780745-00 Rev. B Operating Instructions
780745-00 Rev. B
TABLE OF CONTENTS PAGE Warnings, Cautions, and Notes..............................4-7 Definition of Symbols...................................... 8 Product Description and Features...........................9-14 Operating the CR 50....................................15-20 Accessories and Options................................... 21 Performance Testing...................................... 22 Technical Information..................................... 23 Cleaning and Maintenance................................. 24 Warranty........................................... 24 Important Information About Your Prescription................. 25 CAUTION Federal (U.S.A.) law restricts this equipment to sale by or on the order of a physician. IMPORTANT NOTICE Read these operating instructions thoroughly before attempting to use this device. 780745-00 Rev. B 3
WARNING, CAUTIONS AND NOTES SAVE THESE INSTRUCTIONS Read This First Throughout this manual you will see three kinds of information with emphasis in the text. Be sure to carefully read and understand these notices. Each is important and related to the adjacent text. WARNING Warnings identify conditions that concern your personal safety and the safety of others. They include actions required to prevent injury or death. CAUTION Cautions identify conditions that may cause possible damage to the equipment or other property; or situations which may cause reduced, or loss of, oxygen flow. Ignoring cautions may cause damage or make equipment inoperative. NOTE: Indicates points of particular interest or emphasis for more efficient and convenient operation. 4 780745-00 Rev. B
WARNING Oxygen is a potentially hazardous substance. Although oxygen is nonflammable, it vigorously supports combustion. Keep oils, grease, and other petroleumbased products away from oxygen. Clean only as directed. Keep this product away from open flames. DO NOT ALLOW SMOKING NEAR THIS PRODUCT. This product vents a small amount of oxygen during normal operation. Do not use this product under clothing where oxygen could accumulate and create a fire hazard. Be sure to use the carrying bag designed for the CR 50 to prevent oxygen accumulation. The oxygen source pressure for this product should not exceed 3000 psi. Oxygen supplied from this equipment is for supplemental use and is not intended to be life supporting or life sustaining. This equipment is not intended for use by patients who would suffer immediate, permanent, or serious health consequences as a result of an interruption in their oxygen supply. Always open the oxygen cylinder SLOWLY. Rapid pressurization of this or other regulating devices can cause fire. 780745-00 Rev. B 5
WARNING Always use care in the storage of oxygen cylinders. Injury or fire could result if a pressurized cylinder falls and the cylinder valve or regulator breaks off the cylinder. Always have the CR 50 serviced by an authorized service facility. Internal components are under extreme pressure and improper assembly could result in explosion or fire. Do not remove the regulator from the cylinder before first closing the cylinder valve. Rapid depressurization of the cylinder will occur and a fire could result. CAUTION Use this device during sleep only when approved by your physician. Mechanical failure of the internal sensing circuit normally results in continuous flow delivery at the set flow rate. Do not use this product with a humidifier. Using a humidifier causes difficulty in triggering the flow of oxygen. Take the following precautions to avoid reduced oxygen flow or loss of flow to the patient: - Do not use with a single lumen cannula or cannula in excess of 7 feet. 6 780745-00 Rev. B
CAUTION (continued) - Patients with nasal obstructions or who are chronic mouth breathers should not use this device. - Attach the cannula properly. - Make sure there are no kinks or obstructions in the tubing. - Firmly seat the flow control knob at the desired flow setting. 780745-00 Rev. B 7
DEFINITION OF SYMBOLS SYMBOL DEFINITION Refer to documentation for information. Keep this product away from open flames. Do not smoke near this equipment. Do not oil. Do not place under clothing. 8 780745-00 Rev. B
PRODUCT DESCRIPTION AND FEATURES The CR 50 is a regulator designed for use with high-pressure oxygen cylinders to conserve oxygen. The CR 50 is both a regulator and a conserving device. The center module consists of the regulator, cylinder attachment, and contents gauge. Attached to the right side is the modular flow control and attached to the left is the conserving module (Figure 1). Conserving Module LPM Setting Flow Control Module Yoke Washer LPM Setting Delivery Sensing Vent Port Left Right Front View Warning Label Gauge Figure 1 Left Top View Regulator Right 780745-00 Rev. B 9
