GUS Models G14TC-2, G14TC-3 and G14VCT-2 Instruction Manual June 2006

©2000 PCI medical inc. All rights reserved. Printed in the United States of America GUS is a registered trademark of PCI medical inc. GUS®Models G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual 6/2006

No part of this publication may be reproduced without the express written permission of PCI medical inc. PCI medical inc. 12 Bridge Street, PO Box 188 Deep River, CT 06417 USA Tel:

(860) 526-2862

Fax:

(860) 526-3081

e-mail: [email protected]

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GUS Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

Contents Page Labels and Symbols ... 1 Environmental Conditions... 1 Supply Rating ... 1 Important Information – Please Read Before Use ... 2 Intended Use... 2 Instruction Manual... 2 Repair and Modification ... 2 Signal Words... 2 Precautions ... 3

Chapter 1 Functions ... 4 1.1 General Information... 4 1.2 Side Panel ... 5 1.3 Specifications ... 6

Chapter 2 Installation and Setup ... 7 2.1 Upon Delivery ... 7 2.2 Installation ... 8 2.3 Establishing Soaking Levels in Tubes... 11 2.4 Filling the Soak and Rinse Tubes... 12

Chapter 3 Operation...13 3.1 Placing the TEE Probe into the GUS® System ... 13 3.2 Removing and Rinsing the TEE Probe ... 13 3.3 Optional Storage Tube ... 14 3.4 Optional Leak Testing Assembly... 14

Chapter 4 System Maintenance ...15 4.1 Disposal of Used Disinfectant ... 15 4.2 Glute Out Neutralizer... 15 4.3 Changing the Filters ... 15 4.4 Care ... 17

Chapter 5 Troubleshooting Guide ...18 Warranty...18 Filter Guarantee...18 Parts List ...19

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

Labels and Symbols The meanings of the labels and symbols that appear on the packaging and/or the instrument are as follows:

Dangerous electrical voltage

Hazardous area

Ground point

Environmental Conditions •

For indoor use only.

•

Altitude up to 2,000 meters.

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Temperature range: 5°C to 40°C.

•

Maximum relative humidity: 80% for temperatures up to 31°C, decreasing linearly to 50% relative humidity at 40°C.

•

Main supply voltage fluctuations not to exceed +/- 10% of the nominal voltage.

•

Insulation over voltage category II.

•

Pollution degree 2.

Supply Ratings AC 230V 0.5A - 1.0A 50/60 Hz Fuse: 1.0 amp externally mounted

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

Important Information – Please Read Before Use Intended Use The GUS® Ductless Fume System allows transesophageal ultrasound probes to be safely immersed in high-level disinfectant solution. The unit’s exhaust fan and carbon filter remove fumes from high-level disinfectant solutions while the probe is soaking, preventing them from accumulating in the reprocessing area. Do not use the system for any purpose other than its intended use.

Instruction Manual This instruction manual contains essential information on using this system safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure, and use all equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments regarding any information in this instruction manual, please contact PCI medical.

Repair and Modification This system contains no user-serviceable parts. Do not modify or attempt to repair it; contact your local representative to purchase replacement filters and parts. Equipment damage can result from user attempts to repair or modify system components. Before attempting to perform routine maintenance on the system, thoroughly review and understand this manual for complete familiarization with the system and its operation.

Signal Words The following signal words are used throughout this manual: WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

NOTE

Indicates additional helpful information.

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

Precautions •

Also refer to your probe manufacturer’s reprocessing instructions. It is essential that the probe be pre-cleaned and leakage tested (if required by your probe manufacturer) before being placed into the GUS®system.

•

If the system is used in a manner not specified in this instruction manual, the protection it provides may be reduced.

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Allow the system to be operated only by those individuals trained in its proper use.

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The system is designed for indoor use only.

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Failure to properly clean and disinfect probes after each examination can compromise patient safety.

•

Patient debris and disinfectants are hazardous. Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During cleaning and disinfection or sterilization, wear appropriate personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemicalresistant gloves that fit properly and are long enough so that your skin is not exposed. Always remove contaminated personal protective equipment before leaving the reprocessing area.

•

All disinfectants must be monitored for effectiveness a minimum of once a day. Strictly follow the disinfectant manufacturer’s labeling, or the reuse life could be significantly affected. Do not use disinfectants beyond the time period specified on the manufacturer’s label (e.g., do not use a 14-day disinfectant beyond 14 days ⎯ even if potency test results are favorable), and discard solutions that are below the minimum effective concentration (MEC). Disinfectants may lose effectiveness before the end of the reuse life indicated on the label. To test the efficacy of the solution in the soak tube, attach a test strip to the clip provided and lower into the liquid.

