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Part No. 00SM-0105-6

February 2005

Smiths Medic

Smiths Medical MD, Inc.

al MD, Inc.

1265 Grey Fox Road, St Paul, MN 55112, U.S.A.

European Representative:
Smiths Medic

Smiths Medic

Smiths Medical Int

al Int

al International Limit

ernational Limit

ernational Limited

Watford, Herts, UK, WD24 4LG
www.smiths-medical.com

Smiths Medical - A part of Smiths Group plc

SM0105-COV-6.PMD

2/23/2005, 12:12 PM

Содержание Graseby MS16A

Страница 1: ...d and understood the contents of the complete manual including the warnings and cautions and have been trained in the correct use of the product Smiths Medical cannot be held responsible for the accuracy and any resulting incident arising from information that has been extracted from this publication and compiled into the users documentation This publication maybe subject to revision and it is the...

Страница 2: ...Technical Service Manual Part Number 00SM 0105 6 Issue 6 February 2005 2005 Smiths Medical family of companies All rights reserved Graseby MS16A Syringe Driver SM0105 COV 6 PMD 2 23 2005 12 12 PM 1 ...

Страница 3: ... rights reserved No part of this publication may be reproduced transmitted transcribed or stored in a retrieval system or translated into any human or computer language in any form or by any means without the prior permission of Smiths Medical Smiths Medical MD Inc 1265 Grey Fox Road St Paul MN 55112 U S A European Representative Smiths Medical International Limited Watford Hertfordshire United Ki...

Страница 4: ... i t h s M e d i c a l D R O C E R E U S S I e u s s I o N e g n a h c r o f n o s a e R s e g a P d e t c e f f e e t a D 5 l a u n a M f o e u s s i e R l l A 0 0 0 2 y a M 6 e t a r o p r o C d e d d a s t n a i r a v S U d n a x o b k c o L e g n a h c d i l l A 5 0 0 2 y r a u r b e F SM0105 CON 6 PMD 2 23 2005 12 12 PM 2 ...

Страница 5: ...river operation information only z MS16A Syringe Driver MS26 Syringe Driver Instruction Manual part number 0105 0549 A Smiths Medical service contacts In the event of any queries or problems that cannot be resolved by this manual please contact the appropriate Service Repair Centre UK address SMITHS MEDICAL INTERNATIONAL LIMITED Repair Centre WATFORD WD24 4LG ENGLAND TEL 44 0 1923 246434 FAX 44 0 ...

Страница 6: ...sion pressure 2 3 Controls 2 3 Alarm 2 3 Indicator 2 4 Battery type 2 4 Battery life 2 4 Accuracy of delivery 2 4 Dimensions 2 4 Weight 2 4 Operating conditions 2 4 Transport and storage 2 4 Materials 2 4 Standards 2 5 Electrical safety 2 5 EMC 2 5 Biological evaluation 2 5 Packaging 2 5 Medical device directive 93 42 EEC 2 5 Quality system standards used 2 5 Symbols 2 5 Disposal 2 6 Chapter 3 Cir...

Страница 7: ...and bearing assembly 4 9 Case assembly 4 10 Lockbox 4 12 Chapter 5 Service Test Procedures Service Test Procedures 5 3 Tools and equipment 5 3 Adjustments potentiometers 5 4 Service Testing 5 5 Cam follower adjustment 5 5 9 Volt thrust test 5 7 7 Volt thrust test 5 7 Guard test 5 8 Flash frequency 5 8 Timer and feed rate tests 5 8 Cam alignment 5 9 Half nut slip 5 9 Rate switch test 5 9 Current te...

Страница 8: ...ded view 4 4 4 2 Release piezo transducer assembly 4 6 4 3 Orientation of dials and rate switches 4 7 4 4 Foam pad position 4 8 4 5 Piezo transducer wiring 4 9 4 6 Sealant application 4 10 4 7 Lockbox 4 12 5 1 Cam and cam follower 5 5 5 2 Camswitch operating timing 5 5 5 3 Typical waveform for one pulse 5 6 5 4 Using the cam adjustment tool 5 7 5 5 Thrust rig set up 5 7 6 1 Battery replacement 6 4...

