FCC ID: 2AOJNBS-1507 901077 WEIGHT SCALE

2017 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 Home 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 2017 Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. 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.welchallynhome.com/support.htm. 726196 This manual applies to 901077 Weight scale. DIR 80021989 Ver. B Revised 201702 Manufactured for Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA www.welchallynhome.com iii Contents Introductory information ........................................................................ 1 Introduction .......................................................................................................... 1 Symbols ............................................................................................................... 1 About warnings and cautions ............................................................................... 3 Content list ........................................................................................................... 4 Controls and indicators ........................................................................................ 4 Screen elements .................................................................................................. 5 Use the scale ............................................................................................ 7 Startup ................................................................................................................. 7 Insert or replace the batteries .............................................................................. 7 Install the carpet feet ........................................................................................... 7 Pair a smartphone, a tablet, or a communication hub with the scale .................. 8 Select the measurement unit .............................................................................. 8 Ensure accurate measurements .......................................................................... 8 Obtain measurement ........................................................................................... 9 Stop a measurement ........................................................................................... 9 Maintain the scale ................................................................................................ 9 Troubleshooting .................................................................................................. 9 Appendices ............................................................................................ 13 Specifications ..................................................................................................... 13 General radio compliance ................................................................................... 14 Complied standards list ...................................................................................... 15 Emissions and immunity information ................................................................. 16 Warranty ............................................................................................................ 19 Approved accessories ........................................................................................ 20 iv Contents Welch Allyn Home Scale 1 Introductory information Introduction The Welch Allyn HomeTM 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 Welch Allyn Home technical support at www.welchallynhome.com/support.htm. Indications for use The Welch Allyn Home Scale is intended for adults and children (1017 years old) to measure weight in the 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 Home Scale Power symbols Direct current (DC) Shipping, storing, and environment symbols Humidity limitation Temperature limit Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste. 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 solid foreign objects of 12.5mm and greater, and against vertically falling water drops when ENCLOSURE tilted up to 15 Type BF applied parts Directions for use Introductory information 3 About warnings and cautions Caution statements can appear on the Welch Allyn Home Scale device, packaging, shipping container, or in this Directions for use. The Welch Allyn Home Scale is safe for users 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 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 data. General warnings and cautions Warning Injury risk. Do not use the scale on a slippery floor, such as tile. Warning Injury risk. Do not jump onto the platform immediately after bathing or with wet hands. Warning Injury risk. Dispose of accessories, detachable parts, and the device according to the local guidelines. Warning Injury risk. No modification of this equipment is allowed. Modifying the equipment could damage the device or cause injury. Warning Injury risk. Do not touch output of the batteries and the user simultaneously. Warning Injury risk. Before use, make sure the device functions safely and is in proper working condition. Failure to do so could damage the device or cause injury. Warning Possible injury risk. The device contains small parts. Keep the device 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. 4 Introductory information Welch Allyn Home Scale CAUTION Do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs carried out by authorized service centers. CAUTION Do not use rechargeable batteries. CAUTION Use the scale in the environment described in this Directions for use. Using the scale in other environments will compromise the performance of the scale and reduce the lifetime of the scale. Content list The following items are in the device box:

Home Scale Directions for use

(4) AAA alkaline batteries (1.5V each)

