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Related Manuals for Zimmer Biomet HAMMR
Summary of Contents for Zimmer Biomet HAMMR
- Page 1 HAMMR Operation and Maintenance Guide DOC0179252 IFU-HAMMR-EN-US-Rev.4 Jan-2024...
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Page 2: Table Of Contents
INTRODUCTION HAMMR - Operation & Maintenance Guide TABLE OF CONTENTS INTRODUCTION..................................4 HOW TO USE THIS MANUAL................................. 4 SYMBOLS AND CONVENTIONS IN THIS MANUAL AND ON THE PRODUCT................... 4 HAMMR INTENDED USE................................6 CONTRAINDICATIONS................................... 6 GENERAL CAUTIONS..................................7 GENERAL WARNINGS AND NOTICES.............................7 INITIAL VISUAL INSPECTION................................. - Page 3 INTRODUCTION HAMMR - Operation & Maintenance Guide Maintenance Indicators...............................34 TROUBLESHOOTING GUIDE................................ 36 SERVICE INFORMATION................................38 RETURN AUTHORIZATION AND REPLACEMENT INFORMATION....................38 WARRANTY....................................38 HAND PIECE SPECIFICATIONS AND PERFORMANCE........................39 MECHANICAL CHARACTERISTICS..............................39 ELECTRICAL CHARACTERISTICS..............................40 ELECTROMAGNETIC COMPATIBILITY GUIDANCE TABLES......................41 ENVIRONMENTAL CONDITIONS..............................43 INSTRUMENTS TRAY CHARACTERISTICS...........................
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Page 4: Introduction
INTRODUCTION HOW TO USE THIS MANUAL ● These instructions for use and maintenance manual specifies characteristics and features of the HAMMR equipment, including the Impaction Hand Piece, its attachments (adapters and impacting accessories) and the sterilization tray. ● It briefly addresses the batteries and battery charger needed to use the product. For further information refer to the Zimmer Biomet X-Series manual. - Page 5 INTRODUCTION HAMMR - Operation & Maintenance Guide Scheme of the IECEE for Mutual Recognition of Test Certificates for Electrical Equipment. Indicates manufacturer and is accompanied by the name and address of the manufacturer. Manufacturing date This product contains a Li-ion battery that must be recycled.
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Page 6: Hammr Intended Use
The HAMMR consists of a battery operated Impaction Hand Piece and attachments. The Impaction Hand Piece delivers impacts to instruments and implants similar to a surgical mallet. User profile is a certified clinician and patient population and contraindications as prescribed by the clinician. HAMMR is intended for clinical environments only. -
Page 7: General Cautions
INITIAL VISUAL INSPECTION Unpack the HAMMR upon receipt and inspect the unit for any obvious damage that may have occurred during shipment including damage to any part of the system. If the unit is damaged, notify the carrier and your Zimmer Biomet representative immediately. -
Page 8: System Overview
The Impaction Hand Piece, batteries, chargers, attachments and the sterilization tray described in this section are part of the HAMMR system. WARNING Connect only items specified as part of the HAMMR system. WARNING All parts described in this section are suitable to use within the PATIENT ENVIRONMENT. - Page 9 HAMMR DESCRIPTION HAMMR - Operation & Maintenance Guide CHARGER FOR ASEPTIC BATTERY Refer to X-Series manual REF: 89-8521-470-00 STERILIZATION TRAY & LID HAMMR Instrument Tray MATERIALS 304 Stainless Steel Silicone REF: 110046309 HAMMR Instrument Tray Lid MATERIALS 304 Stainless Steel...
- Page 10 HAMMR DESCRIPTION HAMMR - Operation & Maintenance Guide HAMMR Straight Modular Shell Inserter MATERIAL Stainless Steel 455 H1050 MAX LENGTH 12.57 in (319.20 mm) WEIGHT 355.64 g REF: 110046314 HAMMR G7 Curved Shell Impacter MATERIAL Stainless Steel 455 H1050 MAX LENGTH 12.53 in (318.16 mm)
- Page 11 HAMMR DESCRIPTION HAMMR - Operation & Maintenance Guide HAMMR Femoral Head Impacter MATERIAL Stainless Steel 17-4 PH H1050 MAX LENGTH 6.18 in (156.95 mm) WEIGHT 152.91 g REF: 110046304 HAMMR Strikeplate Adapter MATERIAL SS 17-4 PH H1050 LENGTH 4.25 in (108.46 mm) WEIGHT 350.52 g...
