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Harmony® Vacuum System

Reimbursement Reference Guide


©2013 Otto Bock HealthCare LP . 13012534_1 • 1/13
Harmony Vacuum System
Reimbursement Reference Guide
Effective January 1, 2015
Harmony Vacuum System Harmony® Certification Training
Elevated vacuum suspension has been commercially Ottobock lists Harmony® Trained Practitioners on its
available in the U.S. since 1999 when Total Environmental website. These practitioners have taken a 3.0 CEU on-line
Control (TEC) introduced the Vacuum Assisted Socket course and passed the exam.
System (VASS). Today, the VASS is manufactured by
FDA Status
Ottobock and marketed as the Harmony® Vacuum System.
Under FDA’s regulations, the Harmony® Vacuum System is
Harmony Coding1 a Class I medical device and exempt from the premarket
The Healthcare Common Procedure Coding System notification [510(k)] requirements. Given the low risk of
(HCPCS) for prosthetics is an add-on code system. Primary Class I medical devices, FDA determined that General
codes for vacuum pumps were issued in 2003. Since then, Controls are sufficient to provide reasonable assurance of
additional features have been added to our pumps. the device’s safety and effectiveness; therefore, safety and
Depending on which model is ordered, functions, such as effectiveness research is not required for this device.
shock absorption, torsion, or rotation may be provided in Harmony has met all the General Control requirements
addition to vacuum, which are described by add-on codes. which include Establishment Registration (21CFR 807),
The following HCPCS1 codes are applicable to Medical Device Listing(21 CFR part 807), Quality System
Harmony Products: Regulation (21CFR part820), Labeling (21CFR part 801),
4R144 Harmony P2: L5781 (vacuum pump), L5984* and Medical Device Reporting(21 CFR Part 803). The
(axial rotation), L5988 (vertical shock pylon) Harmony Vacuum System is listed under External Limb
Prosthetic Component; Listing Number E253231.
4R147 Harmony P3: L5781 (vacuum pump), L5984*
(axial rotation), L5988 (vertical shock pylon) Harmony® Warranty
4R150 Harmony HD: L5782 (vacuum pump heavy duty), Otto Bock HealthCare (Otto Bock) warrants all of its
L5984* (axial rotation), L5988 (vertical shock pylon) products, to the original purchaser, to be free from defects
in materials and workmanship. The Limited Warranty for
4R152 Harmony E2: L5781 (vacuum pump)
the Harmony® is 24 months. For additional information on
1C62 Triton Harmony: L5781 (vacuum pump), L5986* the Harmony® System Warranty, see Harmony®
(multi-axial rotation), L5987** (shank foot system) Instructions for Use (IFU).
3R60=VC: L5781 (vacuum pump), L5814** (polycentric
knee), L5845 (stance flexion), L5848** (stance extension
damping), L5930*** (high activity knee frame)
* Medicare covers for K2 and higher; ** Medicare covers for K3 and
higher; ***Medicare covers for K4 only

Other items that may be coded on a claim related to


Harmony® (not all inclusive): ------------------------------------------------------------------------
- Total Surface Weight Bearing (TSWB) Socket and 1
The product/device “Supplier” (defined as an O&P
additional materials/features added to the socket practitioner, O&P patient care facility, or DME supplier)
(various codes) assumes full responsibility for accurate billing of Ottobock
- Flexible Inner Socket – L5645, L5651 products. It is the Supplier’s responsibility to determine
medical necessity; ensure coverage criteria is met; and
- Cushion Socket – L5646
submit appropriate HCPCS codes, modifiers, and charges
- Supracondylar Suspension - L5670 for services/products delivered. It is also recommended that
- Test Sockets, L5618 – L5628 Supplier’s contact insurance payer(s) for coding and
- Custom Socket Inserts (liners), L5681 or L5683 coverage guidance prior to submitting claims. Ottobock
(initial insert), L5679 (additional insert) Coding Suggestions and Reimbursement Guides are based
- Prefabricated Socket Inserts (liners) L5679 on reasonable judgment and are not recommended to
replace the Supplier’s judgment. These recommendations
- Sheaths L8400, L8410
may be subject to revision based on additional information
- Sealing Sleeves L5685 or alphanumeric system changes.
- Socks L8420 , L8430, L8470, L8480

