Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Directions for use
© 2011 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided byWelch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.
iii Contents Initial device setup ................................................................................. 1 Introduction ............................................................................................. 3 Intended use ...................................................................................................................................... 3 Symbols ...................................................................................................
iv Contents Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Battery ................................................................................................... 31 Startup .................................................................................................... 33 Standby mode ....................................................................................... 35 Blood pressure measurement .............................................................. 37 Settings ......
Directions for use Contents v Appendix ................................................................................................ 69 ProBP 3400 approved accessories .............................................................................................. 69 Configuration options .....................................................................................................................
vi Contents Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
1 Initial device setup Before using ProBP 3400 for the first time, you must configure the device for use. See Setup for additional information.
2 Initial device setup Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
3 Introduction This Directions for use manual is a comprehensive guide designed to help you understand the capabilities and operation of the ProBP 3400 non-invasive blood pressure device. The information in this manual includes all options available with the device. Read this manual thoroughly before attempting to setup, configure, use, troubleshoot, or maintain the device.
4 Introduction Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
5 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. Consult operating instructions.
6 Symbols Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Navigation (Up, Down, Left, Right) Shipping, storing, and environment symbols IPXØ Fragile; handle with care Relative humidity limits Temperature limits Lithium-ion battery Recovery/Recyclable Recycle the product separate from other disposables This end up Keep dry Equipment is not protected against the ingress of liquid Connectivity symbols Bluetooth® wireless technology enabled USB connection Devices are connected via
Directions for use Symbols Class II equipment Available for sale only upon order of a physician or licensed health care provider Serial number Manufacturer Reorder number Call for maintenance Non-ionizing electromagnetic radiation 7
8 Symbols Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
9 General warnings and cautions WARNING The information in this directions for use is a comprehensive guide to the operation of ProBP 3400. For best results, read this directions for use thoroughly before using the device. WARNING The device is designed for medical clinician use. Although this directions for use may illustrate medical spot-check techniques, only a trained clinician who knows how to take and interpret a patient's vital signs should use this device.
10 General warnings and cautions Welch Allyn Connex® ProBP™ 3400 digital blood pressure device WARNING Welch Allyn is not responsible for the integrity of any mounting installation. Welch Allyn 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 is not defibrillator proof. WARNING The device may not function properly if dropped or damaged.
Directions for use General warnings and cautions 11 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. Caution Always unplug the external power source from the outlet before moving the device to a new location.
12 General warnings and cautions Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
13 NIBP warnings and cautions WARNING ProBP 3400 is not intended to measure blood pressure on neonatal patients. The AAMI SP10:2002 standard defines neonates as children 28 days or less of age if born at term (37 weeks gestation or more); otherwise up to 44 gestational weeks. WARNING To ensure pediatric blood pressure accuracy and safety, the Small Child Reusable Cuff (REUSE-08) and the Small Child Disposable Cuff (SOFT-08) are the smallest cuffs approved for use with young children.
14 NIBP warnings and cautions Welch Allyn Connex® ProBP™ 3400 digital blood pressure device WARNING NIBP measurements may be inaccurate in the presence of excessive motion artifact. Minimize extremity and cuff motion during blood pressure readings. WARNING The position and physiologic condition of the subject can affect a blood pressure reading. WARNING If the blood pressure cuff is not at heart level, note the difference in reading due to the hydrostatic effect. Add the value of .2 kPa (1.
15 Contents checklist Unpack the ProBP 3400 and any applicable accessories and inspect for missing items. Retain the shipping materials in the event of shipping damage or for return, if necessary, to Welch Allyn for repair or warranty service. Report any signs of shipping damage to the carrier. Report any missing or damaged items to the Welch Allyn Service Center near you. All ProBP 3400 devices include the following components: ProBP 3400 Device.
