SPIDER2 Limb Positioner Operations and Service Manual

Table of Contents

Table of Contents Glossary of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Remove SPIDER2 from O.R. Table Rail... 13

Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Depressurize SPIDER2 for Storage... 13

Intended User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Cleaninig. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Target Patient Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Expected Service Life. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

SPIDER2 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Environmental Conditions... 14

Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

SPIDER2 Battery Charger Specification... 14

Adverse Event Reporting... 6

SPIDER2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Stabilization Kits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Indicator Light. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Guidance and Manufacturer’s Declaration Electromagnetic Emissions. . . . . . . . . . . . . . . . . . . . . . . . . . 16

Changing Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Charging Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Pre-Operative Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Prior to First Use... 8 Set Up... 8

Guidance and Manufacturer’s Declaration Separation Distances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Guidance and Manufacturer’s Declaration Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Unlock Power Switch... 8

Guidance and Manufacturer’s Declaration Special Environment... 18

Instructions for Use... 8

For Further Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

SPIDER2 Attachment to O.R. Table Rail... 8 Setting up SPIDER2 for Surgery... 8 Securing Limb to SPIDER2... 10 Access to Switch Drape Release Button... 10 Operative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Positioning using the SPIDER2 During Surgery... 11 Procedure Set-up Supported by SPIDER2... 11 Post-Operative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

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Glossary of Symbols

Glossary of Symbols

Consult Instructions For Use

Type B applied part

60°C

Caution

Temperature Limitation

-29°C

85%

CE Mark

Humidity Limitation

15%

106kPa

Manufacturer

Pressure Limitation 50kPa

Serial Number

Date of Manufacture

General warning sign

Catalog Number

Nickel–Cadmium battery

Authorized representative in the European community

Do not allow fluids to enter

EU: Not for general waste

Secure Drape under clips

Chinese RoHS

Unique Device Identifier

CSA

Prescription Use Only

Medical Device

Follow instructions for use

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SPIDER2™ Limb Positioner  Operations/Service Manual

Device Description

Device Description

• Single use Stabilization Kits are not to be reused or used if packaging has been damaged. Failure to comply may result in patient injury and/or infection.

The SPIDER2™ combines strength and flexibility to provide optimal intraoperative positioning when used to position a patient’s limbs during surgical procedures. The SPIDER2 has been designed to attach to the rail on all standard operating room tables, as well as the rail on the back of the T-MAX Beach Chair Positioner. to hold and position a limb with the added ability to change the limb positioning intraoperatively from within the sterile field.

• Always use Smith & Nephew stabilization kits. Failure to use the kits or improper use can cause injury. • It is the health care professional’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.

The accessories designed for use with the SPIDER2 Limb Positioner accommodate shoulder, elbow, wrist, ankle and knee procedure applications. This instructions for use provides a brief description of the operation and manufacturer’s suggested positioning.

• Read these instructions completely prior to use.

Intended User

• Surgery specific Instructions for Use contain further warnings; refer to appropriate Instructions for Use prior to use of the product.

• Read and understand the particulars of the Instructions for Use for the specific accessory being used. Do not use the system without having read and understood all relevant Instructions for Use.

The Smith & Nephew SPIDER2 Limb Positioner and accessories are intended for use by health care professionals in accordance with these instructions for use. The use environment is a professional healthcare facility.

• The SPIDER2 system has been tested and found to comply with the emission and immunity limits for medical devices to the IEC 60601-1-2. Compliance to the limits is intended to provide reasonable protection against harmful interference in a hospital environment. There is no guarantee that interference will not occur in an installation. If the SPIDER2 does cause harmful interference to other devices, it is recommended that the user attempt to correct the interference by one or more of the following actions:

Intended Use The Smith & Nephew SPIDER2 Limb Positioner is intended for use during surgical procedures to attach to the rail of standard operating room tables, or T-MAX Beach Chair Positioner.

Indications for Use

– Reorient or relocate this equipment, the other equipment, or both.

The SPIDER2 is indicated for positioning limbs during surgical procedures.

– Increase the separation between the pieces of equipment.

Target Patient Group

– Consult a biomedical engineer.

The targeted population is patients undergoing surgical procedures that require positioning of the limbs.

Contraindications

• Joints of SPIDER2 cannot be locked or unlocked without a battery in place.

None known.

Warnings

• The SPIDER2 Setup Button is disabled when the switch drape and/or foot pedal are plugged in.

