Carl Zeiss Surgical 304970-8200 Bluetooth Module User Manual G 30 1706 bk
Carl Zeiss Surgical GmbH Bluetooth Module G 30 1706 bk
User Manual
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| Document ID | 1065142 |
| Application ID | HL489JlgcdqEuVbQaOiOJQ== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
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| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 173.17kB (2164680 bits) |
| Date Submitted | 2009-02-05 00:00:00 |
| Date Available | 2009-02-05 00:00:00 |
| Creation Date | 2009-01-15 10:28:33 |
| Producing Software | Acrobat Distiller 8.1.0 (Windows) |
| Document Lastmod | 2009-01-19 11:26:38 |
| Document Title | G_30_1706.bk |
| Document Creator | FrameMaker 5.5.6p145 |
| Document Author: | zobnd |
Carl Zeiss c`m=C=c`m=ti cççí=`çåíêçä=m~åÉä User Manual G-30-1706-en Version 1.1 2009-01-15 FCP & FCP WL Foot Control Panel About this manual Orientation aids Applicable area The user manual is part of the scope of delivery. • Carefully read it before using the device. • Keep it at the site of use of the foot control panel. • Store it for the entire service life of the foot control panel. • Pass it on to every subsequent owner or user of the foot control panel. – The chapter overview at the beginning of the user manual provides a summary of all subjects. – The contents of each chapter are specified in detail at the beginning of each chapter. – A keyword index at the end of the manual facilitates the search for specific terms. This user manual applies to foot control panels with the following identification: – Rating label numbers: 304970-9100-000 304970-9200-000 Information on the manufacturer: Carl Zeiss Surgical GmbH A Carl Zeiss Meditec Company 73446 Oberkochen Germany Fax: + 49 (0) 7364 - 20 4823 Email: surgical@meditec.zeiss.com Internet: www.meditec.zeiss.com Subject to change in design and scope of delivery and as a result of ongoing technical development. Printed in Germany. © Carl Zeiss Surgical GmbH 2009 Page 2 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Chapter overview Version 1.1 G-30-1706-en Chapter: Safety measures Chapter: Design and function 19 Chapter: Preparations for use 31 Chapter: Operation 41 Chapter: What to do in the event of malfunctions 45 Chapter: Care and maintenance 51 Chapter: System data 55 Chapter: Index 61 Page 3 FCP & FCP WL Foot Control Panel Page 4 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Safety measures We would like to provide you with information about safety aspects which must be observed when handling this foot control panel. This chapter contains a summary of the most important information concerning matters relevant to instrument safety. Key to the symbols in this user manual ............................................. 6 Hazard symbols ...........................................................................................6 Information symbols....................................................................................7 Directives and standards ................................................................... 7 Target group ..................................................................................... 8 Field of application ............................................................................ 8 Intended use ...............................................................................................8 Normal use..................................................................................................8 Typical misuse .............................................................................................8 Notes for the operator....................................................................... 9 Duties of the operator .................................................................................9 Requirements to be met by the user ..........................................................12 Warranty and liability.................................................................................13 Requirements for operation............................................................. 14 Before every use ........................................................................................14 During use.................................................................................................14 After every use ..........................................................................................15 Warning labels and notes ................................................................ 16 Version 1.1 G-30-1706-en Page 5 Safety measures FCP & FCP WL Foot Control Panel Key to the symbols in this user manual Hazard symbols The following safety information has been incorporated in the user manual. Please note this information and be particularly careful in these cases. WARNING Indicates a hazard which can lead to death or severe injury if it is not prevented. CAUTION Indicates a hazard which can cause slight and medium injury if it is not prevented. NOTE Page 6 Indicates a hazard which can cause damage to material if it is not prevented. Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Key to the symbols in this user manual Information symbols The following information symbols are used in this user manual: – Listing 9 Prerequisite for an action • Prompt for action Æ Result of an action Additional information and tips. No warnings of hazards are provided. Directives and standards The foot control panel described in this manual has been designed and tested in accordance with Carl Zeiss safety standards as well as German and international standards. This guarantees a high degree of safety. The foot control panel has been designed in compliance with the requirements of: – EN (European standard) – IEC (International Electrotechnical Commission) – UL (Underwriters Laboratories) In accordance with Directive 93/42/EEC for medical devices, the complete quality management system of the company Carl Zeiss Surgical GmbH, 73446 Oberkochen, Germany, has been certified by DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen GmbH, a notified body, under registration number 250758 MP23. Version 1.1 G-30-1706-en Page 7 Safety measures FCP & FCP WL Foot Control Panel Target group This user manual is intended for physicians, nurses and other