SME100009
SME100009
SME100009
GRASEBY
...... PRODUCT SPECIFICATION ........................................
and
for
SYRINGE DRIVERS
Code A
Technical~xe{~tive Product Sup_.p.,ort: Date:
Code A
Quality As.sura~r~.o.d÷Re~ulatory Affairs: ......... Date:
Code A i~ 4.nT~., ~ ~
Table of Contents
1. INTRODUCTION .................................................................................................................... 4
2, SCOPE ................................................................................................................................... 4
3. REFERENCES ....................................................................................................................... 5
4. DESCRIPTION ....................................................................................................................... 6
6. CHARACTERISTICS ............................................................................................................. 8
7. PERFORMANCE ................................................................................................................. 13
7,1 PHYSICAL ......................................................................................................................... 13
7.1.! Rate ......................................................................................................................... 13
7.1.2 Drive accuracy ......................................................................................................... 13
7.1.3 Drive force ................................................................................................................ I4
7.1.4 Syringe sizes ........................................................................................................... 14
7,1,5 Audible indicator ...................................................................................................... 15
7.I .6 Visual indicator ........................................................................................................ 16
7.1.7 Battery life ................................................................................................................ 16
7.1.8 Chemical resistance ................................................................................................ 17
7.! .9 Packaging performance ........................................................................................... 17
7.2 ELECTRICAL AND MECHANICAL SAFETY .............................................................................. 18
7.2,1 Classifications .......................................................................................................... 18
7,2,2 Electromagnetic compatibility .................................................................................. 19
7,2,3 Mechanical surfaces ................................................................................................ 19
7.3 BIOLOGICAL ...................................................................................................................... 20
7.3.1 Biocompatibility ........................................................................................................ 20
7.3.2 Cleanliness .............................................................................................................. 20
7,4 ENVIRONMENTAL .............................................................................................................. 21
7,4.1 Temperature ............................................................................................................ 21
7.4.2 Humidity ................................................................................................................... 21
7.4.3 Pressure ................................................................................................................... 21
7.4.4 Shock and vibration ................................................................................................. 22
7.4.5 Operating life ............................................................................................................ 22
7.4.6 Shelf life ................................................................................................................... 22
8. CONSTRUCTION ................................................................................................................ 24
8.1 GENERAL ARRANGEMENT .................................................................................................. 24
8.2 DIMENSIONS .....................................................................................................................25
8.3 WEIGHT ...........................................................................................................................
26
8.4 COMPONENTS .................................................................................................................. 26
8.5 MATERIALS ....................................................................................................................... 27
9. LABELLING ......................................................................................................................... 28
9.I DEVICE LABELLING ............................................................................................................ 28
9.2 PACKAGING LABELLING ..................................................................................................... 30
1. Introduction
........................................................................... Syringe d.dve[s and pumps.ar.e, medical .devices.for delivering liquids .from ..........................................
syringes with more control and over much longer periods than could be
achieved by injecting by hand. This gives the possibility for a wider choice
of treatments to be used. The Syringe Drivers Types MS16A, MS18,
MS26 and MS32 (the Drivers) are simple to operate, battery powered,
devices for ambulatory use.
2. Scope
This specification defines the intended purpose of the Drivers listed and
gives the requirements for their; characteristics, performance,
construction, labelling, packaging, documentation, maintenance and
regulatory compliance.
German 0113-0717
Swedish 0113-0718
Finnish 0113-0742
Danish .......... 0 ;1;i 3-074~4 .....
Greek 0113-0748
3. References
4. Description
.......................................................................... The. Drivers..are. power driven devices that.push.the .plu nger of a syringe
fitted directly onto them forward at a constant controlled rate. The Drivers
are small, light and battery powered so they can be carried around by
patients whilst they are undergoing treatment. The different Drivers cover
a range of delivery rates and times.
The rate of the Drivers is set in miilimetres per hour or 24 hours, with the
exception of the MS32 where the rate is set in millilitres per hour and is
used with a B-D PLASTIPAK 20 ml syringe.
Table 1
6. Characteristics
6.1 Controls
6.1.1 Start
Defines the user controls provided to start the device operating and test the correct operation of the device alarm systems.
