Related Manuals for Welch Allyn Welch Allyn Home 1500 Series
Summary of Contents for Welch Allyn Welch Allyn Home 1500 Series
- Page 1 Welch Allyn Home™ Blood Pressure Monitor 1500 Series Directions for use 901042 Automated Blood Pressure System RPM-BP100 Software version 1.X...
- Page 2 Bluetooth SIG, Inc. and any use of such marks by Welch Allyn is under license. Software in this product is © 2017 Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide.
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Page 3: Table Of Contents
Directions for use iii Contents Contents ......iii Introduction ......1 Indications for use. - Page 4 Welch Allyn Home Blood Pressure Monitor Blood pressure facts, pointers, and best practices ......33 Helpful definitions .
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Page 5: Introduction
Directions for use 1 Introduction The Welch Allyn Home™ Blood Pressure Monitor 1500 Series (blood pressure monitor) is indicated for adult use in the home or domestic setting only. The design provides you with two years of reliable service. Readings taken by the... -
Page 6: Contraindications
Welch Allyn Home Blood Pressure Monitor Contraindications This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator. This blood pressure monitor is not intended to be a diagnostic device. -
Page 7: Symbols
Directions for use 3 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. -
Page 8: Shipping, Storing, And Environment Symbols
Welch Allyn Home Blood Pressure Monitor Shipping, storing, and environment symbols Relative humidity limits Recycle the product separate from other disposables Temperature limits Atmospheric air pressure Recycle Stacking limit by number... -
Page 9: Blood Pressure Device And Cuff Symbols
Directions for use 5 Blood pressure device and cuff symbols Artery marker Range Index edge Limb circumference (Minimum/Maximum) Lot code Not made with natural rubber latex... -
Page 10: Miscellaneous Symbols
Welch Allyn Home Blood Pressure Monitor Miscellaneous symbols Type BF applied part Serial number Product Identifier Manufacturer Reorder number, Model number Non-ionizing electromagnetic radiation Global Trade Identification Number Class II equipment... - Page 11 Directions for use 7 IP22 Ingress protection: the device is protected against solid foreign objects of 12.5mm and greater and against vertically falling water drops when ENCLOSURE is tilted up to 15° Bluetooth...
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Page 12: About Warnings And Cautions
Welch Allyn Home Blood Pressure Monitor About warnings and cautions Caution statements can appear on the Welch Allyn Home blood pressure device, the packaging, the shipping container, or in this Directions for use. The Welch Allyn Home blood pressure device is safe for adults when used in... -
Page 13: Warnings And Cautions
Directions for use 9 equipment or other property, or loss of measurement data. Warnings and cautions WARNING Injury risk. The device is not suitable for measuring the blood pressure of neonatal infants or children. WARNING Injury risk. The device is not suitable for use on pregnant women, users with implanted electrical devices, users with... - Page 14 Welch Allyn Home Blood Pressure Monitor WARNING Injury risk. The device is not intended to be a self- measurement station used in a public place or center. WARNING Injury risk. Do not burn batteries. Batteries may leak or explode. WARNING Injury risk. If you...
- Page 15 Directions for use 11 WARNING Injury risk. Do not kink the connection tube during use. The cuff pressure might continuously increase, which could prevent blood flow and result in injury. WARNING Injury risk. Never apply the cuff over damaged skin. This can cause further injury.
- Page 16 Welch Allyn Home Blood Pressure Monitor WARNING Injury risk. Do not service or perform any maintenance while using the device. WARNING Injury risk. Use only accessories approved by the manufacturer. Using unapproved accessories might cause damage to the unit and injure users.
- Page 17 Directions for use 13 Caution This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than arm or for functions other than obtaining a blood pressure measurement. Caution Do not wrap the cuff on the same arm to which another monitoring device is applied.
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Page 18: Contents List
Welch Allyn Home Blood Pressure Monitor 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. -
Page 19: Controls And Indicators
Directions for use 15 Controls and indicators Monitor front Feature Description D-Ring Apply to upper arm to blood take a blood pressure pressure measurement cuff Air tube Connects the cuff to the air connector plug Air tube connects to the connector air connector plug plug... - Page 20 Welch Allyn Home Blood Pressure Monitor Feature Description Displays blood pressure Display reading and other pertinent information regarding the reading Monitor back Feature Description Direct When used with an current accessory power cord power (not included), connects connection the monitor to a power...
