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OF-1232, North American Emergency ResponseGuide Training Course

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Hi, I’m Dave Marquardowner of Applied HomeHealthcare Equipment Inc.This Oxygen Pocket Reference Guide is dedicatedhome healthcare oxygen providers /dealers who help improve the quality of life formillions of patients everyday.

The Oxygen Pocket Reference Guide is the firstin a series of guides designed to provide a quickoverview of important safety, regulatory, andtechnical information. For example, if you’reusing, storing, transporting, delivering, handling,and / or refilling oxygen you will find highly useful information and products in this guide. Pleasesee our comprehensive table of contents on thenext page or the index in back of the guide.

Please note it is not possible to put all the relevant safety, regulatory, and technical informa-tion 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 canhelp you improve oxygen safety, compliance, revenue, and your profits.

Thank you for choosing Applied as one of yourregulatory, technical, and product resources.

Thank You,

Dave Marquard

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


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

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TABLE OF CONTENTSDelivering Oxygen 1Driver Requirements 1Vehicle Requirements 1-4Requirements 2-11Oxygen Manifest (Shipping Papers) 2Vehicles with Cryogenic Tanks 5Van and Truck Racks and Carts 6Hazardous Material (Haz-Mat) Training 7-8Driver Training 9Drug / Alcohol for Drivers 10Incidents / Accidents Documentation 11

Storing Oxygen 12Building Requirements / Recommendations 12Racks, Multiple and Single Cylinder 13-16Material Handling: Cylinders 13-16

and Cryogenic VesselsCarts, Cylinder and Cryogenic Vessel 13-16

Filling OxygenFilling Oxygen 17Self-Audit / Requirements 17Training Checklists 18-19High Pressure Cylinder Refilling 20-21High Pressure Cylinder Basics 22-23Cryogenic / Liquid Oxygen Basics 24-26Cryogenic Adapters, Quick Connectors 26Labels, Cylinder and Cryogenic Vessels 27Common FDA Violations 28-29How to Increase Production - Helpful Hints 30"Is Filling Right for Me" & Reducing Costs 31 -35

Increasing ProfitsFinancial Analysis, Examples and DIY 36, 45-46Registering with the FDA (requirements) 37

Appendix 38-55References, Individual and Libraries 38-39Building Layouts: Internal and External Models 40-41Oxygen Technical Information for Providers 42-43Cylinder and Cryogenic Vessels: Sizes 43Cylinder Markings; What they mean 44Useful Internet Links: FDA, DOT, CGA, etc. 47Temperature and Vacuum (altitude) Tables 48-49Home Oxygen Safety Info for Patients 50-53

and Care GiversAuditing Your Suppliers 54Please Read: Important Information 55-56FDA Public Health Advisory 56

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DELIVERING OXYGEN

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DELIVERING OXYGEN

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FDA1, CGA2, DOT3, HC4 and TC5 other requirements/recommendations [1]:

A. Driver Requirements1. Driver training

Drivers and delivery techs require DOT, Haz-Mat and FDA training within the scope of their job. (pg. 9)

2. Haz-Mat trainingDelivery drivers require Haz-Mat training if they transport any quantity of oxygen. (pg. 8)

3. Drugs/alcoholTesting, documentation and more. (pg. 10)

4. Incident HandlingTransportation incidents, accidents, violations, inspections, and “what to do”.(pg.11)

B. Vehicle Requirements [1]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 placeCylinders and vessels must be secured so they can’t be ejected, shifted or moved during normal transportation. (pg. 6)

1

1Federal Food & Drug Administration, U.S.2Compressed Gas Association3Department of Transportation, U.S.4Health Canada / Santé Canada5Transport Canada / Transports Canada

1514177_Field Guide 10/6/05 11:07 PM

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) isrequired to be carried on all vehicles transporting oxygen (a hazardous material)*

Example for compressed gases [1]**

Example for cryogenic liquid [1]**

All information must be legible and printed in English

QTY PACKAGE SIZE HAZARD SHIPPING ID NO.TYPE CLASS NAME

1 DEWAR 180 2.2 REFRIGERATED, UN1073GAL. OXYGEN

REFRIGERATED LIQUID

QTY PACKAGE SIZE HAZARD SHIPPING ID NO.TYPE CLASS NAME

1 CYL 684 2.2 COMPRESSED, UN1072LTR. OXYGEN

COMPRESSED GAS

Accurate and current oxygen manifest must remain in vehicle

at all times

2

Note: DOT/TC considers all cylinders and vessels full unless empty and purged. Since there isn’t 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 Applied’s Haz-Mat Pocket Book (PN# OF-1210)

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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 transportedmust have a label on them [1]**

OF-1228, Self adhesive, flexible

OF-1210, HAZ-MAT book

3

OF-1231, NAERG book

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

*Note: For updates and a complete list of requirements see appendix,www.applied-inc.com, and links to FDA, DOT, HC, and related websites

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DELIVERING OXYGEN

Key items recommended on all vehiclestransporting 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 havea. Warning devicesb. Three bidirectional reflective trianglesc. Incident reporting kit

(helps in reacting to an incident)