Failure to do the following may result in injury to the patient and/or health care professional.

• If Switch Drape Button is connected to the limb, do not disconnect patient’s limb from SPIDER2™.

• Prior to each use: Equipment and components are to be inspected for damage. • Prior to each use: Inspect plastic enclosure for any damage that could result in fluid entry. • Do not use any damaged components. Damaged equipment or components may result in injury to the patient and/or health care professional. • Single use Stabilization Kits are supplied as a Radiation Sterilized Product.

• Load on SPIDER2 is not to exceed 40lbs (18.14kg) when fully extended. Failure to comply may result in patient and/or health care staff injury. Specific SPIDER2 orientations can accommodate higher loads; contact Smith & Nephew.

• Always hold the SPIDER2 and/or patient’s limb while positioning the SPIDER2. • No modifications to this equipment are allowed. • If changing batteries during a surgical procedure, do not change the state of the Power Switch. Doing so during surgery may cause the SPIDER2 to release pressure causing unwanted movement. • Do not change the state of power switch if the patient is connected to the SPIDER2.

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Precautions • Do not grasp the SPIDER2™ over the quick connect release buttons as this can disengage the quick connect locks and disconnect the patient’s limb from the SPIDER2. • Do not release the SPIDER2 and/or patient’s limb until you are certain the SPIDER2 has locked. • Ensure all cables are routed to avoid damage. Damaged cables must be replaced. Failure to replace cables may result in injury to patient and/or health care staff. • If SPIDER2 motor runs continuously, or runs more than once per minute while in locked state, disconnect patient and have product serviced. • Do not allow fluids to enter the switch drape connection receptacle or the foot pedal connection receptacle.

• Essential Performance: Hydraulic pressure cannot drop unexpectedly without adequate notice so the health care professional has time to switch to a more traditional means of maintaining damaged joints or bone fractures separated during the surgical procedure. • Prior to use sterilize the Piggy Back. • It is important to secure the drape under the drape clips to prevent liquids from entering the contacts of the SPIDER2. Liquids collecting on the connections can cause unwanted activation. • Do not allow fluids to enter the switch drape connection receptacle or the foot pedal connection receptacle. • DO NOT immerse any portion of SPIDER2 in liquid.

• Use Foot Pedal with Smith & Nephew products only.

Note: If moisture enters the equipment it can cause corrosion, and damage electrical and/or mechanical components.

• Do not use in AP = Anaesthesia proofed and G = Gas (AP, APG, IEC 60601-1), and OEA = oxygen-enriched atmosphere environments.

• DO NOT Autoclave SPIDER2.

• Do not use solvents, lubricants, or other chemicals unless otherwise specified.

Precautions

• Use SPIDER2 battery charger with SPIDER2 battery pack REF 72203301. Other types of batteries may burst, causing personal injury and damage to charger. • The SPIDER2 battery charger is not permitted to be used in patient care areas due to leakage current. Failure to comply could result in injury to the patient and/or health care professional. • The SPIDER2 battery charger is not suitable for the use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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 functioning properly and not damaged. Do not use a damaged device. • Do not store SPIDER2 in locked position as this will drastically reduce the life expectancy of device. Depressurize before storing by turning Power Switch to the DEPRESSURIZE Position for one second and then allowing the Switch to return to the OFF Position.

• The SPIDER2 battery charger is for indoor use only.

• The SPIDER2 contains Nickel (Ni) which may cause allergic reactions.

• Replace defective SPIDER2 battery charger cords and wires immediately.

• Some of the accessories used with this product may contain Nickel (Ni) which may cause allergic reactions.

• Use of accessories or cables with this equipment, other than those specified or provided by the Smith & Nephew, could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation. • Electrical Interference: This equipment is designed to be used as a stand-alone, in proximity too, and with other medical equipment. This equipment and the other equipment should be observed to verify that they are operating normally.

Adverse Event Reporting If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority. complaints@smith-nephew.com

• Abnormal performance: Due to Electromagnetic Disturbances, may be manifested by a failure to properly maintain positioning of the limb. • High Frequency (HF) Interference: This equipment was designed and tested to be used with HF Electrical Surgical Unit (ESU) equipment.

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SPIDER2™ Limb Positioner  Operations/Service Manual

Indicator Light

Components The SPIDER2™ Limb Positioner consists of the SPIDER2, (Figure 1), the Foot Pedal, (Figure 2), and the Switch Drape, (Figure 3).

