Masimo Rad-G Manuel De L'utilisateur page 5

• CAUTION: Do not place the Rad-G near electrical equipment that may affect the device, preventing it from working properly.
• CAUTION: Failure to charge Rad-G promptly after a Low Battery alarm may result in the device shutting down.
• CAUTION: Do not connect the AC power supply to an electrical outlet controlled by a wall switch or dimmer.
• CAUTION: Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently displayed while monitoring consecutive
patients after completing the low SIQ troubleshooting steps listed in the troubleshooting section.
• Note: Cables and sensors are provided with X-Cal® technology to minimize the risk of inaccurate readings and unanticipated loss of patient
monitoring. Refer to the Cable or Sensor Directions for Use for the specified duration of patient monitoring time.
• Note: Physiological conditions that result in loss of pulsatile signal may result in no SpO
• Note: Always charge Rad-G when it is not in use to ensure that the battery remains fully charged.
• Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the Battery Module.
• Note: A functional tester cannot be used to assess the accuracy of Rad-G.
Cleaning, Disinfecting, and Service Warnings and Cautions
• WARNING: Do not attempt to remanufacture, recondition or recycle the Rad-G as these processes may damage the electrical components,
potentially leading to patient harm.
• WARNING: To avoid electric shock, do not attempt to replace or remove the Battery from the Rad-G. Service of Rad-G should be done by qualified
personnel only.
• CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the Rad-G for servicing.
• CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or
bring them into contact with anything that could scratch the display.
• CAUTION: To avoid permanent damage to the Rad-G, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning
solution not recommended.
• CAUTION: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Rad-G. These substances affect the device's
materials and device failure can result.
• CAUTION: Do not submerge the Rad-G in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any
other method. This will seriously damage the device.
• CAUTION: To prevent damage, do not soak or immerse Rad-G in any liquid solution.
Compliance Warnings and Cautions
• WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user's
authority to operate the equipment.
• WARNING: Per RSS-Gen, Section 8.4 This device complies with Industry Canada license-exempt RSS standard(s). 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. Per RSS-Gen, Radio apparatus shall comply with the requirements to include required notices
or statements to the user of equipment with each unit of equipment model offered for sale.
• CAUTION: Comply with local laws in the disposal of the device and/or its accessories.
• CAUTION: Device contains an internal battery. Dispose of the battery according to country or regional requirements.
• Note: Use Rad-G in accordance with the Environmental Specifications section in the Operator's Manual.
• Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following 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.
• Note: 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.
• Note: This equipment has been tested and found to comply with the Class B limits for medical devices according to the EN 60601-1-2:
2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in all
establishments, including domestic establishments.
• Note: In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved
equipment or unshielded cables is likely to result in interference to radio and TV reception. The user is cautioned that changes and modifications
made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment.
• Note: To satisfy RF exposure requirements, this device and its antenna must operate with 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.
• Note: This Class B digital apparatus complies with Canadian ICES-003.
TECHNOLOGY OVERVIEW
The following chapter contains general descriptions about functional oxygen saturation (SpO
Functional Oxygen Saturation (SpO
The Rad-G is calibrated to measure and display functional oxygen saturation (SpO
hemoglobin that is available to transport oxygen.
Note: Dyshemoglobins are not capable of transporting oxygen, but are recognized as oxygenated hemoglobins by conventional pulse oximetry.
Signal IQ
The Signal IQ provides an indicator of the assessment of the confidence in the displayed SpO
occurrence of a patient's pulse.
The height of the vertical line of the SpO
higher confidence in the measurement. A small vertical bar indicates lower confidence in the displayed measurement. When the Signal IQ is very low,
this suggests that the accuracy of the displayed measurement may be compromised.
)
2
SIQ provides an assessment of the confidence in the measurement displayed. A high vertical bar indicates
2
or RRp readings.
2
) and Signal IQ used by Masimo products.
2
): the amount of oxyhemoglobin expressed as a percentage of the
2
value. The SpO
2
5
SIQ can also be used to identify the
2
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