Helix Colour SM en Ver. 3.20

HELIX
Service Manual
REF: M30003.UK
Version 3.20 - English
03.11.2016
Congratulations on your purchase of this quality ANDROMEDA product. Please read this
user’s manual through carefully so you can service your equipment correctly. Keep it in a
safe place so you can refer to it in the future.
The author has carefully striven to make it as complete and accurate as possible. How-
ever, ANDROMEDA accepts no responsibility for its accuracy.
ANDROMEDA medizinische Systeme GmbH

Wallbergstraße 5
D-82024 Taufkirchen/Potzham
Tel.: +49-89-61 41 56-0
Fax: +49-89-61 41 56-11
Email: info@andromeda-ms.com
Web: www.andromeda-ms.com
© ANDROMEDA medizinische Systeme GmbH 2016, all rights reserved.

Copying, duplication or publication of this User Manual, or sections hereof, is permissible
only after prior written consent has been granted by ANDROMEDA medizinische Sys-
teme GmbH. The same applies also to photocopies and electronic data issued by
ANDROMEDA, other than those required for purely personal use by the purchaser.
HELIX – Service Manual Table of Contents
Table of Contents
Table of Contents ..............................................................................................................1
Information and warning advice ......................................................................................3
Applicable guidelines ...........................................................................................................3
Warning advice ....................................................................................................................3
Electromagnetic and other influences .................................................................................3
Transportation and storage .................................................................................................4
Liability limitations................................................................................................................4
Disposal ...............................................................................................................................4
Safety...................................................................................................................................4
Maintenance ........................................................................................................................5
Cleaning and disinfection.....................................................................................................5
Key to the utilized symbols ..................................................................................................5
Electrical safety....................................................................................................................6
Arrangement and set-up.................................................................................................6
Safety inspection according to IEC 60601-1 ..................................................................7
Assembling Instructions...................................................................................................8
Stand....................................................................................................................................8
Basic unit .............................................................................................................................9
Adaption module for EMG, Uroflow and Puller..................................................................10
Pump module.....................................................................................................................10
Pressure module................................................................................................................11
Puller..................................................................................................................................11
Uroflow...............................................................................................................................12
EMG...................................................................................................................................12
Technical Details .............................................................................................................13
Basic Unit (E31003)...........................................................................................................13
Parts List.......................................................................................................................13
Basic Unit Lower Assembly (HGE00041)..........................................................................15
Parts List.......................................................................................................................15
Display Assembly (HGE00039) .........................................................................................17
Parts List.......................................................................................................................17
Printer Assembly (HGE00014) ..........................................................................................19
Parts List.......................................................................................................................19
Basic Unit PCB ..................................................................................................................21
Stand (E30502)..................................................................................................................29
Parts List.......................................................................................................................29
Puller/Flow/EMG Interface Module (E30521) ....................................................................31
Parts List.......................................................................................................................31
Puller/Flow/EMG Interface PCB ........................................................................................33
H2O Pump Module (E30802) ............................................................................................36
Parts List.......................................................................................................................36
Adjustments ..................................................................................................................37
Pump Module PCB ............................................................................................................40
Volume transducer PCB ...............................................................................................40
Adjustment....................................................................................................................40
Functional Test .............................................................................................................40
ANDROMEDA 03.11.2016 1
Table of Contents HELIX Service Manual
Pressure Module (E30537) ............................................................................................... 44

Parts List ...................................................................................................................... 44
Pressure Module PCB ...................................................................................................... 46
Uroflow Module (E31900) ................................................................................................. 49
Parts List ...................................................................................................................... 49
Uroflow Transducer Assembly (E31903) ..................................................................... 52
Uroflow Module PCB......................................................................................................... 53
Adjustment ................................................................................................................... 53
Functional Test ............................................................................................................ 53
Catheter Puller Module (E30402) ..................................................................................... 56
Parts List ...................................................................................................................... 56
EMG Preamplifier (E30901).............................................................................................. 58
Parts List ...................................................................................................................... 58
EMG Preamplifier PCB ..................................................................................................... 60
PC Interface (HGE00045) ................................................................................................. 63
Parts List ...................................................................................................................... 63
Interface PCB (HEB00149)............................................................................................... 65
Calibration and test ........................................................................................................ 68
Uroflow transducer....................................................................................................... 68
Volume transducer....................................................................................................... 70
Pump............................................................................................................................ 71
Pressure transducer..................................................................................................... 73
Maintenance Work Specification................................................................................... 76
Helix Flow / EMG Version ................................................................................................. 76
Helix Urodynamic Version................................................................................................. 77
Electrical Safety Test ...................................................................................................... 79
Needed tools ..................................................................................................................... 79
Preparation........................................................................................................................ 79
Test configuration.............................................................................................................. 80
Typical test values ............................................................................................................ 81
Technical Specifications ................................................................................................ 82
Measurement unit ............................................................................................................. 82
Input and output units ....................................................................................................... 82
Safety ................................................................................................................................ 82
Power supply..................................................................................................................... 83
Dimensions ....................................................................................................................... 83
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HELIX – Service Manual Information and warning advice
Information and warning advice
Applicable guidelines
Helix has been developed and tested in accordance with the European Safety Standard
IEC 60601-1. edition “Medical Electrical Equipment”. This User Manual contains informa-
0123 tion and warning advice which must be heeded by the individual user to ensure safe
operation and to safeguard against damage to the Helix equipment.
The operation of this device is only permitted within buildings with a room temperature
range of between +10°C (+50°F) and +40°C (+104°F).
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards (e.g. IEC 60950 for data processing equipment
and IEC 601-1 for medical equipment). Furthermore, all configurations shall comply with
the valid version of the system standard IEC 60601-1-1. Anybody who connects addi-
tional equipment to the signal input part or signal output part is deemed to be configuring
a medical system and therefore to be responsible for the system complying with the
requirements of the valid version of the system standard IEC 60601-1-1. If in doubt, the
technical service department or a local representative should be consulted.
Warning advice
Only when the mains plug has been withdrawn from the mains supply socket is discon-
nection from the mains supply ensured. Opening a connected device leaves live compo-
nents open to possible bodily contact.
The Helix must be disconnected from all sources of electrical mains power before main-
tenance or repair work is carried-out.
Apart from the applications described in this User Manual, service and maintenance work
may be carried-out by authorized service personnel only.
Electromagnetic and other influences

