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General| Brand | bioMetric |
|---|---|
| Model | SpinalPak |
| Category | Medical Equipment |
| Language | English |
Explains the Biomet SpinalPak system's function in promoting healing via low electrical current.
Details input/output specs for the charger and battery rating for the stimulator system.
Describes the stimulator's operation, battery use, alarms, and data storage capabilities.
Details the two rechargeable battery packs, their charging process, and LED indicators.
Lists potential error conditions for the battery pack and their corresponding resolutions.
Covers electrodes, electrode covers, device holster, and lead wires included with the system.
Specifies the Biomet SpinalPak system's indication as an adjunct electrical treatment for lumbar spinal fusion surgery.
Alerts to potential adverse effects on pacemakers and risks for pregnant women.
Outlines precautions for individuals with specific medical conditions and general device handling.
Reports skin irritation as the most common adverse event observed in a clinical study.
States the system is designed for 270 days of continuous 24-hour therapeutic treatment.
Provides guidance on electrode placement, lead wire connection, and troubleshooting common issues.
Details the first step of inserting a charged battery pack into the stimulator and checking the LED indicator.
Instructs to attach electrodes following specific placement instructions from page 10 and page 6.
Details the procedure for charging the battery pack using the cradle and AC adapter.
Details how to depress the latch, slide the door, and remove/insert battery packs.
Explains how the charger indicates a full charge and how to remove the charged pack.
Emphasizes maintaining one battery pack charged in the charger and one in the stimulator at all times.
Explains the function of the button below the LCD display for controlling the audible alarm.
Details symbols on the LCD, their conditions, and instructions for response.
Emphasizes the criticality of device use and care compliance for proper function and effective treatment.
Instructs patients to insert a fully charged battery pack into the stimulator every 24 hours.
Instructs patients on replacing electrodes and cleaning electrode sites prior to application.
Guides patients to examine skin for irritation and relocate electrodes if present.
Advises patients to keep the audible alarm engaged and to re-engage it if disengaged.
Instructs patients to disconnect the stimulator during bathing, showering and reconnect afterward.
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