`Operation and Maintenance Manual
`CGA Variant
`
`om —
`
`001
`
`
`
`
`
`
`
`
`User Responsibility
`
`This Product will perform in conformity with the description thereof contained in
`
`this operating manual and accompanying labels and/or inserts, when
`
`assembled, operated, maintained, and repaired in accordance with the
`
`instructions provided. This Product must be checked periodically. A defective
`
`Product should not be used. Parts that are broken, missing plainly worn,
`
`distorted, or contaminated should be replaced immediately. Should repair or
`
`replacement become necessary, Datex-Ohmeda recommends that a telephonic
`
`or written request for service advice be made to the nearest Datex-Ohmeda
`
`Field Service Support center. This Product or any of its parts should not be
`
`repaired other than in accordance with written instructions provided by Datex-
`
`Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be
`
`altered without the prior written approval of Datex-Ohmeda’s Quality Assurance
`
`Department. The user of this Product shall have the sole responsibility for any
`
`malfunction which results from improper use, faulty maintenance, improper
`
`
`repair, damage, or alteration by anyone other than Datex-Ohmeda.
`
`A WARNING
`
`U.S. Federal and Canadian law restrict this device to sale by or on the or-
`
`der of a licensed medical practitioner. Outside the U.S.A. and Canada,
`
`check local laws for any restriction that may apply.
`
`
`Inhaled Nitric Oxide mixtures must be handled and stored in compliance
`
`with federal, state and local regulations.
`
`
`
`Datex-Ohmeda products have unit serial numbers with coded logic which
`indicates a product group code, the year of manufacture and a sequential unit
`
`number for identification.
`
`
`AAA A 12345
`
`
`P This alpha character indicates the year of product
`
`
`manufacture and when the serial number was
`
`assigned; “B” = 1998, “C” = 1999, “D” = 2000, etc.
`
`‘‘I’’ and “O” are not used.
`
`
`02/08/00
`
`
`1 605-0014-000
`
`
`002
`
`002
`
`
`
`Contents
`
`1/|nt'-Qduction
`
`Definitions and Abbreviations
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Symbols used in this manual or on the system .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.1—3
`
`.1—4
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .2—2
`
`2/Genera] |nfo|-[nation
`
`Overview .
`
`Configuration options .
`
`.
`
`Main component views
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.2—3
`
`.2—4
`
`. 2-?
`
`Display and user controls .
`
`Theory of operation .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`NO Flow from the cylinder to the patient
`breathing circuit.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`Effect of inserting the |NOvent into a
`breathing circuit.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.2—11
`
`. 2-11
`
`.
`
`.
`
`.2—14
`
`.
`
`.3—2
`
`NO delivery system connections .
`
`Mounting .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.3—2
`
`.3—3
`
`System connections .
`
`Electrical connections
`
`Setup menu .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.3—8
`
`.3—1 0
`
`.3—10
`
`Cylinder concentration .
`
`Hourmeter display .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`To set the alarm loudness .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.3—10
`
`.3—10
`
`.3—11
`
`To set the display brightness .
`
`.
`
`.
`
`.
`
`.
`
`4/Cafibration
`
`Calibration information .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`NO, NO; And O2 Sensor low range
`calibration (daily, room air) .
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .4—2
`
`.
`
`.
`
`.4—3
`
`.4—3
`
`Procedure .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`NO, N02 And O2 Sensor high range calibration .
`
`Procedure .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .4—5
`
`.
`
`.4—5
`
`1605-0014-000
`
`02KJ8lU0
`
`003
`
`
`
`|NOvent delivery system
`
`5/P;-e.|_|se
`P|'0CedU|'e5
`
`1. Initial connections and leak test .
`.
`.
`2. System purge and performance test
`
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`.
`.
`
`. 5-2
`. 5-3
`
`3. Manual N0 delivery system purge and performance test
`
`. 5-5
`
`3/operation
`
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`Before operation .
`Connection to an ICU ventilator circuit .
`
`.
`.
