Quest Engineering MPS 3, Operation Manual

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MPS 3 System – Appendix
17.3.MPS
®
3 Bypass Tubing Instructions for Use
5301016 MPS
®
3 Blood Bypass Tubing
Description
The MPS
®
3 Blood Bypass Tubing contains the following component:
1.
MPS ® 3 Blood Bypass Tubing
Indication For Use
The MPS 3 Blood Bypass Tubing is only for use as a back-up with the Quest MPS 3 Console to continue fluid delivery in the
event of complete battery depletion or if the MPS 3 Console becomes unusable. The Blood Bypass Tubing, when used in
conjunction with the MPS Console and Delivery Set, is intended for use by perfusionists and surgeons trained in the delivery of
cardioplegia solutions to the myocardium during open heart surgery. This is a sterile single use product.
Contraindication
This device is designed for use with only the MPS 3 Console. Use with other systems is contraindicated. This device is not
designed, sold or intended for use except as indicated.
Warnings and Cautions
1.
Read and understand the information in these instructions prior to operating the MPS 3 Console. See MPS 3
Operations Manual for a complete listing of Warnings and Cautions and Storage Conditions. The attending clinician
is solely responsible for the setup and use of the MPS 3 Console, Delivery Set, and Blood Bypass Tubing.
2.
Observe all additional warnings and cautions contained in this Instruction for Use.
3.
Examine sterile package carefully before opening to confirm package integrity and verify that the expiration date has not
passed. The device is supplied in a sterile, single use package and is non-pyrogenic.
DO NOT USE Blood Bypass Tubing with damaged packaging or if the expiration date has passed. DO NOT resterilize or
reprocess.
4.
Observe aseptic technique with all tubing connections. Do not overtighten rigid connections.
5.
The main door must be closed to operate the MPS 3 Console with the Blood Bypass Tubing.
6.
Dispose of this device according to hospital procedure for contaminated material.
Installing the Blood Bypass Tubing
1.
Using sterile technique, remove the Blood Bypass Tubing from the sterile pouch.
2.
Ensure the clamp on the Blood Bypass Tubing is closed prior to installation.
3.
Stop flow and ensure both delivery valves are closed.
4.
Clamp both Blood and Crystalloid inlet lines leading to main pumping cassette distal to the large bore luer connectors.
5.
Vent heat exchanger by manually depressing the vent valve to reduce the system pressure to zero.
6.
Disconnect and cap blood source line from disposable cassette using female cap on Blood Bypass Tubing.
7.
Attach Blood Bypass Tubing large bore luer connector to blood source line.
8.
Connect Blood Bypass Tubing standard male luer connector to the auxiliary luer port of 16 convolution heat exchanger or
disconnect additive check valve
and connect Blood Bypass Tubing onto left port of 10 convolution heat exchanger.
9.
Unclamp Blood Bypass Tubing and blood source line.
10.
Manually depress vent valve to prime Blood Bypass Tubing and heat exchanger of air.
11.
Once primed, clamp Blood Bypass Tubing and release vent valve
12.
As protocols requires, unclamp Blood Bypass Tubing and then initiate flow by manually depressing delivery valve.
13.
If Controller is unresponsive, monitor pressure from Arterial Monitor.
14.
Monitor heat exchanger and delivery line for air bubbles and vent heat exchanger as needed.
Arrest Agent and Additive Delivery with 16 Convolution Heat Exchanger
1.
Ensure delivery valves are closed and Blood Bypass Tubing is clamped.
2.
Manually vent heat exchanger to reduce the system pressure to zero.
3.
Connect syringes to arrest agent and additive stopcocks.
4.
Place arrest agent and additive stopcocks in the refill position and evacuate cartridge content.
5.
Turn and break arrest agent and additive stopcocks towards cartridges.
6.
As protocol requires, inject arrest agent and/or additive cartridge content into drug delivery lines.
7.
Unclamp Blood Bypass Tubing and initiate flow with drug bolus by pressing down on delivery valve.
Arrest Agent and Additive Delivery with 10 Convolution Heat Exchanger
1.
Ensure delivery valves are closed and Blood Bypass Tubing is clamped.
2.
Manually vent heat exchanger to reduce the system pressure to zero.
3.
Connect syringes to arrest agent and additive stopcocks.
4.
Place arrest agent and additive stopcocks in the refill position and evacuate cartridge content.
5.
Turn and break arrest agent stopcock towards cartridge.
6.
Disconnect and connect arrest agent or additive syringe to yellow arrest stopcock as protocol requires.
7.
Inject arrest agent or additive cartridge content into drug delivery line as protocol requires.
8.
Unclamp Blood Bypass Tubing and initiate flow and drug bolus by pressing down on delivery valve.
Operating Precautions
1.
The MPS 3 Delivery Set should not be used if there is any visible damage.
2.
User should first clamp both inlet lines before disconnecting from pump cassette.
3.
User is responsible for pressure monitoring as indicated by hospital protocol.
4.
User is responsible for delivering proper arrest agent and additive concentrations by hospital protocol.
5.
User is responsible for purging air from the system as indicated by hospital protocol.
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