Masimo RD SET Série Mode D'emploi page 6

RD SET Cabled NeoPt: Preterm Sensors
< 1 kg The preferred site is the foot. Alternatively, across the palm and back of the hand can be used.
B) Attaching the sensor to the patient
1. Open the pouch and remove the sensor. Remove the backing from the sensor, if present.
Adt sensor for ADULTS (> 30 kg) and Pdt sensor for PEDIATRICS (10 - 50 kg)
2. Refer to Fig. 1a. Orient the sensor so that the detector can be placed first. Place the tip of the finger on the dashed line with the fleshy part of the finger
covering the finger outline and detector window.
3. Refer to Fig. 1b. Press the adhesive wings, one at a time, onto the finger. Complete coverage of the detector window is needed to ensure accurate data.
4. Refer to Fig. 1c. Fold the sensor over the finger with the emitter window (
the finger.
5. Refer to Fig. 1d. When properly applied, the emitter and detector should be vertically aligned (the black lines should align). Reposition if necessary.
Inf sensor for INFANTS (3 - 10 kg)
2. Refer to Fig. 2a. Direct the sensor cable so that it runs along the top of the foot. Position the detector on the fleshy pad of the great toe. Alternatively, the
toe next to the great toe, or the thumb can be used (not shown).
3. Refer to Fig. 2b. Wrap the adhesive wrap around the toe so the emiter is positioned on the nailbed of the great toe. Complete coverage of the detector
window is needed to ensure accurate data.
4. Refer to Fig. 2c. Ensure that the emitter window (
if necessary.
Neo sensor for NEONATES (< 3 kg) and NeoPt sensor for PRETERMS (< 1 kg)
2. Refer to Fig. 3a. For fragile skin, the stickiness of the medical grade adhesive can be diminished or eliminated by daubing the adhesive areas with a cotton
ball or gauze.
3. Refer to Fig. 3b. Direct the sensor cable toward the ankle (or wrist). Apply the sensor around the lateral aspect of the foot (or hand), aligned with the fourth
toe (or finger). Complete coverage of the detector window is needed to ensure accurate data.
4. Refer to Fig. 3c. Wrap the adhesive/foam wrap around the lateral aspect of the foot (or hand) and ensure that the emitter window (
opposite of the detector. Be careful to maintain proper alignment of the detector and emitter windows while attaching adhesive/foam wrap to secure the
sensor.
5. Refer to Fig. 3d. Verify correct positioning and reposition if necessary.
Neo sensor for ADULTS (> 40 kg) Inf Sensor for INFANTS (10 - 20 kg)
2. Refer to Fig. 4a. Direct the sensor cable so that it runs along the top of the hand. Position the detector on the fleshy part of the finger. Alternatively, the
sensor may also be applied to the toe (not shown).
3. Refer to Fig. 4b. Wrap the adhesive wrap around the finger so the emitter window (
Complete coverage of the detector window is needed to ensure accurate data.
4. Refer to Fig. 4c. Check the sensor to verify correct positioning and reposition if necessary.
C) Attaching the Sensor to the Patient Cable
1. Refer to Fig. 5a. Orient the sensor's connector tab so that the side with the "shiny" contacts is facing up. Orient the patient cable with the color bar and
finger grips facing up.
2. Refer to Fig. 5b. Insert the sensor tab into the patient cable until there is a tactile or audible click of connection. Gently tug on the connectors to ensure a
positive contact. Tape may be used to secure the cable to the patient for ease of movement.
D) Reattachment
• The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin.
• If the adhesive no longer adheres to the skin, use a new sensor.
NOTE: When changing application sites, or reattaching sensor, first disconnect the sensor from the patient cable.
E) Disconnecting the Sensor from the Patient Cable
1. Refer to Fig. 6. Pull firmly on the sensor connector to remove it from the patient cable.
NOTE: To avoid damage, pull on the sensor connector, not the cable.
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules the RD SET Cabled Sensors have the following
specifications:
RD SET Cabled Sensor
Body Weight
Application Site
SpO Accuracy,
2
1, 5
No Motion, (70 - 100% )
SpO Accuracy, Motion 2
2
SpO Accuracy,
2
3
Low Perfusion
Pulse Rate Accuracy,
1
No Motion, (25 - 240 bpm)
Pulse Rate Accuracy, Motion 4
Pulse Rate Accuracy,
3
Low Perfusion
NOTE: A accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the
rms
device measurements fell within ± A
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
1
pigmented skin in induced hypoxia studies in the range of 70%-100% SpO
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
2
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
The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with
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signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.
The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator and
4
Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.
The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for the properties of fetal
5
hemoglobin.
) aligns on the top of the toe directly opposite the detector. Verify correct positioning and reposition
Adt Pdt
> 30 kg 10 - 50 kg 3 - 10 kg
Thumb or
Finger or Toe Finger or Toe
Great Toe
2% 2%
3% 3%
2% 2%
3 bpm 3 bpm 3 bpm
5 bpm 5 bpm 5 bpm
3 bpm 3 bpm 3 bpm
of the reference measurements in a controlled study.
rms
) positioned over the fingernail. Secure the wings down, one at a time, around
Inf Neo
10 - 20 kg < 3 kg
Finger or Hand or
Toe Foot
2% 2% 3%
3% 3% 3%
2% 2% 3%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
against a laboratory co-oximeter.
2
6
) aligns on the top of the finger directly opposite the detector.
NeoPt
> 40 kg < 1 kg
Finger or
Hand or Foot
Toe
2% 3%
3% 3%
2% 3%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
against a laboratory co-oximeter.
2
) aligns directly
9884C-eIFU-0319