Battery Power Line II Instructions for Use

Table of Contents

Introduction

General Information 3 Drive Units8 Universal Battery Charger II13

Operating Instructions

Battery Pack (battery casing with inserted battery)14 Battery Reamer/Drill II (530.705)22 Attachments for Battery Reamer/Drill II23 Battery Oscillator II (530.710)39 Battery Reciprocator II (530.715)42

Care and Maintenance

General Information

45

Cleaning and Disinfection

47

• Preparation prior to Reprocessing 

47

• Manual Cleaning Instructions48 • Automated Cleaning Instructions with Manual Pre-cleaning

51

Maintenance and Lubrication

57

Inspection and Function Test63 Packaging, Sterilization and Storage64 Repairs and Technical Service

67

Disposal of Waste68

Battery Power Line II

Surgical Technique

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Table of Contents

Troubleshooting



69

System Specifications



75

Electromagnetic Compatibility



79

Ordering Information



84

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DePuy Synthes Battery Power Line II Surgical Technique

Introduction

General Information

Intended use The Battery Power Line II is a battery-powered system to be used for treatment in orthopedic and traumatology surgery, i.e. drilling, reaming, cutting, placing of Kirschner Wires on bone of human skeleton.

Battery Reamer/Drill II

Drilling

Reaming

Kirschner wire insertion

Fixing of cutting block with a pin

Battery Oscillator II

Battery Reciprocator II

Oscillating sawing

Reciprocating sawing

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Introduction General Information

Safety instructions The surgeon has to evaluate if the machine is suitable for an application, based on power limitation of the ­machine, attachment and cutting tool regarding bone strength/anatomical situation as well as handling of the machine, attachment and cutting tool regarding bone size. In addition, the contraindications of the implant have to be respected. Please refer to the corresponding surgical techniques of the implant system used. The Battery Power Line II system is only to be used for patient treatment after careful consultation of the instructions for use. It is recommended that an alternative system is available to use during application, as technical problems can never be completely ruled out. The Battery Power Line II is designed for use only by physicians and trained medical personnel. DO NOT use any apparently damaged components. DO NOT use any component if the packaging is damaged. DO NOT use this equipment in the presence of oxygen, nitrous oxide or a mixture consisting of flammable anesthetic and air. To ensure proper operation of the tool, only use ­Synthes­ original accessories. Before first and every use and prior returning for service power tools and their accessories/attachments, excluding the battery, have to be run through the complete reprocessing procedure. Protective covers and films must be fully removed before sterilization. For the tool to function properly, Synthes­recommends that it is cleaned, disinfected and serviced after each use in accordance with the process defined in the “Care and Maintenance” section. Compliance with these specifications can considerably extend the service life of the tool and reduce the risk of malfunction or harm to the user and patient. Only use S­ ynthes­Special Oil (519.970) to lubricate the tool.

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DePuy Synthes Battery Power Line II Surgical Technique

We recommend using new ­Synthes­cutting tools for ­every surgical procedure. Efficiently working cutting tools are the basis for successful surgery. Therefore, check used cutting tools after every use for wear and/or damage and replace them if necessary. Cutting tools must be cooled with irrigation fluid to ­prevent heat necrosis. The user of the product is responsible for proper use of the equipment during surgery. Check proper operation of the tool before using it on the patient. Unusual Transmissible Pathogens Surgical patients identified as at risk for CreutzfeldtJakob disease (CJD) and related infections should be treated with single-use instruments. Dispose of the instruments used or suspected of use on a patient with CJD after surgery and/or follow the current national recommendations. To prevent overheating, always respect the specified duty cycles on page 76. High torque of the powerful Reamer/Drill (530.705) must always be observed. For important information regarding electromagnetic compatibility (EMC) please refer to the “Electromagnetic Compatibility” section in this manual. 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. Servicing This system requires regular maintenance service, at least once a year, in order to maintain its functionality. This service has to be performed by the original manufacturer or an authorized site. The manufacturer assumes no responsibility for damage re­sulting from improper operation, neglected or unauthorized maintenance of the tool.

