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The MetaNeb® System User Manual (174432 REV 7)

 31

Technical Specification for Performance—Breathing Simulator

C

LASSIFICATION AND 

S

TANDARDS

TECHNICAL SPECIFICATION FOR PERFORMANCE—BREATHING 
SIMULATOR

The performance checks shown on page 32 were measured by use of a 
breathing simulator. 

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:

Technical and Quality Assurance

ISO 13485
EN60601-1
EN13544-1

FDA Medical Device Equipment 
Classification

Class II

Classification According to Medical Device 
Directive 93/42/EEC

IIa

Breathing Simulator Settings

Lung Resistance

20 cmH2O/l/s

Lung Compliance

50 mL/cmH2O

Breath Rate

20 bpm

Effort Amplitude

25 cmH2O

Target Volume

500 mL

Содержание MetaNeb System

Страница 1: ...The MetaNeb System User Manual Product No PMN4 174432 REV 7...

Страница 2: ......

Страница 3: ...this manual is confidential and may not be disclosed to third parties without the prior written consent of Hill Rom The information in this manual is subject to change without notice Hill Rom makes n...

Страница 4: ...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...

Страница 5: ...tion 5 Normal Mucus Clearance 5 Mucociliary Escalator 5 Cough 5 Autocephalad Flow 6 The MetaNeb System and Bronchial Hygiene 6 Features 8 Controller 8 Circuit 9 Assemble the Controller System 10 Stand...

Страница 6: ...rcuit 21 Troubleshooting and Maintenance 24 Troubleshooting 24 Maintenance 25 Shipping and Packaging 25 Product symbols 26 Specifications 28 Controller Dimensions 29 Stand Dimensions 30 Classification...

Страница 7: ...or 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 hav...

Страница 8: ...d oxygen Patient Population Adult and children over the age of 2 Absolute Contraindications Untreated tension pneumothorax Untrained or unskilled operator Relative Contraindications History of pneumot...

Страница 9: ...only with hospital grade 50 psi oxygen sources that meet local state and government regulations Continuous Positive Expiratory Pressure CPEP is a therapy and is never to be used for life support Monit...

Страница 10: ...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...

Страница 11: ...in a cephalad fashion 1 3 mm per second The mucus with any entrapped particles is swallowed or coughed to the atmosphere Cough A cough can be voluntary or stimulated as part of a reflex and is an eff...

Страница 12: ...on the process is reversed and the alveolar pressure is greater than atmospheric The flow gradient is now from the alveoli to the mouth and therefore the greatest flow rates will be in the smaller air...

Страница 13: ...irway pressure above atmospheric by use of a venturi a fixed orifice resistor and flow during both inspiration and expiration CPEP Prevents or reverses atelectasis Delivers hyperinflation therapy thro...

Страница 14: ...atures 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...

Страница 15: ...rcuit 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...

Страница 16: ...E 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 Connect the Oxygen Hose 1 Attach and hand tighten t...

Страница 17: ...it in and twist it to the correct orientation CAUTION Use only with the supplied nebulizer 5 Remove the nebulizer from the package 6 Assemble the nebulizer and add the prescribed medication Refer to A...

Страница 18: ...12 The MetaNeb System User Manual 174432 REV 7 Assemble the Circuit Other Configurations Mask Tracheostomy In Line with Ventilator Circuit Flex tube adapter not included T connector not included...

Страница 19: ...o do so could cause equipment damage 1 Remove 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...

Страница 20: ...the handset 7 Watch the pressure gauge The average of pressure fluctuations should not be less than 15 and not more than 30 cm H2O 8 Set the mode to CPEP 9 Turn the CPEP flow dial counterclockwise to...

Страница 21: ...the handset 6 Watch the pressure gauge The average of pressure fluctuations should not be less than 15 and not more than 40 cm H2O 7 Set the mode to CPEP 8 Turn the CPEP flow dial counterclockwise to...

