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Zimmer Biomet HAMMR - User Manual

Zimmer Biomet HAMMR
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HAMMR
Operation and Maintenance Guide
DOC0179252 IFU-HAMMR-EN-US-Rev.4 Jan-2024

Table of Contents

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Overview

The HAMMR is a reusable, handheld, battery-operated Impaction Hand Piece designed for Total Hip Arthroplasty (THA) procedures, specifically for bone preparation and the implantation of acetabular cup and femoral stem implants. It delivers impacts to instruments and implants, similar to a surgical mallet. The system includes the Impaction Hand Piece, various attachments (adapters and impacting accessories), and a sterilization tray.

Function Description:

The HAMMR Impaction Hand Piece is powered by an external rechargeable battery. It can deliver impacts in both forward (insertion) and reverse (removal) directions by attaching impacter shafts and broaches to its chuck mechanism. The device features an energy selector with four positions: 0 (inhibit), 1 (low), 2 (medium), and 3 (high), allowing the user to select the desired impact energy for insertion. Insertion impacts occur when the chuck is compressed against the hand piece while the trigger is pulled. Removal impacts are performed when the chuck is pulled out from the hand piece while the trigger is pulled. The device also supports a "broaching" or "sawing motion" procedure for the THA phase, where dynamically compressing and releasing the chuck against the hand piece while holding the trigger allows for continuous inserting and removing of the broach.

Important Technical Specifications:

  • Rated Supply Voltage: 14.4VDC
  • Battery Peak Current: 25.5 Amps
  • Protection against electric shock: Internally Powered ME Equipment, Type BF Applied Parts. Contains no replaceable fuses.
  • Protection against harmful ingress of water or particulate matter: IPX6 (resists high-pressure, heavy sprays of water).
  • Methods of sterilization: By moist heat (autoclave).
  • Mode of operation: Non-CONTINUOUS OPERATION.
  • Duty Cycle: 10 seconds on max. time followed by 10 seconds off min. time X 14 cycles.
  • Sound Pressure Level (LpA): < 140 dBA.
  • Materials:
    • Hand Piece enclosure: PEEK plastic
    • Chuck: Stainless steel AISI 316L
    • Finger cover: Al 6061-T6 Hard anodized
    • Energy Selector: Stainless steel AISI 316L
    • Front cap: Al 6061-T6 Hard anodized
    • Trigger button: PEEK plastic
    • Sterilization Tray and Lid: 304 Stainless Steel, Silicone
    • Impaction Tools and Accessories (e.g., Impacters, Adapters): Stainless Steel (e.g., 455 H1050, 17-4 PH H1050, ASTM F899 17-4 PH)
  • Weight:
    • Sterilizable Battery: 404.1 g
    • Aseptic Battery: 501.6 g
    • HAMMR Instrument Tray: 3.4 lb (7.5 Kg)
    • HAMMR Instrument Tray Lid: 0.9 lb (2.0 Kg)
    • Populated Tray (Tray + Lid + Instruments): up to 24.7 lbs (11.2 Kg)
  • Environmental Conditions:
    • Operation Temperature: 68 °F (20 °C) to 75.2 °F (24 °C)
    • Storage Temperature: 5 °F (-15 °C) to 140 °F (60 °C)
    • Operation Relative Humidity: 20% to 60%
    • Storage Relative Humidity: 30% to 85%
    • Altitude (Pressure): ≤2,000 m (80KPa) for both operation and storage.
    • Pollution Degree: 2 for both operation and storage.

