Defibrillation made simple Product Description: M4735A HeartStart XL Defibrillator/Monitor Philips Healthcare’s M4735A HeartStart XL offers advanced and basic life-support clinicians a compact, lightweight, easy-touse defibrillator/monitor with both Manual and AED capabilities. HeartStart XL features Philips’ patented SMART Biphasic waveform, ECG monitoring, synchronized cardioversion, and optional non-invasive pacing and SpO2. 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. In AED Mode, the HeartStart 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-touse device. The print quality of this copy is not an accurate representation of the original. Features Standard Features Ordering Option Information SMART Biphasic waveform for defibrillation therapy 0B3 Service Manual ECG monitoring through pads and separate monitoring electrodes OBP User Training Video C01 SpO2 Monitoring with adult reusable transducer Alarms on HR limits and shockable rhythms C02 Non-invasive Pacing Synchronized cardioversion C03 12-pin, 5 lead ECG Cable Manual and AED operation C05 User Training CD-ROM Built-in 50 mm strip chart printer C07 Bright Liquid Crystal Display (LCD) display for viewing waveforms and messages Hands-free cable M3507A (barrel connector) and Text Load (M1781A - barrel connector) C08 Hands-free cable (M3508A - flat connector) and Test Load (M3725A - flat connector) - Default option Voice prompts in AED mode C10 Data Card Adjustable ECG size C13 External paddles with Paddle Contact Indicator Adjustable volume C24 External Sterilizable Paddles (Option not available in the U.S. and Canada) J03 12-pin Sync Cable W18 Extends 1-year CE On-site to 2-Year CE On-site Warranty W19 Extends 1-year CE On-site to 3-Year CE On-site Warranty Non-invasive pacing (using a monophasic truncated exponential current waveform) W20 Extends 1-year CE On-Site to 5-Year CE On-site Warranty 5-lead ECG monitoring cable, AAMI or IEC labeling WA0 Provides a 5-year bench repair with loaner Internally stored event summary which may be printed Setup mode, automatic self-tests and error handling Integrated AC power Optional Features SpO2/Pulse Oximetry with alarms Standard Accessories Sealed Lead Acid Battery (U.S./Canada only) WA1 Converts standard warranty to a 5-year BioMed Warranty (U.S. only) Hands-Free Multifunction Defib Electrode Cable ECG Patient Cable (3 lead) Disposable Monitoring Electrodes (5) Rolls of printer paper (2) Upgrades/Supplies/Accessories Upgrades Instructions for Use M4738A Pacing Upgrade Quick Reference Card M4739A SpO2 Upgrade User Training Workbook Test Load AC Power Cord External Paddles M4745A Sterilizable External Paddles M4746A External Paddles with PCI 2 The print quality of this copy is not an accurate representation of the original. Internal Paddles ECG Cables M1741A 7.5 cm Switchless M1500A 3-Lead ECG Trunk Cable (AAMI) M1742A 6.0 cm Switchless M1663A 10-Lead Trunk Cable M1743A 4.5 cm Switchless M1668A 5-Lead Trunk Cable M1744A 2.8 cm Switchless M1669A 3-Lead Trunk Cable M4741A 7.5 cm Switched M1949A 10-Lead Trunk Cable M4742A 6.0 cm Switched M1605A 3-Lead ECG Patient Cable with Snaps (AAMI) M4743A 4.5 cm Switched M1671A 3-Lead ICU Grabber (AAMI) M4744A 2.8 cm Switched M1672A 3-Lead ICU Grabber (IEC) M4740A Internal Paddles Adapter Cable M1673A 3-Lead ICU Snap (AAMI) M1674A 3-Lead ICU Snap (IEC) M1675A 3-Lead OR Grabber (AAMI) Pads/Electrodes M3713A HeartStart Multifunction Adult Plus M1678A 3-Lead OR Grabber (IEC) M3716A HeartStart Multifunction Adult Radiolucent M1510A 3-Lead ECG Trunk Cable (IEC) M3717A HeartStart Multifunction Pediatric Plus M1615A 3-Lead ECG Patient Cable with Snaps (IEC) M3718A HeartStart Multifunction Adult Radiotransparent/ Reduced Skin Irritation M1520A 5-Lead ECG Trunk Cable (AAMI) M1625A 5-Lead ECG Patient Cable with Snaps (AAMI) M3719A HeartStart Multifunction Pediatric Radiotransparent/Reduced Skin Irritation M1530A 5-Lead ECG Trunk Cable (IEC) M1635A 5-Lead ECG Patient Cable with Snaps (IEC) M3501A Multifunction Defib Adult Electrode, AAMI M1968A 5-Lead ICU Grabber (AAMI) M3502A Multifunction Defib Adult Electrode, IEC M1644A 5-Lead ICU Snap (AAMI) M3503A Multifunction Defib Pediatric Electrode, IEC M1973A 5-Lead OR Grabber (AAMI) M3504A Multifunction Defib Pediatric Electrode, AAMI M1971A 5-Lead ICU Grabber (IEC) DP2 HeartStart AED Defibrillation Pads (2 pack) M1645A 5-Lead ICU Snap (IEC) DP6 HeartStart AED Defibrillation Pads (6 pack) 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 Finger Reusable SpO2 Sensor (2 meters) M1191B Adult Finger Reusable SpO2 Sensor (2 meters) M1191AL Adult Finger Reusable SpO2 Sensor (3 meters) M1191BL Adult Finger Reusable SpO2 Sensor (3 meters) M1192A Pediatric Finger Reusable SpO2 Sensor (1.5 meters) M1192T Pediatric Finger Reusable SpO2 Sensor (45 cm) M1194A Adult/Pediatric Ear Clip, Reusable SpO2 Sensor M1196A Reuseable