Keep placards in good shape with a holder

4

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

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Key points recommended for vehicleswith 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 signsd. Vent lines to carry excess oxygen from

tank outside of vehicle1. from vent valve2. from pressure relief device3. from burst disc

e. At least three cargo area vents1. two in forward area2. 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

DELIVERING OXYGEN 5

*Note: See current edition of CGA SB-9 for additional recommendations (pg. 38, 39)

It is recommended to have a spill pan

under van / truck tank

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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

b. Must be capped or shieldedIf 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 quarantineareas [2].**

For more van racks and carts, see current edition of Applied general catalog and / orwww.applied-inc.com

OF-1790, Layered van rack holds 6 “E” and 4 “M-6” with lockable door 19-1/2”H x 32-1/4”D x 17”W

6

OF-1970, “H” cylinder van rack

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

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DELIVERING OXYGEN 7

Haz-Mat training [1]*How can I receive Haz-Mat Training?Attend an Applied seminar near you by contacting Applied or viewing schedule at www.applied-inc.com. Use training aids below.

Remember oxygen is classified as a class 2.2 hazardous material [1]*.

Refer to Haz-Mat Pocket BookOF-1210 for details on each material

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.

OF-1210, Haz-mat book

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

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DELIVERING OXYGEN

Haz-Mat training for driver [1]*

1. Haz-Mat training and certification course

2. North American Emergency Response training and certification 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.

Meet training requirements for drivers, delivery techs,

supervisors and others

OF-1210, Haz-mat training course

OF-1232, NAERG training course

OF-1230, DOT training course, Part 2

8

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

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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

Drivers delivering over 1000 lbs.All of the above, plusa. Commercial driver’s license as outlined

by your stateb. See page 10 for additional training aids

For updates and more information see the reference pages, the appendix of this guide,

and / or visit www.applied-inc.com

OF-1200, DOT course OF-1201, DOT course V2

OF-1250, Driver log book

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

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DELIVERING OXYGEN

Drugs/alcohol training for drivers [1]*Recommended training aids to assist in drugs and alcohol awarenessOF-1260 Driver drugs and

drinking training kit (includes video and guide)

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

OF-1280 Drug and alcohol files (designed for employee files)

You drink, you drive, you lose

10

OF-1260

OF-1270

OF-1280

* Federal Motor Carrier Safety Regulations, part 382(Recommended for all drivers, required for all CDL drivers)

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DELIVERING OXYGEN

Incident handling [1]*Checklist recommended to be carried on board

a. Incident response kit (includes camera, reports, etc. to document incident)

b. Three bidirectional triangles (recommended on all vehicles transporting oxygen)

c. Warning devices (recommended on all vehicles transporting oxygen)

d. North American Emergency Response Guide (required info to handle incidents)

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Cooperate with authorities. Insure that everyone involvedis okay. Do not make any statements regarding fault, blame, etc...

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Learn to use before an incident.

OF-1208, Driver incident kit

OF-1231, NAERG book

* Federal Motor Carrier Safety Regulations, part 390.5

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STORING OXYGEN

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STORING OXYGEN

Check with local building codes and see appendix for suggested

building layout. (pg. 40 )

1109-0032, self adhesive for mounting

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Storing oxygen [2 - 4,q]*Building requirementsa. 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. Empty2. Quarantine3. Full

i. not approvedii. approved

f. Types of oxygen service1. Compressed gas (for low volume users)2. Liquid to gas (for high volume users)

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.

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STORING OXYGEN

Material Handling [4,q]As your homecare business grows, the type of materialhandling equipment also changes. See the lists belowfor the different types of material handling solutions.

13

1100-1820Large liquid vessel cart with 2 Pneumatic wheels and 2 swivel casters to move 1 Liquid Vessel46”H x 28”W

1100-1950Handtruck w/Stairclimbersfor liquid reservoirs44”H x 22-1/2”W x 17”D

1100-1867Holds 168 M4, M6, B Cylinders66”H x 32”D x 27”W

1100-1863Holds 50 M7, M9, C, D, & E Cylinders66”H x 32”D x 27”W

1100-1932M-6 Rack for 6 Cylinders8-1/4”H x 7-5/8”D x 11-1/2”L

1100-1934M-6 Rack for 24 Cylinders8-1/4”H x 11-1/2”D x 30-5/8”L

Storing M-6 sized cylinders*

Space saving cylinder racks*

Liquid oxygen containers

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STORING OXYGEN

Handling E cylinders*

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See current general Applied catalog and www.applied-inc.com

for more carts and racks

1100-1891 E Vertical Cylinder Stand with hold down bars and feet, for 6 Cylinders19.5”H x 12”D x 15”L

1100-1892 E Vertical Cylinder Stand with hold down bars and feet, for 12 Cylinders 19.5”H x 15”D x 22”L

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

1100-1840 Cylinder Cart for 4 Cylinderswith two wheels and two legs42”H x 10”D x 18”W

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

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

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

Storing E sized cylinders*

Handling M-6 cylinders*

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

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Material handling – Helpful Hints [4,q]Cylinders and cryogenic vessels must be safely andefficiently carried into patient’s homes apartments, nursing homes, etc. They should be secured in a carrying rack or cart to avoid being dropped or damaged. Applied’s carts and racks are designed for this purpose.Use only storage racks and carts 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.

