C-Flex Polar Head Positioning System A-70701 Instructions for Use Rev A7 Sept 2015

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 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.

Jackson is a trademark of Mizuho OSI, Inc. MAYFIELD is a registered trademark of SM USA, Inc. DORO is a registered trademark of Pro Med Instruments, Inc

Document Number

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INSTRUCTIONS FOR USE

TABLE OF CONTENTS 1.0

2.0

3.0

Safety Precautions and General Information 1.1

General Safety Warnings

1.2

Table Compatibility

1.3

Starburst Adaptor Compatibility

1.4

Product Specifications

Component Identification 2.1

Base Unit

2.2

Starburst Adaptor

2.3

Prone Face Mask

2.4

Flat Plate

Equipment Setup and Use 3.1

Mounting

3.2

Head Module Quick Connect

3.3

Head Module Quick Release

3.4

Lateral Adjustment

3.5

Mirror Adjustment

3.6

Adjusting the C-Flex

3.7

Using the Prone Mask

3.8

Using the Flat Plate

3.9

Connecting and Using the Starburst Adaptor 3.9A

Method 1

3.9B

Method 2

3.9C

Translaminar Screws

3.10 Disconnecting the Starburst Adaptor 3.10A

Method 1

3.10B

Method 2

3.11 Applying Traction 3.12 Patient Rotation on the Jackson Table

4.0

3.12A

Rotation with a Skull Clamp

3.12B

Rotation with the Prone Face Mask

Cleaning

Document Number

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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 apply weight when the C-Flex is mounted upside down.

•

Do not hang weights directly off of the C-Flex when using traction.

•

Do not lean on the C-Flex during a procedure.

•

Support patient at the sub-clavicular level.

•

Apply the C-Flex Disposable Cover to the device for each procedure.

1.2 TABLE COMPATIBILITY The Allen C-Flex is compatible with •

Allen Flex Frame

•

Allen AP-Vantage

•

Jackson Spinal Table

•

Most other spinal tables with 1 ¼”W x 1 ½”H x 17” spaced rails

Note: Refer to the Table Manufacturer's User Guide for instructions on use.

1.3 STARBURST ADAPTOR COMPATIBILITY The Allen C-Flex Starburst Adaptors are compatible with •

MAYFIELD® Skull Clamps

•

MAYFIELD® Horseshoe Headrest

•

DORO® Headrest System

Note: Refer to the Doro® or Mayfield® User Guide for instructions on use. Document Number

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01 SEP 2015

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INSTRUCTIONS FOR USE 1.4 PRODUCT SPECIFICATIONS •

500 lbs (227kg) patient weight limit

•

23 lbs (10kg) maximum rated load

RANGE OF MOTION 9” (23 cm)

6” (15 cm) LATERAL

28” (71 cm)

HEIGHT

15°

15°

ROLL Document Number

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INSTRUCTIONS FOR USE 2.0 COMPONENT IDENTIFICATION 2.1 BASE UNIT

ADAPTOR HOUSING

UNIT WEIGHT: 20 lbs (9 kg)

SAFETY LEVER

HANDLES

KNOB FOR ADAPTOR HOUSING

WRIST JOINT ELBOW JOINT KNOBS FOR LATERAL ADJUSTMENT SAFETY LEVER

BRACKETS

ARM KNOB FOR BRACKET

MIRRORS

SHOULDER JOINT

BUMPERS Document Number

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INSTRUCTIONS FOR USE 2.2 STARBURST ADAPTOR

ATTACHMENT KNOB

CONE ADAPTOR

FOR USE WITH:

SKULL CLAMP

HORSESHOE

*Starburst Adaptor is part of the C-Flex Head Positioning System. It is not included in A-70701, but is shown here for reference Document Number

Revision

Effective Date

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01 SEP 2015

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INSTRUCTIONS FOR USE 2.3 PRONE FACE MASK

SUPPORT SURFACE CHIN SUPPORT

CONE ADAPTOR

FOR USE WITH:

ALLEN® COMFORT MASK™ DISPOSABLE A-70302 (SOLD SEPARATELY)

Use with the Allen® Comfort Mask™ Disposable Not intended for rigid fixation *Prone Face Mask is part of the C-Flex Head Positioning System. It is not included in A-70701, but is shown here for reference Document Number

Revision

Effective Date

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A7

01 SEP 2015

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INSTRUCTIONS FOR USE 2.4 FLAT PLATE

SUPPORT SURFACE

CONE ADAPTOR

SUGGESTED CUSHIONS:

PILLOW

FOAM BLOCK

Use with a cushion Not intended for rigid fixation *Flat Plate is part of the C-Flex Head Positioning System. It is not included in A-70701, but is shown here for reference Document Number

Revision

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01 SEP 2015

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INSTRUCTIONS FOR USE 3.0 EQUIPMENT SETUP AND USE 3.1 MOUNTING 1. Completely unscrew the knobs on the brackets.

1

2. Set the brackets on the rails of the Allen Flex Frame or Jackson Table. Make sure that the brackets are fully seated on the rails. 3. Tighten the knobs while applying light upward pressure at the elbow joint.

