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Preguntas Frecuentes

Product/Clinical:

A. What is the difference between HFCWO and HFCC? HFCWO (High Frequency Chest Wall Oscillation) and HFCC (High Frequency Chest Compression) are interchangeable terms that describe the same airway clearance therapy.

B. Is the SmartVest® only for patients with Cystic Fibrosis?
a. No, the SmartVest® may be prescribed by a physician for anyone with a disease or condition that requires aggressive airway clearance therapy for which HFCWO may benefit.
b. To date, HFCWO therapy has been prescribed by physicians for over 400 diagnoses.

C. Why is patient positioning not necessary as it is in manual Chest Physiotherapy (CPT)? The SmartVest® works through a different mechanism of action than conventional CPT and does not require complex Trendelenburg techniques to be effective. The action of the SmartVest® creates upward airflows that loosen and mobilize lung secretions in either standing, sitting, or lying down positions.

D. Can a nebulizer treatment be given at the same time as HFCWO? A nebulizer treatment can be given at the same time as the SmartVest® treatment; however, the patient should first verify with their physician.

E. What is the range of ages and sizes that can be treated with a SmartVest®? The SmartVest® is available in 8 different sizes and is designed to accommodate a wide range from small children to large adults, with chest circumferences ranging from 15" to 52". A vest extender is available to accommodate bariatric patients. For patients finding it difficult to fit or apply the standard SmartVest®, the SmartVest Wrap® is available in 5 sizes with chest circumferences ranging from 25" to 66".

F. How do I determine the correct SmartVest® size? A patient's height, weight and chest circumference are used to determine proper SmartVest® size. The SmartVest Wrap® size is determined by chest circumference alone. Please refer to the SmartVest® sizing guide.

G. How can the patient/family be assured of the proper way to operate the SmartVest®? The patient/family will receive in-home training from an approved professional health care provider (Respiratory Therapist, Nurse or Physical Therapist). Electromed, Inc. also supplies an instruction manual and product training DVD. Additional support is provided by Patient services, staffed exclusively by Respiratory Therapists. (888-966-2525).

H. How does the patient secure an appointment with a trainer? Electromed, Inc. Patient Services Department personnel will contact a trainer who in turn will contact the patient to arrange a convenient training time.

I. Do you have trainers in my area? Who are they? Electromed, Inc. currently has more than 300 approved trainers for the SmartVest® in the USA. The Company provides trainer names to clinics as requested. Please call 1-888-966-2525.

J. Can I travel with my SmartVest®?
a. Yes, the SmartVest® includes a Wheeled Carrier that provides easy portability.
b. The unit is classified as "carry-on luggage" and will fit into the overhead bin of most aircraft. However, please check with your airline first.
c. The SmartVest® System must not be checked as regular luggage. Many airlines allow you to add medical devices to the "two carry-on's" that are normally allowed. Please check with your airline first.
d. We have found it helpful for patients to carry with them a copy of all of their prescriptions.

K. How much does the machine weigh? 23 pounds.

L. When travelling, are there any electrical converter challenges? The SmartVest® is distributed around the world and has a built-in power converter. Contact Electromed, Inc. Patient Services to order a power cord for the countries you will be visiting.

M. How can parents monitor the usage to assure compliance? The SmartVest® has a built-in hour meter that records hours and minutes of usage. Please see the instruction manual for more information.

N. How can I acquire a SmartVest® device? A physician must prescribe HFCWO therapy for your condition. You or your physician may then contact us directly at 800-462-1045 or 952-758-9299.

O. What are some of the advantages of the SmartVest® over other systems?
a. Unique single-hose design offers greater convenience and comfort
b. Full coverage (360 degrees) pulsation
c. Machine-washable SmartVest® (HomeCare) simplifies cleaning
d. Soft Start® technology reduces "squeeze effect" and "vest creep" on start up
e. Wheeled SmartVest® Carrier travels easily – fits inside airplane as carry-on

Warranty:

P. What does the warranty cover? In the U.S. and Canada HomeCare units receive a lifetime warranty. Institutional and international placements receive a three year warranty. See product warranties for more information.

Q. If the SmartVest® is not performing properly, when can the patient expect a replacement? The patient just calls our toll-free patient service line (888-966-2525) and our Patient Service representative will make arrangements to send a replacement out via UPS ground service. The patient will then place their unit in the shipping box and UPS will return to pick it up.

