Invacare® Element™ Pneumatic Conserver

Invacare® Element™ Pneumatic Conserver
Invacare® Element™
Pneumatic Conserver
For HomeFill® Oxygen System
en
This manual MUST be given to the user of the product.
BEFORE using this product, read this manual and save for future reference.
IOCI00P
User Manual
©2016 Invacare®Corporation
All rights reserved. Republication, duplication or modification in whole or in part is prohibited without
prior written permission from Invacare. Trademarks are identified by ™ and ®. All trademarks are
owned by or licensed to Invacare Corporation or its subsidiaries unless otherwise noted.
WD-40 and 3–IN-ONE are registered trademarks of the WD-40 Company.
5.7
Contents
1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3 User Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4 Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.5 Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.6 Component Identification . . . . . . . . . . . . . . . . . . . . . . . . . 8
2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1 General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1 Dealer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2 User Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 Receiving Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4 Cylinder Prefill Inspection. . . . . . . . . . . . . . . . . . . . . . . . .
3.4.1 The Hydrostatic Testing Date . . . . . . . . . . . . . . . . . . .
3.4.2 External Examination . . . . . . . . . . . . . . . . . . . . . . . . .
14
14
14
14
14
15
15
4 Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Installing the Conserving Regulator . . . . . . . . . . . . . . . . . .
4.2 Oxygen Conserving Regulator and Cylinder Assembly
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3 Removing the Conserving Regulator . . . . . . . . . . . . . . . . .
16
16
5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2 Emptying the Cylinder Assembly . . . . . . . . . . . . . . . . . . . .
5.3 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.4 Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.5 Reuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.6 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20
20
20
21
21
22
22
17
19
Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6 After Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6.1 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6.2 Wear and Tear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
7.1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
8 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
8.1 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
8.2 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Invacare® Element™ Pneumatic Conserver
1 General
Read the manual
1.1
No open flame
Symbols
Signal words are used in this manual and apply to hazards or unsafe
practices which could result in personal injury or property damage.
See the information below for definitions of the signal words.
DANGER!
– Danger indicates an imminently hazardous situation
which, if not avoided, will result in death or serious
injury.
DO NOT Smoke
Oxidizer
Recycle
WARNING!
– Warning indicates a potentially hazardous situation
which, if not avoided, could result in death or serious
injury.
CAUTION!
– Caution indicates a potentially hazardous situation
which, if not avoided, may result in property damage
or minor injury or both.
DO NOT dispose of in household waste
Manufacturer
– Indicates a hazardous situation that could result in
damage to property if it is not avoided.
Gives useful tips, recommendations and information for
efficient, trouble-free use.
4
1160840-D-01
General
1.2
Intended Use
This oxygen conserving regulator is intended for prescription use
only, to be part of a portable oxygen delivery system for patients that
require supplemental oxygen in their home and for ambulatory use.
It is for patients who would normally receive the oxygen via a nasal
cannula. This product is to be used as an oxygen supplement and is
not intended to be life supporting or life sustaining.
DANGER!
Risk of Injury or Death
This product is to be used as an oxygen supplement and
is not intended to be life-supporting or life-sustaining.
ONLY use this product if the patient is capable of
spontaneous breath, able to inhale and exhale without
the use of a machine.
WARNING!
Risk of Injury or Damage
Use of this product outside of the intended use and
specifications has not been tested and may lead to
product damage, loss of product function, or personal
injury.
– DO NOT use this product in any way other than
described in the specifications and intended use
sections of this manual.
1.3
User Profile
No specific product knowledge or training is required, other than
what is contained in this manual, to operate the product. It is not
intended for supplying oxygen therapy during refilling. This product is
intended to be used by or under adult supervision only after reading
and understanding the instructions and warnings of this user manual.
1160840-D-01
Only personnel instructed and trained in the use of HomeFill®
cylinder assemblies should operate this product.
The use of this product is limited to the oxygen patient. Oxygen
conserving regulators MUST be used only by the oxygen patient and
are not to be distributed to any other individual for any purpose.
This product is NOT to be used by patients who breathe through
their mouths.
1.4
Service Life
WARNING!
Risk of Injury or Damage
The product has been tested for the service life stated in
this manual. Use of the product beyond this time period
may cause injury or product damage.
– ONLY use the product for the service life stated in
this manual. DO NOT exceed the service life of the
product.
– Perform all maintenance according to the
recommended schedule in this manual.
The expected service life of the conserving regulator is five years
when used in accordance with the safety instructions, maintenance
intervals and correct use stated in this manual. Refer to the
Maintenance section.
The expected service life of the cylinder is based on testing the
cylinder every five years and using it in accordance with the safety
instructions, maintenance intervals and correct use stated in this
manual. Refer to the following procedures:
•
The Hydrostatic Testing Date, External Examination,
Maintenance
5
Invacare® Element™ Pneumatic Conserver
1.5
Limited Warranty
THE WARRANTY BELOW HAS BEEN DRAFTED TO
COMPLY WITH FEDERAL LAW APPLICABLE TO
PRODUCTS MANUFACTURED AFTER JULY 4, 1975.
This warranty is extended only to original purchaser who purchases
this product when new and unused from Invacare Corporation or a
dealer. This warranty is not extended to any other person or entity
and is not transferable or assignable to any subsequent purchaser
or User Coverage under this warranty will end upon any such
subsequent sale or other transfer of title to any other person. This
warranty gives you specific legal rights and you may also have other
legal rights which may vary from state to state.
