Clinician`s Report: HBOT Manufacturing

Perry Baromedical

Riviera Beach, FL • Founded: 1956
www.perrybaromedical.com • kperusse@perryhbo.com

What specific types of product lines that you make?
  • Hyperbaric Chambers: Monoplace (single person) Sigma 34 Largest 34” diameter chamber in the world. Sigma 36 Largest 36” diameter chamber in the world. Sigma 40.5” Largest Monoplace Chamber in the world.
  • Dueplace (2-person) Sigma Plus II 2-person chamber. New 40-II person chamber (newest and largest 2-person chamber in the world.
  • Multiplace (2-24 person) Can build a variety of multiplace chambers. Have multiplace installed chambers throughout North America.

1) Does your company make:
  a) Class A (Single) chambers
  b) Class B (Multiple) Chambers
  c) Both
  Both.

2) How many years has your company been in business? More than 40 years.

3) Number of Chambers sold by your company i
  a) The last 12 months? N/A
  b) The last 36 months? N/A
  Several hundred manufactured, sold, installed and maintained around the world.

4) Who does the servicing on the chamber once it is in a clinic?
  Trained and certified Perry Professional Technician (employee).
  a) The Clinic employees: No, unless certified through Perry.
  b) Representatives from your company: Trained and certified Perry Professional Technicians (employees).
  c) An Outsourced group: No.

5) Do your chambers include an electronic documentation option? Yes.

6) Does the documentation module included:
  a) Meet the HIMSS standard as an "EMR". Yes
  b) Is it an "Automated Heath Record? Yes.

7) a) Are all chambers sold by your company covered by a 510k? Yes.
  b) If your electronic documentation module interfaces with the chamber, are all electronic components covered by a 510k? Yes.

8) Does your company provide industry standard HL7 interfacing for their AHR to the hospital EHR? Yes.

9) How many different models of chambers does your company make? 3 different monoplace chambers.
  • Sigma 34, Sigma 36, Sigma 40
  • 1 duo (2-person) chamber - Sigma 40-II
  • Multiplace Chambers - A variety of different sizes.

10) Do you offer any type of extended warranties on your chambers? Yes. The warranty’s can range from 1 to 5 years.

11) For monoplace chambers, what size interior diameter(s) do they have?
  •Monoplace (single person)
  •Sigma 34 Largest 34” diameter chamber in the world.
  •Sigma 36 Largest 36” diameter chamber in the world.
  •Sigma 40.5” Largest Monoplace Chamber in the world (internal cubic feet).

12) Are all chambers sold by your company constructed in compliance with applicable ASME code and carry both a "U" stamp and National Board registration number? Yes.

13) Which of the following items are standard or extra cost accessories:
  a) IV ports Optional.
  b) Electrical pass-thru ports for monitoring (ECG, pressure, other) Optional.
  c) Electrical pass-thru ports for TcpO2 monitoring Optional
  d) Air break system (specify type) Optional.
  e) Adjustable-height gurney Standard.
  f) Pillows, wedges, or other patient positioning items Optional.
  g) Other accessories not listed above are optional: Sigma Series Mattress, Sigma Series Tool Kit, Sigma Series Chamber Cover, Armrest Assembly, Sigma Series Entertainment System, Case of Adult Breathing Mask, Smoke Hood and Wall Mount, Portable Wrist Strap Tester, Disinfectant Spray, Digital Timers, Patient Wrist Strap.

14) What spare/replacement parts are included with each chamber? We typically include a kit of spare parts.

15) What operational training is provided with the purchase? We include complete installation and chamber training.

16) Who provides operational training? Perry Certified Technicians who are all Perry Baromedical employees.

17) Is maintenance training provided? Yes, Perry offers Technician certification training.

18) What is your response time for service technician dispatch? Service is available 24 hours a day 7 days a week and 365 days a year. We provide onsite service within 24 hours.

19) What is your response time for replacement part shipment? Typically within 24 hours depending upon the part.

Sechrist Industries, Inc.

Anaheim, CA • Founded: 1973
www.sechristusa.com
Mgutierrez@sechristusa.com • 800-Sechrist

1) Does your company make:
  a) Class A (Single) chambers
  b) Class B (Multiple) Chambers
  c) Both
  Class A (Single) chambers.

