Avalon FM20/FM30 Fetal/Maternal Monitor

Transcription

Avalon FM20/FM30 Fetal/Maternal Monitor
Philips M2702A/M2703A Technical Data Sheet - Release J.3
The Philips Avalon FM20/FM30 fetal monitor offers a
reliable, cost-effective, high-performance solution
for fetal monitoring needs in clinics and hospitals,
doctors’ practices and private households, from prenatal check-ups to antepartum monitoring of highrisk pregnancies, and during labor and delivery.
With a cutting-edge feature set, including advance
transducers, triplets monitoring, high-quality signal
processing, and a touchscreen interface, the
Avalon FM20/FM30 sets new standards for
performance, flexibility, convenience, and ease of
use.
The unique Smart Pulse measurement integrated
in the Toco transducer simplifies monitoring.
Without an additional sensor, the maternal pulse
rate is monitored and continuously compared with
the heart rate from the fetal sensor (cross-channel
verification).
In combination with an Avalon CL Transducer
System all fetal and maternal measurements can be
monitored cableless, including twins, triplets, and
Smart Pulse.
The battery option gives monitoring flexibility e.g.
for in-house transport or bridging mains power
outage.
Features (FM20/FM30)
Transducers and Measurements
• Smart transducers are comfortable to wear, waterproof, and easy to
clean
• Ultrasound fetal heart rate monitoring of a singleton, twins, and
even triplets
• Fetal Movement Profile (FMP) automatically detects fetal body
movements for antepartum applications using ultrasound transducer
• External uterine activity (Toco) monitoring
• Smart Pulse integrated in the Toco MP transducer detects the
maternal pulse rate without the need for an additional sensor (SpO2
or MECG), and reassures correct fetal heart rate monitoring
• Cross-Channel Verification (CCV) detects coincidence between
all fetal and maternal heart/pulse rates
• NST timer for antepartum applications
• Optional Non-Stress Test (NST) report software allows
interpretation of fetal heart rate and Toco traces, and generates a
printed report automatically for an NST, using NICHD guidelines
from 2008 for electronic fetal heart rate monitoring
• Optional Maternal non-invasive blood pressure including pulse
rate
• Heart rate with maternal ECG (MECG)
• Cableless monitoring in connection with an Avalon CL or Avalon
CTS Fetal Transducer System
• Monitoring of maternal temperature in connection with the Tympanic
Temperature Module
• Entering of manually taken maternal temperature
FM30 ONLY
• Direct fetal heart rate monitoring with fetal ECG (DECG) including
waveform display
• Intrauterine (IUP) pressure monitoring
• Optional Maternal pulse oximetry (SpO2) and continuous maternal
pulse rate
Monitor
• High-resolution color TFT touchscreen display with a wide viewing
angle, displaying fetal and maternal measurements are as large, easyto-read numerics
2
• Intuitive user functionality via the touchscreen
• Quick and simple cleaning due to the absence of mechanical controls
• Optimized size and presentation of measurements with automatic
screen layouts
• Displaying information such as: Patient identification (including the
bed label when connected to a surveillance system such as
OB TraceVue/IntelliSpace Perinatal), date and time, alarm information,
recorder status, and prompt and error messages
• Fast access to functions e.g. starting a recording or resetting the Toco
baseline via Configurable SmartKeys
• Adjustment of the heart rate and alarm volume with an indication of
the current setting
• Automatic channel management allowing free selectable connection
of all wired fetal transducers, patient module, or remote event
marker to any of the fetal sensor sockets at the left side of the
monitor
• Identification of the relation between transducer and numeric
through a blue transducer Finder LED, while the position indicator
on the screen shows to which fetal sensor socket a transducer is
connected
• Comprehensive patient data presentation, including at-a-glance
patient identification, and the choice to add user-configurable
notes (Roman-8 character set)
• Optional battery operation based on a built-in Smart Battery
(M4605A) and on an external AC/DC power supply (M8023A #E25
option); the monitor can operate using battery power for at least
four hours
Recorder (FM20/FM30)
• Built-in six-inch high-resolution thermal array recorder with paper
type detection and paper-out warning
• Trace output of fetal and maternal heart rates, fetal movements, and
uterine activity and annotation of time, date, trace identification
symbols, patient information, and software versions
• Maternal noninvasive blood pressure values are annotated at the end
of the measurement
• Internal backup memory for at least 7 hours of trace data (>3.5 hours
with previous hardware revision <A 00.18):
– Stored data recording to print a specific patient episode from a
selected patient at high speed, even multiple times
– Bridge paper-out for printing the remaining trace data after new
paper has been loaded
– Data recovery after an interruption of the online data
transmission to an OB TraceVue/IntelliSpace Perinatal system over
a LAN connection.
