Synthes Small Battery Drive User’s Manual Rev G April 2010

Table of Contents

Introduction

Operating Instructions

Product Information

Small Battery Drive

2

12 V Battery

3

14.4 V Battery

4

Universal Battery Charger

5

Universal Battery Charger II

6

Attachments for Small Battery Drive

7

Universal Battery Charger Universal Battery Charger II

10

Battery Pack

11

Drive Unit

12

Attachments

13

Attachments for use with 12 V and 14.4 V Battery

14

Attachments for use with 14.4 V Battery

20

Light Adaptor for Small Battery Drive

24

Graphic Case

26

Sterilization

28

Troubleshooting

29

Set Lists

31

Cutting Tools

34

Synthes

Small Battery Drive (532.010)

– Variable speed: 0 – 3,840 rpm (max. speed varies by attachment) – Maximum torque: 0 – 6.0 Nm (max. torque varies by attachment) – Weight, including 12 V battery: 810 grams, including 14.4 V battery: 916 grams – Cannulation: 3.2 mm Attachment release button Allows easy exchange of attachments

Attachment coupling Accepts a wide variety of attachments Instant-reverse or oscillation trigger Reverses rotation to counterclockwise direction or activates oscillation mode Variable-speed trigger Controls rotational speed Release buttons for battery casing Allow easy intraoperative battery exchange

Battery casing Holds battery in sterile environment

This device complies with the following standards: UL 2601-1 EN 60601 (IEC 601-1) EN 60601-1-1 (VDE 0750 part 1 and 2) EN 55011 (VDE 0875 part 11) Limiting values of class B, group 1

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Synthes Small Battery Drive User’s Manual

Mode switch turns drive off for safe attachment exchange and selects “on” or “oscillation” mode

12 V Battery (532.003)

– Voltage: 12 VDC – Capacity: 0.5 Amp hours – Type: NiCd – Working temperature: 0°C to 50°C (32°F to 122°F) – Charging time: 30 minutes maximum – Discharge protection: prevents total battery discharge, significantly decreases memory effect, maintains battery capacity, and increases battery life – Indications include drilling, sawing, and inserting K-wires Important: Do not sterilize batteries! Batteries will no longer function.

Drilling

Sawing

K-wire insertion

Synthes

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14.4 V Battery (532.033)

– Voltage: 14.4 VDC – Capacity: 0.5 Amp hours – Type: NiCd – Working temperature: 0°C to 50°C (32°F to 122°F) – Charging time: 40 minutes maximum – Discharge protection: prevents total battery discharge, significantly decreases memory effect, maintains battery capacity, and increases battery life – Indications include DHS, DCS, and intramedullary reaming Important: Do not sterilize batteries! Batteries will no longer function.

Reaming

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Synthes Small Battery Drive User’s Manual

Universal Battery Charger (530.601)

– Four charging bays accept Small Battery Drive, Power Drive and Battery Power Line batteries – One (1) battery can be placed in each charging bay allowing a maximum of four (4) batteries to be charged at the same time

Status indicator panels

Power switch Fuse: 2 x 5 AT 250 V (SPT 5 x 20 mm) Socket for power cord

Complies with standards: UL 60950 IEC 60950 EN 55022 class B EN 61000-3-2, 3 EN 61000-4-2, 3, 4, 5, 6, 11

Synthes

5

Universal Battery Charger II (05.001.204)

The Universal Battery Charger II includes four independent charging bays.

Front view

1 2 3 4

5

1 2 3 4 5

Charging bays (4) Symbols for battery type ON / OFF display Control display for each charging bay Ventilation holes

3

Rear view 3 Small Battery Drive Battery (532.003 or 532.033) 6

Complies with standards: UL 60601-1, 1st Edition IEC 60601-1, 2nd Edition

10PB

Universal Battery Charger II With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1

IEC 60601-1-2 IEC 60601-1-4

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Synthes Small Battery Drive User’s Manual

7 8 9

6 7 8 9

Ventilation holes Power switch Fuses: 225 AT Power cord connection

Attachments for Small Battery Drive

Drilling speed attachments 532.011

Mini Quick Coupling

532.012

Stryker J-latch Coupling With 12 V battery: Maximum speed: 3,200 rpm Maximum torque: 0.5 Nm With 14.4 V battery: Maximum speed: 3,840 rpm Maximum torque: 0.6 Nm Accepts mini quick coupling or Stryker J-latch drill bits.