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The system’s soak tubes must be tested for leakage prior to use.

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Factory-supplied replacement parts and filters must be used to assure proper operation and efficacy of the system.

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The system’s carbon filter must be replaced every six (6) months.

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Disconnect the system’s power supply before removing the filter.

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Do not replace the filter unless all disinfectant has been removed from the system.

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

Chapter 1 Functions 1.1 General Information The GUS® Fume Free Soaking System (see Figure 1, below) allows transesophageal ultrasound probes to be immersed in high-level disinfectant solution. The unit’s blower and carbon-filtration system removes fumes from high-level disinfectant solutions at the source while the probe is soaking, preventing them from accumulating in the reprocessing area. The system is designed to remove fumes from:

• • •

glutaraldehyde ortho-phthaldehyde (OPA) other high-level disinfectants

WARNING

Failure to follow the instructions in this manual may result in malfunction, improper reprocessing and/or damage to your transesophageal probe as well as damage to the system.

Padded Storage Compartment

Side (return) Vent

Curved Soak Tube

Rinse Tube Zinc Plated Steel Safety Cage

Figure 1. GUS® Model G14TC-3 Ductless Fume System

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

1.2 Side Panel Left Side Panel (see Figure 2) • • • • •

Power switch – The switch is illuminated red when the system is ON. Power cord – Connect to a hospital-grade electrical wall outlet. Fuse – Type FSF 5 x 20 mm, 1 amp, 250 VAC. Return vent – Filtered air is returned to the room through the side and bottom vents. Ratings plate – The model name, electrical information and serial number are shown.

CAUTION Make sure to turn the system ON before pouring high-level disinfectant into the soak tubes.

On/Off Switch

Fuse

Ratings Plate and Serial Number Power Cord

Figure 2. Left Side Panel

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GUS Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

1.3 Specifications Airflow: Volume of air treated high speed (CMM)...1.46 (CFM)...50 Avg. Face Velocity (MPS) ...0.5 (FPM) ...60 Electrical: Voltage ... 230V 50/60hz Current-Running... 19 watts Current-Max ...0.5 amps Filters: Carbon filter... activated carbon Fan/Blower:...backward curved impeller blower Construction: Fume Hood... powder coated carbon steel Front Panel ...clear acrylic Soak Tubes ...clear acrylic tubing and PVC fittings Dimensions: G14TC (Height x Width x Depth) ... 106.6cm x 35.6cm x 36.2cm

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

Chapter 2 Installation and Setup WARNING Should the slightest irregularity be suspected, do not use the system and refer to Chapter 5, “Troubleshooting Guide”. If the irregularity is still suspected after consulting Chapter 5, contact your local representative. Damage or irregularity may compromise patient or operator safety and may result in damage to the system and/or transesophageal probe. High-level disinfectants can be hazardous. Always wear appropriate personal protective equipment when preparing the system for use.

2.1 Upon Delivery Match all items in the package with those on the list of components given below. Inspect each item for damage. If any components are missing or damaged, or if you have any questions, do not use the system; immediately contact your local representative.

Component List 1 GUS®Model G14TC-2, G14TC-3 or G14VCT-2 Soak System 2 Soak/rinse curved tubes with caps for model G14TC-2, 3 tubes with model G14TC-3 2 Soak/rinse curved tubes with caps and two 30.5cm tubes with cap for model G14VCT-2 1 Support bracket 1 Zinc plated steel safety cage 1 Acrylic front panel 1 Cleaning brush for tubes 10 Hollow wall anchors 1 Test Strip Clip for use when testing efficacy of high-level disinfectant

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

2.2 Installation CAUTION

The unit is 35.6cm wide and needs at least 5cm of space on both sides

1. Establish general location of system ensuring 5cm of space on both sides. 2. See figure 3 for hole locations for anchor bolts. Mark these on the wall.

28 cm

•

• 119,4 cm

•

• 77,8 cm

•

• 56,2 cm

•

• 32,4 cm

•

• 19,7 cm

Floor

Figure 3: Hole locations to wall mount system

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

For sheet rock walls, using a 3/8” (1cm) drill bit, drill through these pencil marks and tap in the hollow wall anchors supplied with the unit. Tighten the screws firmly to lock in the anchors (for masonry walls you will need to use a suitable lead or plastic shield with bolt. These are not supplied with the unit). 3. Install the zinc plated steel safety cage first (see figure 4). Remove the screws from the anchors, place the cage against the wall and re-install the screws into the anchors. 4. Install the support bracket (see figure 5). Remove the screws from the anchors and insert into the black plastic spacers. Screw back into anchors, leaving approximately 4mm of the screw out from the spacers. When all four spacers are in place, slide the bracket over the screws and tighten. 5. Remove the screws from the top two anchors.