• Paper Save Mode for maternal measurements
FM30 ONLY
• Maternal heart rate, SpO2 saturation, and pulse rate values are
printed every five minutes
• Recording of six-second MECG and/or DECG wave snapshots with
25 mm/sec scaling in parallel or separate to the fetal traces
Alarms
When an alarm condition is fulfilled, it is signaled by the monitor in the
following ways:
• An alarm tone sounds
• An alarm message is shown on the screen
• The numeric of the alarming measurement flashes on the screen
Flexible Nurse Call Interface
• Means for alarms generated on the monitor to be signaled on an
external device such as a nurse call system, a beeper, or a light
• Providing three general alarm relays
• Connection of the external device to the alarm relay of the monitor,
and configurable alarm criteria
• Active open and closed contacts and a user-definable delay time
ALARM CATEGORIES
MIB/RS-232 Interface
• MIB, Medical Information Bus (IEEE P1073), is a standard for
interfacing medical devices, used for the Data Export functionality to
export measurement values from the monitor to other devices, or to
connect the Tympanic Temperature Module
• Physiological Alarms for fetal and maternal parameters (to
indicate vital sign alarm limit violations, for instance)
• Technical Alarms (INOPs) are triggered by signal quality
problems, equipment malfunction, or equipment disconnect
Device Interface (USB Interfaces)
• Allowing connection of USB devices (mouse, keyboard, bar code
reader) to the monitor
ALARM MODES
• INOP only: INOPs are enabled, with audible and visual indication
active (default setting)
• All: patient alarms and INOPs are enabled, with audible and visual
indicators active
ALARM SUSPENSION
• Alarms Off/Pause Alarms function
• Alarm pause period: indefinite, or one, two, or three minutes
ALARM LATCHING/NON-LATCHING
• Visual
• Audible
• Visual and audible
Standard Interfaces
• Cableless monitoring using the Avalon CL Transducer System, or the
Avalon CTS Cordless Transducer System with connection at the fetal
sensor socket
Optional Interfaces (FM20/FM30)
LAN/RS-232 System Interface
The LAN/RS-232 interface has two fully isolated ports:
• The LAN port is for connecting the monitor to an OB TraceVue/
IntelliSpace Perinatal obstetrical information and surveillance system
(revision E.0 or later) on a network. OB TraceVue/IntelliSpace
Perinatal controls all patient admit/discharge events.
• The RS-232 port can be used for connecting the monitor to an
obstetrical information and surveillance system, such as
OB TraceVue/IntelliSpace Perinatal.
• Dual system interface support. If an obstetrical information and
surveillance system is connected via LAN, another information
system (EMR) can be connected via RS232 in read-only mode.
Service Features (FM20/FM30)
• The Configuration Mode is password-protected and allows trained
users to customize the monitor configuration
• The Demo Mode is password-protected and is intended for training
and educational purposes
• The Service Mode is password-protected and ensures that only
trained staff can access service tests and tasks
• The Support Tool uses the LAN interface of the fetal monitor
• The Support Tool helps technical personnel to
– carry out configuration, upgrades, and troubleshooting on an
individual monitor
– share configuration settings between monitors
– back up the monitor settings
Related Products (FM20/FM30)
Avalon CL and Avalon CTS Transducer System
The monitor is compatible with the Avalon CL and CTS, allowing
expectant mothers to be continuously monitored without wires,
whether in the bath or shower, in the bed, or while ambulating.
Refer to the Avalon CL and the Avalon CTS Data Sheets for further
information.
Avalon CL Transducer System
Avalon CTS Transducer System
3
Tympanic Temperature Module
The monitor is compatible with the Tympanic Temperature Module
allowing the monitoring of maternal temperature. The temperature is
taken in the ear, but result of this measurement can be automatically
adjusted to correspond to a different body reference site. The result is
shown on the display of the thermometer and transmitted to the
monitor. Refer to the Tympanic Temperature Module Data Sheet for
further information.
The monitor is classified as electromagnetic emissions Class B, except
whenever used with the IUP/ECG patient module M2738A, when it is
classified as Class A.
This ISM device complies with Canadian ICES-003. Cet appareil ISM est
conforme à la norme NMB-001 du Canada.
Environmental Specifications (FM20/FM30)
The monitor may not meet the given performance specifications if
stored and used outside the specified temperature and humidity
ranges.
FM20/FM30 Monitor
Temperature Range
Operating
without battery: 0°C – 45°C (32°F – 113°F)
with fully charged battery: 0°C – 40°C
(32°F – 104°F)
with battery charging: 0°C – 35°C (32°F – 95°F)
Regulatory and Standards Compliance (FM20/FM30)
The monitor is in conformity with the requirements of the European
Medical Devices Directive 93/42/EEC and the following major
international standards:
Safety, Performance
• IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010
• IEC 60601-1-6:2010 / EN 60601-1-6:2010
• IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+AC:2010
• IEC 60601-2-49:2011 / EN 60601-2-49:2001
• ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010
• CAN/CSA C22.2#60601-1-08
• JIS T 1303 2005
• AS/NZS 3200.1.0-1998
The possibility of hazards arising from hardware and software errors
was minimized in compliance with ISO 14971:2012,
IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010.
Alarm sounds are compliant with
Standard IEC 60601-1-8:2006+A1:2012 /
EN 60601-1-8:2007+AC:2010.
Electromagnetic Compatibility
• IEC 60601-1-2:2007/EN 60601-1-2:2007+AC:2010
• ICES-003:2012
4
Storage
-20°C – 60°C (-4°F – 140°F)
(except recorder paper)
Humidity Range
Operating
<95% relative humidity @ 40°C (104°F)
Storage
(except recorder paper)
Altitude Range
Operating
-500 – 3.000 m (-1.640 – 9.840 ft.)
Storage
-500 – 13.100 m (-1.640 – 43.000 ft.)
Transducers (M2734B/M2735A/M2736A/M2738A)
Temperature Range
Operating
0°C – 40°C (32°F – 104°F)
Storage
-20°C – 60°C (-4°F – 140°F)
Humidity Range
Operating
Storage
Altitude Range
Operating
-500 – 3.000 m (-1.640 – 9.840 ft.)
Storage
-500 – 13.100 m (-1.640 – 43.000 ft.)
