1401-0310-024-11 - Service Manual System Sophi and Sophi A

System
Sophi &
Sophi A
Service Manual English
Part No.: 1401-0310-024
1401-0310-024-11_Service Manual System Sophi and Sophi A 2/78
Table of Contents
1 System Sophi & Sophi A in General ................................................................. 6
1.1 Qualification of service personnel /intended use and user profile ............................ 6
1.2 Description of device equipment .............................................................................. 6
1.2.1 General ............................................................................................................... 6

1.2.2 Interfaces ............................................................................................................ 6
1.3 Related documents .................................................................................................. 6

1.4 Supply Network........................................................................................................ 7
1.5 Symbols and Markings ............................................................................................ 7
1.5.1 Symbols .............................................................................................................. 7

1.5.2 Markings on the outside and parts of the device ................................................ 7
1.6 Classification of device and system ......................................................................... 8

1.7 Warning and safety .................................................................................................. 8
1.7.1 Pump System ..................................................................................................... 8
1.8 Service and maintenance ........................................................................................ 9
1.8.1 Instructions for replacements.............................................................................. 9

1.8.2 Returns ............................................................................................................. 10
1.8.3 Service and maintenance check ....................................................................... 10
1.8.4 Functional check device ................................................................................... 14
1.8.5 Cassette system check ..................................................................................... 17
1.9 Spare parts ............................................................................................................ 20

1.10 Required tools........................................................................................................ 23
1.11 Waste Management ............................................................................................... 25
1.11.1 Cassettes and disposable parts........................................................................ 25

1.11.2 Electronic components ..................................................................................... 25
1.12 Foot pedal .............................................................................................................. 26
1.12.1 Foot pedal update ............................................................................................. 26

1.12.2 Foot Pedal reset ............................................................................................... 26

1.12.3 Foot Pedal pairing ............................................................................................ 27
1.12.4 Foot Pedal calibration ....................................................................................... 28
1.12.5 Assemble/ disassemble Foot Pedal Cover ....................................................... 29
1.13 Wi-Fi Box Sophi ..................................................................................................... 31
1.13.1 General information .......................................................................................... 31

1.13.2 Installation ........................................................................................................ 31
1.13.3 Setup Sophi ...................................................................................................... 32
1.13.4 Setup Wi-Fi Box Sophi ..................................................................................... 32
1.13.5 Trouble shooting ............................................................................................... 32
1.14 Service Mode ......................................................................................................... 33

1.15 Trouble shooting .................................................................................................... 33
1.15.1 Reporting to This AG ........................................................................................ 33

1.15.2 EZ-PCB slots .................................................................................................... 34
1.15.3 Frequently mentioned alerts ............................................................................. 36
2 System Sophi .................................................................................................. 37

2.1 Anatomy System Sophi.......................................................................................... 37
2.2 Device installation .................................................................................................. 38
2.2.1 Packing/ unpacking of the transport box ........................................................... 38

2.2.2 Unpacking of the two-way box .......................................................................... 39
2.2.3 First Use System Sophi .................................................................................... 41
2.3 Service and maintenance Sophi ............................................................................ 42

2.4 Disassembly/ Assembly device modules ............................................................... 43
2.4.1 Batteries ........................................................................................................... 43

2.4.2 Device housing ................................................................................................. 44
2.4.3 Cable management .......................................................................................... 47
2.4.4 Cassette pumping system ................................................................................ 49
2.4.5 Main electronics................................................................................................ 50
2.4.6 Battery Control System (BCS) .......................................................................... 51
2.4.7 Touch display ................................................................................................... 53
2.4.8 Fuses ................................................................................................................ 55
2.5 Optional settings .................................................................................................... 56

2.5.1 Adjustment of infusion level guard .................................................................... 56
3 System Sophi A ............................................................................................... 57
3.1 Anatomy Sophi A ................................................................................................... 57

3.2 Device installation .................................................................................................. 58
3.2.1 Unpacking/ packing of the transport box .......................................................... 58

3.2.2 Unpacking of the two-way box .......................................................................... 59
3.2.3 First use system Sophi A .................................................................................. 61
3.3 Service and maintenance Sophi A ......................................................................... 62

3.4 Disassembly/ Assembly device module ................................................................. 63
3.4.1 Update Port ...................................................................................................... 63

3.4.2 Device housing ................................................................................................. 64
3.4.3 Front Panel ....................................................................................................... 65
3.4.4 Pumping System .............................................................................................. 67
3.4.5 Main electronics................................................................................................ 68
3.4.6 Power Supply ................................................................................................... 69
3.4.7 Touch display ................................................................................................... 71
3.5 Repairment peristaltic aspirationsensor DMS ........................................................ 72
3.5.1 Damage ............................................................................................................ 72

3.5.2 Repairment ....................................................................................................... 73
3.6 Lists ....................................................................................................................... 76
3.6.1 Index ................................................................................................................. 76

3.6.2 Directory of tables ............................................................................................. 77
3.6.3 Directory of figures ........................................................................................... 77

1 System Sophi & Sophi A in General
1.1 Qualification of service personnel /intended use and user profile
The service personal must be educated by the manufacturer or by a manufacturer regis-
tered teacher.
These instructions are intended for service personnel to install, maintain and repair Sophi.
For educated hospital personnel and surgeons to handle and troubleshoot the Sophi Sys-
tem. The systems Sophi & Sophi A are equivalent in many respects. If the systems behave
differently, the difference between the systems is listed.
1.2 Description of device equipment
1.2.1 General
The Systems Sophi and Sophi A have fundamental similarities. Chapters such as service
and maintenance or spare parts are described in 1 System Sophi & Sophi A in General.
More differing topics are described in the individual parts 2 System Sophi and 3 System So-
phi A. System Sophi includes the versions Sophi Premium and Sophi Eco.
Information regarding description and application of the system Sophi to be found in the in-
struction for use (IFU). Only components listed in the instruction for use (IFU) chapter
"Scope of Delivery" may be connected and plugged into the system.
The system may only be operated with cassette/tube systems and phaco, vitrectomy and
diathermy instruments validated and recommended by This AG.
1.2.2 Interfaces
USB and LAN
Attention: Only devices with medical grade certification or EN 60950 certification are al-
lowed to connect to Sophi. The person connecting devices to Sophi is responsible for ob-
serving the allowed leakage current.
No connection to the internet is allowed.
1.3 Related documents

The manufacturer will provide instructions for use, circuit diagrams, component part lists,
descriptions, calibration instructions, or other information upon request.

