Read 51699-IMA-EN0421P.fm text version

OLYMPIC MEDICAL

Olympic Vac-Pac

Instruction Manual for Surgical Positioning

®

CAUTION

Read and be familiar with this manual before using this product. This product is for use only under the supervision of a licensed medical practitioner.

Contents

Section 1 About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Section 2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Product Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

Section 3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Section 4 Using Vac-Pacs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Before Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Applying Suction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Molding the Vac-Pac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 Checking the Patient's Position . . . . . . . . . . . . . . . . . . . . . .9 After Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Section 5 Positioning Examples. . . . . . . . . . . . . . . . . . . . . . . . . 12

Lateral Position. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Thyroid Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Prone Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Head Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Back Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Supine Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Frog Leg Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Knee Elevation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Product Manufacturer: Olympic Medical 5900 First Ave S Seattle, WA 98108 USA Toll-free: 1-800-426-0353 (US/Canada) Phone: 206-767-3500 (worldwide) Fax: 206-762-4200 Web: www.OlympicMedical.com

Copyright © 2005 Olympic Medical Corporation. All rights reserved. Printed in USA.

Any product vigilance related communications per 93/42/EEC Article 10 should be referred to: European Union Authorized Representative Medical Device & QA Services 76 Stockport Road, Timperly Cheshire, WA 15 7SN UK Fax: +44.161.903.9787 Web: www.mdqaconsultancy.co.uk

51699-IMA-EN0421P

Contents, Continued

Kidney Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Thoracic Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Shoulder Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Section 6 Maintaining Your Vac-Pac . . . . . . . . . . . . . . . . . . . . . 17

Cleaning Vac-Pacs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 Identifying and Repairing Leaks . . . . . . . . . . . . . . . . . . . . .17 Replacing Vac-Pacs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Factory Inspection and Repair Service . . . . . . . . . . . . . . .20

Section 7 Product Specifications. . . . . . . . . . . . . . . . . . . . . . . . 21 Section 9 Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . 23

Section 1

About This Manual

This manual provides the necessary information to position, maintain, and repair the Olympic Vac-Pac products. The positioning instructions in this manual are intended for use under the direct supervision of a licensed medical practitioner.

®

Table 1 Conventions used in this manual

Convention Description Notes provide additional information to clarify a point in the text.

NOTE

Cautions indicate situations that, if not avoided, could result in minor to moderate injury to the patient or operator, or damage to the equipment.

CAUTION

Warnings indicate situations that, if not avoided, could result in serious injury or death to the patient or operator.

WARNING

Table 2 Symbols used on Vac-Pacs and their packaging

Symbol Description Caution, read instructions Symbol Description Latex free

Section 2

Introduction

Intended Use

Olympic Vac-Pac products are patient positioning supports intended for use during physical therapy and surgical procedures.

Product Overview

Vac-Pac positioners are pads that mold around patients to hold them securely in place during surgery. Each Vac-Pac is filled with thousands of tiny plastic beads. When a suction line is attached to the Vac-Pac, a vacuum is created inside, causing external atmospheric pressure to force the beads together. This pressure is retained by sealing the valve, allowing the firm Vac-Pac to retain the molded shape. After surgery, the valve is opened and, as the air reenters the Vac-Pac, the Vac-Pac becomes soft again, ready for reuse.

Figure 1 Vac-Pac before and after suction

Before suction the tiny, plastic beads inside a Vac-Pac are free to move around, and the Vac-Pac is soft and moldable.

After suction, a vacuum is created inside the Vac-Pac and atmospheric pressure forces the beads together, forming a solid mass.

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When properly applied, Vac-Pacs minimize the possibility of the patient developing pressure point injuries. The Vac-Pac conforms to the shape of the patient's body, allowing even distribution of the patient's weight; support from the body's bony prominences is avoided.