2) How many years has your company been in business? 38 years.

3) Number of Chambers sold by your company in
  a) The last 12 months?
  b) The last 36 months?
  Proprietary information.

4) Who does the servicing on the chamber once it is in a clinic?
  a) The Clinic employees:
  b) Representatives from your company:
  c) An Outsourced group
  All service is handled by Sechrist factory-trained technical service employees

5) Do your chambers include an electronic documentation option? This feature is currently in the final stages of development.

6) Does the documentation module included:
  a) Meet the HIMSS standard as an "EMR"
  b) Is it an "Automated Heath Record?
  It is a hyperbaric treatment record.

7) a) Are all chambers sold by your company covered by a 510k? Yes
  b) If your electronic documentation module interfaces with the chamber, are all electronic components covered by a 510k? Yes, they will be covered by a 510K.

8) Does your company provide industry standard HL7 interfacing for their AHR to the hospital EHR? Yes, HL7 can be provided. However, our industry prefers XML support.

9) How many different models of chambers does your company make? Three models various available in various sizes and colors.

10) Do you offer any type of extended warranties on your chambers? Yes, annual extend warranties are available.

11) For monoplace chambers, what size interior diameter(s) do they have? 28”, 33”, 36” and 41”.

12) Are all chambers sold by your company constructed in compliance with applicable ASME code and carry both a "U" stamp and National Board registration number? Yes.

13) Which of the following items are standard or extra cost accessories:
  a) IV ports
  b) Electrical pass-thru ports for monitoring (ECG, pressure, other)
  c) Electrical pass-thru ports for TcpO2 monitoring
  d) Air break system (specify type)
  e) Adjustable-height gurney
  f) Pillows, wedges, or other patient positioning items
  g) Other accessories not listed above:
  All accessories are available as a part of the overall chamber configuration. Each customer can customize the chamber and accessories to meet their unique needs.

14) What spare/replacement parts are included with each chamber? Spare and replacement parts are covered under the one-year warranty.

15) What operational training is provided with the purchase? In-service training on operation, care and functionality of their Sechrist chamber.

16) Who provides operational training? Factory-trained Sechrist technicians.

17) Is maintenance training provided? All maintenance is performed by authorized, factory-trained Sechrist technicians.

18) What is your response time for service technician dispatch? Within 48 hours based on customer request.

19) What is your response time for replacement part shipment? In most instances, product can delivered the next day.

Pan-America Hyperbarics, Inc.

Richardson, TX • Founded: 2002
www.panamericahbo.com • (972) 235-9331 or (888) 724-4426
sales@panamericahbo.com

Specific types of product lines that you make: Monoplace and Multiplace Hyperbaric Chamber Systems.

1) Does your company make:
  a) Class A (Single) chambers
  b) Class B (Multiple) Chambers
  c) Both
  Both.

2) How many years has your company been in business? 9 years.

3) Number of Chambers sold by your company in
  a) The last 12 months? More than 50.
  b) The last 36 months? More than 100.

4) Who does the servicing on the chamber once it is in a clinic?
  a) The Clinic employees:
  b) Representatives from your company:
  c) An Outsourced group
  All service is handled by representatives from your company.

5) Do your chambers include an electronic documentation option? Current module undergoing upgrade and development.

6) Does the documentation module included:
  a) Meet the HIMSS standard as an "EMR"
  b) Is it an "Automated Heath Record?
  It is an Automated Health Record.

7) a) Are all chambers sold by your company covered by a 510k? Yes.
  b) If your electronic documentation module interfaces with the chamber, are all electronic components covered by a 510k? Not applicable.

8) Does your company provide industry standard HL7 interfacing for their AHR to the hospital EHR? Not currently.

9) How many different models of chambers does your company make? 2.

10) Do you offer any type of extended warranties on your chambers? Yes.

11) For monoplace chambers, what size interior diameter(s) do they have? 32 inch.

12) Are all chambers sold by your company constructed in compliance with applicable ASME code and carry both a "U" stamp and National Board registration number? Yes.

