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SME100009-0001

GRASEBY
...... PRODUCT SPECIFICATION ........................................

and

for

SYRINGE DRIVERS

TYPES" MS16A, MS18, MS26 and MS32

(Ambulatory Syringe Infusion Pumps)

Product Family 002

Product Manager: Date:

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~., ~ ~

16/03/98 First issue.


B 26/11/98 Addition of foreign language variants - see Table on pages 4 &
5,
C
D 09/10/01 Addition of Lock-box to spares list.

Document No: TS/105-001


Filename: TS105001.DOC

Confidential and Proprietary Information - Graseby Medical Limited ]


SME100009-0002

Confidential and Proprietary Information - Graseby Medical Limited

Table of Contents

1. INTRODUCTION .................................................................................................................... 4

2, SCOPE ................................................................................................................................... 4

3. REFERENCES ....................................................................................................................... 5

4. DESCRIPTION ....................................................................................................................... 6

INTENDED PURPOSE OF THE DEVICES ........................................................................... 6

6. CHARACTERISTICS ............................................................................................................. 8

6.1 CONTROLS ......................................................................................................................... 8


6.1.1 Start ........................................................................................................................... 8
6,1.2 Stop ............................................................................................................................ 8
6.1.3 Rate ........................................................................................................................... 8
6.1.4 Syringe plunger position ............................................................................................ 9
6.2 ALARMS AND INDICATIONS ................................................................................................... 9
6.2,1 Audible ....................................................................................................................... 9
6,2.2 Visual ....................................................................................................................... 10
6,3 SYRINGE ATTACHMENT ...................................................................................................... 11
6.3.I Security .................................................................................................................... 11
6.4 POWER SUPPLY ................................................................................................................ 12
6,4.1 Battery .................................................................. : ................................................... 12

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

Product Specification and VerificationfValidation Report for Syringe Drivers


Document No: TS1105-001 issue: D
Date of issue: 9t" October 2001
Page 2 of 34
SME100009-0003

Confidential and Proprietary Information - Graseby Medical Limited

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

10. PACKAGING ..................................................................................................................... 32

10.I PACK ............................................................................................................................. 32


10.2 SECONDARY CONTAINER ................................................................................................. 32
10,3 TERTIARY CONTAINER ..................................................................................................... 33
11. DOCUMENTATION ........................................................................................................... 33

12. MAINTENANCE AND SERVICEABILITY ......................................................................... 33

13. REGULATORY REQUIREMENTS .................................................................................... 34

13.1 COUNTRY/AREA .............................................................................................................. 34


13.t .1 European Community ............................................................................................ 34

Product Specification and VerificationtValidation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9th October 200t
Page 3 of 34
SME100009-0004

Confidential and Proprietary Information - Graseby Medical Limited

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.

Syringe Driver Type MS16A 0105-0504


Syringe Driver Type MS18 0112-0002
Syringe Driver Type MS26 0113-0001
Syringe Driver Type MS32 0113-0707

Where differences exist in the specification of the Drivers these are


shown with an accompanying reference to the type number.

Foreign language variants

MS16A Italian 0105-0711


French 0105-0702
Dutch 0105-0712
Spanish 0105-0725
Norwegian 0105-0715
German 0105-0717
Swedish 0105-0718
Finnish 0105-0742
Danish 0105-0744
Greek 0105-0748
USA 0105-0750
USA (Deltec Variant) 0105-0753

MS18 Italian 0112-0711


Greek 0112-0748

MS26 Italian 0113-071t


French 0113-0705
Dutch 0113-0712
Spanish 0113-0725
Norwegian 0113-0715

Product Specification and VerificationfVafidation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9th October 2001
Page 4 of 34
SME100009-0005

[ Confidential and Proprietary Information - Graseby Medical Limited ]

German 0113-0717
Swedish 0113-0718
Finnish 0113-0742
Danish .......... 0 ;1;i 3-074~4 .....
Greek 0113-0748

MS32 French 0113-0707

3. References

The following standards form part of this specification by reference:

EN 60601-1:1990 Medical electrical equipment- Part 1: General


requirements for safety.

EN 60601-1-2:1993 Medical electrical equipment - Part 1’ General


requirements for safety 2. Collateral standa rd: Electromagnetic
compatibility - Requirements and tests.