Figure 2 Vac-Pacs minimize pressure-point injuries

Vac-Pacs help prevent pressure points

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Section 3

Cautions

CAUTION

Product use: Read and be familiar with this instruction manual before using this product. This product is for use only under the direct supervision of a licensed medical practitioner. The Vac-Pac is intended for use as a positioning aid only. Do not use the Vac-Pac to provide immobilization or restraint. Do not use Vac-Pacs in the presence of flammable gases. To avoid damaging the valve, never hold the Vac-Pac by its valve when lifting or shaking. Patient position and product stability: Only use the Vac-Pac on intact (i.e., uncompromised) skin. Regularly monitor the patient's position and Vac-Pac stability--immediately before draping patient and frequently during the procedure. For sufficient bead thickness to support the patient, ensure that the beads are distributed evenly when molding the Vac-Pac. To prevent the Vac-Pac from rolling, keep its bottom flat when molding to the patient. Position the valve in an accessible position beneath the drapes, so that additional vacuum suction can be applied or released during the procedure, as necessary. Ensure that the valve position cannot be inadvertently pressed, decreasing stability of the Vac-Pac, during surgery. Always close the valve cap after applying suction to prevent air leakage so that the molded shape is retained during the surgical procedure. Skin irritation: Ensure that the surface of any sheets or gel pads placed between patient and Vac-Pac are smooth; wrinkled surfaces may cause skin irritation. To prevent skin irritation, skin wet with prep solution should not be ub contact with the Vac-Pac. Inflation: During evaluation for leaks, do not over-inflate the Vac-Pac. Fill to a maximum pressure of 1 pound per square inch (psi). Cleaning and storage: High temperatures will damage the Vac-Pac; never steam autoclave Vac-Pacs. For information on cleaning the Vac-Pac, see Cleaning Vac-Pacs on page 17. Always close the valve cap before cleaning or sterilizing to prevent liquids from entering the Vac-Pac. Before storing the Vac-Pac, suction out the air and cap the valve. If the Vac-Pac softens within 24 hours, suspect a leak and repair the Vac-Pac before use. Damage and leaks: Inspect Vac-Pacs before and after each use for possible damage or leaks. Never use a damaged or leaking Vac-Pac. Do not attempt to repair Vac-Pacs with adhesive tape; only use Olympic repair patches. Avoid puncturing the Vac-Pac with towel clips or other sharp instruments. Only use the Olympic Medical­supplied 5-in-1 connector. Use of a different connector may damage the Vac-Pac valve.

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Section 4

Using Vac-Pacs

CAUTION

This product is for use only under the direct supervision of a licensed medical practitioner. Do not use in the presence of flammable gases.

Before Use

Before using the Vac-Pac: 1 Select the appropriate size Vac-Pac for the procedure. Examples of positioning and guidance in selecting the appropriate size Vac-Pac for the patient's position,weight, and height are provided on pages 12­16.

Use the appropriate size Vac-Pac for the procedure and patient size; use of an incorrect size decreases patient stability.

CAUTION

2 3

Ensure that the Vac-Pac is clean. For information on cleaning, see page 17. Inspect the firmness of the Vac-Pac. Suction the Vac-Pac before storing, then confirm that it has remained firm for at least 24 hours. If it does not remain firm, a leak may be present, and the Vac-Pac should not be used until it has been tested and/or repaired (see page 17).

Before each use, inspect Vac-Pac for possible damage or holes. Never use a Vac-Pac that has a suspected leak or damage. If a leak is suspected, test and repair the Vac-Pac before use, or replace the Vac-Pac.

CAUTION

4

Soften the Vac-Pac. Remove the valve cap and squeeze the valve, making the Vac-Pac as soft as possible. If necessary, shake the Vac-Pac gently to distribute the beads evenly.

To avoid damaging the valve, never hold the Vac-Pac by its valve when lifting or shaking.

CAUTION

5

Smoothing the beads. Place the soft Vac-Pac on the operating table and smooth the beads to a uniform thickness (see Figure 3). To avoid thick areas that can cause bumps under the patient, taper the beads at the edges of the Vac-Pac.

Figure 3

Smoothing the Vac-Pac

Smooth the beads while the Vac-Pac is soft.

