DORO Headrest System Instruction Manual June 2013

DORO® Instruction Manual

DORO

Quick Guide - DORO Headrest System Rocker Arm

Receptacles for Skull Pins

DORO QR3 Skull Clamp Item-No. 1001.001

Torque Screw

Index Knob

Skull Pin

Starburst for DORO Easy Connect Navigation Adaptors Quick-Rail 3rd Gen.

Skull Clamp Base

Extension Assembly Release Knob

Starburst

Receptacles for Skull Pins

DORO Headrest System shown with Item-No. 3003-00

Rocker Arm

Torque Screw

Index Knob

Quick-Rail

Skull Pin

Extension Assembly

upper Starburst Connection

Release Knob lower Starburst Connection

Skull Clamp Base upper Locking Screw Swivel Base

Transitional Member

lower Locking Screw

Table Rod Adjustable End Bracket

fixed End Bracket Base Handle Assembly

Hex Screw

Connecting Tube

Hex Wrench Tension Knob with Lock Screw -2-

Locking Lever

DORO® Instruction Manual

DORO

Contents 1.

Conformities... 4 1.1 Guidelines and norms... 4 1.2 CE conformity... 4 1.3 FDA Registration... 4

2.

General Safety Information... 4 2.1 Symbols used for safety information... 4 2.2 Proper handling and permitted user... 6 2.3 Creutzfeldt Jakob Disease... 6

3.

Basic Information... 6 3.1 Warranty and liability... 6 3.2 Obligations of the purchaser... 6 3.3 Use as per instructions... 7 3.4 Improper use... 7

4.

Product description... 8 4.1 4.2 4.3 4.4

5.

General description/Intended use... 8 Component description... 8 Components... 8 Technical specifications... 10 Mounting... 12

5.1 Mounting of the DORO Base Unit... 12 5.1.1 Adjusting DORO Base Unit to standard OR Table... 12 5.1.2 Mounting DORO Base Unit to standard OR Table... 13 5.2 Mounting the DORO Swivel Adaptor... 14 5.3 Mounting of the DORO Skull Clamp... 14 5.4 Mounting of the DORO Skull Pins... 14 5.5 Mounting DORO Easy Connect Navigation Adaptors... 15 5.6 Mounting Additional Accessories... 15 5.6.1 Quick-Clamp w/ Interface for Mizuho-Type Retractors... 15 5.6.2 Quick-Clamp and Accessories... 15 6.

Use and Handling... 17 6.1 Detailed description of application... 17 6.2 Function and safety inspection... 22 6.2.1 Prior to clinical use of a DORO device... 22 6.2.2 After clinical use of a DORO device... 22

7.

Care ... 23 7.1 Manual Cleaning... 23 7.2 Automated Cleaning ... 24 7.3 Lubrication... 25

8.

Maintenance and Repair ... 26 8.1 Maintenance intervals... 26 8.2 Maintenance to be performed by the purchaser... 27 8.2.1 Adjusting the Locking Lever... 27 8.2.2 Checking the stability of the Transitional Member... 28 8.2.3 Replacing the Transitional Member... 28

9.

Environmentally Compatible Disposal ... 30

10.

Manufacturer information... 30 -3-

DORO® Instruction Manual

DORO

This instruction manual contains important information on the safe, correct and efficient use of the device. Carefully read this manual and observe all the notes and information. This instruction manual should be used in conjunction with the instruction manuals for your other equipment. Make sure to read those manuals very carefully as well. Always keep all the instruction manuals at hand.

1.

Conformities

1.1

Guidelines and norms

Description

Guidelines and norms

DORO Headrest and DIN EN ISO 13485 Medical Devices - QM System Retractor Systems DIN EN ISO 14971 Risk Management 93/42/EEC Medical Device Directive

1.2

CE conformity DORO Headrest and Retractor Systems conform to the basic requirements of the applicable guideline and the corresponding norms of the Council of the European Union.

1.3

FDA Registration

The DORO Headrest and Retractor Systems are registered with the 510(k) Numbers K001808, K032331, K063494. Note: Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order Only of a physician.

2.