Страница 9: ...t and the syringe before measuring the mm of fluid length otherwise the rate calculation will be incorrect 3 The driver must only be used with the syringe rubber securing strap fixed firmly in place thus preventing an uncontrolled infusion to the patient that could result in serious injury or death 4 Never take a syringe that is not empty off the driver if it is still connected to the patient The ...

Страница 10: ...Failure to observe this caution may cause serious damage to the pump 4 To avoid possible malfunction of the pump do not expose the pump to X rays gamma rays or other ionizing radiation or to the RF interference or strong electric magnetic fields emitted for example by arc welding equipment or mobile transmitting equipment 5 Moving parts of the driver do not require lubrication during their lifetim...

Страница 11: ...iation Meaning ABS Acrylonitrile Butadiene Styrene C Centigrade or capacitor cNm Centinewton metre DC Direct Current gm grams h hr hour hPa Hectopascal 100 pascals IC Integrated Circuit Kg Kilogram Kgf Kilogram force KHz Kilohertz LED Light Emitting Diode ml Millilitre mm Millimetre N Newton PCB Printed Circuit Board R Resistor RH Relative Humidity Sec Second SW Switch TR Transistor V Volts SM0105...

Страница 12: ...M S 1 6 A S y r i n g e D r i v e r P a g e x I s s u e 6 F e b r u a r y 2 0 0 5 Te c h n i c a l S e r v i c e M a n u a l S m i t h s M e d i c a l SM0105 CON 6 PMD 2 23 2005 12 12 PM 10 ...

Страница 13: ...1 Graseby MS16A Syringe Driver Chapter 1 Product Overview SM0105 1 6 PMD 2 23 2005 2 54 PM 1 ...

Страница 14: ...plunger is operated by a linear actuator at rates ranging from 1 to 99 mm hour mm PER The rate required is set by adjusting two digital rotary switches Most brands of syringe can be fitted to the driver and the volumetric delivery depends on the size of the syringe being used A millimetre scale is provided on the front of the driver to measure the stroke length of the syringe so that the rate in m...

Страница 15: ...M0307 A 0 Figure 1 3 MS16A Controls Operation Note For detailed operating information refer to the MS16A MS26 Instruction Manual part number 0105 0549 To start an infusion fit a primed syringe and press the START TEST pushbutton When held down the START TEST pushbutton tests a safety cut out circuit When released it starts the drive circuit Once started the front panel LED flashes approximately ev...

Страница 16: ...cked set The MS16A packed set part number 0105 0504 is supplied with the following items 1 MS16ASyringe Driver 2 Battery type IEC 6LR61 3 Instruction manual 4 Rate adjuster 5 Shoulder holster not US version 6 Clear cover not shown Figure 1 4 Package contents SM0105 1 6 PMD 2 23 2005 2 54 PM 5 ...

Страница 17: ...and the 0105 0108 non slip base syringe drive on a flat surface Cover Clear rigid plastic to protect the syringe 0105 0529 driver and syringe Holster Washable soft fabric holster with cover 0105 0027 Instruction manual Instructions for use Guide to subcutaneous 0105 0549 analgesia technical and performance specifications Rate adjuster Tool to turn slotted rate switches 0105 0023 Training pack A fu...

Страница 18: ...2 Graseby MS16A Syringe Driver Chapter 2 Specification and Standards SM0105 2 6 PMD 2 23 2005 2 55 PM 1 ...

Страница 19: ...racy The accuracy of the linear drive mechanism that pushes the syringe plunger forward 5 Drive force The force the linear drive mechanism that pushes the syringe plunger forward can produce 3 Kg Actuator movement 0 12 mm every time motor turns Actuator stroke 60 mm available depends on syringe Syringe sizes 2 ml to 35 ml The holster supplied will enclose most types of syringe up to 20 ml capacity...

Страница 20: ...plus or minus 5 of the rate set on the rotary switches Dimensions without syringe Height 53 0 0 5 mm Width 166 0 1 0 mm Depth 23 0 1 0 mm Weight including battery 190 gm Operating conditions 10 C to 40 C 30 to 75 RH non condensing 700 hPa to 1060 hPa Transport and storage conditions 40 C to 70 C 10 to 100 RH non condensing 500 hPa to 1060 hPa Materials Case and battery cover ABS RTA 50 injection m...

Страница 21: ...tests Packaging Complies with EN 20780 1993 Packaging Pictorial marking for handling of goods Medical device directive 93 42 EEC CE marked under Annex II risk class IIb active medical device Notified Body AMTAC 0473 Quality system standards used EN ISO 9001 and EN 46001 Symbols An electrical safety classification in the international safety standard for medical electrical equipment Type BF If the ...

Страница 22: ...ful substances First discharge the battery Do not open up the battery or incinerate it as it could explode Contact your local waste disposal service to find out about special recycling or disposal schemes Separate any other parts of the driver where arrangements can be made for their recovery either by recycling or energy recovery Important Existing national or local regulations concerning waste d...

Страница 23: ...3 Graseby MS16A Syringe Driver Chapter 3 Circuit Descriptions SM0105 3 6 PMD 2 23 2005 2 56 PM 1 ...

Страница 24: ...damage if the battery polarity is reversed Motor drive In the operation mode IC1 pin 21 produces a square wave pulse train the frequency of which is determined by the setting of the Set Rate rotary switches SW4 and SW5 When the output from IC1 pin 21 goes high transistor TR2 is turned on and TR1 is turned off With the cam operated switch SW3 in the position shown in Figure 3 1 the motor circuit is...

Страница 25: ...e the motor runs for less than 3 7 seconds so the guard circuit only operates when the motor is stalled e g when the syringe is empty or when the delivery line is occluded if a transistor or the cam operated switch fails or when the START TEST pushbutton is held depressed Secondary guard If the main oscillator ever fails the run time of the motor is limited by a secondary guard circuit When the mo...

Страница 26: ... feature of IC1 is that this area of circuitry is completely separated within the silicon chip by a diffusion well and has a separate power supply VSS Protection against overdosing is provided by three basic concepts 1 Breaking the motor current by the cam operated microswitch 2 The complementary master slave action of transistors TR1 and TR2 3 The Guard circuit with two methods of activation Low ...

Страница 27: ...e 6 February 2005 Technical Service Manual S m i t h s M e d i c a l 3 6 3 M S 1 6 A S y r i n g e D r i ve r Figure 3 1 MS16A Circuit diagram SW2 SW3 SW1 A GM1193 D 1 F m SM0105 3 6 PMD 2 23 2005 2 56 PM 6 ...

Страница 28: ...Te c h n i c a l S e r v i c e M a n u a l Issue 6 February 2005 3 7 S m i t h s M e d i c a l 3 MS16A Syringe Driver Figure 3 2 MS16A Printed circuit board layout SM0105 3 6 PMD 2 23 2005 2 56 PM 7 ...

Страница 29: ...4 Graseby MS16A Syringe Driver Chapter 4 Disassembly and Assaembly SM0105 4 6 PMD 2 23 2005 2 56 PM 1 ...

Страница 30: ...t boards is required during disassembly assembly A static controlled work station including a conductive mat and grounded wrist strap should be used to provide protection against electrostatic discharge ESD or circuit board damage could result The following procedures describe the dismantling and assembly sequence when replacing parts If the case halves are separated the complete test routine see ...

Страница 31: ... a l 4 4 4 M S 1 6 A S y r i n g e D r i v e r Figure 4 1 MS16A exploded view 5 6 7 8 9 4 3 0 1 2 3 4 9 7 3 4 5 6 7 8 9 2 10 1 0 2 3 9 8 7 6 5 4 10 11 10 12 26 22 24 25 1 2 9 GM1198 B 8 3 4 7 21 23 13 14 15 16 19 18 17 20 27 28 29 6 5 SM0105 4 6 PMD 2 23 2005 2 56 PM 4 ...

Страница 32: ...ng disassembly a Separate the case halves and remove the leadscrew and bearing assembly as above b Remove the back bearing item 20 from the end of the leadscrew c Depress the plunger half nut item 18 on the actuator assembly item 19 and slide the actuator off the leadscrew at the back bearing end When the half nut and spring are freed from the leadscrew ensure that they are not mislaid Ensure that...

Страница 33: ...sh the clip through whilst gently holding the transducer assembly Figure 4 2 Release piezo transducer assembly f To remove the PCB assembly completely unsolder the motor gearbox assembly item 14 from the PCB g Ensure that all traces of sealant if applied are removed from mating surfaces 5 Motor and gearbox disassembly a Separate the case halves and remove the leadscrew and bearing assembly as desc...

Страница 34: ...s correctly wired to the PCB blue to TP1 red to TP2 black to TP3 When reassembled ensure that the three pegs on the transducer base are located in the holes in the PCB a Fit the two rate dials items 11 and 12 on the rate switches SW4 and SW5 items 26 A rubber seal item 10 must be fitted firmly into the groove in each of the dials i Place the two dials face upwards on the bench side by side so that...

Страница 35: ...ver the PCB and hold it in position Turn the PCB and case over so that the PCB is uppermost Check that the leads for the motor and battery connector springs are not trapped Figure 4 4 Foam pad position d Push the battery connector springs into their slots Red to and Black to ve as shown on the battery compartment label e Secure the PCB in position with five screws and fibre washers The switch pin ...

Страница 36: ...nd Figure 4 1 shows the correct way the actuator item 18 faces c Fit the back bearing to the end of the leadscrew d Assemble the leadscrew and bearing assembly 4 Leadscrew and bearing assembly a Align the pin on the leadscrew and bearing assembly with the slot in the cam assembly and press the leadscrew into position b Ensure that both front and back bearings fit snugly in their recess in the case...

Страница 37: ... sets NOTES 1 2 3 0 5 1 5 mm to shaded area Extra sealant required in battery contact area Leave this region free of sealant Figure 4 6 Sealant application a Ensure that alternate motor pulses do not differ by more than 20 See Chapter 5 Testing Cam Adjustment b Ensure that all traces of original sealant are removed c Check that mating faces are clean and dry using an isopropyl alcohol cleaner d Ap...

Страница 38: ... the sealant selected Note Ensure that the serial number label item 4 is fitted and complete g Fit the battery observing the correct polarity as shown by the illustration in the battery compartment The alarm sounds for about 15 seconds If this does not happen fit a new battery h Refit the battery compartment cover j Complete tests specified in Chapter 5 Testing SM0105 4 6 PMD 2 23 2005 2 56 PM 11 ...

Страница 39: ...ver in the box mm PER arrow pointing to the lock 3 Ensure the retaining pip clicks into the recess on the driver 4 Close and lock the lid ensuring that the patient line exits via the slot above the key CAUTION Always ensure that the tubing is not kinked or trapped Removal To remove the driver from the lockbox unlock the box and open the lid Ease the retaining pip from the side of the driver and re...

Страница 40: ...5 Graseby MS16A Syringe Driver Chapter 5 Service Test Proceedures SM0105 5 6 PMD 2 23 2005 3 07 PM 1 ...

Страница 41: ...ticularly if they ve been accidently maltreated Although the case is sealed it is not intended to be fully waterproof It is merely a matter of good practice to check the functionality of a unit before using it in a patient critical situation Tools and equipment The following tools and equipment are required to complete the adjustments tests and calibrations Description Part number Cam adjustment t...

Страница 42: ...ust is located directly above the LED VR5 is near the top When adjustments have been completed it may be necessary to replace the front panel label if it does not adhere when pressed back in position When replacing the label ensure that the small clear plastic window is in its recess over the rate dials Notes If any unit is found to be over or under infusing during testing inform your local RAQA D...