medical staff who prepare, operate or maintain the foot control panel after appropriate training and in accordance with the instructions given in this manual. Installation and service work not described in this manual must only be performed by specialists from Carl Zeiss. Field of application Intended use The foot control panel is an accessory for all types of Carl Zeiss surgical microscopes. It enables operation of the motor-driven and controllable functions of the microscope by foot control. Normal use This foot control panel permits either cordless or corded operation of up to 14 different functions of a surgical microscope, including its options, by foot control. Typical misuse The foot control panel must only be operated in combination with devices from Carl Zeiss. Page 8 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Notes for the operator Notes for the operator The correct use of the foot control panel is absolutely vital for safe operation. Therefore, please thoroughly familiarize yourself with the content of this user manual before starting up the foot control panel. Please also observe the user manuals of the other devices used. Further information is available from our service department or from authorized representatives. Duties of the operator Notes on the foot control panel Version 1.1 G-30-1706-en • Make sure that the installation conditions and the use of the foot control panel meet microsurgical requirements: – low vibration – clean environment – avoidance of extreme mechanical stress. • Observe the legal regulations for accident prevention and occupational health and safety applicable in the country concerned. • Do not operate the components contained in the delivery package – in explosion-risk areas, – if inflammable anesthetics or volatile solvents such as alcohol, benzine or similar chemicals are present at a distance of less than 25 cm. • Switch off the connected foot control panel and remove the batteries if you notice any smoke, sparks or unusual noise. Do not use the foot control panel until it has been repaired by our service team. • Do not force cable connections. If the male and female parts do not readily connect, make sure that they are appropriate for one another. If any of the connectors are damaged, have our service representative repair them. • Over long distances (e.g. removal, return for repair, etc.), the foot control panel must always be transported in the original packaging or in special return packaging. For details, please contact your dealer or the Carl Zeiss service team. • Use the foot control panel only for the application described. Page 9 Safety measures Notes on EMC (Electromagnetic Compatibility) FCP & FCP WL Foot Control Panel • Operate the foot control panel only with the components included in the delivery package. If you wish to use other components, make sure that Carl Zeiss or the manufacturer of the components has verified and confirmed that these components meet the respective safety standards and can be used without risk. • If a failure occurs which you cannot correct with the aid of the chapter "What to do in the event of malfunctions“, attach a sign to the foot control panel stating it is out of order and contact our service representative. • The foot control panel must not be modified without the manufacturer's approval. • The foot control panel is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having it checked on a regular basis by our service representative or trained specialist staff. The foot control panel complies with the EMC requirements of IEC 60601-1-2. For operating the foot control panel, observe the EMC precautions specified below. • Only use options approved by Carl Zeiss for this foot control panel. • Do not use any portable or mobile RF communication equipment in the vicinity of the foot control panel as this may lead to an impairment of the foot control panel's function. • The foot control panel meets the RFI requirements of Class B. It cannot be ruled out, however, that interferences may occur in RF receivers (e.g. TV or radio sets) in the vicinity. If such interferences are noticed, please inform the Carl Zeiss Service Dept. Information on exposure to radio frequency radiation in accordance with FCC The emitted output power of the component is far below the FCC limit values for radio frequency exposure. Nevertheless, the component should be used in such a way that potential contact with persons during normal operation is kept to a minimum. NOTE Class This Class B digital component complies with Canadian standard ICES-003. Page 10 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel NOTE Notes for the operator Limit values and what to do in the event of interference with digital equipment This component has been tested and found to comply with the limits for a Class B digital device in accordance with Part 15 of FCC regulations. These limits have been stipulated to provide adequate protection against harmful exposure when the component is operated in residential areas. This component generates and uses radio frequency energy and may emit such energy. If not installed and used in accordance with the relevant instructions, it may cause interference to radio communication. However, there is no guarantee that interference will not occur in a particular installation. If this component causes interference with radio and TV reception, which can be determined by turning the component off and on, the user should try to correct the interference by one or several of the following measures: NOTE – Relocate or reorient the receiving antenna. – Move the component further away from the receiver. – Plug the component into a different outlet so that it is not on the same circuit as the receiver. – Consult an experienced radio/TV technician. Part 15 of FCC regulations This component complies with Part 15 of FCC regulations [and with the Industry Canada RSS-210 standard]. Operation of the component is subject to the following two conditions: NOTE – the component must not cause any harmful interference and – the component must accept any interference received, including interference that may cause undesired operation. Modification or conversion Any modification or conversion not explicitly approved by Carl Zeiss will invalidate the FCC license for the operation of this component. Version 1.1 G-30-1706-en Page 11 Safety measures FCP & FCP WL Foot Control Panel Requirements to be met by the user Page 12 • The foot control panel must only be used by staff who have undergone appropriate training and instruction. It is the duty of the customer or institution operating the component to provide training and instruction for the relevant staff. • Please keep the user manual where it is easily accessible at all times for the persons operating the system. • Modifications and repairs of the foot control panel or any components operated together with the foot control panel may only be performed by our service representative or by other authorized persons. Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Notes for the operator Warranty and liability Warranty and liability depend on the applicable contractual stipulations. NOTE Loss of warranty The manufacturer is not liable for any damage caused by unauthorized persons tampering with the foot control panel. Furthermore, this will forfeit any rights to claim under warranty. Version 1.1 G-30-1706-en Page 13 Safety measures FCP & FCP WL Foot Control Panel Requirements for operation Our service representative or an expert authorized by us will install the foot control panel. Please ensure that the following requirements are met for further operation: 9 The connecting components have been properly connected. The screw connections have been firmly tightened. 9 All cables and plugs are in perfect condition. Before every use • Make sure that all ”Requirements for operation” are fulfilled. • Go through the checklist. • Reattach any covers or caps that were removed from the foot control panel. Close any existing openings with the corresponding caps. • Constantly monitor the foot control panel during use. During use Page 14 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Requirements for operation After every use • Put the foot control panel in its rest position by attaching its bracket e.g. to floor stand (1). Æ The foot control panel is shut down in the rest position to save energy. The energy-saving rest position extends the service life of the batteries in the cordless version of the foot control panel. Version 1.1 G-30-1706-en Page 15 Safety measures FCP & FCP WL Foot Control Panel Warning labels and notes CAUTION Note the warning labels and notes! • 1A If you notice that any label on your foot control panel is missing or has become illegible, please contact us or one of our authorized representatives. We will supply a replacement. 1 Type label A - Label for the corded version of the foot control panel B - Label for the cordless version of the foot control panel IPX8 1B IPX8 – Manufacturer (company name) – Serial number (SN) – Product name – Order number (REF) – IP classification (degree of protection against the harmful ingress of water and solid particles) 2 "Observe the user manual" label Observe the user manual or further applicable documents. 3 "Observe disposal regulations" label Electrical or electronic devices must not be disposed of as normal domestic waste. For more information on the disposal of electrical and electronic devices, please see the chapter "Maintenance and care". 4 "Year of manufacture" label This label indicates the year of manufacturer of the system. 5 Radio equipment approval identification (for FCP WL only) Page 16 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Warning labels and notes 6 Ready for use status indicator 7 Cable connection status indicator 8 Radio link status indicator 9 Battery status indicator 1A IPX8 1B IPX8 Version 1.1 G-30-1706-en Page 17 Safety measures Page 18 FCP & FCP WL Foot Control Panel Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Design and function Versions of the foot control panel ................................................... 21 Components of the foot control panel............................................. 22 Standard assignment in the longitudinal configuration ................... 26 Standard assignment in the transverse configuration...................... 28 Version 1.1 G-30-1706-en Page 19 Design and function Page 20 FCP & FCP WL Foot Control Panel Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Versions of the foot control panel Versions of the foot control panel 1 Cordless foot control panel with 14 functions 2 Corded foot control panel with 14 functions Version 1.1 G-30-1706-en Page 21 Design and function FCP & FCP WL Foot Control Panel Components of the foot control panel 1 Connecting cable Connects the foot control panel to the appropriate connector on a suspension system or wall-mounted control panel. 2 Bracket Allows you to hang up the foot control panel on the floor stand or on the wall when not in use. 3 Controls Buttons operated with your foot. 4 Indicator The adjustable indicator is required for the cordless version. It indicates the assignment to a surgical microscope after pairing. 5 Joystick Permits you to control e.g. an X-Y coupling or the motorized lateral and front-to-back tilt of the surgical microscope. 6 Rocker switch The two rocker switches are used to operate the ”Zoom” and ”Focus” functions. For this, each of the rocker switches contains two switching elements, allowing you to control the functions by toe and heel movement without the need to shift your foot. You can optionally assign the ”Zoom” and ”Focus” functions to the switching elements of the rocker switches. Switchover is performed automatically on the suspension system. A Longitudinal configuration: The left switching elements of the rocker switches are used to operate the ”Zoom” function. The right switching elements of the rocker switches are used to operate the ”Focus” function. For more information, please see page 26. B Transverse configuration: The switching elements of the front rocker switch are used to operate the ”Focus” function. The switching elements of the back rocker switch are used to operate the ”Zoom” function. For more information, please see page 28. 