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HEARTSTART XL DEFIBRILLATOR/MONITOR
Model: M4735A
PRODUCT DESCRIPTION
Philips Medical Systems’ M4735A HeartStart XL offers
advanced and basic life-support clinicians a compact,
lightweight, easy-to-use defibrillator/monitor with both
Manual and AED capabilities. HeartStart XL features
Philips’ patented SMART Biphasic waveform, ECG
monitoring, synchronized cardioversion, and optional noninvasive pacing and SpO
A biphasic waveform is energy delivered in two phases.
During the first phase, the electrical current passes
through the heart muscle, reverses direction, and then
passes through the heart a second time. This efficient
transmission of energy requires less current than that
delivered by a monophasic waveform.
Manual Mode operation is as easy as 1-2-3:
1 - Select an energy level from 2 to 200 Joules.
2 - Charge the unit.
3 - Deliver the shock.
The HeartStart XL charges to its highest energy level in
less than 3 seconds. ALS providers can also perform
synchronized cardioversion and deliver non-invasive pacing
therapy.
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In AED Mode, the Hear tStart XL meets the needs of BLS
users by offering a range of functions from basic AED to
AED with monitoring. BLS clinicians will find these intuitive
AED features supported by straightforward voice prompts
and displayed text messages.
The HeartStart XL records a patient summary in either
mode of operation. Patient data such as continuous ECG,
shocks and alarm violations are stored in the unit's internal
memory. Downloading and reporting data is available by
using a data card. The Event Review Pro data management
system allows authorized users to edit, store, and print
reports.
The HeartStart XL is designed to meet a wide variety of
resuscitation and monitoring needs in one lightweight,
easy-to-use device.
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Features
Standard Features
Ordering Option Information
SMART Biphasic waveform for defibrillation therapy
ECG monitoring through pads and separate monitoring
electrodes
Alarms on HR limits and shockable rhythms
Synchronized cardioversion
Manual and AED operation
Built-in 50 mm strip char t printer
Bright Liquid Crystal Display (LCD) display for viewing
waveforms and messages
Internally stored event summary which may be printed
Voice prompts in AED mode
Adjustable ECG size
Adjustable volume
Setup mode, automatic self-tests and error handling
Integrated AC power
Optional Features
SpO
Non-invasive pacing (using a monophasic truncated
5-lead ECG monitoring cable, AAMI or IEC labeling
/Pulse Oximetry with alarms
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exponential current waveform)
Standard Accessories
Sealed Lead Acid Battery
0B3 Service Manual
OBP User Training Video
C01 SpO
C02 Non-invasive Pacing
C03 12-pin, 5 lead ECG Cable
C05 User Training CD-ROM
C07 Hands-free cable M3507A (barrel connector) and
C08 Hands-free cable (M3508A - flat connector) and
C10 Data Card
C13 External paddles with Paddle Contact Indicator
C24 External Sterilizable Paddles
J03 12-pin Sync Cable
W18 Extends 1-year CE On-site to 2-Year CE On-site
W19 Extends 1-year CE On-site to 3-Year CE On-site
W20 Extends 1-year CE On-Site to 5-Year CE On-site
WA0 Provides a 5-year unit exchange warranty (U.S./
WA1 Converts standard warranty to a 5-year BioMed
Monitoring with adult reusable transducer
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Text Load (M1781A - barrel connector)
Test Load (M3725A - flat connector) - Default
option
Warranty
Warranty
Warranty
Canada only)
Warranty (U.S. only)
Hands-Free Multifunction Defib Electrode Cable
ECG Patient Cable (3 lead)
Disposable Monitoring Electrodes (5)
Rolls of printer paper (2)
Instructions for Use
Quick Reference Card
User Training Workbook
Te s t L o a d
AC Power Cord
