Anda di halaman 1dari 70

APPLIED HOME HEALTHCARE EQUIPMENT INC.

Indicates registered trademarks used in this catalog: Microsoft, DuPont, Airgas,


Puritan-Bennett, Caire, Linde, and others.
Applied Home Healthcare Equipment, Inc. 2005
Printed in the U.S.A. / Suggested retail: $3.95 USD

e-mail: med@applied-inc.com
web-site: www.applied-inc.com

telephone: 1 (440) 716-9962


toll-free: 1 (888) 327-7301 (USA)
fax: 1 (440) 716-9964
8:30 am to 5:00 pm
Eastern Standard Time (USA)

31379 Lorain Road,


North Olmsted, OH
44070-4730 USA

OXYGEN POCKET REFERENCE GUIDE

OXYGEN POCKET
REFERENCE GUIDE

OXYGEN POCKET REFERENCE GUIDE

DELIVERING

STORING

FILLING

INCREASING REVENUE AND PROFITS


TECHNICAL

/
REGULATORY

OXYGEN POCKET REFERENCE GUIDE

MR-100 Series,
free private branding
of medical regulators

1199-1030,
Current good
manufacturing
practice certification
course, V2

Solutions

APPLIED NEW PRODUCTS

SOLUTIONS

OF-1232,
North American
Emergency Response
Guide Training Course

Hi, Im Dave Marquard


owner of Applied Home
Healthcare Equipment Inc.
This Oxygen Pocket
Reference Guide is dedicated
home healthcare oxygen providers /
dealers who help improve the quality of life for
millions of patients everyday.
The Oxygen Pocket Reference Guide is the first
in a series of guides designed to provide a quick
overview of important safety, regulatory, and
technical information. For example, if youre
using, storing, transporting, delivering, handling,
and / or refilling oxygen you will find highly useful
information and products in this guide. Please
see our comprehensive table of contents on the
next page or the index in back of the guide.
Please note it is not possible to put all the
relevant safety, regulatory, and technical information you need to use, store, deliver, refill
oxygen, etc. in this small pocket reference.
However, you will find current general key points,
lists, references, and links that used together can
help you improve oxygen safety, compliance,
revenue, and your profits.
Thank you for choosing Applied as one of your
regulatory, technical, and product resources.
Thank You,

Dave Marquard

APPLIED NEW PRODUCTS


OF-1215,
Haz-mat training
for oxygen drivers,
delivery techs, and
warehouse personnel

MR-100 Series,
free private branding
of medical regulators

OF-1201,
Driver and delivery
tech training course,
Part 2

TA B L E O F C O N T E N T S

Delivering Oxygen
Driver Requirements
Vehicle Requirements
Requirements
Oxygen Manifest (Shipping Papers)
Vehicles with Cryogenic Tanks
Van and Truck Racks and Carts
Hazardous Material (Haz-Mat) Training
Driver Training
Drug / Alcohol for Drivers
Incidents / Accidents Documentation

Storing Oxygen
Building Requirements / Recommendations
Racks, Multiple and Single Cylinder
Material Handling: Cylinders
and Cryogenic Vessels
Carts, Cylinder and Cryogenic Vessel
Filling Oxygen
Self-Audit / Requirements
Training Checklists
High Pressure Cylinder Refilling
High Pressure Cylinder Basics
Cryogenic / Liquid Oxygen Basics
Cryogenic Adapters, Quick Connectors
Labels, Cylinder and Cryogenic Vessels
Common FDA Violations
How to Increase Production - Helpful Hints
"Is Filling Right for Me" & Reducing Costs
Increasing Profits
Financial Analysis, Examples and DIY
Registering with the FDA (requirements)

Appendix
References, Individual and Libraries
Building Layouts: Internal and External Models
Oxygen Technical Information for Providers
Cylinder and Cryogenic Vessels: Sizes
Cylinder Markings; What they mean
Useful Internet Links: FDA, DOT, CGA, etc.
Temperature and Vacuum (altitude) Tables
Home Oxygen Safety Info for Patients
and Care Givers
Auditing Your Suppliers
Please Read: Important Information
FDA Public Health Advisory

1
1
1-4
2-11
2
5
6
7-8
9
10
11
12
12
13-16
13-16
13-16
17
17
18-19
20-21
22-23
24-26
26
27
28-29
30
31 -35

36, 45-46
37
38-55
38-39
40-41
42-43
43
44
47
48-49
50-53
54
55-56
56

DELIVERING OXYGEN

DELIVERING OXYGEN

FDA1, CGA2, DOT3, HC4 and TC5 other


requirements/recommendations [1]:
A. Driver Requirements
1. Driver training
Drivers and delivery techs require DOT,
Haz-Mat and FDA training within the
scope of their job. (pg. 9)
2. Haz-Mat training
Delivery drivers require Haz-Mat training if
they transport any quantity of oxygen. (pg. 8)
3. Drugs/alcohol
Testing, documentation and more. (pg. 10)
4. Incident Handling
Transportation incidents, accidents,
violations, inspections, and what to do.
(pg.11)

1. Oxygen manifest
Required on all delivery vehicles (pg. 2)
2. Key items for vehicles carrying less
than 1000 lbs. (pg. 3)
3. Key items for vehicles carrying
over 1000 lbs. (pg. 4)
4. Haz-Mat information
Haz-Mat training required (pg. 8)
5. Cryogenic tank requirements
Setup requirements and recommendations
(pg. 5)
6. Carts and racks in place
Cylinders and vessels must be secured
so they cant be ejected, shifted or moved
during normal transportation. (pg. 6)
Federal Food & Drug Administration, U.S.
Compressed Gas Association
3
Department of Transportation, U.S.
4
Health Canada / Sant Canada
5
Transport Canada / Transports Canada
1
2

TOLL-FREE 1-888-327-7301

B. Vehicle Requirements [1]

OXYGEN MANIFEST

One of the most common citations by the DOT


is an improperly prepared Haz-Mat manifest.
An oxygen manifest (also called shipping papers) is
required to be carried on all vehicles transporting
oxygen (a hazardous material)*
Example for compressed gases [1]**
COMPRESSED GAS
ID NO.

QTY

PACKAGE
TYPE

SIZE

HAZARD
CLASS

SHIPPING
NAME

CYL

684
LTR.

2.2

COMPRESSED, UN1072
OXYGEN

Example for cryogenic liquid [1]**


REFRIGERATED LIQUID
ID NO.

QTY

PACKAGE
TYPE

SIZE

HAZARD
CLASS

SHIPPING
NAME

DEWAR

180
GAL.

2.2

REFRIGERATED, UN1073
OXYGEN

All information must be legible


and printed in English
Note: DOT/TC considers all cylinders and vessels full unless
empty and purged. Since there isnt any way for most drivers/techs
to purge cylinders and vessels. You should consider all as full. [1]
* 49 CFR 172.602
**For additional information and options see current edition of
Applieds Haz-Mat Pocket Book (PN# OF-1210)

Accurate and current oxygen


manifest must remain in vehicle
at all times

DELIVERING OXYGEN

Key items for vehicles carrying less


than 1,000 lbs.[1]*:
a. Oxygen manifest* (required on all oxygen
deliveries)
b. Proper registration, license or sticker
(refer to your state requirements)
c. Proof of insurance (refer to your state requirements)
d. No smoking signs (post inside
and outside vehicle)
e. Haz-Mat book provides info on Haz-Mat materials
(recommended to be on board)
f. North American Emergency Response Guide
(provides information on how to handle spill or
leak, required to be on board) [1]
All hazardous materials transported
must have a label on them [1]**
*Note: For updates and a complete
list of requirements see appendix,
www.applied-inc.com, and links to
FDA, DOT, HC, and related websites
OF-1228, Self adhesive, flexible

OF-1231, NAERG book

OF-1210, HAZ-MAT book


* 49 CFR 172.602
**49 CFR parts 105-107,
171-180, and 390-397

DELIVERING OXYGEN
Key items recommended on all vehicles
transporting over 1000 lbs. [1]*

All of the prior listed equipment


plus the following:
a. Proper placards (appropriate placard)
b. Driver with CDL (refer to your state requirements)
c. Haz-Mat book (OF-1231 below)
d. Fire extinguisher (recommended and required
when over 1000 lbs.)
e. U.S. DOT or TC motor carrier identification
number (if performing interstate commerce)
Vehicles recommended to have
a. Warning devices
b. Three bidirectional reflective triangles
c. Incident reporting kit
(helps in reacting to an incident)
Keep placards in good shape
with a holder

OF-1221, Aluminum flip placard

OF-1223, Aluminum placard holder

OF-1231, HAZ-MAT book

OF-1208, Driver incident kit

*Note: For updates and a complete list of requirements see


appendix, www.applied-inc.com, and links to FDA, DOT, HC,
and etc. web sites

DELIVERING OXYGEN

Key points recommended for vehicles


with a cryogenic tank* [4,o]

Mounting of the cryogenic tank should include:


a. Bulkhead to separate cargo area from driver area
(required with a cryogenic tank)
b. Tank must be secured to vehicle
(bolted through floor)
c. No smoking signs
d. Vent lines to carry excess oxygen from
tank outside of vehicle
1. from vent valve
2. from pressure relief device
3. from burst disc
e. At least three cargo area vents
1. two in forward area
2. one in rear area
(Totalling 1 sq. ft. or more minimum 1 sq. ft.)
f. Combustible materials such as paneling,
plywood, and carpet should not be in the
cargo area. [4,0]
Keep windows cracked for further ventilation
*Note: See current edition of CGA SB-9 for additional
recommendations (pg. 38, 39)

WWW.APPLIED-INC.COM

It is recommended
to have a spill pan
under van / truck tank

DELIVERING OXYGEN
Racks and carts in vehicles [1]*

DOT / TC requires that all cylinders be secured


when transporting

Small cylinders [1]*


Must be secured to prevent movement
during normal transport

Large cylinders*
a. Must be secured
(strap to the wall
or use proper rack)
Milk crates are not racks
OF-1970, H
cylinder van rack
b. Must be capped or shielded
If using straps, strength must be minimum
1.5 times the weight of the load
Make sure all cylinder carts used
when making deliveries are secured
inside the vehicle [1].

