Data Sheet... RUDOLPH, inc. HANS RUDOLPH,

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Data Sheet... MAKERS MAKERS OF OF RESPIRATORY RESPIRATORY VALVES VALVES SINCE SINCE 938 938 HANS HANS RUDOLPH, RUDOLPH, inc. inc. www.rudolphkc.com www.rudolphkc.com TEL: TEL: (93) (93) 422-7788 422-7788 U.S.A. U.S.A. & & CANADA CANADA (800) (800) 456-6695 456-6695 FAX: FAX: (93) (93) 422-3337 422-3337 E-Mail: E-Mail: hri@rudolphkc.com hri@rudolphkc.com 8325 8325 COLE COLE PARKWAY, PARKWAY, SHAWNEE, SHAWNEE, KANSAS KANSAS 66227 66227 U.S.A. U.S.A. Product Description The Hans Rudolph line of Inflatable Balloon-Type directional control valves are designed specifically for use in respiratory circuits where a valve is required for directional control in the breathing circuit. These valves contain a proprietary inflatable silicone rubber balloon assembly that when inflated occludes (closes off) a flow bore of the valve. Valve configurations are available with one (one-way) through four balloons (five-way) depending on the directional control requirements of the circuit design. The inflatable balloon component will operate for several thousand inflations and is easily replaceable in the field. Controllers are available for use with these valves for manual and external input control of the balloon valve actuation. Typical applications include pulmonary function testing, exercise testing, and primarily respiratory research. Product Features Valve housings machined and polished of clear Acrylic for balloon actuation visualization Balloon inflation and deflation actuation is quick at 20 ms response time Minimal valve breathing resistance to flow Minimal valve rebreathing dead space volume Three standard port sizes available Port connections thread into valve housing for ease of changing sizes Pneumatic Controllers available for one through four balloon valves Pneumatic hand controls available for one and two balloon valves Sampling ports standard at the common port on all valves Custom configurations of valves available Custom connections (medical tapered, o-ring slip-fit, coupler lock-ring assembly) available Reusable Specifications Valve Series Description Number of Balloons 9340 2 Way Shut-Off Number of Valve Ports Common Position Outlet Position Configuration Straight-Through Y-Shape 8240 3 Way 2 2 8250 3 Way 2 2 T-Shape 2540 4 Way 3 3 T-Shape 2550 4 Way 3 3 Gatlin-Shape 2440 5 Way 4 4 Gatlin-Shape Applicable Standards for medical tapered port connections: Hans Rudolph s 5mm, 22mm & 30mm tapered port connections meet the ISO 5356-:205 (E) Standard for Conical Connectors, Cones and Sockets. Other non-standard tapered port connections 7.5mm & 0.5mm are also designed with the same conical taper specifications. General Information Intended Use Inflatable Balloon-Type valves are designed for use as a directional flow control valve in a respiratory circuit. These valves can be assembled with two way non-rebreathing valves to provide additional functions as required by the application. These valves contain a proprietary inflatable silicone rubber balloon that when inflated occludes (closes off) a flow bore of the valve. When the balloon element is not inflated air flow is allowed through that flow bore of the valve. Valves are designed as oneway through five-way configurations. Typical applications are pulmonary function testing, exercise testing and respiratory research. These valves are not designed to be used in life support systems such as a ventilator circuit. The inflatable balloon component of the valve is a replacement item that will rupture after several thousand inflations. Pneumatic controllers are available for these valves. PRINTED IN U.S.A. PRINTED IN 6906-205-08-25 Rev. J PRINTED IN U.S.A. U.S.A. 6906-6906- 203-2-3 203-2-3 Rev. Rev. II Refer to Instructions for Use 6998 and Service Manual 693 shipped with the Inflatable Balloon-Type Valves and Pneumatic Controller for product cleaning, disinfection, operating instructions and maintenance. Controller information refer to Data Sheet 692 Manual Pneumatic Hand Control Switch for one or two balloon valves requires a regulated 6 PSI source refer to Data Sheet 69096 for one balloon and Data Sheet 69097 for two balloon switches These Products are packaged and shipped clean, non-sterile Other Inflatable Balloon-Type Valves configured with 2 Way NonRebreathing for specific applications: 8200 Series for Cardiac Output CO₂ Rebreathing Setup (Data Sheet 69097) 9300 Series for Inspiratory Occlusion Pressure Setup (Data Sheet 69096) Cautions. These valves are not intended for use in a ventilator or other life support system 2. Do not ethylene oxide, steam sterilize or pasteurize these valves 3. Federal (USA) law restricts these devices to sale by or on the order of a physician Warnings & Risks Refer to the Instructions for Use 6998 shipped with the product Ambient Conditions Temperature: 5ºC to 40ºC Relative Humidity: 0% - 95% (non-condensing) Prices and Specifications subject to change without notice Prices Prices & & Specifications Specifications subject subject to to change change without without notice notice ISO 900 / ISO 3485 ISO 900 / ISO 3485 0086 203 Hans Rudolph, inc. 0086 203 Hans Rudolph, inc.

