Vitalograph Cpmpact Precision Syringe Service Manual
Contents
1. Finally check that the Stroke Setting Tool just fits between the operating knob and the end plate with the piston fully withdrawn Copyright Vitalograph 2007 www distrimed com Vitalograph Syringe Service Manual 07184 Issue 1 DECLARATION OF CONFORMITY Product italographi Precision Syringe Vitalograph hereby ensures and declares that the above product associated with this manual is designed and manufactured in accordance with the following QMS regulations and standards e European Medical Devices Directive MDD 93 42 EEC This device classified as 2a as per Annex IX of MDD 93 42 EEC meets the following provisions of Annex II of the Medical Devices Directive as per 0086 Article 11 section 3a excluding point 4 of Annex II e Canadian Medical Device Regulation CMDR e FDA Quality System Regulation QSR 21 CFR 820 e EN ISO 13485 2003 Medical devices Quality management systems Requirements for regulatory purposes Certifying Body for 93 42 EEC and CMDR British Standards Institute BSI Certificate Nos CE 00772 MD 82182 FM 83550 Signed on behalf of Vitalograph Ireland Ltd B R Garbe Group Managing Director This Manual is intended for use only by suitably qualified medical device technicians who have been trained on the procedures in this manual Copyright Vitalograph 2007 10 Vitalograph Syringe Service Manual 07184 Issue 1 Guarantee Terms of Guarantee Subject to the conditions listed be2. is offered as an additional benefit to the Consumer s statutory rights and does not affect these rights in any way FDA Prescription Legend FDA Notice Caution Federal Law restricts this device to sale by or on the order of a physician Copyright Vitalograph 2007 11 Vitalograph Syringe Service Manual 07184 Issue 1 No PPM c o Rtalographi UKAS QUALITY MANAGEMENT Planned Preventive Maintenance Service Calibration Syringe Service Schedule Serial No Cal Syringe SNo Manufacturer Model PRE SERVICE REPORT RE ASSEMBLY Record of Pre Service Condition Re Grease Torque Allen Screws Accuracy 0 5 Pressure Check Leak test Rubber Feet DIS ASSEMBLE Piston Piston Valve FINAL INSPECTION Piston Seal Check Complete Assembly Piston Shaft amp Secure Affix Service Label Piston Shaft Handle Affix Calibration void label where applicable Check for condition amp wear of all components as Complete Calibration Certificate listed above RECORD KEEPING All components cleaned amp lubricated as necessary Post Service Accuracy Tolerance 0 5 Setting Tool No FRONT END PLATE Front End Plate Nozzle Reference Calibration Device used Front End Plate Valve Front End Plate O ring SPECIAL ADVICE TO USER REAR END PLATE Rear End Plate Sleeve Rear End Plate Adjusting Grub Screw Rear End Plate Anti Tamper Grub Screw Se
3. T Copyright Vitalograph 2007 Vitalograph Syringe Service Manual 07184 Issue 1 q q Vitalograph Syringe Service Manual 07184 Issue 1 Introduction The Precision Syringes manufactured by Vitalograph are intended to be used for checking the accuracy and linearity of Vitalograph Spirometers They can also be used to calibrate Vitalograph Spirometers if they have been calibrated to a standard reference and are within calibration date They are manually operated devices that conform to accuracy requirements specified by the American Thoracic Society Description of Syringe The syringes consist of a cylinder with an internal piston and piston seal end plates a handle and support rods The piston is connected to the piston rod with a plastic knob for manual operation 1 Litre Syringe End Plate FIGURE 1 MAIN COMPONENTS OF 1 LITRE SYRINGE Copyright Vitalograph 2007 www distrimed com Vitalograph Syringe Service Manual 07184 Issue 1 3 LITRE SYRINGE Piston Rod Handle E nd Plate End Plate Cyliner Support Rods Outlet Figure 2 Main Components of 3 Litre Syringe Performing a Test The syringes are operated by actuating the piston rod in and out of the cylinder assembly with the outlet port attached to the device under test When actuated the syringes displace known volumes of air into the flow device Accuracy is determined by comparing the volu
4. Vitalograph Syringe Service Manual 07184 Issue 1 italograph Precision Syringe Service Manual ce Copyright Vitalograph 2007 Vitalograph Syringe Service Manual 07184 Issue 1 Vitalograph Ltd Maids Moreton Buckingham MK18 1SW England Phone 01280 827110 Fax 01280 823302 e mail sales vitalograph co uk Vitalograph GmbH Jacobsenweg 12 22525 Hamburg Germany Phone 040 54 73 91 0 Fax 040 547 391 40 e mail info vitalograph de Vitalograph Inc 13310 West 99 Street Lenexa Kansas 66215 U S A Phone 913 888 4221 Fax 913 888 4259 e mail vitcs vitalograph com Vitalograph Irl Ltd Gort Road Business Park Ennis Co Clare Ireland Phone 065 6864100 Fax 065 6829289 e mail sales vitalograph ie Internet www vitalograph com Calibration service and repairs should be carried out only by the manufacturer the approved importer or by Service Agents specifically approved by Vitalograph There are no user serviceable components inside the equipment Copyright Vitalograph 2007 Current Edition Issue 1 Cat No 07184 fitalographi is a registered trademark Copyright Vitalograph 2007 TABLE OF CONTENTS INTRODUCTION DESCRIPTION OF THE PRECISION SYRINGE MAIN COMPONENTS OF THE PRECISION SYRINGE PERFORMING A TEST CLEANING INSTRUCTIONS TECHNICAL SPECIFICATIONS MAINTENANCE CONSUMABLES AND ACCESSORIES CALIBRATION DECLARATION OF CONFORMITY GUARANTEE PPM SERVICE SHEE