- Page 12 REF: 110046301 Table 2 - HAMMR components WARNING Prior to initial usage and after each use, HAMMR must be cleaned and sterilized as per the Cleaning and Sterilization Instructions included in this manual. DOC0179252 IFU-HAMMR-EN-US-Rev.4 Jan-2024 Page 12 of 45...
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Page 13: Impaction Hand Piece
Rechargeable battery that powers the impaction hand piece. Placing the battery ⑦ BATTERY automatically turns on the Impaction Hand Piece. Sterilizable and aseptic battery options are available. Table 3 - HAMMR Impaction Hand Piece parts description DOC0179252 IFU-HAMMR-EN-US-Rev.4 Jan-2024 Page 13 of 45... -
Page 14: Sterilizable Tray
This helps ensure the instruments are cleaned and dried properly. Figure 2 - HAMMR components fitting in the sterilization tray Figure 3 - HAMMR sterilization tray and lid WARNING When placing components into a basket for cleaning/sterilization, avoid all contact between the devices. -
Page 15: Sterilization Tray Handling
HAMMR DESCRIPTION HAMMR - Operation & Maintenance Guide Sterilization tray handling Close tray 1. Install the lid. 2. Attach the latches on both sides. Figure 4 - Close process of the tray. Accessing tray handles Pull both tray handles out through the lid openings. Be sure both latches are closed before handling the tray. -
Page 16: Hand Piece User Operation Guide
USER RESPONSIBILITY AND DECISIONS CAUTION Prior to surgery always inspect the HAMMR handpiece and attachments looking for signs of wear and damage. Some visual indications are provided in section TESTS & CHECKS included in the MAINTENANCE chapter later in this manual. -
Page 17: Switch On
HAMMR Operation & Maintenance Guide SWITCH ON To switch the HAMMR Impaction Hand Piece on, the battery must be plugged in the hand piece handle connector. NOTICE HAMMR Impaction Hand Piece is compatible with X Series system sterilizable and aseptic batteries and chargers. -
Page 18: Switch Off
Remove the battery if the HAMMR is not likely to be used for some time. SWITCH OFF To switch the HAMMR Impaction Hand Piece off, the battery must be unplugged from the hand piece battery connector. Removing The Battery Check that the energy selector is in position 0... -
Page 19: Energy Level Control
HAND PIECE USER OPERATION GUIDE HAMMR Operation & Maintenance Guide ENERGY LEVEL CONTROL The HAMMR Impaction Hand Piece energy control has 4 positions: Figure 8 - Energy level selector 0 POSITION -The energy selector prevents the impaction hand piece from delivering impacts. -
Page 20: Functionality Check
HAND PIECE USER OPERATION GUIDE HAMMR Operation & Maintenance Guide FUNCTIONALITY CHECK CAUTION Before proceeding with functionality check, inspect the handpiece looking for signs of wear and damage. Some visual indications are provided in section TESTS & CHECKS included in the MAINTENANCE chapter later in this manual. - Page 21 HAND PIECE USER OPERATION GUIDE HAMMR Operation & Maintenance Guide FORWARD IMPACTS TEST: ENERGY LEVEL 1 (MIN) Change energy selector to LEVEL 1 (low) Push the Impaction Hand Piece chuck against a stable surface in order to activate the INSERTION mechanism.
- Page 22 Remove from service if the Impaction Hand Piece does not stop or the trigger is not returning to the full out position. CAUTION If the HAMMR Impaction Hand Piece fails to produce the expected results as described, the affected device must be removed from service. DOC0179252 IFU-HAMMR-EN-US-Rev.4 Jan-2024...