FOR FM30 ONLY
Philips SpO2 Sensors
Operating Temperature Range
Reusable sensors (M119xX)
10°C – 37°C (50°F – 98.6°F)
Disposable sensors (M113xA)
0°C – 55°C (32°F – 131°F)
Physical Specifications (FM20/FM30)
FM20/FM30 Monitor
Power (without battery option)
Supply Voltages
100 VAC – 240 VAC ± 10%
Supply Frequency Range
50 Hz – 60 Hz
Power consumption (current)
0.7 – 0.4 A
Dimensions and Weight
Size mm/(in) ±1%: W x H x D
286 x 133 x 335 mm ± 1%
(without options)
(11.3 x 5.2 x 13.2 in ± 1%)
Weight without battery
5.1 kg (11.2 lbs)
Weight with battery
5.3 kg (11.7 lbs)
Classifications
Degree of Protection Against
Type CF
Electrical Shock
Electrical Class
Transducers (M2734B/M2735A/M2736A/M2738A)
Shock Resistance
Withstands a 1 m drop to concrete surface with possible cosmetic
damage only
Water Ingress Protection Code
M2734B/M2735A/
IP 68 (immersion up to 1 m water depth
M2736A
for 5 hours)
M2738A
IP 67 (immersion up to 0.5 m water
depth for 30 minutes)
Dimensions and Weight
M2734B/M2735A/
Size (diameter)
M2736A
Weight (without
cable)
Maximum size
mm/(in.):
WxHxD
Cable length
Weight
83 mm (3.27 in.)
< 220 g (7.8 oz.)
50 x 28 x 135 mm
(2.0 x 1.1 x 5.3 in.)
2.5 m
< 150 g (5.3 oz.)
Degree of Protection Against Electrical Shock
Type CF
Fetal/Maternal Performance Specifications
Ultrasound
Measurement Method
Ultrasound Pulsed
Doppler
Measurement
US
50 – 240 bpm
Range
Resolution
Display
1 bpm
Printer
Class II equipment
Mode of Operation
Continuous operation
Startup Time (Time taken
< 30 seconds
from switching on the monitor
to seeing the first parameter
labels)
Ingress Protection
IP X1 (provided recorder drawer is shut)
M2738A
Performance Specifications (FM20/FM30)
Complies with IEC 60601-2-37:2007/EN 60601-2-37:2008. ECG
measurement follows IEC 60601-2-27:2011+AC:2012/EN 60601-227:2006+AC:2006 except clauses listed below:
• 201.6.2, 201.8.5.5
• 201.12.1.101
• 202.6.2.101
Jitter @ 200 bpm
US Intensity
Average output
power
Peak rarefactional
pressure
Output beam
intensity (Iob)
(= spatial average temporal average
intensity)
Spatial-peak
temporal average
intensity
Effective radiating
area @ -12 dB
1/4 bpm
≤ 3 bpm
P = (7.4 ± 0.4) mW
pr =
(40.4 ± 4.3) kPa
Iob= Isata =
(2.38 ± 0.59) mW/cm2
Ispta =
(15.0 ± 3.2) mW/cm2
(3.11 ± 0.74) cm2
US Frequency
1 MHz ± 100 Hz
US Signal range
Repetition Rate
Duration
Good
3.5 μVpp –
350 μVpp @ 200 Hz
3.0 kHz
≤ 100 μs
Full
Acceptable
Half-full
US Burst
Signal Quality
Indication
Poor
Beat to Beat Change (max.) for
Ultrasound
Toco
Measurement Method
Sensitivity
Resolution
Measurement Range
Display
Printer
Empty
28 bpm
Strain Gauge Sensor
Element
1 unit = 2.5 g
1 unit
1/4 unit
400 units
5
Fetal/Maternal Performance Specifications
Signal Range
0 – 127 Units
Maximum Offset Range
-300 units
Baseline Setting
20 units
Auto Offset Correction
3 seconds after
connecting the
transducer, the Toco
value is set to 20 units
Auto Zero Adjust
Toco value is set to
zero following a
negative measurement
value for 5 seconds
Pulse from Toco MP
Range
40 – 240 bpm
Accuracy
±2% or 1 bpm,
whichever is greater
Resolution
Wavelength Range
Emitted light energy
Maternal Heart Rate
Measurement Range
Resolution
Display
Recorder
Accuracy
Filter Bandwidth
Inop Auxiliary Current (Leads Off
Detection)
Input Signal Range
MECG
Defibrillator Protection
ESU Protection
1 bpm
780 – 1100 nm
≤ 15 mW
30 – 240 bpm
1 bpm
1/4 bpm
± 1 bpm or 1%,
whichever is greater
0.8 – 80 Hz
< 100 μA
150 μVpp to 6 mVpp
None
None
FM30 ONLY
Direct and Maternal ECG
DECG
Single Lead ECG (derived from Fetal Scalp Electrode)
MECG
Single Lead ECG (derived from RA and LA electrodes)
DECG
20 μVpp to 6 mVpp
Input Signal
IUP
Measurement Method
Measurement Range
Signal Range
Resolution
Sensitivity
Offset Compensation
6
Display
Printer
Passive Resistive Strain
Gauge Elements
-100 – 300 mmHg
-99 – 127 mmHg
1 mmHg
1/4 mmHg
5 μ/V/mmHg
+100 – 200 mmHg
IUP
Baseline Setting
Accuracy (not including sensor
accuracy)
Auto Offset Correction
0 mmHg
± 0.5% per 100 mmHg
3 seconds after connecting
the transducer, the IUP value
is set to 0 mmHg
Alarm Specifications (FM20/FM30)
Fetal Heart Rate (Ultrasound Alarm Specifications
FHR/DECG Alarm Limits
Bradycardia
(low limit)
60 – 200 bpm adjustable in 10 bpm steps
Default: 110 bpm
Tachycardia
70 – 210 bpm adjustable in 10 bpm steps
(high limit)
Default: 170 bpm
FHR/DECG Alarm Delay
Bradycardia
10 – 300 seconds in steps of 10 s
(low limit)
Default: 240 s
Tachycardia
(high limit)
Default: 300 s
Signal Loss
Delay
MHR/MECG Alarm Specifications
High Range
31 – 240 bpm adjustable in 1 bpm steps (30 –
40 bpm), and 5 bpm steps 40 – 240 bpm)
Default: 120 bpm
Low Range
30 – 235 bpm adjustable in 1 bpm steps (30 –
40 bpm), and 5 bpm steps 40 – 240 bpm)
Default: 50 bpm
Tachycardia
Difference to high limit: 0 – 50 bpm adjustable in
5 bpm steps, Default: 20 bpm
Clamping at: 150 – 240 bpm adjustable in 5 bpm
steps, Default: 200 bpm
Bradycardia
Difference to low limit: 0 – 50 bpm adjustable in
5 bpm steps, Default: 20 bpm
Clamping at: 30 – 100 bpm adjustable in 5 bpm
steps, Default: 40 bpm
Noninvasive Blood Pressure (FM20/FM30)
Measurement Validation: In adult mode, the blood pressure
measurements determined with this device comply with the American
National Standard for Electronic or Automated Sphygmomanometers
(ANSI/AAMI SP10 - 1992) in relation to mean error and standard
deviation, when compared to intra-arterial or auscultatory
measurements (depending on the configuration) in a representative
patient population. For the auscultatory reference the 5th Korotkoff
sound was used to determine the diastolic pressure. Complies with
IEC 80601-2-30:2010/EN 80601-2-30:2010.
