Design Directions and Trends in Portable Ventilators What This Means for the Ventilator-Dependent Individual
Twyman, Rod 12/17/2011

Abstract
Service, operator, and web site literature on portable ventilators were studied for design “trending” through an examination of the listed specifications and features. If a trend were ascertained, it could provide an assessment tool for ventilator-dependent individuals and their caregivers when surveying the market for a suitable ventilator. An analysis of the results suggested that the portable ventilator market is driven toward developing units of a lighter and smaller chassis, and fewer required service hours. Advances in medical care may separate from or keep pace with advances in certain forms of medical equipment technology. Therefore, a review of what appears to be the interpretive value of current medical trends will require ongoing reexamination.

1

Table of Contents

Abstract…………………………………………………………………………………………..1 Introduction…………………………………………………………………………………...3, 4 Methods/Materials………………………………………………………………………………4 Results……………………………………………………………………………………………4 LP10 Volume Ventilator………………………………………………………………...5 Purpose/Use…………………………………………………………………………...5 Specifications………………………………………………………………………….5 Notable Feature(s).…….………………………………………………………………6 Achieva PSO2 Ventilator………………………………………………………………...6 Purpose/Use…………………………………………………………………………...6 Specifications………………………………………………………………………….6 Notable Feature(s).……….……………………………………………………………7 LTV® 950 Ventilator…………………………………………………………………….7 Purpose/Use…………………………………………………………………………...7 Specifications………………………………………………………………………….7 Notable Feature(s).……….……………………………………………………………8 Trilogy100 Ventilator……………………………………………………………………8 Purpose/Use…………………………………………………………………………...8 Specifications………………………………………………………………………….8 Notable Feature(s).…………..………………………………………………………..9 Bear 33…………………………………………………………………………………...9 Newport HT50®…….……………………………………………………………………9 PLV-102…..………..…………………………………………………..………….....…10 Discussion……….………..……………………………………………………………….…10,11 Glossary of Terms………………………………………………………………………………12 References………………………………………………………………………………………13

2

Introduction
Ventilation is the natural and intrinsic physiological process in which humans exchange air between the lungs and the environment by means of exhalation and inhalation. Muscles are involved in this process, but disease or trauma to our bodies may result in the need for manual and/or mechanical ventilation. This is ventilation by artificial and extrinsic means, but it may sustain the life of an individual with insufficient respiratory function. There are models of mechanical ventilators designed and engineered to be portable so that they can be transported in automobiles, aircraft, harnessed to wheelchairs, or placed in a patient’s home—all while providing life-sustaining artificial respiration. The LP10 volume ventilator with pressure limit control and the Achieva PSO2, both manufactured by Puritan Bennett™, are intended for use in transport and in a non-acute patient care environment (2,3). The Trilogy100 manufactured by Respironics and the LTV® 950 manufactured by Carefusion are different and more current ventilator models in healthcare that are being marketed and circulated with similar portability, simplicity, and functional range and intent (6,8). Several factors may determine the design, size, and functionality of machines able to mechanically ventilate an individual. What are these design-determining factors, and what are the discriminating design features most able to support a large population of individuals whose condition can be stabilized outside the margins of a hospital? An examination of the available operator, clinical, technical, and service literature on the specifications, features, functionality, and use of select competing models of ventilators may permit medical distributors, clinicians, and/or users a partial assessment tool necessary to

3

determine the variety of ventilator with current and future utility in meeting specialized and portable respiratory therapy needs.

Methods/Materials
Seven ventilators were selected for this study. The criteria used for this selection are as follows:  The original equipment manufacturers (OEM) stated portability and/or transportability of the units    First-hand knowledge of market attraction to specific models. Approximate manufacturer design and development year of the model Ventilator models manufactured by competing companies

Manufacturer (OEM) service, technical, clinician and operator manuals were examined for ventilator features whose variability most augmented the distinction between one portable ventilator and another. Manuals were also examined for “cross-model” ventilator features that were relatively invariable over the course of several years. Lastly, manufacturer web-sites and home healthcare distributors of portable ventilators were gleaned for content, web videos, and research relevancy. Information from all sources were cross-referenced and then culled for patterns or trends.

