LIFEPAK 15 monitor/defibrillator

Data sheet

Ease of use Durability

• More than 20 clearly labeled, • LIFEPAK TOUGH™
dedicated buttons • Dual-layer screen
• Front-facing cables, connectors, protector
and 100mm printer • Large, shock
absorbing handle
Clinical effectiveness
• 360J biphasic Reliability
• ST-segment trending • Upgradeable platform
• University of Glasgow 12-Lead • Daily, 3AM diagnostic
ECG Analysis Program self-test

Specifications

General User selectable display mode: full color or interference received, including interference that
SunVue™ display high contrast may cause undesired operation.
The LIFEPAK 15 monitor/defibrillator has six • Serial Port RS232 communication + 12V
Display: a minimum of 5 seconds of ECG and alpha-
main operating modes: available
numerics for values, device instructions, or prompts
AED mode: for automated ECG analysis and • Limited to devices drawing maximum
Display: up to three waveforms
a prompted treatment protocol for patients in 0.5 A current
cardiac arrest. Waveform display sweep speed: 25 mm/sec for
ECG, Sp02, IP, and 12.5 mm/sec for CO2 • Bluetooth® technology provides short-range
Manual mode: for performing manual defibrillation, wireless communication with other Bluetooth-
synchronized cardioversion, noninvasive pacing, and Data management enabled devices
ECG and vital sign monitoring.
Archive mode: for accessing stored patient The device captures and stores patient data, Monitor
information. events (including waveforms and annotations),
and continuous waveform and patient impedance ECG
Setup mode: for changing default settings of the
records in internal memory. ECG is monitored via several cable
operating functions.
The user can select and print reports, and arrangements:
Service mode: for authorized personnel to perform
transfer the stored information via supported A 3-wire cable is used for 3-lead ECG monitoring.
diagnostic tests and calibrations.
communication methods. A 5-wire cable is used for 7-lead ECG monitoring.
Demo mode: for simulated waveforms and trend
Report types: A 10-wire cable is used for 12-lead ECG acquisition.
graphs for demonstration purposes.
• Three format types of CODE SUMMARY™ When the chest electrodes are removed, the
Physical characteristics critical event record: short, medium, and long 10-wire cable functions as a 4-wire cable.
• 12-lead ECG with STEMI statements Standard paddles or QUIK-COMBO pacing/
Weight: • Continuous Waveform (transfer only)
• Basic monitor/defibrillator with new roll paper defibrillation/ECG electrodes are used for paddles
• Trend Summary lead monitoring.
and two batteries installed: 17.5 lb (7.9 kg) • Vital Sign Summary
• Fully featured monitor/defibrillator with new Frequency response:
• Snapshot
roll paper and two batteries installed: 18.5 lb • Monitor: 0.5 to 40 Hz or 1 to 30 Hz
Memory capacity: Total capacity is 360 minutes • Paddles: 2.5 to 30 Hz
(8.4 kg) of continuous ECG, 90 minutes of continuous data
Lithium-ion battery: ≤1.3 lb (0.6 kg) • 12-lead ECG diagnostic: 0.05 to 150 Hz
from all channels, or 400 single waveform events.
Accessory bags and shoulder strap: 3.9 lb (1.77 kg) Lead selection:
Maximum memory capacity for a single patient • Leads I, II, III, (3-wire ECG cable)
Standard (hard) paddles: 2.1 lb (0.95 kg) includes up to 200 single waveform reports and • Leads I, II, III, AVR, AVL, and AVF acquired
Height: 12.5 in (31.7 cm) 90 minutes of continuous ECG. simultaneously (4-wire ECG cable)
Width: 15.8 in (40.1 cm) • Leads I, II, III, AVR, AVL, AVF, and C lead
Communications
Depth: 9.1 in (23.1 cm) acquired simultaneously (5-wire ECG cable)
The device is capable of transferring data • Leads I, II, III, AVR, AVL, AVF, V1,V2,V3,V4,V5,
Display records by wired or wireless connection. This and V6 acquired simultaneously (10-wire
Size (active viewing area): 8.4 in (212 mm) device complies with Part 15 of the FCC rules, ECG cable)
diagonal; 6.7 in (171 mm) wide x 5.0 in (128 mm) high and its operation is subject to the following two ECG size: 4, 3, 2.5, 2, 1.5, 1, 0.5, 0.25 cm/mV
Resolution: display type 640 dot x 480 dot color conditions: (1) this device may not cause harmful (fixed at 1 cm/mV for 12-lead)
backlit LCD interference, and (2) this device must accept any
LIFEPAK 15 monitor/defibrillator

Specifications cont.

