Instructions for Use
13 Pages
![English Hip Positioning System Instructions for Use Device Description Contraindications The Supine Hip Positioning System and the Lateral Hip Positioning System are platforms for providing hip distraction and joint manipulation during arthroscopic hip procedures. • Hip arthroscopy is contraindicated in the presence of ankyloses or advanced arthrofibrosis. Soft tissue compromise, whether from disease, trauma or previous surgery, may contraindicate the passage of instruments into the hip joint. The traditional Supine Hip Positioning System consists of a universal distractor mast, well leg holder, supine table attachment, transfer board assembly, perineal post, storage cart, and either Active Heel[tm] Traction Boots or Leather Boots. An advanced option is available, which includes two universal distractor masts. The Lateral Hip Positioning System consists of a universal distractor mast, a lateral attachment with perineal pad, a storage cart, and either an Active Heel Traction Boot or Leather Boot. Each universal distractor mast has a sliding carriage for gross traction and a fine distraction crank for fine adjustment to the tension force. Intended Users The Supine Hip Positioning System and the Lateral Hip Positioning System are intended to be used by healthcare professionals in accordance with these instructions for use. The use environment is a professional healthcare facility. Intended Use The Supine and Lateral Hip Positioning Systems are intended to apply operative tension force. Indications for Use The Supine and Lateral Hip Positioning Systems are indicated for use to apply operative tension force during arthroscopic hip procedures. Target Patient Groups The patient population is comprised of patients in for whom a hip arthroscopic procedure is determined to be necessary by the operating surgeon. • Bony compromise, either of the joint architecture or potential stress risers, regardless of the cause, may contraindicate application of the traction forces necessary for hip arthroscopy. • Severe obesity may be a relative contraindication to arthroscopic intervention. • Advanced disease states with destruction of the hip joint contraindicate arthroscopy as there can be no reasonable expectation of symptomatic improvement. • Previous surgeries to the operative limb may contraindicate the use of hip distraction. Warnings • This product is shipped non-sterile. It must be cleaned before the first use. It must be cleaned before every subsequent use. • It is the health care professional’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use. System Setup Warnings • Ensure that the operating room table is rated for a 400 lb/181 kg patient. • Do not exceed the Hip Positioning System’s weight limit: – The Traditional Supine Hip Positioning System: 400 lb/181 kg patient weight limit with a well leg holder. – The Advanced Supine Hip Positioning System: 330 lb/150 kg patient weight limit with two universal distractor masts. – The Lateral Hip Positioning System: 400 lb/181 kg patient weight limit. • Do not exceed the Hip Positioning System’s limits of a 27–36” (68–91 cm) inseam. • Do not exceed the Hip Positioning System’s minimum and maximum foot size limits of US size 5 female to US size 14 male, or the international equivalent. 2 10601480 Rev. A Instructions for Use](https://public.bioclinicalservices.com.au/library/representations/proxy/eyJfcmFpbHMiOnsiZGF0YSI6MTk4MDU0LCJwdXIiOiJibG9iX2lkIn19--3ff910a83ad941e023094c2bc3dbec5934e54bea/eyJfcmFpbHMiOnsiZGF0YSI6eyJyZXNpemUiOiIzMjB4In0sInB1ciI6InZhcmlhdGlvbiJ9fQ==--4214356078d1f110e449cda512a9432562da3e70/IFU_10601480_A_HipPositioning_EN.pdf.png)
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Page 1
English
Hip Positioning System Instructions for Use
Device Description
Contraindications
The Supine Hip Positioning System and the Lateral Hip Positioning System are platforms for providing hip distraction and joint manipulation during arthroscopic hip procedures.
• Hip arthroscopy is contraindicated in the presence of ankyloses or advanced arthrofibrosis. Soft tissue compromise, whether from disease, trauma or previous surgery, may contraindicate the passage of instruments into the hip joint.
The traditional Supine Hip Positioning System consists of a universal distractor mast, well leg holder, supine table attachment, transfer board assembly, perineal post, storage cart, and either Active Heel[tm] Traction Boots or Leather Boots. An advanced option is available, which includes two universal distractor masts. The Lateral Hip Positioning System consists of a universal distractor mast, a lateral attachment with perineal pad, a storage cart, and either an Active Heel Traction Boot or Leather Boot. Each universal distractor mast has a sliding carriage for gross traction and a fine distraction crank for fine adjustment to the tension force.
Intended Users The Supine Hip Positioning System and the Lateral Hip Positioning System are intended to be used by healthcare professionals in accordance with these instructions for use. The use environment is a professional healthcare facility.
