Users Manual
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Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
LithoVue™ System Workstation User’s Manual
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User’s Manual
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Table of Contents 1 Introduction...5 1.1 SAFE USE REQUIRES READING THE USER’S MANUAL...7 2 Clinical Information...7 2.1 INDICATIONS FOR USE AND INTENDED USE...7 2.2 CONTRAINDICATIONS...7 2.3 USER TRAINING, KNOWLEDGE, AND SKILLS...7 2.4 WARNINGS...8 2.5 PRECAUTIONS...9 2.6 ADVERSE EVENTS...10 3 How Supplied...10 3.1 System Workstation Components...11 3.2 System Workstation Assembly...12 Assembling the Cart...12 Assembling the Cart Base and Cart Post...12 Attaching the Touch PC Mounting Plate to the Cart Post...13 Attaching the Cart Handle...14 Attaching the Power Transformer Bracket...15 Installing the Touch PC onto the Cart...15 Cart Adjustment...18 Adjusting Touch PC Height...19 Adjusting Touch PC Tilt...19 Confirming Installation...19 Connecting an External Monitor or DVI Switcher with the DVI Cable...20 3.3 Transportation, Use and Storage...21 3.4 Specifications and Device Compatibility...22 Electrical...22 Physical (nominal)...22 Illumination Output (nominal)...23 Medical Electrical Classifications...23 LithoVue™ Flexscope Fluid Compatibility...23 System Workstation Device - Accessory Compatibility...23 Software Information...23 4 LithoVue System...24 4.1 System Workstation Features and User Interface...24 System Workstation Front Panel Features and User Interface...24 System Workstation Rear Panel Features...25 4.2 System Workstation cART FeatureS...25 4.3 mAIN oPERATING sCREEN...27 3
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Light On/Off Button...27 Image Brightness Control Buttons...28 Image Brightness Indicator...28 Time Remaining Indicator...28 Controls Swap Button...29 Live Video Image Display Area...30 Message Screens...30 5 System Operation...31 5.1 STARTING THE SYSTEM WORKSTATION...31 5.2 CHECKING THE QUALITY OF THE VIDEO IMAGE...33 5.3 ADJUSTING THE BRIGHTNESS OF THE VIDEO IMAGE...33 5.4 COMPLETING A PROCEDURE...33 Using the LithoVue™ System in an Ureteroscopy Procedure...33 5.5 SAFELY SHUTTING DOWN THE SYSTEM WORKSTATION...35 5.6 DISPOSAL OF THE PRODUCT, ACCESSORIES, AND PACKING MATERIALS...35 6 Cleaning and Maintenance...35 6.1 CLEANING THE SYSTEM WORKSTATION...35 6.2 MAINTENANCE, SERVICE AND REPLACEMENT PARTS...36 7 Troubleshooting...36 7.1 ISOLATING THE SYSTEM WORKSTATION FROM THE MAINS POWER SUPPLY...36 7.2 LOSS OF IMAGE...36 7.3 LOSS OF ARTICULATION CONTROL ON THE LITHOVUE FLEXSCOPE...37 7.4 SYSTEM WORKSTATION POWER LOSS...39 7.5 SYSTEM WORKSTATION BECOMES NON-OPERATIONAL...39 8 Service and Warranty...42 8.1 Limited Warranty...42 8.2 Obtaining Warranty Service from Boston Scientific Corporation...42 9 Electromagnetic Compatibility (EMC) Requirements...42 9.1 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS...42 9.2 GUIDANCE AND MANUFACTURER’S DECLARATION - IMMUNITY ALL EQUIPMENT AND SYSTEMS...43 9.3 GUIDANCE AND MANUFACTURER’S DECLARATION - EMISSIONS AND EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING...44 9.4 RECOMMENDED SEPARATION DISTANCE OF OTHER EQUIPMENT...45
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ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
1 Introduction This user’s manual describes how to use, maintain, and troubleshoot the LithoVue™ System (see Figure 1.1). The LithoVue System is a software-controlled digital flexible ureteroscope system that consists of the LithoVue System Workstation (Touch PC and Cart) and the LithoVue Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable). The LithoVue System Workstation is referred to as the System Workstation, and the LithoVue Single-Use Digital Flexible Ureteroscope is referred to as the LithoVue Flexscope in these instructions. The LithoVue Flexscope connects to the System Workstation via the Flexscope Connector Cable Plug Receptacle (hereafter referred to as Workstation Receptacle) on the front of the System Workstation (see Figure 1.1). The LithoVue System is designed to allow physicians to access, visualize, and perform procedures in the urinary tract, using appropriate accessory devices (e.g., baskets, laser fibers, and forceps). The LithoVue System is available in the configurations shown in Table 1.1: Table 1.1 LithoVue System Available Configurations
User’s Manual
Description
M0067911000
LithoVue System Workstation Global
M0067913500
LithoVue Single-Use Digital Flexible Ureteroscope (Standard Deflection) - Global
M0067913600
LithoVue Single-Use Digital Flexible Ureteroscope (Reverse Deflection) - Global
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Model Number (UPN)
