Ohio Medical Corporation
Ohio Medical Corporation Suction Regulators
Collection Bottle and Water Seal for Vacuum Suction Units Instructions for Use Rev 8 Nov 2018
Instructions for Use
65 Pages
Preview
Page 1
Table of Contents Safety Instructions... 2 Intended Use... 2 User Responsibility... 2 Definitions... 3 Specifications... 3 Pre-Use Checkout Procedure... 4 Equipment Setup... 5 Disassembly – Collection Bottle... 6 Cleaning... 6 Parts List... 7 Troubleshooting... 8
Safety Instructions This manual provides you with important information about the Collection Bottle and Water Seal. 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 an questions, refer to service manual, contact your supervisor, dealer of the manufacturer before attempting to use the device.
Intended Use The Ohio Medical Suction Bottle Assembly and Water Seal are designed for the collection of various body fluids. •
The water seal is used with the Thoracic Regulator to prevent air from entering the pleural cavity, and to indicate the presence of air leaks in the lungs and/or the collection system.
•
The suction bottle assembly with a float type shut-off is designed to prevent fluids from entering the vacuum regulator or central suction system.
•
The collection bottle includes a splash deflector to control frothing.
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. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ohio Medical and 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.
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6700-0367-000 (Rev. 8) 11/18
Definitions WARNING: Possibility of injury to the patient or the operator exists. CAUTION:
Possibility of damage to the equipment exists.
= water seal line
= unlock, lock
= patient
⚠ 0086
= vacuum Symbol indicates the device complies with the requirements of Directive 93/42/EEC concerning medical devices Warnings and Cautions
Manufacturer
Catalog Number
Manufacturer’s Batch Code
MR Conditional
Consult instructions for use
Manufacturer’s authorized representative in the European Union Caution: Federal (USA) Law restricts this device to sale by or on the order of a licensed healthcare provider.
Specifications
Vacuum: Accuracy: Operating Temperature Range: Storage Temperature Range: Operating and Storage Relative Humidity: Applied Standards:
0 to 650 mm Hg ± 10 % full scale 39.2°F to 120.2°F (4°C to 49°C) -0.4°F to 159.8°F (-18°C to 71°C) 5 to 95% ISO 10079-3 : 2014
Usable Volume 3200 ml 1300 ml Weight 510 g (1.1 lb) 284 g (0.6 lb) Height 27 cm (10.6 in) 21 cm (8.4 in) Diameter 16 cm (6.3 in) 12 cm (4.8 in) Shut Off Volume 3200 ml 1300 ml Max Volume 3785 ml 1892 ml Increments 100 ml 50 ml WARNING
⚠ Do not use this device in the presence of flammable anesthetics. Explosion hazard may exist. CAUTION
⚠ This device is to be used only by persons who have been adequately instructed in its use. ⚠ Only a trained individual should repair this equipment. ⚠ Not for field or transport use.
6700-0367-000 (Rev. 8) 11/18
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Pre-Use Checkout Procedure WARNING
⚠ Perform the Pre-Use Checkout Procedure on the Collection Bottle before using on each patient. If there is any failure, remove from service and repair. Note: If leaks occur, check O-rings and or seals. Collection Bottle
Water Seal WARNING Bubbles in Water Seal indicate leaks in suction system or patient.
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Equipment Setup Use hospital-supplied suction tubing between the end piece and the collection container, and between the patient port and the patient (minimum inside diameter is 6mm).
Tandem Collection Bottle Setup
Thoracic Drainage Setup
WARNING:
⚠ This device must be in the vertical position to function.
MR Conditional
MRI testing demonstrated these devices are MR Conditional under the following conditions ONLY: Static magnetic field of 3-Tesla or less Maximum spatial gradient magnetic field of 720-Gauss/cm or less IMPORTANT NOTE: This product is intended for use inside of the MRI environment (e.g., in the MR system room). However, this product should NOT be utilized directly inside of the MR system (e.g., inside of the bore of the scanner) during the operation of the scanner. The assessment of magnetic field inteactions for this product specifically involved evaluations of magnetic field interactions, ONLY, in association with a 3-Tesla MR system
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Disassembly Cap Removal When the collection bottle shut-off vacuum feature stops vacuum and flow, the device must be emptied to continue the suctioning procedure.
Unlock to remove cap and empty contents
Lock to secure cap to bottle
Cleaning WARNING
⚠ After patient use, suction equipment may be contaminated.
⚠ To reduce service personnel exposure to hazardous contamination, clean and disinfect all suction equipment before disassembly. CAUTION
⚠ To prevent damage to equipment, completely rinse and wipe dry before autoclaving. ⚠ Before cleaning equipment check to be certain the cleaning agent is compatible.