All vehicles are


required to have full,
empty, and quarantine
areas [2].**
OF-1790, Layered van rack holds 6 E
and 4 M-6 with lockable door
19-1/2H x 32-1/4D x 17W

For more van racks and carts,


see current edition of Applied
general catalog and / or
www.applied-inc.com

* 49 CFR 177.840
**21 CFR parts 211.80 - 94

DELIVERING OXYGEN

Haz-Mat training [1]*


How can I receive Haz-Mat Training?

OF-1215,
Haz-mat
training for
oxygen drivers, delivery techs,
and warehouse personnel. Includes
certification for one employee. Certify
additional employees for a nominal fee.

Refer to Haz-Mat Pocket Book


OF-1210 for details
on each material

OF-1210, Haz-mat book

Remember oxygen is classified


as a class 2.2 hazardous material [1]*.
* 49 CFR parts 105-107, 171-180, and 390-397

TOLL-FREE 1-888-327-7301

Attend an Applied seminar


near you by contacting
Applied or viewing
schedule at
www.appliedinc.com. Use
training aids
below.

DELIVERING OXYGEN
Haz-Mat training for driver [1]*
1. Haz-Mat training and
certification course
2. North American Emergency
Response training and
OF-1210,
certification course
Haz-mat
training course
3. Regional training seminars
(Contact Applied or view schedule
at www.applied-inc.com)
All drivers must have at least
some Haz-Mat training within
the scope of their jobs.

OF-1232,
NAERG training course

OF-1230,
DOT training course, Part 2

Meet training requirements


for drivers, delivery techs,
supervisors and others
* 49 CFR parts 105-107, 171-180,
and 390-397

DELIVERING OXYGEN

Driver training [1]*

Drivers delivering under 1000 lbs.


OF-1200 Driver training course
(basic course for delivery drivers)
OF-1201 Driver training course part 2
(advanced course for delivery drivers)
OF-1016 Oxygen safety course (oxygen safety demos)
OF-1250 Driver log book (daily record of transport)
OF-1003 Regional Seminar (Contact Applied or
view schedule at www.applied-inc.com)
Certification provided with successful completion of training courses

OF-1200, DOT course

OF-1201,
DOT course V2

OF-1250,
Driver log book

Drivers delivering over 1000 lbs.


All of the above, plus
a. Commercial drivers license as outlined
by your state
b. See page 10 for additional training aids

Note: See website for current seminar listings


* 49 CFR parts 105-107, 171-180, and 390-397

WWW.APPLIED-INC.COM

For updates and more information see the


reference pages, the appendix of this guide,
and / or visit www.applied-inc.com

10

DELIVERING OXYGEN
Drugs/alcohol training for drivers [1]*

Recommended training aids to assist in drugs


and alcohol awareness
OF-1260 Driver drugs and
drinking training kit
(includes video and
guide)
OF-1260

OF-1270

OF-1280

Easy handbook for


alcohol testing (meet
DOT requirements
for drug and
alcohol testing)
Available in Spanish
OF-1270S

OF-1270

Drug and alcohol files


(designed for employee
files)

You drink, you drive, you lose

OF-1280

* Federal Motor Carrier Safety Regulations, part 382


(Recommended for all drivers, required for all CDL drivers)

DELIVERING OXYGEN

11

Incident handling [1]*

Checklist recommended
to be carried on board
a. Incident response kit
(includes camera, reports,
OF-1208, Driver incident kit
etc. to document incident)
b. Three bidirectional triangles
Learn to use
(recommended on all
before an incident.
vehicles transporting oxygen)
c. Warning devices (recommended on all vehicles
transporting oxygen)
d. North American Emergency Response Guide
(required info to handle incidents)
Cooperate with authorities.
Insure that everyone involved
is okay. Do not make any
statements regarding
fault, blame, etc...

TOLL-FREE 1-888-327-7301

OF-1231, NAERG book

* Federal Motor Carrier Safety Regulations, part 390.5

STORING OXYGEN

STORING OXYGEN

12

Storing oxygen [2 - 4,q]*


Building requirements
a. No smoking signs (should be posted wherever
oxygen is used or stored.)
b. Adequate ventilation (provide ample air
circulation in room)
c. Store 10 feet from open flame
(forced air heating recommended)
d. Store 20 feet from combustibles
(keep cardboard away) [4,i]
e. Cylinder storage areas (FDA required)
1. Empty
2. Quarantine
3. Full
i. not approved
1109-0032,
ii. approved
self adhesive for mounting
f. Types of oxygen service
1. Compressed gas (for low volume users)
2. Liquid to gas (for high volume users)
Check with local building codes
and see appendix for suggested
building layout. (pg. 40 )

WWW.APPLIED-INC.COM

g. Limit entry to authorized personnel only


(doors should be locked when not in use.
Prevent area from patient/customer access)

*Note: For complete information and updates see the reference section
(pg. 38-39) of this guide and www.applied-inc.com and links.

13

STORING OXYGEN
Material Handling [4,q]
As your homecare business grows, the type of material
handling equipment also changes. See the lists below
for the different types of material handling solutions.
Liquid oxygen containers

1100-1820
Large liquid vessel cart with
2 Pneumatic wheels and
2 swivel casters to move
1 Liquid Vessel
46H x 28W

1100-1950
Handtruck w/Stairclimbers
for liquid reservoirs
44H x 22-1/2W x 17D

Space saving cylinder racks*

1100-1863
Holds 50 M7, M9, C, D,
& E Cylinders
66H x 32D x 27W

1100-1867
Holds 168 M4, M6, B Cylinders
66H x 32D x 27W

Storing M-6 sized cylinders*

1100-1932
M-6 Rack for 6 Cylinders
8-1/4H x 7-5/8D x 11-1/2L

1100-1934
M-6 Rack for 24 Cylinders
8-1/4H x 11-1/2D x 30-5/8L

STORING OXYGEN

14

Storing E sized cylinders*

1100-1892 E Vertical Cylinder


Stand with hold down bars
and feet, for 12 Cylinders
19.5H x 15D x 22L

1100-1891 E Vertical Cylinder


Stand with hold down bars
and feet, for 6 Cylinders
19.5H x 12D x 15L

Handling M-6 cylinders*

1100-1844
M-6 Cylinder Cart
for 30 Cylinders
40H x 23D x 19W

1100-1846
M-6 Cylinder Cart
for 60 Cylinders
40H x 39D x 23W

1100-1886
E Cylinder Cart
for 40 Cylinders
with six 6 casters,
45H x 46.5D x 25.25W

1100-1840
Cylinder Cart
for 4 Cylinders
with two wheels
and two legs
42H x 10D x 18W

1100-1873,
E Cylinder Cart
for 12 Cylinders
with four wheels
42H x 20D x 22W

See current general Applied


catalog and www.applied-inc.com
for more carts and racks

*Note: See tables on pg. 15 and 43 for cylinder sizes.

TOLL-FREE 1-888-327-7301

Handling E cylinders*

15

STORING OXYGEN
Material handling Helpful Hints [4,q]
Cylinders and cryogenic vessels must be safely and
efficiently carried into patients
homes apartments, nursing
homes, etc. They should be
secured in a carrying rack or
cart to avoid being dropped or
damaged. Applieds carts and
racks are designed for this purpose. 1100-1866, Holds 84
Use only storage racks and carts M-6 cylinders
33H x 32D x 27W
designed for use with oxygen
1. Use storage racks designed
for specific cylinder diameter.
2.Transport carts can help
reduce employee injuries.
3.Large cylinder carts
make moving different
sized cylinders easy.

1100-1874,
24 E Cylinder cart

42H x 30D x 20W

CYLINDER SIZE GUIDE


CYLINDER

APPROX. DIA.

M4,M6, & B

3.2

M7,M9, C, D, & E

4.3

Jumbo D*

5.3

M, M60, H, J & T

7.0 to 9.5

*Call for Jumbo D stands, and carts

1100-1765,
Multi-cylinder cart

48H x 42D x 32W

Wooden racks are not recommended,


because they are combustible
For more cylinder racks and carts, see current
Applied catalog and www.applied-inc.com

STORING OXYGEN

16

Material handling Helpful Hints [4,q]


Carriers help the delivery process
4. Racks and carts should
have minimum 1.5 times
the strength
of the rack.
5. Non-magnetic
carts for use
with MRI tests.
6. Economy stands for
patients home are
ideal for back-up
cylinder storage or
in nursing homes.