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Figure 1.1 – LithoVue™ System
Main Operating Screen
User Supplied Monitor
DVI Cable
DC Power Cord Flexscope Connector Cable Plug Receptacle
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
AC Power Cord
Connector Cable
LithoVue Flexscope
System Workstation The System Workstation does the following: (a) Provides power for the illuminating LED and video image hardware in the LithoVue Flexscope. (b) Receives video signals from the LithoVue Flexscope and processes the images for display on the System Workstation screen or on a user-supplied monitor, if connected. (c) Provides illumination control. The illumination provided by the LithoVue Flexscope is adjusted automatically by the system to ensure adequate light levels at the treatment site. Additionally, the user may also turn the illumination on/off and adjust the illumination levels using the controls provided on the System Workstation. 6
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(d) Displays the video images. The system workstation can also send the video signals via a DVI Cable for display on a user-supplied video monitor. When using a user-supplied video monitor, the system will duplicate the video image, but will not duplicate the system controls. (e) Provides the user interface. 1.1 Safe Use Requires Reading the User’s Manual Prior to using the LithoVue™ System, you must read this User’s Manual and the LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use to become familiar with the LithoVue System’s features and controls. This manual and the LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use provide the information necessary for inspecting, preparing and operating the system. Failure to thoroughly understand and follow all instructions, cautions and warnings provided in this User’s Manual and the LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use may result in injury to the patient and/or user, and/or may result in damage to, or malfunction of, this equipment. Additionally, damage to other equipment or property may result. Follow all instructions, cautions, and warnings provided with all products and equipment to be used in conjunction with the LithoVue System to avoid any possible hazards due to device incompatibility. If the instructions are unclear to you, contact Boston Scientific for assistance, using the information found in Section 8 “Service and Warranty”. Keep this User’s Manual in an accessible location.
2 Clinical Information 2.1 Indications for Use and Intended Use The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
2.2 Contraindications Contraindications for this device are those specific to urinary tract endoscopy. Diagnostic or therapeutic ureteroscopy is contraindicated in people with an untreated urinary tract infection. Other contraindications to therapeutic ureteroscopy (e.g., lithotripsy, endopyelotomy, tumor therapy) are more numerous and can mirror those associated with the corresponding open surgical interventions. Patients on anticoagulants or with coagulopathies should be managed appropriately. 2.3 User Training, Knowledge, and Skills Read the entire User’s Manual and LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use before using the LithoVue System. Study labeling thoroughly for safe handling and storage. Use the LithoVue System as intended. The LithoVue System Workstation should only be assembled and installed by a trained biomedical technician. Only physicians who have ureteroscopic, diagnostic, and therapeutic training should use the LithoVue System. A thorough understanding of the techniques, principles, clinical applications, and risks associated with endoscopic urinary tract procedures is necessary before using this device. This includes, but is not limited to devices used in laser lithotripsy, administration of irrigation/contrast, and use of procedural accessories such as baskets/forceps, access sheaths, guidewires, and antiretropulsion devices. Nursing support staff should have reasonable experience with common medical equipment and urology procedures. User’s Manual
