pivot guardian hip distraction system€¦ · pivot guardian hip distraction system user guide...
TRANSCRIPT
PPiivvoott GGuuaarrddiiaann HHiipp DDiissttrraaccttiioonn SSyysstteemmUUsseerr GGuuiiddee
3105000100
3105000101, 3105000801, 3105000950
3105000700, 3105000701, 3105000702
1
TTaabbllee ooff CCoonntteennttss
11 WWaarrnniinnggss aanndd CCaauuttiioonnss .............................................................................................................................................................................................................. 331.1 Warnings ........................................................................................................................ 31.2 Cautions ......................................................................................................................... 4
22 PPrroodduucctt DDeessccrriippttiioonn............................................................................................................................................................................................................................ 552.1 Understanding the Device ........................................................................................... 5
2.1.1 Hip Distractor Frame........................................................................................ 62.1.2 Accessories..................................................................................................... 10
2.2 Surgical Table Compatibility Chart ........................................................................... 12
33 IInntteennddeedd UUssee ................................................................................................................................................................................................................................................1144
44 CCoonnttrraaiinnddiiccaattiioonnss................................................................................................................................................................................................................................1155
55 CClleeaanniinngg aanndd DDiissiinnffeeccttiioonn..................................................................................................................................................................................................11665.1 Cleaning ....................................................................................................................... 165.2 Disinfection .................................................................................................................. 16
66 DDeevviiccee SSeett--uupp..............................................................................................................................................................................................................................................11886.1 Transport the Device to the Surgical Area .............................................................. 196.2 Remove the Storage Bin............................................................................................ 196.3 Attach the Hip Distractor Frame to the Surgical Table .......................................... 196.4 Adjust the Hip Distractor Frame for Surgeon Height ............................................. 236.5 Attach the Tabletop Extension.................................................................................. 246.6 Prepare the Fine-Traction Element .......................................................................... 25
77 PPaattiieenntt SSeett--uupp ............................................................................................................................................................................................................................................22667.1 Secure the Patient-Positioning Pad ......................................................................... 277.2 Put the Boot Liners on the Patient............................................................................ 277.3 Put the Boots on the Patient...................................................................................... 297.4 Position the Patient..................................................................................................... 307.5 Put the Hip Distractor in Glide Mode........................................................................ 317.6 Connect the Patient’s Boots to the Device.............................................................. 327.7 Put the Patient into the Trendelenburg Position..................................................... 337.8 (Optional) Install the Perineal Post and Pad........................................................... 347.9 Adjust the Hip Distractor for Patient Height............................................................. 357.10 Drape the Device ...................................................................................................... 38
88 IInnttrraa--pprroocceedduurree UUssee ooff tthhee HHiipp DDiissttrraaccttoorr ........................................................................................................................................33998.1 Pull Gross Traction ..................................................................................................... 398.2 Increase or Decrease Fine Traction......................................................................... 39
2
8.3 Decrease Gross Traction........................................................................................... 398.4 Abduct and Adduct ..................................................................................................... 408.5 Rotate the Foot Internally or Externally ................................................................... 408.6 Flex the Hip.................................................................................................................. 41
99 PPoosstt--OOpp PPrroocceedduurreess......................................................................................................................................................................................................................44229.1 Remove the Boots and Boot Liners.......................................................................... 429.2 Dispose of Single-Use Devices ................................................................................ 429.3 Prepare the Device for Storage ................................................................................ 43
9.3.1 Remove the Base from the Surgical Table................................................. 439.3.2 Attach the Storage Bin to the Hip Distractor Frame.................................. 449.3.3 Remove the Tabletop Extension from the Surgical Table........................ 44
9.4 Store the Device.......................................................................................................... 45
1100 TTeecchhnniiccaall SSppeecciiffiiccaattiioonnss..................................................................................................................................................................................................4466
1111 SSyymmbbooll DDeeffiinniittiioonnss........................................................................................................................................................................................................................4477
3
1�������� ��� ��������
Please read this manual and follow its instructions carefully. The words warning,caution, and note carry special meanings and should be carefully reviewed:• WWaarrnniinngg:: Indicates measures to avoid potential serious injury to the user and the
patient and/or damage to this device.• CCaauuttiioonn:: Indicates risks to the equipment. Failure to follow cautions may result in
product damage.• NNoottee:: Provides special information to clarify instructions or present additional useful
information.
The warranty is void if any of these warnings or cautions are disregarded.
1.1 Warnings1. Carefully unpack the unit and check for any damage that may have occurred during
shipment. If damage is detected, contact your Stryker representative.2. Read this operating manual thoroughly and be familiar with its contents prior to
setting up or using this equipment. The information provided in these instructions arethe manufacturer’s suggested techniques. The final disposition of each patient’s careas related to the use of this device rests with the attending surgeon.
3. Do not use the device for patients weighing more than 400 lbs (181.4 kg) as suchuse may result in damage to the device and possible injury to the patient, and/orhealthcare professionals.
4. Use only the accessories and surgical tables recommended in these instructions.Use of unauthorized accessories or surgical tables may result in harm to the patientand may damage the device.
5. If you want to secure the device when the device is not attached to a surgical table,retract the base wheels before applying the abduction locks. If the abduction locksare applied when the base wheels are deployed, there is a tipping danger that couldcause injury or damage the device.
6. Use Perioperative Standards and Recommended Practices. Monitor patient contactpoints throughout the procedure. Proper perioperative and intra-operativeprocedures must be followed to prevent pressure sore development, neuropathy,hypertension, hypothermia, and venous stasis and pooling, especially when usingthe perineal post.
7. When applying safety straps around the patient, monitor the patient to avoidpressure points that could cause nervous system or circulatory impairments.
8. Limit the time that the patient is in traction, as excessive traction duration may resultin harm to the patient.
9. Ensure patient’s bare back completely contacts the patient safety pad to reducepatient sliding when traction is pulled.
4
1.2 Cautions1. Caution: Federal law (United States of America) restricts this device to use by, or on
order of, a physician.2. Before each use, inspect the device and all of its accessories for damage. Test to
make sure all parts are functioning properly. Do not use if the device is damaged or ifany of its parts are not working properly. Do not use any accessory that is damaged.
3. Do not modify this equipment without authorization from the manufacturer. Do notattempt internal repairs or adjustments not specifically detailed in this manual. Referany adjustments, modifications, and/or repairs to Stryker Endoscopy or its authorizedrepresentatives.
4. Pay close attention to the care and cleaning instructions in this manual. Failure tofollow these instructions may result in product damage.
5. Exercise caution when transporting this device. Impact with another object maycause damage to the device. If an impact occurs, visually inspect the device fordamage and make sure it is in working order. If the device is damaged or not workingproperly, do not use it.
6. Handle the boots carefully. Boots may break if dropped.
5
2������� �����������
The Stryker Pivot Guardian Hip Distraction System allows surgeons to perform hipprocedures in Trendelenburg position, eliminating the need for a perineal post. Thesystem consists of the hip distractor frame, a tabletop extension with pad, boots, bootliners, a patient-positioning kit, and a clear, sterile drape. An optional perineal post andpad may also be used.The Stryker Pivot Guardian Hip Distraction System is to be used in an operating room orother treatment room. The device is mobile and may be moved from one room toanother. The device may be used several times throughout the day. It may only be usedwith compatible surgical tables (See section 2.2).NNoottee::
•• TThhee ddeevviiccee sshhoouulldd bbee cclleeaanneedd aanndd iinnssppeecctteedd pprriioorr ttoo eeaacchh uussee..•• TThhee SSttrryykkeerr PPiivvoott GGuuaarrddiiaann HHiipp DDiissttrraaccttiioonn SSyysstteemm mmuusstt bbee uusseedd oonnllyy bbyy aa
ppeerrssoonn wwiitthh aa mmeeddiiccaall lliicceennssee aanndd bbyy eexxppeerriieenncceedd mmeeddiiccaall pprrooffeessssiioonnaallsswwhhoo hhaavvee ffaammiilliiaarriizzeedd tthheemmsseellvveess wwiitthh tthhee ssyysstteemm aanndd tthheessee iinnssttrruuccttiioonnss..
2.1 Understanding the DeviceThese instructions cover the Stryker Pivot Guardian Hip Distraction System, whichincludes the hip distractor frame (part number 3105–000–100) and its accessories.
6
2.1.1 Hip Distractor Frame
1
2
34
HHiipp DDiissttrraaccttoorr FFrraammee
1 Fine-traction element Increases and decreases fine traction.2 Vertical spar (with gross traction trigger
handle and handle bar)Increases and decreases gross traction;allows hip to be flexed
3 Horizontal spar Supports the vertical spar when grosstraction is increased or decreased.
4 Base with base arms Secures the hip distractor frame tocompatible surgical tables.
NNoottee:: TThhee bbaassee aarrmmss sshhoouulldd bbee iinnvveerrtteedd ffoorr sshhiippppiinngg aanndd ssttoorraaggee.. TThheeyy wwiillll nneeeeddttoo bbee oorriieenntteedd pprrooppeerrllyy pprriioorr ttoo uussee,, aass sshhoowwnn iinn tthhee iimmaaggee aabboovvee..
The fine-traction element, gross traction trigger handle, and base with base arms eachhave individual parts that will be referenced in these instructions. The most commonones are outlined here:
7
• Fine-traction element
1
2
3
4
5
FFiinnee--TTrraaccttiioonn EElleemmeenntt CCoonnttrroollss1 Crank-handle Increases or decreases traction.2 Force indicator Gives an estimation of the force
applied, as a reference.
3 Boot connector Connects the patient’s boot to thefine-traction element.
4 Boot connector pin Secures or releases the patient’sboot.
5 Internal/external rotation lever Rotates or secures the patient’s foot.
8
• Gross traction trigger handle controls
2
1
3
GGrroossss TTrraaccttiioonn TTrriiggggeerr HHaannddllee CCoonnttrroollss
1 Trigger Allows movement to increase traction,decrease traction, or flex the patient’ship.
2 Button (red) Sets the hip distractor to glide mode(when used with the trigger), whichallows the vertical spar to move freely.
3 Release button (gold) Allows middle section of the verticalspar to be raised or lowered. The goldrelease button has a gas-assistedspring action, propelling it up.
WWaarrnniinngg::
Two hands should be used to operate the gross traction trigger handle. While onehand operates the trigger, the other hand should be used to control the movement ofthe vertical spar to prevent injury to the patient.
9
• Base with base arms
1
2
3
4
BBaassee CCoonnttrroollss1 Foot pedal • Retracts the wheels of the base
with the red pedal.• Lowers the wheels of the base with
the green pedal so the base can bemoved.
2 Lock-knob Secures the base arms to the base of
the hip distractor.
3 Base arm plates with lever Aligns with the surgical table locks tosecure the hip distractor frame to the
surgical table.
4 Knob (at far end of base arm)Secures the base arm to the floor.
WWaarrnniinngg:: The surgical table locks must be centered on the base arm plates andthen locked down using the table’s controls. Do not operate the hip distraction systemunless the surgical table locks are properly positioned on the base arm plates.Operating the device when it is not properly secured may result in injury to the patientand may damage the device.
10
2.1.2 AccessoriesThe Stryker Pivot Guardian Hip Distraction System has the following accessories.• Tabletop extension with pad (part number 3105–000–101)• Optional perineal post with pad (part number 3105–000–950)
1
2
3
4
TTaabblleettoopp EExxtteennssiioonn((wwiitthh ooppttiioonnaall ppeerriinneeaall ppoosstt aanndd ppaadd aattttaacchheedd))
1 Latch with turn-knob Slides onto surgical table rails andsecures tabletop extension tosurgical table.
2 Tabletop extension pad Attaches to tabletop extension.
3 Optional perineal post and pad Attaches to tabletop extension (asshown), if used.
4 Tabletop extension perineal postslots
Allows the optional perineal postto be connected on the operativeside.
NNoottee:: TThhee ttaabblleettoopp eexxtteennssiioonn hhaass aann iinncclliinnoommeetteerr oonn eeaacchh ssiiddee ttoo iinnddiiccaattee tthheeaannggllee ooff tthhee ssuurrggiiccaall ttaabbllee wwhheenn tthhee ppaattiieenntt iiss ppuutt iinn TTrreennddeelleennbbuurrgg ppoossiittiioonn..
11
• Pair of boots (part number 3105–000–801)
12 3
4
BBoooott1 Black tab Pulls the laces over the loop to fasten
the boot.2 Loop Holds the black tab and the laces to
fasten the boot.3 Boa® knob Secures and loosens the boot. Push
and turn to tighten. Pull to release.
4 Connection hole Attaches to the boot connector on thefine-traction element to secure theboot to the hip distractor.
• Patient Safety Kit, available in three sizes (part number 3105–000–700, small; 3105–000–701, medium; and 3105–000–702, large). The Patient Safety Kit contains thesesingle-use devices:– Patient-positioning kit with strap– Boot liners (either small, medium or large)– Clear, sterile drape with IobanTM
12
• Storage bin
1
3
2
SSttoorraaggee BBiinn
1 Perineal post with pad slot Holds the perineal post and pad.
2 Storage slot Holds tabletop extension, as shown.
3 Boot slot Holds the boot.
2.2 Surgical Table Compatibility ChartUse the Stryker Pivot Guardian Hip Distraction System only with compatible surgicaltables. The Stryker Pivot Guardian Hip Distraction System is compatible with thefollowing surgical tables.
