Porter NITRONOX HD User manual

FM-1308 Rev C 07/2018 www.porterinstrument.com/nitronox
Parker Hannifin Corporation
Precision Fluidics Division
Porter Instrument
245 Township Line Road
Hatfield, PA 19440
Office 215-723-4000/Fax [phone]
N I T R O N O X ® HD
U S E R ’ S M A N U A L / I N S T R U C T I O N S

Manufacturer:
Parker Hannifin Corporation
Precision Fluidics Division
Porter Instrument
245 Township Line Road
Hatfield, PA 19440
Office 215 723 4000
Fax [phone]
This product complies with the Medical Device Directive (93 / 42 / EEC). A “Declaration of
Conformity” in accordance with the directive has been made and is on file.
European Communities should contact the Authorized Representative listed below regarding any
Medical Device Directive (MDD) inquiries.
Contact Name:
Parker Hannifin Ltd Instrumentation Products Division
Mailing Address:
Riverside Road, Pottington Business Park
Barnstaple, EX 31 1NP, England
Phone:
[phone] Fax: [phone]
The Quality System for Porter Instrument is certified to ISO 13485. The scope of our registration is:
“The design, manufacture, distribution and servicing of fluidic components and integrated systems for use in
the Medical Equipment, Diagnostic, Biopharmaceutical, Agent Detection, Analytical Instrumentation and
Industrial markets, Nitrous Oxide –Oxygen Sedation Flowmeters, Gas Scavenging Systems and Gas
Distribution products for use by a physician, dentist or licensed healthcare professionals and the distribution
of Steam Sterilizers.”
Check our website: www.porterinstrument.com for additional information.
To register your product: www.porterinstrument.com/resources-dental choose Warranty tab.
To download a User’s Manual: www.porterinstrument.com/resources-dental choose Manuals tab

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Nitronox®Inhalation Analgesia System - Serial Number:
Table of Contents
Examination...........................................................................................................1
Warnings and Precautions.....................................................................................2
New or Modified Installations .................................................................................3
Side Effects / Contraindications .............................................................................4
Development of Nitronox Delivery Protocols..........................................................5
Self-Administration vs. Assist to Self-Administration ..............................................6
Demand Valve Instructions....................................................................................7
Installations: Preparation of Mobile E-Stand...........................................................8
Installations: Preparation of Nitronox Demand Valve .............................................9
Description.............................................................................................................10
Functional Schematic.............................................................................................11
Specifications / Functional Features / Tests...........................................................12
Operation / Maintenance........................................................................................13
Functional Checks / Tests......................................................................................15
Cleaning.................................................................................................................16
Troubleshooting.....................................................................................................18
Warranty................................................................................................................19
Examination
Examine shipping carton for signs of external damage.
Remove contents from carton and inspect for visible damage or missing parts.
If damage is discovered or suspected and/or parts are missing, notify Porter or authorized
distributor immediately.