Intended Use The Supine and Lateral Hip Positioning Systems are intended to apply operative tension force.
Indications for Use The Supine and Lateral Hip Positioning Systems are indicated for use to apply operative tension force during arthroscopic hip procedures.
Target Patient Groups The patient population is comprised of patients in for whom a hip arthroscopic procedure is determined to be necessary by the operating surgeon.
• Bony compromise, either of the joint architecture or potential stress risers, regardless of the cause, may contraindicate application of the traction forces necessary for hip arthroscopy. • Severe obesity may be a relative contraindication to arthroscopic intervention. • Advanced disease states with destruction of the hip joint contraindicate arthroscopy as there can be no reasonable expectation of symptomatic improvement. • Previous surgeries to the operative limb may contraindicate the use of hip distraction.
Warnings • This product is shipped non-sterile. It must be cleaned before the first use. It must be cleaned before every subsequent use. • It is the health care professional’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use.
System Setup Warnings • Ensure that the operating room table is rated for a 400 lb/181 kg patient. • Do not exceed the Hip Positioning System’s weight limit: – The Traditional Supine Hip Positioning System: 400 lb/181 kg patient weight limit with a well leg holder. – The Advanced Supine Hip Positioning System: 330 lb/150 kg patient weight limit with two universal distractor masts. – The Lateral Hip Positioning System: 400 lb/181 kg patient weight limit. • Do not exceed the Hip Positioning System’s limits of a 27–36” (68–91 cm) inseam. • Do not exceed the Hip Positioning System’s minimum and maximum foot size limits of US size 5 female to US size 14 male, or the international equivalent.
2
10601480 Rev. A
Instructions for Use
English International Shoe Size Conversion Table: Female (min)
Male (max)
US
5
14
UK
2.5
13.5
Europe
35
48.5
Australia
3.5
13.5
Cm
22.8
29.2
• Ensure that the operating room table will not tip by positioning the longest part of the table base under the Hip Positioning System. • Ensure that the operating room table rails are in good repair. Do not install the Hip Positioning System if the table rails are loose or misaligned or if the clamps cannot be positioned properly. • Do not activate the operating room table’s “AUTO” function or adjust the operating room table while the hip positioning system is installed other than to put the table into Trendelenburg or to return the table to the horizontal position. Injury to the patient or damage to the Hip Positioning System may result.
Active Heel[tm] Traction Boot Warnings • Prior to surgery, inspect all pads and straps for cracks, rips or tears. Replace any damaged or missing pads or straps. • Always use the disposable boot insert pad when using the Active Heel Traction Boot. Failure to use the disposable boot insert pad may result in patient injury. • After wrapping the patient’s foot, inspect the disposable boot insert pad to ensure that there are no creases. Failure to eliminate pressure points may result in patient injury.
Supine Hip Positioning System Warnings • If using the Hip Positioning System without a perineal post then use an additional approved device to resist patient motion on the operating room table. • Failure to properly seat the perineal post, if used, may result in damage to the post mechanism and patient injury.
Lateral Hip Positioning System Warnings • Do not strap the patient’s pelvis to the operating room table as it could restrict movement of the joint. • Beware of pinch hazards where the Lateral Table Attachment expands/contracts to fit varying operating room table widths. • Ensure that the flat portion of the perineal pad is facing down, allowing room for the non-operative leg. • Ensure that the patient does not contact any unpadded portion of the Hip Positioning System.
Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • Prior to each use, inspect the device to ensure it is not damaged. Do not use a damaged device. • Do not spray, soak, or autoclave the Hip Positioning System. • Do not clean the Hip Positioning System with bleach. • Use caution in areas where fluid migration may occur. In particular, ensure that fluid does not migrate under the ball joint sleeve.
• To maintain foot flexion and prevent slippage, ensure that the Active Heel Pad is located above the patient’s heel and that the patient’s heel is set firmly into the heel of the boot.
Intra-Operative Use Precuations
• Tension all three boot straps so that the patient’s foot moves only a minimal distance off the sole of the boot.
• Use only Smith & Nephew rail clamps.
• While adjusting the boot straps, do not apply force to the plastic handles or shell of the boot. Doing so may cause the plastic handles to break or crack. • Beware of pinch hazards at the boot ball joint, especially when the loosening the boot knob.
Leather Boots Warnings • Always use the disposable boot insert pad. Failure to use the disposable boot insert pad may result in patient injury. • After wrapping the patient’s foot, inspect the disposable boot insert pad to ensure that there are no creases. Failure to eliminate pressure points may result in patient injury.