CCoommppaattiibbllee SSuurrggiiccaall TTaabblleess
Berchtold D-SeriesSkytron 3501C EZ Slide
Skytron 3600B Ultraslide
Skytron 6001*
Skytron 6002*
Skytron 6500
Skytron 6600
Steris 3080*Steris 3085*Steris 4085
13
CCoommppaattiibbllee SSuurrggiiccaall TTaabblleess
Steris 5085Trumpf Titan
*Make sure surgical table is lowered completely. The minimum operating height ishigher with this surgical table.
14
3�������� ���
The Stryker Pivot Guardian Hip Distraction System is intended for surgical distraction ofthe patient's hip and positioning of the lower limb in supine position.
15
4�����������������
The use of this device is contraindicated when1. a surgical procedure requiring distraction of the lower limb is not prescribed by an
orthopedic surgeon.2. a surgical procedure requires lateral positioning of the patient.3. a hip arthroscopy procedure requires the direct anterior approach.4. a patient’s weight is in excess of 400 lbs (or 181.4 kg).5. a patient’s height is outside the range of 4'10'' – 6'10'' (or 1.47 – 2.08 meters).
16
5�������� ��� ������������
Prior to each use of the device, the hip distractor frame and its reusable accessoriesneed to be cleaned and disinfected. The hip distractor frame should be cleaned anddisinfected in the most extended positions for all parts. Follow these instructions and useonly recommended products for cleaning and disinfecting.
5.1 Cleaning
After each use, please follow these instructions for cleaning the hip distractor frame andits reusable accessories. These instructions apply to the tabletop extension, the tabletopextension pad, the boots, the optional perineal post and pad (if used), and the hipdistractor frame.1. Use Alcohol Quaternary Ammonium* wipes to clean all surfaces.
CCaauuttiioonn:: Use only Alcohol Quaternary Ammonium wipes for cleaning anddisinfection. Alcohol Free Quaternary Ammonium wipes may damage the hipdistractor frame or its accessories.
2. Wipe the external surfaces of the hip distractor frame and its accessories until allvisible soil is removed.a. While wiping, give particular attention to crevices and hard-to-clean areas.b. Replace soiled wipes as needed and use additional wipes to ensure that all
surfaces are uniformly cleaned.
3. In a well-lit area, from a distance of approximately 12 inches and with an unaidedeye, visually inspect the hip distractor frame and its accessories for the absence orpresence of remaining soil. While inspecting, give particular attention to verifying soilhas been removed from the hard-to-clean areas (e.g., frame screws). If soil ispresent, then repeat the manual cleaning steps until all visible soil is removed.
5.2 Disinfection
After each use, please follow these instructions for disinfecting the hip distractor frameand its accessories. These instructions apply to the tabletop extension, the tabletopextension pad, the boots, the optional perineal post and pad (if used), and the hipdistractor frame.1. Use Alcohol Quaternary Ammonium* wipes to clean all surfaces.2. Thoroughly wipe the external surfaces of the hip distractor frame and its accessories
and allow the surfaces to remain visibly wet for a minimum of two (2) minutes.a. During the two (2) minute contact time, use a disinfecting wipe to thoroughly
wipe crevices and hard-to-disinfect areas.
17
b. If needed, use additional wipes to ensure all surfaces remain wet for the two (2)minute wet contact time.
c. Let air dry.
*Cleaning and Disinfection efficacy was validated with Super Sani-Cloth® GermicidalDisposable Wipes.
18
6������ ������
Set up the device by completing the following tasks sequentially:• Transport the Device to the Surgical Area• Remove the Storage Bin• Attach the Hip Distractor Frame to the Surgical Table• Adjust the Hip Distractor Frame for Surgeon Height• Attach the Tabletop Extension• Prepare the Fine-Traction Element
CCaauuttiioonn:: Prior to each use of the Stryker Pivot Guardian Hip Distraction System,inspect all parts for damage that would affect the function of the device. Test eachelement of the device prior to use to make sure it is fully operational.
WWaarrnniinngg:: The device and its reusable accessories must be cleaned and disinfectedbefore each use.
19
6.1 Transport the Device to the Surgical Area1. Transport the hip distractor frame to the room where it will be used.
CCaauuttiioonn::• Make sure the base wheels and all horizontal spar wheels are unlocked
before transporting the device.• Exercise caution when transporting this device. Impact with another object
may cause damage to the device. If an impact occurs, visually inspect thedevice for damage and make sure it is in working order. If the device isdamaged or not working properly, do not use it.
6.2 Remove the Storage Bin1. Remove the contents from the storage bin, setting them out of the way.2. Lift the storage bin first from the base and then from the hip distractor frame.
3. Set the storage bin out of the way.
6.3 Attach the Hip Distractor Frame to the Surgical Table1. Adjust the surgical table.
a. Remove the foot section of the surgical table, if possible. If it cannot be removed,skip this step.
b. Rotate the foot section down as far as possible.
20
c. Using the surgical table controls, raise the surgical table locks (unlock thesurgical table).
2. Align the base of the hip distractor frame so it is centered in relation to the surgicaltable. Then push the base of the hip distractor frame as close to the surgical table aspossible without them touching.NNoottee:: MMaakkee ssuurree ssuurrggiiccaall ttaabbllee iiss rraaiisseedd hhiigghh eennoouugghh ssoo tthhaatt iittss ffoooott sseeccttiioonnddooeess nnoott ttoouucchh tthhee bbaassee ooff tthhee hhiipp ddiissttrraaccttoorr ffrraammee..
3. Retract the wheels of the base by stepping on the red (inner) foot pedal of the base.
4. Remove and re-attach the base arms.a. Loosen the base arm lock-knob.b. Remove the base arm by sliding it out from the base.
c. Flip the base arm so that the base arm plate is on the ground and the knob at thefar end of the base arm faces up.
d. Reinsert the base arm into the base of the hip distractor, clamping it up to thesurgical table.
e. Tighten the base arm lock-knob.
21
f. Repeat these steps for the second base arm.
5. Secure the hip distractor frame to the surgical table.
CCaauuttiioonn:: Make sure the base wheels of the hip distractor frame have beenretracted. Lowering the surgical table locks onto the base arm plates when the basewheels are deployed may damage the device.
a. Lift the lever on the base arm plate.b. Slide the base arm plate to align it directly under the surgical table locks.
NNoottee:: EEaacchh ooff tthhee bbaassee aarrmm ppllaatteess mmuusstt bbee aalliiggnneedd iinnddiivviidduuaallllyy..c. Push the lever down to lock each base arm plate in place.
22
d. Using the surgical table’s controls, lower the surgical table locks, ensuring thatthey rest completely on both of the base arm plates.
