2500B and 2500BR Operational Instructions Rev 9

SECHRIST INDUSTRIES MONOPLACE HYPERBARIC SYSTEM MODELS: 2500B, 2500BR (NOT SHOWN)

Figure 1

Figure 2

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TABLE OF CONTENTS CHAPTER

PAGE

I.

USER RESPONSIBLITY

5

II.

WARRANTY

6

III. SUMMARY OF WARNINGS AND CAUTIONS

7

IV. INTRODUCTION

16

V.

A. INDICATIONS FOR USE

16

B. CONTRAINDICATIONS FOR USE

17

1

Absolute Contraindications

17

2

Relative Contraindications

17

C. PRESSURE CHAMBER

18

D. PNEUMATIC PRESSURE CONTROL SYSTEM

18

E. INTERCOMMUNICATION SYSTEM

18

INSTALLATION AND SPECIFICATIONS

19

A. GENERAL INSTALLATION REQUIREMENTS

19

B. CHAMBER FACILITY SPECIFICTIONS

19

C. UTILITY CONNECTIONS

23

D. UTILITY CONNECTIONS

29

VI. SYSTEM CONTROLS

31

A. PRESSURE CONTROLS AND INDICATORS

31

B. INTERCOM CONTROLS

35

C. PURGE FLOW CONTROLS

35

D. CHAMBER DOOR CONTROLS

36

E. INTERCOM ELECTRICAL POWER

39

VII. SYSTEM OPERATION SEQUENCE

41

A. DAILY INSPECTIONS

41

B. TYPICAL TREATMENT OPERATION SEQUENCE

42

VIII. SAFETY AND EMERGENCY PROCEDURES

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44

A. SAFETY PRECAUTIONS

44

B. EMERGENCY PROCEDURES

46

IX. PATIENT MONITORING AND SUPPORT

49

A. PATIENT COMFORT

49

B. PATIENT MONITORING

50

C. INTRAVENOUS SUPPORT

51

D. RESPIRATORY SUPPORT

54

EQUIPMENT CARE, MAINTENANCE AND PERFORMANCE VERIFICATION

55

A. DAILY INSPECTION AND PERFORMANCEVERIFICATION

55

B. DAILY INSPECTION AND PERFORMANCEVERIFICATION

56

C. SEMI-ANNUAL PERFORMANCE VERIFICATION

57

D. YEARLY FACTORY AUTHORIZED PREVENTIVE MAINTENANCE

58

E. CARE AND CLEANING OF ACRYLIC CYLINDERS

58

F. CLEANING OF PAINTED AND ANODIZED SURFACES

59

G. GERNERAL CARE OF EQUIPMENT

59

XI. RETROFIT INSTALLATION INSTRUCTIONS

60

X.

A. INSTALLATION INSTRUCTIONS FOR THE PATIENT GROUND ASSEMBLY 60 1

PATIENT GROUND ASSEMBLY (P/N 20091)

XII. SCHEMATICS AND ASSEMBLY DRAWINGS

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60 62

I.

USER RESPONSIBLITY WARNING Federal (U.S.A.) law restricts this device to sale by or on the order of a physician

The SECHRIST INDUSTRIES Model 2500B and 2500BR Monoplace Hyperbaric System will perform in conformance with the specifications and description contained in this Operational Instruction Manual and other accompanying labeling when operated and maintained in accordance with the instructions contained in this Manual and other accompanying documentation. Do not attempt to operate this System before reading and thoroughly understanding these instructions. The System must be checked, maintained and serviced periodically as

specified

in

this

Manual

(See

Section

X.

EQUIPMENT

CARE,

MAINTENANCE AND PERFORMANCE VERIFICATION). A defective device should not be used. Should repair become necessary, contact SECHRIST INDUSTRIES, Anaheim, California. This product should be maintained and repaired by a SECHRIST INDUSTRIES factory trained technician or by written instructions from SECHRIST INDUSTRIES. This product should not be modified in any way, except with prior written approval of SECHRIST INDUSTRIES.

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II.

WARRANTY

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III. SUMMARY OF WARNINGS AND CAUTIONS The SECHRIST INDUSTRIES Model 2500b and 2500BR Monoplace Hyperbaric System is a restricted medical device for use only by qualified personnel under the direction of a fully trained and authorized physician. Personnel operating the equipment are responsible for reading and thoroughly understanding all product documentation provided. Statements throughout the product documentation have special significance as follows.

KEY TO WARNINGS, CAUTIONS AND NOTES: WARNING Means there is a possibility of personnel injury or death to the operator and/or patient.

CAUTION Indicates there is a possibility of damage to the Chamber or other equipment attached to it.

NOTES: Notes are used to call attention to statements pertaining to more efficient/convenient operation or service of equipment.

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III.