1100-1946, M-6 Carrier

7. Cylinder holders for special


uses; wheel chair mount,
walker mount, wall
brackets, stands, and others.
Carriers reduce the number
trips to and from the
delivery vehicle

1100-1808, Wheelchair
mount for D/E cylinders

1100-1901,
E Cylinder stand

WWW.APPLIED-INC.COM

1100-1913, MRI Cart

FILLING OXYGEN

FILLING OXYGEN

17

Filling oxygen self-audit [4,i]


There are a number of different things to address when
filling medical oxygen. Use the list below and this
section to help you with your training all the way to
your building layout.
A. Training [2]
1. Fillers (pg. 18)
require cGMP*, haz-mat, and equipment training
on a regular basis
2. Supervisors (pg. 19)
supervisors require the above plus basic
supervisory training
3. Quality control unit (pg. 19)
quality control personnel require all above plus
basic quality training from an outside source

C. Buildings [2 - 4,i]
1. Internal layout (pg. 40)
basic FDA, CGA and NFPA recommendations
2. External layout (pg. 41)
basic FDA, CGA and NFPA recommendations
D. Inspectors [2]
1. Most common FDA violations (pg. 28 & 29)
help maintain your regulatory compliance
and perform self audit
E. Increasing revenue and profits (pg. 31)
*cGMP: Current Good Manufacturing Practice [4]

TOLL-FREE 1-888-327-7301

B. Equipment [1]
1. Supplies and accessories (pg. 22 & 23)
should be knowledgeable about how and
why accessories are needed
2. Filling equipment (pg. 24-26)
should be knowledgeable about how
equipment is used to prevent accidents
3. Equipment for increasing productivity (pg. 30)
methods to save time and money
4. Labeling requirements (pg. 27)

FILLING OXYGEN

18

Training checklist [2]


Staying up to date with
current regulatory training
is an important part of a
homecare business. Please
use the list below to help
you meet these needs for
your fillers, supervisors and
quality control unit.

OF-1080,
All-in-one reference library kit

Filler Training
Training
1.
2.

3.

Use the Oxygen Safety Course Kit to conduct


oxygen safety training seminars.
Have employees take the cGMP* course by
watching video, reviewing course and taking
exam to receive certificates.
Have employees take cGMP* course version
2 to meet continuing education requirements.

OF-1016,
Oxygen safety training course

1199-1023, cGMP training course

*cGMP: Current Good Manufacturing Practice [4]

FILLING OXYGEN

19

Supervisor Training
Training
1.
2.

All of the prior listed


training plus the following:
Use cGMP required forms
to ensure all filling
documentation is
captured.
1199-1028,
cGMP required
forms binder

Quality Control
Control Unit Training
Training
All of the prior listed training plus the following:
Regional seminar

V2

1199-1030,
cGMP training
course, V2

See website for current seminar listings near you

Applied video courses help meet


training requirements.

WWW.APPLIED-INC
WWW.APPLIED-INC .C OM

1.
2.

FILLING OXYGEN

20

High pressure cylinder refilling [4,i]


All manifold filling sequences, otherwise known as lots or
batches, must have its own unique lot number assigned to it.
(There is no required method for assigning lot numbers
except for that they must be unique. Numbers and / or
letters may be used)

Cylinder Filling Inspections


1. Determine the number of cylinders to be filled in batch
2. Assign lot number to batch
Cylinders failing any inspection should
be placed in the quarantine
area
area [2 - 4,i]

Pre-fill
Pre-fill Inspections
1.

2.

3.

4.

5.

6.

7.

Visual inspection of cylinder


a. check for gouges and dents
b. discoloration (thermal damage)
c. see CGA 6 and 6.1 for more information [4,a and 4,b]
Color of cylinder
a. in U.S.A. cylinder must be green, in Canada white
b. CGA C-9 for more information [4,d]
Valve inspection
a. check for corrosion
b. check for presence of grease or oil
(do not refill if present)
Hydrostatic test date
a. aluminum cylinders and lightweight steel have a
5 year hydrotest
b. steel cylinders have a 10 year test date
if a plus symbol follows the test date (pg. 44)
c. see CGA C-1 for more information [4,p]
Hammer test
a. aluminum cylinders are exempt (record a N/A)
b. steel cylinders tap side of cylinder with hammer
to hear bell sound
c. see CGA P-2.5 for more information [4,i]
Label examination
a. ensure cylinder has proper drug product label
b. See CGA C-7 for more information [4,c]
Vent all residual oxygen
a. perform inspection outdoors
b. allow residual oxygen to escape

FILLING OXYGEN

21

8. Odor test [4,i]


a. whiff contents as it is venting to detect an odor
b. oxygen has no odor
c. no odor is permitted
d. if no residual oxygen is present, use nitrogen
NF to perform the odor test
9. Vacuum/purge
vacuum all cylinders to 25 Hg at sea level
or adjust for elevation (pg. 49)

Filling Inspections
1. Heat of compression
a. cylinders should warm to the touch
b. no change in temperature indicates that it
is not filling
2. Leak test
a. spray valves, connections and seals
to help detect leaks
b. use oxygen compatible leak testing solution
3. Temperature
a. monitor temperature using temperature / pressure
chart and record value
4. Pressure
a. document pressure on batch production record (pg. 48)
b. see CGA P-2.5 for more information [4,i]

Post-fill Inspections
1. Leak test
a. spray valves, connections and seals
2. Record the serial number of the cylinder being tested
3. Odor test
a. whiff the contents of the analyzed cylinder
to check for an odor
4.ID test
a. use an accepted oxygen analyzer (ex. OF-900) [8]
b. identify the gas as oxygen
5. Strength / Purity test
a. use an accepted analyzer to test the purity of the gas
b. record the value shown
c. oxygen USP must be 99.0% or higher [8]
6. Place a lot sticker with the lot number of the batch,
and the expiration date (if required) on each cylinder filled [4,i]

22

FILLING OXYGEN
High pressure equipment basics [2 - 4,i]
When in the oxygen filling business, it is important
to understand the oxygen equipment and supply
basics. Please read through the list below to review
your knowledge.
1. Product: Wetband valve seal
Application: Used to keep dust/dirt
out of valve orifice.
Applies easy and dries to fit.
1109-0019

2. Product: Perforated wetband valve seal


Application: Same as regular wetband
with easier removal for patients.
1109-0037

1109-0013

3. Product: Plastic valve seals


Application: Used to keep dust/dirt
out of valve orifice. Can also hold
spare washer for patient. (order
1109-0068 washers separately)
4. Product: Valve seal buckle style
Application: Buckles around valve easily
and holds washer. (order 1109-0068
washers separately)

1109-0092

5. Product: White Tefzel washers


Application: Used on cylinder filling
racks to seal connection between yoke
and valve.

1109-0070

6. Product: Brass and Viton washer


Application: Great for patients!
Helps sealing regulator connections
easier.

1109-0017

FILLING OXYGEN

23

7. Product: Nylon yoke washers


Application: Standard replacement
washer given to patient for regulator
connections.
1109-0068

8. Product: O2 compatible leak test


Application: Used when filling cylinders
to detect leaks.
1109-1023

1109-5573

1109-0006

10. Product: LR9000 Non-Hydrocarbon


Label Remover
Application: Great for cleaning up
cylinders. Aids in removing old lot stickers,
drug product labels, and left behind
adhesive.
11. Product: Drug product labels
Application: Required by FDA / HC /
DOT / TC to show contents, warning
information, and more.

14. Product: Toggle for post valve


Application: Replacement toggle
(screw type).
1109-5551

TOLL-FREE 1-888-327-7301

1109-0002A

9. Product: Lot stickers for


Oxymark 4 label gun.
Application: Used to apply lot number
and expiration date to cylinders with each
batch filled.

24

FILLING OXYGEN
Cryogenic equipment basics [2 - 4,j]
Equipment, supplies, and accessories should include
clean, serviceable, and properly fitting safety equipment.
Inspect and discard dirty, oily, worn, or torn gloves,
aprons, face shields, safety glasses before they contribute to an accident incident and / or violation.
Safety Equipment
1. Cryogenic gloves
Helps protect hands from frostbite.
0900-0130

0900-0140

2. Cryogenic apron
Helps protect body from frostbite
and liquid spray.

3. Face shield
Helps protect face from frostbite.
0900-0100

4. Safety glasses
Helps protect eyes from frostbite.
0900-0020

5. Ear plugs
Helps protect ears when filling

0900-0120

6. Spill pan
Used to help catch any spills when
filling home units. Helps avoid reaction
with anything that may be on ground.
(do not fill liquid oxygen on asphalt)
0900-0580

Between fills always cap


cryogenic transfer hose to
keep moisture, dust, dirt, etc.
out of equipment

FILLING OXYGEN
7. Cryo-Hose cap with tab
Helps keep dirt/contaminants and
moisture from damaging hose
and equipment.

