Masimo Radical 7 User manual

Operator’s Manual
Wireless Radio Addendum
Pulse CO-Oximeter

2
Radical-7 Operator’s Manual Wireless Radio Addendum
This 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 i
Wireless Radio
FCC ID: VKF-RAD7CPL
IC: 7362A-RAD7CPL
Bluetooth
FCC ID: PVH0925
IC: 5325A-0925
SAFETY 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
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■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/g
Encryption 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES
Authentication Open System, Shared Key, Pre-Shared Key (PSK),
802.1X: LEAP, PEAP, TTLS, TLS, EAP-FAST
Compliance
USA FCC ID: VKF-RAD7CPL
FCC parts 15.207, 15.209, 15.247 and 15.407
Canada IC: 7362A-RAD7CPL
RSS-210
Europe
EN 300 328
EN 301 893
EN 301 489-17
Bluetooth Specifications (if installed)
RF output power (conducted
- excluding antenna gain) Class 2 , max 4dBm (2.5mW)
Output frequency 2.402 - 2.480 GHz, ISM band
Referenced QDIDs B016013 combined with B015102
Modulation FHSS (Frequency hopping)
Compliance
USA FCC ID: PVH0925
Canada IC: 5325A-0925
Europe
EN 300 328
EN 301 489-1
EN 301 489-17
EN 61000-6-2

34168/6394A - 0510
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
www.masimo.com
Manufacturer:
© 2008 Masimo Corporation.
EU Authorized Representative for Masimo
Corporation:
EC REP
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany