BS-1507 User manual

FCC ID: OU9BS-1507

Users Manual

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FCCID_2879495

Welch Allyn Remote Monitoring
Scale RPM-Scale100




Directions for use
901077 Weight scale, Software Version 1.0


© 2015 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.

Welch Allyn Remote Monitoring Scale is a trademark of Welch Allyn.

Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the
product, that may result from failure to use this product in accordance with the instructions, cautions,
warnings, or statement of intended use published in this manual.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any
use of such marks by Welch Allyn is under license.

Software in this product is Copyright 2015 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 software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced
to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title,
and ownership of the software remain with Welch Allyn or its vendors.

For information about any Welch Allyn product, contact your local Welch Allyn representative:
www.welchallyn.com/about/company/locations.htm.


        723809                                                      This manual applies to   901077 Weight scale.

DIR 80020550 Ver. A Revised 2016–01

Manufactured for Welch Allyn, Inc.

4341 State Street Road

Skaneateles Falls, NY 13153-0220 USA

                     Guangdong Transtek Medical Electronics Co., Ltd.
                     Zone A, No. 105, Dongli Road
                     Torch Development District
                     Zhongshan, 528437, Guangdong, China

www.welchallyn.com


                                                                                                                                       iii




Contents
      Introductory information ........................................................................ 1
               Introduction .......................................................................................................... 1
               Symbols ............................................................................................................... 1
               About warnings and cautions ............................................................................... 3
               Ensure accurate measurements .......................................................................... 4
               Content list ........................................................................................................... 4
               Controls and indicators ........................................................................................ 4
               Screen elements .................................................................................................. 5

      Use the scale ............................................................................................ 7
               Startup ................................................................................................................. 7
               Insert or replace the batteries .............................................................................. 7
               Pair a connection hub with the scale ................................................................... 7
               Select the measurement unit .............................................................................. 8
               Obtain measurement ........................................................................................... 8
               Stop a measurement ........................................................................................... 8
               Maintain the scale ................................................................................................ 8
               Troubleshooting .................................................................................................. 9

      Appendices ............................................................................................ 11
               Specifications ..................................................................................................... 11
               General radio compliance ................................................................................... 12
               Complied standards list ...................................................................................... 13
               Emissions and immunity information ................................................................. 14
               Warranty ............................................................................................................ 17
               Approved accessories ........................................................................................ 18


iv   Contents   Welch Allyn Remote Monitoring Scale RPM-Scale100


                                                                                                                              1




Introductory information
Introduction
           The Welch Allyn Remote Monitoring Scale is intended for adults and children (10-17
           years old) to measure weight in a home environment.

           This Directions for use contains important safety and care information and provides step
           by step instructions for using the scale. Read the manual thoroughly before using the
           scale.

           For information about any Welch Allyn product, contact your local Welch Allyn
           representative at www.welchallyn.com/about/company/locations.htm.


Indications for use
           The Welch Allyn Remote Monitoring Scale is intended for adults and children (10–17
           years old) to measure weight in home.


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.

Symbols
Documentation symbols
                       Warning: The warning statements in this manual identify conditions or practices that could lead to
                       illness, injury, or death. Warning symbols will appear with a grey background in a black and white
                       document.


                       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.


                       Mandatory - Consult Directions for Use


2   Introductory information                                                  Welch Allyn Remote Monitoring Scale RPM-Scale100




Power symbols
                                           Direct current (DC)




Shipping, storing, and environment symbols
                               Humidity limitation                                                       Separate collection of
                                                                                                         Electrical and Electronic
                                                                                                         Equipment. Do not
                                                                                                         dispose as unsorted
                                                                                                         municipal waste.

                               Temperature limit                                                         Atmospheric pressure
                                                                                                         limitation



                               Recycle                                                                   Stacking limit by number




Connectivity symbols
                               Bluetooth® wireless technology enabled




Miscellaneous symbols
                               Serial number                                                        Manufacturer




                               Product identifier, product family catalogue number                  Non-ionizing electromagnetic
                                                                                                    radiation



                               Reorder number, Model number                                         Global Trade Item Number



                    IP22       The ingress protection: the device could protected against           Type BF applied parts
                               solid foreign objects of 12.5mm and greater, and against
                               vertically falling water drops when ENCLOSURE tilted up
                               to 15°


Directions for use                                                                       Introductory information   3




About warnings and cautions
                     Caution statements can appear on the Welch Allyn weight scale device, the packaging,
                     the shipping container, or in this Directions for use.
                     The Welch Allyn weight scale is safe for patients and clinicians when used in accordance
                     with the instructions and caution statements presented in this Directions for use.