SUMMARY OF ALL WARNINGS AND CAUTIONS CONTAINED IN THIS DOCUMENT (continued) WARNING Federal (U.S.A.) law restricts this device to sale by or on the order of a physician WARNING Do not “Tee” the exhaust lines together on multiple chamber installations. This may cause the contaminated gases to flow into the other Chambers sharing the exhaust line.

WARNING Only equipment designed to drive an external 8 Ohm Speaker should be connected to the Auxiliary Input Connector (modifying a television set for use as an audio program source may expose dangerous voltages at the Auxiliary Input Connector).

WARNING Gas supplied to the Chamber must be extremely clean (no more than 25 parts per million (ppm) of gaseous hydrocarbons is allowed). A high concentration of gaseous hydrocarbons in the gas supply is a fire hazard.

WARNING The Sechrist Monoplace Hyperbaric Chamber is intended to be used by a qualified practitioner under the direction of a qualified physician.

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III.

SUMMARY OF ALL WARNINGS AND CAUTIONS CONTAINED IN THIS DOCUMENT (continued) WARNING This product should only be maintained and repaired by a SECHRIST INDUSTRIES factory-trained technician or by written instruction from SECHRIST INDUSTRIES. This product should not be modified in any way, except with prior written approval of SECHRIST INDUSTRIES. Unapproved modifications can result in death or serious injury.

WARNING No gas is supplied to the Chamber when the Master Selector Valve is in the “OFF” position and the Chamber Door is closed. To prevent asphyxiation, turn the Master Selector Valve to the ON position as soon as the Chamber Door is in the locked position. When completing a treatment, the Chamber Door must be opened as soon as the Chamber Pressure Indicator shows black.

WARNING Use the Emergency Vent only in extreme emergency situations. Rapid loss of Chamber pressure may result in barotrauma.

WARNING During the patient treatment, a health care professional must be in attendance at all times to react to an alarm or other indications of a problem.

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III.

SUMMARY OF ALL WARNINGS AND CAUTIONS CONTAINED IN THIS DOCUMENT (continued) WARNING Introduce only approved electrical leads and transducers into the Chamber. Never place the control box of an electrical monitor inside the Chamber. Do no attempt to introduce leads into the Chamber by any other means than the 19 Pin Electrical Ports provided by SECHRIST INDUSTRIES.

WARNING All Sechrist manufactured equipment and accessories specified for use with the Sechrist Monoplace Hyperbaric Chamber have been qualified for safe use with the Chambers by Sechrist. ONLY the non-Sechrist, ancillary device models called out in this manual are known by Sechrist Industries to have been specifically validated with 100% hyperbaric oxygen environments and cleared by FDA for use in hyperbaric oxygen applications. For other ancillary devices that the user wishes to use with or without the Chamber, it will be necessary to contact the device manufacturer to determine whether the device has been specifically validated with 100% hyperbaric oxygen environments and cleared for use in hyperbaric oxygen applications by FDA or applicable international regulatory agencies. For further questions regarding use of other ancillary devices with Sechrist Chambers, please contact Sechrist Industries.

WARNING Only interface Sechrist 19-Pin Cable with Host Monitors of Type BF or CF, or those marked: “Patient Connection Electrically Isolated”. - 10 -

III.

SUMMARY OF ALL WARNINGS AND CAUTIONS CONTAINED IN THIS DOCUMENT (continued) WARNING Mechanical ventilation of a patient undergoing pressure changes may present inherent difficulties. Such treatment should only be administered by highly qualified and properly trained personnel

WARNING Seizures as a result of oxygen toxicity may occur without warning.

WARNING Never decompress a patient during the tonic or breath-holding phase of a seizure. Decompressing while a patient is “breath-holding” may result in pneumothroax. Decompress only when the patient is able to breathe freely.

WARNING If the Sechrist Monoplace Hyperbaric Chamber fails to perform as outlined, remove the Chamber from service and contact a Sechrist authorized service technician. The Chamber should not be used until proper performance has been verified. WARNING Chamber installation should only be performed by qualified Sechrist Service Technicians or by personnel that have been specially trained and certified by Sechrist to perform such installations. Always contact Sechrist directly to arrange for chamber installation.

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III.

SUMMARY OF ALL WARNINGS AND CAUTIONS CONTAINED IN THIS DOCUMENT (continued)

WARNING The presence of pure oxygen under pressure causes the smallest spark or flame to burn with magnified intensity.

WARNING The unfinished Sechrist 19-Pin Cable assemblies (P/N 2216/22157) should only be adapted for connection to other monitoring equipment and electrical leads by a qualified biomedical engineer, using workmanship standards appropriate for properly grounded, patient isolated, medical equipment and consistent with each facility’s safety policies/standards. When splicing cables together, all connections should be soldered. Avoid use of wire nuts, twisted wire connections, and electrical tape (in lieu of soldering) when splicing cables.