WWaarrnniinngg:: The surgical table locks must be securely centered on the basearm plates. Do not operate the hip distraction system unless the surgical tablelocks are properly positioned on the base arm plates. Operating the devicewhen it is not properly secured may result in injury to the patient and maydamage the device.
6. Once the surgical table locks are properly positioned on the base arm plates, turn the
knob on the far end of each base arm clockwise.a. Once the plunger side contacts the floor, give the knob three more full turns.b. Repeat this step for the second base arm.
CCaauuttiioonn:: Do not turn this knob excessively as it may damage the device overtime. Once the plunger side contacts the floor, only three more turns are needed toensure the device will not slide along the floor.
23
6.4 Adjust the Hip Distractor Frame for Surgeon HeightNNoottee:: TThhee ssuurrggiiccaall ttaabbllee sshhoouulldd bbee sseett ttoo tthhee aapppprroopprriiaattee hheeiigghhtt ffoorr tthhee ssuurrggeeoonnpprriioorr ttoo uussiinngg tthhee hhiipp ddiissttrraaccttoorr ffrraammee..1. Extend the middle section of the vertical spar until the white line appears, or
approximately 11 inches (28 centimeters).a. To extend the middle section, place one hand on the handle bar and one hand
on the gross traction trigger handle.b. Push and hold the gold release button at the top of the gross traction trigger
handle while controlling its movement with the other hand.
WWaarrnniinngg:: When released, the middle section of the vertical spar may risequickly. To avoid injury, do not put your head, chin or other body part above thefine-traction element or the vertical spar when pushing the gold release button.
c. Release the gold release button when the proper height is reached. The whiteline should be visible just above the lower section of the vertical spar.
d. Repeat these steps for the other vertical spar.
2. Extend the top section of the vertical spar.a. Holding the fine-traction element with one hand, loosen the turn-knob of the top
section of the vertical spar.b. Raise the top section of the vertical spar until the fine-traction element is at the
surgeon’s shoulder height.
24
c. Tighten the turn-knob to secure the top section of the vertical spar. Once the topsection is secured, release the fine-traction element.
d. Repeat these steps for the other vertical spar.
6.5 Attach the Tabletop Extension
The tabletop extension should be used only with compatible surgical tables. (See Section2.2.)1. Raise the latches on both sides of the tabletop extension.
2. Slide the tabletop extension onto the rails of the surgical table.NNoottee:: IIff tthhee ttaabblleettoopp eexxtteennssiioonn ddooeess nnoott pprrooppeerrllyy aalliiggnn wwiitthh tthhee rraaiillss ooff aaccoommppaattiibbllee ssuurrggiiccaall ttaabbllee,, ccoonnttaacctt yyoouurr SSttrryykkeerr rreepprreesseennttaattiivvee ttoo mmaakkee tthheepprrooppeerr aaddjjuussttmmeennttss.. ((SSeeee sseeccttiioonn 22..22 ffoorr lliisstt ooff ccoommppaattiibbllee ssuurrggiiccaall ttaabblleess..))
3. Slide the tabletop extension as far as possible along the surgical table’s rails.4. Press down on each latch so that they are flat against the rail.
25
5. Tighten the knobs on both sides of the tabletop extension.
6.6 Prepare the Fine-Traction Element1. Fully extend each fine-traction element toward the surgical table by turning the fine
traction crank-handle counterclockwise.
NNoottee:: DDuurriinngg tthhee pprroocceedduurree,, ffiinnee ttrraaccttiioonn ccaann oonnllyy bbee aaddddeedd iiff tthhee ffiinnee--ttrraaccttiioonneelleemmeenntt hhaass bbeeeenn eexxtteennddeedd dduurriinngg sseett--uupp..
26
7������� ������
A Patient Safety Kit is required for each case. Have the appropriately-sized PatientSafety Kit ready for use.NNoottee:: TThhee PPaattiieenntt SSaaffeettyy KKiitt iiss pprroovviiddeedd iinn tthhrreeee ssiizzeess ((ssmmaallll,, mmeeddiiuumm aanndd llaarrggee))bbaasseedd oonn tthhee ssiizzee ooff tthhee ppaattiieenntt’’ss ffoooott.. UUssee tthhee ssiizzee cchhaarrtt aaffffiixxeedd ttoo tthhee bbooxx ooff tthheePPaattiieenntt SSaaffeettyy KKiitt aass aa gguuiiddee ffoorr sseelleeccttiinngg tthhee ccoorrrreecctt ssiizzee ffoorr tthhee ppaattiieenntt..
The Patient Safety Kit contains the single-use devices for the patient:• a pair of boot liners• a patient-positioning kit consisting of a patient-positioning pad with a positioning
strap• a clear, sterile drape
WWaarrnniinngg:: To prevent injury to the patient, the Stryker Pivot Guardian Hip DistractionSystem must be used in conjunction with the positioning pad and the boot liners in thePatient Safety Kit.
Set up the patient by completing the following tasks sequentially:• Secure the Patient-Positioning Pad• Put the Boot Liners on the Patient• Put the Boots on the Patient• Position the Patient• Put the Hip Distractor in Glide Mode• Connect the Patient’s Boots to the Device• Put the Patient into Trendelenburg Position• (Optional) Install the Perineal Post and Pad• Adjust the Hip Distractor for Patient Height• Drape the Device
27
7.1 Secure the Patient-Positioning PadThis task may be completed prior to bringing the patient into the room.1. Remove the patient-positioning kit from the Patient Safety Kit.2. Place the positioning pad (blue side up) on the distal portion of the tabletop
extension, aligning the semi-circle curve of the pad with the semi-circle curve of thetabletop extension.
3. Loop the distal straps of the positioning pad through the slots of the tabletopextension and secure them.
4. Loop the positioning pad’s proximal straps around the rails of the surgical table andsecure them tightly.
5. Attach the positioning strap.NNoottee:: TThhee ppoossiittiioonniinngg ssttrraapp ccoommeess iinn ttwwoo ppaarrttss tthhaatt aattttaacchh ttoo ooppppoossiittee ssiiddeess oofftthhee ssuurrggiiccaall ttaabbllee.. OOnnccee aa ppaattiieenntt iiss oonn tthhee ssuurrggiiccaall ttaabbllee,, tthheessee ttwwoo ssiiddeess aarreejjooiinneedd lliikkee aa sseeaattbbeelltt ttoo pprreevveenntt ppaattiieenntt rroollllss oorr ffaallllss ffrroomm tthhee ssuurrggiiccaall ttaabbllee..a. Place one side of the positioning strap (blue side up) on the surgical table near
the proximal strap (and between the proximal and distal straps).b. Take the plastic loop of the positioning strap around the outside of the table rail
and pull it up on the inside of the table rail.c. Thread the Velcro end through the plastic loop of the positioning strap.d. Tighten by pushing the plastic loop back down toward the table rail.e. Repeat these steps with the other side of the positioning strap, attaching to the
opposite side of the surgical table.