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Upgrades/Supplies/Accessories
Upgrades
M4738A Pacing Upgrade
M4739A SpO
External Paddles
M4745A Sterilizable External Paddles
M4746A External Paddles with PCI
Upgrade
2
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Internal Paddles
M1741A 7.5 cm Switchless
M1742A 6.0 cm Switchless
M1743A 4.5 cm Switchless
M1744A 2.8 cm Switchless
M4741A 7.5 cm Switched
M4742A 6.0 cm Switched
M4743A 4.5 cm Switched
M4744A 2.8 cm Switched
M4740A Internal Paddles Adapter Cable
Pads/Electrodes
M3713A HeartStart Multifunction Adult Plus
M3716A HeartStart Multifunction Adult Radiolucent
M3717A HeartStart Multifunction Pediatric Plus
M3718A HeartStart Multifunction Adult Radiotransparent/
Reduced Skin Irritation
M3719A HeartStart Multifunction Pediatric
Radiotransparent/Reduced Skin Irritation
M3501A Multifunction Defib Adult Electrode, AAMI
M3502A Multifunction Defib Adult Electrode, IEC
M3503A Multifunction Defib Pediatric Electrode, IEC
M3504A Multifunction Defib Pediatric Electrode, AAMI
DP2 HeartStart AED Defibrillation Pads (2 pack)
DP6 HeartStart AED Defibrillation Pads (6 pack)
ECG Cables
M1500A 3-Lead ECG Trunk Cable (AAMI)
M1663A 10-Lead Trunk Cable
M1668A 5-Lead Trunk Cable
M1669A 3-Lead Trunk Cable
M1949A 10-Lead Trunk Cable
M1605A 3-Lead ECG Patient Cable with Snaps (AAMI)
M1671A 3-Lead ICU Grabber (AAMI)
M1672A 3-Lead ICU Grabber (IEC)
M1673A 3-Lead ICU Snap (AAMI)
M1674A 3-Lead ICU Snap (IEC)
M1675A 3-Lead OR Grabber (AAMI)
M1678A 3-Lead OR Grabber (IEC)
M1510A 3-Lead ECG Trunk Cable (IEC)
M1615A 3-Lead ECG Patient Cable with Snaps (IEC)
M1520A 5-Lead ECG Trunk Cable (AAMI)
M1625A 5-Lead ECG Patient Cable with Snaps (AAMI)
M1530A 5-Lead ECG Trunk Cable (IEC)
M1635A 5-Lead ECG Patient Cable with Snaps (IEC)
M1968A 5-Lead ICU Grabber (AAMI)
M1644A 5-Lead ICU Snap (AAMI)
M1973A 5-Lead OR Grabber (AAMI)
M1971A 5-Lead ICU Grabber (IEC)
M1645A 5-Lead ICU Snap (IEC)
M1974A 5-Lead OR Grabber (IEC)
Pads/Paddle Cables
M3507A Multifunction Defib Pads Connector Cable
M3508A HeartStart Pads Connector Cable
05-10200 Pads Adapter (use with M3507A)
M4748A Adapter Extension Cable
ECG Monitoring Electrodes
M2202A High Tack Foam ECG Electrode 5 electrodes/
pouch (300 electrodes/case)
Sync Cables
M1783A 12-pin Sync Cable
SpO2 Sensors/Cables
M1191A Adult Reusable SpO
M1192A Pediatric Reusable SpO
M1194A Adult/Pediatric Ear Clip, Reusable SpO
M1941A 2-meter extension cable
M1943A Nellcor SpO
M1131A Disposable SpO
M1903B Disposable SpO
(Available outside the U.S. only)
M1904B Disposable SpO
(Available outside the U.S. only)
2
Sensor
2
Sensor
2
Sensor Adapter Cable
Sensor - Adult/Pediatric
2
Sensor - Pediatric Finger
2
Sensor - Adult Finger
2
Sensor
2
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Miscellaneous
M4751A Accessory Pouch
M1781A Test Load for use with M3507A
M3725A Test Load for use with M3508A
989803147711 Data Card
M3516A HeartStart Sealed Lead Acid Battery
453564045111 User Training CD-ROM
M4747A Battery Charger Kit
40457C 1 box 50 mm Strip Chart Thermal Paper
(10 rolls/box)
40457D 1 box 50 mm Strip Chart Thermal Paper
(80 rolls/box)
989803135291 Cadex C7200 Battery Charger (holds 2 XL
batteries)
989803135321 Cadex C7400 Battery Charger (holds 4 XL
batteries)
989803135341 Cadex C7400 Battery Charger (holds 2 XL and 2
MRx batteries)
Delivered Energy Accuracy:
Selected
Energy
5J 4.7 5.0 5.2 5.4 5.2 ±2J
10J 9.3 10 10.4 10.7 10.4 ±2J
20J 18.6 20 20.8 21.4 20.8 ±4J
30J 27.9 30 31.2 32.1 31.2 ±4J
50J 46.7 50 52.3 53.5 52.1 ±15%
70J 65.4 70 73.1 75.0 72.9 ±15%
100J 93.5 100 104.7 107.2 104.4 ±15%
150J 140.3 150 156.8 161.0 156.5 ±15%
200J 187 200 209.3 214.6 208.6 ±15%
Delivered Energy (J) Accuracy
Load Impedance (Ohms)
25 50 100 125 150
Charge Time: Less than 3 seconds to 200 Joules with a new, fully
charged M3516A SLA battery pack at 25ºC. Less than 15 seconds
to 200 Joules when powered by AC with no battery installed.