Noninvasive Blood Pressure Performance Specifications
Measurement Systolic
30 – 270 mmHg (4 – 36 kPa)
Ranges
Diastolic
10 – 245 mmHg (1.5 – 32 kPa)
Mean
20 – 255 mmHg (2.5 – 34 kPa)
Accuracy
Max. Std. Deviation:
8 mmHg (1.1 kPa)
Max. Mean Error:
± 5 mmHg (± 0.7 kPa)
Pulse Rate
Range
40 – 300 bpm
Accuracy
40 – 100 bpm: ± 5 bpm
(average
101 – 200 bpm: ± 5% of reading
over non201 – 300 bpm: ± 10% of reading
invasive
blood
pressure
measurement cycle)
Measurement Time
Cuff Inflation Time
Initial Cuff Inflation Pressure
Auto Mode Repetition Times
Venipuncture Mode Inflation
Inflation Pressure
Automatic deflation after
Typical at HR > 60 bpm
Auto/manual: 30 seconds
maximum time: 180 seconds
Typical for normal cuff: Less than
10 seconds
165 ± 15 mmHg
1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45,
60, or 120 minutes
SpO2 (FM30 only)
Maternal pulse oximetry provides SpO2, pulse numerics, and a pulse
trace for oxygen saturation (SpO2) of maternal aterial hemoglobin.
Pulse rate is derived from SpO2 if ECG is not connected.
Complies with ISO 80601-2-61:2011/EN 80601-2-61:2011 (except
alarm system; alarm system complies with IEC 60601-2-49:2011/EN
60601-2-49:2001).
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 COoximeter measurements. Display Update Period: Typical: 2 seconds,
Maximum: 30 seconds. Maximum with noninvasive blood pressure
INOP suppression on: 60 seconds. The specified accuracy is the rootmean-square (RMS) difference between the measured values and the
reference values.
SpO2 Performance Specifications
Range
0 – 100%
Accuracy
Philips Reusable Sensors:
M1191A/B, M1191AL/BL, M119 1ANL, M1192A,
M1192AN = 2% (70% to 100%) M1191T, M1192T,
M1194A, M1194AN, M1196A, M1196T = 3% (70%
to 100%)
Philips Disposable Sensors with M1943A(L):
M1131A, M1901B, M1903B, M1904B
= 3% (70% – 100%) M1133A, M1134A
= ±2% (70% – 100%)
NellcorPB® Sensors with M1943A(L):
20 – 120 mmHg (3 – 16 kPa)
170 seconds
MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20,
N-25, OxiCliq A, P, N = 3% (70% – 100%)
Accuracy
ALARM SPECIFICATIONS NBP (FM20/FM30)
Alarm
Specifications
Systolic
Diastolic
Mean
LNC MP10: LNOP DC-I, LNOP DC-IP, LNOP YI,
Range
Adjustment
30 – 270 mmHg (4 –
36 kPa)
10 – 245 mmHg (1.5 –
32 kPa)
10 – 30 mmHg:
2 mmHg (0.5 kPa)
> 30 mmHg:
5 mmHg (1 kPa)
20 – 255 mmHg (2.5 –
34 kPa)
Overpressure Settings
> 300 mmHg (40 kPa) > 2 sec
Masimo Reusable Sensors® with LNOP MP12 or
Adjustment
not user adjustable
LNCS DC-I, LNCS DC-IP: 2% (70% – 100%)
LNOP TC-I, LNCS TC-I: 3.5% (70% – 100%)
Masimo Disposable Sensors® with LNOP MP12 or
LNC MP10: LNOP Adt, LNOP Adtx, LNOP Pdt,
Resolution
Pulse
Range
Accuracy
Resolution
LNOP Pdtx, LNCS Adtx, LNCS Pdtx:
2% (70% – 100%) LNOP Neo-L, LNCS Neo-L:
3% (70% to 100%)
1%
30 – 300 bpm
± 2% or 1 bpm, whichever is greater
1 bpm
7
SpO2 Performance Specifications
Sensors
Wavelength
500 – 1000 nm information about the wavelength
range
range can be especially useful to clinicians (for
instance, when photodynamic therapy is
performed)
Emitted
≤ 15 mW
Light Energy
Pulse
70% – 100%
Oximeter
Calibration
Range
ALARM SPECIFICATIONS SPO2
SpO2 Alarm
Specifications
SpO2
Desat
Pulse
Tachycardia
Bradycardia
(FM30 ONLY)
Range
Adjustment
Delay
50 – 100%
50 – low alarm
limit
30 – 300 bpm
1% steps
1% steps
(0, 1, 2,
3,... 30) +
4 sec
max.
