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. 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. Handle lifting points Swivel monitor mount Removable monitor Backlit touchscreen Backlit monitor display Retractable handle 2 hot swappable lithium ion batteries Battery bay in-use indicators Retractable wheels USB connector Printer Ethernet port Handle lifting point Trainer input Ambient temperature sensor Pressure monitor input ECG monitor input Low level BP output - vent button Low level BP output - to bedside monitor Pressure input ECG input Battery charge indication lights Equipotential lug IABP power button IAB catheter extender input IAB sensor input Random Vibration Dimensions Helium refilling station Standard Accessories Battery charging station Verified at discrete temperature and humidity combinations per “ECRI -PB- 296 892” guidelines. -1250 ft to 12,000 ft 795 mmHg to 483 mmHg Operating Altitude -381.0 m to 3657.6 m 1060 hPa to 644 hPa Operating Humidity 15% to 85% Relative Humidity (non-condensing) Operating Temperature 10°C to 40°C 50°F to 104°F Operating Ambient * All dimensions ± 5%. Dimensions include the Pneumatic Module Barrier Impact Test 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 AC Transport Power Supply EN60068-2-27:2008, 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) Shock - Non-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 - Operational Rough Handling Test - IEC 60601-1 (1988), sub-clause 21.6, with Amendment 1 (1991) and Amendment 2 (1995) Rough Handling Test EN 1789:2007 - Medical Vehicles and their equipment - Road ambulances: Functional shock test per IEC 60068-2-29, Test Eb, 15g, duration 6 ms, 1000 times in normal operating position. Bump Test RTCA/DO-160F “Environmental Conditions and Test rocedures for Airborne Equipment”. For aircraft transport EN 1789:2007 “Medical vehicles and their equipment - Road ambulances”. 2 1 sensor necessitates deviations from test requirements of sections 51.102.1 (Sensitivity, repeatability, non-linearity, drift and hysteresis) and 51.102 2 (Accuracy of systolic and diastolic pressure) of the IEC 606012-34:2000 standard. The test requirements of these two sections were fulfilled via equivalent test methodologies developed by Maquet The technology and auto calibration feature associated with the fiber-optic posable pressure transducers. When tested with Baxter, Model PX 600 or Abbott®, Model 42582-05 dis- CSA C22.2 - No. 601.1 - M90 CSA C22.2 - No. 601.1S1 - 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. UL 60601-1:2003 EN60601-1:1990 +A1:1993, + A2:1995 = 2nd edition EN60601-1-2:2007 EN60601-1-8:2007 1, 2 EN60601-2-34:2000 Agency Compliance * U.S. Department of Commerce, National Technical Information Service, PB-296 892 “Development of Environmental Test Methods for Non-Implantable Devices” by Emergency Care Research Institute (ECRI), Prepared for Food and Drug Administration, Apr. 1979. IEC 60601-1, 1988 (plus Amendment 1:1991, Amendment 2: 1995, and Corrigendum, June 1995) Section 4, Clause 24, Page 119 Tip-over Test ECRI* AIII.3.3 for Class 2 Device (Test 1 - steel ball drop / device on floor) Drop Test ECRI PB-296892*, Section AIII.3.2.2 ECRI PB-296892*, Section AIII.3.1 Note: IEC 68-2-34 has been superseded by IEC 60068-2-64:2008. For ground applications Elevator Threshold Test FDA “Reviewer Guidance for Pre-Market Notification Submissions” section n.4 (iii) specified random vibration test per IEC 68-2-34, frequency range 20 to 500 Hz, ASD 0.02g^2/Hz, duration 9 min. Nonoperational. EN 1789:2007 - 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 1789:2007 - Medical Vehicles and their equipment, section 6.3.5. Crash Test 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 All weights ± 5% EN 60068-2-6:2008 - Environmental Testing, Part 2 Test Fc: Vibration (sinusoidal) EN13718-1:2008 (E) section 4.6.2 which cites ISO 7137:1995. Test method is defined per RTCA/DO-160F par 8.5.1 Cat S, fuselage zone M. Sinusoidal Vibration Including console, removable monitor and 2 batteries 24.1 kg 53 lbs Weight Technical Specifications Ordering Information Product Part No. CARDIOSAVE Rescue 0998-00-0800-83 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 Maquet 1300 MacArthur Blvd., Mahwah, NJ 07430, USA Phone: +1 201 995 8700 www.maquet.com 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. This document is intended to provide information to an international audience outside of the US. PN: 0002-08-1065 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 • CARDIOSAVE Allen Wrench