ECG Salient Characteristic List.docx

12-Lead EKG Monitor Salient Characteristic List

Monitor & Defib

· Due to our remote location and no medical aid facility on installation, the 12-Lead EKG Monitor MUST be compatible with the Emergency Care Facilities off Installation as well as Mutual Aid EMS Agencies for Patient continuity.

· GENERAL. AED Mode: for automated ECG analysis and a prompted treatment protocol for patients in cardiac arrest.

· Manual Mode: for performing manual defibrillation, synchronized cardioversion, noninvasive pacing, and ECG and vital sign monitoring.

· Archive Mode: for accessing stored patient information.

· Setup Mode: for changing default settings of the operating functions.

· Service Mode: for authorized personnel to perform diagnostic tests and calibrations.

· Demo Mode: for simulated waveforms and trend graphs for demonstration purposes.

· PHYSICAL CHARACTERISTICS. Weight: Basic monitor/defibrillator with new roll paper and two batteries installed: 8.6 kg (18.9 lb.) Fully featured monitor/defibrillator with new roll paper and two batteries installed: 9.1 kg (20.1 lb.)

· Lithium-ion battery: 0.59 kg (1.3 lb.)

· Accessory Bags and Shoulder Strap: 1.77 kg (3.9 lb.)

· Standard (hard) Paddles: 0.95 kg (2.1 lb.)

· Height: 31.7 cm (12.5 in)

· Width: 40.1 cm (15.8 in)

· Depth: 23.1 cm (9.1 in)

· DISPLAY. Size (active viewing area): 212 mm (8.4 in) diagonal; 171 mm (6.7 in) wide x 128 mm (5.0 in) high

· Resolution: display type 640 dot x 480 dot color backlit LCD

· User Selectable Display Mode: full color or SunVue™ display high contrast

· Display: a minimum of 5 seconds of ECG and alphanumerics for values, device instructions, or prompts

· Display: up to three waveforms

· Waveform Display Sweep Speed: 25 mm/sec for ECG, Sp02, IP, and 12.5 mm/sec for CO2

· DATA MANAGEMENT. Report Types:

· – Three format types of summaries critical event record: short, medium, and long

· – 12-lead ECG with STEMI statements

· – Continuous Waveform (transfer only)

· – Trend Summary

· – Vital Sign Summary

· – Snapshot

· Memory Capacity: Total capacity is 360 minutes of continuous ECG, 90 minutes of continuous data from all channels, or 400 single waveform events.

· Maximum memory capacity for a single patient includes up to 200 single waveform reports and 90 minutes of continuous ECG.

· COMMUNICATIONS. The device MUST be capable of transferring data records by wired or wireless connection. This device will comply with Part 15 of the FCC rules, and its operation is subject to the following two conditions: (1) the device may not cause harmful interference, and (2) the device must accept any interference received, including interference that may cause undesired operation.

· Serial Port RS232 communication + 12V available

· Limited to devices drawing maximum 0.5 A current

· Bluetooth® technology provides short-range wireless communication with other Bluetooth-enabled devices

· MONITOR. A 3-wire cable is used for 3-lead ECG monitoring.

· A 5-wire cable is used for 7-lead ECG monitoring.

· A 10-wire cable is used for 12-lead ECG acquisition. When the chest electrodes are removed, the 10-wire cable functions as a 4-wire cable.

· Standard paddles or QUIK-COMBO pacing/defibrillation/ECG electrodes are used for paddles lead monitoring.

· Frequency Response: Monitor: 0.5 to 40 Hz or 1 to 30 Hz Paddles: 2.5 to 30 Hz 12-lead ECG diagnostic: 0.05 to 150 Hz

· Lead Selection: Leads I, II, III, (3-wire ECG cable) Leads I, II, III, AVR, AVL, and AVF acquired simultaneously (4-wire ECG cable) Leads I, II, III, AVR, AVL, AVF, and C lead acquired simultaneously (5-wire ECG cable) Leads I, II, III, AVR, AVL, AVF, V1,V2,V3,V4,V5, and V6 acquired simultaneously (10-wire ECG cable)

· ECG size: 4, 3, 2.5, 2, 1.5, 1, 0.5, 0.25 cm/mV (fixed at 1 cm/mV for 12-lead)