The device has been certified according to IEC 60601-1-2 for electromagnetic compatibil-
ity (EMC) in respect to its safety.
It is the responsibility of the user to take the necessary measures to ensure that the limits
of the aforementioned directive are not exceeded.
Information and warning advice HELIX Service Manual
Transportation and storage

The following conditions for transportation and storage up to 15 weeks should be adhered
to:
Temperature: –25°C ... +70°C

Relative humidity: 10 % ... 75 %
Barometric pressure: 500 hPa ... 1060 hPa
after which the values apply as for operating conditions:
Temperature: +10°C ... +40°C

Relative humidity: 30 % ... 75 %
Barometric pressure: 700 hPa ... 1060 hPa
Storage should be under cover or in closed rooms and the equipment should not be
exposed to intensive vibration.
Liability limitations
Attention! HELIX may only be operated according to the provisions of the Instructions for Use. Only
peripheral equipment or expendable materials approved by ANDROMEDA may be used
in combination with the HELIX device. ANDROMEDA accepts no liability for damage
based on improper usage.
All repairs and maintenance work on the equipment may be carried out by authorized
specialists. Unauthorized opening of the unit and/or the intervention of an unauthorized
person will result in the immediate cessation of any liability on the part of ANDROMEDA
for the equipment as well as for all consequent damage arising there from.
Disposal
The equipment packaging should be submitted for recycling; the metal parts in the
equipment as scrap-metal; plastics, electrical components and circuit boards for disposal
as electronic scrap.
The respective national laws and regulations applying to waste disposal and recycling
must be adhered to. It may be necessary to employ specialist waste-disposal companies
which can be found by inquiring through local authority services departments.
Safety
As soon as safety deficiencies become apparent, the equipment must be switched off
and disconnected from all sources of mains electrical power and be secured against
unintentional operation. In such a case, authorized service personnel are to be consulted
to carry-out functional testing and a safety examination including a residual current test
according to the regulations in EN60601-1.
Safety deficiencies could occur if:
visible damage is apparent,
the functionality of the equipment is diminished,
the equipment has been stored over an extended period under unsuitable conditions.
Maintenance
Maintenance work which can be carried out by the user:
Cleaning of the peripherals and the control unit.
Work which may only be carried out by authorised service personal:
Calibration of the device, maintenance work inside the Uroflow measuring device and the
power supply.
Cleaning and disinfection

All surfaces of the equipment and peripherals can be cleaned with a damp cloth. Use
your cleaning solution commonly used for electric medical devices in your house. Wipe
off surplus cleaning solution with a dry cloth. Be careful that no drops enter the connec-
tion sockets or other openings on the equipment.
Note: Do not use solvents for cleaning!
Treat the equipment with care and avoid mechanical forces which could cause damage!
Key to the utilized symbols

The CE marking of the European Union accompanied by the distinguishing
number of the notified body responsible for the surveillance.
The equipment has been denoted as Type BF.
Attention! Observe the Instruction for Use.
With respect to disposal, national regulations must be observed!
Equipotential Terminal.
Attention! The Ellipse must only be connected to a power connector with
protective earth.
Caution! Risk of injury to fingers. Do not touch the roller pump when in opera-
tion.
Information and warning advice HELIX Service Manual
Electrical safety
The Helix is insulated according to electrical class 1 BF, thus permitting the connection of
proprietary PCs and printers without risk to patient safety. The casing of the control unit is
grounded and the transducer, which is situated near the patient, is electrically isolated.
Fig. 1: Block diagram
Arrangement and set-up

Due to adequate isolation, the Helix device including the peripherals may be placed
nd
within the vicinity of the patient (as defined under the directive IEC 60601-1 2 edition).
Fig. 2: The vicinity of the patient according to EN 60601-1
Safety inspection according to IEC 60601-1

All Helix components undergo a safety inspection prior to delivery. It is, however, advis-
able to conduct a final on-site inspection of the complete system including all supplemen-
tary equipment (PCs, printers etc.) which has not been inspected by ANDROMEDA. For
the inspection, the mains connection of the control unit must be connected to the test
equipment. The transducer and its casing must be tested as an applied part.
Please refer to chapter “Electrical Safety Test” on page 79.
Assembling Instructions HELIX Service Manual
Assembling Instructions
Stand
Please notice! Two of the wheels are
equipped with brakes. We recommend to
position these in the front (the bevelling of
the vertical ears points to the rear of the
stand).
5
Insert leg into stand core and fix with Rear
screw and nut - DO NOT TIGHTEN.
3
2
Angle the leg until hole and thread are
aligned and fix with screw . Now tighten
screw and nut . 1
4
Glue the cable guides on the bottom 6
side of the leg. We recommend to use the
rear legs to guide the cables behind the
Helix system.
Place the stand profile on the stand core

and fix it with screws .
Rear
HELIX – Service Manual Assembling Instructions
Basic unit
Optional - only when the delivery includes
the PC interface box:
Mount the PC interface box on basic unit 2
1
and fix with curled screws .
Please notice, if a serial cable connection to

an external PC is used then insert the serial
cable in the slot (connector outside)
before mounting the base unit.
Place basic unit on the stand and fix
with screws . 1
If used then pull the serial cable through the
stand and stand core and fix the cable in 4
the guides under the leg.
2
Pull the mains connection cable through

stand core from bottom to top and connect
to basic unit (either the left or right side of
the core can be used).
Fix cable in the guides under the leg. 6
Fix cable with the clip , disk , and screw 7