Precautions : • Always wear personal protective equipment (PPE) including safety goggles when handling with the BPL II system. • 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. • Only place the tool in an upright position when changing attachments or cutting tools intraoperatively. The handpiece must be laid on its side when not in use in order to avoid the risk of being dropped or contaminating other instruments. • Should the machine drop on the floor and have visible defects, do not use it anymore and send it to the Synthes Service Center. • If a product drops on the floor, fragments may split off. This represents a danger for the patient and user as: –– these fragments may be sharp. –– unsterile fragments may enter the sterile field or hit the patient. • The tool must only be operated with a fully charged battery. Therefore, ensure that the battery is charged in good time. We recommend to install the battery pack just before use in order to prevent ­unwanted discharge of battery capacity. Furthermore, it is recommended that the battery is placed into the charger immediately after surgery. • The aseptic transfer is detailed on page 14ff. Alternatively please follow the guidelines provided in the STERRAD/V-PRO sterilization guide (DSEM/PWT/0615/0068). No other sterilization methods are allowed. • The battery must never be washed, rinsed or dropped. This would destroy the battery with possible secondary damage (explosion hazard!). Only use original Synthes batteries. Further information can be found on page 20ff. • Never place the BPL II in a magnetic environment since the machine might start unintentionally. • Should the system have corroded parts, do not use it any­more and send it to the Synthes Service Center.

Locating of the instrument or fragments of instruments Synthes instruments are designed and manufactured to perform within the scope of their intended use. However, if a Power Tool or accessory/­attachment breaks during use, a visual inspection or a medical imaging device (e.g. CT, Radiation ­Devices, etc.) can aid in locating the fragments and/or components of the instrument.

Battery Power Line II

Surgical Technique

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Introduction General Information

Accessories/scope of delivery The Battery Power Line II consists of three different handpieces, a battery casing, a battery and a range of attachments designed for the system. Please refer to the “Ordering Information” section on page 84ff for an overview of the components of the ­system. To charge the batteries only use the corresponding Synthes Universal Battery Charger II (05.001.204). To reach the specified performance only Synthes cutting tools should be used. These are optimized to meet the specific requirements of the tool. Non Synthes saw blades can considerably reduce the lifetime of the ­system. Special auxiliaries such as cleaning brushes (516.101) and ­Synthes Special Oil (519.970) are available for cleaning and servicing the system. No oils from other manufacturers must be used. Only ­Synthes Special Oil (519.970) must be used to lubricate the power tools and attachments. Lubricants with other compositions may cause jamming, have a toxic effect or have a negative impact on the sterilization results. Only lubricate the power tool, the battery casing and the attachments when clean. Synthes recommends the use of the specifically designed ­Synthes Washing Baskets (68.001.620, 68.001.625) or ­Synthes Vario Case (689.202) to sterilize and store the system. Furthermore, the Washing Baskets (68.001.620, 68.001.625) can be used for the automated cleaning procedure. Further information can be found on page 51ff.

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DePuy Synthes Battery Power Line II Surgical Technique

Storage and transport Only use the original packaging for dispatch and transport as otherwise damage may occur. If the packing ­material is no longer available, please contact your local Synthes office. Please refer to the guidelines for transporting Li-Ion ­batteries when returning them to the Synthes Service Center. Do not store or transport batteries haphazardly in a box or drawer where they may short-circuit each other or be short-circuited by other metal objects. This can damage the batteries and generate heat, which can cause burns. For storage and transport environmental conditions please refer to the section “System Specification” on page 75. Warranty/Liability The warranty for the tools and accessories does not cover damage of any kind resulting from wear, improper use, improper reprocessing and maintenance, damaged seal, use of non S­ ynthes cutting tools and lubricants or improper storage and transport. The manufacturer excludes liability for damage resulting from improper use, neglected or unauthorized maintenance or servicing of the tool. For further information on the warranty please contact your local Synthes office.

