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Summary of Contents for Mallinckrodt INOblender 10026
- Page 1 Operation and Maintenance Manual (English) Part No. 20003 Rev - 01 Part No. 20732 Rev-02 2014-02...
- Page 2 10070 INOblender (NIST, 800 ppm, English) Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademark of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owner. ©2016 Mallinckrodt Part No. 20732 Rev-02...
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Page 3: Table Of Contents
Contents General Information ......................3 Introduction ........................4 Definitions and Abbreviations ................... 4 Theory of Operation ......................5 Environmental Effects ....................... 6 Setup ........................... 7 Pre-Use Checkout ....................... 9 Operation ........................... 12 Maintenance ........................15 Replacing Regulator Tips....................16 Cylinder Leak Check....................... 18 Parts and Accessories ....................19 Specifications........................21 Part No. - Page 4 (Intentionally left blank) Part No. 20732 Rev-02 2014-02...
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Page 5: General Information
1/ General Information Part No. 20003 Rev - 01 Part No. 20732 Rev-02 2014-02... -
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1/ General Information Part No. 20732 Rev-02 2014-02... - Page 7 Cautions and Warnings WARNING: WARNINGS: Warnings tell you about dangerous conditions • The purge procedure must be followed that can cause injury to the operator or the to help ensure NO is purged from the patient if you do not obey all of the instructions pressure regulator, INOblender and hoses in this manual.
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Page 8: Introduction
Introduction The INOblender allows users to select a concentration of INOMAX, (nitric oxide in a balance of nitrogen), to be mixed into a user set flow of oxygen which is delivered to a patient. The intended use for the INOblender is as a back up to a primary INOMAX delivery system; or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary INOMAX delivery system for long term use. Definitions and abbreviations Nitrogen INOMAX (nitric oxide) for inhalation Nitrogen dioxide NO/N Nitric oxide (NO) and nitrogen (N ) gas mixture Oxygen Parts Per Million Set NO The dose of INOMAX set by the user Volume to volume Note: This manual shows the Set NO displays associated with the 0-80 ppm range. Symbols used in this manual or on the system Symbols replace words on the equipment and/or in this manual. These symbols include: Attention, consult accompanying Pneumatic Outlet documents! Rx ONLY Prescription use only Authorized Representative in the European Community Pressure... -
Page 9: Theory Of Operation
Theory of Operation 1. The INOblender connects to a 3-5 bar (45-75 psig) oxygen supply. The oxygen flow is then controlled by an integrated oxygen flow meter (2-14 lpm). There is a fixed restrictor in the oxygen flow path which creates a pressure proportional to the oxygen flow rate. 2. The INOblender is also connected to a 2 bar (30 psig) INOMAX (800 ppm or 400 ppm) supply. • The INOMAX flow is controlled by a balance regulator in proportion to the oxygen pressure caused by the fixed restrictor and the INOblender setting. • The balance regulator maintains a constant INOMAX dose for varying oxygen flow rates. 3. The flows of O and INOMAX are mixed prior to exiting the INOblender outlet. INOblender Schematic Diagram INOMAX Regulator Oxygen Source INOMAX Balance Cylinder Regulator Dose Knob Fixed Laminar INOMAX and Restrictor Outlet INOMAX Oxygen Oxygen/INOMAX Part No. -
Page 10: Environmental Effects
Environmental Effects The National Institute for Occupational Safety and Both methods show that the exposure levels are Health (NIOSH) has recommended exposure limits significantly less than the levels recommended as follows (ref 1). by NIOSH. If the location for using NO has uncertain ventilation, time-weighted (8 hours) average then the location should be evaluated for NO and concentration limit of 25 ppm build up prior to use. ceiling limit of 1 ppm. Ref. 1 Centers for Disease Control, Atlanta, GA The environmental build up of nitric oxide in a well 30333 USA. NIOSH Recommendations for ventilated ICU room can be evaluated using the Occupational Safety and Health Standards following calculation: 1988. - Page 11 2/ Setup Part No. 20003 Rev - 01 Part No. 20732 Rev-02 2014-02...