STORING OXYGEN

Wooden racks are not recommended, because they are combustible

For more cylinder racks and carts, see current

Applied catalog and www.applied-inc.com

1100-1866, Holds 84“M-6” cylinders33”H x 32”D x 27”W

1100-1874, 24 “E” Cylinder cart42”H x 30”D x 20”W

1100-1765, Multi-cylinder cart48”H x 42”D x 32”W

*Call for Jumbo D stands, and carts

CYLINDER SIZE GUIDECYLINDER 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“

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STORING OXYGEN

Material handling – Helpful Hints [4,q]Carriers help the delivery process4. Racks and carts should

have minimum 1.5 timesthe strength of the rack.

5. Non-magnetic carts for use with MRI tests.

6. Economy stands for patient’s home are ideal for back-up cylinder storage orin nursing homes.

7. Cylinder holders for special uses; wheel chair mount, walker mount, wall brackets, stands, and others.

1100-1808, Wheelchairmount for D/E cylinders

1100-1946, “M-6” Carrier

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1100-1913, MRI Cart

1100-1901, “E” Cylinder stand

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Carriers reduce the numbertrips to and from the

delivery vehicle

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F I L L I N G O X Y G E NF I L L I N G O X Y G E N

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Filling oxygen self-audit [4,i]There are a number of different things to address whenfilling 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 plusbasic quality training from an outside source

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)

C. Buildings [2 - 4,i]1. Internal layout (pg. 40)

basic FDA, CGA and NFPA recommendations2. 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 complianceand perform self audit

E. Increasing revenue and profits (pg. 31)

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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.

Filler TFiller Trainingraining1. Use the Oxygen Safety Course Kit to conduct

oxygen safety training seminars.2. Have employees take the cGMP* course by

watching video, reviewing course and taking exam to receive certificates.

3. Have employees take cGMP* course version 2 to meet continuing education requirements.

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

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1199-1023, cGMP training course

OF-1016, Oxygen safety training course

*cGMP: Current Good Manufacturing Practice [4]

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Supervisor TSupervisor Trainingraining1. All of the prior listed

training plus the following:2. Use cGMP required forms

to ensure all filling documentation is captured.

Quality ContrQuality Control Unit Tol Unit Trainingraining1. All of the prior listed training plus the following:2. Regional seminar

1199-1030,cGMP training course, V2

1199-1028, cGMP required forms binder

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See website for current seminar listings near you

Applied video courses help meet training requirements.

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F I L L I N G O X Y G E NF I L L I N G O X Y G E N20

High pressure cylinder refilling [4,i]All manifold filling sequences, otherwise known as lots orbatches, must have its own unique lot number assigned to it.(There is no required method for assigning lot numbersexcept for that they must be unique. Numbers and / or letters may be used)

Cylinder Filling InspectionsCylinder Filling Inspections1. Determine the number of cylinders to be filled in batch2. Assign lot number to batch

PrPre-fill Inspectionse-fill Inspections1. Visual inspection of cylinder

a. check for gouges and dentsb. discoloration (thermal damage)c. see CGA 6 and 6.1 for more information [4,a and 4,b]

2. Color of cylindera. in U.S.A. cylinder must be green, in Canada whiteb. CGA C-9 for more information [4,d]

3. Valve inspectiona. check for corrosionb. check for presence of grease or oil

(do not refill if present)4. Hydrostatic test date

a. aluminum cylinders and lightweight steel have a5 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]5. Hammer test

a. aluminum cylinders are exempt (record a N/A)b. steel cylinders tap side of cylinder with hammer

to hear bell soundc. see CGA P-2.5 for more information [4,i]

6. Label examinationa. ensure cylinder has proper drug product labelb. See CGA C-7 for more information [4,c]

7. Vent all residual oxygena. perform inspection outdoorsb. allow residual oxygen to escape

Cylinders failing any inspection shouldCylinders failing any inspection should

be placed in the quarantine be placed in the quarantine

ararea [2 - 4,i]ea [2 - 4,i]

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F I L L I N G O X Y G E NF I L L I N G O X Y G E N 21

8. Odor test [4,i]a. whiff contents as it is venting to detect an odorb. oxygen has no odorc. no odor is permittedd. if no residual oxygen is present, use nitrogen

NF to perform the odor test9. Vacuum/purge

vacuum all cylinders to 25” Hg at sea levelor adjust for elevation (pg. 49)

Filling InspectionsFilling Inspections1. Heat of compression

a. cylinders should warm to the touchb. no change in temperature indicates that it is not filling

2. Leak testa. spray valves, connections and seals to help detect leaksb. use oxygen compatible leak testing solution

3. Temperaturea. monitor temperature using temperature / pressure

chart and record value4. Pressure

a. document pressure on batch production record (pg. 48)b. see CGA P-2.5 for more information [4,i]

Post-fill InspectionsPost-fill Inspections1. Leak test

a. spray valves, connections and seals 2. Record the serial number of the cylinder being tested3. Odor test

a. whiff the contents of the analyzed cylinder to check for an odor

4.ID testa. use an accepted oxygen analyzer (ex. OF-900) [8]b. identify the gas as oxygen

5. Strength / Purity testa. use an accepted analyzer to test the purity of the gasb. record the value shownc. 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]

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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 sealApplication: Used to keep dust/dirt out of valve orifice. Applies easy and dries to fit.

