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The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons and urologists. The intended use of the DEXTER ENDOSCOPE ARM is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The DEXTER ENDOSCOPE ARM is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, DEXTER ENDOSCOPE ARM is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the DEXTER ENDOSCOPE ARM are general surgeons, gynecologists, cardiac surgeons and urologists. The intended use of the ARTip solo is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The ARTip solo is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, ARTip solo is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic, decompression fixation, wedge resection, lunq biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the ARTip solo are general surgeons, gynecologists, cardiac surgeons and urologists.

DEXTER ENDOSCOPE ARM and ARTip solo + ARTip solo voice are based on the same concept as the already cleared SOLOASSIST II + Voice Control (K200473) and differ only in minor details. All 3 robotic arm systems emulate an arm operating in multiple degrees of freedom. The intended use of the three robotic arm systems is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The surgeon can control the arm with either a joystick, voice control, or by pressing a button on the distal end of the arm. Movement is controlled by 3 motorized axes. The endoscopic camera is registered in the TROCAR POINT, which serves as the pivot point. Starting from this zero point, the device independently calculates the required individual movements of the axes to achieve the desired overall movement. The system offers a wide range of motion, allowing a 360° panoramic view with the endoscope tilted up to 90° from the vertical. Despite their wide range of motion, all arms are lightweight and compact and are attached directly to the operating table with a quick-release clamp. Only a STERILE COVER is required for safe use. The ARTip solo is functionally identical to the already cleared SOLOASSIST II (K200473), but differs only in the color and inscription of the covers and the visual design of the control panel on the arm. The ARTip solo can also be controlled with the ARTip solo voice. This is also identical to the already cleared VOICE CONTROL (K200473) except for the color and inscription. The ARTip solo is not compatible with the VOICE CONTROL (K200473). In addition, the ARTip solo can also be controlled with a joystick. It can only be controlled with the JOYSTICK-IH-IA or JOYSTICK-RH-IIA, which are specially made for the ARTip solo and are only compatible with it. DEXTER ENDOSCOPE ARM is the trade name of the SOLOASSIST IID, which was developed within the SOLOASSIST II. The special feature of the DEXTER ENDSCOPE ARM is that it provides an interface to a customer-specific device and can be controlled by it. The arm can also be controlled by the JOYSTICK LH and JOYSTICK RH. The SOLOASSIST IID has its own CANTILEVER, JOINT, PROBE PIN and ENDOSCOPE CLAMP, which in combination with a tension sleeve hold the endoscope.

The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.

The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement. lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope. An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again. Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime. On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO. To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener. During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.

The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.

The SOLOASSIST II allows the user to hold and control the movements of a rigid endoscope by using a JOYSTICK, manually by pushing the release button on the Control Panel that is located on the SOLOASSIST II or using the VOICE CONTROL. The JOYSTICK or the VOICE CONTROL is linked to related connection of the SOLOASSIST II by wire. The JOYSTICK is mounted on the surgical instrument of the surgeon. The movement will be controlled by three motorized axes inside the SOLOASSIST II. The SOLOASSIST II simulates an arm working in several degrees of freedom. The Control Panel of the SOLOASSIST II has 2 buttons and 5 indications. One button is used to set the TROCAR POINT and the other button is used to move the SOLOASSIST manually by pushing the button while moving the arm. The TENSION SLEEVE and the ENDOSCOPE CLAMP are loosely screwed together. The combination of TENSION SLEEVE and ENDOSCOPE CLAMP are slide over the endoscope and the tension sleeve is tightened so the endoscope can't move out but still can turn. It is important to use the right TENSION SLEEVE for the right diameter of the endoscope. On the rigid endoscope normally there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the SOLOASSIST II. The starting point of the movement for an operation will be saved as the TROCAR POINT. The UNIVERSAL JOINT has to be mounted on the SOLOASSIST II. A mounted UNIVERSAL JOINT can be removed by using the release slider. To define the Trocar point the UNIVERSAL JOINT has a small tracer pin. The tracer pin is placed near the body opening for the endoscope. The TROCAR POINT has to be saved by pushing the button on the control panel of the SOLOASSIST II. The ENDOSCOPE CLAMP (together with TENSION SLEEVE and Endoscope) is mounted on the UNIVERSAL JOINT, so the SOLOASSIST II is ready for operation. Based on the trocar point and the desired view of the software of the device calculates the required individual movements of the axes in order to achieve the desired total movement. For example by pushing the left button on the JOYSTICK the image on the monitor moves left, while the SOLOASSIST II is moving to produce the desired view. By pushing the buttons on the JOYSTICK it is possible to move the image on the monitor to the left, right, up, down, zoom in and zoom out. Additionally it is possible to move the arm of the SOLOASSIST II without the use of the JOYSTICK. Therefore the user has to hold the control panel on the SOLOASSIST II and push the unlocking button (release button) while moving the arm system. Additionally it is possible to move the arm of the SOLOASSIST II with the use of the VOICE CONTROL. Therefore the user has to put the headset on his head that is connected to the VOICE CONTROL by a Bluetooth-Donqle. The VOICE CONTROL is activated by using the hotword "SOLO". The SOLOASSIST II moves by using predefined Movement Commands. To allow the surgeon to convert to an open surgery in case of an emergency, the SOLOASSIST II can be completely mounted or removed by a quick fastener.