Figure 3.  Switch Drape

2. Ribbon

4. Switch Drape Release Button

5. Foam Tab

3. Drape Flare

Indicator Light

Figure 1.  SPIDER2

1. Quick Connect Release Button

2. Female Quick Connect

3. Indicator Light

4. Battery Release Button

5. Drape Clips

6. Foot Pedal Connection Receptacle

7. Switch Drape Connection Receptacle

8. Set Up Button

9. Dumbbell Joint

10. Hinge Joint

11. Battery

12. Clamp Actuating Knob

13. Clamp Indexing Handle

14. Distal Joint

15. Slender Arm

16. Large Arm

17. Power Switch

1

1. Switch Drape Connector

The SPIDER2 contains a single, green indicator light. Indicator

Meaning Light On - Battery is installed, power switch is in the ON position. Light Off - Battery is not installed correctly, power switch is in the OFF position, or unit is defective. Light Blinking - Battery is installed, power switch is in the ON position and battery has low energy.

WARNING:The SPIDER2 battery changer is not permitted to be used in patient care areas due to leakage current. Failure to comply could result in injury to the patient and/or healthcare professional. WARNING:The SPIDER2 battery charger is not suitable for the use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

2

4 3

Figure 2.  Foot Pedal

1. Foot Pedal Connector

2. Cable

3. Foot Switch

4. Foot Pedal Cover

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Changing Batteries

Changing Batteries Batteries may be changed at any time; SPIDER2™ will remain in its original state (joints locked/ unlocked) once battery is removed. If changing battery during surgery DO NOT change the state of the Power Switch. To change batteries: 1. Press Battery Release Button. 2. Slide battery out of track on SPIDER2 (Figure 4).

Figure 6.  Battery Charger plugged into wall outlet

3. Place the SPIDER2 Battery Pack onto the Battery Charger Adapter and slide down to lock in place. Do not place battery on charger until light is yellow (Figure 7).

Figure 4.  Changing Battery Watch Indicator Light

WARNING: Do not change the state of Power Switch if the patient is connected to the SPIDER2. 3. Do not place battery on charger until light is orange. 4. Insert charged battery; SPIDER2 can now operate again. If the Indicator Light is showing a battery with low energy, replace battery. Failure to do so may result in the SPIDER2 not being able to lock/unlock.

Figure 7.  Battery Charger with installed battery

Charging Batteries

4. The battery will be fully charged once the Battery Wall Charger light becomes solid green. The SPIDER2 Battery Pack may be stored on the Battery Charger Adapter when not in use.

The SPIDER2 comes with a battery charger adapter, wall charger, and several cables.

Note: The SPIDER2 Battery Charger has one indicator light. Description of light signals on wall charger:

1. Choose appropriate A/C Power Cable and plug into Battery Wall Charger (Figure 5).

LED* Yellow Yellow Orange Green/Yellow Green Orange/Green

Meaning No Battery Initialization Fast Charge Top-Off Charge Trickle Charge (Charge Completed) Error

* LED Light Mode may take up to 15 seconds to change state. Figure 5.  Charging Components

Note: Choose the appropriate A/C Power Cable and plug into Battery Wall Charger. 2. Plug SPIDER2 Battery Charger into 100-240VAC/50-60hz power outlet (Figure 6).

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SPIDER2™ Limb Positioner  Operations/Service Manual

Pre-Operative Setup

Pre-Operative Setup

Instructions for Use

Sterilize the Piggy Back prior to use.

SPIDER2 Attachment to O.R. Table Rail

Prior to First Use

1. If SPIDER2 has been turned on and joints are locked, holding the Set Up Button allows temporary repositioning of the SPIDER2. When Set Up Button is released, all joints will lock again.

1. Charge SPIDER2™ battery prior to first use, batteries provided are not fully charged. Refer to Charging Battery section in this document. 2. Once the battery is fully charged, attach the battery to SPIDER2. 3. Turn Power Switch to ON Position (Figure 8); SPIDER2 will be activated and all joints will lock. Indicator light should be a solid green color.

2. Open SPIDER2 Clamp by turning Clamp Actuating Knob counter clockwise so clamp opening is larger than table rail. 3. Place Clamp over rail at an angle, placing the top jaw of the Clamp on the rail first then lower bottom jaw into place (Figure 10).

