CARESCAPE V100 - Numed Healthcare

GE Healthcare
CARESCAPE V100
Vital signs monitor
The CARESCAPE* V100 monitor is designed for care areas where patients
require vital signs measurements. It can go with you from one patient
to the next, and because of its speed, accuracy and connectivity, the
CARESCAPE V100 monitor collects the right information at the point of
care to help you make fast, quality care decisions.
Features
• Can be used for spot-checking or for continuous monitoring,
providing you the flexibility of two devices in one
• Designed for adult and pediatric use, as well as neonatal patients
with very low perfusion rates
• Includes the same advanced parameters and algorithms as other
higher acuity GE monitors, helping ensure measurement consistency
across all care areas
• Non-invasive blood pressure measurement uses GE’s exceptional
DINAMAP* technology
• Three choices for pulse oximetry include GE Ohmeda TruSignal*;
Nellcor OxiMax** or Masimo SET**
• Three options for temperature include Exergen** TemporalScanner**,
Alaris** Turbo Temp** and Alaris Tri-Site
• Allows for inflation setpoints, so you can be sensitive to patients’
special circumstances and ensure their comfort
• Large display makes it easy to read even from a distance
• Stores up to 40 measurements for up to 24 hours with the capability
to print strips
• Designed for easy serviceability with a removable panel for easy
access and simple field-replacement kits
• Typical battery life of up to 11 hours before requiring recharge.
If the battery is discharged, it maintains the data.
• Connect up to three additional accessories simultaneously
with the DINAMAP Serial Hub, via the monitor’s HostComm
(sold separately)
Durable plastic
casing
Integrated
printer
(optional)
Large, bright LED
display
Recessed
handle
One-step
start/stop
button
Easy-to-use
scrolling menu
SpO2 connector
GE TruSignal, Nellcor OxiMax or Masimo SET
(optional)
Internal
battery
Smart battery
indicator
NIBP connector
Intuitive help cards
Exergen
TemporalScanner
(optional)
Technical specifications
GE sensor accuracy
Portability
Sensor model
Carried by recessed handle or on
a roll stand
Printer
SpO2 range 70 to 100%
TruSignal
TS-F-D3
±2 digits without motion
Thermal dot array
TS-W-D3
±2 digits without motion
Resolution
384 dots/inch horizontal
TS-E-D ±3 digits without motion
Paper type
Must be compatible with
TS-SE-33
±2 digits without motion
GE PN 770137
TS-AF-103
±2 digits without motion
English, German, French, Italian,
Spanish, Portuguese, Hungarian,
Polish, Czech, Finnish, Swedish,
Danish, Dutch, Norwegian, and
Slovak
3
TS-AF-25 ±2 digits without motion
TS-F2-GE
±2 digits without motion
TS-F4-GE
±2 digits without motion
TS-E2-GE
±3 digits without motion
TS-E4-GE
±3 digits without motion
Printer type
Languages printed
Temperature options
3
TS-SA4-GE
Exergen TemporalScanner temporal artery thermometer
Alaris Turbo Temp** thermometer
Alaris Tri-site thermometer
Performance specifications
TS-SA-D3
For TS-SA4-GE and TS-SA-D sensors the accuracy
range is as following
70 to 100%
90 to 100%
80 to 90%
70 to 80%
below 70%
± 2 digits
± 1 digits
± 2 digits
± 3 digits
unspecified
GE TruSignal SpO2 specifications
Sensor light source
Measurement range
Wavelength4
SpO2 1 to 100%
Pulse rate 30 to 250 bpm
AccuracySaturation
Adult 70 to 100% ±2 digits
(without motion)
Neonate1 70 to 100% ±3 digits
(without motion)
Adult/Neonate2 70 to 100% ±3 digits
(during clinical motion)
Low perfusion 70 to 100% ±2 digits
(during clinical low perfusion)
Pulse rate
Adult/Neonate 30 to 250 bpm: ± 2 digits or ±
2%, whichever is greater, (without
motion)
30 to 250 bpm: ± 5 digits
(during motion)
Low perfusion 30 to 250 bpm ±3 digits
1 SpO2 measurement accuracy is based on deep hypoxia studies using TruSignal
sensors on healthy adult volunteer subjects. Arterial blood samples were analyzed
simultaneously on multiple CO-oximeters. This variation equals plus or minus one
standard deviation. Plus or minus one standard deviation encompasses 68% of the
population.