Figure 4. Safety Cage

Figure 5. Support Bracket

Figure 7. Location of Locking Machine Screw Figure 6. Install System

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

7. Remove the two locking machine screws located under the front corners of the system (see location in figure 7). Place the system over the support bracket (see figure 6) and re-install the two locking machine screws. 8. Re-install the two top screws into the anchors. 9. Place the curved soak and rinse tubes into the rack and slide the clear plastic panel into the front of the system (see figure 8).

Figure 8. G14TC Installed

Figure 9. Model G14VCT-2

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

2.3

Establishing Soaking Levels in Tubes CAUTION

Prior to pouring any liquid into the tubes, fill with water and let sit overnight to test for any leakage that may have occurred due to damage during shipping. If leak is found, do not use system. Contact your local representative.

1. With the soak tubes in place, pour water into one, leaving about 5cm above the plastic ‘T’. 2. Insert your TEE probe into the tube. CAUTION

Use a fluid motion when insertion the probe to prevent it from sticking in the tube. NEVER place the probe into a dry tube.

3. The probe should be fully inserted so that the handle rests on the top of the tube. Place the electrical connector into the top padded compartment. 4. With the probe fully inserted, the water level should be mid-way between the 100cm mark and the end of the strain relief. Add or subtract water as needed to achieve this level. See figure 10.

Figure 10. Establishing Maximum Fill Level

5. Remove the probe. Draw it through a dry paper towel to prevent drips. The water level with the probe removed is the MAXIMUM FILL LEVEL for the tube. Using an indelible pen, mark this water level on all tubes. It is important not to fill above this mark. 6. Repeat this process for additional probes from different manufacturers.

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

2.4

Filling the Soak and Rinse Tubes CAUTION

Make sure to turn the system ON before pouring high-level disinfectant into the soaking tube. Leave the system running whenever it contains high-level disinfectant. Keep the soaking tube covered as often as possible, to minimize evaporation of the disinfectant. Please note that the cover is not intended to be a tightfitting cover. Change the rinse water at least once per day or according to your normal infection control practices. Rinse tube may be sterilized by filling with glutaraldehyde and letting sit for ten hours. After ten hours, remove glutaraldehyde and rinse with sterile water. This should be done on a regular basis.

1. Turn ON the power switch. Confirm that the green light in the power switch goes on. 2. Activate (if required) and slowly pour the high-level disinfectant into the soaking tube. This should be done with the tube in the rack so that any fumes are carried to the filter. Fill the tube until it reaches the MAXIMUM FILL LEVEL established. 3. When testing the efficacy of your disinfectant, attach a test strip to the clip on the test strip clip provided with your station. Slowly lower the test strip into the disinfectant.

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

Chapter 3 Operation 3.1 Placing the TEE Probe in the GUS®System CAUTION

All probes must be manually cleaned, tested for leakage (if applicable), and dried prior to being placed in the GUS®system. Consult the probe manufacturer’s instructions for the proper procedures. Wear appropriate personal protective equipment when working with disinfectant solution.

1. Confirm that the system is switched on and that the fan is running. 2. Remove the cap from the soak tube and, using a fluid motion, insert the probe into the soak tube. CAUTION

Ensure that the end of the probe is in a straight position. DO NOT force the probe into the tube.

3. The handle of the probe should now rest on top of the soak tube. Place the electrical connector into the top compartment. You may wish to use the cushioned spring clip to keep the electrical cord out of the way. 4. Soak the TEE probe for the time recommended by the disinfectant manufacturer.

3.2 Removing and Rinsing the TEE Probe CAUTION 1. Prior to removing the TEE probe, place a damp paper towel or sterile cloth in your gloved hand. Nitrile gloves are the preferred gloves for working with high-level disinfectants. 2. Gripping the probe firmly, draw it through your glove until you reach the flexible end part of the probe. 3. Transfer the tip of the probe over to the rinse tube and insert the probe up to the handle. Use a continuous motion when inserting the probe into the rinse tube. 4. Peel off the glove, trapping the cloth inside, and discard. 5. Remove the probe from the rinse tube and follow your probe’s instruction manual for final rinsing and storage procedures.