• Ensure that all operating room table locks are fully engaged. • To avoid damaging the screws, loosen the universal distractor mast holder knob and well leg holder knob (if used) completely prior to attaching the universal distractor mast and well leg holder. • Ensure that gloves do not interfere with the boot strap buckles locking properly. • If used, ensure that the seams of the perineal post pad are positioned away from the patient.
Unpack and Inspect Carefully unpack and inspect all components shipped with the Hip Positioning System. If any parts are missing or damaged, contact a Smith & Nephew representative. Save the carton and packing materials in the event a component must be returned for repair.
• Tension all three boot straps so that the patient’s foot moves a minimum distance off the metal footplate.
Hip Positioning System Use Warnings • Repositioning the universal distractor mast while the sliding carriage is locked will change the tension on the limb. Significant changes in tension may result in patient injury. • Do not reposition the universal distractor mast while the boot ball joint is locked as patient injury may result. • Do not release traction force via the distractor’s sliding carriage handles (gross traction). This type of rapid traction release may result in patient injury.
Instructions for Use
10601480 Rev. A
3
English
Supine Hip Positioning System
Note: Steps numbered with an “S” are specific to the Supine Hip Positioning System.
Instructions for Use Assembly WARNING: Ensure that the operating room table will not tip by positioning the longest part of the table base under the Hip Positioning System. 1-S. Prepare the operating room table for Hip Positioning System installation.
A
a. Adjust the table so that the longest part of the base is located under the Hip Positioning System. b. Lock the operating room table wheels and controls.
B
2-S. Attach the supine rail clamps to the operating room table side rails. Slide the clamps to the end of the table rails (Figure 1-A). WARNING: Ensure that the operating room table rails are in good repair. Do not install the Hip Positioning System if the table rails are loose or misaligned or if the clamps cannot be positioned properly. CAUTION: Use only Smith & Nephew rail clamps. 3-S. Slide the supine table attachment into the clamps until the table attachment touches the end of the operating room table (Figure 1-B). Tighten the rail clamp knobs until the supine table attachment is securely attached to the operating room table (Figure 1-C and D).
Figure 2.
7-S. If using a universal distractor mast on the non-operative side repeat steps 4S-6S. 8-S. If using a well leg holder, loosen the well leg holder knob completely (Figure 3-B). 9-S. Attach the well leg holder to the non-operative side. Ensure that the well leg holder is fully inserted into the socket (Figure 3-A). 10-S. Tighten the well leg holder knob (Figure 3-B).
C
B A
A D
B Figure 3.
Figure 1.
4-S. Loosen the universal distractor mast knob completely (Figure 2-B). 5-S. Attach the universal distractor mast to the supine table attachment on the same side as the operative hip. Ensure that the mast is fully inserted into the socket (Figure 2-A). 6-S. Tighten the universal distractor mast knob (Figure 2-B). CAUTION: To avoid damaging the screws, loosen the universal distractor mast holder knob and well leg holder knob (if used) completely prior to attaching the universal distractor mast and well leg holder.
4
10601480 Rev. A
Instructions for Use
11-S. Secure the supine table attachment pad to the supine table attachment using the VELCRO® Brand tabs. Install the supine table attachment pad so that the perineal post cutout is on the same side as the operative hip (Figure 4).
English
Prepare the Active Heel Traction Boots Calf Pad
Calf Strap
Center Strap
Heel Strap Toe Strap
Cam Buckle
Figure 4.
12-S. Optional: Attach the patient transfer board assembly to the supine table attachment. 13-S. Use the fine distraction crank to position the operative boot as close to the patient as possible (Figure 5). This will ensure that the maximum range of traction is available during the procedure.
Sole Pad
Receiver Assembly
Figure 6. Active Heel Traction Boot
Figure 5.
14-S. For Knee Holder assembly instructions refer to the Knee Holder instructions for use 10601540.
Transfer the Patient Note: If loading the patient’s foot into the Active Heel Traction Boots prior to transfer to the operating room, complete the Active Heel Traction Boot steps in “Load the Patient’s Feet” prior to transferring the patient. WARNING: If using the Hip Positioning System without a perineal post then use an additional approved device to resist patient motion on the operating room table. 1-S. If using an additional approved device to resist patient motion, place it on the operating room table per its instructions for use. 2-S. Transfer the patient to the operating room table.
