Synthes Small Battery Drive II User’s Manual Rev B Feb 2013

Table of Contents

Introduction

General Information

3

Small Battery Drive II

Handpiece

6

Use

8

General Information

12

Drill Attachments

14

Screw Attachments

15

Ream Attachments

16

Other Rotating Attachments

18

Saw Attachments

23

Other Attachments

27

General Information

28

Preparation Prior to Cleaning

29

Manual Cleaning Instructions

30

Mechanical/Automated Cleaning Instructions with Manual Pre-cleaning

32

Lubrication

35

Function Control

39

Packaging, Sterilization and Storage

40

Repairs and Technical Service

42

Disposal

43

Attachments

Care and Maintenance

Small Battery Drive II

User’s Manual

Synthes

Table of Contents

Troubleshooting

44

System Specifications

46

Electromagnetic Compatibility

51

Ordering Information

55

Synthes

Small Battery Drive II

User’s Manual

Introduction

General Information Intended use The Small Battery Drive II is a battery-driven power tool for use in traumatology, hand and foot surgery, involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue. Safety instructions The Small Battery Drive II is only to be used for patient treatment after careful consultation of the instructions for use. The Small Battery Drive II is designed for use by physicians and trained medical personnel. DO NOT use any component if damage is apparent.

Efficiently working cutting tools are the basis for successful surgery. Therefore, it is mandatory to check used cutting tools after every use for wear and/or damage and to replace them if necessary. We recommend using new Synthes cutting tools for every surgery. Cutting tools must be cooled with irrigation liquid to prevent heat necrosis. The user of the product is responsible for proper use of the equipment during surgery. If the Small Battery Drive II is used in conjunction with an implant system, make sure to consult the corresponding “Technique Guide”.

DO NOT use any component if the packaging is damaged.

For important information regarding electromagnetic compatibility (EMC), please refer to the chapter “Electromagnetic Compatibility” in this manual.

DO NOT use this equipment in the presence of oxygen, nitrous oxide or a mixture consisting of flammable anesthetics and air.

The tool is classified as type BF against electrical shock and leakage current. The tool is suitable for use on patients in accordance with IEC 60601-1.

To ensure the proper operation of the tool, only use Synthes original accessories.

To ensure the proper operation of the tool, Synthes recommends annual maintenance by a Synthes service center. The manufacturer shall assume no responsibility for damage resulting from improper operation, neglected or unauthorized maintenance of the tool.

Before the first and every subsequent use, power tools and their accessories/attachments have to run through the complete reprocessing procedure. Protective covers and foils must be fully removed before sterilization. For the tool to function properly, Synthes recommends cleaning and servicing it after each use in accordance with the process recommended in the chapter “Care and Maintenance”. Compliance with these specifications can considerably extend the service life of the tool. Only use Synthes oil (519.97) to lubricate the tool.

Precautions: – To avoid injuries, the locking mechanism of the tool has to be activated before every manipulation and before placing the tool back down, i.e. the mode switch has to be in the OFF position. – The tool may only be operated with a fully charged battery. To do this, ensure that the battery is charged prior to use. We recommend that the battery is replaced into the charger immediately after surgery. – The batteries may never be sterilized. This would destroy the battery with possible secondary damage. – Should the machine fall and have visible defects, discontinue use and send it to the Synthes service center.

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Introduction

Accessories/scope of delivery The Small Battery Drive II consists of a handpiece, one or several battery casings and batteries and a range of attachments and accessories designed for the system. For the system to operate properly, only Synthes cutting tools should be used. Special auxiliaries such as cleaning brushes and Synthes oil are available for cleaning and servicing the system. No oils from other manufacturers must be used. Only Synthes oil (519.97) must be used. Lubricants with other compositions can cause jamming, can have a toxic effect or can have a negative impact on the sterilization results. Only lubricate the power tool and the attachments when clean. Synthes recommends the use of a case specifically designed for the Synthes Small Battery Drive II and the specifically designed Washing Basket (68.001.610) to sterilize and store the system. The following components are essential to ensure proper operation: – Handpiece (532.110) – Battery Casing (532.132) – Battery (532.103) – Insertion Shield (532.104) – Universal Battery Charger II (05.001.204) – At least one attachment of the system Please refer to the end of this user’s manual for an overview of the components of the system. Storage and transport Please use the original packaging for dispatch and transport. If this is no longer available, please contact the Synthes office.

