Summary of Contents for biodex SURGICAL C-ARM TABLE
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SURGICAL C-ARM TABLE™ INSTRUCTIONS FOR USE 058-840 058-845 058-840-10 058-845-10 FN: 19-259-CLR 9/19...
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840, 058-845, 058-840-10, and 058-845-10. Additional information and resources are available upon request or directly from the Biodex website, www.biodex.com/tables840. If the desired information is not found, contact a local distributor or Biodex directly at supportservices@biodex.com Thank you, Biodex Medical Systems, Inc.
Table of Contents Definition of Symbols ........................ 4 Product Certifications and Classifications .................. 5 Before Proceeding ........................6 Important Safety Information ....................7 Introduction ........................8 Intended Use ......................... 8 Indications for Use ......................8 ...
Product Certifications and Classifications The Surgical C-Arm Table has received the following certifications, and falls within the following classifications: ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010 ● CAN/CSA C22.2 No: 60601-1:14 ● IEC 60601-2-46 ● CAN/CSA-C22.2 NO:60601-2-46 ● FDA Class II Equipment ● CE Class I Non Measuring ●...
Before Proceeding NOTE: The warnings, cautions and instructions provided in this manual must be read, followed and kept available for consultation at all times. Observing the information, instructions and procedures presented throughout this manual is essential for using this product both properly and safely. SPECIFIC CAUTIONS Allow only qualified, trained personnel to operate or service this product.
Before Proceeding section of this manual. This product should be used only as specified in the operation manual. CAUTION: Biodex devices are designed for use in a client environment. For product specifications, refer to the Table of Contents. This medical electrical equipment requires special precautions regarding EMC and must be assembled and placed into service according to EMC information provided in this manual.
Indications for Use The extra-large radiolucent area, free-float X-Y tabletop, motorized control of height, lateral roll, Trendelenburg motions and the catheter tray extension make the Surgical C-Arm Table - 840 ideal for cardiovascular procedures. The radiolucent area is free of cross members, allowing full fluoroscopic visualization and unobstructed C-Arm positioning.
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manufactured NOTE: The 840 tabletop is of carbon fiber. This material, as used in this product, is certified to meet all the requirements of radiation performance standards of 21 CFR Subchapter J. Figure 1.1. Parts and Adjustment Mechanisms Standard Parts and Adjustments: 1.
2. Operating Instructions CAUTION: Refer to instruction manual before operating or servicing system. NOTE: This table can be operated with the power cord connected to an outlet or by using the battery. The battery recharges automatically while the table is plugged into an outlet even if the table is being used.
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Figure 2.1. Locking Brakes and Swivel Casters Figure 2.2. Head End Lock Bar...
Using the Hand-Held Controller The hand-held controller may be used to adjust table height, Trendelenburg/Reverse Trendelenburg, lateral roll and X-Y positioning. When not in use, the Hand-Held Controller can be hooked onto the metal loop on the restraining strap, or on the accessory rail. CAUTION: Before moving the tabletop, be sure that all I.V.
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Figure 2.4. Foot Controller Positioning the X-Y Free-Float Tabletop The X-Y free-float tabletop is positioned using the mushroom top tabletop handgrips. The mushroom top is pressed down to allow the table to move in both the X and Y planes. To move the tabletop, depress the mushroom top on the handgrip and, using both handgrips, slide the tabletop to the desired position.
Disposable Skirt (Optional) The Biodex Surgical C-Arm Table can be ordered with the optional Plastic Sanitary Skirts to protect the table bellows from patient blood and other liquids. The table has plastic clips located immediately above the bellows. Secure the skirt to the clips as described below: 1.
Catheter Tray Extension The removable extension can be used to provide additional table length for accommodation of catheters within the patient’s sterile field. This makes the procedure easier, safer and reduces the risk of breaking the sterility of the catheters. CAUTION: The Catheter Extension is not radiolucent and not suitable for patient support.
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NOTE: The table must remain plugged into an outlet when the battery is removed or reinstalled. If the battery is removed for any reason while the table is not plugged into a working outlet, the battery will discharge at a faster rate. Once the battery has been reinstalled, and it has been verified that the table is operating, the power cord plug can be removed from the outlet and operate on battery power.
3. Maintenance and Cleaning The Biodex Surgical C-Arm Table is virtually maintenance free. By following the instructions below at suggested time intervals, or as often as necessary, the table will remain in “like new” condition. 1. As required, cleanse all exterior surfaces and tabletop pads with a mild detergent solution, such as Parker Laboratories Protex Disinfectant or any one-step disinfectant that does not contain bleach.
4. Specifications Dimensions: 97" l x 26" w (246 x 66 cm) with OR accessory rails Tabletop: 97" l x 24" w (246 x 61 cm) – choice of classic contoured or rectangular design Catheter Tray Extension (removable): 18" l x 24" w (45.7 x 61 cm) non-radiolucent Radiolucent Area: 75"...
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Optional 056-862 Battery and Charging Unit, 115 VAC 056-863 Battery and Charging Unit, 230 VAC 056-850 IV Pole, Rail Mounted 056-865 Arm Board, Carbon Fiber, one arm 056-866 Arm Board, Carbon Fiber, two arms 058-864 Arm Board, Surgical, Carbon Fiber 058-849 Clamp, Accessory, C-Arm Table 058-856...
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