Heel Strap
Quick Disconnect Button
Cam Buckle
Center Strap
Receiver Assembly
Center Strap
Figure 7. Detail of heel area
1-S. Ensure the boot is firmly secured in the receiver assembly on the universal distractor mast or well leg holder. 2-S. Unbuckle the boot’s three buckles. 3-S. Ensure that the center strap buckles are passed through the loops on both ends of the heel strap (Figure 8). 4-S. Ensure that there is adequate slack in the calf strap and toe strap.
Instructions for Use
10601480 Rev. A
5
English Note: The pressure placed over the mid-foot while tensioning each end of the center strap helps to seat the heel inside the boot.
Figure 8.
5. Ensure there is adequate slack in the center strap by pulling one of the free ends of the center strap straight up toward the patient’s hip while pressing the release button on the distal end of the cam buckle. Repeat on the opposite side of the strap. 6. Place the Active Heel[tm] Pad so that the bottom of the heel pad lines up with the bottom of the Boot Calf Pad (Figure 9). 7. Repeat steps 1-6 on the other boot.
Figure 10.
5-S. Firmly tension the toe strap and the calf strap. WARNING: Tension all three boot straps so that the patient’s foot moves only a minimal distance off the sole of the boot. WARNING: While adjusting the boot straps, do not apply force to the plastic handles or shell of the boot. Doing so may cause the plastic handles to break or crack. 6-S. Repeat steps 2S-5S on the other Active Heel Traction Boot.
Calf Pad Active Heel Pad
7-S. For Active Heel Traction Boot Knee Holder use instructions, refer to the Knee Holder instructions for use 10601540. 8-S. If using the leather boots, place the patient’s foot in the boot. 9-S. Secure the center strap by looping it over the boot, through the footplate, and back over itself, locking the VELCRO® Brand surface (Figure 11-A). 10-S. Secure the calf strap by looping it around the calf, through the D-ring, and back over itself, locking the VELCRO Brand surface (Figure 11-B). 11-S. Secure the top strap by looping it over the boot, through the footplate, and back over itself, locking the VELCRO Brand surface (Figure 11-C). WARNING: Tension all three boot straps so that the patient’s foot moves a minimum distance off the metal footplate.
Figure 9.
Load the Patient’s Feet
12-S. Repeat steps 9S-11S on the other boot.
Note: Steps 1S – 7S are specific to the Active Heel Traction Boot. Steps 8S – 13S are specific to the Leather Boot. 1-S. Wrap the patient’s feet in the disposable boot insert pads.
C
WARNING: Always use the disposable boot insert pad. Failure to use the disposable boot insert pad may result in patient injury.
B
WARNING: After wrapping the patient’s foot, inspect the disposable boot insert pad to ensure that there are no creases. Failure to eliminate pressure points may result in patient injury. 2-S. Place the patient’s foot in the Active Heel Traction Boot. WARNING: To maintain foot flexion and prevent slippage, ensure that the Active Heel Pad is located above the patient’s heel and that the patient’s heel is set firmly into the heel of the boot. 3-S. Buckle all three straps. Center the buckles over the foot. CAUTION: Ensure that gloves do not interfere with the boot strap buckles locking properly. 4-S. To tension the center strap, form a C-shape with one hand, and place it over the center strap buckle and pad. While pressing firmly down on the buckle and pad, pull one of the free ends of the center strap towards the patient’s hip until that side is tensioned (Figure 10). Repeat on the opposite side of the strap. 6
10601480 Rev. A
Instructions for Use
A Figure 11.
13-S. For Leather Boot Knee Holder use instructions, refer to the Knee Holder instructions for use (10601540). 14-S. Optional: Remove the patient transfer board assembly.
English
Position the Patient
How to Apply Gross and Fine Traction
1-S. If using the perineal post, attach the perineal post to the supine table attachment via the perineal post hole. Position the perineal post in the hole on the operative side of the patient. Ensure the perineal post is properly seated over the perineal post mount.
1-S. Before setting tension on the operative side, unlock the boot ball joint to allow the foot to float freely (Figure 13-A)
WARNING: Failure to properly seat the perineal post may result in damage to the post mechanism and patient injury. 2-S. Slide the perineal post pad over the perineal post. CAUTION: If used, ensure that the seams of the perineal post pad are positioned away from the patient. 3-S. If using the perineal post, position the bottom of the patient’s pelvis well into the perineal post pad – approximately 3” (7.6 cm) (Figure 12-A). Proper placement is necessary for accurate imaging. 4-S. If using the perineal post, place the patient’s operative-side thigh firmly into the perineal post pad to ensure that the necessary lateral distraction force can be achieved (Figure 12-B).
