Masimo RAD7CPL Radical 7R User Manual LAB6394A indd

Masimo Corporation Radical 7R LAB6394A indd

Contents

User Manual 1

Operator’s ManualWireless Radio AddendumPulse CO-Oximeter
2Radical-7 Operator’s Manual Wireless Radio AddendumThis addendum describes wireless radio licensing and specification information for the Radical-7 Pulse CO-Oximeter. This addendum is used in conjunction with the Radical-7 Operator’s Manual, part number 33975.PAGE iWireless RadioFCC ID: VKF-RAD7CPLIC: 7362A-RAD7CPLBluetoothFCC ID: PVH0925IC: 5325A-0925SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES■ Do not place the Pulse CO-Oximeter or accessories in any position that might cause it to fall on the patient. Pulse CO-Oximeter must be placed greater than 20cm from the patient’s head or torso. ■ This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2, Medical Device Directive 93/42/EEC and Part 15, FCC Rules/USA. ■ This device complies with part 15 of the FCC Rules. Operation is subject to the fol-lowing two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.■ The Bluetooth component in this device has been qualified according to the Blue-tooth specification 2.1+EDR■ 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 other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, 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 device.■ Increase the separation between the equipment.■ Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.■ Consult the manufacturer for help.■ In order to connect wirelessly to a compatible interface system like Patient SafetyNet, the Radical-7 should be placed in an environment free from RF shielding, which could hinder wireless reception.■ To minimize radio interference, other electrical equipment that emits RF transmissions should not be in close proximity to the Radical-7 1
3■ Changes or modifications to the wireless radio feature whether intentional or unintentional are prohibited without written approval from Masimo Corporation.SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ The Radical-7 (device with optional radio) wirelessly transmits real-time sensor connectivity status, indicating a connect and/or disconnect state. If the device is in a failure mode then the radio power is disabled and an error message is indicated on the device display. The device does not have a powered state where no information is transmitted.■ In accordance with FCC requirements, the Radical-7 (device with optional radio) must be placed greater then 20 cm from the patient’s head or torso.■ In accordance with FCC requirements, radio accessories on the Radical-7 (device with optional radio) cannot be attached directly to the patient using any accessory containing metal components.■ In accordance with international telecommunication requirements, the frequency band of 5,150 MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.SECTION 7: SPECIFICATIONS Wireless Radio Specifications (if installed)Radio Modes 8802.11 a/b/gEncryption 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AESAuthentication Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP, TTLS, TLS, EAP-FASTComplianceUSA FCC ID: VKF-RAD7CPLFCC parts 15.207, 15.209, 15.247 and 15.407Canada IC: 7362A-RAD7CPLRSS-210EuropeEN 300 328EN 301 893EN 301 489-17Bluetooth Specifications (if installed)RF output power (conducted - excluding antenna gain) Class 2 , max 4dBm (2.5mW)Output frequency 2.402 - 2.480 GHz, ISM bandReferenced QDIDs B016013 combined with B015102Modulation FHSS (Frequency hopping)ComplianceUSA FCC ID: PVH0925Canada IC: 5325A-0925EuropeEN 300 328EN 301 489-1EN 301 489-17EN 61000-6-2
34168/6394A - 0510Masimo Corporation40 ParkerIrvine, CA 92618USAwww.masimo.comManufacturer:© 2008 Masimo Corporation.EU Authorized Representative for Masimo Corporation:EC REPMDSS GmbHSchiffgraben 4130175 Hannover, Germany

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