2AZIZSR396AVA Activity Analytics System

AVA Activity Analytics Anti-Decubitus Air Alternating Pressure Mattress Replacement System Instructions for Use 1 Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics About This Document Congratulations and thank you for purchasing this high quality anti- decubitus system. Please read these Instructions for Use carefully before use and observe the safety instructions and the requirements for the operation and maintenance of the device. Identification Details of the Device These Instructions for Use are intended exclusively for devices with the following specification: Device name: AVA Activity Analytics System The serial number is shown on the label on the rear panel of the power unit and on the tag sewn on the mattress. Details of the Device Documentation This manual describes the AVA Activity Analytics System. It is part of the device documentation. Do not pass this device to a third party without these Instructions for Use. For the confirmation of the up-to-date status of the documentation, the end page of the Instructions for Use is marked by edition version. The contents of the Instructions for use can be changed by the manufacturer at any time without prior notice. For translations into languages other than English, the English version of these Instructions for Use is authentic. The contents of these Instructions for Use are protected by copyright. The resulting rights, in particular, the reprinting, the photomechanical or digital processing or copying of the contents or any part thereof, are only permitted with the written approval of Carilex Medical, Inc. This provision shall not affect the reproduction for internal use. Device identification Validity of the documentation Subject to change Translations Copyright Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 2 About This Document Information on the Manufacturer's Representative Carilex Medical, Inc. No. 77, Keji 1st Rd., Guishan District, Taoyuan City(33383), Taiwan(R.O.C) EU Representative: Carilex Medical B.V Zekeringstraat 41D, 1014BV Amsterdam Tel:+31 (0) 208905788 Email: [email protected] For Support or Complaints In the event of a complaint, or if you have any questions about the use of the device or a need for spare parts, please contact the supplier, that delivered the device to you or your patients. Sales and service 3 Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics Table of Contents 1 Important Notes for Safe Use 5-11 1.1 Designation of the Groups of Individuals 5 1.2 Notes for the Users 6 1.2.1 Instruction 6 1.2.2 Handing Over the Device 6 1.2.3 Maintenance and Installation 6 1.2.4 Information and Test Obligation of the User 6 1.2.5 Rechargeable Coin Cell Replacement Notice 6 1.3 Procedures for Accident Prevention 7 1.3.1 Procedures for Handing Over the Device 7 1.3.2 Qualification Requirements Hygiene Staff 7 1.3.3 Availability of the Instructions for Use 7 1.3.4 Home Healthcare Environment 7 1.4 Purpose of the Device 8 1.4.1 Intended Use 8 1.4.2 Attention 8 1.4.3 EMC and RF Compliance Statement 9 1.5 Warranty 10 1.6 Safety Information and Symbols of These Instructions for Use 11 1.6.1 Identification of Risks of Injury 11 1.6.2 Identification of Material Damage 11 1.6.3 Identification of Additional Information 11 1.6.4 Additional Symbols to the Safety Information 12 2 Security Norms 13-14 2.1 Correct Use of the System 13 2.2 Advice 14 3 Delivery and Storage 15 3.1 Packaging 15 3.2 Delivery Control 15 3.3 Storage and Transport 15 4 Device and Functional Description 16-17 4.1 Device Description 16 4.2 Operation and Functional Test 17 4 Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics Table of Contents 5 Features 18-21 5.1 Control Panel 18 5.2 Side Panel 21 5.3 Rear Panel 21 6 System Installation, Operation, Transfer and Transport of Patient 22-23 6.1 System Installation 22 6.2 Operation 22 6.3 Transfer and Transport of Patient 23 7 Application 24 7.1 Preparing the Application 24 7.1.1 Inflating the Mattress 24 7.1.2 Patients Positioning 24 8 Cleaning and Disinfection 25-27 8.1 Cleaning 26 8.2 Disinfection 27 9 Care and Maintenance 28 9.1 Inspection 28 9.2 Maintenance 28 10 Troubleshooting 29-31 11 Technical Data 32 12 EMC Declaration 