GPI-M5K001MedSense Badge

MedSense ™ ® Badge M5K001 3 How MedSense Works 4 Wearing the MedSense Badge 7 Using the MedSense Badge 7 Legal Statements 8 Contents Welcome to MedSense Dear MedSense user, We would like to thank you for using our product and welcome you to the MedSense community. We share your goal of achieving the highest possible level of hygiene in your hospital, and we hope using our product makes your life simpler. Sincerely, The General Sensing Team 45 How MedSense Works MedSense is a combination of four easy-to-use wireless devices that monitor and record compliance performance at point-of-care areas. These devices take advantage of low-power wireless communication and the latest web technologies to offer you a simple, powerful, and accurate hand hygiene compliance monitoring solution. 1.2.3. 4. 1. The MedSense Badge The MedSense Badge, worn like an identity card, collects hand hygiene compliance data as the healthcare worker delivers care around the hospital. 2. The MedSense Beacon The MedSense Beacon is a low-profile, battery-powered device that is placed above a patient bed or other point of care with a semi- permanent adhesive backing. The Beacon establishes a wireless patient zone that allows the Badge to identify hand hygiene opportunities. 3. The MedSense Dispenser Monitor The MedSense Dispenser Monitor acts as a holster for sanitizer bottles. When a healthcare worker uses a sanitizer bottle, the Dispenser Monitor signals the user’s Badge, which in turn records a hand hygiene action. 4. The MedSense Base The MedSense Base functions as a wireless base station through which Badges upload compliance data to MedSense HQ. The Base also functions as a battery charger for the Badge, capable of charging up to sixteen Badge batteries to full capacity in two hours. The MedSense HQ MedSense HQ, General Sensing’s cloud-based web application, is what ties all four devices together. 67 Using the MedSense Badge The Badge will automatically upload data to MedSense HQ when in range of a Base. The Badge will vibrate as a reminder to perform hand hygiene when an opportunity is about to be missed. The battery life is approximately one work week and should be swapped out when a low battery indicator is shown. When outside of the MedSense-equipped areas, the Badge goes into standby mode. LED Status Status: Blinking Blue Explanation: Normal operation in MedSense-equipped area or in motion. Status: Blinking Red Explanation: Low battery Status: Off Explanation: Battery depleted or not in motion while outside MedSense-equipped area. Status: Blinking Pink Explanation: Indicates possible connection problems. Contact MedSense support team. CARE INSTRUCTIONS Wipe down with a damp cloth. If the Badge is lost or broken, ask MedSense support team for an exchange or replacement. Wearing the MedSense Badge • Write the health care worker’s name on a label provided and adhere the label to the Badge. • Attach a battery to the Badge. • Clip the Badge on the torso, hanging in portrait mode and facing out, for the most accurate performance. • Placing the Badge in a pocket is not recommended. YESNO NO 98 Legal Statements FCC Statement 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 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 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 radio/TV technician for help. To assure continued compliance, any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. Radiation Exposure Statement This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and it also complies with Part 15 of FCC RF Rules. Operation is subject to the following two conditions: • This device may not cause interference, and • This device must accept any interference, including interference that may cause undesired operation of the device. Caution! The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the user authority to operate the equipment. Canada Statement • This device complies with Industry Canada RSS-210. 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 RSS-210. 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. • The device meets the exemption from the routine evaluation limits in section 2.5 of RSS 102 and compliance with RSS-102 RF exposure, users can obtain Canadian information on RF exposure and compliance. • Le dispositif rencontre l’exemption des limites courantes d’évaluation dans la section 2.5 de RSS 102 et la confor…

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06/26/2014 BABT TCB Balfour House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD Dear Sir or Madam, We, General Sensing Limited Unit 716, Cyberport 1, 100 Cyberport Road, Pok Fu Lam, Hong Kong hereby authorize TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China Felix Li Phone: +86-755-88286998-3243 e-mail: felix [email protected] to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. We also hereby certify that neither we nor any party to this application are subject to denial of U.S Federal benefits, which include FCC benefits, pursuant to section 5301 of Anti-Drug Abuse Act of 1988, U.S.C 862 because of conviction for possession or distribution of controlled substance. This authorization is application to product: Type of equipment: MedSense Badge Model name: M5K001 FCC ID: GPI-M5K001 This authorization expires one year from the current date. Sincerely, CTO: Jonathan Gips Telephone Number: +1 617 785 7882 E-mail: [email protected] !