1.4 Supply Network
If a hardware reset is necessary, it can be done any time with the ON/OFF button of the de-
vice, which is located above the cassette inlet.
Whether the device is battery driven or powered by the power cable, a hardware reset can
always be done with the ON/OFF button.
Sophi: If the device is powered by the power cable, but the batteries are still installed, the
unplugging of the power cable does not lead to a hardware reset. The ON/OFF button only
leads to a hardware reset.
Figure 1: ON/OFF Button
If the batteries are installed, the Battery Control System (BCS) is active or on standby. To
reset the BCS, uninstall both batteries.
1.5 Symbols and Markings
1.5.1 Symbols
See instruction for use (IFU)
1.5.2 Markings on the outside and parts of the device
See Instruction for use (IFU)

1.6 Classification of device and system
According to IEC 60601-1 Chapter 6
1.7 Warning and safety

General warnings: See instruction for use (IFU).
If the battery is damaged (e.g. by dropping the battery), it must be replaced and disposed of
properly.
1.7.1 Pump System

Figure 2: Fluid flow pump system shows the fluid flow in the cassette system peristaltic and
venturi. If the cassette system peristaltic is being used, the venturi chamber with the venturi
vacuum sensor (10) is not existing and the venturi valve (9) is permanently closed.
Figure 2: Fluid flow pump system

1.8 Service and maintenance
1.8.1 Instructions for replacements

Interchangeable or detachable parts specified by the manufacturer must be replaced by
trained service personnel. Ignoring this warning could result in an unacceptable risk.
Documentation
Please consider the following annexes to the distribution contract:
- Annex I: Products and Territory
- Annex VII: Stock of products and spare parts
- Annex IX: Non-conformity and adverse incident
Attention: The form in Annex IX must be filled in for every complaint.
ESD protection
Use suitable ESD protection while working on the device. It is recommended to use an ESD
wrist strap with cord, as displayed in chapter 1.10 Required tools. Connect the ESD wrist
cord with an unvarnished part of Sophi’s or Sophi A’s frame – see suggestions in the follow-
ing picture.
Figure 3: ESD wrist cord connection recommendation Sophi
Unsuitable ESD protection may destroy the device.

Plug/ unplug connectors only when power (power cable and battery) is disconnected from
the device. Plugging/ unplugging the connectors while the device is powered may destroy
the same.

Service and maintenance tools
The tools which are needed for the service and maintenance are listed in Chapter 1.10 Re-
quired tools. Additionally, a cassette (depending on the pump system a cassette peristaltic
or a cassette peristaltic + venturi) is needed. The cassette must not be used more than ten
times. The cassette must be transported in the original blister, to protect its nipples from
damage.
Every service, maintenance or repair case must be protocolled with the newest version of
the document P09F01 Service report.
1.8.2 Returns
If a device is returned to This AG, e.g. for service or repairment, no data will be secured.
Store the data on an external USB drive before returning the device to This AG.
1.8.3 Service and maintenance check

The device must be maintained in a defined interval. Maintenance must be carried out by
educated service personnel. The differences in the service and maintenance check of Sophi
and Sophi A are minor and listed in a separate column.
The positions are described below.
Nr. Check Interval Tool
Sophi Prem.
Sophi Eco
Sophi A
1 Cleaning yearly Permitted disinfectants ✓ ✓ ✓
2 SW-update yearly Torx 20, USB-stick ✓ ✓ ✓
3 Offset ASP sensor yearly Service mode ✓ ✓ ✓
4 Offset Venturi sensor yearly Service mode ✓ ☓ ☓
5 Offset IOP sensor yearly Service mode ✓ ✓ ✓
6 Offset waste sensor yearly Service mode ✓ ✓ ✓
7 Capacity of battery (tbd) - - ✓ ✓ ☓
8 Check ASP peristaltic pump yearly - ✓ ✓ ✓
rolls
9 Check IRR peristaltic pump yearly - ✓ ✓ ✓
rolls
10 Insulation test / STK yearly Insulation test device ✓ ✓ ✓
11 Functional check device yearly - ✓ ✓ ✓

12 Read out failures and warnings yearly Torx 20, USB-stick ✓ ✓ ✓
Table 1: Maintenance and service plan
Cleaning
Clean the surface of the device and the foot pedal. Use permitted disinfectants according to
the IFU, instruction for use 1401-0160-001-14 (Version 14 or higher).
Attention: Cleaning of the cassette slit is at your own risk. Sensors and actors can get
damaged easily. The mechanical sensors on the upper inside of the cassette system are
very sensitive. Do not touch under any circumstances!
Figure 4: Cleaning of cassette slit
Software update
New software versions get announced by e-mail notification. The latest software update file
is always available on OneDrive.
a. Download the software update file to your computer. Do not unzip it. Do not rename it.
b. Transfer the .zip file to an USB memory stick.
c. Insert the USB memory stick into the USB port on the backside of the device (Torx 20
needed).
d. Tap on “settings”, then “software update”,
e. Tap on “start update”.
f. The software is being updated. Reboot the device afterwards.
The software update takes approximately 30 minutes.

Attention:
- Do not unzip the file
- The USB Stick must be formatted to FAT32
- To update the foot pedal, connect the foot pedal with the foot pedal cable to the device.
(not yet available)
Offset sensors
a. Eject cassette.
b. Enter “Service mode/Sensors: Monitor and adjust”
c. Adjust the respective sensor to zero by tapping on “Adjust zero”.
Attention: Always adjust the sensor, even if the measured value is already zero.
Capacity of Battery
The capacity check of the battery is not yet implemented. Tick the box “N/A”.
Check peristaltic pump rolls

a. Remove cassette
b. Turn off the device
c. Check with your fingers if every roll of the two peristaltic pumps is easily movable (9 rolls
per peristaltic pump).
Attention: Do not touch the sensors on the left side of the cassette system (ceramics sen-
sors and bimetal sensors)
Insulation test (STK: Sicherheitstechnische Kontrolle)

Standard: IEC/EN 62353; IEC/EN 60601
Insulation test device e.g. Gossen Metrawatt SIII+ MH, Fluke ESA615, …
Settings: Applied Part: Handpiece Phaco and DIA: Type BF
Test steps / measurements according standard:

a. Mains Voltage
b. Mains Voltage Live to Neutral
c. Mains Voltage Neutral to Earth
d. Mains Voltage Live to Earth
e. Protective Earth (PE) resistance
f. Insulation resistance mains to protective earth
g. Insulation resistance applied parts to protective earth
h. Enclosure leakage current open Earth
i. Enclosure leakage current open Earth, reserved mains

j. Patient leakage current normal condition
k. Patient leakage current normal condition, reserved mains
l. Mains on applied parts single fault condition
m. Mains on applied parts single fault condition, reserved mains
n. Alternative equipment leakage closed earth
o. Alternative equipment leakage open earth
p. Alternative applied part leakage shorted mains
q. Device current
Functional check device

Perform a functional check device, see 1.8.4 Functional check device.
Export failures and warnings

a. Insert the USB memory stick into the USB service port
b. Access settings
c. Tap on “export log files”. This process can take several minutes.
d. The files are now stored on the USB memory stick.

1.8.4 Functional check device
The functional check device must be carried out when the environment of the device is
changing (e.g. installation in a different OR) or when any internal work has been carried out
on the device (e.g. repairment/ exchange).
Differences between Sophi and Sophi A marked in the columns on the right.
Nr. Check Tool
Sophi Prem.
Sophi Eco
Sophi A
1 LED Connect power cable. A light shines on the ground be- ✓ ✓ ☓
charging tween the two front wheels. If the batteries are more than
display 80% charged, a green LED lightens up at the bottom. If
the batteries are less than 80% charged, it turns orange.
2 Buzzer Press the power switch to start Sophi. Buzzer sounds for ✓ ✓ ✓
sound approx. 1 second.
3 LED ring Switch to function DIA 3, all LED’s on the LED ring should ✓ ✓ ☓
be shining in blue.
4 LED func- a) Switch to function Phaco, the LED function plug at the ✓ ✓ ✓
tion plugs Phaco socket should be turned on (flashing if Prime
has not been performed).
b) Switch to function VIT, the LED function plug at the
VIT socket should be turned on.
c) Switch to function DIA, the LED function plug at the
DIA socket should be turned on.
5 Inductive a) Put the foot pedal in park position, hang it on the in- ✓ ✓ ☓
charging ductive charging hook
b) Check if the display header shows a charging foot pe-
dal
6 Infusion Check if the infusion pole is movable with the switch on ✓ ✓ ☓
pole mova- the backside of Sophi.
ble Attention: Infusion type “infusion pole” must be selected!

