Instruction Manual
13 Pages
Preview
Page 1
Instruction Manual
Driver for FLUID CONTROL Arthro 2204 5592615
BB-A 300-06 / en / 2015-12 V2.0 / PDG 15-8286
Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual and by adequately trained and qualified medical personnel, Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned appli cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.
Safety instructions and levels of danger Symbol
Level of danger
WARNING!
Failure to observe can result in death or extremely serious injuries.
CAUTION!
Failure to observe can result in slight injury or damage to the product.
IMPORTANT!
Failure to observe can result in damage to the product or surroundings.
NOTE!
User tips for optimum device use and other useful information.
GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com
USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com
UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com
BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16 [email protected] www.richard-wolf.be
FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33
AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45
[email protected] www.richard-wolf.com
Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard-wolf.com
INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com
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Contents 1 1.1 1.2 1.3 1.4 1.4.1 1.4.2 1.5 1.5.1
General information... Symbol... Intended use... Field of use... Contraindications and side effects... Contraindications... Side effects... Combinations... Possible combinations with core.connect...
1 1 1 1 1 1 1 2 2
2
Setup...
3
3 3.1
Checks... Function check...
3 3
4 4.1 4.2 4.3 4.3.1 4.3.2 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7
Operation in the core nova system... Functional principle within the core system... Combining and controlling the device... Controllable device functions and status messages... Arthro mode... Spine mode... Overview of device messages in the core system... Structure of system messages... Message types... Functionality of control elements... Operating messages (green)... LOW error (turqoise)... MEDIUM error (yellow)... HIGH error (red)...
4 4 4 5 5 5 6 6 6 6 7 8 8 8
5 5.1 5.2 5.2.1
Technical description... Technical Data... Spare parts and accessories... Disposal of product, packaging material and accessories...
10 10 10 10
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1
General information
1.1
Symbol Symbol
Designation Attention, Caution Follow the instruction manual
1.2
Intended use Within the core system, the driver software 5592615 for the FLUID CON TROL Arthro 2204 device installable in the core.connect 5592501 mod ule, serves to remote-control the devices listed under 1.5.1. This product is designed exclusively for use by specialized medical per sonnel and may only be applied by medically qualified and adequately trained persons.
1.3
Field of use
1.4
Contraindications and side effects
1.4.1
Contraindications
The core.connect module 5592501 with installed driver software for the FLUID CONTROL Arthro 2204 device, is used for connecting external medical devices with electronic interface to the core system for controlling predefined functions.
Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical litera ture. 1.4.2
1
Side effects
Side effects directly related to the product are currently unknown.
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1.5
Combinations
1.5.1
Possible combinations with core.connect The following devices can be combined with the core.connect module with installed driver for the FLUID CONTROL Arthro 2204 device. FLUID CONTROL Arthro 2204
IMPORTANT! In addition to this manual follow the manuals of the products used in com bination with this product as well as the latest manual for the core.con nect 5592501 module (GA-A 300). GA-A 300
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2
Setup The CAN-BUS requires an external power supply.Power can be supplied via ENDOCAM 5525, PowerSpeed AS1 Generator 2305 or core.media 5593. See the latest manual for the core.connect module (GA-A GA-A 300). 300)
3
Checks
3.1
Function check
Carry out different settings on the FLUID CONTROL Arthro 2204 de vice and check that the new settings have been adopted by the core system. Then change the settings on the core system and check that the parameters have been adopted correctly by the FLUID CONTROL Arthro 2204 device. The core.connect module features automatic function checks which automatically detect and report various faults.
3
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Operation in the core nova system
4.1
Functional principle within the core system In normal mode the connected device can be controlled via the core sys tem using a control terminal, optional voice control as well as the control options on the device itself. The core system may be equipped with different control terminals. In con junction with the core.browser software, different functions and devices can be called up on the control terminals and controlled independently.
IMPORTANT! The connected device can still be controlled manually via the device con trols should the core system fail. For a description please refer to the in struction manual of the corresponding device.
4.2
Combining and controlling the device The components must fulfill the requirements in accordance with the cur rent instruction manual for the core system, section on "Possible combi nations". Further descriptions of use: Follow the latest instruction manual for the core system. For operation, menu structure, software updates and configurations, follow the latest core.browser instruction manual. For a detailed understanding of the device and menu functions, follow the instruction manuals of the connected devices.
