FIELD MODIFICATION INSTRUCTION. CryoICE BOX Option For AtriCure ORLab ASC1 (400mm) Carts P B

Transcription

1 FIELD MODIFICATION INSTRUCTION CryoICE BOX Option For AtriCure ORLab ASC1 (400mm) Carts P B

2 CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Information in this document is subject to change without notice. Reproduction of this document in any manner whatsoever, without the written permission of AtriCure, Inc. is strictly forbidden. AtriCure and the AtriCure Logo are trademarks of AtriCure, Inc. AtriCure disclaims proprietary interest in the marks and names of others. Manufactured by: AtriCure, Inc Centre Park Drive West Chester, Ohio USA Customer Service Tel: E mail: customerservice@atricure.com European Representative: Köntges SPRL Avenue Hellevelt 35 B 1180 Brussels Belgium Tel: +32 (0) FAX: +32 (0) E mail: herbert.kontges@skynet.be

3 Table of Contents 1. System Upgrade Overview of Upgrade How to Use this Manual Safety Information Tool Kit Upgrade Kit (ASCC 400) Reconfiguration of Cart Removal of the ASU, ASB, Printer, and SGU Remove the Drawer/Shelf Relocate Upper Shelf (ACM, ASU, and ASB): Remove Cable Guards/Covers: Replace the Cable Guard/Covers Return the SGU Pacing Generator and Printer Installing the ACM (CryoICE BOX): Return the ASU and ASB Install the CryoICE BOX Exhaust Hose Hanger Page i

4 List of Figures Figure 1 Cart Prior to Upgrade...2 Figure 2 ASC1 Cart After Upgrade...2 Figure 3 Symbols...3 Figure 4 Tool Kit Supplied...4 Figure 5 Packaged Kit (ASCC 400)...5 Figure 6 Kit Contents...5 Figure 7 Remove HANDPIECE Cable...6 Figure 8 Remove FOOTSWITCH Cable...6 Figure 9 Disconnect Stimulus Connection Box...6 Figure 10 Stimulus Connection Box Disconnected...6 Figure 11 ASU and ASB Removed...7 Figure 12 Unplug Printer...7 Figure 13 Remove Printer...7 Figure 14 Unplug SGU Front...8 Figure 15 Unplug SGU Rear... 8 Figure 16 SGU Removed...8 Figure 17 Remove Drawer...9 Figure 18 Drawer Fasteners...9 Figure 19 Printer Shelf New Location...10 Figure 20 Printer Bracket New Location...10 Figure 21 Upper Shelf Relocation...11 Figure 22 Upper Shelf Relocated...11 Figure 23 Remove Cable Covers...12 Figure 24 Remove Cable Guard...12 Figure 25 Tap Strip Orientation...13 Figure 26 Right Power Column Tap Strips Install...13 Figure 27 Assembling the hinge to the Cart...14 Figure 28 Tank Holder Install...14 Figure 29 Cable Guard Install...15 Figure 30 Cable Cover Install...15 Figure 31 Returning the SGU...16 Figure 32 Retuning the Printer...16 Figure 33 New Rubber Feet Position...17 Figure 34 cryoice BOX Placement...17 Figure 35 ASB Postioning...18 Figure 36 ASU Positioning...18 Figure 37 Exhaust Hose Hanger Spring Fastener...19 Figure 38 Hanger Positioning...19 Figure 39 Secure Exhaust Hose Hanger...19 Page ii

5 1. System Upgrade 1.1. Overview of Upgrade The purpose of this upgrade is to modify an ASC1 Cart to accommodate the cryoice BOX (ACM) and its required accessories. This upgrade requires removing the drawer, moving shelving, and repositioning components to provide space for the cryoice BOX and its accessories. The ASC1 Cart is the carriage-shelving component of the ORLab system. The ASC1 cart was used for the initial release of the ORLab systems and is easily identified by the drawer on which the printer sits. Recent ORLab systems are shipped with ASC2 carts and do not include a drawer. The ASC2 cart has a unique kit and manual available for its upgrades. This manual is specific to the ASC1 Cart Upgrade. If you have any questions regarding ORLab system configuration, contact AtriCure customer service. The instructions in this manual illustrate how to: Disconnect the ORLab system components and remove them from the cart Remove and discard the printer drawer/shelf Install new printer shelf and lower the printer cable bracket Lower the Generator/Switchbox (ASU & ASB) shelf Install the tank bracket to the back of the cart Position the cryoice BOX, ASU, ASB, ORLab components on the cart Connect the ORLab components Install the hose hanger hook. Page 1 of 19

