Vacuum Regulator, Surgical - Free-Flow Instructions for Use Rev 7 Feb 2014

Table Of Contents Safety Instructions ...2 Intended Use ...2 Receiving/Inspection ...2 User Responsibility ...3 Definitions/Abbreviations ...3 Operation ...4 Pre-Use Checkout Procedure...7 Patient Setup ...8 Cleaning ...9 Troubleshooting ...9 Disposal Instructions ...9

Safety Instructions This manual provides you with important information about the Surgical Free-Flow 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® Surgical/Free-Flow Vacuum Regulator is a vacuum-powered body fluid suction apparatus that is intended to collect and remove body fluids in High Pressure/High Flow applications; generally in surgical procedures to aspirate fluid and debris from surgical fields.

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  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 use 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.

 This device should ONLY be used for high flow, high vacuum pressure applications.

NEVER use the Surgical Free-Flow Vacuum Regulator for low flow applications. Improper vacuum levels can cause a variety of injuries. To help reduce the risk of injury, appropriate suction applications MUST be used.

When using the Surgical Free-Flow Device, direct contact with blood vessels and or

vital organs should be avoided. Direct exposure of high vacuum levels to tissue may result in serious injury.

The Surgical Free-Flow Device should never be used for low flow vacuum applications,

including endotracheal suctioning, nasogastric suctioning and Chest Tube suction.

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6700-0372-000 (Rev.7)

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 “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   MAX High Flow High Vacuum Surgical/Free-Flow | (On) O (Off) mmHg kPa mL mm °C °F

= Indicates a potentially hazardous situation, which if not avoided, could result in death or serious injury. = Indicates a potentially hazardous situation, which if not avoided, could result in damage to the device or other property. = Attention. Alerts you to a warning or caution in the text. = maximum = high flow, high vacuum pressure = high vacuum/high flow regulator

= vacuum On = vacuum Off = Millimeters of Mercury = Kilopascal = Milliliter = Millimeter = Degrees Celsius = Degrees Fahrenheit

DISS

= Diameter Index Safety System



= Consult Instructions for Use = Serial Number = Manufacturer

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6700-0372-000 (Rev.7)

Operation - Surgical/Free-Flow 1

Figure 1 Mode Selector Switch Vacuum Gauge Suction Control Knob

 Probe/Adapter Port  Wrench  Fitting Port | (On)









 

Equipment Setup If the regulator is equipped with an adapter for wall outlets, insert the adapter into the vacuum wall outlet.

If the regulator is mounted elsewhere, connect a vacuum supply hose between the regulator’s adapter port and the wall outlet. Connect the collection bottle’s vacuum port to the regulator’s fitting or overflow safety trap with the appropriate vacuum tubing. 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 vacuum regulator and the collection container, as well as between the patient port of the collection container and the patient (minimum inside diameter is 6 mm [0.25 in]). An Ohio Medical® high flow suction filter and/or overflow safety trap (OST) should be used between the collection container and regulator to prevent contamination of the regulator, wall outlet and pipeline equipment. 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

Hydrophobic: Nipple 3 Pack 6700-0570-800 10 Pack 6700-0571-800 50 Pack 6700-0572-800 4

Threaded 6700-0580-800 6700-0581-800 6700-0582-800 6700-0372-000 (Rev.7)

Attaching the Overflow Safety Trap (OST) CAUTION 

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 safety trap and suction filter will help prevent this and extend the life of suction equipment.

Trap Fitting

2

Figure 2

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  Safety Trap



DISS Fitting

3

Figure 3



1. Insert trap into the regulator fitting. Situate the tubing in the desired position. 2. Turn the DISS wing nut clockwise to engage threads and tighten (there is no O-ring, so the vacuum seal depends on a tight connection).



 Regulator  Wing nut  Safety Trap



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Mode Selection

4

Figure 4 | (On)

| (On) - Suction can be adjusted with the suction control knob. (On)

O (Off) - No suction is supplied to the patient.

O (Off)

Setting the suction level

5

Figure 5

(CONT)

1. Clamp the connective tubing to occlude the fitting port.

 Clamp

6



Figure 6

2. Turn the mode selector switch to | (On). | (On)

(On)

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6700-0372-000 (Rev.7)

7

Figure 7

3. Rotate the suction control knob until the vacuum gauge indicates the required setting. Surgical/Free-Flow

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.

All tests must be performed with supply vacuum of 450 mmHg (60.0 kPa) minimum. 1. 2. 3. 4. 5. 6.

Turn the mode selector switch to O (Off). Rotate the suction control knob one full turn clockwise (increase). Clamp tubing to occlude the fitting port. The gauge needle should not move. With the tubing still clamped, turn the mode selector switch to | (On). The gauge needle should not move. Rotate the suction control knob fully anti-clockwise (decrease).

7. With the tubing still clamped, increase the suction to 300 mmHg (40.0 kPa). (For the standard model, increase the suction to 100 mmHg [13.3 kPa]). 8. Slowly open and close the clamped tubing to create various flow rates through the regulator. Ensure that the suction level is maintained when the tubing is clamped. 9. Reduce the suction to zero and set the mode selector switch to O (Off).

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Patient Setup 1. Make sure the Pre-Use Checkout Procedure has been performed.

8

Figure 8

2. Clamp the connective tubing and set the mode selector switch to | (On). (On)

 Clamp

400 300 500 60 70 600

80

50

40

20

90 700

200

30

High Flow High Vacuum

10

100

100

- kP

a

Hg -mm

Surgical/Free-Flow

Underwater Seal Line

2 cm H2O Made in USA



3. Set the prescribed suction level. WARNING 

The regulator MUST be occluded when setting the prescribed suction level so that the patient does not receive higher than required suction.

4. Turn the mode selector switch to O (Off). 5. Attach tubing to the vacuum port of the collection container. 6. Turn the mode selector switch to | (On).

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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 an 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 service personnel exposure to hazardous contamination, clean and disinfect

all suction equipment before disassembly.  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. CAUTION  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).

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 Surgical/Free-Flow 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: +1 866 549 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. ISO is a registered trademark of International Organization for Standardization.

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