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2.4 Warnings • Do not use the LithoVue™ System in the presence of flammable fluids and gases such as alcohol or oxygen. Doing so can result in fire and burns to the operator and patient. • Do not insert or advance the LithoVue Flexscope unless there is a clear live endoscopic view of the lumen through which the scope is being advanced (or confirm with visualization by other imaging modalities). Doing so can cause patient injury such as perforation, avulsion, hemorrhage, or urothelial damage. • In the event that the live endoscopic image is lost, do not advance or insert the LithoVue Flexscope and do not insert, advance or actuate accessories. Doing so can cause patient injury such as perforation, avulsion, hemorrhage, or urothelial damage. • Do not use excessive force when advancing or withdrawing the scope. Doing so can cause patient injury such as perforation, hemorrhage or urothelial damage or damage to the LithoVue Flexscope. If resistance is felt during advancement or withdrawal of the scope, investigate the source of resistance and take remedial action (e.g., fluoroscopy, contrast injection). • Do not force the distal tip of the LithoVue Flexscope against the sidewall of the ureter or renal pelvis. Doing so can cause patient injury such as perforation, avulsion, hemorrhage or urothelial damage. • Do not use excessive force when advancing or withdrawing an accessory within the LithoVue Flexscope. Doing so can cause patient injury such as perforation, avulsion, hemorrhage, urothelial damage or damage to the LithoVue Flexscope. • When inserting or using accessories, maintain continuous visualization of the distal tip. Ensure the distance between the distal tip of the LithoVue Flexscope and the object in view is greater than the LithoVue Flexscope’s minimum visible distance. Failure to do so may result in the accessories causing patient injury such as perforation, hemorrhage or urothelial damage. • Do not withdraw a laser fiber back into the LithoVue Flexscope while the laser is firing. Doing so may cause patient injury and/or scope damage. • Do not look directly into the light emitted from the LithoVue Flexscope. Doing so can result in eye injury. • Verify ground isolation when setting up and using accessories from different manufacturers. Failure to do so can result in shocks and accessory malfunction leading to patient injury. • Do not open the handle of the LithoVue Flexscope. Doing so can damage the waterproof seals and result in risk of electric shock. • The LithoVue Flexscope is a single-use device and there are no serviceable parts. Do not repair damaged or non-operating LithoVue Flexscopes. Do not use the LithoVue Flexscope if damage is discovered or suspected. • Do not excessively bend the flexible shaft or the articulating section of the LithoVue Flexscope as this may break or kink the shaft. • If damage to the LithoVue Flexscope occurs or it malfunctions during a procedure, stop using the LithoVue Flexscope immediately. See Section 7 “Troubleshooting” for more information. Continue the procedure with a new LithoVue Flexscope, as appropriate. • No modification of this equipment is allowed. Do not attempt to repair or alter any components/ parts of the LithoVue System Workstation. The LithoVue System Workstation contains no operatorserviceable components. All repairs and servicing are to be performed only by authorized Boston Scientific service personnel. See Section 8 “Service and Warranty” for additional information. • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Prior to installation, ensure that the selected hospital’s electrical outlet has a proper ground connection and complies with the information listed on the label located on the rear of the Touch PC. 8
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•
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Prior to use of a cardiac defibrillator, remove the LithoVue™ Flexscope from the patient. Failure to remove the LithoVue Flexscope from a patient during use of a cardiac defibrillator could result in damage to the system due to the discharge of the cardiac defibrillator. The use of accessories, a power supply and/or cables other than those specified or supplied as spare parts from Boston Scientific may increase electromagnetic emissions or decrease immunity of the LithoVue System. When the LithoVue System is used with other electrical medical equipment, the applied parts must be Type BF or Type CF applied parts. Components added to the system by the user must be certified to the respective IEC standards (IEC 60601-1 for medical equipment, IEC 60950 for data processing equipment, and IEC 60065 for A/V equipment) or other country equivalent. In addition, the user must ensure the new configuration complies with local regulations and hospital requirements for electrical safety. If the System Workstation stops functioning during a procedure, follow the procedure described in Section 7 “Troubleshooting”. Using a System Workstation without disinfecting it can expose the operator to bio-hazardous materials. To prevent exposure to bio-hazardous materials, disinfect the System Workstation between uses using the cleaning procedure describe in Section 6.1 “Cleaning the System Workstation”.
