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Streamline Series Surgical Tables - User Manual
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1. easily fold for com pact storage when not in use Catalog S ARM Procedure Armboards Optional Carbon Fiber Double Arm Board slides around carbon fiber table top and under the table top pad and supports the patient s 2 arms The patients weight keeps the armboards in place The Procedural Armboards allow both armboards a rotational range of 180 This equipment can easily fold for compact storage when not in use Catalog P ARM Footswitch Optional The Footswitch provides hands free mobility and allows the surgeon to move the patient in all directions Catalog STJO MSRS Modular Side Rail System Optional The Modular Side Rail System is a set of 2 side rail clamps Each side rail clamp has a 6 section of standard OR side rail which provides a hassle free way to attach any standard surgical acces sory to the imaging table Catalog MSRS denotes how many movements Equipment Removal amp Installation mp Patient Safety Straps REMOVAL With the patient positioned in a level position remove the patient straps by disconnecting the joined Velcro INSTALLATION The patient safety straps secure using Velcro The patient is positioned on the imaging table while the imaging table is in a level position The patient straps are wrapped around the imaging table top and around the patient The Velcro is joined and attached together to help secure the patient onto the imaging table The operator must ensure proper placement of patient
2. straps so the patient does not get harmed m Facial Access Plug REMOVAL To remove the Facial Access Plug first remove the donut hole pad and then raise the patient pad and remove the filler piece Replace the patient pad INSTALLATION The facial access plug consists of a donut hole pad and a filler piece To install raise the patient pad and place the filler piece onto the opening in the table top orient the filler piece with the protruding section down to lock the filler piece in place Replace the pad and place the donut hole pad into the opening in the patient pad m Remote control Handset and Footswitch REMOVAL Be sure the imaging table is unplugged To remove existing Handset or Footswitch you must follow the cord to where it is strain relieved Remove strain relief and separate wires Follow the handset or Footswitch cord to where cord enters the control box Remove protec tive cover off the control box Follow cord to connection point at the control box and pull cord plug to remove INSTALLATION Be sure the imaging table is unplugged With the protective cover off the control box plug in new Handset or Footswitch control where previous control removed Replace the protective cover on the control box Attach strain relief where previously removed being sure to attach any wires that were originally strain relieved with original control m Modular Side Rail System MSRS REMOVAL The Modular Side Rail System is a set of two clamps w
3. table First lift the patient pad from the imaging table top and slide the Procedural Armboards towards the head end of the imaging table top until the Procedural Armboards are past the end of the imaging table top Lift and remove Replace patient pad INSTALLATION At the head end of the table top lift the patient pad from the imaging table top Hold the Procedural armboards in a horizontal position Allow the Velcro straps on the Procedural armboards to go around table top Place armboards in desired location and tighten Velcro straps if necessary Replace patient pad ADJUST RADIAL ANGLE Grasp the end of the armboard and move it in the desired direc tion There are no locks to keep in position The Streamline surgical table series is intended to be used with mobile x ray units for minimally invasive procedures on patients as large as 500 Ibs Standard Specifications Table Dimensions 84 x 24 w Mattress 2 thick 5 cm Tabletop Material Carbon fiber skin foam core with integral facial cut out Patient Capacity 500Ib 227kg Tabletop 84 L x 24 W x 1 62 T Radiolucent Area 54 L x 24 W unobstructed Systems Requirements for all models Humidity 0 9296 92 DET GE Ee Allowable Storage and Operating 0 ape _ Allowable Storage 40 C Allowable Operating Temperature 5 C 104 F Temperature OC 32F 5 c 104 F to 40 C 104 F 40 F to 40C 104F 40 F BIS DH CL Mode of Operation 10
4. 510 k Exempt Yes cx KP GURGICAL TABLES Fe Surgical Tables Incorporated Toll Free 888 737 5044 2 DeBush Ave Unit A 2 Middleton MA 01949 www surgicaltables com Manual originally drafted in english Streamline MANUAL Rev A
