Porter Scavenger Rubber Goods System User Instructions Rev P Aug 2010

User Instructions The Porter System is designed to solve the problem of exposure to Nitrous Oxide. Comfortable and quiet, the unique design of the mask minimizes any “competition” between the vacuum source and the patient. It allows the patient to receive the proper amount of Oxygen and Nitrous Oxide with normal respiratory effort. The silicon tubing and mask have increased durability and are steam and chemical vapor autoclavable. Porter features a mask-within-a-mask scavenging system. Metal and plastic parts have been eliminated from the mask so that xrays can be taken during a procedure without removing the mask. The mask includes easyto-remove inner liners that simplify cleaning and sterilization. The soft inner mask provides an excellent seal around the nose and a comfortable fit for the patient. Also available, are single-use personal mask liners for the Porter Scavenging System. A Non-Rebreathing Valve (NRV) and Emergency Air Intake (EAI) located on the bag tee provide safety features and make the “breathing bag” the visual barometer for monitoring the patient’s respiration rate. (See NRV and EAI tests below.) Porter Retrofit Kits Porter Scavenger Retrofit Kits are available for most brands of flowmeters. You can update your present nitrous oxide system for improved safety, durability, and comfort. These kits provide the standard features of NonRebreathing Valves (NRV) and Emergency Air Intakes (EAI) - important safeguards your present system may not have. You can easily check your current system for these safeguards using the following tests: Non-Rebreathing Valve (NRV) Test Disassemble the fresh gas tubing from the mask and “Y” connector, and breathe back into the fresh gas corrugated tubing (Figure 1, Item 9) connected to the flowmeter. You should not be able to fill the reservoir bag with exhaled gas. If the bag fills, this breathing circuit has no NRV and would allow for carbon dioxide (CO2) buildup in the breathing bag.

Emergency Air Intake (EAI) Test With the flowmeter turned off and the breathing bag empty, inhale through the mask. A check valve assembly should open allowing “room air” into the breathing circuit. If no room air enters the breathing circuit, this circuit has no EAI - an essential component for the safe and effective administration of Nitrous Oxide and Oxygen. If your system fails either of these tests, your system should be updated with a Porter Scavenger Retrofit Kit. IMPORTANT: It is not recommended to retrofit Porter Scavenger Rubber Goods to A-dec or Veriflo Flowmeters. It is only recommended to retrofit an AVS to the Porter Scavenger Systems and Porter Flowmeters, with the exception of the Porter Oral Surgeon unit (Model 3000-OS). ASSEMBLY INSTRUCTIONS 1. Bag Tee to Flowmeter: Screw knurled seal nut down tight onto Flowmeter making sure the rubber washer is inside the seal nut. When tight, Bag Tee should not rotate.

2. AVS 5000 / Bag Tee to Flowmeter: Screw AVS 5000 knurled seal nut down tight onto flowmeter making sure the rubber washer is inside seal nut. When tight, AVS should not rotate. Then, screw Bag Tee seal nut onto AVS. Bag Tee should not rotate.

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3. Rubber Goods to Bag Tee: (Refer to item (#) in parts list on the next page and Figures 1 and 2 on pages 4 and 5 for assembly and hook-up options.) A. Attach the nasal inhaler (#3 or #4) to the coaxial tubing assembly (#5) using the diameter indexed connectors (#11). B. Attach one end of the fresh gas corrugated tubing (#9) to the coaxial tubing assembly (#5) at the fresh gas “Y” connector (#7) and the other end to the 22-mm right angle flowmeter adapter (#10). Press fit the 22-mm right angle flowmeter adapter (#10) onto the bag tee (#6). C. Attach the 3 L bag (#13) to the bottom of the bag tee (#6). D. Attach Vacuum Hoses (#8): Refer to Figure 1 page 4. 1. Automatic Vacuum Switch: Attach one end of the vacuum hose (#8) to the vacuum hose “Y” connector (#12) and the other end to the MASK port (labeled on body) of the AVS (#1). Attach a second vacuum hose (#8) to the VAC port (labeled on body) of the AVS (#1), then insert straight end of adapter (#17) into the other end of the vacuum hose and the tapered end of the adapter into the High Volume Evacuation (HVE) Line. 2. Vacuum Control Block: Attach one end of the vacuum hose (#8) to the vacuum hose “Y” connector (#12) and the other end to the vacuum control block (#2). The vacuum control block can then be inserted directly into the High Volume Evacuation (HVE) Line; or may be placed “in line” by cutting the vacuum hose and attaching the cut ends of the tubing to both ends of the vacuum control block. NOTE: To properly read vacuum levels, the vacuum control block must be held upright with the on / off switch above the control valve. See Figure “A” below. Figure A

Note: An adapter (#14 or #15, refer to Figure 2 page 5) is provided if the installer wishes to “tee” into the vacuum line. The “tee” should be located after the solids collector.