16 Contents checklist Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
17 Controls and indicators 1. 2. 3. 4. 5. 6. 7. 8. 9. Power on/power off button: controls power to the device. Blood Pressure Start/Stop button: initiates a new blood pressure cycle from the Home screen. Pressing again aborts an active blood pressure measurement. This button returns user to the Home screen from any other screen on the device. Up navigation button: highlights the previous option in the Display window or increases numeric values. Return button: returns the user to the previous screen.
18 Controls and indicators Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
19 Screen elements The liquid crystal display (LCD) may indicate any of the following: systolic blood pressure (mmHg or kPa), diastolic blood pressure (mmHg or kPa), MAP (mmHg or kPa), pulse rate (bpm), date, time, record number, and battery charge level. Note 1. 2. 3. 4. 5. 6. 7. Your model may not contain all of these options. NIBP display: shows systolic and diastolic values of NIBP readings. Bluetooth radio status (if equipped): indicates status of Bluetooth radio. USB: indicates USB is connected.
20 Screen elements Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
21 Connections 1. 2. 3. 4.
22 Connections Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
23 Blood pressure hose and cuff Identify and have available the ProBP 3400, blood pressure cuff, and the blood pressure hose. 1. 2. 3. Inspect the blood pressure hose; notice that one end has a single, gray Welch Allyn FlexiPort fitting and the other end is plain with two recessed holes. Completely push the plain end of the blood pressure hose onto the two silver blood pressure ports on the device. Make sure the hose is fully seated. Snap the Welch Allyn FlexiPort connector onto the blood pressure cuff.
24 Blood pressure hose and cuff Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Cuff Size Soft Disposable One-Piece Cuff (5 per pack) Reusable OnePiece Cuff (1 per pack) Circumference (cm) Circumference (in) Small child (size 8) Soft-08 Reuse-08 12.0 – 16.0 4.7 – 6.3 Child (size 9) Soft-09 Reuse-09 15.0 – 21.0 5.9 – 8.3 Small adult (size 10) Soft-10 Reuse-10 20.0 – 26.0 7.9 – 10.2 Adult (size 11) Soft-11 Reuse-11 25.0 – 34.0 9.8 – 13.
25 Power transformer Power transformer and wall plug/line cord assembly The power transformer and wall plug are packaged separately and must be assembled prior to use. The power transformer assembles to a line cord for the mobile stand configuration of the ProBP 3400. 1. Align the grooves in the wall plug or line cord with the casing located on the transformer. Ensure that the two prong plug on the wall plug or line cord and the plug receptacle on the power transformer are aligned. 2.
26 Power transformer Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Charge the device Charge the ProBP 3400 with the Welch Allyn-supplied power supply. To charge the device: 1. Insert the USB B connector into the USB/external power connection port on the back of the device. 2. Insert the other end of the USB cord into USB connector on the power transformer, then plug the transformer into the main power source.
27 Setup Before first-time use of the ProBP 3400, complete the following steps: Insert the battery The battery is shipped separately from the ProBP 3400 device. You must install and charge the battery for six hours before the device can be used. 1. Remove the screw from the battery compartment door with a Phillips screwdriver. 2. Remove the battery compartment door. 3. Remove the battery from the shipping bag. 4.
28 Setup Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Mount the device For mounting instructions, see the accessory's directions for use. For mounting options, see the ProBP 3400 approved accessories in the Appendix. Assemble power cord and wall plug/line cord 1. Align the grooves and two prong plug in the wall plug or line cord with the casing and plug receptacle located on the transformer. 2. Slide the wall plug or line cord onto the transformer until it is firmly seated.
Directions for use Setup Set time and time format 1. The Time format field is highlighted. Press the Up navigation or Down navigation buttons to access the correct format option. 2. Press the Select button to accept the time format as shown. 3. Press the Down navigation button to highlight the time. 4. Press the Select button. The first numeric field is highlighted for editing. 5.
30 Setup Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
31 Battery 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.
32 Battery Welch Allyn Connex® ProBP™ 3400 digital blood pressure device 5. Replace the battery compartment door. 6. Secure the screw with the screwdriver. The battery charges when the ProBP 3400 is connected to an external power source. While the ProBP 3400 is charging, the indicator, symbol displays an amber indicator and the battery charging , displays on the Home screen. The battery charging indicator is only visible when the device is powered on.