Product Description The Hans Rudolph line of Inflatable Balloon-Type directional control valves are designed specifically for use in respiratory circuits where a valve is required for directional control in the breathing circuit. These valves contain a proprietary inflatable silicone rubber balloon assembly that when inflated occludes (closes off) a flow bore of the valve. Valve configurations are available with one (one-way) through four balloons (five-way) depending on the directional control requirements of the circuit design. The inflatable balloon component will operate for several thousand inflations and is easily replaceable in the field. Controllers are available for use with these valves for manual and external input control of the balloon valve actuation. Typical applications include pulmonary function testing, exercise testing, and primarily respiratory research. Product Features Valve housings machined and polished of clear Acrylic for balloon actuation visualization Balloon inflation and deflation actuation is quick at 20 ms response time Minimal valve breathing resistance to flow Minimal valve rebreathing dead space volume Three standard port sizes available Port connections thread into valve housing for ease of changing sizes Pneumatic Controllers available for one through four balloon valves Pneumatic hand controls available for one and two balloon valves Sampling ports standard at the common port on all valves Custom configurations of valves available Custom connections (medical tapered, o-ring slip-fit, coupler lock-ring assembly) available Reusable Specifications Applicable Standards for medical tapered port connections: Hans Rudolph s 5mm, 22mm & 30mm tapered port connections meet the ISO 5356- :205 (E) Standard for Conical Connectors, Cones and Sockets. Other non-standard tapered port connections 7.5mm & 0.5mm are also designed with the same conical taper specifications. General Information Intended Use Inflatable Balloon-Type valves are designed for use as a directional flow control valve in a respiratory circuit. These valves can be assembled with two way non-rebreathing valves to provide additional functions as required by the application. These valves contain a proprietary inflatable silicone rubber balloon that when inflated occludes (closes off) a flow bore of the valve. When the balloon element is not inflated air flow is allowed through that flow bore of the valve. Valves are designed as one-way through five-way configurations. Typical applications are pulmonary function testing, exercise testing and respiratory research. These valves are not designed to be used in life support systems such as a ventilator circuit. The inflatable balloon component of the valve is a replacement item that will rupture after several thousand inflations. Pneumatic controllers are available for these valves. Refer to Instructions for Use 6998 and Service Manual 693 shipped with the Inflatable Balloon-Type Valves and Pneumatic Controller for product cleaning, disinfection, operating instructions and maintenance. Controller information refer to Data Sheet 692 Manual Pneumatic Hand Control Switch for one or two balloon valves requires a regulated 6 PSI source refer to Data Sheet 69096 for one balloon and Data Sheet 69097 for two balloon switches These Products are packaged and shipped clean, non-sterile Other Inflatable Balloon-Type Valves configured with 2 Way Non-Rebreathing for specific applications: 8200 Series for Cardiac Output CO₂ Rebreathing Setup (Data Sheet 69097) 9300 Series for Inspiratory Occlusion Pressure Setup (Data Sheet 69096) Cautions. These valves are not intended for use in a ventilator or other life support system 2. Do not ethylene oxide, steam sterilize or pasteurize these valves 3. Federal (USA) law restricts these devices to sale by or on the order of a physician Warnings & Risks Refer to the Instructions for Use 6998 shipped with the product Ambient Conditions Temperature: 5ºC to 40ºC Relative Humidity: 0% - 95% (non-condensing) The 4 PICS and text under the PICS is fine leave as is. PRINTED IN U.S.A. 6906-2 205-08-25 Rev. J Prices and Specifications subject to change without notice

6906-3 205-08-25 Rev. J Prices and Specifications subject to change without notice

6906-4 205-08-25 Rev. J Prices and Specifications subject to change without notice

6906-5 205-08-25 Rev. J Prices and Specifications subject to change without notice

6906-6 205-08-25 Rev. J Prices and Specifications subject to change without notice

HOUSING (TWO BALLOON VALVE) BALLOON ASSEMBLY 9308 O-RINGS RETAINING RING GAS SUPPLY HOSE BARBS SHOULDER PNEUMATIC HOUSING CENTER PIECE (DOUBLE BALLOON) RETAINING RING GAS SUPPLY HOSE BARB COMMON PORT / MOUTH PORT TUBE PNEUMATIC HOUSING BALLOON ASSEMBLY 9308 HOUSING (FOUR BALLOON VALVE) O-RINGS INLET / OUTLET PORT TUBE CENTER PIECE (SINGLE BALLOON) SHOULDER PRINTED IN U.S.A. 6906-7 205-08-25 Rev. J Prices and Specifications subject to change without notice

6906-8 205-08-25 Rev. J Prices and Specifications subject to change without notice