Technical Service Manual
60 Pages
Preview
Page 1
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 ® MS26 Syringe Driver
GM1282-A
Technical Service Manual
Part Number 00SM-0113F-6 Issue 6 (February 2005) © 2005 Smiths Medical family of companies. All rights reserved.
MS26 Syringe Driver
Smiths Medical
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.
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)
Page i
MS26 Syringe Driver
Smiths Medical
ISSUE RECORD Issue No.
Reason for change
Pages effected
Date
5
Re-issue of Manual
All
May 2000
6
Lockbox and US variants added.
All
February 2005 February 2004
Page ii
Issue 6 (February 2005)
Te c h n i c a l S e r v i c e M a n u a l
MS26 Syringe Driver
Smiths Medical
Scope of this manual This manual is for service personnel, enabling them to service and repair the MS26 Syringe Driver. It incorporates recent improvements, including Lockbox information, and the US variant.
Related manuals This manual includes general operating information only. For detailed operating instructions, refer to the MS 16A Syringe Driver, MS 26 Syringe Driver Instruction Manual, (part number 01050549-A).
Smiths Medical service contacts If you have 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.com
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]
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)
Page iii
MS26 Syringe Driver
Smiths Medical
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 - 4 Alarm ... 2 - 4 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 - 3 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 - 6 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 Boost test ... 3 - 5 Boost indicator ... 3 - 5
Page iv
Issue 6 (February 2005)
Te c h n i c a l S e r v i c e M a n u a l
MS26 Syringe Driver
Smiths Medical
Safety features ... 3 - 5 Low battery indication ... 3 - 5
Chapter 4 - Disassembly and Assembly Disassembly and Assembly ... 4 - 3 General ... 4 - 3
Tools, equipment and materials required ... 4 - 3 Removal and dismantling procedures ... 4 - 5 Case separation ... 4 - 5 Leadscrew and actuator 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 Tools and equipment ... 5 - 3 Adjustment potentiometers ... 5 - 4 Service Testing... 5 - 5 Cam follower adjustment ... 5 - 5 Fast run link ... 5 - 7 Guard test ... 5 - 7 9 V thrust test ... 5 - 8 7 V thrust test ... 5 - 8 Flash frequency ... 5 - 8 Timer and feed rate tests ... 5 - 8 Cam alignment ... 5 - 9 LED flash test ... 5 - 9 Half nut slip test ... 5 - 9 Rate switch test ... 5 - 10 Motor pulse flash frequency ... 5 - 10 Current tests ... 5 - 10 Sounder check ... 5 - 10 General ... 5 - 10 Test Checklist - MS26 ... 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
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)
Page v
MS26 Syringe Driver
Smiths Medical
Chapter 7 - Parts List General assembly of the MS26 ... 7 - 3 PCB assembly ... 7 - 7
Figures 1 - 1 MS26 Daily rate syringe driver ... 1 - 3 1 - 2 Lock box ... 1 - 3 1 - 3 MS26 Controls ... 1 - 4 1 - 4 Package contents ... 1 - 5 3 - 1 MS26 Circuit diagram ... 3 - 6 3 - 2 Printed circuit board layout ... 3 - 7 4 - 1 MS26 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 Adjustment potentiometers location ... 5 - 4 5 - 2 Cam and cam follower ... 5 - 5 5 - 3 Camswitch operating timing ... 5 - 5 5 - 4 Typical waveform for one pulse ... 5 - 6 5 - 5 Using the cam adjustment tool ... 5 - 6 5 - 6 Fast run link connection points ... 5 - 7 5 - 7 Thrust rig set-up ... 5 - 8 6 - 1 Battery replacement ... 6 - 4 6 - 2 Continuous alarm conversion ... 6 - 5 7 - 1 Exploded view of MS26 Syringe Driver ... 7 - 4 7 - 2 MS26 PCB assembly ... 7 - 7
Page vi
Issue 6 (February 2005)
Te c h n i c a l S e r v i c e M a n u a l
MS26 Syringe Driver
Smiths Medical
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.
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.
Any damaged pumps must be thoroughly tested by a competent person in accordance with the procedures in this Technical Service Manual before re-use with a patient. Failure to observe this may result in patient injury or death.
6.
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.
7.
The syringe driver must not be used for infusing medication where pulsatile delivery action is unacceptable.
8.
The syringe driver must not be used in environments with flammable gas mixtures or with oxygenenriched atmospheres.
9.
If the syringe driver is used in the lockbox, the alarm volume will be reduced.
10. Always ensure that on successful completion of a full test, there is no temporary fast link connected between pins 13 and 21 of IC1. Failure to observe this may result in patient injury or death.
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)
Page vii
MS26 Syringe Driver
Smiths Medical
Cautions Cautions tell you about dangerous conditions that can occur which may cause damage to the pump if all the instructions in this manual are not obeyed. 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 Technical Service Manual before re-use with a patient.
2.
