Linde LIV IQ User manual

Manual.
LIV® IQ Linde Integrated Valve with digital display
– portable, delivery system for Medicinal Oxygen.
Linde: Living healthcare

02 Manual – LIV® IQ Oxygen
This manual was last revised: July 2015
® LIV is a registered trademark of The Linde Group.

Manual – LIV® IQ Oxygen 03
Contents.
041.Introduction
042.Device Description
043.Intended Use
054.Safety Requirements
065.Operating Instructions
086.MR Compatibility
087.Cleaning
088.Service and Maintenance
099.Fault –Cause –Remedy
1110.Storage and Recycling
1111.Contact Information

04 Manual – LIV® IQ Oxygen
The LIV IQ is an integrated, portable, gas delivery system. The whole package is maintained by Linde
Healthcare as the owner of this product.
The device is MR-conditional (per ASTM standard 2503-05), and is compatible for use during MR
imaging for MRI systems up to 3.0 Teslas.
The LIV IQ product consists of:
→A valve with an integrated pressure regulator, a flow outlet, a pressure outlet (if pro vided) and a
digital display.
→Pressurized gas cylinder (aluminum) filled with medicinal gas.
1. Introduction.
This instruction for use covers the essential information for the proper use of the LIV® IQ product.
Please read this instruction carefully before using the LIV IQ for the first time.
3. Intended Use.
The LIV IQ is suitable for use in all healthcare settings including, but not limited to, hospital, out -
patient, imaging center and ambulatory healthcare. The pressure regulator integrated in the cylinder
valve is designed for use with medical gas cylinders to reduce the pressure to a lower pressure, suit-
able for connecting medical devices (quick-connector) and for the direct administration of breathable
gases to patients (flow connector).
2. Device Description.
Cap color Flow range Pressure outlet
(if provided)
Black 0 – 25 lpm 50 psi
The above components are permanently fitted to the gas cylinder and
must not under any circumstances be removed by the user. Contains high
pressure gas. Risk of severe injury or damage to persons or property.

Manual – LIV® IQ Oxygen 05
4. Safety Requirements.
WARNING
→MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.
→Do not handle until all safety precautions have been read and understood.
→Keep and store away from clothing and other combustible materials.
→Keep valves and fittings free from grease and oil.
→Use and store only outdoors or in a well-ventilated place.
→In case of fire: Stop leak if safe to do so.
→Use a back flow preventive device in the piping.
→Use only with equipment cleaned for oxygen service.
→Open valve slowly. Close valve after each use and when empty.
→Protect from sunlight when ambient temperature exceeds 125 °F (52 °C).
→Do not expose to higher temperature than 149 °F (+65 °C). If at risk of fire, move to a safe place.
→Do not use outside operating temperature range –4 °F to 113 °F (–20 °C to +45 °C).
→Read and follow the Safety Data Sheet (SDS) before use.
→Do not expose to corrosive substances e.g. ammonia.
→Keep the LIV IQ at a minimum distance of 12 inches (30 cm) from the magnet opening, during use in MRI environment.
→Keep out of reach and sight of children.
CAUTION
→Keep the cylinder in storage reserved for medicinal gases.
→Store with valves closed.
→Transport with valves closed, unless in use.
→Make sure that the cylinder package cannot fall and is not dropped.
ADDITIONAL INFORMATION
→Do not move the LIV IQ package during MRI scan as the MR image quality can be degraded.
→If you suspect there may be electro-magnetic interference between the LIV IQ and other electrical devices, move the
LIV IQ away from those devices.
→Do not attempt to disassemble the package.
→Do not attempt to refill the cylinder.
→Do not alter the markings or labels on the LIV IQ package.
→In the event of leakage, defective cylinder package or any adverse event, close the valve, mark as “defective”, put the
product in a well-ventilated area and contact Linde Healthcare, and in the case of an adverse event, the FDA Medwatch
reporting program. See section 11, Contact information.
→Using the pressure outlet and the flow outlet at the same time may result in a lower-than-indicated flow rate, and may
activate a high flow (“HI/FLO”) alarm. It is not recommended that both outlets are used simultaneously. To silence the
alert and continue using both outlets at the same time, single press and hold the mute button for three seconds.
→In the event of extreme temperature changes, the low flow and high flow alerts may be temporarily unavailable.
Cylinders with integrated valves must only be used for the purposes
defined in the intended use. Before using the LIV IQ, you must read the
instructions and understand how to handle it safely.
National laws, specifications and regulations for handling pressurized gas
cylinders must be observed.
Important for Safety – when handling LIV IQ