25

0900-0255

8. Thread in plastic Cryo-Hose cap


Helps protect against dirt, contaminants,
and moisture. Thread in application.

Transporting equipment

0900-0256

1. Liquid home unit


hand truck Used to
help make home unit
deliveries quick
and easy.
2. Large liquid vessel
cart For transporting
heavy VGL/Dewars
in your warehouse.

1100-1950

1100-1820

Liquid O2 Filling equipment

2. Single fill head PB


Single fill adapter with pressure relief
and PB filling head.
3. Single fill head Caire
Single fill adapter with pressure
relief and Caire filling head.
4. Single fill hose Linde
Single fill adapter with pressure relief
and Linde filling head.

*Note: Always use a safety relief valve and


cryogenic transfer hose to help prevent a
rupture from expanding gas.

0900-0531

0900-0555

0900-0558

0900-0557

WWW.APPLIED-INC
WWW.APPLIED-INC .C OM

1. Safety relief T*
Used to help prevent a rupture in a
case where liquid is trapped in a hose.

26

FILLING OXYGEN
5. Double fill head PB/Caire
Double fill adapter with pressure relief
and PB/Caire filling heads.

0900-0550

6. Double fill head PB/Linde


Double fill adapter with pressure relief
and PB/Linde filling heads.

0900-0551

7. Triple fill head PB/Caire/Linde


Triple fill adapter with PB/Caire/Linde
filling heads.

0900-0559

8. Cryogenic 90 elbow
Used to reduce line stress and help
eliminate chatter with transfer hose.
0900-0300

9. Cryogenic swivel
Used to eliminate hose twists and kinks
when filling or making connections.

0900-0511

10. Cryogenic transfer hose


Available in 7, 10, 15 and custom
lengths. (use with safety T, to
prevent rupture. See pg. 25)
1110-0550

11. Cryo-Scale
Used when filling cryo-home units to
measure when container is filled.
0900-0600

FILLING OXYGEN

27

High Pressure Labeling [2 - 4,c]


Examples of custom printed high pressure cylinder
labels (PN 1109-0006). Contact Applied for the most
current version.
Partial list:
Proper shipping name and UN
number to the left of diamond
OXYGEN,
COMPRESSED
USP
UN 1072

Rx only in larger font and bold

C.A.S. NO. 7782-44-7

Cylinder contents shown on label


PRODUCED BY AIR LIQUEFACTION
WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING
IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency
and resuscitation. For all other medical applications, Rx only. 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 with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use
on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.
WARNING: Keep oil and grease away. Store and use with adequate ventilation. Use only with equipment
cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use
and when empty.
Use a back flow preventive device in the piping.
Cylinder temperature should not exceed 52C (125F).
USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.
DO NOT REMOVE THIS PRODUCT LABEL.

Size
E
D
C

Contents
697 Liters
427 Liters
248 Liters

Size
Contents
M-6 165 Liters
H 7,100 Liters
Other ____ Liters

Use a backflow preventative device


in piping statement
Company name and location
See CGA C-7 for more information

Cryogenic Labeling [2 - 4,c]


Examples of custom printed cryogenic cylinder labels
(PN 1109-0003). Contact Applied for the most
current version.
Partial list:
Frostbite warning
OXYGEN,
REFRIGERATED
LIQUID
USP
UN 1073
LOT #:____________

Do not change or force connections

CONTENTS:_________________ LITERS

Keep container upright


For use on container filled by
provider only
Use a backflow preventative
device in piping statement
First aid warning

CAS NO: 7782-44-7

X 45136

See CGA C-7 for


more information

TOLL-FREE 1-888-327-7301

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.

WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS


EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER
PRESSURE
VIGOROUSLY ACCELERATES COMBUSTION.
NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT
COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY
EXPLODE ON IGNITION OR IMPACT.
CAN CAUSE SEVERE FROSTBITE.
Keep oil, grease, and combustibles away.
Use only with equipment cleaned for oxygen service.
Store and use with adequate ventilation.
Do not get liquid in eyes, on skin or clothing.
For liquid withdrawal, wear face shield and gloves.
Do not drop. Use suitable hand truck for container movement.
Avoid spills. Do not walk on or roll equipment over spills.
Container temperature should not exceed 52C (125F).
Close valve after each use and when empty.
Use a back flow preventive device in the piping.
Use in accordance with the Material Safety Data Sheet (MSDS).
FIRST AID: IN CASE OF FROSTBITE, obtain medical treatment immediately.
WARNING: For emergency use only when administered by properly trained
personnel for oxygen deficiency and resuscitation. For all other
medical applications, Rx Only.
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 with pressure reducing
equipment and apparatus designed for oxygen. Do not attempt
to use on patients who have stopped breathing, unless used in
conjunction with resuscitative equipment.
Produced by Air Liquefaction
DO NOT REMOVE THIS PRODUCT LABEL.

28

FILLING OXYGEN
Common FDA violations [2]
Here are some of the common FDA and regulatory
violations found in thousands of inspections over the
last seven years. An example is provided along with
an option and / or Applied product. Please note
violation may take multiple corrective steps,
not only the single example given.
1. Violation: Failure to perform finished
drug product testing.
Example: Use an analyzer that has
an accuracy to one tenth of
one percent.

OF-900,
Oxygen analyzer

2. Violation: Failure to properly calibrate


testing equipment.
Example: Calibrate your analyzer
daily according to its instructions using
specialty gases.
3. Violation: Failure to establish written
procedures.
Example: Use Applieds Model Policy
Procedures manual to write procedures
detailing your oxygen filling operation.

SG-100,
Specialty gas

OQ-111,
Model policy
procedure manual

4. Violation: Failure to establish a


training program.
Example: Use SOP to detail how,
when, and where training takes place.
Use Applieds training aids/seminars
to help educate employees.

FILLING OXYGEN

OQ-111,
Model policy
procedure manual

29

5. Violation: Failure to establish written


quality control procedures.
Example: Document procedures
on how the quality control unit
enforces quality in the policy manual.

6. Violation: Failure to establish adequate


batch production or fill logs.
Example: Use Applieds cGMP forms
and update as needed to document
filling process correctly.
1199-1028,
cGMP required
forms binder

Document logs completely


7. Violation: Failure to adjust for
temperature and pressure when filling.
Example: Use Applieds LCD digital
thermometer when filling cylinders.

1120-0055,
Gauge calibration

1108-0120,
Thermometer calibration

Gauges and thermometers must be


calibrated to N.I.S.T. standards
per manufacturers instructions*
* 21 CFR 211.67 (a)

WWW.APPLIED-INC
WWW.APPLIED-INC .C OM

1108-0115,
Digital thermometer

8. Violation: Failure to calibrate filling


equipment.
Example: Calibrate your gauges
and thermometer in accordance to
equipment manufacturers guidelines
by sending in to Applieds
calibration lab.

30

FILLING OXYGEN
Helpful hints increasing production
Increasing productivity safely, effectively, and in
compliance with regulatory requirements is highly
effective in increasing revenue and profits.
A. Filling
1. Use filling racks to fill more cylinders
at a time. Larger batches and minimal
space consumption will lead to less
paperwork and greater efficiency.
HME-0010

2. Load and unload cylinders in less


than half the time with oxygen yoke
quick connectors.
1109-9928

3. Connect and disconnect pigtails


quickly by using handtight connections
B. Processing
1. Maximize cylinder storage while
minimizing your space consumption
by storing 50 E cylinder in one rack.
(pg. 13) (PN 1100-1863)

1109-9923

2. Maximize cylinder storage while


minimizing your space consumption
by storing 168 M-6 cylinder in one rack.
(pg. 13) (PN 1100-1867)

1100-1863
1100-1867

3. Transport many multiple sized


cylinders from storage to
loading your vans. (pg. 15)
1100-1765

C. Delivering
1. Carry multiple M-6
cylinders when delivering
cylinders to patients. (pg. 16)

1100-1948

2. Deliver liquid home units


quicker and easier using a handtruck
with stair climbers. (pg. 13)
1100-1950

FILLING OXYGEN
Is filling oxygen right for me?
Many dealers face the question of is filling oxygen
right for me? Read through the key points below to
see how filling oxygen can benefit your business.
Challenges to DME profitability
profitability
1. Continued oxygen reimbursement cuts.
2. Some patients require 3 to 6 cylinders
or more per week.
3. Low ambulatory oxygen reimbursements.
4. More and more cylinder purchases to keep
up with patient demands and supplier lead times.
5. Increased fuel costs.
6. Current supplier losses, abuses, cylinder and delivery
charges are excessive.

Advantages to filling your own cylinders


1.
2.
3.
4.

Reduce oxygen gas cost by 50% or more.


Reduce the number of cylinders you have to buy.
Have 24-hour/7 day a week availability of oxygen.
Eliminate supplier cylinder loss, abuse,
and transaction costs. (i.e. delivery costs)
5. Keep more cash in checking account by being
your own supplier.
6. Build your asset base
instead of a stack
of receipts.
7. Eliminate delays
in getting
cylinders
from supplier.

31

INCREASING PROFITS

INCREASING PROFITS

32

Fighting oxygen reimbursement cuts


and cost increases
Problem:
Reimbursement cuts for oxygen.
Solutions:
1. Refill oxygen cylinders / cryogenic vessels
to cut oxygen costs.
2. Use conserving device on cylinders instead
of a regulator.
3. Expand your filling system to fill more
cylinders at one time.

