Oakworks Medical Products - englisch

Position for Successour missionOakworks ® has been providing customers with innovative products, excellent service, and cost effective solutionsfor over 30 years. Oakworks ® Medical has collaborated with leaders in the medical specialties we serve to createcutting edge designs that balance the needs of both patients and practitioners. We are committed to identifyingthe needs of our customers and providing solutions that are cost effective.Our state-of-the-art 90,000 square foot factory in Pennsylvania, coupled with our advanced engineeringdepartment, allows us to quickly meet the needs of our customers. From custom designed tables that complementnew technologies to quick turnarounds on our present product line, Oakworks ® is uniquely positioned to meetyour needs.ISO CertificationOakworks ® Medical is ISO 13485:2003 certified, enhancing our commitment to the safety and comfort of boththerapists and patients. The ISO standard is intended to ensure that medical device manufacturers have therequired quality management systems in place to safely design, manufacture and distribute medical devices.Safety standardsAll Oakworks ® Imaging Tables (including Urology and Lithotripsy Tables) have the following approvalsand regulatory compliance: FDA listed to regulation #892.1980 – Class 2; CE marked – to CE Declaration ofConformity to Annex I of the EC Directives 90/385/EEC and 93/42EEC. Authorization to Mark (ATM) to IEC60601-1-6 3rd Edition, ATM to ANSI/AAMI ES60601-1 3rd Edition, ATM to CAN/CSA-C22.2 No. 60601-1.ETL Test Reports to IEC/EN 60601-1 3rd Edition, IEC/EN 60601-1-2 3rd Edition, IEC/EN 60601-2-32 1stEdition & IEC 62366 1st Edition.for moreinformationVisit www.oakworksmed.comPage 2

c-arm imaging tablesc-ARM IMAGING table overviewTOP DIMENSIONSIntegrated Headrest (IF) 22" x 84"Rectangular (RT) 24" x 80"TOP DIMENSIONSIntegrated Headrest (IF) 22" x 84"Rectangular (RT) 24" x 80"TOP DIMENSIONSRectangular (RT) 24" x 80"750 lb. Bariatric RatedACCESSORIEST-rail Clamp2" Radiolucent Table Top PadCFPM400 & CFPM401INCLUDED FEATURESPatient Weight Capacity:Electric Height Range: 26" - 44"Integrated Headrest Carbon Fiber Top 22"W x 84"LRectangular Carbon Fiber Top 24"W x 80"LWarranty:4 years parts, 1 year laborSafety Standards:FDA listed, CE marked, cETL approvedPatient Safety Strap4" CastersHand Control (all motions)Foot Control (all motions)1" Radiolucent Table Top Pad3 Cranial Positioning Pads (included with Integrated Headrest Top only)(1) 2" thick x 12" square(1) 4" thick x 12" square(1) Crescent face rest padCFPM300 & CFPM301INCLUDED FEATURESPatient Weight Capacity:Electric Height Range: CFPM 300 - 26" - 44"CFPM 301 - 25" - 43"Integrated Headrest Carbon Fiber Top 22"W x 84"LRectangular Carbon Fiber Top 24"W x 80"LWarranty:4 years parts, 1 year laborSafety Standards:FDA listed, CE marked, cETL approvedPatient Safety Strap4" CastersHand Control (all motions)Foot Control (all motions)1" Radiolucent Table Top Pad3 Cranial Positioning Pads (included with Integrated Headrest Top only)(1) 2" thick x 12" square(1) 4" thick x 12" square(1) Crescent face rest padCFPMB301INCLUDED FEATURESPatient Weight Capacity:750 lbs.Electric Height Range: 26.5" - 44.5"Rectangular Bariatric Top 24"W x 80"LWarranty:4 years parts, 1 year laborSafety Standards:FDA listed, CE marked, cETL approvedPatient Safety StrapHeavy Duty 5" CastersHand Control (all motions)Foot Control (all motions)1" Radiolucent Table Top Padmade in the USAwith US & imported parts4 movement imaging tablesMOVEMENTS500lbs. CFPM400Motion 1....................height range 26" - 44"Motion 2.......Trendelenburg tilt +15°/-12°Motion 3....................10" longitudinal travelMotion 4................................lateral tilt ±15°CFPM401Motion 1....................height range 26" - 44"Motion 2.......Trendelenburg tilt +15°/-11°Motion 3....................10" longitudinal travelMotion 4.............................±4" lateral travelOPTION CODES5" Casters................................................... 5C3 movement imaging tablesMOVEMENTS500 lbs. CFPM300Motion 1....................height range 26" - 44"Motion 2.......Trendelenburg tilt +15°/-12°Motion 3................................lateral tilt ±15°CFPM301Motion 1....................height range 25" - 43"Motion 2.......Trendelenburg tilt +15°/-11°Motion 3....................10" longitudinal travelOPTION CODES5" Casters................................................... 5CBariatric imaging tableMOVEMENTSCFPMB301Motion 1.............height range 26.5" - 44.5"Motion 2.......Trendelenburg tilt +15°/-11°Motion 3....................10" longitudinal travelOPTION CODES4" Casters................................................... 4CPage 3