User’s Manual
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
2.5 Precautions • Only use the LithoVue Flexscope in conjunction with the LithoVue System Workstation. Connection to other devices may cause device or property damage or operator injury. • Only physicians with adequate ureteroscopic training should perform procedures with the LithoVue Flexscope. Consult the medical literature regarding techniques, complications, and hazards prior to any procedure. • Use the LithoVue Flexscope with caution in patients who have undergone previous urinary tract reconstructive surgery or with known strictures. These conditions may prevent passage of the flexible scope shaft. • Failure to thoroughly understand and follow all instructions, cautions and warnings provided in this User’s Manual and the LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use may result in injury to the patient and/or user; and/or may result in damage to, or malfunction of, this equipment. Additionally, damage to other equipment or property may result. Follow all instructions, cautions and warnings provided with all products and equipment to be used in conjunction with the LithoVue System to avoid any possible hazards due to device incompatibility. • The LithoVue System has been tested and shown compatible with laser lithotripsy devices. The use of other energized procedural devices may cause loss of image, device damage, or patient injury. • When using the LithoVue Flexscope with a laser lithotripsy device, all personnel within the treatment room shall wear protective laser eyewear in accordance with the laser manufacturer’s Instructions for Use. • Do not use accessories that fail to meet the compatibility requirements of the LithoVue Flexscope as stated in the Lithovue Single-Use Digital Flexible Ureteroscope Directions for Use. Doing so may cause damage to the LithoVue Flexscope, System Workstation and/or accessory.. • To ensure satisfactory LithoVue System performance, perform the prescribed inspections and operational checks on the LithoVue Flexscope described in the Lithovue Single-Use Digital Flexible Ureteroscope Directions for Use before use. Additionally, verify the System Workstation is properly installed. See Section 3.2.“Confirming Installation” for more information.
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•
•
•
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•
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
• •
The distal tip of the LithoVue™ Flexscope should be straight when inserting and withdrawing accessories. Follow the accessory directions for use regarding inserting the accessory into a flexible ureteroscope. Failure to follow the accessory directions for use may result in patient injury, or accessory and LithoVue Flexscope damage or malfunction. The LithoVue Flexscope features a strain relief at the transition from the handle to the shaft. The strain relief protects the device during use. To prevent damage to the shaft and/or light fiber, do not bend the shaft sharply. Use only those fluids/lubricants recommended in the compatibility section of the LithoVue SingleUse Digital Flexible Ureteroscope Directions for Use or see Section 3.4 “LithoVue Flexscope Fluid Compatibility”. Do not use accessories that fail to meet the compatibility requirements of the LithoVue Flexscope as stated in the LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use. Doing so may cause damage to the LithoVue Flexscope and/or accessory. The LithoVue Flexscope Connector Cable (hereafter referred to as Flexscope Cable) should connect to the Workstation Receptacle easily. If the Flexscope Cable does not connect, verify that the arrows on the Flexscope Cable and the Workstation Receptacle line up and that the Workstation Receptacle is not damaged. Forcing the Flexscope Cable into the Workstation Receptacle may damage the scope and/or System Workstation. Do not insert a wet, contaminated, or damaged Connector Cable plug into the System Workstation as poor video performance or damage to the system may result. Do not remove the Connector Cable from the System Workstation by pulling on the cable as poor video performance or damage to the system may result. Slide the locking collar on the Connector Cable’s plug toward the cable and pull the plug out to remove the cable. Placing the System Workstation near other medical electrical equipment may result in electromagnetic interference (EMI) which may degrade the video image. Additionally, EMI from the System Workstation may interfere with other equipment in the operating room. Verify that all electrical equipment is working properly before starting the procedure. Failure to do so may result in the equipment not working properly resulting in either a delay of the procedure or an adverse event. Spilling liquids on the System Workstation can damage it or cause it to shut down. Do not place liquids above or near the System Workstation. During assembly and before each use, inspect all components for damage. Do not use a component if it appears damaged. Contact Boston Scientific for service using the information found in Section 8 “Service and Warranty”.