7 Foot rest The bridge between the two rocker switches (6) serves as a support to rest your foot on. 8 Status indicators Indicate different statuses by shining/not shining. Page 22 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Components of the foot control panel Focus Zoom Focus Zoom Version 1.1 G-30-1706-en Page 23 Design and function FCP & FCP WL Foot Control Panel Functions of the status indicators – During cordless operation, you have to activate the "ready for use", "radio link" and "battery" status indicators by simultaneously pressing a button each on the left and right side of the foot control panel. The status indicators are only active while the buttons are pressed. – During corded operation via the connecting cable, the "ready for use" and "cable connection" status indicators are permanently lit. 1 Ready for use status indicator – Shining green: the foot control panel is ready for use, no error is present. – Shining amber: the foot control panel detects a temporary error and eliminates is automatically. – Shining red: the foot control panel is not ready for use, an error is present. 2 Cable connection status indicator – Shining green: the connecting cable has been plugged in, power supply is present. – Not shining: the foot control panel operates in the cordless mode. 3 Radio link status indicator – Shining green: very good radio link. – Shining amber: reduced radio link, e.g. due to slight interference, shielding or too large a distance between the suspension system and foot control panel. – Shining red: no radio link, e.g. due to non-existent pairing with the suspension system, see page 34, shielding or too large a distance between the suspension system and foot control panel. – Flashing amber: while pairing with the suspension system is in progress. 4 Battery status indicator – Shining green: batteries are OK. – Shining amber: batteries will not last much longer. • – Page 24 Obtain replacement batteries and keep them ready at hand. Shining red: batteries are depleted and need to be replaced immediately. Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Components of the foot control panel Meaning of the acoustic signals Signal Cause Remedy beep Confirms a function -- beep-beep Warning • Put the foot control panel in its rest position (vertical position), see page 38. • Check the status indicators, see page 24. beep-beep-beep Problem Version 1.1 G-30-1706-en see "Troubleshooting" Page 25 Design and function FCP & FCP WL Foot Control Panel Standard assignment in the longitudinal configuration The longitudinal configuration refers to the focus and zoom functions. Joystick The joystick permits control in the following four directions: 1 front, 2 back, 3 left, 4 right. 5 Switch Function depending on surgical microscope used 6 Switch Function depending on surgical microscope used 7 Focus down Focusing on a lower plane, the working distance is increased 8 Focus up Focusing on a higher plane, the working distance is reduced 9 Switch Function depending on surgical microscope used 10 Switch Function depending on surgical microscope used 11 Zoom in Increasing magnification, the field of view is reduced 12 Zoom out Reducing magnification, the field of view is increased 13 Switch Function depending on surgical microscope used 14 Switch Function depending on surgical microscope used Page 26 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Standard assignment in the longitudinal configuration Version 1.1 G-30-1706-en 14 13 12 11 10 Page 27 Design and function FCP & FCP WL Foot Control Panel Standard assignment in the transverse configuration The transverse configuration refers to the focus and zoom functions. Joystick The joystick permits control in the following four directions: 1 front, 2 back, 3 left, 4 right. 5 Switch, Function depending on surgical microscope used 6 Switch Function depending on surgical microscope used 7 Focus down Focusing on a lower plane, the working distance is increased 8 Focus up Focusing on a higher plane, the working distance is reduced 9 Switch Function depending on surgical microscope used 10 Zoom out Reducing magnification, the field of view is increased 11 Zoom in Increasing magnification, the field of view is reduced 12 Switch Function depending on surgical microscope used 13 Switch Function depending on surgical microscope used 14 Switch Function depending on surgical microscope used Page 28 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Standard assignment in the transverse configuration 14 13 12 11 Version 1.1 G-30-1706-en 10 Page 29 Design and function Page 30 FCP & FCP WL Foot Control Panel Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Preparations for use Inserting the batteries for cordless operation.................................. 32 Pairing with the suspension system................................................. 34 Connecting the connection cable..................................................... 36 Exchanging the joystick head .......................................................... 37 Bringing the foot control panel into its working position................ 38 Adapter plate on the operating chair .............................................. 39 Version 1.1 G-30-1706-en Page 31 Preparations for use FCP & FCP WL Foot Control Panel Inserting the batteries for cordless operation NOTE Page 32 The wrong type of batteries may damage the foot control panel or impair its function. • Only use C type 1.5 V alkaline-manganese batteries, also see the chapter "Technical data". • Do not use any rechargeable batteries. The operating duration with rechargeable batteries has not been defined. • Turn the two locks (1) on the battery compartment from the 12 o'clock position to the 3 o'clock position. • Open the cover of the battery compartment (2). • Insert three C type batteries in the battery compartment, ensuring that the polarity is correct. The polarity is shown at the bottom of the battery compartment (3). • Close the cover of the battery compartment (2). • Turn the two locks (1) on the battery compartment from the 3 o'clock position back to the 12 o'clock position. Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Inserting the batteries for cordless operation Version 1.1 G-30-1706-en Page 33 Preparations for use FCP & FCP WL Foot Control Panel Pairing with the suspension system NOTE The foot control panel may be disabled. • If pairing is performed incorrectly or not at all, the foot control panel may be disabled, or activation of a control may trigger functions on a different suspension system not assigned to the foot control panel. Pairing means the fixed relative assignment of the suspension system and foot control panel. Pairing must be performed for cordless operation. • Put the foot control panel in a vertical position (1) in the immediate vicinity of the suspension system. • Start the pairing process on the suspension system, see user manual for the suspension system. Æ "Radio link" status indicator (2) flashes amber. • Press one of the buttons (3) on the foot control panel for about 5 seconds. Æ "Radio link" status indicator (2) on the foot control panel starts flashing. • Release button (3) on the foot control panel. Æ "Radio link" status indicator (2) continues flashing for a few seconds. Successful pairing Æ A beep indicates that pairing has been successfully completed. Æ The "radio link" status indicator (2) shines green for about 1 second. You can also check whether pairing was successful by simultaneously pressing two buttons on the foot control panel. "Radio link" status indicator (2) will be lit. Pairing failed Æ Three beeps indicate that pairing has not been successfully completed. Æ "Radio link" status indicator (2) shines red for about 1 second. • Page 34 Repeat the pairing process as described above. Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel CAUTION Pairing with the suspension system Risk of confusion when using multiple foot control panels • The use of several foot control panels may lead to confusion and, as a result, to malfunction. • After pairing, mark the associated suspension system with a number (stickers provided in the delivery package) and set indicator (4) on the foot control panel to the number assigned to the suspension system. • Make sure that the assigned identification is unique in the entire surgery area. • Check the function of the foot control panel on the basis of the checklist on page 42. 3 4 Version 1.1 G-30-1706-en Page 35 Preparations for use FCP & FCP WL Foot Control Panel Connecting the connection cable CAUTION Tripping hazard caused by loops of the connecting cable • Check the routing of the connecting cable. • Remove any loops and route the connecting cable so as to avoid any tripping hazards. The connecting cable is required for corded operation of the foot control panel. Only use – cable 304970-8730-000 with a 3 m length or – cable 304970-8760-000 with a 6 m length • Insert 6-pin connector (1) in socket (3) on the foot control panel. • Insert 4-pin connector (2) in socket (4) on the suspension system. Page 36 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Exchanging the joystick head Exchanging the joystick head The delivery package of the foot control panel includes an extension for the joystick and a joystick knob. You can use these items to suit your personal work style. • Remove joystick extension (1) by pulling it upward. • Push joystick knob (2) into position as far as it will go. Version 1.1 G-30-1706-en Page 37 Preparations for use FCP & FCP WL Foot Control Panel Bringing the foot control panel into its working position • Bring the foot control panel into its working position (1). – Working position: 0° ... 10° – Rest position: 45 ° ... 90° In its rest position (2), the foot control panel is completely disabled. It shuts down to save energy. The energy-saving rest position extends the service life of the batteries in the cordless FCP version. 90° 45° 10° 0° Page 38 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Adapter plate on the operating chair Adapter plate on the operating chair To permit improved ergonomic use, Carl Zeiss offers an adapter plate for the operating chair. The installation will be performed by Zeiss service staff. 1 Operating chair 304731-9901-000 2 Adapter plate 000000-1117-104 Version 1.1 G-30-1706-en Page 39 Preparations for use Page 40 FCP & FCP WL Foot Control Panel Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Operation Checklist for cordless foot control panel ......................................... 42 Checklist for corded foot control panel ........................................... 43 Version 1.1 G-30-1706-en Page 41 Operation FCP & FCP WL Foot Control Panel Checklist for cordless foot control panel • CAUTION Always check the function of the foot control panel before surgery (without patient!) using the following checklist: Failure of functions! If a function fails, do not use the foot control panel for safety reasons! • CAUTION If possible, correct the malfunction (see "What to do in the event of malfunctions“) or contact the Zeiss service department. Unintended operation of the foot control panel! A vertically adjustable operating table may accidentally activate buttons on the foot control panel. • NOTE Therefore, make sure during installation and use that any unintended activation of controls is not possible. Use of drapes The use of a drape on the foot control panel reduces its friction on the floor, thus impairing slip resistance. Prerequisites 9 The foot control panel is in its working position. 9 The batteries have been inserted with correct polarity. 9 The suspension system has been powered on. 9 The foot control panel has been paired with the suspension system. 9 The number in the indicator of the foot control panel is identical to that on the suspension system. 9 The freely programmable buttons have been configured. • Check all functions of the foot control panel. Æ The suspension system and the surgical microscope must perform the defined functions. Page 42 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Checklist for corded foot control panel Checklist for corded foot control panel • CAUTION Always check the function of the foot control panel before surgery (without patient!) using the following checklist: Failure of functions! If a function fails, do not use the foot control panel for safety reasons! • CAUTION If possible, correct the malfunction (see "What to do in the event of malfunctions“) or contact the Zeiss service department. Unintended operation of the foot control panel! A vertically adjustable operating table may accidentally activate buttons on the foot control panel. • NOTE Therefore, make sure during installation and use that any unintended activation of controls is not possible. Use of drapes The use of a drape on the foot control panel reduces its friction on the floor, thus impairing slip resistance. Prerequisites 9 The suspension system has been powered on. 9 The connecting cable is undamaged and ready for operation. 