14 sec
Difference to
high limit
0 – 50 bpm
Clamping at
150 – 300 bpm
Difference to
low limit
0 – 50 bpm
Clamping at
30 – 100 bpm
1 bpm steps
(30 – 40 bpm)
5 bpm steps
(40 – 300 bpm)
5 bpm steps
max.
14 sec
max.
14 sec
5 bpm steps
External Power Supply Specifications (FM20/FM30)
M8023A External Power Supply Specifications
Power Specifications
Line Voltage
100 – 240 V approximately
Current
1.3 – 0.7 A
Frequency
50 – 60 Hz approximately
Indicators
AC Power
green LED
Ingress Protection for External Power Supply (M8023A)
IP31 (protected against the ingress of solid foreign objects 2.5 mm
in diameter or larger, and the ingress of water when water is
dripping vertically) when rested on its rubber feet on a flat, level
surface
8
Battery Specifications (FM20/FM30)
M4605A Battery Specifications
Performance Specifications
Avalon FM20/30 Battery
Operating Time (with new, fully
Option #E25
charged battery)
Basic monitoring configuration: >2
hours (Display Brightness: 70%,
Recorder: "On" at 3 cm/min,
NBP: Auto Mode at 15 min,
2 US Transducers, 1 Toco+
with MECG, 1 Patient Module with
DECG)
Charge Time
When monitor is off: approx. 6 hours
When monitor is in use: more than
10 hours (depending
on monitor configuration)
Recorder Specifications (FM20/FM30)
5 bpm steps
5 bpm steps
M8023A External Power Supply Specifications
IP32 when mounted with the connectors facing downwards
Built-in Thermal Array Fetal Trace Recorder
Mechanism
Thermal Array Recorder
Paper and
Type
Standard Z-fold
Printing
paper
Standard Speeds (real- 3 cm/min, 2 cm/min,
time traces)
1 cm/min
ECG Wave Recording
Emulated 25 mm/s
(FM30 only. Not realPrint speed is
time.)
variable up to
20 mm/s and
depends on the print
load
Stored Data
Print speed is
Recording/Trace
Recovery Printout
Paper Advance
Sensing
Accuracy
@ 3 cm/min,
2 cm/min,
1 cm/min
± 5 mm/page
variable up to
20 mm/s and
depends on the print
load
Up to 20 mm/s
Optical Reflex
Sensor for black
page marks
Built-in Thermal Array Fetal Trace Recorder
Usable Print
128 mm
Width
Resolution
8 dots/mm (200 dpi)
Time Delay to
< 30s @ 1 cm/min
see trace on
paper
Trace Separation
Twin
Standard
FHR2 +20 bpm
Offset for FHR
Classic
FHR1 +20 bpm
(Ultrasound/
Triplet
Standard
FHR2 +20 bpm
DECG)
FHR3 -20 bpm
Classic
FHR1 +20 bpm
FHR3 -20 bpm
Ordering Guide and Accessory Options (FM20/FM30)
You can order the Avalon FM20/FM30 fetal monitor under the product
number M2702A/M2703A. To order, precede the required option
number with M2702A (for example, M2702A#B71 adds the
noninvasive blood pressure measurement). “K” options let you modify
your order. The following tables give an overview of the monitor’s
standard capabilities, and what is available as options. Refer to
“Standard Accessories Included (FM30 only)” on page 11 for a list of
items shipped as part of the standard configuration. Start-up quantities
of fetal supplies are available in five convenient kits.
Features listed as options can be added at a later time (see “Upgrade
Options (FM20/FM30)” on page 17).
Standard Measurements (FM20/FM30)
Description
FM20
Recommended
Accessory
Option
FM30
FM30
Standard Fetal Measurements
Toco MP
K10
DFHR via Direct ECG (DECG)
–
including DECG waveform
Intrauterine Pressure (IUP)
K03
Standard Maternal Measurements
Maternal ECG and Heart Rate via
K03
MECG electrodes, including MECG
waveform
Optional Measurements (FM20/FM30)
Description
–
K01
Fetal Movement Profile (FMP)
–
Dual PS/2 Interface
for keyboard and mouse
connection
System Interface
(1 x RS232 port and 1 x LAN
port)
Dual MIB/RS232 interface board
(for Data Export functionality
and for maternal infrared
temperature measurement)
Quad. USB Interface (Keyboard,
Mouse, Bar Code Reader)
You can measure MHR using the Toco+
transducer Order M2735A separately (option
K03)
Option
Recommended
Accessory
Option(s)
n/a
K02
K31
K31 + K91
Optional Interfaces (FM20/FM30)
Fetal Heart Rate (FHR) via
ultrasound
Twins monitoring via ultrasound
Toco MP
–
Standard Maternal Measurements
Maternal Heart Rate via MECG
K03
electrodes
Required
NST Report Capability
Non-Stress Test reporting
C71
Optional Fetal Measurements
Triple FHR via ultrasound
C73
Optional Maternal Measurements
Noninvasive Blood Pressure
B71
(NIBP) with Pulse Rate
Pulse Oximetry (maternal
B73
SpO2) together with NBP with
Pulse Rate (FM30 only)
Description
labor.
