Return to site. Stockert S5 Manual. The letter informed users of the potential for shaft encoder failures and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to repair the units onsite.
Customers and distributors were also provided with a Response form to confirm they had received, read and understood the Field Notice. They were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For questions call or The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.
Learn more about medical device recalls. Redgear Gamepad Drivers For Mac. Return to site Powered by Strikingly. With the temperature controlled ablation method, it is not necessary to set the initial RF power level manually. Note: Because the ablation electrode measures only the temperature of the electrode with its integrated temperature sensor and not the actual tissue temperature deep inside the myocardium, tissue overheating can still occur. Therefore, temperature measurement is suitable only for limiting overheating.
However, in some physical circumstances, temperature measurement may not prevent overheating. The temperature indicator is a guide, not an absolute measurement. When standard catheters that are not irrigated are used, the deviation in temperature is proportional to the electrode size due to passive cooling by blood flow. The larger the ablation electrode, the larger the temperature difference. Regardless of the electrode used, the actual tissue temperature is the same as or higher than the indicated temperature.
When an actively cooled ablation electrode is used for example, an irrigated electrode cooled with saline solution , the electrode no longer provides a basis for accurate tissue temperature. In this case, the temperature measurement is an indicator of the irrigation function and is completely dissociated from the tissue temperature.
The current then passes through the biological tissue and is passed back to the generator through a second electrode indifferent electrode. In order for the tissue heating to occur at only the interface between the ablation electrode and the tissue, the second electrode must have a considerably larger surface area than the ablation electrode. This arrangement is known as a unipolar application.
Because the current density is highest at the smaller ablation electrode, most of the RF energy is converted into heat in the area of this electrode. The second, considerably larger RF electrode, is preferably a skin-adhesive electrode. This second electrode is known as an indifferent electrode or a neutral electrode. For safety reasons, care must be taken to ensure that the area of the indifferent electrode is considerably larger than the area of the ablation electrode. If the ratio between the electrodes is too small, severe skin burns can occur at the site of the indifferent electrode.
With this type of application, the information provided by the manufacturer of the indifferent electrode and the information in Chapter 3, Warnings and Precautions, must be heeded. To differentiate between the various types of tissue so that the ablation electrode can be positioned correctly. To confirm that a lesion is being formed during RF current application. During the increase in tissue temperature, the tissue impedance first falls to a minimum value and remains at this level for some time.
Then the impedance rises based on the supplied power see Figure 4. Impedance should be monitored during ablation. A rapid increase in impedance is an indicator that there is a problem and ablation should be stopped. One possible cause for the rapid increase is char formation; another possible cause is that the electrode has become buried in the tissue. Read and follow the instructions for use that are provided in this user manual before using the system in a clinical application.
Also refer to instructions for use that are supplied with the accessories and with the compatible therapeutic catheters. Note especially the instructions in Section 4. Cardiac ablation procedures should be performed only by physicians who have been thoroughly trained in RF catheter ablation techniques. In catheter ablation procedures, fluoroscopy is commonly used. When using fluoroscopy, there is the risk of exposure to considerable radiation.
The intensity of the X-rays and the duration of the radiation can lead to acute radiation damage or to an increased risk of a physical or genetic defects for both patients and medical personnel. Therefore, perform catheter ablations only after carefully considering the potential radiation dose. The advantages and disadvantages of X-ray exposure should be considered carefully before catheter ablation is performed in pregnant women.
Also, the long-term risk of prolonged X-ray imaging has not been researched. Therefore, the advantages and disadvantages should be considered carefully before this procedure is performed in prepubertal children. Consider using a navigation system without fluoroscopy to reduce exposure to X-rays. Doing so might induce ventricular fibrillation. When the generator has been turned off, power continues to be supplied to the generator through the mains cable. To completely cut off power to the generator, disconnect the mains cable from the generator.
