OCULUS SDI 4 User manual

OCULUS SDI®4
INSTRUCTION MANUAL
Stereoscopic Diagonal Inverter

i / iii Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)
Notes on this instruction manual
The SDI® 4 has been manufactured and tested according to strict quality criteria.
To ensure safe operation, it is essential that you use the device correctly. For this
reason, you should thoroughly familiarize yourself with the contents of this instruction
manual before operating the device. In particular, pay attention to the safety
instructions.
This operating manual describes the following SDI® 4 models:
SDI® 4c
SDI® 4e
SDI® 4m
Due to ongoing development, the diagrams shown in the instruction manual may
depict minor changes to the actual device delivered.
If you have any questions or would like additional information about your device,
please do not hesitate to call us or to contact us by mail or fax. Our service team will
gladly assist.
OCULUS Optikgeräte GmbH
OCULUS is certified according to EN ISO 13485, setting high standards of quality where
development, manufacture, quality assurance and service regarding the entire range of
products are concerned.

Table of Contents
Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01) ii / iii
Table of Contents
1 Scope of Delivery.........................................................................................................................1
2 Graphic Symbols SDI® 4............................................................................................................2
3 Safety Instructions......................................................................................................................3
3.1 About this Manual .........................................................................................................3
3.1.1 Used Graphic Symbols.................................................................................3
3.2 Safety Instructions for Use..........................................................................................4
4 Proper Use.....................................................................................................................................7
5 Description of the Unit..............................................................................................................8
6 Functional description ...............................................................................................................9
7 Initial Operation ....................................................................................................................... 10
7.1 Preliminary Steps......................................................................................................... 10
7.2 Attach the SDI® 4 to an Operation Microscope ................................................. 10
8 Operation.................................................................................................................................... 13
8.1 Prior to each Use ......................................................................................................... 13
8.2 Practical Tips for Use.................................................................................................. 13
9 Care and Maintenance ...........................................................................................................14
9.1 Removing the Accessories......................................................................................... 14
9.2 Cleaning ......................................................................................................................... 14
9.3 Sterilization of the Rubber Cap............................................................................... 15
10 Transport and Storage ............................................................................................................ 15
11 Troubleshooting........................................................................................................................ 15
12 Guarantee and Service............................................................................................................ 17
12.1 Assumption of Liability for Functions and Damage .......................................... 17
12.2 Manufacturer’s and Service Addresses.................................................................. 18
13 Disposal of Used Devices........................................................................................................ 18
14 Order Information, Accessories and Replacement Parts............................................... 19
15 Technical Data .......................................................................................................................... 20
15.1 Datasheet for plug-in power supply unit GEM12I 09-P1J (54905).............. 23

Table of Contents
iii / iii Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

1 Scope of Delivery
Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01) 1 / 24
1 Scope of Delivery
SDI® 4
We reserve the right to make changes to deliverables as a part of any
technical improvements.
Product (versions)
SDI® 4m
with two protective dust covers and transportation lock
54302
SDI® 4m (Leica Version)
with two protective dust covers and transporting lock
54312
SDI® 4e
with two protective dust covers and transportation lock
54300
SDI® 4e (Leica Version)
with two protective dust covers and transportation lock
54310
SDI® 4c
with two protective dust covers and transportation lock
54320
SDI® 4c (Leica Version)
with two protective dust covers and transportation lock
54330
Accessories for each SDI® 4
Sterilisable rubber cap 54335
Hexagon screw driver 05490061
Plastic carrying case with liners
Instruction Manual G/54320/EN/...
Conditioning Instructions G/55185/xxxx/en
Accessories for SDI® 4c and SDI® 4e
For SDI® 4c only: Cable duct usable with steam autoclave 54178
Optional: Plug-in power supply GEM12I 09-P1J 54905
Optional: extension cable for voltage power supply plug
(approx. 5 m)
54898
Required accessories:
Combination foot switch SDI® 4c
Footswitch for SDI® 4e
Optional: extension cable to SDI® 4e foot switch (aprrox. 5 m)
54881
54883
54885

2 Graphic Symbols SDI® 4
2 / 24 Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)
If transport damage is discovered from the shipment, please file a
complaint with the shipping company immediately.
Have the damage confirmed on the bill of lading so that an orderly
handling of the complaint for damages is possible.
2 Graphic Symbols SDI® 4
Pictograms on the packaging
1 Company logo + manufacturer 8 Power supply
2 CE marking 9 Date of manufacture
3/5 UDI number 10 Serial number of the device
4 Matrix 11 Reference number
6 Disposal in household trash is prohibited
(SDI® 4c and SDI® 4e only
12 Name of device
7 Protection class (SDI® 4c and SDI® 4e only) 13 Heed Instruction Manual
Fig. 2-1: Example: Graphic Symbols SDI® 4e
1
5
6
12
7
9
10
11
23
4
8
13
Keep dry up fragile
Permitted
temperature range
for transport
Permitted
temperature range
for storage
Transport
Storage

3 Safety Instructions
Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01) 3 / 24
3SafetyInstructions
Attention
All safety-related instructions for use of the SDI® 4 are given in the
Instruction Manual for the unit. It is therefore imperative that you read
and understand the whole Instruction Manual before you use the SDI® 4.
3.1 About this Manual
Carefully read through the Instruction Manual.
Make sure to keep the instruction manual in a safe place and
available to operating personnel at all times.
Observe the legal regulations with regard to accident prevention.
3.1.1 Used Graphic Symbols
Attention
Denotes a potentially hazardous situation which can easily result in minor
physical injury or property damage.
Note
Denotes situations which could result in incorrect findings, denotes user
instructions and useful or other important information.
☞
Denotes important information about the product and its use, which
require special attention.

