HANS RUDOLPH
Volume Calibration Syringes
HANS RUDOLPH Cleaning, Disinfecting, Sterilizations and Maintenance Guides Rev H June 2021
Cleaning, Disinfecting, Sterilizations and Maintenance Guides
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MAKERS OF RESPIRATORY VALVES SINCE 1938
HANS RUDOLPH, inc. www.rudolphkc.com
TEL: (913) 422-7788 U.S.A. & CANADA (800) 456-6695 FAX: (913) 422-3337 E-Mail: [email protected] 8325 COLE PARKWAY, SHAWNEE, KANSAS 66227 U.S.A.
MD MEDICAL DEVICE
HANS RUDOLPH INC. VOLUME CALIBRATION SYRINGES INSTRUCTIONS FOR USE
EN
DE
FR
Instructions For Use
E C Rep Ltd. 5 Fitzwilliam Square East Dublin 2, D02 R744 Ireland Tel: +353 1 2 544 944 Email: [email protected]
VOLUMENEICHSPRITZEN HANS RUDOLPH INC. GEBRAUCHSANWEISUNG
HANS RUDOLPH INC. SERINGUES DE CALIBRATION VOLUMETRIQUE INSTRUCTIONS D'UTILISATION IT
SIRINGHE DA CALIBRAZIONE DI VOLUME HANS RUDOLPH INC. ISTRUZIONI PER L'USO
ES JERINGA PARA CALIBRACIÓN DE VOLUMEN HANS RUDOLPH INC. INSTRUCCIONES DE USO NL HANS RUDOLPH INC. VOLUME-IJKSPUITEN INSTRUCTIES VOOR HET GEBRUIK SV
HANS RUDOLPH, INC. VOLYMKALIBRERINGSSPRUTOR BRUKSANVISNING
(C) Outlet Port
5530 Series 3 Liter 4900 Series 7 Liter 5550 Series ½ Liter 5540 Series 1 Liter
(B) Cylinder Assembly (G) End Plate (A) Zero Graduation
(D) Volume Output Graduations
(F) Stationary DATUM Collar
(E) Adjustable Locking Stop Collar
(H) Locate Locking Stop Collar & End Plate on Center of Graduation Line
5520 Series 10 Milliliter 5510 Series 100 Milliliter
5570 Series 3 Liter
Groove in Plunger Rod
PRINTED IN U.S.A. 691203-1 Rev. H 2021-06-10
(F) Stop Collar
(E) Positive Adjustable Locking Stop Collar
(Semi-permanently Set at Calibration)
(Ball Plungers Mate with Calibration Grooves in Piston Rod)
• Prices & Specifications subject to change without notice •
2021
A.
Intended Use and Indications for Use
Volume Calibration Syringes are designed for testing and calibrating respiratory flow and volume measurement devices. These Calibration Syringes are manually operated by actuating the piston rod in and out of the cylinder assembly. The outlet port of the Syringe assembly is attached to the device under test. The Calibration Syringe, when actuated, displaces known volumes of air into the flow or volume measurement device. The operator compares the calibraion syringe volume with the results obtained from integrating the flow or reading the displaced volume of the measurement device to determine its accuracy. The respiratory flow devices are typically part of spirometer systems, pulmonary function testing systems, or ventilators. Calibration Syringes are used in pulmonary function test laboratories (both hospitals and clinics), bio-medical engineering calibration laboratories, private physician offices, universities, research centers, and by manufacturers of respiratory systems. The Syringes are used by individuals trained to perform the calibration procedures on the equipment under test.
PRINTED IN U.S.A. 691203-2 Rev. H 2021-06-10
• Prices & Specifications subject to change without notice •
2021
G. H. I. J.
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Step 3 Functional Test 1. Leak test the calibration syringe by occluding the outlet port with one hand or plug while pushing on the piston rod with the other. With your ear close to the piston rod end plate listen for a hissing sound indicating a leak. 2. Visually verify the displacement stop positions for location at zero and the desired volume output positions have not moved. 3. Volume displacement of the syringe should be periodically checked on an in-house volumetric standard or a third party test lab approved for this measurement. The syringe should perform within it's stated accuracy when used for calibration or verification. Step 4 Recalibration Recalibration at Hans Rudolph is recommended once per year. A calibration due date is labeled on each syringe from the date of manufacture or from date of first use. Step 5 Storage Calibration syringes should be stored in a way that prevents recontamination of the internal volume of the syringe. Each syringe is shipped with a plastic plug in the outlet port. 1. Place the plastic plug into the syringe outlet port to prevent contamination of the internal volume of the syringe. Each syringe is shipped with a plastic plug in the outlet port. 2. Place the syringe assembly in a clean plastic bag and close the end. Service Life / Reuse Life Hans Rudolph calibration syringes when maintained properly and recalibrated on a regular basis (annual) should function within specification for several years. Visual inspection of all the components of the assembly along with the functional tests as described will identify a defective syringe. Ambient Conditions Temperature Range: 5oC to 40oC Humidity Range: 0 - 95% RH (non-condensing) Caution: United States law restricts this device to sale by or on the order of a physician. Residual Risks The following negligible to minor risks are applicable to all HRI Calibration Syringes 1. A device is incorrectly or not calibrated 2. Syringe falls on a person causing injury 3. Microbe contamination of the outer surfaces of the Syringe causes infection Warnings 1. HRI Calibration Syringes are not intended for direct or indirect connection to patients (or animals) for purposes of conducting diagnostic tests or for ventilation or generation of pressure-volume curves by insufflations of a patientʼs (or animals) lungs. There are no safety mechanisms built into the Syringes and the inside of the Syringes cannot be disinfected without damage. 2. Do not attempt to sterilize these calibration syringes. 3. Do not disassemble this product, contact Hans Rudolph, inc. for service information. 4. Potential hazard of incorrect calibration of diagnostic and ventilator flow or volume transducer. 5. Potential bodily injury if syringe falls or rolls from table. 6. Potential for contamination of syringe from hospital or other contaminants. Safety Information Safety or technical information regarding Hans Rudolph calibration syringes can be obtained from Hans Rudolph, inc. phone 913-422-7788, USA & Canada 800-456-6695, fax 913-422-3337, email: [email protected] or by contacting your Hans Rudolph representative. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Recommendation for Disposal Treat as conventional solid waste in accordance with local and federal regulations.
PRINTED IN U.S.A. 691203-3 Rev. H 2021-06-10
• Prices & Specifications subject to change without notice •
2021
E) Feststellmanschette, verstellbar
F) Feststellmanschette, feststehend
E) Collarino di bloccaggio regolabile E) Collarín de Bloqueo Ajustable
F) Collarino di bloccaggio stazionario
F) Collarín de Bloqueo Estacionario
E) Bague de blocage, adjustable F) Bague de blocage, fixe
E) Regelbare klemring F) Vaste klemring
E) Låskrage, justerbar F) Låskrage, stationär
PRINTED IN U.S.A. 691203-4 Rev. H 2021-06-10
• Prices & Specifications subject to change without notice •
2021