2 Applicability: TS-AF sensors.
NOTE: Accuracy may vary for some sensors; always check the instructions for the
sensor.
Maximum output power
for each LED
Infrared: 930 to 950 (nominal)
Red: 650 to 670 (nominal)
< 15mV
3 Requires compatible interconnect cable TS-G3
4 Information about wavelength range can be especially useful to clinicians.
Masimo SET specifications5
Masimo sensor accuracy10
Measurement range
Sensor model
SpO2 range 70% to 100%
SpO2 1 to 100%
Pulse rate 25 to 240 bpm
LNOP ADT
± 2 digits without motion
Perfusion range 0.02 to 20%
LNOP NEO
± 3 digits without motion
LNOP NEO-L
Foot ± 3 digits without motion
Finger ± 2 digits without motion
LNOP NEO PT-L
± 3 digits without motion
LNOP Adtx
± 2 digits without motion
LNOP Pdtx
± 2 digits without motion
Accuracy and motion
toleranceSaturation
Without motion
adult/pediatric6 70 to 100% ±2 digits
Without motion neonate6 70 to 100% ±3 digits
LNOP
With motion
adult/ped/neonate7, 8 70 to 100% ±3 digits
LNOP DCI
± 2 digits without motion
Low perfusion9 70 to 100% ±2 digits
0 to 69% unspecified
LNOP DCIP
± 2 digits without motion
LNOP Hi Fi-Neo/adult
Foot ± 3 digits without motion
Finger ± 2 digits without motion
Without motion 25 to 240 bpm ±3 digits
LNOP Hi Fi-Infant/Ped
± 2 digits
With motion Normal physiologic range
25 to 240 bpm ±5 digits
LNOP Blue Infant
Thumb/Toe11
± 3 digits (for 80-100) without
motion
± 4 digits (for 60-80) without
motion
± 3.3 digits (for 70-100) without
motion
LNOP YI Multi-Site
Foot/hand ± 3 digits without
motion
Finger/toe ± 2 digits without
motion
LNOP DC-195
± 2 digits without motion
LNOP TC-I
± 3.5 digits without motion
Pulse Rate
Low perfusion performance
0.02% Pulse amplitude Saturation (% SpO2)
% transmission >5%
± 2 digits
Pulse rate ± 3 digits
Interfering substances: Carboxyhemoglobin may
erroneously increase readings. The level of increase is
approximately equal to the amount of carboxyhemoglobin
present. Dyes, or any substance containing dyes, that
change usual arterial pigmentation may cause erroneous
readings.
LNCS
LNCS TCI
± 3.5 digits without motion
LNCS DC-I
± 2 digits without motion
6 The Masimo SET** SpO2 parameter 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% SpO2 against a laboratory CO-oximeter
and ECG monitor. This variation equals plus or minus one standard deviation. Plus or
minus one standard deviation encompasses 68% of the population.
LNCS DC-IP
± 2 digits without motion
LNCS Adult Adtx
± 2 digits without motion
LNCS Ped Pdtx
± 2 digits without motion
7 The Masimo SET SpO2 parameter 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 nonrepetitive 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 COoximeter and ECG monitor. This variation equals plus or minus one standard deviation.
Plus or minus one standard deviation encompasses 68% of the population.
LNCS Infant-L
± 2 digits without motion
LNCS Neo PT-L
± 3 digits without motion
5 Masimo CSD-1201 (MS-2011 specifications cleared by the FDA).
8 The Masimo SET SpO2 parameter with LNOP-Neo Pt sensors has been validated for
neonatal motion accuracy in human blood studies on neonates while moving the
neonate‘s foot at 2 to 4 cm against a laboratory CO-oximeter and ECG monitor. This
variation equals plus or minus one standard deviation. Plus or minus one standard
deviation encompasses 68% of the population.
