Technical Service Manual
61 Pages
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Smiths Medical Publications This publication has been compiled and approved by Smiths Medical for use with their respective products. It is supplied in this format to permit users to access the text and illustrations for their own use e.g. training and educational purposes. Users of the equipment must ensure that they have read 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 users responsibility to ensure that the correct version of manual/ text/illustration is used in conjunction with the equipment.
Graseby® MS16A Syringe Driver
Technical Ser vice M a nu a l Part Number 00SM-0105-6 Issue 6 (February 2005) © 2005 Smiths Medical family of companies. All rights reserved.
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Published by Smiths Medical. All possible care has been taken in the preparation of this publication, but Smiths Medical, accepts no liability for any inaccuracies that may be found. Smiths Medical reserves the right to make changes without notice both to this publication and to the product which it describes. Copyright © 2005 Smiths Medical family of companies. All 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 Kingdom, WD24 4LG http://www.smiths-medical.com
Registered in England.
Company number 362847
Trademarks and acknowledgements: “Graseby” and “Smiths” are trademarks of the Smiths Medical family of companies. All other trademarks are acknowledged as the property of their respective owners.
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ISSUE RECORD Issue No.
Reason for change
5
Re-issue of Manual
All
May 2000
6
Lockbox and US variants added. Corporate i.d. change.
All
February 2005
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Scope of this manual This manual enables service personnel to service and repair the MS16A Syringe Driver. It has been updated to incorporate Lockbox information and the US variant.
Related manuals Refer to the following Instruction Manual when more detailed operating information is required. The Service Manual contains basic driver 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) 1923 447773
Web: www.smiths-medical.co.uk
USA service address MARCAL MEDICAL INC. 1114 BENFIELD BLVD, SUITE H MILLERSVILLE MARYLAND 21108-2540 TEL: (410) 987 4001
FAX: (410) 987 4004
Web: www.marcalmedical.com email: [email protected]
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Contents Chapter 1 - Product Overview Description ... 1 - 3 Controls ... 1 - 4 Operation ... 1 - 4 Packed set ... 1 - 5 Accessories and consumables ... 1 - 6
Chapter 2 - Specification and Standards Specification ... 2 - 3 Type ... 2 - 3 Infusion time ... 2 - 3 Rate range ... 2 - 3 Motor operating interval ... 2 - 3 Drive accuracy ... 2 - 3 Drive force ... 2 - 3 Actuator movement ... 2 - 3 Actuator stroke ... 2 - 3 Syringe sizes... 2 - 3 Occlusion 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 - Circuit Descriptions Circuit descriptions ... 3 - 3 Logic ... 3 - 3 Start ... 3 - 3 Motor drive ... 3 - 3 Primary guard ... 3 - 4 Secondary guard ... 3 - 4 Switch-off alarm ... 3 - 4 Test circuit ... 3 - 5 Safety features ... 3 - 5 Low battery indication ... 3 - 5 MS16A Circuit diagram ... 3 - 6 MS16A Printed circuit board layout ... 3 - 7
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Chapter 4 - Disassembly and Assembly General ... 4 - 3 Tools, equipment and materials required ... 4 - 3 Removal and dismantling procedures ... 4 - 5 Case separation ... 4 - 5 Leadscrew and bearing assembly removal ... 4 - 5 Actuator and back bearing disassembly ... 4 - 5 PCB removal ... 4 - 5 Motor and gearbox disassembly ... 4 - 6 Assembly procedures ... 4 - 7 Motor and gearbox assembly ... 4 - 7 PCB assembly ... 4 - 7 Actuator and bearing ... 4 - 9 Leadscrew 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 tests ... 5 - 9 Sounder check ... 5 - 10 General ... 5 - 10 Test Checklist - MS16A ... 5 - 11
Chapter 6 - Maintenance Maintenance... 6 - 3 Cleaning ... 6 - 3 Annual performance check ... 6 - 3 Battery replacement ... 6 - 4 Continuous alarm conversion ... 6 - 5 Basic troubleshooting ... 6 - 6
Chapter 7 - Parts List General assembly of the MS16A ... 7 - 3 MS16A PCB assembly ... 7 - 7
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Figures 1 - 1 MS16A Hourly rate syringe driver ... 1 - 3 1 - 2 Lockbox ... 1 - 3 1 - 3 MS16A Controls ... 1 - 4 1 - 4 Package contents ... 1 - 5 3 - 1 MS16A Circuit diagram ... 3 - 6 3 - 2 MS16A Printed circuit board layout ... 3 - 7 4 - 1 MS16A exploded 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 6 - 2 Continuous alarm conversion ... 6 - 5 7 - 1 Exploded view of the MS16A Syringe Driver ... 7 - 4 7 - 2 MS16A PCB assembly ... 7 - 7
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Warnings Warnings tell you about dangerous conditions that may occur, and which could lead to death or serious injury to the user or patient if you do not obey all of the instructions in this manual.