EN 30993-1 "1994 Biological evaluation of medical devices - Part 1:


Guidance on selection of tests.

EN 980:1996 Graphical symbols for use in the labelling of medical


devices.
This Standard supports the essential requirements of EC Directive 93/42/EEC.

EN 20780:I993 Packaging - Pictorial marking for handling of goods.

Product Specification and VerificationtValidation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9t" October 2001
Page 5 of 34
SME100009-0006

Confidential and Proprietary Information - Graseby Medical Limited

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.

All the Drivers share a common enclosure and electromechanical drive


components.

5. Intended purpose of the devices

To be used for administering medication, as liquids, from most of the


syringe brands and sizes from 2 ml up to 35 ml capacity. By the epidural,
intra-arterial, intravenous, intramuscular or subcutaneous routes. The
Drivers are suitable for ambulatory use.

They are to be used under medical supervision.

The intended purpose of each type is shown in Table 1.

Table 1

Type Infusion time Rate

MS16A 30 min to 24 h 0- 99 mm/h in 1 mm/h steps ~ :


MS 18 .....’i"~~’ ’ 5 mmih fixed
~$26 24 h to 60 d....................... 0 - 99 mm/24h in 1 mm/24h steps
with on demand user boost
MS32 volumetric 0 - 9,9 mlih in 0,1 ml/h steps
B-D PLASTIPAK 20 ml syringe only

Product Specification and VerificationfValidation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9t" October 2001
Page 6 of 34
SME100009-0007

Confidential and Proprietary Information - Graseby Medical Limited

The Drivers are not suitable for:

1. Use for infusing medication where pulsatile delivery action is


unacceptable.

2. Use in environments with flammable gas mixtures or with oxygen


enriched atmospheres.

3. Use in strong magnetic fields, for example; NMR scanners.

Product Specification and VerificationfValidation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9th October 2001
Page 7 of 34
Confidential and Proprietary Information - SiMS Graseby Limited

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]

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TS/105-001 issue: A
Date of issue: 16 March 1998
!Page 8 of 34
Confidential and Proprietary Information - Graseby Medical Limited

" Validation: Confirmed by inspection of example of a production Driver, MS18. [12;3/98 CW]

6.1,4 Syringe plunger position


Defines the user controls available to move the syringe driving mechanism of the device.
Ref Specification Verificatio nNalidation
6/6 Single release control allowing manual adjustment of the syringe plunger Verification: Confirmed by review of GAs; 0105-0501, 0112-0001, 0I 13-0002 and 0II3-0707.
position with one hand. [t2/3/98 cw}
Validation: Confirmed by inspegtion of examples of production Drivers; MSl.6A, MS18, MS26
and MS32. [I2/3198 CVV]

6.2 Alarms and indications

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

Vaiidation: Confirmed by inspection of example of a production Driver, MS26. [12/3/98 CW].


Lock-box effects detailed within LRi105-004-A. :

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9t’ October 200t

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]

Validation: Confirmed by visual inspection of examples of production Driver‘s; MSI6A, MS18,


MS26 and MS32. [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] :

Validation: Confirmed by visual inspection of examples of production Driver~; MS16A, MS18,


MS26 and MS32, [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

Validation: Confirmed by visual inspection of examples of production Driver,s; MS16A, MS18,


MS26 and MS32. [I2/3/98 CW]

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

Validation: Confirmed by visual inspection of examples of production Drivers; MS16A, MS18,


MS26 and MS32. [12/3/98 CW] :

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] :

Validation: Confirmed by inspection of example of a production Driver, MS18. [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]

Product Specification and VerificationNalidation Report for Syringe Drivers :


Document No: TSf105-001 Issue: D i
Date of issue: 9~h October 2001
Page 10 of 34
Confidential and Proprietary Information - Graseby Medical Limited

6.3 Syringe attachment

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

Effects of Lock-box validated within VR105-003-A.


Note. MS16A, MS18, MS26 and MS32 have a common enclosure and mech~nica! layout

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]

Effects of Lock-box validated within VR105-003-A.

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]

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 m~x.) ml, B Braun
Omnifix 2, 5, 10, 20 (19 max.), 30 (22 max.} ml, Sherwood monoj.ect 5, 10, 20 (17
max.) ml, Terumo 20 (17 max.), 30/35 (22 max.) ml. [12/3/98 CW’J

Effects of Lock-box validated within VRI05-003-A.

