Masimo M-LNCS Série Mode D'emploi page 4

• High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the
sensor.
• To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to take this precaution in high ambient light conditions may
result in inaccurate measurements.
• High levels of COHb or MetHb may occur with a seemingly normal SpO
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
• Elevated Total Bilirubin levels may lead to inaccurate SpO
• Intravascular dyes such as indocyanine green or methylene blue or externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc. may lead to inaccurate SpO
• Inaccurate SpO readings may be caused by severe anemia, low arterial perfusion or motion artifact.
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• To prevent damage, do not soak or immerse the sensor in any liquid solution.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy.
• Do not attempt to reuse on multiple patients, reprocess, recondition or recycle Masimo sensors or patient cables as these processes may damage the electrical components, potentially leading to patient harm.
• High oxygen concentrations may predispose a premature infant to retinopathy. Therefore, the upper alarm limit for the oxygen saturation must be carefully selected in accordance with accepted clinical standards.
INSTRUCTIONS: SENSOR AND CABLE
A) Site Selection
• Always choose a site that is well perfused and will completely cover the sensor's detector window.
• Site should be cleaned of debris and dry prior to sensor placement.
M-LNCS, LNCS NeoPt, Neo-Pt-L, NeoPt-3 and NeoPt-500 Preterm Sensors
• < 1 kg The preferred site is the foot. Alternatively, across the palm and back of the hand can be used.
M-LNCS, LNCS Neo, Neo-L and Neo-3 Neonatal/Adult Sensors
• < 3 kg The preferred site is the foot. Alternatively, across the palm and back of the hand can be used.
• > 40 kg The preferred site is the middle or ring finger of non-dominant hand.
M-LNCS, LNCS Inf, Inf-L and Inf-3 Infant Sensors
• 3-20 kg The preferred site is the great toe. Alternatively, the toe next to the great toe, or the thumb can be used.
M-LNCS, LNCS Pdtx and Pdtx-3 Pediatric Sensors
• 10-50 kg The preferred site is middle or ring finger of non-dominant hand.
M-LNCS, LNCS Adtx and Adtx-3 Adult Sensors
• > 30 kg The preferred site is the middle or ring finger of non-dominant hand.
B) Attaching the sensor to the patient
1. Open the pouch and remove the sensor. Remove the backing from the sensor, if present.
PRETERM (< 1kg) and NEONATES (< 3 kg)
2. Refer to Fig. 1a. 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 with gauze. This step does not apply to the NeoPt-500.
3. Refer to Fig. 1b. Direct the sensor cable so that it either points away from the patient or runs along the bottom of the foot. Apply the detector onto the fleshy part of the lateral aspect of the sole of the foot aligned with the fourth
toe. Alternatively, the detector may be applied to the top of the foot (not shown). Complete coverage of the detector window is needed to ensure accurate data.
4. Refer to Fig. 1c. Wrap the adhesive/foam wrap around the foot and ensure that the emitter window (red star) aligns directly 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. 1d. Verify correct positioning and reposition if necessary.
INFANTS (3 - 20 kg)
2. Refer to Fig. 2a. Direct the sensor cable so that it either points away from the patient or runs along the bottom of the foot. Position the detector onto the fleshy part of the great toe. Complete coverage of the detector
window is needed to ensure accurate data.
3. Refer to Fig. 2b. Wrap the adhesive wrap around the toe and ensure that the emitter window (red star) aligns on the top of the toe directly opposite the detector.
4. Refer to Fig. 2c. Verify correct positioning and reposition if necessary.
PEDIATRIC (10 - 50 kg) and ADULT (> 30 kg)
2. Refer to Fig. 3a. Orient the sensor cable 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 detector window. Refer to Fig. 3b. Press the
adhesive wings one at a time onto the finger. Complete coverage of the detector window is needed to ensure accurate data.
3. Refer to Fig. 3c. Fold the sensor over the finger with the emitter window (red star) positioned over the fingernail. Secure the wings down one at a time around the finger. Refer to Fig. 3d. When properly applied, the
emitter and detector should be vertically aligned.
4. Verify correct positioning and reposition if necessary (the black lines should align).
C) Attaching the Sensor to the Patient Cable
M-LNCS
Refer to Fig. 4. Insert the sensor connector completely into the patient cable connector and lock into place.
LNCS
Refer to Fig. 5. Insert the sensor connector completely into the patient cable connector (1). Completely close the protective cover (2).
Reattachment
ADULT AND PEDIATRIC
• 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.
INFANT AND NEONATAL
• Refer to Fig. 6a. The adhesive tabs included with the M-LNCS, LNCS Inf, Inf-L, Inf-3, Neo, Neo-L and Neo-3 sensors are double sided adhesive tabs used when the stickiness of the adhesive covering the optical components
are no longer effective.
• Refer to Fig. 6b. Place an adhesive tab over each window of the sensor with the white area outside the adhesive area as shown, remove the protective paper that covers each tab and reapply the sensor to the same patient.
• R efer to Fig. 6c. When the adhesive on the first set of tabs is no longer sticky, a second set may be applied. Up to 3 sets of adhesive tabs may be applied to each window, placing one on top of the other.
• If the adhesive no longer adheres to the skin, use a new sensor.
NOTE: When changing application sites, or re attaching sensor, first disconnect sensor from the patient cable.
Disconnecting the Sensor from the Patient Cable
M-LNCS
Refer to Fig. 7. Pull firmly on the sensor connector to remove it from the patient cable.
LNCS
Refer to Fig. 8. Lift the protective cover to gain access to the sensor connector (1). Pull firmly on the sensor connector to remove from the patient cable (2).
CAUTION
To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize by irradiation, steam, autoclave or any method other than ethylene oxide as indicated.
STERILIZATION
The M-LNCS, LNCS Adtx, Adtx-3, Pdtx, Pdtx-3, Neo, Neo-L, Neo-3, NeoPt, NeoPt-L, NeoPt-3, NeoPt-500, Inf, Inf-L and Inf-3 sensors have been validated for sterilization by Ethylene Oxide (EO). The sensors may remain within their pouch, or be
wrapped in sterilization wrap, for the sterilization process. If a sterilization wrap is used, only FDA-cleared sterilization wraps are to be used. The following is the validated sterilization cycle:
Preconditioning Parameters
Temperature
Relative Humidity
Vacuum Set Point
Preconditioning Time
Sterilization Parameters
Temperature
Relative Humidity
EO Concentration
Gas Exposures Time (full cycle)
M-LNCS, LNCS Adtx, Adtx-3, Pdtx or Pdtx-3 Wrapped or Pouched
M-LNCS, LNCS Inf, Inf-L, Inf-3, Neo, Neo-L, Neo-3, NeoPt, NeoPt-L, NeoPt-3 or NeoP-500 Pouched
M-LNCS, LNCS Inf, Inf-L, Inf-3, Neo, Neo-L, Neo-3, NeoPt, NeoPt-L, NeoPt-3 or NeoPt-500 Wrapped
Aeration Time (full cycle)
Aeration Temperature
. When elevated levels of COHb or MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
2
measurements.
2
measurements.
2
measurements.
2
54°C
40%
1.3 psia
30 minutes
54°C
40%
600-750 mg/L
120 Minutes
120 Minutes
180 Minutes
12 Hours
51-59°C
4
measurements.
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37945/8955A-0715