Escolar Documentos
Profissional Documentos
Cultura Documentos
e-mail: med@applied-inc.com
web-site: www.applied-inc.com
OXYGEN POCKET
REFERENCE GUIDE
DELIVERING
STORING
FILLING
/
REGULATORY
MR-100 Series,
free private branding
of medical regulators
1199-1030,
Current good
manufacturing
practice certification
course, V2
Solutions
SOLUTIONS
OF-1232,
North American
Emergency Response
Guide Training Course
Dave Marquard
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
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
OXYGEN MANIFEST
QTY
PACKAGE
TYPE
SIZE
HAZARD
CLASS
SHIPPING
NAME
CYL
684
LTR.
2.2
COMPRESSED, UN1072
OXYGEN
QTY
PACKAGE
TYPE
SIZE
HAZARD
CLASS
SHIPPING
NAME
DEWAR
180
GAL.
2.2
REFRIGERATED, UN1073
OXYGEN
DELIVERING OXYGEN
DELIVERING OXYGEN
Key items recommended on all vehicles
transporting over 1000 lbs. [1]*
DELIVERING OXYGEN
WWW.APPLIED-INC.COM
It is recommended
to have a spill pan
under van / truck tank
DELIVERING OXYGEN
Racks and carts in vehicles [1]*
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].
* 49 CFR 177.840
**21 CFR parts 211.80 - 94
DELIVERING OXYGEN
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.
TOLL-FREE 1-888-327-7301
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
DELIVERING OXYGEN
OF-1201,
DOT course V2
OF-1250,
Driver log book
WWW.APPLIED-INC.COM
10
DELIVERING OXYGEN
Drugs/alcohol training for drivers [1]*
OF-1270
OF-1280
OF-1270
OF-1280
DELIVERING OXYGEN
11
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
STORING OXYGEN
STORING OXYGEN
12
WWW.APPLIED-INC.COM
*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
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
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
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
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
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
1100-1765,
Multi-cylinder cart
STORING OXYGEN
16
1100-1808, Wheelchair
mount for D/E cylinders
1100-1901,
E Cylinder stand
WWW.APPLIED-INC.COM
FILLING OXYGEN
FILLING OXYGEN
17
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
OF-1080,
All-in-one reference library kit
Filler Training
Training
1.
2.
3.
OF-1016,
Oxygen safety training course
FILLING OXYGEN
19
Supervisor Training
Training
1.
2.
Quality Control
Control Unit Training
Training
All of the prior listed training plus the following:
Regional seminar
V2
1199-1030,
cGMP training
course, V2
WWW.APPLIED-INC
WWW.APPLIED-INC .C OM
1.
2.
FILLING OXYGEN
20
Pre-fill
Pre-fill Inspections
1.
2.
3.
4.
5.
6.
7.
FILLING OXYGEN
21
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
1109-0013
1109-0092
1109-0070
1109-0017
FILLING OXYGEN
23
1109-5573
1109-0006
TOLL-FREE 1-888-327-7301
1109-0002A
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
FILLING OXYGEN
7. Cryo-Hose cap with tab
Helps keep dirt/contaminants and
moisture from damaging hose
and equipment.
25
0900-0255
Transporting equipment
0900-0256
1100-1950
1100-1820
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
0900-0551
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
11. Cryo-Scale
Used when filling cryo-home units to
measure when container is filled.
0900-0600
FILLING OXYGEN
27
Size
E
D
C
Contents
697 Liters
427 Liters
248 Liters
Size
Contents
M-6 165 Liters
H 7,100 Liters
Other ____ Liters
CONTENTS:_________________ LITERS
X 45136
TOLL-FREE 1-888-327-7301
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
SG-100,
Specialty gas
OQ-111,
Model policy
procedure manual
FILLING OXYGEN
OQ-111,
Model policy
procedure manual
29
1120-0055,
Gauge calibration
1108-0120,
Thermometer calibration
WWW.APPLIED-INC
WWW.APPLIED-INC .C OM
1108-0115,
Digital thermometer
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
1109-9923
1100-1863
1100-1867
C. Delivering
1. Carry multiple M-6
cylinders when delivering
cylinders to patients. (pg. 16)
1100-1948
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.
31
INCREASING PROFITS
INCREASING PROFITS
32
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.
TOLL-FREE 1-888-327-7301
33
INCREASING PROFITS
Reduce oxygen costs by filling
oxygen cylinders
Gas to gas systems
INCREASING PROFITS
34
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
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
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
CONTENTS:_________________ LITERS
Tip:
Use punch
to mark
contents
UN 1073
LOT #:____________
37
X 45136
1109-0003, Cryogenic
cylinder label, custom printed
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
(R2)
(R3)
(R4)
(R5)
TOLL-FREE 1-888-327-7301
(R1)
APPENDIX
40
Quarantine
Testing
Fill
System
Empty Cylinders
Shelving
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
Patient
Parking
Loaded Vehicles
Homecare Company
Waste
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
APPENDIX
43
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
APPENDIX
Medical Gas Cylinders Technical Information
How to Read Cylinder Markings
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
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
$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
$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
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.
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
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
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
$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
$
$
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.
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
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
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
25
20
15
10
Sea
Level
5,000
10,000
15,000
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:
WWW.APPLIED-INC.COM
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
TOLL-FREE 1-888-327-7301
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
SOLUTIONS
OF-1232,
North American
Emergency Response
Guide Training Course
e-mail: med@applied-inc.com
web-site: www.applied-inc.com
OXYGEN POCKET
REFERENCE GUIDE
DELIVERING
STORING
FILLING
/
REGULATORY