To allow easy disconnection in the event of severe power failure, make sure that the generator is located where there is easy access to the mains cable on the back of the generator. After turning on the generator, always wait until the automatic self test has been successfully completed before starting the first steps of the procedure on the patient for example, before anesthesia or before creating percutaneous access.
Also perform a visual inspection of the accessories see Section 5. Use only catheters that have been approved for use with the maximum voltage specified in this user manual see Section 8. The use of other accessories can have a negative effect on the technical specifications. Do not modify accessories. Visually inspect all accessories on a regular basis. Make sure that the connected cables are not damaged. When using sterile accessories, be sure to maintain the sterility of those accessories.
If the generator is placed on a mounting plate, make sure it is securely fastened. Do not place the generator directly above another device and do not place any other device directly on the generator. Make sure that there is enough free space on all sides of the generator to allow the heat created by the generator to escape.
The skin surface must be free of excessive oil and body hair. See Section 3. The generator is equipped with a contact quality monitoring feature for split indifferent electrodes. If the contact quality falls below a defined value, the generator displays an alert message. However, if two split indifferent electrodes are used at the same time and one loses contact quality but the other maintains contact quality, no alert is triggered. The patient must not be in contact with grounded metal components or with metal components that have a large grounded area for example, the operating table supports.
For this purpose, the use of sufficiently insulating antistatic covers on the operating table is recommended. Electrostatic discharge ESD can give rise to extremely high current densities at the catheter tip, which can injure the patient.
Such contact can be avoided by using dry gauze, for example. Needle electrodes are not recommended for monitoring purposes. In all cases, it is appropriate to use monitoring electrodes and other monitoring devices that limit the RF current. Position the connection cables of the ablation electrodes in such a way that they do not touch either the patient or other cables.
Keep active electrodes that are temporarily not in use at a safe distance from the patient. Set the RF power at only moderate output to avoid charring and clotting at the catheter ablation electrode. The approximate flow rate can be estimated by observing the drip speed in the drip chamber. The hospital staff is responsible for determining and monitoring the flow rate to avoid insufficient flow of the irrigation solution. The hospital staff is responsible for monitoring the total amount of solution delivered to the patient to avoid an excessive loading of the irrigation solution in the patient.
Avoid using flammable anesthetics or oxidizing gases such as nitrous oxide N2O and oxygen O2 if the procedure is being performed in the region of the thorax or head, unless the gases are being aspirated off or an anesthesia-safe device is being used. Before starting RF ablation, allow time for flammable substances that are used as cleaning agents, disinfectants, or solvents to evaporate. Wipe away the liquid in these places away before the generator is turned on. Beware of flammable endogenous gases.
Materials such as cotton and gauze, when saturated with oxygen, can be ignited by sparks that arise even during normal use of the generator.
The foot pedal is suitable for use in operating rooms. Be aware during ablation procedures that in patients with cardiac pacemakers or pacemaker leads, there is a risk of interference with the pacemaker function or damage to the pacemaker. In case of doubt, consult the manufacturer of the device.
The electromagnetic radiation emitted by the generator can interfere with the function of other electrical devices. Conversely, other electrical devices can influence the function of the generator if they are operated at the same time in the immediate vicinity of the generator.
The plugs on the catheter and the catheter connection cable must not be brought into contact with parts that have high voltage such as mains outlets or metallic objects. To avoid damage to the connection cables, do not wrap the cables around the generator or other apparatus.
Coiling the connection cables during normal operation of the generator creates inductive components, which can lead to measurement errors. The values indicated in error can lead to misinterpretations. Special safety measures with regard to electromagnetic compatibility EMC must be taken with electrical medical devices.
This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with this user manual, may cause harmful interference to radio communications. Similarly, portable and mobile communication devices may cause harmful interference to the functioning of the generator. If error messages repeatedly appear, stop using the generator and contact Customer Support.
To avoid damage to the generator and its accessories, use only appropriate cleaning agents see Sections 4.
