Philips IntelliVue Cableless User manual

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Philips IntelliVue Cableless User manual

IntelliVue Cableless Measurements

IntelliVue CL SpO2 Pod, CL NBP Pod & CL Charging Station Technical Data Sheet

The IntelliVue Cableless Measurements Family provides cableless measurement devices for patient monitoring.

The IntelliVue Cableless Measurements family consists of:

IntelliVue CL SpO2 Pod

IntelliVue CL NBP Pod

with their respective accessories and auxiliary devices such as the IntelliVue CL Charging Station.

The devices can be used together with IntelliVue patient monitors or telemetry devices.

Features

Increased patient mobility, safety and comfort

Small, lightweight and robust

Easy to apply and comfortable to wear

Integrated Li-Ion battery in SpO2 Pod and NBP Pod with long battery run-time

Connectivity via Short Range Radio (SRR) to IntelliVue Patient Monitors and Telemetry Transceiver

Compatible with:

IntelliVue MP2/X2

IntelliVue MP5/MP5T/MP5SC

IntelliVue Telemetry SystemTransceiver TRx4841A/TRx4851

Intended Use

IntelliVue CL SpO2 Pod

The intended use of the IntelliVue CL SpO2 Pod when used together with IntelliVue Patient Monitors MP5/MP5T/MP5SC, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRx4841A/TRx4851A, is for monitoring, recording, and alarming arterial oxygen saturation and pulse rate of adult and pediatric patients inside hospitals. The device is intended for use by health care professionals. It is NOT intended for home use.

The IntelliVue CL SpO2 Pod is not a therapeutic device.

IntelliVue CL NBP Pod

The intended use of the IntelliVue CL NBP Pod when used together with IntelliVue Patient Monitors MP5/MP5T/MP5SC, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRx4841A/TRx4851A, is for monitoring, recording, and alarming of systolic, diastolic and mean pressure and pulse rate of adult and pediatric patients inside hospitals. The device is intended for use by health care professionals. It is NOT intended for home use.

The IntelliVue CL NBP Pod is not a therapeutic device.

Rx only: US Federal Law restricts these devices to sale by or on the order of a physician.

Main Components

IntelliVue CL SpO2 Pod

The IntelliVue CL SpO2 Pod is a small, battery powered, wrist worn pulse oximeter device for cableless monitoring of patients.

Contains Philips FAST-SpO2 (Fourier Artifact Suppression Technology) to provide reliable saturation values under various artifact conditions including motion and low perfusion

Continuous operating mode and intermittent operating mode with configurable measurement intervals

Integrated monochrome LCD display shows measured values, measurement signal quality, battery state, and RF signal strength

Three hardkeys for basic operation and navigation

Requires specialized Philips SpO2 sensors

IntelliVue CL NBP Pod

The IntelliVue CL NBP Pod is a small, battery powered , non-invasive blood pressure and pulse rate measurement device for cableless monitoring of patients.

Produces numerics for systolic, diastolic and mean blood pressure values and pulse rate (during NBP measurement)

Integrated monochrome LCD Display for measured values, battery state, and RF signal strength

Three hardkeys for basic operation and navigation

Requires specialized Philips NBP cuffs

Supports reusable and disposable cuffs

IntelliVue CL Charging Station

The IntelliVue CL Charging Station is a battery charger with nine charging slots for SpO2 Pod and NBP Pod.

Supports charging of SpO2 Pod and NBP Pod. SpO2 Pod requires one slot, NBP Pod requires two slots.

Battery status indicator at each slot

Integrated monochrome LCD display for battery status information

Three hardkeys for basic operation.

USB device interface to connect to a PC

built-in power supply

charging time max. 2.5 h

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Specifications

Safety Specifications

IntelliVue CL SpO2 Pod, NBP Pod:

IntelliVue CL Charging Station:

The devices comply with the Medical Device Directive 93/42/EEC. In addition, the devices comply with:

IEC 60601-1:1988 + A1:1991 + A2:1995; EN60601-1:1990 + A1:1993 + A2:1995; UL 60601-1:2003; CAN/CSA C22.2#601.1-M90 + S1 + A2; JIS T 0601-1:1999; IEC 60601-1-1:2000 EN 60601-1-1:2001;

IEC 60601-1-2:2001 + A1 2004; EN 60601-1-2:2001 + A1 2004.

The possibility of hazards arising from software errors was minimized in compliance with ISO 14971:2007, EN60601-1-4:1996 + A1:1999 and IEC 60601-1-4:1996 + A1:1999.

Classification (according to IEC 60601-1):

IntelliVue CL SpO2 Pod, NBP Pod: Class II, Type CF, Continuous Operation

IntelliVue CL Charging Station: Class I, Continuous Operation

EAS Tag

The IntelliVue CL NBP Pod and the IntelliVue CL SpO2 Pod are equipped with a non-deactivatable EAS (Electronic Article Surveillance) Tag for lost/theft protection.

Compatible with 58kHz EAS detection systems. Used EAS Tag type: ZLAML-NDLS4

Further information on: www.sensormatic.com

IntelliVue CL SpO2 Pod

Complies with ISO 9919:2005 / EN ISO 9919:2009.

IntelliVue CL SpO2 Pod Physical Specifications

Size (W X D X H)

53.5 mm x 65 mm x 27 mm

 

±5%

 

(without cradle and sensor)

Weight

80 g ±10%

 

(without cradle and sensor)

Robustness

Provides essential performance

 

during exposure to random

 

vibration according to IEC TR

 

60721-4-7 Class 7M1

 

Survives shock, random

 

vibration and bump according to

 

IEC TR 60721-4-7 Class 7M3 as

 

well as a 1m drop

Ingress Protection

IP34 according to IEC 60529

 

 

IntelliVue CL SpO2 Pod Environmental Specifications

Operating Temperature Range

0 to 40°C (32 to 104°F)

Operating Humidity Range

≤95%RH @ 40°C (104°F)

Operating Altitude Range

-500 to 3000m

Storage / Transportation

-20 to 60°C (-4 to 140°F)

Temperature Range

 

Storage / Transportation

≤90% RH @ 60°C (140°F)

Humidity Range

no condensation

Storage / Transportation

-500 to 4600m

Altitude Range

 

Measurement Validation

The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements.

IntelliVue CL SpO2 Pod Performance Specifications

SpO2

Measurement Range

0 to 100%

Accuracy

Mobile CL DSpO2-1A single

The specified accuracy is the

patient sensor:

root-meansquare (RMS)

3% (70 to 100%)

difference between the

Mobile CL RSpO2-1A reusable

measured values and the

sensor:

reference values

3% (70 to 100%)

Resolution

1%

Pulse Oximeter Calibration

70% to 100%

Range

 

Demo Signal

100%

Pulse

 

Measurement Range

30 to 300 bpm

Accuracy

±2% or 1 bpm, whichever is

 

greater

Resolution

1 bpm

 

60 bpm ±1

Demo Signal

 

 

Sensors

 

 

 

Wavelength Range

500 to 1000 nm

Information about the

 

wavelength range can be

 

especially useful to clinicians

 

(for instance, when

 

photodynamic therapy is

 

performed)

 

 

 

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