`
`.
`.
`
`Connection to a high frequency oscillatory
`ventilator circuit
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`Connection to a circle anesthesia system .
`
`.
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`. 6-2
`. 6-4
`
`. 6-8
`
`. 6-11
`
`. 6-14
`
`Connection to a transport ventilator circuit .
`
`Connection to bagging systems .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 6-16
`
`. 6-23
`
`Operation .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Setting or changing the delivered NO concentration. . 6-23
`
`During operation .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 6-25
`
`. .. 6-25
`
`Pausing NO flow .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Changing NO therapy cylinders and purging the
`regulator assembly .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`Electronic delivery shutdown .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 6-26
`
`. 6-28
`
`. 6-29
`
`Monitoring the environment .
`
`.
`
`.
`
`.
`
`7/A|a[-ms
`
`General alarm information .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`High, medium and low priority alarms .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .. 7-2
`
`.
`
`.
`
`.
`
`.
`
`. 7-2
`
`. 7-3
`
`Alarm silencing .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Changing the alarm settings .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 7-4
`
`. 7-5
`
`Alarm adjustment range .
`
`.
`
`Alarm adjustment procedure .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Clearing resolved alarm messages .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 7-5
`
`. 7-7
`
`. 7-9
`
`Alarm message table .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`Manual N0 delivery system description .
`3/Manua| N0 de|iVe|-y
`system Manual N0 delivery system connections .
`
`Manual N0 delivery system operation .
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`
`9/T;-oub|e3hooting
`
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`Troubleshooting procedure .
`If the system fails to operate properly .
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`.
`
`.
`
`.
`.
`
`. 8-2
`. 8-3
`
`. 8-4
`
`. 9-2
`. 9-2
`
`02.-"08.-"00
`
`1605-0014-000
`
`004
`
`
`
`Troubleshooting guide index .
`
`Troubleshooting guide .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`If the problem can’t be corrected using the
`above suggestions .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`It the |NOvent delivery system must be returned
`for servicing .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .9-3
`
`. .9-4
`
`. .9-13
`
`. .9-13
`
`.
`
`.
`
`. .10-2
`
`10/Maintenance
`
`User maintenance schedule .
`
`.
`
`.
`
`.
`
`|NOvent delivery system cleaning .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Injector Module sterilizing and disinfecting .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .10-4
`
`. .10-5
`
`. .10-5
`
`Autoclave sterilizing .
`
`.
`
`High level disinfecting .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Patient Circuit Adapters & Sample Line .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .10-5
`
`. .10-6
`
`. .10-7
`
`Monthly System Checkout .
`
`.
`
`.
`
`.
`
`1. Initial connections leak tests .
`
`.
`
`.
`
`2. Purge and system alarms tests.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`3. Calibration and monitoring alanns .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`4. |NOvent delivery system performance .
`
`5. Manual NO delivery system purge and
`performance .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .10-7
`
`. .10-10
`
`. .10-12
`
`. .10-14
`
`. .10-15
`
`. .10-17
`
`Emptying the Fluid Trap Bottle .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Replacing the Fluid Trap Filter Cartridge .
`
`Replacing the N02 Sensor .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .10-18
`
`. .10-19
`
`. .10-20
`
`Replacing the N0 Sensor .
`
`Replacing the O2 Sensor .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Cleaning or replacing the Cooling Fan Filter .
`
`.
`
`.
`
`Fuse replacement and line voltage selection .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .10-22
`
`. .1023
`
`. .10-24
`
`Replacing the high pressure hose CGA626 connector tip . .1026
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .11-2
`
`1 1/Parts and
`Accessories
`
`Standard accessories
`
`Optional accessories .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .11-2
`
`. .11-3
`
`12/Ap
`pendix A -
`Specifications
`
`Replaceable parts .
`
`.
`
`Functional
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Ventilator compatibility .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .12-2
`
`. .12-2
`
`1605-0014-000
`
`02208100
`
`005
`
`
`
`INOvent delivery system
`
`Injector Module .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Manual N0 delivery system .