5. Duty Cycle 1 min on 9 minutes off 3 EE Streamline Series Fixed Hieght 1 FIXED HEIGHT 36 TABLE WEIGHT 330lbs 150kg SUREAMLINE Streamline Series 1 Move Surgical Table T HEIGHT 28 TO 38 TABLE WEIGHT 375lbs 170kg Patient Capacity 500lbs 227kg Mode of Operation 1096 Duty Cycle 1 min on 9 minutes off PSUREAMLINE 2 AC Voltage 120V Streamline Series 2 Move Surgical Table 1 HEIGHT za Accurent asa TABLE WEIGHT 390lbs 177kg Patient Capacity 500lbs 227kg i Rtgs D STREAMLINE 3 A AC Voltage 120V Streamline Series 3 Move Surgical Table ee TT Ficom 29 2 LATERAL TILT aall 17 3 TRENDELENBURG 15 5 TABLE WEIGHT 420lbs 191kg Mode of Operation 1096 Duty Cycle Patient Capacity 500lbs 227kg 1 min on 9 minutes off 4 AC Voltage 120V Streamline Series 4 Move Surgical Table acy Ge 2 LATERAL TILT 17 17 Se EEE EOE 4 LONGITUDINAL TRAVEL 10 4 5 TABLE WEIGHT 590lbs 268kg Mode of Operation 1096 Duty Cycle Patient Capacity 500lbs 227kg 1 min on 9 minutes off STREAMLINE 5 AC Voltage 120V Streamline Series 5 Move Surgical Table 1 HEIGHT 33 5 TO 43 5 2 LATERAL TILT 1 17 3 TRENDELENBURG 4 15 4 LONGITUDINAL TRAVEL 10 5 5 LATERAL TRAVEL 10 5 10 Duty Cycle TABLE WEIGHT 695lbs 315kg 1 min on 9 minutes off Patient Ca
6. SUPGIC FIL TABLES I7 SUJREAMLINE s e ri e s INSTRUCTIONS FOR USE Symbols amp Labeling All Symbols featured below shall be referenced in this manual as well as on product labels Represents a caution or warning HH Indicates that the product should Be sure to read and comply with be protected from moisture all precautions and warnings A Warns against an electrical shock hazard 1 1 Indicates this end up on Indicates the potential of exposure memm Shipping label to harmful x rays BOSNAE D Indicates a Protective Earth Ground Terminal the recommended temperature i Indicates information regarding during transport and storing Indicates the components are a RK Type B Applied Part E Warns that there should be no stacking of containers during DS transport aul Indicates place of manufacture Ll Indicates information regarding A the recommended humidity rs A All Labels are adhesively applied and completely waterproof amp stain resistant If any product labeling is damaged or missing contact Surgical Tables Inc immediately Images below are not to exact scale REF SGT ES SE Incorporated SN 021213 06 Middleton MA 01949 ed www surgicaltables com 978 777 4031 Indicates alternating current AC Indicates consult Instructions for Use Indicates Pinch Point risk Indicates Crush risk LATERAL TILT Complies
7. are also manufactured to be quiet rolling washable non marking to floors Facial Access Plug Comes standard While in place the facial access plug allows the table to support the patient as if it were a solid table top while the patient is lying Supine face up When the facial access plug is removed it allows access to the patients face while the patient is lying Prone face down Catalog MAX FILLER Remote control Handset Comes Standard The Remote Control comes standard on all Streamline Series imaging tables with motor ized movements The remote control allows the operator to position their patient Catalog EHA3 The Height buttons raise or lower the table top A DO NOT place undue weight or downward pres sure on any Carbon Fiber Arm Boards It is a positioning device for the arms and should not be used as leverage to get on or off the table Injury can occur The Lateral Tilt buttons control the lateral angle of inclination The Trendelenburg buttons control the angle of inclination of the head end The Longitudinal Travel buttons will move the table top in the longitudinal direction The Lateral Travel buttons will move the table top in theVlateral direction Surgical Armboards Optional Carbon Fiber Single Arm Board conveniently mounts to the MSRS or the table mounted side rail and easily supports the patient s arm The Surgical Armboards allows for a rotational range of 180 This equipment can
