Synthes Compact Air Drive II Instructions For Use Manual

Air-driven universal power tool system designed for traumatology

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Compact Air Drive II

Air-driven Universal Power Tool System

designed for Traumatology

Instructions for Use

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Summary of Contents for Synthes Compact Air Drive II

Page 1 Compact Air Drive II Air-driven Universal Power Tool System designed for Traumatology Instructions for Use...
Page 3 Table of Contents Introduction General Information Explanation of symbols used Using the Compact Air Drive II Handpiece Startup of the Compact Air Drive II system Attachments Care and Maintenance General Information Preparation Prior to Cleaning Cleaning and Disinfection • Manual Cleaning Instruction •...
Page 4 Introduction Patient Target Group Synthes manufactures surgical instruments intended to pre- The Compact Air Drive II consists of a handpiece, a range of pare the site and aide in implantation of Synthes implants. attachments and accessories designed for the system.
Page 5 • Should the system have corroded parts, do not use it • Do not use any component if the packaging is anymore and send it to the Synthes Service Center. damaged. • The air hose must be connected properly and should •...
Page 6 Introduction Accessories/Scope of delivery Servicing The main components in the Compact Air Drive II Sys tem ▲ WARNING: are the handpiece, the air hose and attachments and This system requires regular maintenance service, at least accessories. An overview of all components belong ing to once a year, in order to maintain its functionality.
Page 7 Double Sterile Barrier System Legal Manufacturer Single Sterile Barrier System Manufacturing date Restricted Substance labeling with identifier indicates the presence of a hazardous substance greater than 0.1%: 1: Cobalt: CAS No. 7440-48-4; EC No. 231-158-0 Compact Air Drive II • Instruction for Use...
Page 8 Simultaneously pull the top trigger to immediately switch to reverse mode. Safety system The Compact Air Drive II has a safety system that prevents the drive from being accidentally started. To lock the unit, turn the softmode switch fully clock- wise to the “OFF“...
Page 9 Startup of the Compact Air Drive II system Connecting the compressed air hose to the handpiece Shove the female hose coupling onto the male hose cou- pling until it locks into place. The coupling will lock by itself with an audible click.
Page 10 • The correct function of the speed trigger • When mounting and removing attachments, do (immediate stop of the system when the trigger is not simultaneously pull on the attachment while released) is checked before the reaming process. Instruction for Use • Compact Air Drive II...
Page 11 Pull on the tool to make sure that it is correctly locked in the coupling. Removing cutting tools: First slide the coupling sleeve on the attachment to the rear in the direction of the arrow, and then remove the tool. Compact Air Drive II • Instruction for Use...
Page 12 Make sure that the shaft remains in the middle between the clamps of the chuck. Removing cutting tools: Open the chuck jaws by turning the ring counter-clock- wise, and remove the tool. Instruction for Use • Compact Air Drive II...
Page 13 Removing the Kirschner Wire from the bone: To remove the Kirschner Wire from the bone, grip it with the tension lever and pull it out of the bone while pressing both triggers for reverse. Compact Air Drive II • Instruction for Use...
Page 14 Insert the tool into the opening of the Attachment for Acetabular and Medullary Reaming, and press both parts together until they lock. Removing cutting tools: First pull back the movable ring on the attachment, and then remove the tool. Instruction for Use • Compact Air Drive II...
Page 15 • Check the drill bits for wear and/or damage after each use, and replace if necessary. Synthes recommends that cutting tools are only used once. Compact Air Drive II • Instruction for Use...
Page 16 The target rings also assist centering. The locking hole can now be drilled directly (Figs. 3 and 4). Figure 3 Figure 4 Instruction for Use • Compact Air Drive II...