5. ational standards Calibration service and repairs should be carried out only by the manufacturer the approved importer or by Service Agents specifically approved by Vitalograph There are no user serviceable components inside the equipment For the names and addresses of approved Vitalograph Service Agents please contact any of your local Vitalograph distributors Copyright Vitalograph 2007 www distrimed com 6 Repairs and Spares Consumables Accessories 1Litre Syringe Spares Description Cylinder Seal Front End Plate O Ring Calibration Screw Lock screw Neoprene feet 4 pack Stroke setting tool Piston with valve Front end plate Molykote 111 silicone grease 3Litre Syringe Spares Description Cylinder Seal Front End Plate O Ring Calibration Screw Lock screw Syringe End Plate Stroke setting tool Molykote 111 silicone grease Copyright Vitalograph 2007 Cat No 3231 2spr 32313spr 33275 33276 32494spr 36110 36081spr 36089spr 32254spr Cat No 3231 2spr 32313spr 33275 33276 36118 36129 32254spr Vitalograph Syringe Service Manual 07184 Issue 1 Vitalograph Syringe Service Manual 07184 Issue 1 Calibration of Precision Syringe Equipment Required Description Vitalograph reference 3mm AF Allen Key 1 Litre Syringe Stroke Setting Tool 36110 3 Litre Syringe Stroke Setting Tool 36129 Note The Stroke Setting Tool should always be located on the first stepped face of the knob neares
6. low Vitalograph Ltd and its associated companies hereinafter called the Company guarantee to repair or at its opinion replace any component thereof which in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials The conditions of this Guarantee are 1 This Guarantee shall only apply to hardware defects which are notified to the Company or to its accredited distributor within 1 year of the date of purchase of the equipment unless otherwise agreed in writing by the Company 2 This Guarantee does not cover any faults caused by accident misuse neglect tampering with the equipment use of consumable items or parts not approved by the Company or any attempt at adjustment or repair other than by personnel accredited by the Company nor does it cover reinstatement of any configuration changes caused by the installation of any software 3 If a defect occurs please contact the supplier from whom it was purchased for advice The Company does not authorise any person to create for it any other obligation or liability in connection with Vitalograph equipment 4 This guarantee is not transferable and no person firm or company has any authority to vary the terms or conditions of this Guarantee 5 To the maximum extent permitted by law the Company does not accept liability for any consequential damages arising out of the use of or inability to use any Vitalograph equipment This Guarantee
7. me of the calibration syringe with the volume displayed on the flow measurement system of the connected device Cleaning Instructions The syringes are supplied clean and non sterile Non critical equipment should be kept visibly clean using mild detergent neutral pH 7 soap with tap water or standard hospital disinfectant cleaners Clean soft cloths should be used for wiping and drying Cleaning solutions or cloths should not be used inside the cylinder area of the syringe Disinfection or sterilisation is not required because the syringe will not come into contact with patients Copyright Vitalograph 2007 Vitalograph Syringe Service Manual 07184 Issue 1 Technical Specifications 1 Litre Syringe Volume Measurement 1L Measuring Accuracy 0 5 Operating Temperature 15 40C Safety Standards Medical Devices Directive 9342 EEC Gross Size 300mm x 170mm x 125 mm Gross Weight 2 5kg Storage Temperature 0 50 C Storage Relative Humidity 10 95 3 Litre Syringe Volume Measurement 3L Measuring Accuracy 0 5 Operating Temperature 15 40C Safety Standards Medical Devices Directive 9342 EEC Gross Size 500mm x 170mm x 125 mm Gross Weight 2 5kg Storage Temperature 0 50 C Storage Relative Humidity 10 95 MAINTENANCE A routine annual service and calibration certification on the syringes is strongly recommended The equipment used to perform the accuracy check should itself be certified and traceable to national or intern
8. t Zero Setting fitalograph Trained Service Technician hereby Certify this instrumentation to be safe and in proper working order Name Signature Copyright Vitalograph 2007 12 www distrimed com
9. t the shaft 1 Push piston of syringe in fully 2 Unscrew the spring loaded clearance setting part of syringe Stroke Setting Tool 3 Place spring loaded clearance setting part of tool between the underside of the syringe operating knob and the end plate Unscrew thumb lock and allow spring action to adjust length until it is a close fit between knob and end plate Lock again with thumbscrew Screw clearance setting part onto setting rod making sure it is fully home Withdraw the syringe piston to its full limit Place complete tool between the operating knob and the end plate Compare clearance between the operating knob and the end plate with the Stroke Setting Tool ove Copyright Vitalograph 2007 8 Vitalograph Syringe Service Manual 07184 Issue 1 Figure 3 Location of the Calibration Screw in the 1 Litre Syringe Calibration Screw Figure 4 Location of the Calibration Screw in the 3 Litre Syringe To adjust the stroke setting of the syringe the following procedure must be carried out 1 Remove the locking set screw to obtain access to the calibration screw which is positioned adjacent to the piston rod 2 Insert a 3 0mm AF Allen key and adjust as required Turning the screw clockwise shortens the stroke anti clockwise increases stroke 3 When the correct stroke is achieved lock the calibration screw firmly with the locking setscrew
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