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Welch Allyn Home Directions For Use Manual Download Page 56

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Welch Allyn Home Blood Pressure Monitor

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
standard: Usability

Item

Standard

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Summary of Contents for Home

Page 1: ...Welch Allyn Home Blood Pressure Monitor Directions for use 901042 Automated Blood Pressure System Software version 1 X ...

Page 2: ...are in this product is Copyright 2016 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 Under such laws the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded The softwa...

Page 3: ...gs and cautions 9 Warnings and cautions 10 Contents list 15 Controls and indicators 16 Power options 18 Screen elements 19 Measuring blood pressure 22 Overview 22 Set up your equipment 23 Connect the blood pressure air tube 24 Pair a smartphone a tablet or a communication hub with the monitor 26 Position the blood pressure cuff 27 Start the measurement 29 Some points to remember about your blood p...

Page 4: ...r and cuff 38 Troubleshooting 39 Problems and error messages 39 Technical alarms 39 Physiological alarms 42 Specifications 43 General radio compliance 45 Federal Communication Commission FCC Interference Statement 46 FCC Radiation Exposure Statement 47 Industry Canada IC compliance 47 Complied standards list 50 Warranty 53 Approved accessories 55 Emissions and immunity information 57 ...

Page 5: ...nology that obtains a blood pressure reading during the inflation cycle as the cuff pumps up This technology allows for a faster more comfortable reading If on inflation SureBP Technology is unable to determine a blood pressure due to excessive patient movement or any arrhythmia it will inflate the cuff to a slightly higher pressure then measure the blood pressure while deflating the cuff providin...

Page 6: ...ng the monitor Read the manual thoroughly before using the monitor Indications for use The Welch Allyn Home blood pressure monitor is a digital monitor intended for use in measuring blood pressure and heart rate in adult patient populations with arm circumferences between 15 cm to 54 cm approximately 6 to 21 inches The device detects the appearance of irregular heartbeats during measurement and gi...

Page 7: ...cated 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 Contact your physician if hypertensive values are indicated ...

Page 8: ...is 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 Direct current Power ...

Page 9: ...ons for use 5 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 10: ...h Allyn Home Blood Pressure Monitor Blood pressure device and cuff symbols SureBP technology logo Artery marker Range Index edge Limb circumference Minimum Maximum Lot code Not made with natural rubber latex ...

Page 11: ... use 7 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 12: ... Home Blood Pressure Monitor 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 ...

Page 13: ...t familiarize yourself with all cautions with the steps to power up the device and with the sections of this Directions for use that pertain to your use of the device In addition to reviewing the general cautions presented in the next section you must also review the more specific cautions that appear throughout the manual in conjunction with setup startup operation and maintenance tasks Failure t...

Page 14: ...ibrillation peripheral arterial disease and patients undergoing intravascular therapy or arterio venous shunt or people who received a mastectomy Consult your doctor prior to using the unit if you suffer from any of these illnesses or conditions WARNING Patient injury risk Do not take any therapeutic measures on the basis of a self measurement Never alter the dose of a medicine prescribed by a doc...

Page 15: ...ely to release the air from the cuff Loosen and remove the cuff from your arm WARNING Patient injury risk On the rare occasion of a fault causing the cuff to remain fully inflated during measurement open the cuff immediately Prolonged high pressure applied to the arm cuff pressure 300mmHg or constant pressure 15mmHg for more than 3 minutes might lead to bruising and discolored skin WARNING Patient...

Page 16: ...ies adapter and the patient simultaneously WARNING Patient injury risk Do not use the unit if you are allergic to polyester or synthetic materials WARNING Patient injury risk Excessive tube lengths could cause strangulation if you don t manage them properly WARNING Patient injury risk Do not connect the air tube to other medical equipment This could cause air to be pumped into intravascular system...

Page 17: ...he device WARNING Patient injury risk Use only accessories approved by the manufacturer Using unapproved accessories might cause damage to the unit and injure patients WARNING Patient injury risk No modification to this equipment is allowed Modifying the equipment could damage the unit or endanger the user ...