c-ARM IMAGING table overviewTOP DIMENSIONSIntegrated Headrest (IF) 22" x 84"Rectangular (RT) 24" x 80"TOP DIMENSIONSIntegrated Headrest (IF) 22" x 84"Rectangular (RT) 24" x 80"TOP DIMENSIONSRectangular (RT) 24" x 78"ACCESSORIEST-rail Clamp2" Radiolucent Table Top PadCFPM100INCLUDED FEATURESPatient Weight Capacity:Electric Height Range: 22" - 40"Integrated Headrest Carbon Fiber Top 22"W x 84"LRectangular Carbon Fiber Top 24"W x 80"LWarranty:4 years parts, 1 year laborSafety Standards:FDA listed, CE marked, cETL approvedPatient Safety Strap4" CastersFoot Control1" Radiolucent Table Top Pad3 Cranial Positioning Pads (included with Integrated Headrest Top only)(1) 2" thick x 12" square(1) 4" thick x 12" square(1) Crescent face rest padCFPMFXHINCLUDED FEATURESPatient Weight Capacity:DTPM3001 movement imaging tableMOVEMENTS500 lbs. CFPM100OPTION CODES5" Casters................................................... 5Cfixed height imaging tableMOVEMENTSCFPMFXH500 lbs.Standard Height: 37"Integrated Headrest Carbon Fiber Top 22"W x 84"LCarbon Fiber Rectangular Top 24"W x 80"LWarranty:4 years parts, 1 year laborSafety Standards:FDA listed, CE marked, cETL approvedPatient Safety Strap4" Casters1" Radiolucent Table Top Pad3 Cranial Positioning Pads (included with Integrated Headrest Top only)(1) 2" thick x 12" square(1) 4" thick x 12" square(1) Crescent face rest padOPTION CODES5" Casters................................................... 5C3 movement, dual tower imaging tableINCLUDED FEATURESMOVEMENTS450 lbs. DTPM300Patient Weight Capacity:Electric Height Range: 24" - 40"Rectangular Polycarbonate Top Dimensions: 24"W x 78"LWarranty:4 years parts, 1 year laborSafety Standards:FDA listed, CE marked, cETL approvedPatient Safety Strap4" CastersHand Control (Height, Trendelenburg/Reverse)Foot Control (Height)1" Radiolucent Table Top Padmade in the USAwith US & imported partsMotion 1....................height range 22" - 40"Fixed height, no motionMotion 1....................height range 24" - 40"Motion 2....................23" manual travel topMotion 3................Trendelenburg tilt ±14°OPTION CODES5" Casters................................................... 5CFixed T-rail: 78" Long.........7L (Left), 7R (Right)Fixed T-rail: custom lengthc-arm imaging tablesPage 4

