Masimo Rad-5 Návod k obsluze stáhnout pdf (Strana 24)

Rad-5/5v Signal Extraction Pulse Oximeter Operator’s Manual 8-1

sensors & patient cables

Introduction

This section covers the use and cleaning of Masimo SET sensors and Masimo SET

patient cables.

Masimo SpO

sensors

Before use, carefully read the sensor Directions for Use.

Use only Masimo oximetry sensors for SpO

measurements. Other oxygen transducers

or sensors may cause improper Rad-5/5v Handheld Pulse Oximeter performance.

Tissue damage can be caused by incorrect application or use of a Masimo sensor, for

example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sen-

sor Directions for Use to ensure skin integrity and correct positioning and adhesion of

the sensor.

CAUTIONS:

■

DO NOT USE DAMAGED SENSORS. DO NOT USE A SENSOR WITH EXPOSED

OPTICAL OR ELECTRICAL COMPONENTS. DO NOT IMMERSE THE SENSOR IN

WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE SENSORS AND CON-

NECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRADIATION,

STEAM, OR ETHYLENE OXIDE. SEE THE CLEANING INSTRUCTIONS IN THE

DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS.

■

DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT

CABLES IN WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT

CABLE CONNECTORS ARE NOT WATERPROOF). DO NOT STERILIZE BY IRRA-

DIATION, STEAM, OR ETHYLENE OXIDE.

■

ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MON-

ITORS. VERIFY THE COMPATIBILIY OF THE MONITOR, CABLE AND SENSOR

BEFORE USE, OTHERWISE PATIENT INJURY CAN RESULT.

SELECTING A MASIMO SET SENSOR

When selecting a sensor, consider, the patient’s weight, the adequacy of perfusion, the

available sensor sites, and the duration of monitoring. For more information refer to the

following table or contact your Sales Representative. Use only Masimo SET sensors and

sensor cables. Select an appropriate sensor, apply it as directed, and observe all warn-

ings and cautions presented in the directions for use accompanying the sensor.

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 an SpO

sensor. To prevent interference from ambi-

ent 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 condi-

tions may result in inaccurate measurements.

PHYSICAL CHARACTERISTICS

Dimensions: 6.2” x 3.0” x 1.4” (15.8 cm x 7.6cm x 3.6 cm)

Weight: 13oz. (0.32 kg)

Rad-5 Modes

Rad-5 Averaging mode: 2, 4, 8,10, 12, 14 or 16 seconds

Rad-5 Sensitivity: Normal, Maximum and APOD

Rad-5v Averaging mode: 8 seconds

Rad-5v Sensitivity: Normal

Alarms

Sensor condition, system failure and low battery alarms

Rad-5 only: Audible and visual alarms for high low saturation and pulse rate

(SpO

range 1-100%, pulse rate range 25-240 bpm)

High Priority: 799 Hz tone, 5 pulse burst, pulse spacing: 0.250s,

0.250s, 0.500s, 0.250s, repeat time:10s

Low Priority: 432 Hz tone, 3 pulses, repeat time: 5s

Alarm Volume: High Priority: 75 dB (max), Low Priority: 75 dB (max)

Display/Indicators

Data display: %SpO

, pulse rate, alarm status, alarm silenced status,

Signal IQ / pleth bar, perfusion index bar, battery status

Rad-5 only: MAX, FastSat

Type: LED

Compliance

EMC Compliance: EN60601-1-2, Class B

Equipment Classification: IEC 60601-1-1 / UL 60601-1

Type of Protection: Internally powered (on battery power)

Degree of Protection-Patient Cable: Type BF-Applied Part

Rad-5 Mode of Operation: Continuous

Rad-5v Mode of Operation: Not Continuous (Spot Check)

1 Masimo SET technology with LNOP Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult

volunteers in induced hypoxia studies in the range of 70-100% SpO

against a laboratory co-oximeter and ECG monitor. This varia-

tion equals plus or minus one standard deviation which encompasses 68% of the population.

2 Masimo SET technology with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers

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

against a laboratory co-oximeter

and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

3 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 a % transmission of greater than 5% for saturations ranging from

70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

4 This represents approximate run time at lowest indicator brightness and pulse tone turned off using new, fully charged batteries.

Ensure trending is off to maximize battery life.

5 If alkaline batteries are to be stored for extended periods of time, it is recommended that they be stored between -0°C to +30°C, and

at a relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery

capacity may be diminished, and lifetime of the batteries may be shortened.

6 With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from

2-4 and 4-6 seconds, respectively.

specifications

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