly before using the device.
2 Introduction Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Symbols Documentation symbols Warning: The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. 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. Follow instructions/directions for use (DFU) -- mandatory action. A copy of the DFU is available on this website.
Directions for use Introduction Cuff symbols Artery marker Range Artery index marker Limb circumference (Minimum/Maximum) Lot Code Not made with natural rubber latex Miscellaneous symbols Manufacturer Date of manufacture Type BF applied part Serial Number Product Identifier Lot Code Reorder Number 3
4 Introduction Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Non-ionizing electromagnetic radiation Global Trade Item Number Class II equipment IP22 Ingress protection: the device is protected against solid foreign objects of diameter 12.5mm and greater and against vertically falling water drops when ENCLOSURE is tilted up to 15° Prescription only or "For Use by or on the order of a licensed medical professional" The product contains certain hazardous substances.
Directions for use Introduction 5 About warnings and cautions Warning and caution statements can appear on the Welch Allyn ProBP™ 2000 Digital Blood Pressure Device, the packaging, the shipping container, or in this Directions for use. Warnings and cautions WARNING Patient injury risk. The device is not suitable for measuring the blood pressure of neonatal infants or children. WARNING Patient injury risk.
6 Introduction Welch Allyn ProBP™ 2000 Digital Blood Pressure Device WARNING Inaccurate measurement risk. Do not place the cuff where it can disturb proper circulation. Do not place the cuff on any area where circulation is compromised or on any extremity used for intravenous infusions. Do not use an SpO2 finger clip sensor and a blood pressure cuff simultaneously on the same limb.
Directions for use Introduction CAUTION Use the device in the environment described in this directions for use. Otherwise, you will compromise the device's performance and reduce its lifetime. CAUTION Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by authorized service centers. CAUTION Report any unexpected operation or events to the manufacturer. CAUTION Use a soft cloth to clean the entire unit. Do not use any abrasive or volatile cleaners.
8 Introduction Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Controls and indicators Device front No.
Directions for use Introduction Device back No. Feature Description 1 Direct current power connection When used with an accessory power cord (optional), connects the device to a power outlet 2 Battery compartment (behind cover) Houses 4 AA alkaline batteries Power options CAUTION To get optimal performance and protect your device, use only the correct batteries or the Welch Allyn-approved power adapter.
10 Introduction Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Screen elements The liquid crystal display (LCD) displays the following: systolic blood pressure (mmHg), diastolic blood pressure (mmHg), pulse rate (bpm), heart beat while acquiring blood pressure measurements, excessive motion alert, alarm priority, and battery charge level.
Directions for use Introduction Symbol Description Reading out of range Either SYS > 260mmHg or DIA > 220mmHg. The symbol may appear in either the SYS or DIA area of the screen. Alarm priority = Low (an ! appears near the top of the screen) Reading out of range Either SYS < 50mmHg or DIA <25mmHg. The symbol may appear in either the SYS or DIA area of the screen. Alarm priority = Low (an ! appears near the top of the screen) Insert or replace the batteries WARNING Injury risk. Do not burn batteries.
12 Introduction Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Before taking an NIBP measurement, follow these steps to properly attach the cuff to the patient. For information about obtaining blood pressure measurements, refer to Blood pressure guidelines at: https://www.welchallyn.com/probp2000.To achieve an accurate blood pressure reading, follow these steps to position the blood pressure cuff properly. 1. Place the cuff on a bare arm. 2. Use the proper size cuff.
13 Maintenance Maintain the device The device does not require calibration. To get the best performance from your device, follow the maintenance steps below. • Store the device in a dry place away from direct sunlight. • Avoid shaking and dropping the device. • Avoid operating the device in dusty and unstable temperature environments. Visible soil must be removed prior to cleaning and disinfection.
14 Maintenance Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Troubleshooting This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure device. If the device is not operating as you think it should, check here before contacting Welch Allyn Technical Support: http://www.welchallyn.com/support. Problems and error messages The device presents technical alarms and low-priority physiological alarms.
Directions for use Maintenance Physiological alarms Symptom Root cause Solution Out of range. Either SYS >260mmHg or DIA >220mmHg. The symbol may appear in either the SYS or DIA area of the screen. Press and hold the Power button. Measure again. If the problem persists, contact www.welchallyn.com for further assistance. Alarm priority = Low Out of range. Either SYS <50mmHg or DIA <25mmHg. The symbol may appear in either the SYS or DIA area of the screen. Press and hold the Power button.