General Safety Information

2.1

Symbols used for safety information

This instruction manual contains the basic information required for the safe use of the device. The symbols explained below might be used in this instruction manual and/or on the product labels to point out safety-relevant information: Danger: This symbol indicates a danger to the health of the patient. Failure to observe this information and to follow the appropriate instructions may result in serious injury to the patient and may even endanger the patient’s life. Warning: This symbol indicates a danger of injury to the user of the device. -4-

DORO® Instruction Manual

DORO

Important: This symbol indicates important information on the proper use of the device. Failure to observe this information and to follow the appropriate instructions may cause damage to the equipment. Note: This symbol provides tips concerning the use of the device. Such information will help you use the device to its full potential. Exclusion of liability: This symbol points out exclusions of liability of the manufacturer. Such disclaimers result if the purchaser or user does not employ the device properly or fails to follow the instructions. Attention: Read operating instructions! Manufacturer: Manufacturer's name and address. Production date: Printed on package! Safe usage until: Printed on package! Do not use after this date. Sterile: Sterilized with gamma radiation or ethylene oxide according to the label on the outside box. Use only once: Do not reuse! Destroy after usage! MR Safe an item that poses no known hazards in all MR environments. MR Unsafe an item that is known to pose hazards in all MR environments. Lot number: Printed on package or product. Item number: Printed on package or product. Serial number: Printed on package or product. -5-

DORO® Instruction Manual

2.2

DORO

Proper handling and permitted user

The device may only be used and applied by qualified professional persons belonging to the operating team.

2.3

Creutzfeldt Jakob Disease Warning: If the patient is suspected of having the Creutzfeldt Jakob Disease, adequate measures must be taken to prevent possible transmission to other patients, users, and third parties. The device also should not be reused with any other patient. Please consult individual national infection control/ prevention protocols for specific guidance regarding processing medical devices with suspected exposure to Creutzfeldt Jakob Disease.

3.

Basic Information

3.1

Warranty and liability

All warranty claims presuppose proper operation and treatment of the device. The manufacturer guarantees that all parts are free from defects in both materials and workmanship at the time of delivery. Exclusion of liability: The manufacturer shall not be liable for damages resulting from incorrect use of the device, failure to follow the instructions furnished in this manual or improper or insufficient maintenance.

3.2

Obligations of the purchaser

The purchaser must ensure that all users of the device are trained in the proper use of the device and fully understand all safety-relevant information. o

The purchaser shall be obliged to permit only trained staff, i.e. the OR team, to use the device.

o

The purchaser shall also be responsible for storing this instruction manual in such a way that it is always available when the device is being used. Exclusion of liability: The manufacturer shall not be liable for damages resulting from the failure of the purchaser to train the users of the device.

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DORO® Instruction Manual

3.3

DORO

Use as per instructions

The device is designed and built according to the latest technical developments and to approved safety standards. DORO Headrest and Retractor Systems may be used o

only as a support mechanism for head and neck surgery,

o

only if the device is in a proper state as far as the safety aspects are concerned.

Use as per instructions also implies o

that you follow all information furnished in this manual

o

that you clean and maintain the device as described.

3.4

Improper use

Improper use or use not conforming to the instructions contained in this manual may result in serious injuries or even death to the patient or the user and damage the device and other equipment. Exclusion of liability: The manufacturer shall not be liable for damages resulting from improper use. Exclusion of liability: DORO Headrest and Retractor Systems can be mounted to all standard OR Tables. The manufacturer shall not be liable for damages resulting from the use of the device in conjunction with non-standardized OR Tables.

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DORO® Instruction Manual

DORO

4.

Product description

4.1

General description/Intended use

The DORO Headrest System is a mechanical support system which is used in head and neck surgery. This system allows the patient’s head to be positioned and secured for the operation. It can be used for cranial fixation of the patient in prone, supine, lateral and sitting positions.

4.2

Component description

DORO Base Unit The Base Unit is designed for patient positioning in prone or supine positions. For lateral positioning we recommend using the DORO Adjustable Base Unit Parkbench (Item-No. 3001-006). Note: For patients undergoing surgery in sitting positions, use the DORO Crossbar Adaptor (Item-No. 3007-00) which is mounted to the side rails of the OR Table (see instruction manual DORO Crossbar Adaptor for mounting instructions). DORO Swivel Adaptor The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the Skull Clamp. The Swivel Adaptor is pivotable by 360 degrees. This allows a fully flexible adjustment of the DORO Headrest System to the patient’s position. DORO Skull Clamp Item-No. 3003-00 and 1001.001 The Skull Clamp provides the receptacles for the Skull Pins which penetrate the patient’s skull for rigid cranial fixation.