Страница 43: ...transition causes the motor current to be cut off Pulses 1 3 and 5 will be terminated by the microswitch MAKING and pulses 2 4 and 6 will be terminated by the microswitch BREAKING the circuit The motor must be restarted with a fresh command to continue making the system inherently safe in operation Pulses 1 3 and 5 are likely to be very similar to each other as are pulses 2 4 and 6 If wear or dama...

Страница 44: ...e of the waveform where it is cut off by the cam s action Volts 0 00 0 05 0 10 0 15 0 20 0 25 0 30 0 35 0 40 0 45 0 50 0 55 0 60 0 65 Time seconds Cam Period Cam Period 0 16 0 14 0 12 0 10 0 08 0 06 0 04 0 02 0 MS16 Motor Pulses GM0105_8044 GB B Figure 5 3 Typical waveform for one pulse The variation in duration of the six consecutive pulses in each revolution should not be more than 20 If necessa...

Страница 45: ...tment tool 2 9 Volt thrust test a Fit the dummy case to the driver b Ensure that the battery and battery cover are removed c Load the unit onto the Thrust rig as shown in Figure 5 5 Thrust rig set up Set the actuator 50 mm from end of travel Syringe Driver Actuator assembly GM1276 D Thrust test rig Figure 5 5 Thrust rig set up SM0105 5 6 PMD 2 23 2005 3 07 PM 7 ...

Страница 46: ...tor pulses Load the actuator with a 3 Kg load The unit must run for six or more motor pulses without stalling c Reset the power supply to 9 V DC d Remove the driver from the Thrust rig 4 Guard test a Temporarily short pin 20 IC1 to rail Hold down the START TEST pushbutton and check that the motor starts and then stops in 5 10 seconds b Remove the short from pin 20 5 Flash frequency a Set rate to 0...

Страница 47: ... a single motor pulse 7 Cam alignment Increase power supply to 10 V DC and check that six pulses equals one revolution of the leadscrew 8 Half nut slip Set the supply at 10 V DC and rate at 99 Check for correct stalling The LED must stop flashing the alarm must sound and the half nut must not slip when the actuator runs to the end of the leadscrew Repeat at least twice 9 Rate switch test a Set rat...

Страница 48: ...ngth and lasting 5 20 seconds is produced 12 General a Check that both case halves are in good condition and that all interior screws are present and tightened b Remove the dummy case and fit the rear case see Chapter 4 Case assembly c Affix new front label if required and seal unit d Clean the unit and fix the appropriate Service Label e Ensure that the History record sheet is completed SM0105 5 ...

Страница 49: ...t o m s c e s 5 3 3 x a m s c e s 0 3 n i M c 6 0 1 e m i t 9 9 o t s e h c t i w s e t a r t e S s e s l u p r o t o m s c e s 5 4 x a m s c e s 0 4 n i M d 6 n u r d l u o h s T S E T T R A T S d l o H t u o t u c n e h t s c e s 4 3 p o t s r o t o m r e t f a s d n o c e s w e f r o f s d n u o s r e d n u o S d e t a e p e r e b n a c r u o i v a h e B e 6 n o t t u b h s u p e s a e l e R y ...

Страница 50: ...6 Graseby MS16A Syringe Driver Chapter 6 Maintenance SM0105 6 6 PMD 2 23 2005 3 03 PM 1 ...

Страница 51: ... to the Department of Health publication SAB 94 26 July 1994 we recommend that for any of our products that have been dropped or subjected to severe fluid spills should be removed from use immediately and be checked by a qualified technician Cleaning Warnings To prevent serious damage to the driver it must not be immersed in any liquids or exposed to strong organic solvents Wipe off spills immedia...

Страница 52: ...attery replacement 3 Turn the driver upside down and carefully remove and discard the battery ensure that national or local regulations concerning battery disposal are followed 4 Insert a new battery into the battery compartment ensuring correct polarity as shown by the illustration in the battery compartment Notes The driver is protected against the effects of accidental reverse polarity of the b...