Invacare warrants this product to be free from defects in materials
and workmanship for a period of three years from date of purchase
from Invacare or a dealer, with a copy of the seller’s invoice required
for coverage under this warranty.
For Model Nos. IOH2MD, IOH2M6, IOH2M9, HF2PCL4, HF2PCL6
and HF2PC9, Invacare warrants the HomeFill conserver or regulator
(NOT including the cylinder) to be free from defects in materials
and workmanship for a period of two years from date of purchase
from Invacare or a dealer, with a copy of the seller’s invoice required
for coverage under this warranty.
DO NOT OPEN OR ATTEMPT TO SERVICE UNLESS SERVICE
IS PROVIDED BY AN INVACARE-CERTIFIED TECHNICIAN;
otherwise, this will void any and all warranties. If within such warranty
periods any such product shall be proven to Invacare's satisfaction to
be defective, such product shall be repaired or replaced, at Invacare's
option. This warranty only applies to the labor for repairs performed
by the Invacare Service Department or Invacare dealers. It does not
apply to the labor performed by the purchaser or user or shipping
charges incurred in replacement part installation or repair of any
6
such product. This warranty does not include normal wear and tear
and failure to adhere to the product instructions, . Invacare's sole
obligation and your exclusive remedy under this warranty shall be
limited to such repair or replacement. Routine maintenance items,
such as filters, are excluded from this warranty.
For warranty service, please contact Invacare's service department at
the toll free number on the back page during normal working hours.
Upon receiving notice of an alleged defect in a product, Invacare will
issue a serialized return authorization. It shall be the responsibility of
the purchaser, at the purchaser's cost, to return the unit, pack the
unit in a manner to avoid shipping damage and to ship the unit to
either Invacare's plant or service center as specified by Invacare in
advance. Defective units must be returned for warranty inspection
using the serial number as identification within thirty days of return
authorization date. Do not return products to our factory without
prior consent. C.O.D. shipments will be refused; please prepay
shipping charges.
LIMITATIONS AND EXCLUSIONS: THE FOREGOING
WARRANTY SHALL NOT APPLY TO PRODUCTS SUBJECTED
TO NEGLIGENCE, ACCIDENT, IMPROPER OPERATION,
MAINTENANCE OR STORAGE, SOOT OR SMOKE-FILLED
ENVIRONMENTS, OR OTHER THAN NORMAL APPLICATION,
USE OR SERVICE, OR TO PRODUCTS MODIFIED WITHOUT
INVACARE CORPORATION'S EXPRESS WRITTEN CONSENT
(INCLUDING, BUT NOT LIMITED TO, MODIFICATION
THROUGH THE USE OF UNAUTHORIZED PARTS OR
ATTACHMENTS) OR TO PRODUCTS DAMAGED BY REASON
OF REPAIRS MADE TO ANY COMPONENT WITHOUT THE
SPECIFIC CONSENT OF INVACARE CORPORATION OR
TO PRODUCTS DAMAGED BY CIRCUMSTANCES BEYOND
INVACARE CORPORATION'S CONTROL.
1160840-D-01
General
THE FOREGOING EXPRESS WARRANTY IS EXCLUSIVE AND IN
LIEU OF ANY OTHER WARRANTIES WHATSOEVER, WHETHER
EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE, AND THE SOLE REMEDY FOR VIOLATIONS OF ANY
WARRANTY WHATSOEVER, SHALL BE LIMITED TO REPAIR OR
REPLACEMENT OF THE DEFECTIVE PRODUCT PURSUANT TO
THE TERMS CONTAINED HEREIN. THE APPLICATION OF ANY
IMPLIED WARRANTY WHATSOEVER SHALL NOT EXTEND
BEYOND THE DURATION OF THE EXPRESS WARRANTY
PROVIDED HEREIN. INVACARE SHALL NOT BE LIABLE FOR ANY
CONSEQUENTIAL OR INCIDENTAL DAMAGES WHATSOEVER.
SOME STATES DO NOT ALLOW THE EXCLUSION OR
LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGE,
OR LIMITATION OF HOW LONG AN IMPLIED WARRANTY
LASTS, SO THE ABOVE EXCLUSION AND LIMITATION MAY
NOT APPLY TO YOU.
THIS WARRANTY SHALL BE EXTENDED TO COMPLY WITH
STATE/PROVINCIAL LAWS AND REQUIREMENTS.
1160840-D-01
7
Invacare® Element™ Pneumatic Conserver
1.6
8
Component Identification
Item
Description
A
Cylinder Post Valve T-Handle
Clamp
B
Cylinder Alignment Pins
C
Cylinder Gauge
D
Oxygen Supply Outlet Fitting
E
Vent Hole
F
Cylinder Gauge Needle
G
Selector Switch
H
CGA870 Seal Washer
I
Connection to Cylinder View
1160840-D-01
Safety
2 Safety
2.1
General Guidelines
In order to ensure the safe installation, assembly and operation of the
product these instructions MUST be followed.
DANGER!
Risk of Death, Injury or Damage
Improper use of this product may cause death, injury or
damage. This section contains important information for
the safe operation and use of this product.
– DO NOT use this product or any available optional
equipment without first completely reading and
understanding these instructions and any additional
instructional material such as user manuals, service
manuals or instruction sheets supplied with this
product or optional equipment.