Nr. Check Tool
Sophi Prem.
Sophi Eco
Sophi A
7 Foot pe- a. Enter „service mode/combine and adjust pedal” ✓ ✓ ✓
dal check b. Check if the foot pedal position on the screen matches
with the actual foot pedal position (100%).
Figure 5: Foot pedal calibration
c. If the foot pedal position on the screen matches with

the actual position, the foot pedal check is completed
and the foot pedal does not require a calibration.
d. If the foot pedal does not match, the foot pedal needs
to be calibrated. See 1.12.4 Foot Pedal calibration.

Nr. Check Tool
Sophi Prem.
Sophi Eco
Sophi A
8 Pump a. Insert a Cassette Peristaltic & Venturi ✓ ✓ ✓
check b. Connect a full BSS bottle and a phaco handpiece with
tip, sleeve and testchamber to the cassette
c. Press button “Prime”
d. Check if the venturi compressor starts during Prime
(Sophi Premium only)
e. Check if the ultrasound is working during phaco test
f. Check if prime completes without any error message
g. Set the pump to “peristaltic”, clamp the aspiration tub-
ing, start aspiration, check if the vacuum is rising to
the set value.
h. Sophi Premium only: Set the pump to “venturi”,
clamp the aspiration tubing, start aspiration, check if
the vacuum is rising to the set value.
i. Eject cassette
9 Vitrectomy a) Switch to function VIT ✓ ✓ ✓
pressure b) Tap on the button “Test” and hold for 5 seconds
check c) Check, if pressurized air is leaving the VIT port
If no air is leaving the VIT port, the tubing might not be

connected.
10 BSS level a) Enter „Service mode/Sensors: Monitor and adjust” ✓ ✓ ☓
indicator b) Mount a full BSS bottle/ water bottle to the BSS level
check
indicator. The value of the “BSS Detected” must show
“Yes/True”.
c) Remove the BSS bottle/ water bottle. The value of the
“BSS Detected” must show “No/False”.
Table 2: Functional check device

1.8.5 Cassette system check
The cassette system check is a detailed check of the pumping system and its sensors. It
must be performed if the values are not seen as plausible.
The cassette system check must be performed with new, unused cassettes.
The system including the pressure sensor needs to be primed properly, no air is allowed in-
side the tubings.
Set the following parameters before starting with the cassette system check as standard
values:
Program: I/A
Pump: Peristaltic Pump
Peristaltic control: Vacuum
Flow: 30ml/min
Vacuum: 400mmHg
Infusion type: Active infusion
Infusion IOP: 60mmHg
Differences between Sophi and Sophi A marked in the columns on the right.
Nr. Check Measurand Tool
Sophi Prem.
Sophi Eco
Sophi A
1 Precision of IOP con- 60mmHg pressure Service Pressure ✓ ✓ ✓
trol pump Sensor
2 Precision of aspiration 400mmHg vacuum Service Pressure ✓ ✓ ✓
peristaltic pump Sensor
3 Precision of aspiration 400mmHg vacuum Service Pressure ✓ ☓ ☓
venturi pump Sensor
4 Waste bag sensor Qualitative - ✓ ✓ ✓
5 Fluency detection Failure message Wire ✓ ☓ ☓
check
Table 3: Cassette system check
Precision of IOP control pump

a. Insert cassette, connect infusion bottle and tubing set.
b. Connect tubing set to the Manometer
c. Enter function I/A, set infusion type as “active” (pump), set IOP to 60mmHg
d. Turn on irrigation
e. Measured IOP must be between 48-72mmHg

Precision of aspiration peristaltic pump
c. Enter function I/A, set pump as peristaltic pump, set vacuum to 400mmHg
d. Clamp the irrigation tubing
e. Turn on irrigation, then aspiration
f. Measured vacuum must be between 320-480mmHg
Figure 6: Fold the tubing
Precision of aspiration venturi pump

c. Enter function I/A, set pump as venturi pump, set vacuum to 400mmHg
d. Clamp the irrigation tubing
e. Turn on irrigation, then aspiration
f. Measured vacuum must be between 320-480mmHg
Waste bag sensor

b. Enter „Service mode/Sensors: Monitor and adjust”
c. Remove the waste bag from the cassette. Then attach it back to the cassette while
pressing the finger on the waste bag port.
d. The pressure value of the disposable bag sensor should now have increased.

Fluency detection check
a. Open the back cover of Sophi.
b. Turn on Sophi.
c. Connect the wire into the boreholes
d. If the message “Fatal error 79” appears, the fluency detection is working properly.
e. The fatal error will disappear after restarting Sophi.
Figure 7: fluency detection test insert

1.9 Spare parts
Differences between Sophi Premium, Sophi Eco and Sophi A marked in the columns on the
right. The minimum recommended quantity of spare parts can be taken from the recom-
mendations (last three columns) and the devices concerned. E. g. if a spare part is needed
in both Sophi A and Sophi Eco, the number of devices can be summed up.
Part no. / Description
Sophi Prem.
20+ devices
Order no.
10 devices
Sophi Eco
5 devices
Sophi A
Spare Part Electronic Sophi
1401-0008 ✓ ✓ X 1 1 2
System
1801-5001 Pump System Peristaltic X ✓ ✓ 1 1 2
1401-0111-000 Power Supply ✓ ✓ ✓ 0 0 1
Spare Part Strain Gauge Sen-

1401-0007 ✓ ✓ ✓ 1 2 4
sor Peristaltic /Venturi
Spare Part Ceramic Pressure

1401-0002 ✓ ✓ ✓ 1 2 3
Sensor
Spare Part Peristaltic Valve

1401-0004 X ✓ ✓ 2 3 4
Sophi A / ECO
1401-0001 Spare Part BSS Level Guard ✓ ✓ X 1 2 2

Sophi Prem.
20+ devices
Order no.
10 devices
Sophi Eco
5 devices
Sophi A
Spare Part Peristaltic / Venturi
1401-0005 ✓ ✓ ✓ 1 2 2
Lock
Spare Part Phaco Socket So-

1401-0009 ✓ ✓ ✓ 1 1 2
phi
Pump System Peristaltic +

1401-9990 ✓ X X 1 1 2
Venturi
1401-0107-001 Battery Control System ✓ ✓ X 0 1 1
Spare Part Electronic CCB So-

1401-0003 X X ✓ 1 1 2
phi System
1401-0110-000 Touch Display 19“ ✓ ✓ X 1 1 1
Spare Part Peristaltic / Venturi

1401-0006 ✓ X X 2 3 4
Valve Sophi P
1801-0110-012 Touch Display 15“ X X ✓ 1 1 1
1401-0199-250 Fuse ✓ ✓ ✓ 2 4 6

Sophi Prem.
20+ devices
Order no.
10 devices
Sophi Eco
5 devices
Sophi A
Power cable Switzerland: Plug
1401-0199-100 ✓ ✓ ✓ NA NA NA
type J
Power cable Schuko: Plug type
1401-0199-102 ✓ ✓ ✓ NA NA NA
E/F; CEE 7/7
1401-0199-103 Power cable Italy: Plug type L ✓ ✓ ✓ NA NA NA
Power cable England: Plug

1401-0199-104 ✓ ✓ ✓ NA NA NA
type G
Power cable Denmark: Plug
1401-0199-105 ✓ ✓ ✓ NA NA NA
type K
1401-0199-106 Power cable India: Plug type D ✓ ✓ ✓ NA NA NA
Power cable Australia, New