WARNING: Beware of pinch hazards at the boot ball joint, especially when loosening the boot knob. 2-S. Unlock the distractor’s sliding carriage knob (Figure 13-B). 3-S. Pull back firmly on the distractor’s sliding carriage handles to achieve gross traction (Figure 13-C). 4-S. While maintaining tension on the distractor’s sliding carriage, turn the distractor’s sliding carriage knob until it is firmly locked (Figure 13-B). 5-S. Use the fine distraction crank to increase tension to the desired level (Figure 13-D). 6-S. Lock the boot ball joint (Figure 13-A). The boot ball joint can be partially tightened to allow for hip joint manipulation. 7-S. If using a universal distractor mast on the non-operative side, repeat steps 1S-6S.
B A
A C D Figure 12.
5-S. If not using a perineal post then position the patient onto the additional approved device to resist patient motion per its instructions for use.
B
Figure 13.
8-S. If using a well leg holder on the non-operative side, unlock the boot knob (Figure 14-B) and pull firmly on the boot to apply tension to the well leg (Figure 14-A). 9-S. While maintaining tension, turn the boot knob until it is firmly locked (Figure 14-B). Proper tension on the well leg is necessary to prevent pelvic rotation.
B A
Figure 14.
10-S. Drape the patient and the Hip Positioning System. A clear drape is recommended. Ensure that there is enough extra drape for the Hip Positioning System to move through its range of motion and remain covered. Instructions for Use
10601480 Rev. A
7
English
Repositioning the Universal Distractor Mast WARNING: Repositioning the universal distractor mast while the sliding carriage is locked will change the tension on the limb. Significant changes in tension may result in patient injury. 1-S. Unlock the boot ball joint (Figure 15-A). This can be done through the drape. WARNING: Do not reposition the universal distractor mast while the boot ball joint is locked as patient injury may result. 2-S. To achieve flexion/extension or abduction/adduction of the hip, twist and hold the orange distractor positioning handle to unlock the universal distractor mast (Figure 15-B). 3-S. Move the mast into the desired position and release the orange distractor positioning handle to lock the mast in place.
A
How to use the Supine Hip Positioning System during Dynamic Assessment 1-S. Unlock the boot ball joint (Figure 16-A). This can be done through the drape. WARNING: Do not reposition the distractor mast while the boot ball joint is locked as patient injury may result. 2-S. Use the fine distraction crank to reduce tension (Figure 16-B). WARNING: Do not release traction force via the distractor’s sliding carriage handles (gross traction). This type of rapid traction release may result in patient injury. 3-S. Unlock the distractor’s sliding carriage knob (Figure 17-D). WARNING: Repositioning the universal distractor mast while the sliding carriage is locked will change the tension on the limb. Significant changes in tension may result in patient injury. 4-S. Use the sliding carriage handles to bend the knee into the desired position. Once the sliding carriage is positioned as desired, lock the boot ball joint (Figure 16-A) and sliding carriage knob (Figure 16-D). Note: Locking the boot ball joint and sliding carriage knob will allow for easy reattachment of the boot to the Hip Positioning System. 5-S. If using the Active Heel[tm] Traction Boot, use the white quick disconnect button to release the boot from the Hip Positioning System (Figure 16-C).
B
6-S. Following dynamic assessment, reconnect the Active Heel Traction Boot to the Hip Positioning System using the connection slot. Check to ensure that the boot is secure and locked in the connector. Note: Listen for a click when reconnecting the Active Heel Traction Boot. If no click is heard, remove the boot from the connector and reconnect it to ensure that the boot has clicked into the connector. 7-S. Loosen the boot ball joint (Figure 16-A) and distractor’s sliding carriage knob (Figure 16-D) and reposition the carriage as desired.
Figure 15.
4-S. Relock the boot ball joint (Figure 15-A). This can be done through the drape. If desired, the boot ball joint can be partially tightened to allow for hip joint manipulation.
8-S. Relock the boot ball joint (Figure 16-A). This can be done through the drape. If desired, the boot ball joint can be partially tightened to allow for hip joint manipulation.
A B
C D
Figure 16.
8
10601480 Rev. A
Instructions for Use
English
Lateral Hip Positioning System
Note: Steps numbered with an “L” are specific to the Lateral Hip Positioning System.
Instructions for Use Assembly
Prepare the Active Heel[tm] Traction Boots
WARNING: Ensure that the operating room table will not tip by positioning the longest part of the table base under the Hip Positioning System.
Calf Pad
1-L. Prepare the operating room table for Lateral Hip Positioning System installation: a. Adjust the table so that the longest part of the base is located under the Lateral Hip Positioning System.