– If you are unable to understand the warnings, cautions
or instructions, contact a healthcare professional,
dealer or technical personnel before attempting to
use this equipment.
– Check ALL external components and carton for
damage. In case of damage, or if the product is not
working correctly, contact a technician or Invacare
for repair.
– THE INFORMATION IN THIS DOCUMENT IS
SUBJECT TO CHANGE WITHOUT NOTICE.
1160840-D-01
DANGER!
Risk of Death, Injury or Damage
– Use this oxygen conserving regulator and cylinder
in accordance with the HomeFill compressor user
manual.
– DO NOT handle the conserving regulator/cylinder
assembly or use the contents until you are
professionally trained, including emergency
procedures. Training required to operate the product
is contained in the user manual.
– This product is not intended for supplying oxygen
therapy during refilling.
– This product is intended to be used by or under adult
supervision.
– Oxygen Cylinders filled by the Invacare HomeFill
oxygen system shall be used for personal use only.
They are not to be filled for resale or use by
professional users.
– This conserving regulator is to be used with an
Invacare HomeFill oxygen system cylinder. The
cylinder contains 93±3% oxygen produced by an
oxygen concentrator using the pressure swing
adsorption process.
– ALWAYS open the valve slowly and close the valve
after each use and when empty.
9
Invacare® Element™ Pneumatic Conserver
DANGER!
Risk Of Death, Injury, Or Damage From Fire
Textiles, oil or petroleum substances, grease, greasy
substances and other combustibles are easily ignited
and burn with great intensity in oxygen enriched air and
when in contact with oxygen under pressure. To avoid
fire, death, injury or damage:
– DO NOT SMOKE while using this product.
– DO NOT use near OPEN FLAME or IGNITION
SOURCES.
– DO NOT use any lubricants on the cylinder unless
recommended by Invacare.
– NO SMOKING signs should be prominently displayed.
– Avoid creation of any spark near oxygen equipment.
This includes sparks from static electricity created by
any type of friction.
– Keep all matches, lighted cigarettes, electronic
cigarettes or other sources of ignition out of the room
in which the cylinder is located and away from where
oxygen is being delivered.
– Keep the oxygen tubing, cord, and cylinder out from
under such items as blankets, bed coverings, chair
cushions, clothing, and away from heated or hot
surfaces including space heaters, stoves, and similar
electrical appliances.
CAUTION!
Federal (statutory) law restricts this device sale to or
on the order of a medical practitioner licensed by a
governmental agency where he/she practices.
– ONLY a licensed medical practitioner may order the
purchase or use of this device.
10
Operating Information
DANGER!
Risk of Fire
Dirt or contaminants on the cylinder assembly or
conserving regulator can cause fire, injury or death.
– DO NOT use if dirt or contaminants are present on
or around cylinder or conserving regulator.
– DO NOT use or fill cylinder assembly if the cylinder
fillport is dirty or contaminated. Contact your
provider for service or repair.
– DO NOT allow oil from your hands or other sources
to come into contact with the compressor coupling
or cylinder assembly fittings. These substances may
become flammable in the presence of oxygen and
cause injury. Examples of items to avoid are hand
cream or lotion, cooking oil, suntan oil or sunblock
and similar oily products. If you use these types of
products Invacare suggests you wash your hands prior
to using the HomeFill system. If the cylinder fillport
should come in contact with such substances, contact
your provider for service. Avoid touching the cylinder
fillport.
– NEVER oil or lubricate the compressor coupler or
cylinder fillport. NEVER use any penetrating oil
or lubricant such as WD-40® or 3-IN-ONE®. If
connection difficulty is experienced, verify that the
cylinder fillport is being inserted straight down into
the compressor coupler. If continued difficulty is
experienced, contact your provider for assistance.
– DO NOT clean with aromatic hydrocarbons,
including, but not limited to benzene and toluene.
1160840-D-01
Safety
DANGER!
Risk of Fire
Dirt or contaminants on the cylinder assembly or
conserving regulator can cause fire, injury or death.
– DO NOT use cleaning/disinfecting solutions on the
fillport fitting.
– DO NOT immerse product in any kind of liquid.
– DO NOT allow any kind of liquid to get inside
openings of the conserving regulator.
– DO NOT spray cleaning/disinfecting solutions on
product.
– DO NOT autoclave.
– DO NOT gas sterilize with ethylene oxide.
– DO NOT attempt to repair conserving regulator or
cylinder assembly. All repairs MUST be performed
by Invacare Corporation or in an Invacare approved
repair center.
– Store conserving regulator and cylinder assembly in a
clean, dry and cool area when not in use.
DANGER!
Risk of Injury or Death
To avoid choking or ingestion of chemicals from airway
contamination:
– DO NOT use the product in the presence of
pollutants, smoke, fumes, flammable anesthetics,
cleaning agents, or chemical vapors.
1160840-D-01
WARNING!
Risk of Injury or Death
Contaminants in the oxygen may cause injury or death.
– DO NOT use if the oxygen has an unusual odor.
– DO NOT use if particulates are inhaled.
– Contact Invacare or a dealer for service.
WARNING!
Risk of Injury or Damage
To avoid injury or damage from product misuse:
– The flow dial should be turned with normal pressure
from one’s hand. If the flow dial is stiff to turn, do not
force, otherwise damage or injury could occur.