8. d to make sure the system operates as intended This can include to check the brakes on the system and all of the motion controls Additionally check all supporting structures and pivot points for unusual wear or loose parts If anything noticed call Surgical Tables Incorporated immediately Preventative maintenance is not required SERVICE Do not service your Streamline Series imaging table unless you have consulted Surgical Tables Incorporated No user serviceable parts Surgical Tables Incorporated provides a 4 Year Limited Warranty 4 year war ranty on non electrical parts and 1 year warranty on electrical components The warranty is only valid to the original purchaser and is not transferable Surgical Tables Incorporated has the right to assess if mis use has occurred In the case of mis use the warranty is void Compliance Surgical Tables Incorporated STI manufactures medical devices that are compliant with the Center for Devices and Radiological Health CDRH Code of Federal Regulation 21 Subchapter J Part 1020 Section 30 CFR21 Subchapter J part 1020 30 the performance standard for ionizing radiation emitting products Additionally STI s products are manufactured according to the Food amp Drug Administrations FDA Current Good Manufacturing Practices CGMP s FDA PRODUCT CLASSIFICATION Device Description Radiologic Table Device Class 2 Product Code KXJ GMP Exempt No Regulation Number 892 1980
9. ith 6 side rails The side rail clamps are removed by loosening the locking handle located underneath the side rail clamp Turning the handle counter clockwise loosens the side rail clamp so it can be removed or repo sitioned INSTALLATION To attach the side rail clamp there is a groove on the bottom of the imaging table top that the side rail clamp jaw has to be line up with Place the side rail into the desired location and attach by tightening the locking handle located underneath the side rail clamp Turning the handle clockwise tightens the clamp me Surgical Armboards REMOVAL The Surgical Armboard mounts to the MSRS or the table mounted side rail The Surgical Armboard is removed by grasping one end of the armboard lift the latch handle and lift up and off the side rail INSTALLATION Hold the armboard in a horizontal position Tilt the end of the board up approximately 2 to 3 Hook the upper jaw of the mount over the side rail lift the latch handle and allow the end of the board to return to horizontal position Release the latch and the arm board should now be fastened to the table ADJUST RADIAL ANGLE Lift up on the end of the armboard and move it in the desired direc tion Lower the end of the armboard and the weight of the arm will lock the board in position Do not apply excessive force when lifting the end of the armboard m Procedural Armboards REMOVAL The Procedure Armboards are removed without the patient on the imaging
10. ns to the Streamline Series imaging table that is out of the normal conditions of operation or the Streamline Series imaging table is not functioning normally call Surgical Tables Incorporated Do not attempt to fix your Streamline Series imaging table without consulting Surgical Tables Incorporated Surgical Tables Incorporated must have knowledge of any com plaints problems or issues with the Streamline Series imaging tables Patient is to be restrained to the Streamline Series imaging table during use The operator of the Streamline Series imaging table is responsible for the patients safety during use The operator must be certain the patient can not be harmed during operation of the Streamline Series imaging table Make sure all 4 castors are locked before allowing a patient to board the Streamline Series imaging table In order to separate equipment from supply mains disconnect power cord at wall Do not position equipment so that power cord can not be unplugged There is a possibility of electromagnetic or other interference while table is in operation The use of a power conditioning outlet strip one which is specified to reduce EMI or electromagnetic interference is recommended to avoid interference d It is suggested that when moving the table to use 2 people at all times It is also important to be aware of inclines and all accessories f Environmental conditions for transport and storage specified in accompa nying docume
11. nts and marked on packaging Equipment is capable while packed for transport or storage of being exposed to the conditions stated by the manufacturer Instructions for use contain all information necessary to operate the equip ment in accordance to its specification Table is not intended to transport patients It is intended for positioning patients when used with mobile x ray A Type of protection against electric shock Class Equipment A Degree of protection against electric shock Type B applied part EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE and also Not for use with oxygen or oxygen enriched atmospheres Any items placed on table patient surface reduces the allowable patient load Example Lead drapes Medical Equipment et Classification according to the degree of protection against ingress of water IPX1 footswitch and hand control only When disposing of equipment follow local federal and or country guidlines and be sure to follow appropriate disposal instruction provided for all waste products to assure that any potential risk to patients or medical staff is mitigated The Streamline imaging tables do not offer protection from harmful x rays Use caution and personal protection when using x rays d This product is intended for minimally invasive procedures it is not intend ed for use in operating rooms The use of accessories tran