To avoid the risk of electric shock, connect the mains cable from the generator mains socket see Item 6 in Section 4. The generator may be opened only by persons authorized by the manufacturer. When the generator is open, parts that have high voltage or are very hot are accessible and can cause injury. If the generator is opened by an unauthorized person, any claims on the warranty are void. No modification of the generator is permitted.
If fluid penetrates into the generator, stop using the generator and contact Customer Support. In the unlikely event that there is a fatal system error the system will stop and the Alarm indicator will flash red , immediately disconnect the mains cable from the generator.
Electrodes and probes for monitoring and stimulation devices can be electrical conductors of RF current. Reduce the risk of burns by placing the electrodes and probes as far away as possible from the site of ablation and from the indifferent electrode. To avoid possible injury to patients and medical personnel, do not start RF power application before the catheter is positioned in the intended ablation area.
To minimize electrical noise on the ECG recordings, position catheter connection cables so that they do not touch either the patient or other cables. For an optimal ECG trace, keep unused active surface electrodes at a distance from the patient.
To prevent fluid from impairing system performance, ensure that sterile catheters and cable plugs are completely dry. To prevent a system malfunction, inspect all reusable accessories regularly.
Do not use damaged cables. Ablation data stored electronically must not be used for diagnosis or therapy. The intended use is for archiving or research only. The generator connections for the ECG signals and for the stimulator are galvanically connected with the ablation catheter.
Only cables and plugs approved for a CF type of device CF safety classification may be used see Section 5. All system components must comply with all applicable requirements and standards and be labeled pursuant to these standards. If there are any concerns regarding the use of a component, contact the distributor of the component to obtain further information.
Heating of these electrodes gives rise to a shift in direct current voltage which, in turn, leads to a displacement of the baseline. In this case, check the whole system combination to avoid uncontrolled current leakage. It may also be the case, however, that the electrocardiograph is unsuitable for this use or that the body surface ECG electrodes have too high a contact impedance.
Make sure that the ECG device is appropriate for this application. Skin burns at the body surface ECG electrodes can be a sign of uncontrolled current leakage. There are many electrocardiographs to which a stimulator can be directly connected. The stimulator must be galvanically isolated or physically disconnected before the RF current is turned on. The reason for this is the parallel connection between the output of the generator and the stimulator.
The transfer of RF energy into the electrodes connected to the stimulator can also cause injury to the patient. Only classified electrical medical devices may be connected to the generator. Warnings and Precautions: During an Ablation Procedure 1. Blood vessel perforation is a risk inherent in the placement of an electrophysiology catheter. The catheter needs to be moved carefully to avoid damage or perforation of blood vessels. When performing ablation of the posterior wall of the left atrium, beware of the risk of forming a lesion in the esophagus.
Avoid high ablation temperatures. Note: The temperature indicated on the generator is not the tissue temperature. This applies especially when catheters with saline-cooled ablation electrodes are used.
When catheters with cooled ablation electrodes are used, the temperature measurement reflects the temperature of the cooled electrode, not the temperature of the tissue. The temperature of the tissue may be distinctly higher and the risk of pop explosion of steam bubbles may increase. Therefore, use only moderate RF power output. Follow the recommendations in the instructions for use provided with the therapeutic catheters that are used with the system.
Keep in mind when setting the temperature that only the temperature of the electrode and not the temperature of the heart tissue is measured. Because of the cooling effect of blood flow, the temperature of the heart tissue may be higher than the temperature measured at the ablation electrode. Avoid sudden increases in impedance to minimize charring at the ablation electrode. Make sure that the active RF electrode of the ablation catheter is not in contact with another catheter or with another metallic conductor, such as an implanted pacemaker lead.
This could lead to uncontrolled conduction of the RF energy to other parts of the body, or to an uncontrolled increase in the effective size of the active RF electrode. Do not set any extreme, unrealistic limit values. The limit values serve to trigger an alarm when a limit value is exceeded. If unrealistic values are set, important alarm functions will be triggered too late or not at all.
