Continuous - Intermittent Digital Analog Vacuum Regulators Operating and Maintenance Manual Dec 2010

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2 Mode Face Assembly 3 Mode Face Assembly

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2. Analog Lens 0-200mmHg Gauge (Analog or Digital) 3. Gauge 0-300mmHg Gauge (Analog or Digital) 0-160mmHg Gauge (Analog or Digital) 4. Gauge O-rings (2pcs) 5. Selector Screw 3 Mode 6. Selector Face Plate 2 Mode Intermittent 7. Selector Switch 8. Selector Gasket 9. Index ball 10. Index Spring 11. Back Body 12. Selector Plug 13. Selector Plug O-ring 14. Back Gasket 15. Back Plate 16. Cover Screws (4 pcs) 2 17. Back Plate Screws (2 pcs)

1. Face Assembly

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18. Bottom Plate Screw 19. Orifice 20. Regulating Module (Standard, Pediatric & Neonatal Regulating Module) 21. Port O-rings (2 pcs) 22. Port Plug 23. Pediatric Relief Screw 12 11 24. Pediatric Relief Body Pediatric 25. Pediatric Relief Ball models only 26. Pediatric Relief O-ring 8 9 10 27. Intermittent Module 7 28. Chamber O-ring

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Regulating Module RegulaParts ting MList: A. Cap Screws (2pcs) G. Regulating Spring B. Regulating ACap Stem . Cap ScH. rew g C. Stem ScrewB. RegulatI.inRegulating Body creBody O-rings (2 pcs) D. Top Plate C. Stem SJ. te Stem O-ring E. Diaphragm D. Top PlaK. E. Diaphragm F. Support Plate

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INTERMITTENT VACUUM REGULATOR PART IDENTIFICATION

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IMPORTANT: SAFETY INSTRUCTIONS This manual provides you with important information about the Vacuum Regulators and should be read carefully to ensure the safe and proper use of this product. Read and understand all the safety and operating instructions contained in this booklet. If you do not understand these instructions, or have any questions, contact your supervisor, dealer or the manufacturer before attempting to use the apparatus.

! WARNING: Indicates a potentially hazardous situation, which if not avoided, could result in death or serious injury. ATTENTION: Indicates a potentially hazardous situation, which if not avoided, could result in minor or moderate injury. CAUTION: Indicates a potentially hazardous situation, which if not avoided, could result in property damage.

Receiving Inspection Remove product from package and inspect for damage. Verify that the model received is in working order. If product is damaged or incorrect do not use. Contact your dealer, equipment provider or manufacturer. ATTENTION:

It is very important to allow product to remain in original packaging for 12-24 hours to acclimatize to room temperature before use.

User Responsibility ! WARNING:

This device is to be used only by people who have been properly trained on the operation of the device. Operation of this device is not to be done if flammable anesthetics are present due to the possibility of explosion caused by static charge.

This product performs as explained in this manual. This holds true as long as the assembly, use, repair and maintenance are properly followed according to our instructions. Periodic review of this device is recommended. If any damage or defects are present, the product should not be used. This includes parts that may have been altered, become contaminated, and are worn or missing. If any of the above are noted, immediate repair / replacement is required. In compliance with the Amvex Warranty, repair of this device is not to be performed by anyone other than a qualified professional and done in strict accordance to the written instructions provided by Amvex. If this device is subject to improper maintenance, repair, use and/or abuse leading to malfunction of the device, replacement is the sole responsibility of the user. ATTENTION:

Service of this device should only be performed by properly trained individuals.

! MRI WARNING: This product contains magnetic, ferrous material that may affect the result of an MRI. MR Conditional options may be available, contact your Amvex sales representative at 1-866-462-6839 or 905-764-7736.

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Intended Use Amvex Vacuum Regulators are intended to regulate a supplied vacuum pressure to the users desired vacuum level. A gauge shows the value of the regulated vacuum, which is adjustable via a regulating knob. DO NOT change, alter or modify intended use of the product. Vacuum Regulator Model

Gauge Range

Gauge Accuracy Analog

Digital

0 - 300 mmHg

+/- 3% F.S.

+/- 1% F.S. at 22ºC

0 - 200 mmHg

+/- 3% F.S.

+/- 1% F.S. at 22ºC

Pediatric Continuous / Intermittent

0 - 160 mmHg

+/- 3% F.S.

+/- 1% F.S. at 22ºC

Neonatal Continuous / Intermittent

0 - 100 mmHg

+/- 3% F.S.

+/- 1% F.S. at 22ºC

Continuous / Intermittent

Please note: F.S. = Full Scale

Operating Instructions ATTENTION:

The operating and storage temperature for the regulator should reflect typical environmental conditions of a medical facility environment.