Cost and Reimbursement:

R. What is the cost of the machine?
a. The amount a patient's insurance will actually disburse varies with insurance coverage. In most cases a patient will have complete or nearly complete coverage.
b. If an insurer prefers to lease the equipment, full payment is usually reached within 15 months under a rent to buy program.

S. What kind of diagnosis is typically needed for reimbursement?
a. The SmartVest® is indicated for any disease or condition where external manipulation of the chest wall is the physician's treatment of choice to enhance mucus transport.
b. Requirements vary with insurance or state Medicaid.
c. Reimbursement specialists will contact the insurance company to determine coverage. If there are any issues, Electromed Inc. contacts the clinic.

T. Do I need Doctor's notes filled in on the CMN/Rx? This information can be extremely helpful for the insurance payer in understanding the patient's medical situation in formulating a decision on covering the SmartVest®.

U. Is the Medicare Form the same form used by all companies? No, a form was developed by Electromed's Reimbursement Department to meet the need and to improve information flow.

V. Is coverage 80/20 for Medicare patients?
a. Medicare will cover 80% if the patient meets criteria; however, many patients have a secondary insurance which may cover the remaining amounts.
b. Reimbursement specialists will contact the insurance company to determine coverage. Electromed, Inc. will then contact the patient/family and inform the ordering clinic if there are any issues.

W. What is the annual Medicare allowance? Medicare pays for the SmartVest® under a "capped rental" program wherein they pay for the system over a 13 month rental period. At the end of the rental period the patient may then keep the system.

X. Can you start to process my order before all the paperwork is complete? We must have the following items in order to process an order:
i. Physicians Rx (see CMN/Rx form)
ii. Insurance and patient information (see referral form a current insurance face sheet from the patients chart may be substituted for the referral form.)
iii. The patient/family will be contacted by a Patient Services representative before shipping to ensure that all shipping, sizing, and insurance information is correct.

Y. How long will it take for my patient to receive their machine?
a. After the insurance verification takes place we contact the patient/family to verify delivery.
b. After the delivery information is verified, shipping time is from one to five days depending on the patient's location.

Company (Electromed, Inc.):

Z. How long has Electromed, Inc. been in business? The Company was founded is 1992.

AA. Can you comment on the Company's history? Electromed, Inc. is the Innovative Leader in Airway Clearance Therapy. It focuses solely on pulmonary patient care. The Company is located in a suburb of Minneapolis, New Prague, MN. It is vertically integrated, designing, manufacturing and selling its products. Since 2003 the Company's Sales have been growing at more than 30% per year.

BB. Do you have yearly quality goals and how often are they reviewed? The Electromed, Inc. quality system is FDA compliant and certified to ISO 9001:2000 and ISO 13485:2003 standards, and is accredited by The Joint Commission. We review and re-define the Company's quality objectives on a semi-annual basis.

Additional Frequently Asked Questions1
1. What is the difference between the SmartVest® Airway Clearance System, which features a single-hose, and other two hose systems? Does the treatment efficacy change?
HFCWO treatment is scientifically proven to have the same clinical performance and efficacy whether the system uses a single-hose or two hoses. Importantly, the FDA has approved single-hose and two hose HFCWO systems as equivalent. Electromed, Inc., however, believes that its single-hose design has a competitive advantage over two hose systems. The single-hose design simplifies delivery of the air pulses to the lungs. The pulses are delivered from the base of the SmartVest® with the force pulsing upward and inward in strong, but smooth, cycles of 360-degree coverage, which deliver simultaneous treatment to the patient's chest and back and all lobes of the lungs. The single-hose is less obtrusive, less complicated, and more comfortable than a two hose system. Electromed offers a longer hose than competing products, allowing the patient more freedom of movement during the course of treatment. This greater comfort and simplification of treatment may increase patient compliance.

2. What is Electromed, Inc.'s flow through system, and how does it improve patient comfort?
The flow-through system design utilizes small air release holes in the SmartVest® air bladder that continually adjust the pressure during inspiration and expiration. This can prevent lags in pulse pressure normally caused by a closed-loop system, in which electronic sensors must continuously send changes to the air pulse generator to adjust pressure in the garment during inspiration and expiration. We believe greater patient comfort is realized in our flow-through system design.

3. What are the benefits of Soft Start® technology?
With Soft Start® technology, the SmartVest® fills slowly from the bottom up, reducing "squeeze effect" and "vest creep" on start-up. The SmartVest® delivers HFCWO with a calmer, gentler, more relaxed treatment experience.