– DO NOT use a flow outlet for driving any medical
equipment.
CAUTION!
Risk of Injury or Damage
To reduce the risk of injury or damage from dropped or
impacted cylinder assemblies:
– Use two hands when handling/transporting oxygen
cylinders.
– Only use Invacare Corporation carrying bag.
– DO NOT allow cylinder assemblies to tip or fall. DO
NOT drop cylinder assemblies.
– Secure gas cylinders so they cannot fall.
– Ensure cylinder is always in upright position when not
connected to the HomeFill compressor.
– DO NOT allow cylinders to impact inanimate objects.
11
Invacare® Element™ Pneumatic Conserver
CAUTION!
Risk of Damage
To avoid product damage:
– DO NOT block the outlet fitting or kink the cannula
when the product is in use, as this may damage the
unit.
– DO NOT fill the cylinder assembly outdoors or
anywhere below 13°C (55°F).
DANGER!
Risk of Injury or Death
The cannula can cause tripping, falling, or other injury if
improperly positioned and secured. To avoid injury or
death:
– The cannula MUST be routed and secured properly.
– DO NOT position the cannula around the neck.
Ensure the patient can move freely while wearing the
cannula.
– Avoid positioning cannulas across areas of high foot
traffic (i.e. aisles, doorways, hallways, etc.)
WARNING!
Risk of Injury or Death
To reduce the risk of injury or death from illness:
– Before the first patient use, the provider MUST
disinfect the product. Refer to the Disinfecting
section.
– Replace the nasal cannula on a regular basis. Check
with your equipment provider or physician to
determine how often the cannula should be replaced.
– DO NOT share cannulas between patients.
The cylinder poses no biocompatibility hazards and is
latex and phthalate free. The biocompatibility of cylinder
accessories may vary by manufacturer. Invacare accessories
such as the cylinder bag and Invacare oxygen tubing are latex
and phthalate free. Refer to the packaging on any cylinder
accessories to determine the biocompatibility hazard.
WARNING!
Risk of Injury or Death
To avoid choking and/or strangulation from tubing
entanglement:
– Keep children and pets away from nasal cannula and
tubing.
– Close supervision is necessary when the nasal cannula
is used by or near children and/or disabled persons.
12
1160840-D-01
Safety
The cylinder assembly MUST be emptied of gas prior to shipping by
courier or postal service. Refer to Emptying the Cylinder Assembly
in the cylinder’s user manual.
Because the cylinder contains magnetic, ferrous material, it is not
suitable to be in an MRI room.
Be sure all connections are tight and leak free. DO NOT use a liquid
leak detector to test for leaks. Leaks are indicated by loss of pressure
when the cylinder assembly is not in use and by hissing sounds. This
product is equipped with a relief valve. If you hear a loud hissing or
popping sound coming from the product, discontinue use of product,
turn the flow dial to the “Off” setting, and contact your dealer/Home
Care equipment provider.
ALWAYS confirm prescribed dose before administering to patient
and monitor on a frequent basis.
NO OXYGEN is delivered when the conserving regulator flow dial
setting is “Off”.
DO NOT use a humidifier with this product.
Keep cylinder in a well ventilated place.
This product is designed to operate with a standard or high flow
single lumen, adult oxygen nasal cannula with a maximum length of
2.1 m (7 ft).
The cannula is for single patient use only.
Cannula MUST be installed on outlet connection prior to use.
Refer to the HomeFill User Manual for additional warnings, cautions
and safety instructions.
1160840-D-01
13
Invacare® Element™ Pneumatic Conserver
3 Setup
3.1
Dealer Setup
WARNING!
– Before the first patient use, the provider MUST
disinfect the product. Refer to the Disinfecting
section.
– Before patient use, the provider MUST check the
hydrostatic testing date. Refer to The Hydrostatic
Testing Date section.
WARNING!
Risk of Injury
For medical applications, it is very important to select
the prescribed level of oxygen flow. Uninterrupted use
of high concentrations of oxygen over a long duration,
without monitoring its effect on oxygen content of
arterial blood, may be harmful.
– Use ONLY as directed by a licensed practitioner.
– DO NOT increase or decrease the flow unless a
change has been prescribed by your physician or
therapist.
3.2
User Setup
WARNING!
– When receiving the oxygen conserving regulator and
cylinder assembly from the provider, the user/patient
MUST perform a receiving inspection. Refer to the
Receiving Inspection section.
14
3.3
Receiving Inspection
Remove product from package and inspect for damage. If there is any
damage, DO NOT use. Contact your dealer/Home Care equipment
provider.
3.4
Cylinder Prefill Inspection
WARNING!
Risk of Injury or Damage
– Oxygen cylinder assemblies shall be used for personal
use only. Not to be filled for resale or use by
professional users.
– Filling of cylinder assemblies is performed by Invacare
HomeFill Oxygen System only.
– The cylinder assembly is to be used with the HomeFill
system. This cylinder contains 93±3% oxygen
produced by an oxygen concentrator using the
pressure swing adsorption process.
– DO NOT handle the cylinder assembly or use
contents until you are professionally trained, including
emergency procedures.
– Use this cylinder assembly in accordance with the
HomeFill user manual.
– Secure the cylinder assembly during storage and use.
DO NOT drop.
– No smoking in cylinder assembly area. Keep away
from heat, flame or spark.