2. Product: Perforated wetband valve sealApplication: Same as regular wetband with easier removal for patients.

3. Product: Plastic valve sealsApplication: 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 styleApplication: Buckles around valve easily and holds washer. (order 1109-0068 washers separately)

5. Product: White Tefzel® washersApplication: Used on cylinder filling racks to seal connection between yoke and valve.

6. Product: Brass and Viton® washerApplication: Great for patients! Helps sealing regulator connections easier.

1109-0019

1109-0037

1109-0013

1109-0092

1109-0070

1109-0017

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7. Product: Nylon yoke washersApplication: Standard replacement washer given to patient for regulator connections.

8. Product: O2 compatible leak testApplication: Used when filling cylinders to detect leaks.

9. Product: Lot stickers for Oxymark™ 4 label gun.Application: Used to apply lot number and expiration date to cylinders with each batch filled.

10. Product: LR9000 Non-HydrocarbonLabel RemoverApplication: Great for cleaning up cylinders. Aids in removing old lot stickers, drug product labels, and left behind adhesive.

11. Product: Drug product labelsApplication: Required by FDA / HC / DOT / TC to show contents, warning information, and more.

14. Product: Toggle for post valveApplication: Replacement toggle (screw type).

1109-0068

1109-1023

1109-0002A

1109-5573

1109-0006

1109-5551

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Cryogenic equipment basics [2 - 4,j]Equipment, supplies, and accessories should includeclean, serviceable, and properly fitting safety equipment.Inspect and discard dirty, oily, worn, or torn gloves,aprons, face shields, safety glasses before they con-tribute to an accident incident and / or violation.

Safety Equipment1. Cryogenic gloves

Helps protect hands from frostbite.

2. Cryogenic apronHelps protect body from frostbiteand liquid spray.

3. Face shieldHelps protect face from frostbite.

4. Safety glassesHelps protect eyes from frostbite.

5. Ear plugsHelps protect ears when filling

6. Spill panUsed 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)


0900-0130

0900-0140

0900-0100

0900-0120

0900-0580

0900-0020

24

Between fills always capBetween fills always capcryogenic transfer hose tocryogenic transfer hose to

keep moisture, dust, dirt, etc.keep moisture, dust, dirt, etc.out of equipmentout of equipment

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.

7. Cryo-Hose cap with tabHelps keep dirt/contaminants and moisture from damaging hose and equipment.

8. Thread in plastic Cryo-Hose capHelps protect against dirt, contaminants, and moisture. Thread in application.

Transporting equipment1. 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.

Liquid O2 Filling equipment1. Safety relief “T”*

Used to help prevent a rupture in a case where liquid is trapped in a hose.

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.


0900-0256

1100-1950 1100-1820

0900-0255

0900-0555

0900-0531

0900-0557

0900-0558

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*Note: Always use a safety relief valve and cryogenic transfer hose to help prevent a rupture from expanding gas.

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5. Double fill head – PB®/Caire®

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

6. Double fill head – PB®/Linde®

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

7. Triple fill head – PB®/Caire®/Linde®

Triple fill adapter with PB®/Caire®/Linde®

filling heads.

8. Cryogenic 90° elbowUsed to reduce line stress and help eliminate chatter with transfer hose.

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

10.Cryogenic transfer hoseAvailable in 7’, 10’, 15’ and custom lengths. (use with safety “T”, to prevent rupture. See pg. 25)

11. Cryo-ScaleUsed when filling cryo-home units to measure when container is filled.

0900-0550

0900-0551

0900-0559

0900-0300

0900-0511

1110-0550

0900-0600

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High Pressure Labeling [2 - 4,c]Examples of custom printed high pressure cylinder labels (PN 1109-0006). Contact Applied for the most current version.

Cryogenic Labeling [2 - 4,c]Examples of custom printed cryogenic cylinder labels (PN 1109-0003). Contact Applied for the most current version.

2

OXYGEN,REFRIGERATED

LIQUID USP

UN 1073LOT #:____________

CONTENTS:_________________ LITERS

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.� �

WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER

PRESSUREVIGOROUSLY ACCELERATES COMBUSTION.NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULTCOMBUSTIBLES 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 52°C (125°F).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 othermedical applications, Rx Only.

Uninterrupted use of high concentrations of oxygen over a longduration, without monitoring its effect on oxygen content ofarterial blood, may be harmful. Use only with pressure reducingequipment and apparatus designed for oxygen. Do not attemptto use on patients who have stopped breathing, unless used inconjunction with resuscitative equipment.Produced by Air LiquefactionDO NOT REMOVE THIS PRODUCT LABEL.

CAS NO: 7782-44-7X 45136

2

OXYGEN,COMPRESSED

USPUN 1072

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

PRODUCED BY AIR LIQUEFACTIONWARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKINGIN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiencyand resuscitation. For all other medical applications, Rx only. Uninterrupted use of high concentrations ofoxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harm-ful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to useon 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 equipmentcleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each useand when empty. Use a back flow preventive device in the piping.