Explanation of symbols used The following symbols are applied to the device or ­individual components. Information on additional symbols is given in the relevant sections of this document.

Caution

The European directive 2012/19/EC on waste electrical and electronic equipment (WEEE) applies to this device. This device contains materials MH that should be disCd posed of in accord­ance with environment protection require­ments. Please observe national regulations. See section entitled “Disposal of Waste” on page 68.

Consult the provided 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 IEC 60601-1. Indicates Environment Friendly Use Period of 5 years in China.

S9

IP X4

Duty cycle type according to IEC 60034-1.

Ingress protection rating according to IEC 60529.

Indicates Environment Friendly Use Period of 10 years in China. Locked symbol. Drive Unit is off for safety. Do not immerse device in liquids. Manufacturer Product is UL Classified to the requirements of both the United States and Canada

Date of manufacture

Non sterile

0123

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.

Temperature

Relative humidity

Li-Ion

The European Battery Directive 2006/66/ EC applies to this device. See section “Disposal of Waste” on page 68. This MHLithium-Ion batteries that ­dCd evice contains should be disposed of in accordance with environment protection requirements. Please observe national regulations. See section entitled "Disposal of Waste" on page 68.

Atmospheric pressure

Do not use if package is damaged.

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Introduction

Drive Units

Battery Reamer/Drill II (530.705) Speed (without attachment)

0–340 rpm (maximum speed varies with attachment)

Torque (without attachment)

0–15 Nm (maximum torque varies with attachment)

Weight of handpiece (including battery pack)

1565 g/3.4 lbs

Cannulation

B 4.0 mm

Protection against electric shock

BF

Protection against water ingress

IP X4

Cleaning brush (516.101) and Synthes Special Oil (519.970) included Technical data is subject to tolerances. Mode switch

Attachment release ring Facilitates one-handed removal of attachments Locked symbol Drive unit is off for safety Variable-speed trigger Controls rotational speed

Release buttons Both release buttons must be pressed simultaneously to remove battery casing

FWD Clockwise rotation

Battery casing Protects sterile environment from contamination by non-sterile battery

REV Counterclockwise rotation

Battery casing locks To open and close the lid of the battery casing and prevent the casing from opening during surgery. Both battery casing locks must be pressed simultaneously to open and close the lid.

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Battery Oscillator II (530.710) Speed

0–12 000 oscillations per minute

Deflection

4.5° (0°/2.25°)

Weight of handpiece (including battery pack)

1685 g/3.7 lbs

Protection against electric shock

BF

Protection against water ingress

IP X4

Synthes Special Oil (519.970) included Technical data is subject to tolerances. Saw head Mode switch Saw blade coupling To insert or remove saw blade

Locking knob Allows keyless assembly and removal of saw blades

Sliding sleeve Allows sawing plane to be adjusted through 360°, in 45° increments Locked symbol Drive unit is off for safety

Variable-speed trigger Controls oscillating frequency

Release buttons Both release buttons must be pressed simultaneously to remove battery casing

Battery casing Protects sterile environment from contamination by non-sterile battery

ON Drive unit is on for sawing

Battery casing locks To open and close the lid of the battery casing and prevent the casing from opening during surgery. Both battery casing locks must be pressed simultaneously to open and close the lid.