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Page 21: Power Options
Directions for use 17 Power options Caution To get optimal performance and protect your monitor, use only the correct batteries or the Welch Allyn- approved power adapter. The monitor is powered by one of two sources: • 4 AA alkaline batteries •... -
Page 22: Screen Elements
Welch Allyn Home Blood Pressure Monitor Screen elements The liquid crystal display (LCD) displays the following: systolic blood pressure (mmHg), diastolic blood pressure (mmHg), pulse rate (bpm), heart beat (regular or irregular) while acquiring blood pressure measurements, excessive motion alert, Bluetooth connectivity status or data transmission error, alarm priority, and battery charge level. - Page 23 Directions for use 19 Symbol Description Systolic blood pressure mmHg = measurement unit of the blood pressure Diastolic blood pressure mmHg = measurement unit of the blood pressure Pulse in beats per minute Irregular heartbeat Monitor is detecting an irregular heartbeat during measurement Heart beat Monitor is detecting a...
- Page 24 Welch Allyn Home Blood Pressure Monitor Symbol Description Bluetooth connectivity status or data transmission error Motion indicator Motion may result in an inaccurate measurement. Reading out of range Either SYS > 260mmHg or DIA > 220mmHg. The symbol may appear in either the SYS or DIA area of the screen.
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Page 25: Measuring Blood Pressure
Blood pressure air tube To save and transfer blood pressure measurements, you also need a smartphone or tablet with Bluetooth wireless connectivity and the application or software to receive your data, such as the Welch Allyn Home application or another healthcare provider application. -
Page 26: Set Up Your Equipment
Welch Allyn Home Blood Pressure Monitor Set up your equipment Insert or replace the batteries WARNING Injury risk. Do not burn batteries. Batteries may leak or explode. Caution Remove the batteries if the device is not used regularly. Caution Dispose of old batteries by following your local recycling guidelines. -
Page 27: Connect The Blood Pressure Air Tube
Directions for use 23 Install the batteries by matching the polarity as shown in the diagram. Replace the cover. Connect the blood pressure air tube Locate the air connector plug on the left side of the blood pressure monitor. - Page 28 Welch Allyn Home Blood Pressure Monitor Place your thumb and forefinger on the metal air tube connector and slide it onto the air connector plug. Confirm that the air tube connector locks into place. Listen for a click. When the air tube connector is properly seated, you cannot pull it off the air connector plug.
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Page 29: Pair A Smartphone, A Tablet, Or A Communication Hub With The Monitor
You have two alternatives to pair the monitor with these devices: • If you are using the Welch Allyn Home application, follow the pairing instructions presented in the application. • Contact your Remote Monitoring... -
Page 30: Position The Blood Pressure Cuff
Welch Allyn Home Blood Pressure Monitor seconds to power on the device and activate Bluetooth pairing. The Bluetooth symbol flashes while discovering the monitor. If successful, a steady symbol surrounded by a dotted line appears on the LCD screen. If unsuccessful, the appears. - Page 31 Directions for use 27 Place the cuff loosely over your arm so that the blood pressure tube extends down over your hand. It should appear on your arm as shown. Open the cuff to resize it as needed and slide it over your bare upper arm. The bottom edge of the cuff should be 2 to 3 centimeters (0.8 to 1.2 inches) above the bend in your arm,...
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Page 32: Start The Measurement
Welch Allyn Home Blood Pressure Monitor Keeping the artery marker and the tube in place, wrap the cuff snugly around your arm, but not too tight. If you can insert just two fingers between the cuff and your arm, the tightness is acceptable. - Page 33 Directions for use 29 Ensure the cuff is level with your heart (right atrium). Rest for 5 minutes after sitting down and positioning the blood pressure cuff. Verify that the cuff is positioned correctly with the tube running down the middle of your forearm. Press the Power button to power up the monitor and begin the blood pressure measurement.
- Page 34 Welch Allyn Home Blood Pressure Monitor Record your measurement results. Either record these measurements manually along with the time of measurement, or transfer them electronically to your connected device. Caution The device that receives transferred measurements displays the most recent record first as record 1.
