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The MetaNeb® System

Instructions for Use

Product No. PMN4

Summary of Contents for MetaNeb

Page 1: ...The MetaNeb System Instructions for Use Product No PMN4 ...

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Page 3: ...Hill Rom The information in this manual is subject to change without notice Hill Rom makes no commitment to update or keep current the information in this manual Hill Rom reserves the right to make changes without notice in design specifications and models The only warranty Hill Rom makes is the express written warranty extended on the sale or rental of its products This manual 174432 was original...

Page 4: ...nc MetaNeb and MetaTherapy are registered trademarks of Comedica Inc Replace this manual 174432 if it is damaged and or can not be read For product support or to order additional copies of this manual 174432 contact your distributor local Hill Rom representative or go to www hill rom com Reference Documents MetaNeb System Service Manual International 187293 MetaNeb System Service Manual North Amer...

Page 5: ...iary Escalator 4 Cough 4 Autocephalad Flow 4 The MetaNeb System and Bronchial Hygiene 5 Symbols 6 Document Symbols 6 Product Symbols 7 Features 9 Controller 9 Circuit 10 Assemble the Controller System 11 Stand Assembly and Controller Installation 11 Installation of 183808 and 207384 Stands 11 Installation of M08183 Stand 12 Connect the Oxygen Hose 14 Assemble the Circuit 14 Typical Mouthpiece Conf...

Page 6: ...and Stand 27 Cleaning the Circuit 27 Troubleshooting and Maintenance 29 Troubleshooting 29 Maintenance 30 Shipping and Packaging 30 Specifications 31 Controller Dimensions 32 Stand Dimensions 183808 and 207384 33 Stand Dimensions M08183 34 Classification and Standards 35 Technical Specification for Performance Breathing Simulator 36 CHFO Pulses Airway Pressure Reading 37 CPEP Airway Pressure Readi...

Page 7: ...ressed oxygen PATIENT POPULATION Adults and children over the age of 2 ABSOLUTE CONTRAINDICATIONS Untreated tension pneumothorax Untrained or unskilled operator RELATIVE CONTRAINDICATIONS History of pneumothorax Pulmonary air leak Recent pneumonectomy Pulmonary hemorrhage Myocardial infarction Vomiting POSSIBLE ADVERSE REACTIONS Hyperventilation Gastric distension Decreased cardiac output Increase...

Page 8: ...local state and government regulations Continuous Positive Expiratory Pressure CPEP is a therapy and is never to be used for life support Monitor the patient patient lines and circuit lines during therapy and or bed articulation Make sure you connect the nebulizer to the nebulizer tubing only Only persons trained to use The MetaNeb System and ventilators should perform therapy on ventilated patien...

Page 9: ...pand the airways Aerosol for the delivery of aerosol only In this mode CHFO and CPEP are not available The MetaNeb System supplies a platform from which both CHFO and CPEP can be administered contiguously This composite therapy is referred to as MetaTherapy Treatment MetaTherapy Treatment is a combination therapy that seamlessly alternates between CPEP and CHFO modes CPEP is a therapy and is never...

Page 10: ...ve even large quantities of secretions from the upper airways 6th 7th generations This is accomplished by creating high velocity flow rates at high lung volumes through the generation of intrapleural pressures 100 mmHg then releasing this pressure explosively to the atmosphere Air can be expelled in excess of 100 miles per hour These high airflows create shear forces which in turn cause mucus to b...

Page 11: ...hial Hygiene The MetaNeb System supplies aerosol CHFO and CPEP therapy modes CHFO is a pneumatic form of chest physiotherapy that uses a systematic approach to enhance normal mucus clearance and resolve patchy atelectasis CHFO Supplies aerosolized medication and humidification to relax bronchial smooth muscle so that airway resistance is decreased and at the same time hydrates thickened retained s...

Page 12: ...sed for regular data Boldface text emphasizes a word or phrase NOTE sets apart special data or important instruction clarification WARNING or CAUTION A WARNING identifies situations or actions that may have an effect on patient or user safety To ignore a warning could cause patient or user injury A CAUTION identifies special procedures or precautions that persons must obey to help prevent equipmen...

Page 13: ...irways Continuous High Frequency Oscillation CHFO mode is a pneumatic form of chest physiotherapy that delivers medicated aero sol while oscillating the airways with continu ous pulses of positive pressure Refer to instructions for use Aerosol mode CHFO and CPEP are not avail able during this mode Higher Lower used with CHFO Flow used with CPEP Fire Hazard keep away from ignition sources This prod...

Page 14: ... Directive 93 42 EEC Units made on and after Septem ber 14 2018 Authorized European Representative Maintain the circuit tri connector bio filter in an upright position when in use Turn the circuit tri connector bio filter clockwise for secure fit with the control unit Mass of medical equipment including the mobile stand control unit patient circuit and the maximum load permitted to put in the bask...