1210-0100,

Problem:
Pneumatic oxygen conserver
Cost increases on supplies.
Solution:
Purchase supplies in bulk and take
advantage of Applieds quantity discounts.
Problem:
Increasing regulatory compliance costs.
Solutions:
1. Use Applieds library of training aids to train
patients, care givers, drivers, supervisors, and
quality control personnel.
2. Attend Applieds regional seminars.

OF-757, turn key liquid to gas filling system (includes installation,


operational and regulatory training)

TOLL-FREE 1-888-327-7301

Pneumatic conserver offers


3:1 oxygen conservation

33

INCREASING PROFITS
Reduce oxygen costs by filling
oxygen cylinders
Gas to gas systems

Ideal for companies using


1-50 cylinders per week
Oxyfill high pressure
refilling system, OF-600

Oxyfill System, Fills 5 from 6 supply


cylinders

Ideal for companies using


50-100 cylinders per week
Oxysupply high pressure
refilling system, OF-686

Oxysupply System, Fills 12 from 6


supply cylinders

Liquid to gas systems

Ideal for companies using or refilling over 100 cylinders


per week, OF-700

Systems are available as complete


turnkey packages. See latest catalog for more information
or consult www.applied-inc.com
All systems are available in multiple sizes
and custom configurations

INCREASING PROFITS

34

Basic Compressed gas


cylinder filling equipment
A. Cylinders (pg. 43)
Cylinders available in a wide
range of sizes
B. Safety equipment (pg. 24)
1. Goggles
2. Natural fiber clothes
3. Gloves
4. Ear protection
C. Filling equipment (pg. 33)
1. Gas to gas
2. Liquid to gas
(see page 33
to find out what type
is right for you)

OQ-111,
Model policy
procedure manual
1199-1028,
cGMP required forms
binder, provides supply of
required forms and masters
on CD-ROM

WWW.APPLIED-INC.COM

D. Required forms for


filling cylinders (pg. 19)
1. Policy manual
2. Batch production
3. Label inventory
4. DOT log
5. Calibration log
6. Distribution record
7. Maintenance log

35

INCREASING PROFITS
Basic Liquid oxygen refilling equipment
A. Liquid reservoirs
B. Safety equipment (pg. 24)
1. Safety glasses
2. Face shield
3. Gloves
4. Apron
5. Ear protection
6. Safety shoes
7. Cuffless trousers
C. Filling equipment (pg. 25-26)
1. Proper fill head to fill reservoir
2. Pressure relief device
3. Cryogenic fill hose
4. Cryogenic scale
5. Spill pan

0900-0130,
Cryogenic gloves

0900-0555,
Single PB fill head

D. Record keeping forms


(pg. 18-19)
1. Policy manual
2. Filling forms
3. Lot stickers
OQ-111,
Model policy
procedure manual

INCREASING PROFITS

36

Financial analysis
Typical oxygen costs for refilling oxygen cylinders
CYLINDER SIZE
SYSTEM TYPE
GAS TO GAS
LIQUID TO GAS

$1.11
$.55

$.78
$.45

$.61
$.40

M-6
$.51
$.37

Assumptions:
1. $20 per hour labor cost
2. Gas to gas uses $8.00 cost for supply cylinder
3. Liquid to gas uses $1.00 per CFT liquid
Call Applied or download from
www.applied-inc.com for a complete, no obligation
cost / savings analysis.
Note: See page 45 and 46 for example of typical
savings worksheet.

INCREASING PROFITS
Registering to refill oxygen [2]*
A. Register with FDA
1. Complete form 2656
2. Complete form 2657
Download forms and example from web site
www.applied-inc.com
3. Include sample label and lot sticker
OXYGEN,
REFRIGERATED
LIQUID
USP

1109-0006, High pressure


cylinder label, custom printed

CONTENTS:_________________ LITERS

Tip:
Use punch
to mark
contents

UN 1073
LOT #:____________

37

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.

WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS


EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER
PRESSURE
VIGOROUSLY ACCELERATES COMBUSTION.
NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT
COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY
EXPLODE ON IGNITION OR IMPACT.
CAN CAUSE SEVERE FROSTBITE.
Keep oil, grease, and combustibles away.
Use only with equipment cleaned for oxygen service.
Store and use with adequate ventilation.
Do not get liquid in eyes, on skin or clothing.
For liquid withdrawal, wear face shield and gloves.
Do not drop. Use suitable hand truck for container movement.
Avoid spills. Do not walk on or roll equipment over spills.
Container temperature should not exceed 52C (125F).
Close valve after each use and when empty.
Use a back flow preventive device in the piping.
Use in accordance with the Material Safety Data Sheet (MSDS).
FIRST AID: IN CASE OF FROSTBITE, obtain medical treatment immediately.
WARNING: For emergency use only when administered by properly trained
personnel for oxygen deficiency and resuscitation. For all other
medical applications, Rx Only.
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 with pressure reducing
equipment and apparatus designed for oxygen. Do not attempt
to use on patients who have stopped breathing, unless used in
conjunction with resuscitative equipment.
Produced by Air Liquefaction
DO NOT REMOVE THIS PRODUCT LABEL.

CAS NO: 7782-44-7

X 45136

1109-0003, Cryogenic
cylinder label, custom printed

1109-0002A, Lot and expiration stickers


for Oxymark 4 label gun

4. Send via method that provides delivery


confirmation
B. Register with state agencies (if required)
1. Consult
www.palmettogba.com/palmetto/statelicensure.nsf
2. Your state board of pharmacy
C. Comply with regulations
1. FDA guidance [2-3]
2. CGA standards and bulletins [4]
3. Code of Federal Regulations (CFR) [1-2-3]
* 21 CFR 510

APPENDIX

38

APPENDIX
REFERENCES
(Order by part number or as a complete library shown below)
1. Title 49 of the Code of Federal Regulation: Transportation (CFR)
(USA), Parts 40, 105-107, 171-180, 382, 383, 387, 390-397, 399,
172, in general, and specifically parts 173.34 and 173.3000 to
173.316 (R1) (PN OF-1060)
2. Title 21 of the CFR, parts 11, 201, 210 and 211(R1) Title 21 Code
of Federal Regulations (21 CFR Part 11): Electronic Records;
Electronic Signatures & Drug CGMP Regulation (PN OF-1061)
3. Title 29 of the CFR, parts OSHA Safety and Health, OSHA
Regulations (Standards - 29 CFR) Bloodborne pathogens. 1910.1030. (PN OF-1062)
4. Compressed Gas Association (CGA) Publications(R2):
a. Pamphlet C-6, Standards for Visual Inspection of Steel
Compressed Gas Cylinders (PN OF-1042)
b. Pamphlet C-6.1, Standards for Visual Inspection of
Aluminum Compressed Gas Cylinders (PN OF-1026)
c. Pamphlet C-7, Guide to the Preparation of Precautionary
Labeling and Marking of Compressed Gas Containers.
(PN OF-1055)
d. Pamphlet C-9 Standard Color-Marketing of Compressed
Gas Cylinders Intended for Medical Use. (PN OF-1047)
e. Pamphlet G-4, Oxygen. (PN OF-1039)
f. Pamphlet G-4.1, Cleaning Equipment for Oxygen Service.
(PN OF-1040)
g. Pamphlet P-1, Safely Handling of Compressed
Gases in Containers. (PN OF-1024)
h. Pamphlet P-2, Characteristics and Safe Handling of
Medical Gases. (PN OF-1027)
i. Pamphlet P-2.5, Transfilling of High Pressure Gaseous
Oxygen to be Used for Respiration: (PN OF-1031)
j. Pamphlet P-2.6, Transfilling of Liquid Oxygen to be
Used for Respiration: (PN OF-1035)
k. Pamphlet P-39 Oxygen-Rich Atmospheres (PN OF-1038)
l. Pamphlet S-1.1, Pressure Relief Device Standards.
Part 1- Cylinders for Compressed Gases. (PN OF-1052)
m. Standard V-1, American National Canadian Standard
Compressed Gas Cylinder Valve Outlet and Inlet
Connections; ANSI-B57-1; CSA-B96.: (PN OF-1050)
n. Video, AV-8, Characteristics & Safe Handling of
Cryogenic Liquid Gaseous Oxygen (PN OF-1030)
o. Pamphlet SB-9, Recommended practice for outfitting
and operation of vehicles used in the transportation and
transfilling of liquid oxygen used for respiration
(PN OF-1049)
p. Pamphlet C-1, Methods for hydrostatic testing of
compressed gas cylinders (PN OF-1053)

APPENDIX

39

5. European Industrial Gas Association (EIGA) (R3)


a. EIGA 33/97/E Cleaning of Equipment for Oxygen
Service (PN OF-1081)
b. EIGA 79/4/E Prevention of Accidents Arising from
Enrichment or Deficiency of Oxygen in the
Atmosphere (PN OF-1082)
6. National Fire Protection Association, Inc. (R4)
a. NFPA 55 Standard for Storage, Use, and Handling of
Compressed Gases and Cryogenic Fluids in Portable
& Stationary Containers, Cylinders, and Tanks
(PN OF-1083)
b. NFPA 99 Standard for Health Care Facilities
(PN OF-1085)
c. NFPA Health Care Facilities Handbook (PN OF-1086)
7. National Technical Information Service (R5) (PN OF-1084)
NASA Safety Standard for Oxygen & Oxygen
Systems- Guidelines for Oxygen System Design,
Materials, Selection, Operations, Storage, and
Transportation (NTIS Order No. N96-24534/5INZ)
8. U.S.P. 99 Oxygen Monograph

REFERENCE LIBRARY FROM APPLIED


(PN OF-1088) All in one easy to order kit. includes comprehensive library of all the references used in this guide.
Available from http://www.gpoaccess.gov/ or Applied
www.applied-inc.com

(R2)

Available from Compressed Gas Association,


4221 Walney Road, 5th Floor, Chantilly VA 20151-2923
Phone: 703-788-2700 Fax: 703-961-1831
www.cganet.com or Applied www.applied-inc.com

(R3)

Available from European Industrial Gas Association


(EIGA), Publication de la Soudure Autogene 32
Boulevard de la Chapelle 75880 Paris Cedex 18, France,
www.eiga.be/home2.asp or Applied www.applied-inc.com

(R4)

Available from National Fire Protection Association, Inc.