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Surgical Technique

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Introduction Drive Units

Battery Reciprocator II (530.715) Speed

0–14 000 oscillations per minute

Stroke

4 mm

Weight of handpiece (including battery pack)

1675 g/3.6 lbs

Protection against electric shock

BF

Protection against water ingress

IP X4

Synthes Special Oil (519.970) included Technical data is subject to tolerances. Saw head

Mode switch

Saw blade coupling To insert or remove saw blade

Release knob Ejects saw blade

Sliding sleeve Allows sawing plane to be adjusted through 360°, in 45° increments

Locked symbol Drive unit is off for safety

Variable-speed trigger Controls reciprocating frequency

Release buttons Both release buttons must be pressed simultaneously to remove battery casing

Battery casing Protects sterile environment from contamination by non-sterile battery

ON Drive unit is on for sawing

Battery casing locks To open and close the lid of the battery casing and prevent the casing from opening during surgery. Both battery casing locks must be pressed simultaneously to open and close the lid.

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Battery for Battery Power Line II Art. no.

530.630

Type

Li-Ion (Lithium Ion)

Voltage

14.8 V

Capacity

1.5 Ah/22.2 Wh

Charging Time typically < 60 minutes Technical data is subject to tolerances.

Note: For further information on the correct method of charging, storing and using the battery, please ­refer to page 20ff.

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Introduction Drive Units

Compatibility between BPL and BPL II batteries Existing BPL handpieces are compatible with BPL II batteries The existing BPL handpieces (530.605, 530.610, 530.615) can be used with the new BPL II battery (530.630), battery casing (530.690) and sterile cover (530.660) as seen in Fig. 1.

530.605

530.690

Figure 1

Existing BPL batteries are compatible with BPL II handpieces The existing BPL battery (530.620), battery casing (530.680) and sterile cover (530.650) can be used with the new BPL II handpieces (530.705, 530.710, 530.715) as seen in Fig. 2.

530.705

Note: All BPL/BPL II attachments are fully compatible with the BPL/BPL II handpieces (530.605/530.705).

530.680

Note: Technical data is subject to tolerances and may vary when combining the two systems.

Figure 2

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Battery Power Line II

Surgical Technique

Introduction

Universal Battery Charger II

The Universal Battery Charger II (05.001.204) includes four independent charging bays. Each charging bay has three slots; the Battery Power Line II battery (530.630) fits into the top slot.

Front view

1 2 3

Note: In order that the BPL II battery can be recognized and charged by the UBC II, a minimum of firmware version 14.0* is required. If necessary, send the charger to a Synthes representative for a firmware update.

4

5

For further information on the Universal Battery ­Charger II please consult the relevant Instructions for Use (DSEM/PWT/1114/0050) or contact your local Synthes ­office. The BPL II battery cannot be charged with the Universal Battery Charger (item number 530.600 or 530.601). 1 Charging bays (4) 2 Symbols for battery type 3 ON/OFF display 4 Control display for each charging bay 5 Ventilation holes 6 Ventilation holes 7 Power switch 8 Fuses: 2 × 5 AT/250 V 9 Power cord connection 10 Symbol for BPL and BPL II batteries (530.620 or 530.630)

Rear view

6

7 8 9

10

* Sticker as shown on the underside of the charger with firmware version 14.0:

SW-Rev.14.0 2013/01/09 Battery Power Line II Surgical Technique

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Operating Instructions

Battery Pack (battery casing with inserted battery)

Synthes non-sterile batteries and advanced charging technology optimize intraoperative battery capacity, maximize battery lifespan and shorten turnaround time. One Universal Battery Charger II (05.001.204) for multiple Synthes battery-driven systems simplifies the charging process. Simple aseptic technique preserves the sterile field when assembling the battery pack. The aseptic transfer is detailed below. Alternatively use the STERRAD/V-PRO sterilization guide if preferred (DSEM/PWT/0615/0068). Instruments 530.630

Battery for Battery Power Line II

530.660

Sterile Cover for Battery Power Line II

530.690

Battery Casing for Battery Power Line II

Figure 1

Assembling and inserting the battery pack Scrubbed person Open the lid of the battery casing as shown in Fig. 1. Ensure the lid of the battery casing is fully open (Fig. 2).