4.3

Components

The DORO Headrest System consists of the following components: Description: Item-No. DORO Base Unit Aluminum 3001-00 DORO Swivel Adaptor Aluminum 3002-00 And one of the DORO Skull Clamps: DORO Skull Clamp Aluminum 3003-00 DORO QR3 Skull Clamp 1001.001 We recommend using the following components with the Headrest System (refer to instruction manual Skull Pins): Description DORO Reusable Skull Pins for Adults DORO Reusable Skull Pins Pediatric DORO Disposable Skull Pins Adult DORO Disposable Skull Pins Pediatric DORO Disposable Skull Pins Titanium, Adult DORO Disposable Skull Pins Titanium, Pediatric -8-

Item-No. 3005-00 3004-00 3006-00 3006-10 3006-20 3006-30

DORO® Instruction Manual

DORO

DORO Disp. Skull Pins Stainless Steel, Adult DORO Disp. Skull Pins Stainless Steel, Pediatric

3006-50 3006-60

Additional Base Units: DORO Adjustable Base Unit US DORO Adjustable Base Unit Muranaka DORO Adjustable Base Unit Mizuho DORO Base Unit Eschmann DORO Base Unit Parkbench DORO Base Unit Australia DORO Base Unit Eschmann T-Series

3001-00-US 3001-001 3001-002 3001-003 3001-006 3001-008 3001-010

Additional Swivel Adaptors: DORO Ball Pivot Adaptor DORO Swivel Adaptor Navigation

3002-50 3002-60

Navigation Adaptors (refer to instruction manual Navigation Adaptors) used with Skull Clamp 3003-00:

Navigation Adaptor Quick-Rail, Stryker®, Aluminum 3114-64 Navigation Adaptor Quick-Rail, Medtronic, Aluminum 3114-65 Navigation Adaptor Quick-Rail, BRAINLAB, Aluminum 3114-66

used with Skull Clamp 1001.001:

DORO Easy Connect Navigation Adaptor, Stryker® DORO Easy Connect Navigation Adaptor, Brainlab DORO Easy Connect Navigation Adaptor, Medtronic

1204.001 1204.002 1204.003

Accessories: DORO Quick-Clamp DORO Quick-Clamp w/ Interface for Mizuho-Type Retractors

1202.014 1201.045

Additional Accessories (refer to the appropriate instruction manuals): DORO Armrest Parkbench DORO Crossbar Adaptor Universal Side Rail Fitting Table Adaptor Side Rail Adaptor Side Rail Adaptor Amsco® DORO Amsco® Headrest Adaptor Cervical Spine Support Headrest Wall Storage Unit

3001-007 3007-00 3007-50 3010-00 3011-00 3011-10 3011-11 3012-00 3013-00

For more accessories and product pictures please refer to our DORO Cranial Stabilization and Retractor Systems brochure or visit us at www.headrest.de. -9-

DORO® Instruction Manual

DORO

Always make sure to have the complete set of accessories and tools available. Exclusion of liability: The manufacturer shall not be liable for third-party components which are used in conjunction with the DORO Headrest System and DORO Accessories.

4.4

Technical specifications

Type of device: DORO Headrest System Serial number: on each part Weight: Base Unit 3110 g Swivel Adaptor 480 g Skull Clamp (3003-00) 1750 g Skull Clamp (1001.001) 1700 g Material: aluminum cast, stainless steel, high performance polymer materials Dimensions: see outline drawings Outline drawing Item-No. 1001.001 in mm

Outline drawing Item-No. 3003-00 in mm

300-430 85-215 24,0

247

111,72

113

254

158

75

24,5

Outline drawing DORO Swivel Adaptor in mm

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DORO® Instruction Manual

DORO

Outline drawing DORO Base Unit in mm max.

The two table rods of the DORO Base Unit are equipped with an internal isolation to prevent electrical stray currents when the Base Unit is connected to the OR Table.

Type of device: Serial number: Weight: Material: Dimensions:

Outline drawing Item-No. 1202.014 in mm

DORO Quick-Clamp on part 180g stainless steel see outline drawings

Outline drawing Item-No. 1201.045 in mm

Type of device: DORO Quick-Clamp w/ Interface for Mizuho Type Retractors Serial number: on part Weight: 300g Material: stainless steel Dimensions: see outline drawings

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DORO® Instruction Manual

DORO

5.