7.2 Put the Boot Liners on the Patient1. If the patient is ambulatory, have the patient lie on the surgical table with his or her
feet at the edge of the tabletop extension. Secure the position strap around thepatient. If the patient is not ambulatory, put the boot liners on the patient while theyare still on the gurney, starting with step 2.
28
WWaarrnniinngg:: Do not allow the patient to sit on the tabletop extension. The tabletopextension has a weight limit of 250 pounds (113.4 kg). Exceeding the weight limitmay result in harm to the patient or damage to the tabletop extension.
2. Place the patient’s heel into the center of one of the boot liners.NNoottee::
•• TThhee bboooott lliinneerrss aarree iinntteerrcchhaannggeeaabbllee:: tthheerree iiss nnoo lleefftt oorr rriigghhtt bboooott lliinneerr..•• FFlleexxiioonn ooff tthhee kknneeee ccaann hheellpp ttoo sseeaatt tthhee hheeeell oorr,, iiff tthhee lleegg iiss llaayyiinngg ffllaatt,,
ttuugg oonn tthhee ttoopp aanndd bboottttoomm ooff tthhee iinnnneerr aanndd oouutteerr bboooott lliinneerr ttoo hheellpp sseeaatttthhee hheeeell..
•• TThhee bboooott lliinneerrss hhaavvee ffoouurr ppaaiirrss ooff ffllaappss tthhaatt ccoonnnneecctt wwiitthh VVeellccrroo.. TThhee ttwwoossmmaalllleerr ((iinnnneerr)) ppaaiirrss hhaavvee ffooaamm ccuusshhiioonniinngg.. OOnnee ooff tthheessee ssmmaalllleerr ppaaiirrsswwrraappss aarroouunndd tthhee ppaattiieenntt’’ss ffoooott aanndd tthhee ootthheerr wwrraappss jjuusstt aabboovvee tthheeppaattiieenntt’’ss aannkkllee.. TThhee ttwwoo llaarrggeerr,, oouutteerr ppaaiirrss ooff ffllaappss wwrraapp aarroouunndd tthheessmmaalllleerr oonneess..
3. Grab the topmost inner pair of flaps and pull each flap around the patient’s ankle untilthe edges of foam cushioning meet each other, then secure the Velcro.NNoottee:: TThhee iinnnneerr,, ffooaamm ccuusshhiioonneedd ffllaappss ddoo nnoott nneeeedd ttoo bbee ttiigghhtt.. IItt iiss mmuucchh mmoorreeiimmppoorrttaanntt tthhaatt tthhee ffooaamm ccuusshhiioonniinngg ddooeess nnoott oovveerrllaapp..
4. Pull the second pair of inner flaps around the patient’s foot until the edges of thefoam cushioning meet, then secure the Velcro.
WWaarrnniinngg:: Do not overlap the foam cushioning of the inner flaps, and do notleave a wide gap between the edges of the foam cushioning. Improperly securingthe boot liner may result in unwanted pressure points for the patient.
5. Pull the smaller pair of outer flaps around the patient’s foot and secure the Velcro,taking care to work out any folds or creases in the process.
29
6. Pull the last pair of outer flaps around the patient’s calf and secure the Velcro, takingcare to work out any folds or creases in the process.
WWaarrnniinngg:: Inspect the boot liner to ensure there are no folds or creases, as thesemay cause unwanted pressure points.
7. Repeat these steps with the other foot.
7.3 Put the Boots on the Patient
The boot liners must be put on the patient before putting on the boots. The top shell ofthe boot is connected to the boot with six black tabs. Each boot also has three Boa®knobs that are pressed and turned to tighten the boot. When pulled out, the Boa® knobsloosen automatically, without the need for turning. If the patient is not ambulatory, put theboots on the patient while the patient is on the gurney.
CCaauuttiioonn:: Handle the boots carefully. Boots may break if dropped.1. Open the boot by releasing the three black tabs on the lateral side of the boot. The
other three black tabs should remain connected.NNoottee::
•• TThhee bboooottss aarree iinntteerrcchhaannggeeaabbllee:: tthheerree iiss nnoo lleefftt oorr rriigghhtt bboooott..•• FFlleexxiioonn ooff tthhee kknneeee ccaann hheellpp ttoo sseeaatt tthhee hheeeell ooff tthhee ppaattiieenntt iinnttoo tthhee hheeeell
ooff tthhee bboooott..
30
2. Place the heel of the patient’s wrapped foot into the heel of the boot. Make sure theheel is seated fully in the boot.
3. Pull the boot shell over the top of the patient’s foot.4. Attach the three black tabs. Ensuring there are no twists in the laces, pull each black
tab over its loop to secure it.
NNoottee::•• TThhee bbllaacckk ttaabb sshhoouulldd eenndd uupp sseeccuurreellyy oonn tthhee lloooopp..•• TToo eennssuurree pprrooppeerr ffiitt,, mmaakkee ssuurree tthhee llaacceess aarree nnoott ttwwiisstteedd..
5. Tighten the boot.a. Push each Boa® knob down.b. Using the thumb and pointer finger, tighten all Boa® knobs until they each feel
tight to the fingers.NNoottee:: DDoo nnoott ttiigghhtteenn aa BBooaa®® kknnoobb ccoommpplleetteellyy bbeeffoorree mmoovviinngg ttoo tthhee nneexxttoonnee.. IInnsstteeaadd,, ggoo bbaacckk aanndd ffoorrtthh bbeettwweeeenn aallll tthhrreeee,, ttiigghhtteenniinngg tthheemm aasseevveennllyy aass ppoossssiibbllee..
c. Once all three Boa® knobs have been tightened, give each Boa® knob one or twomore turns, as needed.
WWaarrnniinngg:: Do not over-tighten the boots. The boots should be tight enoughto hold a foot in place, but not so tight that they restrict circulation.NNoottee:: TToo lloooosseenn tthhee bboooott aatt aannyy ppooiinntt,, ppuullll uupp oonn tthhee BBooaa®® kknnoobb.. DDoo nnoott ttuurrnntthhee BBooaa®® kknnoobb ttoo lloooosseenn..
6. Repeat these steps for the other boot.
7.4 Position the PatientNNoottee:: FFoollllooww ffaacciilliittyy ppaattiieenntt--ppoossiittiioonniinngg pprroocceedduurreess aatt aallll ttiimmeess..1. Unstrap the positioning strap from the patient.2. Slide the patient toward the hip distractor frame. If the patient was not ambulatory,
transfer the patient from the gurney to the surgical table.
31
3. Position the operative hip on the lateral edge of the tabletop extension, just distal tothe metal supports on the side of the tabletop extension.