06 Manual – LIV® IQ Oxygen
5. Operating Instructions.
Pressure outlet, 1) – additional connection information
If provided, the pressure outlet is equipped with a quick-connector and
allows connection to a medical device. Output pressure 50 psi nominal. The
flow selector does not control the flow from the pressure outlet.
To connect a delivery device to the quick-connector (pressure outlet):
→Make sure that the probe connector is compatible with the respective
medicinal gas.
→Insert the probe connector into the quick-connector so that it engages
correctly. Pull on the connector to make sure that it is sitting correctly.
This quick-connector does not have a function to retain the inserted probe.
Therefore, do not disconnect the connector until the valve is closed and
depressurized.
A faulty connection can result in leaks and/or to the ejec-
tion of the connector, with potential injuries/damage.
Flow outlet, 4) – additional connection information
To connect a delivery device to the flow outlet, make sure that:
→The patient is not connected to the delivery device.
→The dimension of the delivery device hose fits the flow outlet of the
valve (6 mm outer diameter).
→The delivery device hose is firmly attached.
Push delivery device hose onto the flow outlet of the LIV IQ and make
sure that it is firmly attached before opening the shut-off valve.
→The flow selector dial has engaged.
An audible alert and the words “Set FLO” will appear on the display if
the flow selector is between settings.
Make sure that the flow selector dial has engaged and is
not in between two settings. Otherwise, the flow regula-
tor will not allow the required volumetric flow rate for
the medicinal gas.
3) Flow selector
4) Flow outlet
2) Shut-off valve1) Pressure outlet equipped with
quick-connector (if provided)
General instructions for use
All personnel handling cylinders with integrated valves should
be fully trained to carry out each operation and be fully aware
of the requirements detailed in this instruction for use.
→Operating temperature –4 °F to 113 °F (–20 °C to +45 °C).
→Only use with devices intended for the product administration.
→Prepare to change the cylinder when the digital display contents
indicator shows only the segments in the red area.
→To ensure the correct, prescribed flow rate, always make sure that the
flow selector is positioned on a numbered flow setting, not between
flow settings.
5) Digital display
6) Mute button
Before Use
→Make sure that the digital display (5) contents indicator shows there is
enough content for intended use.
→Make sure that the flow selector (3) is set at zero.
→Connect the delivery device to outlet (1 or 4), see below.
→Slowly turn the shut-off valve (2) anticlockwise to open the LIV IQ fully.
→If a delivery device is connected to the flow outlet (4), turn flow
selector (3) stepwise up through flow settings to select flow.
The patient can now be connected to the delivery device.
After Use
At conclusion of treatment or at exchange of an empty cylinder:
→Remove the delivery device from the patient.
→Turn flow selector (3) stepwise down through flow settings to zero.
→Turn the shut-off valve (2) clockwise to close the LIV IQ.
→Turn the flow selector (3) fully to vent the equipment.
→Turn the flow selector (3) back to zero.
→Disconnect the delivery device from outlet (1 or 4 ).

