ConMed. ConMed reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.
INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean, or sterilize this or associated equipment. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual.
1.5 Warnings and Precautions Do not bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient and/or surgical staff. The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully.
11. Do not attach, insert or remove accessories or attachments while the handpiece is operating. Injury to the operator and/or damage to the equipment may occur. Place the handpiece safety mechanism in the “safe” position prior to installation or removal of items. 12.
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4. Use only associated ConMed approved equipment and accessories. Using unapproved accessories may result in improper operation, and may result in non-compliance to medical standards. 5. The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: •...
For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact ConMed. 1.7 Product Photographs and Drawings The pictures in this manual are for reference only.
1.8 Symbol Definitions 1.8.1 Product Symbols “Safe” or “Off” position. “Reverse” position of the PRO7100B handpiece. “Forward” position of the PRO7100B “Run” position of the PRO7400B and handpiece. PRO7450B handpieces. “Run” position of the PRO7300B Screw/tap operating mode for the handpiece.
CE Mark of Conformity European Community Prescription Only: Federal Law No User Service Recommended. Refer restricts this device to sale by or on servicing to qualified ConMed service the order of a physician personnel Non Sterile Sterile Sterile - Sterilized Using EO...
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Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-800-237-0169, or outside the U.S. contact your local ConMed representative for additional information on battery disposal or recycling.
SYSTEM INSTALLATION AND OPERATION 2.1 Product Description 2.1.1 PRO7100B Hall 50 Single Trigger Modular Battery Handpiece The PRO7100B Hall 50 Single Trigger Modular Battery Handpiece is designed to be used as an all-purpose driver for reaming, drilling, wire and pin driving, and with the proper attachments (reciprocator and sagittal only) will perform sawing applications.
2.1.2 PRO7200B Hall 50 Two-Trigger Modular Battery Handpiece The PRO7200B Hall 50 Two-Trigger Modular Battery Handpiece is designed to be used as an all-purpose driver for reaming, drilling, wire and pin driving, and with proper attachments (reciprocator and sagittal only) will perform sawing applications. The Hall 50 Two-Trigger handpiece is also ideal for ACL and trauma procedures.
2.1.3 PRO7300B Hall 50 Oscillating Saw Battery Handpiece The PRO7300B Hall 50 Oscillating Saw Battery Handpiece is designed for sawing in transverse or longitudinal bone osteotomies, removal of the femoral head and neck, removal of the greater trochanter, repeat sternotomies, resurfacing the tibial plateau and the distal end of the femur, and for other bone cuts as required in large bone procedures.
2.1.4 PRO7400B Hall 50 Reciprocating Saw Battery Handpiece The PRO7400B Hall 50 Reciprocating Saw Battery Handpiece is designed for sawing in large bone total arthroplasties. 1. Blade Collet — Insert a blade here. Also used to rotate the blade to any of four (4) positions at 90° intervals for appropriate surgical access.
2.1.5 PRO7450B Hall 50 Sternum Saw Battery Handpiece The PRO7450 Hall 50 Sternum Saw Battery Handpiece is designed to be used for primary sternotomies. The Hall 50 PRO7450B is designed to accept 5059-532 and 5059-531 blades, and to be used with 5059-006, 5059-011, and 5059-006-03 blade guards.
2.2 Assembly/Installation Instructions 2.2.1 Battery Installation To attach the desired battery pack to the handpiece: 1. Align the contacts on the top of the battery pack with the connector on the handpiece. 2. Slide the battery pack until it snaps into place. To remove the battery pack from the handpiece: 1.
2.2.2 Connecting and Removing Attachments to the Modular Handpiece (PRO7100B/PRO7200B) All attachments for the Hall 50 Modular Handpieces connect/disconnect in the same manner. For more information, refer to the PowerPro Attachment Instruction Manual or the Information Insert supplied with each attachment. To connect an attachment: 1.
2.2.3 Connecting and Removing Blades to the Oscillator Handpiece (PRO7300B) To attach a blade: 1. Place the mode lever in the “safe” position. 2. Rotate the blade locking knob in the direction of the arrow to the “open” position. The blade locking collet will disengage.
2.2.4 Connecting and Removing Blades to the Reciprocator Handpiece (PRO7400B) To attach a blade: 1. Place the mode lever in the “safe” position. 2. Rotate the blade locking knob counterclockwise to open the blade collet. 3. Completely insert the blade shank. 4.
2.2.5 Connecting and Removing Blade and Blade Guard to the Sternum Saw (PRO7450B) WARNING: Never operate the Sternum Saw without the saw blade, collet nut, and blade guard locked securely in place. To install a blade: 1. Place the handpiece in the “safe” position. 2.
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Align the slots on the connecting portion of the blade guard with the pins inside the blade guard locking sleeve. Pull the locking sleeve back (see above picture) and insert the blade guard completely into the blade guard locking sleeve. With the blade guard in the proper position, release the locking sleeve.
2.3 Operating Instructions NOTE: The connected attachment (drill or reamer) determines the speed and torque of the Hall 50 Modular handpiece. 2.3.1 PRO7100B Hall 50 Single Trigger Modular Battery Handpiece Operation To operate the handpiece, place the handpiece mode lever in either the “forward” or “reverse” position and depress the trigger.
2.3.3 PRO7300B Hall 50 Oscillating Saw Battery Handpiece Operation Position the rotating head to the desired position for the appropriate surgical access. 1. Ensure the mode lever is in the “safe” position. 2. Carefully pull the rotating head out and away from the handpiece body. 3.