. 8
Adaption module for EMG, Uroflow and Puller

Connect flat cable to the module and
guide both cables up through the
stand. Please notice that the cable slings
through the stand core.
Fix module to the stand with screws .
Connect cable to basic unit. 2
1
(DO NOT CONNECT CABLE )
Pump module
Connect flat cable from the adaption
module for EMG, Uroflow and Puller and
the flat cable to the pump module .
Guide both cables up through the 3
2
stand.
1
Fix module to the stand with screws .
Connect cables to the basic unit.
4
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HELIX – Service Manual Assembling Instructions
Pressure module
Connect flat cable to the module and
basic unit.
Fix module to the stand with screws . 1
2
Puller
Fix puller on stand with screws .
Pull cable through the stand core from
the bottom into the adapter module and
connect.
Prevent the cable sliding on the floor by
pulling the cable into the adapter module. 1
Notice!
Be sure to attach the plug to connector
named “Puller”. Attaching it to other
connectors may damage the puller.
2 3
ANDROMEDA 03.11.2016 11
Uroflow
Open door.
Connect the uroflow cable to the uroflow
stand and the adapter module.
EMG
Place EMG preamplifier in the holder left or
right of the basic unit.
Connect the EMG cable to the the adap-
ter module.
Close door.
Attention! Please pay attention to section „Electrical safety“ on page 6.
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HELIX – Service Manual Technical Details
Technical Details
Basic Unit (E31003)
Parts List
# Art. No. Description Qty.
1 HGE00041 Basic Unit Lower Assembly 1
2 HGE00039 Display Assembly 1
3 HMN00025 Nut M3, DIN 934, A2 4
4 HGE00014 Printer Assembly 1
5 HMN00099 Lens head screw recessed, M4x6,0mm, DIN 7985, A2 3
6 HGE00039 Basic Unit Upper Assembly 1
7 HMN00038 Lens head screw recessed, M3x6mm, DIN 7985, A2 4
8 HKB00042 Power Cable 5m 1
9 HMN00090 Washer M3 D=9mm, DIN 9021, zinked, 3,2mmx9mmx0,8m 1
10 HMN00150 Cable Clamp 1
ANDROMEDA 03.11.2016 13
Technical Details HELIX – Service Manual
8
3
10 9
1
11
5
7
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Basic Unit Lower Assembly (HGE00041)
Parts List
1 HMB00432 Lower Housing 1
2 HEM00061 Power connector with EMC filter 1A A, Type Snap 1
3 HEM00112 Power switch with cables (together with 11) 1
4 HEM00076 Loudspeaker LSM-S30 1
5 HMN00092 Nut M2,5, DIN 934, steel 8 zinc coated 4
6 HEB00154 Main PCB Helix colour 1
8 HMN00115 Distance bolt, M3x20mm, female-female thread 4
9 HMB00300 Isolation plate POM 104x53xx0,5 1
10 HEB00116 Power supply AC/DC 30W medical grade 1
11 HEM00112 Power cable for Main Board (together with 3) 1
13 HKB00135 Protective Earth cable 1
14 HMN00017 Serrated lock washer M3 2
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15
14 13
12
11
10
9 7
16
8
4
5
1
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Display Assembly (HGE00039)
Parts List
1 HMB00440 Upper frame 1
2 HMB00412 Lower frame 1
3 HEM00104 Colour LCD 1
5 HKB00159 Flat band cable 40p 1
6 HMN00209 Cable clip 1
7 HKB00057 LED with cable 1
8 HEB00004 LED socket 1
9 HEM00105 Backlight module 1
11 HWS00003 Silicone tube 7,0x0,5mm (not on drawing) 1
12 HKB00081 Cable strap (not on drawing) 1
ANDROMEDA 03.11.2016 17
10
7
6
2
1
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Printer Assembly (HGE00014)
Parts List
1 HMB00442 Basis bin 1
2 HMB00441 Paper tray 1
4 HEM00075 Thermal printer 112mm, basis part (part of 15) 1
5 HMN00109 Self-tapping screw, M2,5x4mm 2
6 HMB00430 Fixing bracket 1
8 HMB00345 Lever 1
9 HMB00346 Arm 1
10 HMB00348 Opener connection plate 1
11 HMN00110 Hex-nut, M3 poly stop, DIN 985 3
12 HMN00111 Spacer polyamid 6,6, M3x1mm 1
13 HMN00108 Sheet metal screw, CH St2,9x6,5mm, DIN 7981 form C 1
14 HMB00347 Door hinge 1
15 HEM00075 Thermal printer 112mm, Paper drum (part of 4) 1
16 HMN00109 Self-tapping screw, M2,5x4mm 3
17 HMB00366 Printer door 1
18 HMN00090 Washer M3 D=9mm * 0,8mm, DIN 9021 4