1 Batterymarch Park, Quincy MA 02269-9101,
www.nfpa.org or Applied www.applied-inc.com

(R5)

Available from National Technical Information


Service5285 Port Royal Road, Springfield, VA 22161,
www.ntis.gov or Applied www.applied-inc.com

TOLL-FREE 1-888-327-7301

(R1)

APPENDIX

40

Filling oxygen internal building layout


As you increase your number of oxygen patients your
cylinder usage also rapidly increases. Suggested model
layout to help increase productivity for your oxygen
processing/filling procedures.

Model Homecare Warehouse


Minimum 10 ft. x 15 ft. for filling area

Truck entrance door

Filled cylinders Filled cylinders


Approved
Unapproved

Quarantine

Testing

Fill
System

Empty Cylinders

Shelving

Work Flow Diagram

Rev 1

Legend
Empty cylinder path
Filled cylinder path

Electrical power
1. High pressure, 110 volt a/c 20 amp
2. Liquid to gas
a. 220 volt a/c, 3 phase 20 amp
b. 220 volt a/c, 1 phase 30 amp (optional)

APPENDIX

41

Filling oxygen external building layout


As your business grows, the amount of traffic through your
building also increases. Please review this model layout to
help increase your loading efficiency.

Model Homecare Company


Road

Patient
Parking

12 ft. Cement pad


with fence
Truck
entrance
door
Oxygen
Bulk
Tank

Loaded Vehicles

Homecare Company

Foundation based on site survey


Empty vehicles

Waste

Model Homecare Co.

Empty cylinder path


Filled cylinder path

WWW.APPLIED-INC.COM

Legend

Rev 1

42

APPENDIX
Oxygen technical information
for providers
Origin: Natural
Physical state: Gas
Description: A colorless, nonflammable and odorless
gas. Sustains combustion of many materials. Helpful
in aiding the quality of life for COPD patients.
Typical Service Pressures at 70 F
Medical Gas Cylinders
M6 =
2,216 psig
C =
2,015 psig
D =
2,015 psig
E =
2,015 psig
H =
2,400 psig
Common Pressures for Liquid Gas Cylinders
Service at 70 F
50 psi
= Optimal for liquid transfers
100 psi = Faster liquid transfers with increased
gas loss
150 psi = Very fast liquid transfer with a great amount
of gas loss
250 psi = Optimal for gas withdrawal purposes
Oxygen Conversion Chart
Wt. of
Liquid
or Gas

Pounds
1.000
2.571
9.527
8.281

Vol of Liquid
at Normal
Boiling Point
-297.3 F (-183 C)
Liters
0.397
1.000
3.785
3.290

Gallons
0.105
0.264
1.000
0.869

Vol. of Gas
at 70

Cu. Ft.
12. 08
30.38
115.05
100.00

Cubic Feet to Gaseous Liters: Cu. Ft. x 28.32 = Liters


Website: www.applied-inc.com

APPENDIX

43

Cylinders and Cryogenic Vessels

It is recommended that cylinder users purchase


and use Compressed Gas Association (CGA) Standards
for Visual Inspection of High Pressure Compressed Gas
Cylinders 6.0 for steel and 6.1 aluminum cylinders.
These standards help users meet safety and regulatory
requirements. CGA standards are available from
Applied or CGA at cganet.com.

TOLL-FREE 1-888-327-7301

Cylinder
Dia./in.
Ht./in.

Cylinders shown
are not to scale

M09A ML6
3.4 4.3
12.4 7.5
PN-w/o toggle
3050 3004
Contents/cubic ft.
9
6

M6,B M9,C
D
JD
E
3.2
4.3
4.3 5.3
4.3
11.5
12 16.5 25.5 23
3001 3005 3009 3011 3013
6
9
15
21
24

M60
7.3
36
3015
61

M
8
36
3017
122

H,T
9.3
50-52
3022
243

LL
21
62-67
3025
7,363

Quality cylinders and cryogenic vessels play an important


role in delivering oxygen to patients. Applied cylinders and
cryogenic vessels provide years of service and meet the
latest DOT, FDA, TC, HC and CGA requirements.

APPENDIX
Medical Gas Cylinders Technical Information
How to Read Cylinder Markings

Top view of typical high-pressure cylinder permanent markings.


Note: Markings may vary based on manufacturer, cylinder size, and material.

MARKINGS PRIOR TO JANUARY 1. 1983


TW-133

57 +

TC-

3
4

12
P 23

AR

AA AA BB BB

1
2

D O T 3A -20 15
A 55699 7
PC GC O

11

10
REE-181

15

14
6

13

MARKINGS AFTER TO JANUARY 1. 1983


TW-133

8
11
AR

C-A
BBB
DO A AA B 5 P 23
T 3 A-2 01
A 55699 7
P CG CO

1
6

+
83

10
REE-181

15

13
14
15

12

Item
1
2
3
4
5
6
7
8
9
10
11
12

44

14

Description
13
7
Brand Identification
Manufacturers Test Date
Manufacturers Registered Symbol
Cylinder Meets 10% Overfill Specification
Cylinder Meets 10 Year Hydrostatic Test Exemption
Collar
Cylinder
Tare Weight
DOT Specification and Service Pressure
Manufacturers Serial Number
Inspectors Mark
Registered Owner
(PCGCO= Puritan Medical Products)
Rejection Elastic Expansion Limit in
Cubic Centimeters
Canadian specifications number and service pressure
Cleaned for oxygen service

Contents (CFT)
24
14
9
6

Usage / Wk
50
15
10
125
200

Current Cost Each


$3.50
$3.50
$3.50
$3.50

$215,425

Sa ving s
$30,775
$30,775
$30,775
$30,775
$30,775
$30,775
$30,775

$184,650

Net Savings**
-$2,887
$30,775
$30,775
$30,775
$30,775
$30,775
$30,775

** Includes allowance for training, start up, and misc. costs.


*** Savings less investment

$33,662

Investment**
$33,662

WWW.APPLIED-INC.COM

Totals

Year
2005
2006
2007
2008
2009
2010
2011

Liquid O2 CFT*
$0.24
$0.14
$0.09
$0.06

Labor cost
$0.31
$0.31
$0.31
$0.31

New Cost Ea
$0.55
$0.45
$0.40
$0.37

0.01 * Estimated liquid oxygen cost per cubic foot

Assumptions:
1. Cylinder usage is constant
2. Savings are based on oxygen gas and labor costs only,
no hazmat and delivery charges are included.
3. Depreciation expenses are not included.

Current Total Cost


$175.00
$52.50
$35.00
$437.50
Savings per year:

For any assistance please feel free to call or email us at med@applied-inc.com

Investment analysis & return based on useful life of seven (7) years:

Cylinder Size
"E"
"D"
"C/Med 9"
"M-6"

Instructions

Yellow area is where you input your weekly usage, current cost per cylinder, and estimated liquid cost
Green area is where your caculated savings is shown

Savings / Wk
$147.50
$45.75
$31.00
$391.25
$615.50

Annual Savings
$7,375.00
$2,287.50
$1,550.00
$19,562.50
$30,775.00

APPENDIX
45

Cost Justification

Sample Liquid to Gas Savings

Instructions:
Yellow area represents your weekly usage, current cost per
cylinder, and estimated liquid cost.
Green area shows your calculated savings is shown.
For assistance, please call or email us at med@applied-inc.com
or download a do-it-yourself cost savings Excel sheet from
www.applied-inc.com .