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9t" October 2001

Page 11 of 34
Confidential and Proprietary Information - Graseby Medical Limited

6.4 Power supply

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] :

Validation: Confirmed by ViSL~al inspection of examples of production DriverS; MS16A, MS18,


MS26 and MS32. [I2/3/98 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]

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9th October 2001
Page 12 of 34
Confidential and Proprietary Information - Graseby Medical Limited

7. Performance

7.1 Physical

7.1.1 Rate
Defines the delivery rate range of the device.
Ref Specification VerificationNalidation

Rate Steps Type


711 0 to 99 mm/h I mm/h MS16A Verification: Confirmed by review of GA 0105-0501, [12/3/98 CWJ
Validation: Confirmed by inspection of test record of production Driver, MS16A SN 41233.
[1213/98 CVV]

7/2 5 mm/h fixed MS18 Verification: Confirmed by review of GA 0112-0001. [12/3/98 cwrJ

Validation: Confirmed by inspection of test record of production Driver, MS18 SN 21200.


[12/3/98 CW]

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.

.............. [12/3/98 CW]

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] :

7.1.2 Drive accuracy


Defines the accuracy of the linear drive mechanism that pushes the syringe plunger forward.
Ref Specification VerificationNalidation

7/6 _+ 5 % Verification: Confirmed by review of GAs; 0105-0501, 0112-0001,0113-0002 and 0113-0707.


[12/3/98 CW]

Validation: Confirmed by inspection of test records of production Drivers; MSI6A SN 41233,


MS18 SN 21200, MS26 SN 27143 and MS32 SN 28643. [I2/3/98 cwrJ

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9t" October 200t
Page 13 of 34
Confidential and Proprietary Information - Graseby Medical Limited

7.1.3 Drive force

Ref Specification VerificationNalidation


7/7 30 N to 50 N Verification: Confirmed by review of GAs; 0105-0501, 01 I2-0001,01 I3-0002 and 01 I3-0707.
[12/3/98 CW]

Validation: Confirmed by inspection of test records of production Drivers; MS16A SN 41233,


MS18 SN 21200, MS26 SN 27143 and MS32 SN 28643. [12/3/98 CW]

7.1.4 Syringe sizes


Defines the range of syringe sizes that the device can be used with. Some sizes may not be able to be filled to their designated capacity, Some brands:i may not be
accommodated.. ...............
Ref Specification Verification/Validation : .....

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 :.

MS26 Validation: Confirmed by visual inspection and functional evaluation of representative


examples of production Drivers, MS26 SN 27143. / 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, I0, 20 (17 max.) ml, Terumo 20
(I7 max.}, 30135 (22 max.) ml, [12/3/98 CVV]
Note: MS16A, MS18, MS26 and MS32 have a common enclosure and mechanical layout

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

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSI105-00t Issue: D
Date of issue: 9~h October 2001
Page 14 of 34
Confidential and Proprietary Information - Graseby Medical Limited

7.1.5 Audible indicator

Ref Specification VerificationNalidatio n


7/10 Frequency 3 kHz + 0,5 kHz Verification: Confirmed by review of GAs; 0105-0501, 0113-0002 and 0113-0707.
[12/3/98 CW]

Validation: Awaiting validation .by measurement when suitable equip.ment is available.

7/11 Duration 5 s to 20 s Verification: Confirmed by review of GAs; 0105-0501,0113-0002 and 0113-0707.


[I2/3/98 CVV]
Validation: Confirmed by inspection of test records of production Drivers; MS16A SN 41233,
MS26 SN 27143 and MS32 SN 28643. [12/3/98 CW] :
7/t 2 Volume Audible at 1 m with normal or corrected hearing. Verification; Confirmed by review of GAs; 0105-050I, 0I 13-0002 and 0113-d707.
[12/3/98 CW]

Validation: Confirmed by inspection of test records of production Drivers; MS16A SN 41233,


MS26 SN 27143 and MS32 SN 28643. [12/3/98 CW]

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9th October 2001

Page 15 of 34
Confidential and Proprietary Information - Graseby Medical Limited

7.1.6 Visual indicator

Re/ Specification Verification/Validation


7/13 Yellow light. (Green on Deltec MS16A Verification: Confirmed by review of GAs; 0105-0501, 0113-0002 and 0113-0707.[12/3/98 CW’J
Variant MS16A). MS26 Validation: Confirmed by visual inspection of examples of production Driver~; MS16A, MS26
MS32 and MS32. [12/3!98 CW]

7/I4 Red light MS18 Verification: Confirmed by review of GA 0112-0001. [12/3/98 CW]

Validation: Confirmed by visuaI inspection of an example of a production Driver, MSI8.