                     Before using the device, you must 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 to understand and observe any warning statement in this manual could lead
                         to patient injury or illness.
                     •   Failure to understand and observe any caution statement in this manual could lead to
                         damage to the equipment or other property, or loss of patient data.


General warnings and cautions
                                  Warning Patient injury risk. Do not use the scale on a slippery floor, such
                                  as tile.

                                  Warning Patient injury risk. Do not jump onto the platform immediately
                                  after bathing or with wet hands.

                                  Warning Patient injury risk. Keep the device clean. Patient contact with
                                  contaminated equipment can spread infection. Clean the device after each
                                  patient use.

                                  Warning Patient injury risk. Dispose of accessories, detachable parts, and
                                  the ME equipment according to the local guidelines.

                                  Warning Patient injury risk. The device is not suitable for use in the
                                  presence of flammable anesthetic mixtures with air or with oxygen or
                                  nitrous oxide.

                                  Warning Patient injury risk. No modification of this equipment is allowed.
                                  Modifying the equipment could cause patient injury.

                                  Warning Patient injury risk. Do not touch output of the batteries and the
                                  patient simultaneously.

                                  Warning Patient injury risk. Before use, make sure the device functions
                                  safely and is in proper working condition.

                                  Warning Patient injury risk. When the scale is in use, there should not be
                                  any electrical appliances nearby, such as high voltage cables, X-ray
                                  machines, or ultrasound equipment.

                                  Warning Possible injury risk. The device contains small parts. Keep the
                                  equipment away from children and pets.

                                  CAUTION Avoid storing the device where the device may be exposed to
                                  extreme temperatures, humidity, moisture, direct sunlight, dust, or salt air.


4   Introductory information                                       Welch Allyn Remote Monitoring Scale RPM-Scale100




                                  CAUTION Avoid storing the device where there is risk of shock or
                                  dropping.

                                  CAUTION Avoid storing the device where you store chemicals.

                                  CAUTION Avoid storing the device where there are corrosive gases.

                                  CAUTION Avoid storing the device near infants or children.

                                  CAUTION The device does not need to be calibrated in two years of
                                  reliable service.

                                  CAUTION Do not attempt to repair the unit yourself in the event of
                                  malfunctions. Only have repairs carried out by authorized service centers.

                                  CAUTION Manufacturer will make available on request circuit diagrams,
                                  component parts lists, and the like.

                                  CAUTION Wireless communications equipment, such as wireless home
                                  network devices, mobile phones, cordless telephones and their base
                                  stations, walkietalkies 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).

                                  CAUTION Do not use rechargeable batteries.


Ensure accurate measurements
                    To ensure the accuracy of measurements, follow the recommendations below when you
                    start a measurement.
                    •    Place the scale on a flat, hard surface. If you put the scale on carpet, fit the
                         extension feet before taking the measurement. Placing the scale sensors directly on
                         carpet may affect the accuracy of the measurement.
                    •    Always start a measurement at the same time on the same scale located on the
                         same flat surface.


Content list
                    The following items are in the device box:
                    •    Remote Monitoring Scale
                    •    (4) AAA alkaline batteries (1.5V each)
                    •    (4) extension feet for use on carpet
                    •    Directions for use

Controls and indicators
                    The Welch Allyn weight scale is simple to use.


Directions for use                                                                                 Introductory information         5




Scale top




                      No. Feature                               Description

                       1   LCD display                          Displays measurement

                       2   UNIT and activation button           The button enables you to select kg or lb unit measure. Press and
                                                                hold for 3 seconds to enter pairing mode.

                       3   Battery compartment (behind cover)   Houses (4) AAA alkaline batteries (1.5V each)

                       4   Sensors (4)                          4 load cell sensors which conduct weight measurement



Screen elements
                     The liquid crystal display (LCD) display registers the measurement. The display also may
                     show other icons that provide information about the functionality of the scale.


6   Introductory information                              Welch Allyn Remote Monitoring Scale RPM-Scale100




                    Icon       Description                Icon               Description

                    kg         Kilogram                                      Data transmitting

                    lb         Pound                                         Data pending to transmit to
                                                                             wireless wellness system

                               Low battery charge                            Full battery charge




                               Bluetooth wireless                            Bluetooth wireless technology
                               technology is powered on                      connected (dotted area is not
                                                                             flashing)


                               Data being transferred                        Scale not paired with device
                               using Bluetooth wireless
                               technology (dotted area
                               flashes)


                                                                                                      7




Use the scale
Startup
          The Welch Allyn weight scale uses SENSE ON™ technology to turn on the scale. Step
          on the scale with bare feet to begin a measurement.