WWaarrnniinngg:: Ensure patient’s bare back completely contacts the patient safety padto reduce patient sliding when traction is pulled.
4. To reduce the risk of the patient rolling, angle the patient’s head toward the non-operative side of the surgical table.
5. Secure the patient again with the positioning strap.
7.5 Put the Hip Distractor in Glide Mode
Glide mode allows the device to move freely. Putting the device in glide mode makes iteasier to accomplish patient set-up activites. Glide mode is useful during the procedure,as well, to aid in increasing or decreasing gross traction and flexing the hip.To put the device into glide mode:1. Depress and hold the red button on the trigger handle.2. Pull the trigger.
1
2
3. Release the red button first, followed by the trigger.NNoottee::The button will remain depressed and the trigger will stay in the pulled position.
4. Repeat these steps for the other vertical spar.
NNoottee::To take the one of the vertical spars out of glide mode, press the red button to reset thebutton and the trigger. The vertical spar will now be locked in its position.
32
7.6 Connect the Patient’s Boots to the Device1. Make sure the vertical spar is in glide mode so that it moves freely.2. Slide the vertical spar close enough to the surgical table to connect the boots.3. Connect the boot to the boot connector.
a. Turn the internal/external rotation lever on the fine-traction element to loosen theboot connector.
b. Support the patient’s leg.c. Pull the metal pin of the boot connector located on the fine-traction element.d. Align the hole on the boot with the pin.e. Release the pin.
NNoottee:: IIff pprrooppeerrllyy aalliiggnneedd,, nnoo rreedd wwiillll sshhooww oonn tthhee ssiiddeess ooff tthhee ppiinn.. IIff rreeddsshhoowwss,, ppuullll tthhee ppiinn aanndd rreeaalliiggnn tthhee bboooott..
f. Secure the boot connector in place by turning the internal/external rotation leverto tighten it.
4. Repeat these steps for the second boot.NNoottee:: AAlltthhoouugghh oonnllyy oonnee ssiiddee wwiillll bbee ppuulllliinngg ttrraaccttiioonn,, bbootthh bboooottss mmuusstt bbeesseeccuurreedd..
33
7.7 Put the Patient into the Trendelenburg Position
WWaarrnniinngg:: To avoid injury to the patient when putting him or her into theTredelenburg position, make sure the vertical spar is in glide mode and that the internal/external rotation lever on the boot connect is loosened.
NNoottee:: IIff uussiinngg tthhee ooppttiioonnaall ppeerriinneeaall ppoosstt,, sseeee iinnssttrruuccttiioonnss ffoorr iinnssttaalllliinngg tthhee ppeerriinneeaallppoosstt aanndd ppaadd ((sseeccttiioonn 77..88)).. WWhheenn uussiinngg tthhee ppeerriinneeaall ppoosstt,, tthhiiss sstteepp mmaayy bbee sskkiippppeeddbbuutt iiss ssttiillll rreeccoommmmeennddeedd..1. Make sure each vertical spar is in glide mode.2. Put the patient in Trendelenburg position, with an angle of 10°.
NNoottee::•• TThhee ttaabblleettoopp eexxtteennssiioonn hhaass aa gguuiiddee ((aann iinncclliinnoommeetteerr)) aaffffiixxeedd ttoo iittss ssiiddee
ttoo hheellpp vviissuuaallllyy eessttiimmaattee tthhee aannggllee..•• AAnn aannggllee ooff uupp ttoo 1155°° ooff TTrreeddeelleennbbuurrgg mmaayy bbee nneeeeddeedd ffoorr ppaattiieennttss wwhhoo
aarree hhaarrddeerr ttoo ddiissttrraacctt..•• TTiillttiinngg tthhee ttaabbllee 11––22 ddeeggrreeeess ttoo tthhee ccoonnttrraa--llaatteerraall ((nnoonn--ooppeerraattiivvee)) ssiiddee
mmaayy aallssoo bbee hheellppffuull ffoorr ppaattiieennttss wwhhoo aarree hhaarrddeerr ttoo ddiissttrraacctt
34
7.8 (Optional) Install the Perineal Post and PadAt the surgeon’s discretion, a perineal post may be used with the Stryker Pivot GuardianHip Distractor. Except where noted, all other set-up and operational instructions apply.
NNoottee:: IIff TTrreennddeelleennbbuurrgg ppoossiittiioonniinngg iiss uusseedd,, tthhee ppeerriinneeaall ppoosstt aanndd ppaadd aarree nnoottnneecceessssaarryy..1. Make sure approximately 5 inches (13 cm) of the perineal post extends from the
bottom of the pad so it can be inserted into the tabletop extension.2. Insert the perineal post into the tabletop extension, using the hole that is on the
operative side.
3. Make sure each vertical spar is in glide mode.4. Position the patient on the surgical table so that his or her upper thigh rests against
the perineal post pad.
WWaarrnniinngg:: When using the perineal post, limit the time that the patient is intraction to no more than 90 minutes. Excessive traction duration may result in harmto the patient.
35
7.9 Adjust the Hip Distractor for Patient Height
The patient should be properly positioned for the procedure before the device is adjustedfor the patient’s height. Also, each vertical spar should be in glide mode and eachinternal/external rotation lever on the boot connector should be loosened.
NNoottee:: IInn aaddddiittiioonn ttoo ffoolllloowwiinngg ffaacciilliittyy ppaattiieenntt--ppoossiittiioonniinngg pprroocceedduurreess,, aaddjjuussttiinngg tthheehhiipp ddiissttrraaccttoorr ffrraammee ffoorr tthhee ppaattiieenntt’’ss hheeiigghhtt rreeqquuiirreess oonnee ppeerrssoonn ttoo mmaanniippuullaattee tthheehhiipp ddiissttrraaccttoorr ffrraammee wwhhiillee aannootthheerr ppeerrssoonn ssuuppppoorrttss tthhee ppaattiieenntt’’ss lleegg..
1. Loosen the knob on the side of the horizontal spar until the horizontal spar extendseasily.
NNoottee:: MMaakkee ssuurree tthhee aabbdduuccttiioonn lloocckkss oonn bbootthh hhoorriizzoonnttaall ssppaarrss aarree uunnlloocckkeedd.. IIffeeiitthheerr aabbdduuccttiioonn lloocckk iiss lloocckkeedd,, sstteepp oonn tthhee ffoooott ppeeddaall ooff tthhee hhoorriizzoonnttaall ssppaarr ttoorreelleeaassee iitt..
2. While one person supports the patient’s leg, slide the vertical spar to the startingzone, aligning the white arrow on the vertical spar with the white arrow on thehorizontal spar.
36
3. Push the red button on the trigger handle to lock the vertical spar in place (and take itout of glide mode).
4. Extend the horizontal spar.a. Pull back on the locked vertical spar to extend the horizontal spar until there is no
more flexion in the patient’s knees and the proper hip flexion has been achieved.