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Small Battery Drive II

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Warranty The warranty for the tools and accessories does not cover damage of any kind resulting from improper use, damaged seals or improper storage and transport. The manufacturer does not accept liability for damage resulting from repairs or maintenance carried out by unauthorized sites.

Explanation of the general symbols used Caution Read the provided Instructions for Use before operating the device.

2

Reuse or reprocessing (e.g. cleaning and resterilization) may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury, illness or death.

Consult the Instructions for Use before operating the device. The device is classified as type BF against electrical shock and leakage current. The device is suitable for use on patients according to the standards defined by CSA 601.1, IEC 60601-1 and UL 60601-1. IEC 60601-1:2005, ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No. 60601-1 (2008).

Furthermore, reuse or reprocessing of single use devices may create a risk of contamination, e.g. due to the transmission of infectious material from one patient to another. This could result in the injury or death of the patient or user. Synthes does not recommend reprocessing contaminated products. Any Synthes product that has been contaminated by blood, tissue and/or bodily fluids/matter should never be used again and should be handled according to hospital protocol.

Do not immerse device in liquids.

10PB

Do not reuse Products intended for single use must not be reused.

Small Battery Drive II With regard to electrical shock, fire, mechanical hazards, only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1. IEC 60601-1:2005, ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No. 60601-1 (2008)

Even though they may appear undamaged, the products may have small defects and internal stress patterns that may cause material fatigue. Temperature

The device meets the requirements of directive 93/42/EEC for medical devices. It is authorized by an independent notified body for which it bears the CE symbol.

Li-Ion

This device contains Lithium-Ion batteries that should be disposed of in an environmentally friendly manner. The European Battery Directive 2006/66/EC applies to this device. See section “Disposal” on page 43.

Precaution: Risk of fire, explosion and burns. Do not disassemble, crush, heat above 100 °C or incinerate the battery cells.

Relative humidity

Atmospheric pressure

S9

Duty cycle type according to IEC60034-1

IPX4

Ingress protection rating according to IEC 60529 Image intensifier control

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Small Battery Drive II

Handpiece 1 2 3 4 5 6 7 8

Attachment coupling Trigger for speed regulation Trigger for switching to reverse/oscillating drilling Mode selector switch Battery pack (battery casing with inserted battery) Release buttons for attachment Release buttons for battery casing Knob for the battery casing cover

6 1

4 3 2

Safety system The Small Battery Drive II is equipped with a safety system that prevents the machine from being unintentionally started. To lock and unlock the tool, turn the mode selector switch 4 to the appropriate setting on the front plate of the handpiece: OFF, or ON position.

7

Protective systems The Small Battery Drive II is equipped with three protective systems: – A thermal overload safety system that shuts off the tool if it becomes too hot during use. After cooling, the tool can be used again. – An exhaustive discharge protection ensures that the battery does not completely discharge. This protects the battery and extends its life. – An internal fuse in the battery that blows in case of unintended short circuit. This prevents excessive heat, fire or explosion. If this happens, the battery can not be used anymore.

Speed and rotational direction control Mode selector switch in the ON position The bottom trigger 2 gradually controls the forward speed (up to approx. 1440 rpm with the AO quick coupling). When the bottom and top triggers 2 and 3 are pressed at the same time, the tool operates in reverse. The top trigger 3 can be depressed first. Depressing the bottom trigger 2 with the top trigger already depressed will ensure the tool will start in reverse and allow for precise speed control. The speed of rotation may be controlled by how much depression is placed on trigger 2. When the bottom trigger 2 is released, the tool immediately stops.

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8

6 4 3 2

6

Mode selector switch in the oscillating drilling position ( ) When both triggers are depressed, the tool operates in oscillating rotation. The top trigger 3 can be depressed first. Depressing the bottom trigger 2 with the top trigger already depressed will ensure the tool will start in reverse and allow for precise speed control. The speed of the oscillation may be controlled by how much depression is placed on trigger 2. When the top trigger 3 is released, the tool returns to normal forward rotation.