2.6 Adverse Events Possible complications include, but may not be limited to: • • • • •
Bleeding Avulsion Stenosis/Stricture Inflammation Laceration
• • • • •
Pain Discomfort Urinoma Infection Fever
• Sepsis • Renal Failure • Perforation (ureter, renal pelvis or bladder) • Hematuria
• Ureteral reflux • Hematoma • Urothelial damage
3 How Supplied CAUTION: Examine the System Workstation packaging. Do not use if packaging has been opened or the components appear damaged. Do not use if labeling is incomplete or illegible. 10
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CAUTION: Inspect the components for damage. Do not use a component if it appears damaged. Contact Boston Scientific for service. 3.1 System Workstation Components The LithoVue™ System Workstation is shipped in a cardboard shipping crate. Inside the shipping crate, the components of the System Workstation are packaged separately, as noted in Figure 3.1. The lists below detail the contents included in each component box. NOTE: Depending on the model, the power cord may be packaged either in the Touch PC box or in the cardboard shipping crate. Figure 3.1 – LithoVue System Workstation Packaging
Touch PC
Packaging Fillers
Workstation Cart
Outer Shipping Box
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Final Packaging Shipping Configuration
Label
Shipping Pallet
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Touch PC Packaging: • Touch PC • Power Transformer • (8) No. M4 x 10 mm pan-head Phillips Mounting Screws {(4) required for mounting the Touch PC to the Touch PC Mounting Plate} Note: (4) extra Mounting Screws are provided • DVI Cable • LithoVue™ System Workstation User’s Manual
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Cart Packaging: • Cart Base with attached wheels • Cart Post • Touch PC Mounting Plate • Cart Handle with (2) No. 10-32 x 9/16” Phillips-head screws pre-installed • Power Transformer Bracket Kit containing: - Power Supply Holder with Velcro straps and Clamping Block - Cord Wrap Hook with Clamping Block - (2) No. 10-32 x 9/16” Phillips-head screws - Power cord strain relief kit containing: (1) nylon cable clamp, (1) #8 flat washer and (1) 8-32 x 1/4” Phillips-head screw • Hardware bag containing: - (3) No. 10-32 x 9/16” flat-head Phillips screws (for Touch PC Mounting Plate) - #2 Phillips-head Screwdriver - 9/64” Hex Wrench (used to adjust Tilt Tension Adjustment Screws) - 1/2” (13 mm) Socket Wrench - (1) Manual Tilt Lexan Cover (optional - cover the screws on Touch PC Mounting Plate) - (1) 5/16” flat washer, (1) 5/16” split lock washer and (1) 5/16”-18 x 1” Hex Head Cap Screw 3.2 System Workstation Assembly CAUTION: Do not attempt to repair or alter any components/parts of the LithoVue System Workstation. The LithoVue Touch PC contains no operator-serviceable components. All repairs, upgrades and servicing are to be performed only by authorized Boston Scientific service personnel. See Section 8 “Service and Warranty” for additional information. Assembling the Cart Follow these steps to assemble the Cart: Assembling the Cart Base and Cart Post 1. Remove the Cart components from the box. The Cart Post, Cart Base, Touch PC Mounting Plate, Cart Handle, Power Transformer Bracket and hardware are all packaged separately within the outer Cart Box. 2. Confirm that all components listed in Section 3.1, “System Workstation Components”, are included in the packaging and that the components are not damaged. 3. Insert the Cart Post into the Cart Base and lay the assembly on its side for access to the bottom of the Cart Base.
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4. Assemble the (1) 5/16” hex head cap screw, (1) 5/16” flat washer and (1) 5/16” split lock washer as shown in Figure 3.2 Start the screw by hand before using the 1/2” (13 mm) wrench to fully tighten the screw. Tighten the screw until fully seated and the post no longer rotates. Figure 3.2 – Attaching the Cart Post to the Cart Base
Cart Post
Cart Base
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
5/16" flat washer, 5/16" split lock washer, and hex head cap screw 5. Return the Cart to the upright position and confirm that the three caster locks are pressed down to lock the Cart into position. Attaching the Touch PC Mounting Plate to the Cart Post The three-hole pattern on the top of the Cart Post is designed to orient the Touch PC Mounting Plate in one direction only. The Touch PC Mounting Plate is designed to always position the Touch PC opposite the Cart’s Height Adjustment Knob. Secure the Touch PC Mounting Plate to the Cart Post as follows: 1. Place the Touch PC Mounting Plate on the Cart Post, aligning the three-hole pattern. 2. Insert the (3) flat-head Phillips Mounting Screws into the Touch PC Mounting Plate and Cart Post. Start the screws by hand before tightening with the Phillips-head screwdriver. Tighten the screws until they are snug and fully seated. See Figure 3.3. 3. Optional – if desired, cover the top of the mount with the included adhesive Lexan cover.