Страница 53: ...zo transducer assembly are secured with an adhesive pad to the motor clamp carefully lift the leads from the pad 4 Pull the battery connector springs from their locating slots and lift out the PCB assembly complete with microswitches and motor and gearbox assembly The START TEST pushbutton seal and switchplate may remain in the case 5 Remove the PCB completely 6 Remove capacitor C5 and resistor R1...

Страница 54: ...u l p e g n i r y S e s a c r o r o t a u t c a e h t n i d l e h t o n s p i r g y l t c e r r o c y l g n o r w d e r u s a e m n o i t i s o p r e g n u l P r e g n u l p e h t r e t f a d e l l i f s a w e n i L d e r u s a e m s a w n o i t i s o p A 6 1 S M e h t n o 6 2 S M r o f t e s e t a R t e w e m o c e b s a h r e v i r d e g n i r y S r o r r e t c e r r o C r o r r e t c e r r o C ...

Страница 55: ...7 Graseby MS16A Syringe Driver Chapter 7 Parts List SM0105 7 6 PMD 2 23 2005 2 59 PM 1 ...

Страница 56: ...ked label will be issued It is the responsibility of the owner to ensure that the correct labels are replaced on the Syringe Driver Non CE marked English 0105 0023 Non CE marked MS16 only English 0105 0118 Non CE marked French 0105 0109 Non CE marked German 0105 0119 Non CE marked Dutch 0105 0578 Non CE marked Italian 0105 0581 CE marked English 0105 0563 CE marked Spanish 0105 0565 CE marked Germ...

Страница 57: ...Issue 6 February 2005 Technical Service Manual Smiths Medical 7 4 MS16A Syringe Driver 7 Figure 7 1 Exploded view of the MS16A Syringe Driver SM0105 7 6 PMD 2 23 2005 2 59 PM 4 ...

Страница 58: ...sembly Camspring 16 Leadscrew and bearing assembly 0105 0031 17 Actuator body 0105 0116 18 Blue Half nut Button assembly 0105 0801 19 Actuator assembly 0105 0041 consists of the following parts Blue Half nut Button Actuator body Actuator spring 20 End back bearing 0105 0011 21 Battery contact 0105 0069 22 PCB assembly 0105 0503 23 Spacer insulating 0105 0520 24 Switch pin insulator 0105 0542 25 Pi...

Страница 59: ...30 Instruction manual Not illustrated English 0105 0549 GMI USA 0105 0550 German 0105 0559 French 0105 0560 Italian 0105 0562 Spanish 0105 0564 Dutch 0105 0576 Danish 0105 0587 Swedish 0105 0592 Greek 0105 0604 Marcal Made in UK 0105 0629 31 Carrying case 0000 0001 Not illustrated 32 Syringe cover 0105 0529 Not illustrated 33 Syringe driver base 0105 0108 Not illustrated 34 Fabric holster 0105 002...

Страница 60: ...ber C4 C4 SW4 C1 R3 LK1 TR7 TR9 R17 D1 R2 TR3 R18 R16 TR8 TR2 TP3 TP2 TP1 SW3 C5 2 2 2 SW1 SW2 TR1 R1 IC1 C3 TR5 R13 D4 C2 TR4 R8 R7 3 3 3 1 1 1 M M 9V 0V 4 6 6 GM1228 A 1 3 5 5 2 6 8 7 6 7 D2 SW5 R4 D3 D5 R5 R9 R10 R12 LED R11 R19 MS16A PCB assembly 38 Service manual 00SM 0105 Not illustrated 39 Cam adjusting tool 0105 0079 Not illustrated 40 Spring test gauge assembly 0105 0083 Not illustrated 4...

Страница 61: ...l MD Inc 1265 Grey Fox Road St Paul MN 55112 U S A European Representative Smiths Medic Smiths Medic Smiths Medic Smiths Medic Smiths Medical Int al Int al Int al Int al International Limit ernational Limit ernational Limit ernational Limit ernational Limited ed ed ed ed Watford Herts UK WD24 4LG www smiths medical com Smiths Medical A part of Smiths Group plc SM0105 COV 6 PMD 2 23 2005 12 12 PM 4...

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