Indications For Use; Contraindications - Medtronic MYOtherm XP Gebrauchsanweisung

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MYOtherm XP
Cardioplegia Delivery System
Description
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The MYOtherm XP systems are designed to mix arterial blood from an oxygenator with asanguineous
cardioplegia solution in specific ratios, depending upon the system chosen. The MYOtherm XP
Delivery System, depending on the model selected, may be used with either a standard roller pump or the
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Medtronic CSS™ Cardioplegia Safety System (Model 990 instrument). The Medtronic CSS system is a
micro-computer controlled cardioplegia delivery instrument featuring dual, independently operating pumps.
The dual-pump design allows desired blood and solution ratios to be delivered based on the relative speeds
of each pump (for detailed information, refer to the CSS instrument Operator and Reference Manual). The
specifications provided by each standard system and their corresponding product designations are presented
below in Table 1. The patient delivery line is packaged separately to allow for ease of sterile transfer to the
operative field prior to connection to the delivery outlet of the cardioplegia system. Depending on the system
selected, a pressure monitoring line, three-way stopcock, and gauge protector, as well as a pressure relief line
with pressure relief valve may be preconnected.
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MYOtherm XP Model
41, 41-B
CSS Custom Only
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NOTE: MYOtherm XP -B (Bridge) series provides the ability to administer 100% blood as prescribed by physician.
Specifications
Bellows:
Recommended Blood Flow Rate:
Filter Screen:
Heat Exchanger Volume:
Heat Exchanger Blood Contact Surface Area:
Size:
Inlet Connector:
Outlet Connector:
Pressure Monitor/Pressure Relief Ports:
Waterports:
Water phase pressure limit:
Blood phase pressure limit (post prime):
Maximum water temperature:

Indications for Use

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The MYOtherm XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling and
delivery of oxygenated blood/cardioplegia solution in a predetermined ratio.
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The Medtronic MYOtherm XP
Models) is intended only for mixing and delivery of oxygenated blood and/or asanguineous cardioplegia
solution with the CSS instrument, Model 990. The MYOtherm XP
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MYOtherm XP CSS Custom Models) is used with the instrument to warm, cool, and deliver oxygenated
blood and/or asanguineous cardioplegia solution.

Contraindications

This device used for any other purposes than for the indicated use is the responsibility of the user.
Warnings
Read all Warnings, Precautions, and Instructions for Use carefully prior to use. Failure to read and follow
all instructions, or failure to observe all stated warnings, could cause serious injury or death to
the patient.
Only persons thoroughly trained in cardiopulmonary bypass procedures should use this device. Operation
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of each device requires constant supervision by qualified personnel for patient safety.
Each device has been carefully manufactured, tested and packaged; however, the state of the art has not
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been developed to the point that Medtronic
during use. Perfusion must be carefully and constantly monitored.
Each device is intended for single use only. Do not reuse or resterilize. EO sterilized.
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Table 1.
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Delivery Ratio
4:1 0.6 cm (1/4 in)
Set on CSS Instrument 0.6 cm (1/4 in)
Stainless Steel
Up to 500 mL/min.
150 micron
44 mL
0.06 m
Adult
0.6 cm (1/4 in)
0.5 cm (3/16 in)
Standard Female Luer Lock
Hansen Series 3-ST Quick Disconnect [1.3 cm (1/2 in)]
40 psi
750 mmHg
42°C
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Cardioplegia Delivery System (when using the MYOtherm XP
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is able to ensure that the device will not leak, crack, or fail
Tubing ID Dimensions
Blood Line Cardioplegia Line
0.3 cm (1/8 in)
0.3 cm (1/8 in)
2 2
(95 in )
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Heat Exchanger (when part of the
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Cardioplegia
Pump Type
Standard Roller Pump
CSS 990 Instrument
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CSS Custom
Instructions for Use 5