Notes: – Once the SPIDER2 is activated all three joints will lock. – The ON/OFF Switch has 3 positions: a) ON, b) DEPRESSURIZE, c) OFF/STORAGE (Figure 8). – The SPIDER2 set up button is disabled when the switch drape and/or foot pedal are plugged in.

Figure 10.  Lower Clamp onto table rail

4. Tighten the clamp onto table rail by turning Clamp Actuating Knob clockwise (Figure 11).

Figure 8.  Power Switch States

WARNING: Do not change the state of the power switch if the patient is connected to the SPIDER2.

Set Up

Figure 11.   Tighten Knob

The SPIDER2 is designed to attach to either the rail of the O.R. table, or the SPIDER Attachment Rail. The rail attachment is on the back of the Smith & Nephew T-MAX Beach Chair Positioner.

5. Verify that the Clamp is rigidly attached; if not, additional tightening of the Clamp Actuating Knob may be required.

Unlock Power Switch

Setting up SPIDER2 for Surgery

Once locked, the joints can be released in one of two ways: 1. Turn the Power Switch to the depressurize position (Figure 8). 2. Press the Set Up Button (Figure 9).

1. Turn SPIDER2 Power Switch to the ON position. 2. Adjust angle of Dumbbell Joint (relative to table rail) by turning Clamp Indexing Handle counter clockwise. This separates the Clamp and allows repositioning of SPIDER2 to vertical, horizontal, or a 45° angle (Figure 127). Turn Clamp Indexing Handle clockwise to tighten clamp.

Figure 12.  SPIDER2 Vertical, Horizontal, 45° Figure 9.  SPIDER2 Set-up button

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Pre-Operative Setup 3. The SPIDER2™ Clamp Indexing Handle (Figure 1, Item #13) position can be re-oriented by pulling up on the Clamp Indexing Handle and turning clockwise or counter-clockwise. Once the ideal position is found, release to lock into position. 4. Press Set Up Button to adjust SPIDER2 to approximate setup position and check range of motion prior to draping. Note: The Set Up Button must be pressed the entire time to allow the SPIDER2 to move.

Figure 15.   Switch Drape connection

5. Insert the male post of the sterile Piggy Back into the non-sterile female receptor on the SPIDER2 Quick Connect (Figure 13).

Align red dots Figure 16.  Foot Pedal Connection

Figure 13.  Piggy Back insertion into SPIDER2

8. Slide Drape under Drape Clips (Figure 17) and ensure that the Drape completely covers the receptacles to shield them from fluids.

Note: The blue Lock must NOT make contact to the Quick Connect Button. An audible click provides assurance that the two parts are connected. Pull up on the Piggy Back to ensure it is locked in place. 6. Place the Switch Drape over top of the Piggy Back and SPIDER2 Arm. Pull the drape down, past the Dumbbell Joint (Figure 14) , (or standard Drape if only Foot Pedal is to be used). Figure 17.  Pull Drape over connections and secure under the clips.

9. Pull the drape aperture over the Piggy Back to expose the top surface (Figure 18).

Figure 14.  Drape going over SPIDER2.

7. Connect Foot Pedal (Figure 16), Switch Drape (Figure 15), or both, to appropriate Connection Receptacle. Note: To connect the Foot Pedal, align the red dots and insert the Foot Pedal Connector into the Foot Pedal Connection Receptacle.

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SPIDER2™ Limb Positioner  Operations/Service Manual

Figure 18.  Exposed female Quick Connect Receptor

Pre-Operative Setup 10. Slide the blue Quick Connect Ring on the SPIDER2™ up behind the button (through the drape) to secure the Piggy Back in place (Figure 19).

Warnings • It is important to secure the drape under the drape clips to prevent liquids from entering the contacts of the SPIDER2. Liquids collecting on the connections can cause unwanted activation. • Do not allow fluids to enter the switch drape connection receptacle or the foot pedal connection receptacle. • Do not grasp the SPIDER2 over the quick connect release buttons. This can release the lock and disconnect the limb from the SPIDER2.

Figure 19.  Engage locks on Piggy Back and SPIDER2 Distal Ball Joint.