cfpmB301Electric 3 Movement, 750 lb.Bariatric Rated Imaging Tablec-arm imaging tables• 750 lb. Patient Weight Capacity• Best Adjustable Height Range26.5”- 44.5” Industry’s Lowest• Warranty: 4 years parts, 1 year labor• Cost Effective 3 Movement Table• 52.5” Metal Free Imaging SpaceMotion 1Motion 2Height RANGE 26.5”- 44.5” trendelenburg tilt +15º/ - 11ºIncluded features:Heavy Duty 5" CastersPatient Safety Strap84" L with 24" of Velcro ® at each end1" Comfort Foam Table Top Padmade in the USAwith US & imported partspatient weight capacitybariatric topMOTION 15” Locking castersProduct specs750 lbs (340kg)rectangular 24" x 80" (61cm x 203cm)height range 26.5" - 44.5" (67cm - 113cm)MOTION 2 Trendelenburg tilt +15º/-11°MOTION 3controlstable weightwarrantyMotion 3Longitudinal travel 10”4" (10cm) longitudinal travel1 foot (3 motion), 1 hand (3 motion)475 lbs (216kg)4 years parts, 1 year laborsafety standards FDA listed, CE marked, cETL approved (details on pg. 2)Page 9

cfpm1001 Movement TableElectric adjustabletable height range of 22” - 40”• 56” Metal Free Imaging Space• 500 lb. Patient Weight Capacity• Warranty: 4 years parts,1 year labor4” Locking castersProduct specspatient weight capacity500 lbs (227kg)carbon fiber top integrated Headrest 22" x 84" (56cm x 214cm)rectangular 24" x 80" (61cm x 203cm)motion 1height range 22" - 40" (56cm - 102cm)controls1 foot (1 motion)table weight343 lbs (156kg.)warranty4 years parts, 1 year laborsafety standards FDA listed, CE marked, cETL approved (details on pg. 2)made in the USAwith US & imported partsRectangular Top OptionIncluded features:Patient Safety Strap84" L with 24" of Velcro ® at each end1" Comfort Foam Table Top Pad4" Casters3 Cranial Positioning Pads(Integrated Headrest Top Only)• 2” (5cm) thick x 12” (31cm) (square)• 4” (10cm) thick x 12” (31cm) (square)• Crescent face rest padc-arm imaging tablesPage 10

cfpmfxhFixed Height TableRectangular Top Optionc-arm imaging tables4” Locking casters• Best value in full carbon fiber top design• 500 lb. Patient Weight Capacity• 56” of Metal Free Imaging Area• Warranty: 4 years parts, 1 year laborProduct specspatient weight capacity500 lbs (227kg)carbon fiber top integrated Headrest 22" x 84" (56cm x 214cm)rectangular 24" x 80" (61cm x 203cm)heightStandard Height 37" (94cm)controlsn/atable weight343 lbs (156kg)warranty4 years parts, 1 year laborsafety standards FDA listed, CE marked, cETL approved (details on pg. 2)made in the USAwith US & imported partsIncluded features:Patient Safety Strap84" L with 24" of Velcro ® at each end1" Comfort Foam Table Top Pad4" Casters3 Cranial Positioning Pads(Integrated Headrest Top Only)• 2” (5cm) thick x 12” (31cm) (square)• 4” (10cm) thick x 12” (31cm) (square)• Crescent face rest padPage 11

dtpm3003 Movement Table±14º23" Manual 23” Travel Top24”- 40”Motion 1Motion 2Motion 3Product specs40”between towersAdjustable table height range of 24” - 40”INDUSTRY'S LOWEST!patient weight capacity450 lbs (205kg)Rectangular Polycarbonate top24” (61cm) W, 78” (198cm) Lmotion 1height range 24” - 40” (61cm - 102cm)motion 223” (56cm) overall manual travel topmotion 3 Trendelenburg tilt ±14°controls 1 foot (motion 1), 1 hand (motion 1 & 3)table weight354 lbs (161kg)warranty4 years parts, 1 year laborsafety standards FDA listed, CE marked, cETL approved (details on pg. 2)made in the USAwith US & imported parts• Most Cost-effective3 Movement Imaging Table• 2 Tower Lift Design• 40” Open Space Between Towers• Warranty: 4 years parts,1 year laborIncluded features:Patient Safety Strap84" L with 24" of Velcro ® at each end1" Comfort Foam Table Top Pad4" Casters4” Locking castersc-arm imaging tablesPage 12

