background image

Electromagnetic immunity

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines
IEC 61000-4-11

<5% U

T

(>95% dip in U

T

) for 0.5

cycle
40% U

T

(60% dip in U

T

) for 5

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 0.5

cycle
40% U

T

(60% dip in U

T

) for 5

cycles
70% U

T

(30% dip in U

T

) for 25

cycles
<5% U

T

(>95% dip in U

T

) for 5

seconds

Mains power quality should be that of a typical

commercial or hospital environment. If the user

of the Welch Allyn Home Blood Pressure

Monitor requires continued operation during

power mains interruptions, it is recommended

that the Welch Allyn Home Blood Pressure

Monitor be powered from an uninterruptible

power supply or a battery.

Power frequency

(50Hz/60Hz) magnetic

field IEC 61000-4-8

3A/m & 30A/m

3A/m & 30A/m

Power frequency magnetic fields should be at

levels characteristic of a typical location in a

typical commercial or hospital environment.

Note: U

T

 is the AC mains voltage prior to application of the test level.

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 AllynHome Blood Pressure Monitor should assure that it is used in such an

environment.

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

Conducted RF
IEC 61000-4-6

3 Vrms & 6Vms
150 kHz to 80 MHz

3 Vrms & 6Vms

d

= 1,2 

Radiated RF
IEC 61000-4-3

3 V/m 80 MHz to 2.5

GHz

3 V/m

d

= 1,2 

 80 to 800 MHz

d

= 1,2 

 800 MHz to 2,5 GHz

10 V/m

d

= 2,3 

 800 MHz to 2,6 GHz

80 MHz to 2,6 GHz

10 V/m

where

P

 is the maximum output power rating of

the transmitter in watts (W) and

d

 is the

recommended separation distance in meters

(m).

26  Appendix

Welch Allyn Remote Monitoring Blood Pressure Device RPM-BP100SBP

Summary of Contents for 901042

Page 1: ...Welch Allyn Remote Monitoring Blood Pressure Device RPM BP100SBP Directions for use 901042 Automated Blood Pressure System Software Version 1 X...

Page 2: ...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 lic...

Page 3: ...e 11 Overview 11 Set up your equipment 11 Position the blood pressure cuff 13 Start the measurement 14 Blood pressure facts pointers and best practices 16 Maintenance and troubleshooting 19 Maintain t...

Page 4: ...iv Contents Welch Allyn Remote Monitoring Blood Pressure Device RPM BP100SBP...

Page 5: ...s of reliable service Readings taken by the monitor are equal to those obtained by a trained observer using the cuff and stethoscope auscultation manual method This Directions for use contains importa...

Page 6: ...d result in damage to the equipment or other property or loss of data Follow instructions directions for use DFU mandatory action Power symbols Direct current Power Shipping storing and environment sy...

Page 7: ...nce Minimum Maximum Lot code Not made with natural rubber latex Miscellaneous symbols Type BF applied part Serial number Product Identifier Manufacturer Reorder number Model number Non ionizing electr...

Page 8: ...nt or other property or loss of measurement data Warnings and cautions Warning Patient injury risk The device is not suitable for measuring the blood pressure of neonatal infants or children Warning P...

Page 9: ...sk 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 Pa...

Page 10: ...is 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...

Page 11: ...ff 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...

Page 12: ...rtment behind cover Houses 4 AA alkaline batteries Power options CAUTION To get optimal performance and protect your monitor use only the correct batteries or the Welch Allyn approved power adapter Th...

Page 13: ...and battery charge level Symbol Description Systolic blood pressure result mmHg measurement unit of the blood pressure Diastolic blood pressure result mmHg measurement unit of the blood pressure Pulse...

Page 14: ...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 a...

Page 15: ...r blood pressure measurements you also need a smartphone or tablet with Bluetooth wireless connectivity and the app or software to receive your patient data Set up your equipment Insert or replace the...

Page 16: ...r connector plug 3 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 Note You may lea...

Page 17: ...d in discoverable mode ready for pairing Note Bluetooth wireless connectivity is only available for devices which support Bluetooth 4 0 technology 2 Press and hold the Power button on the blood pressu...

Page 18: ...arm on a flat surface e Ensure the cuff is level with your heart right atrium f Rest for 5 minutes after sitting down and positioning the blood pressure cuff 2 Verify that the cuff is positioned corr...

Page 19: ...me on the same upper arm or as directed by your physician Some points to remember about your blood pressure device After 10 seconds of inactivity the device powers down If you press and release the Po...

Page 20: ...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 The device does not replace a cardiac examina...

Page 21: ...n the upper arm Proper cuff tightness No clothing under the cuff or restricting circulation above the cuff Proper posture feet flat on the floor back straight legs uncrossed arm resting on a flat surf...

Page 22: ...18 Measuring blood pressure Welch Allyn Remote Monitoring Blood Pressure Device RPM BP100SBP...

Page 23: ...lcohol 10 chlorine bleach 90 water solution standard bleach wipe 2 If necessary you may wipe the cuff with a soft damp cloth Troubleshooting This section includes a list of error messages and frequent...

Page 24: ...r EE and E 19 shows Malfunctioning hardware Measure again If the problem persists contact the retailer or Welch Allyn customer service at www welchallynhome com for further assistance Physiological al...

Page 25: ...scillometric testing mode Measurement range Rated cuff pressure 0mmHg to 300mmHg 0kPa to 40kPa Measurement pressure SYS 50mmHg to 260mmHg DIA 25mmHg to 220mmHg Pulse value 40 to 199 beats per minute A...

Page 26: ...is subject to the following two conditions This device may not cause harmful interference This device must accept any interference received including interference that may cause undesired operation T...

Page 27: ...et appareil doit tre install dans un emplacement o les antennes de l appareil sont au moins 20 cm de distance de toute personne L utilisation d antennes et de types d antennes gain sup rieur non garan...

Page 28: ...magnetic compatibility IEC EN 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirem...

Page 29: ...ic equipment RF emissions CISPR 11 Class B The Welch Allyn Home Blood Pressure Monitor is suitable for use in all establishments other than domestic establishments and those directly connected to the...

Page 30: ...C mains voltage prior to application of the test level Electromagnetic immunity The Welch Allyn Home Blood Pressure Monitor is intended for use in the electromagnetic environment specified below The c...

Page 31: ...sure Monitor bOver the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the Welc...

Page 32: ...t and the Welch Allyn Home Blood Pressure Monitor Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects a...

Page 33: ...nance contrary to labeled instructions 3 alteration or repair by anyone not authorized by Welch Allyn and 4 accidents The product warranty is also subject to the following terms and limitations Access...

Page 34: ......

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