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4.3
Controllable device functions and status messages
4.3.1
Arthro mode Model 2204
Device functions controllable via the core Description system Select program
Selects a program (profile) from a list
X
Irrigation ON/OFF
Switches the irrigation function ON and OFF
X
Wash ON/OFF
Switches the wash function ON and OFF
X
Vacuum ON/OFF
Switches the vacuum function ON and OFF
X
Pressure plus/minus
Sets the nominal pressure
X
Flow plus/minus
Sets the nominal flow
X
Vacuum plus/minus
Sets the vacuum value
X
Status messages in the core system
Display
Pressure
Display of actual pressure
X
Best Flow
Display of symbol
X
Wash
Display of symbol
X
Additional function On-screen display of intraarticular pressure in the video image of ENDOCAM 5525.
4.3.2
X
Spine mode Model 2204
Device functions controllable via the core Description system
5
Select mode
Selects the required mode from a list
X
Select height of device
To ensure an optimal irrigation flow the user is requested to correct the difference in height rela tive to the patient, if necessary. The height adjustment can be corrected up to a negative level difference of 40 cm between the device position and the patient, i.e. a compensa tion ist possible even if the device is postitioned up to 40 cm below the patient.
X
Select instrument
Select instrument from a list
X
Flow plus/minus
Sets the nominal flow
X
Irrigation ON/OFF
Switches the irrigation function ON and OFF
X
Vacuum ON/OFF
Switches the vacuum function ON and OFF
X
Status messages in the core system
Display
Overpressure
Display of symbol
X
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4.4
Overview of device messages in the core system
4.4.1
Structure of system messages There are 4 different types of message. The system messages are displayed in the corresponding color together with a symbol and the associated message number, as required by the message type. For certain messages the core system will only display the "Follow messages on device" note.
Message text XXX-XXX-XXX XXX
optional fault correction
OK
4.4.2
Message types
Symbol
Color
Message type
Green
operating note
Turquoise LOW error
4.4.3
Yellow
MEDIUM error
Red
HIGH error
Description
Informs about relevant events. (Audio signal can be activated/deactivated in the "Audio Audio" Audio menu).
Informs the user about imminent dangers. Error of low priority.
Informs the user about imminent dangers. Error of medium priority.
Indicates severe device errors excluding any further control of the device. High-priority error.
Functionality of control elements
Control element No button
OK
Description
The message window is displayed until the conditions are fulfilled. The message window can be exited. Device operation may be continued but with limited functions.
Audio
The audio alarm signals are activated. The audio alarm signals can be switched off by pressing the button.
Audio
The audio alarm signals are deactivated. Pressing the button switches on the audio alarm signals.
Service
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Once this button is displayed, you can only switch to the "Service Service" Service submenu. The device can no longer be operated (controlled).
6
4.4.4
Operating messages (green)
Message number
Message text
-------
Please note message on unit
-------
Tube filling phase 0%
-------
Tube filling phase 20%
-------
Tube filling phase 40%
-------
Tube filling phase 60%
-------
Tube filling phase 80%
Possible cause
Corrective action
For this message various causes are possible
See device manual
First-time start of irrigation in spine mode.
Wait until the tube system and the instrument are com pletely filled with the fluid or until the tube filling phase is completed, respectively.
Day tube set has been installed
Remove the day tube set.
-------
Tube filling phase 100%
-------
The day tube set is not permitted for this mode
-------
Upper range limit reached
-------
Status message
-------
Lower range limit reached
-------
Status message
-------
Insert tube
No valid tube has been inserted.
Please insert a valid tube
-------
Start pump
Irrigation has not been started.
Press the irrgation button to start the pump.
-------
Tube OK
-------
Status message
-------
Tube OK – 3 applications possible
A valid tube has been inserted. Appli cation counter allows another 3 appli cations
Status message
-------
Tube OK – 2 applications possible
A valid tube has been inserted. Appli cation counter allows another 2 appli cations
Status message
-------
Day set inserted
A valid day tube set has been in serted.
Status message
-------
Standard operation mode
-------
Shaver active
-------
-------
Overpressure
Actual pressure is 30 mmHg above nominal pressure, up to max. 250 mmHg.
Reduce intraarticular pres sure, e.g. by opening the out flow stopcock
-------
Critical overpressure
Actual pressure above 250 mmHg.