9 The connecting cable has been connected to the suspension system. 9 The freely programmable buttons have been configured. • Check all functions of the foot control panel. Æ The suspension system and the surgical microscope must perform the defined functions. Version 1.1 G-30-1706-en Page 43 Operation Page 44 FCP & FCP WL Foot Control Panel Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel What to do in the event of malfunctions What to do in an emergency ........................................................... 46 Failure of the cordless foot control panel ...................................................46 Troubleshooting in the cordless foot control panel ......................... 47 For your safety ..........................................................................................47 Malfunction of the foot control panel........................................................47 Troubleshooting in the corded foot control panel ........................... 49 For your safety ..........................................................................................49 Malfunction of the foot control panel........................................................49 Version 1.1 G-30-1706-en Page 45 What to do in the event of malfunctions FCP & FCP WL Foot Control Panel What to do in an emergency Failure of the cordless foot control panel The suspension system or the surgical microscope does not respond to the activation of any of the controls on the foot control panel. • Insert 6-pin connector (1) of the connecting cable in socket (3) on the foot control panel. • Insert 4-pin connector (2) of the connecting cable in socket (4) on the suspension system. Æ The foot control panel now operates in the corded mode. Page 46 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Troubleshooting in the cordless foot control panel Troubleshooting in the cordless foot control panel For your safety This device is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having it checked by our service representative as part of regular scheduled maintenance. • If a failure occurs which you cannot correct with the aid of the chapter "What to do in the event of malfunctions“, attach a sign to the device stating it is out of order and contact our service representative. Malfunction of the foot control panel The status indicators and acoustic signals help you diagnose malfunctions, see page 24 f. Problem Possible cause Remedy See Replace batteries page 32 Use of rechargeable batteries Replace batteries page 32 Temporary failure of function Batteries are depleted Failure of individual button functions Version 1.1 G-30-1706-en Reconfigure button function - -only possible if functions can be configured on suspension system Contact service dept. -- Failure / malfunction of radio link in cordless foot control panel Connect cable page 36 Position switch always detects rest position Connect cable page 36 Interference in radio link Connect cable page 36 Weak radio signal Connect cable page 36 No pairing with suspension system Perform pairing with suspension system page 34 Page 47 What to do in the event of malfunctions FCP & FCP WL Foot Control Panel Problem Possible cause Remedy See Unintended activation of function Button got jammed after acti- Put foot control panel in its vation rest position page 15 Reconfigure button function - -only possible if functions can be configured on suspension system -Contact service dept. Foot control panel sends incorrect activation signal Put foot control panel in its rest position page 15 Reconfigure button function - -only possible if functions can be configured on suspension system Wrong foot control panel Check whether the identifica- -tions on the suspension system and in the indicator of the foot control panel are identical. Perform pairing with the sus- page 34 pension system Page 48 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Troubleshooting in the corded foot control panel Troubleshooting in the corded foot control panel For your safety This device is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having it checked by our service representative as part of regular scheduled maintenance. • If a failure occurs which you cannot correct with the aid of the chapter "What to do in the event of malfunctions“, attach a sign to the device stating it is out of order and contact our service representative. Malfunction of the foot control panel The status indicators and acoustic signals help you diagnose malfunctions, see page 24 f. Problem Possible cause Remedy See Foot control panel is inopera- Connecting cable not contive nected to suspension system Connect the connecting cable page 36 Temporary failure of function Failure of individual button functions Reconfigure button function - -only possible if functions can be configured on suspension system Contact service dept. Version 1.1 G-30-1706-en -- Page 49 What to do in the event of malfunctions FCP & FCP WL Foot Control Panel Problem Possible cause Remedy See Unintended activation of function Button got jammed after acti- Disconnect cable from susvation pension system. page 15 Reconfigure button function - page 36 only possible if functions can be configured on suspension system Foot control panel sends incorrect activation signal Contact service dept. -- Disconnect cable from suspension system. page 36 Reconfigure button function - -only possible if functions can be configured on suspension system Page 50 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Care and maintenance Care of the device............................................................................ 52 Cleaning ....................................................................................................52 Disinfection ...............................................................................................52 Environmental protection measures ................................................ 