Insert or replace the batteries

                       CAUTION When the                  symbol appears, the device will power off
                       in four seconds. Replace the old batteries with a new set of four batteries.
                       Always replace all four batteries with new batteries. Do NOT mix old
                       batteries with new batteries

                       CAUTION Remove the batteries if the device is not to be used for some
                       time.

                       CAUTION Dispose old batteries by following your local recycling
                       guidelines.

                       CAUTION Do not burn batteries. Batteries may leak or explode.

          1. Open the battery door on the under side of the scale.
              The digits “8888” appear on the LCD screen.
          2. Insert the four AAA alkaline batteries (1.5V each) into the battery compartment
             according to the polarity indications marked inside the battery compartment.
          3. Close the battery door.
          4. Wait until the digits “0.0lb”appear on the LCD screen.

Pair a connection hub with the scale
          With advanced Bluetooth 4.0 Technology applied, a communication hub is capable of
          receiving your personal health data. Contact your Remote Patient Monitoring Solution
          provider for connectivity instructions and troubleshooting.

          1. Confirm that both the connection hub and the weight scale are powered on.

              Note         Bluetooth wireless connectivity is only available for devices
                           which support Bluetooth 4.0 technology.


8   Use the scale                                                   Welch Allyn Remote Monitoring Scale RPM-Scale100




                    2. Press and hold the Unit button on the bottom of the scale for 2 seconds.
                        The Bluetooth pairing sequence is activated. The dotted line surrounding the
                        Bluetooth symbol flashes while discovering the weight scale.



                    If successful, a steady       symbol surrounded by a dotted line appears on the scale's

                    LCD screen. If unsuccessful, the        appears.

Select the measurement unit
                    The default measurement unit is pound (lb).

                    Press the Unit button on the bottom of the scale to change from pound (lb) to
                    kilogram (kg).

Obtain measurement
                    With the original SENSE ON patent technology, the scale automatically powers on when
                    you step on the platform in your bare feet.

                    1. Step on the platform in your bare feet.
                        The scale automatically powers on and begins the measurement.
                    2. Stand still and keep full contact with the scale until the LCD stops blinking and
                       displays the weight.

Stop a measurement
                    You can stop a measurement before it is complete.

                    Step off the platform.
                    The scale returns to a ready / zero state.

                    After approximately 2 seconds, the scale powers down automatically.

Maintain the scale
                                  Warning Patient injury risk. Keep the device clean. Patient contact with
                                  contaminated equipment can spread infection. Clean the device after each
                                  patient use.
                    Clean on a routine basis according to facility protocols and standards or local regulations.

                    Disinfect according to facility protocols and standards or local regulations.

                    The following agents are compatible with the device:
                    •   CaviWipes or Sani-Cloth Plus
                    •   70 percent isopropyl alcohol
                    •   10 percent chlorine bleach/90 percent water solution


Directions for use                                                                                                           Use the scale      9




Troubleshooting
                     This section includes a list of error messages and frequently asked questions for
                     problems you may encounter with your weight scale. If the device is not operating as
                     you think it should, check here before arranging for servicing.


Error prompt
                     Error                                   Description                              Solution

                     Dotted lines                            Overload. The device will power off      Stop using this scale for measurement

                                                             Low Battery. The device will power off Replace all four batteries at the same
                                                             in four seconds.                       time. Purchase the authorized batteries
                                                                                                    for replacement.



                     Error condition                         At any point, when a situation occurs    Check the following items:
                                                             that prevents a successful test          • Bluetooth wireless technology is
                                                             acquisition, an error code will be            on.
                                                             displayed in the LCD area. The           • The application is on.
                                                             message will persist for several         • Both devices are within the
                                                             seconds until the device times out and        transmission distance of
                                                             powers down.                                  Bluetooth devices.




When measuring
                     Problem                                 Root cause                               Solution

                     No display on the LCD screen with the Batteries are not installed or not         Install the batteries. Go to "Insert or
                     scale powers on                       installed properly                         replace the batteries"

                                                             Worn batteries                           Replace all four batteries at the same
                                                                                                      time. Purchase the authorized batteries
                                                                                                      for replacement.