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

3.3 Optional Storage Tube An optional storage tube is available for storing your transesophageal probe after disinfection procedures. The tube has an open slot running half down the front for easy insertion and removal of your scope. The base of the tube is open to aid in drying of the probe. To install, position the tube on the wall next to the GUS®system. Holding the tube in correct position, mark the wall for the anchor bolts. Using 3/8” (1cm) drill bit, drill through these marks and install the anchor bolts. Refer to figure 11.

Figure 11. Storage Tube

Figure 12. Leak Testing Assembly

3.4 Optional Leak Testing Assembly The Leak Testing Assembly includes: 1 2 2 2

White mounting plate Leads with banana clips on each end Electrodes factory installed in one of your tubes Anchor bolts

1.

Place white mounting plate on top of GUS® system as shown in figure 12.

2.

Mark location of the anchor bolts. Drill holes and install anchor bolts.

3.

Place your leak tester on the bracket as shown and plug the leads into the front of the tester.

4.

Plug the other ends of the leads into the two electrodes on the soak tube. Your tester is now ready to use.

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

Chapter 4 System Maintenance 4.1 Disposal of Used Disinfectant CAUTION

Remove and thoroughly rinse all tubes in which disinfectant is held, even if all disinfectant has been previously neutralized. Disinfectant residues can be hazardous. The tubes cannot be sterilized by autoclaving. Doing so will damage the tubes.

Disposing of used high-level disinfectant places users at risk of exposure to fumes. Such a risk arises from carrying a full tube of disinfectant to the sink, tipping and pouring into the sink. This creates the highest levels of disinfectant fumes and an increased potential for spills. PCI medical strongly recommends the use of a neutralizing agent when disposing of used glutaraldehyde and OPA from the system. Many municipalities require that glutaraldehyde and OPA be neutralized prior to disposing of into the sewer system. Follow the manufacturer’s instructions for use of the neutralizer, and refer to your hospital guidelines, national and local guidelines and policies.

4.2 Glute-Out II™ Neutralizer Glute-Out II™neutralizer is available in convenient 2-ounce bottles and will neutralize glutaraldehyde in five minutes. Each 2-ounce bottle deactivates 1 quart of glutaraldehyde solution or 1 gallon of OPA. With the GUS® system running, open and sprinkle slowly into the tubes containing high-level disinfectant and cover for five minutes. Use one bottle per tube. To order Glute-Out II™, contact your local representative.

4.3 Changing the Filters The GUS® System has a patented carbon filter that will last six months, even during continuous use. There are no individual pre-filters to be changed; this is automatically done by replacing the main filter every six months. CAUTION

The system’s filter must be replaced every six (6) months. Wear personal protective equipment – such as eyewear, facemask, moistureresistant clothing and chemical-resistant gloves – to protect against dangerous chemicals and infectious material. Prior to changing the filter, neutralize and dispose of any high-level disinfectant in the soaking tubes, and remove all equipment from the system. Disconnect the system’s power supply before removing the filter.

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

1. Turn the system’s power switch OFF, and disconnect the power cord from the electrical wall outlet. 2. Remove the foam pad and plate located in the top compartment by turning the screws counterclockwise (See figure 13)

Figure 13. Remove the Top Filter Plate

3. Remove the old filter by pulling up on the strap located on top of the filter. Place in plastic bag and discard with other non-hazardous waste. 4. Replace with a new filter. Verify that the direction of the arrows on the filter are pointing to the back of the GUS®system. 5. Replace the top plate and tighten the screws by turning clockwise.

NOTE Contact your local representative to order replacement filters.

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GUS®Model G14TC-2, G14TC-3 and G14VCT-2 230V Version Instruction Manual

4.4 Care Cleaning the System WARNING

When cleaning the system, always wear appropriate personal protective equipment. Potentially infectious material adhering to the unit could pose an infection control risk.

CAUTION

Do not use solvents to clean the acrylic front panel or tubes. Doing so may cause equipment damage. Do not wipe surfaces with hard or abrasive materials. Doing so will scratch the surfaces.

1. Turn the power switch OFF and disconnect the power cord from the wall-mains outlet. 2. To clean the acrylic tubes use the cleaning brush provided with your system and a mild detergent. Do not use solvents. 3. To clean metal surfaces: Use a clean, lint-free cloth moistened with a mild detergent solution and water. A mild solvent may be used on these surfaces for difficult-to-clean areas. 4. Make sure that the unit is completely dry before use.

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