`
`NO delivery .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .. 12-3
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 12-3
`
`. 12-4
`
`. 12-4
`
`Maximum NO delivery .
`
`Gas monitoring .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Calibration Gas cylinders .
`
`Calibration Gas regulator .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 12-5
`
`. 12-5
`
`. 12-5
`
`. 12-5
`
`NO Delivery shutdown .
`
`Physical .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Dimensions .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 12-6
`
`. .. 12-6
`
`.
`
`.
`
`. 12-?
`
`Environmental .
`
`Electrical .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`13/Appendix B -
`Cylinder |nf0|'mati0n
`
`Preparing the NO therapy gas cylinder for use .
`Replacing the N0 therapy gas cylinder
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 12-8
`
`.
`.
`
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`
`.
`.
`
`.
`
`. 13-2
`. 13-3
`
`. 13-4
`
`NO therapy gas cylinder leak check .
`
`Cylinder information .
`
`Warnings .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 13-5
`
`. 13-6
`
`. 14-1
`
`C - Pre-
`Use Procedures Card
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`Description .
`15/Appendix D -
`Battery operation information .
`T|'a|'|3P0|'t |NoVe|'|t
`defivery system Setup .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`.
`.
`
`Regulator connection diagrams .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`.
`.
`.
`
`.
`
`.
`
`. 15-2
`.
`.
`. 15-2
`.
`.
`. .. 15-4
`
`.
`
`.
`
`.
`
`.
`
`. 15-4
`
`. 15-5
`
`Operation .
`
`.
`
`.
`
`.
`
`Maintenance .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`User maintenance schedule .
`
`.
`
`.
`
`Replaceable parts and accessories .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 15-6
`
`. 15-6
`
`. 15-?
`
`. 15-8
`
`Specifications .
`
`.
`
`.
`
`.
`
`Dimensions .
`
`Electrical .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .. 15-8
`
`.
`
`.
`
`. 15-8
`
`02.-"08.-"00
`
`1605-0014-000
`
`006
`
`
`
`Cart mount .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .16-2
`
`. .16-4
`
`16/Appendix E -
`Optional Mounting
`
`Shelf or table mount .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Optional Cylinder Mount Fiegulator and
`Hose assembly .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`In ’Section 3fSetup’ of this manual .
`
`Cylinder concentration .
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .16-4
`
`.
`
`.
`
`.
`
`.
`
`. .17-2
`
`. .17-2
`
`17/Appendix F -
`Alternate Cylinder
`Concentrations
`
`In ’Section 5!Pre-Use Procedures’ of this manual .
`
`2. System purge and performance test .
`
`.
`
`3. Manual NO delivery system purge and
`performance test .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`In ’Section 10fMaintenance’ of this manual
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .17-3
`
`. 17- 3
`
`. .17-3
`
`. .17-4
`
`. .17-4
`
`Monthly System Checkout .
`
`.
`
`.
`
`.
`
`4. |NOvent delivery system performance .
`
`.
`
`Warranty
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. .17-4
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. ..W-1
`
`1605-0014-000
`
`02KJ8lU0
`
`007
`
`
`
`|NOvent delivery system
`
`02.-"08.-"00
`
`1605-0014-000
`
`008
`
`
`
`
`
`Introduction
`
`
`AWARNING If an alarm occurs, safeguard the patient first before
`troubleshooting or repair procedures.
`
`Use only pharmaceutical grade NOIN2.
`
`In this section
`
`Definitions and Abbreviations .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`. 1-3
`
`
`Symbols used in this manual or on the system .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`. 1-4
`
`
`1605-0014-000
`0
`
`02208200
`
`009
`
`
`
`|N0vent delivery system
`
`|mpo|-[ant
`
`Before using the |N0vent delivery system, read through this manual
`and the related manuals provided. Read through the manuals for the
`ventilator, humidifier and any other accessory items used. Follow the
`manual instructions and obey Warnings and Cautions.
