Riester RVS-100 Manual Del Usuario página 82

the sensor becomes dislodged from the patient, the potential for false readings may occur due to environmental „noise" such as light, vibration, and excessive
air movement.
Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling.
Additional information specific to the Masimo sensors compatible with the pulse oximeter, including information about parameter/measurement
performance during motion and low perfusion, may be found in the sensor's directions for use (DFU).
Cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring.
Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time.
5.2.9 Masimo Information
Masimo Patents: http://www.masimo.com/patents.htm
No Implied License: Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables
which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
10.1 SpO2
10.1 SpO2
Masimo SpO2 Sensor
Masimo SpO2 Sensor
Type
Disposable
Reusable
Patient cable
Masimo SpO2
Measurement range
Resolution
Accuracy
75147 rev. 0 2020-01 Änderungen vorbehalten · Subject to alterations · Sous réserve de modifications · Sujeto a modificaciones · Con riserva di apportare
Average time
Update Period
Recovery time after
defibrillation
PR
Reference method for the
computation of PR accuracy
Measurement range
Resolution
PI
Measurement range
Low perfusion performance
82
Model / PN
4000 RD SET Adult SpO2 Adhesive Sensor Single Patient Use
4001 RD SET Pediatric SpO2 Adhesive Sensor Single Patient Use
4002 RD SET Infant SpO2 Adhesive Sensor Single Patient Use
4003 RD SET Neo Adult / Neonatal SpO2 Adhesive Sensor Single
Patient Use
4050 RD SET DCI Adult Reusable Sensor 3ft non-sterile
4051 RD SET DCI-P Pediatric/Slender Digit Reusable Sensor, 3ft non-
sterile
4054 RD SEET YI Multi-Site Reusable Sensor, 3ft non-sterile multiple
foam and adhesive wraps
4104 RD SET MD20-12RD SET 20-pin SpO2 patient cable, 12 ft.
0% to 100%
1%
70% to 100%: ±2% (adult/pediatric, non-motion conditions)
70% to 100%:±3%（neonate, non-motion conditions）
70% to 100%:±3%（motion conditions）
1 The Masimo SET technology with Masimo sensors has been validated for no motion accuracy in human blood studies on
healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of
70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals ±1standard deviation. Plus or
minus one standard deviation encompasses 68% of the population.
2 The Masimo SET technology with Masimo sensors has been validated for motion accuracy in human blood studies on
healthy adult male and female volunteers with light to dark skin pigmentation 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% SpO2 against a laboratory CO-Oximeter and
ECG monitor. This variation equals ±1 standard deviation, which encompasses 68% of the population.
3 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 signal strengths of greater than 0.02% and transmission of greater than 5% for
saturations ranging from 70 to 100%. This variation equals ±1 standard deviation. Plus or minus one standard deviation
encompasses 68% of the population.
4 The Masimo SET Technology with Masimo Neo sensors has been validated for neonatal motion accuracy in human blood
studies on healthy adult male and female volunteers with light to dark skin pigmentation 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% SpO2 against a laboratory CO-
Oximeter and ECG monitor. This variation equals ±1 standard deviation. Plus or minus one standard deviation
encompasses 68% of the population. 1% has been added to the results to account for the effects of fetal hemoglobin
present in neonates.
5 The Masimo SET technology with Masimo sensors has been validated for pulse rate accuracy for the range of 25 -240
bpm in bench top testing against a Biotek Index 2™ simulator. This variation equals ±1 standard deviation. Plus or minus
one standard deviation encompasses 68% of the population.
6 See sensor directions for use (DFU) for complete application information. Unless otherwise indicated, reposition reusable
sensors at least every 4 hours and adhesive sensors at least every 8 hours.
7 Sensor accuracy specified when used with Masimo technology using a Masimo patient cable for LNOP sensors, RD SET
sensors, the LNCS sensors, or the M-LNCS sensors. Numbers represent Arms (RMS error compared to the reference).
Because pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be
expected to fall within a range of ± Arms compared to the reference value. Unless otherwise noted, SpO2 accuracy is
specified from 70% to 100%. Pulse Rate accuracy is specified from 25 to 240 bpm.
8 Masimo M-LNCS, LNOP, RD SET, and LNCS sensors types have the same optical and electrical properties and may differ
only in application type (adhesive/non-adhesive/hook & loop), cable lengths, optical component locations (top or bottom
of sensor as aligned with cable), adhesive material type/size, and connector type (LNOP 8 pin modular plug, RD 15 pin
modular plug, LNCS 9 pin, cable based, and M-LNCS 15 pin, cable based). All sensor accuracy information and sensor
application instructions are provided with the associated sensor directions for use.
2-4s, 4-6s, 8s, 10s, 12s, 14s, 16s
<30s
<5s
Electronic pulse simulator
25 bpm to 240 bpm
1bpm
0.02% - 20%
>0.02% Pulse Amplitude and % Transmission > 5%
Saturation (SpO2%) +/- 2 digits
Pulse rate +/- 3 digits
Patient category
Adult use weight >30kg
Pediatric use weight 10kg – 50kg
Infant use weight 3kg – 20kg
Neo Use weight <3kg or >40kg
Adult weight >30kg
Pediatric/Slender Weight 10-
50kg
Weight >1kg
SpO2 patient cable
modifiche
PN
13339
13340
13341
13342
13343
13344
13345
13346