Ref Specification VerificationNalidation
6/1 Start/test MS16A Push to test. Verification: Confirmed by review of General Assemblies (GAs); 0105-050I, 0112-0001 and
MS 18 Release to start. 0I 13-0707. [12/3/98 CW] :
MS32 Validation: Confirmed by inspection of examples of production Drivers; MS16A MS18 and
MS32. [12/3/98 CW] :
6/2 Start/boost/test MS26 Push to boost or test. Verification: Confirmed by review of GA 0113-0002. [12/3/98 CW}
Release to start. Validation: Confirmed by inspection of example of a production Driver, MS26, [12/3/98 CW]
6.1.2 Stop
Defines the user controls provided to stop the d@vice operating.
Ref Specification Verification/Validation
6/3 Stop Automatically switches off when Verification: Confirmed by review of GAs; 0105-0501, 0112-0001,0113-0002 :and 0113-0707.
syringe is empty, maximum drive [l 2/3/98 CW] :
force is exceeded or motor over- Validafion: Confirmed by inspection of examples of production Drivers; MS18A, MS18, MS26
runs. and MS32. [12/3/98 CW~ i
6.1.3 Rate
Defines the user controls p[0~.ided to set the delivery rate of the device. ................
Ref Specification Verification/Validation
6/4 Set rate MS16A Two ten position rotary Verification: Confirmed by review of GAs; 0105-0501,01 I3-0002 and 0113~0707.[12/3/98 CW]
MS26 switches. Tool required Validation: Confirmed by inspection of examples of production Drivers; MSI~A, MS26 and
MS32 to operate switches. MS32. [12/3/98 CW~
6/5 Fixed rate MS18 No controIs. Verification: Confirmed by review of GA 01 I2-0001. [12t3/98 CW]
" Validation: Confirmed by inspection of example of a production Driver, MS18. [12;3/98 CW]
6.2.1 Audible
Defines the audible alarms and indications given by the device.
Ref Specification VerificationNalidation
6/7 Driver stops MS 16A Audible tone Verification: Confirmed by review of GAs; 0105-0501,0I 13-0002 and 0113-0707.[12/3/98 CW]
MS26 Validation: Confirmed by inspection of examples of production Drivers; MS1BA, MS26 and
MS32 MS32. [12/3/98 CW]. Lock-box effects detailed within LR/105-004-A.
6/8 Test finished MS 16A Audible tone Verification: Confirmed by review of GAs; 0"t05-0501, 0113-0002 and 0I 13-0707.[12/3/98 CW]
MS26 Validation: Confirmed by inspection of examples of production Drivers; MS18A, MS26 and
MS32 MS32. [12/3/98 CW]. Lock-box effects detailed within LRi1
6/9 Motor over-runs MS 16A Audible tone Verift cation: Confirmed by review of GAs; 0105-0501, 0113-0002 and 0113-0707.[12/3/98 CW]
MS26 Validation: Confirmed by inspection of examples of production Drivers; MS16A, MS26 and
MS32 MS32, [I2/3/98 CVV]. Lock-box effects detailed within LRi105-004-A.
6/! 0 Boost dose MS26 Audible tones Verification: Confirmed by review of GA 0113-0002. [12/3/98 CWJ
Page 9 of 34
Confidential and Proprietary information - Graseby Medical Limited
6.2.2 Visual
Defines the visual alarms and indications given by the device.
Ref Specification VerificationNalidatio n
6/11 Driver operating Flashing light. The flash period allows the drive Verification: Confirmed by review of GAs; 0105-0501, 0112-0001, 0113-0002==and 0113-0707.
control system function to be confirmed. [12/3/98 CW]
6/t 2 Test finished ’Driver operating’ light extinguishes Verification: Confirmed by review of GAs; 0105-0501,0112-0001,0113-0002 iand 0113-0707.
[12/3/98 CW] :
6/13 Driver stops ’Driver operating’ light extinguishes Verification: Confirmed by review of GAs; 0105-0501,0! 12-00011 0I 13-00021and 0113-0707.
[I 2/3/98 CWJ
6/14 Motor over-runs ’Driver operating’ light extinguishes Verification: Confirmed by review of GAs; 0!05-0501, 0112-000!, 01 I3-0002 !and 0113-0707.