shown with urologyconfigurationCompatible with alllegholders using the U.S.standard side T-railattachment systems.heavy duty 5"locking casterspatient weight capacitycarbon fiber topmotion 1t-rail slide & locklateral Extensions2 end extensions and 4 lateral extensionsare included and easily lock onto T-railson either side of the table.cflu401 Product specs500 lbs (227kg)Included Extensions - 200 lbs (90kg)23" x 47" (58cm x 119cm)height range 27.5” - 45.5” (69cm - 114cm)motion 2 Trendelenburg tilt +15º/-11°motion 3MOTION 4included extensionsOPTIONSACCESSORIEScontrolstable weightwarranty10" (25cm) longitudinal travel± 4" (10cm) lateral travel(1) End Extension-23" x 28" (58cm x 71cm)(1) Short End Extension MUST SPECIFY:23" x 16" (58cm x 40cm) or23" x 20" (58cm x 50cm)(1) Lateral Extension-8" x 24" (20cm x 60cm)(1) Lateral Extension-8" x 14" (20cm x 36cm)(2) Angled Lateral Extensions-8" x 11" (20cm x 28cm)4" Casters2" Comfort Foam Table Top Pad,Protective Clear PVC Drape1 foot (4 motion), 1 hand (4 motion)618 lbs (280kg)4 years parts, 1 year laborsafety standards FDA listed, CE marked, cETL approved (details on pg. 2)Included features:Patient Safety Strap84" L with 24" of Velcro ® at each end1" Comfort Foam Table Top PadHeavy Duty 5" CastersIndustry Standard FullLength T-rails on each sideThe Integrated T-rails are US standard size of.375" (9.5mm) thick by 1.25" (28.6mm) wide.Digital Angle GaugeUrology Bag HoopModel: Urocatch ® with intergrak clamps(Bag not included)made in the USAwith US & imported partsurology/lithotripsy tablesPage 16

pain management positioningspine positioning system IINew & Improved!• Optimal ImagingHigh radiolucency and flexibilityfor ideal cervical, thoracic andlumbar visualization.• Enhanced Patient ComfortMinimize unwanted movement andreduce procedure time.• Easy Set-upsNew simplified system of padsminimize the complexity of set-up.• Stable DesignNew, larger contoured torso padcradles patient & the strap securelyfastens the system to the table.Radiolucent frameCrescentFace Rest PadRadiolucent frame withadjustable face restUsed to support the Torso support and Crescent face rest pad.One cam lock facilitates cervical flexion and extension.Adequate free space under see through face section foraeration, supplemental O2, jaw/face contact as necessary;prevents patient overheating, can more easily communicatewith the patient without sound muffling.Stabilizing StrapNew strap system secures SPS II to the table.Product specsWeightframe with face restCrescent Face Padcontoured Torso Support padcontoured torso wedgelarge Adjuster Padsmall Adjuster Pad16 lbs (7kg)12” x 32.5” (30 x 84cm)12” (30cm) diameter6.5” x 23” x 30” (17 x 58 x 76cm)2” x 22” x 29” (5 x 56 x 74cm)8” x 22” x 2” (20 x 56 x 5cm)7” x 12” x 1.5” (18 x 30 x 4cm)8” semi-round bolster 6” x 8” x 26” (15 x 20 x 66cm)Framecarry casewarrantysafety standardsContouredTorsoWedge8” x 22” x 2”Large adjuster pad7” x 12” x 1.5”Small adjuster padContoured Torsosupport pad8” x 26” semiroundbolsterrAdiolucent FrameFrame, Fabric and Padding - 2 yearsFDA listed, CE markedFDA listed to regulation #892.1830 – Class 1; CE marked– to CE Declaration of Conformity to Annex I of the ECDirectives 90/385/EEC and 93/42EEC.SPS II available through select dealers only.Please contact us for a complete list.Page 17