1401-0199-107 ✓ ✓ ✓ NA NA NA
Zealand, China: Plug type I
Power cable USA, Canada:
1401-0199-108 ✓ ✓ ✓ NA NA NA
Plug type B, NEMA 5-15
Power cable South Africa: Plug
1401-0199-109 ✓ ✓ ✓ NA NA NA
type M
1401-0199-110 Power cable China: Plug type I ✓ ✓ ✓ NA NA NA

Table 4: Spare parts

1.10 Required tools
For maintenance or repair the following tools and accessories are needed. The tool box So-
phi can be ordered with the order number, listed in 1.9 Spare parts.
Description
Sophi Prem.
Sophi Eco
Sophi A
Tool box Sophi ✓ ✓ ✓
Contains all tools listed below.
ESD wrist strap with cord ✓ ✓ ✓
Allen key set ✓ ✓ ✓

Size: 1.5, 2, 2.5, 3, 4, 5
L-Key set with torx ✓ ✓ ✓

Sizes: T10, T15, T20, T25, T30
Allen key ✓ ✓ ✓
0.9mm
Open-end wrench ✓ ✓ ☓
Sizes: 8mm (2 pcs), 10mm, 17mm

Description
Sophi Prem.
Sophi Eco
Sophi A
Socket wrench ✓ ✓ ✓
with extension and wrench socket
Sizes: 5.5mm, 7mm, 8mm, 10mm,
13mm
Set of screwdriver bits for Torx ✓ ✓ ✓

TX10; TX15; TX20; TX25; TX30
Knurled screw M4 ✓ ✓ ☓
to open back cover
(2pcs)
ESD tweezers ✓ ✓ ✓
Wire cutter ✓ ✓ ✓
Cable ties ✓ ✓ ✓
Wire ✓ ☓ ☓
Ø1mm
Slot screwdriver ✓ ✓ ☓
0.8mm
Slot screwdriver ✓ ✓ ☓
4mm
Short slot screwdriver ✓ ✓ ☓
6.5mm

Description
Sophi Prem.
Sophi Eco
Sophi A
Socket wrench screwdriver ✓ ✓ ✓
5.5mm
Bar magnet ✓ ✓ ✓
Bit E6. 400/6T ✓ ✓ ✓
Torque 0.2 Nm ✓ ✓ ✓
Service Pressure Sensor ✓ ✓ ✓

(not included in tool box Sophi)
Includes luer adapter
Order-Nr. to be found in chapter
1.9 Spare parts
Table 5: Required tools
1.11 Waste Management
1.11.1 Cassettes and disposable parts

The cassettes and disposable parts must be disposed of separately from domestic waste.
1.11.2 Electronic components

The device with its electronic parts and the batteries must be transported and recycled by a
specialist.

1.12 Foot pedal
The same foot pedal can be used for Sophi Premium, Sophi Eco and Sophi A.
1.12.1 Foot pedal update
1. Connect the foot pedal with the CAN-cable and activate the “Easy Move” (press
down the lever at the rear of the foot pedal – light in front gets activated)
2. After the device has been updated, the foot pedal update follows.
3. If you have done step 1, you can confirm the instruction on the display and start the
:“Connect Pedal Cable, set Pedal in update mode and press start”
4. press “start pedal update”
5. Reboot the device after completion (prompt is displayed on the device after success-
ful update).
6. The foot pedal must be rested after the update has been carried out: make sure that
the “Easy Move” is deactivated. Pull all four rocker switches together and release
them shortly after. It takes a few seconds until the pedal is reseted.
7. After the update the foot pedal must be recalibrated. Instructions for this can be
found in chapter 1.12.4
8. Check in the service mode in menu “Foot Pedal” whether the deflections of the foot
pedal correspond to the displayed values.
9. If this matches, you can restart the device and you are done with the update.
1.12.2 Foot Pedal reset

If there is no foot pedal connection or a problem with the functionality of the foot pedal, the
foot pedal must be reset. To reset the foot pedal, press the four switches towards each
other and release them shortly after. Take care that the Easy-Move button is NOT acti-
vated. Do not activate any switch of the foot pedal for the next 10 seconds. After the
10 seconds, the foot pedal is reset.

Figure 8: Foot Pedal reset
1.12.3 Foot Pedal pairing

To pair a foot pedal with a device, follow the instructions below:
a. Connect the foot pedal with the foot pedal cable to the device
b. Reset the foot pedal
c. Turn on device
d. Go to settings
e. Enter “Service mode”, password: SM
f. Enter “combine and adjust pedal”
g. Tap on button “command mode”.
h. Wait until Bluetooth module is in command mode.
i. Tap on button “combine with unit” and wait until a passkey is shown
j. Afterwards the Bluetooth module runs back in data mode.
k. Unplug the foot pedal cable and restart the device
l. Check if the foot pedal is connected to the device. If it’s not connected, repeat
the sequence.
The foot pedal is now connected to the device and can be used without a cable connection.

1.12.4 Foot Pedal calibration
a. Enter „service mode/combine and adjust pedal”
b. Check if the foot pedal position on the screen matches with the actual foot pedal po-
sition (100%).
Figure 9: Foot pedal calibration
c. If the foot pedal position on the screen matches with the actual position, it does not
require a calibration.
d. If the foot pedal does not match, tap on “adjust pedal”.
Attention: To calibrate the foot pedal, connect the foot pedal with the foot pedal cable to the
device.

a. To calibrate the pedal, the process must be followed step by step from top to bottom,
pressing the pedal to the positions that are specified. At the position "Pedal calibra-
tion clear" and "Pedal neutral position", the pedal must not be moved to any position.
b. deflect the foot pedal 100% within the sector to the V1 position and hold it. Press the
"Store" button (only once). Afterwards you can release the pedal again.
c. The same must be done for the remaining positions. First move the pedal to the ex-
act position (100 % deflected within the position) then press at the same time “Store”
position (only once).
e. When you have reached the end of the calibration, an error message appears
shortly.
f. Calibration was successful when “pedal ok” shows “Yes/True”.
g. If “pedal ok” shows “No/False” start again at the begining.
Table 6 Legend: pedal sectors/deflections
Pedal sector V1 position Vertical step 1

Pedal sector V2 position Vertical step 2
Pedal sector V3 position Verticl step 3
Pedal sector R1 position Vertical rear
Pedal sector HL position Horizontal deflection Left
Pedal sector HR position Horizontal deflection Right
1.12.5 Assemble/ disassemble Foot Pedal Cover
1 2
a) Remove threaded pin (4x 0.9mm a) Remove screw: (4x 2.5mm hexagon
hexagon socket) socket)
b) Remove rocker switches (4x)

3 4
a) Remove screw nut (1x 5.5mm hexa- a) Remove the foot shell
gon screwdriver) b) Remove the cover
b) Remove screw nut (1x 13mm hexa-
gon)
Table 7: Foot pedal cover

1.13 Wi-Fi Box Sophi
1.13.1 General information

Use the Wi-Fi Box Sophi to stream the camera signal of an ophthalmic microscope to
Sophi. Any camera with a HDMI output can be connected to the Wi-Fi Box Sophi. The Wi-Fi
Box Sophi is paired with one Sophi system and cannot be connected to another Sophi.
Figure 10: Wi-Fi Box Sophi
Needed accessories
• HDMI cable (Male-Male)
Optional accessories
• HDMI splitter box
• [camera cable] to HDMI converter
1.13.2 Installation
• Connect the output of the camera to the Wi-Fi Box Sophi.
o If you wish to play the video simultaneously on other monitors too, you may need a
HDMI splitter box to split the HDMI signal into two different HDMI cables.
• Connect the power cable of the Wi-Fi Box Sophi to the socket.
Attention: Do not place the Wi-Fi Box Sophi further away as 5m from Sophi!
Figure 11: Installation Wi-Fi Box Sophi