Results
See glossary for terms found in this section (note: list of specifications and features are not comprehensive)
4

LP10 (see figure 1 and table 1)
1994: approximate manufacture and development date (3)

Figure 1: LP10 Volume Ventilator with Pressure Limit Control by Puritan Bennett (~34 lbs.) (3)

™

Purpose/Use The LP10 Volume Ventilators are intended for use in a non-acute care institution or acute transport, on pediatric and adult patients (3). Table 1: LP10 Specifications and Features (3)
Weight ~34 lbs. Internal: Approximately 1 hour operation. External: Approximately 20 hrs. operation with 75-80 Amp-hour 12 VDC Amp deep-cycle, gel-cell battery. Approximately 10 hrs operation with 35-40 cell 35 Amp-hour 12 VDC deep-cycle, gel-cell battery. 9.75”H x 14.5”W x 13.25”L (24.6 x 36.8 x 33.6 cm) Assist/Control Mode SIMV Mode Pressure Cycle Mode Every 6000 operating hours or recertification every twelve (12) months, whichever occurs first. Not applicable (n/a). Control knobs with tick marks Motor: Brushless induction. Pump: Piston, 100 to 2200 ml tidal volume capability.

Battery (internal/external)

Dimensions Operation/Therapy Modes Preventive maintenance schedule (Service frequency) Display Screen Type (Motor/Pump)

5

Notable Feature(s) The LP10 Volume Ventilator delivers breaths to the patient by way of a piston that mechanically displaces a prescribed volume of air in a cylinder with a capacity of 2200 ml (3). .

Achieva PSO2 (see figure 2 and table 2)
2007: approximate manufacture and development date (2)

Figure 2: Achieva PSO2 Ventilator Tyco Healthcare/Puritan Bennett (~32 lbs.) (2)

™

Purpose/Use
The Achieva PSO2 is intended to provide ventilator support for pediatric and adult patients who require positive pressure mechanical ventilation (2).

Table 2: Achieva PSO2 Specifications and Features (2)
Weight Battery (internal/external) Less than 32 lbs. Internal: At least 4 hours under normal load, and 1 hour under heavy load. load External: At least 19 hours under normal load, and 5 hours 30 minutes under heavy load. 24 VDC (or 12 VDC, 32 Ah) 10.75"H x 13.30"W x 15.60"L (27.3 x 33.8 x 39.6 cm) Assist/Control Mode (Volume and Pressure) SIMV Mode with Pressure Support SIMV Mode with CPAP Spontaneous Mode (Pressure Support and CPAP) Every 6000 operating hours or recertification every twelve (12) months, whichever occurs first. Liquid Crystal Display (LCD) Motor: 3-Phase Brushless Motor Pump: Piston, 50 ml to 2200 ml tidal volume capability

Dimensions

Operation/Therapy Modes

Preventive maintenance schedule (Service frequency) Display Screen Type (Motor/Pump)

6

Notable Feature(s) The Achieva PSO2 (similar to the LP10) delivers breaths to the patient by way of a piston that mechanically displaces a prescribed volume of air (2).

LTV® 950 (see figure 3 and table 3)
2005: approximate manufacture and development date (6)

Figure 3: LTV® 950 Ventilator by Carefusion (~13.4 lbs.) (6)

Purpose/Use Designed for use by adults and pediatrics needing positive pressure ventilation delivered esigned ressure invasively or non-invasively (6). invasively Table 3: LTV® 950 Specifications and Features (6)
Weight Battery (internal/external) Dimensions ~13.4 lbs. Internal: 12V sealed lead acid battery. 4.5Ah. Approximately 1 hour operation. External: -3.25” x 10.5” x 13.5” Control and Assist/Control Modes SIMV Mode CPAP Mode NPPV Mode Every 10,000 operating hours or 2 yrs, whichever occurs first. Light-Emitting Diode Display (LED) Motor: Rotary compressor turbine

Operation/Therapy Modes Preventive maintenance schedule (Service frequency) Display Screen Type (Motor/Pump)

7

Notable Feature(s) The LTV® 950 uses turbine technology (in contrast to the piston-cylinder technology) to urbine cylinder deliver forced breaths to the patient (6).