Contents (CFT)
24
14
9
6

Usage / Wk
15
5
5
60
85

Current Cost Each


$3.50
$3.50
$3.50
$3.50

Totals

Year
2005
2006
2007
2008
2009
2010
2011

$68,298

Savings
$9,757
$9,757
$9,757
$9,757
$9,757
$9,757
$9,757

$61,585

Net Savings**
$3,043
$9,757
$9,757
$9,757
$9,757
$9,757
$9,757

** Includes allowance for training, start up, and misc. costs.


*** Savings less investment

$6,714

Investment**
$6,714

O2 CFT*
$0.99
$0.58
$0.37
$0.25

Labor cost
$0.80
$0.80
$0.80
$0.80

New Cost Ea
$1.79
$1.38
$1.17
$1.05

$
$

0.04 * Estimated oxygen cost per cubic foot


10.00 Price of an "H" Cylinder of Oxygen

Assumptions:
1. Cylinder usage is constant
2. Savings are based on oxygen gas and labor costs only,
no hazmat and delivery charges are included.
3. Depreciation expenses are not included.

Current Total Cost


$52.50
$17.50
$17.50
$210.00
Savings per year:

For any assistance please feel free to call or email us at med@applied-inc.com

Investment analysis & return based on useful life of seven (7) years:

Cylinder Size
"E"
"D"
"C/Med 9"
"M-6"

Instructions

Yellow area is where you input your weekly usage, current cost per cylinder, and estimated Oxygen cost
Green area is where your caculated savings is shown

Savings / Wk
$25.69
$10.62
$11.65
$147.19
$195.14

Annual Savings
$1,284.26
$530.97
$582.41
$7,359.26
$9,756.89

46

APPENDIX

Cost Justification

Sample Gas to Gas Savings

Instructions:
Yellow area represents your weekly usage, current cost per
cylinder, and estimated gas cost.
Green area shows your calculated savings is shown.
For assistance, please call or email us at med@applied-inc.com
or download a do-it-yourself cost savings Excel sheet from
www.applied-inc.com .

APPENDIX
USEFUL LINKS
For more information, please visit the
websites listed below.
Applied Home Healthcare Equipment Inc.
http://www.applied-inc.com
For current FDA guidance
http://www.fda.gov/cder/dmpq/gases.htm
For FDA Frequently Asked Questions on Drug Firm
annual registration status
http://www.fda.gov/dfars/dlrsfaq.htm
For the Compress Gas Association documents and standards
http://www.cganet.com
For State Licensure Requirements
http://www.palmettagba.com/palmetto/statelicensure.nsf
U.S. Department of Transportation
http://www.dot.gov
For Code of Federal regulations (CFR), main search page
http://www.gpoaccess.gov/cfr/index.html
For Health Canada / Sant Canada
http://www.hc-sc.gc.ca/
For Transport Canada / Transports Canada
http://www.tc.gc.ca/

47

APPENDIX

48

TEMPERATURE/PRESSURE CONVERSION CHART


Avg.Temp
of Gas
Pres

2000 PSI
Settled Pres
@70

2200 PSI
Settled Pres
@70

3000 PSI
Settled
@70

1,630

1,781

2,283

1,656

1,811

2,327

10

1,683

1,841

2,371

15

1,709

1,871

2,415

20

1,736

1,901

2,459

25

1,762

1,931

2,503

30

1,789

1,961

2,547

35

1,815

1,991

2,592

40

1,841

2,020

2,636

45

1,868

2,050

2,680

50

1,894

2,080

2,724

55

1,921

2,110

2,768

60

1,947

2,140

2,812

65

1,974

2,170

2,856

70

2,000

2,200

3,000

75

2,026

2,229

3,044

80

2,052

2,259

3,089

85

2,079

2,288

3,133

90

2,105

2,317

3,177

95

2,131

2,347

3,221

100

2,157

2,376

3,266

105

2,183

2,405

3,310

110

2,209

2,435

3,354

115

2,236

2,464

3,398

120

2,262

2,493

3,443

125

2,288

2,523

3,487

130

2,314

2,552

3,531

APPENDIX

49

Transfilling Evacuation Limits at


Various Elevations
A perfect vacuum at sea level is considered to be 29.92
in. Hg. As elevation increases, the equivalent gauge
value in inches of mercury to obtain the same level of
vacuum at sea level decreases.
For example: A person transfilling cylinders at 5,200 feet
(Denver, CO) above sea level would only have to draw
a vacuum of approximately 20.8 in. Hg on the system to
achieve the same level of vacuum as a person drawing
a vacuum of 25 in. Hg at sea level.
Below is a chart listing the approximate vacuum levels
that would have to be achieved at different altitudes
during the cylinder evacuation process to equate to 25 in.
Hg at sea level.
The accompanying graph depicts the effect of altitude on
atmospheric pressure.

Effect of Altitude on Atmospheric Pressure


Altitude Pressure
Transfilling Table
Pressure
in Hg
25.00
24.56
24.11
23.68
23.25
22.83
22.41
22.00
21.59
21.20
20.81
20.42
20.04
19.66
19.29
18.93
18.57
18.22
17.87
17.53
17.20

Atmospheric Pressure Chart for


Illustration Purposes (In. Hg)
30

25

20

15

10

Sea
Level

5,000

10,000

15,000

Altitude of work site (Ft.)

20,000

TOLL-FREE 1-888-327-7301

Altitude
Feet
0
500
1000
1500
2000
2500
3000
3500
4000
4500
5000
5500
6000
6500
7000
7500
8000
8500
9000
9500
10000

25,000

50

APPENDIX
Home Oxygen Safety
Awareness for Patients
and Care Givers *
This section is designed to
give patients and care givers
general safety information
for oxygen concentrators,
compressed gas cylinders,
oxygen conserving devices, and liquid oxygen systems
used in private homes, apartments, and condominiums.
Oxygen
Oxygen is colorless, odorless, and tasteless. It makes
up about 1/5 or 20% of the air we breathe. Oxygen is
not air! Oxygen is not flammable, but it can cause other
materials that burn to ignite more easily and to burn far
more rapidly. The result is that a fire involving oxygen
can appear explosive-like.
Oxygen is of great benefit to those in need of oxygen
therapy but, it should always be handled with caution
and awareness of the potential hazards.
The Equipment
There are three common ways of providing oxygen therapy. Oxygen can be delivered to your home in the form
of a gas in various-sized cylinders or as a cryogenic
liquid state in a container or vessel. The third way or
method to provide oxygen therapy is by using an oxygen
concentrator. Each method is examined in more
detail below.
Compressed Gas in Cylinders- Oxygen is stored under
pressure in a cylinder with a regulator that controls the
flow rate. Because the flow of oxygen out of the cylinder
is constant, an oxygen conserving device maybe
attached to the system to avoid waste. This device
releases the gas only when you inhale and cuts it off
when you exhale. Oxygen can be provided in a small

APPENDIX

51

cylinder that can be carried with you, but large tanks are
heavy and are only suitable for stationary use.
Liquid Oxygen- Oxygen is stored as a very cold liquid,
nearly -297 degrees F. in a vessel similar to a large
thermos bottle. When released in a controlled manner,
the liquid converts to a gas and you breathe it in just like
compressed gas. This storage method takes up less space
than the compressed gas cylinder, and you can transfer
the liquid to a small, lightweight portable vessel at home
(be sure to follow your providers instructions carefully
when refilling or transfilling liquid). Liquid oxygen is more
expensive than compressed gas and the vessel vents
when it is not in use. A conversing device may be built
into the portable to converse the oxygen.
Oxygen Concentrators- This an electrically powered device
that separates the oxygen out of the air, concentrates it,
and stores it. This system has a number of advantages
because it doesnt have to be re-supplied and it is not as
costly as liquid or cryogenic oxygen mentioned above.
Extra tubing permits the user to move around with minimal
difficulty. Small, portable systems have been developed
that afford even greater mobility. You must have a
cylinder(s) of oxygen as a back up in the event of a
power failure.
Quantity limits: May depend on your local fire
codes but, generally:

* Seattle Fire Department, Information Bulletin


#2003-5, Seattle, WA

WWW.APPLIED-INC.COM

Do not store individual compressed cylinders that


add up to exceed 250 to 345 cubic feet of oxygen at
normal pressure and temperature (70 degrees F.).
Do not store liquid oxygen vessels which exceed
10 gallons.

52

APPENDIX

* Safety:
Liquid oxygen is
extremely cold (-297
degrees F.).
Touching liquid oxygen
or parts of liquid oxygen
system in contact with
liquid oxygen can quickly
freeze the skin.
The vapors from liquid oxygen are
also extremely cold and can damage delicate
tissues, such as eyes. To help prevent injury from
freezing never allow any unprotected skin to
contact frosted parts of liquid oxygen vessels and
stand clear of vapors.
Never, never smoke while using oxygen.
Warn visitors not to smoke near you when you
are using oxygen.
Post at least one NO SMOKING sign in a
prominent place at the entrance to your home.
When you go to a restaurant with your portable
oxygen source, sit in the non-smoking section and
away from any open flame such as candles or
warming burners.
Stay at least five feet from gas stoves, candles,
lighted fire places and other heat sources.
Keep oxygen cylinders and vessels in a well
ventilated area (not in closets, behind curtains, or
other confined spaces). The small amount of
oxygen gas that is continually vented from these
units can accumulate and become a fire hazard.
Keep oxygen cylinders and vessels a minimum of
8-10 feet from heaters, heat producing devices,
and electrical appliances.
Secure oxygen cylinders and vessels to a fixed
object or place in a stand or cart.
Oxygen cylinders and vessels must remain upright
at all times. Never tip an oxygen vessel or cylinder
on its side or try to roll it to a new location.