WARNING Only medical devices which have been fully validated in 100% HYPERBARIC OXYGEN APPLICATIONS and cleared for use by FDA or applicable international regulatory agencies for hyperbaric applications should be used with Sechrist Hyperbaric Chambers.

WARNING If major scratches (.010”deep or deeper), or signs of crazing are present in the acrylic cylinder, immediately contact SECHRIST INDUSTRIES. Deep scratches or crazing can cause the acrylic cylinder to rupture. DO NOT USE the Chamber in this condition.

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III.

SUMMARY OF ALL WARNINGS AND CAUTIONS CONTAINED IN THIS DOCUMENT (continued) WARNING The Stretcher Safety Latch must be locked in place to prevent movement of the stretcher when patients are loaded or unloaded from the gurney.

WARNING The Sechrist Standard Stretcher (P/N 21487) should be used only to move patients into and out of a Chamber and is not for general transport use.

WARNING Never attempt to open the Chamber Door when any orange/pink color is visible on the Chamber Pressure Indicator. Open the Chamber Door only when all black is showing on the Chamber Pressure Indicator.

WARNING Always be aware that it is possible for a patient to attempt suicide while inside the Chamber.

WARNING DO NOT OPERATE THE CHAMBER IF THE SEAL WIRE ON THE MANUAL SHUTOFF VALVE HAS BEEN BROKEN. Rewire and reseal the Manual Shutoff Valve in the full open position before resuming operation.

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III.

SUMMARY OF ALL WARNINGS AND CAUTIONS CONTAINED IN THIS DOCUMENT (continued) WARNING The Sechrist Ground Assembly is the only authorized patient grounding system for the Chamber. The use of an unauthorized patient grounding assembly may introduce dangerous levels of static electricity.

CAUTION Before using the Chamber, ensure that the Patient Grounding Assembly is in the proper working condition by verifying the continuity between the appendage strap and the Chamber ground lug located on the back end of the Chamber.

CAUTION Do not attempt to perform maintenance or repairs other than those described in this Manual without instructions from SECHRIST INDUSTRIES. Do not make modifications to interface equipment to the Chamber unless authorized by SECHRIST INDUSTRIES. CAUTION Avoid abrasion and introduction of static electricity on the polished Acrylic Cylinder during cleaning. Use only a water-moistened, damp, pure cotton or linen cloth to remove dust. DO NOT USE A DRY CLOTH to wipe the cylinder. CAUTION Never use any oil or alcohol based substances on the Acrylic Cylinder

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III.

SUMMARY OF ALL WARNINGS AND CAUTIONS CONTAINED IN THIS DOCUMENT (continued) CAUTION Avoid contamination of the inside of the Demand Valve with fluids or other materials, as this may cause the Valve to malfunction. Use only medical grade air or oxygen. CAUTION Do not allow water to accumulate on the bottom of the Chamber while cleaning. The water could drain into and contaminate the supply piping system. CAUTION Use only disinfectants approved by Sechrist Industries to disinfect Chamber.

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IV. INTRODUCTION The SECHRIST INDUSTRIES Model 2500B and 2500BR Monoplace Hyperbaric System is a Single Place Pressure Chamber designed to administer oxygen at 100% concentration and/or medical breathing air up to 3 atmospheres (absolute) of pressure (2.07 kg/cm2). The system consists of a Double Hulled Pressure Chamber with Quick Opening Door, a Pneumatic Pressure Control System, and an Intercommunication System. A.

INDICATIONS FOR USE The indications for use for hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (UHMS). Currently, there are thirteen, clinically accepted indications that are approved by the Committee1

1

•

Air or gas embolism

•

Carbon Monoxide Poisoning and Smoke Inhalation

•

Clostridial Myonecrosis (Gas Gangrene)

•

Crush Injury, Compartment Syndrome, and other Acute Traumatic Ischemias

•

Decompression Sickness

•

Enhancement of Healing in Selected Problem Wounds

•

Exceptional Blood Loss (anemia)

•

Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, and Fascia)

•

Chronic Refractory Osteomyelitis

•

Radiation Tissue Damage (Osteoradinecrosis)

•

Skin Grafts and Flaps (compromised)

•

Thermal Burns

•

Adjunctive Hyperbaric Oxygen in Intracranial Abscess

Undersea Medical Society, Inc., Hyperbaric Oxygen Therapy: A Committee Report, 1996.

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B.