Cylinder temperature should not exceed 52°C (125°F).USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

DO NOT REMOVE THIS PRODUCT LABEL.Size Contents Size Contents“E” 697 Liters “M-6” 165 Liters “D” 427 Liters “H” 7,100 Liters “C” 248 Liters Other ____ Liters

Partial list:• Proper shipping name and UN

number to the left of diamond

• “Rx only” in larger font and bold

• Cylinder contents shown on label

• “Use a backflow preventative devicein piping” statement

• Company name and location

• See CGA C-7 for more information

Partial list:• Frostbite warning

• Do not change or force connections

• Keep container upright

• For use on container filled by provider only

• “Use a backflow preventative device in piping” statement

• First aid warning

• See CGA C-7 for more information

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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 Please note violation may take multiple corrective steps, violation may take multiple corrective steps, not only the single example given.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.

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 Applied’s Model Policy Procedures manual to write procedures detailing your oxygen filling operation.

4. Violation: Failure to establish a training program.Example: Use SOP to detail how, when, and where training takes place. Use Applied’s training aids/seminars to help educate employees.

OF-900, Oxygen analyzer

SG-100,Specialty gas

OQ-111,Model policy procedure manual

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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 Applied’s cGMP forms and update as needed to document filling process correctly.

Document logs completelyDocument logs completely

7. Violation: Failure to adjust for temperature and pressure when filling.Example: Use Applied’s LCD digitalthermometer when filling cylinders.

8. Violation: Failure to calibrate filling equipment.Example: Calibrate your gauges and thermometer in accordance to equipment manufacturers guidelines by sending in to Applied’s calibration lab.


1199-1028, cGMP required forms binder

1108-0115,Digital thermometer

1120-0055,Gauge calibration

1108-0120,Thermometer calibration

* 21 CFR 211.67 (a)

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Gauges and thermometers must be calibrated to N.I.S.T. standards

per manufacturer’s instructions*

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Helpful hints – increasing productionIncreasing productivity safely, effectively, and in compliance with regulatory requirements is highly effective in increasing revenue and profits.

A. Filling1. Use filling racks to fill more cylinders

at a time. Larger batches and minimal space consumption will lead to less paperwork and greater efficiency.

2. Load and unload cylinders in less than half the time with oxygen yoke quick connectors.

3. Connect and disconnect pigtails quickly by using handtight connections

B. Processing1. Maximize cylinder storage while

minimizing your space consumption by storing 50 “E” cylinder in one rack.(pg. 13) (PN 1100-1863)

2. Maximize cylinder storage while minimizing your space consumption by storing 168 “M-6” cylinder in one rack.(pg. 13) (PN 1100-1867)

3. Transport many multiple sized cylinders from storage to loading your vans. (pg. 15)

C. Delivering1. Carry multiple M-6

cylinders when delivering cylinders to patients. (pg. 16)

2. Deliver liquid home units quicker and easier using a handtruck with stair climbers. (pg. 13)


HME-0010

1109-9928

1100-1867

1100-1765

1100-1948

1109-9923

1100-1863

1100-1950

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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 prChallenges to DME profitabilityofitability1. 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 cylindersAdvantages to filling your own cylinders1. Reduce oxygen gas cost by 50% or more.2. Reduce the number of cylinders you have to buy.3. Have 24-hour/7 day a week availability of oxygen.4. 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 delaysin getting cylindersfrom supplier.

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INCREASING PROFITS

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INCREASING PROFITS

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.

Problem:Cost increases on supplies.

Solution:Purchase supplies in bulk and take advantage of Applied’s quantity discounts.

Problem:Increasing regulatory compliance costs.

Solutions:1. Use Applied’s library of training aids to train

patients, care givers, drivers, supervisors, and quality control personnel.

2. Attend Applied’s regional seminars.

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Pneumatic conserver offers3:1 oxygen conservation

1210-0100, Pneumatic oxygen conserver

OF-757, turn key liquid to gas filling system (includes installation,operational and regulatory training)

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Reduce oxygen costs by filling oxygen cylinders

Gas to gas systemsIdeal for companies using 1-50 cylinders per weekOxyfill® high pressure refilling system, OF-600

Ideal for companies using 50-100 cylinders per weekOxysupply™ high pressure refilling system, OF-686

Liquid to gas systemsIdeal 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

INCREASING PROFITS

Oxyfill® System, Fills 5 from 6 supplycylinders

Oxysupply™ System, Fills 12 from 6 supply cylinders

33

All systems are available in multiple sizes and custom configurations

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Basic Compressed gas cylinder filling equipment

A. Cylinders (pg. 43)Cylinders available in a wide range of sizes

B. Safety equipment (pg. 24)1. Goggles2. Natural fiber clothes3. Gloves4. Ear protection

C. Filling equipment (pg. 33)1. Gas to gas 2. Liquid to gas(see page 33to find out what typeis right for you)

D. Required forms for filling cylinders (pg. 19)1. Policy manual2. Batch production3. Label inventory4. DOT log5. Calibration log6. Distribution record7. Maintenance log