Only on LOT < 130221
19 HMN00025 Nut M3, DIN 934, A2 4
ANDROMEDA 03.11.2016 19
17
18
20
15
16
14
19
4
3
6 1
10
13
11
12
9
20 03.11.2016 ANDROMEDA
Basic Unit PCB
Attention! This part is high sensitive to electrostatic discharges and may only be han-
dled using proper ESD protection!
ANDROMEDA 03.11.2016 21
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HELIX – Service Manual Basic Unit PCB Technical Details
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Stand (E30502)
Parts List
1 HMB00398 Stand profile 1
2 HMB00433 Thread bar 2
3 HMN00024 Countersunk screw recessed M3x6mm, zinc 8
4 HMB00408 Blind plate 1
5 HMN00104 Countersunk socket screw, M4x12,0mm, DIN 7991, A2 4
6 HMB00396 Foot 4
7 HMB00265 Wheel without brake, d=75,0mm, black, antistatic 2
8 HMN00059 Nut DIN439 B, M10, A2 4
9 HMB00266 Wheel with brake, d=75,0mm, black, antistatic 2
10 HMN00196 Cover plug 4
11 HMB00431 Bed-plate 1
12 HMN00212 Cylinder screw M6x55mm, VA2 4
13 HMN00017 Serrated lock washer M3 4
15 HMN00072 Countersunk-head screw DIN 7991 A2 M6x12 4
ANDROMEDA 03.11.2016 29
12
14
15 13
11
6 4
5
10
8
16
9
7
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Puller/Flow/EMG Interface Module (E30521)
Parts List
1 HMB00400 Front plate 1
2 HMB00403 Hinge plate 1
3 HMN00025 Nut M3, DIN 934, A2 2
4 HMB00401 Door 1
5 HMN00204 Hinge rod 1
6 HMN00203 Lock rings 2
7 HMB00402 Upper housing 1
9 HEB00148 PCB with cable 1
13 HMB00404 Lower housing 1
14 HMN00025 Nut M3, DIN 934, A2 4
15 HMN00202 Knurled head screw 1
16 HMN00090 Washer M3 D=9mm, DIN 9021, zinc 1
17 HMN00025 Nut M3, DIN 934, A2 1
18 HKB00125 E/F/P module cable 1
19 HMN00215 Module mounting kit (not shown) 1
ANDROMEDA 03.11.2016 31
14
13
8
7
9
9
10
9
11 12
17
16
4
15
5
6
2
3
18
1
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Puller/Flow/EMG Interface PCB
ANDROMEDA 03.11.2016 33
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H2O Pump Module (E30802)
Parts List
2 HMB00419 Mounting plate 1
3 HMN00025 Nut M3, DIN 934, A2 6
4 HMB00417 Over-bend protection plate 1
5 HMN00028 Toothed lock washer M3 2
6 HMN00025 Nut M3, DIN 934, A2 2
7 HMB00421 Right hook 1
9 HMN00025 Nut M3, DIN 934, A2 2
10 HMB00354 Load cell isolator 1
12 HMN00025 Nut M3, DIN 934, A2 4
13 HMB00333 Load cell 1
14 HMB00329 Hook isolator 1
15 HMN00062 Countersunk screw M4x8mm 8
16 HMB00422 Left hook 1
18 HMN00183 Hexagon socket head cap screw M3x16,0mm, DIN 912 2
20 HEB00155 Volume/Flow transducer PCB ver. 2.10 1
22 HMN00020 Soldering eye M3 1
25 HMB00414 Tube bracket 1
26 HMB00439 Bracket lock 1
27 HMN00211 Spring d=0,63mm l=20,0mm 1
28 HMN00026 Washer M3, D=7mm, zinc 1
29 HMN00205 Excenter screw with lock washer (30) 1
30 HMN00205 Lock washer (together with 29) 1
36 03.11.2016 ANDROMEDA
31 HMN00138 Grub screw M3x6,0mm 1
32 HMB00415 Pump wheel protection 1
34 HMN00132 Hex nut M4 poly-stop, DIN 985 1
36 HEB00076 Pump driver PCB with cable (39/40) 1
40 HMB00316 Vibration buffer 3
41 HEM00054 Pump motor 1
43 HMN00040 Sleve nut M4x10mm 3
44 HEB00076 Pump driver cable (together with 31/40) 1
45 HEB00076 Cable protection (together with 31/39) 1
46 HMB00420 Housing 1
47 HMN00025 Nut M3, DIN 934, A2 4
48 HMN00121 Bearing bush, with bund polyamide 6.6, 12x8mm 1
49 HMB00258 Pump wheel hub 1
50 HMN00148 Grub screw M4x6,0mm, DIN 913, A2 1
51 HMB00423 Pump wheel 1
52 HKB00124 Volume transducer cable 1
Adjustments
The over-bend protection plate should be adjusted to block the load cell at 6kg load.
Adjust excenter screw to an average output pressure

of 2 bar. Notice that the outer hexagon angle denotes
the point of adjustment. The point must only be in the
left 180 degr. range.
ANDROMEDA 03.11.2016 37
21
20
18
19
17
23 24
22
14
15
13
16
12
11
10
9
8 6
5
4
7
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47
46
45
44
43
42
41
41
37 39
38
36
34
35
52
25
27
30
26
31 30
48
28
51
29
50 33
49
ANDROMEDA 03.11.2016 39
Pump Module PCB
Volume transducer PCB

The soldering bridge “VOL” must be short-cut. Do not short-cut “FLO”.
Adjustment
Adjust potentiometer to an output voltage (on soldering bridge) off around -1V at zero
load (0kg).
Functional Test
The output voltage should increase 0.5V / Kg load:
1kg: 0.5V above adjusted zero point.
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Attention! The soldering bridge “VOL” must be short-cut!
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Pressure Module (E30537)
Parts List
1 HMB00288 Connector bracket 1
2 HKB00002 Monitor cable PVB 3
3 HMB00289 Connector bracket clamp 1
4 HMN00141 Countersunk screw recessed, M3x20,0mm, DIN 965, A2 4
5 HMB00287 Connector plate 1
7 HMB00286 Connector housing 1
8 HMN00024 Countersunk screw recessed, M3x6,0mm, DIN 965, zinc 4
10 HMB00361 Mounting plate 1
11 HMN00025 Nut M3, DIN 934, A2 4
12 HMN00096 Nut M4, DIN 934, A2 3
14 HEB00089 Pressure module PCB 1
17 HMN00025 Nut M3, DIN 934, A2 4
18 HVP00196 Label “Pves Pabd Pura” 1
19 HKB00123 Cable for Pressure module 1
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17
16
15
14 13
12
11
10
5
19
3
6
2
4
1
18
ANDROMEDA 03.11.2016 45
Pressure Module PCB
This part is not sensitive to electrostatic discharges and may be handled without ESD
protection!
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Uroflow Module (E31900)
Parts List
1 HMB00217 Stand base 1
2 HMN00123 Rubber pad 4
4 E31903 Uroflow transducer 1
5 HMB00357 Stand pole 1
7 HMB00240 Receptacle 1
8 HMB00242 Funnel 1
9 E31700 Transducer cable 1
10 HGE00027 Arm 1
11 HMB00359 Load cell base plate 1
12 HMB00238 Cable nipple, M10 1
13 HKB00169 Load cell cable 1
14 HMB00314 Cable guide 1
15 HMN00025 Nut M3, DIN 934, A2 3
16 HGE00021 Load cell housing 1
17 HMB00281 Load cell 1
19 HMN00025 Nut M3, DIN 934, A2 2
20 HEB00130 Load cell PCB 1
22 HMB00310 Load set isolation set (include 23) 1
23 HMB00310 Load set isolation set (include 22) 1
24 HMN00078 Hexagon socket head cap screw, M4x20mm, DIN 6912,A2 2
25 HMN00135 Cable protecting sleeve, 9,0x6,0x1,0mm, form A 1
26 HKB00151 Connector, 6P, Micro 1.27mm 1
27 HMB00358 PCB mounting plate 1
28 HMN00032 Cylinder spacer Polyamide M3x4mm 4
29 HEB00155 Volume/Flow transducer PCB ver. 2.10 1
30 HMN00025 Nut M3, DIN 934, A2 4
ANDROMEDA 03.11.2016 49
31 HMN00025 Nut M3, DIN 934, A2 2
32 HMB00297 Brake 1
33 HMN00144 Spring DIN17223, ends grinded and applied, d1, D7,3, L10 1
34 HMB00264 Knurled handle M8x30mm 1
36 HMN00100 Lens head sunk screw recessed, M3x6,0mm, DIN 966, A2 4
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4
9
7
1
2
3
ANDROMEDA 03.11.2016 51
Uroflow Transducer Assembly (E31903)
34
16
33
32
18
17
19
29
20 28
22 27
21 31
11
30
25
35
36
10 26
14
12
23 15
13
24
52 03.11.2016 ANDROMEDA
Uroflow Module PCB
The soldering bridge “FLO” must be short-cut. Do not short-cut “VOL”.
Adjustment
Adjust potentiometer to an output voltage (on soldering bridge) off around -1V at zero
load (0kg).
Functional Test
The output voltage should increase 1.2V / Kg load:
ANDROMEDA 03.11.2016 53
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Attention! The soldering bridge “FLO” must be short-cut!
ANDROMEDA 03.11.2016 55
Catheter Puller Module (E30402)
Parts List
1 HMB00223 Mounting bracket 1
2 HMN00146 Cord grip M12 1
3 HKB00191 RJ-45 cable 1
4 HMB00279 Lower flexible arm 1
5 HMB00226 Flexible arm adapter 1
6 HMB00317 Arm 1
7 HMB00271 Upper flexible arm
8 HKB00017 Shrinking tube 24.0mm-8.0mm, black 2
9 HMB00296 Motor housing 1
10 HEM00094 Gear motor 1
11 HMB00224 Motor mounting plate 1
12 HMN00134 Lens head screw recessed, M2x4.0mm, DIN 7985, A2 2
13 HMB00221 Catheter slide guide 1
14 HMN00152 Countersunk screw recessed, M2.5x8mm, DIN 965, A2 2
15 HKB00076 & Shrinking tube 3.2-1.6mm & 6.4-3.2mm 1