Page 17 Oscillating Drill Attachment (511.200) The Oscillating Drill Attachment (511.200) can be used on the Compact Air Drive II together with the AO/ASIF Quick Coupling (511.750). Mounting the attachment: Slide the Oscillating Drill Attachment from the front over the quick coupling (511.750) up to the stop (Fig. 1). Rotate...
Page 18 3. Insert the new saw blade by exerting a slight pressure against the screw head and then adjusting it to the position required. The saw blades can be locked in different positions. 4. Retighten the screw with the key (518.090). Instruction for Use • Compact Air Drive II...
Page 19 To adjust the deflection, turn the adjuster lever to the desired deflection. “Min” corresponds to a deflection of 2.5°, “Max” to 5°, and the neutral position equals 4° of deflection. Maximum sawing power is obtained in the center position. Compact Air Drive II • Instruction for Use...
Page 20 3. Lock the saw blade coupling by tightening the fixation knob clockwise. Make sure that the fixation knob is firmly tightened. Otherwise the screw can loosen during use causing the saw blade to vibrate. Instruction for Use • Compact Air Drive II...
Page 21 (the slot of the lock knob and saw blade coupling are axially offset). Check if the saw blade is seated tightly by pulling in a lengthwise direction. Compact Air Drive II • Instruction for Use...
Page 22 Instructions for handling saw blades Synthes recommends using a new blade for each op- eration to ensure that the saw blade is optimally sharp and clean. The following risks are associated with used blades: ▲...
Page 23 If proper maintenance is not provided the device is potentially out of calibration respectively the torque limit could not be within the declared range of limit. Compact Air Drive II • Instruction for Use...
Page 24 Attachment for Acetabular and Medullary Reaming that is coupled to the Compact Air Drive II. Rotate the drive unit to achieve the optimum grip, and lock it in place by tightening the lock- ing screw clockwise.
Page 25 Check that the tool is properly locked in the adapter by gently pulling on it. Removing cutting tools: First shove the coupling sleeve on the adapter toward the rear, and then remove the tool. Compact Air Drive II • Instruction for Use...
Page 26 For more information about Care and Maintenance, (such as AAMI TIR 34 “Water for the reprocessing of please refer to the Compact Air Drive II Care and Mainte- medical devices”) and this Instructions for Use. nance Poster.
Page 27 • Cleaning Agent Information: Examples of deter gents that were used by Synthes during the clean ing validations include ProlysticaTM 2X Concen trate Enzymatic Cleaner, ProlysticaTM 2X Neutral Detergent, Neodisher MediZym. These cleaning ® agents are not listed in preference to other available cleaning agents which may perform satisfactorily.
Page 28 Compact Air Drive II handpiece Put the seal nipple (519.596) on the machine’s air inlet. 511.701 Synthes Double Air Hoses Seal the Synthes Double Air Hose by joining the inlet and outlet. 519.510 519.530 Instruction for Use • Compact Air Drive II...
Page 29 (265 mm) (78 mm) (61 mm) Cleaning brush (519.400) Compact Air Drive II • Instruction for Use...
Page 30 70% alcohol-based disinfectant each time. 8. Visually inspect device Inspect the device including cannulations, sliding sleeves, attachment release rings, etc. for visible soil. Repeat the process if visible soil remains. Instruction for Use • Compact Air Drive II...
Page 31 Put the seal nipple (519.596) on the machine’s air inlet. 511.701 Synthes Double Air Hoses Seal the Synthes Double Air Hose by joining the inlet and outlet. 519.510 519.530 (265 mm) (78 mm) (61 mm) Cleaning brush (519.400) Compact Air Drive II • Instruction for Use...
Page 32 Plug the air inlet of the drive unit with the seal nipple remove gross debris. (519.596). Seal the air hoses with the Synthes coupling by joining the 3. Spray and wipe inlet and outlet. Place all articles in the washing tray in a way that an Spray the device with newly prepared neutral pH enzy- effective washing/disinfection can be performed.
Page 33 Therefore, devices must be properly lubricated after automated cleaning. Furthermore, the device must be serviced at least once per year as specified under the section “Repairs and Technical Services”. Compact Air Drive II • Instruction for Use...