INCREASING PROFITS

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1199-1028, cGMP required formsbinder, provides supply ofrequired forms and masterson CD-ROM


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INCREASING PROFITS

Basic Liquid oxygen refilling equipment A. Liquid reservoirs

B. Safety equipment (pg. 24)1. Safety glasses2. Face shield3. Gloves4. Apron5. Ear protection6. Safety shoes7. Cuffless trousers

C. Filling equipment (pg. 25-26)1. Proper fill head to fill reservoir2. Pressure relief device3. Cryogenic fill hose4. Cryogenic scale5. Spill pan

D. Record keeping forms (pg. 18-19)1. Policy manual2. Filling forms3. Lot stickers

0900-0130,Cryogenic gloves

0900-0555, Single PB® fill head

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Financial analysis

Typical oxygen costs for refilling oxygen cylinders

Assumptions: 1. $20 per hour labor cost2. Gas to gas uses $8.00 cost for supply cylinder3. Liquid to gas uses $1.00 per CFT liquid

Note: See page 45 and 46 for example of typical savings worksheet.

SYSTEM TYPE E D C M-6GAS TO GAS $1.11 $.78 $.61 $.51LIQUID TO GAS $.55 $.45 $.40 $.37

INCREASING PROFITS

CYLINDER SIZE

Call Applied or download fromwww.applied-inc.com for a complete, no obligation

cost / savings analysis.

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INCREASING PROFITS37

* 21 CFR 510

2

OXYGEN,REFRIGERATED

LIQUID USP

UN 1073LOT #:____________

CONTENTS:_________________ LITERS

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.� �

WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER

PRESSUREVIGOROUSLY ACCELERATES COMBUSTION.NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULTCOMBUSTIBLES 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 52°C (125°F).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 othermedical applications, Rx Only.

Uninterrupted use of high concentrations of oxygen over a longduration, without monitoring its effect on oxygen content ofarterial blood, may be harmful. Use only with pressure reducingequipment and apparatus designed for oxygen. Do not attemptto use on patients who have stopped breathing, unless used inconjunction with resuscitative equipment.Produced by Air LiquefactionDO NOT REMOVE THIS PRODUCT LABEL.

CAS NO: 7782-44-7X 45136

1109-0006, High pressure cylinder label, custom printed

1109-0002A, Lot and expiration stickersfor Oxymark™ 4 label gun

1109-0003, Cryogenic cylinder label, custom printed

Tip: Use punch

to mark contents

Registering to refill oxygen [2]*

A. Register with FDA1. Complete form 26562. Complete form 2657

Download forms and example from web sitewww.applied-inc.com

3. Include sample label and lot sticker

4. Send via method that provides delivery confirmation

B. Register with state agencies (if required)1. Consult

www.palmettogba.com/palmetto/statelicensure.nsf2. Your state board of pharmacy

C. Comply with regulations1. FDA guidance [2-3]2. CGA standards and bulletins [4]3. Code of Federal Regulations (CFR) [1-2-3]

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APPENDIX

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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, OSHARegulations (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)

38

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APPENDIX

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 com-prehensive library of all the references used in this guide.

(R1) 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

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APPENDIX

Filling oxygen – internal building layout

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

Model Homecare WarehouseMinimum 10 ft. x 15 ft. for filling area

Truck entrance doorQuarantine

Testing

FillSystem

Empty Cylinders

Shelving

Work Flow Diagram

Filled cylindersApproved

Filled cylindersUnapproved

e

Legend

Empty cylinder path

Filled cylinder path

Electrical power1. High pressure, 110 volt a/c 20 amp2. Liquid to gas

a. 220 volt a/c, 3 phase 20 ampb. 220 volt a/c, 1 phase 30 amp (optional)

40

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APPENDIX

Filling oxygen – external building layout

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

Model Homecare Company

PatientParking

Model Homecare Co.

Homecare Company

Empty vehicles

Load

edV

ehic

les

12 ft. Cement padwith fence

OxygenBulkTank

Truckentrancedoor

Foundation based on site survey

Waste

RoadT

LegendEmpty cylinder path

Filled cylinder path

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APPENDIX

Oxygen technical information for providers

Origin: NaturalPhysical state: GasDescription: 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 CylindersM6 = 2,216 psigC = 2,015 psigD = 2,015 psigE = 2,015 psigH = 2,400 psig

Common Pressures for Liquid Gas CylindersService at 70° F50 psi = Optimal for liquid transfers100 psi = Faster liquid transfers with increased

gas loss150 psi = Very fast liquid transfer with a great amount

of gas loss250 psi = Optimal for gas withdrawal purposes

Oxygen Conversion Chart

Wt. of Vol of Liquid Vol. of Gas Liquid at Normal at 70°or Gas Boiling Point

-297.3° F (-183 C)

Pounds Liters Gallons Cu. Ft.1.000 0.397 0.105 12. 082.571 1.000 0.264 30.389.527 3.785 1.000 115.058.281 3.290 0.869 100.00

Cubic Feet to Gaseous Liters: Cu. Ft. x 28.32 = Liters Website: www.applied-inc.com

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APPENDIX

M09

A M

L6M

6,B

M9,

CD

JDE

M60

MH

,TLL

3.4

4.3

3.2

4.3

4.3

5.3

4.3

7.3

89.