1.13.3 Setup Sophi
To enable a Wi-Fi connection between Sophi and the Wi-Fi Box Sophi, the Wi-Fi on Sophi
needs to be activated:
• Go to Service Mode
• Press Button “WLAN” in the upper right corner
If the button says “Server started, start client” the Wi-Fi signal on Sophi has been activated
successfully.
1.13.4 Setup Wi-Fi Box Sophi

To turn the Wi-Fi Box Sophi on, press button “1” for 3 seconds.
To turn the Wi-Fi Box Sophi off, press button “1”, then press button “2”.
Figure 12: Display and buttons
Do not press any other button at any time. If you do so, the pairing between Sophi and the
Wi-Fi Box Sophi may be lost.
1.13.5 Trouble shooting

Connection error
If a connection error is shown on the display of the Wi-Fi Box Sophi, try the following ac-
tions:
• Turn off the Wi-Fi Box Sophi and turn it on again.
• Ensure that the Wi-Fi on Sophi is activated.
• Ensure that the Wi-Fi Box Sophi is within a range of 5 meters to Sophi. Any objects be-
tween Sophi and the Wi-Fi Box Sophi may interrupt the Wi-Fi signal.
• Ensure that the Wi-Fi Box Sophi is configured to the Sophi you wish to connect. The se-
rial number of Sophi is shown on the display of the Wi-Fi Box Sophi.
Foot Pedal tile disappeared, but no video appears
The connection between Sophi and the Wi-Fi Box Sophi is working, but the signal from the
camera is not transmitted to the Wi-Fi Box Sophi.
• Ensure that the camera is on. If you use a HDMI splitter, remove the HDMI splitter and
try to connect the camera directly to the Wi-Fi Box Sophi.
• Check the connection from the camera to the Wi-Fi Box Sophi.

Any other issue
Contact the service center:
support@sophi.info
1.14 Service Mode

The service mode displays different measured system values, system information and sys-
tem settings. The service mode may only be accessed by personnel trained by the manu-
facturer.
Attention: When closing the service mode, the device automatically reboots with a 5s delay.
The password to enter the service mode is “SM” in capital letters.
1.15 Trouble shooting

The following tables and figures should assist the Service Technician in finding the cause of
any alerts or misbehaviour of Sophi. In any case of an issue with a Sophi device, the manu-
facturer must be informed according to the required information to This AG as listed below.
The complete list of error messages can be found in the instruction for use (IFU) System
Sophi.
1.15.1 Reporting to This AG

The reporting will improve Sophi’s future reliability and quality. In such cases the following
information should be provided to the manufacturer to ensure a proper investigation:
• Any video material of the appearance
• Export of the logfiles
• Information about previous executed maintenance
• Behaviour of the machine before the alert occurred

1.15.2 EZ-PCB slots
Figure 13: EZ-PCB slots
Slot Nr. Description Fatal Error Error Warning

X1 Main Power Source
X2 Inductive charging
X3 BSS Sensor 57, 401
X4 Infusion pole switch 350, 351 73, 74, 353
X5 Infusion pole motor 71, 72, 352
X6 Infusion pole height detec- 75
tion (potentiometer)
X8 Barcode scanner 106
X9 Aspiration pressure sen- 53 502
sor peristaltic (bimetal
sensor)
X10 Venturi safety valve 505
X11 Speaker
X13 LED indication ring 103

X15 Ceramics pressure sen- 454 Irrigation 602 Wastebag 50 Wastebag
sors (Irrigation pressure 455 Irrigation 600 Wastebag
sensor, wastebag pres- 601 Wastebag
sure sensor)
X16 Air detection sensors (Irri- 51 Wastebag
gation, peristaltic aspira- 54 Aspiration
tion, wastebag) 68 Irrigation
X19 Vitrectomy pressure 81
X22 Peristaltic pumps (IOP 56 ASP Pump
Control Pump, peristaltic 452 IRR Pump
aspiration pump)
X23 Cassette position detec- 63 Top position
tion sensors 64 End position
X27 Venturi fluid detection 79
X28 PCB front cover left side 104
(phaco and VIT LED ring,
Venturi compressor)
X29 PCB front cover right side 105
(DIA LED ring, VIT com-
pressor)
X30 On/Off button device
X31 Diathermy connection ca-
ble
X32 Phaco connection cable 650 open
651 short
X33 Vitrectomy pressure valve
X34 Cassette slot in motor 58
X35 Venturi valve 76
X40 CAN bus 100
X41 CAN bus 100
X42 CAN bus 100
X43 CAN bus 100
X60 Aspiration pressure sen- 503 77
sor venturi (bimetal sen-
sor)
X61 Venturi lock motor 60
X62 Peristaltic lock motor 59
Table 8: Slot description

1.15.3 Frequently mentioned alerts
The following alerts might occur during the use of Sophi. The recommended actions will
help to continue working with Sophi.
Alert Reaction/ Workaround

Fatal Error -2 Restart the device
Fatal Error -1 Restart the device
Fatal Error 56 Eject cassette and restart device; Connect power cable and restart device
Fatal Error 66 Restart the device
Fatal Error 452 Eject cassette and restart device; Connect power cable and restart device
Fatal Error 455 Go to Service Mode/Sensors: Monitor and adjust, then adjust the four sen-
Error 502 sors to zero (cassette must be ejected)
Error 503
Error 600
Error 204 Reset the Foot pedal according to 1.12.2 Foot Pedal reset
Error 250 Check if batteries are built-in correctly according to 2.4.1 Batteries; to check
Error 251 if both batteries are working correctly, remove one battery and start the de-
Warning 258 vice (without power cable connected). If it starts the battery is not defective.
Do the same with the other battery.
Error 651 Insert a USB stick in the back of Sophi, then perform phaco test (with cas-
Warning 653 sette, handpiece, BSS bottle)
Warning 200 Reset the Foot pedal according to 1.12.2 Foot Pedal reset; Charge Foot Pe-
dal; Connect Foot Pedal cable for further usage
Warning 352 Lubricate the pole with a recommended grease (contact This AG for recom-
mended grease), then restart device (pole might needs to be supported for
the first movement)
Warning 401 If appears unjustified: Set the BSS Level Detector according to 2.5.1 Adjust-
ment of infusion level guard; tie the BSS bottle with the velcro to the BSS
Level Detector
Warning 550 Check the infusion set; Go to Service Mode/Sensors: Monitor and adjust,
then adjust the four sensors to zero (cassette must be ejected)
Warning 1004 Foot pedal movement during prime aborts priming. Take care the foot pedal
isn’t deflected during priming.
Warning 1007 Repeat phaco test, loosen phaco tip and tie again
Warning 1021 Check the nipples at the cassette. If crushed exchange the cassette.
Warning 1022
Warning 1023
Warning 1024
Warning 2002 Use FAT32 formatted USB-sticks only; try a different USB-stick; check that
Warning 2003 the file’s name wasn’t changed; check that the software update is a .zip file
Table 9: Frequently mentioned alerts