Has the Mute button been pressed?
Yes – An active alert has been muted
No – Due to a rapid change in temperature, the low flow
or high flow alert is temporarily disabled
Current set flow rate
Therapy time remaining at
selected flow setting
Flow is active
D
E
F
Manual – LIV® IQ Oxygen 07
Digital display, 5) – additional information
If no lines or numbers are visible around the content indicator, do not use the product. Mark it as defective and contact Linde Healthcare.
The digital display has a number of elements and audible alerts that communicate the status of the LIV IQ:
The mute button can be pressed to silence audible alerts.
When an active alert is muted, the icon shown in “O” above, will appear in
the upper-left corner of the display.
A single short press of the button will mute the active alert for one minute.
A single long press of three seconds will mute the active alert until the
alert condition disappears or until the next alert condition occurs.
Set flow selector to zero before
opening shut-off valve
Warning triangle
G
H
A
B
C
DF
E
G
H
I
J
K
L
M
O
N
Full
¾full
½full
¼full
New, full cylinder (diamond)
Content indicator
B
AAs gas is consumed, the black
vertical segments of the con-
tents indicator will disappear
C
Gas contents Low
(Contents Bars 4 & 3)
Gas contents Very Low
(Contents Bars 2 & 1)
Gas contents Empty
Incorrect use (Flow selector set with
Shut-off valve closed)
Incorrect use (Flow selector is between two settings)
Alerts described in I –M
Mute button, 6) – additional information
An audible signal sounds in the following cases:
Cylinder package is too hot
– do not use
Cylinder package is too cold
– do not use
Low battery – do not use
Low flow
The LIV IQ has detected that the flow
from the cylinder is lower than the
selected flow
High flow
The LIV IQ has detected that the flow from
the cylinder is higher than the selected flow
Strong magnetic field
The LIV IQ has detected a strong magnetic
field. Gas flow continues unaffected, but
the digital display and audible alerts will
not work while in this field. Removal of the
LIV IQ from the magnetic field recovers its
normal functionality.

08 Manual – LIV® IQ Oxygen
If a leak occurs, never try to tighten individual components or to stop the leak.
6. MR Compatibility.
The LIV IQ products include aluminum cylinders, regardless of cylinder size
and contents. Aluminum cylinders have no magnetic parts.
The integrated cylinder valve has a low residual magnetism, which means
that the pull forces of a 3-tesla magnet are barely perceptible.
The LIV IQ must not be brought any nearer than 30 cm from the opening of
the magnet. Do not move the package during MRI scan, as the MR image
quality can be degraded.
7. Cleaning.
The user is not expected to clean the LIV IQ package routinely. The LIV IQ
package is a multi-use device and maintenance and cleanliness is
managed by Linde Healthcare.
The customer is recommended to keep the cylinder package clean, dry and
free from oil and grease as most malfunctions are caused by the intrusion
of particles, dust or other contamination.
If the outside surface of the package must be cleaned, use only a soft
cloth. The cloth may be dry or damp (with clean water).
If local disinfection procedures require that the LIV IQ must be cleaned, the
cleaning solutions used must be compatible with: brass, plastic materials of
components (including labels) and oxygen.
Do not use cleaning solutions containing ammonia.
Do not immerse the product in water or any other liquids.
Do not expose the product to higher temperature than 149 °F, +65 °C (like
autoclave).
Do not pour any liquids into the user outlets.
When using the product in the hospital, the standards and practices of the
hospital’s hygiene plan must be applied accordingly.
Do not use any cleaning solutions containing aldehyde,
ammonia or peroxide compounds.
8. Service and Maintenance.
The serial number of the product can be found on the back of the
valve, beneath the pressure outlet (if fitted) or blanking cap (if no
pressure outlet is fitted). The serial number consists of the year and month
of valve manufacture, two letters and five numeric digits.
In the event of a leakage or suspected defective LIV IQ package – do not try
to perform any repair or maintenance by yourself but return the product to
Linde Healthcare. Repair and maintenance activities must only be performed
by Linde Healthcare.
Non-certified repair and maintenance irrevocably leads to loss of the liability
from the manufacturer for the safety and functionality of the product.
SN
O2 ISOV U12 0029
CGA540 WP2000PSI
201506 IH 00041

