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bioMetric SpinalPak, Complete Manual

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bioMetric SpinalPak Complete Manual Download Page 13

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 

 

cardiologist on an  

 

individual basis with an  

 

Electrocardiogram (EKG).

 

 

Caution: The safety of  

 

this device used during  

 

pregnancy and nursing  

 

in humans has not  

 

been established.

Symbol Description

Equipment Classification

•   Stimulator - Internally powered by rechargeable batteries 
•   Charger - Class II, Type B
•   Ordinary Equipment without protection against ingress of water
•   Equipment not suitable for use in presence of flammable anesthetic mixture with air or oxygen 
  or nitrous oxide. 
•   Mode of operation - continuous

Cleaning Instructions

Use a damp cloth for cleaning any part of the Biomet

®

 SpinalPak

®

 Non-invasive Spine Fusion 

Stimulator System. Do not use cleaning products or detergents. 

2

Rx only

Summary of Contents for SpinalPak

Page 1: ...Biomet SpinalPak Non invasive Spine Fusion Stimulator System Complete Manual and Package Insert ...

Page 2: ...dverse Effects 5 DIRECTIONS FOR USE 6 Recommended Usage 6 OPERATING INSTRUCTIONS 6 7 CHARGING THE BATTERY PACK 7 8 BUTTON FUNCTIONS 9 LCD SYMBOL DESCRIPTION AND INSTRUCTIONS 9 TREATMENT COMPLETION 10 PATIENT COMPLIANCE MONITORING 10 ORDERING INFORMATION 10 ELECTRODE INSTRUCTIONS FOR USE 10 SYMBOL DESCRIPTION 11 EQUIPMENT CLASSIFICATION 11 CLEANING INSTRUCTIONS 11 ELECTROMAGNETIC COMPATIBILITY 12 1...

Page 3: ...ft 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 Adaptor ...

Page 4: ...nsert any foreign object into any opening of the system 11 Do not expose the stimulator or the battery charger to prolonged heat or direct sunlight Normal operating temperature range is 5 C to 38 C 41 F to 100 F normal storage transport temperature is 15 C to 50 C 5 F to 122 F 12 Use this product only for its intended use as described in this manual 13 The Biomet SpinalPak Non invasive Spine Fusio...

Page 5: ...3 7 VDC 800 mAh Do not use the battery pack supplied with this unit in any other device Use of the Biomet SpinalPak Non invasive Spine Fusion Stimulator System battery pack in any other device may cause damage or malfunction to the battery pack and or device System Components STIMULATOR The Biomet SpinalPak Non invasive Spine Fusion Stimulator System operates on a rechargeable battery pack which a...

Page 6: ...The LT 4500 electrodes have black writing on their packaging The 72R electrodes have a hydrogel that is stickier than the LT 4500 electrode hydrogel The patient can use whichever electrodes best suit their skin type Electrode Covers The electrode covers are water resistant and are intended to enhance electrode security to the skin if needed or for showering with the electrodes attached if desired ...

Page 7: ...dividuals are unknown spondylitis infection Paget s disease cancer diabetes mellitus renal disease trauma of the lumbar spine osteoporosis Apply the electrodes after the skin has been cleaned and dried If erythema develops at the electrode sites the electrodes should be relocated adjacent to the original sites If the reaction does not resolve after 48 hours after relocating the electrodes the pati...

Page 8: ...bility to move after surgery it may be helpful for the patient to ask another person to assist them in placing the electrodes See instructions for use on Page 10 The patient should consult their prescribing physician or Biomet if they have any questions or concerns regarding proper electrode placement If their skin becomes abnormally red at the electrode sites the electrodes should be moved adjace...

Page 9: ...tem Figure 4 The LED light on top of the device will blink indicating power Each symbol will be indicated on the display and the alarm will flash and beep if the electrodes are not properly applied To silence the audio alarm press the button below the display If the light does not blink which indicates that the battery pack is not charged change the battery pack See Charging the Battery Pack below...

Page 10: ...appears the battery pack is fully charged Remove the battery pack 1 2 from the battery charger cradle with a gentle lift on the battery tab Figure 9 and place the fully charged battery pack into the Biomet SpinalPak Non invasive Spine Fusion Stimulator System in order to commence treatment D There should always be one battery pack in the charger and one battery pack installed in the stimulator at ...

Page 11: ... to audible alarm Press the button below the display on the front of the stimulator to silence the alarm After silenced the light will continue to flash and the display will indicate the alarm condition Symbol Condition Instructions Treating Continue use Audible alarm If beeping depress the button briefly to silence the alarm Depress the button approximately 3 seconds to engage or disengage the au...

Page 12: ...via the use of Biomet Compliance Data Download Software Please call your local Biomet representative to obtain more information Ordering Information To order supplies contact Biomet See page 2 Important Safeguards for contact information The following information is necessary to expedite any inquiry Patient name Physician name Address to send replacement parts patient home MD office etc Electrode ...

Page 13: ...vice used during pregnancy and nursing in humans has not been established Symbol Description Equipment Classification Stimulator Internally powered by rechargeable batteries Charger Class II Type B Ordinary Equipment without protection against ingress of water Equipment not suitable for use in presence of flammable anesthetic mixture with air or oxygen or nitrous oxide Mode of operation continuous...

Page 14: ...s 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 Stimulator System should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance Group 1 The Biomet SpinalPak Non invasive Spine Fusio...

Page 15: ...agnetic environment guidance Electrostatic discharge ESD IEC 610004 2 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 Not Applicable Surge IEC 61000 4 5 Not applicable Voltage dips short interruptions and voltage variations on power supply inp...

Page 16: ...usion Stimulator System is used exceeds the applicable RF compliance level the Biomet SpinalPak Non invasive Spine Fusion Stimulator System device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Biomet SpinalPak Non invasive Spine Fusion Stimulator System b Over the frequency range 150 kHz ...

Page 17: ...imum power output of the communications equipment Rated maximum output power of transmitter W Separation distance meters according to frequency of transmitter 150 kHz to 80 MHz d 3 5 P 80 MHz to 800 MHz d 3 5 P 800 MHz to 2 5 GHz d 7 P 0 01 35 35 7 0 1 1 1 1 1 2 21 1 3 5 3 5 7 10 11 06 11 06 22 13 100 35 35 70 For transmitters rated at a maximum output power not listed above the recommended separa...

Page 18: ... adjacent to the original sites The patient should be evaluated periodically to assess the skin for sensitivity Alarms See LCD Symbol Descriptions and Instructions page 9 The patient should be instructed to keep the audible alarm system engaged as often as practical and to engage the alarm system if it has been disengaged as soon as practical Bathing The patient should be instructed to disconnect ...

Page 19: ...17 Notes ...

Page 20: ...eage Biomet has helped over one million people To learn more about this product contact your local Biomet Sales Representative today PN 1067795 00 Rev D Biomet SpinalPak Non invasive Spine Fusion Stimulator System Complete Manual and Package Insert 399 Jefferson Road Parsippany NJ 07054 800 526 2579 www biomet com BNS231002L 11 13 2013 EBI LLC All trademarks are the property of Biomet Inc or one o...

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