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Page 23: Attachments Connection And Disconnection
HAND PIECE USER OPERATION GUIDE HAMMR Operation & Maintenance Guide ATTACHMENTS CONNECTION AND DISCONNECTION Follow the procedure below to connect and disconnect any attachment to the Impaction Hand Piece chuck. WARNING Always manipulate or change the adapters and accessories on the back table with the handpiece energy selector set to the position 0. -
Page 24: Attachment Disconnection
Cleaning and Sterilization section of this document. Broaches Connection And Disconnection Follow below procedure to attach a broach to the HAMMR Impaction Hand Piece: Insert the BROACH tang into the desired adapter by pressing the BROACH into the ADAPTER interface. Connect by fully closing the ADAPTER release lever. -
Page 25: Insertion/Removal Impact Control
HAND PIECE USER OPERATION GUIDE HAMMR Operation & Maintenance Guide INSERTION/REMOVAL IMPACT CONTROL The HAMMR has two primary control modes: insertion movement (forward impaction) and removal movement (reverse impaction) Depending on the trigger press duration, the impaction can be single or multiple. - Page 26 HAND PIECE USER OPERATION GUIDE HAMMR Operation & Maintenance Guide Releasing the trigger stops the removal impacts sequence. Figure 14 - Single/multiple reverse impacts (removal procedure) DOC0179252 IFU-HAMMR-EN-US-Rev.4 Jan-2024 Page 26 of 45...
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Page 27: Insertion-Removal Dynamic Operation (Broaching)
HAND PIECE USER OPERATION GUIDE HAMMR Operation & Maintenance Guide Insertion-Removal Dynamic Operation (Broaching) This function is intended for the broaching phase in a THA procedure. While holding the trigger ⓵, dynamically compressing and releasing the chuck against the Impaction Hand Piece ⓶, allows to perform continuous inserting and removing the broach ⓷... -
Page 28: Cleaning And Sterilization
● Do not immerse, do not use ultrasonic bath. ● Use of the Zimmer Biomet sterilization tray is strongly recommended. The processes described in this manual are the only cleaning and sterilization processes recommended by Zimmer Biomet. ● Final responsibility for verifying cleaning and sterilization, using the equipment and processes of the healthcare facility, and the equipment and parameters supplied by Zimmer Biomet, lies with the healthcare facility. -
Page 29: Impaction Hand Piece Manual Cleaning Process
CLEANING AND STERILIZATION HAMMR - Operation & Maintenance Guide Impaction Hand Piece Manual Cleaning Process Manual cleaning is required to remove gross debris and traces of blood, debris and stains from usage. This is a critical step in the cleaning and sterilization strategy. -
Page 30: Manual Cleaning Process For Adapters
Zimmer Biomet representative when the instrument set is returned. ● Only agents with proven efficacy (FDA approved) should be used. As a large variety of cleaning agents and disinfectants exists around the globe, Zimmer Biomet does not recommend any specific brand. -
Page 31: Automated Cleaning Process For Adapters
Place adapters into their assigned positions within the tray, secure lid and process through a standard instrument washer cleaning cycle. CAUTION The HAMMR Impaction Hand Piece is not intended to be cleaned in an automatic washer. The following minimum parameters are essential for thorough cleaning and disinfection: Step Phase... -
Page 32: Steam Sterilization (Storage)
WARNING Use only the Zimmer Biomet specified sterilization tray for autoclave sterilization processing and allow the handpiece to cool to ambient temperature and evacuate any residual inner condensed water before use. -
Page 33: Immediate Use Steam Sterilization (Iuss)
Sterility cannot be guaranteed if the wrapping is opened, modified, damaged, or wet. ● Check the tray and the instruments of the HAMMR before using any of them (integrity, no excessive humidity). ● If traces are exposed to moisture, the HAMMR components must be cleaned and sterilized again. -
Page 34: Maintenance
Failure to perform routine visual inspection and functionality checks may result in undesired performance. Maintenance Indicators This section is intended to assist the user in determining whether a HAMMR instrument has worn to an extent that it is no longer suitable for use by providing some visual indications. - Page 35 MAINTENANCE HAMMR - Operation & Maintenance Guide WARNING Not following this instruction can lead to an unusable device during surgery that could potentially lead to harm to the user or patient. All visual assessment of indicators shall be executed after cleaning and sterilization of the devices.