REGULATOR CYLINDER ATTACHMENT MODULE This module contains the high-pressure portion and all the pressure regulating components to produce a continuous flow at 22 psi. The body material is brass or aluminum depending upon the model selected. Gas cylinder connection options (Figure 2): CGA 870 yoke for standard pin indexed oxygen post valve CGA 540 nut and tailpiece for large oxygen cylinders Inlet Seal Washer CGA 870 CGA 540 Tighten Figure 2 A seal washer is provided with the yoke connections for the CGA 870 fitting to seal the regulator body to the post valve (Figure 2 and Figure 3). WARNING Use only Mallinckrodt (Nellcor Puritan Bennett) seal washers. Rapid depressurization and fire can result from the use of an improper seal washer. 10 780745-00 Rev. B
The cylinder contents gauge is located on the top of the regulator and reads to 3000 psi to provide a visual reference of cylinder contents (Figure 3). Cylinder Contents Gauge Seal Washer 2000 psig 3000 psig Figure 3 780745-00 Rev. B 11
FLOW CONTROL MODULE The flow control module is a sealed unit connected to the right side of the regulator body. Its purpose is to control the flow of oxygen to the patient. Flow is set by turning the control knob to one of 12 positions (Figure 4). Flow Control Figure 4 CAUTION Do not set the flow control between settings. This will result in inaccurate flows. Make sure the flow control is firmly seated on the desired flow setting. 12 780745-00 Rev. B
CONSERVING MODULE The conserving module is attached to the left side of the regulator body (Figure 5). Two tubing connectors are located on this component. The one nearest the center of the cylinder provides oxygen flow. The other senses inspiratory effort. A small bleed hole is located on the body of this module, below and behind these connectors. During normal operation when the cylinder is opened, a small amount of oxygen constantly vents through this hole. Do not block this hole or the regulator will deliver continuous flow. Conserving Module Sensing Vent Port Delivery Warning Label Figure 5 CAUTION Do not allow fluids or foreign material to enter the vent port. Failure to follow these instructions can result in malfunction of the device. 780745-00 Rev. B 13
Both tubes of the dual-lumen cannula supplied with this regulator must be attached to the two tubing connectors on the conserving module. Since both tubes are of equal diameter, it makes no difference which tube you attach to which connector (Figure 6). Attachment of Dual Lumen Cannula Figure 6 14 780745-00 Rev. B
OPERATING THE CR 50 1. Read this operating manual thoroughly before attempting to use this device. When in doubt, consult your home care provider or your physician. 2. Attach the regulator to the oxygen cylinder to be used. When attaching the yoke to a post valve, be sure to use the seal washer provided to prevent leaks. WARNING Use only Mallinckrodt (Nellcor Puritan Bennett) seal washers. Rapid depressurization and fire can result from the use of an improper seal washer. 3. Place the cylinder in the carrying bag, cart, or cylinder stand. If using the carrying bag, adjust the straps to a comfortable length. WARNING Be sure to use the bag designed for the CR 50 to prevent oxygen accumulation. 780745-00 Rev. B 15
There are two options for carrying bags: A carrying bag with shoulder strap can carry either an M6 or M9 cylinder. Use the padded sleeve when carrying the narrower M6 to fill up the space. Be sure to cinch the elastic around the neck of the cylinder to prevent oxygen from building up inside the bag (Figure 7). Waste Pack carry bag Figure 7 To Tighten ILLUSTRATION OF CARRYBAG Figure 8 16 780745-00 Rev. B
4. Attach both ends of the dual-lumen cannula to the CR 50 (Figure 9). Attachment of Dual Lumen Cannula Figure 9 5. Set the flow to OFF by rotating the flow selector to 0. WARNING Rapid pressurization of the regulator can cause fire. SLOWLY open the cylinder valve and check for audible leaks around the cylinder connection. If detected, turn off the cylinder valve and retighten the connection. SLOWLY reopen the cylinder valve and check again. 780745-00 Rev. B 17
6. Set the flow selector to the prescribed setting (Figure 10). Less Flow More Flow Figure 10 7. Place the cannula around the ears and position the prongs in your nose as instructed by your home care provider (Figure 11). Figure 11 18 780745-00 Rev. B
8. Breathe in through your nose and feel the flow of oxygen as you inhale. Note how the oxygen flow stops as you exhale through your nose. If flow is set at 1 L/min or above and is continuous, ensure the cylinder is upright and try again. If flow does not stop during exhalation, contact your home care provider to insure the unit is operating properly. (Flows of ¾ L/min and below will always be continuous.) 9. During normal operation, normal patient inspiration is sufficient to trigger the device. Once triggered, the CR 50 delivers a 12 ml pulse of oxygen followed by continuous flow at the set flow rate throughout the entire portion of inspiration. When inspiratory pressure stops, flow stops. 10. Because inhalation and exhalation times vary between patients, oxygen savings vary. Nominal savings will be about 50% of continuous flow. NOTE: Failure of the patient to trigger a breath results in no flow delivery. 780745-00 Rev. B 19