[12/3/98 c~&rJ

7/I5 Flash period 1,05 s + 2% MS16A Verification: Confirmed by review of GA 0105-0501. [12/3/98 C~

Validation: Confirmed by inspection of test record of production Driver, MS1BA SN 41233.


[12/3/98 CW]

7/16 Flash period 1,93 s + 4% MS18 Verification: Confirmed by review of GA 0I 12-0001. [12/3/98 CW]

VaIidation: Confirmed by inspection of test record of production Driver, MS18 SN 21200.


[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]

Validation: Confirmed by inspection of test record of production Driver, MS2B SN 27143.


[12/3/98 CW’J

7/18 Flash period 3s ±2% MS32 Verification: Confirmed by review of GA 0113-0707. [12/3/98 CW’J :

Validation: Confirmed by inspection of test record of production Driver, MS32 SN 28643.


[I2/3/98 CW]

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]

7.1.7 Battery life


Defines the duration the device will operate with a fresh battery of the specified type. i
Re/ Specification VerificationNalidatio n
7/20 50 full deliveries Verification: Confirmed by review of GAs; 0105-0501,0112~0001,01 I3-0002 and 01 I3-0707.
[12/3/98 CW]

Validation: No complaints found in Complaints History Review CHR002i01. [12/3/98 CW]

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9t" October 2001
Page 16 of 34
Confidential and Proprietary Information - Graseby Medical Limited ’

7.1.8 Chemical resistance


Defines the chemicals that must not affect the other performance requirements, when the device is used as intended.
Ref Specification VerificationNalidatio n
7/21 The performance of the Driver is unaffected by substances that come into Verification: Confirmed by review of GAs; 0105-0501,0112-000I, 0113=0002 and 01 t3-0707.
contact with it in normal use. [12/3/98 cw]
Validation: No complaints found in Complaints History Review CHR002/01. [~I2/3!98 OWl
............

7.1.9 Packaging performance


Defines that the packagi~ protects the devices and maintains their intact state, when transported and stored as advised.
Ref Specification Verification/Validation
7/22 The specified performance of the Driver is maintained by the packaging Verification: Confirmed by review of Packed Sets (PSs); 0105-0504, 0112-0~02, 01 t3=0001
system, and 0I I3-0707. [12/3/98 CW] :
Validation; No compIaints found in Complaints History Review CHR002i01. ti2/3/98 CW]

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TS/I05-001 issue: D
Date of issue: 9th October 2001
Page 17 of 34
Confidential and Proprietary Information - Graseby Medical Limited

7.2 Electrical and Mechanical Safety

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 :

validation: As Ref 7/23. [12/3/98 CW]

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]

Validation: Appropriate warnings given in Instruction Manuals; MS16AiMS26 0105~0549,


MS 18 0112-0031, MS32 0113-0045. [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] :

Validation: As Ref 7/23. [12/3/98 CW~

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSI105-001 Issue: D
Date of issue: 9th October 2001
Page 18 of 34
Confidential and Proprietary Information - Graseby Medical Limited

7.2.2 Electromagnetic compatibility


Defines the level o.t..emissions of and !l~.e immunity to, 9!.ectromagnetic radiation.
Ref Specification Verification/Validation
7/28 Emissions EN 6060I-1-2 Group 1 Class B Verification: As Validation.