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Olympic Vac-Pac Instruction Manual

Applying Suction

Adequate suction is required to mold the Vac-Pac to the patient. In the operating room, use a regular wall suction or an aspirator pump. For other environments, a hand vacuum pump is available from Olympic Medical (see Repair Parts on page 22). A tapered 5-in-1 connector is provided with each Vac-Pac. Required items: Suction or pump source Suction tubing Vac-Pac 5-in-1 connector

CAUTION

Only use the Olympic Medical­supplied connector. Use of a different connector may damage the Vac-Pac valve.

Figure 4

Correct and incorrect 5-in-1 connectors

Correct Connector: height: 2.75" (6.99 cm) largest diameter: 0.5" (1.27 cm) smallest diameter: 0.625" (1.59 cm)

Correct

Incorrect

To apply suction to the Vac-Pac:

Jamming the connector too far into the valve, or use of a needle-nose or other type of connectors, can damage the valve.

CAUTION

1 2 3

Insert one end of the Vac-Pac's 5-in-1 connector into the suction tubing. Insert the opposite end of the 5-in-1 connector into the Vac-Pac's valve (see Figure 5). Apply suction until the desired firmness is achieved. Next, disconnect the suction line, and then close the valve cap (see Figure 5).

Once the suction line is attached, the Vac-Pac will become firm within a few seconds.

NOTE

To avoid the possibility of leakage from undetected holes, the suction line may remain attached to the Vac-Pac during surgery.

CAUTION

Ensure that the valve cap is securely closed to prevent air leakage so that the molded shape is retained during the surgical procedure.

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Figure 5

Applying suction and retaining firmness

Insert the suction line connector into the valve.

After suction, close the valve cap to retain firmness.

To soften the Vac-Pac: Open the valve cap, and then squeeze the raised bumps on the sides of the valve to allow air to enter the Vac-Pac (see Figure 6).

Figure 6 Softening the Vac-Pac

Open the valve, and then squeeze the raised bumps to soften the Vac-Pac.

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Molding the Vac-Pac

To mold the Vac-Pac to the patient's shape, vacuum suction must be applied to the Vac-Pac. Required items: Suction or pump source Suction tubing Vac-Pac 5-in-1 connector

CAUTION

Only use the Olympic Medical­supplied connector. Use of a different connector may damage the Vac-Pac valve.

To mold the Vac-Pac: 1 Place the patient on the soft Vac-Pac (see Figure 7).

To prevent the Vac-Pac from rolling, ensure that its bottom is flat when molding to the patient. Ensure that the surface of any sheets or gel pads placed between patient and Vac-Pac are smooth; wrinkled surfaces may cause skin irritation. To prevent skin irritation, skin wet with prep solution should not contact the Vac-Pac. Only use the Vac-Pac on intact (i.e., uncompromised) skin.

CAUTION

Figure 7

Positioning the patient on the Vac-Pac

Patient in position on a soft Vac-Pac.

2

Figure 8

Mold the soft Vac-Pac around the patient's body or extremities so as to support the patient in the desired position (see Figure 8).

Molding the Vac-Pac to the patient

It typically requires two people to hold the patient and mold the Vac-Pac.

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CAUTION

To prevent the Vac-Pac from rolling, keep its bottom is flat when molding to the patient. Jamming the connector too far into the valve, or use of a needle-nose or other type of connectors, can damage the valve. When the suction is connected, the Vac-Pac becomes firm within seconds. Kinking the suction line before attaching it to the molded Vac-Pac blocks the suction, allowing you to kink/unkink the suction line to easily achieve the correct firmness.

TIP

3 4

Attach the 5-in-1 connector to the suction tubing. Attach the suction line and apply suction (see Figure 9): a Insert one end of the 5-in-1 connector into the suction tubing. b Insert the opposite end of the 5-in-1 connector into the Vac-Pac's valve. c Continue to press the Vac-Pac firmly against the patient while molding it and applying suction -- when the suction is disconnected, the Vac-Pac will relax a fraction of an inch.

Once the suction line is attached, the Vac-Pac will become firm within a few seconds. To avoid the possibility of leakage from undetected holes, the suction line may remain attached to the Vac-Pac during surgery.

NOTE

Figure 9

Connecting suction to the Vac-Pac valve

Insert the suction line connector into the valve.

d Apply suction until the desired firmness is achieved. Next, disconnect the suction line, and then close the valve cap.