Heart rate display: Respiration rate range: 0 to 99 breaths/minute Delay: 8 seconds

• 20–300 bpm digital display Rise time: 190 msec Autoprint: Waveform events print automatically
• Accuracy: ±4% or ±3 bpm, whichever is greater Response time: 4.3 seconds (includes delay time Frequency response:
• QRS Detection Range Duration: 40 to 120 msec and rise time) • Diagnostic: 0.05 to 150 Hz or 0.05 to 40 Hz
• Amplitude: 0.5 to 5.0 m Initialization time: 30 seconds (typical), • Monitor: 0.67 to 40 Hz or 1 to 30 Hz
Common mode rejection (CMRR): ECG Leads: 10-180 seconds
90 dB at 50/60 Hz Defibrillator
Ambient pressure: automatically compensated
Sp0 2 /SpC0/SpMet internally Biphasic waveform: Biphasic Truncated
Sensors: Optional display: CO2 pressure waveform Exponential
• MASIMO® sensors including RAINBOW® sensors • Scale factors: Autoscale, 0–20 mmHg (0–4 Vol%), The following specifications apply from 25 to
• NELLCOR® sensors when used with the MASIMO 0–50 mmHg (0–7 Vol%), 0–100 mmHg (0–14 Vol%) 200 ohms, unless otherwise specified:
RED™ MNC adapter Invasive pressure Energy accuracy: ±1 joule or 10% of setting,
Sp0 2 whichever is greater, into 50 ohms, ±2 joules or 15%
Transducer type: Strain-gauge resistive bridge
of setting, whichever is greater, into 25-175 ohms.
Displayed saturation range: “<50” for levels below Transducer Sensitivity: 5µV/V/mmHg
Voltage compensation: Active when disposable
50%; 50 to 100% Excitation voltage: 5 Vdc therapy electrodes are attached. Energy output
Saturation accuracy: 70–100% (0–69% unspecified) Connector: Electro Shield: CXS 3102A 14S-6S within ±5% or ±1 joule, whichever is greater, of
Adults/pediatrics: Bandwidth: Digital filtered, DC to 30 Hz (< -3db) 50 ohms value, limited to the available energy which
±2 digits (during no motion conditions) Zero drift: 1 mmHg/hr without transducer drift results in the delivery of 360 joules into 50 ohms.
±3 digits (during motion conditions) Zero adjustment: ±150 mmHg including Paddle options: QUIK-COMBO® pacing/
Dynamic signal strength bar graph transducer offset defibrillation/ECG electrodes (standard). Cable
Pulse tone as Sp02 pulsations are detected Numeric accuracy: ±1 mmHg or 2% of reading, Length 8 foot long (2.4 m) QUIK-COMBO cable
Sp02 update averaging rate user selectable: whichever is greater, plus transducer error (not including electrode assembly).
4, 8, 12 or 16 seconds Pressure range: -30 to 300 mmHg, in six user Standard paddles (optional)
Sp02 sensitivity user selectable: Normal, High selectable ranges Manual mode
Sp02 measurement: Functional Sp02 values are Invasive pressure display Energy select: 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 50,
displayed and stored 70, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325,
Display: IP waveform and numerics
Pulse rate range: 25 to 240 bpm and 360 joules
Units: mmHg
Pulse rate accuracy (adults/pediatrics): Charge time: Charge time to 360 joules in less than
Labels: P1 or P2, ART, PA, CVP, ICP, LAP
±3 digits (during no motion conditions) (user selectable) 10 seconds, typical
±5 digits (during motion conditions) Synchronous cardioversion: Energy transfer
Temperature
Optional Sp02 waveform display with begins within 60 msec of the QRS peak
autogain control Range: 76.6° to 113.4°F (24.8° to 45.2°C) Paddles leads off sensing: When using
SpC0® Resolution: 0.1°C QUIK-COMBO electrodes, the device indicates
Accuracy: ±0.2°C including sensor Paddles Leads Off if the resistive part of the patient
SpC0 concentration display range: 0 to 40%
Reusable temperature cable: 5 foot or 10 foot impedance is greater than 300 ±15% ohms, or if the
SpC0 accuracy: ±3 digits
Disposable sensor types: Surface–Skin; magnitude of the patient impedance is greater than
SpMET® Esophageal/Rectal 440 ±15% ohms.
SpMet saturation range: 0 to 15.0% Trend AED Mode
SpMet display resolution: 0.1% up to 10% Shock Advisory System™ (SAS): an ECG analysis
Time scale: Auto, 30 minutes, 1, 2, 4, or 8 hours
SpMet accuracy: ±1 digit system that advises the operator if the algorithm
Duration: Up to 8 hours
NIBP ST segment: After initial 12-lead ECG analysis, detects a shockable or non-shockable ECG rhythm.
Blood pressure systolic pressure range: 30 to automatically selects and trends ECG lead with the SAS acquires ECG via therapy electrodes only.
255 mmHg greatest ST displacement Shock ready time: Using a fully charged battery
Diastolic pressure range: 15 to 220 mmHg Display choice of: HR, PR (SpO2), PR (NIBP), at normal room temperature, the device is ready to
SpO2 (%), SpCO (%), SpMet (%), CO2 (EtCO2 /FiCO2), shock within 20 seconds if the initial rhythm finding
Mean arterial pressure range: 20 to 235 mmHg
RR (CO2), NIBP, IP1, IP2, ST is “SHOCK ADVISED”
Units: mmHg
Biphasic output: Energy Shock levels ranging from
Blood pressure accuracy: ±5 mmHg Alarms 150–360 joules with same or greater energy level for