16 Maintenance Welch Allyn ProBP™ 2000 Digital Blood Pressure Device
17 Specifications Item Specification Model 2000-A Power supply: Battery powered mode 6VDC 4 AA batteries Power supply: AC adapter powered mode Input: 100–240V, 50–60Hz, 400mA Output: 6V, 1A Power supply model number UE08WCP-06100SPA Display mode Digital LCD V.A.
18 Specifications Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Item Specification Protection against ingress of water IP22 Software version A01
Directions for use Specifications 19 Transducer accuracy test Required tools, equipment, and accessories To complete the transducer accuracy test, the following tools and accessories are required: • scissors or other cutting device • one 4-way hose barb tee for 1/8 inch ID tubing • a minimum of 32 inches of 1/4 inch (.25) OD and 1/8 inch (.
20 Specifications Welch Allyn ProBP™ 2000 Digital Blood Pressure Device 2. Set up the test equipment. a. Connect the device tubing to the 4-way tee. b. Connect the silicone rubber tubing to the 4-way tee and to the 500 ml volume port of the test manifold. c. Connect the hand bulb (with bleed valve) to the silicone rubber tubing and to the 4-way tee. d. Connect the pressure meter simulator to the silicone rubber tubing and to the 4way tee. 3.
Directions for use Specifications 21 12. After the test completes, disassemble the test equipment and slide the end of the device tubing over the Flexiport® hose fitting barb. 13. Open the battery door and remove one of the batteries to power off the device. Note Press the Power button to ensure that all power has been removed from the device. The device can now be powered on to begin using the device in normal mode.
22 Specifications Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Item Standard Small-bore connectors IEC 80369-5 Small-Bore Connectors for Liquids and Gases in Healthcare Applications - Part 5: Connectors for Limb Cuff Inflation Applications
23 Warranty Welch Allyn will warranty the blood pressure device to be free of defects in material and workmanship and to perform in accordance with manufacturer specifications for the period of one year from the date of purchase from Welch Allyn or its authorized distributors or agents.
24 Warranty Welch Allyn ProBP™ 2000 Digital Blood Pressure Device
25 Approved accessories Item Description REUSE-11L Adult long cuff (25–34cm) 107041 RPM BP AC Adapter. This adapter is an alternate power source for the blood pressure device. For a list of additional cuff sizes visit www.welchallyn.com/probp2000.
26 Approved accessories Welch Allyn ProBP™ 2000 Digital Blood Pressure Device
27 EMC guidance and manufacturer’s declarations EMC guidance This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided. This unit also can be affected by portable and mobile RF communications equipment. WARNING Patient injury risk. The device has not been designed for use with high-frequency (HF) surgical equipment and does not protect against hazards to the patient.
28 EMC guidance and manufacturer’s declarations Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Emissions and immunity information Electromagnetic emissions The ProBP™ 2000 Digital Blood Pressure Device is intended for use in the electromagnetic environment specified below. The customer or user of the ProBP™ 2000 Digital Blood Pressure Device should assure that it is used in such an environment.
Directions for use EMC guidance and manufacturer’s declarations 29 Guidance and manufacturer’s declaration – electromagnetic immunity IEC 61000-4-11 Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8 0% 1 cycle and 70% 0% 1 cycle and 70% 25/30 cycles 25/30 cycles Single phase: at 0 0% 300 cycle Single phase: at 0 0% 300 cycle 30 A/m 30 A/m 50Hz/60Hz 50Hz/60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environme
30 EMC guidance and manufacturer’s declarations Welch Allyn ProBP™ 2000 Digital Blood Pressure Device Guidance and manufacturer’s declaration –electromagnetic immunity If the measured field strength in the location in which the ProBP™ 2000 Digital Blood Pressure Device is used exceeds the applicable RF compliance level above, the ProBP™ 2000 Digital Blood Pressure Device should be observed to verify normal operation.
Directions for use EMC guidance and manufacturer’s declarations 31 Guidance and manufacturer’s declaration –electromagnetic immunity 450 380-390 2 0.3 28 0.2 0.3 9 2 0.3 28 GSM 1800; CDMA 1900; Pulse GSM 1900; modulation b) DECT; LTE 217Hz Band 1, 3, 4, 25; UMTS 2 0.3 28 Blue-tooth, Pulse WLAN, 802. modulation b) 11 b/g/n, 217Hz RFID 2450, LTE Band 7 2 0.3 28 0.2 0.