Ensure that the valve cap is securely closed to prevent air leakage so that the molded shape is retained during the surgical procedure.

CAUTION

Figure 10 Capping the valve of the molded Vac-Pac

Molded Vac-Pac with suction line removed and valve capped.

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Checking the Patient's Position

Periodically check the patient's position and stability during the procedure. As necessary, remove the valve cap and squeeze the valve to soften the Vac-Pac, then reposition the patient as described in Molding the Vac-Pac on page 7.

Regularly monitor the patient's position and Vac-Pac stability--immediately before draping patient and frequently during the procedure.

CAUTION

Additional Stability

For additional patient stability, use other positioning or immobilizing devices, such as kidney rests or safety belts, with Vac-Pacs (see Figure 11).

Figure 11 Using pads for additional stability

A kidney rest may be used to provide additional stability.

Things to Check--Before Surgery

Before surgery, do the following: Ensure that the Vac-Pac has a flat bottom. To prevent the Vac-Pac from rolling, ensure that its bottom is flat when molding to the patient. Confirm that no thin spots are present on the Vac-Pac. The thicker the layer of beads in a given area, the stronger the Vac-Pac. When molding the Vac-Pac, ensure that no thin spots exist, with too few beads to make it firm (see Figure 12).

Figure 12 Checking the Vac-Pac before surgery ­ end view

Thin side has less strength Thicker side has more strength

Mold a flat bottom

Adequately expose the patient. If more patient exposure is needed near the corner of a Vac-Pac, push the beads out of that corner and fold it over before applying suction. Protect the Vac-Pac while prepping the patient. Before prepping a patient in a Vac-Pac, temporarily tuck a prep pad around the upper edge of the Vac-Pac to prevent prepping solution from running down between the patient and the Vac-Pac (see Figure 13). After prepping, remove the pad.

To prevent skin irritation, skin wet with prep solution should not contact the Vac-Pac.

CAUTION

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Figure 13 Applying a prep pad

Applying a prepping pad around the upper edge of the Vac-Pac.

Ensure that the valve is accessible. Always place the valve in an easily accessible location under the drapes. It may be necessary to re-attach the suction line to firm-up the Vac-Pac during surgery. Remove wrinkles from sheets and gel pads. If a sheet or gel pad is placed between the patient and the Vac-Pac, it should be stretched and smoothed to avoid wrinkles which may cause skin irritation.

When a Vac-Pac is molded around a patient, the surface will have wrinkles in it. However, these wrinkles are inverted -- drawn inward by vacuum pressure-- and will not cause skin irritation.

NOTE

Use Vac-Pacs for x-ray procedures. Vac-Pacs are radiolucent. The only artifacts normally seen are the wrinkles on the Vac-Pac's surface, which are usually easily identified.

Things to Check ­ During Surgery

Regularly monitor the patient's position and Vac-Pac stability--immediately before draping patient and frequently during the procedure.

CAUTION

During surgery, do the following: Continually check the stability of the Vac-Pac. Ensure that the firmness of the Vac-Pac and the stability of the patient is retained. Check the stability of the Vac-Pac immediately before draping and frequently during surgery. If a Vac-Pac softens during surgery, immediately re-attach the suction line and leave it attached for the duration of the procedure. Adhesive tape can also be applied as a temporary patch to any obvious holes (see page 17). Avoid puncturing the Vac-Pac. Be careful not to puncture the Vac-Pac with towel clips or sharps. Reposition the patient in the Vac-Pac as appropriate. If it is necessary to reposition the patient during surgery, soften the Vac-Pac as much as necessary by removing the valve cap, then squeezing the valve. Next, mold the Vac-Pac to its new position, re-apply suction, then close the valve cap.

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After Use

Thoroughly clean the Vac-Pac after each use (see page 17), and then place it in storage as described below.

Storing the Vac-Pac

To help prevent leaks, always store the Vac-Pac in a flattened, firm state (i.e., suctioned).

Before storing the Vac-Pac, suction out the air and cap the valve. If the Vac-Pac softens within 24 hours, suspect a leak and repair the Vac-Pac before use.

