CARDIOSAVE Rescue Product Specifications - English

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