· Heart Rate Display: 20–300 bpm digital display Accuracy: ±4% or ±3 bpm, whichever is greater QRS Detection Range Duration: 40 to 120 milliseconds Amplitude: 0.5 to 5.0 m

· Common Mode Rejection (CMRR): ECG Leads: 90 dB at 50/60 Hz

· SpO2. Sp02 Displayed Saturation Range: “<50” for levels below 50%; 50 to 100%

· Saturation Accuracy: 70–100% (0–69% unspecified)

· Adults/Pediatrics: ±2 digits (during no motion conditions) ±3 digits (during motion conditions)

· Dynamic signal strength bar graph

· Pulse tone as Sp02 pulsations are detected

· Sp02 Update Averaging Rate User selectable: 4, 8, 12 or 16 seconds

· Sp02 Sensitivity User selectable: Normal, High

· Sp02 Measurement: Functional Sp02 values are displayed and stored

· Pulse Rate Range: 25 to 240 bpm

· Pulse Rate Accuracy (Adults/Pediatrics): ±3 digits (during no motion conditions) ±5 digits (during motion conditions)

· Optional Sp02 waveform display with autogain control

· SpCO. SpC0 Concentration Display Range: 0 to 40%

· SpC0 Accuracy: ±3 digits

· SpMET. SpMet Saturation Range: 0 to 15.0%

· SpMet Display Resolution: 0.1% up to 10%

· SpMet Accuracy: ±1 digit

· NIBP. Blood Pressure Systolic Pressure Range: 30 to 255 mmHg

· Diastolic Pressure Range: 15 to 220 mmHg

· Mean Arterial Pressure Range: 20 to 235 mmHg

· Units: mmHg Blood Pressure Accuracy: ±5 mmHg

· Blood Pressure Measurement Time: 20 seconds, typical (excluding cuff inflation time)

· Pulse Rate Range: 30 to 240 pulses per minute

· Pulse Rate Accuracy: ±2 pulses per minute or ±2%, whichever is greater

· Operation Features Initial Cuff Pressure: User selectable, 80 to 180 mmHg

· Automatic Measurement Time Interval: User selectable

· Automatic Cuff Deflation Excessive Pressure: If cuff pressure exceeds 290 mmHg

· Excessive Time: If measurement time exceeds 120 seconds

· CO2. CO2 Range: 0 to 99 mmHg (0 to 13.2 kPa) Units: mmHg, %, or kPa

· Respiration Rate Accuracy: 0 to 70 bpm: ±1 bpm 71 to 99 bpm: ±2 bpm

· Respiration Rate Range: 0 to 99 breaths/minute Rise Time: 190 milliseconds

· Response Time: 3.3 seconds (includes delay time and rise time)

· Initialization Time: 30 seconds (typical), 10-180 seconds

· Ambient Pressure: automatically compensated internally

· Optional Display: CO2 pressure waveform

· Scale factors: Autoscale, 0–20 mmHg (0–4 Vol%), 0–50 mmHg (0–7 Vol%), 0–100 mmHg (0–14 Vol%)

· INVASIVE PRESSURE. Transducer Type: Strain-gauge resistive bridge

· Transducer Sensitivity: 5µV/V/mmHg

· Excitation Voltage: 5 Vdc

· Connector: Electro Shield: CXS 3102A 14S-6S

· Bandwidth: Digital filtered, DC to 30 Hz (< -3db)

· Zero Drift: 1 mmHg/hr without transducer drift

· Zero Adjustment: ±150 mmHg including transducer offset

· Numeric Accuracy: ±1 mmHg or 2% of reading, whichever is greater, plus transducer error

· Pressure Range: -30 to 300 mmHg, in six user selectable ranges

· INVASIVE PRESSURE DISPLAY. Display: IP waveform and numerics

· Units: mmHg

· Labels: P1 or P2, ART, PA, CVP, ICP, LAP (user selectable)

· TEMPERATURE. Range: 24.8° to 45.2°C (76.6° to 113.4°F)

· Resolution: 0.1°C

· Accuracy: ±0.2°C including sensor

· Reusable Temperature Cable: 5 foot or 10 foot

· Disposable Sensor Types: Surface–Skin; Esophageal/Rectal

· TREND. Time Scale: Auto, 30 minutes, 1, 2, 4, or 8 hours

· Duration: Up to 8 hours

· ST Segment: After initial 12-lead ECG analysis, automatically selects and trends ECG lead with the greatest ST displacement