33-34 5 Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1.1 Designation of the Groups of Individuals The named groups of persons in these Instructions for Use are as follows. Operators An operator (surgical supplier, health insurance, clinic, etc.) is any legal person, who owns AVA Activity Analytics System and uses it, or on whose behalf the device is in use. The operator is responsible for providing a safe device and to instruct the user properly on the operation and safe use of the device. Users Users are people who are entitled, due to their training or a corresponding instruction to: • Operate the AVA Activity Analytics System • Supervised patients using the device for therapy or care purposes. Users are fully responsible for the safe and correct use of the device. A review of the functions has to be carried out and the proper condition of the device has to be checked and confirmed by the user before each use or transfer for use. Professionals The authorized persons are skilled personnel, who are as a rule, the employees of the operator and who : • Have acquired their knowledge through professional training in the medical-technical field, • Carry out their activity on the basis of professional work experience and instructions according to safety-related regulations and are able to detect possible hazards during work. In countries in which the pursuit of an activity in the medical-technical area is certified, the classification as qualified personnel is subject to…

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ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 1 of 4 Sheets Rev. No 2.0 CONSTRUCTION PHOTOS OF EUT 1. Outside view of EUT 2. Outside view of EUT ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 2 of 4 Sheets Rev. No 2.0 3. Outside view of EUT 4. Outside view of EUT ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 3 of 4 Sheets Rev. No 2.0 5. Outside view of EUT 6. Outside view of EUT ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 4 of 4 Sheets Rev. No 2.0 7. Outside view of EUT

ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 1 of 6 Sheets Rev. No 2.0 CONSTRUCTION PHOTOS OF EUT 1. Inside view of EUT 2. Inside view of EUT ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 2 of 6 Sheets Rev. No 2.0 3. Inside view of EUT 4. Inside view of EUT ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 3 of 6 Sheets Rev. No 2.0 5. PCB Photos 6. PCB Photos ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 4 of 6 Sheets Rev. No 2.0 7. PCB Photos 8. PCB Photos ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 5 of 6 Sheets Rev. No 2.0 9. PCB Photos 10. PCB Photos ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 6 of 6 Sheets Rev. No 2.0 11. PCB Photos 12. PCB Photos

FCC ID: 2AS9BYP1 Sheet 1 of 6 Sheets Rev. No 2.0 RF Exposure Evaluation of E.U.T. : AVA Activity Analytics System Model No. : SR396 Serial Model : --- FCC ID : 2AZIZSR396 for APPLICANT : Carilex Medical Inc. ADDRESS : No.77, Keji 1 st Road, Guishan District, Taoyuan City 33383, Taiwan(R.O.C) Test Performed by ELECTRONICS TESTING CENTER, TAIWAN NO. 34. LIN 5. DINGFU VIL., LINKOU DIST., NEW TAIPEI CITY, TAIWAN, 24442, R.O.C. Tel : (02)26023052 Fax : (02)26010910 http://www.etc.org.tw ; e-mail: [email protected] Report Number : 21-01-RBF-019-02 FCC ID: 2AS9BYP1 Sheet 2 of 6 Sheets Rev. No 2.0 TEST REPORT CERTIFICATION Applicant : Carilex Medical Inc. No.77, Keji 1 st Road, Guishan District, Taoyuan City 33383, Taiwan(R.O.C) Manufacturer : Carilex Medical Inc. No.77, Keji 1 st Road, Guishan District, Taoyuan City 33383, Taiwan(R.O.C) Description of EUT a) Type of EUT : AVA Activity Analytics System b) Trade Name : Carilex c) Model No. : SR396 d) Serial Model : --- e) Power Supply : 100-240Vac , 50/60Hz, 0.5-0.3A f) Frequency Range : 2412-2472 MHz Regulation Applied : FCC KDB447498 D01. The equipment fulfills the requirements on power density for general population/uncontrolled exposure and therefore fulfills the requirements of section 1.1310 of FCC 47 CFR Part 1. Note: 1. The result of the testing report relate only to the item tested. 