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Battery-driven power tool system for orthopedics and traumatology
Battery Power Line II User’s Manual
Table of Contents
Introduction
Operating Instructions
Care and Maintenance
General Information
2
Drive Units
8
Universal Battery Charger II
12
Battery Pack (battery casing with inserted battery)
13
Battery Reamer/ Drill II
19
Attachments for Battery Reamer/ Drill II
20
Battery Oscillator II
35
Battery Reciprocator II
37
General Information
39
Preparation Prior to Cleaning
40
Manual Cleaning Instructions
41
Automated Cleaning Instructions With Manual Precleaning
44
Lubrication50
DePuy Synthes Power Tools
Battery Power Line II
User’s Manual
Inspection and Function Test
56
Packaging, Sterilization, and Storage
57
Battery Sterilization using STERRAD® and V-PRO® Systems Sterilization
60
Repairs and Technical Service
63
Disposal of Waste
64
Table of Contents
Troubleshooting
65
System Specifications
70
Electromagnetic Compatibility
74
Ordering Information
78
Warning: This description alone does not provide sufficient background for the direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended.
Battery Power Line II
User’s Manual
DePuy Synthes Power Tools
Introduction
General Information
Intended Use The Battery Power Line II is a heavy duty battery-driven system intended for orthopedic and trauma applications including: • Drilling • Reaming • Inserting/removing Kirschner wires and pins • Cutting bone
Battery Reamer/ Drill II
2
Drilling
Reaming
Kirschner wire insertion
Fixing of cutting block with a pin
DePuy Synthes Power Tools Battery Power Line II
User’s Manual
Introduction General Information
Battery Oscillator II
Oscillating sawing
Battery Reciprocator II
Reciprocating sawing
Battery Power Line II
User’s Manual DePuy Synthes Power Tools
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Introduction General Information
Safety Instructions The Battery Power Line II (BPL II) 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 component if damage is apparent. 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 DePuy Synthes original accessories. Before first and every use and prior to 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, DePuy Synthes recommends that it is cleaned and serviced after each use in accordance with the process recommended in the “Care and Maintenance” section. Compliance with these specifications can considerably extend the service life of the tool. Only use Synthes Special Oil (519.97) to lubricate the tool.
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. To prevent overheating, always respect the specified duty cycles on page 71. If the Battery Power Line II is used in conjunction with an implant system, make sure to consult the corresponding Technique Guide. 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. Note: To ensure proper operation of the tool, annual maintenance by a DePuy Synthes service center is necessary. The manufacturer shall assume no responsibility for damage resulting from improper operation, and neglected or unauthorized maintenance of the tool.
We recommend using new DePuy Synthes cutting 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.
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DePuy Synthes Power Tools Battery Power Line II
User’s Manual
Introduction General Information
Notes • Always wear personal protective equipment (PPE) including safety goggles when handling the BPL II system. • To avoid injuries, the locking mechanism of the tool has to be activated before every manipulation and when laying the tool 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 to avoid the risk of being dropped or contaminating other instruments. • If the machine has been dropped, it should be checked carefully for damage. In the event that any damage is visible, do not use it anymore and send it to the DePuy Synthes service center. • The tool may only be operated with a fully charged battery. Therefore, ensure that the battery is charged in good time. We recommend that the battery is placed into the charger immediately after surgery. • The batteries must never be sterilized, washed, rinsed, or dropped. This would destroy the battery with possible secondary damage (explosion hazard!). Only use original DePuy Synthes batteries. Further information can be found on page 17. • Never place the BPL II in a magnetic environment since the machine might start unintentionally.
Battery Power Line II
User’s Manual DePuy Synthes Power Tools
5
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.
Storage and Transport Only use the original packaging for dispatch and transport as otherwise damage may occur. If this is not possible, please contact your local DePuy Synthes office.
To charge the batteries, only use the corresponding DePuy Synthes Universal Battery Charger II (05.001.204).
For storage and transport environmental conditions, please refer to the “Packaging, Sterilization, and Storage” section on page 58.
To reach the specified performance, only DePuy Synthes cutting tools should be used. These are optimized to meet the specific requirements of the tool. Non-DePuy Synthes saw blades can considerably reduce the lifetime of the system. Special auxiliaries such as cleaning brushes (516.101) and Synthes Special Oil (519.97) are available for cleaning and servicing the system. No oils from other manufacturers may be used. Only Synthes Special Oil (519.97) must be used to lubricate the power tools and attachments.