1
The Harmony® Vacuum System
Features and Benefits

Volume Control Reduced Moisture Build-up


Compared to a standard transtibial The Harmony® System pulls air from the
prosthetic socket, the Harmony® System’s sealed socket creating an even pressure
elevated vacuum pulls more oxygenated total contact environment reducing the
fluids into the residual limb during swing likelihood of sweating. The Harmony
phase and pushes less fluids out during system can also be configured for direct
weight bearing. The result is less than 1% evacuation of moisture from the socket
volume loss during the course of the system thus greatly reducing moisture
day.1,2 As a result, the socket fit is more buildup.
consistent and may eliminate the need for
the user to remove the prosthesis multiple Shock Absorber and Torsion Adapter
times/day while attempting to manage The Harmony® System mechanical pump
volume changes with socks and/or spots. has an integrated, adjustable shock
absorber and torsion adapter, which work
Reduced Forces together to increase walking comfort and
In standard sockets daily volume relieve strain on joints and spine. These
fluctuations inherently cause an features may also contribute to a more
inconsistent fit for many amputees not natural gait pattern.4
under vacuum and can lead to pressure
points on the limb.2,3 Controlling volume
1
under vacuum may reduce these forces Ottobock Healthcare. Harmony Spec Sheet.
http://ottobockus.com/cps/rde/xbcr/ob_us_en/04
and-promote better limb health.2 020441.7BHarmonySpecSheet.pdf.
2
Board WJ, Street GM, Caspers CA.
Proprioception Comparison of trans-tibial amputee suction and
vacuum socket conditions. Prosthet Orthot Int.
The Harmony® System’s elevated vacuum
2001, 25, 202-209.
leads to heightened proprioception which 3
Beil TL, Street GM, Covey SJ. Interface
increases the awareness a user has of her pressures during ambulation using suction and
or his leg during walking. As a result, vacuum-assisted prosthetic sockets. J Rehabil
users may experience increased balance, Res Dev. 2002;39(6):693-700.
4
Ottobock Healthcare. Harmony® P2 and HD.
stability and control over the prosthesis.2 http://ottobockus.com/cps/rde/xchg/ob_us_en/hs.
xsl/16873.html.

Ottobock
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Clinical Research Summary
Results: Four surveys were excluded from
The Benefits of Vacuum the final analysis; (survey not complete,
subject did not use both suspension systems,
Compared to Other vacuum system was not electronic, and
Suspension Methods incorrect amputation level). The ABC scores
for the remaining 9 surveys were Vacuum
Elevated vacuum suspension systems Suspension (80±10) and Pin Suspension
manage limb volume fluctuation, a problem (65±20), resulting in a confidence level of
that people with limb loss are challenged 95% (p=0.0359) in favor of vacuum.
with. Over time and on a daily basis, these Subjects (n=13) were also surveyed on a
volume changes can affect how the socket variety of related problems experienced with
fits. When the limb volume increases, the suspension systems. Results for pistoning,
socket becomes tighter, exerting pressure, blisters, volume change, difficulty knee
restricting blood flow, and allowing for bending, redness, falls, and walking time, all
accumulated cell waste. When limb volume favored vacuum suspension over pin
decreases, the socket is loose-fitting often suspension; however the results were not
causing pressure to bony prominences, significant, possibly due to small sample
which may result in pain and/or injury to the size.1
limb.1
An earlier study by Beil5 (2004) compared pin
Vacuum Compared to Pin suspension to suction suspension (n=9) by
Suspension measuring impulse and peak pressures in the
socket during ambulation. Results: During
Ferraro (2011) conducted an outcomes study
stance phase there was no difference between
(n=13) comparing pin suspension to
the two suspension methods (p=0.076);
electronic vacuum suspension. All subjects
however, during swing phase, differences
used each suspension system for at least 30
were significant (positive pressure impulses
days. 2 A validated measurement tool called
p=0.008, average positive pressure p-0.004,
the Activity-specific Balance Confidence
distal negative impulse p=0.053 and peak
(ABC) scale was used to evaluate the subject’s
pressure p=0.026) demonstrating that pin
confidence when performing certain
suspension exerts an occlusive pressure on
activities (n=16) with regard to balance.
the proximal tissues of the residual limb,
Subjects taking the survey rated their
while at the same time generating
confidence in performing each activity on a
considerable suction at the distal end of the
scale from 0 (no confidence) to 100
socket, and that these pressures are likely
(completely confident). 3 A score below 67
causing both the persistent and the day-to-
indicates a risk for falling.4
day skin issues witnessed with pin
suspension users.