Mounting

5.1

Mounting of the DORO Base Unit

The DORO Base Unit is mounted to the receptacles of the OR Table. Since the distance between the receptacles of OR Tables vary, the distance of the end brackets need to be adjusted. Inspect all parts prior to use for any noticeable damage i.e. cracking, surface defects etc. Note: The adjustable end bracket allows you to easily mount the DORO Base Unit to standard OR Tables.

5.1.1

Adjusting the DORO Base Unit to a standard OR Table 1. Remove the Hex Wrench from its storage holder on the lefthand side of the Connecting Tube.

↑



2. Locate the Hex Screw at the adjustable End Bracket to adjust the width.



3. Using the Hex Wrench, loosen (do not remove) the Hex Screw at the left End Bracket by turning the Hex Screw counter-clockwise until the adjustable end bracket is loose.





4. Carefully slide the Adjustable End Bracket over the connecting tube to adjust the width of the table rods to the width of the receptacles of the OR Table. 5. Insert the two table rods into the receptacles of the OR Table to verify that the width match and the Base Unit is seated properly.



6. Make sure that the Hex Screw is seated properly in the slot of the connecting tube. Using the Hex Wrench, lock the width by turning the Hex Screw clockwise. Return the Hex Wrench to its storage holder.

Once this adjustment is made for your OR Table, this step can be skipped in future use.

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DORO® Instruction Manual

open



DORO

Open the Locking Lever to position the Base Handle Assembly at the center of the connecting tube. Make sure that the Transitional Member is connected to the Base Handle Assembly, otherwise connect the Transitional Member before closing. Close the Locking Lever to lock the position.

close

To adjust the Locking Lever tension see chapter 8.2.1

Important: Never close the Locking Lever without the Transitional Member and the Connecting Tube in place. This will damage the Base Handle Assembly.

5.1.2

Mounting the DORO Base Unit to a standard OR Table

1.

Position the Base Unit at the head of the OR Table with the Base Handle Assembly centered on the connecting tube.

2.

If you need to adjust the Base Unit to the width of the receptacles of the OR Table see chapter 5.1.1.

3.

Insert the two table rods into the receptacles of the OR Table.

4.

Turn the receptacle fastening screws at the OR Table until they are fully tightened.

5.

Position the Base Handle Assembly at the desired position as described in chapter 5.1.1.7.

6.

Ensure that all adjustable joints are tightly fastened and secured.

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DORO® Instruction Manual

5.2

DORO

Mounting the DORO Swivel Adaptor

Mount the Swivel Adaptor to the Transitional Member of the Base Unit: 1. Position the teeth of the starburst connection of the Transitional Member and the teeth of the lower starburst connection of the Swivel Adaptor in a manner that they engage.

 5.3

2. Fully tighten the lower locking screw of the Swivel Adaptor by turning it clockwise. Note: the teeth of the starburst connections must be fully engaged and seated properly.

Mounting of the DORO Skull Clamp

Mount the Skull Clamp (Item-No. 3003-00 or 1001.001) to the Swivel Adaptor 1. Position the teeth of the upper starburst connection of the Swivel Adaptor and the teeth of the starburst connection of the Skull Clamp in a manner that they engage.



2. Position the Skull Clamp as desired. 3. Fully tighten the upper locking screw of the Swivel Adaptor by turning it clockwise. Note: the teeth of the starburst connections must be fully engaged and seated properly. Danger: Check all fastening screws and all starburst locking mechanisms on the device and check the stability of the complete DORO system before and after each clinical use. Make sure that the device is exactly mounted as described in this manual. Important: QR3 only : The main starburst of the QR3 Skull Clamp (base) is designed for connecting the QR3 Skull Clamp to DORO Swivel Adaptors and other accessories. When connecting non-DORO accessories with similar starburst connections, test that the connection is tight and secure and the teeth of both starbursts are fully engaged with no gap. A poor connection could be caused by a screw on the accessory which is too long. These accessories must not be used with the QR3 Skull Clamp.