3 Safety Instructions
4 / 24 Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)
3.2 Safety Instructions for Use
Attention
Risk of personal injury or property damage due to improper operation
Observe the following safety instructions.
Risk of personal injury or property damage due to equipment
modifications that could jeopardize safety
This equipment may not be modified without the permission of the
manufacturer. Changes or modifications may only be made by
OCULUS Service and authorized dealers.
Instructions for operating personnel
Ensure that the SDI® 4 is used only by duly trained physicians and
operating theatre personnel, who, due to their training or their
knowledge and practical experience, can guarantee proper handling
of the device. Only OCULUS or an authorized dealer is allowed to
train the personnel.
Transport and storage instructions
Refer to the notes in sect. 10, page 15.
Instructions for setup and connection
Only OCULUS, an authorized dealer or trained personnel are allowed
to setup and connect the SDI® 4.
Comply with the legal provisions in force in your country, and with
the hygiene and waste disposal regulations of the hospital or clinic.
Set up the SDI® 4 so that the power plug is easy to access. That way,
you can easily disconnect it from the power supply for any repairs or
maintenance work.
Do not use excessive force to plug in the electrical plugs for the
OCULUS BIOM® 5.
If you are unable to make a plug connection, check whether the plug
fits the socket.
If you find damage to the plug connector, have the damage
corrected by our service department.
Heed unconditionally the operating in-structions and safety advice
of the operating microscope and of the additional equipment.
Familiarize yourself with all safety features and devices before you
put the unit into initial operation.

3 Safety Instructions
Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01) 5 / 24
Operation and Maintenance Information
Before initial operation: Let OCULUS or an authorized dealer train
you in the operation of the SDI® 4.
Never operate a damaged SDI® 4. Inform the supplier of any damage.
Only operate the SDI® 4 with the original accessories supplied by us
and only when the unit is in a technically perfect condition.
Only operate the equipment after your have read and understood the
Instruction Manual.
Do not touch the patient and the device at the same time.
If a malfunction occurs that you cannot rectify by following in the
instructions in the troubleshooting table (sect. 11, page 15), you
must not use the device. Clearly mark the unit as non-operational
and get in touch with our service personnel.
The sterilisable rubber cap for the adjusting knob of the SDI® 4 must
be sterilised before the first and before each subsequent use.
It is imperative that you heed the cleaning, disinfection and
sterilisation instructions given in the Conditioning Manual.
A sterilisation of the SDI® 4 is not possible.
Instructions for disassembly and disposal
When disconnecting electrical connections, pull on the respective
plug and not on the cable itself. Take hold of the plug, do not pull on
the cable.
Dispose of the equipment in compliance with the corresponding
legal requirements. Comply with the hygiene and disposal
regulations of the hospital or clinic.
Patient environment information
Patient environment is the area where patients can come into contact
with any part of a medical electrical equipment (ME equipment) or with
another person being in contact with the ME equipment.
In the patient environment, use devices that conform to IEC 60601-1. If
a multiple power socket is to be used, or if a device is to be used that
does not meet the IEC 60601-1 standard, use an isolating transformer.

3 Safety Instructions
6 / 24 Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)
EMC and Electrical Safety Information
The SDI® 4c, a connected BIOM® 5 and a microscope constitute a Medical Electrical
System (ME System) in accordance with DIN EN 60601-1. If you connect any more
devices, they too become part of the ME System.
Make sure that all devices of the ME System meet the provisions of IEC 60601-1
or of IEC 60950-1
Use the plug-in power supply unit included in the scope of delivery.
Attention
Use of a Multiple Socket Extension Cord
Risk of personal injury or material damage caused by unsafe multiple socket extension
cord
If you use a multiple socket extension cord to connect the SDI® 4 to the power supply,
you must heed the following information:
Use a multiple socket extension cord that complies with the requirements of DIN
EN 60601-1:2005 section 16.
Do not place the multiple socket extension cord on the floor.
Do not use more than one multiple socket extension cord.
Plug only the SDI® 4 into this multiple socket extension cord.
If you use a multiple socket extension cord, it must be supplied with power via an
isolating transformer.
Electromagnetic Compatibility (EMC / Cables)
Risk of personal injury or damage to property due to electromagnetic interference
Portable and mobile HF communications appliances (high frequency) can affect
medical, electric equipment.
Make sure that portable and mobile RF communications equipment do not cause
interference.
Recommendation: Maintain a minimum distance of 4 m. If the distance is shorter,
you must ensure that the SDI® 4 functions correctly.