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ITEM 1 2 3 3a 4 4a 5 6 7 8 9 9a 9b 10 10a 11 12 13a 13b 14 14a 15 16 17 *Can be

PART NUMBER. / REF AVS 5000 5501-RK 5054A 5054-1 5054B 5054-2 5056 P1407A (US) 5058 5059 5060-3 5060-6 4200* 1571-22 1570-24 5061 5062 4100-3NL* 4100-2NL* 5063 5068 5064 5065 A-3679-000

DESCRIPTION (Refer to Figure 1 for Assembly & Figure 2 for Options for Vacuum Hook-up.) Automatic Vacuum Switch (AVS) Vacuum Control Block Kit (Optional) Porter Adult Nasal Inhaler Complete with 3 liners. Package of 3 Adult Inner Liners Porter Pedo Nasal Inhaler Complete with 3 liners. Package of 3 Pedo Inner Liners Coaxial Tubing Assembly (Set of 2) Bag Tee (REF P1407E for European) Fresh Gas “Y” Connector Vacuum Hose (8 ft.) Fresh Gas Corrugated Tubing, Non-Latex (3 ft.) Fresh Gas Corrugated Tubing, Non-Latex (6 ft.) (Optional) Fresh Gas Corrugated Tubing, Latex (2 ½ ft.) (Optional) 22mm Right Angle Flowmeter Adapter 24mm Right Angle Flowmeter Adapter (Optional) Mask to Tubing Plastic Connectors (Set of 2) Vacuum Hose “Y” Connector 3 Liter Bag, Non-Latex 2 Liter Bag, Non-Latex 1/2” ‘T’ Adapter for In-line Vacuum Block (See Figure 2) 5/8” ‘T’ Adapter for In-line Vacuum Block (See Figure 2) “Straight” Adapter for In-line Vacuum Block (See Figure 2) Vacuum Tube Holder Adapter, Black, ¾” Round (VAC/MASK)

5. The bag should stay inflated. If so, the test has been successful and there are no excessive leaks. 6. If the bag does not stay inflated, the 3-liter bag or rubber goods have an excessive that leak. Replace any parts that leak and retest until results are successful. 7. Disconnect one of the duplex hoses from the plastic connector and re-install the nosepiece. Figure B

Quick Test to Check 3 Liter Bag / Rubber Goods for Leaks 1. With the flowmeter, bag tee and Porter rubber goods in place, remove the nosepiece and one of the two plastic connectors from the Porter rubber goods. Refer to Figure B. 2. With the other plastic connector, join the two duplex hoses together making a closed system. 3. Taking care not to fill the bag too much (bag could burst), open the oxygen control valve until the 3 liter bag starts to overinflate or “balloon”, then turn the meter off at the ON / OFF switch. 4. Observe the 3 liter bag for five minutes.

Remove one connector and join hoses together. . 3

4.3. 100% Oxygen only should be administered while the mask is being placed. Flowing Nitrous Oxide while fitting the mask will significantly increase N2O ppm (parts per million) exposures.

CAUTION The vacuum system should be equipped with a back flow shutoff device to prevent carryover of fluids into equipment attached to the piping systems. It is recommended that a separate vacuum trap be used between the piping system and the vacuum station inlet or any equipment that is attached to the system.

4.4. All Porter masks are sealed (no hole in the front of the mask). An open air valve or air dilution technique is not recommended. 4.5. Flow only the volume of gas required by the patient. An over-full reservoir bag indicates excessive gas flow, which could increase N2O ppm exposures.

CAUTION DO NOT PROCESS ANY LIQUIDS OR DEBRIS THROUGH THE AVS. This contamination can cause damage and affect the function of the unit. The AVS is designed to regulate the vacuum flow level for scavenging of Nitrous Oxide / Oxygen gas only.

4.6. 100% Oxygen only should be administered for several minutes at the end of the procedure. This will flush the Nitrous Oxide from the patient. Failure to follow this procedure will result in higher N2O ppm exposure in the operatory.