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Page 13: Setup
Setup Check the INOMAX gas cylinder for the correct product identity labels, cylinder concentration (800 or 400 ppm) and expiration date. Ensure the INOMAX gas cylinder has > 14 bar (200 psig). Note: • For the CGA-type INOMAX regulator connector, ensure the white plastic tip is not chipped or cracked. Remove and replace as necessary. (see Replacing the tip on the INOMAX regulator, Page 16). • For the ISO-type regulator connector, check that the O-ring is present and is not damaged (see Replacing the tip on the INOMAX regulator, Page 17). 1. Connect a high-pressure regulator to an INOMAX cylinder and hand tighten the fitting to the INOMAX cylinder. 2. Connect the INOMAX regulator hose to the INOblender inlet hose using the quick connect fittings. 3. Connect the oxygen supply to the O inlet fitting. (see part list for correct oxygen hose) Note: 3.5 bar (50 psig) nominal To oxygen source 1. Make sure the NO dose setting dial is turned to zero. 2. Attach a manual resuscitation bag to the INOblender outlet fitting. The INOblender is now set up. Proceed to Section 3/Pre-use Checkout. Part No. 20732 Rev-02 2014-02... - Page 14 (Intentionally left blank) Part No. 20732 Rev-02 2014-02...
- Page 15 3/ Pre-Use Checkout Part No. 20003 Rev - 01 Part No. 20732 Rev-02 2014-02...
- Page 16 3/ Pre-Use Checkout Part No. 20732 Rev-02 2014-02...
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Page 17: Pre-Use Checkout
Pre-use Checkout Caution: To help ensure proper operation, complete the pre-use checkout prior to each use. Set-up the INOblender as described in Section 2/Setup High-Pressure Leak Test 1. Make sure NO dose setting dial is turned to zero and flow meter is OFF. 2. Open and then close the cylinder valve. 3. Pressure gauge should indicate > 14 bar (200 psig). 4. Monitor pressure gauge for 30 seconds for any signs of pressure decrease. If no pressure decrease is observed, high-pressure leak test successful, proceed to Delivery Confirmation and Purge. 5. If observed pressure decrease continues, see Section 5/ Maintenance; Cylinder Leak Check. 6. If leak cannot be traced, replace the INOblender. Delivery Confirmation and Purge 1. Set the INOblender to 40 ppm when using an 800 ppm cylinder (20 ppm when using a 400 ppm cylinder). 2. Set the oxygen flow on the INOblender flow meter to 10 L/min to begin purge. 3. Ensure the pressure gauge decreases approximately 14 bar (200 psig) in 10 seconds (+ 2 sec.). 4. Continue purging until pressure gauge reads zero. Note: If the pressure does not decrease, then the INOblender is not delivering NO and the INOblender should be replaced. The INOblender is now ready for use. Proceed to Section 4/Operation. Part No. - Page 18 (Intentionally left blank) Part No. 20732 Rev-02 2014-02...
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Page 22: Operation
Operation WARNINGS: • The purge procedure must be followed to help ensure NO is purged from the system before the manual resuscitator bag is connected to the patient. • The manual bag should be squeezed repeatedly during use to avoid NO from building up in the bag. - Page 23 Prior to operation, complete the Pre-Use Checkout in Section 3. The purge procedure contained in the Pre-use Checkout helps ensure any NO is purged from the pressure regulator, INOblender and hoses before the manual resuscitator bag is connected to the patient. Note: Depressurize the INOMAX regulator by using the purge port on the back of the INOmax DS prior to removing from the cylinder valve. 1. Open the INOMAX cylinder valve. 2. Check for supply pressure of > 14 bar (200 psig). Adjust Settings 1. Turn the INOblender setting dial to the desired concentration (5 to 80 ppm for an 800 ppm cylinder and 2.5 to 40 ppm for a 400 ppm cylinder). 2. Turn the O flowmeter to the desired flow rate (5 to 14 L/min). 3. Squeeze the manual resuscitator 3-4 times to purge the NO from the system. The INOblender is now ready for patient use. Part No. 20732 Rev-02 2014-02...
