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
DIR 80020550 Ver. A Revised 2016–01
This manual applies to
901077 Weight scale.
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
Contents
Introductory information ........................................................................ 1
Use the scale ............................................................................................ 7
iv ContentsWelch Allyn Remote Monitoring Scale RPM-Scale100
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.
Directions for use contains important safety and care information and provides step
This
by step instructions for using the scale. Read the manual thoroughly before using the
scale.
1
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.
Electrical and Electronic
Equipment. Do not
dispose as unsorted
municipal waste.
Temperature limitAtmospheric pressure
limitation
RecycleStacking limit by number
Connectivity symbols
Bluetooth® wireless technology enabled
Miscellaneous symbols
Serial numberManufacturer
Product identifier, product family catalogue numberNon-ionizing electromagnetic
Reorder number, Model numberGlobal Trade Item Number
IP22
The ingress protection: the device could protected against
solid foreign objects of 12.5mm and greater, and against
vertically falling water drops when ENCLOSURE tilted up
to 15°
radiation
Type BF applied parts
Directions for use Introductory information
About warnings and cautions
Caution statements can appear on the Welch Allyn weight scale device, the packaging,
the shipping container, or in this
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
Directions for use.
3
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.
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
Scale top
5
No. FeatureDescription
1LCD displayDisplays measurement
2UNIT and activation buttonThe button enables you to select kg or lb unit measure. Press and
4Sensors (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.
Data being transferred
using Bluetooth wireless
technology (dotted area
flashes)
Bluetooth wireless technology
connected (dotted area is not
flashing)
Scale not paired with device
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
7
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 scaleWelch 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
LCD screen. If unsuccessful, the
symbol surrounded by a dotted line appears on the scale's
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
appears.
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
ErrorDescriptionSolution
Dotted linesOverload. The device will power offStop using this scale for measurement
Error conditionAt any point, when a situation occurs
When measuring
ProblemRoot causeSolution
No display on the LCD screen with the
scale powers on
Low Battery. The device will power off
in four seconds.
that prevents a successful test
acquisition, an error code will be
displayed in the LCD area. The
message will persist for several
seconds until the device times out and
powers down.
Batteries are not installed or not
installed properly
Worn batteriesReplace all four batteries at the same
Replace all four batteries at the same
time. Purchase the authorized batteries
for replacement.
Check the following items:
Bluetooth wireless technology is
•
on.
•The application is on.
•Both devices are within the
transmission distance of
Bluetooth devices.
Install the batteries. Go to "Insert or
replace the batteries"
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 scaleWelch Allyn Remote Monitoring Scale RPM-Scale100
When transmitting data
ProblemRoot causeSolution
Data transmission failed
Bluetooth wireless technology is offTurn on the Bluetooth wireless
technology via the Settings.
Application is off
Out of range of Bluetooth transmission. Place your mobile or portable device
Press the icon to run your application.
closer to the scale.
Appendices
Specifications
Warning: No modification of this equipment is allowed.
ItemSpecification
11
Power supply
Display modeBlue LCD with White Backlight V.A.: 74x53mm
Measurement unitKilogram / Pound
Measurement range
Resolution
Normal working conditionTemperature: 5℃ to 40℃Humidity: ≤ 85%RH
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
ItemStandard
Risk managementISO/EN 14971 Medical devices — Application of risk
management to medical devices
LabelingISO/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
User manualEN 1041 Medical equipment manufacturers to provide
information
General Requirements for Safety
Electromagnetic compatibilityIEC/EN 60601-1-2 Medical electrical equipment - Part 1-2:
Software life-cycle processes
Usability
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
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC/EN 62304+AC Medical device software - Software life
cycle processes
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.
NoteAs 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.
Group 1The Welch Allyn Remote Monitoring Scale RPM-Scale100 uses RF
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
CISPR 11
Class B
The Welch Allyn Remote Monitoring Scale RPM-Scale100 is suitable
for use in all establishments other than domestic establishments and
those directly connected to the public low-voltage power supply
Harmonic emissions
Not applicable
network that supplies buildings used for domestic purposes.
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 testIEC 60601 test level Compliance levelElectromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV 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
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
±2 kV for power supply
lines
±2 kV for power supply
lines
± 1 kV line(s) to line(s) ± 1 kV differential
mode
<5% U
T
(>95% dip in UT) for 0.5
cycle
40% U
T
(60% dip in UT) for 5
cycles
70% U
T
(30% dip in UT) for 25
cycles
<5% U
T
(>95% dip in UT) for 5
seconds
<5% U
T
(>95% dip in UT) for 0.5
cycle
40% U
T
(60% dip in UT)for 5
cycles
70% U
T
(30% dip in UT) for 25
cycles
<5% U
T
(>95% dip in UT) for 5
seconds
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the Welch Allyn Remote Monitoring
ScaleRPM-Scale100 requires continued
operation during power mains interruptions, it
is recommended that the Welch Allyn Remote
Monitoring Scale RPM-Scale100 be powered
from an uninterruptible power supply or a
battery.
Power frequency
(50Hz) magnetic field
IEC 61000-4-8
3A/m3A/mPower frequency magnetic fields should be at
levels characteristic of a typical location in a
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 testIEC 60601 test level Compliance levelElectromagnetic 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
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d= (1.167)
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
P is the maximum output power rating of
where
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.
a
Field 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 RPMScale100 is used exceeds the applicable RF compliance level above, the Welch Allyn Remote Monitoring Scale RPM-
Directions for use Appendices
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.
b
Over 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 RPMScale100 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)
17
Warranty
Rated max. output
power of transmitter
(W)
0.010.1670.1670.233
0.10.3690.3690.738
11.1671.1672.333
103.6903.6907.338
10011.6711.6723.33
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.
150 kHz to 80 MHz
d= (1.167)
80 MHz to 800 MHz
d= (1.167)
800 MHz to 2.5 GHz
d= (2.333)
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
•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
ItemDescription
RPM-SCALEACC-01 Carpet Feet 40EA
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