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The Benefits of Vacuum Compared to
Other Suspension Methods (cont.)

Vacuum compared to Suction


Suspension impulse and peak pressures during
ambulation (n=9). Results: Findings were
Board6 (2001) conducted a randomized trial
favorable for vacuum, both during stance
comparing suction suspension to vacuum-
phase (impulse p=0.00, peak p=0.003) and
assisted suspension; evaluating changes in
during swing phase (impulse p=0.000,
volume, tibia and liner pistoning, and stance
average p=0.000, and peak 0.001). It is
phase and step length symmetry. Volume:
believed that lower pressures seen during
Residual limb volume (n=10) was measured
stance when using the vacuum-assisted
prior to and after a 30 minute treadmill walk,
socket force less fluid out and greater
and a significant increase of 3.7% or 30 ml
negative pressures seen during swing
(p=0.007) was found when using vacuum as
increases the amount of fluid drawn into the
compared to a significant decrease of 6.5% or
limb, thereby preventing volume loss.
52 ml when using suction. Pistoning:
Pistoning of the tibia and liner (n=11) were 1
Sanders JE, Harrison DS, Myers TR, Allyn KJ.
measured using X-ray and extraction force Effects of elevated vacuum on in-socket residual limb
and a significant decrease (p=0.000) in both fluid volume: Case study results using bioimpedance
tibia and liner pistoning was found in favor of analysis. JRRD. 2011;48(10):1231-1248
2
the vacuum system. Symmetry: Gait Ferraro C. Outcomes study of transtibial amputees
using elevated vacuum suspension in comparison
symmetry (n=10) was assessed with video with pin suspension. Journal of Prosthetics and
and found significant improvements in both Orthotics. 2011;23(2):78-81
stance phase symmetry (p=0.037) and step 3
Powell LE, Myers AM. The activities-specific
length symmetry (p=0.000). Conclusion: balance confidence (ABC) scale. J Gerontol Med Sci
1995;50A:M28–M34.
The authors concluded that while suction 4
Lajoie, Y. and Gallagher, S. P. (2004). Predicting
suspension fits well, it also causes volume falls within the elderly community: comparison of
loss due to the pressure that it exerts, which postural sway, reaction time, the Berg balance scale
in turn worsens the fit, subjecting the skin to and the Activities-specific Balance Confidence
(ABC) scale for comparing fallers and non-fallers.
higher stresses and “shear forces” with Archives of Gerontology and Geriatrics 38(1):11-26
potential for ulcers. Vacuum suspension, 5
Beil TL, Street GM. Comparison of interface
such as the Harmony®, retains correct fit, pressures with pin and suction suspension systems.
JRRD. 2004;41(6A): 821-828
averts volume loss, and lessons pistoning in 6
Board WJ, Street GM, Caspers C A comparison of
the socket; maintaining skin integrity, trans-tibial amputee suction and vacuum socket
symmetry, and comfort. conditions. Prosthet Orthot Int 2001; 25:202-209
7
Beil TL, Street GM, Covey SJ. Interface pressures
Beil7 (2002) also compared vacuum during ambulation using suction and vacuum-
suspension to suction suspension (using total assisted prosthetic sockets. J Rehabil Res Dev.
surface weight-bearing sockets) by measuring 2002;39(6):693-700

Ottobock
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Clinical Research Summary