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Page 35: Some Points To Remember About Your Blood Pressure Device
Directions for use 31 Some points to remember about your blood pressure device: • After 10 seconds of inactivity, the device powers down. • If you press and release the Power button, the device powers down. • After successful transfer, the device powers off the Bluetooth radio, and the Bluetooth icon (and rectangle) disappear. -
Page 36: Disconnect The Blood Pressure Air Tube
Welch Allyn Home Blood Pressure Monitor Disconnect the blood pressure air tube NoteYou may leave the air tube connected to the blood pressure monitor if you take your blood pressure regularly. Store the monitor and cuff in a convenient place; do not kink the tube. -
Page 37: Blood Pressure Facts, Pointers, And Best Practices
Directions for use 33 Blood pressure facts, pointers, and best practices Helpful definitions When ventricles Systolic pressure contract and pump blood out of your heart, the point at which blood pressure reaches its maximum value in the cycle. When the ventricles Diastolic pressure relax, the point at which blood pressure reaches its minimum value in the cycle. - Page 38 Welch Allyn Home Blood Pressure Monitor Caution The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice.
- Page 39 Directions for use 35 Factors that could cause inaccurate measurements • Cuff position is poor • Cuff is too loose or too tight • Cuff is applied over clothing rather than on a bare upper arm • Taking a measurement within 1 hour of eating or drinking •...
- Page 40 Welch Allyn Home Blood Pressure Monitor and before taking a blood pressure measurement • Sitting still during measurement • Not talking during measurement • Waiting at least 3 minutes between measurements...
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Page 41: Maintenance
Directions for use 37 Maintenance Maintain the monitor and cuff The monitor does not require calibration. To get the best performance from your monitor, follow the maintenance steps below. • Store the unit in a dry place away from direct sunlight. •... -
Page 42: Troubleshooting
Welch Allyn Home Blood Pressure Monitor Troubleshooting This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the device is not operating as you think it should, check here before arranging for service. - Page 43 Directions for use 39 Problem Symptom Root Solution cause The display Batteries are Replace batteries indicates low. with new the “BAT- batteries LO” message, pauses for 3 seconds. The battery icon shows empty (does not flash.) Error E 01 shows The cuff is Readjust messages...
- Page 44 Welch Allyn Home Blood Pressure Monitor Problem Symptom Root Solution cause E 20 shows Loosen measurem clothing process on the does not arm and detect a then pulse measure signal again E 21 Relax for shows measure- ment is moment...
- Page 45 Directions for use 41 Problem Symptom Root Solution cause Visit www.welchallynhome.com for further assistance.
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Page 46: Physiological Alarms
Welch Allyn Home Blood Pressure Monitor Physiological alarms Symptom Root cause Solution Out of range. Press and Either SYS hold the >260mmHg or Power button to >220mmHg. reestablish The symbol Bluetooth may appear in connectivity. either the SYS Measure or DIA area of again. -
Page 47: Specifications
Directions for use 43 Specifications Item Specification Power supply: 6VDC 4*AA batteries Battery powered mode: Power supply: AC Input: 100-240V, 50- adapter powered 60Hz, 400mA; mode: Output: 6V, 1A Power supply model UE08WCP-06100SPA number Display mode Digital LCD V.A.68mm*90mm Measurement model Oscillometric testing mode Measurement range Rated cuff pressure:... - Page 48 Welch Allyn Home Blood Pressure Monitor Item Specification Normal working Temperature: 5°C to conditions 40°C Relative humidity 85% Atmospheric pressure: 86kPa to 106kPa Storage and Temperature:-20°C to transportation 60°C condition Relative Humidity: 10% RH–93% RH Atmospheric Pressure: 50kPa to 106 kPa...
