Ohio Medical Corporation
Vacuum Regulator, Thoracic Instructions for Use Rev 6 Feb 2014
Instructions for Use
70 Pages
Preview
Page 1
Table of Contents
Safety Instructions...2 Intended Use
...2
Receiving/Inspection...2 Definitions/Abbreviations...3 Operation
...4
Pre-Use Checkout Procedure...6 Patient Setup
...7
Cleaning
...10
Troubleshooting ...10 Disposal Instructions...10
Safety Instructions
This manual provides you with important information about the Thoracic Vacuum Regulators. To ensure the safe and proper use of this device, READ and UNDERSTAND all of the safety and operating instructions. IF YOU DO NOT UNDERSTAND THESE INSTRUCTIONS, OR HAVE ANY QUESTIONS, REFER TO SERVICE MANUAL, CONTACT YOUR SUPERVISOR, DEALER OR THE MANUFACTURER BEFORE ATTEMPTING TO USE THE DEVICE.
Intended Use: The Ohio Medical Corporation® Thoracic Vacuum Regulator is a vacuum-powered suction apparatus that is intended for use with Chest Drainage Systems in Thoracic, Cardiovascular, Trauma and Critical Care applications. DO NOT use this vacuum regulator for anything other than its intended use.
Receiving / Inspection: Remove product from package and inspect for damage. If product is damaged, DO NOT USE and contact your dealer or equipment provider. WARNINGS
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This device is to be used ONLY by persons who have been properly trained on the operation of the device. Incorrect use of this device may cause serious injury to a patient.
DO NOT operate this device in the presence of flammable anesthetics. Static charges may not dissipate and a possible explosion hazard exists in the presence of these agents.
Thoracic Vacuum Regulator vacuum pressures used should not exceed the recommendations of the Chest Drainage System Manufacturer. Use of excessive vacuum pressure may render the Chest Drainage System ineffective and may result in patient harm. 6700-0358-000 (Rev.6) 02/2014
User Responsibility
This Product will perform as described in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective product should not be used. Parts that are broken, missing, worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, see the Ohio Medical service manual for service or repairs to this product. For service advice, Ohio Medical recommends that a telephone request be made to the nearest Ohio Medical Regional Service Center. This product and any of its parts should only be repaired using written instructions provided by Ohio Medical or by Ohio Medical trained personnel. The Product must not be altered without the prior written approval of Ohio Medical’s Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Ohio Medical. AAA A 12345 This alpha character indicates the year of product manufacture and when the serial number was assigned; “Y” = 1995, “Z” = 1996, “A” = 1997, etc. “I” and “O” are not used. CAUTIONS Only competent individuals trained in the repair of this equipment should attempt to service it. Detailed information for more extensive repairs is included in the service manual for users having proper knowledge, tools and test equipment, and for service representatives trained by Ohio Medical. Not for field or transport use.*
* The categories of Field and Transport Use are specifically defined in ISO 10079-3 (BS 7259: Part 2) “Field” means accidents or emergencies outside the hospital. “Transport” means use in ambulances, cars and airplanes. These situations may expose the equipment to uneven support, dirt, water, mechanical shock and temperature extremes. Ohio Medical suction equipment has not been tested to comply with the specific requirements of these categories.
Definitions/Abbreviations WARNING CAUTION Note
= possible injury to patient or operator = possible damage to equipment = Provides additional information to clarify a point in the text. = Attention. Alerts you to a warning or caution in the text.
High Flow Low Vacuum
= high flow, low vacuum
| (On) O (Off) mmHg kPa mL mm cmH2O
= on = off = Millimeters of Mercury = Kilopascal = Milliliter = Millimeter = Centimeters of Water
6700-0358-000 (Rev.6) 02/2014
= Consult Instructions for Use = Serial Number = Manufacturer
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Thoracic Vacuum Regulator
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Figure 1 Mode Selector Switch Vacuum Gauge Suction Control Knob
Probe/Adapter Port Fitting/Patient Port
Operation Equipment Setup If the regulator is equipped with a adapter/probe for wall outlets, insert the adapter/ probe into the vacuum wall outlet. If the regulator is mounted elsewhere, connect a vacuum supply hose between the regulator’s probe adapter and the wall outlet. WARNING:
Connection to positive pressure sources such as oxygen and medical air, even momentarily, could injure the patient or operator.