The Harmony®: Early Fitting of


Transtibial Amputees with
Early Fitting with Prompt Ambulation Using
Unhealed Residual Limb the Harmony® Vacuum System
Wounds A randomized controlled trial recently published by
Traballesi, et al,7 evaluated fitting of the Harmony®
According to the most recent update by the Amputee System on subjects with open ulcers/wounds (n=10)
Coalition (2012), close to two-million persons with compared to fitting a standard suction socket (n=10)
limb loss reside in the United States, and of those, after wounds were healed to 1cm2 (control group).
54% of their amputations were a result of vascular Subjects were limited community ambulators (MFCL-
disease.1,2 Furthermore, in 2009, hospitals reported 2) or full community ambulators (MFCL-3), average
costs related to limb loss as being greater than 8.3 age 61.3±13.2, with recent admission to the
billion dollars.1,3 rehabilitation hospital after transtibial amputation
When there is Presence of Unhealed due to dysvascular cause.
Wounds A twelve-week rehabilitation program was initiated
for all subjects and additional follow-up conducted
Until recently, standard practice was to delay the
at weeks 28 and 36. First Steps: Harmony® users
prosthetic fitting until the residual limb was in good
took their first step at 16±8.6 days, while the control
condition and could withstand the forces generated
group took their first step at 58.6±24.7 days
by the prosthesis. In his research, VanVelzen (2005)
(p=0.012). Independent Walking: At week 12 all
found that ideally, the surgical wound from the
Harmony® users were independent walkers, while
amputation must be healed, the stump matured and
only 5 in the control group were independent
conically shaped, and there should be no remaining
(p=0.001). Prosthetic Use: At 2-months the
edema when the prosthesis is fit.4,5,6
Harmony® group used their prostheses 62 hours/wk.
Persons with transtibial limb loss have (4X) greater (mean), while the control group used theirs 12
likelihood of successful prosthetic use than persons hours/wk. (p=0.003). At 6 months, prosthetic use
with higher-level amputations.6 However, they are was 80 hours/wk. for the Harmony® group compared
also more likely to experience skin complications on to 59 hours/wk. for the control group; however,
the residual limb.7, 8 Presence of ulcers or unhealed results were no longer significant (p=0.191).
surgical wounds may delay prosthetic rehabilitation Locomotor Capability Index (LCI): At week 12
and increase the need for medical treatment . 6,9 the median LCI score for the Harmony® group was 42
(maximum score possible) versus 21 for the control
As a result, it has been suggested that there are
Group (p=0.002). Drop-outs: Three subjects
benefits to accelerating the initiation of
dropped out of the control group (one each at 4
rehabilitation after amputation surgery.10,11 One weeks, 6 weeks, and 16 weeks) and one dropped out
way that this may be achieved when there are of the Harmony® group at 20 weeks. Wound
wound-healing issues is by early fitting with a Healing and Pain: Considering the difference in
vacuum-assisted socket system (VASS), such as prosthetic use between the two groups, one would
the Harmony® Vacuum System. expect the Harmony® users to experience increased