– Keep out of the reach of children.
1160840-D-01
Setup
DANGER!
Risk of Injury or Death
Improper filling or abuse of the cylinder assembly, or
failure to follow these safety instructions may cause
serious bodily injury or death. High pressure oxidizing
gas vigorously accelerates combustion.
– DO NOT alter or modify cylinder assembly or related
components.
– DO NOT use oil or grease. Keep cylinder, all
equipment and connections free of oil and grease to
avoid violent ignition resulting in serious bodily injury
or death.
3.4.1
WARNING!
Risk of Injury
To reduce the risk of injury:
– DO NOT use oxygen conserving regulators that have
not been tested in the past five years. Otherwise,
serious personal injury may result. Contact
your dealer/Home Care equipment provider for
replacement.
3.4.2
WARNING!
Risk of Injury or Damage
To reduce the risk of injury or product damage:
– DO NOT use the cylinder if any of the following
items are found. Contact your dealer/Home Care
equipment provider for a replacement.
The Hydrostatic Testing Date
Aluminum cylinders MUST undergo testing every five years.
DANGER!
Risk of Death, Injury or Damage from Fire
To avoid fire, death, injury or damage:
– Cylinders that have been refinished and/or exposed
to elevated temperatures MUST be hydrostatically
tested before filling. Cylinder temperature should not
exceed 60° C (140° F). Aluminum cylinders subject to
the action of fire or heated temperatures in excess of
177° C (350° F) MUST be withdrawn from service
and condemned by trained personnel. DO NOT
use caustic paint strippers. Valve and safety relief
devices MUST be removed and replaced by trained
and authorized personnel. DO NOT alter or change
valve assembly.
– All cylinders MUST be inspected before attempting to
fill; otherwise, injury or damage may occur.
1160840-D-01
External Examination
1.
Examine the outside of the cylinder for the following conditions.
If they exist, contact your provider for service.
•
2.
3.
Dents or dings, arc burn, soil or grease, any other signs
of damage that might cause a cylinder to be unacceptable
or unsafe for use
Examine the cylinder for evidence of fire or thermal damage.
Evidence includes charring or blistering of the paint, or other
protective coating or heat sensitive indicator. If fire or thermal
damage is found, contact your dealer/Home Care equipment
provider for a replacement.
Inspect the cylinder assembly for the following conditions. If they
exist, contact your provider for a replacement.
•
Debris, oil or grease, noticeable signs of damage, signs of
corrosion, signs of excessive heat or fire damage, signs of
pressure leaks
15
Invacare® Element™ Pneumatic Conserver
4 Usage
4.1
CAUTION!
– DO NOT use tools to tighten T-handle. This can
lead to over tightening and will cause damage to the
oxygen conserving regulator.
– Ensure all connections are tight and leak free.
– DO NOT use liquid leak detector to test for leaks.
Installing the Conserving Regulator
WARNING!
– DO NOT allow oil from your hands or other sources
to come into contact with the conserving regulator
gasket or cylinder post valve. These substances may
become flammable in the presence of oxygen and
cause injury. Avoid touching the cylinder post valve
whenever possible. Example of items to avoid are
hand creams or lotions, cooking oils, suntan oils or
sun blocks and similar oily products. If you use these
types of products, wash your hands prior to use. If the
cylinder post valve should come in contact with such
substances it should be cleaned off with a damp cloth
prior to connecting it to the conserving regulator.
– DO NOT direct flow of oxygen at any person or
flammable material when opening the cylinder.
– DO NOT use without CGA870 Seal Washer (metal
washer with elastomer seal).
– DO NOT use plastic yoke seals (plastic compression
gasket).
– Use CGA870 Seal Washer made of viton and brass.
– The CGA870 Seal Washer supplied with the oxygen
conserving regulator is reusable.
For information on how to operate the cylinder, consult
your equipment provider.
1.
2.
3.
Loosen the T-Handle A on the conserving regulator device.
Lower the conserving regulator device over any CGA870 post
valve cylinder with the alignment pins B toward the holes on the
cylinder neck as displayed by the connection to cylinder view I.
Align the two pins and gasket with the corresponding holes on
the cylinder post valve.
The T-Handle on the conserving regulator device should
be aligned with indentation on the post valve.
16
1160840-D-01
Usage
4.
5.
While holding the unit in place, tighten the T-Handle on the
conserving regulator device by turning clockwise.
Attach a standard cannula (7 ft (2.1 m) or less in length) to the
oxygen supply outlet fitting.
Tighten only by hand. The use of a tool to tighten the
T-Handle A may damage the unit.
4.2 Oxygen Conserving Regulator and Cylinder
Assembly Operation
DANGER!
Risk of Fire
– NEVER smoke in an area where oxygen is being
administered.
– NEVER use near any type of flame or
flammable/explosive substances, vapors or
atmosphere.
If for any reason, any label becomes illegible or lost, contact
your dealer/Home Care equipment provider.
1.
2.
3.
4.
5.
Prior to each use, inspect product for visible damage. Refer to
the External Examination section. DO NOT use if any damage is
found.
Turn the selector switch G on the oxygen conserving regulator
to the “Off” position before opening the cylinder valve.
To reduce the risk of rapid oxygen recompression and fire, open
the cylinder post valve slowly and completely so the pressure
gauge moves slowly as it indicates the cylinder pressure.