CONTRAINDICATIONS FOR USE While the indications for use for hyperbaric oxygen are relatively well documented in current literature, contraindications (both absolute and relative) are less well-defined and continue to evolve as clinicians critically evaluate their treatment successes and failures. The following list of possible contraindications is not exhaustive and must be carefully weighed by the physician with each patient’s unique preexisting conditions or current therapies in mind: 1

2

ABSOLUTE CONTRAINDICATIONS •

Untreated Pneumothorax 2 , 3 (can result in tension pneumothorax during hyperbaric treatment)

•

Concomitant administration of Doxorubicin 2,3 or Cis-Platinum 2,3 as chemotherapeutic agents for cancer (hyperbaric therapy may increase cytotoxic effects of these medications)

•

Disulfiram2 (reduces body’s protection against oxygen toxicity)

•

Mafenide Acetate as a topical antibacterial drug (can promote CO2 buildup during HBO therapy; resulting in peripheral vasoconstriction) 2

RELATIVE CONTRAINDICATIONS Conditions in which caution must be observed but may not necessarily contraindicate use of hyperbaric oxygen therapy. •

Optic neuritis 3

•

Sever chronic obstructive pulmonary disease (COPD) or emphysema with carbon dioxide retention, pulmonary blebs, and/or dyspnea with slight exertion2,3

•

Acute viral infection (possible exacerbation by hyperbaric therapy) 3

•

Congenital spherocytosis2,3

•

Uncontrolled, acute seizure disorders 2,3

•

Upper respiratory tract infections and chronic sinusitis (difficulties in pressure equalization) 2,3

•

Uncontrolled high fever (may predispose to oxygen seizures) 2,3

•

Prior thoracic surgery (predisposes to pneumothorax or arterial gas emboli) or middle ear surgery (difficulties in pressure equalization) 3

•

History of spontaneous pneumothorax 2

•

History of surgery for otosclerosis (difficulties in pressure equalization) 2

2

Kindwall, E.P., “Contraindications and Side Effects to Hyperbaric Oxygen Treatment,” Hyperbaric Medicine Practice, Kindwall, E.P. (Ed.), Best Publishing, Flagstaff, AZ, 1994:46-55. 3 Foster, J.H., “Hyperbaric Oxygen Therapy: Contraindications and Complications, “J. Oral Maxillofac. Surg,. 1992; 50: 1081-1086.

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C.

PRESSURE CHAMBER The Pressure Chamber is built in accordance with the American Society of Mechanical Engineers (A.S.M.E.) Code, Section 8 and Pressure Vessels for Human Occupancy (P.V.H.O.-1). It consists of the following components.

D.

1.

Seamless Acrylic Pressure Cylinder.

2.

Bonded Outer Acrylic Impact Resistant Cylinder.

3.

Hard Anodized Aluminum Door Assembly and End Cover.

4.

Door Locking Mechanism and Interlock Safety Device.

5.

Stainless Steel Tie Rods.

6.

Floating Gaskets for Cylinder and Door Sealing.

PNEUMATIC PRESSURE CONTROL SYSTEM The Pneumatic Pressure Control System is non-electrical and operates from the supply gas pressure. It incorporates the following assemblies.

E.

1.

Pneumatic Analog Computer for controlling and programming pressure control variables.

2.

Control Panel for operation of the Hyperbaric System.

3.

Purge Control and Emergency Vent System.

4.

Main Pressure Regulator Assembly

5.

Gas Silencing Assembly.

6.

Two Overpressure Safety Relief Valves each equipped with a Manual Shutoff Valve sealed in the frangible wired open position as required by P.V.H.O. -1 Standard.

7.

Associated Headers, Tubing and Fittings.

INTERCOMMUNICATION SYSTEM The Intercommunications System allows two way conversation with the patient and auxiliary sound input to the patient while treatment is performed. It is comprised of the following components. 1.

Intercom Assembly mounted at the Chamber Control Panel.

2.

Intercom Power Supply.

3.

Wall Socket Mounted Battery Charger with Cable and Jack Plug.

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V.

INSTALLATION AND SPECIFICATIONS

A.

GENERAL INSTALLATION REQUIREMENTS

B.

1.

The Chamber must not be installed close to any heat sources.

2.

The room housing the Chamber should be used exclusively as a Hyperbaric Oxygen Therapy treatment facility.

3.

The room must be posed as a “NO SMOKING AREA”.

4.

All electrical equipment in the hyperbaric treatment facility must be properly grounded and in optimum working condition.

5.

Stringent fire precautions must be taken.

6.

Fire extinguishers must be installed.

CHAMBER FACILITY SPECIFICTIONS 1.

Room size should be a minimum 20 feet (6.10 m) long by 10 feet (3.05 m) wide. Bathroom, dressing room, office and storage require additional space.

2.

Temperature in the room should be maintained in the range of 68º-74º Fahrenheit (20º-23.3º Celsius).

3.

Flooring should be tile or hard surface. Carpeting is not acceptable because of generation of static electricity.

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V. INSTALLATION AND SPECFICIATIONS (continued) ROOM LAYOUT FOR 1 CHAMBER (With or without Gas Selection Panel)

FIGURE 3

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