(4) extension feet for use on carpet Controls and indicators The Welch Allyn Home scale is simple to use. Scale top No. Feature 1 LCD display Description Displays measurement Directions for use Introductory information 5 No. Feature Description 2 3 4 UNIT / Power button The button enables you to select kg or lb unit measure. Press and hold for 3 seconds to enter pairing mode. Battery compartment (behind cover) Houses (4) AAA alkaline batteries (1.5V each) 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. Icon kg Description Kilogram Icon lb Description Pound Low battery charge Full battery charge Bluetooth wireless technology is powered on Data being transferred using Bluetooth wireless technology (dotted area flashes) Bluetooth wireless technology connected (dotted area is not flashing) Scale not paired with device 6 Introductory information Welch Allyn Home Scale 7 Use the scale Startup The Welch Allyn Home 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. 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 0.0lbappear on the LCD screen. Install the carpet feet Install the carpet feet if you use the device on carpet to avoid the device slipping. 1. Peel off and removethe rubber stickers on the four corner posts. 2. Remove the four carpet feet from the packaging. 3. Insert the carpet feet prongs into the posts. 8 Use the scale Welch Allyn Home Scale Pair a smartphone, a tablet, or a communication hub with the scale Advanced Bluetooth 4.0 technology enables your smartphone, tablet, or a communication hub to receive your personal health information from your device. You have two alternatives to pair your device with these devices. If you are using the Welch Allyn Home application, follow the pairing instructions presented in the application. Contact your Remote Monitoring Solution provider or use the instructions that office provided to set up these communications devices. With either alternative, you complete the same steps on the Home scale. 1. Confirm that both the smart device and the Home scale are powered on. Note Bluetooth wireless connectivity is only available for devices which support Bluetooth 4.0 technology. 2. Press and hold the Unit / Power button on the bottom of the scale for 3 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 / Power button on the bottom of the scale to change from pound (lb) to kilogram (kg). 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 for at least 10 seconds. Obtaining the measurement immediately after placing the scale on a flat, hard surface may affect the accuracy of the measurement. If you place 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. Directions for use Use the scale 9 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 Injury risk. Keep the device clean. Contact with a contaminated device can spread infection. Clean the device after each use. The Home scale does not require calibration. Note To get the best performance from your Home scale, follow the maintenance steps below. Avoid shaking and dropping the device Avoid operating the device in dusty and unstable temperature environments. Store the device in a dry place away from direct sunlight. CAUTION Use a soft cloth to clean the entire device. Do not use any abrasive or volatile cleaners. The following agents are compatible with the device:

70 percent isopropyl alcohol 10 percent chlorine bleach/90 percent water solution 1. Clean the Home scale only when necessary with one of the compatible cleaning agents listed above. If necessary, wipe the device with a soft, damp cloth. 2. Troubleshooting This section includes a list of error messages and frequently asked questions for problems you may encounter with your Home scale. If the device is not operating as you think it should, check here before arranging for servicing. 10 Use the scale Error prompt Error Dotted lines Error condition Welch Allyn Home Scale Description Solution Overload. The device will power off Weight exceeds scale maximum Low Battery. The device will power off in four seconds. Replace all four batteries at the same time. Purchase the authorized batteries for replacement. At any point, when a situation occurs 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. Check the following items:

Bluetooth wireless technology is on. The application is on. Both devices are within the transmission distance of Bluetooth devices. E02 Movement while weighing Remain motionless while weighing Weight fluctuates Placement on scale is improper Moved scale Cannot power on scale Batteries inserted improperly Scale halted Electrostatic interference Place scale on hard ground, then weigh again after returning scale to 0.0 kg. Place scale on hard ground, then weigh again after returning scale to 0.0 kg. Move scale and insert batteries. Reboot the scale and weigh again. Move scale and insert batteries. Reboot the scale and weigh again. When measuring Problem Root cause Solution No display on the LCD screen or display flickers with the scale powers on Batteries are not installed or not installed properly Install the batteries. Go to "Insert or replace the batteries"

Worn batteries The scale powers off automatically Low Battery.

"Bat" symbol appears for 3 seconds then the scale powers off No batteries Replace all four batteries at the same time. Purchase the authorized batteries for replacement. Replace all four batteries at the same time. Purchase the authorized batteries for replacement. Replace all four batteries at the same time. Purchase the authorized batteries for replacement. Measurement fluctuates by several pounds from last measurement Scale was not placed on a hard, flat surface for at least 10 seconds before obtaining measurement Place the scale on a hard, flat surface for at least 10 seconds before stepping Directions for use Use the scale 11 Problem Root cause Solution onto the scale to begin the measurement 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. 12 Use the scale Welch Allyn Home Scale 13 Appendices Specifications Warning: No modification of this equipment is allowed. Item Power supply Display mode Specification 6V 4*AAA alkaline batteries Blue LCD with White Backlight V.A.: 74x53mm Measurement unit Kilogram / Pound Measurement range 5kg to 200kg / 11lb to 441lb Resolution The measurement resolution shall be:

0100kg: 0.1kg 100200kg: 0.2kg 0220 lb: 0.2lb 220440lb: 0.5lb Normal working condition Temperature: 5 (41F) to 40

(104F) Humidity: 85%RH Atmospheric pressure: 86kPa to 106kPa Storage & transportation condition Temperature:-20 (-4F) to 60