The Spine Positioning System II (SPS II) is an integral component of the pain management fluoroscopy suite. With thissystem, procedural set up time is reduced, patient comfort is enhanced, and unwanted movement is minimized. Mostimportantly, the target anatomy is more readily visualized, which allows the physician to perform spine procedures in a moreefficient and secure manner.OAKWORKS ® designed the SPS II in an effort to achieve the critical balance between optimal imaging and patient comfort.The radiolucent adjustable frame and versatile padding system provide a metal-free imaging support platform capable ofquickly positioning a wide variety of patient physiques. The adjustable face rest position provides individualized positioning forall types of cervical procedures and anatomy. The contoured torso support pad is complimented by a host of uniquely shapedand sized adjuster pads and wedges that enable a multitude of positioning combinations for ideal patient comfort and imagingneeds for all spinal column procedures.The SPS II was designed with the input of experienced interventional spine physicians under the direction of Paul Dreyfuss,MD. An extensive trial period was undertaken such that various modifications were made to accommodate the precise needs ofthe interventional pain physician and their patients.Primary advantages of the Spine Positioning System II:• No metal (radiopaque) components are present underthe spine- unobstructed visibility of the entire spinefrom C0-C1 to the coccyx with all imaging angles(AP, oblique and lateral). All radiopaque componentsare placed proximal to the forehead.• Adjustment easily made to maximize openingand imaging of the cervico-thoracic junction.• Secure and easy to use single locking face restmechanism to adjust cervical flexion, extensionand height.• Torso pad elevation under the chest allows forthe shoulders to drop out of the plane of imagingwhen obtaining a lower cervical and upperthoracic lateral and oblique views.• Adequate free space under open air face sectionfor aeration, supplemental O2, jaw/face contactas necessary; prevents patient overheating andeasy communication with the patient withoutsound muffling.• Contoured torso support allows the shouldersto drop yet be adducted/slightly extended nextto the body for comfort where they are alsoless likely to lose position/fall off thefluoroscopic table.made in the USAwith US & imported partsFDA listed to regulation #892.1830 – Class 1; CE marked– to CE Declaration of Conformity to Annex I of the ECDirectives 90/385/EEC and 93/42EEC.• Current design obviates the need to pull thearms back to the side to obtain imaging of thecervico-thoracic junction; the more comfortableadducted and slightly extended position suffices.• Adequate adjuster pads to maximize torsobuild up for larger frame patients.• Not only for cervical cases; also useful forthoracic and lumbar cases.• Comfortable for patients with cervical painwhen longer duration thoracic and lumbarcases are performed.• Softer foam under the breasts and shouldersfor comfort; firmer central foam for enhancedstability.• Wider and longer torso pad gives extra supportresulting in less sway and improved patient comfort.• Torso pad restraint strap secures the pad to the table;more stability when mounting and dismounting the system.• Torso pad with abdominal recess for extracomfort and support.• All prone positioning needs met with the SPS II;no need for additional pillows.• Very firm adjuster wedges prevent unduecompression and loss of the original position.pain management positioningPage 18

pain management positioningThe following scenarios in factitious patients will demonstrate:• Various body types using the Spine Positioning System II• Their positioning and specific configurations of the SPS II used in particular clinical situations• Various fluoroscopic images of these factitious patients that exemplify the value of the SPS IIPatient - LizComponents used: Platform Frame,Crescent Face Rest Pad, Contoured TorsoSupport Pad, Contoured Torso Wedge,8” Semi-Round Bolster (not pictured)Liz in the SPS II while obtaining anAP image of the upper thoracic spine.AP image visualizing theT1-2 interlaminar space.Liz in the SPS II while obtaining a lateralimage of the upper thoracic spine.Lateral image primarily throughthe C7—T2 segments.made in the USAwith US & imported partsSPS II set up for Liz shown hereContralateral oblique showingthe upper thoracic facet joints.Page 19

spine positioning system IIPatient - carlComponents used: Platform Frame,Crescent Face Rest Pad, Contoured TorsoSupport Pad, Contoured Torso Wedge,8” Semi-Round Bolster (not pictured)Carl in the SPS II while obtaining anAP image of the mid-thoracic spineAP image of the midthoracicspine for planningthe trajectory for a leftthoracic facet injectionSPS II set up for Carl shown heremade in the USAwith US & imported partsRight thoracic oblique image tovisualize the trajectory for atransforaminal injectionContralateral obliqueshowing the trajectory fortargeting the mid-thoracicfacet jointpain management positioningPage 20