Patient Impedance Range:
Minimum: 10-25 Ohm, depending upon energy level
Specifications
General
Dimensions: 19.0 cm (H) x 37.6 cm (W) x 34.6 cm (L)
(7.5 in. x 14.8 in. x 13.7 in.)
Weight: 6.0 kg (13.3 lbs.) including battery and full roll of paper.
Defibrillator
Waveform: Biphasic Truncated Exponential. Waveform
parameters adjusted as a function of patient impedance.
Shock Delivery: Via multifunction defib electrode pads or paddles.
Maximum: 180 Ohm
Manual Mode
Manual Output Energy (Delivered): 2, 3, 5, 7, 10, 20, 30, 50, 70,
100, 150, 200 Joules. Energy limited to 50 Joules for internal
defibrillation.
Controls: Manual/AED On/Energy Select knob, Charge/Disarm,
Shock, ECG Lead Select, SpO
Sync On/Off, Pacer, Pacer Start/Stop, Pacer Rate, Pacer Current,
Pacer Mode, ECG Gain, Volume, Strip, Summary Mark.
Indicators: LCD display for ECG waveforms and text prompts,
Audio alerts, QRS Beeper, Charging tones (for sync and
asychronous modes), AC Power LED, Batter y Charging LED, Sync
LED, Pacer LED.
Armed Indicators: Charge Done tone and available energy
indicated on display.
Energy Selection: Front panel rotary knob.
Charge Control: Front panel “2” key or buttons on paddles.
Shock Control: Front panel “3” key or buttons on paddles.
Synchronizer: SYNC message appears on the monitor and is
annotated on the printer (if printing while in Sync mode). An
audible beep sounds with each detected R-wave while a tick mark
on the monitor and printed strip indicate the discharge points.
On/Off, SpO2 Alarm, HR Alarm,
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Synchronizer delay is less than 60 msec from peak R-wave to peak
current of the defibrillation discharge.
Heart Rate Alarms: Configurable pairs of low and high heart rate
alarm limits: 30 to 100, 60 to 140, 90 to 160 and 120 to 200 bpm.
AED Mode
AED Energy Profile: Fixed energy (150 Joules).
AED Shock Series: 1, 2, 3, 4 shocks per series.
Shock Series Timer: off, 30, 60, 90, 120, 150, 180, or 210 seconds.
Text and Voice Prompts: Extensive text/audible messages guide
user through protocol.
AED Controls: On, Off, Pause/Resume, Analyze/Stop Analysis,
Shock, Lead Select, SpO
Gain, Volume, Strip, Summary Mark.
Indicators: LCD display for ECG waveforms and text prompts,
Audio alerts, voice prompts, QRS Beeper, Charging tones, Charge
Done Tone, Printer, AC Power LED, Battery Charging LED.
Armed Indicators: Charge Done tone, available energy indicated
on display; Voice Message.
Patient Analysis: Per protocol, evaluates patient ECG and signal
quality to determine if a shock is appropriate and evaluates
connection impedance for proper defibrillation pad contact.
Shockable Rhythms: Ventricular fibrillation with amplitude greater
than 100 uV and wide complex ventricular tachycardia with rates
greater than 150 bpm.
On/Off, SpO2 Alarms, HR Alarms, ECG
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Hands Free Defibrillation Cable Length: 7 ft. (2.13 m).
ECG Cable Length: 12 ft. (3.7 m).
Common Mode Rejection: Greater than 90 dB measured per
AAMI standard for cardiac monitors (EC 13).
ECG Size: 2.5, 5, 10, 20, 40 mm/mV.
Frequency Response:
AC Line Filter: 60 Hz or 50 Hz.