APPENDIX

53

* Seattle Fire Department, Information Bulletin


#2003-5, Seattle, WA

TOLL-FREE 1-888-327-7301

Always operate oxygen cylinder or container


valves slowly. Abrupt starting or stopping oxygen
flow may ignite any contaminant that might be in
the system.
Turn the cylinder valve off when not using your
system to help reduce the chances of leaking.
Only use a properly grounded wall outlet with your
oxygen concentrator.
Do not place the electrical cord or oxygen tubing
under rugs, carpeting, and /or furniture.
Do not use any flammable products like cleaning
fluids, paint thinner, or aerosol sprays while using
your oxygen because they could easily ignite.
Keep all grease, oil, and petroleum products (even
small amounts) and flammable materials away from
your oxygen equipment. Some organic materials
can react violently with oxygen with or without
being ignited by a spark.
Use water-based lubricants on your lips and hands.
Dont use an oil based product like petroleum jelly,
petroleum based creams or lotions.
Do not using bedding or clothes made of wool,
nylon, or synthetic fabrics as these materials have
the tendency to produce static electricity and
sparks. The use of cotton material bedding and
clothes helps avoid this hazard from static
electricity.
Do not allow children or untrained individuals to
handle or operate oxygen equipment.
Always have your gas and equipment suppliers
telephone number handy.
Ensure that you have an all purpose fire
extinguisher close by and familiarize yourself
with its use.
Refer to the gas suppliers material safety
data sheet (MSDS) for more information.

54

APPENDIX
Auditing Your Suppliers
Applied recommends in addition to meeting regulatory
requirements that suppliers of medical gases, devices,
equipment, components, and/or services be reviewed for
qualifications before purchasing and re-qualified on
routine and regular basis. The following guideline was
developed to help firms develop a standard operating
procedure to qualifying new and existing suppliers.
At least once per year:
1. Visit the supplier to determine if the supplier is
registered with the FDA or Health Canada.
Record the registration number and labeling code
for use with preparing your firms future drug
product listing (FDA form 2657).
2. Assure the supplier is following appropriate
written testing procedures.
3. Witness analytical testing being performed,
including calibration of the analytical equipment.
4. Document that the analytical testing was
performed.
5. Does the suppliers quality management system
address current good manufacturing practice
(CGMP) regulations?
6. Has management defined and documented its
quality objectives and commitment to quality?
7. Is there a written procedure for handling customer
complaints?
8. Are there written procedures for handling, storage,
packaging and availability of quality records?
9. Are there written procedures for the preparation,
storage, retention and availability of quality records?
10. Is there a written procedure requiring periodic
quality audits?
For additional information, please see CGA M-7 Guidelines
for Qualifications of Medical Gas Suppliers and FDA CGMP
regulations (see pg 38-39 for references).

APPENDIX
Please read:
Please note the information contained in this pocket
reference guide were obtained from sources believed
to be reliable and are based on technical information
and experience currently available from Applied Home
Healthcare Equipment Inc. and others. However Applied
Home Healthcare Equipment Inc. jointly or separately,
makes no guarantee of the results and assumes no
liability or responsibility in connection with the information
or suggestions herein or on the training aids contained.
Moreover, it should not be assumed that every
acceptable commodity grade, test or safety procedure
or method, precaution, equipment or device is contained
within, or that abnormal or unusual circumstances
may not warrant or suggest further requirements or
additional procedure.
Product instructions and training aids are subject
to periodic review and users are
cautioned to obtain the
latest edition. Comments and suggestions are invited
from all users for
consideration by
Applied Home
Healthcare
Equipment Inc.
in connection with such
review; any such
comments or suggestions will be
fully reviewed by Applied Home Healthcare
Equipment Inc.
For more information and links to the Compressed
Gas Association, FDA, DOT, and others please see the
reference section of this guide and www.applied-inc.com.

55

56

INDEX
FDA Public Advisory:
Medical Gas mix-ups
can cause death and
serious injury
Gases for medical use are prescription drugs that
must be carefully regulated and handled.
Adapters should never be used and fittings never
changed on medical gas containers. If a connection
doesn't fit, it isn't supposed to fit. Contact the supplier
immediately.
Store medical grade products separately from
industrial grade products in well-defined areas.
Educate and train personnel who are directly
responsible for handling medical gas to:
a. recognize medical gas labels
b. examine all labels carefully before hooking
containers to the system.
Skilled and knowledgeable personnel should always
check the container and connection prior to introducing
the gas into the system.

Wont Connect?
Dont Connect!
Patients have been injured and some have died because
of medical gas mix-ups. This usually occurs when the
wrong gas is forcibly connected to the oxygen supply
system. Please promote the importance of properly
handling medical gases.
Manufacturers who receive reports of death or serious
injury associated with the use of medical gases are
required by law to report those incidents to the FDA.
Hospitals, nursing homes, and other health care
facilities should submit reports of such mix-ups
(whether or not they resulted in a serious injury)
to FDA's voluntary reporting program, MedWatch:
800-FDA-1088, Fax 800-FDA-0178.

INDEX
Description
Accidents, handling
Adapters, cryogenic
Alcohol / drug training, etc.
Analysis, financial
Analyzer, oxygen
Appendix
Building, layouts
Carts, cylinder
CGA Standards, bulletins
Cost, justification, filling
Cryogenic carts
Cryogenic equipment
Cryogenic, filling
Cryogenic vessel labels
Cylinder filling
Cylinder holders
Cylinder labels
Cylinder markings
Cylinder racks, carts
Cylinder racks, Vans
Cylinder sizes
Disclaimer
Driver requirements
Driver training
Drugs / alcohol training, etc.
EIGA
Face shield
FDA Public Advisory
FDA registration
FDA violations
Filling equipment
Filling oxygen
Financial analysis, filling
Gas, calibration
Gloves, cryogenic
Haz-Mat Book
Haz-Mat training
High pressure filling
How to use the guide
Incident handling
Inspections, pre-fill
Inspections, violations
Label remover, liquid
Labels, cylinder & cryogenic
Links (web sites)
Liquid to gas filling
Manifest, shipping, Haz-Mat
Material handling

57

Page(s)
11
24-26
10
36, 45-46
28
38-55
40-41
14-16
38
45-46
13
24-26
35
27
33-34
16
27
44
13-16
6
15 & 43
55
1
8,9
10
39
24
56
37
28-29
22, 23 33-35
17-21, 33-37
36 & 45-46
28
24
3
8
33 -34
Opp. INFC
11
20-21
28-29
22-23
27
47
33
2
13-17

58

Description

Page(s)

NA Emergency Response
NAERG Guide
No Smoking Signs
Oxygen manifest
Oxygen, technical info
Placarding, placards
Pre-fill cylinder inspections
Production, increasing
Profits, increasing
Racks and carts, cylinder
References
Reimbursement cuts, fighting
Requirements, driver, vehicle
Safety awareness, patient
Safety glasses
Safety supplies
Safety, cryogenic relief "T"
Scale, cryogenic
Shipping document, required
Spill pan
Storing oxygen
Supplier, audit
Temperature / psig chart
Thermometer, filling
Training aids

3
3
3
2
42
4
20-21
30
33-37
13-16
36-37
31-36, 44-45
1
50-53
24
24
25
26
2
24
13-15
54
48
29
7-9, 18-19,
ISFC, ISBC
8-9
18
8
30
49
22
6
6
1
5
3-6
18-19
28-29
22, 23
22

Training, driver
Training, filling
Training, Haz-Mat
Quick connector, yoke
Vacuum, elevation chart
Valve seals
Van racks, carts
Vehicle racks, carts
Vehicle requirements
Vehicle w/ Cryogenic Tank
Vehicles, key items
Videos, training
Violations, regulatory
Washers, yoke
Wetband valve seals

MR-100 Series,
free private branding
of medical regulators

1199-1030,
Current good
manufacturing
practice certification
course, V2

Solutions

APPLIED NEW PRODUCTS

SOLUTIONS

OF-1232,
North American
Emergency Response
Guide Training Course

APPLIED HOME HEALTHCARE EQUIPMENT INC.

Indicates registered trademarks used in this catalog: Microsoft, DuPont, Airgas,


Puritan-Bennett, Caire, Linde, and others.
Applied Home Healthcare Equipment, Inc. 2005
Printed in the U.S.A. / Suggested retail: $3.95 USD

e-mail: med@applied-inc.com
web-site: www.applied-inc.com

telephone: 1 (440) 716-9962


toll-free: 1 (888) 327-7301 (USA)
fax: 1 (440) 716-9964
8:30 am to 5:00 pm
Eastern Standard Time (USA)

31379 Lorain Road,


North Olmsted, OH
44070-4730 USA

OXYGEN POCKET REFERENCE GUIDE

OXYGEN POCKET
REFERENCE GUIDE

OXYGEN POCKET REFERENCE GUIDE

DELIVERING

STORING

FILLING

INCREASING REVENUE AND PROFITS


TECHNICAL

/
REGULATORY

OXYGEN POCKET REFERENCE GUIDE

Anda mungkin juga menyukai