Recommended
Accessory
Option
Description
Standard Fetal Measurements
We recommend switching off FMP during
FM20
ADDITIONAL STANDARDS MEASUREMENTS (FM30 ONLY)
J22
Recommended
Accessory
Option
M8024A #A01
J70
–
J13
–
J25
–
Required
Option
9
Required
Option
Description
Flexible Nurse Call Relay
Interface
J30
Recommended
Accessory
Option
–
K30
K31
Product
Number
CL Base Station
866074
CL Toco+ MP Transducer
866075
CL Ultrasound Transducer
866076
CL ECG/IUP Transducer
866077
Mounting brackets
order directly
from GCX
Tympanic Temperature Module, including:
• a base station for mounting on a table, wall,
or a roll stand
• A starter pack of 96 probe covers
Adding a 1.5 m, RS232 connection cable for
use with the fetal monitors
Adding a 3.0 m, RS232 connection cable for
use with the fetal monitors
Product
Number
866149
866149 #A01
K02
K03
10
Cable and Transducer Options Description
The monitor comes with one ultrasound transducer.
To add a second M2736A ultrasound transducer,
order option K01
The monitor comes with one ultrasound transducer.
To add two additional M2736A ultrasound
transducers, order option K02 (only in conjunction
with C73)
Order ECG Patient Module M2738A, using option
K03 (includes MECG adapter cable M1363A)
Order the Remote Event Marker (989803143411)
using option K04
Avalon CTS Interface Cable M2731-60001
Order Antimicrobial NBP Cuff assortment kit with
3 m (10 ft) connection tubing (M1599B) using option
K31: M1573A; M1574A; M1575A
ACCESSORIES (FM30 ONLY)
Option
Number
K10
K11
Toco MP transducer and Patient Module (instead of
Toco+ transducer) as standard
Toco+ Transducer (replaces K10)
Paper Scaling Options (FM20/FM30)
Option
Number
P01
P02
Description
50 – 210 bpm paper scaling
30 – 240 bpm paper scaling
Transport Options (Battery and External Power Supply FM20/
FM30)
Option
Number
E25
866149 #A02
Accessories (FM20/FM30)
Option
Number
K01
Option
Number
K04
Description
Battery (M4605A), external power supply (M8023A
#E25) and MSL cable (1 m)
Fetal Supplies Starter Kits (FM20/FM30)
Kit
Number
862214
862215
862216
Description
Contents
Standard Antepartum Kit
Paper (30 – 240),
(North America)
belts, gel, belts
buttons, belt clips
Paper (50 – 210),
belts, gel, belts
buttons, belt clips
Paper (50 – 210),
belts, gel, belts
buttons, belt clips
(Europe, Latin America,
Asia)
(Japan)
Fetal Accessories (FM20/FM30)
FETAL SUPPLIES STARTER KITS (FM30 ONLY)
Kit
Number
862217
862218
Description
Contents
Intrapartum DECG Kit
(single spiral)
Fetal scalp
electrodes, fetal
adhesive pad
electrodes
Fetal scalp
electrodes, fetal
adhesive pad
electrodes
Intrapartum DECG Kit
(double spiral)
Europe only, not for USA
Standard Accessories Included (FM20/FM30)
Description
Ultrasound transducer
Toco MP transducer
Butterfly Belt Clips
Fetal paper pack (country-specific, installed)
Power cable
Instructions for Use
Documentation DVD (includes Service Guide and
Instructions for Use)
Quantity
1
1
1 per
Transducer
1
1
1
1
Quantity
1
1
1
Transducers (FM30/FM20)
Supported Transducers
Ultrasound transducer
Toco MP transducer for monitoring external Toco
and maternal pulse
Part
Number
M2736A
M2734B
TRANSDUCER (FM30 ONLY)
Supported Transducers
Toco+ transducer for monitoring Toco, DECG,
MECG, or IUP (K11)
Patient Module for monitoring maternal heart
rate, DECG or IUP
Part Number
Belt buttons, pack of 10
Butterfly belt clip (pack of 6)
Telemetry Interface Cable
Telemetry
Avalon CTS Cable M2731interface
60001
cable
External Marker
M1569A
989803143401
M4601A1
M4602A
M4603A
M1562B
M2208A
40483A
40483B
453564203941
989803143411
1 Note: 32 mm belts for use with M2738A Patient Module only
FETAL ACCESSORIES (FM30 ONLY)
STANDARD ACCESSORIES INCLUDED (FM30 ONLY)
Description
Patient module for DECG, MECG, or IUP
monitoring (K10)
DECG adapter cable 989803137651
MECG adapter cable M1363A
Fetal Accessories
Belt (reusable, gray, water resistant)
32 mm wide, 15 m roll
60 mm wide, 5 belts
60 mm wide, 15 m roll
50 mm wide, 5 belts
Belt (disposable, yellow, water resistant)
60 mm wide, pack of 100
Ultrasound Gel
12 Bottles
5 liter refill (with dispenser) for 40483A
Shelf life: 24 months maximum
Belt Buttons and Belt Clip
Part
Number
M2735A
M2738A
Fetal Accessories
Part Number
DECG Accessories: New Philips DECG Solution
DECG reusable leg plate adapter cable (with
989803137651
flushing port)
DECG leg attachment electrode for DECG leg
989803139771
plate adapter cable
DECG fetal scalp electrode: single spiral,
989803137631
worldwide availability
DECG fetal scalp electrode: double spiral,
989803137641
Europe only. Not for USA
DECG Accessories: QwikConnect Plus™ Solution
DECG reusable leg plate adapter cable
M1362B
(QwikConnect Plus™)
DECG leg attachment electrode for DECG leg
M1349A
plate adapter cable
DECG fetal scalp electrode: single spiral,
15133E
worldwide availability
DECG fetal scalp electrode: double spiral,
15133D
Europe only. Not for USA
Koala IUP Accessories
Disposable Koala IUP catheter
M1333A
Reusable Koala IUP adapter cable
989803143931
11
MECG ACCESSORIES (FM30 ONLY)
Maternal Heart Rate Accessories
MECG adapter cable
Foam MECG electrodes, snap-fit, for MECG
adapter cable
Part
Number
M1363A
40493D/E
Recorder Paper (FM20/FM30)
Supplied in cases of 40 packs. Each pack has 150 numbered pages
Product No.
