INTRODUCING CARDIOSAVE™ RescueTHIS 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.

CARDIOSAVE RESCUE: SUMMARY TECHNICAL SPECIFICATIONS

Weight Including console, removable monitor and 2 batteries24.1 kg 53 lbsAll weights ± 5%

DimensionsDisplay Closed - Includes console and removable monitor57.2 cm high x 40.6 cm deep x 33.0 cm wide22.5 in high x 16 in deep x 13 in wide

Display Open 90°- Includes console and removable monitor78.0 cm high x 40.6 cm deep x 33.0 cm wide30.7 in high x 16 in deep x 13 in wide* All dimensions ± 5%. Dimensions include the Pneumatic Module

Operating AmbientOperating Temperature10°C to 40°C 50°F to 104°F

Operating Humidity15% 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NOTE: IEC 68-2-34 has been superseded by IEC 60068-2-64:2008.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 60068-2-29, 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, saw-tooth, 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.

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

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.

Agency Compliance:

EN60601-1:1990 +A1:1993, + A2:1995 = 2nd edition EN60601-1-2:2007EN60601-1-8:2007EN60601-2-34:2000

1, 2

UL 60601-1:2003CSA C22.2 - No. 601.1 - M90CSA C22.2 - No. 601.1S1 - 94EC Medical Device Directive 93/42/EECWEEE 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:

Battery charging station AC Transport Power Supply

Helium refilling station Transport mounting plate

Removable monitor

Swivel monitor mount

Handle lifting points

Handle lifting point

Ethernet port

Printer

USB connector

ECG input

Pressure input

Low level BP output - to bedside monitor

ECG monitor input

Low level BP output - vent button

Pressure monitor input

Ambient temperature sensor

Trainer input

Equipotential lug

Battery charge indication lights

IABP power button

IAB catheter extender input

IAB sensor input

Retractable wheels

2 hot swappable lithium ion batteries

Battery bay in-use indicators

Backlit touchscreen

Backlit monitor display

Retractable handle

CARDIOSAVE RESCUE: SUMMARY TECHNICAL SPECIFICATIONS

Weight Including console, removable monitor and 2 batteries24.1 kg 53 lbsAll weights ± 5%

DimensionsDisplay Closed - Includes console and removable monitor57.2 cm high x 40.6 cm deep x 33.0 cm wide22.5 in high x 16 in deep x 13 in wide

Display Open 90°- Includes console and removable monitor78.0 cm high x 40.6 cm deep x 33.0 cm wide30.7 in high x 16 in deep x 13 in wide* All dimensions ± 5%. Dimensions include the Pneumatic Module

Operating AmbientOperating Temperature10°C to 40°C 50°F to 104°F

Operating Humidity15% 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 60068-2-29, 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, saw-tooth, 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.

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

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.

Agency Compliance:

EN60601-1:1990 +A1:1993, + A2:1995 = 2nd edition EN60601-1-2:2007EN60601-1-8:2007EN60601-2-34:2000

1, 2

UL 60601-1:2003CSA C22.2 - No. 601.1 - M90CSA C22.2 - No. 601.1S1 - 94EC Medical Device Directive 93/42/EECWEEE 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:

Battery charging station AC Transport Power Supply

Helium refilling station Transport mounting plate

Datascope Corp.15 Law DriveFairfield, NJ 07004, USATel +1 973 244 6100Fax +1 973 244 6279 Visit our websitehttp://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 provi-des solutions for infection control and prevention within healthcare and life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions and intensive care.

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. ORDERING INFORMATION

Product Part Number

CARDIOSAVE Rescue 0998-00-0800-83

Accessories shipped with CARDIOSAVE Rescue:

CARDIOSAVE Battery Pack (qty 2) CARDIOSAVE Helium Refilling StationCARDIOSAVE Battery Recharging StationCARDIOSAVE Transport Mounting PlateCARDIOSAVE AC Transport Power SupplyHelium TanksCARDIOSAVE Accessory Kit:n CARDIOSAVE Blood Pressure Transducer Adapter Cablen CARDIOSAVE ECG Trunk Cable - 5 leadn CARDIOSAVE ESIS Lead Wires 50" – 5 Lead (Op Rm)n External Signal Cablen CARDIOSAVE Operators Manual - DVDn CARDIOSAVE Non-locking Male Luer Plug (qty 5)n Helium Cylinder Washer (qty 5)n Thermal Recorder Chart Paper Starter Packn Fiber Optic Cleaning Swabs (qty 5)n Fiber Optic Connector Cleanern CARDIOSAVE Plastic Weather Covern CARDIOSAVE Allen Wrench