06/26/2014 BABT TCB Balfour House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD Confidentiality Request FCC ID: GPI-M5K001 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, we General Sensing Limited hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Parts List PCB Layout Block Diagrams Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, CTO: Jonathan Gips Telephone Number: +1 617 785 7882 E-mail: [email protected]

M5K001 External Photos

Label location Label location

Katharina Meister Nurse Silkprint MedSense Model: M5K001 FCC ID: VLF-M5K001 IC: 7310A-M5K001 www.generalsensing.com Manufactured in China Device ID: XXXXXXXX Transparent Sticker 37mm x 8mm White Sticker ( Printed at Hospital ) 37mm x 8mm Device ID: XXXXXXXX     Label pocket for staff identifier 46 mm x 14 mm 0.15 mm depth 0.5 mm radius corners Silkprint Label pocket for device ID 38 mm x 9 mm 0.15 mm depth 0.5 mm radius corners

N5K001 Internal Photos

TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China Exemption from Routine Evaluation – SAR Evaluation for M5K001 1. Introduction M5K001 is a Medsense badge, which is a 2.4GHz short range device. 2. Limit and Guidelines on Exposure to Electromagnetic Fields According to RSS-102 § (2.5.1), SAR evaluation is required if the separation distance between the user and the device is less than or equal to 20 cm, except when the device operates: above 2.2 GHz up to 3 GHz inclusively and its output power (i.e. the higher of the conducted or radiated (e.i.r.p.) source-based time-averaged output power) is less than, or equal to 20 mW for General Public Use and 100 mW for Controlled Use 3. Calculation method Maximum radiated power of M5K001 is 0.67mW(-1.77dBm), it is below 20mW, Exemption from Routine Evaluation Limits – RF Exposure Evaluation, so SAR evaluation is not necessary. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Reviewed by: Prepared By: Ken Li/ EMC Project Manager Felix Li/ EMC Project Engineer Date: 2014-06-26 Date: 2014-06-26

Report Number: 68.760.12.309.01 Page 1 of 27 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China FCC/IC - TEST REPORT Report Number : 68.760.12.309.01 Date of Issue: June 20, 2014 Model : M5K001 Product Type : MedSense Badge Applicant : General Sensing Limited Address : Unit 716, Cyberport 1, 100 Cyberport Road, Pok Fu Lam, Hong Kong Manufacture : General Sensing Limited Address : Unit 716, Cyberport 1, 100 Cyberport Road, Pok Fu Lam, Hong Kong Test Result :  Positive  Negative Total pages including Appendices : 27 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch is a subcontractor to TÜV SÜD Product Service GmbH according to the principles outlined in ISO 17025. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch reports apply only to the specific samples tested under stated test conditions. Construction of the actual test samples has been documented. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. The manufacturer/importer is responsible to the Competent Authorities in Europe for any modifications made to the production units which result in non-compliance to the relevant regulations. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval Report Number: 68.760.12.309.01 Page 2 of 27 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China 1 Table of Contents 1 Table of Contents.......................................................................................... 2 2 Details about the Test Laboratory..................................................................... 3 3 Description of the Equipment Under Test............................................................ 4 4 Summary of Test Standards............................................................................. 5 5 Summary of Test Results................................................................................ 6 6 General Remarks.......................................................................................... 7 7 Test setups 8 8 Technical Requirements................................................................................. 9 8.1 Field strength of emissions and Restricted bands ....................................... 9 8.2 Out of band emissions .......................................................................... 18 8.3 20dB Bandwidth & 99% bandwidth .......................................................... 23 9 Test equipment list 26 10 System Measurement Uncertainty................................................................... 27 Report Number: 68.760.12.309.01 Page 3 of 27 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China 2 Details about the Test Laboratory Details about the Test Laboratory Test site1: Company name: TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China Telephone: 86 755 8828 6998 Fax: 86 755 8828 5299 Test site2: Company name: Audix Technology (shenzhen) Co.,Ltd Block Shenzhen, Science & Industry Park, Nantou, Shenzhen, Guangdong, China Telephone: 86 755 2663 9496 Fax: 86 755 2663 2877 Report Number: 68.760.12.309.01 Page 4 of 27 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China 3 Description of the Equipment Under Test Description of the Equipment Under Test Product: MedSense Badge Model no.: M5K001 Brand Name: MedSense Options and accessories: NIL Rating: DC3.7V RF Transmission Frequency: 2402MHz - 2480.980MHz Antenna Gain: 6dBi Description of the EUT: NIL Auxiliary Equipment Used during Test: DESCRIPTION MANUFACTURER MODEL NO.(SHIELD) S/N(LENGTH) --- --- --- --- Report Number: 68.760.12.309.01 Page 5 of 27 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China 4 Summary of Test Standards Test Standards FCC Part 15 Subpart C 10-1-2013 Edition PART 15 - RADIO FREQUENCY DEVICES Subpart C - Intentional Radiators RSS-Gen Issue 3 December 2010 General Requirements and Information for the Certification of Radio Apparatus RSS-210 Issue 8 December 2010 RSS-210 — Licence-exempt Radio Apparatus (All Frequency Bands): Category I Equipment Report Number: 68.760.12.309.01 Page 6 of 27 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P.R. China 5 Summary of Test Results Technical Requirements FCC Part 15 Subpart C, RSS-Gen, RSS-210 Test Condition Pages Test Site Test Result Pass Fail N/A 15.207 & RSS-Gen A7.2.4 Conducted emission AC power port* -- -- §15.205(a), §15.209(a), §15.249(a), §15.249(c) & RSS-210 A2.9(a), RSS-Gen 7.2.2 Field strength of emissions and Restricted bands 9 Site 2 RSS-GEN 4.10 Receiver Spurious Emissions* -- Sit…

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M5K001 Test Setup Photo Radiation emission (below 1G) Radiation emission (Above 1G)