2. The testing report shall not be reproduced expect in full, without the written approval of ETC FCC ID: 2AS9BYP1 Sheet 4 of 6 Sheets Rev. No 2.0 Product Information: Type of EUT: AVA Activity Analytics System FCC ID: 2AZIZSR396 Model: Serial Model: SR396 Description: Yardian Pro is a Wi-Fi smart sprinkler controller with access to local weather forecasts and a unique Local Municipal Water Restrictions database. Maximum conducted output power (rated): 22.72 dBm or 187.068 mW The following table lists the provided authorized antennas: Model Antenna Type Antenna Gain (dBi) Numeric N/A PIFA Antenna 3.65 2.317 Below is an example of the RF Exposure Statement: IMPORTANT NOTE: To comply with the FCC RF exposure compliance requirements, the antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. No change to the antenna or the device is permitted. Any change to the antenna or the device could result in the device exceeding the RF exposure requirements and void user’s authority to operate the device. FCC ID: 2AS9BYP1 Sheet 5 of 6 Sheets Rev. No 2.0 Relative Requirement for Compliance According to section 1.1310 of FCC 47 CFR Part 1, limits for maximum permissible exposure (MPE) are as following: TABLE 1 – LIMITS FOR MAXIMUN PERMISSIBLE EXPOSURE (MPE) Frequency Range (MHz) Electric Field Strength (V/m) Magnetic Field Strength (A/m) Power Density (mW/cm 2 ) Averaging Time (minutes) (A) Limits for Occupational/Controlled Exposures 0.3-3.0 .................. 614 1.63 *(100) 6 3-30 ..................... 1842/f 4.89/f *(900/f 2 ) 6 30-300 .................. 61.4 0.163 1.0 6 300-1500 ............... ...................... ...................... f/300 6 1500-100,000 ......... ...................... ...................... 5 6 (B) Limits for General Population/Uncontrolled Exposure 0.3-1.34 ............... 614 1.63 *(100) 30 1.34-30 ............... 824/f 2.19/f *(180/f2) 30 30-300 .................. 27.5 0.073 0.2 30 300-1500 ............... ...................... ...................... f/1500 30 1500-100,000 ......... ...................... ...................... 1.0 30 f = frequency in MHz * = Plane-wave equivalent power density NOTE 1 TO TABLE 1: Occupational/controlled limits apply in situations in which persons are exposed as a consequence of their employment provided those persons are fully aware of the potential for exposure and can exercise control over their exposure. Limits for occupational/controlled exposure also apply in situations when an individual is transient through a location where occupational / controlled limits apply provided he or she is made aware of the potential for exposure. NOTE 2 TO TABLE 1: General population/uncontrolled exposures apply in situations in which the general public may be exposed, or in which persons that are exposed as a consequence of their employment may not be fully aware of the potential for exposure or can not exercise control over their exposure. FCC ID: 2AS9BYP1 Sheet 6 of 6 Sheets Rev. No 2.0 RF Exposure Calculations: The following information provides the minimum separation distance for the highest gain antenna provided. This calculation is based on the highest EIRP possible from the system, considering maximum power and antenna gain, and considering a 1.0 mW/cm 2 uncontrolled exposure limit. The formula shown in OET Bulletin 65 is used in the calculation. Equation from page 19 of OET Bulletin 65, Edition 97-01 is: S= PG / 4πR 2 where: S = power density (in appropriate units, e.g. mW/cm 2 ) P = power input to the antenna (in appropriate units, e.g., mW) G = power gain of the antenna in the direction of interest relative to an isotropic radiator R = distance to the center of radiation of the antenna (appropriate units, e.g., cm) hence R= (PG / 4πS) 1/2 For our device P = 187.068 mW G = 2.317 R = 20 cm S = (187.068 * 2.317) / (4* π*20 2 ) = 0.0862 mW/cm 2 < 1.0 mW/cm 2 For complying the FCC limits for general population/uncontrolled exposure, the power density limit is 1.0 mW/cm 2 . The calculation result of the power density at a distance of 20 cm of our device is less than the limit. This means that according to OET Bulletin 65 (Edition 97-01), Supplement C (Edition 01-01), the equipment fulfills the requirements on power density for general population/uncontrolled exposure and therefore fulfills the requirements of section 1.1310 of FCC 47 CFR Part 1.

ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 1 of 102 Sheets Rev. No 2.0 FCC Part 15 EMI TEST REPORT of E.U.T. : AVA Activity Analytics System FCC ID. : 2AZIZSR396 Model No. : SR396 for APPLICANT : Carilex Medical Inc. ADDRESS : No.77, Keji 1 st Road, Guishan District, Taoyuan City 33383, Taiwan (R.O.C) Test Performed by ELECTRONICS TESTING CENTER, TAIWAN NO. 34. LIN 5. DINGFU VIL., LINKOU DIST., NEW TAIPEI CITY, TAIWAN, 24442, R.O.C. Tel : (02)26023052 Fax : (02)26010910 http://www.etc.org.tw ; e-mail: [email protected] Report Number : 21-01-RBF-019-01 ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 2 of 102 Sheets Rev. No 2.0 TEST REPORT CERTIFICATION Applicant : Carilex Medical Inc. No.77, Keji 1 st Road, Guishan District, Taoyuan City 33383, Taiwan (R.O.C) Manufacturer : Carilex Medical Inc. No.77, Keji 1 st Road, Guishan District, Taoyuan City 33383, Taiwan (R.O.C) Description of EUT a) Type of EUT : AVA Activity Analytics System b) Trade Name : Carilex c) Model No. : SR396 d) Power Supply : 100-240Vac , 50/60Hz, 0.5-0.3A Regulation Applied : FCC Rules and Regulations Part 15 Subpart C I HEREBY CERTIFY THAT: The data shown in this report were made in accordance with the procedures given in ANSI C63.10-2013, and the energy emitted by the device was founded to be within the limits applicable. I assume full responsibility for accuracy and completeness of these data. Note: 1. The result of the testing report relate only to the item tested. 2. The testing report shall not be reproduced expect in full, without the written approval of ETC Summary of Tests Test Results Radiated Emission Pass Conducted Emission Pass Duty Cycle N.A. Emission Bandwidth Pass Output Power Pass 100 kHz Bandwidth of Band Edges Pass Power Density Pass Out-of-Band Conducted Emission Pass Radio Frequency Radiation Exposure Requirements Pass ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 4 of 102 Sheets Rev. No 2.0 Table of Contents Page 1 GENERAL INFORMATION ....................................................................................................... 6 1.1 Product Description ...................................................................................................................... 6 1.2 Characteristics of Device ............................................................................................................. 6 1.3 Test Methodology ........................................................................................................................ 6 1.4 Test Facility .................................................................................................................................. 6 2 PROVISIONS APPLICABLE ...................................................................................................... 7 2.1 Definition ..................................................................................................................................... 7 2.2 Requirement for Compliance ....................................................................................................... 8 2.3 Restricted Bands of Operation ................................................................................................... 10 2.4 Labeling Requirement ................................................................................................................ 10 2.5 User Information ........................................................................................................................ 11 2.6 Measurement Uncertainty .......................................................................................................... 12 3. SYSTEM TEST CONFIGURATION ........................................................................................ 13 3.1 Justification ................................................................................................................................ 13 3.2 Devices for Tested System ......................................................................................................... 14 4 RADIATED EMISSION MEASUREMENT ............................................................................ 15 4.1 Applicable Standard ................................................................................................................... 15 4.2 Measurement Procedure ............................................................................................................. 15 4.3 Measuring Instrument ................................................................................................................ 17 4.4 Radiated Emission Data ............................................................................................................. 18 4.5 Field Strength Calculation .......................................................................................................... 38 4.6 Photos of Radiation Measuring Setup ........................................................................................ 39 5 CONDUCTED EMISSION MEASUREMENT ........................................................................ 42 5.1 Standard Applicable ................................................................................................................... 42 5.2 Measurement Procedure ............................................................................................................. 42 5.3 Conducted Emission Data .......................................................................................................... 43 5.4 Result Data Calculation .............................................................................................................. 45 5.5 Conducted Measurement Equipment ......................................................................................... 45 5.6 Photos of Conduction Measuring Setup ..................................................................................... 46 6 ANTENNA REQUIREMENT ...........................…

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ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 1 of 4 Sheets Rev. No 2.0 4.6 Photos of Radiation Measuring Setup (Below 1GHz) ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 2 of 4 Sheets Rev. No 2.0 (Above 1GHz-6GHz) ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 3 of 4 Sheets Rev. No 2.0 (Above 6GHz) ETC Report No. :21-01-RBF-019-01 FCC ID.: 2AZIZSR396 Sheet 4 of 4 Sheets Rev. No 2.0 5.6 Photos of Conduction Measuring Setup