1.
Remember the rate is set in milliMETRES NOT milliLITRES. The correct rate is essential to prevent serious injury or death to the patient.
2.
Any damaged pumps must be thoroughly tested by a competent person in accordance with the procedures in this service manual before re-use with a patient. Failure to observe this may result in patient injury or death.
2.
Completely prime the administration set, and remove all air from both the administration set 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 infusion line must first be clamped or disconnected to prevent serious injury or death to the patient.
5.
The use of spare parts other than those recommended is not advised, and may affect the correct operation of the driver, resulting in injury or death.
6.
The syringe driver must not be used for infusing medication where pulsatile delivery action is unacceptable.
7.
The syringe driver must not be used in environments with flammable gas mixtures or with oxygenenriched atmospheres.
8.
If the syringe driver is used in the lockbox, the alarm volume will be reduced.
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Cautions Cautions tell you about dangerous conditions that can occur which may cause damage to the pump if you do not obey all of the instructions in this manual. A damaged pump must never be put into active service, as it may be a hazard to patients through under- or over-infusing.
1.
To prevent serious damage to the driver it must not be immersed in any liquids or exposed to strong organic solvents. If immersion occurs or the driver is subject to a serious spillage or wetting incident, it must be thoroughly tested by a competent person in accordance with the procedures in this service manual before re-use with a patient.
2.
Wipe off spills immediately. Do not allow fluid or residues to remain on the pump.
3.
The pump is not designed to be autoclaved, steam-sterilised, ETO sterilised or subjected to temperatures in excess of 45° C (113° F). 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 lifetime. Worn or stiff parts should be replaced.
6.
Handling the printed circuit board 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. Take care to avoid contamination of the exposed switches, circuit tracks and components, e.g. by the entry of solder particles.
7.
Refer all service, repair, testing and calibrations to suitably qualified technical personnel. Unauthorised modifications to the driver must not be carried out.
8.
Federal law restricts these Syringe Drivers for use by or on the order of a physician. This applies to drivers distributed only within the United States.
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Glossary Abbreviations The following abbreviations are used in this Manual. Abbreviation 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
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Meaning
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Chapter 1 Product Overview
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MS16A Syringe Driver
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Chapter 1 - Product Overview
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Figure 1-1 MS16A Hourly rate syringe driver
Description The MS16A Syringe Driver (Figure 1-1) is a portable, batteryoperated device, designed for the continuous infusion of small volumes of liquid from commercially available disposable syringes. The driver operates over time spans ranging from less than 30 minutes to 60 hours. The syringe 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 mm/hour may be calculated. For added security, the syringe driver can be secured in a transparent plastic, lockable box (see Figure 1-2). When fitted, the box minimises the risk of tampering with the infusion.