Compatibility between Small Battery Drive and Small Battery Drive II

Oscillating drilling ( ) mode To protect soft tissue when drilling and inserting Kirschner wires, the Small Battery Drive II has an electronically controlled oscillating mode.

Existing Small Battery Drive handpiece is compatible with Small Battery Drive II battery pack The existing Small Battery Drive handpiece (532.010) can be used with the new battery pack of the Small Battery Drive II (532.103 with battery casing 532.132).

Existing Small Battery Drive battery packs are compatible with Small Battery Drive II handpiece The small 12 VDC battery pack of the Small Battery Drive (532.003 with battery casing 532.002) as well as the large 14.4 VDC battery pack (532.033 with battery casing 532.032) can both be used with the new Small Battery Drive II handpiece (532.110).

To preset the oscillating mode, switch the mode selector switch to position. Pressing the bottom trigger causes the tool to rotate clockwise as usual. Simultaneously pressing the top and bottom triggers causes the tool to immediately switch to oscillating mode. The clamped tool oscillates clockwise /counterclockwise. The speed can be changed by means of the bottom trigger. After the top trigger is released, the tool returns to normal clockwise rotation. Precautions: – Oscillating mode may only be used with the following attachments: – AO Quick Coupling (532.013, 05.001.250) – Chuck (05.001.252, 05.001.253) – Quick Coupling for Kirschner Wires (532.022) – Do not use the oscillating mode with the oscillating saw attachments! – You can only switch to reverse by turning the mode selector switch to ON position. – The maximum speed of a cutting tool is slightly less in oscillation mode than in normal mode.

Important: – The information contained in this user’s manual concerns the Small Battery Drive II system. For more information on the Small Battery Drive, please refer to the Small Battery Drive User's Manual (J2968). – To prevent injury, the machine must be locked with the mode selector switch 4 when coupling and removing attachments and tools, and before laying it down (see page 6). – Always check correct functioning before use on patient. – Never place the Small Battery Drive II on a magnetic surface since the machine might start unintentionally. – Pay particular attention to all the instructions in the individual sections that are identified with “Caution”. – Components that are no longer useful must be disposed of in accordance with the local and national regulations. – Always wear personal protective equipment (PPE) including safety goggles when working with the Small Battery Drive II system.

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Small Battery Drive II

Use Before initial use, brand-new tools and accessories must undergo the entire reprocessing process and the batteries should be charged. Completely remove protective caps and films. Inserting the battery in the battery casing To ensure sterility, the battery is inserted into the battery casing by two people, one of whom is wearing sterile garments: 1. The person with the sterile garments holds the sterile battery casing. If the casing is not opened, the same person presses the central button to unlock (Fig.1) turns the lid sideways (90°) as indicated by the arrow (Fig. 2) and pulls to open (Fig. 3). Leave the locking mechanism swung outward. 2. The person wearing the sterile garments places the sterile insertion shield on the battery casing (Fig. 4) and checks if it is seated correctly. The sterile insertion shield ensures that the unsterile battery does not contact the outside of the sterile casing. 3. The person not wearing sterile garments carefully guides the unsterile battery through the sterile insertion shield (Fig. 5). As an orientation, the two symbols on the battery and the sterile insertion shield should face each other (Fig. 6). The same person presses it completely into the battery casing to ensure a correct seat (Fig. 7).This person may not contact the outside of the battery casing. 4. The person not wearing sterile garments grasps the flanges on the sterile insertion shield and removes it from the battery casing (Fig. 8). 5. The person wearing the sterile garments closes the casing cover from the outside without contacting the battery or the inside of the casing. After having closed the casing cover, turn the lid sideways (90°) until it clicks.

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Small Battery Drive II

User’s Manual

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Precautions: – Normally, one battery is sufficient for one surgery. A second battery pack (battery casing with the battery) should be kept ready to ensure fast intraoperative changing of batteries under sterile conditions if necessary. – Never open a battery casing intraoperatively to insert a new battery. Always replace the whole battery pack with another battery pack, which should have been prepared before the start of the surgery. – If the unsterile battery contacts the outside of the casing, the casing must be resterilised before being used in the OR. – To close the casing cover, press it firmly to ensure that it is completely closed (Fig. 9 and 10) so that the locking mechanism properly engages. Always ensure that the cover is totally closed before using the system. – Sterilize the insertion shield after each use to ensure aseptic conditions when inserting the unsterile battery into the sterile battery casing.