Geography
M1910A
USA/Canada and Asia
M1911A
Europe/Japan
M1913A
Japan
M1913J
Japan
*Bradycardia and tachycardia alarm ranges are shaded.
FHR Scale
Grid Color
Scale Units
30 – 240
50 – 210
50 – 210
50 – 210
Red/Orange
Green
Green
Green*
mmHg
mmHg and kPa
mmHg
mmHg
High-lighted 3cm
Lines?
Yes
No
Yes
Yes
Noninvasive Blood Pressure Accessories (FM20/FM30)
Multi-Patient Comfort Cuffs and Disposable Cuffs
Maternal Patient
Category
Adult (Thigh)
Large Adult
Adult
Small Adult
Cuff kit of 4 adult
sizes
12
Limb Circumference
42.0—54.0 cm
34.0—43.0 cm
27.0—35.0 cm
20.5—28.0 cm
Bladder
Width
20.0 cm
16.0 cm
13.0 cm
10.5 cm
Disposable cuff
Part No.
M1879A
M1878A
M1877A
M1876A
Reusable cuff
Part No.
M1576A
M1575A
M1574A
M1573A
M1578A
Tubing
M1598B (1.5 m) or
M1599B (3.0 m)
Antimicrobial Coated Reusable Cuffs
Maternal Patient Category (color)
Limb Circumference
Adult Thigh (gray)
Adult Thigh (gray)
pack of 5 cuffs
Large Adult X-Long (burgundy)
Large Adult X-Long (burgundy)
pack of 5 cuffs
Large Adult (burgundy)
Large Adult (burgundy)
pack of 5 cuffs
Adult X-Long (navy blue)
Adult X-Long (navy blue)
pack of 5 cuffs
45.0—56.5 cm
45.0—56.5 cm
Bladder
Width
21.0 cm
21.0 cm
35.5—46.0 cm
35.5—46.0 cm
17.0 cm
17.0 cm
M4558B
M4558B5
35.5—46.0 cm
35.5—46.0 cm
17.0 cm
17.0 cm
M4557B
M4557B5
27.5—36.5 cm
27.5—36.5 cm
13.5 cm
13.5 cm
M4556B
M4556B5
Adult (navy blue)
Adult (navy blue)
pack of 5 cuffs
Small Adult (royal blue)
Small Adult (royal blue)
pack of 5 cuffs
Cuff kits containing one small adult, one
adult, one large adult and one thigh cuff
Cuff kits containing one small adult, one
adult, one adult X-long, one large adult, one
large adult X-long and one thigh cuff
27.5—36.5 cm
27.5—36.5 cm
13.5 cm
13.5 cm
M4555B
M4555B5
20.5—28.5 cm
20.5—28.5 cm
10.6 cm
10.6 cm
M4554B
M4554B5
Part No.
Tubing
M4559B
M4559B5
M1598B (1.5 m) or
M1599B (3.0 m)
864288
864291
Soft Single Patient Single-Hose Disposable Cuffs
Patient Category
Adult (Thigh)
Large Adult X-Long
Large Adult
Adult X-Long
Adult
Small Adult
Limb Circumference (cm)
45.0 – 56.5
35.5 – 46.0
35.5 – 46.0
27.5 – 36.5
27.5 – 36.5
20.5 – 28.5
Bladder Width (cm)
20.4
16.4
16.4
13.1
13.1
10.4
Part No.
M4579B
M4578B
M4577B
M4576B
M4575B
M4574B
Tubing
M1598B (1.5 m)
or
M1599B (3.0 m)
13
SpO2 Accessories (FM30 only)
All listed sensors operate without risk of exceeding 41°C on the skin if
the initial skin temperature is below 37°C.
Philips Reusable Sensors
Description
Adult sensor (2.0 m cable), for patients over 50 kg. Any finger,
except thumb.
M1191A with longer cable (3.0 m)
Small adult, pediatric sensor (1.5 m cable) for patients
between 15 kg and 50 kg. Any finger except thumb.
Use only on adult patients with FM30/40/50.
Ear sensor (1.5 m cable) for patients more than 40 kg.
Adult clip sensor (3 m cable) for patients over 40 kg. Any
finger except thumb.
Adult clip sensor (2 m cable) for patients over 40 kg. Any
Adult sensor (0.45 m cable), for patients over 50 kg. Any
Adult clip sensor (0.9 m cable) for patients over 40 kg. Any
Special Edition (SE)
Adult sensor (3 m cable), for patients over 50 kg. Any finger
except thumb.
Ear sensor (1.5 m cable) for patients more than 40 kg.
Comments
No adapter cable required.
Product Number
M1191B
M1191BL
M1192A
M1194A
M1196A
M1196S
Requires M1943A (1.0 m) or M1943AL
(3.0 m) adapter cable.
M1191T
M1192T
M1196T
No adapter cable required.
M1191ANL
SE sensors work with FM30/40/50, as well
as with OxiMax-compatible SpO2 versions
of other Philips monitors.
M1192AN
M1194AN
Philips Disposable Sensors
Not available in the USA:
Description
Identical to OxiMax MAX-A
Identical to OxiMax MAX-P
Identical to OxiMax MAX-N
14
Comments
Requires M1943A (1.0 m) or M1943AL (3.0 m)
adapter cable
Product Number
M1904B
M1903B
M1901B
Available worldwide:
Description
Adult/Pediatric finger sensor (0.45 m cable)
Adult/Pediatric finger sensor (0.9 m cable) for
patients >40 kg. Any finger except thumb.
