Masimo Rad-G Manuel De L'utilisateur page 3

Rad-G™
Pulse Oximeter
Not for Sale in the USA - For Export Only
These instructions provide the necessary information for proper operation of all models of the Rad-G™ Pulse Oximeter. There may be information
provided in this manual that is not relevant to your device model. General knowledge of pulse oximetry and an understanding of the features and
functions of the Rad-G Pulse Oximeter are prerequisites for its proper use. Do not operate Rad-G Pulse Oximeter without completely reading and
understanding these instructions.
Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in
combination with this device, fall within the scope of one of the relating patents.
CAUTION: Use of this device must follow the order of a physician.
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, and
precautions.
If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer.
ABOUT THIS MANUAL
This manual explains how to set up and use Rad-G Pulse Oximeter. Important safety information relating to general use of Rad-G appears in
this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings,
cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device, or damage
to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.
PRODUCT DESCRIPTION
The Rad-G Pulse Oximeter is a noninvasive device intended to measure functional oxygen saturation of arterial hemoglobin (SpO
Perfusion Index (Pi), and Pleth Respiration Rate (RRp).
The following key features are available for Rad-G:
• Masimo SET® technology performance.
• SpO and pulse rate measuring in motion and low perfusion environments.
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• Respiration rate determined by plethysmographic waveform (RRp).
INDICATIONS FOR USE
The Masimo Rad-G Pulse Oximeter and accessories are indicated for noninvasive spot-checking of functional oxygen saturation of arterial
hemoglobin (SpO ), pulse rate (PR), and/or respiratory rate (RR). The Masimo Rad-G Pulse Oximeter and accessories are indicated for use with adult,
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pediatric, and infant patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-
type facilities, home, and mobile environments.
CONTRAINDICATIONS
The Rad-G device is not intended for use as an apnea monitor.
SAFETY INFORMATION, WARNINGS, AND CAUTIONS
CAUTION: Rad-G is to be operated by, or under the supervision of, qualified personnel only. Read the manual, accessories directions for use, all
precautionary information, and specifications before use.
Safety Warnings and Cautions
• WARNING: Do not use Rad-G if it appears or is suspected to be damaged. Damage to the device can result in exposed electrical circuits that may
cause patient harm.
• WARNING: Do not adjust, repair, open, disassemble, or modify the Rad-G. Damage to the device may result in degraded performance and/or
patient injury.
• WARNING: Do not start or operate the Rad-G unless the setup was verified to be correct. Improper set-up of this device may result in degraded
performance and/or patient injury.
• WARNING: Do not place the Rad-G or accessories in any position that might cause it to fall on the patient.
• WARNING: Only use Masimo authorized devices with Rad-G. Using unauthorized devices with Rad-G may result in damage to the device and/
or patient injury.
• WARNING: All sensors and cables are designed for use with specific devices. Verify the compatibility of the device, cable, and sensor before use;
otherwise degraded performance and/or patient injury can result.
• WARNING: Do not use the Rad-G in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-
enriched environments, or nitrous oxide to avoid risk of explosion.
• WARNING: Do not use the Rad-G during magnetic resonance imaging (MRI) or in an MRI environment.
• WARNING: Rad-G may be used during defibrillation. However, to reduce the risk of electric shock, the operator should not touch the Rad-G
during defibrillation.
• WARNING: To protect against electrical shock injury, follow the directions below:
• Avoid placing the device on surfaces with visible liquid spills.
• Do not soak or immerse the device in liquids.
• Do not attempt to sterilize the device.
• Use cleaning solutions only as instructed in this Operator's Manual.
• Do not attempt to clean the Rad-G while monitoring patient.
O P E R AT O R ' S M A N U A L
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en
), Pulse Rate (PR),
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39296/9527H-0320