Blood pressure measurement time: 20 seconds, each successive shock
typical (excluding cuff inflation time) Quick set: Activates alarms for all active vital signs
cprMAX™ Technology: In AED mode, cprMAX™
Pulse rate range: 30 to 240 pulses per minute VF/VT alarm: Activates continuous (CPSS)
technology provides a method of maximizing the
Pulse rate accuracy: ±2 pulses per minute or ±2%, monitoring in Manual mode
CPR time that a patient receives, with the overall
whichever is greater No breath alarm: Occurs when 30 seconds has goal of improving the rate of survival of patients
Operation features initial cuff pressure: User elapsed since last detected respiration treated with AEDs.
selectable, 80 to 180 mmHg Heart rate alarm limit range: Upper, 100–250 Setup options:
Automatic measurement time interval: User bpm; lower, 30–150 bpm • Auto Analyze: Allows for auto analysis. Options
selectable, from 2 min to 60 min Interpretive algorithm are OFF, AFTER 1ST SHOCK
Automatic cuff deflation excessive pressure: • Initial CPR: Allows the user to be prompted for
If cuff pressure exceeds 290 mmHg 12-Lead interpretive algorithm: University of CPR for a period of time prior to other activity.
Excessive time: If measurement time exceeds Glasgow 12-Lead ECG Analysis Program, includes Options are OFF, ANALYZE FIRST, CPR FIRST
120 seconds AMI and STEMI statements • Initial CPR Time: Time interval for Initial CPR.
Options are 15, 30, 45, 60, 90, 120, and
CO 2 Printer 180 seconds.
CO2 range: 0 to 99 mmHg (0 to 13.2 kPa) Prints continuous strip of the displayed patient • Pre-Shock CPR: Allows the user to be prompted
Units: mmHg, %, or kPa information and reports for CPR while the device is charging. Options are
Respiration rate accuracy: Paper size: 3.9 in (100 mm) OFF, 15, 30 seconds.
• 0 to 70 bpm: ±1 bpm Print speed: 25 mm/sec or 12.5 mm/sec • Pulse Check: Allows the user to be prompted
• 71 to 99 bpm: ±2 bpm • Optional: 50 mm/sec time base for 12-lead for a pulse check at various times. Options are
ECG reports ALWAYS, AFTER EVERY SECOND NSA, AFTER
EVERY NSA, NEVER
 • Stacked Shocks: Allows for CPR after 3 Chemical resistance: 60 hour exposure to specified
consecutive shocks or after a single shock. chemicals: Betadine (10% Povidone-Iodine solution),
Options are OFF, ON Coffee, Cola, Dextrose (5% Glucose solution),
• CPR Time: 1 or 2 User selectable times for CPR. Electrode Gel/Paste (98% water, 2% Carbopol 940),
Options are 15, 30, 45, 60, 90, 120, 180 seconds HCL (0.5% solution, pH=1), Isopropyl Alcohol, NaCl
and 30 minutes. solution (0.9% solution), Cosmetic discoloration of the
paddle well shorting bar shall be allowed following
Pacer exposure to HCL (0.5% solution).
Pacing mode: Demand or non-demand rate and
Power
current defaults
Pacing rate: 40 to 170 PPM Power adapters: AC or DC
Rate accuracy: ±1.5% over entire range Power Adapters provide operation and battery
Output waveform: Monophasic, truncated charging from external AC or DC power
exponential current pulse (20 ± 1 ms) • Full functionality with or without batteries when
Output current: 0 to 200 mA connected to external AC/DC
• Typical battery charge time while installed in
Pause: Pacing pulse frequency reduced by a factor
LIFEPAK 15 device is 190 minutes
of 4 when activated
• Indicators: external power indicator, battery
Refractory period: 180 to 270 msec (function charging indicator
of rate)
Dual battery: Capability with automatic switching
Environmental Low battery indication and message: Low battery
fuel gauge indication and low battery message in
Unit meets functional requirements during status area for each battery
exposure to the following environments unless
Replace battery indication and message: Replace
otherwise stated.
battery fuel gauge indication, audio tones and replace
Operating temperature: 32° to 113°F (0° to battery message in the status area for each battery.
45°C); -4°F (-20°C) for 1 hour after storage at room When replace battery is indicated, device auto-
temperature; 140°F (60°C) for 1 hour after storage switches to second battery. When both batteries
at room temperature reach replace battery condition, a voice prompt
Storage temperature: -4° to 149°F (-20° to 65°C) instructs user to replace battery.
except therapy electrodes and batteries
Relative humidity, operating: 5 to 95%, non- Battery capacity
condensing. NIBP: 15 to 95%, non-condensing For two, new fully-charged batteries, 68°F (20°C)
Relative humidity, storage: 10 to 95%,
non-condensing Operating Monitoring Pacing Defibrillation
mode (minutes) (minutes) (360J discharges)
Atmospheric pressure, operating: -1,253 to
15,000 ft (-382 to 4,572 m). NIBP: -500 to 10,000 ft Total Typical 360 340 420
(-152 to 3,048 m) capacity
Water resistance, operating: IP44 (dust and to shutdown Minimum 340 320 400