Страница 22: ...rescribed medications if applicable Add Medication to the Nebulizer on page 13 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...

Страница 23: ...atient to inhale normally and exhale slowly 3 4 seconds against pulsations keeping his or her cheeks firm to avoid pressure loss 22 Continue CHFO mode for approximately 2 minutes 23 Alternate between...

Страница 24: ...14 2 Follow your institutional guidelines for infection control 3 Introduce yourself and explain the procedure to the patient 4 Make a note of the current ventilator alarm and mode settings 5 The pati...

Страница 25: ...during treatment 16 Remove the handset and adapter from the spring valve tee and cap the spring valve tee before you put the The MetaNeb System master switch in the OFF position 17 Return the ventilat...

Страница 26: ...ollow these cleaning instructions could cause injury or equipment damage WARNING Failure to discard the SPU circuit in accordance with facility protocol could cause the spread of infection WARNING Do...

Страница 27: ...clean the controller and stand with a soft cotton cleaning pad that is moistened with the cleaner Do not use excessive liquid or harsh cleansers Do not immerse the controller in water or let liquids...

Страница 28: ...tient multiple use Clean the circuit as follows 1 Disconnect the circuit from the controller 2 Discard any unused medication in accordance with facility protocol 3 Disconnect the handset from the circ...

Страница 29: ...r for cracks or other damage If there is damage replace the circuit Refer to Circuit Part Numbers on page 38 Assemble the nebulizer Refer to Add Medication to the Nebulizer on page 13 Do the Pre Use C...

Страница 30: ...ct 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 oxygen source Selector ring...

Страница 31: ...nd 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 y...

Страница 32: ...ositive pressure to help hold open and expand the airways Continuous High Frequency Oscillation CHFO mode is a pneumatic form of chest physiotherapy that delivers medicated aerosol while oscillating t...

Страница 33: ...d date of manufacture Non sterile product By Prescription Only USA only Single patient use product The MetaNeb System conforms to the European Medical Device Directive 93 42 EEC a Authorized European...

Страница 34: ...ter 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 Oxygen Supply Hose USA only not applicable for other countries Color...

Страница 35: ...The MetaNeb System User Manual 174432 REV 7 29 Specifications Controller Dimensions...

Страница 36: ...t and Storage Environmental Conditions for Use Condition Range Temperature 40 to 158 F 40 to 70 C ambient temperature Relative humidity 10 to 95 non condensing Condition Range Temperature 50 to 94 F 1...

Страница 37: ...educed 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 setti...

Страница 38: ...ation 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...

Страница 39: ...rformance 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...

Страница 40: ...ured by use of a breathing simulator 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...

Страница 41: ...reathing Simulator Settings Bench Check 1 Lung Resistance 5 cmH2O l s Lung Compliance 70 mL cmH2O Breath Rate 15 bpm Effort Amplitude 15cmH2O Effort Slope 18 Effort Inhale 33 Effort Offset 0 cmH20 Tar...

Страница 42: ...ve Breathing Simulator Settings Bench Check 2 Lung Resistance 5 cmH2O l s Lung Compliance 90 mL cmH2O Breath Rate 15 bpm Effort Amplitude 15cmH2O Effort Slope 18 Effort Inhale 33 Effort Offset 0 cmH20...

Страница 43: ...e Breathing Simulator Settings Bench Check 3 Lung Resistance 30 cmH2O l s Lung Compliance 25 mL cmH2O Breath Rate 15 bpm Effort Amplitude 15cmH2O Effort Slope 18 Effort Inhale 33 Effort Offset 0 cmH20...

Страница 44: ...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 NOTE The performance data shown below may not...

Страница 45: ...pecifications 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 l...

Страница 46: ...imited 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...

Страница 47: ...ide 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 Devic...

Страница 48: ...42 The MetaNeb System User Manual 174432 REV 7 Particle Specifications NOTES...

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