⚠ After each cleaning or sterilization, inspect components and replace any that are damaged. Reassemble and perform pre-use check prior to returning to service. Note: To ensure the longest life of equipment: Clean all parts with a mild soap, rinse and dry. Ohio Medical recommends replacing product after 30 cycles of cleaning and disenfecting or sterilization. Note: Sparingly lubricate the rubber O-ring on the cap with Vac Kote® 37951 M (6700-0092-200) when reassembling the overflow trap following cleaning and sterilization. Table 1 – Cleaning Agent Compatibilityß and Sterilization Guidelines
*
Collection Bottle
Cap and Float
Water Seal
Recommended Cleaning Agents
Soaps Detergents Ammonia Alcohol†
Soaps Detergents
Soaps Detergents
Steam Sterilization*£
3-5 min. at 269.6°F (132°C)
3-5 min. at 269.6°F (132°C)
3-5 min. at 269.6°F (132°C)
3 min. at 273.2°F (134°C)
3 min at 273.2°F (134°C)
3 min. at 273.2°F (134°C)
1 min. at 285.8°F (141°C)
1 min. at 285.8°F (141°C)
1 min. at 285.8°F (141°C)
15-25 min. at 249.8°F (121°C)
15-25 min. at 249.8°F (121°C)
15-25 min. at 249.8°F (121°C)
Preferred temperature and duration in bold type.
£ Orientation - Bottle and jar upside down, all other parts upright or flat, parts not touching. † Alcohol may be used, but may cause cracking or crazing to highly stressed area with repeated use. ß Do not use Sodium Hypochlorite (bleach), Quaternary Ammonium, Glutaraldehyde acetone, methylene chloride or chloroform.
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Parts List
19
20
1.
0221-6289-300
Bushing, wing
13.
6700-0140-500
Float guide
2.
0221-6265-300
Tube, inlet vacuum bottle
14.
0221-6291-300
Float
3.
0210-0629-300
O-ring 2-010 neoprene
15.
4.
0221-6237-300
Wing, lock
0221-6251-300 0221-6252-300
Cap, underwater seal 1 gal. Cap, underwater seal 1/2 gal.
5.
0221-6242-300
Link, conductivity
16.
6700-0001-500
Bracket, wall (int'l, small mouth)
6.
0221-6266-300
Cap, vacuum bottle w/gasket
17.
0221-6267-300
Bracket, bottle wall/stand
7.
0210-1063-300
Gasket, cap vacuum trap bottle
18.
0221-6236-300
Bracket, bottle, floor
8.
6700-0183-400
Nut, tube bushing
19.
9.
0221-6290-300
Deflector, splash
0221-6256-300 0221-6257-300
Tube-underwater seal, 10-5/32L" Tube-underwater seal, 8-15/16L"
10.
6700-0092-500
O-ring 2-005 BUNA-N
20.
11.
6700-0179-400
Stem, stem & seat assembly
0212-0302-600 0212-0301-600
Bottle, plastic (3000ml) Bottle, plastic (1300ml)
12.
6700-0180-400
Filter screen, cap & float assembly
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Troubleshooting Problem Float Stuck No Suction
Probable Cause 1. Float neck dirty 1. Leaking Connections 2. Cap Assembly Loose 3. Suction Source not turned “ON” 4. Collection Bottle Full
Fluid Exits Bottle
1. Cap Assembly Loose 2. F loat doesn’t rise, float neck dirty 3. Crack in Bottle 1. Improper Cleaning agents used 2. Excessive Autoclaving
Cloudy/Opaque Bottle
Remedy 1. Clean float and float neck 1. Check connections and reconnect 2. C heck Cap Assembly and reconnect to Bottle 3. Turn Suction Source “ON” 4. Empty Collection Bottle 1. C heck Cap Assembly and reconnect 2. Clean float and float neck 3. Replace Collection Bottle 1. C lean Bottle with recommended cleaning agents 2. Replace Collection Bottle
© 2018 Ohio Medical, LLC. This document contains information that is proprietary and confidential to Ohio Medical, LLC. Use of this information is under license from Ohio Medical, LLC. Any use other than that authorized by Ohio Medical, LLC is prohibited. Ohio Medical and the Ohio Medical Logo are registered trademarks of Ohio Medical, LLC. Loctite is a registered trademark of Henkel Corporation. Cavicide is a registered trademark of Metrex Research Corporation.
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North America United States Customer Service, Distribution Center Technical Support, Sales and Service Equipment Service Center Ohio Medical, LLC 1111 Lakeside Drive Gurnee, IL 60031 USA P: +1 866 549 6446 P: +1 847 855 0800 F: +1 847 855 6218 www.ohiomedical.com
6700-0367-000 (Rev. 8) 11/18