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BioMetric SpinalPak Complete Manual
Summary of SpinalPak
Page 1
Biomet ® spinalpak ® non-invasive spine fusion stimulator system complete manual and package insert.
Page 2: Table Of Contents
1 table of contents system contents .....................................................................................................................1 important safeguards .........................................................................................................2 biomet ® spinalpa...
Page 3: System Contents
1 system contents • electrodes - soft touch ® - 72r • electrodes - soft touch ® - lt-4500 • charger cradle • rechargeable battery packs (2) • electrode covers • stimulator • device holster • lead wires - 20” lead wire and 48” lead wire • patient manual • complete manual and package insert • a/c adap...
Page 4: Important Safeguards
2 3 important safeguards read all instructions before using save these instructions when using electrical products, basic safety precautions should always be followed, including: attention: to reduce the risk of electric shock, fire or injury: 1. Do not use this product while bathing, showering or s...
Page 5: Biomet
2 3 biomet ® spinalpak ® non-invasive spine fusion stimulator system caution: federal law (u.S.A.) restricts this device to sale by or on the order of a physician. Rx only. 2 this device is not intended for re-sale or re-distribution. Single patient use. Description the biomet ® spinalpak ® non-inva...
Page 6: System Components
4 5 system components battery pack and battery charger the biomet ® spinalpak ® non-invasive spine fusion stimulator system includes two rechargeable battery packs. Upon receipt, it is recommended that the second battery pack be immediately placed into the charger cradle and fully charged. In the me...
Page 7
4 5 full prescribing information indications for use the biomet ® spinalpak ® non-invasive spine fusion stimulator system is a noninvasive spine fusion stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. Warnings cardiac pacemakers o...
Page 8: Directions For Use
6 7 directions for use recommended usage the biomet ® spinalpak ® non-invasive spine fusion stimulator system is designed to deliver 270 days of continuous therapeutic treatment for 24 hours per day. The recommended daily therapeutic treatment is continuous for 24 hours. Operating instructions the b...
Page 9: Operating Instructions
6 7 operating instructions both battery packs provided with the biomet ® spinalpak ® non-invasive spine fusion stimulator system are charged prior to being packaged and distributed. Upon receipt of the biomet ® spinalpak ® non-invasive spine fusion stimulator system, it is recommended that the secon...
Page 10
8 9 step 2: changing battery packs each day, preferably at the same time to ensure treatment is continued without interruption, patients should do the following: a. Depress the latch (1) on the battery door and slide down the battery door on the back of the stimulator (2) and remove the depleted bat...
Page 11: Button Functions
8 9 button functions alarm on/off button the biomet ® spinalpak ® non-invasive spine fusion stimulator system is activated as soon as a charged battery pack is inserted. The button located below the lcd display enables or disables the audible alarm. During an alarm condition, depressing the button q...
Page 12: Treatment Completion
10 11 treatment completion therapeutic treatment should not be suspended until fusion occurs or until such time as a determination is made by the prescribing physician. The device is programmed to deliver 270 continuous days of therapeutic treatment and automatically discontinues operation after the...
Page 13: Symbol Description
10 11 attention see instructions alternating current direct current type b storage/transport temperature limits class ii non sterile manufacturer weee single patient use prescription only warning: the concomitant use of the stimulator and a pacemaker or cardioverter must be assessed by a cardiologis...
Page 14: Table 1
12 13 rf emissions cispr 11 electromagnetic compatibility a. The use of accessories, cables or replacement parts other than those supplied by biomet may result in increased emissions or decreased immunity of the equipment or system. B. This equipment should not be used adjacent to or stacked upon ot...
Page 15: Table 2
12 13 guidance and manufacturers declaration - electromagnetic immunity the biomet ® spinalpak ® non-invasive spine fusion stimulator system is intended for use in the electromagnetic environment specified below. The customer or the user of the biomet ® spinalpak ® non-invasive spine fusion stimulat...
Page 16: Table 3
14 15 guidance and manufacturers declaration - electromagnetic immunity the biomet ® spinalpak ® non-invasive spine fusion stimulator system is intended for use in the electromagnetic environment specified below. The customer or the user of the biomet ® spinalpak ® non-invasive spine fusion stimulat...
Page 17: Table 4
14 15 recommended separation distances between portable and mobile rf communications equipment and the biomet ® spinalpak ® non-invasive spine fusion stimulator system the biomet ® spinalpak ® non-invasive spine fusion stimulator system is intended for use in an electromagnetic environment in which ...
Page 18: Storage And Handling
16 17 patient counseling information the patient should be thoroughly instructed on how to properly use and care for the biomet ® spinalpak ® non-invasive spine fusion stimulator system and receive the patient manual, which provides detailed instructions. A summary of the key points in the patient l...
Page 19: Notes:
16 17 notes:.
Page 20: Options
Options the industry’s most comprehensive options: • pemf, cc and dc • anatomy specific coils • wear-time choice evidence • backed by proven science • multiple scientific papers • the proof is in the patient experience recognized as an industry pioneer with ebi lineage, biomet has helped over one mi...