Page 18: ...m at the same time Caution To avoid measurement errors avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient burst signal Caution The materials of the cuff have been tested and found to comply with requirements of ISO 10993 5 2009 and ISO 10993 10 2010 It will not cause any potential sensitization or irritation reacti...

Page 19: ... Directions for use 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 See the cleaning instructions presented later in this Directions for use ...

Page 20: ...re cuff Apply to upper arm to take a blood pressure measurement 2 Air tube Connects the cuff to the air connector plug 3 Air connector plug Air tube connects to the air connector plug 4 Power button Powers on the monitor starts and stops a blood pressure measurement and when pressed for 2 seconds initiates a Bluetooth pairing ...

Page 21: ...other pertinent information regarding the reading No Feature Description 1 Direct current power connection When used with an accessory power cord not included connects the monitor to a power outlet 2 Battery compartme nt behind cover Houses 4 AA alkaline batteries No Feature Description ...

Page 22: ...Power options The monitor is powered by one of two sources 4 AA alkaline batteries AC adapter 6v 1A not included Caution To get optimal performance and protect your monitor use only the correct batteries or the Welch Allyn approved power adapter ...

Page 23: ...e 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 24: ... 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 heartbeat during measurement Battery indicator Indicates the current battery charge Battery indicator Indicates the current battery charge ...

Page 25: ... 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 Symbol Description ...

Page 26: ...ur device and its accessories and you can change the batteries under normal circumstances To measure your blood pressure you need the following Blood pressure monitor with batteries inserted Blood pressure cuff D ring style for easy one handed adjustment Blood pressure air tube To save and transfer blood pressure measurements you also need a smartphone or tablet with Bluetooth wireless connectivit...

Page 27: ...ries when any of the following occurs The battery charge indicator indicates a low charge The display dims The display does not light up 1 Slide off the battery cover WARNING Patient 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 28: ...d Pressure Monitor 2 Install the batteries by matching the polarity as shown in the diagram 3 Replace the cover Connect the blood pressure air tube 1 Locate the air connector plug on the left side of the blood pressure monitor ...

Page 29: ...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 NoteYou may leave the air tube connected to the blood pressure monitor if you take your blood pressure regularly and have a convenient place to store the blood pressure monitor and cuff together without kinking the tube ...

Page 30: ...ent Monitoring Solution provider or use the instructions that office provided to set up these communications devices If you are using the Welch Allyn application follow the pairing instructions presented in the application With either alternative you complete the same steps on the monitor 1 Confirm that smartphone tablet or communication hub is powered on and in discoverable mode ready for pairing...

Page 31: ...dy symbol surrounded by a dotted line appears on the LCD screen If unsuccessful the appears Position the blood pressure cuff To achieve an accurate blood pressure reading follow these steps to position the blood pressure cuff properly 1 Remove any sleeves covering your upper arm NoteThe preferred site for taking a blood pressure measurement is your bare upper arm ...

Page 32: ... extends down over your hand should appear on your arm as shown 3 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 and the tube and artery marker should appear on your arm as shown shown ...

Page 33: ... too tight If you can insert just two fingers between the cuff and your arm the tightness is acceptable Start the measurement 1 Prepare yourself to take your blood pressure a Sit comfortably in a chair that supports your back b Keep legs uncrossed c Place feet flat on the floor d Support your arm on the flat surface ...

Page 34: ...in the blood pressure measurement The cuff inflates and tightens around your arm until it completes the measurement A vertical stack of segments appears onscreen to show increasing pressure in the cuff The heart icon in the upper left corner blinks to indicate your pulse rate until the measurement is complete When the inflation cycle is complete systolic and diastolic measurements as well as your ...

Page 35: ...he most recent record first as record 1 Each new measurement becomes record 1 and all other records move down the list for example 2 becomes 3 and so on You can store a maximum of 99 records When you pass that limit the oldest record drops from the list NoteFor a meaningful comparison try to take measurements under consistent conditions For example take daily measurements at approximately the same...

Page 36: ... 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 37: ...d portion of the metal air tube connector and pull it back Do not twist the connector 2 Gently pull the air tube away from the monitor You can now store the monitor and the cuff NoteYou may leave the air tube connected to the blood pressure monitor if you take your blood pressure regularly and have a convenient place to store the blood pressure monitor and cuff together without kinking the tube ...

