exclusive cardiocomfort™ treatment option the high

THE HIGH TECH SOLUTION
QUIETER
AND
SMALLER
FEATURING:
TRUMOBILITY ™
HEARTSMART FULL DISCLOSURE™
PATIENT RECORD S YSTEM
5
AND
10-LEAD ECG
I NTEGRATED BP
SP O2 C OMPATIBLE
EXCLUSIVE CARDIOCOMFORT™ TREATMENT OPTION
THE PIONEER
CARDIOMEDICS
TRACES ITS
CARDIOMEDICS
CARDIOMEDICS
IS THE
OF
ECP
RECEIVED ITS
FIRST
ECP TECHNOLOGY
ROOTS TO THE
IS THE
FIRST
CARDIOMEDICS
IS THE
FIRST COMPANY
AT
HARVARD
FIRST FDA 510(K) CLEARANCE
COMPANY WITH A
CARDIOMEDICS
1960’S
Q UIET, SMALL AND
IN
TRULY
AND
MIT
1987
PORTABLE SYSTEM
COMPANY WITH A SYSTEM THAT REQUIRES LESS PRESSURE TO BE
TO PROVIDE AN
ERGONOMIC DESIGN THAT
PIONEERING...YET AGAIN
CARDIOCOMFORT
™
IS
VERY
THERAPEUTIC
USER
FRIENDLY
2
LEADING EDGE DESIGN FOR
PATIENT AND OPERATOR INTERFACE
1
Operator selectable “Normal” or Exclusive CardioComfort™ treatment setting.
1
One set of cuffs fits virtually all sizes of patients.
1
The cuffs are easily adjusted for fit and positioning to maximize the patient’s comfort.
1
TruMobility™ portability - the entire system is self-contained, light in weight and truly mobile.
1
No “special bed” is required, though two optional beds are available.
1
Built-in Safety Features - total patient isolation with auto system alarm for high and low tank
pressures, high and low cuff pressures and high and low heart rate.
1
19” fully articulated color monitor allows easy setup and adjustment before and during the
procedure.
1
Optimized system design improves diastolic augmentation at lower cuff pressures improving
patient comfort.
CONTINUING
TO
L EAD THE WAY
THE ONLY CE ACCREDITED TRAINING
Peace of mind with the quality of your training
The only training program that provides Continuing Education points for nurses and physicians.
Peace of mind with your equipment investment
First FDA clearance received in 1987, with subsequent 510(k)’s received in 2001, 2003 and 2005.
Manufactured in the USA insures convenient parts and ser vice availability.
Intel® Pentium® based PC Hardware platform runs on Embedded Windows® XP based software.
Technical support provided by factory-trained technicians.
Peace of mind with proven Financial Benefits
Covered by Medicare and many health insurance plans.
The treatment is far less costly than invasive procedures.
CMS recently announced plans to reduce funds for invasive procedures and increase funds for
alternative, effective, non-invasive procedures.
4
CONTINUING
TO
L EAD THE WAY
R EAL PATIENTS...REAL RESULTS
5
CONTINUING TO L EAD THE WAY
R EAL PATIENTS...REAL STORIES
ECP
TESTIMONIAL
Lynn Butler, 57, had Coronary Arter y Bypass Surgery 14 years
ago. However, like many diabetics, his grafts closed back up
again. Since he was not a candidate for additional surger y or
angioplasty, Mr. Butler was told by his Cardiologist to go home
and take it easy. Adding to Mr. Butler’s burden was the
psychological impact of his Cardiologist’s statement that nothing
else could be done. His only option, or so he thought, was to sit
at home, take his medicine and pray he would make it through
another day.
Although skeptical at first, after receiving 35 CardiAssist ECP
treatments, Lynn is now living life again. It has been several
years since he last took any nitroglycerin and he now works a 40
hour work week. Lynn is a firm believer in ECP saying, “I have my
life back without drugs, surger y or angioplasty, it’s amazing.”
