The LNOP TF-I and TC-I sensors were not validated under motion conditions.
The LNOP YI was not validated under low perfusion conditions.
When used with Philips FAST-SpO
• FAST-SpO
Intellivue Module M1020B #A01
2
• FAST-SpO
M3/M4 Multi-Measurement Server (MMS) M3000A #A01
2
• FAST-SpO
Intellivue Multi-Measurement Server (MMS) M3001A #A01
2
• FAST-SpO
Intellivue Multi-Measurement Server X2 (MMS X2) M3002A #A01
2
• FAST-SpO
Intellivue MP2, M8102A
2
• FAST-SpO
Intellivue MP5/MP5T/MP5SC, M8105A/AT/AS
2
Sensors
LNOP Adt/Adtx
LNOP Pdt/Pdtx
LNOP Inf-L
LNOP Neo-L
LNOP NeoPt-L
LNOP DCI
LNOP DCIP
LNOP DC-195
LNOP YI
LNOP TC-I
LNOP Trauma
1
LNOP Newborn
Neonatal
1
LNOP Newborn
Infant/Pediatric
1
1
Provides saturation and pulse rate values when used with Philips technology but does not operate in the specialty mode unless used with Masimo technology.
A
accuracy is a statistical calculation of the difference between device measurements and reference measurements.
rms
Approximately two-thirds of the device measurements fell within ± A
LNOP MP Series Patient Cables and the above Masimo Sensors have been validated with the Masimo SET and Philips FAST-
SpO
devices listed above. The saturation accuracy of the neonatal sensors were validated on adult volunteers and 1% was
2
added to account for the properties of fetal hemoglobin. The LNOP YI multisite sensor was validated on adult digits.
ENVIRONMENTAL
Operating Temperature
Storage Temperature
Relative Humidity
WARRANTY
Masimo warrants to the initial buyer only that these products, when used in accordance with the directions provided with the
Products by Masimo, will be free of defects in materials and workmanship for a period of six (6) months. Single use products
are warranted for single patient use only.
THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER.
MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION
ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. MASIMO'S SOLE OBLIGATION AND
BUYER'S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MASIMO'S OPTION, TO REPAIR OR REPLACE THE
PRODUCT.
Technology:
2
Weight
Range
> 30 kg
10-50 kg
3-20 kg
< 3 kg
> 40 kg
< 1 kg
> 30 kg
10-50 kg
> 30 kg
1-3 kg
> 3 kg
> 30 kg
> 30 kg
< 3 kg
3-10 kg
10-30 kg
41°F to 104°F (5°C to 40°C)
-40°F to 158°F (-40°C to 70°C)
5% to 95% noncondensing
Saturation Accuracy
(70-100% SpO
)
2
No Motion
2%
2%
2%
3%
2%
3%
2%
2%
2%
3%
2%
3.5%
2%
3%
2%
of the reference measurements in a controlled study.
rms
5
Pulse Rate Accuracy
(25-240 bpm)
No Motion
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
4222E-eIFU-0617