Figure 9

Figure 10

Inserting the battery pack into the power tool Guide the battery pack (battery casing with inserted battery) from below into the shaft of the handpiece (Fig. 11). The shape of the battery casing prevents the battery from being inserted incorrectly. Check if the battery pack is seated correctly by gently pulling on it. Removing the battery pack from the power tool Simultaneously press the release buttons for the battery casing with one hand (Fig. 12) and use the other hand to remove the battery pack from the handpiece. Figure 11

Figure 12

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Small Battery Drive II

Charging, storing and using Small Battery Drive II batteries (532.103) Charging – The batteries should always be charged before use. – Only use the Synthes Universal Battery Charger II (05.001.204) to charge the batteries. Using another charger can damage the battery. – Charge the batteries within an ambient temperature range of 0 °C to 40 °C. Storage – When the battery is not being used, store it in the Synthes Universal Battery Charger II (05.001.204). This will prevent it from discharging, and the battery will be fully charged and ready to use. – Never load the batteries in a charger other than the Universal Battery Charger II (05.001.204). – The charging station should always be turned on when a battery is in the charging base. This ensures availability and prevents discharge. Use – Only insert the battery pack directly before using the Small Battery Drive II. This saves battery energy and prevents having the need to change it during surgery. – Only use batteries for the indicated purpose. – Do not transport or store the batteries together with materials that conduct electricity and can cause a shortcircuit. This can damage the battery and generate heat which can cause burns. – Never open the battery (532.103). – Never expose batteries to temperatures above 60 °C. – Do not apply force to the batteries and do not let them fall. – Never use damaged batteries; they can damage the power tool. – Follow the additional information in the chapter “Care and Maintenance“ starting on page 28 as well as the user manual of the Synthes Universal Battery Charger II (J8895).

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Small Battery Drive II

User’s Manual

Using the Small Battery Drive II with the light adapter The Small Battery Drive II can also be operated with the light adapter (05.001.108) connected to one of the electrical consoles belonging to the Electric Pen Drive (05.001.000 or 05.001.002). When the Small Battery Drive II is operated electrically, it is classified as type B against electrical shock and leakage current. The adapter can be inserted into the Small Battery Drive II handpiece and removed like a battery pack (see Fig. 13 and 14). Also follow the Electric Pen Drive User’s Manual (J6374).

Figure 13

Figure 14

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Attachments

General Information The Small Battery Drive II system offers a broad range of attachments. A wide range of rotating attachments has color-coded rings, so that they can easily be identified. The table on the next page lists the different types of attachments available, the color coding, as well as the speed of each attachment. Mounting the attachments Insert the attachment into the attachment coupling (Fig. 1). If the positioning pins do not lock into place right away, twist the attachment slightly to the right or left until it locks into the correct position. Check if the attachment is seated correctly by gently pulling on it. Removing the attachments Press the attachment release buttons 6 (see figure on page 6) simultaneously and remove the attachment from the coupling. Precautions: – To prevent injury, the power tool must be switched off with the safety system (see page 6) during each manipulation. – Only use original attachments and tools from Synthes. Damage that arises from using attachments and tools made by other manufacturers is not covered by the warranty. – Never use an attachment in reverse mode with an old flexible shaft as this could cause serious injury to the patient.