53 Note on disposal .......................................................................................53 Version 1.1 G-30-1706-en Page 51 Care and maintenance FCP & FCP WL Foot Control Panel Care of the device Cleaning Contamination of the foot control panel – If possible, clean the foot control panel and its components directly after use. – Contaminations should not be allowed to dry on the objects, as this would make cleaning and disinfecting more difficult. Cleaning mechanical surfaces All mechanical surfaces of the foot control panel and its components can be cleaned by wiping them with a damp cloth. Do not use any aggressive or abrasive cleaning agents. Clean off any residue using a mixture of 50% ethyl alcohol and 50% distilled water plus a dash of household dish-washing liquid. Disinfection CAUTION Observe the manufacturer's instructions for use! • Use MELISEPTOL in accordance with the manufacturer's specifications and observe the instructions for use provided with the product. • Wear disposable plastic gloves to prevent skin contact with the disinfectant. It may be necessary to disinfect the foot control panel to permit its use in the OR, for example. We recommend using MELISEPTOL disinfectant from B. Braun, Melsungen AG. MELISEPTOL is available from Carl Zeiss, and you can also obtain it locally in many countries from representatives of B. Braun, Melsungen AG. Page 52 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Environmental protection measures Environmental protection measures Note on disposal User information on the disposal of electrical and electronic devices This symbol means that the product must not be disposed of as normal domestic waste. The correct disposal of electrical or electronic devices helps to protect the environment and to prevent potential hazards to the environment and/or human health which may occur as a result of improper handling of the devices concerned. For detailed information on the disposal of the product, please contact your local dealer or the device manufacturer or its legal successor. Please also note the manufacturer's current information on the Internet. In the event of resale of the product or its components, the seller is required to inform the buyer that the product must be disposed of in accordance with the applicable national regulations currently in force. For customers in the European Union Please contact your dealer or supplier if you wish to dispose of electrical or electronic devices. Information on disposal in countries outside the European Union This symbol is only applicable in the European Union. For the disposal of electrical and electronic devices, please observe the relevant national legislation and other regulations applicable in your country. Version 1.1 G-30-1706-en Page 53 Care and maintenance FCP & FCP WL Foot Control Panel Disposal of batteries WARNING Risk of explosion! • Never throw batteries into a fire. Please observe the local directives relating to the disposal of batteries, or contact your local sales organization for further information. The batteries must no be disposed of as normal domestic waste. Use an appropriate facility for the disposal of batteries. Page 54 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel System data Technical data ................................................................................. 56 Mechanical data ........................................................................................56 Electrical data ............................................................................................56 Ordering data .................................................................................. 58 Approval verification ....................................................................... 59 Ambient conditions ......................................................................... 60 Version 1.1 G-30-1706-en Page 55 System data FCP & FCP WL Foot Control Panel Technical data Mechanical data Component Feature Dimensions L x W x H approx. 410 x 243 x 128 mm Weight approx. 2.4 kg Electrical data Electrical data, cordless operation Component Feature Power supply 3 x C type 1.5 V alkaline-manganese batteries Current consumption Max. 100 mA Service life of batteries Approx. 2 to 6 months - depending on the operating duration of the foot control panel Electrical standard Complying with IEC 60601-1; UL 60601-1; Degree of protection IPX8 Cable connection Remote socket for connecting cable The device has been designed for continuous operation. Page 56 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Technical data Electrical data, corded operation Component Feature Power supply 15 VDC ± 10 % via the suspension system Current consumption Max. 200 mA Electrical standard Complying with IEC 60601-1; UL 60601-1; Degree of protection IPX8 Cable connection Remote socket for connecting cable The device has been designed for continuous operation. Version 1.1 G-30-1706-en Page 57 System data FCP & FCP WL Foot Control Panel Ordering data Foot control panel with 14 functions - cordless and corded Description Cat. No. Foot control panel with 14 functions, corded 304970-9100-000 Foot control panel with 14 functions, cordless 304970-9200-000 Joystick knob 304970-8807-000 Joystick extension 304970-8808-000 C type 1.5 V alkaline-manganese battery 000000-0035-244 3 batteries required Connecting cable, 3 m 304970-8730-000 Connecting cable, 6 m 304970-8760-000 Adapter plate for operating chair 000000-1117-104 Disinfection - Meliseptol Description Cat. No. 1 l MELISEPTOL in vario bottle 000000-0103-907 MELISEPTOL HBV spray, 250 ml 000000-0103-910 MELISEPTOL HBV cloths 000000-0103-911 Disposable gloves Page 58 Description Cat. No. Size 1 (large) size 8-9 000000-0117-736 Size 2 (medium) size 7-8 000000-0117-737 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Approval verification Approval verification Description Identification ARIB The foot control panel meets the requirements of ARIB (Association of Radio Industries and Businesses, Japan) EMC requirements The foot control panel meets the EMC requirements in accordance with IEC 60601-1-2. The foot control panel meets the RFI requirements of Class B. FCC The foot control panel meets the requirements of Part 15 of FCC (Federal Communications Commission, USA) Radio equipment The foot control panel meets the requirements of EC Directive 1999/5/EC The system is marked with Medical device Version 1.1 G-30-1706-en The system meets the essential requirements stipulated in Annex I to Directive 93/42/EEC governing medical devices. Page 59 System data FCP & FCP WL Foot Control Panel Ambient conditions For operation Feature Admissible range Temperature + 10 °C ... + 40 °C Relative humidity 30 % ... 