Ottobock
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The Harmony®: Early Fitting of
Transtibial Amputees with Unhealed Results: Despite having such a large open wound,
when tested using the Harmony®, the subject’s LCI
Residual Limb Wounds (cont.) score was 41 and BI was 85. Additionally, after 3-4
hours of continuous ambulation and standing
pain and possibly less healing. However, wound- activities, VAS (pain) score was 0. At the end of 4
healing and pain perception scores were not months, the wound area was reduced to 28cm2,
statistically significant between the groups. which equated to a 34% reduction in wound area.
Conclusion: The authors concluded that that early
use of the Harmony® in the presence of open 1
Amputee Coalition. Limb loss statistics.
ulcers/wounds did not impede healing, nor did it http://limblossawareness.org/about-llam/limb-loss-
increase pain. statistics/index.php.
2
Ziegler‐Graham K, MacKenzie EJ, Ephraim PL, et al.
When Compared to Amputees without Estimating the prevalence of limb loss in the United States:
2005 to 2050. Arch Phys Med Rehabil. 2008;89(3):422‐429.
Ulcer/Wound Healing Failure 3
HCUP Nationwide Inpatient Sample (NIS). Healthcare Cost
An earlier study by Brunelli,12 conducted at the same and Utilization Project (HCUP). Rockville, MD: AHRQ; 2009.
4
Traballesi M, Averna T, Delussu AS, Brunelli S. Trans-tibial
rehabilitation facility, reported on 24 transtibial prosthesization in large area of residual limb wound: Is it
amputees; 7 subjects with ulcer/wound healing possible? A case report. Disability and Rehabilitation: Assistive
failure fit with the Harmony® and 17 subjects with no Technology. 2009;4(5):373–375.
5
ulcer/wound healing failure fitted with a standard Van Velzen AD, Nederhand MJ, Emmelot CH, Ijzerman MJ.
Early treatment of trans-tibial amputees: Retrospective analysis
PTB socket (PTB Group). Locomotor Capability of early fitting and elastic bandaging. Prosthet Orthot Int
Index (LCI): Subjects were measured using LCI to 2005;29:3 –12.
6
determine prosthetic use. At nine months, the Gauthier-Gagnon C, Grise MC, Potvin D. Predisposing
factors related to prosthetic use by people with a transtibial
Harmony® group scored 36±6.7 on the LCI compared
and transfemoral amputation. JPO. 1998;10(4):99-109; Waters
to the PTB group which scored 28±4.2. Pain RL, Mulroy S. The energy expenditure of amputee gait. Gait
Perception: Subjects were measured using the and Posture. 1999:9(3):207-231; Bowker JH, Michael JW
Visual Analog Scale (VAS) for pain perception. VAS (ed):In: Atlas of limb prosthetics: Surgical, prosthetic and
rehabilitation principles. St. Louis: Mosby Year Book,
scores were favorable for the Harmony® group both 1992;381-387.
at 1 month (6.3±2.2 compared to 7.5±2.5) and at 9 7
Trabalessi M, Delussu AS, Fusco A, et al. Residual limb
months (4.6±1.3 compared to7±1.8). Conclusion: wounds or ulcers heal in transtibial amputees using an active
suction socket system. A randomized controlled study. Eur J
The authors concluded that patients fit with the Phys Rehabil Med 2012:48:1-2
Harmony® were compliant in its use, and their 8
Dudek NL, Marks MV, Marshll SC, Chardon JP.
ulcers/wounds improved during the study. Dermatologic conditions associated with use of lower extremity
prosthesis. Arch Phys Med Rehabil. 2005:86:659-663
Large Wound Case Study 9
Meulenbelt HE, Geertzen JH, Jonkman MF, Dijkstra PU.
Determinants of skin problems of the stump in lower-limb
Traballesi4 also reported on a 60 year-old, amputees. Arch Phys Med Rehabil. 2009:90:74-81
dysvacular, transtibial amputee with a 43.5cm2 10
Munin et al. Predictive factors for successful early prosthetic
category IV wound on his residual limb. ambulation among lower-limb amputees. J Rehabil Res Dev.
2001:38;4
Measurements included the LCI for prosthetic use, 11
White SA, Thompson MM, Zickerman AM, et al. Lower limb
the Barthel Index (BI) for functional independence, amputation and grade of surgeon. Br J Surg 1997; 84(4): 509-
and digital photos of the wound for healing. The 11.
12
subject wore the Harmony® 8 hours per day for 4 Brunelli S, Averna T, Delusso AS, Traballesi M. Vacuum
assisted socket system in trans-tibial amputees: Clinical report.
months and participated in outpatient gait therapy. Orthopädie-Technik Quarterly, English edition. 2009; II:2-4

Ottobock
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Vacuum Studies Bibliography
Reverse Chronological Order

1. Samitier BC, Guirao L, Costea M, Camós JM, Pleguezuelos E. Hospital de Mataró,


Barcelona, Spain. The benefits of using a vacuum-assisted socket system to improve
balance and gait in elderly transtibial amputees. Prosthet Orthot Int. 2014 Sep 26. pii:
0309364614546927. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/25261489

2. Kahle JT, Orriola JJ, Johnston W, Highsmith MJ. The effects of vacuum-assisted
suspension on residual limb physiology, wound healing, and function: A systematic
review. Technol Innov. 2014; 1(15): 333-341.
http://www.ingentaconnect.com/content/cog/ti/2014/00000015/00000004/art00009

3. Kahle JT, Highsmith MJ. Transfemoral interfaces with vacuum assisted suspension
comparison of skeletal kinematics, pressure and preference: Ischial containment versus
brimless. J Rehabil, Res, Dev. 2013; 50(9): 1241-1252.
http://www.rehab.research.va.gov/jour/2013/509/jrrd-2012-01-0003.html

4. Kahle JT, Highsmith MJ. Transfemoral sockets with vacuum-assisted suspension


comparison of hip kinematics, socket position, contact pressure, and preference: Ischial
containment versus brimless. J Rehabil Res Dev. 2013; 50(9):1241–52.
http://dx.doi.org/10.1682/JRRD.2013.01.0003

5. Hoskins RD, Sutton EE, Kinor D, Schaeffer JM, Fatone S. Using vacuum-assisted
suspension to manage residual limb wounds in persons with Transtibial amputation: A
case series. POI. 2013;05 DOI:10.1177/0309364613487547
http://www.researchgate.net/publication/236920322_Using_vacuum-
assisted_suspension_to_manage_residual_limb_wounds_in_persons_with_transtibial_a
mputation_A_case_series