[12/3/98 OWl
6/15 Battery power low MS16A ’Driver operating’ light Verification: Confirmed by review of GAs; 0105-0501,0113-0002 and 0113-0707.[12/3/98 CW]
MS26 intensity fades Validation: Confirmed by inspection of examples of production Drivers; MSl~A, MS26 and
MS32 MS32. [12/3/98 C~fJ ~
6/16 Set rate mmih MS16A Numerals 0 to 9 for Verification: Confirmed by review of GA 0105-050I. [12/3/98 CVV}
tens and units digits Validation: Confirmed by inspection of example of a production Driver, MS16A. [12/3/98 CW]
6/17 5 mm/h MS18 Marked 5 mm/h Verification: Confirmed by review of GA 0112-0001. [12/3/98 CW] :
6/18 Set rate mm/24h MS26 Numerals 0 to 9 for Verification: Confirmed by review of GA 0113-0002. [12/3/98 CW] ~
tens and units digits Validation: Confirmed by inspection of example of a production Driver, MS26÷ [12/3/98 CW]
6/19 Set rate mlih MS32 Numerals 0 to 9 for Verification: Confirmed by review of GA 0113-0707. [1213/98 CW]
units and tenths digits Validation: Confirmed by inspection of example of a production Driver, MS32. [12/3/98 CW]
6.3.1 Security
Defines the p~Fts of the syringe that a[e secured for safe..?.p.eration by the .~evice.
Ref Specification VerificationNalidation
6/20 Syringe barrel Verification: Confirmed by review of GAs; 0105-0501, 0112-0001, 0113-0002 :,and 011340707.
[I 2/3/98 CVV~
Validation: Confirmed by visual inspection and functional evaluation of reprdsentative
examples of production Drivers, MS26 SN 27143 and MS32 SN 28643.
Equipment used: Syringes; B-D PLASTIPAK 2, 5, 10, 20 {16,5 max.) ml, B Braun
Omnifix 2, 5, 10, 20 (I9 max.), 30 (22 max.) ml, Sherwood monoject 5, 10, 20 (17
max.) ml, Terumo 20 (17 max.), 30/35 (22 max,) mI. [12/3/98 CW-J
6/21 Syringe finger grips Verification: Confirmed by review of GAs; 0105-050I, 0112-00(~ii 0113-0002 and 0113~07.
[12/3/98 OWl
Validation: Confirmed by visual inspection and functional evaluation of representative
examples of production Drivers, MS26 SN 27143 and MS32 SN 28643. /
Equipment used: Syringes; B*D PLASTIPAK 2, 5, 10, 20 (16,5 max.) ml, B Braun
Omnifix 2, 5, 10, 20 (19 max.), 30 (22 max,) ml, Sherwood monoject 5, t0, 20 (I7
max.) mI, Terumo 20 (17 max,}, 30/35 (22 max.) ml. [12/3198 CW]
6/22 Syringe plunger push-button Verification: Confirmed by review of GAs; 0105-0501, 0112-0001,0113-0002 and 0113-0707.
[I2/3/98 CVV]
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Confidential and Proprietary Information - Graseby Medical Limited
6.4.1 Battery
Defines the battery size and tYl?e for powering the device.
Ref Specification Verification/Validation
6/23 Single 9 volt primary alkaline lEC 6LR6I or 6LF22 Verification: Confirmed by review of GAs; 0105-0501, 0112-0001, 0113-0002 and 0I 13-0707.
battery [12/3/98 CW] :
6/24 Installing battery with polarity reversed causes no damage. Verification: Confirmed by review of GAs; 0105-0501, 0112-0001, 0113-0002 !and 01 I3-0707.
[t2/3/98 OWl
Validation: Confirmed by inspection of examples of production Drivers; MSI~A, MS18, MS26
and MS32. No complaints found in Complaints History Review CHR002!01.
[1 2/3/98 CW]
7. Performance
7.1 Physical
7.1.1 Rate
Defines the delivery rate range of the device.
Ref Specification VerificationNalidation
7/2 5 mm/h fixed MS18 Verification: Confirmed by review of GA 0112-0001. [12/3/98 cwrJ
7/3 0 to 99 mmi24h 1 mm/24h MS26 Verification: Confirmed by review of GA 0113-0002. [12/3/98 CW]
Validation: Confirmed by inspection of test record of production Driver, MS26 SN 27143.