CAUTION:
Connection to positive pressure sources such as oxygen and medical air, even momentarily, could damage the equipment. Use hospital-supplied suction tubing between the end piece and the collection container, and between the patient port and the patient (minimum inside diameter is 6 mm [0.25 in.]). An Ohio Medical® high flow suction filter and overflow safety trap should be used between the collection container and regulator to prevent contamination of the regulator. ISO 10079-3 (section 5.1.2) states that “the usable volume of the collection container shall not be less than 500 mL.”
High Flow Suction Filters Hydrophilic: Nipple 20 Pack 6730-0350-800 200 Pack 6730-0351-800
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Hydrophobic: Nipple Threaded 3 Pack 6700-0570-800 6700-0580-800 10 Pack 6700-0571-800 6700-0581-800 50 Pack 6700-0572-800 6700-0582-800
6700-0358-000 (Rev.6) 02/2014
Attaching the Overflow Safety Trap (OST) CAUTION:
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To help prevent aspirate from entering the regulator, wall outlet and pipeline equipment, a safety trap should be attached prior to its use. Aspirate in the regulator, wall outlet and pipeline equipment may impair its operation. The use of the overflow safety trap and suction filter will help prevent this and extend the life of suction equipment.
Figure 2
Trap fitting
1. Raise the sleeve and insert the trap into the regulator fitting. 2. Turn the trap clockwise about one and a half turns to engage the threads. The trap does not need to be screwed tight; an O-ring in the regulator fitting provides a vacuum seal. The trap should rotate freely to allow the desired tubing positioning.
3. Lower sleeve to lock trap in position. Regulator Sleeve
Mode Selection
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Figure 3
| (On) - Suction can be adjusted with the suction control knob.
O (Off) - No suction is supplied to the patient.
WARNING
A positive pressure relief valve in the Thoracic regulator will prevent pressure buildup in the system if suction is turned off using the mode selector switch.
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Setting the suction level
4 1.
Figure 4 Clamp the connective tubing to occlude the patient port
Clamp
5 2.
6 3.
Figure 5 Turn the mode selector switch to | (On).
Figure 6 Rotate the suction control knob until the vacuum gauge indicates the required setting.
WARNING
The regulator must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction.
Pre-Use Checkout Procedure WARNING
The Pre-Use Checkout Procedure must be performed before using the equipment on each patient. If the regulator fails any part of the Pre-Use Checkout Procedure, it must be removed from service and repaired by qualified service personnel.
Important: All tests must be performed with supply vacuum of 40.0 kPa (300 mm Hg) minimum. 1.
Turn the mode selector switch to O (Off).
2.
Rotate the suction control knob one full turn clockwise (increase).
3.
Clamp the connective tubing to occlude the fitting port. The gauge needle should not move.
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4.
Turn the mode selector switch to | (On).
5.
Rotate the suction control knob fully counter-clockwise (decrease).
6.
Clamp the connective tubing. The gauge needle should not move.
7.
With the tubing still clamped, increase the suction to 35 cmH2O (3.4 kPa).
8.
Slowly open and close the clamped tubing to create various flow rates through the regulator. Check that the suction level is maintained when the tubing is clamped.
9.
Clamp the connective tubing.
10. Rotate the suction control knob fully clockwise (increase) to check that the relief valve opens (begins to flow) at 55 cmH2O ± 5 cmH2O (5.4 kPa ± 0.5 kPa). As suction is increased, the relief valve should not allow levels of more than 60 cmH2O (5.9 kPa). 11. Reduce the suction to zero and set the mode selector switch to O (Off).
Patient Setup 1.
Make sure the Pre-Use Checkout Procedure has been performed.
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Figure 7
Setup with reusable collection system 2.
Clamp the connective tubing and turn the mode selector switch to | (On) Clamp
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Figure 8
Setup with disposable collection system 3.