CAUTION

To prepare the Vac-Pac for storage: 1 Smooth the beads into a uniform layer. 2 3 4 Apply suction until the Vac-Pac is firm (see Figure 14). Once the Vac-Pac is fully compacted, disconnect the suction line (see Figure 10 on page 8) and close the valve cap. Check the Vac-Pac after 24 hours. If the Vac-Pac retains its original firmness for at least 24 hours, it is ready for immediate use. If the Vac-Pac has softened within 24 hours, a leak is suspected.

Never use a damaged or leaking Vac-Pac.

CAUTION

NOTE

During long periods of storage, Vac-Pacs may lose some firmness from minute air leakage that may not affect their normal use.

Figure 14 Make Vac-Pacs firm before storing

Suction air from the Vac-Pac before storing.

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Section 5

Positioning Examples

The following illustrations show common patient positions in which Olympic Vac-Pacs are used. Vac-Pac sizes noted are for average-size adult patients.

The most appropriate size depends upon the height and weight of the patient and any special positioning requirements.

NOTE

Lateral Position

Vac-Pac Options Patient Size one 30 (shown) one 31 one 32 one 35 small/average average/large extra large small/average Push the beads and fold the corner under for more patient exposure, as appropriate.

1

Place the soft Vac-Pac on the table and smooth out the beads. The U-shape cut-out should be towards the patient's head. If more patient exposure is needed near a corner of the Vac-Pac, push the beads out of that area and fold under the Vac-Pac corners.

2

Place the patient on the soft Vac-Pac. Support the patient's arms and head, and pad any bony prominences that are not resting on the Vac-Pac.

Check the patient's stability throughout the procedure.

3

Mold the Vac-Pac to the patient. Typically this is a two-person task -- one on the patient's left, the other on the right -- ensuring that the Vac-Pac molds appropriately on both sides.

4

Connect the suction to the Vac-Pac valve and remove the extra air. Within a few seconds the Vac-Pac becomes firm. Remove the suction line and close the valve.

5

A patient laterally positioned in the Vac-Pac. Use additional padding as required ­ under the patient's head, arms, or between the legs for support, or to protect any exposed bony prominences.

Push the beads and fold the corner under for more patient exposure, as appropriate. For lateral positioning of larger patients, use a Size 32 Vac-Pac. For additional support or stability, use kidney rests (shown) or safety belts.

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Olympic Vac-Pac Instruction Manual

Thyroid Position

Vac-Pac Options one 25 (shown)

1

Remove the valve cap and squeeze the valve to allow air in, making the Vac-Pac soft. Next, smooth out the beads. Finally, place the patient on the Vac-Pac. The smaller, tapered end should be even with top of the patient's head.

2

Attach the suction line. While removing air, mold the Vac-Pac to the patient to provide adequate neck extension and head support.

Prone Position

Vac-Pac Options two 25 (shown)

1

Fold the Vac-Pacs double-lengthwise, then place them on the table. Position the patient with chest on the Vac-Pacs.

2

Apply only enough suction to make the Vac-Pacs partially firm. Leave space between the Vac-Pacs to allow for chest expansion.

Head Positioning

Vac-Pac Options one 11 (shown) one 20 one 25

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Back Support

Vac-Pac Options one 20 (shown) To reduce post-operative back pain, mold the Vac-Pac to support the hollow of the patient's back.

Supine Position

Vac-Pac Options one 40 (shown) Use the full-length Vac-Pac to support the patient's full body and minimize post-operative back pain.

Frog Leg Position

Vac-Pac Options one 35 (shown) one 30 one 31 Place the shorter section of the Vac-Pac under the patient's hips, with the longer end toward the patient's feet. Next, push the beads toward the outer ends of the T-shaped section. Finally, mold the Vac-Pac around the patient's feet, ankles, and lower legs.

Knee Elevation

Vac-Pac Options one 30 (shown) one 35 Position the Vac-Pac under the patient's knee, then attach the suction to compact the Vac-Pac.