37
b. Secure the horizontal spar by tightening the knob on the side of the horizontalspar.
5. Step on the foot pedal (abduction lock) of the horizontal spar to secure the horizontalspar.
38
6. Repeat these steps for the patient’s other leg.
7.10 Drape the Device
WWaarrnniinngg:: The drape provided contains iodine. Do not use this drape if the patient isallergic to iodine.
CCaauuttiioonn:: For use of the drape, follow the instructions provided with the drape.1. Affix the drape to the patient per the drape’s instructions. (After the procedure,
remove the drape from the patient per the drape’s instructions.)2. Pull the upper portion of the drape over the patient’s head and attach it per facility
practices.3. Pull the lower portion of the drape over the fine-traction elements of the hip distractor
frame.NNoottee:: SSoommee ooff tthhee hhiipp ddiissttrraaccttoorr ffrraammee’’ss ccoonnttrroollss mmaayy tthheenn bbee aacccceesssseedd ffrroommtthhee sstteerriillee ffiieelldd tthhrroouugghh tthhee ttoopp ooff tthhee ddrraappee.. AAllll ffuunnccttiioonnss ooff tthhee hhiipp ddiissttrraaccttoorrffrraammee ccaann bbee ppeerrffoorrmmeedd ffrroomm oouuttssiiddee ooff tthhee sstteerriillee ffiieelldd bbyy aacccceessssiinngg ccoonnttrroollssuunnddeerr tthhee ddrraappee oorr bbeeyyoonndd tthhee ddrraappee’’ss rreeaacchh..
39
8��������������� ��� �� ��� ��� ����������
During the procedure, the hip distractor can be used to perform various tasks, includingincreasing or decreasing gross traction and fine traction, abducting and adducting,rotating the foot internally or externally, and flexing the hip.
8.1 Pull Gross Traction1. To increase gross traction, put the vertical spar into glide mode.2. Using two hands, pull the vertical spar away from the patient using smooth,
controlled movement.
WWaarrnniinngg:: To avoid injury to the patient, do not pull gross traction too quickly orfarther than needed.
3. When appropriate traction is achieved, press the red button to lock the vertical sparin place.
8.2 Increase or Decrease Fine TractionWWaarrnniinngg:: To avoid injury, do not increase or decrease fine traction too quickly.
Increase and decrease fine traction with slow, controlled movements.
1. To increase fine traction, turn the fine traction crank-handle clockwise.2. To decrease fine traction, turn the fine traction crank-handle counterclockwise.
NNoottee:: TThhee ffiinnee--ttrraaccttiioonn eelleemmeenntt hhaass aa ffoorrccee iinnddiiccaattoorr ttoo hheellpp eessttiimmaattee tthheeaammoouunntt ooff ttrraaccttiioonn aapppplliieedd.. UUssee iitt oonnllyy aass aa rreeffeerreennccee.. IItt sshhoouulldd nnoott bbee uusseedd ttoogguuiiddee tthhee aapppplliiccaattiioonn ooff ttrraaccttiioonn ffoorrccee..
8.3 Decrease Gross Traction
WWaarrnniinngg:: To avoid injury to the patient, always first decrease fine traction beforedecreasing gross traction.1. Hold the handle firmly to secure the device.2. Put the device in glide mode.3. Guide the vertical spar toward the patient with smooth, controlled movements.
WWaarrnniinngg:: Make sure you have control of the device to ensure smoothmovement. To avoid injury to patient, decrease gross traction slowly.
40
4. When appropriate traction is achieved, press the red button to lock the vertical sparin place.
8.4 Abduct and Adduct1. Step on the foot pedal of the horizontal spar to release the abduction lock.
2. Slide the horizontal spar outward or inward until the proper position is reached.3. Step on the foot pedal of the horizontal spar to lock the abduction lock.
8.5 Rotate the Foot Internally or Externally1. Support the patient’s foot while turning the internal/external rotation lever (on the
fine-traction element).2. Rotate the foot internally or externally.
WWaarrnniinngg:: To avoid injury to the patient, do not rotate the foot too quickly. Useslow, controlled movements.
3. To secure the foot in the chosen position, turn the internal/external rotation lever totighten it.
41
8.6 Flex the Hip
The hip can be flexed in two ways:1. Flex the hip by moving the vertical spar along the horizontal spar.
a. Put the vertical spar in glide mode.b. Loosen the internal/external rotation lever of the boot connector.c. Guide the vertical spar toward the patient.
NNoottee:: TToo lloocckk tthhee vveerrttiiccaall ssppaarr iinn ppllaaccee,, pprreessss tthhee rreedd bbuuttttoonn..
2. Flex the hip by moving the middle section of the vertical spar up and down.a. Put the vertical spar in glide mode.
WWaarrnniinngg:: To avoid injury to the patient when raising the middle section ofthe vertical spar, the device should be in glide mode and the internal/externalrotation lever should be loosened.
b. To extend the middle section, place one hand on the handle bar and one handon the gross traction trigger handle.
c. Push and hold the gold release button at the top of the gross traction triggerhandle while controlling its movement with the other hand.
WWaarrnniinngg:: When released, the middle section of the vertical spar may risequickly. To avoid injury, do not put your head, chin or other body part above thefine-traction element or the vertical spar when pushing the gold release button.
42
9������� ����������
Post-Op procedures include removing the boots and boot liners from the patient,disposing of all single-use devices, as well as all the tasks necessary to prepare thedevice for storage and to store it away.
9.1 Remove the Boots and Boot LinersCCaauuttiioonn:: Handle the boots carefully. Boots may break if dropped.
1. Put the device in glide mode so the device can move freely.2. Loosen the internal/external rotation lever of the boot connector.3. Move the vertical spar toward the surgical table.4. Make sure one person is supporting the patient’s leg.5. Pull the metal pin of the boot connector (located on the fine-traction element) to
release the boot.6. While holding the pin, pull the boot out of the boot connector.7. Pull up on the Boa® knobs to loosen the boots.8. One at a time, release each of the three black tabs on the lateral side of the boot to
open the shell.NNoottee:: DDoo nnoott rreelleeaassee aallll ssiixx ttaabbss oonn tthhee bboooott.. RReelleeaassee oonnllyy tthhee tthhrreeee oonn tthheellaatteerraall ssiiddee ooff tthhee bboooott..
9. Gently free the patient’s foot from the boot.10. Undo the Velcro on the boot liners to remove them.11. Repeat these steps for the other foot.
9.2 Dispose of Single-Use DevicesAfter the procedure, throw away all disposable devices per facility regulations. Thedisposable, single-use devices include the boot liners, the patient-positioning pad andpositioning straps, and the drape.