To minimize the risk to the patient, keep the ablation duration to one minute or less. When using the usual operating settings, a low output RF power or a problem with the ablation device can be a sign that the indifferent electrode is not correctly positioned or has poor contact with its connection cable.
If a sudden increase in impedance is observed, stop the RF energy delivery. If there is any doubt about an unintended increase in RF energy or the proper functioning of the touch screen, Data Entry Knob , foot pedal, or remote control during RF delivery, immediately stop the RF energy delivery by pressing the Stop button on the generator, releasing the foot pedal, or pressing the Stand-by button.
If none of these measures stops the RF energy delivery, disconnect the mains cable from the generator. The indifferent electrode is monitored at all times by the generator. When a split indifferent electrode is used, the generator displays an alert message as soon as skin contact with the electrode surface decreases by an unacceptable amount.
After the indifferent electrode is applied to the patient, the generator continuously monitors the contact quality and updates an internal value for best achieved contact quality the minimum 3 Warnings and Precautions Page 11 RF Generator User Manual contact impedance of the split indifferent electrode.
This value is reset every time the indifferent electrode is disconnected from the patient. If a solid non-split indifferent electrode is used and the electrode partially detaches itself, no alert is triggered. The danger of a skin burn under the indifferent electrode is thus increased. Solid indifferent electrode Split indifferent electrode The generator provides the option of connecting two separate indifferent electrodes.
Both split and solid indifferent electrodes can be connected. In this case as well, the contact quality monitoring feature works only with split indifferent electrodes.
If two indifferent electrodes are used, apply one electrode to the left side of the ablation site and the other electrode to the right side of the ablation site, both at approximately the same distance from the ablation site. The two indifferent electrodes must not overlap. If it is dry, replace it with a new, unused electrode before continuing with the ablation procedure. Do not use any contact gel with single-use electrodes. Use the single-use electrode for only one procedure.
If the indifferent electrode becomes loose or needs to be moved, use a new indifferent electrode. Repeated use of an already applied electrode can mean a loss of adhesiveness and thus lead to distinctly poorer contact quality. If it is dry, use a small, evenly distributed quantity of conductive gel. Do not place the indifferent electrode near wounds. Place the indifferent electrode closer to the ablation site than any ECG electrode or other products that could represent an alternative lead.
Shave and degrease the skin. There should be no pockets of air between the skin and the indifferent electrode. Oil, hair, dirt, repeatedly used adhesive electrodes, and electrodes of low quality can impair contact quality and increase the risk of a skin burn.
This increases the risk of skin burns. Do not use such sources of heat in immediate proximity to the indifferent electrode. Check the indifferent electrode and the connection cable before use.
Do not use these if they are damaged or modified. The generator can be configured to work with a variety of other devices and meets the highest standards for safety, precision, and ease of operation. The generator is compatible with a large number of catheters and devices. For a listing of devices and accessories, see Section 5. The generator is operated via an easy-to-use user interface. Selections can be made on the screen by touching it even when wearing surgical gloves or by tapping it with a pen.
A central computer processor operates the device. Several other microprocessors control the various functions, such as RF power output and calculation of impedance. The generator is equipped with a memory unit that stores the settings even after the generator has been turned off. These settings are active when the generator is turned on again.
Operating errors and defects in the attached devices are detected and error messages are issued. For a list of possible error messages, see Sections 7. In some countries, in order to comply with local regulations, the generator may not be put into service until the distributor has subjected the generator to a functional test on site and has trained the person responsible for operating the device in the handling of the generator per this user manual. All applicable requirements of local regulations must be followed.
See the instructions for use that are provided with the test box. If the generator is placed on any other surface, make sure it is securely fastened. Use only the mains cable supplied by the manufacturer or distributor for the country where the generator is being used.
Use only fuses approved by the manufacturer. Connect one end of the green and yellow potential equalization cable provided with the generator to the grounding connection on the back of the generator see Item 8 in Section 4. To connect an accessory cable to the generator, align the arrow on the plug with the mark on the receptacle and push in without unnecessary force until a click indicates that the connector is locked in the receptacle.