splash resistance) per IEC 529 and EN 1789 (without Capacity Typical 21 20 30
accessories except for 12-lead ECG cable, hard after low
paddles, and battery pack) battery Minimum 12 10 6
Vibration: MIL-STD-810E Method 514.4, Propeller
Aircraft - category 4 (figure 514.4-7 spectrum a),
Helicopter - category 6 (3.75 Grms), Ground Mobile - Battery
category 8 (3.14 Grms), EN 1789: Sinusoidal Sweep, 1 Battery specifications
octave/min, 10-150 Hz, ±0.15 mm/2 g Battery type: Lithium-ion
Shock (drop): 5 drops on each side from 18 inches Weight: ≤1.3 lb (0.6 kg)
onto a steel surface EN 1789: 30-inch drop onto each
Charge time (with fully depleted battery):
of 6 surfaces
< 190 minutes (typical)
Shock (functional): Meets IEC 60068-2-27 and MIL-
Battery indicators: Each battery has a fuel gauge
STD-810E shock requirements 3 shocks per face at 40
that indicates its approximate charge. A fuel gauge
g, 6 ms half-sine pulses
that shows two or fewer LEDs after a charge cycle
Bump: 1000 bumps at 15 g with pulse duration of indicates that the battery should be replaced.
6 msec
Charging temperature range: 41° to 113°F
Impact, non-operating: EN 60601-1 0.5 + 0.05 (5° to 45°C)
joule impact UL 60601-1 6.78 Nm impact with 2-inch
Operating temperature range: 32° to 113°F
diameter steel ball. Meets IEC62262 protection level
(0° to 45°C)
IK 04.
Short term (<1 week) storage temperature range:
EMC: EN 60601-1-2:2006 Medical Equipment
-4° to 140°F (-20° to 60°C)
-General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility - Long term (>1 week) storage temperature range:
Requirements and Tests EN 60601-2-4:2003: 68° to 77°F (20° to 25°C)
(Clause 36) Particular Requirements for the Operating and storage humidity range:
Safety of Cardiac Defibrillators and Cardiac 5 to 95% relative humidity, non-condensing
Defibrillator-Monitors
Cleaning: Cleaning 20 times with the following:
Quaternary ammonium, isopropyl alcohol,
hydrogen peroxide
LIFEPAK 15 monitor/defibrillator