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Page 36: Troubleshooting Guide
MAINTENANCE HAMMR - Operation & Maintenance Guide TROUBLESHOOTING GUIDE To aid in unscheduled maintenance, the TROUBLESHOOTING table delineates a number of possible malfunctions that could occur with the unit. The most likely causes are shown for each symptom. While it is not practical to enumerate every conceivable malfunction and all possible causes, the table will assist in isolating the most common problems. - Page 37 MAINTENANCE HAMMR - Operation & Maintenance Guide ● The trigger is contaminated with ● Clean the trigger per manual The Impaction Hand Piece is running without the trigger being debris causing sticking. cleaning instructions. ● The trigger is collapsed and not ●...
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Page 38: Service Information
RETURN AUTHORIZATION AND REPLACEMENT INFORMATION • When it is necessary to return the HAMMR Impaction Hand Piece for inspection, preventive maintenance or repair within the U.S.A. call 1-800-830-0970 to receive a Return Goods Authorization (RGA) number. • Outside the U.S.A., contact your local Zimmer Biomet representative. -
Page 39: Hand Piece Specifications And Performance
TECHNICAL CHARACTERISTICS HAMMR Operation & Maintenance Guide HAND PIECE SPECIFICATIONS AND PERFORMANCE MECHANICAL CHARACTERISTICS Weight And Dimensions Figure 16 - HAMMR device dimensions Dimensions in inches (mm) 15.5 (395) 8.2 (210) 3.93 (100) 1.7 (45) 1.6 (42.3) 0.7 (17) 1.3 (35) 3.34 (85) -
Page 40: Electrical Characteristics
TECHNICAL CHARACTERISTICS HAMMR Operation & Maintenance Guide ELECTRICAL CHARACTERISTICS Supply Mains ⎓ Rated Supply Voltage 14.4VDC 25.5 Amps Battery Peak Current IEC 60601-1 Classification INTERNALLY POWERED ME EQUIPMENT Contains no replaceable fuses Protection against electric shock TYPE BF APPLIED PARTS Protection against harmful ingress IPX6 –... -
Page 41: Electromagnetic Compatibility Guidance Tables
HAMMR is working correctly. Do not use in environments with uncontrolled or strong radiofrequency energy, a static magnetic field, or a magnetic field that changes with time. If placed in these environments, the HAMMR Impaction Hand Piece should be observed to verify it is functioning normally. - Page 42 Recommended separation distances between portable and mobile RF communication equipment and the HAMMR The HAMMR is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the HAMMR can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HAMMR as recommended below, according to the maximum output power of the communications equipment.
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Page 43: Environmental Conditions
TECHNICAL CHARACTERISTICS HAMMR Operation & Maintenance Guide ENVIRONMENTAL CONDITIONS OPERATION STORAGE Temperature 75.2 °F (24 °C) 140 °F (60 °C) 68 °F (20 °C) 5 °F (-15 °C) Relative Humidity ≤2,000 m (80KPa) ≤2,000 m (80KPa) Altitude (Pressure) Pollution Degree Table 20 - Operation and storage environmental conditions The following are the sounds pressure emission levels and sound power levels according to IEC 60601-1:2005 + Corr.1:2006 +... -
Page 44: Instruments Tray Characteristics
TECHNICAL CHARACTERISTICS HAMMR Operation & Maintenance Guide INSTRUMENTS TRAY CHARACTERISTICS Weight And Dimensions Figure 17 - HAMMR Instrument Tray Lid dimensions Figure 18 - HAMMR Instrument Tray dimensions Weight in lb (Kg) Tray Tray Lid Tray loaded 3.4 (7.5) 0.9 (2.0) 11.2 (24.7) -
Page 45: Contact Information
Outside the U.S.A., contact your local Zimmer Biomet sales representative. REPORTING PROBLEMS The user should report any suspected serious incident related to the HAMMR by informing Zimmer Biomet official distributor and the competent authority of the state or the country in which the serious incident has occurred.