532.022

Quick Coupling for K-Wires Cannulation: 3.2 mm (fully open) With 12 V battery: Maximum speed: 800 rpm Maximum torque: 3.0 Nm With 14.4 V battery: Maximum speed: 900 rpm Maximum torque: 3.2 Nm To insert / remove Kirschner wires and guide pins 0.6 mm –3.2 mm in diameter (any length)

The following drilling speed attachments are geared for a maximum drive speed of 1,200 rpm with the 12 V battery and 1,440 rpm with the 14.4 V battery. The maximum torque is 1.3 Nm with the 12 V battery and 1.6 Nm with the 14.4 V battery.* 05.001.250

AO Quick Coupling for Drill Bits Cannulation: 2.1 mm Accepts cutting tools and instruments with the AO quick coupling fitting.

05.001.252

Small Chuck with Key Cannulation: 3.3 mm Accepts round and triangular shafts: up to 4.5 mm

* Performance specifications on file at Synthes.

Synthes

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Attachments for Small Battery Drive continued

05.001.253

Large Chuck with Key Cannulation: 3.3 mm Accepts round and triangular shafts: up to 7.3 mm

Saw attachments 532.021

Sagittal Saw Attachment Maximum speed: With 12 V battery= 15,000 oscillations per minute With 14.4 V battery= 18,000 oscillations per minute

532.023

Oscillating Saw Attachment II Maximum speed: With 12 V battery= 15,000 oscillations per minute With 14.4 V battery= 18,000 oscillations per minute

532.026

Oscillating Saw Attachment, large Maximum speed: With 12 V battery= 15,000 oscillations per minute With 14.4 V battery= 18,000 oscillations per minute

Reaming speed attachments The following reaming speed attachments are geared for a maximum speed of 384 rpm and a maximum torque of 6.0 Nm with the 14.4 V battery.* All reduction drive units allow intramedullary reaming with most IM nail systems. Note: The reaming speed attachments should only be used with the 14.4 V battery for optimal performance. 05.001.251

AO Screw Attachment Cannulation: 2.0 mm Accepts AO coupling screwdriver

* Performance specification on file at Synthes.

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Synthes Small Battery Drive User’s Manual

Reaming speed attachments continued 05.001.254

Chuck with Key Cannulation: 3.2 mm Accepts round and triangular shafts: up to 7.3 mm

532.015

Large Quick Coupling Cannulation: 3.2 mm Accepts DHS and DCS triple reamers, screwdriver shafts and cannulated drill bits with large quick coupling fitting

532.017

AO Reduction Drive Unit Cannulation: 3.2 mm Accepts cutting tools and instruments with AO reaming fitting

532.018

Hudson Reduction Drive Unit Cannulation: 3.2 mm Accepts cutting tools and instruments with Hudson fitting

532.019

Trinkle Reduction Drive Unit Cannulation: 3.2 mm Accepts cutting tools and instruments with Trinkle fitting

532.020

Modified Trinkle Reduction Drive Unit Cannulation: 3.2 mm Accepts cutting tools and instruments with modified Trinkle fitting

Synthes

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Operating Instructions

Universal Battery Charger (530.601) Universal Battery Charger II (05.001.204) Note: For instructions for the Universal Battery Charger II, please refer to the user’s manual. Connect the charger to the electrical cord, and plug the cord into a 110/120 VAC outlet. Turn on the charger by pressing the power switch to ON. All LEDs on the status indicator panels will illuminate (red, yellow and green), when the charger is empty and ready to charge (Figure 1). Insert the battery into one of the appropriate charging bays. Only the yellow LED should remain illuminated, indicating that the battery is charging (Figure 2).

Figure 1

When the green LED illuminates, the battery is fully charged and operational (Figure 3). The battery should be left in the charging bay until needed. The battery can be removed during the charging process; however, the battery may not be fully charged and operational duration may be shorter. Important: Always leave the charger switched on when a battery is inserted in a charging bay. Leaving a battery in the charger when it is switched off or unplugged may permanently discharge the battery.