33 Startup Press the Power on/power off button to turn the device on or off. Upon each power up, the display lights up and the ProBP 3400 displays the model number. When the internal self-check completes, the display shows the Home screen with all values blank, and the device is ready for operation. If disconnected from an external power source, the ProBP 3400 automatically powers off when not used for 30 minutes.
34 Startup Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
35 Standby mode The standby mode conserves battery power. The display goes black, then enters standby mode two minutes after a reading or last button pressed. Press any button to bring the ProBP 3400 out of Standby Mode. If disconnected from an external power source, the ProBP 3400 automatically powers off when not used for 30 minutes. When the device is connected to external power, the device will automatically power off after three hours of non-use.
36 Standby mode Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
37 Blood pressure measurement The preferred blood pressure measurement site for adults and children is the upper arm. Keep the patient’s arm relaxed and motion-free during measurement(s). 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.
38 Blood pressure measurement Welch Allyn Connex® ProBP™ 3400 digital blood pressure device When complete, the ProBP 3400 device displays systolic, diastolic, pulse rate measurements, and if enabled, MAP calculation.
39 Settings 1. From the Home screen, press the Right navigation button. Settings is highlighted. 2. Press the Select button. The Settings menu displays. 3. Use Up or Down navigation buttons to highlight the Unit of measure, Pressure preset, Bluetoothradio, or Advanced menus. Note The Bluetooth radio menu option is only visible for devices that contain the Bluetooth licensed feature. The NIBP algorithm is only visible for devices that contain the SureBP licensed feature.
40 Settings Welch Allyn Connex® ProBP™ 3400 digital blood pressure device The default unit of measure is mmHg. Pressure presets To select a pressure preset: 1. From the Settings screen, use Up or Down navigation buttons to highlight Pressure presets. 2. Press the Select button. The Pressure presets menu displays. 3. Use Up or Down navigation buttons to highlight desired pressure. 4. Press the Select button to select the pressure. The default inflation pressure is 160 mmHg or 21.3 kPa.
Directions for use Settings 41 Connect the ProBP 3400 to a target device When the ProBP 3400 is paired to a target device, it will attempt to automatically reconnect each time you turn on the ProBP 3400. If the devices do not connect within 60 seconds of turning on the ProBP 3400, the Bluetooth radio will shut down to conserve battery power. If the ProBP 3400 does not automatically reconnect, 1. Press the Power on/power off button to turn the device off. 2.
42 Settings Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Select date To modify the date shown on the Home screen: 1. From the Advanced screen, use Up or Down navigation buttons to highlight Date. 2. Press the Select button to edit the entry. 3. The Date format field is highlighted. Press the Up navigation or Down navigation buttons to access the correct format option. 4. Press the Select button to accept the date format as shown. 5.
Directions for use Settings 43 NIBP algorithm To modify the NIBP algorithm used on the device: 1. From the Advanced screen, use Up or Down navigation buttons to highlight NIBP algorithm. 2. Press the Select button to edit the entry. 3. Use the Up or Down navigation buttons to highlight SureBP or Step. 4. Press the Select button to accept the entry as shown. If SureBP is selected, the device inflates the cuff to the appropriate level, measuring the blood pressure as the cuff is inflating.
44 Settings Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
45 Data review Data is accessed through the Review menu. Data can be identified by number, date, time reading was taken, diastolic/systolic parameters, MAP, and pulse rate data captured at the time of the reading. Review data 1. From the Home screen, press the Left navigation button. The Review menu option is highlighted. 2. Press the Select button. Review menu displays. 3. Use Up or Down navigation buttons to review the desired reading. Delete data 1.
46 Data review Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
47 Maintenance and service Calibrate the device Welch Allyn recommends annual calibration of the ProBP 3400. To calibrate the ProBP 3400, • Use the Welch Allyn Service Tool. • Send the device to a Welch Allyn Service Center near you. Change the battery 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.
