Mark 7A respirator Instruction Manual Rev C

Mark 7A® 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 7A 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

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+49.931.4972.0 tel +49.931.4972.423 fax

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Literature number: L1101 Revision C

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Contents Introduction ...1 Features ...1 Operating procedures (assist mode) ...3 Cleaning and decontamination ...6 Specifications ...7

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Introduction The Mark 7A® respirator is a pneumatically powered, flow adjustable, pressure/time cycled device. The Mark 7A, with apneustic flow time, is a second generation of the time proven Mark 7® respirator. The addition of apneustic flow time allows you to select a dynamic post-inspiratory apneustic hold, which begins at the end of a preset, pressure-cycled Inspiratory phase. During the apneustic flowtime phase, a plateau type inspiratory wave form is generated. This inspiratory pressure plateau serves to enhance inspired gas distribution. The apneustic flow time phase provides a dynamic, mechanical breath hold and should increase the distribution and deposition of inspired aerosols. The Mark 7A can be used to provide IPPB therapy and, when combined with CareFusion pneumatic flow clutching during the inspiratory phase for maximum pulmonary gas distribution, makes the unit an effective and versatile clinical device.

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 CareFusion accessories ● Adjustable peak inspiratory pressure of 60 cmH2O with overpressure governor factory preset at 30 cmH2O ● Circuit pressures are monitored internally on a standard dual-gauge manometer, calibrated in cmH2O and KPa. ● Manual override of all basic functions ● Automatic inspiratory and apneustic nebulization (independent of basic flow-rate setting) ● Adjustable dynamic apneustic hold utilizing the CareFusion apneustic flow time concept with terminal apneustic flow (150-200 ml/sec) adjustable from .3 to 3.0 seconds ● Quick disconnect fittings with number coding on all internal interconnections for ease of service ● External ambient filter for ease-of-service and installation of accessory 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 Mark 7A respirator using a standard 133S positive phase breathing circuit. Please follow each step as indicated while setting up and operating the unit even though its appearance and some of the controls resemble those which are used on the familiar Mark 7 respirator. Although initial setup and in-service training are generally performed by the CareFusion distributor or commercial agency effecting delivery, instructions for this operation are provided to accommodate certain emergency situations when it necessary to set up the equipment without assistance. 1. Remove all components from the shipping carton and inspect them for completeness and possible damage. A complete assembly consists of: ● P/N 7150 Mark 7A Respirator ● P/N 133S Positive Phase Breathing Circuit ● P/N 6893 Ambient Air Filter ● P/N 4230 Overpressure Governor 2. Place the air filter (P/N 6893) into the port located on the side of the ambient compartment (Figure 1).

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3. Place the over-pressure governor securely into the rear port located on the side of the pressure compartment (Figure 2).

4. Connect the breathing circuit (P/N 133S) to the ventilator by: ● Placing the large, elbow adaptor 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). 5. Connect the respirator to a 50 PSIG gas source.

Operating procedures (assist mode) 1. Complete the setup procedure. 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 MicroNEBULIZER® from the breathing head assembly and add 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 the 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 red cap located on the nebulizer housing is positioned on top of the nebulizer. 7. Turn the master switch to ON

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8. Set the pressure-cycled limit by adjusting the indicator arm located on the side of the pressure compartment (Figure 2). ● Pressure limits can be adjusted to a maximum of 65 cmH2O, provided the venting pressure of the over-pressure governor is adjusted accordingly. ● Adjust the over-pressure governor to relieve at a slightly higher pressure than the anticipated peek inspiratory pressure. To adjust, make sure patient is NOT connected to ventilator and move pressure control to maximum. Occlude breathing circuit and trigger ventilator ON with the hand timer. Adjust the flow-rate control to the 12:00 o’clock position. You should now be escaping from the overpressure and manometer will indicate the relief pressure. To increase the relief pressure, turn the small hex nut on the governor CLOCKWISE until desired relief pressure is achieved. To reduce relief pressure, turn the hex nut COUNTERCLOCKWISE. ● 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 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. 9. Rotate the Controlled Expiratory Time knob CLOCKWISE to the OFF position (Figure 3). 10. Adjust the Inspiratory Flowrate (Figure 3) to the 12:00 o’clock position as a starting point. Further adjustments will be made as the patient’s inspiratory flow demand is assessed and satisfied. ● 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 fully COUNTERCLOCKWISE.

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11. Adjust the starting effort to 20, as indicated on sensitivity ring. This results in an inspiratory starting effort of 2 cmH2O (Figure 1). Movement of the indicator arm away from 20 will result in an increased or decreased starting effort, with the actual effort shown by movement of the manometer needle into the pink zone as decreased pressure is created at the patient connector. 12. Pull the Pressure/Time Cycled control knob OUT (located on the front of the center body) for pressure cycled operation.

NOTE: This control is used only in conjunction with Apneustic Flowtime in that it activates the apnaustic hold cartridge. When pulled OUT, the inspiratory phase is pressure cycled. When pushed IN, there is an adjustable time cycled inspiratory phase following the initial pressure cycled phase. 13. Adjust the Apneustic Flowtime control (Figure 3), located on top of the center body, CLOCKWISE unless otherwise prescribed. ● Apneustic Flowtime is not functional unless the Pressure/Time Cycled knob is pushed IN. ● When the Pressure/Time Cycled knob is pushed IN, the apneustic time is adjusted by the Apneustic Flowtime knob. Apnaustic time is adjusted from 0.3 seconds (Full CLOCKWISE) to 3.0 seconds (Full COUNTERCLOCKWISE). These time intervals, when integrated with the apneustic flow of 150-200 ml/sec, results in the dynamic apneustic hold. Corresponding increases in airway pressure are a function of the patient’s pulmonary dynamics. 14. 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 15. 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 16. Adjust respiratory as indicated.

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Cleaning and decontamination The Mark 7A® 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 quatemary ammonium agents, used according to manufacturer’s instructions. For cleaning, use only detergents compatible with plastic materials. Phenols must NOT be used. Plastics must NOT be abused by 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). For further information, refer to CareFusion form P/N L768.

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Specifications Dimensions

8 1/4 “ (21cm) high 12” (30 cm) wide 6-1/4” (16cm) deep

Weight

6 lbs (2.7kg)

Power source

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

Inspiratory pressure limit

To 60 cm H2O

Overpressure governor factory preset at

30 cmH2O

Inspiratory flow rate

≥68 LPM (adjustable)

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

.5 sec to ∞

Apneustic FLowtime

Adjustable (0.3 to 3.0 sec) with apneustic flow of 150-200 ml/second

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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