Pads ECG for Display: Monitor (.15-40 Hz) or EMS (1-30 Hz).
Pads ECG for Printer : Monitor (.15-40 Hz) or EMS (1-30 Hz).
Leads ECG for Display: Monitor (.15-40 Hz) or EMS (1-30 Hz).
Leads ECG for Printer : Diagnostic (.05-150 Hz) or EMS (1-30 Hz)
or Monitor (.15-40 Hz).
Patient Isolation (defibrillation proof):
ECG: Type CF
SpO
: Type CF
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Defib: Type BF
Display
Type: LCD - TFT Color Liquid Cr ystal Display.
Size: 111.4 mm x 83.5 mm.
Sensitivity and Specificity: Meets AAMI guidelines.
ECG Monitoring
Inputs: Single channel ECG may be viewed on display and printed.
Pads ECG is obtained through 2 multifunction defibrillation
electrode pads. Lead I, II, or III is obtained through the 3-lead ECG
cable and separate monitoring electrodes. With a 5-lead cable,
lead aVR, aVL, aVF, and any one of the V (1-6) leads can also be
obtained.
Lead Fault: LEADS OFF message and dashed line appear on the
display if an electrode or lead wire becomes disconnected.
Paddle Fault: NO PADDLES CONNECTED message and dashed
line appear on the display if paddles become disconnected.
Pad Fault: PADS OFF message and dashed line appear on the
display if the pads become disconnected.
Heart Rate Display: Digital readout on display from 15 to 300
bpm, with an accuracy of ±10%.
Resolution: 320 x 240 pixels.
Sweep Speed: 29 mm/s nominal (stationary trace; sweeping
erase bar).
Viewing Time: 4 seconds.
Battery
Type: 2 Ah, 12V, rechargeable, Sealed Lead Acid.
Dimensions: 2.4 in. (H) x 0.94 in. (W) x 7.2 in. (D) (61.7 mm x
23.9 mm x 182 mm).
Weight: 1.4 lbs. (0.65 kg)
Charge Time: Approximately 14.5 hours to 100%. Approximately
3 hours to 90%, indicated by LED on front panel.
Capacity: 100 minutes ECG monitoring or 50 full-energy
discharges or 75 minutes ECG monitoring while pacing (with a
new, fully charged battery at room temperature, 25º C).
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Battery Indicators: LOW BATTERY message appears on display
when at least 10 minutes of monitoring time and 5 maximum
energy discharges remain (with a new batter y at room
temperature, 25º C).
Noninvasive Pacing
Waveform: Monophasic Truncated Exponential
Battery Storage: Should not be stored above 40ºC for extended
periods of time.
Charger Output: Unit can be operated using only AC Power, with
no battery installed.
Thermal Array Printer
Continuous Real-Time Strip: User starts and stops the strip. The
strip prints the selected ECG lead with the following data:
Header 1: Date, Time, Heart Rate, the SpO
and the text “Delayed” if printing has been configured for Delayed
Mode. Prints every 12 seconds.
Header 2: Current mode (AED/Manual), Lead, Gain, filter setting,
the text “Sync” (if Sync has been enabled), and Pacer Settings
(consisting of the Pacer Mode, Rate and Current, if presently
pacing the patient). Prints every 12 seconds with Header 1.
Header 3: Changes in Mode, Gain, Lead, Sync, and Pacer Settings.
Footer: Drug Annotations, HR/SpO
Results of Analysis in AED Mode (No Shock Advised, Shock
Advised or Cannot Analyze), Charging to xxx J, Shock Delivered,
No Shock Delivered, Disarm, Battery Low.
Symbols: Mark Triangle (for presses of the Mark key), an Alarm
Bell (Alarm Limits Violations), Lightning Bolt (Shock Delivered;
followed by “b” for biphasic), Vertical Strip Boundaries/Pacer/Sync
Tick marks.
Event printing: Mark key automatically documents ECG and events
during defibrillation episodes. The Mark key can annotate the
event with one of the following labels: Epinephrine (Adrenaline in
U.K. and Australia), Atropine, Lidocaine and Other.
Auto Printing: The printer can be configured to automatically print
on Mark, Charge, Shock and Alarm.
Delayed Printing: The printer can be configured to run real time or
with a 6 second delay.
Reports: The following can be printed: Event Summary,
Configuration, Extended Self Test, System Log, Battery Capacity
Test, Shift/System Check.