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Page 27: Maintenance
Maintenance Cautions: • When cleaning, do not submerge in liquid. • Do not autoclave. Note: The INOblender does not contain any user repairable parts. Cleaning Procedure Caution • Apply cleaning agent to a cloth before application; do not spray cleaning agent directly on the device. It is important to prevent pooling and direct contact with open connections which can cause damage over time. - Clean the outer surface of the INOblender with a soft cloth dampened in a mild soap and water solution (Example: Palmolive Ultra antibacterial, 4 drops per 50 mL of warm water), isopropyl alcohol (70%), or with one of the following cleaning agents while following the manufacturer’s recommendations. Cleaning Agent Active Ingredients Precise Hospital Foam Cleaner o-Phenylphenol < 0.37% Disinfectant by Caltech Industries Other ingredients 99.63% Pure Green 24 by Pure Green, LLC SDC – silver ions 0.003% Citric acid 4.84% Other ingredients 95.157% PDI Super Sani Cloth by PDI n-Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl ammonium chlorides 0.25% n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium chlorides 0.25% Isopropyl alcohol 55% Inert ingredients 44.50%... - Page 28 Yearly Calibration The INOblender calibration should be checked every 12 months using the NO monitor of the primary NO delivery system. The test points should include all the control settings at oxygen gas flows of 5 and 14 L/min. If the INOblender is outside of the accuracy specification, it should not be used. Contact Customer Support at the number on the back cover of this manual for repair. Replacing the CGA 626 tip on the INOMAX regulator Note: • Depressurize the INOMAX regulator by using the purge port on the back of the INOmax DS prior to removing from the cylinder valve. • Check the INOblender and connection hoses for signs of wear and damage. • For the CGA-type regulator connector, ensure the white plastic tip is not chipped or cracked. Remove and replace as necessary. (see Figure 5-1). 1. Disconnect the regulator from the INOMAX gas cylinder. 2. Remove the old CGA 626 tip (for ISO see Figure 5-2) by pulling on the tip (a) and turning it counterclockwise (b) (see Figure 5-1). 3. Ensure the threads are clean on the regulator tip (if required, use a lint free cloth). 4. Install the new tip: Flex the four prongs by squeezing two prongs at a time using only your fingers. This will help start the new tip into the threads. Turn the tip clockwise when threading the tip. When the Figure 5-1 tip is fully inserted, it should turn freely. Part No. 20732 Rev-02 2014-02...
- Page 29 Replacing the O-ring on the ISO 5145 INOMAX regulator fitting Note: • Depressurize the INOMAX regulator by using the purge port on the back of the INOmax DS prior to removing from the cylinder valve. • Check the INOblender and connection hoses for signs of wear and damage. • For the ISO-type regulator connector, check that the O-ring is present and is not damaged (see Figure 5-2). Note: Depressurize the INOMAX regulator by using the purge port on the back of the INOmax DS prior to removing from the cylinder valve. 1. Disconnect the regulator from the INOMAX therapy gas cylinder. 2. Remove the old ISO O-ring by rolling it off its groove (see Figure 5-2). 3. Clean the connector tip (if required, use a lint free cloth). 4. Roll the new O-ring into its groove. When correctly installed, it should not be removable O-ring by turning it. Gland Figure 5-2 Caution: Do not use hard objects to remove the O-ring as they may damage the metal gland and cause a leak. Part No. 20732 Rev-02 2014-02...