Wipe off spills immediately, and 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 of printed circuit 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. 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):
Page viii
Issue 6 (February 2005)
Te c h n i c a l S e r v i c e M a n u a l
MS26 Syringe Driver
Smiths Medical
Glossary Abbreviations The following abbreviations are used in this Manual. Abbreviation
Meaning
ABS
Acrylonitrile Butadiene Styrene
C
Centigrade or Capacitor
DC
Direct Current
gm
grams
h/hr
hour
IC
Integrated Circuit
Kg
Kilograms
KHz
Kilohertz
LED
Light Emitting Diode
ml
Millilitre
mm
Millimetre
PCB
Printed Circuit Board
R
Resistor
SW
Switch
TR
Transistor
V
Volts
VR
Variable Resistor
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)
Page ix
Graseby® MS26 Syringe Driver
Chapter 1 Product Overview
1
MS26 Syringe Driver
Smiths Medical
Chapter 1 - Product Overview Infusion Syringe Syringe Syringe plunger line finger grip barrel pushbutton Syringe Syringe Securing nozzle Actuator plunger strap
1 Rate setting START/BOOST pushbutton mm PER 24 hours GM1215-D
Indicator lamp (Flashes once every 25 seconds)
Figure 1-1 MS26 Daily rate syringe driver
Description The MS 26 Syringe Driver (Figure 1-1) is a portable, battery-operated device, designed for the continuous infusion of small volumes of liquid over a period of 24 hours using commercially available disposable syringes. The driver operates within time spans ranging from 18 hours to 60 days. The driver is equipped with a boost facility that enables doses to be administered during the infusion. The syringe plunger is operated by a linear actuator, at rates ranging from 1 to 99 mm/ 24 hours (mm PER). The rate required is set by adjusting two slotted digital rotary switches. Most brands of syringe can be fitted to the driver, the volumetric delivery being dependant on the size of the syringe being used. A millimetre scale on the front of the driver measures the stroke length of the syringe, allowing the rate in mm/hour to 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 n u a l
Issue 6 (February 2005)
1 - 3
MS26 Syringe Driver
Smiths Medical
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 made and the START/ BOOST pushbutton pressed, the loaded driver is located in the box which is then locked. The syringe driver controls (Figure 1-3) may be viewed through the clear window at the top of the lockbox.
Controls The MS26 controls (Figure 1-3) consist of two slotted rotary set rate mm PER switches, and a START/BOOST pushbutton.
1
0 9 mm PER GM0307-A
Figure 1-3 MS26 Controls
Operation Detailed operating instructions on how to use the syringe driver are given in the Instruction Manual (part number 0105-0549). To start an infusion, fit a primed syringe and press the START/BOOST pushbutton. When held down, the START/BOOST pushbutton tests a safety cut-out circuit. When released it starts the drive circuit. Once started, the front panel indicator lamp (LED) flashes approximately every 25 seconds. 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 required, the driver can be modified to sound a continuous tone when the driver stops. For modification instructions, see Chapter 6, Maintenance. If the START/BOOST pushbutton is held down for more than 3 seconds, its function becomes that of issuing a manually controlled bolus. While held, the unit will infuse continuously, while at the same time bleeping a warning. Each bleep corresponds to 0.23 mm of infusion. If this facility is not to be offered to the patient, consideration should be given to the use of a lockbox. When fitted and locked, the lockbox protects the syringe from tampering only; it provides no other security. It does not give audible or visual alarms when opened.
1 - 4
Issue 6 (February 2005)
Te c h n i c a l S e r v i c e M a nu a l
MS26 Syringe Driver
Smiths Medical
Packed set The MS26 packed set (part number 0113-0001) is supplied with the following items:1.
MS26 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
MS 26 DAILY RATE Syringe Driver
! 0
10
20
30
40
5
5
mm PER 50
24
2
HR
START/BOOST 1 bleep = 0.23 mm
0086
10 bleeps 60mm
3
1
4
5
GM1281-B
Figure 1-4 Package contents
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)
1 - 5
Accessories and consumables
1
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 driver 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 2 keys). See page 1-3.
Graseby® MS26 Syringe Driver
2 Chapter 2 Specification and Standards
Smiths Medical
MS26 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:
2
18 hours - 60 days
Rate range: Variable delivery rate of 0 - 99 mm/24 hrs in steps of 1 mm/24 hrs with an on demand user booster.
Motor operating interval: Interval between pulses = 168 / rate (minutes, nominal).
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: 30N - 50N
Actuator movement: 0.12 mm every time motor turns (nominal).
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: 30N - 50N Maximum actuator force 50 N (5Kgf) @ 9 V.
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)
2 - 3
MS26 Syringe Driver
Smiths Medical
Controls: START/BOOST and mm PER rate adjusters (tens and units digit controls).
Alarm: Alarm conditions: Driver stops; Test finished; Motor over-runs; Boost dose. Audible frequency: 3 kHz ± 0.5kHz (end of travel: occlusion). Duration: 5 - 20 secs. Volume: Audible at 1m with normal or corrected hearing.
Indicator: Low battery level: 7.0 V to 5.5 V (LED stops flashing). Flash period: 25.2 s ± 2% Yellow solid state LED.
2
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.
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
2 - 4
Issue 6 (Febuary 2005)
Technical Ser vice Manual
Smiths Medical
MS26 Syringe Driver
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.
2
Standards Electrical safety: Complies with EN 60601-1: 1990 (IEC 601-1:1988). Type BF Applied Part for protection against electric shock.
EMC: Complies with EN 60601-1-2:1993 for emissions and immunity to electromagnetic disturbances. Group 1 Class B for emitted RF radiation according to EN 55011:1991 making it acceptable for use in domestic establishments. Complies with RTCA DO-160D (Operation in a commercial aircraft with controlled pressurised cabin area which maintains cabin pressure at normal cabin environment.) Smiths Medical International Ltd. ref CIB B1100.
Biological evaluation: Complies with EN 30993-1:1994 Biological evaluation of medical devices - Part 1: Guidance on selection of 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
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)
2 - 5