Philips IntelliVue Cableless User manual

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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 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
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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.
2
Pod and NBP Pod. SpO2 Pod requires one
2
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)
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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IntelliVue CL SpO2 Pod Performance Specifications
LED Power Dissipation Temperature rise at sensor skin
interface in compliance with ISO
9919
Optical Output Power ≤15mW
For further information on accessory specifications, refer to the
accessory IfU.
Display Specifications
Ty p e monochrome (4 gray scales),
passive LCD (STN), positive/
transflective
Viewing Area 25.6 mm x 19.2 mm
Dot Size 0.2 mm x 0.2 mm
IntelliVue CL SpO2 Pod Performance Specifications
Receiver bandwidth 5 MHz
Effective radiated power (ERP) max. 0 dBm (1mW)
Realtime Clock Specifications
Accuracy less than 5 seconds (typ.) per
day, as long as device is in power
state “Device On” or “Device
off”. Automatically synchronized
with assigned patient monitor/
telemetry device.
IntelliVue CL NBP Pod
Complies with IEC 60601-2-30:1999 / EN 60601-2-30:2000.
Resolution 128 x 96 pixel
Backlight white LED
Sounds
Sounds Audible feedback for user input
Prompt tone
Pulse tone
Battery
Battery Integrated rechargeable Li-Ion
battery with battery gauge and
cycle counter
Runtime (fully charged battery) Continuous measurement:
Typically 24 hours
minimum 12 hours
Intermittent measurement:
Typically > 32 hours with
repetition interval of 2.5
minutes
Charging Time max 2.5 hours
Short Range Radio Specifications
Ty p e built in interface with integrated
antenna
Technology IEEE 802.15.4
Frequency band 2.4 GHz ISM (2.400 - 2.483
GHz)
Modulation DSSS (O-QPSK)
IntelliVue CL NBP Pod Physical Specifications
Size (H x W x D) 138 x 65 x 30.5 mm ±5%
(without cradle and cuff)
Weigh t 200g ±10%
(without cradle and cuff)
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
IntelliVue CL NBP 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) (non­condensing)
-500 to 4600m
Altitude Range
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IntelliVue CL NBP Pod Performance Specifications
NBP
Measurement Ranges Adult:
Systolic: 30 to 270 mmHg
(4.0 to 36.0 kPa)
Mean: 20 to 255 mmHg
(2.5 to 34.0 kPa)
Diastolic: 10 to 245 mmHg
(1.5 to 32.0 kPa)
Ped iatri c:
Systolic: 30 to 180 mmHg
(4.0 to 24.0 kPa)
Mean: 20 to 160 mmHg
(2.5 to 21.0 kPa)
Diastolic: 10 to 150 mmHg
(1.5 to 20.0 kPa)
Pressure Transducer Accuracy
(0 to 300 mmHg)
±3 mmHg @ 15 to 25 °C
±(3 mmHg or 2% whichever is
greater) @ 10 to 40°C
Blood Pressure Measurement
Accuracy
According to ANSI/AAMI SP 10
- 1992/2002
8 mmHg standard deviation
±5 mmHg mean error
Pulse Rate Measurement Range 40 to 300 bpm
Pulse Rate Measurement
Accuracy
40 - 100 bpm: ±5 bpm
101 - 200 bpm: ±5% of reading
201 - 300 bpm: ±10% of reading
(average over NBP
measurement cycle)
Measurement Time Auto/manual/sequence mode:
Typical 40 seconds @ >60 bpm
and normal adult cuff
Maximum 180 seconds
STAT Mode:
Typical 30 seconds @ >60 bpm
and normal adult cuff
Maximum 180 seconds
STAT Mode Cycle Time 5 minutes
Initial Cuff Inflation Pressure Adult: 165 ±15 mmHg
Pediatric: 130 ±15 mmHg
Venipuncture Pressure Range Adult: 20 to 120 mmHg in steps
of 5 mmHg
Pediatric: 20 to 80 mmHg in
steps of 5 mmHg
Venipuncture Pressure
±10 mmHg
Accuracy
IntelliVue CL NBP Pod Performance Specifications
Cuff size detection INOP, if neonatal cuff size is
detected
Demo Signal Adult: 120/80 (90) mmHg
Pediatric: 100/60 (80) mmHg
Display Specifications
Ty p e monochrome (4 gray scales),
passive LCD (STN), positive/
transflective
Viewing Area 25.6 mm x 19.2 mm
Dot Size 0.2 mm x 0.2 mm
Resolution 128 x 96 pixel
Backlight white LED
Sounds
Sounds Audible feedback for user input
Prompt tone
Pulse tone
Battery
Battery Integrated Li-Ion battery with
battery gauge and cycle counter
Runtime (fully charged battery) Minimum 8 hours @ 4
measurements per hour
Typical 24 hours @ 2
measurements per hour
Battery Recharge Time Maximum 2.5 hours
Short Range Radio Specifications
Ty p e built in interface with integrated
antenna
Technology IEEE 802.15.4
Frequency band 2.4 GHz ISM (2.400 - 2.483
GHz)
Modulation DSSS (O-QPSK)
Receiver bandwidth % MHz
Effective radiated power (ERP) max. 0 dBm (1mW)
Realtime Clock Specifications
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IntelliVue CL NBP Pod Performance Specifications
Accuracy less than 5 seconds (typ.) per
day, as long as device is in power
state "Device on" or "Device
off".