9 The Masimo SET SpO2 parameter has been validated for low-perfusion accuracy in
bench-top testing against a Bio-Tek 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. Plus or minus one standard deviation encompasses 68% of the
population.
Resolution
Saturation (% SpO2)1%
Pulse rate (bpm)
1
10Masimo CSD-1109 (sensor specification)
11Masimo SET Technology with LNOP Blue sensors have been validated for no-motion
accuracy in human blood studies on neonatal, infant and pediatric patients with
congenital, cyanotic cardiac lesions in the range of 60% to 100% SpO2 against a
laboratory CO-oximeter. This variation equals plus or minus one standard deviation,
which encompasses 68% of the population.
Oxi-Max sensor accuracy16
Sensor light source
Wavelength12
Infrared: 905 nm (nominal)
Red: 660 nm (nominal)
NOTE: All Nellcor** OxiMax sensors must be used with the Nellcor cable; the SCP-10
cable. RS-10 and Oxisensor** II sensors are not compatible with the CARESCAPE V100.
Power dissipation
Infrared: 22.5 mW (max)
Red: 27.5 mW (max)
Sensor model
Nellcor OxiMax specifications13
Measurement range
SpO2 range 70 to 100%
OxiMax
MAX-A, MAX-AL
±2 digits
MAX-N (adult)
±2 digits
MAX-N17 (neonate)
±3 digits
SpO2
1 to 100%
MAX-P
±2 digits
Pulse rate 20 to 250 bpm
MAX-I
±2 digits
Perfusion range
0.03 to 20%
MAX-FAST
±2 digits
AccuracySaturation
SC-A (adult)
±2 digits
Adult14 70 to 100% ±2 digits
SC-PR (neonate)
±3 digits
70 to 100% ±3 digits
SC-NEO
±3 digits
70 to 100% ±2 digits
MAX-R ±3.5 digits
Neonate 14
Low perfusion 15
Pulse rate
18
OxiCliq**
Adult and neonate 20 to 250 bpm ±3 digits
OxiCliq A
±2.5 digits
Low perfusion 20 to 250 bpm ±3 digits
OxiCliq P
±2.5 digits
OxiCliq N (adult)
±2.5 digits
OxiCliq N17 (neonate)
±3.5 digits
OxiCliq I
±2.5 digits
15
13Nellcor N600x Operator’s Manual
14Adult specifications are shown for OxiMax** MAX-A and MAX-N sensors with the
N-600. Saturation accuracy will vary by sensor type. This variation equals plus or
minus one standard deviation. Plus or minus one standard deviation encompasses
68% of the population. Accuracy is based on deep hypoxia studies on healthy adult
volunteer subjects. Arterial blood samples were analyzed simultaneously on multiple
CO-oximeters.
15Applicability: OxiMax MAX-A, MAX-AL, MAX-P, MAX-I, and MAX-N sensors.
Reusable sensor models
D-YS (infant to adult)
±3 digits
D-YS (neonate)
±4 digits
D-YS & D-YSE
±3.5 digits
D-YS & D-YSPD
±3.5 digits
DS-100A
±3 digits
OXI-A/N (adult)
±3 digits
OXI-A/N (neonate)
±4 digits
OXI-P/I
±3 digits
Sensor light source
Wavelength19
Infrared: 890 nm (nominal)
Red 660 nm (nominal)
Power dissipation
Infrared: 22.5mW (max)
Red: 30 mW (max)
16Nellcor oxygen saturation accuracy specification grid (DOC0318495)
17The MAX-N, D-YS, OXI-A/N, and OxiCliq N were tested on patients >40 kg.
18The accuracy specification has been determined between saturations of 80% to
100%.
19Information about wavelength range can be especially useful to clinicians.
Note: Neonatal Sensor Accuracy: When sensors are used on neonatal subjects as
recommended, the specified accuracy range is increased by ±1 digit, as compared to
adult usage, to account for the theoretical effect on oximeter measurements of fetal
hemoglobin in neonatal blood. For example, MAX-N accuracy on neonates is ±3 digits,
rather than ±2 digits.