[12/3/98 CW]
7/4 Boost 0,23 ram/audible tone MS26 Verification: Confirmed by review of GA 0113-0002. [1213/98 CW]
Validation: Confirmed by inspection of test record of production Driver, MS26 SN 27143.
7/5 0 to 9,9 m I/h 0,1 m lih MS32 Verification: Confirmed by review of GA 0113-0707. [12/3/98 OWl
Validation: Confirmed by inspection of test record of production Driver, MS32 SN 28643.
[12/3/98 CW] :
7/8 2 ml to 35 ml MS 16A Verification: Confirmed by review of GAs; 0105-0501, 0112-0001 and 0113-0002.
MS18 [12/3/98 CWJ :.
7/9 20 ml B-D PLASTIPAK, MS32 Verification: Confirmed by review of GA 0I 13-0707. [12/3/98 CW]
with scale 20 ml = 70 mm Validation: Confirmed by visual inspection and functional evaluation of an e~ample of a
production Driver, MS32 SN 28643. / Equipment used: Syringe, B*D PLASTIPAK
20 (16,5 max.) ml, [1213/98 CW] i
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Confidential and Proprietary Information - Graseby Medical Limited
7/I4 Red light MS18 Verification: Confirmed by review of GA 0112-0001. [12/3/98 CW]
7/I5 Flash period 1,05 s + 2% MS16A Verification: Confirmed by review of GA 0105-0501. [12/3/98 C~
7/16 Flash period 1,93 s + 4% MS18 Verification: Confirmed by review of GA 0I 12-0001. [12/3/98 CW]
7/17 Flash period 25,2 s + 2% MS26 Verification: Confirmed by review of GA 0113-0002. [12/3;98 CW]
7/18 Flash period 3s ±2% MS32 Verification: Confirmed by review of GA 0113-0707. [12/3/98 CW’J :
7/19 Battery low level 7,0 V to 5,5 V MS16A Verification: Confirmed by review of GAs; 0105-0501, 01 t3-0002 and 0113-0707.[12/3/98 CV~
MS26 Validation: Confirmed by inspection of test records of production Drivers; MS16A SN 41233,
MS32 MS26 SN 27143 and MS32 SN 28643. [1213/98 CW]
7.2.1 Classifications
Defines the safety classifications applied from the standard EN 60601-I.
Ref Specification VerificationNalidation
7/23 Type of protection against electric shock. Internally powered Verification: Confirmed by review of GAs; 0!05-0501,0112-0001, 0113-0002 and 0I I3-0707.
equipment [12/3/98 CW] ~
Va}idation: Confirmed by review of Report 087585 on MS26 SN 3112 issued by BSl Testing
and the EC Type Examination Certificate No. 1247 for the MS26::issued by BSI.
There have been no ma,ior changes to the design since these were issued. The
MS16A, MS18 and MS 32 are of the same basic construction. TSe MS32 design is
derived from the MS26 in which only the rate range has been int&rnally adjusted.
Certificates issued by BSI Testing show the Syringe Drivers mee~. the
requirements of standard IEC 60%1; MS16A Cert. No, 1t5636/1! MS18 Cert. No,
1 I5637/I and MS26 Cert. No. 115638/1. [12/3/98 CW]
7/24 Degree of protection against electric shock. Type BF Applied Part Verification: Confirmed by review of GAs; 0105-0501, 01 I2-000I, 0113-0002 and 0113-0707.
[12/3/98 OWl :
7/25 Degree of protection against water ingress. IPX0 Verification: Confirmed by review of GAs; 0105~0501, 0112-000I, 0113-0002 ~and 0113-0707,
[12/3/98 CW]
7/26 Degree of safety of application in the presence of Not suitable Verification: Confirmed by review of GAs; 010540501, 0112-0001,0113-0002 and 0I 13-0707.
a flammable anaesthetic mixture with air or with [12/3/98 CW]
oxygen or nitrous oxide. Validation: Appropriate warnings given in Instruction Manuals; MS16AJMS26 0105-0549,
MSI8 0112-0031, MS32 0113-0045. [12/3/98 CW]
7/27 Mode of operation. Continuous Verification: Confirmed by review of GAs; 0105-0501,0112-0001, 0113-0002 ~nd 0113-0707.