75 % Air pressure 700 hPa ... 1060 hPa For transportation and storage Page 60 Feature Admissible range Temperature - 40 °C ... + 70 °C Rel. humidity (without condensation) 10 % ... 90 % Air pressure 500 hPa ... 1060 hPa Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Index Index Acoustic signal .........................................................................................25 Approval verification .................................................................................59 Batteries, depleted .................................................................................... 47 Batteries, disposal .....................................................................................54 Batteries, inserting .................................................................................... 32 Battery compartment ................................................................................32 Battery type ..............................................................................................32 Bracket .....................................................................................................22 Checklist for corded foot control panel .....................................................43 Checklist for cordless foot control panel ...................................................42 Cleaning ...................................................................................................52 Connecting cable ......................................................................................22 Connecting cable, not connected .............................................................49 Controls ...................................................................................................22 Current consumption ................................................................................56 Electrical standard .................................................................................... 56 Electromagnetic compatibility ...................................................................10 Electromagnetic interference .................................................................... 10 EMC requirements of IEC 60601-1-2 ........................................................10 Failure of a function ...........................................................................42, 43 Failure of the cordless foot control panel ..................................................46 Foot rest ...................................................................................................22 Indicator .............................................................................................22, 35 Intended use ..............................................................................................8 Version 1.1 G-30-1706-en Seite 61 Index FCP & FCP WL Foot Control Panel Joystick ...............................................................................................22, 37 Labels on the foot control panel ...............................................................16 Limit class .................................................................................................10 Longitudinal configuration ..................................................................22, 26 Malfunction when using multiple foot control panels ................................35 Normal use .................................................................................................8 Notes on EMC ..........................................................................................10 Pairing ......................................................................................................34 Power supply ............................................................................................56 Problem ..............................................................................................47, 49 Radio frequency radiation in acc. with FCC ...............................................10 Radio link ..................................................................................................47 Radio signal ..............................................................................................47 Rest position .......................................................................................15, 38 Rocker switch ...........................................................................................22 Safety .........................................................................................................7 Safety standards .........................................................................................7 Service life of batteries ..............................................................................56 Status indicators .................................................................................22, 24 Target group ...............................................................................................8 Technical data ..........................................................................................56 Transverse configuration .....................................................................22, 28 Troubleshooting in the corded foot control panel .....................................49 Troubleshooting in the cordless foot control panel ...................................47 Seite 62 Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel Index Use of multiple foot control panels ...........................................................35 Working position ................................................................................38, 42 Version 1.1 G-30-1706-en Seite 63 Index Seite 64 FCP & FCP WL Foot Control Panel Version 1.1 G-30-1706-en FCP & FCP WLFoot Control Panel (Blank page, for your notes . . .) Version 1.1 G-30-1706-en Page 65 Carl Zeiss Surgical GmbH A Carl Zeiss Meditec Company 73446 Oberkochen Germany Fax.: + 49 (0)7364 - 20 4823 Email: surgical@meditec.zeiss.com Internet: www.meditec.zeiss.com
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