5.4

Mounting of the DORO Skull Pins

This system requires three DORO Skull Pins of the same versions to be used. Please refer to the instruction manual of the appropriate DORO Skull Pins. -14-

DORO® Instruction Manual

5.5

DORO

Mounting of the DORO Easy Connect Navigation Adaptors

The Navigation Adaptors (1204.001/ 1204.002) can be attached directly to the built-in starburst connections on each Quick-Rail of the QR3 Skull Clamp (1001.001). Please refer to the instruction manual of the DORO Easy Connect Navigation Adaptors.

5.6

Mounting Additional Accessories

5.6.1

Quick-Clamp w/ Interface for Mizuho-Type Retractors

Use the Quick-Clamp w/ Interface for Mizuho-Type Retractors, Item-No. 1201.045, to connect Mizuho-Type Retractors to the DORO Skull Clamp 3003-00 or 1001.001.

1.

 2.

2. To mount the Mizuho-Type Retractor Arm, insert the connection piece of the Retractor Arm into the reception of the Quick-Clamp until the stop is reached and position the retractor arm as desired.

X

3.



5.6.2

1. Mount the Quick-Clamp w/ Interface for Mizuho-Type Retractors (1201.045) on the Quick-Rail of the Skull Clamp (3003-00 or 1001.001) over the sterile drape that is covering the Skull Clamp. Fully tighten the Locking Screw of the Quick-Clamp w/ Interface for Mizuho-Type Retractors by turning it clockwise. (Picture shows Quick-Clamp w/ Interface for Mizuho-Type Retractors mounted on QR3 Skull Clamp without sterile drape).

3. Securely tighten the locking screw of the Quick-Clamp w/ Interface for Mizuho-Type Retractors by turning it clockwise. The teeth of the starbust connections must be fully engaged and seated properly.

Quick-Clamp and Accessories

Connecting the DORO Quick-Clamp to the Skull Clamp 3003-00 or 1001.001

 1202.014

1. Mount the Quick-Clamp (1202.014) on the Quick-Rail of the Skull Clamp (3003-00 or 1001.001) over the sterile drape that is covering the Skull Clamp. Fully tighten the Locking Screw of the Quick-Clamp by turning it clockwise. (Picture shows Quick-Clamp mounted on QR3 Skull Clamp without sterile drape).

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DORO® Instruction Manual

DORO

There are two possibilities to secure additional accessories to the Quick-Clamp: 2.

Use the appropriate accessories to mount the DORO Quick-Clamp Retractor Systems like the DORO Quick-Clamp Halo and Quick-Clamp McCue Halo Retractor System, the DORO Quick-Clamp J-Arm Retractor System or the DORO Quick-Clamp Brain Retractor System or the DORO Quick-Clamp IGS Support Arm. Refer to the appropriate instruction manuals for further mounting and use instructions.

Quick-Clamp 1202.014 shown with Quick-Clamp Coupling Universal 1202.015 and Halo Support rod Holder 1202.016

Quick-Clamp 1202.014 shown with Quick-Clamp Coupling Twin QR 1201.043

Quick-Clamp 1202.014 shown with IGS Articulated Support Arm 1201.041

Use the built-in Quick-Rail of the Quick-Clamp 1202.014 to connect current accessories (with interface for the Quick-Rail of the Skull Clamp (3003-00)) like the Quick-Rail Adaptor Halo 3114-55 and Quick-Rail Adaptor J- Arm 3114-56 as well as the Flexible Arms.



3.

Quick-Clamp 1202.014 shown with Quick-Clamp Coupling J-Arm 1203.015

Danger: Ensure that all adjustable joints are tightly fastened and secured.

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DORO® Instruction Manual

DORO

6.

Use and Handling

6.1

Detailed description of application Note: The user decides the best approach to secure the patient to the Skull Clamp. We recommend to secure the patient‘s head first to the Skull Clamp with Skull Pins and then to connect the Skull Clamp carefully by means of the Swivel Adaptor to the Base Unit and the OR Table.

The following 3 steps - A

B C - are required:

A

Mount the Base Unit and the Swivel Adaptor to the OR Table

1. Mount the Base Unit to the OR Table (see Chapter Mounting). 2. Mount the Swivel Adaptor to the Transitional Member of the Base Unit (see Chapter Mounting). 3. For ease in mounting, we recommend that the Transitional Member of the Base Unit and the Swivel Adaptor are loosely connected (not fully tightened) and the Swivel Adaptor is hanging loose and pointing to the floor.