Reduce intraarticular pres sure, e.g. by opening the out flow stopcock
-------
Day set contaminationCritical overpressure
Only for day set: Actual pressure obove 300 mmHg for > 30 s, roller wheel reversed
Reduce intraarticular pres sure, e.g. open outflow stopcock. Use new tube for the next surgery.
-------
Day set contamination
Only for day set: Actual pressure obove 300 mmHg for > 30 s, roller wheel reversed
Reduce intraarticular pres sure, e.g. open outflow stopcock. Use new tube for the next surgery.
-------
Vacuum pump defective
Vacuum pump defective.
Contact service department.
-------
Compatibility conflict
Wrong software version
Contact the service depart ment.
-------
System connection No arthro pump connected
Device not connected or switched off.
Connect or switch on the de vice.
251-250-419
Please insert tube. Please insert a valid tube.
1. There has been an attempt to start irrigation without a tube in place. 2. The tube has not been detected.
Install a valid tube
251-250-428
Demo mode time limit expired Next irrgation possible in 30s
Demo mode acticated
Deactivate demo mode
7
Instrument recognition is currently car ried out or recognition has not been successful.
Carry out instrument detec tion once more. See device manual Status message
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4.4.5
LOW error (turqoise)
Message number
Message text
3xx-050-0xx
Please note message on unit
4.4.6
Possible cause For this message various causes are possible
Corrective action See device manual
MEDIUM error (yellow)
Message number
Message text
55x-050-0xx
Please note message on unit
551-250-414
Day set contamination The pump tube can not be used for the next surgery.
Roller wheel has reversed Is dis played after irrigation stop
Use new tube for the next surgery.
551-250-416
Tube OK. Last application
The tube application counter allows only one final application.
Use new tube after this ap plication.
551-250-426
Tube incorrectly installed. Please check the pump tube position and press OK.
Tube incorrectly installed.
Install tube correctly. See device manual
551-250-430
Vacuum pump defective. Suction not available. Irrigation can be used normally. Please contact the service department.
Suction not available. Irrigation can be used normally.
Contact the service depart ment.
551-250-431
Overpressure
Actual pressure is 30 mmHg above nominal pressure, up to max. 250 mmHg.
Reduce intraarticular pres sure, e.g. by opening the out flow stopcock
Wrong instrument has been selected
Check that the correct VERTEBRIS endoscope system is connected and selected. Return to instrument selec tion and select the VERTE BRIS endoscope system suitable for the indication.
551250435
Instrument recognition has failed! Back to instrument selection
Possible cause For this message various causes are possible
Instrument set has not been assem bled correctly.
Inflowstopcock is not completely open. No instrument connected.
4.4.7
Corrective action See device manual
Check that the connected VERTEBRIS endoscope system is leak-tight at the supply stopcock. Check the inflow stopcock. Connect the selected in strument.
HIGH error (red)
Message number
Message text
752x-250-42xx
Please note message on unit
For this message various causes are possible
750-250-413
Critical overpressure
Actual pressure above 250 mmHg.
Reduce intraarticular pres sure, e.g. by opening the out flow stopcock
750-250-417
Sensor Offset. Remove tube Switch pump off and back on. Insert tube after switching on the device.
Tube was installed before starting the pump.
Remove tube. Switch pump off and back on. Insert tube after switching the device on.
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Possible cause
Corrective action See device manual
8
Message number
Message text
751-250-415
Possible cause
Corrective action
Day set contamination Please insert a new tube.
The day set was contaminated during the previous treatment and has not been replaced. Display when attempt ing to start irrigation.
Please use a new tube for the next surgery.
751-250-418
No remaining uses. Please insert a valid tube.
The tube application counter does not allow further applications.
751-250-425
Critical overpressure. Please open the outflow stopcock.
Actual pressure above 250 mmHg.
Install a valid tube Reduce the intraarticular pressue. e.g. by opening the outflow stopcock.
IMPORTANT! For possible causes and corrective action in the case of malfunctions, also observe the instruction manuals of the products used in combination with this product.
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Technical description
5.1
Technical Data
5.2
Driver software
Model
Combinable modules
Model
Driver for FLUID CONTROL Arthro 2204
5592615
core.connect
5592501
Spare parts and accessories Model
Designation
643211527
CAN BUS power supply cable, 1.5 m Further accessories on request
5.2.1
Disposal of product, packaging material and accessories For the disposal observe the relevant regulations and laws valid in your country. For further information please contact the manufacturer.
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