Page 34 Lubricating the Power Tool Single air hose Adapter for oiling • After each use, apply around 5 drops of the Synthes special oil (oil dispenser 519.970) into the air inlet of the cleaned power tool. • Connect the handpiece to a single air hose (Fig. 2), or to a double hose using an adapter for oiling (Fig.
Page 35 Lubricating the attachments After each use, lubricate all moving parts of the attach- ments with 1–2 drops of Synthes special oil (519.970). Distribute the oil by moving the parts, and remove excess oil with a cloth. ▲ WARNINGS: • To ensure a long service life and reduce repairs, the power tool and all attachments must be lubri cated after each use.
Page 36 Failing to follow these instructions will lead to damage and malfunction, increasing the risk of harm to the user and pa tient. For further information on inspection and function test, please refer to the CADII Care and Maintenance Poster (038.000.017). Instruction for Use • Compact Air Drive II...
Page 37 ■ Note: manu facturer’s instructions and does not exceed the maximal sterilizer load. Synthes Compact Air Drive II system may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Synthes recommendations for packed devices and cases are as follows.
Page 38 Use products in the order in which they are received (“first-in, first-out principle“), taking note of any expiration date on the label. Instruction for Use • Compact Air Drive II...
Page 39 Repairs and Technical Service The power tool should be sent to the Synthes office for re pair if it is faulty or malfunctions. ▲ WARNINGS: • Contaminated products have to run through the complete reprocessing procedure before being sent to the Synthes office for repair or techni cal service.
Page 40 The device may not be disposed of with house hold waste. To prevent damage during shipping use the original packag ing to return devices back to Synthes. If this is not possible, please contact the Synthes affiliate. ▲ WARNING:...
Page 41 Do not use sharp objects for this. The connection geometry at the Send attachments for repair attachments is faulty. to your Synthes representative. Compact Air Drive II • Instruction for Use...
Page 42 If the recommended solutions do not work, send the power tool to your Synthes service center. For further technical questions or information on our services, please contact your Synthes representative. Instruction for Use • Compact Air Drive II...
Page 43 Technical Data CAD II Handpiece (511.701) Continuously adjustable speed 0–900 rpm Weight 780 g Air consumption Approx. 250 l/min Recommended operating pressure 6–7 bar (max. 10 bar) Power output (mechanical) 120 W Cannulation B 3.2 mm Compact Air Drive II • Instruction for Use...
Page 44 * products have been tested according to ISTA 2A ▲ WARNING: Do not use this equipment in the presence of oxygen, nitrous oxide or a mixture consisting of flammable anesthetics and air. Instruction for Use • Compact Air Drive II...
Page 45 **** Handpiece 511.701 with 511.902 at idle speed (12 000 Osc./min) and with 6 bar ▲ Precaution: Carefully observe the above recom mended maximum daily exposure time. Technical data is subject to tolerances. The values are determined with Synthes saw blades. Compact Air Drive II • Instruction for Use...
Page 46 *** Handpiece 511.701 with 511.801 at idle speed (14 000 Osc./min) and with 6 bar **** Handpiece 511.701 with 511.902 at idle speed (12 000 Osc./min) and with 6 bar Technical data is subject to tolerances. The values are determined with Synthes saw blades. Instruction for Use • Compact Air Drive II...
Page 47 ISO 7153-1 518.090 Key, for fixing of saw blades Nylon 519.400 Cleaning brush 519.596 Seal nipple for Compact Air Drive II Handpiece 05.001.087 Adapter for Schrader/Synthes Coupling 05.001.088 Adapter for Dräger/Synthes Coupling 519.970 Oil dispenser with Synthes special oil 689.200...
Page 48 Not all products are currently available in all markets. Please contact your DePuy Synthes representative for more information. This publication is not intended for distribution in the USA. All Synthes implant instructions for use as well as general instructions for use are available as PDF files at www.e-ifu.com. The legal manufacturer of the Wall Couplings (520.501;...

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511.701