STILLE imagiQ2 User manual

Stille imagiQ2
Service and technical manual
Surgical Perfection. For life.

Copyright © 2015 STILLE AB. All rights reserved.
The contents of this manual are the property of STILLE AB. Any reproduction in whole or in part is strictly prohi-
bited. Trade marks: True Free Float™, ISO ROLL™ and imagiQ2™ are trademarks owned by Stille AB.
At the time of printing, this manual correctly described the device and its functions. However, as modifications
may have been carried out since the production of this manual, the system package may contain one or more
amendments to the manual. This manual including any such amendments must be thoroughly read, before using
the device.
The English version of the User Manual and Service Manual is the original instructions. Manuals in other langu-
ages are a translation of the original instructions.
The following imagiQ2™ models are covered by this manual: 530-1700 imagiQ2 EU 230V, 530-1701 imagiQ2
GB 230V, 530-1702 imagiQ2 JP100V, 530-1703 imagiQ2 US 120V.
The imagiQ2 operating table is CE marked in conformity with the essential requirements, according to annex I,
and classified, according to annex IX, as Class I (rule 12) of the Medical Device Directive 93/42/EEC.
We declare the compliance of the medical device concerned with the Swedish Medical Devices Act (1993:584)
and the regulation LVFS 2003:11 of the Medical Products Agency. Hereby, the medical device complies with the
requirements of the Medical Device Directive 93/42/EEC, the amending Directive 2007/47/EC and the appli-
cable harmonized standards as well as the RoHS directive 2011/65/EU and the WEEE directive 2012/19/EU.
The device does also comply with the International standards, IEC 60601-1, IEC/EN 60601-2-46, UL 60601-
1. CAN/CSA C22.2 No 601.1-M90. Any modification to the device, not authorized by us, will invalidate this
declaration.
The original signed CE declaration of conformity is a separate document can be obtained upon request.
Classifications
CE Medicla device classification: Class 1
GMDN code: 36606
FDA Regulation Status: Class 1 Exempt 878.4960 (GDC)
FDA List No.: E130044
Warranty terms for imagiQ2™ vascular imaging table:
To be able to benefit the full warranty terms of the Stille imagiQ2, the installation report that comes enclosed
with the documetation must be filled in at installation and returned to [email protected]
Information regarding Stille Warranty Provisions can be found on Stilles website, http://www.stille.se.
If you do not find the installation report please do contact [e-mail] for a copy.
It is recommended that all repairs and modifications are carry out by authorized personnel.
Manufacturer:
Stille AB
Ekbacken 11
SE-644 30, Torshälla
Sweden

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Stille imagiQ2™ Service manual Contents 3
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CONTENTS
SAFETY INFORMATION 4-5
OVERVIEW of imagiQ2™ 6-13
Overview 6-7
Intended use 7
Detailed description 7
1:st time start up procedure 8
Daily control 8
Target group (Service) 9
Scope of the manual 9
Technical knowledge 9
Applied part 9
Technical lifetime 9
Table function priority 10
Periodic maintenance 11
Cleaning of the mattress 11
Removal of table top 12
Installation 13
Site planning 13
Transportation/ storage 13
Tools for service and repair 13
TECHNICAL 14-76
Position for service 14
LoTo 15-21
Replacement of:
Connection board 22
Inclinometer board 23
Main board 24
PSU 25
AC-inlet 26
Wheel cylinder 27
Lateral cylinder 28
Lift cylinder 29
Trend cylinder 30
Hydraulic pump 31
Solenoide valve 32
Brake- clamp valve 33
Bleed brakes- clamps 34
Internal fuses 35
Adjust the Pan handle 36
Lower the wheels 37
Trouble shooting guide 38-47
Drawings and schematics 48-67
Spare part service kit 68
Electrical and EMC 69-71
Service protocol 72-74
ISO/EN 62353 protocol 75
Specifications 76
Electricla standards 76
Notes 77-79

