Mark 7 respirator Instruction Manual Rev U

Mark 7® respirator

This document is protected by United States and International Copyright laws. This document may not be copied, reproduced, translated, stored in a retrieval system, transmitted in any form, or reduced to any electronic medium or machine-readable form, in whole or in part, without the written permission of CareFusion. Information in this document is subject to change without notice. This document is for informational purposes only and should not be considered as replacing or supplementing the terms and conditions of the License Agreement. © 2009–2010 CareFusion Corporation or one of its subsidiaries. All rights reserved. Mark 7 is a registered trademark of CareFusion Corporation or one of its subsidiaries. All other trademarks are the property of their respective owners. USA CareFusion 22745 Savi Ranch Parkway Yorba Linda, California 92887-4668

Authorized European Representative CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg, Germany District Court Wuerzburg HRB7004

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+49.931.4972.0 tel +49.931.4972.423 fax

carefusion.com

Literature number: L948 Revision U

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Contents Introduction ...1 Features ...1 Setup procedure...2 Operating procedure (assist mode) ...4 Cleaning and decontamination ...6 Specifications ...7

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Introduction The Mark 7® respirator is a pneumatically powered, pressure cycled, flow adjustable device used for delivery of routine IPPB therapy. The Mark 7 respirator features automatic inspiratory nebulization that is independent from the inspiratory flow-rate setting. This feature permits optimal aerosol production even when using low inspiratory flow rates. In addition, a number coding system on all internal circuits simplifies maintenance and repair.

Features ● Independent flow-rate control ● Pneumatic flow clutching during inspiration for maximum pulmonary gas distribution ● Precision ceramic sequencing for friction-free cycling ● Magnetic clutch control over inspiratory pressure cycling and starting effort ● Use of standard accessories ● Pneumatically powered with any 50 PSIG source of medical gas ● Circuit pressures are monitored on a standard CareFusion dual-gauge manometer, calibrated in cmH2O with an over-pressure governor factor preset at 30 cmH2O. ● Adjustable peak inspiratory pressure of 60 cmH2O with an over-pressure governor factory preset at 30 cmH2O ● Manual override for all basic functions ● Automatic inspiratory nebulization (independent of basic flow-rate setting) ● Quick disconnect fittings with number coding on all internal interconnects for ease of service ● External ambient filter for ease of service and installation of entrainment reservoir ● Failsafe ambient-entrainment valve opens to accommodate the spontaneous breathing patient if the total gas supply fails ● Manual ON-OFF rotary switch

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Setup procedure The following instructions relate to the operation of the CareFusion Mark 7 respirator using a standard P/N 00133S Positive Phase Breathing Circuit. Although initial setup and in-service training are generally performed by the CareFusion distributor or the commercial agency effecting delivery, instructions for this operation are provided to accommodate certain emergency situations when the user may find it necessary to set up the equipment without assistance. Please follow each step as indicated for setting up and operating the unit. 1. Remove all components from the shipping carton and inspect them for completeness and possible damage. A complete assembly consists of: ● P/N 07100, Mark 7 Respirator ● P/N 00133S, Positive Phase Breathing Circuit ● P/N 06893, Ambient Air Filter ● P/N 04230, Over-pressure Governor 2. Place the air filter (P/N 06893) into the port located on the side of the ambient compartment (fig 1).

3. Place the over-pressure governor securely into the rear port located on the pressure compartment (Figure 2). 4. The over-pressure governor (P/N 04230) is factory set to relieve at 30 cmH20. If you plan to use a peak pressure higher than 25-30 cmH20, you will need to adjust the valve to relieve at a pressure of about 5 cmH20 above the anticipated peak pressure. Adjust the valve to a higher setting by turning the hex nut clockwise and a lower setting by turning the nut counterclockwise. Check the relief-valve setting by setting the ventilator pressure control to maximum, setting the flow control to 12:00 o’clock, occluding the breathing circuit and cycling the ventilator ON with a hand timer. The gas manometer indicates the pressure limit established by the relief valve. Adjust the valve to the desired level.

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5. Connect the breathing circuit (P/N 133S) to the ventilator by: ● Placing the large elbow located on the end of the large bore tube into the breathing tube outlet located on the side of the pressure compartment. ● Insert the small metal connector into the green, color-coded port marked Insp. Power (Figure 2). 6. Connect the respirator to a 50 PSIG gas source.

