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

Tr a ns c e i ve r

• 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

• 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 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

IntelliVue CL Charging Station

The IntelliVue CL Charging Station is a battery charger with nine

charging slots for SpO

• Supports charging of SpO

Pod and NBP Pod.

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

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)

Weigh t 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

Humidity Range

Storage / Transportation

≤90% RH @ 60°C (140°F)

no condensation

-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

The specified accuracy is the

root-meansquare (RMS)

difference between the

measured values and the

reference values

Mobile CL DSpO2-1A single

patient sensor:

3% (70 to 100%)

Mobile CL RSpO2-1A reusable

sensor:

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

Demo Signal 60 bpm ±1

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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