STILLE imagiQ2 Скачать руководство пользователя страница 2 | Manualshive

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STILLE imagiQ2 Скачать руководство пользователя страница 2

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
( http://www.stille.se/iq2registration/ ) 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 [email protected] 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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Содержание imagiQ2

Страница 1: ...Stille imagiQ2 User manual Surgical Perfection For life ...

Страница 2: ...993 584 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 ...

Страница 3: ...end 16 Return to zero Horizontal 16 Battery and charging indicators 17 Flashing green light 17 Flashing blue light 17 Rapidly flashing blue light 17 Charging in progress 17 Constant blue light 17 Constant blue and green light 17 Sounds 17 PATIENT POSITIONING 18 Imaging of the torso 18 Imaging of the legs 19 ACCESSORIES 20 Pan handle 21 Hand control 21 Hand control extension cable 21 CARE and MAINT...

Страница 4: ...ources 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 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 T...

Страница 5: ... 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 En...

Страница 6: ...plies with the EC directive 93 42 EEC on medical devices Type B equipment providing a particular degree of protection against electric shock Degree of protection EN 60529 ingress of water and foreign objects Duty cycle icon duty cycle 100 Potential equalization connection point The battery must be disposed of properly due to the lead material component Connection for pan handle Connection for hand...

Страница 7: ...E On the equipment Follow instructions for use Read accompanying documents Serial number lable Fuse rating Risk for pinch squeeze injury Risk for electrical shock Max safe work load 1779 2LA009 01 1779 2LA010 01 STILLE AB publ Ekbacken 11 SE 644 30 Torshälla Sweden 225 300 kg 1779 2LA000 imagiQ 2 EU 230V 170013001 530 1700 100 230V 50 60Hz Max 510 VA 1779 2LA006 02 T 6 3A H 250V 250V SB 1779 2LA01...

Страница 8: ...8 Stille imagiQ2TM user manual Overview n Overview OVERVIEW of the imagiQ2 TABLE 2 3 5 4 7 6 8 9 10 7 4 7 5 7 3 7 2 7 1 1 7 6 ...

Страница 9: ...vated by the use of the hand control and can manually be achieved as an emergency function in cases of power failure Potential equalization The potential equalization conductor is the zero poten tial connector Detailed description 1 The table top is made of translucent carbon fibre composite Accessory rails run along 2 3 of the table top Static electricity is discharged from the bottom of the matt...

Страница 10: ...tabletop from zero position to maximum head up and then zero the table 8 Quick trend Trendelenburg Run tabletop from zero position to maximum head down and then zero the table 9 Zero position Lateral tilt Run tabletop from maximum left inclination to maximum right incli nation and back Make sure that the table stops both times it passes zero position 10 Longitudinal tilt Trendelenburg Run tabletop...

Страница 11: ...l result in an automatic parking of the table The table can only be unparked when the table is in safe position or if the weight of the load on the table is less than the unregula ted transport weight 100kg If the table is loaded with a higher weight load than allowed a fixed sound signal gives indication that the table is overloaded the sound signal can be reset by lowering the weight load Safe p...

Страница 12: ... off switch If the switch is tripped wait several seconds and then reset the switch upward position If the main fuse is blown a service technician should be contacted If the table is not to be used put away for a longer period the batteries should be fully char ged before switching the table off with the main switch Quick shut off Move the switch downwards ...

Страница 13: ...delenburg position Open the handle for manual longitudinal tilting slowly for a controlled movement Close the handle after desired lowering If the far end of the table is to be raised a number of people must hold the end of the table before lengthways tilting is started Follow instructions on emergency control cover 2 Extra safety hand control Use the extra safety hand control in the same way as t...

Страница 14: ...ntrol or foot pedal is released If no buttons are pressed for two hours the table is switched off automatically The ON lamp flashes and a repeated beep gives a ten minute warning before automatic switch off Press any button to prevent automatic switch off If no movement is required press the ON button Overview 1 Off 2 On 3 Parked table 4 Unparked table 5 Setting of head end 6 Setting of head end 7...

Страница 15: ...able and unlock If an uncentered table is loaded a constant beep is heard Centre the table in order to clear the alert see page 11 Safe position The table is more stable when parked Always park the table when it s not being transported If power is cut off during the parking unparking sequence the wheels may be left halfway out and could be damaged in the event of a collision for example with a thr...

