SmartDose CTPT-3LPZ Manuale utente

Manufactured by Inovo, Inc. dba Chad®Therapeutics

2975 Horseshoe Dr. South Suite 600 | Naples, FL 34104

Toll Free: 877-224-0946

www.drivemedical.com

Toll Free: 877-224-0946

www.drivemedical.com

SmartDose and CHAD are registerd trademarks of Inovo, Inc.

PM-00074/12/A

Parent Company:

Drive Medical Design & Manufacturing

99 Seaview Boulevard

Port Washington, NY 11050

PRODUCT MANUAL

SmartDose®

Liquid Oxygen Portables

Model CTPT-3LPZ

Model CTPT-6LPZ

CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician.

124

Welcome!

Thank you for choosing the SmartDose Liquid Oxygen Portable from

CHAD Therapeutics.

The SmartDose Liquid Oxygen Portable gives you the freedom and

confidence to live a more active life.

The SmartDose Liquid Oxygen Portable is the only conserver that

monitors your breathing patterns and automatically delivers more

oxygen when you need it most to help you stay active and saturated.

Before You Begin

Please read this entire manual before you use your SmartDose Liquid

Oxygen Portable. If you do not understand the warnings, cautions and

instructions, contact your medical equipment provider before using

this equipment. Otherwise, there is a risk of injury to you or damage

to the equipment.

When using oxygen products, expecially when children are present,

you must follow several important safety precautions. Please read the

following safety information before you use your SmartDose Liquid

Oxygen Portable.

Product Classification

The SmartDose Liquid Oxygen Portable is classified as:

Not suitable for use in the presence of a flammable anesthetic mixture

with air, or with nitrous oxide.

Class II

Equipment

Type B

Equipment

Important Information

Physician Information:

Name _____________________________________________________

Address ____________________________________________________

__________________________________________________________

Telephone __________________________________________________

Emergency Telephone _________________________________________

Prescription Information:

Patient’s Name ______________________________________________

Flow Setting (LPM) ___________________________________________

Set-Up Information:

Name of person setting up _____________________________________

Oxygen Provider:

Company___________________________________________________

Emergency Telephone _________________________________________

This instruction guide was reviewed with me and I have been instructed on the safe

use and care of the SmartDose Conserving Device.

__________________________________________________________

Patient or Caregiver Signature Date

232

How SmartDose Works

SmartDose extends the use time from a supply of oxygen by only

delivering oxygen during the portions of the breath that put the

gas into the lungs. SmartDose delivers a volume of oxygen on

each breath, right at the start of inhalation. It delivers the full dose

(bolus) of oxygen within 2/3 of the inhale cycle. By doing so, it is not

delivering oxygen at the end of inhalation or during exhalation, as

other devices do.

The normal volume of oxygen that SmartDose delivers is 16 ml per

setting, so that a setting of 2 delivers 32 ml of oxygen on each breath,

in the first 2/3 of the inhale cycle.

SmartDose monitors a patient’s breathing patterns and automatically

turns up the oxygen volume by one setting (SportDose 1) during

exertion, and if breath rate continues to rise, by another setting

(SportDose 2). Many patients turn their settings up and down

throughout the day, but this self administered approach is inconsistent

and by the time most patients feel the need to turn it up, their oxygen

levels have already dropped. SmartDose responds more quickly and

consistently. SmartDose recognizes when exertion stops and lowers

the volume back down to normal levels thus saving oxygen.

Again, this is often an improvement over manual adjustments since

patients often forget to turn the volume down after exerting.

Most patients are able to be titrated at lower base settings due to

SmartDose’s efficient delivery and auto-adjusting features. This

extends the use time of your oxygen supply.

SmartDose also uses a multi-valve system that has multiple delivery

flow rates. The unit can deliver a volume at two flow choices. The

unit constantly monitors the patient’s breath rate and determines the

lowest flow option to “fit” the oxygen into the first 2/3 of the inhalation

cycle. By delivering at lower flows, the unit is more comfortable, and

quieter than units that deliver at higher flows all the time.