Speed: 25 mm/s with an accuracy of ± 5%.
limits on a Limit Alarm, the
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Value (if available)
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Current Pulse Amplitude: 10 mA to 200 mA (5 mA resolution);
accuracy 10 mA to 50 mA ± 5 mA, 50 mA to 200 mA ± 10%.
Pulse Width: 20 ms with accuracy +0, -5 ms.
Rate: 30 ppm to 180 ppm (10 ppm increments); accuracy ± 1.5%.
Modes: Demand or Fixed Rate
Refractory Period: 340 msec (30 to 80 ppm); 240 msec (90 to
180 ppm).
SpO2 Pulse Oximetry
Accuracy with:
M1191A sensor - 1 standard deviation 70% to 100%, ± 2.5%
M1192A sensor - 1 standard deviation 70% to 100%, ± 2.5%
M1194A sensor - 1 standard deviation 70% to 100%, ± 4.0%
M1131A sensor - 1 standard deviation 70% to 100%, ± 3.0%
M1903B sensor - 1 standard deviation 70% to 100%, ± 3.0%
M1904B sensor - 1 standard deviation 70% to 100%, ± 3.0%
Pulse Rate Accuracy: 2% or 1 bpm (whichever is greater).
Wavelength Range: 500 to 1000 nm.
Emitted Light Energy: Less than or equal to 15 mW.
Display Update Interval: Less than or equal to 60 seconds.
Resolution: 1%.
SpO
Alarm Limits: Three preset low alarm limits: 90%, 85% and
2
80%.
INOP Alerts: Triggered by disconnected sensor, noisy signal, light
interference or low signal (non-pulsatile).
Event Storage
Internal Event Summary: The Internal Event Summar y stores up to
300 events and up to 50 waveforms.
Events can be marked with a Mark symbol and, if configured for
drug annotation, the following labels can be added: Epinephrine
(Adrenaline in U.K. and Australia), Atropine, Lidocaine or Other.
The Summary key on the front panel is used to print the internal
Event Summary.
Amplitude Accuracy: ± 10% or ± 50 uV, whichever is greater.
Paper Size: 50 mm by 30 m (100 ft.).
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Data Card Event Summary: The Data Card stores continuous
ECG waveforms and events on a Type II PCMCIA card.
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Environmental
Temperature: 0º C to 55ºC operating; -20º to 70ºC storage.
Charging the battery at temperatures above 35ºC may degrade
battery life.
Storing the battery for extended periods at temperatures above
40ºC will reduce battery capacity and degrade battery life.
Humidity: Up to 95% Relative Humidity
Printer paper may jam if paper is wet.
Thermal Printer may be damaged if wet paper is allowed to dry
while in contact with printer elements.
Altitude:
Operating: up to 15,000 ft.
Storage: up to 15,000 ft.
Shock: Philips Medical Systems, Section 760 Class B1 Drop Test
(200 G’s <3 msec pulse).
Vibration: Philips Medical Systems, Section 759 Class B1 Vibration.
Water Resistance: Meets IEC 60601-2-4, IPX 0.
EMC: Meets EN 60601-1-2
Safety: Meets IEC 60601-1 (EN 60601-1), UL 2601-1, CAN/CSA
C22.2 No. 601-1.
Other Considerations: Equipment not suitable for use in the
presence of a flammable anesthetic mixture with air, ox ygen o r
nitrous oxide.
Mode of Operation: Continuous.
AC Line Powered: 100-240 VAC, 50/60 Hz, 1.5A (Class 1)
Battery Powered: 12 V rechargeable, SLA
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Philips Medical Systems is part
of Royal Philips Electronics
On the web:
www.philips.com/heartstart
Via email:
medical@philips.com
Via fax:
+ 31 40 27 64 887
By postal service:
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1085
Asia:
Tel: + 852 2821 5888
EUROPE, MIDDLE EAST AND AFRICA:
Tel: +49 7031 463 2254
LATIN AMERICA:
Tel: +1 954 628 1000
NORTH AMERICA:
Tel: +1 800 934 7372
© Koninklijke Philips Electronics N.V. 2007
All rights are reserved. Reproduction in whole or in part is prohibited without the
prior written consent of the copyright holder.
Philips Electronics North America Corporation reserves the right to make changes
in specifications 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.
Published February, 2007
452296221401
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