Страница 16: ...ble top is tilted longitudinally by pressing and holding one of the hand control buttons for Antitrendelenburg until you reach the desired position Movement stops automatically when the table top is in zero position Hori zontal You can move past the zero position by releasing the hand control button and then pressing it again 13 Quick Trendelenburg Quick lowering of head end Press button for extra...

Страница 17: ...two hours the table is switched off automatically The ON lamp on the hand control flashes and a repeated beep gives a ten minute warning before automatic switch off Press any button to prevent automatic switch off If no movement is required press the ON button 2 Short repeated beeps trying to unpark loaded table If table is uncentered and then is unparked with 100kg load on the table top the table...

Страница 18: ...utton on the hand control briefly 1 Pan the table top lengthways as far out from the column as possible Centre the patient sideways 2 Position the image intensifier over the patient s groin Check the imaging area by panning the patient maximally length and sideways 3 Check that attached accessories on the accessory rails do not collide with the side protection covers by Choose maximum ISO ROLL lat...

Страница 19: ...O ROLL lateral tilt in one direction and float the patient length ways as far as possible Choosing maximum ISO ROLL lateral tilt to the opposite direction and repeat the procedure above Imaging of the legs using True Free Float Note 1 A greater longitudinal angle than 2 will lock the lengthways panning function Note 2 Centre the table top longitudinally over the column as far as possible before lo...

Страница 20: ...e Side rail UK Old UK standard verify before ordering x UK 535 1724 Side rail short US x World wide 535 1725 Side rail short DIN x World wide 535 1726 Side rail short UK old standard x UK 535 1730 Fistula arm board x World wide 535 1740 Head rest adjustable does only fit on the top side of the table requires 2 pcs of Detachable side rails to be attached x World wide 535 1741 Head rest fixed does o...

Страница 21: ... 530 1703 512 5010 IV Pole w o clamp x Only for USA 530 1703 512 5013 IV pole clamp x Only for USA 530 1703 512 5040 Foot board carbon fiber with pad x Only for USA 530 1703 O RSX2 Deluxe Maximum Retraint x Only for USA 530 1703 Pan handle Hand control Hand control extension cable Side rail Arm board ...

Страница 22: ... not light up if the Quick Stop is off If the batteries are not charged correctly they might become damaged See page 17 for additional battery information CARE and MAINTENANCE 1 Constant blue light indicates the charging is in progress The table is connected to mains 2 Constant blue and green light indicates the batteries are fully charged Maintenance charging in progress 1 2 Charging instructions...

Страница 23: ...f chlorine on decomposition Do not use steam cleaning The imagiQ2 table should only be cleaned and disin fected by hand Cleaning and care of the polyurethane coated mattress General Guidance Attention must be paid to the properties of any other materials eg washing agents and washing instruc tions Some surface wrinkling may result from cleaning procedures This has no adverse effect on the fabric s...

Страница 24: ... the hand control and can manually be achieved as an emergency function in cases of power failure The Type B Applied Part is the mattresses The definition Technical Lifetime is the same as Expected Service Life 10 years The technical life time for the batteries if well main tained and charged regularly is 3 years The technical lifetime for the mattress is 3 years The definition Maximum patient wei...

Страница 25: ...ected to mains Duty cycle 100 Battery type 24 V DC Battery recycling Follow the environmental authority instructions carefully Hydraulic system Max system pressure 190 bar Oil volume approx 1 5L Max flow of pump 0 9 L min Oil grade Castrol Hyspin AWH M32 or equivalent Electrical standards applied IEC 60601 1 2005 third edition Medical electrical equipment Part 1 General Requirements for basic safe...

Страница 26: ...NOTES ...

Страница 27: ...NOTES ...

Страница 28: ...Surgical Inc 915 Parkview Blvd Lombard IL 60148 United States Phone 1 800 6651614 General enquiries US office sales us stille se Stille Service Centers Customer Service USA Phone 1 800 665 1614 E mail imagiQ2 stille se Technical Service USA Phone 1 800 665 1614 ext 105 E mail service us stille se Customer Service International Phone 46 8 588 58 011 E mail imagiQ2 stille se Technical Service Intern...

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