The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.

The SOLOASSIST II allows the user to hold and control the movements of a rigid endoscope by using a joystick or manually by pushing the release button on the Control Panel that is located on the SOLOASSIST II. The joystick is linked to related connection of the SOLOASSIST II by a wire. The joystick is mounted on the surgical instrument of the surgeon. The movement will be controlled by three motorized axes inside the SOLOASSIST II. The SOLOASSIST II simulates an arm working in several degrees of freedom. The Control Panel of the SOLOASSIST II has 2 buttons and 5 indications. One button is used to set the TROCAR POINT and the other button is used to move the SOLOASSIST manually by pushing the button while moving the arm. The Tension Sleeve and the Endoscope clamp are loosely screwed together. The combination of Tension Sleeve and Endoscope clamp are slide over the endoscope and the tension sleeve is tightened so the endoscope can't move out but still can turn. It is important to use the right tension sleeve for the right diameter of the endoscope. On the rigid endoscope normally there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the SOLOASSIST II. The starting point of the movement for an operation will be saved as the TROCAR POINT. The Universal Joint has to be mounted on the SOLOASSIST II. A mounted Universal Joint can be removed by using the release slider. To define the Trocar point the Universal Joint has a small tracer pin. The tracer pin is placed near the body opening for the endoscope. The TROCAR POINT has to be saved by pushing the button on the control panel of SOLOASSIST The Endoscope Clamp (together with Tension Sleeve and Endoscope) is mounted on the Universal Joint, so the SOLOASSIST II is ready for operation. Based on the trocar point and the desired view of the software of the device calculates the required individual movements of the axes in order to achieve the desired total movement. For example by pushing the left button on the joystick the image on the monitor moves left, while the SOLOASSIST II is moving to produce the desired view. By pushing the buttons on the joystick it is possible to move the image on the monitor to the left, right, up, down, zoom in and zoom out. Additionally it is possible to move the arm of the SOLOASSIST II without the use of the iovstick. Therefore the user has to hold the control panel on the SOLOASSIST II and push the unlocking button (release button) while moving the arm system. To allow the surgeon to convert to an open surgery in case of an emergency, the SOLOASSIST II can be completely mounted or removed by a quick fastener.

Intended Use: Localized cold therapy for post-traumatic and post-surgical medical and or surgical conditions. Indications For Use: 1. Treatment of pain and swelling of acute periarticular processes. 2. Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia. 3. Treatment of pain and swelling postoperatively for bones, joints and soft tissue. 4. Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.

The Artrocool® - S is a typical cold liquid recirculating cryotherapy device. The Artrocool® -S is an insulated ice chest-like box with a closed loop liquid recirculating pump and tubing. The tubing connects to a variety of cuffs designed to be placed on or around injured or post surgical body structures, limbs or joints. The device operates by the use of a water filled cartridge and an insulated chest. The water filled bottle is frozen solid prior to first use. When the bottle is frozen, it is placed within the insulated chamber of the Artrocool. A 4:1 mixture of water and alcohol is poured into the fluid reservoir (balancing container) until full. The pump is circulated with the connecting tubing and cuff attached. Once both are filled and all air bubbles have been purged from the system the unit is ready for service.

Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and or surgical conditions. 1) Treatment of pain and swelling of acute periarticular processes. 2) Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia. 3) Treatment of pain and swelling postoperatively for bones, joints and soft tissue. 4) Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.

The ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit utilizes a small portable heating and cooling unit, a length of dual lumen connecting tubing and assorted thermal therapy cuffs/pads. The various cuff/pads of the ARTROTHERM™ are shaped to better contour to different body surfaces. Therapy pads designed to accommodate the ankle, foot, wrist, hand, back, shoulder, hip, neck and knee are offered at present. The pads are held in place with straps and/or wraps. The unit requires 110 -115 or 220-230 VAC 50/50Hz current for operation. The unit is fully electrically isolated and meets UL-544 requirements. The ground leakage current value for the water circulating electric pump is less than 55 micro-amps. Minimum and maximum cooling and heating temperatures are affected by available environmental conditions, size of pad selected and patient temperature. Under typical conditions, best low temperature is +4 °C. Best low temperature is achieved after approximately 30 minutes of operation. Maximum high temperature is +50 °C and the unit requires about 15 minutes to reach this level. A high temperature alarm is utilized to warn of temperatures in excess of the +50 °C.