Table of Contents
SYSTEM CONTENTS ............................................................................................................................. 1
IMPORTANT SAFEGUARDS ................................................................................................................. 2
THE BIOMET
®
ORTHOPAK
®
NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM ......................... 3
• Description ................................................................................................................................... 3
• Electrical Requirements for Battery and Charger .......................................................................... 3
SYSTEM COMPONENTS .................................................................................................................... 3,4
FULL PRESCRIBING INFORMATION .................................................................................................. 5,6
• Indications For Use, Contraindications, Warnings, Precautions, Adverse Effects ..................... 5,6
OPERATING INSTRUCTIONS ....................................................................................................... 6,7,8,9
• Recommended Usage .................................................................................................................. 6
• STEP 1: Battery Pack Charging ................................................................................................. 6,7
• STEP 2: Preparing the System to Begin Treatment ...................................................................... 8
• STEP 3: Recharging the Battery Pack ........................................................................................... 9
BUTTON FUNCTION .............................................................................................................................. 9
• Alarm On/Off Button ..................................................................................................................... 9
DIRECTIONS FOR USE ...................................................................................................... 9,10,11,12,13
LCD SYMBOLS DESCRIPTION AND INSTRUCTIONS ......................................................................... 14
TREATMENT COMPLETION ................................................................................................................ 14
PATIENT COMPLIANCE MONITORING .............................................................................................. 14
ORDERING INFORMATION ................................................................................................................ 15
EQUIPMENT CLASSIFICATION .......................................................................................................... 15
SYMBOL DESCRIPTION ...................................................................................................................... 15
CLEANING INSTRUCTIONS ............................................................................................................... 16
ELECTROMAGNETIC COMPATIBILITY ................................................................................. 16,17,18,19
PATIENT COUNSELING INFORMATION .............................................................................................. 20
STORAGE AND HANDLING ................................................................................................................ 20
DISPOSAL INSTRUCTIONS ............................................................................................................... 20
ELECTRODE INSTRUCTIONS FOR USE .............................................................................................. 21