`
`Know the proper setup and operation of the ventilator and the
`humidifier you are using.
`
`Know the proper information provided in this Operation and
`Maintenance manual before operating the |N0vent delivery system.
`
`Keep this manual readily available to answer questions.
`
`Read through each step or procedure to understand it before doing it.
`
`All specifications in this manual are nominal.
`
`Read the User Responsibility statement on the inside front cover of
`this manual; it describes what the user must do to maintain this
`product.
`
`
`A WARNING The |N0vent delivery system must only be used in accordance
`with the indications, usage, contraindications, warnings and
`precautions described in the nitric oxide drug package inserts
`and labeling. Drug package inserts and labeling are packaged
`with each drug cylinder. Refer to this material prior to use.
`
`The use of devices which radiate high-intensity electrical fields
`may affect the operation of the delivery system. Do not drape the
`leads of these devices across the delivery system. Constant
`surveillance of all monitoring and life support equipment is
`mandatory whenever interfering devices are in operation on or
`near a patient.
`
`02r'08.-"00
`
`1605-001 4-000
`
`010
`
`
`
`Definitions and abbreviations
`
`Introduction
`
`°/o vfv:
`
`Button:
`
`% volumefvolume
`
`A pushbutton control used to select a function.
`
`Control wheel:
`
`Rotary control used to change and confirm
`settings or actions.
`
`Display:
`
`HFOV:
`
`Menu:
`
`The electronic information panel on the front of
`the delivery system.
`
`High frequency oscillating ventilator.
`
`A list of available choices for an operation.
`
`Menu area:
`
`Area in the display where choice selections are
`shown.
`
`Message area:
`
`Area in the display where information is shown.
`
`N2:
`
`N0:
`
`N02:
`
`Nitrogen.
`
`Nitric oxide.
`
`Nitrogen dioxide.
`
`NOIN2:
`
`Nitric oxide (NO) and nitrogen (N2) gas mixture.
`
`Numeric area:
`
`Area in the display where values and settings
`are shown.
`
`02:
`
`Oxygen.
`
`Pop-up box:
`
`Menu or message which appears on the display.
`
`Resolved alarm:
`
`An alarm whose cause has been corrected.
`
`Set NO:
`
`The concentration of N0 delivered by the
`system as set by the user.
`
`1605-0014-000
`
`02i‘08lD0
`
`011
`
`
`
`|NOvent delivery system
`
`Symbols used in the manual or on the system
`
`WARNINGS and CAUTIONS tell you about dangerous conditions that
`can occur if you do not obey all of the instructions in this manual.
`
`Warnings tell you about a condition that can cause injury to the
`operator or the patient.
`
`Cautions tell you about a condition that can cause damage to the
`equipment. Fiead and obey all warnings and cautions.
`
`Other symbols replace words on the equipment or in this manual.
`These symbols include:
`
`
`I On (power.)
`
`
`fl This way up.
`
`Dangerous voltage.
`
`Input.
`
`
`
`Output.
`
`Stock number.
`
`Serial number.
`
`
`
`O Off.
`
`d) Standby.
`
`~ Alternating current.
`
`
`
`J,— Earth ground.
`
`(9 Protective earth ground.
`
`fig Alarm Silence.
`
`Sample gas outlet.
`
`
`Vgy Eqwpotenflal‘
`
`O2 Sensor connector.
`
`+ Plus’ positive polarity‘
`
`NOIOZ Manual delivery system.
`
`- Minus, negative polarity.
`
`2
`NO Sensor
`
`.
`
`02r'08.-"00
`
`1605-001 4-000
`
`012
`
`
`
`Introduction
`
`
`
`Movement In one direction.
`
`NO Sens“
`
`Autoclavable.
`
`O2 Sensor_
`
`
`
`Not autoclavable.
`
`Product “Use by" information (indicating
`warranty expiration date as YYYY—M M).
`
`
`
`Type B equipment‘
`
`Replace fuse only as marked.