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IMPORTANT:
READ MANUAL COMPLETELY BEFORE OPERATING THIS DEVICE
Basic delivery technique is described. Also, this manual contains instructions on periodically
required checks to be performed by the user. These checks are necessary to insure the proper
performance of this device and its safety features. Retain this manual for future reference.
WARNINGS AND PRECAUTIONS
These warnings and precautions are to help you
to understand how to safely operate the
Nitronox device. A WARNING alerts you to a
possible hazard to people. A CAUTION alerts
you to the possibility of equipment damage.
WARNING: New or modified installations -
properly connected gas pipelines are
absolutely essential to patient safety. The
ultimate responsibility of assuring that lines
are not crossed rests with the user. See next
page for details.
WARNING: An oxygen enriched environment
can accelerate the spread of ignited materials.
Therefore, when used in conjunction with
energy producing devices such as lasers, RF
sources, or other heat sources the user must
adhere to the instructions for use of those
devices to avoid ignition of combustible
materials.
WARNING: Nitronox Inhalation Analgesia
systems are intended to be used by medical
professionals trained in its use, and are
responsible for administering nitrous oxide and
oxygen for medical applications with
consideration of contraindications for use as
well as for other risks that could cause harm to
the healthcare professional, staff, patient, or
facility
WARNING: Do not use this device for the
administration of general anesthesiaor as a part
of, or in conjunction with, a general anesthesia
administration system.
WARNING: Inspect and maintain the
analgesia delivery system to prevent N2O leaks
in all hoses, connections and fittings. Have all
leaks repaired immediately.
WARNING: Use Scavenging: Medical workers
are exposed to N2O during administration of
N2O/O2 conscious sedation analgesia. Controls
are effective in the patient treatment area to
achieve low levels of ppm (parts per million)
exposure. Controls include System
Maintenance, Ventilation and Work Practices.
Your accessory Scavenger System is an
important part of the system of controls in
medical settings.
WARNING: During any power outage,
remember to turn OFF the tank valves (or
external supplier). With centralized, electrically
powered gas systems, if gas was flowing when
the power went out and the Nitronox is left ON,
gas will be capable of flowing when the power is
restored.
WARNING: When using a single use full face
mask (not supplied sterile), dispose of mask
after use to prevent patient cross-
contamination. When using multiple use mask,
follow manufacturer’s sterilization instructions.
WARNING: Always use clean, dry medical
gradegases. Donotintroducemoistureorother
contaminants into the system and flowmeter
device. Never oil or grease any part of this
system (minimize fire or explosion
potential). Cylinder mount: Do not clean
check valve entrance or sealing washer
(replace as needed) with disinfectant. User
should ensure that the cylinder valve is clear of
dust or dirt which may be carried to regulator
and cause damage or accident. One clearing
technique is to “crack” [secure] cylinder valve
before installing cylinder to E-Block. Open valve
slightly and then close. Do not discharge flow of
gas at any person or flammable material.
CAUTION: Do not attempt to repair, alter or
calibrate this device. Unauthorized repair,
alteration or misuse of this device is likely to
adversely affect the performance and will void
the warranty.

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WARNING:
NEW OR MODIFIED INSTALLATIONS
ALWAYS ASSURE THAT LINES ARE NOT CROSSED!
WARNING: New or modified central supply installations - properly connected gas pipelines are
absolutely essential to patient safety. Per NFPA 99, the certified medical gas plumber, and verifier, should
provide written documentation that all gas pipelines are connected properly and that the system has been
pressure tested prior to use. While this is a good business practice, it is important that the user verify by their
own test, independent of the authorized distributor or contractor, that all gas pipelines are connected correctly
prior to using the system. The ultimate responsibility of assuring that lines are not crossed rests with
the user.
WARNING: Porter equipment utilizes the cross+protection system. The flexible hose and connectors
that connect to the housing are diameter indexed; 3/8” O.D. for Nitrous Oxide and ½” O.D. for Oxygen.
The cross+protection system is designed to prevent misconnection of Oxygen and Nitrous Oxide
hoses. DO NOT ATTEMPT TO CHANGE THE DIAMETERS OR CONNECTORS OF THE DEVICE!
Tampering with the cross+protection system constitutes acceptance of liability by the installer.
Do not allow crossed lines to defeat the safety features of the Nitronox and/or central gas
supply manifold systems. Crossed lines will create a dangerous and hazardous condition where,
under a loss of oxygen supply, 100% nitrous oxide will be delivered through the oxygen delivery path
and subsequently to the patient.
User should observe the patient to prevent over sedation in the event of an oxygen failsafe
malfunction or crossed lines. If a patient becomes over sedated when being delivered 100% oxygen
[during an apparent loss of nitrous oxide supply], it is a definite indication of crossed lines or a
failsafe malfunction. Remove the mask immediately and encourage mouth breathing. Deliver pure
oxygen from an oxygen demand valve only if the oxygen source is independent from the suspected
crossed lines area.
INPUT PRESSURE DIFFERENCES
WARNING: DO NOT use Nitronox if O2 and N2O input pressures are not within 15 psi (1 bar) of each
other.