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Page 49: General Radio Compliance
Directions for use 45 General radio compliance Item Specification Bluetooth Module No. AW2540MV1 Radio Frequency 2402 MHz to 2480 MHz (RF) Range Output Power -1.0 dBm Supply Voltage 2.0 to 3.6V Antenna Gain 0.0 dBi Transmitting Distance 10 meters (30 feet) Federal Communication Commission (FCC) Interference Statement This device complies with part 15 of the... - Page 50 Welch Allyn Home Blood Pressure Monitor Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
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Page 51: Fcc Radiation Exposure Statement
Directions for use 47 void the user's authority to operate this equipment. FCC Radiation Exposure Statement This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. - Page 52 Welch Allyn Home Blood Pressure Monitor d'antennes à gain supérieur non garantis avec ce produit est interdite. L'appareil ne doit pas être installé à proximité d'un autre émetteur. This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two...
- Page 53 Directions for use 49 répertoriée dans la table des spécifications. This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.
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Page 54: Complied Standards List
Welch Allyn Home Blood Pressure Monitor Complied standards list Item Standard Risk ISO/EN 14971 Medical management devices — Application of risk management to medical devices Labeling ISO/EN 15223-1 Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. - Page 55 Directions for use 51 Item Standard Electromagnetic IEC/EN 60601-1-2 Medical compatibility electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests Performance IEC 80601-2-30 Medical requirements electrical equipment- Part and clinical 2-30: Particular investigation...
- Page 56 Welch Allyn Home Blood Pressure Monitor Item Standard Usability IEC 62366 Medical devices - Application of usability engineering to medical devices (IEC 62366) IEC 60601-1-6 Medical electrical equipment - Part 1 -6: General requirements for basic safety and essential performance - collateral...
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Page 57: Warranty
Directions for use 53 Warranty Welch Allyn will warranty the blood pressure monitor to be free of defects in material and workmanship and to perform in accordance with manufacturer specifications for the period of two years from the date of purchase from Welch Allyn or its authorized distributors or agents. - Page 58 Welch Allyn Home Blood Pressure Monitor The product warranty is also subject to the following terms and limitations. • Accessories are not covered by the warranty. • Shipping cost to return a device to a Welch Allyn service center is not included.
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Page 59: Approved Accessories
Directions for use 55 Approved accessories Item Description RPM-BPACC-02 D-Ring Standard Wide Cuff (22-42cm) RPM-BPACC-04 RPM BP AC Adapter. This adapter is an alternate power source for the blood pressure monitoring device. - Page 60 Welch Allyn Home Blood Pressure Monitor...
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Page 61: Emissions And Immunity Information
Emissions and immunity information Electromagnetic emissions The Welch Allyn Home Blood Pressure Monitor RPM-BP100 is intended for use in the electromagnetic environment specified below. The customer or user of the Welch Allyn Home Blood Pressure Monitor should assure that it is used in such an environment. - Page 62 Electromagnetic emissions RF emissions Class B The Welch Allyn Home Blood Pressure Monitor is suitable for use in all establishments, including domestic CISPR 11 establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
- Page 63 Electromagnetic immunity The Welch Allyn Home Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn Home Blood Pressure Monitor should assure that it is used in such an environment.
- Page 64 40% U 40% U recommended that the Welch Allyn Home Blood Pressure Monitor be IEC 61000-4-11 (60% dip in U (60% dip in U powered from an uninterruptible...
- Page 65 Electromagnetic immunity The Welch Allyn Home Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn Home Blood Pressure Monitor should assure that it is used in such an environment.
- Page 66 Electromagnetic immunity Radiated RF 3 V/m 3 V/m d = 1,2 80 to 800 MHz IEC 61000-4-3 80 MHz to 1 GHz d = 2,333 800 MHz to 2,5 GHz where P is the maximum output power rating ofthe transmitter in watts (W) and d is the recommended separation distance in meters (m).
- Page 67 If the measured field strength in the location in which the Welch Allyn Home Blood Pressure Monitor is used exceeds the applicable RF compliance level above, the Welch Allyn Home Blood Pressure Monitor should be observed to verify normal operation.
- Page 68 Welch Allyn Home Blood Pressure Monitor The Welch Allyn Home Blood Pressure Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Welch Allyn Home Blood Pressure Monitor can help prevent electromagnetic interference...
- Page 69 Recommended separation distances between portable and mobile RF communications equipment and the Welch Allyn Home Blood Pressure Monitor For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
- Page 72 Welch Allyn® Home™ Blood Pressure Monitor Model: RPM-BP100 726882 DIR 80022180 Ver. A...