If the plug does not fit in the receptacle, verify that the color coding matches and that the number of pins in the plug is appropriate for the receptacle. To remove the plug, gently pull back the sleeve on the plug and pull the plug out of the receptacle. Other catheters may be used only after consultation with the distributor.
For recommended accessories, see Section 5. To connect an ablation catheter, use a sterile cable and connect one end to the Catheter 1 receptacle on the front of the generator see Item 4 in Section 4. To connect an esophageal probe, connect the appropriate cable to the Catheter 2 receptacle on the front of the generator see Item 5 in Section 4.
An esophageal probe cannot be used with the US or JP versions of the generator. The Catheter 2 receptacle is not functional. For other indifferent electrodes, appropriate adapter cables are available. Do not connect any other USB devices such as a printer, mouse, or scanner ; these other devices are not supported by the generator.
Note: The USB ports on the back of the tilting front panel of the generator are for use by service technicians only. Also see Section 6. Press the Tilt Panel button see Item 7 in Section 4. Before moving the generator, make sure that the front panel is closed. Gently pull the bottom of the front panel forward until it is at the desired angle, then release it. The front panel will lock into place. To lower the front panel, gently pull the front panel forward slightly and then let it glide backward.
Note: Some accessories may need sterilization; follow the instructions for use that are provided with the accessories. If damp cleaning is necessary, moisten a soft cotton or linen cloth with commercial glass cleaner that does not contain alcohol and wipe the screen. Do not spray the cleaner directly onto the screen. Use a soft, damp, lint-free cloth to clean and disinfect the housing of the generator.
Use only nonflammable and non-explosive substances. Water or soapy water is recommended for cleaning. Make sure that no liquid penetrates the inside of the generator.
Do not use any agent containing ethyl alcohol to clean the generator. Iodine or disinfectants containing dyes cause discoloration of the housing and should not be used. Perform disinfection by wiping, not by spraying. Avoid condensation. If cleaning or disinfecting the generator with flammable or explosive substances cannot be avoided, make sure these substances have completely evaporated before the generator is turned on.
Check the vents on the bottom and sides of the generator regularly for excessive deposits of dust and foreign bodies.
Carefully brush or wipe off the unwanted material. This includes installing the generator in a safe location and protecting the generator against moisture, contamination, and contact with flammable or explosive substances. Make sure that all cables to devices and accessories are arranged in a way that prevents tripping.
Hold the sides of the generator, not the front panel, when lifting the generator. Carry the generator with two hands. To transport the generator over long distances or to send the generator for service, use the original packaging. If the original packaging is not available, contact the manufacturer or distributor for a replacement.
To ensure proper disposal, there is also the option of contacting your Biosense Webster representative regarding return of the generator and its accessories. If you use accessories that are not authorized by the manufacturer, the safety of the device and system is not guaranteed. Note: The UL mark on this generator is only valid with accessories tested by Underwriters Laboratories.
Coiling the connection cables during normal operation of the generator creates inductive components which can lead to measurement errors. When plugging in a cable or unplugging a cable, hold the cable by the plug housing, not by the cable itself. Do not coil the cable closely around the foot pedal. Check the cable regularly for visible damage. Do not use a damaged foot pedal. Make sure that any liquid is removed from electrical contacts after cleaning, disinfecting, or sterilizing.
Notes , make sure that Ablation Start 1. When you press Stand-by and the foot pedal are not pressed. The Alarm indicator flashes alternately red and orange for a short time to indicate that the Alarm indicator is working. If the indicators listed above do not perform as described, there is a problem with the generator and you should contact Customer Support.
Progress dots in the bottom left corner of the screen indicate that the system is performing a self test. When the self test is successfully completed, a confirmation message appears asking you to press Stop to continue. After you press Stop , the Ablation screen will appear. If the progress dots do not appear, or if the number of dots stops increasing and the logo remains on the screen, or if the confirmation message does not appear, there could be a problem see Section 7.
