AtriCure CRYO1 Bedienungsanleitung
CRYO1 ACCESSORY KIT INSTALLATION
INSTRUCTIONS
Cylinder Pressure Regulator
European Representative:
Köntges SPRL
Avenue Hellevelt 35
B-1180 Brussels Belgium
Tel: +32 (0) 2 375 51 63
FAX: +32 (0) 2 375 89 06
e-mail: [email protected]
AtriCure Incoporated
7555 Innovation Way
Mason, Ohio 45040 USA
Customer Service:
1-866-349-2342 (toll free)
1-513-755-4100 (phone)
P000622 Rev E
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Table of Contents
Page
1. About This Installation 3
2. CCS–200 Shut Down 4
3. Replacement versus First Time Installation 4
4. Cylinder Pressure Regulator Removal 5
5. Cylinder Pressure Regulator Installation 6
6. Verify Accessory Kit Installation 8
7. Care and Maintenance 8
8. Return of Product 10
9. Disclaimer Statements 10
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Cryo1 Accessory Kit Installation Instruction
1. About This Installation
The Cryo1 Accessory Kit consists of three (3) unit installation. The
installation of each unit is required for use of the AtriCure®Cryo1 cryo–
ablation probe with the frigitronics®CCS-200 Cardiac Cryosurgical
System (CCS–200). This kit must be installed by personnel properly
trained on the CCS-200.
The three units can be installed in any order:
1. CPR1 – Cylinder Pressure Regulator Unit
2. CPT1 – Cylinder Pressure Temperature Display Unit
3. OTS1/OTS2 – Nitrous Oxide Tank Heater
WARNINGS
The Cryo1 accessory kit is for use with the frigitronics CCS–200 Cardiac
Cryosurgical System and Cryo1–cryo ablation probe.
The Cryo1 accessory kit is used to maintain appropriate operating pressure levels in
the compressed nitrous oxide gas cylinders of the frigitronics CCS–200 Console.
Do not use with gas cylinders other than nitrous oxide.
CAUTIONS
Read all instructions carefully for the Cryo1 accessory kit prior to installing the
components. Failure to properly follow instructions may lead to injury and may
result in improper functioning of the accessory components.
Use of the Cryo1 accessory kit should be limited to properly trained and qualified
medical personnel.
To avoid damage to the device, do not drop or toss any of the Cryo1 accessory
components.
Do not use the Cryo1 components if damaged in any way.
Do not remove or install Cryo1 accessory components unless the line and exhaust
pressure gauge read "0" psi on the CCS-200 console.
Do not restrict, kink, bend, clamp or otherwise damage nitrous oxide lines.
Getting Help
If you need help with this procedure please contact AtriCure, Inc. Customer
Support at 1-877-492-1066.
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2. CCS–200 Shut Down
NOTE: For additional help on shutting down the system, please refer to the
frigitronics CCS-200 Operation and Maintenance Manual.
1. Turn the Nitrous Oxide Cylinder Valves clockwise to the “OFF”
position.
Turn the system On/Off Valves “ON” and “OFF” repeatedly until all
pressure gauges read “0” psi and the Exhaust Pressure Gauge needles
touch the silver stop.
2. Turn system On/Off Knobs to the “OFF” position.
CAUTION: Do not remove or install probes unless the line and exhaust
pressure gauge read “0” psi.
3. If attached, remove probe(s).
4. Turn Main Meter switch to the “OFF” position.
5. The CCS–200 shut down is complete.
3. Replacement versus First Time Installation
NOTE: If this is a first time installation of the Cylinder Pressure Regulator,
skip Section 4 and proceed directly to Section 5.
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4. Cylinder Pressure Regulator Removal
Cylinder Pressure Regulator Kit
Item
Description
Quantity
1.
Pressure Regulator (with rubber boots)
1
2.
Band-Clamp (with screws)
1
3.
5/64” Allen Wrench
1
Confirm that all items listed above are in the Cylinder Pressure Regulator
Kit.
1. Using the 5/64” allen wrench provided with the Cylinder Pressure Regulator Kit,
move the two clamp ring screws holding the Cylinder Pressure Regulator to the
CCS–200 console as shown below.
2. Once the screws and the ring clamps have been removed, the Cylinder Pressure
Regulator will slide out. See below.
3. Package the defective Cylinder Pressure Regulator unit in the box that the
replacement unit was delivered, and return to customer service with an RGA
number for service.