Basic Operation: For the AVS or Vacuum Control Block (Note: Use either an AVS or a Vacuum Control Block, not both): 1. AVS will automatically open upon the delivery of 1.5 to 3.5 L/min of gas flow. The Vacuum Control Block is manually operated and must be opened by pushing “on/off” toggle to “on” position. 2.

Field Performance Check of Adjustment of Vacuum Flow Using the AVS: 1.

Set a high flow: After assembly of AVS and Scavenging System to the Flowmeter, set flowmeter to flow 8 L/min of 100% Oxygen to fully open AVS vacuum interlock.

2.

Set vacuum level (green bar or higher): Turn vacuum control knob to set vacuum flow, as indicated by the vacuum indicator, in the desired area *.

Adjust vacuum flow by using vacuum control knob and acrylic sight glass on side of AVS or Vacuum Control block. Vacuum flow with ball float within the green bar area is effective; ball above green bar is for highest vacuum flows.

3.

Monitor the vacuum conditions during the procedure by observing the sight glass; adjust vacuum flow at any time as necessary.

4.

Follow good work recommended by NIOSH.

*Porter recommends that effective scavenging can be achieved with the ball float in the green bar area of the acrylic sight glass, however NIOSH publications conclude that higher vacuum flows of up to 45 L/min are most effective. To meet the NIOSH recommendation of 45 L/min, adjust the ball above the green bar area.

as

3.

4.1. Caution the patient not to talk unnecessarily or breathe through the mouth.

Close the flowmeter flow to zero. The ball float will drop to the bottom of the sight glass.

4.

Check at low flow: Open the flowmeter, again with 100% Oxygen, slowly to 3.5 L/min. Observe that the AVS vacuum flow indicator reaches the same level as in the setting of Step 2.

practices

4.2. The mask must be fitted properly to avoid leaks. (Pedo mask for children.)

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2. Inspect and maintain the analgesia delivery system to prevent N2O leaks in all hoses, connections, and fittings. Repair all leaks immediately. 3. Use scavenging. Exhaust ventilation of N2O from the patient’s mask should be maintained at an appropriate air flow rate as indicated by the calibrated flowmeter sight glass, and vented outdoors – not into the room ventilation system. 4. Supply and exhaust vents should be well separated to allow good mixing and prevent “short-circuiting.” 5. Fit mask to patient so inner mask is secure to the face. Outer mask should not be against face. Vacuum needs to be drawn into outer mask during inhalation. 6. Use minimum N2O levels to achieve desired analgesia effects. 7. Monitor work area for N2O to insure controls are effective in achieving low levels of PPM exposure. Contact your Porter dealer for details on monitors and testing.

NOTE: If low flow check does not show high enough vacuum flow, repeat Steps 1 - 4, and adjust vacuum control knob to a higher vacuum flow setting. Effective scavenging is achieved if vacuum flow can be verified to be within the green bar area of the acrylic sight glass. However, if the check of Step 4 fails, it may be an indication that the AVS requires maintenance. Contact your Porter dealer. Cleaning Methods: For cleaning the AVS and accessories, we recommend the use of an approved disinfectant for the dental environment. Follow the disinfectant manufacturer’s directions for use and their cautions. Recommended methods for cleaning and sterilizing rubber goods are listed in the chart. System Maintenance, Ventilation and Work Practices: 1.

It is advisable, on a two (2) year cycle, to have the AVS and flowmeter factory checked and serviced.

Recommended Methods for Cleaning and Sterilizing Porter Nasal Assembly

NOTE: The following items are not autoclaveable: Fresh Gas Tubing, 3L Latex Bags and Vacuum Control Valves. Nasal Hood and Liners Before cleaning, remove inner mask from hood. Pinch top and bottom of inner mask with thumb and forefinger then pull toward center. Follow recommended cleaning and sterilization as detailed in chart with hood and liner still separated. Then, replace inner mask into hood by pushing the tube connectors into large holes with thumb or forefinger.

W A R N I N G : Chemical Disinfectants should not be used! Disinfectants do not provide the same reduction in microbial contamination levels as sterilization. These techniques can leave a residue on the mask and liner that can irritate or even chemically burn the patient’s skin or mucous membranes if the mask / liner is not rinsed thoroughly with clean water.