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Small Battery Drive II

User’s Manual

Figure 1

Article

Drill Attachments

Product

Speed

Color coding

05.001.250 AO Quick Coupling 05.001.252 Chuck (Drilling Speed), with Key, clamping range up to Ø 4.0 mm

1440 rpm 1440 rpm

Blue Blue

05.001.253 Chuck (Drilling Speed), with Key, clamping range up to Ø 7.3 mm

1440 rpm

Blue

Screw Attachments

05.001.251 Screw Attachment with AO Quick Coupling

384 rpm

Red

Ream Attachments

532.017

AO Quick Coupling for Medullary Reaming

384 rpm

Red

532.018

Hudson Quick Coupling for Medullary Reaming

384 rpm

Red

532.019

Trinkle Quick Coupling for Medullary Reaming

384 rpm

Red

532.020

Trinkle Quick Coupling, modified, for Medullary Reaming

384 rpm

Red

532.015

Quick Coupling for DHS/DCS triple reamers

384 rpm

Red

05.001.254 Chuck (Reaming Speed), with Key, clamping range up to Ø 7.3 mm, with reverse motion

384 rpm

Red

532.011 532.012

Mini Quick Coupling J-Latch Coupling

3840 rpm 3840 rpm

None None

532.022

Quick Coupling for Kirschner Wires

960 rpm

None

05.001.187 Burr Attachment

16000 rpm

None

511.30

Radiolucent Drive

3840 rpm

None

532.021 532.023

Oscillating Saw Attachment Oscillating Saw Attachment II (Crescentic Technique)

19200 cpm 19200 cpm

None None

532.026

Large Oscillating Saw Attachment

19200 cpm

None

511.773 511.776

Torque Limiter, 1.5 Nm, for AO Quick Coupling Torque Limiter, 0.8 Nm, with AO Quick Coupling

– –

None None

511.777

Torque Limiter, 0.4 Nm, with AO Quick Coupling

–

None

Other Rotating Attachments

Saw Attachments

Other Attachments

Technical data is subject to tolerances. Specifications are approximate and may vary from one device to another or as a result of power supply fluctuations.

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Attachments

Drill Attachments AO Quick Coupling (05.001.250) For tools with an AO coupling shaft. Mounting and removing the tools Insert the tool into the attachment from the front applying slight pressure and turning slightly. It is not necessary to operate the coupling sleeve of the attachment. To disconnect, push the coupling sleeve of the attachment back and remove the tool.

Chucks There are two Chucks available as Drill Attachments for the Small Battery Drive II system. Article number

Clamping range

Spare key

Comments

05.001.252

0 – 4.0 mm

310.93K

For drilling

05.001.253

0 – 7.3 mm

510.19

For drilling

Inserting cutting tools Open the jaws of the Chuck using the appropriate key or by hand. Insert the shaft of the tool into the open drill chuck and close it by twisting the chuck. Make sure that the shaft lies central to the three jaws. Tighten the drill chuck with the key. Make sure that the teeth of the key engage correctly in the toothed rim of the chuck. Removing cutting tools Open the Chuck with the key and remove the tool. Precautions: – Do not use the Small Battery Drive II for acetabular reaming. – Check the cutting tool for wear and/or damage after each use and replace if necessary. – To ensure good fixation of the tools, make sure the toothed rims on the drill chuck and key are not worn.

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Small Battery Drive II

User’s Manual

Screw Attachments Screw Attachment, with AO Quick Coupling (05.001.251) Mounting and removing the tools Insert the tool into the attachment from the front by applying slight pressure and turning slightly. It is not necessary to operate the coupling sleeve of the attachment. To disconnect, push the coupling sleeve of the attachment back and remove the tool. Precautions: – Care should be taken when inserting screws with the drive unit. – Never fully insert screws with the drive unit. The final turns or locking should always be done manually. – Always use an appropriate torque limiting attachment when putting locking screws into a locking plate. – Theoretically, it is also possible to use the AO Quick Coupling (05.001.250) to insert screws. However, the Screw Attachment (05.001.251) has a lower speed and a higher torque and is therefore more suitable. Screws with a large diameter may not be able to be inserted with the AO Quick Coupling as the torque may not suffice. – The attachment is also suitable for application at a lower rpm and/or higher torque.

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Attachments

Ream Attachments Quick Couplings for Medullary Reaming AO Quick Coupling (532.017) Hudson Quick Coupling (532.018) Trinkle Quick Coupling (532.019) Trinkle Quick Coupling, modified (532.020) The Quick Couplings for Medullary Reaming enable the use of flexible shafts with the appropriate coupling geometry. Reverse motion, which can damage the flexible shafts, is prevented by a special mechanical system. Inserting cutting tools into the coupling Maneuver the unlocking ring on the attachment backward and insert the tool (such as a drill bit) while rotating it slightly until it locks into place. Release the ring. Check if the tool is seated correctly in the coupling by gently pulling on it. Removing cutting tools Push the unlocking ring on the attachment backward and remove the tool. Precautions: – Do not use “Quick Couplings for Medullary Reaming” for acetabular reaming. They may only be used for medullary reaming. – Check the cutting tool for wear and/or damage after each use and replace if necessary.