Refer to Appendix for oxygen duration times at various settings.

NOTES:

Terms, Abbreviations & Symbols

This guide and the SmartDose Liquid Oxygen Portable product labeling

uses the following terms, abbreviations and symbols:

Important Safeguards

When using oxygen products, especially when children are present, basic

safety precautions should always be followed. Read all instructions before

using. Important information is highlighted by these terms:

Important safeguards are indicated through this guide; pay special

attention to all safety information. Read all instructions before using.

Save these instructions.

DANGER Urgent safety information for hazards

that will cause serious injury or death.

322

WARNING Important safety information for hazards

that might cause serious injury.

CAUTION Information for preventing damage to

the product.

NOTE Information to which you should pay

special attention.

Warranty Claim Procedures and Requirements

To obtain warranty service, you may return a defective product to CHAD

Therapeutics, A Drive Medical Company, after receiving a Return Material

Authorization number (RMA) from our customer service department

When calling for an RMA number, please have ready product identification

information, including model number and serial number with a detailed

description of the problem you are experiencing.

Once you have obtained an RMA number from CHAD, you must, within

thirty (30) days, send the product freight-prepaid and insured to 2975

Horseshoe Drive South, Suite 300, Naples, FL 34104, USA. Products

shipped to the factory must be properly packaged to prevent damage

in transit. You must include the RMA number prominently displayed on

the outside of your package. If you send your product to the factory

without the RMA number prominently displayed on the outside of the

package, it will be returned to you unopened.

214

General Dangers & Warnings

In order to ensure the safe operation and achieve maximum benefit of the

SmartDose Liquid Oxygen Portable, these instructions MUST be followed.

Fire hazard. Do not lubricate. Do not allow grease or oil

from your hands or other source to come into contact with

the internal tubing of the SmartDose Liquid Oxygen

Portable. These solutions may be flammable and may

cause injury.

Oxygen causes rapid burning. Do not smoke in the vicinity

of your SmartDose Liquid Oxygen Portable or when you

are near a person utilizing oxygen therapy. Keep the Smart

Dose Liquid Oxygen Portable at least 5 feet (1.6M) from hot,

sparking objects or open sources of flame.

Warnings

Read instruction manual ﬁrst. Do not operate this

equipment without ﬁrst reading and understanding this

instruction manual and the warning labels on the product.

If you do not understand the warnings, cautions and

instructions, contact your medical equipment provider or

technical personnel before attempting to install or use this

equipment; otherwise, injury or damage may occur.

Patient use only. The use of this device is limited to an

oxygen patient. Oxygen MUST be used ONLY by an oxygen

patient and is not intended to be distributed to any other

individual for any purpose.

Use only authorized parts. Do not use parts, accessories,

or adapters other than those authorized by CHAD

Therapeutics.

DANGER

WARNING

Warranty Information

CHAD Therapeutics, a Drive Medical Company warrants to the original

customer of its products that its products are free from defects in material

and workmanship. Subject to the conditions and limitations set forth

below, CHAD will, at its option, either repair or replace any part of its

products that prove defective by reason of improper workmanship or

materials. Repaired parts or replacement products will be provided by

CHAD on an exchange basis. If CHAD is unable to repair or replace the

product, it will refund or credit the current value of the product at the

time the warranty claim is made.

This limited warranty does not cover any damage to this product that

results from improper installation, accident, abuse, misuse, natural

disaster, improper or excessive electrical supply, abnormal mechanical

or environmental conditions, or any unauthorized disassembly, repair,

or modification. This limited warranty also does not apply to any

product which has been handled or packaged incorrectly, has been sold

as second-hand or has been resold contrary to the US export regulations.

This limited warranty covers only repair, replacement, refund or credit for

defective CHAD products, as provided above. CHAD is not liable for, and

does not cover under warranty, any loss of data or any costs associated

with determining the source of system problems or removing, servicing

or installing CHAD products.

• Duration of Warranty: 3 years from date of purchase

This limited warranty applies only to the original customer of the product

for so long as the original end user customer owns the product.