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SIDE EFFECTS & CONTRAINDICATIONS
Note: This is not an exhaustive list. It is the responsibility of the medical establishment and
the medical professional to have complete knowledge of side effects and contraindications.
Possible Side Effects of Nitrous Oxide –Oxygen Conscious Sedation: May experience
nausea, vomiting, excessive sweating, euphoria, excitement, deep sedation, drowsiness, sleep,
dizziness, lightheadedness, dysphoria, amnesia, and headaches.
Precautions and Contraindications for Nitrous Oxide Use
Precautions/Relative Contraindications
Discontinue the Nitrous Oxide delivery if observed: prolonged inspirations, irregular
breathing, involuntary eye movements, swallowing or gagging, dilated pupils and
rigid muscles.”
Side effects, e.g., nausea, vomiting, dizziness, dysphoria, etc., are not tolerable;
Current vitamin B12 deficiency; Bronchoconstrictive disease (asthma) –(at
determination of medical professional)
The use with pediatric patients, especially age 1 to 4 years, requires caution and
specific protocols developed by the medical professional; upper age limit at
determination of medical professional. Weight limitations at the determination of
medical professional.
Contraindications
Inability to hold own face mask, impaired oxygenation, or hemodynamic instability;
Acute drug or alcohol intoxication or impaired consciousness (head injury, endocrine
or metabolic disease, patients taking antidepressant or psychotropic drugs),
psychologic impairment, patient who has taken medication to induce sleep.
Decompression injuries, increased intracranial pressure, increased intraocular
pressure, intraocular surgery, bowel obstruction, middle ear surgery, emphysema,
pulmonary hypertension and others;
Current upper respiratory tract infection, chronic obstructive pulmonary disease
(COPD), cystic fibrosis, shock, acute pulmonary edema (APE), pneumothorax, and
major chest or maxillofacial trauma, bleomycin therapy, recent
pneumoencephalography; Pregnancy (first trimester).

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Development of Nitronox Delivery Protocols
It is the responsibility of the medical establishment and the medical professional to develop and
establish specific delivery protocols.
The Nitronox® Inhalation Analgesia System is designed to deliver a fixed concentration of 50%
nitrous oxide and 50% oxygen on the demand flow [self-administration] principle. The medical
professional will turn on and observe the operating indicators of the device. In order to receive the
analgesic, the patient will self-administer by holding the face mask firmly in place during the
procedure. With the face mask sealed every time the patient takes a breath, the patient inhalation
will open the demand valve and deliver the mixed gas through the face mask.
Common procedures conducted with Nitrous Oxide –Oxygen Sedation include:
General Pain Management, Labor and Delivery, Wound Debridement, Fracture Reduction,
Catheter Insertion, Foreign Object Removal, Setting Broken Bones, Lacerations, Botulinium
Injection, Barium Enema,Joint Injections, Gastrostomy, Sutures, IV Starts,CT Scans, Non-Invasive
Lipolysis, Hair Removal, Tattoo Removal, and Skin Revitalization.
The Nitronox Inhalation Analgesia System is considered transient (less than 60 minutes) in terms
of continuous use when providing Analgesia (pain management), Minimal Sedation or Moderate
Sedation. However, a procedure or medical condition that occurs over the course of many hours,
also is considered to be using transient delivery, in that, given self-administration techniques, the
patient will be unlikely to hold the face mask to the face continuously for over 60 minutes. For
example, a woman in labor may safely use Nitronox in a transient self-administration mode over
the course of several hours as secondary labor and end labor stages are experienced. The upper
limit of the number of hours of this described transient delivery is at the determination of the medical
professional.
Patient Population (Adult and Pediatric): Used to deliver a gas mixture to a conscious
spontaneously breathing patient who is awake, alert and cooperative and requires relief
from moderate to severe pain and is under the supervision of a healthcare professional.
Age/Weight limitations: see Relative Contraindications (at the determination of medical
professional).
Note: Porter recommends the use of a disposable full face mask (DEHP-free and Latex-free) that
is biocompatible for medical use. The disposable mask materials have been chosen by the medical
device manufacturers of the masks intendedfor medical usage. Many establishment protocols also
call for the use of a bacterial filter. Follow manufacturer’s instructions.
Continuous flow vs. demand flow devices
Equipment to deliver nitrous oxide and oxygen sedation are often categorized as demand
flow or continuous flow devices. The Nitronox is a demand flow device. Different specific
delivery protocols will be established for the two categories of equipment. The differences
center around self-administration for demand flow devices vs. direct administration by
medical professionals for continuous flow devices. Also, continuous flow devices typically
allow the administration of variable concentrations of nitrous oxide and variable flow rates
of delivered mixture. However, some establishments have developed specific protocols for
delivery with continuous flow devices, where the medical professional is able to adjust to
deliver various percentage mixes, where, with supervision, the delivery could be described
as “self-administration,” in that the patient will hold the full face mask to the face.