HKB00176
16 HMN00124 Cover plug 1
17 HMB00426 Tooth wheel 1
18 D30402 Catheter slide set (3 pcs.) 1
19 HMN00219 Countersunk socket screw, M6x45.0mm, DIN 7991, A2 2
20 HMB00283 Rubber O-ring 2
Gluing positions, “UHU Endfest 3000” 5
56 03.11.2016 ANDROMEDA
2
20 19
1
4
7
8
17
18
16
9
11
15 10 12
13
14
ANDROMEDA 03.11.2016 57
EMG Preamplifier (E30901)
Parts List
2B HEM00019 Plastics One connector 1,5mm, black 1
2G HEM00020 Plastics One connector 1,5mm, green 1
2R HEM00018 Plastics One connector 1,5mm, red 1
3 HMB00262 Connector bracket 1
4 HVP00139 Isolation foil 1
5 HEB00131 EMG Amplifier PCB 1
6 HKB00199 Wire 0,5mm black 4
7 HMN00020 Soldering eye M3x12mm 1
10 HKB00168 EMG Preamplifier cable 1
11 HKB00081 Cable strap 1
12 HMB00375 Foam plate 1
13 HMB00356 Cover 1
14 HMN00153 Countersunk screw recessed, M2,5x5,0mm, DIN 965, A2 4
58 03.11.2016 ANDROMEDA
14
13
12
10
11 9
8
6 7
2
B
G
R
ANDROMEDA 03.11.2016 59
EMG Preamplifier PCB
Attention! Do not adjust potentiometers P1 and P2 for common mode rejection without
using the proper equipment. The common mode rejection adjustment re-
quires special equipment only owned by ANDROMEDA.
If the PCB or the internal cables are exchanged or manipulated the Amplifier
must be common mode adjusted by ANDROMEDA.
Notice The amplifier PCB contains an isolation barrier for patient safety. Do not
short-cut primary and secondary sides.
60 03.11.2016 ANDROMEDA
61 03.11.2016 ANDROMEDA
62 03.11.2016 ANDROMEDA
PC Interface (HGE00045)
Parts List
1 HMB00399 Housing (basis part) 1
2 HEB00149 PCB 1
3 HMN00108 Sheet metal screw, CH St2,9x6,5mm, DIN 7981 form C 4
4 HKB00142 Cable set with D-Sub connector 1
5 HMB00399 Housing (cover part) 1
6 HMN00151 Threaded bolt UNC4-40 / UNC 4-40 with nut and wascher 2
7 HMB00399 Housing (screws) 4
ANDROMEDA 03.11.2016 63
64 03.11.2016 ANDROMEDA
7
Interface PCB (HEB00149)
Notice The interface PCB contains an isolation barrier for patient safety. Do not
short-cut primary and secondary sides.
ANDROMEDA 03.11.2016 65
66 03.11.2016 ANDROMEDA
67 03.11.2016 ANDROMEDA
HELIX – Service Manual Calibration and test
Calibration and test

Before delivery of the unit all of the transducers were
calibrated by ANDROMEDA.
In order to achieve maximum accuracy, the trans-
ducers can be recalibrated. Linear transducers are
calibrated with two known physical values. HELIX
stores the corresponding values for internal conver-
sion. The more accurate the calibration, the more
exact the measurement results. Transducers with
linear working range include pressure transducers,
uroflow transducers and volume transducers.
Fig. 3: Calibration
Uroflow transducer
Configuration
HELIX
Uroflow transducer with stand
1 kg weight.
Calibration
Fig. 4: Configuration for calibration of the uroflow transducer
68 03.11.2016 ANDROMEDA
Select Settings and then the

selection item Calibration.
Mark Vura with the slider on the

right-hand side of the screen.
Define a zero point with the funnel

empty and press the symbol 0 ml.
Fill the funnel with a weight (1000

ml in this example). Calibrate the
value by pressing on the symbol
1000 ml.
A message appears on the screen: Calibration

OK!
Fig. 5: Calibrate Vura
If the message Calibration unsuccessful!
Appears, check that the plugs are all correctly fitted.
Repeat the calibration steps from the zero point setting.
If the fault message continues to appear, the device is defective. Please contact Techni-
cal Support.
Note: It is also possible to achieve accurate results using media other than water (e.g. contrast
medium). In this case carry out the calibration with 1000 ml of the infusion medium you
wish to use.
Test
Start an uroflow measurement.
Set the channels, if necessary,

with the funnel empty, to zero.
Fill the funnel with a weight (1000

ml in this example).
The display must indicate 1000 ml. The error should be less than 1 %.
In order to measure the linearity, repeat the test procedure (from zero setting) with
500 g or 500 ml.
The deviation should be less than 1 %.
Note: ANDROMEDA states a relative error of less than 1 %. A properly calibrated device,
however, offers much greater accuracy (rel. error less than 0.2 %).
ANDROMEDA 03.11.2016 69
Volume transducer
Configuration
HELIX
Volume transducer at the stand, connected to Vinf
1-kg weight with wire eye
Fig. 6: Configuration for the calibration of the volume transducer
Calibration
Select Vinf.
With the left-hand hook unloaded,

set Vinf to zero by pressing the 0
ml key.
Load the left-hand hook with a

weight (from the list, e.g. 1000
ml). 1kg
Wait 10 seconds and calibrate

1000 ml with the corresponding
symbol
A message appears on the screen: Calibration OK!