This limited warranty is non-transferable.

520

Do not use if. . .

Do not use the SmartDose Liquid Oxygen Portable if it:

It is not working properly.

Has been dropped or damaged.

Has been submersed in water.

Call a qualified technician for examination and repair.

Unintended oxygen leakage. If any unintended leakage of

oxygen is detected, do not attempt to use the product. Turn

the product off. If leakage persists, place the product out

doors and notify your medical equipment provider or service

representative.

Over pressure relief valve. The SmartDose Liquid Oxygen

Portable is equipped with a pressure relief valve to ensure

the user’s safety. When activated, this safety feature may

make a slight hissing noise. If this noise occurs and persists,

turn the unit off and contact your medical equipment

provider or service representative.

Always supervise children. Children should always be

supervised around the SmartDose Liquid Oxygen Portable.

Failure to do so may result in damage to the unit or personal

injury.

Use in accordance with your prescription. For your safety,

the SmartDose Liquid Oxygen Portable must be used in

accordance with the prescription determined by your

physician.

Not for use in emergency transport vehicles. The SmartDose

Liquid Oxygen Portable is not intended to be used in

emergency transport vehicles (ambulances or helicopters),

or other similar areas where high levels of Electromagnetic

Interference (EMI) may be expected.

WARNING

FCC Statement

NOTE: This equipment has been tested and found to comply with the

limits for a Class B digital device, pursuant to Part 15 of the FCC

Rules.

These limits are designed to provide reasonable protection against

harmful interference in a residential installation.

This equipment generates, uses and can radiate radio frequency

energy and, if not installed and used in accordance with the

instructions, may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a

particular installation.

If this equipment does cause harmful interference to radio or

television reception, which can be determined by turning the

equipment off and on, the user is encouraged to try to correct the

interference by one or more of the following measures:

-- Reorient or relocate the receiving antenna.

-- Increase the separation between the equipment and receiver.

-- Connect the equipment into an outlet on a circuit different from

that to which the receiver is connected.

-- Consult the dealer or an experienced technician for help.

196

Warnings About Handling

Use extreme care when filling.

Use extreme care when filling your SmartDose Liquid

Oxygen Portable.

Keep unit in an upright position. Always ensure that the

portable is in an upright position. Turning the portable on its

side will cause venting of oxygen from the relief valve. It is

normal to hear a loud noise when a full unit is moved into

a horizontal position. The noise is excess gas pressure

escaping from the relief valve.

Cautions & Notes

Do not disassemble. The SmartDose Liquid Oxygen Portable

contains no user serviceable parts. If service is required,

contact your home medical equipment provider or

authorized service center.

Use AA alkaline batteries. If using rechargeable batteries,

it is recommended to use ≥1800 mAh Ni-MH (Nickel Metal

Hydride) batteries. Both batteries must be of the same type

capacity. Do NOT mix battery types.

Federal law restricts this device to sale by or on the order of

a physician.

Portable and mobile RF (Radio Frequency) communications

equipment can affect the SmartDose Liquid Oxygen

Portable.

Have a full cylinder of oxygen on hand. CHAD Therapeutics

recommends the medical equipment provider leave a full

cylinder of oxygen with the patient after setting up the

SmartDose Liquid Oxygen Portable, and instructing the

patient to always keep a full cylinder on hand.

Allow portable to stabilize after ﬁlling. After filling the

SmartDose Liquid Oxygen Portable, CHAD Therapeutics

recommends waiting at least 5 to 10 minutes before using

it. This allows the liquid oxygen to stabilize within the

portable and better maintain the prescription ﬂow setting.

Continuous Flow may be less than prescribed dose.

WARNING

CAUTION

NOTE

Appendix

Oxygen Duration of Portable

The SmartDose Liquid Oxygen Portable comes in two sizes. The table

shows approximately how long liquid oxygen lasts at different settings for

each model.

*These durations are based on the SmartDose Liquid Oxygen Portable being set in

SmartDose mode, settings at a nominal 20 BPM.