                     The scale powers off automatically      Low Battery.                             Replace all four batteries at the same
                                                                                                      time. Purchase the authorized batteries
                                                                                                      for replacement.


10   Use the scale                                                    Welch Allyn Remote Monitoring Scale RPM-Scale100




When transmitting data
                     Problem                    Root cause                              Solution

                     Data transmission failed   Bluetooth wireless technology is off    Turn on the Bluetooth wireless
                                                                                        technology via the Settings.

                                                Application is off                      Press the icon to run your application.


                                                Out of range of Bluetooth transmission. Place your mobile or portable device
                                                                                        closer to the scale.


                                                                                                         11




Appendices
Specifications
        Warning: No modification of this equipment is allowed.

        Item                       Specification

        Power supply               6V 4*AAA alkaline batteries

        Display mode               Blue LCD with White Backlight V.A.: 74x53mm

        Measurement unit           Kilogram / Pound

        Measurement range          5kg to 200kg / 11lb to 441lb

        Resolution                 The measurement resolution         0–220 lb: 0.2lb
                                   shall be:                          220–440lb: 0.5lb
                                   0–100kg: 0.1kg
                                   100–200kg: 0.2kg

                                   100-150kg: ±0.5kg;                 150-200kg: ±0.7kg

        Normal working condition   Temperature: 5℃ to 40℃             Humidity: ≤ 85%RH

                                   Atmospheric pressure: 86kPa to 106kPa

        Division                   0.1kg / 1.2lb

        Storage & transportation   Temperature:-20℃to 60℃             Relative Humidity: 10% RH–93% RH
        condition
                                   Atmospheric Pressure: 50kPa to 106 kPa

        Net Weight                 Approximately 1.98kg ( Excluding the dry cells)

        Dimensions                 360mm x 408mm x 32.5mm with carpet feet

        Accessories                •    (4) AAA alkaline batteries
                                   •    (4) extension feet
                                   •    Directions for use


12   Appendices                                                              Welch Allyn Remote Monitoring Scale RPM-Scale100




                  Item                            Specification

                  Mode of operation               Continuous operation

                  Auto-ON                         SENSE ON technology

                  Auto-OFF                        About 10 seconds when showing 0.0
                                                  About 15 seconds after the weight data is locked

                  Degree of protection            Type BF applied part

                  Protection against ingress of   IP22
                  water

                  Software Version                Version 1.0


General radio compliance
                  Item                                                     Specification

                  Bluetooth Module No.                                     AW8001

                  RF Frequency Range                                       2402 MHz to 2480 MHz

                  Output Power Range                                       -2.27dBm to -5.88 dBm

                  Supply Voltage                                           1.8-3.6 V

                  Antenna Gain                                             1.0dBi

                  Transmitting Distance                                    10 meters, (30 feet)



Federal Communication Commission (FCC) Interference Statement
                  This device complies with part 15 of the FCC Rules. Operation 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.

                  This equipment (FCC ID: OU9BS-1507) has been tested 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 communications. However, there is no guarantee that interference
                  will not occur in a particular installation. If this equipment does cause harmful
                  interference to radio or television reception, which can be determined by turning the
                  equipment off and on, the user is encouraged to try to correct the interference by one of
                  the following measures.

                  1.Reorient or relocate the receiving antenna.


Directions for use                                                                                         Appendices     13




                     2.Increase the separation between the equipment and receiver.

                     3.Consult the dealer or an experienced radio/TV technician for help.

                     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.


Industry Canada (IC) compliance
                     To ensure compliance with FCC and Industry Canada RF exposure requirements, this
                     device must be installed in a location where the antennas of the device will have a
                     minimum distance of at least 20 cm from all persons. Using higher gain antennas and
                     types of antennas not certified for use with this product is not allowed. The device shall
                     not be co-located with another transmitter.

                     Installez l'appareil en veillant à conserver une distance d'au moins 20 cm entre les
                     éléments rayonnants et les personnes. Cet avertissement de sécurité est conforme aux
                     limites d'exposition définies par la norme CNR-102 at relative aux fréquences radio.

                     This device complies with Industry Canada licence-exempt RSS standard(s). Operation is
                     subject to the following two conditions: (1) this device may not cause interference, and
                     (2) this device must accept any interference, including interference that may cause
                     undesired operation of the device.

                     Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
                     radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1)
                     l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter
                     tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en
                     compromettre le fonctionnement.

                     This radio transmitter (IC ID: 12725A-BS1507) has been approved by Industry Canada to
                     operate with the antenna listed in the specification table.