If the message Calibration unsuccessful! appears, check
that the plugs are all correctly fitted. Fig. 7: Calibrate Vinf
Repeat the calibration steps from the zero point setting.

If the fault message continues to appear, the device is defective. Please contact Techni-
cal Support.
Note: It is also possible to achieve accurate results using infusion media other than water (e.g.
contrast medium). In this case carry out the calibration with 1000 ml of the infusion me-
dium you wish to use.
70 03.11.2016 ANDROMEDA
Test
Start a cystometry measurement.
Set Vinf at zero with a load of 1 kg or 1000 ml.
Remove the 1 kg weight.
The error should be less than 1 % (at 1000 ml ±10 ml).
To measure the linearity, repeat the test procedure (from zero setting) with 3 kg or
3000 ml.
The error should be less than 1 % (at 3000 ml less than ±30 ml).
Pump
Calibrating the pump

The pump can be calibrated either automatically, using a previously calibrated volume
transducer, or using the fixed conveyance quantities in a measuring beaker of 100 or
200 ml.
Configuration
HELIX
A bottle or a bag with water connected to a pump tube set.
A measurement beaker; for calibration without a volume transducer the beaker should
have very accurate level marks.
Fig. 8: Configuration for calibration of the pump
ANDROMEDA 03.11.2016 71
Calibration with volume transducer (recommended)

Select the H2O pump with the slider.
Set the most-used infusion rate.
Ventilate the pump tube.
Start the pump from the calibration menu and allow it to
run for 2 minutes.
Stop the pump from the calibration menu.
If the message Calibration unsuccessful! appears, check
that the plugs are all correctly fitted and repeat the cali-
bration steps from the start of pumping.
If the fault message continues to appear, the device is
defective. Please contact Technical Support.
Note: You will achieve the greatest accuracy for the infusion rate Fig. 9: Calibrate the pump
if you
1. calibrate with the most-used infusion rate,
2. calibrate using the same water bottle (or bag) that you always use.
Calibration without volume transducer

Press Setup, then the selection item Calibration.
Select pump.
Set the most-used infusion rate.
Ventilate the pump tube.
Start the pump from the calibration menu and allow it to run until 200 ml has
collected in the measurement beaker.
Stop the pump from the calibration menu.
If the message Calibration unsuccessful! appears, check that the plugs are all cor-
rectly fitted and repeat the calibration steps from the start of pumping.
If the fault message continues to appear, the device is defective. Please contact
Technical Support
Note: You will achieve the greatest accuracy for the infusion rate if you
1. calibrate with the most-used infusion rate,
2. calibrate using the same water bottle (or bag) that you always use and
3. if the markings on the measurement beaker are very precise.
72 03.11.2016 ANDROMEDA
Test
Set Vinf at zero with the bottle or bag attached.
Set the infusion rate at 100 ml.
Start the pump and let it run for 2 minutes. Then stop the pump.
Check the Vinf- value in the display.
The relative error should be less than 5 % (200 ml ±10 ml).
Pressure transducer
Configuration
HELIX
A bottle or bag with water, connected to a transducer tube set
A pressure transducer connected to the transducer tube set
A pressure transmission tube connected to the pressure transducer
A ruler (20 cm) to measure the height of the water column
Fig. 10: Configuration for the calibration of the pressure transducers
ANDROMEDA 03.11.2016 73
Calibration
The calibration procedure is shown for one pressure channel (Pves). All of the other
pressure channels are calibrated in the same way. The following pressure channels are
allocated to the measurement channels in the calibration menu:
Open the calibration menu

and select Pves.
Fill the pressure transducer

with water. The water-filled
tube must not have any air
bubbles.
Place the water level of the

tube at the height 0 cm and
calibrate at 0 cmH2O.
Place the water level of the

tube at the height 20 cm
and calibrate at 20 cmH2O.
A message appears: Calibration OK!

If the error message Calibration unsuccessful! appears, Fig. 11: Calibrate pressure channels
check that the plugs are fitted correctly.
Repeat the calibration steps from the start of pumping.
If the error message continues to appear, the device is defective. Please consult
Technical Support.
Repeat the calibration steps as of water level 0 cm.
If the error message continues to appear, the device is defective. Please contact
Technical Support.
Now: The calibration using a water column is very exact
1. if the measurement tube does not contain any air bubbles,
2. if the water column is very precisely aligned with the ruler.
For even greater accuracy, HELIX also offers the option of calibrating with water columns
of 50 or 100 cmH2O. Calibration with 20 cm is somewhat simpler, however.
74 03.11.2016 ANDROMEDA
Test
An example of the test procedure is given here for one channel (Pves). The other pres-
sure channels are tested in the same way. The following table shows which pressure
channels are used in which measurement programs.
Position the water column at 0 cm

ruler height and set the pressure
channel Pves at zero.
Position the water column at 20 cm The relative error is

ruler height and check the value for less than 1%,
Pves in the display. 20 cmH2O ±0,2 cm
Position the water column at 100 cm 100 cmH2O ±1 cm
ruler height and check the value for
Pves in the display.
ANDROMEDA 03.11.2016 75
HELIX – Service Manual Maintenance Work Specification
Maintenance Work Specification

Work which may only be carried out by authorised service personal:
Calibration of the device, maintenance work inside the measuring device and peripherals.
Attention! The Helix must be serviced once in a year by means of electrical safety test, functional
tests, and calibration.
Helix Flow / EMG Version
Visual inspection of all components.

Basic unit:
• Housing, Keypad, Thermal printer, Power cable, PC communication box

Stand:
• Wheels inclusive brakes, Connectors for uroflow and EMG

Uroflow transducer:
• Receptacle, Housing
Uroflow stand:
• Funnel, Connectors and flow cable, Mechanical high adjustment and fixation
EMG Preamplifier:
• Cable, Electrode Connectors

Any damage that might increase the risk of injuries of the patient or user or influence the
functionality must be repaired. Especially damages on cables could lead to hazards.
Electrical Safety Test.