Calf Strap
b. Lock the operating room table wheels and controls. 2-L. Attach the lateral rail clamps to the operating room table side rails on the foot end of the center section of the table WARNING: Ensure that the operating room table rails are in good repair. Do not install the Hip Positioning System if the table rails are loose or misaligned or if the clamps cannot be positioned properly. CAUTION: Use only Smith & Nephew rail clamps. 3-L. Ensure that the two lateral clamps are aligned opposite each other (Figure 17).
Center Strap
Heel Strap Toe Strap
Cam Buckle
Sole Pad Receiver Assembly Figure 18. Active Heel Traction Boot
Heel Strap Figure 17.
Transfer the Patient
Quick Disconnect Button
Cam Buckle
1-L. Transfer the patient to the operating room table. Center Strap
Receiver Assembly
Center Strap
Figure 19. Detail of heel area
1-L. Unbuckle the boot’s three buckles. 2-L. Ensure that the center strap buckles are passed through the loops on both ends of the heel strap (Figure 20). 3-L. Ensure that there is adequate slack in the calf strap and toe strap.
Instructions for Use
10601480 Rev. A
9
English
Load the Patient’s Feet Note: If using the Leather Boot, move to section “Position the Patient”. 1-L. Wrap the patient’s operative-side foot in the disposable boot insert pad. WARNING: Always use the disposable boot insert pad. Failure to use the disposable boot insert pad may result in patient injury. WARNING: After wrapping the patient’s foot, inspect the disposable boot insert pad to ensure that there are no creases. Failure to eliminate pressure points may result in patient injury. 2-L. If using the Active Heel Traction Boot, place the patient’s operativeside foot in the boot. Figure 20.
WARNING: To maintain foot flexion and prevent slippage, ensure that the Active Heel Pad is located above the patient’s heel and that the patient’s heel is set firmly into the heel of the boot.
4-L. Ensure there is adequate slack in the center strap by pulling one of the free ends of the center strap straight up toward the patient’s hip while pressing the release button on the distal end of the cam buckle. Repeat on the opposite side of the strap.
3-L. Buckle all three straps. Center the buckles and pads over the foot.
5-L. Place the Active Heel[tm] Pad so that the bottom of the heel pad lines up with the bottom of the Boot Calf Pad (Figure 21).
4-L. To tension the center strap, form a C-shape with one hand, and place it over the center strap buckle and pad. While pressing firmly down on the buckle and pad, pull one of the free ends of the center strap towards the patient’s hip until that side is tensioned (Figure 22). Repeat on the opposite side of the strap.
Calf Pad Active Heel Pad
CAUTION: Ensure that gloves do not interfere with the boot strap buckles locking properly.
Note: The pressure placed over the mid-foot while tensioning each end of the center strap helps to seat the heel inside the boot.
Figure 21.
Figure 22.
5-L. Firmly tension the toe strap and the calf strap. WARNING: Tension all three boot straps so that the patient’s foot moves only a minimal distance off the sole of the boot. WARNING: While adjusting the boot straps, do not apply force to the plastic handles or shell of the boot. Doing so may cause the plastic handles to break or crack.
10
10601480 Rev. A
Instructions for Use
English
Position the Patient WARNING: Do not strap the patient’s pelvis to the operating room table as it could restrict movement of the joint. 1-L. Position the patient in the lateral position, operative side up. WARNING: Beware of pinch hazards where the Lateral Table Attachment expands/contracts to fit varying operating room table widths.
8-L. Use the fine distraction crank to position the boot as close to the patient as possible (Figure 25). This will ensure the maximum range of distraction is available during the procedure. 9-L. If the patient’s operative-side foot has been preloaded into the Active Heel Traction boot, attach the boot to the universal distractor mast. Ensure that the boot is firmly secured in the receiver assembly on the universal distractor mast.
WARNING: Ensure that the flat portion of the perineal post pad is facing down, allowing room for the non-operative leg. 2-L. While holding the operative leg up, slide the Lateral Table Attachment with the Perineal Post Pad between the patient’s legs and into the lateral rail clamps until fully seated. 3-L. Lift the Lateral Table Attachment vertically by pivoting it around the lateral rail clamps (Figure 23-A). 4-L. Tighten both lateral rail clamps once the Lateral Table Attachment is in the desired position (Figure 23-B).
Figure 25.
10-L. If using the Leather boot, place and firmly secure the patient’s operative-side foot into the Leather Boot.
5-L. Drop the operative leg and position the Perineal Post Pad into the patient’s groin.
11-L. Secure the center strap by looping it over the boot, through the footplate, and back over itself, locking the VELCRO® Brand surface (Figure 26-A).
