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M-LNCS™ Series, LNCS® Series
Adult, Pediatric, Infant, Neonatal and Preterm SpO
Single Patient Use Only
INDICATIONS - When Used With Masimo Set® and Masimo compatible Pulse Oximeters:
The M-LNCS™, LNCS® Adult, Pediatric, Infant, Neonatal and Preterm adhesive sensors are indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO
) and pulse rate (measured by an SpO
2
poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
PCX-2108A
02/13
Sensor
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
NON
Application site
STERILE
5%-95% RH
LATEX
Saturation Accuracy,
95%
No Motion
%
5%
Saturation Accuracy, Motion
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
Pulse Rate Accuracy,
No Motion
Pulse Rate Accuracy, Motion
Low Perfusion Accuracy
INDICATIONS- When used with Nellcor
The M-LNCS, LNCS Adult, Pediatric, Infant, Neonatal and Preterm adhesive sensors are indicated for single patient use for the continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO
) and pulse rate (measured by an SpO
2
Sensor
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
NON
STERILE
5%-95% RH
Application site
Finger or toe
LATEX
95%
%
Saturation Accuracy,
5%
No Motion
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
Pulse Rate Accuracy,
No Motion
DESCRIPTION
The M-LNCS, LNCS sensors are for use with instruments containing Masimo SET® oximetry or licensed to use M-LNCS, LNCS sensors and also with Nellcor and Nellcor compatible pulse oximeters, except Nellcor
OxiMax® enabled instruments. Consult individual instrument manufacturer for compatibility of particular instrument and sensor models. Each instrument manufacturer is responsible for determining whether
its instruments are compatible with each sensor model.
The M-LNCS, LNCS series has been validated with Masimo SET Oximetry Technology and on Nellcor's N-200 Pulse Oximeter. 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 hemoglobin.
The sensor site must be inspected at least every eight (8) hours; and if the circulatory condition or skin integrity has changed, the sensor should be applied to a different site.
WARNING: Masimo sensors and cables are designed for use with instruments containing Masimo SET® oximetry or licensed to use Masimo sensors.
CONTRAINDICATIONS
The M-LNCS, LNCS sensors are contraindicated for patients who exhibit allergic reactions to foam rubber products and/or adhesive tape.
WARNINGS
•
All sensors and cables are designed for use with specific monitors. Verify the compatibility of the monitor, cable and sensor before use, otherwise degraded performance and/or patient injury can result.
•
The site must be checked frequently or per clinical protocol to ensure adequate adhesion, circulation, skin integrity and correct optical alignment.
•
Exercise caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the sensor is not frequently moved. Assess site as frequently as every (1) hour with poorly perfused
patients and move the sensor if there are signs of tissue ischemia.
•
Circulation distal to the sensor site should be checked routinely.
•
During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to pressure necrosis.
•
With very low perfusion at the monitored site, the reading may read lower than core arterial oxygen saturation.
•
Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of additional tape can cause skin damage, and/or pressure necrosis or damage the sensor.
•
Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure necrosis.
•
Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements.
•
Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from monitored site. Sensor should not be below heart level (e.g. sensor on hand
of a patient in a bed with arm dangling to the floor).
•
Venous pulsations may cause erroneous low SpO
•
The pulsations from intra-aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display. Verify patient's pulse rate against the ECG heart rate.
•
The sensor should be free of visible defects, discoloration and damage. If the sensor is discolored or damaged, discontinue use. Never use a damaged sensor or one with exposed electrical circuitry.
•
Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
•
Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff.
•
If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If sensor is exposed to the radiation, the reading might be inaccurate or the unit might read zero for the
duration of the active radiation period.
•
Do not use the sensor during MRI scanning or in a MRI environment.
D I R E C T I O N S F O R U S E
Not made with natural rubber latex
LATEX
sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or
2
Adtx
Pdtx
Adtx-3
Pdtx-3
> 30 kg
10 - 50 kg
Finger or toe
Finger or toe
± 2%
± 2%
± 3%
± 3%
± 3 bpm
± 3 bpm
± 5 bpm
± 5 bpm
SpO
± 2%
SpO
± 2%
2
2
Pulse ± 3 bpm
Pulse ± 3 bpm
Pulse ± 3 bpm
and Nellcor Compatible Pulse Oximeters:
®
sensor) for use with adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
2
Adtx
Pdtx
Inf, Inf-L
Adtx-3
Pdtx-3
Inf-3
> 30 kg
10 - 50 kg
3 - 20 kg
Thumb or
Finger or toe
great toe
± 2%
± 2%
± 2%
± 3 bpm
± 3 bpm
± 3 bpm
readings (e.g. tricuspid value regurgitation).
2
adhesive sensors
2
Inf, Inf-L
Neo, Neo-L
5%
Inf-3
Neo-3
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
< 3 kg
3 - 20 kg
> 40 kg
Thumb or
Neonatal: hand or foot
great toe
Adult: finger or toe
Neonatal ± 3%
± 2%
Adult ± 2%
± 3%
± 3%
± 3 bpm
± 3 bpm
± 5 bpm
± 5 bpm
SpO
2
SpO
± 2%
Neonatal ± 3%
2
Adult ± 2%
Pulse ± 3 bpm
Neo, Neo-L
Neo-3
< 3 kg
> 40 kg
Neonatal: hand or foot
Adult: finger or toe
Neonatal ± 3%
Adult ± 2%
± 3 bpm
3
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-sterile
NON
STERILE
5%-95% RH
LATEX
95%
%
NeoPt, NeoPt-L
NeoPt-
500
NeoPt-3
< 1 kg
< 1 kg
Hand or foot
Hand or foot
± 3%
± 3%
± 3%
± 3%
± 3 bpm
± 3 bpm
± 5 bpm
± 5 bpm
SpO
± 3%
SpO
± 3%
2
2
Pulse ± 3 bpm
Pulse ± 3 bpm
NeoPt, NeoPt-L
NeoPt- 500
NeoPt-3
< 1 kg
< 1 kg
Hand or foot
Hand or foot
± 3%
± 3%
± 3 bpm
± 3 bpm
en
37945/8955A-0715
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