`
`
`
`Type BF equipment‘
`
`Indicates operating-on-battery.
`
`
`
`Warning and Caution symbol.
`
`(E European Union Representative
`
`
`
`Attention, consult accompanying
`documents, IEC 601-1.
`
`A system with this mark agrees with the
`European Council Directive (93/42/EEC)
`for Medical Devices when it is used as
`
`specified in the Operation and
`Maintenance Manual. The xxx:-< is the
`
`certification number of the Notified Body
`used by Datex-Ohmeda's Quality
`Systems.
`
`160 5-001 4-000
`
`02308300
`
`013
`
`
`
`|NOvent delivery system
`
`02!'08.-"00
`
`1605-001 4-000
`
`014
`
`
`
`
`
`
`
`
`
`
`
`
`
`2/General Information
`
`In this section
`
`Overview .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`. 2-2
`
`
`
`Configuration options .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`. 2-3
`
`Main component views .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`. 2-4
`
`
`Display and user controls.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`. 2-7
`
`
`Theory of operation .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`. 2-11
`
`
`NO Flow from the cylinder to the patient breathing
`circuit .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`. 2-11
`
`
`Effect of inserting the lN0vent into a breathing
`circuit .
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`. 2-14
`
`1605-0014-000
`0
`
`02208100
`
`015
`
`
`
`lN0vent delivery system
`
`Overview
`
`The lN0vent delivery system delivers nitric oxide therapy gas into
`the inspiratory limb of the patient breathing circuit in a way that
`provides a constant concentration of NO, as set by the user, to the
`patient throughout the inspired breath.
`
`The lN0vent delivery system uses a specially designed Injector
`Module which enables the tracking of ventilator waveforms and the
`delivery of a synchronized and proportional dose of NO.
`
`The lN0vent delivery system may be used with most ventilators.
`
`The lN0vent delivery system provides continuous on—|ine integrated
`monitoring of delivered 02, N02, and NO, and a comprehensive
`alarm system.
`
`The interactive control panel and display provide a simp|e—to—
`understand interface for operation of the lN0vent delivery system.
`
`The battery system provides up to 30 minutes of uninterrupted nitric
`oxide delivery in the absence of an extemal power source.
`
`The lN0vent delivery system provides an integrated Manual NO
`delivery system for administration of a fixed concentration of NOIOQ
`therapy with a resuscitator bag.
`
`02:08.-"00
`
`1605-001 4-O00
`
`016
`
`
`
`Configuration Options
`
`2!Genera| Information
`
`The |NO\rent delivery system is available in two configuration options:
`
`- Shelf or table option and
`
`- Mounted on a transport cart which holds two N0 therapy gas
`cylinders.
`
`The options let you choose the setup which meets the needs of the
`work environment.
`
`1605-0014-000
`
`02lU8lU0
`
`017
`
`
`
`|NOvent delivery system
`
`Main component views
`
`Measured Values llnsillrerll
`N02
`(Wm
`
`0 . 0SJ]
`
`02
`(*2)
`
`40
`
`AA.69.034
`
`. Display and operating panel
`. Manual NO Delivery System Activity Indicator
`. NOINZ Injector Tube connector
`. Injector Module Electrical Cable connector
`. Fluid Trap Bottle
`. Inspiratory Gas Sample Line connector
`. Inspiratory Gas Sample Line
`. Fluid Trap Filter Cartridge
`
`1 2 3 4 5 6 7 8
`
`
`Figure 2-1 -
`
`INOvent delivery system, front View
`
`02:08.-"00
`
`1605-001 4-O00
`
`018
`
`
`
`2;’Genera| Information
`
`
`
`I‘-V
`5:‘L0
`<1:<t
`
`1. NO Sensor
`
`. N02 Sensor
`. Nurse Call connector
`.Seria| Port connector
`
`. Power Entry Module
`. Power Cord connector
`
`. External Ground connection point
`.ON!STANDBY switch
`
`. Cooling Fan and Filter
`10. O2 Sensor
`11. Sample gas outlet
`12. Regulator Low Pressure Hose with Quick Connector (2)
`13. NOfNg Input Hose Connector (2)
`14. Resuscitator Bag 02 Tube connector
`15. Connector to the O2 Flowmeter
`
`
`Figure 2-2 -
`
`|NOvent delivery system, rear View
`
`1605-0014-O00
`
`O2f08a"00
`
`019
`
`
`
`|NOvent delivery system
`
`1
`
`\:§D/
`
`1. NOINZ injector tube connection to the INOvent delivery system
`2. Inspiratory limb breathing circuit connection; to humidifier
`3. Inspiratory limb breathing circuit connection; from ventilator
`4. Electrical cable connection to the lNOvent delivery system
`
`
`Figure 2-3 -
`
`Injector Module, side View
`
`02:08.-"00
`
`1605-001 4-O00
`
`020
`
`
`
`Display and user controls
`
`2!Genera| Information
`
`The |NOvent delivery system display and control panel has a control
`wheel, buttons, and an easy-to-view electroluminescent display. All
`the |NOvent delivery system controls and monitoring are in one place
`which reduces the need for extensive visual scanning.