Listen for leaks. If a leak is present, close the cylinder valve,
check the CGA870 Seal Washer H, and reinstall. If the leak
persists, DO NOT use the equipment. Contact your home care
provider for repair.
Inspect the cylinder gauge C to ensure the pressure is at least
1500 psig (10342 kPa). If below 1500 psig (10342 kPa), then refill
the cylinder assembly using the HomeFill system.
WARNING!
– When cylinder gauge needle enters red zone, it is
recommended to refill the cylinder assembly on
the Invacare HomeFill Compressor.
6.
7.
Ensure that the vent hole on the side of the unit is not obstructed.
Position the cylinder assembly so the outlet connection is
pointing away from the user and any other person(s).
WARNING!
Risk of Injury
To reduce the risk of injury:
– DO NOT direct flow of oxygen at any person, or
flammable material when adjusting the selector
switch.
8.
1160840-D-01
Remove the outlet connection cap, if present.
17
Invacare® Element™ Pneumatic Conserver
9.
Attach a standard or high flow single lumen adult oxygen nasal
cannula with a maximum length of 2.1 m (7 feet) to the product’s
outlet connection according to the cannula manufacturer’s
instructions.
DO NOT use pediatric cannulas with this product.
A unit without cannula attached may pulse if set at
position 1–6.
12. Turn the selector switch G to the prescribed setting.
WARNING!
– To avoid injury to patient, ALWAYS confirm
prescribed setting before administering to patient
and monitor flow on a frequent basis.
– Only use the Invacare Corporation carrying bag.
The continuous flow (CF) setting is designed for
emergency use only. The amount of oxygen delivered
when using the oxygen conserving regulator in
continuous flow mode is preset to 2 L/min (liters per
minute). Remember that in this mode the oxygen will
be consumed at a much faster rate. Return to another
source before running out of oxygen.
DANGER!
Risk of Injury or Death
The cannula can cause tripping, falling, or other
injury if improperly positioned and secured. To
avoid injury or death:
– The cannula MUST be routed and secured
properly.
– DO NOT position the cannula around the neck.
Ensure the patient can move freely while wearing
the cannula.
– Avoid positioning cannulas across areas of high
foot traffic (i.e. aisles, doorways, hallways, etc.)
13. Breathe through the nose and feel a flow of oxygen as you inhale.
When on the pulse setting, there is flow or a pulse only
at the beginning of each breath. If you do not feel the
pulse at the beginning of each breath, check the setting.
If there is still no pulse, turn dial to 2 L/min continuous
setting.
Because each patient’s breathing pattern is different and
the environment varies, it may be difficult to feel some
low setting pulses.
10. Place the cannula over your ears and position the prongs in
your nose as instructed by your health care provider or cannula
manufacturer.
11. Ensure there are no kinks or twists in the cannula tubing.
18
1160840-D-01
Usage
14. When finished using the cylinder assembly, perform the following
steps:
a.
b.
Close the conserving regulator device and continue
breathing through the nasal cannula until no further oxygen
flow is detected.
Remove the nasal cannula and turn the selector switch to
setting “Off”.
15. When not in use, store in a clean, dry location.
4.3
Removing the Conserving Regulator
For information on how to operate the cylinder, consult
your equipment provider.
1.
2.
3.
4.
5.
6.
Completely close the oxygen cylinder post valve.
Turn the oxygen conserving regulator selector switch G to 2
L/min. continuous flow position.
Wait for oxygen to stop flowing from the oxygen conserving
regulator.
Turn the conserving regulator to “Off”.
Turn the T‐Handle A to loosen the connection to the post.
Remove the oxygen conserving regulator from the post.
DANGER!
– NEVER attempt to remove the oxygen conserving
regulator from an oxygen cylinder unless the cylinder
valve is completely closed.
CAUTION!
– DO NOT try to loosen the T-handle beyond the
stop. Otherwise, damage to the oxygen conserving
regulator will occur.
1160840-D-01
19
Invacare® Element™ Pneumatic Conserver
5 Maintenance
5.1
Maintenance
WARNING!
Risk of Injury or Damage
Lack of product maintenance can lead to injury and loss
of product function or damage.
– Maintenance MUST be performed ONLY by qualified
personnel.
– Regular maintenance is necessary to assure proper
operation.
DANGER!
Risk of Fire
Dirt or contaminants on the cylinder assembly or
conserving regulator can cause fire.
– DO NOT use or fill cylinder assembly if the cylinder
fillport is dirty or contaminated. Contact your
provider for service or repair.
– DO NOT clean with aromatic hydrocarbons,
including, but not limited to benzene and toluene.
– DO NOT use cleaning/disinfecting solutions on the
fillport fitting.
– DO NOT immerse product in any kind of liquid.
– DO NOT allow any kind of liquid to get inside
openings of the regulator.
– DO NOT spray cleaning/disinfecting solutions on
product.
– All repairs MUST be performed by Invacare
Corporation or in an Invacare approved repair center.
20
WARNING!
Risk of Injury or Damage
– The cylinder assembly MUST be disconnected from
the HomeFill and emptied of gas prior to cleaning or
disinfecting. Refer to Emptying the Cylinder Assembly.
The fillport cover MUST also be installed.
– All cylinders MUST be inspected before attempting to
fill; otherwise, injury or damage may occur. Refer to
Cylinder Prefill Inspection.