Figure 1-2 Lockbox Te c h n i c a l S e r v i c e M a nu a l
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The clear plastic lockbox is hinged at the back and features a lock at the front. The syringe is held in place on the driver by the securing strap and the infusion line passed through the slot at the front of the box. When the mm PER setting has been selected and the START/ TEST pushbutton pressed, the loaded driver is located in the box which is then locked. The patient controls (Figure 1-3) may be viewed through the clear window at the side of the lockbox.
Controls Patient controls (Figure 1-3) consist of two rotary set rate mm PER slotted switches, and a START/TEST pushbutton.
1
START/TEST
50
0 9
60mm
mm PER GM0307-A
GM0418-A
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 every second. When the plunger reaches the end of travel (syringe empty) or is occluded, the driver switches off, the LED stops flashing and an audible alarm sounds. If the START/TEST pushbutton is held down for more than 3 seconds, the alarm sounds, the driver stops and the LED stops flashing. If required, the driver can be modified to sound a continuous tone when the driver stops. See Chapter 6, Maintenance for modification instructions. For additional protection, the syringe driver can be secured in a Lockbox.
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Packed set The MS16A packed set (part number 0105-0504) is supplied with the following items:1.
MS16A Syringe Driver.
2.
Battery, type IEC 6LR61.
3.
Instruction manual.
4.
Rate adjuster.
5.
Shoulder holster (not US version).
6.
Clear cover (not shown).
1
Figure 1-4 Package contents
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Accessories and consumables
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Item
Description
Part number
100 cm infusion set
PVC line with 25 gauge needle.
0105-0029
Subcutaneous infusion pack
BD 10 ml syringe, Tegaderm dressing alcohol wipe, transfer needle, 100 cm infusion set.
0105-0117
Syringe driver non-slip base
Provides a secure base to stand the syringe drive on a flat surface.
0105-0108
Cover
Clear rigid plastic to protect the syringe driver and syringe.
0105-0529
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 full package of presentation, instruction and testing materials.
TPF-00130
Lockbox
A transparent plastic, lockable security 0105-0640 container (includes two keys). See page 1-3.
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Chapter 2 Specification and Standards
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MS16A Syringe Driver
Chapter 2 - Specification and Standards Type: Syringe driver with motor driven linear actuator, pulsed motion. Internal 9 V alkaline battery power source. Digital electronic rate control. Automatic switch off when the syringe is empty.
Infusion time: < 30 min. - 60 hours
Rate range:
2
Variable delivery rate of 0 - 99 mm/h in steps of 1 mm/h.
Motor operating interval: 420 ÷ rate = seconds
Drive accuracy: 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.
Occlusion pressure: 3 - 5 Kg Maximum actuator force 50 N (5 Kgf) @ 9 V
Controls: START/TEST and mm PER rate adjusters (tens and units digit controls).
Alarm: Audible frequency: Duration: Volume:
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3 kHz ± 0.5 kHz (end of travel: occlusion). 5 - 20 secs. Audible at 1m with normal or corrected hearing
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Indicator: Low battery level: 7.0 V to 5.5 V (LED stops flashing) Flash period: 1.05 secs ± 2% Yellow solid state LED Green solid state LED (US)
Battery type: PP3 size. 9 V, primary alkaline, IEC 6LR61 (or 6LF22) type. (Duracell MN1604 recommended)
Battery life: 50 full deliveries depending on the operating conditions and battery condition. Automatic switch off at end of plunger travel.
2
Accuracy of delivery: The rate of the actuator is accurate to within plus or minus 5% of the rate set on the rotary switches.
Dimensions (without syringe): Height: Width: Depth:
53.0 ± 0.5 mm 166.0 ± 1.0 mm 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 moulding. Labels - 125 micron fine matt Lexan. Other materials - nitrile rubber, small plastic parts - Acetal (25% glass filled Kemetal) and PA-GF (glass-filled nylon). Metal parts - stainless steel, mild steel. Circuit board - epoxy glass fabric. Holster - elasticated soft-backed fabric. Note: All materials used in this product are latex free.
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