2 System Sophi
2.1 Anatomy System Sophi
Figure 14: Sophi’s anatomy
Touch Display
Electronic Boards
Pumping System
Compressors
Power Supply
Batteries & BCS
BSS infusion level guard

2.2 Device installation
2.2.1 Packing/ unpacking of the transport box

1
Preparation
2
3
Loading
Fixation

4 5
Tray Finish
Table 10: Packing/ unpacking transport box
2.2.2 Unpacking of the two-way box
Attention: Do not unload alone or stand on the platform! Use railing only to lift the device!
1 2
Remove packing cord and cardboards Remove foot pedal box, wood and foam,
untie clamping set

3 4
Tilt device to remove foam pad. Tilt device to remove foam pad
Attention: Apply the brake!
5 6
Lift device, put it on the ground and remove Lift device and put it on the ground
palette
Table 11: Unpacking of the two-way box

2.2.3 First Use System Sophi
Installation report
After unpackaging Sophi, the installation report, P05F05_installation-form_XX, must be
completed and forwarded to customerservice@sophi.info. The checklist must be followed. If
a row is not applicable, the box “n/a” must be ticked. If a row shows no mark, the installation
report may not be accepted. Each time the device gets modified, changed or handed out,
the installation report must be completed and signed.
Visual device inspection

Check the covers and the display of the device for damage. If there is any damage to the
device, report it immediately.
Batteries
Batteries can be shipped with a battery charge of <30% only. Therefore, the machine needs
to be charged once it arrived at its destination. Connect the power cable.
It is recommended to charge the device overnight and to use it without connecting the
power cable during the day.
If the device is put in storage, ensure an 80%-100% battery capacity before storage.
Charge Sophi at least every 2 months. Do not charge Sophi continuously for several
months.
Place the foot pedal on the hook of the front cover of the device to charge it.
The foot pedal is charging if it is connected with the foot pedal cable to the device (if device
is turned on) or when hung on the hook of the front cover of the device (device can be
switched off).
Time settings
Set the device’s time to the correct time zone.
1. Tap the clock/date information in the upper right corner.

2. Set date and time.
Height settings
To prevent the infusion pole from touching the hospital ceiling, the maximal height can be
adjusted. In addition, you may also set the height of the patient’s eye for a more accurate
pressure display.
1. Enter “service mode/set patient's height and maximal pole height”

2. Set the height of the patient’s eye. Height depends on OR. In service cases set 104cm
to ensure that the calibration is made with the correct settings.
3. Set maximum pole height: Height depends on OR. Maximum: 240cm

Enable/disable daypack
In the service mode you may choose if the device is to be used in daypack mode or single
use mode.
1. Enter “service mode/manage surgeon parameter and password”

2. Enable or disable daypack use
Daypack
- If the machine is set to daypack mode (daypack enabled), reflux can be activated for
1 second only because of contamination risks. After 1 second, the surgeon needs to
aspirate again (approx. for 3 seconds) before being able to activate reflux again.
- When tapping on “END”, the machine will flush the tubings and change the active
program to phaco 1. Take care to connect the irrigation tube to the aspiration tube
before tapping on “END”. After the 10th surgery the cassette will be automatically
ejected.
Single use
- If the machine is set to single use mode (daypack disabled), reflux can be activated
for a maximum of 10 seconds for an unlimited number of times.
- When tapping on “END”, the machine automatically eject the cassette and change
the active program to phaco 1.

Perform a general system check according to 1.8.3 Service and maintenance check, which
includes the functional check of the device.
Training hospital personnel

The hospital personnel must get trained in the use of the Sophi device through its sales
partner. The training must contain information about the graphical user interface and other
security relevant parts, as described in the document 1401-0160-001-XX, instruction for use
system Sophi.
2.3 Service and maintenance Sophi

Service and maintenance has to be performed according to 1.8 Service and maintenance,
page 9.

2.4 Disassembly/ Assembly device modules
The following chapter describes the disassembly of various modules. For assembly follow
the instructions backwards.
Attention:
Unplug cables by pulling the plug, never the cable!
2.4.1 Batteries
1 2
a) Unplug all cables a) Pull out the shown module
b) Remove the screws (4x 2.5mm hexa-
gon socket)
3 4
a) Remove the butterfly nut a) Remove the batteries (2x)
b) Remove the metal sheet
Table 12: Disassembly / Assembly battery

2.4.2 Device housing
The functional check (chapter 1.8.4 Functional check device) must be performed every time
a cover gets removed.
1 2
a) Remove screws on cap (3x Torx 25) a) Pull up the cap and turn it around
b) Remove break handle (1x 3mm hexa-
gon socket)
c) Remove reeling screws (3x 4mm
hexagon socket)
d) Remove distancer (1x 17mm open-
jaw wrench)
3 4
a) Unplug cable X4 a) Pull up the cover using the knurled
screws
b) Unplug cable device ground

5 6
a) Unplug cables a) Unplug pneumatic hose (Vitrectomy
X28 / X29 / X30 / X31 / X32 connection to front cover)
7 8
a) Unplug the inductive charging cable a) Remove screws (4x Torx 25)
b) Unplug cable device ground
Pay attention during assembly: Risk of

squashing cables under screw!

9 10
a) Unplug the two shown cables with a) Remove the front cover
black plugs (both sides) by tilting the
front cover
Please note: Ribbon cables (X3, X28, X29) can be plugged in in wrong direction. Check the
position of the nose to plug them in correctly.
Table 13: Disassembly / Assembly device housing

2.4.3 Cable management
To prevent any cable from potential damage it is recommended to guide the cables accord-
ing to the images below.
Left side front
Figure 15: Cable management left side front
Left side back
Figure 16: Cable management left side back

Right side
Figure 17: Cable management right side

2.4.4 Cassette pumping system
The functional check (chapter 1.8.4 Functional check device) must be performed every time
a cover gets removed.
Remove the batteries and unplug power cable (2.4.1 Batteries) before replacing the cas-
sette pumping system!
1 2
a) Unplug cables (left side) a) Unplug pneumatic hose (Venturi con-
X60 / X8 / X35 / X16 / X34 / X9 / X23 nection)
/ X15
b) Unplug cables (right side)
X61 / X27 / X22 / X62
3 4
a) Remove screws (4x Torx 25) a) Pull out the pump unit carefully.
Make sure that no cables are at-
tached.
Table 14: Disassembly / Assembly cassette pumping system

2.4.5 Main electronics
Remove the batteries and unplug power cable (2.4.1 Batteries) before replacing the main
electronics!
Before exchanging/removing the electronics, save the surgeon parameters to an USB-Stick.
Upload the saved parameters again after exchanging the electronics.
1 2
a) Unplug all cable from the electronic a) Remove screws (4x Torx 10)
(On top print, NEZ)
b) Remove the Electronic Linux System
(NEZ) carefully by lifting it vertically.
3 4
a) Remove screws (4x Torx 20) Please note: Ribbon cables (X3, X28, X29)
b) Remove the electronic unit carefully can be plugged in the wrong orientation.
Check the position of the nose to correctly
plug them in.
Table 15: Disassembly / Assembly main electronics

2.4.6 Battery Control System (BCS)
Remove the batteries and unplug power cable (2.4.1 Batteries) before replacing the BCS!
1 2
a) Remove the batteries as described in a) Remove the screws inside the battery
Chapter 2.4.1 Batteries compartment (4x Torx 25)
3 4
a) Remove the bottom screws (2x Torx a) Remove cable
25)
5 6
a) Remove the cover a) Remove the threaded rod