The cannula does not require maintenance and needs to be replaced
at the manufacturer’s recommended interval.
The conserving regulator should be inspected and tested at a
minimum every 5 years. This inspection and test MUST be performed
by Invacare Corporation or by an Invacare approved repair center.
The aluminum cylinder must undergo hydrostatic testing every 5
years. Refer to The Hydrostatic Testing Date.
5.2
Emptying the Cylinder Assembly
DANGER!
Risk of Fire
– NEVER smoke in an area where oxygen is being
administered.
– NEVER use near any type of flame or
flammable/explosive substances, vapors or
atmosphere.
– DO NOT direct flow of oxygen at any person, or
flammable material when adjusting the flow dial.
1160840-D-01
Maintenance
CAUTION!
Risk of Damage
– DO NOT completely empty the cylinder. Otherwise,
damage to the cylinder could occur.
5.3
Cleaning
Refer to the safety information in the Maintenance section
before performing this procedure.
Follow the cleaning/disinfectant product manufacturer’s instructions
for use, handling, storage and disposal of the product.
Follow this procedure to clean the cylinder assembly as required
when visibly soiled.
1.
2.
3.
4.
1.
2.
3.
4.
5.
Position the cylinder assembly so the outlet connection is
pointing away from the user and any other person(s).
Ensure the selector switch G to setting “Off”.
To reduce the risk of rapid oxygen recompression and fire, open
the cylinder post valve slowly and completely so the pressure
gauge moves slowly as it indicates the cylinder pressure.
Slowly turn the selector switch G to setting “2”.
Examine the cylinder gauge C until the pressure is below 500
psig (3447 kPa).
Cylinder pressure is below 500 psig (3447 kPa) when
the cylinder gauge needle is in the red zone.
6.
Turn the selector switch G to setting “Off”.
5.
5.4
Ensure the cover is installed on the fillport.
Clean exterior surfaces of the cylinder with a lint free cloth
dampened with 70% isopropyl alcohol.
Clean the exterior surfaces of the conserving regulator with a
dry, lint free cloth.
If the conserving regulator is still visibly soiled, clean with a lint
free cloth dampened with 70% isopropyl alcohol. DO NOT wipe
the fillport or outlet fitting.
Wipe the cylinder and conserving regulator with a dry lint free
cloth. Ensure the product is dry before using.
Disinfecting
Refer to the safety information in the Maintenance section
before performing this procedure.
Follow the cleaning/disinfectant product manufacturer’s instructions
for use, handling, storage and disposal of the product.
This procedure is for disinfecting the cylinder assembly and is to be
performed by the provider prior to a patient change and as otherwise
required.
Recommended disinfectant products:
•
1160840-D-01
Quaternary ammonium based wipes selected by the provider
for the desired disinfecting characteristics
21
Invacare® Element™ Pneumatic Conserver
•
1.
2.
3.
4.
5.5
70% isopropyl alcohol wipes
Ensure the cover is on the fillport.
If heavily soiled, first clean the cylinder assembly. Refer to the
Cleaning section.
Use a wipe to disinfect the external surfaces of the conserving
regulator and cylinder. Follow the disinfectant manufacturer’s
instructions. DO NOT wipe the fillport or outlet connection.
Wipe the cylinder and conserving regulator with a dry lint free
cloth. Ensure the product is dry before using.
Reuse
WARNING!
Before transferring the product to a different user,
providers MUST inspect the product for damage and
disinfect the product. Refer to the following procedures:
– Disinfecting, Cylinder Prefill Inspection, The
Hydrostatic Testing Date, External Examination
5.7
Optional Accessories
WARNING!
Risk of Serious Injury or Damage
Use of non-Invacare accessories may result in serious
injury or damage.
– Invacare products are specifically designed and
manufactured for use in conjunction with Invacare
accessories. Accessories designed by other
manufacturers have not been tested by Invacare are
not recommended for use with Invacare products.
– DO NOT use non-Invacare accessories.
– To obtain Invacare accessories, contact Invacare by
phone or at www.invacare.com.
The cylinder assembly and conserving regulator can be transferred to
a different patient. The cannula is for single patient use only.
5.6
1.
2.
3.
22
Storage
Disconnect all connections before cleaning.
After each use, clean exterior of the conserver with a clean,
lint-free cloth.
Store conserver in a clean area free from grease, oil, and other
sources of contamination.
1160840-D-01
After Use
6 After Use
6.1
Disposal
This product has been supplied from an environmentally aware
manufacturer that complies with the Waste Electrical and Electronic
Equipment (WEEE) Directive 2002/96/CE. This product may contain
substances that could be harmful to the environment if disposed of in
places (landfills) that are not appropriate according to legislation.
Follow local governing ordinances and recycling plans regarding
disposal of the product or components normally used in operation.
The device does not generate waste or residue in operation.
•
•
6.2
DO NOT dispose of the device in the normal waste stream.
Any accessories not part of the device MUST be handled in
accordance with the individual product marking for disposal.
Wear and Tear
Invacare reserves the right to ask for any item back that has an
alleged defect in workmanship. See Warranty that shipped with the
product for specific warranty information.
Refer to the Maintenance section for proper preventative
maintenance schedule and use of the product.