48 Maintenance and service Welch Allyn Connex® ProBP™ 3400 digital blood pressure device To remove the battery: 1. Remove the screw from the battery compartment door with a Phillips screwdriver. 2. Remove the battery compartment door. 3. Remove the battery from the battery compartment. 4. Remove the new battery from the shipping bag. 5. Using the polarized guidelines on the battery label, insert the battery, positive (+) side first, into the battery compartment. 6.
Directions for use Maintenance and service 49 10 percent chlorine bleach/90 percent water solution 1. Wipe the device with a clean cloth slightly dampened with a 10 percent bleach and 90 percent water solution. 2. Rinse with a clean cloth slightly dampened with clean water. 3. Allow the device surface to dry for a minimum of 10 minutes before using the device. Clean the accessories Wipe the NIBP hose and any reusable cuffs with a damp cloth moistened in a mild detergent solution.
50 Maintenance and service Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
51 Specifications Physical specifications Performance This section describe normal ranges for the ProBP 3400 device. Blood Pressure Accuracy Blood pressure accuracy meets or exceeds ANSI.AAMI SP10:2002 standards for noninvasive blood pressure accuracy (±5 mmHg mean error, 8 mmHg standard deviation). Blood pressure accuracy is validated for pressure measurement using the upper arm only.
52 Specifications Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Electrical specifications Power requirements: Input: 100-240VAC, 0.18A, 50-60Hz Output: 5VDC, 0.5A Degree of protection: Type BF applied part Safety classification: Class II Internally powered: Battery, lithium-ion type, 3.7V, 2100mAh, 7.
Directions for use Specifications Product disposal Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal information, see www.welchallyn.
54 Specifications Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
55 Standards and compliance General radio compliance The Bluetooth Wireless Card must be used in strict accordance with the manufacturer’s instructions as described in the user documentation that comes with the product. This device complies with Part 15 of the FCC rules and with the rules of the Canadian ICES-003.
56 Standards and compliance Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Welch Allyn is not responsible for any radio or television interference caused by unauthorized modification of the devices included with this Welch Allyn product, or the substitution or attachment of connecting cables and equipment other than specified by Welch Allyn. The correction of interference caused by such unauthorized modification, substitution, or attachment will be the responsibility of the user.
57 Guidance and manufacturer's declaration Emissions and immunity information Electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
58 Guidance and manufacturer's declaration Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Directions for use Guidance and manufacturer's declaration 59 Electromagnetic immunity whereP is the maximum output power rating of the transmitter in watts (W) andd is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a , should be less than the compliance level in each frequency range b.
60 Guidance and manufacturer's declaration Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Recommended separation distances between portable and mobile RF communications equipment and the device Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
61 Warranty Welch Allyn will warranty the ProBP 3400 device and battery 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. The warranty period shall start on the date of purchase.
62 Warranty Welch Allyn Connex® ProBP™ 3400 digital blood pressure device
63 Troubleshooting Inaccurate blood pressure readings Possible cause Corrective action and explanation Incorrect cuff size Use Welch Allyn approved cuffs only. Measure patient’s arm circumference midway between elbow and shoulder (see “Blood pressure cuff selection” to select correct cuff size). Patient’s arm position Ensure patient’s arm is at heart level. Arm movement during blood pressure cycle Keep arm still during blood pressure cycle. Movement may cause inaccuracies from artifact.
64 Troubleshooting Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Possible cause Corrective action and explanation recommends deflation no faster than 3 mmHg per second. Only use a sphygmomanometer that is calibrated. • An uncalibrated sphygmomanometer may result in inaccurate blood pressure measurements. Poor auscultatory sound recognition by observer Use high-quality stethoscope. Have a different observer check patient’s blood pressure.
Directions for use Troubleshooting 65 Possible cause Corrective action and explanation Device is being used in inclimate environment Ambient temperature is outside of operating range. Retry measurement may display. Operate the device within temperature range in the Environmental specifications section. Internal errors or messaging error occurred NIBP feature not functional. Call for service may display. Contact a Welch Allyn Service Center.