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*NOTE: The following items are not autoclaveable: Fresh Gas Tubing, 3L Latex Bags and Vacuum Control Valves.

Recommended Cleaning and Sterilizing Product Frequency

Nasal Hood and Liners

Coaxial Hoses*

Latex-free 2L and 3L Bag*

After every patient.

Once a week

Once a week

Recommended: Wash in warm water with a mild detergent. Proceed to sterilization step.

Cleaning

Alternate Method: A thermal washer-disinfector may be used instead of warm soap and water. Proceed to sterilization step. (A washer-disinfector is not a substitute for sterilization, as it does not provide the same reduction in microbial contamination levels as sterilization.) Alternate Method: An ultrasonic cleaner may be used. Generally only required when dealing with blood or heavy bioburden. Proceed to sterilization step. Required: Rinse with water then follow the recommended Sterilization. Steam Autoclave:

Sterilize

bag or wrap. 134°C to 137°C for 3 minutes minimum; or bag or wrap. 121°C to 123°C for 15 minutes minimum Chemical Vapor Sterilizer: Let cleaned items dry completely then sterilize on any cycle recommended by the sterilizer manufacturer. Dry Heat Sterilization and Chemical Disinfectants should not be used!

WARNING: Dental workers are exposed to Nitrous Oxide (N2O) during administration of N2O/ O2 conscious sedation analgesia. NIOSH has recommended that exposures should be minimized. Contact NIOSH (1-800-35-NIOSH) to receive NIOSH Publications on Control of Nitrous Oxide in Dental Operatories. Exposure can be minimized by effective controls. National Institute for Occupational Safety and Health (NIOSH) publications state that controls, including System Maintenance, Ventilation and Work Practices can effectively reduce N2O concentrations in dental operations. Your Porter Scavenger System is an important part of the system of controls.

CAUTION 3L Breathing Bag 4100 and Corrugated Tubing 4200: These products contain Natural Rubber Latex, which may cause allergic reactions.

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CERTIFICATE OF WARRANTY THIS WARRANTY IS GIVEN IN PLACE OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE. Under no circumstances shall Parker Hannifin Corporation be liable for incidental or consequential damages as those terms are defined in the uniform commercial code. Parker Hannifin Corporation, Porter Instrument Division warrants that each product or part shall be free from defects in workmanship and materials, under normal use and with appropriate maintenance, for one (1) year from the date of delivery to customer unless otherwise specified in writing. All rubber and plastic parts and accessories are warranted under the same conditions for a period of ninety (90) days from date of purchase. No statement or claim about the product by any employee, agent, representative, or dealer of Parker Hannifin Corporation shall constitute a warranty by Parker Hannifin Corporation or give to rise to any liability or obligation of Parker Hannifin Corporation. Parker Hannifin Corporation shall not be liable for any damage, injury or loss arising out of the use of the product, whether as a result of a defect in the product or otherwise, if, prior to such damage, injury or loss, the product was (1) damaged or misused; (2) repaired, altered or modified by persons other than Parker Hannifin Corporation; (3) not installed in strict compliance with applicable codes and ordinances; or (4) not installed by an authorized Parker Hannifin Corporation dealer. Parker Hannifin Corporation's obligation for breach of this warranty, or for negligence or otherwise, shall be strictly and exclusively limited to the repair or replacement of the product or part. This warranty shall be void on any product on which the serial number has been altered, defaced or removed. ORDERS All orders are to be made through authorized Parker Hannifin Corporation distributors. All billing will be done through said distributors. Direct orders will be handled through the authorized local dealer as determined by Parker Hannifin Corporation. RETURNS All returned merchandise will be handled through the local Parker Hannifin Corporation distributor. No returns will be accepted unless authorized in writing by Parker Hannifin Corporation and accompanied by the original shipping invoice. All returns are subject to restocking charge. Policies subject to change without notice.

Manufacturer:

0473 This product complies with the Medical Device Directive (93 / 42 / EEC). A “Declaration of Conformity” in accordance with the directive has been made and is on file. European Communities should contact the Authorized Representative listed below regarding any Medical Device Directive (MDD) inquiries. Authorized Representative: Contact Name: Mailing Address: Phone: Fax:

Parker Hannifin Ltd Instrumentation Products Division Riverside Road, Pottington Business Park Barnstaple, EX 31 1NP, England +44 (0) 1271-313131 +44 (0) 1271-373636

Catalog No. FM-809 Rev. P 8/10