WARNING: Ensure that the patient does not contact any unpadded portion of the Hip Positioning System.
12-L. Secure the calf strap by looping it around the calf, through the D-ring, and back over itself, locking the VELCRO Brand surface (Figure 26-B). 13-L. Secure the toe strap by looping it over the boot, through the footplate, and back over itself, locking the VELCRO Brand surface (Figure 26-C).
A
C
B
B
x2
Figure 23.
6-L. Loosen the universal distractor mast knob completely. Attach the universal distractor mast to the Lateral Table Attachment. Ensure that the mast is fully inserted into the socket (Figure 24-A). CAUTION: To avoid damaging the screws, loosen the universal distractor mast knob completely prior to attaching the distractor mast. 7-L. Tighten the distractor mast knob (Figure 24-B).
A Figure 26.
How to Apply Gross and Fine Traction 1-L. Before setting tension, unlock the boot ball joint to allow the foot to float freely (Figure 27-A). WARNING: Beware of pinch hazards at the boot ball joint, especially when loosening the boot knob.
A
2-L. Unlock the distractor’s sliding carriage knob (Figure 27-B). 3-L. Pull back firmly on the distractor’s sliding carriage handles to achieve gross traction (Figure 27-C). 4-L. While maintaining tension on the distractor’s sliding carriage, turn the distractor’s sliding carriage knob until it is firmly locked (Figure 27-B).
B Figure 24.
5-L. Use the fine distraction crank to increase tension to the desired level (Figure 27-D). 6-L. Lock the boot ball joint (Figure 27-A). The boot ball joint can be partially tightened to allow for hip joint manipulation.
Instructions for Use
10601480 Rev. A
11
English
How to Use the Lateral Hip Positioning System during Dynamic Assessment 1-L. Unlock the boot ball joint (Figure 29-A). This can be done through the drape. A
C
WARNING: Do not reposition the distractor mast while the boot ball joint is locked as patient injury may result. 2-L. Use the fine distraction crank to reduce the tension (Figure 29-B).
D B
WARNING: Do not release traction force via the distractor’s sliding carriage handles (gross traction). This type of rapid traction release may result in patient injury. 3-L. Unlock the distractor’s sliding carriage knob (Figure 29-D).
Figure 27.
7-L. Drape the patient and the Hip Positioning System. A clear drape is recommended. Ensure that there is enough extra drape for the Hip Positioning System to move through its range of motion and remain covered.
Repositioning the Universal Distractor Mast WARNING: Repositioning the universal distractor mast while the sliding carriage is locked will change the tension on the limb. Significant changes in tension may result in patient injury. 1-L. Unlock the boot ball joint (Figure 28-A). WARNING: Do not reposition the universal distractor mast while the boot ball joint is locked as patient injury may result. 2-L. To achieve flexion/extension or abduction/adduction of the hip, twist and hold the orange distractor positioning handle to unlock the universal distractor mast. 3-L. Move the mast into the desired position and release the orange distractor positioning handle to lock the mast into place (Figure 28-B).
WARNING: Repositioning the universal distractor mast while the sliding carriage is locked will change the tension on the limb. Significant changes in tension may result in patient injury. 4-L. Use the sliding carriage handles to bend the knee into the desired position. Once the sliding carriage is positioned as desired, lock the boot ball joint (Figure 29-A) and sliding carriage knob. Note: Locking the boot ball joint and carriage knob will allow for easy reattachment of the boot to the Hip Positioning System. 5-L. If using the Active Heel Traction Boot, use the white quick disconnect button to release the boot from the Hip Positioning System (Figure 29-C). 6-L. Following dynamic assessment, reconnect the Active Heel Traction Boot to the Hip Positioning System using the connection slot. Check to ensure that the boot is secure and locked in the connector. Note: Listen for a click when reconnecting the Active Heel Traction Boot. If no click is heard, remove the boot from the connector and reconnect to ensure that the boot has clicked into the connector. 7-L. Loosen the boot ball joint (Figure 29-A) and the sliding carriage knob (Figure 29-D) to reposition the carriage as desired. 8-L. Relock the boot ball joint (Figure 29-A). This can be done through the drape. If desired, the boot ball joint can be partially tightened to allow for hip joint manipulation.
A
B
A B
C
Figure 28.
4-L. Relock the boot ball joint (Figure 28-A). This can be done through the drape. The boot ball joint can be partially tightened to allow for hip joint manipulation.
D Figure 29.