Trilogy100 (see figure 4 and table 4)
2009: approximate manufacture and development date (8)

Figure 4: Trilogy100 Portable Ventilator by Respironics (~11 lbs.) (8)

Purpose/Use Intended for use in homes, hospitals, and portable applications such as wheelchairs and gurneys (8). Table 4: Trilogy100 Specifications and Features (8)
Weight ~11 lbs. Internal: Lithium Ion ( 14.4 VDC, 41.76 Ah). Approximately 1 hour operation. External: -Detachable: Lithium Ion ( 14.4 VDC, 41.76 Ah). Approximately Ah) 1 hour operation. 9.3"H x 11.2"W x 6.6"L (23.52 x 28.45 x 16.68 cm) Assist/Control Mode (Pressure and Volume) Spontaneous and Spontaneous/Timed Mode SIMV Mode (Pressure and Volume controlled) CPAP Mode Every 10,000 operating hours or 2 yrs, whichever occurs first. , Liquid Crystal Display (LCD) Motor: Blower Motor

Battery (internal/external)

Dimensions

Operation/Therapy Modes Preventive maintenance schedule (Service frequency) Display Screen Type (Motor/Pump)

8

Notable Feature(s) The Trilogy100 uses a blower motor technology (in contrast to the turbine technology) to deliver forced breaths to the patient. This unit also has a card slot for a Secure Digital (SD) data Card—for storage of patient usage and therapy information (8). for (8)

Bear® 33

Figure 5:Bear 33 Volume Ventilator by Bear Medical Systems, Inc. (1, 9) 5:Bear Inc

1990: approximate manufacture and development date (1) Dimensions: 7.5” x 14” x 11.6” (19.2 x 35.8 x 28.2 cm) (1) Weight: Approximately 32 lbs. (1) Service frequency: Every 7,000 operating hours (1)

Newport HT50®

Figure 6: Newport HT50® Ventilator by Newport Medical Instruments, Inc. (5) Inc

2001: approximate manufacture and development date Dimensions: 10.24” x 10.63” x 7.87” (26 x 27 x 20 cm) Weight: Approximately 15 lbs. Service frequency: Every 10,000 operating hours 000

9

PLV-102

Figure 7 PLV-102 Ventilator by Lifecare/Respironics (7, 10) 7:

1988: approximate manufacture and development date (7) Dimensions: 9" x 12.25" x 12.25" (22.9 x 31.1 x 31.1 cm) (7) Weight: Approximately 28.9 lbs. (7) Service frequency: Every 1, 500 operating hours (7) :

Table 5: Comparison Table of 7 Sampled Portable Ventilators (Figures 1 – 7) n
Portable Ventilator Specifications and Features (Avg of 7 sampled Portable Ventilators). Weight (lbs.) Year Pre-2000 (3 Sample Portable Ventilators) ~32 Year Post-2000 (4 Sample Portable Ventilators) Ventilators ~18

Dimensions (In3)

~1,481

~1,051

Service frequency (operating hrs.)

~4,833 – 7,667

~9,000

Discussion
The primary aim of the research contained in this paper has been to take a renewed look at the real problem of how ventilator-dependent individuals and/or their caregivers should approach the dependent selection of a suitable portable machine for ventilation. Are there design directions and trends of esign direction portable ventilators that would aid users and caregivers in making an informed decision? de

10

Based on an analysis of the information culled in this paper’s results, the answer to that question is not completely transparent. Technological advancement does not easily lend itself to constrained interpretations and predictions—i.e., faster, smaller, and greater efficiency does not necessarily equate with better quality. A more comprehensive study with additional and varied sources (e.g., revenue generated by sales, manufacturer intramural technical and sales reports, subject relevant discussions with healthcare providers and/or patients) may only serve to buttress the available data but without the force of lending interpretive value. Notwithstanding, the results section of this paper may point toward a market in which portable ventilator design is driven toward developing a unit with a lighter and smaller chassis, and fewer required service hours (see Table 5). For individuals who are ventilator-dependent and require assisted breaths around the clock, the market will exist for a highly portable, reliable, and yet affordable ventilator. The exponential growth of technology also applies to the design technology underlying the processor board, motor, and chassis of the portable ventilator. Future medical technologies that aim to lift the physical limitations of the ventilated patient and thereby increase patient mobility must also aim to address present-day limitations in “portable” ventilators that continue to oppose high levels of patient mobility. Thus, as we advance toward our future, an increase in patient mobility will further raise the market demand for improved ventilator portability, versatility, and ease of use. Lastly, quality of patient life will be an ongoing issue to address. Portable ventilators can no longer be alarm-prone and finicky—requiring the operational and monitoring oversight of a caregiver or clinician. The ventilator of the future will need to be virtually self-sufficient in the ability to track, adjust to, and compensate for disruptions in the irregular and non-assisted breaths of a newly high functioning and active individual.
11