12Information about wavelength range can be especially useful to clinicians.
NIBP specifications
Cuff pressure range Exergen TemporalScanner specifications
0 to 290 mmHg (adult/ped)
Accuracy ± 0.1°C or 0.2°F
(Normal operating range) 0 to 145 mmHg (neonate)
Temperature range
16° to 43°C (61° to 110°F)
Blood pressure accuracy
Operating environment
16° to 40°C (60° to 104°F) (ambient)
SuperSTAT
Mean error ≤5 mmHg,
NIBP algorithm Standard deviation ≤8 mmHg
(Meets ANSI/AAMI Standard
SP10:1992)
Classic and auscultatory
Mean error ≤5 mmHg,
standard deviation ≤8 mmHg
(Meets ANSI/AAMI Standard
SP10:2002)
Maximum
determination time
120 s (adult/ped)
85 s (neonate)
Overpressure cutoff 300 to 330 mmHg (adult/ped)
150 to 165 mmHg (neonate)
Blood pressure range
Arterial heat balance range
for body temperature20 34.5° to 43°C (94° to 110°F)
Resolution 0.1 °C or 0.1°F
Response time
0.04 seconds (approx.)
Alaris Turbo Temp specifications
Accuracy21
± 0.1°C or 0.2°F
Temperature range
Predictive mode
35.6° to 41.1°C (96° to 106°F)
Monitor mode
26.7° to 42.1°C (80° to 107.9°F)
Response time
As fast as 7 seconds
SuperSTAT NIBP Algorithm
Systolic 30 to 290 mmHg (adult/ped)
30 to 140 mmHg (neonate)
MAP
20 to 260 mmHg (adult/ped)
20 to 125 mmHg (neonate)
Diastolic 10 to 220 mmHg (adult/ped)
10 to 110 mmHg (neonate)
Classic and auscultatory
Alaris Tri-Site specifications
Accuracy21
Temperature range
Predictive mode
35° to 41.1°C (95° to 106°F)
Monitor mode
26.7° to 42.1°C (80° to 107.9°F)
Response time
Systolic 30 to 245 mmHg (adult/ped)
40 to 140 mmHg (neonate)
MAP 15 to 215 mmHg (adult/ped)
30 to 115 mmHg (neonate)
Diastolic
10 to 195 mmHg (adult/ped)
20 to 100 mmHg (neonate)
Pulse rate range
SuperSTAT 30 to 240 beats/min (adult/ped)
NIBP algorithm
30 to 240 beats/min (neonate)
Classic and auscultatory
30 to 200 beats/min (adult/ped)
30 to 220 beats/min (neonate)
Pulse rate accuracy ± 3.5% or 3 bpm, whichever is
greater
NOTE: To ensure accurate measurements, use only recommended blood pressure cuffs
available from GE.
± 0.1°C or 0.2°F
As fast as 11 seconds
20Automatically applied when temperature is within normal body temperature range,
otherwise reads surface temperature.
21When tested in a calibrated liquid bath; meets ASTM E1112, Table 1, in range specified. Accuracy measured in continuous (monitor) mode.
NOTE: To ensure accurate measurements, use only recommended blood pressure cuffs
available from GE.
Power specifications
Environmental specifications
Universal power converter P/N 2018859-001
Operating conditions
AC input voltage
100 to 250VAC, 12VA
Temperature
5° to 40°C (41° to 104°F)
DC output voltage 12VDC at 1A
Atmospheric pressure
500 hPa to 1060 hPa
The AC mains power adapter
contains a non-resettable and
non-replaceable fuse.
Protection against
electrical shock
Internally powered or Class II
when powered from specified
external power supply
DC input voltage 12 VDC, supplied from a source
conforming to IEC 60601-1.
Fuses
Monitor contains three fuses,
mounted within. The fuses protect
the low voltage DC input, the
battery, and the remote alarm
output. The +5 V output on the
host port connector is regulated
by internal supply.