7 8
a) Remove the power supply (black a) Disconnect the power supply cables:
box) (4x Torx 10) Black cable: RTN
White cable: V+
9 10
a) Remove the bottom screws (2x Torx a) Disconnect the marked cables
30)
11 12
Remove the BCS unit. Attention:
When assembling the power source, the ca-
bles are not allowed to get into the compres-
sor!
Tip: For assembly use the threaded rod to

position the BCS unit correctly.
Table 16: Disassembly / Assembly battery control system

2.4.7 Touch display
Remove the batteries and unplug power cable (2.4.1 Batteries) before replacing the display!
1 2
a) Remove screws (8x Torx 20) a) Remove cable ties
b) Remove the back cover
3 4
a) Remove screws (2x Torx 10) a) Disconnect marked plugs
b) Remove screw nut (1x 7mm hexagon
socket)

5 6
a) Remove screws (8x 2.5mm hexagon a) If a new screen gets mounted, re-
socket) move the textile seals from the old
b) Remove the display screen and attach them at the same
position on the new screen.
IMPORTANT: HOLD THE SCREEN ON
TOP!
Table 17: Disassembly / Assembly touch screen

2.4.8 Fuses
1 2
a) Remove the fuse box a) Exchange the defect fuse
The fuses are located underneath the
power cable connection.
Table 18: Disassembly / Assembly fuses

2.5 Optional settings
2.5.1 Adjustment of infusion level guard

The warning level of the infusion level guard is adjustable. If the standard adjustment is too
precise / too imprecise for the surgeon, it can be adjusted easily by manipulating the screw
on the side of the infusion level guard. A more precise adjustment needs rotation of the
screw in counterclockwise direction. Adjustments made in clockwise direction allow for
more tolerance.
1. Mount a half-filled infusion bottle on the infusion pole.

2. Position the infusion level guard, so that the water level is approx. 1cm below the ar-
row on the infusion level guard.
3. Enter “Service mode/Sensors: Monitor and adjust”
4. If BSS Detected shows “yes/true”, turn the screw in counterclockwise direction, until
it switches between “yes/true” and “no/false”.
5. If BSS Detected shows “no/false”, turn the screw in clockwise direction, until it
switches between “no/false” and “yes/true”.
Tool: Slot screwdriver 0.8mm
Adjustment of the precision of the infusion level guard sensor:
Figure 18: Infusion level guard adjustment

3 System Sophi A
3.1 Anatomy Sophi A
Figure 19: Sophi A’s anatomy
Touch Display
Electronic Boards
Pumping System
Compressor
Power Supply
VIT pneumatic components

3.2 Device installation
3.2.1 Unpacking/ packing of the transport box
1 2
Overview Mount the straps on the bottom side of the
device and on the display support.
3 4
Place the foam cover next to the box. Use Place the device on a soft base.
the orange straps to lift the device.

5
Remove the straps.
Table 19: Packing/ unpacking transport box Sophi A
3.2.2 Unpacking of the two-way box
1 2
Open the cardboard box at the top. Remove the top foam part with the cables,
instructions, bottle cage and charging sta-
tion.

3 4
Tilt the screen vertically. Remove the remaining foam parts and the
foot pedal.
5
Take the device out of the box.
Table 20: Unpacking two-way box

3.2.3 First use system Sophi A
Sophi A is a table-top machine. It is supposed to be set on an OR table. A table height of

80-90cm is recommended.
Installation report
After unpackaging Sophi, the installation report, P05F05_Übergabeprotokoll-installation-
form_XX, must be completed and forwarded to customerservice@sophi.info. The checklist
must be followed. If a row is not applicable, the box “n/a” must be ticked. If a row shows no
mark, the installation report may not be accepted. Each time the device gets modified,
changed or handed out, the installation report should be completed and signed.
Visual device inspection

Check the covers and the display of the device for damage. If there is any damage to the
device, report it immediately.
Charge Foot Pedal

Connect the device with the power cable to a power socket. Connect the delivered charging
station to the device. Place the foot pedal on the charging station to charge it. To check if it
is charging, turn the device on and check if the charging symbol appears on the foot pedal
charging status on the display.
Time settings
Set the device’s time to the correct time zone.
1. Tap the clock/date information in the upper right corner.

2. Set the time and date.
Height settings
To ensure an accurate display of the measured pressures, the correct heights need to be
set in the Service Mode.
1. Enter “service mode/set patient's height and maximal pole height”

2. Set the height of the patient’s eye. Height depends on OR. In service cases set 104cm to
ensure that the calibration is made with the correct settings.
3. Set device height: Height depends on the height of the table Sophi A is placed on. 86cm
is recommended.

Enable/ disable daypack
In the service mode you may choose if the device is to be used in daypack mode or single
use mode.
1. Enter “service mode/manage surgeon parameter and password”

2. Enable or disable daypack use
Daypack
- If the machine is set to daypack mode (daypack enabled), reflux can be activated for
1 second only because of contamination risks. After 1 second, the surgeon needs to
aspirate again (approx. for 3 seconds) before being able to activate reflux again.
- When tapping on “END”, the machine will flush the tubings and change the active
program to phaco 1. Take care to connect the irrigation tube to the aspiration tube
before tapping on “END”. After the 10th surgery the cassette will be automatically
ejected.
Single use
- If the machine is set to single use mode (daypack disabled), reflux can be activated
for a maximum of 10 seconds for an unlimited number of times.
- When tapping on “END”, the machine automatically eject the cassette and change
the active program to phaco 1.

See 1.8.4 Functional check device.
Training hospital personnel

The hospital personnel must be trained in the use of the device through its sales partner.
The training must contain information about the graphical user interface and other security
relevant parts, as described in the document 1401-0160-001-XX, Instruction for Use Sys-
tem Sophi & Sophi A.
3.3 Service and maintenance Sophi A

Service and maintenance to be performed according to 1.8 Service and maintenance, page
9.

3.4 Disassembly/ Assembly device module
The following chapter describes the disassembly of various modules. For assembly follow
the instructions backwards.
Attention:
Unplug cables by pulling the plug, never pull the cable!
3.4.1 Update Port
1
a) Remove screw (2x Torx 10)
Attention: Max. Torque 0.55Nm
Table 21: Disassembly / Assembly update port

3.4.2 Device housing
1 2
a) Pull the device to the edge of the ta- a) Remove screw nut (3x hexagon
ble to gain access to the nuts acces- 5.5mm)
sible from below.
Alternatively the device can be put on
its “belly” on a soft base (cassette slit
facing down).
Table 22: Disassembly / Assembly device housing

3.4.3 Front Panel
1 2
a) Remove Bottle holder a) Remove flat cable
b) Unplug pneumatic hose
c) Unplug cable device ground
3 4
a) Remove screw (4x Torx 20) a) Unplug cable X28/ X29/ X30/ X31/
b) Unplug cable X32

5
a) The dowel pins (2x) must remain in
the pumping system
Table 23: Disassembly / Assembly front panel

3.4.4 Pumping System
1 2
a) Unplug cables (left side) a) Remove screw (4x Torx 20)
X8/ X35/ X16/ X34/ X9/ X23/ X15
b) Unplug cables (right side)
X22/ X62
Table 24: Disassembly / Assembly pumping system

3.4.5 Main electronics
1
a) Unplug all cables from the electronic
boards
b) Remove screws (4x Torx 20)
Table 25: Disassembly / Assembly main electronics

3.4.6 Power Supply
1 2
a) Remove screws (4x hexagon socket a) unplug cable device ground (2x)
3mm) b) Remove screws (2x Torx 20)
3 4
a) Remove screws (6x Torx 20) a) Remove cables with slit screwdriver

5 6
a) Remove screw (4x Torx 20) a) Remove screw (4x Torx 10)
Table 26: Disassembly / Assembly power supply

3.4.7 Touch display
1 2
a) Remove screws (8x Torx 10) a) Remove flat cable
Attention: Max. Torque 0.55Nm b) Remove screws (4x hexagon socket
4mm)
Table 27: Disassembly / Assembly touch display

3.5 Repairment peristaltic aspirationsensor DMS
3.5.1 Damage
This repair instructions can be used if the peristaltic aspiration sensor of the Sophi Pump
System P+V needs to be replaced.