See chapter Electrical Safety Test on page 79.
Calibration and test measurement

Please refer to detailed calibration guide in chapter “Calibration and test” on page 68
Uroflow transducer:
• Test measurement - if the actual value is more than 500g inaccurate the trans-
ducer might be defective and must be serviced.
• Calibrate using 1 kg for most accurate result.
• Test measurement - if the actual value is more than 2g inaccurate the transducer
might be defective and must be serviced.
EMG pre-amplifier:
• Short-cut all three electrode inputs – if the ground noise is higher than 5µV the
pre-amplifier might be defective and must be serviced.
• Generate test signal using the hand - if the signal peak is less than 100µV the
76 03.11.2016 ANDROMEDA
Helix Urodynamic Version
Visual inspection of all components.

Basic unit:
• Housing, Keypad, Thermal printer, Power cable, PC communication box

Stand:
• Wheels inclusive brakes, Connectors for uroflow and EMG

Pressure Module:
• Housing, Connectors
Pump and Volume Module:
• Housing, Hooks, Pump wheel

Uroflow transducer (optional):
• Receptacle, Housing
Uroflow stand (optional):
• Funnel, Connectors and flow cable, Mechanical high adjustment and fixation
EMG Preamplifier (optional):
• Housing, Cable, Electrode Connectors

Catheter Puller (optional):
• Housing, Cable, Slide

Any damage that might increase the risk of injuries of the patient or user or influence the
functionality must be repaired. Especially damages on cables could lead to hazards.
Electrical Safety Test.

See chapter Electrical Safety Test on page 79.
Calibration and test measurement

Please refer to detailed calibration guide in chapter “Calibration and test” on page 68
Uroflow transducer (optional):
• Test measurement - if the actual value is more than 500g inaccurate the trans-
ducer might be defective and must be serviced.
• Calibrate using 1 kg for most accurate result.
• Test measurement - if the actual value is more than 2g inaccurate the transducer
might be defective and must be serviced.
Infused Volume transducer:
• Test measurement using 3kg - if the actual value is more than 1000g inaccurate
the transducer might be defective and must be serviced.
• Calibrate using 1 kg for an accurate result or 3kg for an even better.
ANDROMEDA 03.11.2016 77
• Test measurement using 3kg - if the actual value is more than 10g inaccurate the
transducer might be defective and must be serviced.
Filling Pump:
Attention! To test the pump, use always a new pump tube.
• Test output pressure using a pump tube connected to a manometer. If the pres-
sure is higher than 2.5 bars or lower than 1.5 bar then the pump mechanics might
be defective.
• Adjust pump output pressure to 2 bars +/-0.3 bar.
• Test measurement – let the pump run for 2 minutes at 50 ml/min. If the actual
value is more 40ml inaccurate the pump mechanics might be defective and must
be serviced.
• Calibrate letting the pump run for 2 minutes and the “Vinf automatic” function for
most accurate result.
• Test measurement - if the actual value is more than 5ml inaccurate the pump
mechanics might be defective and must be serviced.
Pressures:
Attention! To test the pressures, use always new pressure transducers.
• Test measurement - if the actual value is more than 10 cm/H2O inaccurate the
device might be defective and must be serviced.
• Calibrate using 20cm water column for accurate result or 100cm for even better.
• Test measurement - if the actual value is more than 3 cm/H2O inaccurate the de-
vice might be defective and must be serviced.
EMG pre-amplifier (optional):
• Short-cut all three electrode inputs – if the ground noise is higher than 5µV the
• Generate test signal using the hand - if the signal peak is less than 100µV the
Catheter Puller (optional):
• Test measurement – let the puller run for 1 minute at 1 mm/sec. If the actual
value is more 10mm inaccurate the pump mechanics might be defective and
must be serviced.
• Calibrate by letting the puller run at a speed of 1mm/sec. for 100mm for most ac-
curate result.
• Test measurement - if the actual value is more than 10mm inaccurate the puller
mechanics might be defective and must be serviced.
78 03.11.2016 ANDROMEDA
HELIX – Service Manual Electrical Safety Test
Electrical Safety Test
Needed tools
• Insulation pad (only EMG test)
• ANDROMEDA – Test cable HKB30020
• ANDROMEDA – Test cable HKB30030
• Safety tester according to EN 62353
Preparation
EMG pre-amplifiers with serial numbers less than 08110401 must be opened before
testing.
In the case that the two red marked circuits are not present, then the pre-amplifier must
be modified. This is done by ANDROMEDA free of charge. Please continue the test
without EMG or suspend the test until the modified pre-amplifier is returned from
ANDROMEDA.
ANDROMEDA 03.11.2016 79
Test configuration
1. Attach the Helix mains power cable to the safety tester.
2. Attach the two test cables HKB30020 and HKB30030 to the safety tester. The
EMG pre-amplifier must during the entire test stay attached to the Helix. Attach
the test cable to the electrode inputs and the applied part connector of the safety
tester.
Attention:
• The EMG housing is applied to high voltage during the test!
• The EMG must during the test be placed on an insulation pad!
• Do not touch the EMG housing during the test.
3. Attach the test cable to the transducer inputs of the Helix and the applied part
connector of the safety tester.
80 03.11.2016 ANDROMEDA
4. Attach the safety tester protective earth pin to the housing of the Helix. Use a
mounting screw under the Helix Basic Unit.
5. Go through all test steps specified by the normative.
Attention! The Helix must be ON during the leakage current tests. If the safety
tester turns OFF the device then press the ON button on the Helix key pad.
Typical test values
Step Description IEC 62353 Unit Min Max Result