6 Figure 1 Cart Prior to Upgrade Figure 2 Cart After Upgrade Page 2 of 19

7 1.2. How to Use This Manual This manual is designed to help upgrade your ASC1 (400mm) AtriCure System Cart to utilize the cryoice BOX option. Illustrations complement the text to explain how to upgrade the cart, components, and accessories. The following information is essential for safe and efficient upgrade of the AtriCure System Cart. Below is a list of symbols used in this manual Item # Symbol Description 1. Consult operating instructions. 2. Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. 3. Manufactured by. 4. CE Mark. Figure 3 Symbols Page 3 of 19

8 1.3. Safety Information PRECAUTION: To avoid electrical hazards, the ASU, ASB, computer, monitor, Stimulus Generator Unit (SGU), and printer must be connected to the Mains Isolation Transformer and never directly to a mains outlet. PRECAUTION: DO NOT connect the cryoice BOX to the Mains Isolation Transformer. The Isolation Transformer is 1000VA and does not have the capacity to power the ORLab system and cryoice BOX. The cryoice BOX must be connected to the same grounded hospital AC power receptacle as the Isolation Transformer. PRECAUTION: To avoid electrical hazards and prevent overloading the transformer, DO NOT connect any non-atricure approved equipment to the supplied Mains Isolation Transformer. PRECAUTION: To avoid risk of explosion, use AtriCure System Cart only in ventilated areas, as gasses may be released during charging of backup battery. PRECAUTION: AtriCure System Cart is not suitable for use in the presence of a flammable anesthetic mixture or other flammable gases. PRECAUTION: Secure tank with chain and ONLY use N 2 O Tanks 20 cm (8") in diameter that weigh 29.5 kg (65 pounds) PRECAUTION: Tank fastener and brace must be secured prior to moving or transporting the cart. (Reference Figure 28) 1.4. Tool Kit NOTE: This tool kit is specific to ASCC-400. The Tool Kit contains the following items: (1) User and Assembly Manual; (2) Flat Washers; (3) Lock Washers; (4) Socket Head Cap Screws for Tank Holder; (5) 5 mm Hex Key; (6) 3/32 In Hex Key; (7) Loctite brand Threadlocker. Figure 4 Tool Kit Supplied Page 4 of 19

9 1.5. Upgrade Kit (ASCC-400) Unpack the cryoice BOX Upgrade Kit (ASCC-400). Kit includes the following: cryoice BOX Tank Mount, Replacement Shelf, Tool kit, and tank chain. Figure 5 Packaged Kit (ASCC-400) Figure 6 Kit Contents (Exhaust Hose Hanger Not Shown) Page 5 of 19

10 2. Reconfiguration of Cart 2.1. Removal of the ASU, ASB, Printer, and SGU Disconnect Cables and remove units as described below in Figures Figure 7 Remove HANDPIECE Cable Figure 8 Remove FOOTSWITCH Cable Remove the power cables from the rear of the ASU and ASB (not shown) Figure 9 Disconnect Stimulus Connection Box Figure 10 Stimulus Connection Box Disconnected Page 6 of 19

11 Remove the ASU & ASB from Cart Remove the Printer Figure 11 ASU and ASB Removed Figure 12 Unplug the Printer Figure 13 Remove the Printer Page 7 of 19

12 Remove the SGU Figure 14 Unplug the SGU from Front Figure 15 Unplug all cables from rear of SGU Figure 16 SGU Removed Page 8 of 19

13 2.2. Remove the Drawer/Shelf Slide the drawer out and lift slightly at end of travel for complete removal. Figure 17 Removing Drawer Remove Shelf: Using the 5mm Allen wrench, remove five fasteners from each side as shown in Figure 18. Figure 18 Drawer Fasteners View from under the shelf to show fasteners Discard drawer, shelf and fasteners. Page 9 of 19

14 Install New Printer Shelf. Install new printer shelf in location shown, Dim. Approximately 28cm. (11in.) to top of shelf. Figure 19 Printer Shelf New Location Lower the printer bracket. Crossbar to be 4cm (1 ½ in) above the new printer shelf. Figure 20 Printer Bracket New Location Page 10 of 19