Page 15: ...0 9 Features FEATURES CONTROLLER Item Description Item Description A Pressure manometer E CPEP flow adjuster B Higher lower switch F Master ON OFF switch C Mode selector G Oxygen gas connector D Circuit tri connector port H Mount bracket A C D B E F G H ...

Page 16: ...res CIRCUIT Item Description Item Description A Mouthpiece G Orifice indicators B Selector ring H Adapter 22 mm x 15 mm C Handset I Adapter 22 mm x 22 mm D Circuit tri connector bio filter J Occlusion ring E Tubing K Silicon adapter F Nebulizer L Nebulizer tubing ...

Page 17: ...contents list STAND ASSEMBLY AND CONTROLLER INSTALLATION Some older devices may have a different stand For a stand that differs from that shown refer to the instructions that were supplied with the stand If a two parts pole construction is used make sure the two parts are fully tightened to each other and there is no gap at the joint Installation of 183808 and 207384 Stands ...

Page 18: ...12 The MetaNeb System Instructions for Use 174432 REV 10 Assemble the Controller System Installation of M08183 Stand ...

Page 19: ...The MetaNeb System Instructions for Use 174432 REV 10 13 Assemble the Controller System ...

Page 20: ...ircuit tri connector bio filter to the tri connector port on the control unit NOTES Do not apply force or pull the device when it is connected to the oxygen source Do not pull the device using the circuit tubing when in use or during transportation 2 Remove the mouthpiece from the package 3 Attach the mouthpiece to the handset insert the mouthpiece at a 45 angle and gently push it in and twist it ...

Page 21: ...nect but do not twist the nebulizer hose of the tubing to the bottom of the nebulizer Make sure to push the bushing all the way on to the nebulizer stem NOTE A twisted hose can cause the nebulizer container to become loose OTHER CONFIGURATIONS Mask NOTE It may be difficult to connect the adapter to the facemask If needed apply more pressure when you are connecting the two parts Tracheostomy Flex t...

Page 22: ...ilter distal as recommended to the handset and moving the nebulizer distal to the bacterial filter has minimal impact on the oscillating pressure delivered by the device Specifications of the bacterial filter that can be used with the MetaNeb System Bacterial Filtration efficiency or equal to 99 Viral Filtration efficiency or equal to 99 Low Flow Resistance or equal to 2 0 cm H2O at 60 LPM Dead Sp...

Page 23: ...aline Insert the bacterial filter A into the handset B to contain potentially contaminated aerosol particles from the patient breathing or coughing within the ventilator breathing circuit Configuration 2 Using a Bacterial Filter and Nebulizer with the MetaNeb System NOTE This configuration is for use with a nebulizer with medication or saline See Add Medication to the Nebulizer on page 19 Insert t...

Page 24: ...e the container cap 1 from the nebulizer 2 If the green cone is not already installed put the green cone 2 into the container 3 3 Fill the container 3 with the prescribed medication The minimum capacity of the nebulizer is 1 mL and the maximum capacity is 5 mL NOTE If there is no medication administered use normal sterile saline to ensure the hydration of secretions 4 Install and tighten the conta...

Page 25: ...set to the three dots position 5 Put the master switch in the ON position 6 Occlude the patient opening of the handset 7 Watch the pressure gauge The pressure fluctuations should be noticeable the needle should not be steady and the average of pressure fluctuations should be between 15 and 30 cm H2O 8 Set the mode to CPEP 9 Turn the CPEP flow dial counterclockwise to full flow 10 With the selector...

Page 26: ...mode to CHFO and select Higher 4 Put the master switch in the ON position 5 Occlude the patient opening of the handset 6 Watch the pressure gauge The pressure fluctuations should be noticeable the needle should not be steady and the average of pressure fluctuations should be between 15 and 40 cm H2O 7 Set the mode to CPEP 8 Turn the CPEP flow dial counterclockwise to full flow 9 With the black occ...

Page 27: ...nstitutional guidelines 6 Fill the nebulizer with the prescribed medications if applicable See Using a Bacterial Filter In Line with the MetaNeb System on page 16 7 Set the mode to CPEP 8 Turn the CPEP flow dial all the way clockwise to the lowest position 9 Set the selector ring on the handset to the one dot position 10 Connect The MetaNeb System to an approved 50 psi oxygen source 11 Put the mas...

Page 28: ...her 20 During the treatment the selector ring may be adjusted and the Higher Lower switch may be moved to Lower NOTE The Lower setting on the Higher Lower switch reduces the percussion rate and the pressure and may be used as an introductory mode Subsequently the switch may be returned to the Higher position for enhanced therapy 21 Encourage the patient to inhale normally and exhale slowly 3 4 sec...

