1 10545100-Australia Rev. – 08/2018
Parker Hannifin Corporation
Precision Fluidics Division
Porter Instrument
245 Township Line Road
Hatfield, PA 19440
Office 215 723 4000
Fax 215 723 5106
Digital MDM® Mixer
Operations Manual
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.
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.
2 10545100-Australia Rev. – 08/2018
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 ensure 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 Digital MDM Mixer.
A WARNING alerts you to a possible hazard to people. A
CAUTION alerts you to the possibility of equipment
damage.
WARNING: Do not use this device for the administration
of general anesthesia or as a part of, or in conjunction
with, a general anesthesia administration system.
WARNING: Use scavenging. Workers are exposed to
N2O during administration of N2O/O2 conscious sedation
analgesia. Exposure should be minimized. Time
Weighted Average (TWA) for Australia is 25ppm (parts
per million). Refer to SDS (Safety Data Sheet) for Medical
Nitrous Oxide.
WARNING: The Digital MDM Mixer utilizes the
cross+protection system. The flexible hose and
connectors that connect to the flowmeter are diameter
indexed; 3/8” O.D.for Nitrous Oxide and ½” for Oxygen.
The cross+protection system is designed to prevent
misconnection of Oxygen and Nitrous Oxide piping. DO
NOT ATTEMPT TO CHANGE THE DIAMETERS OR
CONNECTORS OF THE FLOWMETER! Tampering with
the cross+protection system constitutes acceptance of
liability by the installer. For your own protection, as well
as that of the Doctor and the patients, use 3/8” O.D. tubing
for all Nitrous Oxide lines and ½” O.D. tubing for all
Oxygen lines.
To ensure safe operation and conformation to local fire
codes, all Digital MDM Mixer systems are designed to be
used with sedation delivery systems mounted inside walls
and they meet or exceed the guidelines established by the
National Fire Protection Association for Nonflammable
Medical Gas Systems, NFPA 99.
WARNING: During any power outage, remember to turn
OFF the flowmeter and manually turn OFF the cylinder
valves. With centralized, electrically powered gas
systems, if gas was flowing when the power went out and
the flowmeter is left ON, gas will be flowing when the
power is restored.
CAUTION: This device is intended to be used by medical
personnel trained in its use and the use of nitrous oxide
and oxygen for medical applications.
CAUTION: Always use clean, dry medical grade gases.
Introduction of moisture or other contaminants into this
device may result in defective operation.
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.
CAUTION: 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.
CAUTION: The user is responsible to choose how to
provide a cylinder valve clear of dust or dirt (which may
be carried to regulator and cause damage or accident).
One technique is “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.
WARNING: New or modified installations - properly
connected gas pipelines are absolutely essential to
patient safety. The authorized distributor or contractor
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.
3 10545100-Australia Rev. – 08/2018
Symbol
Description
MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS IN ACCORDANCE WITH UL 2601-1, AND CAN/CSA C22.2 NO. 601.1
Alternating Current
Protective Earth (ground)
Attention, consult the accompanying documents
Manufactured By
ELECTRICAL CONNECTIONS & GROUNDING INSTRUCTIONS
The unit must be grounded. If it should malfunction or breakdown, grounding provides a path of
least resistance for electrical current to reduce the risk of electric shock.
A known Protective Earth (ground) connection must be made via one of the following methods:
1) The third wire on the power cord when plugged into an appropriate outlet that is properly
installed and grounded in accordance with all local codes or ordinances.
2) The external ground lug on the rear of the device.
A Protective Earth (ground) connection is a connection attached to the facility grounding point
outside the facility. A licensed electrical person should be consulted to confirm the Protective Earth
(ground) connection.
Do not use an electrical cord with nicks, cuts, or other damage. Do not use the unit with an
extension cord as it will be subject to electromagnetic interference (EMI).
There are no user-serviceable parts inside this unit. A shock hazard exists if power is not
disconnected prior to any internal servicing or maintenance. Always disconnect the power source
before inspection or repair.
4 10545100-Australia Rev. – 08/2018
REQUIREMENTS AND FEATURES
Bag Tee (Breathing Bag) Requirements
A bag tee (with attached breathing bag or capped breathing bag port) containing an air inlet valve is required for use with
this unit. The bag tee is factory mounted on the unit or provided separately for remote mounting. Matrx by Parker Scavenging
Nasal Masks (or other suitable breathing circuits – see Breathing Circuits page 5) provide the patient connection. An
Anaesthetic Breathing Circuit incorporating Scavenging with face mask/nasal hood may also provide the patient
connections. Refer to: Breathing Circuits on page 5.
Use of Scavenging
A patient breathing circuit that incorporates scavenging and a one-way exhalation valve must be used with this device. For
applications other than Dental use, a separate Scavenger Interface must be used with this system for connection between
patient breathing circuit and facility evacuation system. If used in a dental application, the scavenging tube of the patient
breathing circuit may connect directly to chair suction and a scavenging interface may not be required.
A Scavenger interface contains an internal pathway for gas passage permitting waste gas to follow a preferential path to
vacuum. Scavenger Interfaces must meet the following criteria:
• Must be open to ambient air at either top or bottom of interface (via perforations)
• Must contain a sintered filter for particulate capture
• A barb tail connector for connection to wall evacuation system
• A rigid conical 19mm connection for connection to the breathing circuit scavenging tube (refer AS/NZ 2496:
Breathing attachments for anaesthetic purpose for human use)
Note: Follow specific manufacturer Instructions for Use for individual Scavenger Interfaces
Monitor for N2O in the patient treatment area to ensure that controls are effective in achieving low PPM (parts per million)
exposure (TWA = 25ppm in Australia). Contact your dealer for details on monitors and testing.
Room Ventilation
Mechanical ventilation requirements shall conform to Australian Standard AS1668.2: The use of ventilation and air-
conditioning in buildings Part 2: Mechanical ventilation in buildings, Section 5: Enclosures used for particular healthcare
functions or those specified in The Australasian Healthcare Facility Guidelines and/or State and Territory Engineering
Services/Healthcare Infrastructure Guidelines and Specifications on air change requirements as applicable.
Facility Piping
The user MUST perform tests independent of the dealer or contractor to verify that all pipelines are connected correctly. If
you are unfamiliar with piping systems, refer to Australian Standard AS2896: 2011 Medical gas systems – Installation and
testing on non-flammable medical gas pipeline systems. The user has the ultimate responsibility for properly connected
pipelines essential to patient safety.
Sleeve Index System (SIS)
Gas connections in the DIGITAL MDM mixer are mechanically indexed using the Australian Sleeve Indexed System (SIS).
This feature helps to prevent the crossing of pipelines. Under no circumstances should these connections be altered.
Alarm Test
The user should test the alarm system for proper operation prior to each clinical use.
Machine Diagnostics
The Digital MDM Mixer performs self-checks at start up and during operation. If any errors are detected, the unit displays
EE on the % OXYGEN display and an error code on the LPM FLOW display. If an error code appears, remove the unit from
patient service and call Air Liquide Healthcare on 1300 36 02 02.
To aid in the diagnostics of the unit, make note of the final error code displayed on the unit.
Loading...