Automatically synchronized with
assigned patient monitor/
telemetry device.
Measurement Validation: The blood pressure measurements
determined with this device comply with the American National
Standard for Electronic or Automated Sphygmomanometers (ANSI/
AAMI SP10:2002/(R)2008 + A1:2003/(R)2008)) in relation to mean
error and standard deviation, when compared to auscultatory
measurements in representative patient population. For the
auscultatory reference the 5th Korotkoff sound was used to determine
the diastolic pressure.
IntelliVue CL Charging Station
IntelliVue CL Charging Station Physical Specifications
Size (W X D X H) 343 mm x 172 mm x 117 mm
±5%
Weigh t 2000 g ±10%
Robustness Operating within specification
during exposure to random
vibration according to IEC TR
60721-4-7 Class 7M1
Survives shock and 0.05 m free
fall according to IEC TR 60721-
4-7 Class 7M1
IntelliVue CL Charging Station Environmental
Specifications
Operating Temperature Range 0 to 35°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
IntelliVue CL Charging Station Performance Specifications
Display Specifications
Ty p e monochrome (4 grey scales),
passive LCD (STN), positive/
transflective
Viewing Area 25.6 mm x 19.2 mm
Dot Size 0.2 mm x 0.2 mm
Resolution 128 x 96 pixel
Backlight white LED
General Specifications
Sounds Audible feedback for user input
Prompt tone
Mains Power 50/60 Hz; 1.3 - 0.7A; 100 -
240V~
USB Downstream Standard: USB 2.0 low/full speed
Host Port
Power Output: 5V ± 5%, 500mA
max
Connector: USB series
"Standard-A" receptacle
USB Upstream Standard: USB 2.0 full speed
Device Port
Power input: "self powered
device"
Connector: USB series
"Standard-B" receptacle
Ordering Information
Description Option Number
20 Mobile CL DSpO2-1A Sensors
865215 #K01
(disposable)
20 Wristbands
20 Cradles
20 Mobile CL Disposable Adult Cuffs
865216 #K01
20 Mobile CL NBP Cradles
Accessories
IntelliVue CL SpO2 Pod
All listed sensors operate without risk of exceeding 41°C on the skin, if
the initial skin temperature does not exceed 35°C.
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Make sure that you use only the accessories that are specified for use
with this device, otherwise patient injury can result.
Description Contents Order Number
Mobile CL 20 single
patient SpO2
Sensors and
Cradles for use on
pediatric and adult
patients >10kg
Mobile CL 20 single
patient SpO2
Sensors for use on
pediatric and adult
20 Disposable
Mobile CL DSpO2-
1A Sensors
20 Wristbands
20 Cradles
pre-configured
20 Disposable
Mobile CL DSpO2-
1A Sensor Pack of
20
989803165941
989803165921
patients >10kg
Mobile CL 20 SpO2
Cradles
Mobile CL 50 SpO2
20 Cradles
989803165951
20 Wristbands
50 Wristbands 989803165961
Wristbands
Mobile CL SpO2
Battery Kit
1 Battery
1 disassembly tool
989803168861
1 front panel
IntelliVue CL NBP Pod
Description
Mobile CL
Limb
Circumference
Range
21 - 27 cm 10.5 cm 989803163181
Bladder
Width
Order
Number
Disposable
Small Adult
Cuff (20 cuffs)
Mobile CL
26.0 - 34.5 cm 13.0 cm 989803163201
Disposable
Adult Cuff (20
cuffs)
Description
Mobile CL
Limb
Circumference
Range
33.5 - 45.0 cm 16.0 cm 989803163221
Bladder
Width
Order
Number
Disposable
Large Adult
Cuff (20 cuffs)
Description Order Number
Mobile CL NBP Cradle Kit (20 cradles) 989803163251
Mobile CL Extension Air Hose, 1.0 m 989803163131
Mobile CL NBP Battery Kit
989803163261
(1 Battery, 1 disassembly tool,1 front panel)
Telemetry Pouch w/window
989803137831
(50 pouches)
Telemetry Pouch w/window
989803140371
(4 boxes of 50 pouches)
White Telemetry Pouch with Snaps; box of
50.
989803101971
(9300-0768-050)
(50 pouches)
White Telemetry Pouch with Snaps; 4 boxes
of 50.
989803101981
(9300-0768-200)
(4 boxes of 50 pouches)
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Philips Healthcare is part of
Royal Philips Electronics
How to reach us
www.philips.com/healthcare
healthcare@philips.com
fax: +31 40 27 64 887
Asia
+852 2821 5888
Europe, Middle East, Africa
+49 7031 463 2254
Latin America
+55 11 2125 0744
North America
+1 425 487 7000
800 285 5585 (toll free, US only)
0366
The 865215 CL SpO2 Pod, 865216 CL NBP
Pod and CL 865220 CL Charging Station
comply with the requirements of the
Council Directive 93/42/EEC of 14 June
1993 (Medical Device Directive).
Please visit www.philips.com/
© 2010 Koninklijke Philips Electronics N.V. All rights are reserved.
Philips Healthcare reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication.
Printed in The Netherlands. 4522 962 65231 * SEP 2010
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