Manual – LIV® IQ Oxygen 09
9. Fault – Cause – Remedy.
Fault/error Cause Remedy
Digital display content
indicator has no
segments illuminated. An audible signal
sounds.
Cylinder is empty. Use alternative cylinder.
No gas coming from flow outlet. 1. Shut-off valve is closed.
2. Flow selector dial set to “0” posi-
tion.
3. Flow selector not correctly
engaged.
4. Cylinder is empty.
1. Return the flow selector to zero, open the shut-off valve
and set the flow selector to the desired flow.
2. Set the flow selector to the desired flow.
3. Set the flow selector to the desired flow and make sure
that it has engaged properly.
4. Use alternative cylinder.
Shut-off valve is difficult to turn and cannot
be opened/closed without applying
significant force.
Valve too firmly opened or closed. Verify direction of rotation using a flow test. If there is a flow,
turn hand wheel to “OFF”. Alternatively, contact Linde
Healthcare.
In combination with no flow of gas and an
audible signal.
1. Shut-off valve is closed.
2. Malfunction.
1. Return the flow selector to zero, open the shut-off valve
and set the flow selector to the desired flow.
2. Make sure that the flow selector is set at zero, close the
shut-off valve and mark the cylinder as defective. Put the
product in a well-ventilated area and contact Linde
Healthcare.
Battery is low. Use alternative cylinder. Mark the cylinder as defective and
return it to Linde Healthcare
Cylinder is too hot (sunshine) or too
cold (snowflake).
Do not use the cylinder at this time. Store the cylinder within
the temperature range –4 °F to 113 °F (–20 °C to +45 °C). The
warning symbols will disappear when the cylinder is at a
usable temperature.
The cylinder is in an area with a
strong magnetic field.
Gas delivery is not interrupted and will be delivered at the
rate chosen on the flow selector. The device will not be able
to display therapy time remaining, the current set flow rate or
the remaining content.
1. The mute button was pressed by
the user, muting the active alert.
2. The cylinder is changing tempera-
ture rapidly. The HI FLO or low flow
alerts are temporarily disabled
while this symbol is shown.
1. The active alert will remain muted for one minute
(short press) or until the next alert event occurs
(pressed for three seconds).
2. Continue to use the cylinder, but ensure the patient’s
tube is not blocked. The symbol will automatically
clear when the cylinder has acclimatized.
Continues on next page.

10 Manual – LIV® IQ Oxygen
9. Fault – Cause – Remedy. (cont...)
Fault/error Cause Remedy
An audible signal sounds and
the bars flash.
Gas contents low. Consider changing to alternative cylinder.
An audible signal sounds and
the bars flash.
Gas contents very low. Change to alternative cylinder.
An audible signal sounds.
The flow from the cylinder is
different from the selected flow.
This could be caused by a
restriction in the flow of the gas.
Check the tube and medical device connected to the flow
outlet. The warning symbols will disappear a short time after
the restriction has been cleared. If no restriction is found,
make sure that the flow selector is set at zero, close the shut-
off valve and mark the cylinder as defective. Put the product
in a well-ventilated area and contact Linde Healthcare.
alternating in the flow rate area
of the display. An audible signal
sounds.
1. Two devices draw gas
simultaneously.
2. One device draws gas.
1. Press and hold the mute button for three seconds.
2. Make sure that the flow selector is set at zero, close the
shut-off valve and mark the cylinder as defective. Put the
product in a well-ventilated area and contact Linde
Healthcare.
An audible signal sounds.
Flow selector is between two set-
tings.
Check that the flow selector is set to a flow setting and is not
between flow settings.
and a number or letters alternating in
the Flow rate area of the display. In
some cases an audible signal sounds.
Digital component or software
malfunctioning.
Make sure that the flow selector is set at zero, close the
shut-off valve and mark the cylinder as defective. Put the
product in a well-ventilated area and contact Linde
Healthcare.

Manual – LIV® IQ Oxygen 11
10. Storage and Recycling.
The LIV IQ package must be stored and transported in a secured position,
and stored in dry and clean conditions.
Do not stack LIV IQ packages on top of each other as this can cause
damage to the valve or the handling device.
Storage temperature range: –40 °F to 149 °F (–40 °C to +65 °C).
Never store gas cylinder near a heat source (see Safety Requirements).
Do not use the medicinal gas after its expiry date (see product label).
Warning notices prohibiting smoking and naked lights must be posted
clearly in the cylinder storage area and the Emergency Services should be
advised of the location of the cylinder store.
The LIV IQ package should be returned to Linde Healthcare for refilling or
package recycling.
Linde Healthcare,
Attn: Customer Service
6600 Peachtree Dunwoody Road
Building 400 , Suite 300 Atlanta, GA 30328
Office: 866-543-3427
[e-mail]
Contact details of national competent authority:
FDA Medwatch program
http://www.fda.gov/Safety/MedWatch/
11. Contact Information.

Linde Gas North America LLC
575 Mountain Ave, Murray Hill, NJ 07974
Phone [phone], www.linde-healthcare.us
MED-769en US – 2015-09