Instructions for Use
126 Pages
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Page 1
INSTRUCTIONS FOR USE IMPORTANT NOTICES READ THESE INSTRUCTIONS COMPLETELY BEFORE USING THIS PRODUCT.
• Read and understand all warnings in this manual and on the device itself prior to use with a patient. • The symbol is intended to alert the user to important procedures or safety instructions regarding the use of this device. • The symbol on the labels is intended to show when the IFU should be referenced for use. • The techniques detailed in this manual are only manufacturer’s suggestions. The final responsibility for patient care with respect to this device remains with the attending physician. • Device function should be checked prior to each usage. • This device should only be operated by trained personnel.
• All modifications, upgrades, or repairs must be performed by an authorized specialist. • Keep this manual available for future reference.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 1.0 SAFETY PRECAUTIONS AND GENERAL INFORMATION 1.1 GENERAL SAFETY WARNINGS • Do not use if product shows visible damage. • Do not exceed device weight limits. • Ensure device is securely attached and locked to OR Table accessory rail before transferring patient. • Whenever inclining the patient, monitor the head closely to insure that the head positioner slides freely without obstruction to prevent undue pressure on the patient’s head and neck.
1.2 TABLE COMPATIBILITY The Lift-Assist™ Beach Chair is compatible with the following surgical table rail styles: US, UK, EU, DEN, JP Note: Refer to the surgical table manufacturer's user guide for instructions on use. Always refer to the surgical table manufacturer’s weight limits.
NEVER EXCEED THE WEIGHT CAPACITY OF THE O.R. TABLE
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 1.3 PRODUCT SPECIFICATIONS 500 lb (227 kg) patient weight limit 61 lb (28 kg) shoulder panel weight limit 0°- 85° articulation range 20” - 26” width extension
2.0 COMPONENT IDENTIFICATION 2.1 ® Lift-Assist™ Beach Chair
FRONT Intubation Pad
Intubation Plate
Shoulder Panels
Rail Clamp Mounts
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Rail Clamp Knobs
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE
BACK Head Positioner Tube Handle
Head Positioner Tube Release
Head Positioner Tubes Beach Chair Release Handle Pendant Holders
Shoulder Panel Locks
Width Extension Knob
Support Bar
RAIL CLAMP Top Jaw Bottom Jaw (hinged) Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 3.1 PRIOR TO USE 1. Ensure surgical table is in its final operation location with respect to the room. 2. Ensure the table is locked. 3. Remove X-ray tops and back section pads from the surgical table. 4. Remove or lower the back (PREFERRED) or leg section of the table by 90°. 5. Loosen both rail clamp mount knobs. 3.2 SET-UP 1. Unlock shoulder panel locks and remove shoulder panels as shown below by swinging panels back and unhooking from head positioner tubes. This will make beach chair lighter and easier to manage.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
Page 6 of 126
Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE
2. Place top jaw of the rail clamp onto the torso (seat) section of the table rail as shown.
3. Snap hinged bottom jaw onto the rail.
4. Slide rail clamp to the end of the table rail. Preferably to rail stops.
5. Repeat steps 2-4 with second rail clamp on opposite side of table.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE
6. Loosen width extension knob by turning to the left.
7. Fully extend width of the support bar.
8. Back-out (loosen) rail clamp knobs completely.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 9. Lift Beach Chair by placing dominant hand on the red release handle and opposite hand on the appropriate side as shown. The non-dominant hand should be placed well behind the rail clamp mount.
10. Align rail clamp mounts above rail clamps.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 12.
Rest rail clamp mount on edge of rail clamp.
13 .
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Adjust width of support bar as needed until second rail clamp mount is correctly aligned with second rail clamp.
Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 14. Lower rail clamp mount onto rail clamp. Rail clamp mount should slide over rail clamp. Do NOT Force. Rail clamp mount is not installed properly until green is visible through indicator slot and pin is flush with top (Both Circled)
15. Ensure there is No Gap between the Beach Chair and the OR table pad. Ensure blue foam roll is hanging below the Beach Chair.
16. Tighten both rail clamp mount knobs by turning clockwise.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 17. Tighten width extension knob by turning it clockwise (to the right).