[12/3/98 CW] :
7.3 Biological
7.3.1 Biocompatibility
Defines the biological compatibility of the device when used on humans, as intended.
Guidance: De~{!c,e category - Non-c.£.n,,tact device (EN 30993-1:1994). No, testing required.
Ref Specification VerificationNalidation :
7/31 The Device does not contain any material unsuitable for the intended Verification: Confirmed by review of GAs; 0105-0501, 0112-000I, 0113-0002 and 0113-0707,
purpose. [12/3/98 Cw] :
Validation: No complaints found in Complaints History Review CHR002/01. [42/3/98 CW]
7.3.2 Cleanliness
Defines the pi~..y.§.i.cal cleanliness required.
Ref Specification Verification/Validation
7/32 NOT USED
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Confidential and Proprietary Information - Graseby Medical Limited
7.4 Environmental
7.4.1 Temperature :
Defines the permitted temperature range for the device to be used and stored in.
Ref Specification :
Verification/Validation
7/33 Operating +10 °C to +40 °C Verification: Conditions not special or abnormal. Specific design output not required.
[12/3/98 CW]
Validation: No complaints found in Complaints History Review CHR002/01, [1~2/3/98 CW}
7/34 Storage -40 °C to +70 °C Verification: Outer packaging labelling has instruction to keep out of direct sufllight. Confirmed
by review of PSs; 0105-0504, 0112-0002, 0113-0001 and 0113-0:.707.
[12/3/98 CW]
VaIidation: No complaints found in Complaints History Review CHR002/01. [I~/3/98 CW]
7.4.2 Humidity
Defines the permitted h, umidity range for the device to be used and stored in.
Ref Specification Verification/validation :
7/35 Operating 30 % to 75 % RH Verification: Conditions not special or abnormal. Specific design output not required.
[12/3/98 CW] ~
nomcondensing Validation: No complaints found in Complaints History Review CHR002i0I. [1~2/3/98 CW]
7/36 Storage 10 % to 100 % RH Verification: Outer packaging labelling has instruction to keep dry. Confirmed by review of PSs;
0105-0504, 0112~0002, 0113-0001 and 0113r0707. [12/3/98 CW]!
non-condensing Validation: No complaints found in Complaints History Review CHR002i01. [12/3/98 CW]
~
7.4.3 Pressure
Defines the permitted atmospheric pressure range for the device to be used and stored in. ~
7/40 Drop from 1 m onto a hard surface EN 60601-1 Verification: Confirmed by review of GAs; 0105-0501, 0112-0001, 0113-00021and 0I 13-0707,
[12/3/98 CWJ
Validation: Confirmed by review of Report 087585 on MS26 SN 3112 issued by BSI Testing
and the EC Type Examination Certificate No. 1247 for the MS26:.issued by BSI.
There have been no major changes to the design since these were issued. The
MSI6A, MS18 and MS 32 are of the same basic construction, certificates issued
by BSl Testing show the Syringe Drivers meet the requirements 6f standard IEC
601-1; MS16A Cert. No. 115636/1, MS18 Cert. No. 115637/1 and MS26 Cert. No.
115638/1. [12/3/98 CW]
Page 22 of 34
Confidential and Proprietary Information - Graseby Medical Limited J
7/42
I NOT USED
Page 23 of 34
Confidential and Proprietary Information - Graseby Medical Limited
8. Construction
The movable linear actuator that pushes the syringe plunger has provision
to secure the syringe plunger push-button.
8.2 Dimensions
De~!nes the physicaL,dimensions of the assembled device.
Ref Specification Verification/Validation
8/3 Depth of body 23,0 mm + 0,5 mm Verification; Confirmed by review of GAs; 0105-050I, 0112-0001,0113-0002 and 0113-0707.
[12/3/98 CWJ
8/6 Width of cover 180 mm Verification: Confirmed by review of PSs; 0105=0504, 0112-0002, 0113-0001 &nd 0t 13-0707,
[12/3/98 CW] :
Validation: Example of Cover 0105-0529 met specification. / Equipment used: Digital gauge
TVM300 SN I578. / 21 °C. [t2/3/98 CW] i
8/7 Depth of cover 36 mm + 2 mm Verification: Confirmed by review of PSs; 0105-0504, 01 ! 2-0002, 0113-0001 and 0113-0707.