CONTINUOUS FLOW BAND Installation of this product on a CR 50 will allow for the device to be switched to continuous flow for settings of 1 L/min and higher for those situations where oxygen conservation is not indicated (nasal blockage or restriction due to cold, allergic reaction, etc). Proper installation will permit the patient to block a vent opening on the conserving module defaulting the unit to continuous flow at the set flow rate. 1. Position the band to engage the detent position as shown for the continuous flow mode. The vent opening should be completely blocked. 2. Position the band to engage the detent position as shown for the demand mode for normal operation of the CR 50. The vent opening should be exposed. 20 780745-00 Rev. B
ACCESSORIES AND OPTIONS Part Number Description 6-290694-00 CR 50 Bag for M6/M9 Cylinders 6-290695-00 CR 50 Bag for MD Cylinders 6-135016-00 Small Cart Cylinder for MD and ME cylinders 6-778057-00 7 Foot Dual-Lumen Nasal Cannula, 1 ea 6-778058-00 5 Foot Dual-Lumen Nasal Cannula, Case of 25 6-290654-33 Padded Carry Strap (optional) B-701508-00 B-701804-00 OxiClip/CR 50 Carry Bag Continuous Flow Band 780745-00 Rev. B 21
PERFORMANCE TESTING Qualified service personnel should perform this procedure between patients or when a problem is suspected with the CR 50. 1. Visually inspect the CR 50 for loose or missing parts. Ensure a NPB seal washer is provided at the inlet of the regulator if the connection is a CGA 870. 2. Attach the CR 50 to a full oxygen cylinder. 3. Attach a dual-lumen cannula to the CR 50. 4. Open the cylinder valve slowly and pressurize the CR 50. Check cylinder contents gauge and verify it reads full. 5. Set the CR 50 flow to 2 L/min. 6. Place cannula in nose and breathe normally. Verify CR 50 triggers on each breath. 7. Connect oxygen delivery leg of the cannula to a flowmeter. 8. Place finger over vent port located between the two hose barbs thereby placing CR 50 into continuous flow. 9. Turn the CR 50 flow control knob to each setting and check flow accuracy. 10. If sensing is suspect, replace the conserving module. If flow is suspect, replace the Flow Control Module. 22 780745-00 Rev. B
TECHNICAL INFORMATION Twelve flow settings in L/min: 0, ¼, ½, ¾, 1, 1½, 2, 2½, 3, 4, 5, 6 Oxygen Savings: nominal 50% at settings of 1 to 6 L/min based on average patient I:E Ratio. Settings.75 L/min and below are continuous flow. Materials of construction - Body: Aluminum or brass, depending on model - High-pressure inlet connection: Brass Inlet pressure range: 100 to 3000 psi Nominal regulating pressure: 22 psi Oxygen connections: CGA 870 or CGA 540 Safety relief valve setting: 50 psi Regulator weight: Oxygen Connection CGA 870 CGA 540 Regulator with aluminum body 1.1 lb 1.2 lb Regulator with brass body 2.1 lb 2.0 lb M6 cylinder systems holds 164.3 gaseous liters, weighs 5.43 lb and lasts about 2.7 hr at 2 L/min with the CR 50. M9 cylinder system holds 248 gaseous liters, weighs 7.15 lb and lasts about 4.1 hr at 2 L/min with the CR 50. MD cylinder system holds 415 gaseous liters, weighs 9.4 lb and lasts about 6.9 hr at 2 L/min with the CR 50. ME cylinder system holds 680 gaseous liters, and lasts about 11.3 hr at 2 L/min with the CR 50. 780745-00 Rev. B 23
CLEANING AND MAINTENANCE Do not use alcohol, solvents, polishes, or any oily substance on oxygen equipment. If cleaning is necessary, use only warm water or MadaCide (disinfectant). Dampen a cloth in the water or MadaCide and wipe the outside surfaces of the equipment until clean. Do not allow water to enter the vent port, the sensing or delivery connectors, or the oxygen supply connector. WARNING NEVER attempt to repair or disassemble this equipment. You could create a hazardous condition or cause equipment failure. If you have problems, questions, or are unsure if the equipment is operating properly, contact your home care provider. Warranty: Parts and labor are under warranty for one year. Opening the regulator module, conserving module, or flow control module voids all warranties. Thank you for using Mallinckrodt equipment. Please record the important information on the following page for later use. 24 780745-00 Rev. B
IMPORTANT INFORMATION ABOUT YOUR PRESCRIPTION Date your unit was received: Your name: Prescribed oxygen flow setting: during sleep at rest during exercise Doctor s name: Doctor s phone number: Home care company s name: Home care company s phone number: Emergency contact s name: Emergency contact s phone number: Special Instructions: 780745-00 Rev. B
Companion is a trademark of Puritan-Bennett Corp. Mallinckrodt Inc., 1999. All rights reserved. Printed U.S.A. Corporate Headquarters Mallinckrodt Inc. 675 McDonnell Boulevard P.O. Box 5840 St. Louis, MO 63134 USA Telephone: 314-654-2000 Toll Free: 1-800-635-5267 26 780745-00 Rev. B