321

12.4

7.5

11.5

1216

.525

.523

3636

50-5

262

-67

3050

3004

3001

3005

3009

3011

3013

3015

3017

3022

3025

96

69

1521

2461

122

243

7,36

3

Cylin

der

Dia.

/in.

Ht./

in.

PN-w

/o t

oggl

e

Cont

ents

/cub

ic f

t.

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 regulatoryrequirements. CGA standards are available from Applied or CGA at cganet.com.

Cylinders shown are not to scale

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Cylinders and Cryogenic VesselsQuality cylinders and cryogenic vessels play an importantrole in delivering oxygen to patients. Applied cylinders andcryogenic vessels provide years of service and meet thelatest DOT, FDA, TC, HC and CGA requirements.

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APPENDIX

Medical Gas Cylinders Technical InformationHow to Read Cylinder MarkingsTop 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

MARKINGS AFTER TO JANUARY 1. 1983

Item Description1 Brand Identification 2 Manufacturer’s Test Date3 Manufacturer’s Registered Symbol 4 Cylinder Meets 10% Overfill Specification 5 Cylinder Meets 10 Year Hydrostatic Test Exemption 6 Collar7 Cylinder8 Tare Weight9 DOT Specification and Service Pressure10 Manufacturer’s Serial Number 11 Inspector’s Mark 12 Registered Owner

(PCGCO= Puritan Medical Products) 13 Rejection Elastic Expansion Limit in

Cubic Centimeters14 Canadian specifications number and service pressure15 Cleaned for oxygen service

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44

1514177_Field Guide 10/6/05 10:23 PM

APPENDIX

Cost JustificationSample Liquid to Gas SavingsInstructions:• 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 [email protected] or download a do-it-yourself cost savings Excel® sheet from www.applied-inc.com .

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1514177_Field Guide 10/11/05 12:22 AM

creo

APPENDIX

Cost JustificationSample Gas to Gas SavingsInstructions:• 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 [email protected] or download a do-it-yourself cost savings Excel® sheet from www.applied-inc.com .

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1514177_Field Guide 10/10/05 9:22 PM

creo

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 / Santé Canada

http://www.hc-sc.gc.ca/

For Transport Canada / Transports Canada

http://www.tc.gc.ca/

47

1514177_Field Guide 10/11/05 12:22 AM

creo

APPENDIX

TEMPERATURE/PRESSURE CONVERSION CHART

Avg.Temp 2000 PSI 2200 PSI 3000 PSI

of Gas Settled Pres Settled Pres Settled

Pres @70° @70° @70°

0 1,630 1,781 2,283

5 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

48

1514177_Field Guide 10/6/05 10:15 PM

APPENDIX

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301

Transfilling Evacuation Limits at Various ElevationsA perfect vacuum at sea level is considered to be 29.92in. Hg. As elevation increases, the equivalent gaugevalue in inches of mercury to obtain the same level ofvacuum 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 toachieve 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 levelsthat 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 onatmospheric pressure.

Altitude Pressure Feet in Hg0 25.00500 24.561000 24.111500 23.682000 23.252500 22.833000 22.413500 22.004000 21.594500 21.205000 20.815500 20.426000 20.046500 19.667000 19.297500 18.938000 18.578500 18.229000 17.879500 17.5310000 17.20

Effect of Altitude on Atmospheric Pressure

30

25

20

15

10

5

0

SeaLevel

5,000 10,000 15,000 20,000 25,000

Altitude of work site (Ft.)

49

Altitude Pressure Transfilling Table

Atmospheric Pressure Chart for Illustration Purposes (In. Hg)

1514177_Field Guide 10/6/05 11:35 PM

creo

APPENDIX

Home Oxygen SafetyAwareness for Patientsand 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 systemsused in private homes, apartments, and condominiums.

OxygenOxygen 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 othermaterials that burn to ignite more easily and to burn farmore rapidly. The result is that a fire involving oxygen can appear explosive-like.

Oxygen is of great benefit to those in need of oxygentherapy but, it should always be handled with caution and awareness of the potential hazards.

The EquipmentThere are three common ways of providing oxygen ther-apy. 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 ormethod to provide oxygen therapy is by using an oxygenconcentrator. Each method is examined in more detail below.

Compressed Gas in Cylinders- Oxygen is stored underpressure in a cylinder with a regulator that controls theflow rate. Because the flow of oxygen out of the cylinderis constant, an oxygen conserving device maybeattached to the system to avoid waste. This devicereleases the gas only when you inhale and cuts it offwhen you exhale. Oxygen can be provided in a small

50

1514177_Field Guide 10/10/05 9:25 PM

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APPENDIX

cylinder that can be carried with you, but large tanks areheavy 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 spacethan the compressed gas cylinder, and you can transferthe liquid to a small, lightweight portable vessel at home(be sure to follow your provider’s instructions carefullywhen refilling or transfilling liquid). Liquid oxygen is moreexpensive than compressed gas and the vessel ventswhen it is not in use. A conversing device may be built into the portable to converse the oxygen.