[12/3/98 OWl :
Validation; Example of Cover 0105-0529 met specification. / Equipment use6: Digital gauge
TVM300 SN 1578, / 21 °C. [1213/98 CW] :.
8/8 Height of cover 94 mm ± 2 mm Verification: Confirmed by review of PSs; 0105@504, 0! 12-0002, 0113-000I ~nd 0113-0707.
[12/3/98 OWl
8.3 Weight
Defines the total weight of the assembled device.
Ref Specification VerificationNalidation
8/9 190 g maximum (including the battery) Verification: Determined by densities of materials and volumes of components specified.
Materials and components have been confirmed by review of GAs; 0105-050I,
0112~0001, 0113-0002 and 0113-0707. [12/3/98 CW]
Validation: SampIe of production Drivers met specification, 5/MS16A and 10/MS32 with
examples of Duracell MN 1604 batte~. The MS 18 has fewer components and will
be lighter and the MS26 will weigh the same as the MS32, / Weight: I83,2 g to
I84,7 g. / Equipment used: Weighing balance TE5726. [12/3/98 CVV]
8.4 Components
Defines the components used in the device.
Ref Specification VerificationNalidatio n
8/10 NOT USED
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Confidential and Proprietary information - Graseby Medical Limited
8.5 Materials
Hardness (Rockwell) = 70
8/1 3 No medicinal products (Directive 65/65/EEC) Verification: Confirmed by review of GAs; 0105~0501, 0112-000l, 0113-0002 and 0"~ 13-0707,
[12/3/98 CW]
Validation: Confirmed by audit of component and material specifications used in a~sembly and then
review of manufacturer’s data, [12/3/98 CW] :
8/14 All No materials of animal origin Verification: Confirmed by review of GAs; 0105-0501,0112-0001, 0113~0002 and 0"J 13-0707,
[12/3/98 CW]
Validation: Confirmed by audit of component and material specifications used for dxternal parts and
then review of manufacturer’s data. [12/3/98 CW]
8/15 All No natural latex Verification; Confirmed by review of GAs; 0105-0501.0112-0001, 01 I3-0002 and 0i 13-0707.
[12/3/98 CW]
Validation: Confirmed by audit of component and material specifications used for e:xternal parts and
then review of manufacturer’s data, [12/3/98 CW’J
9. Labelling
Information Format
9/1 Type identification colour Blue MS16A Verification: Confirmed by review of GAs: 0105-0501, 0112-0001, (~i13-0002 and 0I 13-0-707.
Silver MS 18 [I 2/3/98 CW]
Green MS26 Validation: Awaiting ~roduction exam.p es of Dr vers with latest labelling.
Light grey MS32 ..............................................................
9/2 Instructions for use. Abbreviated instructions. Verification: Confirmed by review of GAs; 0105-050i, 0112-0001,0113-0002 and 01 i3-0707.
[12/3/98 CVV]
Prominent warning on MS32 to only use
with B-D PLASTIPAK 20 ml syringe. Validation: .A.~.aiting p.r..o.d..~.c.ti_qn___e_x_.a..m..ql.e.s.M D.r!v_e.r.s...w.i.t.h_!_a_t_e_.s.t.l.a..bLe.!ling.
9/3 The Company name. Verification: Confirmed by review of GAs; 0105-05011~:112-0001, 0!I3-0002 and 01i3-0707.
[12/3/98 CW]
Validati on: ~wajtj~g. # .r.o_d_ _u_c. t_i .o..n..e.x~ .a.~p e.s.. ~o.f..D..r .v..e_r_s_ __w. _t~...a.t.e..s.U a belling.
914 The Company postal address. Verification: Confirmed by review of GAs; 0105-0501, 0112-0001, 0113-0002 and 0113-0707.
[12/3/98 CW]
Validation: .A..w..ajt.i.n_g production examPJ.e.s..g.f__D_r_i_v..e.r.s...w.i.tb, late~st.l.a.be...P.g.
9/5 The device name. MS16A Houdy Rate Syringe Driver Verification: Confirmed by review of GAs; 0105-0501,0112-0001,0113-0002 and 0t 13-071~:7.
[12/3/98 CW] .