2

4. Test that the device is properly mounted.

3 FLUSH

Make sure that the Allen C-Flex is fully locked onto the rails prior to loading a patient. Document Number

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INSTRUCTIONS FOR USE 3.2 HEAD MODULE QUICK CONNECT 1. Unscrew the knob on the side of the adaptor housing by 2-3 turns. 2. Insert the cone on the head module into the adaptor housing. Push Head Module in until it “CLICKS”. 3. Fully tighten the knob on the side of the adaptor housing.

3.3 HEAD MODULE QUICK RELEASE

1. Unscrew the knob on the side of the adaptor housing by 2-3 turns. 2. Squeeze the levers on the bottom of the adaptor housing and remove the head module.

Document Number

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INSTRUCTIONS FOR USE 3.4 LATERAL ADJUSTMENT 1. Loosen the lateral adjustment knobs. 2. Slide the arm laterally while applying light upward pressure at the elbow joint.

1 3. Fully tighten the knobs while still applying light upward pressure at the elbow joint.

3.5 MIRROR ADJUSTMENT 1. Rotate the larger mirror so that it reflects the patient’s face.

2

2. Rotate the smaller mirror so that it reflects the image in the larger mirror. TIP: If the mirrors become loose, tighten the appropriate screw a few turns.

1

2 Document Number

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INSTRUCTIONS FOR USE 3.6 ADJUSTING THE C-FLEX

(B) 1. Depress the safety levers (A) and squeeze the handles (B). 2. Position the arm. 3. Slowly release the handles while still supporting the handlebars.

1

(A)

4. Ensure that the arm is locked. This can be done by lightly pulling down on the handlebars to verify that the arm does not move.

3

4

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INSTRUCTIONS FOR USE 3.7 USING THE PRONE MASK 1.

Place the Allen Comfort Mask on the patient while in the supine position.

2.

Transfer the patient to the prone position ensuring that the torso is supported at the sub-clavicular level.

3.

Guide the intubation tubes into the chin cradle of the Prone Face Mask.

4.

Rotate the mirrors as described in Section 3.5.

5.

Ensure that the patient’s eyes are free and the chin is supported.

1

2

SUB-CLAVICULAR SUPPORT

5

3 EYES FREE

CHIN SUPPORTED

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INSTRUCTIONS FOR USE 7 6.

Fold the mirrors away.

7.

Person #1 - Support the patient’s head.

8.

Person #2 - Position the arm, slowly releasing the handles when finished.

9.

Person #2 - Ensure that the arm is locked as described in section 3.6.

8

10. If necessary, reposition the patient’s body.

11. Readjust the mirrors.

9 Document Number

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INSTRUCTIONS FOR USE 3.8 USING THE FLAT PLATE

1.

Transfer the patient to the prone position ensuring that the torso is supported at the sub-clavicular level.

2.

Rotate the mirrors as described in Section 3.5

3.

Ensure that the patient’s eyes are free and the chin is supported.

4.

Adjust the head position as needed. Verify the C-Flex is locked as described in Section 3.6.

Document Number

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01 SEP 2015

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INSTRUCTIONS FOR USE 3.9 CONNECTING AND USING THE STARBURST ADAPTOR

1&2

3.9A - METHOD 1 1.

Attach the Skull Clamp to the patient’s head while in the supine position.

2.

Attach the Starburst Adaptor to the Skull Clamp.

3.

Fully tighten the knob, ensuring that teeth are fully engaged.

4.

Fold the mirrors away.

5.

Unscrew the knob on the side of the adaptor housing by 2-3 turns.

5 Refer to the Skull Clamp User Guide for instructions on use. Document Number

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INSTRUCTIONS FOR USE 3.9A - METHOD 1 6.

Transfer the patient to the prone position ensuring that the torso is supported at the sub-clavicular level.

7.

Person #1 – Support the patient’s head.

8.

Person #2 – Drive the adaptor housing onto the cone. Push the Skull Clamp in until it “CLICKS”.

7&8

Verify that the handles are fully released and free from obstruction.

9

9.

CLICK

10. Fully tighten the knob on the side of the adaptor housing. 11. Adjust the C-Flex as needed. Verify the C-Flex is locked as described in section 3.6.

11 Document Number

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INSTRUCTIONS FOR USE 3.9B - METHOD 2 1.

Insert starburst adaptor into adaptor housing.

2.

Fully tighten the knob on the side of the adaptor housing.

3.

Fold the mirrors away.

4.

Attach the Skull Clamp to the patient’s head while in the supine position.

1

2

4

Refer to the Skull Clamp User Guide for instructions on use. Document Number

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INSTRUCTIONS FOR USE 3.9B - METHOD 2

6&7 5.

Transfer the patient to the prone position ensuring that the torso is supported at the sub-clavicular level.

6.

Person #1 – Support the patient’s head.

7.

Person #2 – Bring the screw of the starburst adaptor up to the skull clamp and screw the starburst adaptor into the skull clamp.

8.

Verify that the handles are fully released and free from obstruction.

9.

Adjust the C-Flex as needed. Verify the C-Flex is locked as described in section 3.6.

8

9 Document Number

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Effective Date

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