· Display Choice of: HR, PR (SpO2 ), PR (NIBP), SpO2 (%), SpCO (%), SpMet (%), CO2 (EtCO2 /FiCO2 ), RR (CO2 ), NIBP, IP1, IP2, ST

· ALARMS. Quick Set: Activates alarms for all active vital signs

· VF/VT Alarm: Activates continuous (CPSS) monitoring in Manual mode

· Apnea Alarm: Occurs when 30 seconds has elapsed since last detected respiration

· Heart Rate Alarm Limit Range: Upper, 100–250 bpm; lower, 30–150 bpm

· 12-Lead Interpretive Algorithm: University of Glasgow 12-Lead ECG Analysis Program, includes AMI and STEMI statements

· PRINTER. Prints continuous strip of the displayed patient information and reports

· Paper Size: 100 mm (3.9 in)

· Print Speed: 25 mm/sec or 12.5 mm/sec Optional: 50 mm/sec time base for 12-lead ECG reports

· Delay: 8 seconds

· Auto print: Waveform events print automatically

· Frequency Response: Diagnostic: 0.05 to 150 Hz or 0.05 to 40 Hz Monitor: 0.67 to 40 Hz or 1 to 30 Hz

· DEFIBRILLATOR. Biphasic Waveform: Biphasic Truncated Exponential

· The following specifications apply from 25 to 200 ohms, unless otherwise specified:

· Energy Accuracy: ±1 joule or 10% of setting, whichever is greater, into 50 ohms, ±2 joules or 15% of setting, whichever is greater, into 25-175 ohms.

· Voltage Compensation: Active when disposable therapy electrodes are attached. Energy output within ±5% or ±1 joule, whichever is greater, of 50 ohms value, limited to the available energy which results in the delivery of 360 joules into 50 ohms.

· Paddle Options: QUIK-COMBO® pacing/defibrillation/ECG electrodes (standard). Cable Length 8-foot-long (2.4 m) QUIK-COMBO cable (not including electrode assembly).

· Standard paddles (optional)

· MANUAL MODE. Energy Select: 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 50, 70, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, and 360 joules

· Charge Time: Charge time to 360 joules in less than 10 seconds, typical

· Synchronous Cardioversion: Energy transfer begins within 60 milliseconds of the QRS peak

· Paddles Lead Off Sensing: The transition point at which device changes from assuming that QUIK-COMBO electrodes are properly connected to patient to assuming that electrodes are not connected is 300±50 ohms

· AED MODE. Shock Advisory: an ECG analysis system that advises the operator if the algorithm detects a shockable or non-shockable ECG rhythm. SAS acquires ECG via therapy electrodes only

· Biphasic Output: Energy Shock levels ranging from 150–360 joules with same or greater energy level for each successive shock

· In AED mode, the monitor provides a method of maximizing the CPR time that a patient receives, with the overall goal of improving the rate of survival of patients treated with AEDs.

· Setup Options:

· – Auto Analyze: Allows for auto analysis. Options are OFF, AFTER 1ST SHOCK

· – Initial CPR: Allows the user to be prompted for CPR for a period prior to other activity. Options are OFF, ANALYZE FIRST, CPR FIRST

· – Initial CPR Time: Time interval for Initial CPR. Options are 15, 30, 45, 60, 90, 120, and 180 seconds.

· – Pre-Shock CPR: Allows the user to be prompted for CPR while the device is charging. Options are OFF, 15, 30 seconds.

· – Pulse Check: Allows the user to be prompted for a pulse check at various times. Options are ALWAYS, AFTER EVERY SECOND NSA, AFTER EVERY NSA, NEVER

· – Stacked Shocks: Allows for CPR after 3 consecutive shocks or after a single shock. Options are OFF, ON

· – CPR Time: 1 or 2 User selectable times for CPR. Options are 15, 30, 45, 60, 90, 120, 180 seconds and 30 minutes.

· PACER. Pacing Mode: Demand or non-demand rate and current defaults

· Pacing Rate: 40 to 170 PPM Rate Accuracy: ±1.5% over entire range

· Output Waveform: Monophasic, truncated exponential current pulse (20 ±1.5 milliseconds)

· Output Current: 0 to 200 mA

· Pause: Pacing pulse frequency reduced by a factor of 4 when activated

· Refractory Period: 180 to 280 milliseconds (function of rate)

· ENVIROMENTAL. Unit meets functional requirements during exposure to the following environments unless otherwise stated.