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Kidney Position

Vac-Pac Options one 35 (shown) one 30

1

Place the upper end of the T-shape toward the patient's head. With the table broken, mold the Vac-Pac to support the patient in the lateral position. Before straightening out the table for closing, reach under the drapes, remove the valve cap and squeeze the valve to partially soften Vac-Pac. Next, straighten the table, then reposition the patient.

2

Re-attach the suction line and form the Vac-Pac to the patient.

Thoracic Position

Vac-Pac Options one 35 (shown) one 30 See lateral position on page 12. Use Size 35 Vac-Pac with T-shape toward foot of table, molded to support hips. (Reverse from that shown for Kidney position above). The other end of the Vac-Pac molds around the upper body. Alternately, use the Size 30, 31, or 32 Vac-Pac.

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Shoulder Position

Vac-Pac Options one 38 (shown)

Extend the Vac-Pac approx. 6 in. (15.45 cm) above the head of the table.

1

Place the soft Vac-Pac on the table, with the U-shape cutout toward the foot of the table and its valve opposite to the operative side. Next, smooth out the beads so the Vac-Pac is somewhat thinner on the operative side. Extend the Vac-Pac approx. 6 in. (15.24 cm) beyond the head of the table so it can be formed into a pillow around the patient's head. Place the patient in the supine position on the Vac-Pac, with the operative shoulder over the moon-shape cutout. Pull the operative arm across the patient's body, placing the scapula in the protracted position.

Mold around patient for stability

2

Mold the Vac-Pac to the patient, forming a cradle around the patient's head while the surgical assistants make adjustments. Assistant 1: Roll the patient's torso away from the operative side, and slide the edge of the Vac-Pac under the patient's shoulder to expose the posterior operating side. Assistant 2: Help roll the patient by gently pulling the patient's arm across the body, placing the scapula in the protracted position.

Allow operative access

Elevate back 45­60º

3

While holding the molded Vac-Pac, apply suction until the Vac-Pac becomes firm. Next, remove suction and cap the valve. Slide the patient and Vac-Pac together, toward the edge of the table to provide access to the posterior operative site. Ensure that the remainder of the patient's body rests securely on the table.

4

When elevating the table, check for neck hyper-extension. Insert a small pad between the Vac-Pac and the back of the patient's head to minimize pressure. Also, avoid placing pressure on the ears.

5

Place the patient in the beach-chair position. Next, adjust the table 45­60 degrees, elevating the patient's back. Higher elevations assist arthroscopy; lower positions provide easier anterior access. Facilitate conversion from arthroscopy to open surgery by adjusting from higher-to-lower positions. Note: To improve patient stability, slightly tilt the table laterally away from the operative side.

CAUTION

Avoid placing the patient's neck in hyperextension or hyperflexion. To avoid creating pressure points, fold the Vac-Pac away from the patient's ears.

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Section 6

Maintaining Your Vac-Pac

Cleaning Vac-Pacs

Clean the Vac-Pac after each use.

Always close the valve cap before cleaning or sterilizing to prevent liquids from entering the Vac-Pac. Do not use aromatic hydrocarbons (e.g., acetone) as these agents will damage the Vac-Pac.

CAUTION

Required items: Common liquid disinfectant (e.g., Cavicide , Sporicidin )

® ®

Towel or cloth To clean the Vac-Pac: 1 Close valve cap to prevent liquid from getting inside. 2 Wipe the exterior of the Vac-Pac with a cloth dampened with a liquid disinfectant.

To gas sterilize the Vac-Pac:

High temperatures will damage the Vac-Pac; never steam autoclave Vac-Pacs. After gas sterilization is complete, aerate the Vac-Pac in a manner appropriate for plastic products.

CAUTION

1 2

Flatten the Vac-Pac. Apply suction to the Vac-Pac until it becomes firm, and then close the valve cap. Gas-sterilize the Vac-Pac, and then aerate to dry.

Identifying and Repairing Leaks

With extensive use or improper care, Vac-Pacs can develop leaks from punctures in the fabric, tears on the seams, or wear on the valve. Small holes or leaks generally cause the Vac-Pac to lose some of its firmness over a period of time, while larger holes may cause the Vac-Pac to soften as soon as the suction is removed.