Adult/Pediatric finger sensor (0.9 m cable) for
patients >40 kg. Any finger except thumb.
Adhesive-free
Comments
Requires M1943A (1.0 m) or M1943AL (3.0 m)
adapter cable
Product Number
M1131A
M1133A
M1134A
Nellcor Sensors
Nellcor sensors must be ordered from Nellcor/Covidien.
Product Number
OxiMax MAX-A
OxiMax MAX-AL
OxiMax MAX-P
OxiMax MAX-N
Oxisensor II D-25
Oxisensor II D-20
Oxisensor II N-25
OxiCliq A
OxiCliq P
OxiCliq N
Description
Adult finger sensor (patient size >30 kg)
OxiMax MAX-A with long cable
Pediatric foot/hand sensor (patient size 10—50 kg)
Adult finger or neonatal foot/hand sensor
(patient size >40 kg or <3 kg)
Adult sensor (patient size >30 kg)
Pediatric sensor (patient size 10—50 kg)
Neonatal/Adult sensor (patient size <3 kg or >40 kg) Use only on adult patients
with FM30/40/50.
See OxiMax MAX-A
See OxiMax MAX-P
See OxiMax MAX-N
Use only on adult patients with FM30/40/50
Comments
Requires M1943A (1.0 m) or
M1943AL (3.0 m) adapter
cable.
cable.
cable together with OC-3
adapter cable.
Masimo LNOP Reusable Sensors
Product Number
LNOP DC-I
LNOP DC-IP
Description
Adult Finger Sensor (>30 kg)
Pediatric Finger Sensor (10—50 kg)
Philips Part Number
989803140321
989803140331
LNOP YI
Multi-Site Sensor (>1 kg)
Ear Sensor (>30 kg)
n/a
LNOP TC-I
989803140341
For use with this sensor the adapter cable LNOP MP12 (M1020-61102)
is needed.
15
Masimo LNCS Reusable Sensors
Product Number
LNCS DC-I
LNCS DC-IP
Description
Adult Finger Sensor (>30 kg)
Philips Part Number
989803148281
989803148291
LNCS TC-I
Ear Sensor (>30 kg)
989803148301
For use with this sensor the adapter cable LNC MP10 (989803148221)
is needed.
Masimo LNOP Disposable Adhesive Sensors
Product Number
LNOP Adt
Description
Adult Sensor (>30 kg)
Philips Part Number
989803140231
LNOP Adtx
LNOP Pdt
Pediatric Sensor (10—50 kg)
Pediatric Sensor (10—50 kg)
Neonatal (<3 kg) or Adult adhesive Sensor (>40 kg)
n/a
989803140261
LNOP Pdtx
LNOP Neo-L
n/a
989803140291
Masimo LNCS Disposable Adhesive Sensors
Product Name
LNCS Adtx
LNCS Pdtx
LNCS Neo-L
Description
Neonatal Foot Sensor (<3 kg)
or Adult Finger Sensor (>40 kg)
Philips Part Number
989803148231
989803148241
989803148271
Input Devices (FM20/FM30)
Description
Slimline keyboard with integrated trackball
(includes spill cover)
Optical mouse
16
Option
M8024A #A01
M8024A #B01
Description
Trackball
Wireless trackball
Hand-Track
Option
M8024A #C01
M8024A #C02
M8024A #C03
Mounting Hardware (FM20/FM30)
Mounts, Carts, and Rollstands
M2740A #A01
M2740A #A05
M2740A #B01
M2740A #C02
Cart with fixed angle mount and
two drawers
Flush Wall Mount for a flat
wall mounting
M2740A #R01
Wall Mount (Arm)
Bed Hanger
M2740A #U01
M2740A #W01
Rollstand with tray
Mounting Kit for Avalon CTS for
use with M2740A #C02
Wall Channel required for wall
mounts A01 and A05
Upgrade Options (FM20/FM30)
Upgrade options are prefixed with M2702AU/ M270203AU. For
example, to add a system interface upgrade, order M2702AU Option
J70.
Upgrade Options
Option
Option Adds
Number
B71
Noninvasive Blood Pressure, no supplies included
B72
Pulse oximetry (SpO2), no supplies included
B73
Connector cover for NBP and SpO2 connectors
C71
NST Report Capability
C73
Triplets monitoring capability
CL2
Support for cableless maternal measurements
(IntelliVue CL NBP and CL SpO2). Not available with
E25
Upgrade Options
Option
Option Adds
Number
J13
Dual MIB/RS232 Interface for Data Export
functionality, and for maternal infrared temperature
measurement
J22
Dual PS/2 Interface for connecting a keyboard and
mouse
J25
Quad. USB Interface (Keyboard, Mouse, Bar Code
Reader)
J30
Flexible Nurse Call Relay Interface
J70
System Interface: 1 x RS232 port and 1 x LAN port
K30
Avalon CTS Interface Cable M2731-60001
SJ3
Rel. J.3 Software Upgrade
option E25.
Battery upgrade for monitors with Rev. G software or
higher
17
18
19
Philips Healthcare is part of
Royal Philips
How to reach us
www.philips.com/healthcare
[email protected]
fax: +31 40 27 64 887
0366
Avalon FM20/M2702A and FM30/M2703A
comply with the requirements of the
Council Directive 93/42/EEC of 14 June
1993 (Medical Device Directive).
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)
Please visit www.philips.com/
© 2014 Koninklijke Philips 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 99821 * APR 2014

Avalon FM20/FM30 Fetal/Maternal Monitor

Transcription

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