2.4 Preoperative Functional Test Prior to each use, perform the following preoperative functional test: Attach battery to handpiece. Insert an attachment or blade into the handpiece. Gently pull on the attachment or cutting accessory to ensure it is properly seated. Run the handpiece for less than 5 seconds to observe any abnormal noises, vibrations or heat rise.
MAINTENANCE 3.1 Cleaning Information 3.1.1 Warnings, Precautions and Notes 1. Follow universal precautions for protective apparel when handling and cleaning contaminated instruments. 2. Clean instruments within 30 minutes after use to minimize the potential of blood and debris drying. 3. Never clean equipment in an ultrasonic cleaner. 4.
3.1.3 Manual Cleaning Instructions (PRO7450B) 1. Thoroughly scrub the handpiece and attachments with a clean, soft brush dampened with a mild, pH-balanced detergent. Remove all traces of blood, debris and stains. Do not immerse equipment in cleaning solution. 2. Remove the collet nut from the handpiece using the locking wrench and rotating counterclockwise. 3.
3.1.4 Automated Cleaning Instructions Hall 50 handpieces are suitable for use in washer/sanitizers. They are designed with advanced materials and sealing technologies and are individually tested to ensure the prevention of ingress of fluids during use and cleaning. Hall 50 has an Ingress Protection rating of IPX6 and IPX8, ensuring they are suitably protected against water intrusion when exposed to water jets and immersion.
8. Do not use equipment while warm. Allow adequate time for cooling prior to use. Cool by exposure to room temperature. Operation of equipment that is not completely cool or dry may decrease performance and/or reliability. 9. An eight (8) minute minimum dry cycle must be run on all equipment and attachments every time the product is sterilized.
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Recommended sterilization cycles outside the United States: Table 3: Sterilization Parameters for Hall 50 Battery Handpieces without a System Sterilization Tray Outside the United States Minimum Maximum Minimum Maximum Minimum Maximum Method Cycle Temperature Temperature Exposure Exposure Dry Cycle Dry Cycle Steam Pre-vacuum 273°F (134°C) 278°F (137°C) 3 minutes 18 minutes 40 minutes No maximum (wrapped)
The equipment is not field repairable. Your ConMed authorized service department is the most knowledgeable about this equipment and its accessories and will provide competent and efficient services. Service at ConMed at the recommended service interval is mandatory to keep your product warranties in effect. Any services and/ or repairs done by any unauthorized repair facility may result in reduced performance of the equipment or equipment failure.
TECHNICAL SPECIFICATIONS Medical electrical equipment complies with and was tested with respect to electric shock, fire, electromagnetic compatibility, mechanical and other specified hazards only, in accordance with UL60601-1, CAN/CSA C22.2 No. 601.1-M90, IEC60601-1:1988 +A1:1991 +A2:1995, ES60601-1:2005 +A1: 2009 +A2: 2010, CAN/CSA C22.2 No.60601-1-1-08 and IEC60601-1:2005 +C1:2006 +C2:2009. Tested to IEC60601-1-2:2007 and Part 15 of the FCC Rules as follows: 1) The system may not cause harmful interference: 2) The system will accept interference, including interference that might cause undesired operation.
4.1.3 PRO7300B Hall 50 Oscillating Saw Battery Handpiece I.E.C Classification: Internally Powered, Applied Part Type BF. Protection Ingress of Fluids: IPX6 and IPX8 Mode of Operation: Intermittent Loading Speed Range: 0 - 11,000 cpm with all batteries Oscillation Range: 4.5° Height: 6.4 in.
4.2.2 Electromagnetic Requirements Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Use of accessories other than those recommended may result in non-compliance with electromagnetic compatibility and immunity standards.
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Table 8: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Hall 50 Handpieces are intended for use in the electromagnetic environment specified below. The customer or the user of the Hall 50 Handpieces should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity Test...
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Table 8: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued) The Hall 50 Handpieces are intended for use in the electromagnetic environment specified below. The customer or the user of the Hall 50 Handpieces should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity Test...
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Table 9: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Hall 50 Handpieces @ 3Vrms Hall 50 Handpieces are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Hall 50 Handpieces can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Hall 50 Handpieces as recommended below, according to the maximum output power of the communications equipment.
4.3 Accessories Description Attachments PRO1540 AO Drill/Ream Attachment PRO1541 1/4 in. Chuck Drill/Ream Attachment PRO1547 Zimmer/Hudson Drill/Ream Attachment PRO1548 DePuy/Hudson Drill/Ream Attachment PRO2029 Trinkle/AO Attachment PRO2030 5/32 in. (4.0 mm) Chuck Attachment w/key PRO2033 High Speed Drill Attachment PRO2038 AO Small Attachment PRO2040 AO Reamer Attachment PRO2041...
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Batteries L3000LG Large Lithium Battery, 13.2 Volt PRO3010 Large PowerPro Standard Battery, 9.6 Volt PRO3011 Large PowerProMAX Standard Battery, 12 Volt PRO3020 Small PowerPro Standard Battery, 12 Volt PRO3115 Large Sterile Transfer Battery, 9.6 Volt PRO3520 Small Sterile Transfer Battery, 12 Volt Blades 5059-531 Extended Sternum Saw Blade...
Refer to this number if making inquiries about the repair status. Please call ConMed Customer Service and provide the following information to obtain an S.R. number prior to returning any product for repair: •...
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525 French Road Utica, NY 13502-5994 USA (727) 392-6464 Customer Service: 1-800-237-0169 EC REP USA FAX: (727) 399-5256 MDSS GmbH International FAX: +1(727) 397-4540 Schiffgraben 41 D-30175 Hannover, Germany email: customer_service@conmed.com www.conmed.com All rights reserved. W41-254-004 Rev AD 12/2013...
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