Validation: Confirmed by review of EMC reported in Validation Report VR/105-002. No


complaints found in Complaints History Review CHR002/01. [12/3/98 OWl
7/29 Immunity EN 60601-1-2 ESD at 3 kV contact Verification: As Validation.
and 8 kV air Validation: Confirmed by review of EMC reported in Validation Report VR/ld5-O02. No
complaints found in Complaints History Review CHRO02/01. [12/3/98 CW]
Radiated RF
26 MHz to 1 GHz
at 10 V/m

7.2.3 Mechanical surfaces


Defines the physical condition required for the surfaces of th~..~evice.
Ref Specification Verification/Validation
7/30 The Device surfaces are free of sharp or rough features liable to damage Verification: Confirmed by review of GAs; 0105-050I, 0112-0001,0113-0002 :and 0! 13-0707.
the skin. [12/3/98 CW’J i

Validation: Confirmed by visual inspection of examples of production Drivers; MS16A, MS18,


MS26 and MS32. [12/3/98 CW]

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TS1105-001 Issue: D
Date of issue: 9th October 2001
Page 19 of 34
Confidential and Proprietary Information - Graseby Medical Limited

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

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TS/I05-001 Issue: D
Date of issue: 9th October 2001

Page 20 of 34
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. ~

Ref Specification Verification/Validation


7/37 Operating 700 hPa to 1060 hPa Verification: Conditions not special or abnormaI. Specific design output not required.
[12/3/98 CWJ
Validation: No complaints found in Complaints History Review CHR002/01. [12/3/98 C~
.
7/38 Storage 500 hPa to 1060 hPa Verification: Conditions not special or abnormal. Specific design output not required.
[I2/3/98 CW]
Validation: No complaints found in Complaints History Review CHR002/01. [12./3/98 CW]

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSft05-001 Issue: D
Date of issue: 9th October 2001
Page 21 of 34
Confidential and Proprietary Information - Graseby Medical Limited

7.4.4 Shock and vibration

Ref Specification Verification/Validation


7/39 Drivers withstand levels of shock EN 60601-1 Verification: Confirmed by review of GAs; 0105-0501,0112-0001,0113-0002 and 0113-0707.
and vibration encountered in normal [12/3/98 CWJ
use. Validation: Confirmed by review of Report 087585 on MS26 SN 3112 issued by BS! Testing
and the EC Type Examination Certificate No. 1247 for the MS26!issued by BSl.
There have been no major changes to the design since these were issued. The
MS16A, MS18 and MS 32 are of the same basic construction, certificates issued
by BSl Testing show the Syringe Drivers meet the requirements bf standard ~EC
601-1; MSI6A Cert. No. 115636/1, MS18 Cert. No. 115637/1 and MS26 Cert. No.
115638/1. [12/3/98 CWJ

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]

7.4.5 Operating life


Defines the dura.~!~n of use the device wilt continue to meet the specified perfo~:~ance requirements, when used as intended.
Ref Specification Verificatio nNalidation
7/41 Continuous use Verification: Confirmed by review of GAs; 0105-0501,01 I2-0001, 0113-00{)2 :and 0I 13-0707.
[12/3/98 CW] .

Validation: No complaints found in Complaints Histor~ Review CHR002/01. [1;:2/3/98

7.4.6 Shelf life


Defines the duration the device can be stored without deteriorating and meet the specified performance requirements, when stored in the specified storage
.Conditions. ....................... :
Ref Specification VerificationNalidation

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9t" October 2001

Page 22 of 34
Confidential and Proprietary Information - Graseby Medical Limited J

7/42
I NOT USED

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9th October 2001

Page 23 of 34
Confidential and Proprietary Information - Graseby Medical Limited

8. Construction

8.1 General arrangement


Defines the ~,,rrangement of the parts of the device.
Ref Specification Verification/Validation
8/1 The Driver consists of a small rigid plastic enclosure for the drive motor Verification: Confirmed by review of GAs; 0105-0501, 01 I2-0001, 0113-00021and 0I 13-0707.
and control electronics. This enclosure can only be opened with the use of [12/3198 CW] :
a tool. The battery is contained in a separate compartment within this
Validation: Confirmed by visual inspection of representative example of production Drivers;
enclosure accessible to the user without the use of a tool. MS26 SN 27143. [12/3/98 CW]
Note: MS16A, MS18, MS26 and MS32 have a common enclosure and mechanical layout.
Provision is made for securing the syringe on top of the enclosure and
retaining the syringe barrel and finger grips.

The movable linear actuator that pushes the syringe plunger has provision
to secure the syringe plunger push-button.

The enclosure with a syringe fitted can be further protected with a


transparent cover.