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Operating procedure (assist mode) 1. Complete the setup procedure as detailed in proceeding section. 2. Use a decontaminated breathing circuit. 3. Attach a mouthpiece, mask or other appropriate adjunct to the patient adaptor on the exhalation valve. 4. Check the external tubing connections for tightness. 5. Remove the CareFusion MicroNEBULIZER from the breathing head assembly and install medication, as prescribed, into the barrel of the nebulizer. Ensure that the medication does not spill down the breathing tube. 6. Place the MicroNEBULIZER back into the breathing head assembly so that medication is located at the bottom of the nebulizer barrel when the treatment is administered.

NOTE An arrow on the nebulizer indicates the DOWN position. In addition, when the nebulizer is properly placed, the cap located on the nebulizer housing is positioned on top of the nebulizer. 7. Turn the MASTER SWITCH to ON. 8. Set the PRESSURE CYCLE LIMIT by adjusting the indicator arm located on the side of the pressure compartment (Figure 2). ● Pressure limits may be adjusted to a maximum of 60 cmH2O, if the over-pressure governor has been adjusted to a higher relief setting. ● An initial estimate of pressure limit can be selected by using the number 20, located on the pressure arm housing, as a beginning point and subsequently adjusting the pressure either above or below this level as indicated. ● Actual pressures are shown on the pressure manometer when the breathing circuit is occluded and the machine is cycled ON.

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9. Rotate the CONTROLLED EXPIRATORY TIME knob CLOCKWISE to the OFF position (Figure 3). 10. Adjust the INSPIRATORY FLOWRATE to the 12:00 o’clock position as a starting point. Further adjustment may be required as the patient’s inspiratory flow demand is assessed and satisfied (Figure 3). ● Moving the control CLOCKWISE from the 12:00 o’clock position results in a decreased flow. ● Moving the control COUNTERCLOCKWISE from the 12:00 o’clock position results in an increased gas flow with maximum flow occurring when the control is full COUNTERCLOCKWISE. 11. Adjust the starting effort to 20 as indicated on the sensitivity ring. This results in an inspiratory starting effort of –2 cmH2O (Figure 1). Movement of the indicator arm away from 20 results in an increased or decreased starting effort, with the actual effort shown by movement of the manometer needle into the negative zone as decreased pressure is created at the patient connector. 12. Prepare the patient for therapy by: (The following is offered only as a recommendation.) ● Informing patient of benefits of treatment ● Explaining the procedure ● Answering any questions ● Positioning the patient ● Monitoring vital signs 13. Administer therapy and assess the patient’s response by noting: ● Chest excursion/breath sounds/tidal volume ● Relaxation/cooperation of patient ● Vital signs ● Desired physiological/pharmacological results 14. Adjust the respirator as indicated.

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Cleaning and decontamination The Mark 7 respirator manufactured by CareFusion is compatible with ethylene oxide gas sterilization. Breathing circuits are compatible with ethylene oxide gas sterilization and liquid agents, activated glutaraldehyde, and quaternary ammonium agents, if used according to the manufacturer’s instructions. For cleaning, use only detergents compatible with plastic materials. Phenols must NOT be used. Plastics must NOT be abused by the excessive thermal stress of incompletely vaporized (liquid phase) ETO. DO NOT steam autoclave or otherwise subject ventilators or components manufactured by CareFusion to temperatures over 60˚C (140˚F).

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Specifications Dimensions

8 1/2” (22cm) high 10 1/2” (27 cm) wide 6-1/8” (16cm) deep

Weight

5¾ lbs. (2.6 kg)

Power source

Compressed air or oxygen at 50 PSIG (± 5 PSIG)

Inspiratory pressure limit

5 – 60 cm H2O (adjustable)

Pressure relief (adjustable)

Preset at 30 cmH2O

Inspiratory flow rate

≥ 68 LPM

Assisted starting effort (sensitivity)

–.5 to –5 cmH2O

Manual cycling

PUSH/PULL control rod

Inspired oxygen percentage (assuming 100% oxygen as source gas)

40% – 90% O2

Expiratory time

0.5 sec to ∞

Inspiratory time (adjustable)

Variable, dependent upon inspiratory flow rate and inspiratory pressure.

NOTE: Prices, terms, conditions, and product specifications are subject to change without notice. Regulatory notice This symbol indicates the product contains phthalates.

The benefit of treatment with medical respiratory support devices outweighs the remote possibility of exposure to phthalates.

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