`
`The buttons and control wheel on the |NOvent delivery system
`control panel perform an assortment of functions and access various
`features.
`
`The steps for performing any operation, or accessing any function, on
`the |NOvent delivery system require the same interaction with the
`control panel, namely:
`
`1. Select (press) a button associated with the desired function or
`operation,
`
`2. Rotate the control wheel to select a menu item or value,
`
`3. Confirm the selection by pressing either the control wheel or the
`function button.
`
`The control panel display, buttons and control wheel are used to:
`
`- Set the concentration of delivered NO,
`
`- Adjust alarms,
`
`- Pause NO delivery,
`
`- Silence alarms,
`
`Review alarm history,
`
`Define setup options,
`Calibrate the monitors.
`
`A single tone indicates:
`
`- Your choice of an action with a button or the control wheel,
`- An invalid action with a button or the control wheel or
`
`- A message box appearance on the display.
`
`In normal operation, a typical display presents these major sources of
`information:
`
`- The Set NO value,
`
`- The measured values of three inspired gases 02, N02 and NO,
`- Alarm information.
`
`Menus guide you through the steps needed to deliver NO. Display
`and user controls are also discussed in the sections of this manual
`
`where system operations are explained.
`
`1605-0014-000
`
`02K)8iU0
`
`021
`
`
`
`|NOvent delivery system
`
`
`
`4
`
`5
`
`Measured Values (Inspired)
`
`0?
`(7%
`40
`
`1D!)
`
`N902
`N0
`(ppm)
`3.0
`10
`canmmmI G ‘
`nlnu-augg
`
`21
`
`I
`
`Oil
`
`15
`
`D
`
`Alarms
`
`Setup
`
`I
`
`15
`
`14
`
`13
`
`12
`
`11
`
`10
`
`9
`
`1. Alarm Silence button
`2. Alarm Silenced Countdown Timer
`
`3. Alarm message area
`4. Alarm History indication are
`5. Alarm History button
`6. NO Bargraph
`7. Control Wheel
`8. Set NO button
`9. Pause Flow button
`
`10. Inspired NO Measured Value
`11.CaIibration button
`
`12. Inspired N02 Measured Value
`13. Setup button
`14. Inspired O2 Measured Value
`15. Alarms button
`
`16. Mains Power light
`
`
`Figure 2-4 - User controls and indicators on the front
`
`Following are brief descriptions of display and user controls shown in
`figure 2-4. See the other areas in the manual for more information.
`
`1. Alarm Silence
`buflon
`
`Pushing the Alarm Silence button silences an audible alarm and
`starts the alarm silence countdown timer in the upper left location of
`figure 2-4 (item 2). The counter shows the remaining silence time. A
`new alarm will sound even if the Alarm Silence function has
`
`previously been activated.