Accessoriespatient safety strap• INCLUDED with all Imaging Tables &Urology /Lithotripsy Tables• Easily adjusted and repositioned with Velcro ®• Durable radiolucent material6" adjustable t-rail clampThe Patient Safety Strap helps eliminate unwanted patient movementand injury during surgical procedures. The strap is easily adjusted toaccommodate a variety of patient sizes.FDA listed to regulation #892.1980 – Class 2.• Can be attached at any designated location on the table• Accommodates a variety of T-rail attachable accessoriesThe adjustable T-Rail clamp can be positioned along the grooved table topedge. Clamp is also removable. (For all Models except DTPM300)FDA listed to regulation #892.1980 – Class 2.fixed t-rail attachment• Custom lengths available• Accommodates a variety of T-rail attachable accessoriesThe fixed T-Rail attachment is available for the DTPM300 table. 78" fulllength or custom sizes offered.FDA listed to regulation #892.1980 – Class 2.Single CARBON FIBER ARM BOARD7.5” x 24” base6” x 23”arm boardor7.5” x 24”arm board• 180º range of motion• Compatible with all tables• Requires no mounting orattachment hardware -slides under table top pad• Comes with removable pad• Folds for safe and compact storageShown here with removable pad.Slides undertable top pad.made in the USAwith US & imported partsThe Oakworks ® Carbon fiber arm board is fully radiolucent with a 180°range of motion. The arm board requires no mounting or attachmenthardware and simply slides under the table top pad. This product can beused on any fluoroscopy table and can support arms and feet in a varietyof positioning configurations. This unique design allows the product to befolded together for safe and compact storage when not in use.FDA listed to regulation #892.1980 – Class 2.Foldedfor storage.Page 21

AccessoriesFluoro Extenderarm hammockarmsupportfootsupport• Made of radiolucent, polycarbonate material• Organic shape is conducive to a variety oftable placement applications• 30” long x 23.5” wide x 1/4” thick• Can be used with any fluoroscopy table• Inserts under the table top padThe OAKWORKS® Fluoro Extender is radiolucent and offers extrawidth only where you need it for greater positioning accuracy with optimumimaging. The Fluoro Extender is inserted under the table top pad.This optional accessory can be used with any Fluoroscopy Table.FDA listed to regulation #892.1980 – Class 2.• Easily attached to the Integrated Head RestThis unique product will comfortably and easily support your patient’s armswhen prone. Eliminate the awkward feeling your patients experience by notknowing where to place their arms.FDA listed to regulation #892.1980 – Class 2.OAKWORKS ® PRONE PILLOW• Soft contact surfaces offer exceptional support• Design has large vent areas for easy breathing• Low profile reduces cervical extension/flexionFDA listed to regulation #892.1830 – Class 1; CEmarked – to CE Declaration of Conformity to Annex Iof the EC Directives 90/385/EEC and 93/42EEC.Prone PositionSupine PositionThe Oakworks ® Prone Pillow is an affordable radiolucent solution forboth simple prone and supine patient positioning as well as advancedpositioning for imaging applications. This patented pillow is ideal for basiccranial positioning and contains no metal, making it fully compatible withc-arm imaging systems, CT imaging systems and MRI systems. Oakworks’advanced lower profile design reduces excessive cervical extension/flexionwhile the resilient platform provides the optimal support needed to ensureyour patient stays comfortable, still and compliant throughout treatment.disposable face rest covers• Provides a hygienic covering for your face restFlat covers sold 100 per box; Fitted covers sold 50 per box.FlatFittedmade in the USAwith US & imported partsPage 22

OAKWORKS medical tables & accessoriesPlease visit our website, www.oakworksmed.com, to view our complete line of tables andaccessories for C-arm Imaging, Pain Management, Ultrasound, Urology, Lithotripsy, Examand Treatment.Vascular TablesProcedure ChairsUltrasound Tablesmade in the USAwith US & imported partsISO 13485:2003FM 584901www.oakworksmed.com 717.235.6807MMBRMD0003 rev. 4.16.13