43
9.3 Prepare the Device for Storage
Collapse the device while it is still attached to the surgical table, as this takes less effortthan collaspsing it after it has been detached from the surgical table.
NNoottee:: TThhee hhiipp ddiissttrraaccttoorr ffrraammee aanndd iittss rreeuussaabbllee aacccceessssoorriieess mmuusstt bbee cclleeaanneedd aannddddiissiinnffeecctteedd bbeeffoorree bbeeiinngg ttrraannssppoorrtteedd ffoorr ssttoorraaggee.. TThhee hhiipp ddiissttrraaccttoorr ffrraammee sshhoouullddbbee cclleeaanneedd aanndd ddiissiinnffeecctteedd iinn tthhee mmoosstt eexxtteennddeedd ppoossiittiioonnss ffoorr aallll ppaarrttss..
WWaarrnniinngg:: When collapsing the device, be careful not to pinch or smash fingers inthe moving parts.1. Lower the vertical spar.
a. Press the gold release button on the top of the gross traction trigger handle andpush the middle section of the vertical spar down using the handle bar on thevertical spar.
b. Loosen the knob for the top section of the vertical spar to lower the top section.c. Lower the top section of the vertical spar by pushing down on the side of the fine-
traction element where the boot connects.NNoottee:: TThhee ttoopp sseeccttiioonn ooff tthhee vveerrttiiccaall ssppaarr iiss ttaappeerreedd,, ssoo iitt wwiillll nnoott ffuullllyyrreettrraacctt uunnlleessss tthhee kknnoobb iiss lloooosseenneedd ssuuffffiicciieennttllyy..
d. Repeat these steps for second vertical spar.
2. Retract the horizontal spar.a. Loosen the knob on the side of the horizontal spar.b. Step on the abduction lock to release the brakes of the horizontal spar.c. Make sure the vertical spar is locked in place.d. Collapse the extension of the horizontal spar by pushing the vertical spar toward
the surgical table.NNoottee:: TThhee eexxtteennssiioonn ooff tthhee hhoorriizzoonnttaall ssppaarr iiss ttaappeerreedd,, ssoo iitt wwiillll nnoott ffuullllyyrreettrraacctt uunnlleessss tthhee kknnoobb iiss lloooosseenneedd ssuuffffiicciieennttllyy..
e. Tighten the knob on the side of the horizontal spar so that the extension of thehorizontal spar stays in place.
f. Repeat these steps for the second horizontal spar.
9.3.1 Remove the Base from the Surgical Table1. Turn the knob at the far end of base counterclockwise until its plunger side if off the
ground.2. Using the surgical table controls, raise the surgical table locks to unlock the surgical
table.
3. Remove the base arms from the base and invert them to reattach..a. Loosen the knob on the top of the base.b. Slide the base arm out.c. Flip the base arm so that it is both upside down and facing away from the
surgical table.
44
d. Slide the short end of the base arm back into the base.e. Tighten the knob on the top of the base to secure the base arm in this inverted
position.f. Repeat these steps for the other base arm.
4. Step on the outer (green) foot pedal of the base to lower its wheels.5. Unlock the abduction locks on the horizontal spars.6. Using the trigger handles of the vertical spars, pull the hip distractor frame away from
the surgical table.
9.3.2 Attach the Storage Bin to the Hip Distractor Frame1. Step on the green pedal of the base to engage the wheels.
NNoottee:: TThhee wwhheeeellss oonn tthhee bbaassee ccaannnnoott bbee lloowweerreedd oonnccee tthhee ssttoorraaggee bbiinn iissaattttaacchheedd..
2. After collasping the device and inverting the base arms, put the storage bin on thehip distractor frame.a. Abduct the horizontal spars.b. Put the vertical spars in glide mode.c. Place the front end of the storage bin onto the base, aligning the hole in the
storage bin with the peg on the base.d. Move each vertical spar until its base is under the storage bin.e. Lock each vertical spar in place by pressing the red button.f. Adduct the horizontal spars until they are parallel and the storage bin comes to
rest securely on them.
3. Load the storage bin.a. Put the boots into their storage slots.b. If applicable, put the perineal post and pad into the storage bin.
9.3.3 Remove the Tabletop Extension from the Surgical TableNNoottee:: LLoocckk tthhee ssuurrggiiccaall ttaabbllee uussiinngg tthhee ssuurrggiiccaall ttaabbllee ccoonnttrroollss bbeeffoorree rreemmoovviinngg tthheettaabblleettoopp eexxtteennssiioonn..1. Loosen the knobs on both sides of the tabletop extension.2. Raise the latches on both sides of the tabletop extension.3. Slide the tabletop extension away from the surgical table.4. Place the tabletop extension into the storage bin.
45
9.4 Store the Device
Once the storage bin is properly attached and loaded, the device may be moved forstorage.1. Transport device to its storage area.
CCaauuttiioonn::• Make sure the base wheels and all horizontal spar wheels are unlocked
before transporting the device.• Exercise caution when transporting this device. Impact with another object
may cause damage to the device. If an impact occurs, visually inspect thedevice for damage and make sure it is in working order. If the device isdamaged or not working properly, do not use it.
NNoottee:: SSttoorree tthhee ddeevviiccee iinn aa ddrryy,, sseeccuurree llooccaattiioonn..
46
10��������� ��������������
Weight 254 lbs. (115 kg.)
Dimensions (collapsed for storage) Length x Width x Height: 52” x 24” x 44”(132 cm x 61 cm x 112 cm)
Weight Limitations System supports patients up to 400pounds or 181.4 kilograms. Tabletopextension supports direct weight up to 250pounds or 113.4 kilograms.
Height Limitations System supports patients from 4’10” to6’10” (1.47 to 2.08 meters)
Expected Service Life 4 years
47
11������ �����������
This product and its labeling contain symbols that provide important information for thesafe and proper use of the device. These symbols are defined below.
Catalog number
Lot number
Serial number
Date of manufacture
Legal manufacturer
Consult instructions for use
Warning/Caution: see instructions for use
Federal (USA) law restricts this device to sale by or on the order of aphysician.
Complies with the requirements of directive 93/42/EEC
Authorized representative in Europe
Quantity
Made In U.S.A.
Do not resterilize
Do not reuse
Do not use if package is damaged
Turn clockwise
Pinch point
Do not sit
48
Move the lever or knob in the direction indicated to lock
Move the lever in direction indicated to unlock
P35387 C
Produced For:Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138 USA1-800-624-4422
U.S. Patents: www.stryker.com/patents
Stryker Corporation or its divisionsor other corporate affiliated entitiesown, use or have applied for thefollowing trademarks or servicemarks: tthhee SSttrryykkeerr LLooggoo.. All othertrademarks are trademarks of theirrespective owners or holders.
2017/12WCR: C.3