15 2.3. Relocate Upper Shelf (ACM, ASU, and ASB) Move Upper shelf down to measure 61cm (24in.) Figure 21 Upper Shelf Relocation Figure 22 Upper Shelf Relocated Page 11 of 19

16 2.4. Remove Cable Guards/Covers: Remove Cable Cover Figure 23 Remove Cable Covers Remove Cable Guard Figure 24 Remove Cable Guard Page 12 of 19

17 Install the Tank Holder: Install the two Tap Strips provided in the kit Figure 6. NOTE: Ensure that the embossed features (bumps) on the tap strips are oriented toward the outside of the cart. Figure 25 Tap Strip Orientation Figure 26 Right Power Column Tap Strips Install Place the Hinge Leaf of the Tank Holder against the Right Power Column. (As looking at the rear of the cart.) NOTE: Ensure it is resting at the bottom of the Power Column Figure 27. NOTE: The bolt assemblies consist of a Socket Head Cap Screw, Flat Washer and Lock Washer Figure 27. (1) 5 mm Hex Key; (2) Socket Head Cap Screw (3) Flat Washer; (4) Lock Washer; (5) Bracket; and (6) Hinge Leaf. Page 13 of 19

18 Figure 27 Assembling the Hinge to the cart Rotate the Tank Holder (5) on the hinge (6) against the Right Power Column. Use the (1) 5 mm Hex Key, (2) Socket Head Cap Screw, and (3) Lock Washer, and (4) Flat Washer to attach and secure the hardware. Figure 28 Tank Holder Install PRECAUTION: This fastener and brace must be secured prior to moving or transporting the cart. (Reference Figure 28) NOTE: The hinge is provided to permit access to the Isolation Transformer for any service or repairs. Hinge must be secured with the brace and hardware Figure 28. Page 14 of 19

19 2.5. Replace the Cable Guard/Covers. Replace cable guard Replace cable covers Figure 29 Cable Guard Install (Tank holder not shown for clarity) Figure 30 Cable Cover Install Page 15 of 19

20 2.6. Return the SGU Pacing Generator and Printer Replace SGU on original shelf. Plug in the SGU. Reference Figure 14 and 15. Figure 31 Returning the SGU Replace Printer Plug in the printer. Reference Figure 12 (Printers supplied in the US Only) Figure 32 Returning the Printer Page 16 of 19

21 2.7. Installing the cryoice BOX Carefully place the cryoice BOX on its top to access the rubber feet. Using the 3/32 Hex Wrench provided in your Tool Kit; unfasten and remove the two larger front rubber feet in Position 1 and move them to Position 2. Figure 33 New Rubber Feet Position Place the cryoice BOX on the top shelf NOTE: The cryoice BOX will overhang the shelf as shown below Figure 34 cryoice BOX Placement Page 17 of 19

22 PRECAUTION: DO NOT connect the cryoice BOX to the Mains Isolation Transformer. The Isolation Transformer is 1000VA and does not have the capacity to power the ORLab system and cryoice BOX. The cryoice BOX must be connected to the same grounded hospital AC power receptacle as the Isolation Transformer Reference the instruction manuals received with the CryoICE BOX and CryoICE BOX accessories for all set-up and operation of the ACM product Return the ASU and ASB. Place the ASB on the cryoice BOX, with the ASB feet nested in the rubber bumpers on top of the cryoice BOX. Place the ASU on top of the ASB with the feet nested in the rubber bumpers on top of the ASB. Plug in the Footswitch and Handpiece cables to the ASU and ASB. Reference: Figures 7 & 8 Attach the power cables from the cart to the rear of ASB and ASU (not shown). Figure 35 ASB Positioning Figure 36 ASU Positioning Page 18 of 19

23 2.9. Install the cryoice BOX Exhaust Hose Hanger Obtain the Cryo Exhaust Hose Hanger bracket from the kit Remove the plastic cap from the top of the cart s vertical column. (Note: the bracket can be mounted on either the left or right side of the cart. Either side is acceptable per customer preference.) Squeeze the spring on the back of the nut, so it fits into the track reference Figure Slide the bracket down the track to the approximate position shown. Figure 38 (Note: position height is not critical. Bracket needs to be high enough to prevent the cryoice BOX exhaust hose from reaching the floor.) Using the supplied Allen Wrench, tighten the bolt and assure the bracket is secure. Figure 39. Figure 37 Exhaust Hose Hanger Spring Fastener Figure 38 Hanger Positioning Figure 39 Secure Exhaust Hose Hanger Page 19 of 19