MS18 Fixed Rate Syringe Driver Validation:
.A..w..a.i!i.n. g p rp.d..u.c.t.i.o.0..e.x. _a__m_ p.I .e.s...o.f..D..riNe rs ~i.t.h...a~t. # b#.. ~g’
MS26 Daily Rate Syringe Driver
9/6 A unique manufacturing serial Symbol from EN 980 Verification: Confirmed by review of GAs; 0t05-0501, 0112-0001 0113-0002 and 011:3-0707.
number. [12/3/98 CW~J
Validation:
Awaiting p~r.9.ductiq0~ ~x.~..m.p.l.e.s..9_f- _D_ _ri_v_ .e.r~ ..w..t .hL ~ .a.te.s.t ab.e. ~..ng.
9/7 The manufacturing year. Symbol and date format from EN 980 Verification: Confirmed by review of GAs; 0105-0501,0112-0001, 0113-0002 and 0113-0707.
[I2/3/98 CW]
Validation: .A..w..ajt.i.n.g_p_E.o.d.~.c.t.i.o.n~.p.x.am#le.s~.g.f..D..rixg~ Ai~h ].a.t.e..s.t.Ip..b.e... ~ng
9/8 Degree of protection against Symbol from EN 6060I-1 for Type BF Verification: Confirmed by review of GAs; 0105-050I, 0112-0001, 0113-0002 and 0113-0707.
Information Format
9/9 Read accompanying instructions Symbol from EN 60601-1/EN 980 Verification: Confirmed by review of GAs; 0105-0501,01 I2-0001,0113-0002 and 01 i3-0707.
for use. [1213/98 OWl
9/10 The CE mark (with Notified Body As required by Directive 93/42/EEC Verification: Confirmed by review of GAs; 0105-050I, 0112-0001, 0113-0002 and 01 i3-0707.
number). [12/3/98 cw]
Validation: Awaitingp.roduction exam~ es of Dr vers with latest labelIi.ng.
9/11 Battery voltage and type. 9 v, 6LR61 Verification: Confirmed by review of GAs; 0105-0501,0112-0001, 0113-0002 and 0113-0707.
[12/3/98 OWJ
9/12 Measuring scale, 60 mm linear MS16A Verification: Confirmed by review of GAs; 0105-0501, 0112-0001 and 0113-0002. [12i3/98 CW]
scale, MS18
9/13 Start control START/TEST MS16A Verification: Confirmed by review of GAs; 0t05-0501, 0112-000l, 0113-0002 and 0II3-0707.
MS18 [12/3/98 CW]
MS32
Validation: Awaiting_p.r.9.d..u.c.tjpn .e.x..a..m.p.l.e.s.._o.f__D__ri_v_.e.r.s...w..tb.L.at.est a..b.e....ng.
START!BOOST MS26
9/14 Rate units mm per ! h MS16A Verification: Confirmed by review of GAs; 0105-0501,0112-0001,0113-0002 and 0113-0707.
5 mm per 1 h MS18 [12/3/98 CW] :
mm per 24 h MS26
mI per 1 h MS32 Validation: ~.w..aj.ti.n.g p. r.o_d_ _u_c.ti.o.[3..e.x. an.1 pies.of D..r .v..e.r.s.._w_ lib..#j~:[..a..b.c.. Lng
KEY: P = Pack, S..= Secondary container, T = Tertiary containe.r, ¢" = required, o = ,optional, - = not used
Ref Specification Verification/Validation
Information Format P S T
9/15 The Company name. ¯/ _ Verification: Confirmed by review of PSs; 0108-0504, 0112-0002, 0113-000I and 0113-0707.
[12/3/98 C%rJ
Validation: Awaitinq~production examP_!.e.s.#.f.p..acka.ged Drivers.
9/16 The Company postal address. Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 0113-0001 !and 0113-0707.
[12/3/98 CW]
Validation: .~A.w..a..iti.n.g_[3roduction exam~p!.e.s..o.f..p..a_c__k_a.ged Drivers~
9/17 The device name. Verification: Confirmed by review o~~Ss; 0105-0504, 0112~0002, 0113-0001 :and 0113[~707.