Battery
Type
Sealed lead acid, 6V, 3.3 Ahr
Battery life
5 hours with NIBP every 5 minutes
and SpO2, temperature and printer
active
11.5 hours non-SpO2 versions
with a usage scenario of: NIBP
determinations every 15 minutes
without temperature active.
Charge time
Approximately 5 hours from full
discharge when the monitor is off.
Approximately 8 hours when the
monitor is on.
Storage conditions
Storage temperature
–20° to 50°C (– 4° to 122°F)
Atmospheric pressure
500 to 1060 hPa
Humidity range
5 to 95% noncondensing
Radio frequency
Complies with IEC 60601-1-2.
Medical Electrical Equipment,
Electromagnetic Compatibility
Requirements and Tests and CISPR
11 (Class B, Group 1) for radiated
and conducted emissions
Physical specifications
Dimensions (H x W x D)
19.5 x 21.9 x 13.5 cm
(7.7 x 8.6 x 5.3 in)
19.5 x 25.4 x 13.5 cm
(7.7 x 10 x 5.3 in)
with Alaris temperature option
Weight
2.4 kg (5.4 lb) including battery
Mountings
Self-supporting on rubber feet,
pole mounted, or wall mount
bracket
Roll stand (optional)
Height to mounting
platform
100 cm (39 in) from floor to
lowest position
125 cm (49 in) from floor to
highest position
Base Diameter
48 cm (19 in)
5 - 7.6 cm (3 in) casters—all non
locking
Basket (H x W x D)
14.6 x 26.3 x 16.8 cm
(5.75 x 10.375 x 6.625 in)
Weight
11 kg (24 lb)
Certifications
UL 60601-1, CAN/CSA C22.2 No. 601.1, IEC 60601-1,
IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, IEC 60601-2-30,
IEC 60601-2-49, EN 1060-1, EN 1060-3, ISO 9919
CE marked to the Medical Devices Directive - 93/42/EEC
© 2012 General Electric Company – All rights reserved.
* GE, GE Monogram, CARESCAPE, CARESCAPE iPanel
and CARESCAPE Mobile Viewers, CRITIKON, DINAMAP,
Ohmeda and TruSignal are trademarks of General
Electric Company.
** Exergen and TemporalScanner are trademarks of
Exergen Corporation. Alaris, Turbo-Temp and IBAC
are trademarks of CareFusion Corp. Oxicliq, OxiMAX,
Oxisensor, SatSeconds and Nellcor are trademarks of
Nellcor Puritan Bennett, Inc. Masimo SET is a trademark
of Masimo Corporation.
GE Healthcare reserves the right to make changes in
specifications and features shown herein, or discontinue
the product described at any time without notice or
obligation. Contact your GE Healthcare representative
for the most current information.
GE Medical Systems Information Technologies, Inc. a
General Electric Company, doing business as
GE Healthcare.
GE Healthcare Finland Oy, a General Electric company,
doing business as GE Healthcare.
GE Healthcare, a division of General Electric Company.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that
are shaping a new age of patient care. Our broad expertise in medical imaging and
information technologies, medical diagnostics, patient monitoring systems, drug
discovery, biopharmaceutical manufacturing technologies, performance improvement
and performance solutions services help our customers to deliver better care to more
people around the world at a lower cost. In addition, we partner with healthcare leaders,
striving to leverage the global policy change necessary to implement a successful shift
to sustainable healthcare systems.
Our “healthymagination” vision for the future invites the world to join us on our
journey as we continuously develop innovations focused on reducing costs, increasing
access and improving quality around the world. Headquartered in the United Kingdom,
GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare
employees are committed to serving healthcare professionals and their patients in more
than 100 countries. For more information about GE Healthcare, visit our website at
www.gehealthcare.com.
GE Healthcare
P.O. Box 900, FIN-00031 GE, Finland
GE Direct United Kingdom: +44 (0)800 0329201
www.gehealthcare.com
EMEA DOC0436627 Rev3 10/12
(Global version DOC0385787 rev4)