INTRODUCING CARDIOSAVE Rescue THIS IS BIG. EVEN THOUGH IT S REALLY SMALL. SPECIFICATIONS

INTRODUCING CARDIOSAVE™ Rescue THIS IS BIG. EVEN THOUGH IT’S REALLY SMALL. SPECIFICATIONS INTRODUCING A WHOLE NEW PARADIGM IN HEMODYNAMIC SUPPORT CA...
Author: Mary Lamb
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INTRODUCING CARDIOSAVE™ Rescue THIS IS BIG. EVEN THOUGH IT’S REALLY SMALL. SPECIFICATIONS

INTRODUCING 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 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.

Retractable handle

Backlit monitor display

Backlit touchscreen

Removable monitor Swivel monitor mount Handle lifting points

IAB sensor input ECG input

Pressure input

IAB catheter extender input

Low level BP output - to bedside monitor Low level BP output - vent button ECG monitor input Pressure monitor input IABP power button

Ambient temperature sensor Trainer input Handle lifting point

Ethernet port Printer

Equipotential lug

USB connector Retractable wheels

Battery bay in-use indicators

Battery charge indication lights 2 hot swappable lithium ion batteries

CARDIOSAVE RESCUE: SUMMARY 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 -381.0 m to 3657.6 m 1060 hPa to 644 hPa -1250 ft to 12,000 ft 795 mmHg to 483 mmHg Verified at discrete temperature and humidity combinations per “ECRI -PB- 296 892” guidelines. Sinusoidal Vibration: 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. Random Vibration: 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. NOTE: IEC 68-2-34 has been superseded by IEC 60068-2-64:2008. For ground applications: EN 1789:2007 “Medical vehicles and their equipment Road ambulances”. For aircraft transport: RTCA/DO-160F “Environmental Conditions and Test Procedures for Airborne Equipment”.

Bump Test: EN 1789:2007 - Medical Vehicles and their equipment Road ambulances: Functional shock test per IEC 600682-29, Test Eb, 15g, duration 6 ms, 1000 times in normal operating position. Rough Handling Test: Rough Handling Test - IEC 60601-1 (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: 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) Crash Test: 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.

Agency Compliance: EN60601-1:1990 +A1:1993, + A2:1995 = 2nd edition EN60601-1-2:2007 EN60601-1-8:2007 1, 2 EN60601-2-34:2000 UL 60601-1:2003 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. 1

When tested with Baxter, Model PX 600 or Abbott®, Model 42582-05 disposable pressure transducers.

2

The technology and auto calibration feature associated with the fiber-optic 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

Standard Accessories:

Elevator Threshold Test: ECRI PB-296892*, Section AIII.3.1 Barrier Impact Test: ECRI PB-296892*, Section AIII.3.2.2 Drop Test: ECRI* AIII.3.3 for Class 2 Device (Test 1 - steel ball drop / device on floor) Tip-over Test: IEC 60601-1, 1988 (plus Amendment 1:1991, Amendment 2: 1995, and

Helium refilling station

Transport mounting plate

Battery charging station

AC Transport Power Supply

Corrigendum, June 1995) Section 4, Clause 24, Page 119 * 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.

CARDIOSAVE RESCUE: SUMMARY 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 -381.0 m to 3657.6 m 1060 hPa to 644 hPa -1250 ft to 12,000 ft 795 mmHg to 483 mmHg Verified at discrete temperature and humidity combinations per “ECRI -PB- 296 892” guidelines. Sinusoidal Vibration: 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. Random Vibration: 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. NOTE: IEC 68-2-34 has been superseded by IEC 60068-2-64:2008. For ground applications: EN 1789:2007 “Medical vehicles and their equipment Road ambulances”. For aircraft transport: RTCA/DO-160F “Environmental Conditions and Test Procedures for Airborne Equipment”.

Bump Test: EN 1789:2007 - Medical Vehicles and their equipment Road ambulances: Functional shock test per IEC 600682-29, Test Eb, 15g, duration 6 ms, 1000 times in normal operating position. Rough Handling Test: Rough Handling Test - IEC 60601-1 (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: 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) Crash Test: 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.

Agency Compliance: EN60601-1:1990 +A1:1993, + A2:1995 = 2nd edition EN60601-1-2:2007 EN60601-1-8:2007 1, 2 EN60601-2-34:2000 UL 60601-1:2003 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. 1

When tested with Baxter, Model PX 600 or Abbott®, Model 42582-05 disposable pressure transducers.

2

The technology and auto calibration feature associated with the fiber-optic 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

Standard Accessories:

Elevator Threshold Test: ECRI PB-296892*, Section AIII.3.1 Barrier Impact Test: ECRI PB-296892*, Section AIII.3.2.2 Drop Test: ECRI* AIII.3.3 for Class 2 Device (Test 1 - steel ball drop / device on floor) Tip-over Test: IEC 60601-1, 1988 (plus Amendment 1:1991, Amendment 2: 1995, and

Helium refilling station

Transport mounting plate

Battery charging station

AC Transport Power Supply

Corrigendum, June 1995) Section 4, Clause 24, Page 119 * 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.

Product

Part Number

Accessories shipped with CARDIOSAVE Rescue:

CARDIOSAVE Rescue

0998-00-0800-83

CARDIOSAVE Battery Pack (qty 2) CARDIOSAVE Helium Refilling Station CARDIOSAVE Battery Recharging Station CARDIOSAVE Transport Mounting Plate CARDIOSAVE AC Transport Power Supply Helium Tanks CARDIOSAVE Accessory Kit: n CARDIOSAVE Blood Pressure Transducer Adapter Cable n CARDIOSAVE ECG Trunk Cable - 5 lead n CARDIOSAVE ESIS Lead Wires 50" – 5 Lead (Op Rm) n External Signal Cable n CARDIOSAVE Operators Manual - DVD n CARDIOSAVE Non-locking Male Luer Plug (qty 5) n Helium Cylinder Washer (qty 5) n Thermal Recorder Chart Paper Starter Pack n Fiber Optic Cleaning Swabs (qty 5) n Fiber Optic Connector Cleaner n CARDIOSAVE Plastic Weather Cover n CARDIOSAVE Allen Wrench

Datascope Corp. 15 Law Drive Fairfield, NJ 07004, USA Tel +1 973 244 6100 Fax +1 973 244 6279 Visit our website http://ca.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 and prevention within healthcare and life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions and intensive care.

MCV-BR-80000204-EN-01 · PN: 0002-08-1065 R0 MAQUET Trademark of MAQUET GmbH & Co. KG · CARDIOSAVE is a trademark of Datascope Trademark Corp. 2011 Copyright Datascope Corp. or its affiliates. All rights reserved. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician. Refer to Instructions for Use for current indications, warnings, contraindications, and precautions.

ORDERING INFORMATION

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