Specifications - Masimo Rad-G Gebrauchsanweisung

• To prevent damage, do not soak or immerse the sensor in any liquid solution.
• Do not attempt to sterilize by irradiation, steam, autoclave or ethylene oxide as it will damage the sensor.
• Do not attempt to reprocess, recondition or recycle Masimo sensors or patient cables as these processes may damage the electrical
components, potentially leading to patient harm.
• Caution: Replace the sensor when a replace sensor message is displayed, or when a low SIQ message is consistently displayed while
monitoring consecutive patients after completing the low SIQ troubleshooting steps identified in the monitoring device operator's manual.
• Note: The sensor is provided with X-Cal® technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring.
The sensor will provide up to 8,760 hours of patient monitoring time. Replace the sensor when the patient monitoring time is exhausted.
INSTRUCTIONS
A) Site Selection
• Choose a site that is well perfused and least restricts a conscious patient's movements.
• Always choose a site that will completely cover the sensor's detector window.
• Site should be cleaned of debris prior to sensor placement.
• Select a digit without long fingernails.
CAUTION: Before using the sensor, ensure that the sensor is physically intact, with no broken or frayed wires or damaged parts.
Preferred Site By Weight Range
• 3 - 10 kg (Infant)- The preferred site is the Great toe. Alternatively, either thumb can be used.
• 10-50 kg (Pediatric)- The preferred site is the finger of the non-dominant hand; however, the other digits can be used.
• > 30 kg (Adult)- The preferred site is the 5th digit of the non-dominant hand; however, the other digits can be used.
B) Connecting the Sensor to the Device
1. Insert the sensor connector of into the top of the device.
2. Push the connector cover closed until a tactile or audible click of connection is heard.
3. Ensure the connector is fully engaged with the device.
C) Attaching the Sensor to the Patient
1. Refer to Fig. 1. Orient the cable away from the sensor site. Open the sensor by pressing on the sensor indentations.
2. Refer to Fig. 2. Place the selected digit over the sensor window in the bottom half of the sensor. The fleshiest part of the digit should be
covering the detector window. The tip of the finger, thumb or toe not the nail, should touch the digit stop on the back of the pad.
3. The sensor should be opened enough to evenly distribute the grip pressure of the sensor along the length of the finger. Check the
arrangement of the sensor to verify correct positioning. Complete coverage of the detector window is needed to ensure accurate data.
NOTE: The sensor is not intended for use across a child's hand or foot.
D) Removing the Sensor from the Patient
1. Open the sensor by pressing on sensor indentations. Remove the sensor from the digit and follow the cleaning instructions.
E) Disconnecting the Sensor from the Device
1. Lift up the sensor connector cover and Pull firmly on the Sensor connector to disconnect it from the Device.
NOTE: To avoid damage, pull on the sensor connector, not the cable.
CLEANING
To clean the sensor:
1. Remove the sensor from the patient and disconnect it from the patient cable.
2. Wipe the sensor pads and outer 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 sensor thoroughly prior to placement on a patient.
The surfaces of the Rad-G reusable sensor have been tested to be chemically resistant to following solution(s): Glutaraldehyde, quaternary ammoni-
um chloride, 10% bleach (sodium hypochlorite) to 90% 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 sensor may occur.
• To prevent damage, do not soak or immerse the sensor in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave or ethylene oxide.

SPECIFICATIONS

When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules, Rad-G reusable sensors have the
following specifications:
Rad-G Sensor
Body Weight
Application site
SpO Accuracy, No Motion
2 1
SpO Accuracy, Motion
2
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, No Motion
4
Pulse Rate Accuracy, Motion
Pulse Rate Accuracy, Low Perfusion
NOTE: A
accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-
rms
thirds of the device measurements fell within +/- A
1
The Masimo SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to
dark pigmented skin in induced hypoxia studies in the range of 70%-100% SpO
2
The Masimo SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark
pigmented skin 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
> 30 kg
Finger or toe
2%
3%
2%
3
3 bpm
5 bpm
4
3 bpm
4
of the reference measurements in a controlled study.
rms
Adult
10 - 50 kg
Finger, thumb or great toe
2%
3%
2%
3 bpm
5 bpm
3 bpm
against a laboratory co-oximeter.
2
4
Pediatric
3-10 kg
Finger, thumb or great toe
2%
3%
2%
3 bpm
5 bpm
3 bpm
against a laboratory co-oximeter.
2
Infant
9399E-eIFU-0820