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Figure 3.3 – Installing the Touch PC Mounting Plate
Touch PC Mounting Plate
(3) No. 10-32 x 9/16" Mounting Screws
Top of Cart Post
Attaching the Cart Handle 1. Separate the two pieces of the Cart Handle by using a Phillips-head screwdriver to remove the (2) pre-installed screws. 2. Attach the two pieces of the Cart Handle together around the Cart Post below the Cart label. The dark part of the handle should face in the same direction as the Cart’s Height Adjustment Knob. See Figures 3.4 and 3.5. 3. Re-insert the (2) screws and use a Phillips-head screwdriver to secure the two handle pieces firmly around the Cart Post. Be careful not to overtighten the screws. Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Figure 3.4 – Attaching the Cart Handle Cart Handle
Cart Post
10-32 x 9/16" Phillips-head screws
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Figure 3.5 – Proper Placement of the Cart Handle
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Attaching the Power Transformer Bracket 1. Attach the Cord Wrap Hook and Power Transformer Bracket’s Clamping Blocks together around the Cart Post approximately 40 cm (16”) from the Cart Base. Ensure the Velcro straps for the Power Transformer are facing forward (same direction as the Touch PC Mount). See Figure 3.9 for correct installation with the Power Transformer. 2. Insert the (2) screws using a Phillips-head screwdriver to secure the Cord Wrap Hook and Power Transformer Bracket firmly to the Cart Post. Be careful not to overtighten the screws. Installing the Touch PC onto the Cart Follow these steps to install the Touch PC onto the Cart: 1. Remove the Touch PC and ancillaries from the box. 2. Confirm that all components listed in Section 3.1 “System Workstation Components” are included in the packaging and that the components are not damaged. 3. Loosen the Tilt Adjustment Lever and adjust the mounting plate so that it is approximately vertical. See Figure 3.6. NOTE: if the Touch PC Mounting Plate is difficult to adjust, the tilt tension adjustment screws will need to be loosened. See Section 3.2 “Adjusting Touch PC Tilt” for instructions on how to adjust the tilt tension adjustment screws.
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Figure 3.6 – Touch PC Tilt Adjustment Lever
Tilt Adjustment Lever
4. Tighten the Tilt Adjustment Lever to prevent movement of the mounting plate during assembly. 5. Using a Phillips-head screwdriver, install two of the four M4 x 10 mm Mounting Screws in the two upper holes of the inner set of the Touch PC’s VESA-mounting holes (See Figure 3.7). Leave about 1/4” of space between the head of the screw and the Touch PC.
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Figure 3.7 – Touch PC Mounting Holes
6. Have an assistant lift the Touch PC using the handholds molded into the sides of the Touch PC, and slide the two M4 x 10 mm Mounting Screws on the Touch PC into the two top slots on the mounting plate. The assistant should hold the Touch PC in this position. 7. Using a Phillips-head screwdriver, insert and tighten the lower two M4 x 10 mm Mounting Screws in the two lower holes of the Touch PC Mounting Plate. See Figure 3.8.
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Figure 3.8 – Installing the Touch PC Mounting Plate Inner VESA Mounting Hole Set
8. Tighten the top two M4 x 10 mm Mounting Screws holding the Touch PC to the mounting plate. 9. Install the Power Transformer into the Power Transformer Bracket with the power switch facing down and hold it in place using the Velcro straps. See Figure 3.10. 10. Attach the AC Power Cord to the Power Transformer. Place the Nylon Cable Clamp (from the Power Cord Strain Relief Kit) over the AC Power Cord. 11. Mount the Nylon Cable Clamp to the bottom of the Power Transformer Bracket using the #8 flat washer and 8-32 x 1/4” Phillips-head screw (from the Power Cord Strain Relief Kit). NOTE: The loop of the Nylon Cable Clamp should point out the side of the Power Transformer Bracket. See Figure 3.9.
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Figure 3.9 – Installing the Power Cord Strain Relief Kit
Close-up View Showing Bottom of Bracket
Front View
Power Cord Strain Relief Kit with Phillips-head Screw
Power Cord Strain Relief Kit 12. Organize the Power Cord in the Cord Wrap Hook. 13. Run the DC plug up the outside of the cart post and plug it into the DC power receptacle on the bottom of the Touch PC. User’s Manual
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Figure 3.10 – Installing the Power Transformer Bracket
Power Transformer
Cord Wrap Hook
Power Transformer Holder with Velcro Straps Clamping Blocks
Cart Adjustment The Cart is equipped with (2) adjustment mechanisms, one for adjusting the Touch PC’s height and another for adjusting the Touch PC’s tilt. See Figure 3.11. Figure 3.11 – Cart Adjustments
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Tilt Adjustment Lever
Height Adjustment Knob
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Adjusting Touch PC Height CAUTION: The Touch PC Cart Post operates by pneumatic pressure and will travel upward when disengaged. Ensure that nothing obstructs upward travel before turning the Height Adjustment Knob. Grasp the Touch PC using the side handholds to control the upward travel of the Touch PC when the Height Adjustment Knob is loosened. 1. To adjust the Touch PC’s height, loosen the Cart’s Height Adjustment Knob while supporting the Touch PC using the handholds molded into the sides of the Touch PC. Move the Touch PC to its desired location. 2. Tighten the Cart’s Height Adjustment Knob. Adjusting Touch PC Tilt 1. 2. 3. 4.
