Matrx Scavenger Instruction Manual

16 Pages

Table of Contents Notes and Contact Information ……………………………………………………………...iv Introduction ……………………………………………………………………………………..1 Intended Use ……………………………………………………………………………………..1 CE Notice …………………………………………………………………………………………1 Section 1 Description ………………………………………………………………………………………2 Section 2 2.1 2.2 2.3 Installation ……………………………………………………………………………………….3 Fresh Gas Tubing ………………………………………………………………………………..3 Vacuum Tubing …………………………………………………………………………………..3 Matrx MDM® and RA® Analgesia Heads ……………………………………………………..4 Section 3 Operation ………………………………………………………………………………………...4 Section 4 Changing the Hood …………………………………………………………………………….5 Section 5 Cleaning Instructions ………………………………………………………………………….6 Section 6 Assembly after Cleaning ………………………………………………………………………7 Section 7 Replacement Parts ……………………………………………………………………………..8 ii

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Ref. 10489600 Rev H

SAFETY SUMMARY CAUTIONS Federal Law in the U.S.A. and Canada restricts this device to sale by or on the order of a licensed practitioner. The Vacuum nipple, the vacuum adapter, the vacuum shutoff valve, and the scavenging control valve are not autoclavable (Figure 2). When autoclaving the Matrx Scavenger, follow the validated cleaning and sterilization methods provided. You can use temperatures in the range 120°C (248°F) to 134°C (274°F). Do not autoclave “white” single-use nasal hoods, the vacuum nipple, the vacuum adapter, the vacuum shutoff valve, or the scavenger control valve.

Table of Contents Notes and Contact Information ……………………………………………………………...iv Introduction ……………………………………………………………………………………..1 Intended Use ……………………………………………………………………………………..1 CE Notice …………………………………………………………………………………………1 Section 1

Description ………………………………………………………………………………………2

Section 2 2.1 2.2 2.3

Installation ……………………………………………………………………………………….3 Fresh Gas Tubing ………………………………………………………………………………..3 Vacuum Tubing …………………………………………………………………………………..3 Matrx MDM® and RA® Analgesia Heads ……………………………………………………..4

Section 3

Operation ………………………………………………………………………………………...4

Section 4

Changing the Hood …………………………………………………………………………….5

Section 5

Cleaning Instructions ………………………………………………………………………….6

Section 6

Assembly after Cleaning ………………………………………………………………………7

Section 7

Replacement Parts ……………………………………………………………………………..8

Table of Illustrations Figure 1. Figure 2. Figure 3. Figure 4. Figure 5. Figure 6. Figure 7.

Matrx Scavenger ……………………………………………………………………… 2 Shutoff Connection Options …………………………………………………………. 3 Direct Connection to HVE Piping System ………………………………………….. 3 Installing the Retaining Clip ………………………………………………………….. 4 Removing the Y from the Hood ……………………………………………………... 5 Correctly Seating the Cone in the Hood ……………………………………………. 5 Assembling the Cone …………………………………………………………………. 6

iii

Notes and Contact Information

Date Purchased

Dealer Name

Dealer Phone Number

Notes:

Introduction CAUTION Federal Law in the U.S.A. and Canada restricts this device to sale by or on the order of a licensed practitioner.

Intended Use The Matrx Scavenger is intended to deliver and remove oxygen and analgesic gas to the patient’s upper airway. It is designed for use by medical professionals trained in the administration of conscious sedation.

CE Notice The symbol on this product indicates compliance with the Medical Device Directive of the European Community. 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. Direct inquiries may be made to the following addresses:

Porter Regulatory Affairs: Parker Hannifin Corporation Precision Fluidics Division 245 Township Line Road Hatfield, PA 19440 USA Tel: 215-723-4000

Parker Hannifin Manufacturing Sarl Via privata Archimede 1, 20094 Corsico, Italy Phone: +0223077419

Section 1 Description The Matrx Scavenger is an autoclavable nitrous oxide scavenging system consisting of four parts (see Figure 1): 

a Matrx nasal hood (small, medium, or large)



a scavenging cone system



a vacuum tubing assembly



a fresh gas tubing assembly

The vacuum ports and a one-way exhalation valve make up the scavenging cone system. The vacuum tubing assembly consists of an integral Y-piece and vacuum hose. The fresh gas tubing comprises an integral Y-piece, a fresh gas tube, a slide, and a corrugated, 22 mm fresh gas connector. All components shown in Figure 1 (except single-use nasal hoods) are autoclavable.

The design and the small number of parts precludes missassembly during cleaning and mask changes.

Figure 1.

Matrx Scavenger

Section 2 Installation 3. Tee into an HVE line. The vacuum adapter diameter is stepped to accept either 1/2” or 7/16” inside diameter hose. The properly sized tee (dealer supplied) can be inserted into the HVE line ahead of the tip. Using the appropriately sized tubing supplied by the dealer, connect the scavenger to the free leg of the tee.

2.1 Fresh Gas Tubing Connect the Matrx Scavenger fresh gas tubing to the fresh gas outlet of the analgesia flowmeter. The 22 mm fresh gas connector of the Matrx Scavenger connects directly to a Matrx analgesia flowmeter or to one from a different manufacturer.