Adult SpO2 Clip Sensor (3 meters) M1196T Reuseable Adult SpO2 Clip Sensor (0.9 meters) 3 The print quality of this copy is not an accurate representation of the original. M1941A 2-meter extension cable M1943A Nellcor SpO2 Sensor Adapter Cable M1131A Disposable SpO2 Sensor - Adult/Pediatric 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) 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 Delivered Energy Accuracy: Selected Delivered Energy (J) Energy Load Impedance (Ohms) Accuracy 25 50 100 125 150 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 ±15% 30J 27.9 30 31.2 32.1 31.2 ±15% 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% 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 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, SpO2 On/Off, SpO2 Alarm, HR Alarm, 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, Battery Charging LED, Sync LED, Pacer LED. Armed Indicators: Charge Done tone and available energy indicated on display. Waveform: Biphasic Truncated Exponential. Waveform parameters adjusted as a function of patient impedance. Energy Selection: Front panel rotary knob. Shock Delivery: Via multifunction defib electrode pads or paddles. Shock Control: Front panel “3” key or buttons on paddles. Charge Control: Front panel “2” 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. 4 The print quality of this copy is not an accurate representation of the original. Synchronizer delay is less than 60 msec from peak R-wave to peak current of the defibrillation discharge. 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, SpO2 On/Off, SpO2 Alarms, HR Alarms, ECG 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. 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%. 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. 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 SpO2: Type CF Defib: Type BF Display Type: LCD - TFT Color Liquid Crystal Display. Size: 111.4 mm x 83.5 mm. 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). 5 The print quality of this copy is not an accurate representation of the original. 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 battery at room temperature, 25º C). Waveform: Monophasic Truncated Exponential Battery Storage: Should not be stored above 40ºC for extended periods of time. 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%. Charger Output: Unit can be operated using only AC Power, with no battery installed. Pulse Width: 20 ms with accuracy +0, -5 ms. 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 SpO2 Value (if available) 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/SpO2 limits on a Limit Alarm, the 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. Noninvasive Pacing 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% M1191AL sensor - 70% to 100%, ± 2.5% M1191B sensor - 70% to 100%, ± 2.5% M1191BL sensor - 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% M1191T sensor - 70% to 100%, ± 3.0% M1192T sensor - 70% to 100%, ± 3.0% M1196T sensor - 70% to 100%, ± 3.0% M1196A sensor - 70% to 100%, ± 3.0% 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. Pulse Rate Accuracy: 2% or 1 bpm (whichever is greater). 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. Display Update Interval: Less than or equal to 60 seconds. 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%. Amplitude Accuracy: ± 10% or ± 50 uV, whichever is greater. Paper Size: 50 mm by 30 m (100 ft.). Wavelength Range: 500 to 1000 nm. Emitted Light Energy: Less than or equal to 15 mW. Resolution: 1%. SpO2 Alarm Limits: Three preset low alarm limits: 90%, 85% and 80%. INOP Alerts: Triggered by disconnected sensor, noisy signal, light interference or low signal (non-pulsatile). Event Storage Internal Event Summary: The Internal Event Summary 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. 6 The print quality of this copy is not an accurate representation of the original. The Summary key on the front panel is used to print the internal Event Summary. Data Card Event Summary: The Data Card stores continuous ECG waveforms and events on a Type II PCMCIA card. 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, oxygen or 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 7 The print quality of this copy is not an accurate representation of the original. Philips Healthcare is part of Royal Philips Electronics How to reach us www.philips.com/healthcare firstname.lastname@example.org fax: +31 40 27 64 887 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) Philips Healthcare Global Information Center P.O. Box 1286 5602 BG Eindhoven The Netherlands © 2008 Koninklijke Philips Electronics 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 32531/861 * MAY 2008 The print quality of this copy is not an accurate representation of the original.
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