(140F) Relative Humidity: 10% RH93% RH Net Weight Dimensions Accessories Atmospheric Pressure: 50kPa to 106 kPa Approximately 2.75kg (6.1 lb.) ( Excluding the dry cells) 360mm x 408mm x 32.5mm (14.2inches x16.1inches x 1.3inches) with carpet feet

(4) AAA alkaline batteries

(4) extension feet Directions for use Mode of operation Continuous operation 14 Appendices Welch Allyn Home Scale Item Auto-ON Auto-OFF Specification SENSE ON technology About 15 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 water IP22 Software Version Version 1.0 General radio compliance Item Bluetooth Module No. RF Frequency Range Output Power Supply Voltage Antenna Gain Specification AW51822 2402 MHz to 2480 MHz 4.0 dBm 1.8-3.6 V 0dBi Transmitting Distance 10 meters, (30 feet) FCC Statements:

This equipment 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. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna.

Increase the separation between the equipment and receiver.

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

Consult the dealer or an experienced technician for help. MODIFICATION: Any changes or modifications not expressly approved by to operate the device. the grantee of this device could void the users authority Directions for use Appendices 15 Complied standards list Item Risk management Labeling User manual General Requirements for Safety Standard ISO/EN 14971 Medical devices Application of risk management to medical devices 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 EN 1041 Medical equipment manufacturers to provide information 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 Item Standard Electromagnetic compatibility Software life-cycle processes Usability medical electrical equipment and medical electrical systems used in the home healthcare environment 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 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 16 Appendices Welch Allyn Home Scale Emissions and immunity information The Welch Allyn Home Scale RPM-SCALE100 is intended for use in the electromagnetic environment specified below. The customer or user of the Welch Allyn Home Scale 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 Home Scale is intended for use in the electromagnetic environment specified below. The customer or user of the Welch Allyn Home Scale should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 RF emissions CISPR 11 Group 1 Class B Harmonic emissions IEC 61000-3-2 Not applicable The Welch Allyn Home Scale 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. The Welch Allyn Home Scale is suitable 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. Directions for use Appendices 17 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Not applicable Electromagnetic emissions Electromagnetic immunity The Welch Allyn Home Scale is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn Home Scale should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic 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 Mains power quality should be that of a typical commercial or hospital environment. 1 kV line(s) to line(s) 1 kV differential mode 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 Home Scale requires continued operation during power mains interruptions, it is recommended that the Welch Allyn Home Scale be powered from an uninterruptible power supply or a battery.

<5% UT

(>95% dip in UT) for 0.5 cycle

<5% UT

(>95% dip in UT) for 0.5 cycle 40% UT

(60% dip in UT) for 5 cycles 40% UT

(60% dip in UT)for 5 cycles 70% UT

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

(30% dip in UT) for 25 cycles

<5% UT

(>95% dip in UT) for 5 seconds

<5% UT

(>95% dip in UT) for 5 seconds Power frequency

(50Hz) magnetic field IEC 61000-4-8 3A/m 3A/m Power 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 Home Scale is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn Home Scale should assure that it is used in such an environment. 18 Appendices Welch Allyn Home Scale Electromagnetic immunity 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 Scale, 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 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 Vrms 3 V/m 80 MHz to 1 GHz 3 V/m d= (1.167) d= (1.167) 80 to 800 MHz 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 Home Scale is used exceeds the applicable RF compliance level above, the Welch Allyn Home Scale 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 Home Scale. 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 Home Scale The Welch Allyn Home Scale is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Welch Allyn Home Scale can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Welch Allyn Home Scale as recommended below, according to the maximum output power of the communications equipment. Directions for use Appendices 19 Recommended separation distances between portable and mobile RF communications equipment and the Welch Allyn Home Scale Separation distance according to frequency of transmitter (m) Rated max. output power of transmitter

(W) 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) 0.01 0.1 1 10 100 0.167 0.369 1.167 3.690 11.67 0.167 0.369 1.167 3.690 11.67 0.233 0.738 2.333 7.338 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 Home 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. Failure caused by unauthorized repairs or modifications This warranty does NOT cover damages caused by misuse or abuse, including but not limited to:

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. 20 Appendices Welch Allyn Home Scale Approved accessories Item Description RPM-SCALEACC-01 Carpet Feet 40EA