11. Patient’s limb is attached to SPIDER2 by various accessories. Each accessory has a male post that connects into the female receptor on the sterile Piggy Back. After inserting accessories, lock the blue Quick Connect on the Piggy Back to avoid accidental disconnection. 12. Position Switch Drape Release Button (if used) in convenient location for easy access throughout procedure. 13. Refer to the desired accessory’s Instructions for Use for set up and positioning instructions. Table 1 - Procedure Set-up and Accessories supported by SPIDER2, provides an overview of the various set-up procedures and accessories supported by SPIDER2. 14. Attach the appropriate accessory to the SPIDER2 by fitting the male Quick Connect into the female receptor of the Piggy Back. Note: An audible click provides assurance that the two parts are connected. 15. Pull up on the accessory to ensure it is locked in place (Figure 20). Engage the blue Lock on the Piggy Back to maintain a secure connection.

Securing Limb to SPIDER2 The patient’s limb can be attached to the SPIDER2 by various connection accessories. 1. Attach the patient’s operative limb to the desired accessory, using the appropriate Stabilization Kit. Note: Refer to the Operative section in this document for set up and positioning instructions related to the accessory being used. 2. After inserting the accessories, lock the Quick Connect to avoid accidental disconnection.

Access to Switch Drape Release Button The Switch Drape Release Button can be utilized to move the patient’s limb without having to use the Foot Pedal. The Release Button is placed in the ideal position on the limb, and using the Connection Accessory or Slender Arm of the SPIDER2 to position the limb. To move the Switch Drape Button, peel foam tab off of the drape (Figure 21) and re-adhere to a convenient location (i.e accessory, patient’s limb, etc.) Example: Wrap the Release Button tightly around the Slender Arm and attach to the Traction Accessory to the patient’s limb. (Figure 22) Note: Prior to adhering the Release Button to metal, it is recommended to place a layer of self-adhering wrap over the metal surface to prevent the adhesive from bonding to the accessory. The optimal Switch Drape Button position is then determined by the surgeon.

Figure 20.  Attach the selected accessory to the Piggy Back.

. Figure 21.  Remove foam tab of the Switch Button.

Figure 22.  Re-attach the Switch Drape Button to a more convenient location.

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Operative

Operative Positioning using the SPIDER2™ During Surgery 1. Ensure Power Switch is in ON position; indicator light should be lit and a solid green color. If blinking, or OFF, replace battery. 2. Grasp the patient’s limb (attached to SPIDER2) and/or SPIDER2 slender arm. 3. Press with your finger on the Switch Drape Release Button or step on Foot Pedal; this immediately releases all three SPIDER2 joints. 4. Move the patient’s limb to the desired position. Take your finger off the Switch Drape Release Button or foot off Foot Pedal to immediately lock all three SPIDER2 joints.

Procedure Set-up Supported by SPIDER2 Smith & Nephew’s Sterile Stabilization Kits have been specifically designed to provide control of the limb while ensuring the safety of the patient. WARNING: Single use Stabilization Kits are not to be reused or used if packaging has been damaged. Failure to comply may result in patient injury and/or infection. Table 1 provides an overview of the various set-up procedures and accessories supported by SPIDER2.

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Operative Table 1.  Procedure Set-up and Accessories supported by SPIDER2™

Procedure

SPIDER Table Attachment Side

SPIDER Location to Patient

SPIDER Orientation

Required Per Procedure

Optional Accessories

Beach Chair Positioner Shoulder

Operative Side or Attachment Rail/ T-MAX frame

If operative side at knee level

Horizontal on Rail

Shoulder Connection Bar (7210571) Shoulder Stabilization Kit (7210573) Piggy Back (7210570) Switch Drape (72203300)

T-MAX (7210551) SPIDER Attachment Rail (72200659)

Lateral Shoulder

Operative Side

Thigh level

Vertical on Rail

Lateral Shoulder Connection Bar (7210576) Traction Accessory (7210577) Shoulder Stabilization Kit (7210573) or (72203833) Piggy Back (7210570) Switch Drape (72203300)

Lateral JACK (72201428) (non – operative side, secure to table rail) Lateral JACK sterile cover (72202466)

Supine Elbow

Non-operative Side

Hip level

Vertical on Rail

Elbow Connection Bar (7210572) 90 degree Connector (7210749) or Traction Accessory (7210577) Elbow Stabilization Kit (7210574) Piggy Back (7210570) Switch Drape (72203300)

Wrist

Non-Operative Side (Counter Traction attached on Operative Side via a Clark Socket)