Quick Coupling for DHS/DCS Triple Reamers (532.015) For DHS/DCS Triple Reamers; can also be used to open the medullary cavity with most of the Synthes nailing systems. Mounting and removing the tools To connect the tool, push the coupling sleeve forward and then introduce the tool while turning slightly. To disconnect, push the coupling sleeve of the attachment forward and remove the tool.

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Small Battery Drive II

User’s Manual

Chucks There is one chuck available as a Ream Attachment for the Small Battery Drive II system. Article number

Clamping range

Spare key

Comments

05.001.254

0 – 7.3 mm

510.19

For drilling and medullary reaming, with reverse motion

Inserting cutting tools Open the jaws of the chuck using the appropriate key or by hand. Insert the shaft of the tool into the open drill chuck and close it by twisting the chuck. Make sure that the shaft lies central to the three jaws. Tighten the drill chuck with the key. Make sure that the teeth of the key engage correctly in the toothed rim of the chuck. Removing cutting tools Open the chuck with the key and remove the tool. Warnings: – During reaming procedure, high torque values must be provided by the power tool to the reaming head to allow efficient bone removal. In cases where the reaming head suddenly is blocked, these high torque values can be transferred onto the user’s hand, wrist and/or the patient’s body. In order to prevent injuries it therefore is essential that: – the power tool is held in an ergonomical position with a firm grip. – if the reamer head blocks, the speed trigger is released immediately. – the correct function of the speed trigger (immediate stop of the system when the trigger is released) is checked before the reaming process. – Use the Chuck with Reverse motion (05.001.254) only with tools that are approved for such use. Otherwise, the tool may break with subsequent damage. Precautions: – Do not use the Small Battery Drive II for acetabular reaming. – Check the cutting tool for wear and/or damage after each use and replace if necessary. – To ensure good fixation of the tool, make sure the toothed rims on the drill chuck and key are not worn.

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Attachments

Other Rotating Attachments Mini Quick Coupling (532.011), J-Latch Coupling (532.012) Accepts mini quick couplings or Stryker J-latch bits. Mounting and removing the tools To connect the tool, pull the coupling sleeve back and then introduce the tool while rotating slightly. To disconnect, push the coupling sleeve of the attachment back and remove the tool.

Quick Coupling for Kirschner Wires (532.022) Kirschner Wires of any length with a diameter of 0.6 – 3.2 mm can be used with the Quick Coupling for Kirschner Wires. 1. Adjust the Kirschner Wire diameter according to the label on the adjusting sleeve K. Slightly press the adjusting sleeve axially against the handpiece and rotate the sleeve. 2. Apply a slight amount of pressure to insert the Kirschner Wire from the front into the cannulation J. The wire is held automatically. 3. Adjust the working length by pulling on the wire. 4. To affix the wire, pull the tension lever L against the tool with your little finger and ring finger. Only pull the tension lever against the tool as much as necessary. The clamping force can be varied by pulling and releasing the clamping lever. 5. Insert the wire into the bone. Apply the clamping force as long as the wire is advanced. 6. To adjust the grip on the wire, reduce the clamping force and move the tool to the desired length. Reclamp the wire by pulling on the tension lever.

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Small Battery Drive II

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J

K

L

Radiolucent Drive (511.30) The Radiolucent Drive can be used with the Small Battery Drive II in combination with the AO Quick Coupling (05.001.250) and the Adapter for the Radiolucent Drive (532.031). Coupling the Radiolucent Drive to the power tool Connect the AO Quick Coupling to the Small Battery Drive II and the adapter to the Quick Coupling. Position the Radiolucent Drive as far as it will go over the Quick Coupling and the adapter and rotate it into the desired working position. Support the drive with your free hand.

05.001.250

532.031

511.30

Inserting the drill bit Pull the ring on the attachment forward and position the drill bit inside the coupling as far as it can go while rotating it slightly. Engage the ring on the attachment back in order to fix the drill. Check if the drill bit is seated correctly by gently pulling on it. Removing the drill bit Follow the same procedure in reverse order.

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