B Secure the patient's head to the Skull Clamp (Item-No. 3003-00 or 1001.001)

Insert the Skull Pins into the receptacles of the Skull Clamp (refer to instruction manual Skull Pins). Adjusting the required Skull Clamp width:

↑

↑

1. Pull down the Release Knob at the Skull Clamp base and pull the Extension Assembly away from the Skull Clamp base to widen the Skull Clamp. 2. Place the patient’s head in the desired position within the Skull Clamp. Push the Extension Assembly into the Skull Clamp Base to reduce the Skull Clamp width.

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↑

DORO® Instruction Manual

3.

DORO

When you have obtained the desired width make sure that the theeth of the Extension Assembly and the Skull Clamp Base are fully enganged. Danger: Avoid inadvertent opening of the the Quick-Release Knob of the Skull Clamp (Item-No. 3003-00) during procedure.

4.

Adjust the Skull Clamp to the width of the patient’s head in the manner that the two Skull Pins in the rocker arm are equidistant from the centerline of the head and the single Skull Pin at the Extension Assembly is in line with this centerline.

CORRECT INCORRECT 5.

Adjust the Rocker Arm to the desired position. 6. Turn the Index Knob from „OPEN“ until it engages in the „Lock“ position and make sure that the mark is in the correct position. If this cannot be done without problems, return to the „OPEN“ position, turn the rocker arm slightly and try again to engage the Index Knob in the „LOCK“ position. Important Only turn the rocker arm while the Index Knob is in the “OPEN” position. Otherwise the locking mechanism will be damaged.

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DORO® Instruction Manual

DORO

Danger: The pinning of the patient should only be performed by a licensed physician or a licensed surgeon. Danger: Take extra precautions when pinning young infants, the elderly, or on restored surgical areas, including previously drilled burr holes, or any diseased bone because of the varying consistencies and thickness from that of healthy bone. It is the responsibility of the user to select the proper type of fixation and the correct clamping pressure in view of the skull thickness and bone structure of the patient’s head. For rigid fixation, ensure the proper position of the patient’s head. The two skull pins in the Dual-Pin Rocker Arm should be equidistant from the centerline of the head and the single skull pin in line with this centerline. The angle of the pins should be as close to 90 degrees possible to the patient skull. Use the proper clamping force. Danger: The user decides which type of fixation and what clamping force are required, based on the thickness of the skull and the bone structure. Therefore: refer to the instruction manual Skull Pins. For pediactric cases we recommend the DORO Multi-Purpose Skull Clamp with 4-point fixation or non-invasive gel pads Danger: Failure to properly position the Skull Pins may cause serious injury to the patient. Therefore: Avoid sensitive areas like the frontal sinus, temporal fossa, blood vessels or nerves.

7. Turn the torque screw in order to drive the Skull Pins at an angle of 90 degrees into the patient’s head (refer to instruction manual Skull Pins, section mounting). Danger: Angles other than 90 degrees may cause the system to become unstable and may result in serious injury to the patient. 8.

Ensure proper position of the Skull Pins.

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DORO® Instruction Manual

DORO

9. Adjust the clamping force by means of the torque screw. The adjusted clamping force is readable at the scale in stages up to 360 N/80 lbs (maximum setting). The visible scale stages are 90/180/270/360 N or 20/40/60/80 lbs. 10. If necessary, readjust the clamping force. Turn the torque screw clockwise to increase the clamping force.

Note: Before applying pressure make sure that the four pressure lines are not showing. When applying pressure the first line (20lbs/90N) becomes visible, then the second line and the third line become visible. Danger: The DORO Skull Clamp may cause damage to the patient’s skull. The head may fall out of the Skull Clamp or the Skull Pins may break through into the brain if using an incorrect clamping force. It is absolutely necessary to follow the instruction of the surgeon, when defining the clamping force to be applied. Danger: The DORO Headrest System is temporarily destabilized when you loosen handles and fastening screws. Therefore: Ensure that all handles and fastening screws at the device are properly locked prior to each clinical application of the system. Danger: The maximum load for the Headrest System is 12.5 kgs/27.5 lbs. Please make sure to safely position the patient’s neck and shoulders to avoid excess weight.

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