6. Traballesi M, Delussu AS, Fusco A, et al. Residual limb wounds or ulcers heal in
transtibial amputees using an active suction socket system. A randomized controlled
study. Eur J Phys Rehab Med 2012;48:1-2.
http://www.ncbi.nlm.nih.gov/pubmed/22641248

7. Ferraro C. Outcomes study of transtibial amputees using elevated vacuum suspension in


comparison with pin suspension. JPO 2011;23(2):78-81.
http://journals.lww.com/jpojournal/Abstract/2011/04000/Outcomes_Study_of_Transtib
ial_Amputees_Using.7.aspx
Ottobock
800.328.4058
http://professionals.ottobockus.com 8
Vacuum Studies Bibliography
Reverse Chronological Order

8. Gerschutz MJ, Denune JA, Colvin JM, and Schober G. Elevated vacuum suspension
influence on lower limb amputee’s residual limb volume at different vacuum pressure
settings. JPO 2010;22(4):252-256.
http://courses.washington.edu/rehab427/Fall%202010/Student%20Papers%20for%20
Review/Phil%20-%20Gerschutz%20(2010).pdf

9. Gerschutz MJ, Haynes ML, Colvin JM, Nixon D, Denune JA, and Schober G. A vacuum
suspension measurement tool for use in prosthetic research and clinical outcomes:
Validation and analysis of vacuum pressure in a prosthetic socket. JPO 2010;22(3): 172-
176.
http://journals.lww.com/jpojournal/Fulltext/2010/07000/A_Vacuum_Suspension_Meas
urement_Tool_for_Use_in.8.aspx?WT.mc_id=HPxADx20100319xMP

10. Traballesi M, Averna T, Delussu AS, et al. Trans-tibial prosthesization in large area of
residual limb wound: is it possible? A case report. Disabil Rehabil Assist Technol
2009;4:373–375.
http://www.hsantalucia.it/ric/attivita2009/AutoPlay/Docs/I%20pagine%20pubblicazio
ni/295-Trans-tibial%20prosthesization.pdf

11. Brunelli S, Averna T, Delusso S, et al. Vacuum assisted socket system in trans-tibial
amputees: Clinical report. The Orthopadie Technik, 2009;2:2-8. http://www.ot-
forum.de/verlag_ot/otquarterly/e30554/infoboxContent30555/OT_Quarterly_2_09_72_
dpi_ger.pdf

12. Fairley M. ‘Hanging Tight’: elevated vacuum suspension systems step forward. The O&P
Edge, March 2008. http://www.oandp.com/articles/2008-03_03.asp

13. Street G. Vacuum suspension and its effects on the limb. The Orthopadie Technik,
2006;4:1–4 http://www.ottobockus.com/cps/rde/xbcr/ob_us_en/Street-
0661_OT_GB.pdf

14. Beil TL, Street GM. Comparison of interface pressures with pin and suction suspension
systems. J Rehabil Res Dev 2004;41:821–828.
http://www.rehab.research.va.gov/jour/04/41/6/pdf/Beil.pdf

Ottobock
800.328.4058
http://professionals.ottobockus.com 9
Vacuum Studies Bibliography
Reverse Chronological Order

15. Goswami J, Lynn R, Street G, Harlander M: Walking in a vacuum-assisted socket shifts the
stump fluid balance Prosthet Orthot Int 2003;27(2):107-113
http://www.ottobockus.com/cps/rde/xbcr/ob_us_en/harmony_article_1.pdf

16. Beil TL, Street GM, Covey SJ. Interface pressures during ambulation using suction and
vacuum-assisted prosthetic sockets. J Rehabil Res Dev 2002;39(6):693-700.
http://www.rehab.research.va.gov/jour/02/39/6/pdf/Beil.pdf

17. Board WJ, Street GM, Caspers C A comparison of trans-tibial amputee suction and vacuum
socket conditions. Prosthet Orthot Int 2001;25:202-209
http://www.ottobockus.com/cps/rde/xbcr/ob_us_en/harmony_article_3.pdf

© 2015 Otto Bock HealthCare ● 30HAR.05282015

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