Warranty The warranty for the tools and accessories does not cover damage of any kind resulting from wear, improper use, damaged seal, use of non-DePuy Synthes cutting tools and lubricants, or improper storage and transport. The manufacturer shall assume no responsibility for damage resulting from improper operation, and neglected or unauthorized maintenance of the tool. For further information on the warranty, please contact your local DePuy Synthes office.
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. DePuy Synthes recommends the use of the specifically designed DePuy Synthes Washing Basket (68.001.620, 68.001.625) to sterilize and store the system. Furthermore, the Washing Basket (68.001.620, 68.001.625) can be used for the automated cleaning procedure. Further information can be found on page 47. Please refer to the “Ordering Information” section on page 78 for an overview of the components of the system.
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DePuy Synthes Power Tools Battery Power Line II
User’s Manual
Introduction General Information
Explanation of Symbols The following symbols are applied to the device or individual components. SAFE
Caution
This symbol indicates that this battery contains rechargeable lithium-ion cells. The battery is rechargeable.
Consult the provided instructions for use before operating the device.
F
R
S9
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: 2005 + CORR. 1 (2006) + CORR. 2.4 1.6 2 (2007) ANSI/AAMI ES60601-1:2005, Dated December 2005 and CAN/CSA-C22.2 0.5 No. 60601-1:08, Dated February 2008.
IP X4
Duty cycle type according to IEC 60034-1.
Ingress protection rating according to IEC 60529.
Locked symbol. Drive Unit is off for safety.
2.4
1.6
Date of manufacture
0.5 3.2
4.8
3.2
4.8 6.4
6.4 8.0 8.0
Do not immerse device in liquids.
non sterile
Non-sterile
Accredited test house for IEC 60601
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.
Relative humidity
10PB
0123
The European Battery Directive 2006/66/ EC applies to this device. See section “Disposal” on page 64. This device contains lithium-ion batteries that should be disposed of in accordance with environment protection requirements.
Battery Power Line II
Atmospheric pressure
Do not use if package is damaged.
User’s Manual DePuy Synthes Power Tools
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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 lb
Cannulation
4.0 mm diameter
Protection against electric shock
BF
Protection against water ingress
IP X 4
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 unsterile 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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DePuy Synthes Power Tools Battery Power Line II
User’s Manual
Introduction Drive Units
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 lb
Protection against electric shock
BF
Protection against water ingress
IP X 4
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
Locked symbol Drive unit is off for safety
Sliding sleeve Allows sawing plane to be adjusted through 360°, in 45° increments
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 unsterile 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
Battery Power Line II
User’s Manual DePuy Synthes Power Tools
9
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 lb
Protection against electric shock
BF
Protection against water ingress
IP X 4
Technical data is subject to tolerances. Mode switch Saw head 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 unsterile battery 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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DePuy Synthes Power Tools Battery Power Line II
ON Drive unit is on for sawing
User’s Manual
Introduction Drive Units
Battery for Battery Power Line II (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 17.
Battery Power Line II
User’s Manual DePuy Synthes Power Tools
11
Operating Instructions
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
Note: For the BPL II battery to be recognized and charged by the UBC II, firmware version 14.0* is required. If necessary, send the charger to a DePuy Synthes representative for a firmware update.
4
1 2 3
5
For further information on the Universal Battery Charger II, please consult the relevant Instructions for Use or contact your local DePuy 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 x 5 AT/250 V 9 Power cord connection 10 Symbol for BPL and 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
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DePuy Synthes Power Tools Battery Power Line II
User’s Manual
Operating Instructions
Battery Pack (battery casing with inserted battery)
DePuy 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 DePuy Synthes battery-driven systems simplifies the charging process. Simple aseptic technique preserves the sterile field when assembling the battery pack. Instruments 530.630
Battery for Battery Power Line II
530.660
Insertion Shield for Battery Power Line II
530.690
Battery Casing for Battery Power Line II
Figure 1
Assembling and Inserting the Battery Pack For instructions on Assembling and Inserting a battery sterilized in Sterrad® or V-PRO® systems, please refer to page 61. Scrubbed Person Open the lid of the battery casing (Figure 1).
Figure 2
Ensure the lid of the battery casing is fully open (Figure 2). Ensure that the lid of the battery casing is facing towards the scrubbed person (Figure 3). Position the insertion shield securely on top of the battery casing (Figure 4). Notes • The insertion shield helps to guide the battery into the battery casing and prevents contamination of the sterile casing by the non-sterile battery. • Sterilize the insertion shield 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
Battery Power Line II
User’s Manual DePuy Synthes Power Tools
11
Operating Instructions Battery Pack
Circulating Person Insert the non-sterile battery through the insertion shield into the battery casing (Figure 5a). Press down on the battery to ensure it is fully seated (Figure 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 insertion shield from the battery casing (Figure 6).