[12/3/98 CW~J
Validation: A~wa.it.i.n.g.~)£o__d_u__c_tj.o.n...e.x.a~.mple.s 9.frp..a.c..k.a.g_e__d__Drivers. :
9/18 The device item number. Symbol from EN 980 ,,," Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 0113~0001 and 0113-0707.
and Ddver reference [12/3/98 CV~
number. Validation: .Awa!tiRg.[~roductio.n..e..x..a~.!es of~.c.k#ge..d.__D_rj_v#rs
9/I 9 A unique manufacturing serial Symbol from EN 980 ,/" Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 0113-0001 and 01 ! 3-0707.
[!2/3/98 CW]
number. Validation:
Awaiting.producti.o~..e.x.a..m.~.!~ _o_f__9.a.c..k.a.ge..d" Dr vers, "
9/20 The CE mark (with Notified Body As required by Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 0113-0001 and 0113~0707.
Directive 93/42/EEC [12/3/98 CW]
number). Validation:
.A.w..a.[tj.ng.prpduc.t!9~..e.x..a.m_p_!~_s" 9.f#.a.c..k.a.ge.d Dr vers
9/21 List of contents of packaging. Verification: Confirmed by review of PSs; 0105-0504, 0112~0002, 0113-000I and 0113-0707.
[12/3/98 CW]
Validation: Awaiting.Droductio.n...e.x.a..m..p.[9~s ofga.@a.g.e..d...D.r.y_e__r_s_
9!22 Instruction to store out of direct Symbol from Verification: Confirmed by review of PSs; 0105-0504, 0112*0002, 0113-0001 and 0113-0707.
EN 20780 [12/3/98 CW]
sunlight.
9/23 Instruction to keep dry. Symbol from Verifi~ii0n: Confirmed by review of PSs; 010~-0504, 0112-0002, 0113-0001 and 0113-0707.
EN 2078O [12/3/98 c~rJ
VaIidation: Awaiting production...e.x.a..m..p.!.e.s. _o.f__p__a_c_ _k_a_g.&d...D.ri.v#~r~s,
9/24 Instruction that contents are fragile. Symbol from Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 0113-0001 and 0I 13-0707.
EN 20780 [12/3/98 OWl
KEY: P = Pack, S = Secondary container, T = Tertiary container, v" = required, o = optional, - = not used
Ref Specification Verification/Validation
Information Format P S T
Validation: ._A.vyaiting.production exarnp_[.e.s..o..f.p..a..c.kage.d...Drivers.
10. Packaging
10.1 Pack
Defines the packaging for the device.
Ref Specification VerificationNalidation
10/1 Type!construction Carton, box with top opening lid and Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 01 I3-0001 and 0113-0707.
locking tabs, single-walt corrugated [12/3/98 CW]
VaIidation:
fibreboard 125OY/EI125T. A..w#[t.i.n_g_Er.o..d.u..qtjon ex~&mp...e.s._o__f_p.a.c..k.a.g_9.dL.Driv.e..r.s’
10/2 Size - internal 222 mm wide x 130 mm deep x Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 0113-0001 and 0113-0707.
60 mm high + 2 mm. [12/3/98 CW]
10/3 Contents 1 Driver Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 0113-000 ! and 0113-0707.
1 Instruction manual [12/3/98 cw]
1 battery Validation: Awaiting. p rod u ction .e..x.a..m.j?!e..s. _o_f_ p_ _a.c..k.a. gg.d..O r v.e. r~s.
1 cover
1 carrying holster
1 rate adjusting tool (MS16A,
MS26, MS32)
1014 Weight (filled) g_+2g Verification: Determined by densities of materials and volumes of components specified.
Materials and components have been confirmed by review of PSs; 0105-0504,
0112-0002, 0I 13-000I and 01 I3-0707. [12/3/98 CW]
10/5 Print colour Blue (Pantone PMS 286). Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 0113-0001 ~and 0113-0707.
[12/3/98 CW]
11. Bocumentation
11/2 Service manual intended for technical personnel involved in maintaining Verification: Confirmed by review of Master Record Indexes; 7T/I05-504, 7T/i 12-002,
Drivers. 7T/1 I3-001 and 2E/I 13-707. [12/3/98 CW] "
13.1 Country/Area
Notes,
2, All temperatures were in the range 18 °C to 25 °C and were measured or confirmed using digital thermometer TE5597.