66 Troubleshooting Possible cause Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Corrective action and explanation the Step algorithm to inflate the cuff to a higher pressure, then attempt to measure the blood pressure while deflating the cuff. Arm movement during blood pressure cycle Keep arm still during blood pressure cycle. Movement may cause inaccuracies from artifact. Blood pressure taken over clothing Take blood pressure on a bare arm.
Directions for use Troubleshooting 67 Bluetooth troubleshooting ProBP 3400 and the target device will not pair Possible cause Corrective action and explanation Bluetooth radio is not enabled on the ProBP 3400 See Bluetooth wireless technology section for instructions on enablingBluetooth functionality in the device. ProBP 3400 is not in Pairing mode See Bluetooth wireless technology section for instructions on enabling pairing in the device.
68 Troubleshooting Welch Allyn Connex® ProBP™ 3400 digital blood pressure device ProBP 3400 and the target device lost connection Possible cause Corrective action and explanation Unexpected loss in Bluetooth communication The ProBP 3400 powered down 1. 2. 3. 4. Exit the target application. Power down the ProBP 3400 Restart the ProBP 3400 Relaunch the target application. There is too much distance between ProBP 3400 and Move the ProBP 3400 closer to the target device.
69 Appendix ProBP 3400 approved accessories Flexiport® cuffs (Latex free) Part Number Model Description Reuse-08 Reusable Cuff, reuse, SM CHILD, 2-tube Reuse-09 Reusable Cuff, reuse, CHILD, 2-tube Reuse-10 Reusable Cuff, reuse, SM AD, 2-tube Reuse-11 Reusable Cuff, reuse, ADULT, 2-tube Reuse-11L Reusable Cuff, reuse, AD LONG, 2-tube Reuse-12 Reusable Cuff, reuse, LG AD, 2-tube Reuse-12L Reusable Cuff, reuse, LG AD LONG, 2-tube Reuse-13 Reusable Cuff, reuse, THIGH, 2-tube Soft-08
70 Appendix Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Blood pressure accessories (Latex free) Part Number Model Description 3400-30 ProBP 3400 Double tube blood pressure hose (5 ft) 3400-31 ProBP 3400 Double tube blood pressure hose (10 ft) Mounting options Part Number Description 4600-61 Mobile stand with basket and mounting kit for ProBP 3400 4601-61 Wall mount with basket for ProBP 3400 4602-61 Desk mount for ProBP 3400 Accessories and replacement parts Part Number
Directions for use Appendix 71 Part Number Description PWCD-5WT-6 Power cord assembly 6, for mobile stand mounted ProBP 3400, Australia/New Zealand —Orange PWCD-5WW-C Power cord assembly C, for handheld, or desk or wall mounted ProBP 3400, China PWCD-5WT-C Power cord assembly C, for mobile stand mounted ProBP 3400, China PWCD-5WW-7 Power cord assembly 7, for handheld, or desk or wall mounted ProBP 3400, South Africa PWCD-5WT-7 Power cord assembly 7, for mobile stand mounted ProBP 3400, South Af
72 Appendix Welch Allyn Connex® ProBP™ 3400 digital blood pressure device Part Number Description Startup Guide 407673 Startup Guide ProBP 3400 Directions for Use, Mounting Options 104388 Directions for use, Mounting kit instructions for ProBP 3400 mobile stand 104387 Directions for use, Mounting kit instructions for ProBP 3400 wall mount 104386 Directions for use, Mounting kit instructions for ProBP 3400 desk mount Configuration options Model Description 34BFHT-B* Includes Welch Allyn SureBP
Directions for use Appendix 73 Model Description 34XXST-B* Includes rechargeable lithium-ion battery, size 11 and size 12 FlexiPort® cuffs, mobile stand mounted configuration *Replace final digit in model number with regional code listed in the table below.