Equipment Setup: Depending on the desired location of the regulator, connect the vacuum adapter directly into the wall outlet, or connect one end of an Amvex Corporation vacuum hose assembly onto the supply port of the suction regulator and the other end onto the vacuum source (i.e. wall outlet). Suction tubing, provided by the hospital, is required between the patient and patient port of the canister, as well as between the outlet port of the Vacuum Regulator and canister. 1/4” connection tubing is recommended by NFPA.* To prevent possible contamination of the regulator, a high flow suction filter or an overflow safety trap provided by Amvex is recommended between the regulator and the collection canister. NFPA recommends use of an overflow trap to protect the vacuum regulator outlet and vacuum system. Selecting the Mode:

REG: OFF: INT:

NOTE:

Allows degree of vacuum to be adjusted by use of the regulating knob. Vacuum is no longer on or being supplied to patient. Vacuum in intermittent (cycling between “ON” and “OFF”). Degree of vacuum can be adjusted with the regulating knob. REG mode is only available on the 3 mode models

Battery Low Indicator: NOTE: When the battery low icon is illuminated on the digital gauge, an Amvex representative should be contacted for battery replacement. *National Fire Protection Association (NFPA 99-2002). Healthcare facilities pages 497-498. 4

Procedures Prior to Use List: ! WARNING: The following checklist is recommended prior to use on each patient. If the Vacuum Regulator does not pass one or more of the following tests outlines on the checklist it should be evaluated, repaired and/or replaced by a qualified individual. The following tests must be done with a minimum supply vacuum of -53 kPa(-400 mmHg):

1. Move the selector switch to the “OFF” position. Turn the regulator knob one complete turn in the clockwise direction. Kink the vacuum tubing to block the outlet. There should be no movement of the gauge needle (or in case of a digital gauge, no change in display). 2. Move the selector switch to the “REG” position. Turn the regulator knob fully in the counter-clockwise direction. Kink the vacuum tubing; again, there should be no movement of the gauge needle (or in case of a digital gauge, no change in display). 3. Kink vacuum tubing. Regulator Setting: Standard: Increase the vacuum to -12 kPa (-90 mmHg) Pediatric & Neonatal: Increase the vacuum to -5 kPa (-40 mmHg) 4. Open and close the kinked vacuum tubing slowly to reach various vacuum rates. Ensure that the level of vacuum is staying consistent when the vacuum tubing is kinked. 5. Move the selector switch to “INT”. 6. Kink vacuum tubing. 7. Timing cycles are approximately 16 seconds on and 8 seconds off. NOTE:

The intermittent unit starts in the off cycle.

8. Decrease the vacuum level to zero and move the selector switch to the “OFF” position. Pediatric & Neonatal: 9. In the “REG” position, kink the vacuum tubing and turn the regulator control knob fully in the clockwise direction to ensure that the vacuum level does not go over -21 kPa (-160 mmHg) for Pediatric and -13 kPa (-100mmHg) for Neonatal. NOTE:

This feature is only present in the Pediatric and Neonatal models.

10. Decrease the vacuum level to zero and move the selector switch to the “OFF” position.

! WARNING:

Always verify vacuum setting prior to performing any procedure. Vacuum levels set in the “REG” mode will remain the same when switched to the “INT” mode; and vacuum levels set in the “INT” mode will remain the same when switched to the “REG” mode.

CAUTION:

When the collection canister is full DO NOT operate the Vacuum Regulator. The WARRANTY WILL BE VOIDED if the canister overflows and contaminates the Vacuum Regulator. 5

Setup for Patient use: Setting the Level of Vacuum for Patient use: 1. Move the selector switch to the “REG” position 2. Kink the vacuum tubing. 3. Set the required vacuum level.

! WARNING:

The vacuum tubing must be kinked to ensure that the patient is not exposed to a higher level of vacuum than what is required.

5. Move the selector switch to the “OFF” position. 6. Attach the vacuum tubing to the vacuum canister. Instructions for Setting the Intermittent Timing: 1. Remove the four cover screws [16] located at the back of the Vacuum Regulator and pull the Face Assembly [1] from the Back Body [11]. 2. Connect the Supply Port of the Vacuum Regulator to a vacuum source. 3. Occlude the Patient Port. 4. Switch the Vacuum Regulator to “INT” mode. 5. The Intermittent Module [25] must be held firmly against the Vacuum Regulator body during timing. NOTE:

The off time must be adjusted prior to the on time.

6. The unit will begin in the off mode of the intermittent cycle. To increase the off time, turn the “OFF” Needle Valve clockwise. To decrease the off time, turn the “OFF” Needle valve counterclockwise. 7. After the off time has been adjusted to the desired timing the on time may be adjusted. To increase the on time, turn the “ON” Needle Valve clockwise. To decrease the “ON” time, turn the “ON” Needle Valve counterclockwise. 8. Once the desired cycle time has been reached, slide the Face Assembly [1] back on the Back Body [11] and re-insert the four Cover Screws [16] the body and re-insert the four cover screws. 9. Amvex recommends that the user complete the Procedures Prior to Use List to assure Vacuum Regulator is operating correctly.