· Operating Temperature: 0° to 45°C (32° to 113°F); -20°C (-4°F) for 1 hour after storage at room temperature; 60°C (140°F) for 1 hour after storage at room temperature

· Storage Temperature: -20° to 65°C (-4° to 149°F) except therapy electrodes and batteries

· Relative Humidity, Operating: 5 to 95%, non-condensing. NIBP: 15 to 95%, non-condensing

· Relative Humidity, Storage: 10 to 95%, non-condensing Atmospheric Pressure, Operating: -382 to 4,572 m (-1,253 to 15,000 ft). NIBP: -152 to 3,048 m (-500 to 10,000 ft)

· Water Resistance, Operating: IP44 (dust and splash resistance) per IEC 529 and EN 1789 (without accessories except for 12-lead ECG cable, hard paddles, and battery pack)

· Vibration: MIL-STD-810E Method 514.4, Propeller Aircraft - category 4 (figure 514.4-7 spectrum a), Helicopter - category 6 (3.75 Grams), Ground Mobile - category 8 (3.14 Grams), EN 1789: Sinusoidal Sweep, 1 octave/min, 10-150 Hz, ±0.15 mm/2 g

· Shock (drop): 5 drops on each side from 18 inches onto a steel surface EN 1789: 30-inch drop onto each of 6 surfaces

· Shock (functional): Meets IEC 60068-2-27 and MIL-STD810E shock requirements 3 shocks per face at 40 g, 6 ms half-sine pulses

· Bump: 1000 bumps at 15 g with pulse duration of 6 milliseconds

· Impact, Non-operating: EN 60601-1 0.5 + 0.05 joule impact UL 60601-1 6.78 Nm impact with 2-inch diameter steel ball. Meets IEC62262 protection level IK 04.

· EMC: EN 60601-1-2:2001 Medical Equipment -General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests EN 60601-2-4:2003: (Clause 36) Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors

· Cleaning: Cleaning 20 times with the following: Quaternary ammonium, isopropyl alcohol, hydrogen peroxide

· Chemical Resistance: 60 hour exposure to specified chemicals: Betadine (10% Povidone-Iodine solution), Coffee, Cola, Dextrose (5% Glucose solution), Electrode Gel/ Paste (98% water, 2% Carbopol 940), HCL (0.5% solution, pH=1), Isopropyl Alcohol, NaCl solution (0.9% solution), Cosmetic discoloration of the paddle well shorting bar shall be allowed following exposure to HCL (0.5% solution).

· POWER. Power Adapters: AC or DC Power Adapters provide operation and battery charging from external AC or DC power

· – Full functionality with or without batteries when connected to external AC/DC

· – Typical battery charge time while installed in LIFEPAK 15 device is 190 minutes

· – Indicators: external power indicator, battery charging indicator

· Dual battery: Capability with automatic switching

· Low battery indication and message: Low battery fuel gauge indication and low battery message in status area for each battery

· Replace battery indication and message: Replace battery fuel gauge indication, audio tones and replace battery message in the status area for each battery. When replace battery is indicated, device auto-switches to second battery. When both batteries reach replace battery condition, a voice prompt instructs user to replace battery.

· BATTERY. Battery Specifications

· Battery Type: Lithium-ion

· Weight: 0.59 kg (1.3 lb..)

· Voltage: 11.1V typical

· Capacity (rated): 5.7-amp hours

· Charge Time (with fully depleted battery): 4 hours and 15 minutes (typical)

· Battery indicators: Each battery has a fuel gauge that indicates its approximate charge. A fuel gauge that shows two or fewer LEDs after a charge cycle indicates that the battery should be replaced.

· Charging Temperature Range: 0° to 50°C (32° to 122°F)

· Operating Temperature Range: 0° to 50°C (32° to 122°F)

· Short Term (<1 week) Storage Temperature Range: -20° to 60°C (-4° to 140°F)

· Long Term (>1 week) Storage Temperature Range: 20° to 25°C (68° to 77°F)

· Operating and Storage Humidity Range: 5 to 95% relative humidity, non-condensing Battery

· Capacity For two, new fully charged batteries, 20°C (68°F)

· 4G Modem with Plan

· Software Upgrades Plan

· NO Annual Maintenance/ Inspections