Avoid puncturing the Vac-Pac with towel clips or other sharp instruments. Inspect Vac-Pacs before and after each use for possible damage or leaks. Never use a damaged or leaking Vac-Pac.

CAUTION

To determine the Vac-Pac has a leak: 1 Flatten the Vac-Pac. Apply suction to the Vac-Pac until it becomes firm, and then close the valve cap. 2 Wait 24 hours and then examine the Vac-Pac. If the Vac-Pac retains its original firmness for at least 24 hours, it is ready for use. If the Vac-Pac has softened within 24 hours, suspect a leak.

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To locate a leak:

Do not over-inflate the Vac-Pac. Fill to a maximum pressure of 1 psi.

CAUTION

1 2

Carefully inflate the Vac-Pac with compressed air until it appears like a soft balloon, and then close the valve cap. Submerge the Vac-Pac in a tank or sink of water, and then look for air bubbles, which indicate leaks.

Required items: Olympic Vac-Pac repair patch kit Isopropyl alcohol or mineral spirits Towel or cloth Label applicator squeegee (or smooth, rigid plastic object to smooth the repair patch) To repair leaks:

Do not attempt to repair Vac-Pacs with adhesive tape; only use Olympic Repair Patches. To preserve the effectivity of the product, and prevent patient injury, never attempt to repair or use Vac-Pacs with a leaking valve or tears/holes that are: Longer than 1 in. (2.54 cm). Within 2 in. (5 cm) of the valve. Around the edges of the valve. Located on a seam. To ensure the best possible adhesion: Apply the repair patch to Vac-Pacs at room temperature--at least 65ºF (18°C). Ensure that the surfaces of the repair patch and Vac-Pac are clean and dry. Use a steady vacuum source to keep the Vac-Pac firm during patching. Ensure that the Vac-Pac and repair patch are in complete contact--with no air bubbles between.

CAUTION

NOTE

The repair patch does not feel tacky to the touch.

1 2 3 4 5

Using a cloth dampened with isopropyl alcohol or mineral spirits, clean a 3-inch­square area (7.62-cm­square) around the leak. Next, thoroughly dry the area. Smooth the Vac-Pac to distribute the beads evenly. When the Vac-Pac is lying as flat as possible, further flatten the patch area with a book. With the book in place, apply suction and leave the suction source attached. Remove the repair patch backing. Center the patch above the hole, and then starting at one edge, use your finger to smooth the patch onto the Vac-Pac over the hole. Press out all air bubbles (see Figure 15 on page 19).

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Olympic Vac-Pac Instruction Manual

Figure 15 Placing the patch

6

Firmly smooth the repair patch out toward the edges using a smooth, rigid plastic object, such as a label applicator squeegee, until the patch conforms to the slightly bumpy surface texture of the Vac-Pac (see Figure 16).

Figure 16 Smoothing the patch

7 8

Remove the vacuum source, and then close the valve cap. Allow the Vac-Pac to sit in a firm state for at least 24 hours. If the patch is successful, the Vac-Pac will retain its firmness and shape.

Non-Repairable Leaks

Do not attempt to repair Vac-Pacs with adhesive tape; only use Olympic Repair Patches. To preserve the effectivity of the product, and prevent patient injury, never attempt to repair or use Vac-Pacs with a leaking valve or tears/holes that are: Longer than 1 in. (2.54 cm). Within 2 in. (5 cm) of the valve. Around the edges of the valve. Located on a seam.

CAUTION

If in doubt as to whether your Vac-Pac is repairable, contact Olympic Medical and request information about factory inspection and repair (see page 20), or the Olympic Vac-Pac trade-in program.

Olympic Vac-Pac Instruction Manual

19

Replacing Vac-Pacs

Vac-Pacs are durable, and when properly cared for, will give years of service. However, like any product made of various plastic components, they are subject to normal wear and tear, as well as damage.

To assure that your Vac-Pacs are in optimal condition, and to minimize potential problems and repairs, it is recommended that you replace Vac-Pacs that: Are more than five years old and have been in use several times a week. Are more than three years old and have been in heavy daily use. Have been patched more than once. Have damage that is beyond repair, as described in Non-Repairable Leaks, above.