13) Which of the following items are standard or extra cost accessories:
   Standard.
  b) Electrical pass-thru ports for monitoring (ECG, pressure, other) Standard.
  c) Electrical pass-thru ports for TcpO2 monitoring Standard.
  d) Air break system (specify type) Standard, Continuous flow non-rebreathing mask.
  e) Adjustable-height gurney Standard.
  f) Pillows, wedges, or other patient positioning items Standard.
  g) Other accessories not listed above: HD-TV, Built-in DVD player, Digital timer, Oxygen Analyzer, Chamber cover, Chamber grounding kit, Disinfectant, Smoke hood, Battery and charger, Medical Air regulator.

14) What spare/replacement parts are included with each chamber? Battery.

15) What operational training is provided with the purchase? Highly experienced qualified Hyperbaric Technician to train personnel on safe use of the PAHI-S1 system and ancillary equipments. Assist the director with developing written Policy & Procedures specific to the hyperbaric oxygen therapy program. Involvement in preparation for UHMS accreditation surveys for hyperbaric programs.

16) Who provides operational training? Barry Baker, VP of Pan-America Hyperbarics, Inc

17) Is maintenance training provided? Yes- Preventive Maintenance only.

18) What is your response time for service technician dispatch? Within 24 hours or next business day.

19) What is your response time for replacement part shipment? Same day.

Environmental Tectonics Corporation

www.etcusa.com
Contact person: Brad Baker • Business Development Manager
(215) 355-9100 ext. 1278 • Email: bbaker@etcusa.com

1) Does your company make:
  a) Class A (Single) chambers
  b) Class B (Multiple) Chambers
  c) Both
  Both.

2) How many years has your company been in business? 40 years.

3) Number of Chambers sold by your company in
  a) The last 12 months? 55.
  b) The last 36 months? 130.

4) Who does the servicing on the chamber once it is in a clinic?
  a) The Clinic employees:
  b) Representatives from your company:
  c) An Outsourced group
  A, B, and C.

5) Do your chambers include an electronic documentation option? Standard.

6) Does the documentation module included:
  a) Meet the HIMSS standard as an "EMR"
  b) Is it an "Automated Heath Record?
  Our chambers generate and retain data regarding specific hyperbaric oxygen treatments that can be provided to an EMR though an interface. There is a coded identifier, only, to connect the patient to related medical records systems.

7) a) Are all chambers sold by your company covered by a 510k? Yes, all hyperbaric chambers.
  b) If your electronic documentation module interfaces with the chamber, are all electronic components covered by a 510k? Yes.

8) Does your company provide industry standard HL7 interfacing for their AHR to the hospital EHR? Yes.

9) How many different models of chambers does your company make? 5 or more The chambers are as follows - BARAMED®, BARAMED Select, BARAMED XD, R100, R200 6/2/6 Multiplace Chamber, 12/2/6 Multiplace chamber

10) Do you offer any type of extended warranties on your chambers? Yes.

11) For monoplace chambers, what size interior diameter(s) do they have? Our chambers have 30” and 34” ID. Because of efficient use of space, however, the 34-inch chamber has the equivalent patient internal volume to other chambers with a 36-inch ID. The 30-inch chamber has equivalent patient internal volume to other chambers with a 32-inch ID. ETC prides itself on making optimal use of the chamber volume to balance patient comfort with operating cost.

12) Are all chambers sold by your company constructed in compliance with applicable ASME code and carry both a "U" stamp and National Board registration number? Yes.

13) Which of the following items are standard or extra cost accessories:
  a) IV ports Standard.

  b) Electrical pass-thru ports for monitoring (ECG, pressure, other) Standard.
  c) Electrical pass-thru ports for TcpO2 monitoring Standard.
  d) Air break system (specify type) Standard - Both on demand mask and flow thru mask devices
  e) Adjustable-height gurney Standard.
  f) Pillows, wedges, or other patient positioning items Standard.
  g) Other accessories not listed above: Covers.

14) What spare/replacement parts are included with each chamber? None.

15) What operational training is provided with the purchase? Operator training is supplied with each chamber.

16) Who provides operational training? ETC Staff.

17) Is maintenance training provided? Daily maintenance and care of the chamber is provided when the chamber is installed. As an option, ETC offers service training on ETC chambers to qualified personnel.

18) What is your response time for service technician dispatch? Our normal response time is usually within twenty-four (24) hours, and guaranteed within forty-eight (48) hours.

19) What is your response time for replacement part shipment? Usually within 24 hours.