2.2 Vacuum Tubing

4. Direct connection to an HVE piping system (see Figure 3)

Vacuum tubing lacks corrugations on the hose. A white, hard, threaded fitting, called the vacuum nipple, attaches to the tubing’s termination. The vacuum nipple connects to the vacuum shutoff valve or to the optional scavenging control valve. The shutoff valve or the scavenging control valve attaches to the vacuum adapter. See Figure 2.

a. PVC Plumbing. The scavenger vacuum shutoff valve has 1/4 NPT female pipe threads. From a plumbing supply house, purchase the proper saddle (to fit the PVC pipe), bushing, and nipple to reduce the 1/4 NPT. Following the plumbing instructions, install the saddle and the bushings. Remove the vacuum adapter from the scavenger’s vacuum shutoff valve and thread the purchased nipple into the vacuum shutoff valve. Connect the nipple to the bushing. b. Hard copper plumbing. From a plumbing supply house, obtain a copper flush bushing with 1/4 NPT female pipe threads. Measure the inside diameter to determine the proper drill size. At the position where you plan to place the bushing, center punch the main copper pipe. Drill an 1/8” diameter hole through one wall only. Use successively larger drills until the hole’s diameter matches the outside diameter of the flush bushing. Insert the bushing, with the nipple in place, and attach the scavenging shutoff valve to the nipple.

Figure 2.

Shutoff Connection Options

CAUTION The vacuum nipple, the vacuum adapter, the vacuum shutoff valve, and the scavenging control valve are not autoclavable (Figure 2). The four methods to connect the vacuum adapter to a vacuum source are: 1. Direct connection to a high volume evacuation (HVE) line. The leading diameter of the vacuum adapter is sized to fit the HVE line inlet. Remove the HVE tip and insert the vacuum adapter. Figure 3.

2. Vacuum source in a junction box. Manufacturers provide junction boxes that have at least two vacuum terminals. You must use dealer-supplied hose and/or adapters to make this connection.

Direct connection to HVE Piping System

2.3 Matrx MDM® and RA® Analgesia Heads If you purchase the scavenger with the shutoff valve, the supplied clip is used to support the valve at the back of the MDM® or the RA® analgesia head. See Figure 4. 1. From the rear of the head, remove the lower left hand cover retaining screw. 2. Insert the screw through the mounting hole in the retaining clip. 3. Install the screw, securing the retaining clip to the machine head. 4. Snap the scavenger vacuum shutoff valve into the retaining clip. Figure 4.

5. Using dealer-supplied vacuum hoses, make the vacuum connection as previously described.

Installing the Retaining Clip

Section 3 Operation 1. Check the system before operation. Ensure that: 

The fresh gas tubing is connected to the analgesia flowmeter.



The vacuum system is connected to the vacuum shutoff valve or the scavenger control valve.



The vacuum shutoff valve or the scavenger control valve is connected to the vacuum system.



Or, open the scavenger control valve, adjusting the vacuum within the green band. Note that the line between red and green is in the American Dental Association’s (ADA) recommended 45 LPM scavenging flow. Any adjustment above this level improves the scavenging efficiency. 3. Operate the analgesia machine, according to the manufacturer’s instructions. 4. At the completion of the procedure, shut off the vacuum shutoff valve or the scavenger control valve.

The vacuum system is operating.

2. Open the vacuum shutoff valve completely.

Section 4 Changing the Hood 1. Hold the nasal hood in one hand. 2. With your other hand, gently pull the scavenging cone from the hood. 3. Disconnect the long sections of the gas Y and the vacuum Y from the hard plastic cone. 4. Pinching the gas Y just behind the hose connector, work the hood free from the gas Y. Repeat for the vacuum Y. These procedures leave the hose connectors connected to the Ys. See Figure 5.

Figure 6.

Correctly Seating the Cone in the Hood

7. Gently stretch the hole in the hood over the retaining tabs on the scavenging cone. When the cone is seated in the nasal hood properly, three segments of the cone base are visible inside the nasal hood. See Figure 6.

Figure 5.

8. Note the natural bend of the long tubing sections of the gas Y and the vacuum Y. Use this bend as a guide to determine a natural fit to the left and the right sides of the hood and cone assembly.

Removing the Y from the Hood

9. Pinching the hose connector in the gas Y, insert it into the hood fully. Repeat for the vacuum Y.

5. Remove the hood from the scavenging cone. 6. Turn the new hood upside down. Place your thumbs inside the hood.

10. Connect the long sections of the Y pieces to the two ports on the scavenging cone.

4. Follow the procedure below for automatic cleaning.

Section 5 Validated Cleaning Instructions You can autoclave all Matrx Scavenger components, except the components of the vacuum shutoff valve and the scavenging control valve. The nasal hood, fresh gas tubing, and vacuum tubing should be cleaned and sterilized after each use. To ensure proper cleaning, follow the directions below. Note: The 2L or 3L breathing bag may be cleaned as needed, and is able to be cleaned using manual, automatic, and sterilization cleaning methods. The breathing bag can also be sterilized using a steam autoclave using the standard cycles recommended by the manufacturer of the autoclave.

Transfer the test articles onto the 4–Level manifold rack accessory (or other appropriate rack system) contained inside the washer for processing. Angle the article in the washer basket to aid with drainage.

Document the placement location in the washer.

Select the appropriate cycle as listed below. detergent type and concentration (if applicable)

STAGE

RECIRCULATION TIME (MINUTES)

Temperature

Pre-wash 1