For more information, refer to the “SmartDose Liquid Oxygen Portable

Delivery Modes” section in this manual.

WARNING

NOTE

718

Indications for Use

The SmartDose Liquid Oxygen Portable CTPT-3LPZ and/or

CTPT-6LPZ provides a source of supplemental oxygen for

ambulatory home healthcare patients, by vaporizing medical

grade liquid oxygen and then dispensing it to the patientvia an

integral electronic conserving device. The SmartDose Liquid

Oxygen Portable CTPT-3LPZ and/or CTPT-6LPZ is neither a

life-sustaining nor a life-supporting device.

Provider Checklist

Before leaving the SmartDose Liquid Oxygen Portable with a

patient, the following checklist MUST be completed:

Check all parts for shipping damage. In case of damage, do not

use. Contact CHAD Therapeutics for further instructions.

Make sure the SmartDose Liquid Oxygen Portable is compatible

with the liquid oxygen source. Be sure to use a liquid oxygen

reservoir with a compatible99%coupler.

Instruct the patienton the safe operation of the SmartDose Liquid

Oxygen Portable andall associated accessories andreview ALL

warnings.

Leave a copy of this productmanual with the patient.

Transporting and Storing SmartDose Liquid Oxygen Portables

Preparing for Shipping

Prior to shipping the SmartDose Liquid Oxygen Portable, remove the

batteries andempty any residual oxygen from the unit. Allow the

portable to restfor at least8 hours to empty.

Storage

Store the SmartDose Liquid Oxygen Portable in a cool, clean, dry area

when not in use. Avoid storing in directsunlight.

Battery Disposal

Dispose of all batteries in accordance with local, state, andfederal

regulations.

Specifications

Batteries Required* 2 AA batteries

*If using rechargeable batteries, it is recommended to use >1800 mAh

Ni-MH (Nickel Metal Hydride) batteries. Do NOT mix battery types.

Oxygen Pressure22 to 25 psig

CTPT-3LPZ Content Volume0.33 liters (approx)

CTPT-6LPZ Content Volume0.6 liters (approx)

CTPT-3LPZ Weight (empty) 3.5 lb

CTPT-6LPZ Weight (empty) 4.5 lb

Storage Temp/Transport -20 to 50ºC

Operating Temperature -8 to 40ºC

Storage Humidity 0 to 95% RH

(non-condensing)

Operating Humidity 15 to 95% RH

SmartDose Liquid Oxygen Portable Overview

The illustrations show the parts of the SmartDose Liquid Oxygen Portable.

Cleaning and Maintenance

Removing Frost

Under certain environmental conditions, frost may form on the vaporizer

coil and on the case. As the unit thaws, the possibility exists for melted

frost to leak from the bottom of the unit. You can remove it by wiping

the case with a cloth. Exercise caution when placing the unit on valu-

able, water sensitive surfaces.

Cleaning and Maintenance

There are no user-serviceable components inside the LOX

portable. Contact your medical equipment provider in the event that

your SmartDose unit requires service.

Keep the exterior of the SmartDose Liquid Oxygen Portable clean using

a clean, damp, oil-free, lint-free cloth.

Clean and dry the coupler on the SmartDose Liquid Oxygen

Portable with a clean, dry, oil-free, lint-free cloth before each portable

ll.

Cleaning and Maintenance

Chad Therapeutics recommends using only cannula specically intended

to be used with oxygen delivery systems.

Cannula should be capable of delivering up to 10 LPM of

continuous ow; maximum length that can be used is 7 feet. Contact

your medical equipment provider for recommendations and details.

Refer to the cannula manufacturer’s instructions for proper cleaning and

maintenance procedures.

178

LOX Fill Coupler

Dose Indicator Lights

CF (Continuous Flow/SmartDose) Switch

(Pull out for Continuous Flow only.)

Fill Valve

Batteries

(2AA cells)

Battery

Indicator

Light

Activation Button

(also used to adjust settings)

Oxygen

Outlet

Connector

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