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Instructions for Use Instructions for Use Masimo iSirona™ Masimo iSirona™ Contents Contents Preface........................................................................................................................ 4 Symbols................................................................................................................................4 Intended audience............................................................................................................. 4 Compliance and safety information.................................................................................5 Notices........................................................................................................................7 Legal..................................................................................................................................... 7 Authorized representative.................................................................................................7 Contacts..................................................................................................................... 8 Support contact information.............................................................................................8 Manufacturer contact......................................................................................................... 8 Chapter 1: About the Masimo iSirona................................................................. 9 Included in the Masimo iSirona kit.................................................................................. 9 Masimo iSirona diagrams................................................................................................10 Masimo iSirona size and weight.................................................................................... 12 Connectivity options........................................................................................................ 12 Power sources...................................................................................................................13 Turn the Masimo iSirona on and off..............................................................................13 Chapter 2: Install and remove the Masimo iSirona......................................... 14 Install the Masimo iSirona...............................................................................................14 Remove the Masimo iSirona from mounting bracket..................................................14 Mounting bracket configurations...................................................................................14 Chapter 3: Battery maintenance......................................................................... 15 Charge the battery...........................................................................................................15 Replace the battery..........................................................................................................15 Battery cautions................................................................................................................ 15 Chapter 4: View the Masimo iSirona status...................................................... 17 Chapter 5: General handling instructions......................................................... 19 Appendix A: Appendix....................................................................................20 Electromagnetic emissions............................................................................................. 20 Immunity Standards (Non-Life Support)....................................................................... 20 Masimo Corporation 2 www.masimo.com Masimo iSirona™ Contents Trademark attributions These trademarks and all related logos and brandings are trademarks of Masimo Corporation. All other trademarked product names, brands, images, and other material are the property of their respective owners. Their use in this document does not imply a relationship between Masimo Corporation and the trademark holder. • iSirona™ • DCX™ • Shuttle™ • Masimo® Revision history Date Revision number Description January 5, 2021 1.0 Initial version January 8, 2021 2.0 Note added: Masimo iSirona is compatible with DCX versions 05.16.000-0 and above. Masimo Corporation 3 www.masimo.com Masimo iSirona™ Preface Preface Symbols Caution Manufacturer Authorized representative The CE mark indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area Consult the user manual Separate collection for waste of electrical and electronic equipment The Nationally Recognized Testing Laboratory (NRTL) mark is the certification mark of a nationally recognized test lab as accredited by the Occupational Health and Safety Administration (OSHA). The Federal Communications Commission (FCC) mark is a certification mark on electronic products manufactured or sold in the United States that certifies that the electromagnetic interference from the device is under limits approved by the FCC. Temperature Humidity Atmospheric pressure Intended audience Masimo iSirona is a medical device integration (MDI) solution intended to be used in clinical settings including hospitals, medical centers, and clinics. The intended users of iSirona include hospital technical personnel, including IT professionals and biomedical engineers, who install, maintain, and troubleshoot iSirona. Intended users also include hospital clinical personnel including nurses and nursing aids who clean iSirona and ensure that medical device data is flowing through iSirona to the EMR. Masimo Corporation 4 www.masimo.com Masimo iSirona™ Preface Compliance and safety information The Masimo iSirona meets regulations for use in the United States, Canada, and Europe. Federal Communications Commission (FCC) The Masimo iSirona contains FCC ID VKF-IRISA1. This device complies with part 15 of the Federal Communications Commission (FCC) rules and regulations delineated in Title 47 CFR, Part 15, Subpart B, Class B for unintentional radiators. 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: • Increase the separation between the equipment and the 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. Any changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment. This device is restricted to indoor use only when operating in the 5.15 GHz to 5.25 GHz frequency band (U-NII 1). Canadian ISED Compliance The Masimo iSirona complies with Canada's Interference-Causing Equipment Standards, ICES-003 Class B for unintentional radiators. Conformité Européenne (CE) The Masimo iSirona complies with the following CE directives: • Electromagnetic Compatibility Directive, 2014/30/EU • Restriction of Hazardous Substances Directive, 2011/65/EU • Waste Electrical and Electronic Equipment Directive, 2012/19/EU • LVD - The Low Voltage Directive, 2014/35/EU • RED - the Radio Equipment Directive, 2014/53/EU Dodd-Frank Consumer Protection Act All components and materials in the iSirona conform to Section 1502 Dodd-Frank Consumer Protection Act (commonly referred to conflict minerals). FCC radiation exposure statement The equipment must be installed to provide a separation distance of at least 7.9 inches (20cm) from all persons during operation, and must not be co-located or operated in conjunction with any antenna or transmitter subject to the conditions of the FCC Grant. Cautions Only use the provided AC power cable to connect the power supply to a main power outlet that is properly installed and grounded, in accordance with all local codes and ordinances. If the power supply cord is damaged, contact Masimo for a replacement. Masimo Corporation 5 www.masimo.com Masimo iSirona™ Preface Only use the Masimo-provided battery. Power over Ethernet is an available feature defined by IEEE 802.3 Type 1, Class 3. As a safety measure to prevent potential adverse results to data transmission, do not plug personal electronics into a iSirona USB port. Any and all configurations that use this device must be tested for electrical isolation before being used for patient care. Do not modify the device without authorization. Any modifications must be inspected and approved by Masimo. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation or degraded performance. Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
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