BRIEF SUMMARY OF INDICATIONS AND IMPORTANT SAFETY INFORMATION

LIFEPAK 15 is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols.
INTENDED USE: LIFEPAK 15 intended for use by trained medical personnel out-of-doors, in indoor emergency care settings, and is designed to be used for ground
transportation. Monitoring and therapy functions may only be used on one patient at a time. Manual mode monitoring and therapy functions are intended for use on adult and
pediatric patients. Automated external defibrillation (AED) mode intended for use on patients ≥ 8 years of age.
INDICATIONS FOR USE – MANUAL DEFIBRILLATION: Indicated for termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic
ventricular tachycardia. Delivery of energy in synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in
relatively stable patients, ventricular tachycardia.
CONTRAINDICATIONS - MANUAL DEFIBRILLATION: Contraindicated in treatment of PEA and asystole. AED MODE: To be used only on patients in cardiopulmonary
arrest. Patient must be unconscious, pulseless, and not breathing normally before using defibrillator to analyze patient’s ECG rhythm. In AED mode, the LIFEPAK 15 is
intended for use on pediatric patients ≥ 8 years of age.
CONTRAINDICATIONS - AED MODE: None known.
INDICATIONS FOR USE – MONITORING. AQUIRING 12-LEAD ECG: 12-lead electrocardiogram used to identify, diagnose, and treat patients with cardiac disorders and is
useful in early detection and prompt treatment of patients with STEMI.
MONITORING SPO2, SPCO, AND SPMET: Pulse oximetry indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or
methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies
have not been validated under motion or low perfusion conditions.
MONITORING NONINVASIVE BLOOD PRESSURE: Intended for detection of hypertension or hypotension and monitoring blood pressure trends in patient conditions. NIBP
monitoring not indicated for neonatal patients <1-month-old.
MONITORING ETCO2: Used to detect trends in level of expired CO2, used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care
MONITORING INVASIVE PRESSURE: Indicated for use in patients who require continuous monitoring of physiological pressures to rapidly assess changes in patient’s
condition or response to therapy. May also be used to aid diagnosis
MONITORING CONTINUOUS TEMPERATURE: Indicated for use in patients who require continuous monitoring of body temperature.
MONITORING CONTRAINDICATIONS: None known
Operating Instructions provide important information to help you operate LIFEPAK 15. Become familiar with all terms and warnings. GENERAL DANGER:
Explosion hazard
GENERAL/THERAPY/MANUAL DEFIBRILLATION WARNINGS and CAUTION: Shock or fire hazards • Possible patient skin burns and ineffective energy delivery •
Possible device failure, damage, inability to deliver therapy, shutdown, loss of power during patient care, improper device performance • Possible electrical interference with
device performance or with other equipment • Safety risk • Failure to detect change in ECG rhythm • Possible failure to detect out of range condition • Possible interference
with implanted electrical device • Possible paddle damage • Possible incorrect energy delivery
CPR METRONOME WARNING: CPR delivered when not needed
SYNCHRONIZED CARDIOVERSION WARNING: Possible lethal arrhythmia
NONINVASIVE PACING WARNING: Possible inability to pace, interruption of therapy, ineffective pacing, and patient skin burns
PEDIATRIC ECG MONITORING AND MANUAL MODE THERAPY: Possible patient skin burns
AED WARNINGS: Possible misinterpretation of data or ECG misinterpretation • Pediatric patient safety risk
ECG MONITORING WARNING: Possible misinterpretation of ECG data
12-LEAD ECG WARNINGS: Possible inability to obtain diagnostic quality 12-lead ECG or inaccurate diagnosis • Possible incorrect treatment with reperfusion therapy
SPO2, SPCO, AND SPMET WARNINGS AND CAUTION: Shock or burn hazard • Inaccurate pulse oximeter readings • Possible skin injury • Possible strangulation •
Inaccurate SPO2, SPCO and/or SPMET readings • Possible equipment damage
NIBP MONITORING WARNINGS AND CAUTION: Possible loss of IV access and inaccurate infusion rate, circulation impairment or inaccurate blood pressure or oxygen
saturation readings • Possible patient harm • Equipment damage
ETCO2 MONITORING WARNINGS AND CAUTION: Fire hazard • Possible inaccurate patient assessment or inaccurate CO2 readings • Possible strangulation • Infection
hazard • Possible equipment damage
IP MONITORING WARNINGS: Possible inaccurate pressure readings, air embolism, blood loss or loss of sterility • Possible patient injury or equipment damage • Possible
lethal arrhythmia • Increased intracranial pressure
TEMPERATURE MONITORING WARNINGS: Possible inaccurate temperature readings • Infection hazard • Possible strangulation
VITAL SIGN/ST SEGMENT TRENDS WARNING: Inaccurate interpretation of patient status
U.S. Federal law restricts this device to sale by or on the order of a physician.
Please consult Operating Instructions at www.strykeremergencycare.com or call 800.442.1142 for complete list of indications, contraindications, warnings, cautions, potential
adverse events, safety and effectiveness data, instructions for use and other important information.

For further information, please contact Stryker at 800 442 1142 (U.S.), 800 668 8323 (Canada) or visit our website at
strykeremergencycare.com

Emergency Care
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