CAUTION

If you are in doubt as to the age of your Vac-Pacs, contact Olympic Medical and request information about your Vac-Pac records.

Factory Inspection and Repair Service

Vac-Pacs with leaks, or suspected leaks, can be returned to Olympic Medical for inspection and repair. A base cost of $40 will be charged for inspecting and testing each Vac-Pac. If the Vac-Pac is repairable, no additional cost is charged. If the Vac-Pac is not repairable, and if a new replacement Vac-Pac is purchased within 90 days, the $40 charge will be waived.

Olympic Medical offers trade-in discounts on Vac-Pacs that are beyond repair.

NOTE

20

Olympic Vac-Pac Instruction Manual

Section 7

Product Specifications

Table 3 Vac-Pac sizes and dimensions

Catalog No. Dimensions* Shape Imperial Metric 76.2 x 92.7 cm 86.4 x 133.4 cm 40.6 x 30.5 cm 52.8 x 27.9 cm 45.7 x 50.8 cm 72.9 x 90.2 cm 98.3 x 90.2 cm 118.6 x 90.2 cm 87.6 x 71.1 cm 98.3 x 90.2 cm 76.2 x 193.1 cm Three sections / flaps Three sections / flaps U-shape Small rectangle Small U-shape cutout on 18-in. side, small Small U-shape cutout on 28.7-in. side, medium Small U-shape cutout on 38.7-in. side, large Small U-shape cutout on 46.7-in. side, extra large T-shape / flaps Shoulder positioner with U-shape and moon-shape cutouts Large rectangle

Size 6 8 11 20 23 25 30 31 32 35 38 40

*

51606 30 x 36.5 in. 51608 34 x 52.5 in. 51611 16 x 12 in. 51620 20.8 x 11 in. 51623 18 x 20 in. 51630 28.7 x 35.5 in. 51631 38.7 x 35.5 in. 51632 46.7 x 35.5 in. 51635 34.5 x 28 in. 51638 38.7 x 35.5 in. 51640 30 x 76 in.

51625 36.5 x 14.8 / 18.5 in. 92.7 x 37.6 / 47.0 cm Tapered rectangle

Measurements (width x length) of compressed Vac-Pac. Depth is dependent upon positioning and bead compression.

Figure 17 Vac-Pac Shapes

Size 11 Size 6 Size 25 Size 23 Size 30

Size 38 Size 8

Size 31

Size 40

Size 35 Size 32 Size 20

Olympic Vac-Pac Instruction Manual

21

Section 8

Product Specifications, Continued

Service Punctured Vac-Pacs may require patching or may be returned to factory for repair or trade-in discounts. Environment Use: 65­85°F Shipping/Storage: -40­158°F

18­29°C -40­70°C

Product Material Outer skin: 20-mil polyvinyl chloride (PVC) film Valve: White PVC Inner beads: Expanded polystyrene, 0.023­0.047 mm Note: Vac-Pacs are latex-free. Repair Parts Patch Kit .......................................301350-T509

Includes repair patch, plug, and 5-in-1 connector

Warranty Unconditional one-year warranty against all manufacturing defects. CE Conformance Vac-Pacs conform to the European Device Directives (EDD) for Class I products. Product Disposal The Vac-Pac covering and valves are made of PVC; the inside beads are made of polystyrene. Follow your local ordinances and regulations for disposal. For More Information For more information, contact Olympic Medical or your local Olympic Vac-Pac distributor.

Olympic Medical Toll-free: 1-800-426-0353 (US/Canada) Phone: 206-767-3500 (worldwide) E-mail: [email protected] Web: www.OlympicMedical.com

Patch Kit ...................................... 301350-K509

Includes label applicator squeegee, repair patch, plug, and 5-in-1 connector.

Patch Only ...................................... 301350-509 5-in-1 Connector .............................. 100197-01 Replacement Valve Plug................ 300932-503 Hand Vacuum Pump ...............................51650

22

Olympic Vac-Pac Instruction Manual

Section 9

Declaration of Conformity

Olympic Vac-Pac Instruction Manual

23

24

Olympic Vac-Pac Instruction Manual

Information

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