1160840-D-01
23
Invacare® Element™ Pneumatic Conserver
7 Troubleshooting
7.1
Troubleshooting
If oxygen conserving regulator fails to function, consult the Troubleshooting guide. If problem cannot be corrected, consult your dealer/Home
Care equipment provider.
Problem
Possible Cause
Solution
No flow.
1.
2.
3.
4.
5.
Cylinder valve is closed.
Conserving regulator in “Off” position.
Cylinder empty.
Kinked or blocked cannula.
Shutoff valve closed.
1.
1.
2.
Unit is set to the “CF” position.
Unit was not set to “Off” prior to opening
the cylinder valve.
Vent hole is obstructed
1.
Unit does not pulse.
Unit flows or pulses continuously.
3.
2.
3.
4.
5.
2.
3.
24
Turn the cylinder valve to the “ON”
position.
Set to prescribed setting.
Replace cylinder.
Check to see if the cannula is kinked.
Slowly open shutoff valve.
Turn the selector switch to the
appropriate delivery setting.
Turn the selector switch to “OFF”, wait a
few moments, then set at proper delivery
settings.
Remove obstructions, such as labels or
carrying bag, and resume use as usual.
1160840-D-01
Technical Data
8 Technical Data
8.1
Technical Description
The Invacare IOCI00P Element Pneumatic Conserver is designed for use with high pressure oxygen systems, which can deliver up to 2 L/min
of continuous and/or pulse flow oxygen to the patient via a nasal cannula. The cylinders are designed to store compressed oxygen up to 2,100
psig (14479 kPa). The continuous flow conserver consists of a cylinder connection, cylinder contents gauge (if equipped), high to low pressure
conserving regulator, orifice plate and a conserving demand module. The conserving regulator reduces the high pressure of the cylinder to the
working pressure of the orifice plate. The orifice plate uses calibrated orifices to deliver a selected flow to the conserving demand module. The
conserving demand module controls the pulse size and timing to the patient. It supplies a pulse of oxygen at the beginning of each breath. This
reduces the oxygen demand on the system and limits the drying of airways. The flow is determined by setting the flow control knob to the
prescribed flow. The conserving regulator reduces the pressure at the cannula connection to 50 psig (345 kPa) and contains a rotary flow dial
that is used to adjust the oxygen flow rate to the prescribed setting. The cylinders are filled with USP 93±3% oxygen using their proprietary
fillports that allow filling only through the use of an Invacare HomeFill System. The duration of oxygen flow between fills is dependent on the
size of the cylinder and the flow setting.
8.2
Specifications
Flows
1160840-D-01
Selector Switch Position
Liter Flow Equivalency
0
Off
1
1
2
2
3
3
4
4
5
5
6
6
25
Invacare® Element™ Pneumatic Conserver
Pressures
Continuous Flow Emergency Bypass Setting:
Required Operating Pressure:
Regulator:
Factory Preset at 2 ± .5 L/min
200 psig to 3000 psig (1379 kPa to 20684 kPa)
Built-in, 25 ± 5 psig (172 kPa ± 35 kPa), brass high pressure
with aluminum low pressure materials
Environmental Temperature Range
Operating Conditions Temperature:
Operating Relative Humidity:
Operating Altitude:
32°F to 122 °F (0°C to 50°C)
15% to 95%
0 to 10,000 ft (0 to 3,048 m)
Maximum Storage Temperature:
–40°F (–40°C), 1% RH
Maximum Transportation Temperature:
145°F (63°C), 44% RH
Shock Vibration:
Not to exceed IEC 601–1 requirements
Not to exceed IEC 68–2–6, IEC 68–2–34
Dimensions
Weight
Overall Length
26
Approximately 14.8 ounces (420 grams)
Approximately 5” L x 2.5” H x 2.5” W (12.7 cm x 6.4 cm x 6.4 cm)
1160840-D-01
Technical Data
Estimated Cylinder Oxygen Duration in Hours (Based on 20 breaths/min.)
Cylinder
Type
Cylinder
Volume Liters
at 2015 psig
Setting 1
Setting 2
Setting 3
Setting 4
Setting 5
Setting 6
Continuous
Flow 2 L/min.
M2
36
1.9
.9
.6
.5
.4
.3
.3
M4(A)
113
5.9
2.9
2.0
1.5
1.2
1.0
.9
M6(B)
164
8.5
4.3
2.8
2.1
1.7
1.4
1.4
ML6
171
8.9
4.5
3.0
2.2
1.8
1.5
1.4
M9(C)
246
12.8
6.4
4.3
3.2
2.6
2.1
2.1
D
425
22.1
11.1
7.4
5.5
4.4
3.7
3.5
E
680
35.4
17.7
11.8
8.9
7.1
5.9
5.7
Accessories
Single Lumen Cannula
4’ (1.21 m) recommended. 7’ (2.1 m) tubing length maximum
Regulatory Compliance
CGA G-4.1 (Cleaning Equipment For Oxygen Service)
DOT & TC (3AL & 3ALM)
1160840-D-01
27
Invacare Corporation
Manufactured For:
USA
Invacare Corp.
2101 E. Lake Mary Blvd.
Sanford, FL 32773
Tel: 407–321–5630
One Invacare Way
Elyria, Ohio USA
44036–2125
440–329–6000
800–333–6900
Technical Services
440–329–6593
800–832–4707
www.invacare.com
1160840-D-01
2016-08-12
*1160840D-01*
Making Life’s Experiences Possible™
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