Figure 2

Never attempt to insert more than one battery in the same charging bay. Note: If LEDs do not follow this sequence, refer to the troubleshooting section, page 29.

Figure 3

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Synthes Small Battery Drive User’s Manual

Operating Instructions - Battery Pack

The battery pack assembly requires a scrubbed person and a circulating person to insert the battery and preserve the sterile field.

1

2

Scrubbed person

Scrubbed person

Scrubbed person 1 Hold the sterilized battery casing and open the lid. 2 Place the sterilized battery insertion shield on the battery casing. Circulating person 3 Carefully insert the nonsterile battery into the sterile battery casing. 4 Press firmly until it engages. 5 Remove the battery insertion shield.

3

4

Circulating person

Scrubbed person 6 Close and lock the lid.

Scrubbed person

5

Circulating person

Scrubbed person

Circulating person

Scrubbed person

Synthes

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Operating Instructions - Drive Unit

Speed control For forward/reverse operation, position the mode switch to “ON”. For forward (clockwise) rotation, press the variable-speed trigger of the drive unit. For reverse (counterclockwise) rotation, press both triggers. For forward/oscillate operation, position the mode switch to “OSC DRILL”. For forward rotation, press the variable-speed trigger of the drive unit. For oscillating, press both triggers. Important: Mode switch must be in the “ON” or “OSC DRILL” position to operate drive.

Attachment release button

Attachment coupling

Instant-reverse or oscillation trigger

Variable-speed trigger

Battery casing

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Synthes Small Battery Drive User’s Manual

Release buttons for battery casing

Operating Instructions - Attachments

Important: To prevent injuries, the mode switch should always be in the “OFF” position when inserting or removing instruments.

Install attachment Insert the attachment into the attachment coupling. It is not necessary to press the release buttons for installation. Check the correct engagement of the attachment by pulling it slightly. Remove attachment Simultaneously press the attachment release buttons and remove the attachment from the coupling.

Synthes

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Operating Instructions - Attachments for use with 12 V and 14.4 V Batteries

Quick Coupling for K-Wires (532.022) – For insertion of Kirschner wires from 0.6 mm to 3.2 mm diameters (see page 12 for installation and removal of attachments). Important: To prevent injuries, the mode switch should always be in the “OFF” position when inserting or removing instruments.

Insert K-wire into Quick Coupling for K-Wires Select and set the adjustment range for the diameter of the K-wire according to the inscription. • = 0.6 mm – 1.2 mm •• = 1.2 mm – 2.2 mm ••• = 2.2 mm – 3.2 mm Insert the K-wire from the front opening to the desired working depth. Note: The K-wire is “presqueezed” upon insertion into the coupling to prevent slippage during handling. Pulling back on the lever grasps the K-wire securely for insertion into bone.

Insert K-wire into bone Grasp the K-wire by pulling the lever toward the drive unit, and press the lower (forward) trigger. Remove K-wire from bone Slide the drive unit and coupling over the K-wire. Grasp the wire by squeezing the lever toward the drive unit, and press both triggers (reverse) simultaneously to remove the wire from the bone. Note: The mode switch must be in the “ON” position to enable reverse.

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Synthes Small Battery Drive User’s Manual

Mini Quick Coupling (532.011) Stryker J-latch Coupling (532.012) – Accept mini quick coupling or Stryker J-latch drill bits To insert an instrument into the Mini Quick Coupling or Stryker J-latch Coupling, retract the collar of the coupling and insert the instrument shaft completely with a slight rotation to align the keyway. When the shaft is fully inserted, release the collar. Pull on the instrument slightly to ensure that it is held securely.

AO Quick Coupling for Drill Bits (05.001.250) – Accepts quick coupling drill bits – Allows use of Radiolucent Drive (511.30) with Adaptor (532.031) See page 12 for installation and removal of attachments. Important: To prevent injuries, the mode switch should always be in the “OFF” position when inserting or removing instruments.

Insert an instrument into the quick coupling Insert the instrument shaft completely with a slight rotation to align the keyway. Pull on the instrument slightly to ensure that it is held securely. Note: Collar does not need to be retracted to insert instrument.

05.001.250

Remove the instrument Retract the collar of the quick coupling to release the instrument.