Remove ring
clamp screws
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5. Cylinder Pressure Regulator Installation
Confirm that all items listed above are in the Cylinder Pressure Regulator Kit.
1. The Cylinder Pressure Regulator will be installed on System II of the CCS–200
console. Refer to figure below to identify System I and System II Probe Socket
Supply Connectors.
Cylinder Pressure Regulator Kit
Item
Description
Quantity
1.
Pressure Regulator (with rubber boots)
1
2.
Band-Clamp (with screws)
1
3.
5/64” Allen Wrench
1
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2. Remove the clamp from the Cylinder Pressure Regulator by completely
removing the two screws with the provided 5/64” allen wrench.
3. Push the Cylinder Pressure Regulator shaft all the way into the desired Probe
Supply Socket Connector. There should be no shaft showing when completely
inserted.
4. Attach Cylinder Pressure Regulator to Supply Socket Connector with clamp.
•Align the grooves and capture with clamp
•Align the two clamp pieces by matching up the larger hole with the smaller hole.
•Tighten the clamp down with the two screws using the allen wrench.
5. The Cylinder Pressure Regulator Unit installation is complete.
NOTE: The color bands around the System ports are for identification and
reference only. Actual color may vary from Green that is shown in this
instruction.
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6. Verify Accessory Kit Installation
WARNING: Installation of all three (3) of the Cryo1 Accessory Components
listed in this document is required to the CCS–200 prior to using the AtriCure
Cryo1 cryo–ablation probe.
7. Care and Maintenance
1. The CCS-200, including Cryo1 accessory components, should be handled
with the care appropriate to any precision medical instrument. Avoid
banging, dropping or mishandling the system. Periodically inspect the
hoses and fittings for any damage or wear. Other than maintaining an
adequate supply of medical grade nitrous oxide, the system is essentially
maintenance free.
2. Cleaning:
NOTE: Do not spray or pour liquids directly on the unit.
NOTE: The unit and/or accessories cannot be sterilized.
WARNING: Ensure Isopropyl Alcohol (IPA) is completely dry before
operating the unit.
CAUTION: Avoid caustic or abrasive cleaners
Guidelines
The following guidelines are recommended for cleaning the unit. It
is the user’s responsibility to qualify any deviations from these
processing methods.
1. Disconnect the unit or cart from the outlet before cleaning.
2. If the unit and/or accessories are contaminated with blood or other
body fluids, they shall be cleaned before the contamination can dry
(within two hours of contamination).
3. The outer surfaces of the unit and/or accessories shall be cleaned
with 70% -90% Isopropyl alcohol (IPA) wipes for a minimum of
two minutes. Do not allow fluids to enter the chassis.
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4. Pay attention to all areas where fluids or soil may gather, such as
under/ around the handles or any tight crevices/ grooves.
5. Dry the unit and/or accessories with a dry, white lint-free cloth.
6. Conduct a final confirmation of the cleaning process by visually
inspecting the white cloth for remaining soil.
7. If soil remains on the white cloth, repeat steps 3 through 6.
8. After cleaning is complete, turn the unit on to perform Power On
Self-Test (POST). If any errors are received, contact AtriCure to
begin return process.
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8. Return of Product
If for any reason this product must be returned to AtriCure, Inc., a return goods
authorization (RGA) number is required from AtriCure, Inc., prior to shipping.
CAUTION: It is the responsibility of the health care institution to adequately
prepare and identify the product for shipment.
If the product has been in contact with blood or body fluids, it must be
thoroughly cleaned and disinfected before packing. It should be shipped in
either the original carton or an equivalent carton, to prevent damage during
shipment; and it should be properly labeled with an RGA number and an
indication of the bio-hazardous nature of the contents of shipment.
Instructions for cleaning and materials, including appropriate shipping
containers, proper labeling, and an RGA number may be obtained from
AtriCure, Inc.
9. Disclaimer Statements
Users must assume responsibility for approving the condition of the installation
before it is used. AtriCure, Inc., cannot be held liable for any consequential
damage, personal injury or damage to property caused by improperly installed
products.
Users must assume responsibility for approving the condition of the installation
before it is used. AtriCure, Inc., cannot be held liable for any consequential
damage, personal injury or damage to property caused by improperly installed
products.
This document describes the proper procedures for the product installation. Any
deviation from these procedures, which may compromise the function of the
product, is the responsibility of the user.
Andere Handbücher für CRYO1
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