Page 29: ...WARNING Warning Only persons trained to use The MetaNeb System and ventilators should perform therapy on ventilated patients FREQUENCY In line use of The MetaNeb System with a ventilator ranges in frequency from four 4 to eight 8 times daily as determined by the patient s response to the therapy There is no need for CPEP as this therapy can be accomplished with the ventilator PROCEDURE 1 Make sure...

Page 30: ...nspiratory limb of the ventilator circuit 13 Monitor the patient response to the therapy and continue the treatment for 10 minutes or per facility protocol 14 Adjust the alarm parameters as necessary while The MetaNeb System supplies in line therapy WARNING Warning As secretions mobilize it is not uncommon for plugs to momentarily occlude the upper airways Do not leave the patient during the thera...

Page 31: ...EVALUATION Patients should be evaluated every 24 hours while on The MetaNeb System to make sure that an acute change has not occurred MOVE THE STAND NOTES Do not apply force or pull the device when it is connected to the oxygen source Do not pull the device using the circuit tubing when in use or during transportation 1 Disconnect the oxygen hose from the facility connection and put the hose aroun...

Page 32: ...en tested for compatibility with these cleaning and disinfecting solutions CLEANING THE CONTROLLER AND STAND Clean the controller and stand between patients when visibly soiled or according to facility protocols Do not spray the cleaner on to the controller We recommend that you clean the controller and stand with a soft cotton cleaning pad that is moistened with the cleaner Do not use excessive l...

Page 33: ...y the same patient These cleaning instructions are for multiple usage of the circuit by a single patient The circuit has been tested for compatibility with warm soapy water for cleaning The facility should follow their internal infection control policies on cleaning the nebulizer and circuit If a policy is not in place the following is a guideline for proper cleaning of the circuit 1 Disconnect th...

Page 34: ...ore the next use of the system do these Examine the nebulizer for cracks or other damage If there is damage replace the circuit See Circuit Part Numbers on page 43 Assemble the nebulizer See Using a Bacterial Filter In Line with the MetaNeb System on page 16 Do the Pre Use Check on page 20 For units used with an in line ventilator do the Pre Use Check For In Line Use with a Ventilator on page 21 ...

Page 35: ...sconnect the circuit and connect it correctly Replace the circuit Replace the O rings Make sure the master switch is ON CHFO or CPEP therapy weak Connected to an approved 50 psi oxy gen source Selector ring is on the single dot setting CPEP flow knob Connect to an approved 50 psi oxygen source Turn the selector ring to the 2 or 3 dot setting for the applicable effect Turn the CPEP knob to the appl...

Page 36: ...ipping and packaging instructions 1 Request and get a return goods authorization RGA number from Hill Rom NOTE You will get a return kit in the mail 2 Clean and disinfect the unit Make sure it is dry before you pack it See Cleaning on page 26 3 Follow the instructions in the return kit to pack the unit 4 Close and seal the box and apply the applicable labels on the outside of the box 5 During ship...

Page 37: ... and pole Height base to top of pole 50 6 0 04 128 5 cm 1 cm Pole diameter 1 2 5 cm Pole total length 45 115 cm Base height 8 7 22 cm includes casters Base width 23 2 58 9 cm Rolling diameter 25 63 5 cm Stand M08183 See page 34 Weight 22 3 lb 10 1 kg Height base to top of pole 49 6 0 04 126 cm 1 cm Pole diameter 1 3 3 30 cm 0 5 cm Pole total length includ ing bottom cart 42 5 108 cm 0 5 cm Base he...

Page 38: ...materials are not manufactured with natural latex Power Requirements b Minimum 50 psi 345kPa with 60 L min flow rate of hospital grade oxygen Sound Level 85 dBA during operation a Single and 5 pack options are available see Circuit Part Numbers on page 43 b The supply pressure is regulated to 50 psi 345 kPa if a higher pressure source is connected Feature Dimension ...

Page 39: ...The MetaNeb System Instructions for Use 174432 REV 10 33 Specifications STAND DIMENSIONS 183808 and 207384 ...

Page 40: ...34 The MetaNeb System Instructions for Use 174432 REV 10 Specifications STAND DIMENSIONS M08183 ...

Page 41: ...sing 1 These conditions and values apply to a fully assembled MetaNeb System Condition Range Temperature 40 to 158 F 40 to 70 C ambient temperature Relative humidity range 10 to 95 non condensing Atmospheric pressure 55 kPa to 106 kPa Condition Range Temperature 41 to 104 F 5 to 40 C ambient temperature Relative humidity range 15 to 90 non condensing Atmospheric pressure 70 kPa to 106 kPa Technica...