Glossary of Terms (6)
Term/Acronym Assist breath bpm Control mode Definition A volume or pressure breath that the patient triggers, and which is then controlled and cycled by the ventilator. Assist breaths may occur in Assist / Control and SIMV modes. Breaths Per Minute. A ventilation mode where the ventilator delivers machine breaths at a set rate. In Control Mode, patient triggers are not allowed. Continuous Positive Airway Pressure. The ventilator continuously maintains Positive gas pressure through the patient circuit during the entire breath cycle. A ventilation mode where the patient triggers all breaths. Available breath types are Pressure Support and Spontaneous. The ratio of the inspiration period to the expiration period for a breath. The lesser value is normalized to 1. Calculated Inspiratory : Expiratory ratio, based upon the Inspiratory Time setting and the Breath Rate setting A volume or pressure breath that is started by the operator or the ventilator, and is controlled and cycled by the ventilator. Machine Breaths may occur in Control and Assist / Control modes. The operator may cause a machine breath in any mode using the Manual Breath Button. A Machine Breath initiated by the operator pushing the Manual Breath Button. Non-invasive Positive Pressure Ventilation Synchronized Intermittent Mandatory Ventilation. A ventilation mode where a minimum number of machine or assist breaths are given, and the patient is allowed to trigger additional Patient breaths. Available breath types are volume control, pressure control, pressure support, and spontaneous.

CPAP

CPAP mode I:E ratio, monitored I:E ratio, calculated

Machine breath

Manual breath NPPV SIMV

SIMV mode

12

References
Bear Medical Systems, Inc. Bear®33 Volume Ventilator Maintenance Manual Part # 5000-12066. Riverside, CA: Bear Medical Systems, Inc.; 1990. 142 p. Nellcor Puritan Bennett Inc. Achieva User’s Manual:Ventilator with Flow Acceleration Limit and Apnoea Backup. Pleasanton, CA: Nellcor Puritan Bennett Inc.; 2007. 80 p. Nellcor Puritan Bennett Inc. LP6 Plus Volume Ventilator-And-LP10 Volume Ventilator With Pressure Limit Clinician’s Manual. Pleasanton, CA: Nellcor Puritan Bennett Inc.; 2005. 74 p. Newport Medical [Internet]. Costa Mesa, CA: Newport Medical Instruments: [cited 2011 Nov 17]. Available from: http://www.newportnmi.com/HT50.ASP Newport Medical Instruments Inc. Newport HT50 Ventilator Service Manual. Rev B. Newport Beach, CA: Newport Medical Instruments Inc.; 2001. 142 p. Pulmonetic Systems, Inc. LTV® Series Ventilator Operator’s Manual. p/n 10664, Rev. T. Minneapolis, Minnesota: Pulmonetic Systems, Inc.; 2005. 272 p. Respironics Inc. PLV®-102 Service Manual. Revision # 1013705. Murrysville, Pennsylvania: Respironics Inc.; 2003. 266 p. Respironics Inc. Trilogy 100 Clinician Manual. Ref 1066819. Murrysville, Pennsylvania: Koninklijke Philips Electronics N.V.; 2011. 164 p. SOMA Technology, Inc.: Worldwide Medical Equipment Sales and Service [Internet]. Bloomfield, CT: SOMA Technology, Inc.: [cited 2011 Nov 17]. Available from: http://www.somatechnology.com/MedicalProducts/Bear33.asp SOMA Technology, Inc.: Worldwide Medical Equipment Sales and Service [Internet]. Bloomfield, CT: SOMA Technology, Inc.: [cited 2011 Nov 17]. Available from: http://www.somatechnology.com/MedicalProducts/plv102_portable_ventilator.asp SOMA Technology, Inc.: Worldwide Medical Equipment Sales and Service [Internet]. Bloomfield, CT: SOMA Technology, Inc.: [cited 2011 Nov 17]. Available from: http://www.somatechnology.com/Portable%20Ventilators.asp
11 10 9 8 7 6 5 4 3 2 1

13