Chest level

Vertical on Rail

Wrist Counter Traction Post Wrist Arthroscopy Accessory (72200660) Traction Accessory (7210577) Wrist Stabilization Kit (S, M, L) (72201550) - S (72201551) - M (72201552) - L Finger Trap Sizing Ring (72200665) Piggy Back (7210570) Switch Drape (72203300)

Ankle

Non-Operative Side

Calf level

Horizontal on Rail

Ankle Arthroscopy Accessory (72202932) Traction Accessory (7210577) Ankle Stabilization Kit (72202931) Piggy Back (7210570) Switch Drape (72203300)

Knee: Leg Accessory

Operative Side

Hip level

Horizontal on Rail

3-D Connector (72203239) Leg Accessory, Left (72203235) Leg Accessory, Right (72203236) Leg Stabilization Kit (72203238) Piggy Back (7210570) Switch Drape (72203300)

Knee: Distal Thigh Holder

Operative Side

Shoulder level

Horizontal on Rail with the elbow joint of the SPIDER2 under the patient’s hip. When used with the arm board at a 45 degree angle on the Rail with the elbow joint of the SPIDER2 under the patient’s hip.

Distal Thigh Holder (72204133) includes plate and rotational collar Thigh Stabilization Kit (72204134) Piggy Back (7210570) Switch Drape (72203300)

Operations/Service Manual  SPIDER2™ Limb Positioner

FERKEL Thigh Support (72201812)

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Post-Operative

Post-Operative Remove SPIDER2™ from O.R. Table Rail 1. Turn the Clamp Actuation Knob counterclockwise to release jaw from table rail (Figure 23).

Cleaning Clean the SPIDER2 after each use.

Warnings • DO NOT immerse any portion of SPIDER2 in liquid. Note: If moisture enters the equipment it can cause corrosion, and damage electrical and/or mechanical components. • DO NOT Autoclave SPIDER2. 1. Remove all single use components and accessories. Discard single use components. 2. Clean and process each reusable accessory.

Figure 23.  Clamp Actuation Knob Releasing Jaw

2. Tilt SPIDER2 over the rail and lift (Figure 24).

Note: Refer to cleaning and sterilization instructions for accessories: 79-99-04 Cleaning and Sterilization Instructions. 3. Wipe entire SPIDER2 with mild detergent / disinfectant, taking care to avoid fluid entry into Switch Drape or Foot Pedal Receptacles and the dumbbell joints. 4. Wipe battery with mild detergent / disinfectant. Note: Avoid the use of excessive amounts of liquid during cleaning. 5. Wipe the dumbbell and distal joints with a dry cloth to remove excess oil on the joint. Note: A dark oily residue in the joints is normal. If the dry cloth does not remove the residue, isopropyl alcohol on a cloth may be used. Do not pour or spray fluid into the joints.

Figure 24.  Tilting and lifting SPIDER2 off of O. R. Table Rail

3. If Clamp does not release rail after Clamp Actuating Handle has been turned counterclockwise, tap the top of the Clamp Actuating Handle; Clamp should then release the rail.

6. Dry SPIDER2 with a cloth or allow to air dry.

Depressurize SPIDER2 for Storage

1. Turn OFF and DEPRESSURIZE the SPIDER2 by disconnecting the Foot Pedal and/or Switch Drape and pressing the Power Switch to the DEPRESSURIZE Position for 1 second (Figure 84).

1. DEPRESSURIZE before storing; by disconnecting the Foot Pedal and/or Switch Drape, and then pressing the Power Switch to the DEPRESSURIZE Position for 1 second.

Storage CAUTION: Do not store SPIDER2 in locked position as this will drastically reduce the life expectancy of device. Depressurize before storing by turning Power Switch to the DEPRESSURIZE Position for 1 second and then allowing the Switch to return to the OFF Position.

2. The Power Switch will then return to the OFF/STORAGE Position (Figure 8).

2. Store the SPIDER2 on the SPIDER2 Cart by hanging the Hinge Joint over the support hook.

Maintenance There are no user-serviceable components inside the SPIDER2. Only trained individuals should perform maintenance on SPIDER2. Contact Smith & Nephew to determine which maintenance can be performed on site.

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Expected Service Life

Expected Service Life

SPIDER2 Specifications*

Smith and Nephew SPIDER2™ and its accessories are reusable instruments. The functional life of these devices depends on various factors, including frequency of use, the method and duration of each use, as well as post-operative methods and handling. Proper usage of the equipment is essential to achieve optimal performance over time.