Usage Features:

  • Battery Connection: The HAMMR Impaction Hand Piece is switched on by plugging a charged battery into its handle connector. The energy selector must be in the "0" position before attaching the battery. The device performs an automatic system check upon power-up.
  • Battery Removal: To switch off, the battery must be unplugged from the hand piece. The energy selector should be in the "0" position before removal.
  • Energy Level Control: The energy selector allows for precise control of impact energy (Low, Medium, High). Position "0" disables the trigger. It is recommended to start with the lowest energy level (level 1) and increase as needed.
  • Attachment Connection: Adapters are inserted into the chuck and locked by turning the collar chuck until symbols match. Verification of secure connection is crucial before use.
  • Attachment Disconnection: Unlocking the chuck by turning the collar and pulling the attachment away.
  • Broach Connection/Disconnection: Broaches are inserted into adapters by pressing them into the adapter interface and closing the release lever. Disconnection involves opening the release lever and pulling the broach away.
  • Two-Handed Operation: The device must be operated with two hands for safety: one hand holding the handle and pressing the trigger, and the other supporting the device.
  • Patient Environment: All described parts are suitable for use within the patient environment.
  • Contraindications: Contraindicated for use with the size 7 Echo® Bi-Metric® Full Length High Offset stem (REF: 192107).

Maintenance Features:

  • Cleaning and Sterilization:
    • Manual Cleaning: Required to remove gross debris, blood, and stains. Involves preparation with enzymatic detergent, rinsing, soaking with soft clothes, brushing critical areas, and flushing cannulas. Followed by rinsing with purified water, drying, and inspection.
    • Automated Cleaning (for Adapters): After manual cleaning, adapters are placed in the tray for an automated washer/disinfector cycle, including pre-wash, enzyme spray/soak, multiple rinses, detergent wash, thermal rinse, and hot air dry. The Impaction Hand Piece itself is not intended for automatic washing.
    • Steam Sterilization (Storage): The Impaction Hand Piece and attachments are sterilized using a Dynamic-air-removal (Pre-vac) Steam Sterilization Cycle. Components are placed in the specified sterilization tray, double-wrapped, and processed at 132 °C for 4 minutes with a 45-minute drying time.
    • Immediate Use Steam Sterilization (IUSS): For immediate use, devices can be sterilized without wrapping at 132 °C for 4 minutes with no dry time.
    • Cooling: After sterilization, the HAMMR equipment must be allowed to cool to room temperature to prevent performance decrease, sterility compromise, or burns. Rapid cooling techniques are prohibited.
  • Visual Inspection: Prior to surgery and after any maintenance, the HAMMR handpiece and attachments must be visually inspected for signs of wear and damage (fractures, deformation, surface damage, chuck loosening, discoloration, corrosion, marking damage, leakage, particle release, overheating, adapter damage, internal loose particles, handle gasket protrusion).
  • Functionality Check: Prior to each use, a functionality check is recommended. This includes verifying the energy selector in "0" position, connecting a charged battery, observing the motor's self-check, and testing the trigger for impact delivery in "0" position. Forward and reverse impact tests are performed at different energy levels by pressing/pulling the chuck against a stable surface and activating the trigger.
  • Servicing:
    • Avoid rough handling and disassembly. The unit is factory sealed with no user-serviceable parts.
    • Servicing and repairs must be performed by Zimmer Biomet authorized service centers.
    • The HAMMR Impaction Hand Piece must be returned sterilized every 3 months for inspection and preventive maintenance.
    • If any functionality checks fail or damage is observed, the device must be removed from service and returned for inspection/repair.
    • For returns, a Return Goods Authorization (RGA) number is required in the U.S.A. The instrument must be cleaned, sterilized, and properly packaged.
  • Battery Disposal: Lithium-Ion batteries must be disposed of by a qualified recycler or hazardous materials handler, not with solid waste.
  • Electromagnetic Compatibility (EMC): The device complies with EMC criteria. Users should be aware of potential interference with other medical equipment and maintain separation distances as recommended in the manual. Not suitable for use in the presence of flammable anesthetic or gasses.

Zimmer Biomet HAMMR Specifications

General IconGeneral
BrandZimmer Biomet
ModelHAMMR
CategoryMedical Equipment
LanguageEnglish

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