12. pacity 500lbs 227kg all degree measurements 2 all height measurements to carbon fiber top Base I Shaped Steel Base 82 L x 26 Maintenance Preventative Maintenance amp Service ROUTINE CARE The unit needs to be unplugged from the wall power before any cleaning Using a soft cloth dampened with mild soap suds and luke warm water wipe all surfaces and dry with soft cloth Wait at least 10 minutes after cleaning before plugging unit into wall power DISINFECTION The unit needs to be unplugged from the wall power before any disinfecting Contamination with blood can be disinfected with 1 10 dilution of bleach 5 2596 sodium hypochlorite as recommended by the CDC US Department of Health and Human Services February 1989 Using a soft cloth dampened with 1 10 dilution of bleach 5 25 sodium hypochlorite wipe all surfaces and dry with soft cloth Wait at least 10 minutes after disinfecting before plugging unit into wall power WARNING lodophor type disinfectants Betadine for example with stain the patient pad WARNING Prolonged contact with bleach solutions improper dilution ratios for any cleaning agent or poor rinsing after disinfecting and cleaning may cause damage to both the appearance and performance INSPECTION Preventative Inspection is required every 6 months This includes checking the system to ensure it is working properly checking to make sure no cords are frayed or damaged an
13. sducers and or cables other than those specified with the exception of those sold by the manufacturer as replace ment parts for internal components may result in increased emissions or decreased immunity of the equipment or system Operation amp Equipment To begin operating the Streamine Surgical table you must position it in place lock the table castors and plug the power cord into a receptical With the table top in a level position and the table castors locked assist the patient onto the table After the patient is correctly positioned apply the patient safety restarint straps It is now safe to use the hand or foot controls to move the table to the desired position Always make sure the patient is safe while oper ating the imaging table you may need to re position patient straps to increase patient safety To stop table in case of emergency remove plug from wall power Always make sure plug is accessible and easily removed The following describes the imaging tables motorized movements LATERAL TILT Height Lateral Tilt Trendelenburg Longitudinal Travel Lateral Travel Patient Safety Straps Comes standard The patient safety straps help to immobilize the patient during a procedure Catalog AP STRAP Lockable Castors Comes standard Each Streamline Series imaging table comes equipped with 5 rotating and lockable casters that allow for table mobility ease The castors
14. with HHS Radiation Performace Standard 21 CFR Subchapter J ATTENTION Lj N DO NOT EXCEED 500 LB LOAD Supply Vi nt 6 52 y 60 Hz Equipment Continuous Operation 10 Duty Cycle TRENDELENBURG STREAMLINE SLABEL Rev B Serial Number Label Z SURGICAL TABLES INC AK OONELOGO Re Handset Label Pinch Point Label Rev A gt Pinch Point Label MAX GNDLABEL Rev A Ground Label During transport have table at lowest height position Shipping Label Transport Label Rev A Crush Sticker Label Rev A Crush Label STI Brand Dome Label MAXIMUM LOAD 500 LBS 227 kg Any items placed on table patient surface reduces the allowable patient load Example Lead drapes Medical Equipment etc Warning Labels Es 92 HK Allowable Humidity 0 92 ddd 40 C 5 C 104 F 40 F E Shipping Label Shipping Label Cautions Warnings Do not operate any of the Streamline Series imaging tables without proper training or without reading and understanding this user s manual The Streamline Series imaging tables are rated for a 500 pound patient Do not place a load larger than 500 pounds onto the Streamline Series imaging table Do not allow a patient to board at the head end of the table Do not attempt to move the Streamline Series imaging table with the brakes locked If anything happe
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