Oxygen Concentrators- This an electrically powered devicethat separates the oxygen out of the air, concentrates it,and stores it. This system has a number of advantagesbecause it doesn’t have to be re-supplied and it is not ascostly as liquid or cryogenic oxygen mentioned above.Extra tubing permits the user to move around with minimaldifficulty. Small, portable systems have been developedthat 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:

• 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.

* Seattle Fire Department, Information Bulletin

#2003-5, Seattle, WA

51

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1514177_Field Guide 10/6/05 11:35 PM

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 quicklyfreeze 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 cylinderon its side or try to roll it to a new location.

52

1514177_Field Guide 10/10/05 9:26 PM

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APPENDIX

• 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 fromyour 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.Don’t 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 supplier’stelephone number handy.

• Ensure that you have an all purpose fire extinguisher close by and familiarize yourself with it’s use.

• Refer to the gas supplier’s material safety data sheet (MSDS) for more information.

* Seattle Fire Department, Information Bulletin

#2003-5, Seattle, WA

53

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1514177_Field Guide 10/6/05 11:35 PM

Auditing Your SuppliersApplied 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 firm’s 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 supplier’s 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 CGMPregulations (see pg 38-39 for references).

APPENDIX54

1514177_Field Guide 10/6/05 10:17 PM

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. Com-

ments and sugges-

tions 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.

APPENDIX 55

1514177_Field Guide 10/11/05 12:23 AM

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INDEX56

• 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 labelsb. 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.

Patients have been injured and some have died becauseof medical gas mix-ups. This usually occurs when thewrong gas is forcibly connected to the oxygen supplysystem. Please promote the importance of properlyhandling medical gases.

• Manufacturers who receive reports of death or seriousinjury associated with the use of medical gases arerequired by law to report those incidents to the FDA.

• Hospitals, nursing homes, and other health carefacilities 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.

FDA Public Advisory:Medical Gas mix-ups can cause death and serious injury

Won’t Connect?Don’t Connect!

1514177_Field Guide 10/10/05 9:27 PM

creo

INDEX 57

Description Page(s)Accidents, handling 11Adapters, cryogenic 24-26Alcohol / drug training, etc. 10Analysis, financial 36, 45-46Analyzer, oxygen 28Appendix 38-55Building, layouts 40-41Carts, cylinder 14-16CGA Standards, bulletins 38Cost, justification, filling 45-46Cryogenic carts 13Cryogenic equipment 24-26Cryogenic, filling 35Cryogenic vessel labels 27Cylinder filling 33-34Cylinder holders 16Cylinder labels 27Cylinder markings 44Cylinder racks, carts 13-16Cylinder racks, Vans 6Cylinder sizes 15 & 43Disclaimer 55Driver requirements 1Driver training 8,9Drugs / alcohol training, etc. 10EIGA 39Face shield 24FDA Public Advisory 56FDA registration 37FDA violations 28-29Filling equipment 22, 23 33-35Filling oxygen 17-21, 33-37 Financial analysis, filling 36 & 45-46Gas, calibration 28Gloves, cryogenic 24Haz-Mat Book 3Haz-Mat training 8High pressure filling 33 -34How to use the guide Opp. INFCIncident handling 11Inspections, pre-fill 20-21Inspections, violations 28-29Label remover, liquid 22-23Labels, cylinder & cryogenic 27Links (web sites) 47Liquid to gas filling 33Manifest, shipping, Haz-Mat 2Material handling 13-17

r

1514177_Field Guide 10/6/05 11:35 PM

58

Description Page(s)

NA Emergency Response 3NAERG Guide 3No Smoking Signs 3Oxygen manifest 2Oxygen, technical info 42Placarding, placards 4Pre-fill cylinder inspections 20-21Production, increasing 30Profits, increasing 33-37Racks and carts, cylinder 13-16References 36-37Reimbursement cuts, fighting 31-36, 44-45Requirements, driver, vehicle 1Safety awareness, patient 50-53Safety glasses 24Safety supplies 24Safety, cryogenic relief "T" 25Scale, cryogenic 26Shipping document, required 2Spill pan 24Storing oxygen 13-15Supplier, audit 54Temperature / psig chart 48Thermometer, filling 29Training aids 7-9, 18-19,

ISFC, ISBCTraining, driver 8-9Training, filling 18Training, Haz-Mat 8Quick connector, yoke 30Vacuum, elevation chart 49Valve seals 22Van racks, carts 6Vehicle racks, carts 6Vehicle requirements 1Vehicle w/ Cryogenic Tank 5Vehicles, key items 3-6Videos, training 18-19Violations, regulatory 28-29Washers, yoke 22, 23Wetband valve seals 22

1514177_Field Guide 10/7/05 12:55 AM

Solut ions

SOLUTIONS

1199-1030, Current good manufacturing practice certificationcourse, V2

OF-1232, North American Emergency ResponseGuide Training Course

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compressed gas cylinder

Documents

oxygen safety

oxygen drivers

refilling oxygen

refill oxygen

cryogenic liquid oxygen

filling oxygenfilling

driver training

driver requirements