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9th October 2001
Rage 24 of 34
Confidential and Proprietary Information - Graseby Medical Limited J

8.2 Dimensions
De~!nes the physicaL,dimensions of the assembled device.
Ref Specification Verification/Validation

Dimension Value Tolerance


8/2 Width of body 166 mm ± 1 mm Verification: Confirmed by review of GAs; 0105-0501, 0112-0001,0113-0002 and 0113-0707.
[I 2/3/98 CW] ~

Validation: Representative example of production Drivers met specification, MS26 SN 27143


/ Equipment used: Digital gauge TVM300 SN 1578. / 21 °C, [12/3/98 OWl
Note, MS16A, MS18, MS26 and MS32 have a common enclosure and mechanical layout.

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

Validation: Representative example of production Drivers met specification, MS26 SN 27143.


/ Equipment used: Digital gauge TVM300 SN 1578. / 21 ~C, [I2/~/98 OWl
8/4 Height of body 53,0 mm ±0,5mm Verification: Confirmed by review of GAS; 0105@501,0I 12-0001, 0113-0002!and 0! 13-0707.
[12/3/98 CW]

Validation: Representative example of production Drivers met specification, :MS26 SN 27143.


/ Equipment used: Digital gauge TVM300 SN 1578. / 21 °C. [12/3/98 CW]
8/5 Actuator travel 6O mm minimum Verification: Confirmed by review of GAs; 0105-0501, 0112-0001, 0113-0002 !and 0113-0707.
[I2/3/98 CW] :

Validation: Representative example of production Drivers met specification, MS26 SN 27143.


/ Equipment used: Digital vernier calliper (150 ram) Mitutoyo. / 2f °C.
[12/3/98 CW] ~

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

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Document No: TS/105-001 issue: D
Date of issue: 9t" October 2001
Page 25 of 34
I Confidential and Proprietary Information - Graseby Medical Limited 1

I I I I TVM300 SN 1578./21 °C. [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

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSI105-001 Issue: D
Date of issue: 91" October 200!

Page 26 of 34
Confidential and Proprietary information - Graseby Medical Limited

8.5 Materials

Ref Specification VerificationNalidatio n


8/t 1 Body Rigid plastic, white, antistatic grade. Verification: Confirmed by review of GAs; 0105-0501,0112-000I, 0113-0002 and 0i I3-0707.
[12/3/98 CWJ
Typical mechanical properties at +23~C 50% RH:
Validation: Confirmed by audit of material specifications used in assembly and then review of
Tensile strength at break = 50 MPa manufacturer’s data. / ABS DSM Ronfalin RTA 50. [12/3/98 CWJ ~

Impact strength (Charpy notched) = 13 kJmT2

Hardness (Rockwell) = 100


8112 Cover Rigid plastic, transparent, impact resistant. Verification: Confirmed by review of PSs; 0105-0504, 0112-0002, 01 I3-0001 and 0 i’13-0707.
[12/3/98 CW-J i
Typical mechanical properties at +23°C 50% RH:
Validation: Confirmed by audit of material specifications used for Cover 0105-0529 and then review
Tensile strength at break = 70 MPa of manufacturer’s data. / PC GE Plastics Lexan 121. [I2/3/98 CW]

Impact strength (Charpy notched) = 35 kJm2

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

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9t" October 2001
Page 27 of 34
I. Confidential and Proprietary information - Graseby Medicat Limited

9. Labelling

9.1 Device labelling


..,Defines the lab~!!.i, ng on the device, either directly marked or on labels.
Ref Specification VerificationNalidation

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

MS32 Volumetric 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.

electric shock. Applied Part [12/3/98 CVV] :


Validation: A. .w.a.jt.~.n.g~ p.r-9~d.~..c.t.i.~.n~ " .e~‘a m#~es~ ~f~~ D. ~v.e..r.s. ~w.. !b~ ~ ~ ~#~. ~g.

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9th October 2001
Page 28 of 34
Confidential and Proprietary Information - Graseby Medical Limited j

9.1 Device labelling


Defines the labe~!.l.i.ng on the device, either directly marked or on labels. ¯
Ref Specification VerificationNalidation

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

Validation: Awaiting p.roduction examp es of Dr vers with latest labe ng

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

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9{h October 2001
Page 29 of 34
Confidential and Proprietary Information - Graseby Medical Limited

9.2 Packaging labelling


Defines the minimum information appearing on the packaging, either directly printed or on labels.

