CARDIOSAVE. rescue This is big. Even though it s really small. Product Specifications

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1 CARDIOSAVE rescue This is big. Even though it s really small. Product Specifications This document is intended to provide information to an international audience outside of the US.

2 A whole new paradigm in hemodynamic support CARDIOSAVE represents a giant leap forward in functionality and versatility while continuing to deliver the performance and intuitiveness of the earlier generation Maquet/Datascope pumps you know and trust. With its large touchscreen display, dramatically smaller and lighter design, and seamless transition from in-hospital use to transport mode, this revolutionary pump redefines counterpulsation therapy. CARDIOSAVE. Setting a new standard in hemodynamic support.

3 Retractable handle Backlit monitor display Backlit touchscreen Removable monitor Swivel monitor mount Handle lifting points

4 ECG input Pressure input Low level BP output - to bedside monitor Low level BP output - vent button ECG monitor input Pressure monitor input Ambient temperature sensor Trainer input Handle lifting point Ethernet port Printer USB connector Retractable wheels Battery bay in-use indicators 2 hot swappable lithium ion batteries IAB sensor input IAB catheter extender input IABP power button Equipotential lug Battery charge indication lights

5 Technical Specifications Weight Including console, removable monitor and 2 batteries 24.1 kg 53 lbs All weights ± 5% Dimensions Display Closed - Includes console and removable monitor 57.2 cm high x 40.6 cm deep x 33.0 cm wide 22.5 in high x 16 in deep x 13 in wide Display Open 90 - Includes console and removable monitor 78.0 cm high x 40.6 cm deep x 33.0 cm wide 30.7 in high x 16 in deep x 13 in wide * All dimensions ± 5%. Dimensions include the Pneumatic Module Operating Ambient Operating Temperature 10 C to 40 C 50 F to 104 F Operating Humidity 15% to 85% Relative Humidity (non-condensing) Operating Altitude m to m 1060 hpa to 644 hpa ft to 12,000 ft 795 mmhg to 483 mmhg Verified at discrete temperature and humidity combinations per ECRI -PB guidelines. Standard Accessories Sinusoidal Vibration EN : Environmental Testing, Part 2 Test Fc: Vibration (sinusoidal) EN :2008 (E) section which cites ISO 7137:1995. Test method is defined per RTCA/DO-160F par Cat S, fuselage zone M. Random Vibration FDA Reviewer Guidance for Pre-Market Notification Submissions section n.4 (iii) specified random vibration test per IEC , frequency range 20 to 500 Hz, ASD 0.02g^2/Hz, duration 9 min. Nonoperational. Note: IEC has been superseded by IEC :2008. For ground applications EN 1789:2007 Medical vehicles and their equipment - Road ambulances. For aircraft transport RTCA/DO-160F Environmental Conditions and Test rocedures for Airborne Equipment. Bump Test EN 1789: Medical Vehicles and their equipment - Road ambulances: Functional shock test per IEC , Test Eb, 15g, duration 6 ms, 1000 times in normal operating position. Rough Handling Test Rough Handling Test - IEC (1988), sub-clause 21.6, with Amendment 1 (1991) and Amendment 2 (1995) Shock - Operational RTCA/DO-160F Shock, Category B Operational standard test for fixed wing and helicopter: 6g, duration 11ms, sawtooth, 3 times in each orientation Shock - Non-Operational EN :2008, Environmental Testing, Part 2 Test Ea and guidance: Shock per Table 1: 20g, duration 11 ms, saw-tooth, one in each orientation (6 total, can use dummy load) Helium refilling station Battery charging station AC Transport Power Supply Crash Test EN 1789: Medical Vehicles and their equipment. RTCA/ DO-160F - Environmental Conditions and Test Procedures for Airborne Equipment: Crash safety test for fixed wing and helicopter, 20g, duration 6ms, sawtooth, one in each orientation (11 total, can use dummy load) Test also satisfies EN 1789: Medical Vehicles and their equipment, section Elevator Threshold Test ECRI PB *, Section AIII.3.1 Barrier Impact Test ECRI PB *, Section AIII Drop Test ECRI* AIII.3.3 for Class 2 Device (Test 1 - steel ball drop / device on floor) Tip-over Test IEC , 1988 (plus Amendment 1:1991, Amendment 2: 1995, and Corrigendum, June 1995) Section 4, Clause 24, Page 119 * U.S. Department of Commerce, National Technical Information Service, PB Development of Environmental Test Methods for Non-Implantable Devices by Emergency Care Research Institute (ECRI), Prepared for Food and Drug Administration, Apr Agency Compliance EN :1990 +A1:1993, + A2:1995 = 2nd edition EN :2007 EN :2007 EN :2000 1, 2 UL :2003 CSA C No M90 CSA C No S1-94 EC Medical Device Directive 93/42/EEC WEEE Compliance: this system is in compliance with European Community Directive, 2002/96/EC with regard to waste management. 1 2 When tested with Baxter, Model PX 600 or Abbott, Model disposable pressure transducers. The technology and auto calibration feature associated with the fiber-optic sensor necessitates deviations from test requirements of sections (Sensitivity, repeatability, non-linearity, drift and hysteresis) and (Accuracy of systolic and diastolic pressure) of the IEC :2000 standard. The test requirements of these two sections were fulfilled via equivalent test methodologies developed by Maquet

6 Ordering Information Product Part No. CARDIOSAVE Rescue Accessories shipped with CARDIOSAVE Rescue: CARDIOSAVE Battery Pack (qty 2) CARDIOSAVE Helium Refilling Station CARDIOSAVE Battery Recharging Station CARDIOSAVE AC Transport Power Supply Helium Tanks CARDIOSAVE Accessory Kit: CARDIOSAVE Blood Pressure Transducer Adapter Cable CARDIOSAVE ECG Trunk Cable - 5 lead CARDIOSAVE ESIS Lead Wires 50" 5 Lead (Op Rm) External Signal Cable CARDIOSAVE Operators Manual - DVD CARDIOSAVE Non-locking Male Luer Plug (qty 5) Helium Cylinder Washer (qty 5) Thermal Recorder Chart Paper Starter Pack Fiber-optic Cleaning Swabs (qty 5) Fiber-optic Connector Cleaner CARDIOSAVE Plastic Weather Cover CARDIOSAVE Allen Wrench Maquet 1300 MacArthur Blvd., Mahwah, NJ 07430, USA Phone: Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, Getinge and Maquet. ArjoHuntleigh focuses on patient mobility and wound management solutions. Getinge provides solutions for infection control within healthcare and contamination prevention within life sciences. Maquet specializes in solutions, therapies and products for surgical interventions, interventional cardiology and intensive care. PN: Rev B Maquet is a trademark of Maquet GmbH CARDIOSAVE is a U.S. registered trademark of Datascope Trademark Corp. Copyright 2015 Datascope Corp. or its affiliates. All rights reserved. 06/15 This document is intended to provide information to an international audience outside of the US.

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