`
`2. Alarm Silenced
`Countdown Timer
`
`The Alarm Silenced Countdown Timer shows a silenced bell and the
`
`remaining silence time when the Alarm Silence button is pushed. The
`timer counts down from 120 seconds to zero for high and medium
`priority alarms.
`
`02:08.-"00
`
`1605-001 4-O00
`
`022
`
`
`
`2!Genera| Information
`
`3. Alarm message area
`
`The highest priority most recent alarm message appears in the top
`part of this alarm message area first. On high priority alarms, the
`elapsed-time counter counts up. Alarm messages are also
`accompanied by audio signals. Refer to section 7!Alarms for
`additional information on alarms.
`
`4. Alarm History
`indication area
`
`This normally blank area displays “Alarm History” if there are resolved
`alarms. See section 7l'Alarms for information on resolved alarms.
`
`5. Alarm History button
`
`Pushing the Alarm History button shows the Alarm History menu
`listing the resolved alarms. There is an option to clear the displayed
`resolved alarms.
`
`6. NO Bargraph
`
`The NO Bargraph shows the Set N0 value in ppm.
`
`7. control wheel
`
`The Control Wheel’s function is defined by the information on the
`display. When a menu is displayed, turning the wheel in either
`direction selects a choice or adjusts device settings on the menu.
`Pressing the wheel then selects the current menu item or confirms the
`adjusted setting.
`
`8. Set NO button
`
`Pushing the Set NO button allows adjustment of the Set NO bargraph.
`
`9. Pause Flow button
`
`Pushing the Pause Flow button displays the “Pause F|ow” message
`box but does not pause the NO flow. To pause NO flow, you must
`push the Pause Flow button a second time.
`
`10. Inspired N0
`Measured Value
`
`The measured value of inspired NO (in ppm) is displayed in large
`numbers. Low and high alarm settings for inspired N0 appear below
`these numbers.
`
`11. Calibration button
`
`Pushing the Calibration button displays the menu for calibrating the
`high and low range of the sensors. Flefer to section 4!Calibration for
`information on calibration.
`
`12. Inspired N02
`Measured Value
`
`The measured value of inspired N02 in ppm is displayed in large
`numbers. The high alarm setting for inspired N02 appears below
`these numbers.
`
`13. Setup button
`
`Pushing the Setup button displays the Setup menu for setting the
`alarm volume and display brightness or returning to the normal
`display. See section 3fSetup and Calibration for additional
`information.
`
`1605-0014-000
`
`02lU8iU0
`
`023
`
`
`
`|NOvent delivery system
`
`14. Inspired 0; Measured
`Value
`
`The inspired 02 measured value in °/o is displayed in large numbers.
`The low and high alarm settings for inspired 02 appear below these
`numbers.
`
`15. Alarms button
`
`Pushing the Alarms button displays the menu for setting the user-
`adiustable alarm limits. High limits can be set for 02, N02 and NO.
`Low limits can be set for O2 and NO. See section 7!Alarms for
`additional information on alarms.
`
`16. Mains Power light When the green Mains Power light is on, the system is connected to a
`functioning mains power outlet.
`
`02:08.-"00
`
`1605-001 4-O00
`
`024
`
`
`
`2;’Genera| Information
`
`Theory of Operation
`
`The lNOvent delivery system delivers nitric oxide therapy gas into the
`inspiratory limb of the patient breathing circuit in a way that provides a
`constant concentration of NO to the patient throughout the inspired
`breath.
`
`The |NOvent delivery system uses a specially designed Injector
`Module which enables the tracking of ventilator waveforms and the
`delivery of a synchronized and proportional dose of NO.
`
`NO Flow from the
`Cylinder to the
`Patient Breathing
`Circuit
`
`‘
`
`:;9g“..';':,:5"'e
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`_
`s
`-
`
`E
`2
`'
`M°"it°ri"9
`
`and
`
`Alarm Board
`
`Controls and Display
`
`
`Inspired Gas
`Sample Port
`
`
`
`Quick Connec