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

Product Specification and Verification/Validation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9~h October 2001
Page 30 of 34
Confidential and Proprietary Information - Graseby Medical Limited

9.2 Packaging labelling


Defines the minimum information appearing on the packaging, either directly printed or on labels.

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.

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TS/105-001 Issue: D
Date of issue: 9t" October 2001
Page 31 of 34
Confidential and Proprietary Information - Graseby Medical Limited

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]

Validation: .A..w.a.[t.i.qg~pro.d#p.ti.o.n...e_x_a__m_j?!e..s..o..fj3ackag¢~ Drivers. i

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]

Validation: Aw~[tjp,g productig.n..e..x.a..m.p!es Qf p~c..k.a.ge..d...D_rjy_e_ .r.s.

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]

Validation: .A..w.a.itjo~g Erq.d.qp.tj.o.n...e.x_a__m_p.[.e.s..o..f.p.a.c~kaged DLy.e..r.s

10.2 Secondary container


Defines the packaging for a number £~..l~.9£kgged devices.
Ref Specification

10/6 NOT USED

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSI105-001 Issue: D
Date of issue: 9~" October 2001
Page 32 of 34
Confidential and Proprietary Information - Graseby Medical Limited

10.3 Tertiary container


Defines th~,,,packaging for final shipment 0f,.,p. ,ackaged devices. . ..............
Ref Specification VerificationNalidation
10/7 NOT USED

11. Bocumentation

Ref Specification VerificationNalidation


1 !/1 Instruction manual intended for user. Verificatiom Confirmed by review of PSs; 0105-0504, 0112-0002, 01 I3-0001 ~nd 0113-0707.
[12/3/98 CW]

Validation: Confirmed by inspection of Instruction Manuals; MS16A/MS26 0105-0549, MS18


0112-0031, MS32 0113-0045. No complaints found in Complaints History Review
CHR002/01. [!2/3/98 CW]

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] "

Validation: Confirmed by inspection of Service Manuals SM105/5, SM112, SM113,


SM-MS32. No complaints found in Complaints History Review CHR002/01.
[12/3/98 CW]

12. Maintenance and Serviceability

Ref Specification VerificationNafidation


I2/1 The Device requires maintenance. Annual performance checks are Verification: Confirmed by review of Instruction Manuals; MSI6A/MS26 0105-0549, MS18
advised. 0112-0031, MS32 0113-0045. [12/3/98 CW]

Validation: No complaints found in Complaints History Review CHR002!01. [I2/3/98 CW]

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSf105-00t Issue: D
Date of issue: 9t" October 2001
Page 33 of 34
Confidential and Proprietary Information - Graseby Medical Limited

13. Regulatory requirements

13.1 Country/Area

13.1.1 European Community


Defines the regulatory requirements for the EC and EFTA member states.
Ref Specification VerificationNalidation
t 3/1 The Drivers are specified to meet all the relevant requirements of the Verification: Confirmed by review of Master Record Indexes; 7T/105-50~., ’7T/~112-002,
Medical Device Directive 93/42/EEC of June 1993, as amended. 7T/113-001 and 2E/I13-707. And by review of Report 087585 or~ MS26 SN 3I 12
issued by BSl Testing and EC Type Examination Certificate No. ;1247 for the
MS26 issued by BSl. There have been no major changes to theldesign since
The devices have been classified for the requirements of this directive as: these were issued. Certificates issued by BSl Testing show the Syringe Drivers
Risk Class lib (active devices). meet the requirements of standard IEC 601-1 ; MS16A Cert. No. ~115636/1, MS18
Cert. No. I15637/1 and MS26 Cert. No. 115638/1, The MS32 c~esign is derived
from the MS26 in which only the rate range has been internally adjusted,
[12/3/98 CV~J

Validation: Conformity to all relevant requirements of Directive shown in Essential


Requirements Checklist ER002/01. [12/3/98 CWJ :

Notes,

1. Key: x = mean value, s = sample standard deviation.

2, All temperatures were in the range 18 °C to 25 °C and were measured or confirmed using digital thermometer TE5597.

Product Specification and VerificationNalidation Report for Syringe Drivers


Document No: TSf105-001 Issue: D
Date of issue: 9t~ October 2001
Page 34 of 34

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