INTERMITTENT MODULE OFF Needle Valve

CAUTION: To prevent stripping of the plastic threads first turn the screw counterclockwise until it drops into its original threading. Now the screw may be turned clockwise and tightened.

ON Needle Valve

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Cleaning Instructions 1. Connect the supply port of the Vacuum Regulator to the patient port of a collection canister. 2. Attach the vacuum port of the collection canister to a vacuum source. 3. Connect a hose from the patient port of the Regulator to be cleaned and place the other end into a container containing 100cc of a cold sterilant. 4. Fully increase the regulating knob of the vacuum regulator (clockwise). 5. Turn on the Vacuum Regulator to the “REG” mode. Wait until all of the cold sterilant is passed through the regulator. 6. Repeat steps 3,4 & 5 for all modes of the Vacuum Regulator. 7. Repeat steps 3,4 & 5 using 100cc of isopropyl alcohol to purge the Vacuum Regulator of the sterilant. 8. The Regulator should run for 30 sec. in each mode with its patient port open to atmosphere to dry internal parts. CAUTION: Ethylene oxide is not recommended. Sterilization using an ethylene mixture may cause small surface cracks to some of the plastic parts that may not be apparent to the user. CAUTION: Do not steam autoclave, immerse in liquid or gas sterilize the Vacuum Regulators. This may damage the unit. CAUTION: If Vacuum Regulator becomes contaminated internally, warranty is voided. Do not send Vacuum Regulator back to the manufacturer. Follow your facilities procedures for handling contaminated products.

-ODE 3ELECTOR 3WITCH Mode Selector

3UPPLY 0ORT Supply Port G +NOB

To Vacuum Source

Regulating Knob 0ATIENT 0ORT Patient Port

Recommended Maintenance Container with cold sterilizer or alcohol #ONTAINER WITH COLD STERILANT OR ALCOHOL

The following are recommended maintenance steps that should be taken after each patient: 1. Clean the exterior of the Vacuum Regulator with a solution of a diluted mild detergent. 2. Make sure all secondary apparatus such as canisters and tubing are thoroughly cleaned. 3. Inspect the bacteria filter. If it has been contaminated replace with a new one. 4. Inspect the overflow safety trap to make sure it is free of any restrictions.

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Replacement Parts VR-AG-100MM-WL VR-AG-160MM-WL VR-AG-200MM-WL VR-AG-300MM-WL VR-DG-100MM VR-DG-160MM VR-DG-200MM VR-DG-300MM VR-MODULE VR-ORING-KIT-PI VR-ORING-KIT-CI

Analog Gauge with Lens 100mmHg Analog Gauge with Lens 160mmHg Analog Gauge with Lens 200mmHg Analog Gauge with Lens 300mmHg Digital Gauge with Lens 100mmHg Digital Gauge with Lens 160mmHg Digital Gauge 200mmHg Digital Gauge with Lens 300mmHg Regulating Module Assembly 1 Set of O-rings, Gaskets and Filters for all Pediatric & Neonatal Models. (PI, PP & NI, NN) 1 Set of O-rings, Gaskets and Filters for Continuous/ Intermittent Models (CI & I2)

WARRANTY During the term of your warranty: Within the first Twelve (12) months from date of shipment Amvex will repair or replace any part which is proven to be defective at Amvex’s cost. After the first Twelve (12) months, Amvex will send the parts to the customer free of charge, but the shipping and installation will be borne by the Customer. The warranty is valid only when the product has been properly installed according to Amvex specifications, used in a normal manner and serviced according to factory recommendations. It does not cover failures due to damage occurring in shipments or failures resulting from accidents, misuse, abuse, neglect, mishandling, alteration, misapplication or damage that may be attributable to acts of God. AMVEX CORPORATION DOES NOT HONOR VERBAL STATEMENTS CONCERNING THE WARRANTY. The distributor and/or dealer are not sanctioned to create verbal warranties about the product described in this agreement. Any statements will not be honored or be made part of the agreement of sale. This document is the final, complete and exclusive terms of the agreement. THIS WARRANTY IS INCLUSIVE AND REPLACES ALL OTHER WARRANTIES. Amvex Corporation shall not, under any circumstances, be liable for incidental or consequential damages including, but not limited to, profit loss, loss of sales or injuries to person(s) or property. Correction of non-compliances as noted above will result in completion of all liabilities of Amvex Corporation whether based on agreement, neglect or otherwise. Amvex Corporation reserves the right to stop manufacturing any product or change materials, designs or specifications without notice. All claims for warranty must first be approved by Amvex’s Repair Department: ([email protected] or 905-764-7736). A valid Return Goods Authorization (RGA) number must be obtained from Amvex prior to commencement of any warranty claim.

Authorized Representative in the European Union:

EC REP

Oxygen Care Ltd. 2 Holfeld Business Park Kilmacanogue Co Wicklow Ireland VR-I-MANUAL 12/10 8