Synthes

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Operating Instructions - Attachments for use with 12 V and 14.4 V Batteries continued

Large Chuck with Key (05.001.253) – Accepts round shafts from 1.0 mm to 6.0 mm in diameter, or triangular shafts up to 7.3 mm

Small Chuck with Key (05.001.252) – Accepts round shafts from 0.5 mm to 4.0 mm in diameter, or triangular shafts up to 4.5 mm See page 12 for installation and removal of attachments. Important: To prevent injuries, the mode switch should always be in the “OFF” position when inserting or removing instruments. Always remove the key from the chuck before operating the drive unit.

Insert an instrument Open the chuck jaws by turning the key counterclockwise, or by manually turning the collar. Insert the instrument shaft into the opened chuck. Close the chuck manually by rotating the collar, keeping the shaft centered in the jaws. Tighten the chuck by turning the key clockwise. Remove an instrument Turn the key counterclockwise to open the jaws. Remove the instrument.

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Synthes Small Battery Drive User’s Manual

Sagittal Saw Attachment (532.021) – Accepts small saw blades

Saw blade mount Locking knob

Important: To prevent injuries, the mode switch should always be in the “OFF” position when inserting or removing instruments. The saw blade should always be handled near the hub. Note: To minimize heat generation and provide optimal sawing results, always use new Synthes saw blades. Used blades cannot be resharpened.

Position the saw attachment Once mounted, the saw attachment can be locked in eight different positions in 45° increments. To reposition the saw attachment, push the adjustment sleeve and turn the attachment to the desired position (Figure 1). Insert saw blade Open the blade coupling by pulling the locking knob and turning it counterclockwise (Figure 2). Insert the new saw blade and adjust it to the desired position (Figure 3). The blade position can be locked in 45° increments. Squeeze the blade coupling closed and turn the locking knob clockwise to tighten (Figure 4).

Figure 1

Figure 2

Figure 3

Figure 4

Remove saw blade Open the blade coupling. Remove the blade. Important: Mode switch should always be in the “ON” position while using the Oscillating Saw Attachment.

Synthes

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Operating Instructions - Attachments for use with 12 V and 14.4 V Batteries continued

Oscillating Saw Attachment II (532.023) – Accepts crescentic saw blades and intraoral saw blades (shown with dimensions on page 33). Large Oscillating Saw Attachment (532.026) – Please refer to Operating Instructions in package insert.

Important: To prevent injuries, the mode switch should always be in the “OFF” position when inserting or removing instruments. The saw blade should always be handled near the hub. Synthes recommends using a new saw blade for each surgery, as used saw blades may increase the risk of necrosis and increase the cutting time. All oscillating and intraoral saw blades are sold sterile. Insert saw blade Pull back the collar of the attachment.

Crescent blades for halux valgus 03.000.311S 03.000.312S 03.000.313S 03.000.316S

Saw blades, 105° angled for intraoral

Insert a saw blade into the saw blade coupling and move it into the desired position.

03.000.343S

Release the collar. Pull lightly on the saw blade to confirm that it is secure.

03.000.341S

03.000.342S

03.000.340S Remove saw blade Pull back on the collar of the attachment, and remove the saw blade.

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Synthes Small Battery Drive User’s Manual

Adaptor for Radiolucent Drive (532.031) – Allows use of Radiolucent Drive (511.30) with Small Battery Drive Important: To prevent injuries, the mode switch should always be in the “OFF” position when inserting or removing instruments.

Insert adaptor – Insert the Quick Coupling for Drill Bits (05.001.250) into the Small Battery Drive – Insert the Adaptor (532.031) into the quick coupling – Slide the Radiolucent Drive (511.30) over the adaptor and the quick coupling and rotate until the Radiolucent Drive engages in the adaptor Remove adaptor Pull the Radiolucent Drive off the Small Battery Drive and its attachments. Remove the adaptor from the quick coupling.

Small Battery Drive with Quick Coupling for Drill Bits and Adaptor for Radiolucent Drive

See page 12 for installation and removal of attachments.

Small Battery Drive and Radiolucent Drive assembled

Radiolucent Drive (511.30)

Adaptor (532.031)

Quick Coupling for Drill Bits (05.001.250)

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