To adjust the Touch PC’s tilt, loosen the Cart’s Tilt Adjustment Lever. Grasp the handholds molded into the sides of the Touch PC and tilt to the desired angle. Retighten the Tilt Adjustment Lever. If the Touch PC does not hold its tilt position, use the 9/64” (3.5 mm) hex wrench provided with the Cart to tighten the tilt tension adjustment screws equally. See Figure 3.12. 5. If the Touch PC is too difficult to tilt, use the 9/64” (3.5 mm) hex wrench provided with the Cart to loosen the tilt tension adjustment screws equally. See Figure 3.12. Figure 3.12 – Adjusting Cart Tilt Tilt Tension Adjustment Screws
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Tilt Adjustment Lever
Confirming Installation Confirm the correct installation of the System Workstation after assembly by following these steps: 1. Verify that all fasteners on the Cart and Touch PC mounting system are secure. 2. Plug the System Workstation into the hospital’s electrical outlet and ensure the switch on the Power Transformer is turned on. The green LED on the Power Transformer will light when the Power Transformer is turned on. CAUTION: To avoid risk of electric shock, ensure the Power Cord is plugged into the Touch PC before plugging the System Workstation into the hospital’s electrical outlet. 3. Press the power button on the front panel to power on the System Workstation. (see Figure 3.13). User’s Manual
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Figure 3.13 – Front Panel Power Button
Power Button
The System Workstation displays the boot screen (see Figure 3.14). Figure 3.14 – Boot Screen
4. The System Workstation will display the LithoVue™ Flexscope disconnected message screen (see Figure 3.15) in the image display area. Once this image has been displayed, the System Workstation is functioning correctly and is now ready for use. Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Figure 3.15 – Flexscope disconnected message screen
Connecting an External Monitor or DVI Switcher with the DVI Cable If desired, you can display the live video image on an external DVI-compatible monitor or split the image signal using a DVI switcher by following these steps:
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User’s Manual
1. Confirm that the external monitor and/or DVI switcher meets the specifications described in Section 3.4 “System Workstation Device - Accessory Compatibility”. 2. Connect the supplied DVI Cable from the DVI output jack on the bottom of the System Workstation to the DVI In jack on the external monitor or DVI switcher. 3. Turn on the external monitor. The video image (but no touch screen buttons) will be displayed on the external monitor. CAUTION: Users are responsible for using appropriate audio-visual equipment and for verifying proper installation prior to use. 3.3 Transportation, Use and Storage The following instructions provide information for proper movement and storage of the System Workstation. 1. Ensure the Power Cord is securely looped around the Cart’s Cord Wrap Hook to prevent cord damage during transportation. 2. Lift the pedal on the locking casters to unlock the System Workstation and move to the desired location. To ensure safe movement of the system, check that the wheels are free of obstacles. 3. Store the System Workstation in an area that is safe from impact or other accidental damage. 4. Confirm that storage area environment is within the limits provided in Table 3.1. 5. Confirm that the storage area is free from risk of water leakage or splashes. 6. Push pedal on the locking casters down to secure the system’s position. This will prevent accidental rolling and potential impact damage. Table 3.1 Transportation, use, and storage environmental limits
Ambient temperature (°C)
10 to 35
Relative humidity (%)
30 to 75 RH (non-condensing)
Atmospheric pressure (hPa)
700 to 1060
Boston Scientific (Master Brand User’s Manual Template 8.5in x 11in), LithoVue System Workstation User’s Manual, Global, 91012672-01C
Environmental Limits during Use
Environmental Limits during Transport and Storage Ambient temperature (°C)
-20 to 60
Relative humidity (%)
10 to 90 RH (non-condensing)
Atmospheric pressure (hPa)
500 to 1060
User’s Manual
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