Page 38: ...e A measurement of the heart rate or the number of times the heart beats per minute As the heart pushes blood through the arteries the arteries expand and contract with the flow of the blood Irregular heartbeat detector An irregular heartbeat IHB is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure During each measurement the monitor reco...

Page 39: ...lood pressure on your other arm Use the same arm for blood pressure measurements Medication might affect your blood pressure The white coat effect might cause your blood pressure to be higher in a hospital or doctor s office 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 f...

Page 40: ...ately after smoking or drinking caffeinated beverages Taking a measurement while talking or moving your fingers Taking a measurement when you need to urinate Taking measurements in rapid succession Factors that promote accurate blood pressure measurements Proper cuff position on the upper arm Proper cuff tightness No clothing under the cuff or restricting circulation above the cuff Proper posture ...

Page 41: ...Directions for use 37 and before taking a blood pressure measurement Sitting still during measurement Not talking during measurement Waiting at least 3 minutes between measurements ...

Page 42: ...unlight Avoid shaking and dropping the monitor Avoid operating the monitor in dusty and unstable temperature environments Cleaning 1 Clean the monitor only when necessary with one of the following compatible cleaning agents 70 isopropyl alcohol 10 chlorine bleach 90 water solution standard bleach wipe 2 If necessary you may wipe the cuff with a soft damp cloth Caution Use a soft cloth to clean the...

Page 43: ...ages The device presents technical alarms and low priority physiological alarms Technical alarms occur when there is a device relatederror Physiologicalalarms occur when blood pressure measurements fall outside of set alarm limits Technical alarms Problem Symptom Root cause Solution No power Display will not light up Batteries are drained Replace with new batteries Batteries are inserted incorrect...

Page 44: ...eplace with new batteries Error messages E 01 shows The cuff is not secure Readjust the cuff relax for a moment and then measure again E 03 shows There is too much pressure in the cuff Refasten the cuff and then measure again E 10 or E 11 shows The monitor detected motionwhile measuring Readjust the cuff relax for a moment and then measure again Problem Symptom Root cause Solution ...

Page 45: ...se 41 EE or E 19 shows Hardware error Measure again If the problem persists contact the retailer or Welch Allyn custom er service at www welch allyn home com for further assist ance Problem Symptom Root cause Solution ...

Page 46: ...ess and hold the Power button to reestablish Bluetooth connectivity Measure again If the problem persists contact your physician 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 to reestablish Bluetooth connectivity Measure again If the problem persists contact your physician Alarm prio...

Page 47: ...40V 50 60Hz 400mA Output 6V 1A Power supply model number UE08WCP 06100SPA Display mode Digital LCD V A 68mm 90mm Measurement model Oscillometric testing mode Measurement range Rated cuff pressure 0mmHg to 300mmHg 0kPa 40kPa Measurement pressure SYS 50 to 260mmHg DIA 25 to 220mmHg Pulse value 40 to 199 beat minute Accuracy Pressure 0 4kPa 3mmHg Pulse value 4 ...

Page 48: ...rage and transportation condition Temperature 20 C to 60 C Relative Humidity 10 RH 93 RH Atmospheric Pressure 50kPa to 106 kPa Circumferenceofthe upper arm Part Number Cuff size Extra small RPM BPACC 01 15cm to 24cm Standard wide RPM BPACC 02 22cm to 42cm Extra large RPM BPACC 03 40cm to 54cm Net Weight Approx 283g Excluding the dry cells Item Specification ...

Page 49: ... Type BF applied part Protection against ingress of water IP22 Software Version Version 1 X Item Specification Item Specification Bluetooth Module No AW51822 Radio Frequency RF Range 2402 MHz to 2480 MHz Output Power 4 0 dBm Supply Voltage 1 8V to 3 6V Antenna Gain 0 0 dBi TransmittingDistance 10 meters 30 feet ...

Page 50: ...d and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC 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 com...

Page 51: ...elp Any changes or modifications not expressly approved by the party responsible for compliance could 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 Indust...