3.5.2 Repairment
Instruction
Nr. Step
1 Remove the cassette system according to the Service Manual System
Sophi & Sophi A
2 Remove zip tie (red circle)
3 Remove 4 screws Torx 20 (blue circles)
4 Pull pump unit with the peristaltic pumps away sideways

5 Remove 2 screws Torx 6 (green circle)
6 Adhesive strips are glude on the opposite side of the replaced sensor to protect it
from water.

7 Exchange sensor
Attention! Extremely little torque 0.2Nm, secure with Loctite 243.
8 Repeat the steps in reversed order

9 Perform checks according to Service Manual System Sophi & Sophi A

3.6 Lists
3.6.1 Index
Keyword Explanation
ASP Aspiration
IRR Irrigation
BATT Battery
BSS Balanced Salt Solution, infusion solution
BTLE Bluetooth LE: Wireless standard for foot pedal
IOP Intraocular Pressure
Table 28: Index

3.6.2 Directory of tables
Table 1: Maintenance and service plan .......................................................................................... 11
Table 2: Functional check device .................................................................................................... 16
Table 3: Cassette system check ..................................................................................................... 17
Table 4: Spare parts ....................................................................................................................... 22
Table 5: Required tools................................................................................................................... 25
Table 6 Legend: pedal sectors/deflections ...................................................................................... 29
Table 7: Foot pedal cover ............................................................................................................... 30
Table 8: Slot description ................................................................................................................. 35
Table 9: Frequently mentioned alerts.............................................................................................. 36
Table 10: Packing/ unpacking transport box ................................................................................... 39
Table 11: Unpacking of the two-way box ........................................................................................ 40
Table 12: Disassembly / Assembly battery ..................................................................................... 43
Table 13: Disassembly / Assembly device housing ......................................................................... 46
Table 14: Disassembly / Assembly cassette pumping system ........................................................ 49
Table 15: Disassembly / Assembly main electronics ....................................................................... 50
Table 16: Disassembly / Assembly battery control system .............................................................. 52
Table 17: Disassembly / Assembly touch screen ............................................................................ 54
Table 18: Disassembly / Assembly fuses ........................................................................................ 55
Table 19: Packing/ unpacking transport box Sophi A ...................................................................... 59
Table 20: Unpacking two-way box .................................................................................................. 60
Table 21: Disassembly / Assembly update port .............................................................................. 63
Table 22: Disassembly / Assembly device housing ......................................................................... 64
Table 23: Disassembly / Assembly front panel ............................................................................... 66
Table 24: Disassembly / Assembly pumping system ...................................................................... 67
Table 25: Disassembly / Assembly main electronics ....................................................................... 68
Table 26: Disassembly / Assembly power supply ........................................................................... 70
Table 27: Disassembly / Assembly touch display............................................................................ 71
Table 28: Index ............................................................................................................................... 76
3.6.3 Directory of figures

Figure 1: ON/OFF Button .................................................................................................................. 7
Figure 2: Fluid flow pump system ..................................................................................................... 8
Figure 3: ESD wrist cord connection recommendation Sophi............................................................ 9
Figure 4: Cleaning of cassette slit ................................................................................................... 11
Figure 5: Foot pedal calibration ...................................................................................................... 15
Figure 6: Fold the tubing ................................................................................................................. 18
Figure 7: fluency detection test insert ............................................................................................. 19
Figure 8: Foot Pedal reset .............................................................................................................. 27
Figure 9: Foot pedal calibration ...................................................................................................... 28
Figure 10: Wi-Fi Box Sophi ............................................................................................................. 31
Figure 11: Installation Wi-Fi Box Sophi ........................................................................................... 31
Figure 12: Display and buttons ....................................................................................................... 32
Figure 13: EZ-PCB slots ................................................................................................................. 34
Figure 14: Sophi’s anatomy ............................................................................................................ 37
Figure 15: Cable management left side front .................................................................................. 47
Figure 16: Cable management left side back .................................................................................. 47
Figure 17: Cable management right side ........................................................................................ 48
Figure 18: Infusion level guard adjustment ..................................................................................... 56
Figure 19: Sophi A’s anatomy ......................................................................................................... 57

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This GmbH
Millennium Park 9 | 6890 Lustenau | Austria
This AG
Widnauerstrasse 1 | 9435 Heerbrugg | Switzerland 0123
www.thisag.ch | T +41 71 544 08 70
2022-06-20

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1401-0310-024-11 - Service Manual System Sophi and Sophi A

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System

1.2.1 General ............................................................................................................... 6

1.3 Related documents .................................................................................................. 6

1.5.1 Symbols .............................................................................................................. 7

1.6 Classification of device and system ......................................................................... 8

1.7.1 Pump System ..................................................................................................... 8

1.8 Service and maintenance ........................................................................................ 9

1.8.1 Instructions for replacements.............................................................................. 9

1.9 Spare parts ............................................................................................................ 20

1.11.1 Cassettes and disposable parts........................................................................ 25

1.12 Foot pedal .............................................................................................................. 26

1.12.1 Foot pedal update ............................................................................................. 26

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1.13 Wi-Fi Box Sophi ..................................................................................................... 31

1.13.1 General information .......................................................................................... 31

1.14 Service Mode ......................................................................................................... 33

1.15.1 Reporting to This AG ........................................................................................ 33

2 System Sophi .................................................................................................. 37

2.2.1 Packing/ unpacking of the transport box ........................................................... 38

2.3 Service and maintenance Sophi ............................................................................ 42

2.4.1 Batteries ........................................................................................................... 43

2.5 Optional settings .................................................................................................... 56

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3 System Sophi A ............................................................................................... 57

3.1 Anatomy Sophi A ................................................................................................... 57

3.2.1 Unpacking/ packing of the transport box .......................................................... 58

3.3 Service and maintenance Sophi A ......................................................................... 62

3.4.1 Update Port ...................................................................................................... 63

3.5 Repairment peristaltic aspirationsensor DMS ........................................................ 72

3.5.1 Damage ............................................................................................................ 72

3.6 Lists ....................................................................................................................... 76

3.6.1 Index ................................................................................................................. 76

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1.2 Description of device equipment

No connection to the internet is allowed.

1.3 Related documents

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Figure 1: ON/OFF Button

1.5 Symbols and Markings

1.5.2 Markings on the outside and parts of the device

See Instruction for use (IFU)

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1.7 Warning and safety

1.7.1 Pump System

Figure 2: Fluid flow pump system

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1.8.1 Instructions for replacements

Attention: The form in Annex IX must be filled in for every complaint.

Figure 3: ESD wrist cord connection recommendation Sophi

Unsuitable ESD protection may destroy the device.

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1.8.3 Service and maintenance check

Nr. Check Interval Tool

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Figure 4: Cleaning of cassette slit

The software update takes approximately 30 minutes.

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Check peristaltic pump rolls