Indications For Use; Contraindications - Medtronic MYOtherm XP Gebrauchsanweisung

MYOtherm XP™
Cardioplegia Delivery System with Trillium™ Biosurface
1. Description
The MYOtherm XP™ cardioplegia delivery system with Trillium™ biosurface is designed to mix arterial blood
from an oxygenator with asanguineous cardioplegia solution in specific ratios, depending upon the system
1
chosen . 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. A pressure
monitoring line, three-way stopcock, gauge protector, and a pressure relief line with pressure relief valve are
preconnected.
MYOtherm XP system with Tril-
lium biosurface model
XP41T, XP41BT
a Note: XP41BT (Bridge) series provides the ability to administer 100% blood as prescribed by physician.
1.1. Specifications
Bellows
Recommended blood flow rate
Filter screen
Heat exchanger nominal 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 (postprime)
Maximum water temperature
Maximum transit temperature
Store the product at room temperature.
1.2. Accessories available separately
■
Temperature probe TP
■
MYOtherm XP™ cardioplegia holder

2. Indications for use

The MYOtherm XP system with Trillium biosurface is a device intended for the mixing, warming/cooling, and
delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary
bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient
through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller
pump.

3. Contraindications

Use the device only as indicated.
4. 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 CPB procedures should use this device. Operation of each device
requires constant supervision by qualified personnel for patient safety. Perfusion must be carefully and
constantly monitored.
■
Each device is intended for single use only. Do not reuse or resterilize. Sterilized using ethylene oxide.
■ The fluid pathway is sterile and nonpyrogenic. Inspect each package and device prior to use. Do not use the
device if the package is opened or damaged or the protective caps are not in place.
1 Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
Table 1.
Tubing inner diameter dimensions Pump type
a
Delivery ratio
Blood line
4:1 0.64 cm (1/4 in) 0.32 cm (1/8 in)
Stainless steel
≤500 mL/min
150 μm
44 mL
0.06 m
Adult
0.64 cm (1/4 in)
0.48 cm (3/16 in)
Standard female luer lock
Quick coupling connectors [1.3 cm (1/2 in)]
275.8 kPa (40 psi)
750 mmHg
42°C (107°F)
50°C (122°F)
Cardioplegia line
2 (95 in 2 )
Instructions for Use
Standard roller
pump
English 7