Figure 2

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DePuy Synthes

Battery Power Line II

Surgical Technique

Ensure that the lid of the battery casing is facing towards the scrubbed person (Fig. 3). Position the sterile cover securely on top of the battery casing (Fig. 4). Notes: • The sterile cover helps to guide the battery into the battery casing and prevents contamination of the sterile casing by the non-sterile battery. • Sterilize the sterile cover after each use to ensure aseptic conditions when inserting the non-sterile battery into the sterile battery casing. Precautions: • If the non-sterile battery contacts the outside of the battery casing, the battery casing must be cleaned and resterilized before being used in the operating room. • Do not insert the non-sterile battery into the battery casing whilst a handpiece is attached.

Figure 3

Figure 4

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Operating Instructions Battery Pack (battery casing with inserted battery)

Circulating person Insert the non-sterile battery through the sterile cover into the battery casing (Fig. 5a). Press down on the battery to ensure it is fully seated (Fig. 5b).

Circulating person

Note: The shape of the battery ensures that it is inserted with the correct pole alignment. The circulating person must not touch the outside of the battery casing. Remove the sterile cover from the battery casing (Fig. 6). Precaution: Avoid all contact with the outside of the battery casing in order not to contaminate it. Should the non-sterile battery or the circulating person’s hand come into contact with the outside of the battery casing, it must be cleaned and resterilized before being used in the operating room.

Scrubbed person Figure 5a

Circulating person

Scrubbed person Figure 5b

Circulating person

Scrubbed person Figure 6

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Scrubbed person Close the battery casing (Figs. 7a and 7b). Both battery casing locks must be pressed simultaneously to close the lid of the battery casing (Fig. 7a). Note: Ensure that both battery casing locks engage and that the lid of the battery casing is closed properly. Always ensure that the lid of the battery casing is totally closed before using the system. Precaution: Do not contact the non-sterile battery or the inside of the battery casing in order to avoid contamination. Should the scrubbed person come into contact with either the non-sterile battery or the inside of the battery casing, they must be scrubbed again. Should the battery casing be contaminated it must be cleaned and resterilized before being used in the operating room. Notes: • Normally, one fully charged battery has sufficient capacity for an entire operation. As a precaution, a second battery pack (battery casing with inserted battery) should be kept ready, so that the battery pack can be quickly exchanged under sterile conditions during surgery if necessary. • Never open a battery casing intraoperatively to insert a new battery. Always replace the whole battery pack with another battery pack prepared before the start of the surgery.

Figure 7a

Figure 7b

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Operating Instructions Battery Pack (battery casing with inserted battery)

Insert the battery pack into the drive unit, ensuring the contacts on the battery pack align with the contacts in the recess of the drive unit (Fig. 8). Press firmly to ensure the battery pack is engaged correctly, and check by pulling lightly downward on the battery pack. Precautions: • For safety reasons, the battery pack can only be inserted fully when it is in the correct orientation. • To prevent injuries, the mode switch of the drive unit should always be in the off position when inserting or removing the battery pack. • Installing the battery pack just before use prevents unwanted discharge of battery capacity. Figure 8

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Removing and disassembling the battery pack Press both release buttons simultaneously on the drive unit to remove the battery pack (Fig. 9). Open the casing by pressing both battery casing locks and remove the battery or hold open the battery casing to allow another person to remove the battery (Fig. 10). Ensure that the battery does not touch the exterior of the battery casing in order to avoid contaminating the battery. If this occurs follow the information in the “Care and Maintenance” section starting on page 45. Store battery in Universal Battery Charger II (05.001.204) when not in use (Fig. 11).

Figure 9

Alternatively please follow the guidelines provided in the STERRAD/V-PRO sterilization guide (DSEM/PWT/0615/0068). No other sterilization methods are allowed.

Circulating person

Precautions: Do not wash, rinse, drop or apply force to the battery (530.630). This will destroy it with possible secondary damage.

Scrubbed person Figure 10

Figure 11

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