Always wait until the automatic self test has been successfully completed before starting the first steps of the procedure on the patient for example, before anesthesia or before creating percutaneous access. Note You can turn off the pump and remote control before or after you turn off the generator. See Section 6. Ablation 6. You can press Irrigation Control to modify irrigation settings for an irrigated catheter. You can press System Control to change the volume or the brightness of the screen and to indicate whether the generator or remote control has control of the system.
Esophageal temperature shown above is not applicable for the US and JP versions of the generator. Selection button Gray, flat white when selected Press one button to make a selection from a group of buttons. The workflow button for the displayed screen has an orange underscore. Icon Image Press the icon to perform the action represented by the image on the icon see Section 6. System Status icon Image, triangle See Sections 7. Pane Rectangular gray section of the screen Provides visual grouping of related buttons and information.
Note: When raised buttons are gray and when icons are gray, either they are not available for use on the screen that is displayed or their functions are not supported by the software version. When you press a displayed value on the touch screen, the ring around the Data Entry Knob turns on. The color of the ring matches the color of the value or the color of the background surrounding the value.
When you turn the Data Entry Knob , the value changes. Press the knob to save the new value. The ring around the knob will turn off. You can also save the new value by pressing a different displayed value or by waiting until the ring around the knob turns off by itself.
Note: At the Ablation screen, the changed values take effect immediately it is not necessary to press the knob. At a minimum, connect a catheter and an indifferent electrode to the generator. Notes 6. Optionally, connect other devices shown on the Connections screen.
You can also start ablation by pressing Ablation Start remote control or by pressing the foot pedal connected to the remote control when the remote control is the system Master see Section 6. Note See Section 7. The mapping system image on the Connections screen will change when this screen closes. The color in the arrow moves from left to right to indicate that the test is running. The number on the screen is the impedance value being sent to the mapping system.
The numbers on the screen are the values being sent to the recording system. Flush active when the pump is connected Press Flush. When a message appears, press and hold the Data Entry Knob to flush air bubbles from the irrigation tubing and the catheter. Use this function carefully! For details, see Section 6. During the foot pedal test, a tone is emitted and the image changes to a pressed foot pedal. RF energy is not delivered during the foot pedal test while the Foot Pedal device screen is displayed.
Service button This button is for use by service technicians. This preset is always the first in the list and it cannot be deleted. You can designate one of the displayed presets to be the new default for the catheter type. Notes 1. The currently selected preset is highlighted white background. The preset workflow button displays the name of the selected preset. For instructions on displaying the presets for only one physician, see Section 6. The choices in each pane vary depending on the catheter type you select.
The selections in the panes vary depending on the mode. Temperature Control Mode is not available for all catheter types and is not applicable for the US and JP versions of the generator. The Irrigation Control Settings pane appears only when you select an irrigated catheter.
When you press Save selected preset or Save temporarily. Select In selected preset. When you press Save preset is saved with the revised values. You cannot save changes to the standard presets that come with the generator. If you make changes to a standard preset and want to save the changes, press Save As and follow the instructions in Section 6. Ablation will stop automatically after this time.
Power only in Temperature Control Mode Upper power limit for the temperature control algorithm. The temperature control algorithm will automatically set the power without exceeding this value. Consult the instructions for use for the catheter to determine the appropriate power setting for the catheter. Power only in Power Control Mode The output power to be maintained by the generator during the ablation.
The generator will generate power up to the Max. Power setting in an attempt to reach the Target temperature. Warning only in Power Control Mode The temperature of the ablation electrode at which a warning will occur.
RF energy will remain on. If you select Warning, then select the temperature of the esophageal probe at which you want a warning to occur.
If you select Warning, then select the increase of temperature of the esophageal probe at which you want a warning to occur during ablation—the increase will be determined from a baseline measurement taken just before ablation.
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