Page 52: ...e installé dans un emplacement où les antennes de l appareil sont au moins à 20 cm de distance de toute personne L utilisation d antennes et de types 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 ...

Page 53: ... le fonctionnement This radio transmitter IC 12725A TMB1591A has been approved by Industry Canada to operate with the antenna listed in the specification table Ce transmetteur de radio IC 12725A TMB1591A a été approuvé par l Industry Canada pour fonctionner avec l antenne répertoriée dans la table des spécifications This Class B digital apparatus complies with Canadian ICES 003 Cet appareil numéri...

Page 54: ...ed General requirements User manual EN 1041 Medical equipment manufacturers to provide information General Requirements for Safety IEC 60601 1 A1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 1 11 Medical electrical equipment Part 1 11 General requirements for basic safety and essential performance Collateral standard Requirements for...

Page 55: ...sts Performance requirements and clinical investigation IEC 80601 2 30 Medical electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers ISO81060 2 2013 Non invasive sphygmomanometers Part 2 Clinical validation of automated measurement type Software life cycle processes IEC EN 62304 AC Medical device software S...

Page 56: ...y 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 standard Usability Item Standard ...

Page 57: ...od shall start on the date of purchase The date of purchase is 1 the invoiced ship date if the device was purchased directly from Welch Allyn 2 the date specified during product registration 3 the date of purchase of the product from a Welch Allyn authorized distributor as documented from a receipt from said distributor This warranty does not cover damage caused by 1 handling during shipping 2 use...

Page 58: ...ing cost to return a device to a Welch Allyn service center is not included A service notification number must be obtained from Welch Allyn prior to returning any products or accessories to Welch Allyn s designated service centers for repair To obtain a service notification number contact Welch Allyn Technical Support at www welchallyn com about company locations htm ...

Page 59: ...ption RPM BPACC 01 D Ring Extra Small Cuff 15 24cm RPM BPACC 02 D Ring Standard Wide Cuff 22 42cm RPM BPACC 03 D Ring Extra Large Cuff 40 54cm RPM BPACC 04 RPM BP AC Adapter This adapter is an alternate power source for the blood pressure monitoring device ...

Page 60: ...56 Welch Allyn Home Blood Pressure Monitor ...

Page 61: ...es cordless telephones and their base stations walkie talkies can affect this equipment and should be kept at least a distance d 3 3m away from the equipment Note As indicated in Table 6 of IEC 60601 1 2 2007 for ME Equipment a typical cell phone with a maximum output power of 2 W yields d 3 3m at an IMMUNITY LEVEL of 3V m Emissions test Compliance Electromagnetic environment guidance RF emissions...

Page 62: ...table for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Electromagnetic emissions ...

Page 63: ... discharge ESD IEC 61000 4 2 8 kV contact 15kV air 8 kV contact 15kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Mains power quality should be that of a typical commercial o...

Page 64: ...d that the Welch Allyn Home Blood Pressure Monitor be powered from an uninterruptible power supply or a battery 40 U T 60 dip in U T for 5 cycles 40 U T 60 dip in U T for 5 cycles 70 U T 30 dip in U T for 25 cycles 70 U T 30 dip in U T for 25 cycles 5 U T 95 dip in U T for 5 seconds 5 U T 95 dip in U T for 5 seconds Power frequency 50Hz magnetic field IEC 61000 4 8 3A m and 30 A m 3A m and 30 A m ...

Page 65: ...onment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Welch Allyn Home Blood Pressure Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conduc...

Page 66: ...here P is the maximum output power rating ofthe transmitter in watts W and d 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 Interference may occur in the vicinity of equipment marked with the following symbol Electromagnetic immunity P ...

Page 67: ...etically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered 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 If abno...

Page 68: ...Blood Pressure Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Welch Allyn Home Blood Pressure Monitor as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of...

Page 69: ...ng of the transmitter in watts W according to the transmitter manufacturer 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 Recommended separation distances between portable and mobile RF communica...

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Page 71: ...Welch Allyn Home Blood Pressure Monitor Model H BP100SBP 725435 DIR 80021551 Ver C ...

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