* Specifications are approximate and may vary from unit to unit or as a result of power supply fluctuations. Model

REF 72203299 SPIDER2 Length: 1495 mm Width: 180 mm Height: 200 mm 30 lbs [13.6 kg]

Size (fully extended)

The SPIDER2 should be inspected before procedural use. Smith and Nephew recommends returning the device for service if any of the below are indicated.

Weight

IEC 60601-1:2005 +A1:2012

Compliance

IEC 60601-1-2:2015

• Cracked case • Clamp does not function as intended

Type B Applied Part

Equipment type Power Supply Battery Type Battery Model

• System does not pressurize (ensure battery is charged and connected) • System slowly pressurizes

Internally Powered 24V 20A NiCd 24V 1.8Ah REF 72203301 SPIDER2 Battery Pack EU: Not for general waste

• System does not maintain pressure • Joints are unusually stiff and difficult to manipulate • Motor runs continuously, or more than once per minute while in locked state • Unit leaks oil in excess of oil residue in the joints. e.g. dripping from or pooling around the device.

Contact Smith & Nephew for appropriate methods of disposal.

Disposal

Environmental Conditions Transport and/ or Storage -29°C–60°C

Condition Temperature

Use 10°C–40°C

Humidity 15%–85% (no condensation allowed)

30%–70%

Atmospheric Pressure

70 kPa–106 kPa

50 kPa–106 kPa

SPIDER2 Battery Charger Specification Compliance Power supply

IEC 60601-1:2005 +A1:2012 IEC 60601-1-2:2015 100–240 VAC, 50–60 Hz, Max 0.9 A

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SPIDER2™ Accessories

SPIDER2™ Accessories REF

Description

72203301

SPIDER2 Battery Pack

72203840

SPIDER2 24V Battery Charger

7210570

Piggy Back

7210749

90° Connector

7210577

Traction Accessory

7210571

Shoulder Connection Bar

7210576

Lateral Shoulder Connection Bar

7210572

Elbow Connection Bar

72200660

Wrist Arthroscopy Accessory

72202932

Ankle Arthroscopy Accessory

72203235

SPIDER Leg Accessory (Left)

72203236

SPIDER Leg Accessory (Right)

72203239

3-D SPIDER Connector

72204133

Distal Thigh Holder

72200918

SPIDER Cart

72203839

SPIDER2 Electric Foot Pedal Replacement Kit

72200487

Quick Connect Replacement Kit

72200488

Index Handle Replacement Kit

72200665

Finger Trap Sizing Ring Replacement Kit

72200666

Wrist Plate Replacement Kit

Stabilization Kits

* SPIDER2 is packaged with: (1) SPIDER2 - 126-00-00 (72203299) (1) SPIDER2 Battery Pack - 126-00-17 (72203301) (1) SPIDER2 Battery Charger - 126-00-41 (72203840) (1) SPIDER 2 Electric Foot Pedal Battery Charger (3) Power Cords (Type A - NEMA 1-15, Type C - CEE 7/16 Europlug, Type G - BS 1363). Contact Smith & Nephew for additional power cords, if required.

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REF

Description

72203833

SPIDER2 Shoulder Stabilization Kit

7210573

Shoulder Stabilization Kit

7210574

Elbow Stabilization Kit

72201550

Small Wrist Stabilization Kit

72201551

Medium Wrist Stabilization Kit

72201552

Large Wrist Stabilization Kit

72202931

Ankle Stabilization Kit

72203238

Leg Stabilization Kit

72203300

Switch Drape, 20 Pack

72204134

Distal Thigh Stabilization Kit, 10 Pack

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Smith & Nephew SPIDER2™ is intended for use in the electromagnetic environment specified below. The customer or the user of the SPIDER2 should assure that it is used in such an environment. The Smith & Nephew SPIDER2 was tested to the following:

IEC/EN 60601-1-2: 2014/2015 Specification

IEC 60601-1-2 (2014) / EN 60601-1-2 (2015) MEDICAL ELECTRICAL EQUIPMENT - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. Hydraulic pressure cannot drop unexpectedly without adequate notice so that practitioner has time to switch to a more traditional means of maintaining damaged joints or bone fractures separated during the surgical procedure.

Test Method

IEC CISPR 11 (2010) / EN 55011 (2010), Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement Radiated.

Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF emissions CISPR 11

Group 1 Environment, Professional Healthcare Facility, and not compatible with a Magnetic Resonance (MR) environment.

The SPIDER2 is suitable for use in a Professional Healthcare environment where utility mains are privately used by the Healthcare Facility.

(2003)

RF emissions CISPR 11

Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A), (2003). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Class A

(2003)

Warning: Use of accessories or cables with this equipment, other than those specified or provided by the Smith & Nephew could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation. Harmonic emissions EN 61000-3-2

N/A

Voltage fluctuations/flicker emissions EN 61000-3-3

N/A

Guidance and Manufacturer’s Declaration - Separation Distances WARNING: Electrical Interference. This equipment is designed to be used as a stand-alone, in proximity too, and with other medical equipment. This equipment and the other equipment should be observed to verify that they are operating normally. If interference does occur it may be corrected by one or more of the following measures: – Reorient or relocate this equipment, the other equipment, or both. – Increase the separation between the pieces of equipment. – Consult a biomedical engineer.

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Smith & Nephew SPIDER2™ is intended for use in the electromagnetic environment specified below. The customer or the user of the SPIDER2 should assure that it is used in such an environment. Specification

IEC 60601-1-2 (2014) / EN 60601-1-2 (2015) MEDICAL ELECTRICAL EQUIPMENT - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Test Method

EN 61000-4-2 (2009) / IEC 61000-4-2 (2008), Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test EN 61000-4-3 (2010) / IEC 61000-4-3 +A1+A2 (2010), Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test EN 61000-4-4 (2012) / IEC 61000-4-4 (2012), Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques – Electrical fast transient/burst immunity test EN 61000-4-5 (2006) / IEC 61000-4-5 (2005), Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity test EN 61000-4-6 (2008) / IEC 61000-4-6 (2008), Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement techniques – Immunity to conducted disturbances, induced by radio-frequency fields EN 61000-4-8 (2010) / IEC 61000-4-8 (2009), Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement techniques – Power frequency magnetic field immunity test EN61000-4-11 (2004) / IEC 61000-4-11 (2004), Electromagnetic compatibility (EMC) – Part 4-11: Testing and measuring techniques – Voltage dips, short interruptions and voltage variations immunity tests EN55014-(2006) / IEC CISPR 14 (2005), Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus Part 1: Emmission

Electromagnetic Environment – Guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. All portable and mobile RF communications equipment, including cables, should be at least 30 cm (12 inches) from any part of the SPIDER2. Field strengths from RF transmitters, such as base stations for radio, (cellular/cordless) telephones, land mobile radios, amateur radios, AM and FM radio broadcasts, and TV broadcasts cannot be predicted. The Professional Healthcare Facility must assess the electromagnetic environment due to RF transmitters, an electromagnetic site survey should be considered to ensure compatibility with the immunity levels contain in IEC/EN 60601-1-2. The SPIDER2 normal operation is to control patient limb position throughout the duration of surgical procedures. WARNING: Abnormal performance, due to Electromagnetic Disturbances, may be manifested by a failure to properly maintain positioning of the limb. If abnormal performance is observed, additional measures may be necessary, such as: – Reorient or relocate this, the other equipment, or both. – Increase the separation between the pieces of equipment. – Consult a biomedical engineer. WARNING: Use of accessories or cables with this equipment, other than those specified or provided by the Smith & Nephew, could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation.

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Guidance and Manufacturer’s Declaration – Special Environment

Guidance and Manufacturer’s Declaration – Special Environment The SPIDER2™ is intended for use in a Special Environment using HF surgical equipment. WARNING - HF Interference: This equipment was designed and tested to be used with HF ESU equipment. However, if interference occurs with other equipment it may be corrected by one or more of the following measures: – Reorient or relocate this equipment, the other equipment, or both. – Increase the separation between the pieces of equipment. – Consult a biomedical engineer.

For Further Information If further information, including warranty, on this product is needed, contact Smith & Nephew Customer Service at +1 800 343 5717 in the U.S., or an authorized representative

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Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA

™Trademarks of Smith & Nephew. Certain marks registered U.S. Patent & Trademark Office. +1 978 749 1000 Telephone +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service

©2014, 2020 Smith & Nephew, Inc. www.smith-nephew.com ifu.smith-nephew.com

All rights reserved. 04/2020

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