                     This Class B digital apparatus complies with Canadian ICES-003.

                     Cet appareil numérique de la classe B est conform à la norme NMB-003 du Canada

Complied standards list
                     Item                                           Standard

                     Risk management                                ISO/EN 14971 Medical 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. General requirements
                                                                    Tested in accordance with ISO 10993 Biocompatibility


14   Appendices                                                               Welch Allyn Remote Monitoring Scale RPM-Scale100




                  Item                                                      Standard

                  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
                                                                            medical electrical equipment and medical electrical
                                                                            systems used in the home healthcare environment

                  Electromagnetic compatibility                             IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2:
                                                                            General requirements for basic safety and essential
                                                                            performance - Collateral standard: Electromagnetic
                                                                            compatibility - Requirements and tests

                  Software life-cycle processes                             IEC/EN 62304+AC Medical device software - Software life
                                                                            cycle processes

                  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



Emissions and immunity information

                  The Welch Allyn Remote Monitoring Scale RPM-SCALE100 is intended for use in the
                  electromagnetic environment specified below. The customer or user of the Welch Allyn
                  Remote Monitoring Scale RPM-SCALE100 should assure that it is used in such an
                  environment.

                  This equipment needs to be installed and put into service in accordance with the
                  information provided in the user manual.

                                    CAUTION Wireless communications equipment, such as wireless home
                                    network devices, mobile phones, cordless telephones and their base
                                    stations, walkie-talkie 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).

                                                           Electromagnetic emissions

                  The Welch Allyn Remote Monitoring Scale RPM-Scale100 is intended for use in the electromagnetic environment
                  specified below. The customer or user of the Welch Allyn Remote Monitoring Scale RPM-Scale100 should assure that it
                  is used in such an environment.

                  Emissions test         Compliance             Electromagnetic environment - guidance


Directions for use                                                                                                            Appendices       15




                                                                 Electromagnetic emissions

                     RF emissions            Group 1                  The Welch Allyn Remote Monitoring Scale RPM-Scale100 uses RF
                     CISPR 11                                         energy only for its internal function. Therefore, its RF emissions are very
                                                                      low and are not likely to cause any interference in nearby electronic
                                                                      equipment.

                     RF emissions            Class B                  The Welch Allyn Remote Monitoring Scale RPM-Scale100 is suitable
                     CISPR 11                                         for use in all establishments other than domestic establishments and
                                                                      those directly connected to the public low-voltage power supply
                                                                      network that supplies buildings used for domestic purposes.
                     Harmonic emissions      Not applicable
                     IEC 61000-3-2

                     Voltage fluctuations/   Not applicable
                     flicker emissions
                     IEC 61000-3-3



                                                                  Electromagnetic immunity

                     The Welch Allyn Remote Monitoring Scale RPM-Scale100 is intended for use in the electromagnetic environment
                     specified below. The customer or the user of the Welch Allyn Remote Monitoring Scale RPM-Scale100 should assure
                     that it is used in such an environment.

                     Immunity test           IEC 60601 test level     Compliance level         Electromagnetic environment - guidance

                     Electrostatic discharge ±6 kV contact            ± 6 kV contact           Floors should be wood, concrete or ceramic
                     (ESD)                   ± 8 kV air               ± 8 kV air               tile. If floors are covered with synthetic
                     IEC 61000-4-2                                                             material, the relative humidity should be at
                                                                                               least 30%.

                     Electrical fast         ±2 kV for power supply ±2 kV for power supply Mains power quality should be that of a typical
                     transient/burst         lines                  lines                  commercial or hospital environment.
                     IEC 61000-4-4

                     Surge                   ± 1 kV line(s) to line(s) ± 1 kV differential     Mains power quality should be that of a typical
                     IEC 61000-4-5                                     mode                    commercial or hospital environment.


                     Voltage dips, short     <5% UT                   <5% UT                   Mains power quality should be that of a typical
                     interruptions and                                                         commercial or hospital environment. If the user
                     voltage variations on   (>95% dip in UT) for 0.5 (>95% dip in UT) for 0.5 of the Welch Allyn Remote Monitoring
                     power supply input      cycle                    cycle                    ScaleRPM-Scale100 requires continued
                     lines                                                                     operation during power mains interruptions, it
                     IEC 61000-4-11                                                            is recommended that the Welch Allyn Remote
                                             40% UT                   40% UT
                                                                                               Monitoring Scale RPM-Scale100 be powered
                                             (60% dip in UT) for 5 (60% dip in UT)for 5        from an uninterruptible power supply or a
                                             cycles                   cycles                   battery.