6
T ECHNICAL FEATURES:
HEART SMART FULL DISCLOSURE™
PATIENT RECORD SYSTEM
FULLY ARTICULATED 19” MONITOR - KEYBOARD/MOUSE
I NTEGRATED BLOOD P RESSURE SYSTEM
SP O2 COMPATIBLE
5
LEAD -3 CHANNEL
10
ECG
LEAD-12 CHANNEL
ECG
SPACE E FFICIENT FOOTPRINT
WHISPERQUIET™ OPERATION
T RUMOBILITY ™ PORTABILITY
LEADING THE WORLD IN PATIENT COMFORT
WITH OUR NEW CARDIOCOMFORT PATIENT TREATMENT OPTION
™
7
CONTINUING
TO
L EAD THE WAY
R EAL PATIENTS...REAL RESULTS
8
CONTINUING
CLINICALLY PROVEN
WITH
TO
LEAD THE WAY
PUBLISHED STUDIES
FROM
1980
TO
2005
Clinical and Financial Benefits of ECP
Published Clinical Benefits
1-5
The treatment regimen is well tolerated and comfortable even for very sick patients who cannot
tolerate surgery or balloon angioplasty.1
Over 75% of patients improve (exercise times, reduction in anginal episodes, reduction in NTG, or
improvements, in time, to ST depression).4
After treatment, many patients maintain their improvement (Angina Remission).4-5
Because the therapy is non-invasive, most patients continue to work or carry on normal activities. 4-5
The quality of life for many patients improves (functional capacity without crippling chest pain).4
Studies indicate benefits occur from improved diastolic flow, increased venous return and reduced
afterload (Cardiac Output increases while oxygen demand remains the same).2
Excellent long-term prognosis (up to 5 years).4
9
10
CONTINUING TO LEAD
THE
WAY
DEPENDABLE REVENUE STREAM
BILLING CODES; MEDICARE, THIRD PARTY AND ICD-9-CM CODES
MEDICARE BILLING
HCPCS CODE: G0166-External Counterpulsation (Physician)
APC CODE: 0972-External Counterpulsation (Hospitals)
ICD-9-CM CODES: 413.0: Angina Decubitus
413.1: Prinzmetal Angina
413.9: Other and unspecified angina pectoris
THIRD PARTY BILLING
CPT 4 PROCEDURE CODES:
92971: CardioAssist - method of circulatory assist; external
93922: Noninvasive physiological studies of the upper or lower extremity artery
94761: Noninvasive ear or pulse oximetry for oxygen saturation; multiple determinations
99354-99355: Prolonged physician service with direct patient contact in an office or outpatient setting
These codes repor t the total duration of face to face time spent by the physician on a given date, even if the time is not continuous.
11
Triggering Method
Treatment Pressure Range
Device Dimensions and Weight
Precise, hardware generated
Adjustable from 0 to 310 mmHg
Trigger Range: 40-120+ bpm
System Protection
Height:
Width:
Depth:
Weight:
Cardiomedics Treatment Bed Options
One main circuit breaker
36” wide treatment bed - 47 lb (21kg)
Patient Protection
30” wide Electric Lift - 200 lb (90kg)
• 12” height adjustment range, 25” to 37”
Automatic inflation stop and release of
pressure on early extra systole
Voltage Requirements
Automatic treatment stop and pressure
release if power outage occurs
51” (130 cm)
24” (61 cm)
32” (82 cm)
350 lb (160 kg)
Filter Technique
Low-pass digital filter eliminates 50/60 Hz and
high-frequency interference.
Recommended Operating Environment
Temperature:
120VAC/60Hz, 20A
Automatic high-pressure limit
230VAC, 50Hz, 10A
Integrated Bood Pressure
Auto treatment stop if heart rate
exceeds 120bpm or drops under 40bpm
Relative Humidity:
Atmospheric Pressure:
Atmosphere:
50 to 140º F
(10 to 40º C)
30 to 75%
700 to 1060 hPa
Free of corrosive gas
Transport/Storage Environment
Pressure - range
Systolic 90 to 220mmHg
Diastolic 46 to 140mmHg
Accuracy +/- 5mmHg (Standard Deviation
8mmHg or less)
Cuffs
Temperature:
1 Set - “one size fits all”: calf, thigh and
buttocks
Relative Humidity:
Atmospheric Pressure:
Atmosphere:
20 to 120º F
(-6 to 50º C)
25 to 90%
500 to 1060 hPa
Free of corrosive gas
1. Soran O, DeMarco T, Crawford L, et al. Enhanced external counterpulsation in management of patients with cardiovascular disease. Clinical Cardiology, 1999, 172-178
2. Amsterdam, E, Banas, J et al. Clinical assessment of external pressure circulator y assistance in Acute Myocardial Infarction, JACC, 1979
3. Urano, H., Ikeda, H. Enhanced external counter pulsation improves exercise tolerance, reduces exercise-induced myocardial ischemia and improves left ventricular diastolic
filling in patients with coronar y artery disease, JACC, 2001
4. Lawson WE, et al. Benefit and safety of Enhanced External Counterpulsation in Treating coronary Arter y Disease Patients with a History of Congestive Heart Failure.
Cardiology 12/2001
5. Weisfogel et al. External Counterpulsation Produces a Significant Reduction in Stable Angina Class, Episodes, Medication Use and Hospitalization. CVR&R 3, 2002
U.S. Patent number 4,388,919 Additional Patents pending.
© 2005 Cardiomedics, Inc. All rights reserved
Cardiomedics, CardiAssist, CardioComfort, HeartSmart, WhisperQuiet and TruMobility are trademarks of Cardiomedics, Inc.
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