Service And Maintenance; Performance Verification; Return Procedure - Masimo Rad-G Manuel De L'utilisateur

CITATIONS
[1] The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the
range of 70-100% SpO against a laboratory CO-Oximeter and ECG monitor.
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[2] The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while
performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100%
SpO against a laboratory CO-Oximeter and ECG monitor.
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[3] The Rad-G has been validated for low perfusion accuracy in bench-top testing against a Biotek Index 2TM* simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission
of greater than 5% for saturations ranging from 70%-100%.
[4] Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Fluke Biotek Index 2 simulator.
[5] The Masimo RRp™ (Respiration Rate from Pleth) spot-check technology used in Rad-G has been bench tested for respiration rate accuracy in the range of 4-90 rpm.
[6] RRp has been validated on subjects 11 days to 6 years old, in the range of 22 to 86 rpm.
[7] The Rad-G reusable finger clip sensor accommodates digits and measurement sites for populations ≥ 3kg. See the sensor DFU for more information. Sensor size on these patients is applicable based on the
sensor.
[8] This represents approximate run time at the lowest indicator brightness and pulse tone turned off using a fully charged battery. The minimum run time estimate is based on a fully charged battery and the
following specific operating modes: SpO
[9] If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20°C to +30°C, and at a relative humidity less than 85%. If stored for a prolonged period at
environmental conditions beyond these limits, overall battery capacity may be diminished, and lifetime of the batteries may be shortened.
*Registered trademark of Fluke Biomedical Corporation, Everett, Washington.

SERVICE AND MAINTENANCE

Cleaning
To clean the device:
1. Turn off device, disconnect the AC Power supply, and remove the sensor from the patient.
2. Wipe the device surfaces using 70% Isopropyl Alcohol or Quaternary ammonium chloride solution wipes.
3. Wipe twice or until the surfaces are free of any visible residue.
4. Dry the device thoroughly prior to using on a patient.
The surfaces of the Rad-G device have been tested to be chemically resistant to following solution(s): Glutaraldehyde, quaternary ammonium
chloride, 10% bleach (5% - 5.25% sodium hypochlorite) to water solution, 70% Isopropyl Alcohol.
Cautions
• Do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any cleaning solution other than those recommended here because permanent
damage to the device may occur.
• To prevent damage, do not soak or immerse the device in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave or ethylene oxide.
Maintenance
Battery Operation and Maintenance
The Rad-G includes a lithium ion rechargeable battery.
Before using the Rad-G without the AC power connected, check the battery status indicator and ensure that the battery is fully charged. See AC
Power Indicator section.
To charge the Rad-G battery, refer to Initial Battery Charging section.
Note: When battery run time is significantly reduced, it is advisable to completely discharge and fully recharge the battery.

PERFORMANCE VERIFICATION

Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified
personnel only. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations.
To test the performance of the Rad-G following repairs or during routine maintenance, follow the procedure outlined in this chapter. If the Rad-G fails
any of the described tests, discontinue its use and correct the problem before returning the device back to the user.
Before performing the following tests, do the following:
• Connect the Rad-G to AC power and fully charge the battery.
• Disconnect the Rad-G sensor.
Power-On Self-Test
1. Power on the device by pressing the power button.
2. Upon powering on, the device should emit a tone and the Rad-G logo should display.
Note: If the Rad-G does not pass the Power-On Self-Test see the Troubleshooting section.
Touchscreen Function Test
1. Connect the Rad-G to AC power.
2. Perform the operations outlined in the Operation section.
REPAIR POLICY
Masimo or an authorized service department must perform warranty repair and service. Do not use malfunctioning equipment. Have the device
repaired. Clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in the Cleaning section. Make sure
the equipment is fully dry before packing. To return the device for service, refer to the Return Procedure section.

RETURN PROCEDURE

Clean contaminated/dirty equipment before returning, following instructions in the Cleaning section. Make sure the equipment is fully dry before
packing. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA number. Package the equipment securely, in the original
shipping container if possible, and enclose or include the following information and items:
• A letter describing in detail any difficulties experienced with the Rad-G. Include the RMA number in the letter.
only operation and default value of Brightness set for a display.
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