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Page 30: Cylinder Leak Check
Cylinder Leak Check If a leak is suspected during the high-pressure leak test (see Section 3/Pre-Use Checkout; High Pressure Leak Test), the following steps can be taken to check for leaks (see Figure 5-3 for possible cylinder gas leak locations) in the INOMAX regulator or INOMAX cylinder. 1. Ensure that INOMAX regulator is connected to Note: R efer to hospital policies and procedures cylinder valve outlet (hand-tighten only), that the for dealing with leaking gas cylinders. cylinder valve is open, and that the cylinder has Additional information regarding more than 14 bar (200 psig). environmental effects can be found in 2. Apply soapy water to points 1, 2, 3, 5 and 6 (see the section 1/General Information. Figure 5-3); if bubbles form, there is a leak. 3. If there are no bubbles, leak may be inside INOblender or INOmax DS and cannot be repaired. Replace INOblender or INOmax DS and contact Customer Support. Recommended actions should a leak be detected: 1. A leak detected at points 1 and 2 (see Figure 5-3) may be corrected by tightening the INOMAX regulator hand wheel. a. If cylinder valve is open, close cylinder valve and tighten INOMAX regulator hand wheel. -
Page 31: Parts And Accessories
Parts and Accessories WARNING: Use only parts/accessories designated for use with this system. Parts/Accessories Part Number Clamp Assembly 10008 Hose Assembly, Oxygen Green, DISS to DISS, 15 Feet 80344 Hose Assembly, Oxygen White, DISS to DISS, 15 Feet 80345 Hose Assembly, Oxygen White, DISS to SIS, 15 Feet 80353 Hose Assembly, Oxygen White, NIST to NIST, 15 Feet 80481 INOMAX Regulator, CGA 626 10006 INOMAX Regulator, ISO 5145 10020 INOMAX Regulator Extension Hose 10014 Operation and Maintenance Manual 20732 O-ring, ISO 5145 INOMAX Regulator 80470 Tip, CGA 626 INOMAX Regulator 1605-3149-000 Transport Mounting Bracket Assembly/Spacer 50041 Operation and Maintenance Manual Part Number... - Page 32 (Intentionally left blank) Part No. 20732 Rev-02 2014-02...
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Page 35: Specifications
Specifications INOblender Ü NO Set Range 5 to 80 ppm (800 ppm cylinder) 2.5 to 40 ppm (400 ppm cylinder) Setting accuracy +/- 20 % indicated or 2 ppm, whichever is greater Gas flow range 5 to 14 L/min of O inlet connection DISS (male), 3.4 bar (50 psig, nominal) NO/N inlet pressure 1.7 to 2.4 bar (25 to 35 psig) NO inlet Quick disconnect with shut-off (Female) NO/O outlet Barb fitting for oxygen supply tubing Max. Dimensions 200 mm (W) X 120 mm (H) X 110 mm (D) DISS (clamp included) 200 mm (W) X 120 mm (H) X 131 mm (D) NIST (clamp included) Max. weight 1.7 kg (clamp included) Operating and Storage Conditions Operating Temperature 10 to 40°C Operating Humidity 15% to 95% non-condensing Operating Barometric Pressure 57 to 110 kPa Storage Temperature -40 to + 70°C Storage Humidity 15% to 98% non condensing Storage Barometric Pressure 57 to 110 kPa INOMAX Pressure Regulator Cylinder Valve Connector... - Page 36 (Intentionally left blank) Part No. 20732 Rev-02 2014-02...
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- Page 38 Manufacturer North America Mallinckrodt Manufacturing LLC 6603 Femrite Drive, Madison, WI 53718-6801 USA 877-566-9466 www.mallinckrodt.com Europe Australia Europe Australia Representative European Authorized Representative Ikaria Australia Pty Ltd. MDSS GmbH 1300-198-565 Schiffgraben 41 30175 Hannover, Germany Part No. 20732 Rev-02 2014-02...