Scrubbed person
Precaution: Avoid all contact with the outside of the battery casing to prevent contamination. 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.
Figure 5a
Circulating person
Scrubbed person Figure 5b
Circulating person
Scrubbed person Figure 6
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DePuy Synthes Power Tools Battery Power Line II
User’s Manual
Operating Instructions Battery Pack
Scrubbed Person Close the battery casing (Figures 7a and 7b). 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 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.
Figure 7a
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 by another battery pack prepared before the start of the surgery. Figure 7b
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 (Figure 8). Press firmly to ensure the battery pack is engaged correctly, and check by pulling lightly downward on the battery pack. Notes • 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
Battery Power Line II
User’s Manual DePuy Synthes Power Tools
11
Operating Instructions Battery Pack
Removing and Disassembling the Battery Pack Press both release buttons simultaneously on the drive unit to remove the battery pack (Figure 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 (Figure 10). Ensure that the battery does not touch the exterior of the battery casing to avoid contaminating the battery. If this occurs, follow the information in the “Care and Maintenance” section starting on page 40. Store battery in Universal Battery Charger II (05.001.204) when not in use (Figure 11). Precaution: Do not wash, rinse, drop, or apply force to the battery (530.630). This will destroy it with possible secondary damage.
Figure 9
Circulating person
Scrubbed person Figure 10
Figure 11
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DePuy Synthes Power Tools Battery Power Line II
User’s Manual
Operating Instructions Battery Pack
Charging, Storing, and Using Batteries
Do not expose batteries to heat or fire. Avoid storage in direct sunlight.
Charging Only use the DePuy Synthes Universal Battery Charger II (05.001.204) to charge the battery. Using a charger that does not originate from DePuy Synthes can damage the battery. For the BPL II battery to be recognized and charged by the Universal Battery Charger II, a minimum firmware version of 14.0 is required. If necessary, send the charger to a DePuy Synthes representative for a firmware update.
Keep the charger and the batteries clean and in a cool and dry place. Use Do not remove battery from its original packaging until required for use. Do not drop or apply force to the battery. This will destroy it with possible secondary damage. Do not use any battery which is not designed for use with the equipment.
The BPL II battery cannot be charged with the Universal Battery Charger (item number 530.600 or 530.601).
Do not use a faulty or damaged battery, as this may damage the power tool.
The batteries should always be charged before use. Do not short circuit a battery. Place the battery into the charger immediately after surgery. 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.
Charge the batteries within an ambient temperature range of 10 °C/50 °F to max. 40 °C/104 °F. Keep the charger and the batteries clean and in a cool and dry place.
Batteries give their best performance when they are operated at normal room temperature (20 °C/68 °F +/- 5 °C/9 °F).
Detailed information on the Universal Battery Charger II can be found in the relevant User’s Manual (J8895). Storage Always recharge the Li-Ion Battery for Battery Power Line II (530.630) after each use. Do not store an empty battery as this will shorten the life span and will not be covered by warranty. When the battery is not in use, store it in the DePuy Synthes Universal Battery Charger II (05.001.204). This will guarantee that the battery is always fully charged and ready to use.
The power tool may only be operated with a fully charged battery. Therefore the batteries should always be charged before use. Place the battery into the charger immediately after surgery. Only insert the battery pack directly before using the power tool. This saves battery energy and prevents having to change it during surgery. Follow the information in the “Care and Maintenance” section starting on page 40 as well as the User’s Manual of the DePuy Synthes Universal Battery Charger II (J8895).
The Universal Battery Charger II should always be turned on when a battery is in the charging bay. This ensures availability of charged batteries. Battery Power Line II
User’s Manual DePuy Synthes Power Tools
11
Operating Instructions Battery Pack
Notes • Generally, medical power tools can heat up if in constant use. The cool down times should be observed; see “Duty Cycle” section on page 71, to prevent the power tool from exceeding its acceptable surface temperature. • In case of cell leakage, do not allow the leaking fluid to come into contact with skin or eyes. In case of contact, wash the affected area with copious amounts of water and seek medical advice. • Faulty batteries may not be reused and should be disposed of in an environmentally friendly manner and in accordance with national regulations. Warnings • Never expose batteries to temperatures over 60 °C/140 °F. The maximum exposure time at 60 °C/140 °F is 72 hours. • Do not dismantle, open, or shred batteries.
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DePuy Synthes Power Tools Battery Power Line II
User’s Manual