Clamp the connective tubing, turn the mode selector switch to | (On), and occlude vent on disposable collection system. Clamp Occlude vent
WARNING
When using a disposable collection system, the atmospheric vent at the top of the suction control chamber must be occluded for proper suction regulation with the Thoracic regulator. Important: Once the atmospheric vent is occluded, the Thoracic regulator controls vacuum level regardless of the presence or amount of water in the suction control chamber. 4.
Set the prescribed suction level.
WARNING
The patient port of the regulator must be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction levels.
Important: Add 2 cm water seal amount from the level set on the regulator gauge to determine the total suction level applied to the patient. WARNING
5.
Turn the mode selector switch to O (Off).
WARNING
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Continuing to rotate the suction control knob past the point where the relief valve opens may result in suction levels higher than the preset relief pressure. A water seal system must be used with the thoracic regulator to prevent atmospheric air from entering the pleural cavity, and to show the presence of air movement into the collection system.
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6.
Fill the water seal to its designated level.
7.
Connect the regulator to a reusable water seal or a disposable system with a water seal.
8.
Connect the water seal to the collection bottle's vacuum port.
9.
With reusable collection systems, connect the water seal to the vacuum port of the collection container.
10. Attach the patient tubing to the patient port of the collection container. 11. Clamp the patient tubing. 12. Turn the mode selector switch to | (On). 13. After a brief period the bubbling in the water seal should stop. WARNING
With the patient tubing occluded, all the bubbling in the water seal system should stop. If bubbling does not stop, check all connections to troubleshoot and eliminate leaks.
14. Release the clamp on the patient tubing. WARNINGS
When a leak free collection system connected to a patient is turned on, and after initial air in the system is eliminated, only patient air will produce bubbles in the water seal.
Do not clamp the tubing between the patient and the collection bottle; a pressure build up in the catheter and tubing will result.
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Cleaning Routine cleaning of the regulator is recommended as a standard procedure after each use. Wipe all exterior surfaces with a solution of water and mild detergent and/or approved cleaning solution. Should misuse occur resulting in accidental flooding of the regulator, the regulator may be sterilized after cleaning using ethylene oxide (ETO). See section 5.2 (Sterilization) of the regulator service manual. After sterilization follow the service checkout procedures in section 8 (Service Checkout Procedure) of the regulator service manual. WARNINGS
After patient use, regulators may be contaminated. Handle in accordance with your hospital’s infection control policy.
To reduce transportation personnel and/or service personnel exposure to hazardous contamination, clean and disinfect all suction equipment before shipping for service.
Following sterilization with ethylene oxide, parts should be quarantined in a well ventilated area to allow dissipation of residual ethylene oxide gas absorbed by the material. Aerate parts for 8 hours at 54°C (130°F). Follow your hospital sterilization procedure.
Do not steam autoclave or liquid sterilize the regulator. Severe impairment to the operation of the regulator will result. The only acceptable method of sterilization is with gas (ethylene oxide).
CAUTION
Troubleshooting
If the regulator does not operate and you have performed the Pre-use Checkout Procedure, remove the regulator from service and refer to the Thoracic service manual or refer servicing to qualified service personnel.
Disposal Instructions Dispose of vacuum regulator in accordance with local regulations.
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North America United States Customer Service, Distribution Center Technical Support, Sales and Service Equipment Service Center Ohio Medical Corporation 1111 Lakeside Drive Gurnee, IL 60031 USA P: 866 549 6446 P: +1 847 855 0500 F: +1 847 855 6218
Ohio Medical Corporation Authorized Representative
EC REP
OxygenCare Ltd. 2 Holfeld Business Park Kilmacanogue Co Wicklow Ireland Tel: +353 1 2769700 Fax: +353 1 2764970
© 2013 Ohio Medical Corporation. This document contains information that is proprietary and confidential to Ohio Medical Corporation. Use of this information is under license from Ohio Medical Corporation. Any use other than that authorized by Ohio Medical Corporation is prohibited. Ohio Medical, Ohio Medical Corporation, and the Ohio Medical Corporation Logo are registered trademarks of Ohio Medical Corporation.
6700-0358-000 02/2014 Rev.6