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10601480 Rev. A
Instructions for Use
English
Replacing the Distractor’s Sliding Carriage
Compatible Devices 72200627 - Leather Boot Knee Holder
In the event that the distractor’s sliding carriage assembly needs to be repaired or replaced, follow these steps to remove it from the distraction mast:
72203800 - Active Heel[tm] Traction Boot Holder
1. Lower the mast to a position horizontal to the floor by turning the orange distractor positioning handle at the end of the mast.
WARNING: This product is shipped non-sterile. It must be cleaned before the first use. It must be cleaned before every subsequent use.
2. Use a 3/16” hex driver to remove the screw holding the distractor positioning handle (Figure 30).
Cleaning CAUTION: Do not spray, soak, or autoclave the Hip Positioning System. CAUTION: Do not clean the Hip Positioning System with bleach. CAUTION: Use caution in areas where fluid migration may occur. In particular, ensure that fluid does not migrate under the ball joint sleeve. After each use, clean the Hip Positioning System as follows: 1. Remove the boot from the Hip Positioning System. 2. Clean the entire boot with a neutral pH detergent following each case until visibly clean. 3. Wipe with a clean, dry cloth. 4. Clean the rest of the system, including the post, universal distractor mast, carriage, well leg holder, and boot connector with a neutral pH detergent following each case until visibly clean. 5. Wipe with a clean dry cloth.
Figure 30.
3. Use a 1/8” hex driver to remove the screw at the top of the distractor mast (Figure 31).
6. Wipe all components using a quaternary ammonium disinfecting wipe following each case. Allow the surfaces to remain wet for 4 minutes. Use additional wipes if necessary to ensure disinfectant dwell time is achieved. 7. Wipe with a clean dry cloth. 8. Reconnect the clean, dry boot for storage. 9. To prevent damage, ensure that the Hip Positioning System is dry prior to storage or reinstallation. 10. Repeat these instructions for the well leg holder of the Supine Hip Positioning System.
Storage Figure 31.
4. Unlock the sliding carriage cam. Slide the distractor’s sliding carriage off the end of the distractor mast (Figure 32).
Between uses, store the Hip Positioning System in a clean, dry place where it will not be knocked over. Dropping or knocking over the Hip Positioning System could damage the system and render it inoperable. The Hip Positioning System Storage Cart (REF 72200669) can be ordered separately. Note: Clean prior to disposal.
Figure 32.
5. Reverse these instructions to replace the carriage.
Instructions for Use
10601480 Rev. A
13
English
Expected Service Life
References
Smith & Nephew Hip Positioning System includes medical devices. The functional life of these devices depends on various factors including frequency of use, the method and duration of each use, as well as postoperative methods and handling. Proper maintenance of your equipment is essential to achieve optimal performance over time.
• ASTM F3208-17. Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices.
The Hip Positioning System should be inspected before each procedural use. If the below indications occur, Smith and Nephew suggests to return the device: • Active Heel[tm] Traction Boot shell breaks • Active Heel Traction Boot shell handle breaks
• ASTM F3293-18. Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices. • AAMI TIR 12. Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers. • AAMI TIR30. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
• Active Heel Traction Boot or Leather Boot does not hold patient properly
• ISO/TS 15883-5. Washer-Disinfectors-Part 5: Test soils and methods for demonstrating cleaning efficacy.
• Quick Disconnect is damaged
• ISO 17664. Processing of Health Care Products.
• Any pad falls off adhesive
• ISO 17664-2. Part 2 Non critical medical devices.
• Active Heel Traction strap and buckle is damaged and cannot be properly used
• US FDA Guidance. Guidance for Industry and FDA Staff- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
• Active Heel Traction Cam Buckle no longer grips strap weave • Ball joint is damaged
For Further Information
• Patient Transfer Board breaks
If further information on this product is needed, including warranty, contact Smith & Nephew Customer Service at +1 800 343 5717 in the U.S., or an authorized representative.
• Well leg holder breaks • Perineal Post breaks • Rail Clamps break • Distractor Mast breaks
Symbols Glossary Medical Device
Manufacturer
Prescription use only
Non-sterile
Date of Manufacture
Do not use if package is damaged
CE Mark
Catalog Number
Authorized Representative in the European Community
Caution
Batch Code
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA 14
10601480 Rev. A
+1 978 749 1000 Telephone +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service Instructions for Use
Consult instructions for use
™Trademark of Smith & Nephew. Active Heel[tm] is a trademark of Allen Medical. VELCRO® Brand is a registered trademark of Velcro BVBA. Used with permission. All trademarks acknowledged. www.smith-nephew.com ifu.smith-nephew.com
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