Page 42: ... simulator WARNING Warning Due to excessive restriction of valves in the Controller reduced performance levels may result when gas supply pressures 50 psi 345 kPa are used For these checks we used a compressed gas supply of 50 to 55 psi 345 to 379 kPa and the Breathing Simulator settings shown here Breathing Simulator Settings Lung Resistance 20 cm H2O l s Lung Compliance 50 mL cm H2O Breath Rate ...

Page 43: ...cification for Performance Breathing Simulator CHFO PULSES AIRWAY PRESSURE READING CPEP AIRWAY PRESSURE READING CHFO Results CHFO High Rate 240 60 bpm 300 bpm max CHFO Low Rate 70 of CHFO High Rate 100 bpm min Peak Pressure 30 cm H2O Oscillating Amplitude 5 cm H2O minimum ...

Page 44: ...or Performance Breathing Simulator HI PRESSURE CHFO PULSES AIRWAY PRESSURE READING HI PRESSURE CPEP AIRWAY PRESSURE READING CHFO Results CHFO High Rate 240 60 bpm 300 bpm max CHFO Low Rate 70 of CHFO High Rate 100 bpm min Peak Pressure 40 cm H2O Oscillating Amplitude 5 cm H2O minimum ...

Page 45: ...asured by use of a breathing simulator WARNING Warning Due to excessive restriction of valves in the Controller reduced performance levels may result when gas supply pressures 50 psi 345 kPa are used For these checks we used a compressed gas supply of 50 to 55 psi 345 to 379 kPa The breathing simulator was configured with different compliance and resistance values to represent different degrees of...

Page 46: ...rm Breathing Simulator Settings Bench Check 1 Lung Resistance 5 cm H2O l s Lung Compliance 70 mL cm H2O Breath Rate 15 bpm Effort Amplitude 15 cm H2O Effort Slope 18 Effort Inhale 33 Effort Offset 0 cm H2O Target Volume 650 mL Flow Conversion Factor 1 Time between Samples 30 1 milliseconds Number of Samples 400 ...

Page 47: ...ctive Breathing Simulator Settings Bench Check 2 Lung Resistance 5 cm H2O l s Lung Compliance 90 mL cm H2O Breath Rate 15 bpm Effort Amplitude 15 cm H2O Effort Slope 18 Effort Inhale 33 Effort Offset 0 cm H2O Target Volume 650 mL Flow Conversion Factor 1 Time between Samples 30 1 milliseconds Number of Samples 400 ...

Page 48: ...ctive Breathing Simulator Settings Bench Check 3 Lung Resistance 30 cm H2O l s Lung Compliance 25 mL cm H2O Breath Rate 15 bpm Effort Amplitude 15 cm H2O Effort Slope 18 Effort Inhale 33 Effort Offset 0 cm H2O Target Volume 650 mL Flow Conversion Factor 1 Time between Samples 30 1 milliseconds Number of Samples 400 ...

Page 49: ...w The performance is dependent on the type of drug and nebulizer unit that is used For more information contact Hill Rom your distributor or the drug supplier The performance data shown below may not be applicable for suspensions or medications with a high viscosity Representative Particle Size Distribution per EN13544 1 CIRCUIT PART NUMBERS Part Number Description C20000N Circuit SPU With Nebuliz...

Page 50: ...icle Specifications with 95 Confidence Level NOTE Coarse particles due to oro pharyngeal deposition and ultra fine particles due to exhalation are not likely to deposit in the patient s airway and provide limited clinical benefit Particle Characterization Drug MetaNeb MMAD um Albuterol Ipratropium Cromolyn 0 98 1 28 0 81 1 20 0 83 1 19 GSD 2 65 3 05 2 5 3 81 2 17 3 42 Total Dose Delivered by Devic...

Page 51: ...vide limited clinical benefit Particle Characterization Drug MetaNeb MMAD um Albuterol Ipratropium Cromolyn 0 83 1 19 0 51 1 00 0 59 0 85 GSD 2 79 3 75 2 76 4 01 2 55 3 335 Total Dose Delivered by Device ug 421 6 572 4 124 5 204 6 1367 9 1903 9 Total Respirable Dose 0 5 5 um 139 2 200 2 27 54 6 673 6 948 1 Coarse Particle Dose 4 7 microns ug 186 8 317 60 3 126 5 199 8 266 9 Fine Particle Dose 4 7 ...

Page 52: ... and provide limited clinical benefit Particle Characterization Drug MetaNeb MMAD um Albuterol Ipratropium Cromolyn 0 71 1 12 0 33 0 83 0 27 0 44 GSD 3 99 4 76 3 23 6 93 3 77 5 04 Total Dose Delivered by Device ug 389 6 529 149 180 1 647 5 929 9 Total Respirable Dose 0 5 5 um 89 137 8 16 6 46 4 208 299 2 Coarse Particle Dose 4 7 microns ug 205 7 338 6 87 8 119 122 4 150 Fine Particle Dose 4 7 micr...

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