                                             70% UT                   70% UT
                                             (30% dip in UT) for 25   (30% dip in UT) for 25
                                             cycles                   cycles


                                             <5% UT                   <5% UT
                                             (>95% dip in UT) for 5   (>95% dip in UT) for 5
                                             seconds                  seconds


16   Appendices                                                                    Welch Allyn Remote Monitoring Scale RPM-Scale100




                                                               Electromagnetic immunity

                  Power frequency          3A/m                     3A/m                     Power frequency magnetic fields should be at
                  (50Hz) magnetic field                                                      levels characteristic of a typical location in a
                  IEC 61000-4-8                                                              typical commercial or hospital environment.

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



                                                               Electromagnetic immunity

                  The Welch Allyn Remote Monitoring Scale RPM-Scale100 is intended for use in the electromagnetic environment
                  specified below. The customer or the user of the Welch Allyn Remote Monitoring Scale RPM-Scale100 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 Remote Monitoring Scale
                                                                                             RPM-Scale100, including cables, than the
                                                                                             recommended separation distance calculated
                                                                                             from the equation applicable to the frequency
                                                                                             of the transmitter.

                                                                                             Recommended separation distance

                  Conducted RF             3 Vrms                   3 Vrms                   d= (1.167)
                  IEC 61000-4-6            150 kHz to 80 MHz

                  Radiated RF              3 V/m 80 MHz to 1 GHz 3 V/m                       d= (1.167)        80 to 800 MHz
                  IEC 61000-4-3


                                                                                             d= (2.333)        800 MHz to 2,5 GHz

                                                                                             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
                                                                                             surveya, should be less than the compliance
                                                                                             level in each frequency rangeb. Interference
                                                                                             may occur in the vicinity of equipment marked
                                                                                             with the following symbol:




                  Note1: At 80 MHz and 800 MHz, 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.
                  aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
                  radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically 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 Remote Monitoring Scale RPM-
                  Scale100 is used exceeds the applicable RF compliance level above, the Welch Allyn Remote Monitoring Scale RPM-


Directions for use                                                                                                          Appendices 17




                                                                 Electromagnetic immunity
                     Scale100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may
                     be necessary, such as reorienting or relocating the Welch Allyn Remote Monitoring Scale RPM-Scale100.
                     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 Welch Allyn Remote Monitoring scale RPM-SCALE100

                     The Welch Allyn Remote Monitoring Scale RPM-Scale100 is intended for use in an electromagnetic environment in
                     which radiated RF disturbances are controlled. The customer or user of the Welch Allyn Remote Monitoring Scale RPM-
                     Scale100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and
                     mobile RF communications equipment (transmitters) and the Welch Allyn Remote Monitoring Scale RPM-Scale100 as
                     recommended below, according to the maximum output power of the communications equipment.

                                             Separation distance according to frequency of transmitter (m)

                     Rated max. output    150 kHz to 80 MHz          80 MHz to 800 MHz        800 MHz to 2.5 GHz
                     power of transmitter d= (1.167)                 d= (1.167)               d= (2.333)
                     (W)

                     0.01                    0.167                   0.167                    0.233

                     0.1                     0.369                   0.369                    0.738

                     1                       1.167                   1.167                    2.333

                     10                      3.690                   3.690                    7.338

                     100                     11.67                   11.67                    23.33

                     For transmitters rated at a maximum output power not listed above, the recommended separation distanced 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.
                     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.



Warranty
                     Welch Allyn will warranty the Transtek weight scale 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 retail purchase.

                     The warranty period 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 damages caused by misuse or abuse, including but not
                     limited to:
                     •      Failure caused by unauthorized repairs or modifications
                     •      Damage caused by shock or dropping during transportation


18 Appendices                                                    Welch Allyn Remote Monitoring Scale RPM-Scale100




                •      Damage caused by improper use of the power supply
                •      Failure caused by improper operation not consistent with the instructions stated in
                       this Directions for use

                Should this device require maintenance (or replacement at our option) under warranty,
                please deliver the original package to Welch Allyn prepaid. Please return the store receipt
                (with the retail purchase date) and a note with the reasons for the return.

Approved accessories
                Item              Description

                RPM-SCALEACC-01 Carpet Feet 40EA





Document Created: 2017-11-15 19:36:23
Document Modified: 2017-11-15 19:36:23

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