4. How can treatment be customized with the SmartVest®?
The SmartVest® Air Pulse Generator has dual position controls, which adjust to operate the generator either upright or horizontally, whichever works best in the area where treatment is taking place. Complementing the Manual Mode, the Air Pulse Generator also offers a Program Mode, which allows up to three customized treatment protocols to be saved. Additionally, the SmartVest® is available in alternative fabric colors, allowing patient choice.

5. Who staffs Electromed, Inc.'s Patient Services, and what are the hours?
Electromed, Inc. Patient Services is staffed by Respiratory Therapists and offers exceptional customer service. A toll-free support HELPLINE is always available for individuals using the SmartVest® Airway Clearance System.

6. How easy is it to travel with the SmartVest®?
The SmartVest® is portable, making travel easy. The two-piece Wheeled SmartVest® Carrier fits inside most airplanes as a carry-on. The device is compatible with both USA and International voltages.

7. Who pays for the SmartVest® Airway Clearance System?
Within the United States, Medicare, many private insurance plans, numerous state medical assistance programs, and the Department of Veterans Affairs cover the SmartVest® Airway Clearance System for most individuals. Electromed, Inc.'s Reimbursement Specialists will work closely with the patient, medical team, and insurance provider to find the best solution. Internationally, the SmartVest® Airway Clearance System is primarily paid for by the patient.

8. What if a patient has a tracheostomy? How does that work with the SmartVest®?
The medical literature reports that HFCWO works equally as well on patients with a tracheostomy and compromised airway clearance; however, such a medical decision should always be left up to the attending physician.

9. Will someone instruct the patient on how to use the SmartVest® Airway Clearance System?
For patients in the United States, every the SmartVest® Airway Clearance System is accompanied by in-home training by a licensed medical professional. An Instruction Manual and Training DVD are also included with every system. International distributors will be trained on the proper use of the SmartVest® Airway Clearance System.

10. What do clinicians say they like most about the SmartVest®?
The SmartVest® is gentler on the body while delivering highly efficacious clinical outcomes Unique airflow produces no direct pounding on the abdomen by filling "from the bottom up" while producing equivalent oscillation; users indicate less abdominal discomfort Soft, breathable, washable fabric
Elimination of "plasticized" fabrics allows for a more naturally comfortable fit and feel
All Velcro®- like closures make adjustments and on and off simple
An offset single-hose improves maneuverability and comfort during treatment
Simultaneous tasks such as watching TV, playing computer games, and doing homework are easier with a longer hose

11. What is the advantage of 360-degree pulsation?
360-degree pulsation ensures full coverage pulsation of the front, back, and sides of the torso to simultaneously treat all areas of the lungs equally.

12. How does the SmartVest® enhance patient comfort?
The SmartVest® has patient comfort features such as Soft Start® technology, an offset single-hose, no direct pounding on the sternum or abdomen, and soft, breathable fabrics that reduce perspiration and itching. Additionally, the SmartVest® is the only HFCWO product currently on the market that uses a flow-through system design, which improves patient comfort by using air release holes in the garment air bladder, allowing the pressure to automatically adjust. This can prevent the lags in pulse pressure that closed-loop systems experience. We believe heightened patient comfort is realized because of our flow-through design.

13. What kind of quality standards does Electromed, Inc. meet? (FDA, ISO, TJC)
All Electromed, Inc. products have been cleared for sales by the United States Food and Drug Administration (FDA). Electromed, Inc. is ISO 9001: 2008 and ISO 13485: 2003 certified. As a result, it has been certified to apply the CE Mark for sales in the European Union, is licensed for sales in Canada, the Pacific Rim, and other countries. Electromed, Inc. is the only HFCWO vest company to have earned The Joint Commission's (TJC) Gold Seal of Approval for HomeCare.

14. What are the different generator modes, and how do they assist in improving patient compliance?
The SmartVest® Air Pulse Generator offers two operating modes – Manual and Program. In Manual Mode, the treatment protocol is entered for each treatment. Program Mode allows up to three treatment protocols to be entered and stored, eliminating the need to remember protocols and ensuring that treatments are consistent each day.

15. How is the SmartVest® cleaned?
The SmartVest® garment for HomeCare use is machine washable for easy cleaning. The SmartVest Wrap® must be spot cleaned. Institutional garments are intended for single patient use only.

 

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