18. Replace shoulder panels by hooking the latches around the head positioner tubes, and swinging the panel forward as shown. Engage shoulder panel locks by turning it outward.
UNLOCKED
LOCKED
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 19. Adjust lateral position of Beach Chair by gently sliding it near the base along support bar until desired position is achieved.
20. Turn Beach Chair release handle to the right or left. Lower Beach Chair slowly until it lies horizontal, flush with the OR Table pad. Use head positioner handle to assist in lowering.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE
21. Transfer patient onto table in supine position. Ensure patients hip is located as shown in image. (ALIGNED WITH EDGE OF O.R. TABLE)
22. Ensure patient’s head is placed on the intubation pad as shown below. Perform necessary anesthetization and intubation.
23. Open head positioner tube release as shown below.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 24. Extend head positioner tubes by grasping the handle at the top of the tubes and pulling gently outward. Be sure to keep intubation pad in place and monitor the patient’s head during this process.
25. Slide patient head positioner onto head positioner tubes.
26. Lift patient’s head and remove intubation pad. Slide head positioner forward and place the patient’s head in the device. Ensure that patient’s head and neck are always fully supported.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE
27. Secure patient’s head into the head positioner as dictated by the device user instructions.
28. Ensure head positioner tubes are extended at ≥8” (20cm) above head positioner.
≥ 8” (20cm)
29. Lock head positioner tubes by engaging head positioner tube release as shown below.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE
30. Place nonoperative arm in restraint pad as shown.
There are 4 simple steps to achieving the modified Fowler Position (the “Beach Chair” position)
31(a). Place OR Table into 5°-10° of Trendelenburg. Monitor the patient’s head and neck during adjustments.
31(b). While holding head positioner tube handle, unlock Beach Chair release handle (shown in step 20) and raise Beach Chair and patient approximately 45°. Monitor the patient’s head and neck during adjustments.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
Page 17 of 126
Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 31(c). Flex OR Table to achieve flexion in the knee (10°-30° of flexion is desirable) Monitor the patient’s head and neck during adjustments.
31(d). Raise Beach Chair until desired angle is achieved. Monitor the patient’s head and neck during adjustments.
32. Unlock and remove shoulder panels from operative side of patient as shown below. Be sure to support the patient and arm to avoid unwanted movement.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 33. Apply counter traction device to non-operative side of patient using a strap or brace. Be sure to follow the device user instructions.
34. Use headrest lock if needed. Slide headrest lock below head positioner and tighten knob.
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
Page 19 of 126
Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 3.4 REMOVAL AND STORAGE 1. Remove counter traction device, arm supports, or other restrain devices from patient.
2. Ensure head positioner lock is unlocked and free floating.
3. Reverse steps 28-30 to return patient to horizontal position. Monitor the patient’s head and neck during adjustments. 4. Remove patient’s head from the head positioner. While supporting the patient’s head. Remove head positioner from head positioner tubes, and replace intubation pad before placing patient’s head down.
5. Remove patient from device and remove Beach Chair from OR table by reversing steps 11-18. Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
Page 20 of 126
Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015
INSTRUCTIONS FOR USE 4.0 CLEANING AND MAINTENANCE • After each use, clean the device. • Clean and disinfect using a quaternary ammonium disinfecting/cleaning solution following the manufacturers recommendation for achieving low-level disinfection. • Read the cleaning product’s directions and follow the instructions on the label. Use caution in areas where fluid migration may occur. • Wipe device with a clean, dry cloth. • Make certain the product is dry prior to reinstalling to avoid damage.
WARNING: Damage may result if product is cleaned with bleach.
North America
Latin America
1-866-267-9138 1-239-643-5553, ext. 5603 1-239-591-6943
001 954-447-6815
Europe and other Countries / Continents 0049 8131 5957 0
001 954-447-6814
0049 8131 5957 631
Distributed By: Arthrex, Inc. 1370 Creeside Blvd. Naples, FL 34108, USA 1-(800) 934-4404
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Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0
Hill Rom SAS B.P. 14 Z.I. du Talhouet 56330 Pluvigner, France Tel. +33 (0) 2 97 50 92 12 Fax. +33 (0) 2 97 50 92 00 D-720667-A3
22 APR 2015