Safety Information
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SAFETY INFORMATION
Always follow the manufacturer’s instructions!
Read carefully and always follow the instructions in the users manual before first using the imagiQ2™ operating
table. This manual has been written to ensure that you will handle the table in a safe and correct manner, use this
manual together with the users manual.
n The device is intended to be used by qualified surgical staff.
n Quick Stop/ Main switch: Move the switch downwards for immediate shut-off (see page 12).
n All movements are interrupted when the hand control is switched off (OFF), or when the Quick Shut-off
switch is turned off.
n All table top movements cease immediately if the button in question is released.
n Charge the batteries if the battery indicator is indicating low battery.
n Avoid discharging the batteries completely. Maximum battery life-time is achieved if charged regularly.
n The manual must always be stored within reach of the operating table.
n The main switch must be turned “ON” when charging the table.
n Follow the packaging / unpackaging procedure to avoid personal injuries, equipment damage or property
damage.
n This device, as all medical electric equipment in general, need special precautions regarding EMC and need to
be installed and put into service according to information in the user and service manual.
n During operation make sure to not touch external ports or conenctors and patient at the same time.
n Always use anti-static cushions to ensure that static electricity is discharged to the anti-static floor.
n The table is intended to be used on an anti-static floor.
n Always connect the table’s potential equalization connection point to protective earth.
n Never place surgical cloths/ sheets so that the grounding rails are totally covered. Surgical cloths/ sheets pre-
vent electric discharge to anti-static floors.
n Radio transmitting equipment, cellular phones etc. shall not be used in the close proximity of the imagiQ2™
table since this could influence the performance of the imagiQ2™ table.
n Particular precaution must be considered during use of strong emission sources such as High Frequency
surgical equipment and similar so that e. g. the HF-cables are not routed on or near the imagiQ2™ table. If in
doubt, contact qualified technician or your local representative.
n Do not subject the operating table to electromagnetic fields that exceed the applicable standards for radio
frequency equipment, such as diathermy apparatus, defibrillators and defibrillator monitors.
n The table is only to be used with medical equipment complying with EN 60601-1, EN 60601-1-2.
n The imagiQ2™ table complies with the EMC requirements according to IEC 60601-1-2.
n The device is not intended for use with flammable anaesthetic gases. A possible explosion hazard exists and
personal injury or equipment damage could occur.
n The device shall be cleaned / disinfected according to the user manual.
n Do not immerse the control unit device in water or any other liquid (see the care / maintenance section for
specific details).
n The operating table is disconnected from mains by disconnecting the AC-power cord from the table.
n Unplug the power connector from its power source before moving the table, cleaning or servicing. Failure to
do so could result in equipment damage.
n The table is more stable when parked. Always park the table when it’s not being transported.
n Only use accessories approved by STILLE AB.
n Always check that mounted accessories do not collide with the operating table or surrounding equipment
when movement is activated
n Remove any obstacles before lowering or tilting the operating table. It could tip over.
n The operating table base must always be stable and horizontally level.
n Centre the table top longitudinally over the column as far as possible before lowering the free end of the table
top.
n When adjusting or when panning the operating table, never put your fingers under the table top or cover. Risk
of injury.
n Secure the patient before changing the position of the operating table.
n The patient must not lie on conductive mattresses or on damp bedding when defibrillators, defibrillator moni-
toring screens or high frequency apparatus are being used. Nor should the patient come into contact with
metal parts or their accessories on the operating table. This could result in burns.
n Keep the patient under constant observation.
n Use only STILLE spare parts.

Safety Information
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4Stille imagiQ2TM service manual Safety Information Stille imagiQ2TM service manual Safety Information
n Ensure that hands, feet and equipment are clear of the frame assemblies when changing positions of the table.
n Use precaution as the imagiQ2™ table can be activated by another operator.
n Particular precaution must be taken during use of the foot control to avoid unwanted movements.
n Not intended to be used in an oxygen rich environment.
n Do not subject the operating table to electromagnetic fields that exceed the applicable standards for radio
frequency equipment, such as diathermy apparatus, defibrillators and defibrillator monitors.
n All service shall be performed without any patient placed on the table. In case of emergency service and repair
shall be performed without any connections between the technician and the patient or the operator.
n For moving safely over a threshold 15 mm or higher, it´s required to be two persons.
n Before moving over a threshold always makes sure that the table top is centre.
n The battery shall only be changed by service personnel.
n Replenishment of oil into the hydraulic system shall only be done by service personnel.
n Addition to the Service Manual: Never overfill the hydraulic system when refilling oil.
n Do not place or position imagiQ2 so that it is difficult to disconnect the table from the supply mains socket.
n Do not touch the patient and accessible contacts of connectors simultaneously.
n The table shall be centered and turned OFF on the hand control before and during transport.
n Extra precaution must be taken during service when a guard is open and someone is activating a movement.
Risk of injury.
n A clicking sound shall be heard when attaching the head rest to be sure that its attached safely.
n Preventive maintenance of the table shall always be performed according to the Service Manual.
n Always check that the accessories are securely attached to the table before use.
n Always check accessories before use. Damaged or worn accessories shall never be used as they can cause
injury.
n Do not operate the device if the protective covers are removed, risk for personal injury.
n Skin contact with hydraulic fluid may cause skin irritation, clean and wash with soap and water.
n If another mattress is used than the original mattress, a grounding connection must be established.
n When the AC cable is connected to the device, the batteries are charging if the main switch is ON, if the bat-
teries are completely discharged it may take some time before the device can be restarted.
n Isolation from the supply mains is made by disconnecting the AC power cable from the equipment.
n Enclosure protection of the foot control is IP68.
No specific warnings specified in the service manual according to use of other accessories, transducers and
cable other than those specified by Stille.
n Precautions has to be taken to equipment and surrounding equipment in relation to specific EMC requirements
see tables for EMC specifications.
n Testing against IEC/EN 62353 shall be performed by Qualified personnel according to the requirements in the
standard.
n Use of accessories, cables and spare parts other than those sold by Stille as replacement for internal compo-
nents, may result in increased emissions or decreased immunity of the operating table imagiQ2.
n Warning: imagiQ2™ should not be used adjacent to or stacked with other equipment. If adjacent or stacked use
is necessary, imagiQ2™ should be observed to verify normal operation in the configuration in which it will be
used.
n WARNING: if the table is beeping continously every 30 second, table is in failstate, all safetyfunctions are
turned OFF, do not transport patients on the table park the table during procedures.
n WARNING: Risk for pinch/squees damage when installing/ removing the detachable table top.
n WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply main with
protective earth.
n WARNING: Using other cables and accessories than the specified, can possibly increase the emission and
decrease the immunity in regards of EMC requirement.
n WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
n WARNING: No modification of this equipment is allowed.
n Do not position the imagiQ2™ operation table so that it is difficult to operate the disconnection device.
n Means for isolating imagiQ2™ operation table from mains supply, trough disconnecting the power cord from
the ME equipment.
n It is recommended that at least 2 persons are transporting the imagiQ2™ operation table.
n If in doubt, consult the supplier or person responsible for operating room equipment.