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SELF-ADMINISTRATION VS. ASSIST TO SELF-ADMINISTRATION
WARNING: Encourage patient to self-administer. Self-administration is a safety feature of the
demand flow Nitronox in that, if for any reason the patient becomes over sedated, the patient will
be unable to successfully hold the mask in a tight seal position on the face. The result will be that
the mask falls away from the face and the demand flow will cease, allowing the patient to breathe
room air in through the mouth or nose.
WARNING: If a patient is unable to fully self-administer, and the medical professional provides an
assist to placement of the mask in a sealing position on the face, maintain patient observation to
prevent over sedation under any conditions. Discontinue the assistance in mask placement
immediately upon any observation of over sedation; remove the mask from the face entirely. Never
use a mask strap to hold the mask to the face. Never force the mask on the face; the patient must
always be spontaneously breathing.
At the determination of a medical professional, as an added precaution for procedures where an
assist to self-administration is used, the medical establishment may elect to continuously sample
the mixture delivery downstream from the demand valve by installation of an oxygen analyzer.
Self-administration for pediatric patients
Some establishments have developed specific protocols instructing the provider to
administer (“assisted-mask application” of Nitronox) nitrous oxide to pediatric patients,
typically ages 1 to 4. The concept that, for certain circumstances, the use of the Nitronox,
or the use of other demand valve delivery systems, should have a protocol where the
provider administers the nitrous oxide, as opposed to complete self-administration, is in
potential conflict with protocols for labor analgesia, where there is an emphasis on self-
administration. It is the responsibility of the medical establishment and the medical
professional to develop and establish specific delivery protocols.
Self-administration for laboring women
Establishments that have developed specific protocols for laboring women often include a
particular emphasison self-administration and education for the laboring woman andfor her
support persons on the techniques of self-administration. In these specific protocols, the
establishments have concluded that nitrous oxide can only safely be self-administered by
the laboring woman; with support persons needing to be educated that they absolutely
cannot assist in the delivery of nitrous oxide by holding the mask up to the laboring woman’s
face, since an integral safety feature of nitrous oxide use is that when the woman has
physiologically reached her limit of nitrous oxide intake, she will no longer be able to hold
the mask up to her face for more, thus self-regulating the intake. The establishments have
concluded that when someone else is allowed to hold the mask up to her face, the potential
risk of losing consciousness increases dramatically. Thus, there is an initial and repetitive
education for the laboring women and support persons.

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DEMAND VALVE
Description: The demand valve of the Nitronox Inhalation Analgesia System is designed to be
used with a full face mask (Porter recommends a standard, single use, disposable mask (not
supplied sterile), DEHP-free, Latex-free, with materials chosen by the manufacturer for
biocompatibility in a medical setting) for administration of nitrous oxide to a breathing patient. It
contains no buttons or levers to force the gas into the patient and is for self-administration.
Do not strap mask on patient. Allow the patient to hold the mask over the nose and mouth to self-
administer. Upon inhalation, the demand valve opens and the nitrous oxide / oxygen mixture will
start to flow. Ceasing to inhale or if the patient stops breathing, the valve automatically closes to
stop the flow of the nitrous oxide / oxygen mixture.
WARNING: Do not use near open flame or in an unventilated area. Can accelerate
burning and be toxic.
Specifications:
Flow: The demand valve (through the Nitronox housing) is to be connected to gas supply capable
of delivering a minimum of 100 LPM @ 40-90 psig (2.8–6.2 bar). The valve itself: 160 LPM set
flow: As required in demand mode 0-160 LPM at 40 psig.
Inlet fitting: Quick connect.
Filter: 2 micron sintered stainless steel.
Outlet: 22 mm outside diameter x 15 mm inside diameter (fits standard medical masks).
Materials: Housing and plastic parts: “Noryl”, polyester, polysulfone. Moving and adjusting parts:
Stainless steel. Fasteners: Steel, brass and aluminum all plated for corrosion resistance. Rubber
parts (except hose): Silicone

8
Installations
Instructions References
FM-1346 for 2 Cylinder Mobile Cart User’s Manual / Instructions
FM-916 for 4 Cylinder Mobile “E” Tank Stand Installation and Instructions
FM-1330 for Medical Breathing Circuit Scavenger System User’s Manual / Instructions
4 Cylinder E-Stand 2 Cylinder Mobile Cart
With Nitronox With Nitronox
4 Cylinder E-Stand 2 Cylinder Mobile Cart
Wall Mount
Mounting on Mobile Stand