1 Protected earth resistance Ω - 0.3 0.12
2 Device leakage current, direct, PE µA - 500 146.1
3 Device leakage current, diff, PE µA - 500 147.1
4 Leakage current Applied part, PE µA - 5000 158.9
5 Device leakage current, direct µA - 500 142.1
6 Device leakage current, diff µA - 500 143.4
7 Leakage current Applied part µA - 5000 159.2
8 Mains voltage V - - 227.5
9 Power consumption A - - 0.08
ANDROMEDA 03.11.2016 81
HELIX – Service Manual Technical Specifications
Technical Specifications
Signal processing 16 Bit, digital filters, artefact detection
Measurement pro- User-defined, unlimited quantity
grams
Analyses Uroflow, cystometry, rest and stress profilometry, pressure/flow,
ICS nomograph, chess, linear PURR, CLP, VLPP
Measurement unit
Pcs Designation Range Error Sampling/ Oversam-

pling
3 Pressure measure- ±1000 cmH2O <1 % 20 Hz/ 2 kHz
ment channels
1 Uroflow channels 200 ml/s, 1500 ml <1 % 8 Hz/ 2 kHz
1 Volume channel 500 ml/min, 5000 ml <1 % 4 Hz/ 2 kHz
1 EMG input 100–3400 µV (pp) 5% 20 Hz/ 20 kHz
1 Catheter puller 0.5; 1; 2 mm/s <2 %
1 Infusion rate (pump) 1–100 ml/min <5 %
1 Analogue/digital con- 16 Bit ½ bit
verter
Measured on calibrated standard devices
Input and output units
Printer Resolution: 200 dpi

Speed: 0.25; 0.5; 1; 2; 5 mm/s
2nd print: 10 mm/s
LC display Resolution: 320 × 240 Dots, 18 bit colour
depth
Operation Membrane Keyboard
Communication PC-Link, Cable or Wireless
Safety
HELIX System IEC 601-1:1988 + a1:1991 + a2:1995

VDE750 / VDE751
MDD Class II a
Protection Class I, BF
Humidity class IPX 0
82 03.11.2016 ANDROMEDA
Power supply
Voltage 100–240 V
Mains frequency 50–60 Hz
Power consumption 30 W
Fuses 2 × T1AH/250 V
Stand-by mode <1 W
Dimensions
Unit Height Depth/length Width Weight

HELIX base unit includ- 100 cm Rollers: 55 cm Rollers: 47 cm 13.3 kg
ing stand and pump Device: 23 cm Device: 28 cm
module
Uroflow transducer 67 cm 52 cm Stand foot: 50 cm 5.8 kg
compl. Transducer: 30 cm
Catheter puller 115 cm 11 cm 4 cm 0.7 kg
ANDROMEDA 03.11.2016 83
ANDROMEDA medizinische Systeme GmbH

Wallbergstraße 5
D-82024 Taufkirchen/Potzham
Germany
Tel.: +49-89-61 41 56-0
Fax: +49-89-61 41 56-11
Email: info@andromeda-ms.com
Web: www.andromeda-ms.com
© ANDROMEDA medizinische Systeme GmbH 2016, all rights reserved.

Copying, duplication or publication of this User Manual, or sections hereof, is permissible
only after prior written consent has been granted by ANDROMEDA medizinische Sys-
teme GmbH. The same applies also to photocopies and electronic data issued by
ANDROMEDA, other than those required for purely personal use by the purchaser.
84 03.11.2016 ANDROMEDA

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Version 3.20 - English

ANDROMEDA medizinische Systeme GmbH

© ANDROMEDA medizinische Systeme GmbH 2016, all rights reserved.

Pressure Module (E30537) ............................................................................................... 44

Information and warning advice

Electromagnetic and other influences

Transportation and storage

Temperature: –25°C ... +70°C

Temperature: +10°C ... +40°C

Cleaning and disinfection

Key to the utilized symbols

The equipment has been denoted as Type BF.

Attention! Observe the Instruction for Use.

With respect to disposal, national regulations must be observed!

Fig. 1: Block diagram

Arrangement and set-up

Fig. 2: The vicinity of the patient according to EN 60601-1

Safety inspection according to IEC 60601-1

Place the stand profile on the stand core

Please notice, if a serial cable connection to

Pull the mains connection cable through

Fix cable with the clip , disk , and screw 7

Adaption module for EMG, Uroflow and Puller

Attention! Please pay attention to section „Electrical safety“ on page 6.

Basic Unit (E31003)

1 HGE00041 Basic Unit Lower Assembly 1

2 HGE00039 Display Assembly 1

3 HMN00025 Nut M3, DIN 934, A2 4

4 HGE00014 Printer Assembly 1

5 HMN00099 Lens head screw recessed, M4x6,0mm, DIN 7985, A2 3

6 HGE00039 Basic Unit Upper Assembly 1

7 HMN00038 Lens head screw recessed, M3x6mm, DIN 7985, A2 4

8 HKB00042 Power Cable 5m 1

9 HMN00090 Washer M3 D=9mm, DIN 9021, zinked, 3,2mmx9mmx0,8m 1

10 HMN00150 Cable Clamp 1

11 HMN00038 Lens head screw recessed, M3x6mm, DIN 7985, A2 1

Basic Unit Lower Assembly (HGE00041)

1 HMB00432 Lower Housing 1

2 HEM00061 Power connector with EMC filter 1A A, Type Snap 1

3 HEM00112 Power switch with cables (together with 11) 1

4 HEM00076 Loudspeaker LSM-S30 1

5 HMN00092 Nut M2,5, DIN 934, steel 8 zinc coated 4

6 HEB00154 Main PCB Helix colour 1

7 HMN00038 Lens head screw recessed, M3x6mm, DIN 7985, A2 4

8 HMN00115 Distance bolt, M3x20mm, female-female thread 4

9 HMB00300 Isolation plate POM 104x53xx0,5 1

10 HEB00116 Power supply AC/DC 30W medical grade 1

11 HEM00112 Power cable for Main Board (together with 3) 1

12 HMN00038 Lens head screw recessed, M3x6mm, DIN 7985, A2 3

13 HKB00135 Protective Earth cable 1

14 HMN00017 Serrated lock washer M3 2

15 HMN00038 Lens head screw recessed, M3x6mm, DIN 7985, A2 2

Display Assembly (HGE00039)

1 HMB00440 Upper frame 1

2 HMB00412 Lower frame 1

3 HEM00104 Colour LCD 1

4 HMN00038 Lens head screw recessed, M3x6mm, DIN 7985, A2 4

5 HKB00159 Flat band cable 40p 1

6 HMN00209 Cable clip 1

7 HKB00057 LED with cable 1

8 HEB00004 LED socket 1

9 HEM00105 Backlight module 1

10 HMN00134 Lens head screw recessed, M2x4,0mm, DIN 7985, A2 2