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Zimmer Biomet OrthoPak, Полное руководство

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Important Safeguards

READ ALL INSTRUCTIONS BEFORE USING

SAVE THESE INSTRUCTIONS
When using electrical products, basic safety precautions should always be followed:

ATTENTION: To reduce the risk of electric shock, fire or injury:
  1.   Do not use this product while bathing, showering or swimming.
  2.   Do not place or store this product where it can fall or be pulled into a tub or sink.
  3.   Do not immerse the stimulator, battery charger or battery pack in water or any liquid.
  4.   Do not reach for this product if it has fallen into water. Unplug from the wall outlet immediately.
  5.   Do not permit the battery charger to be connected to the stimulator when wet.
 6.   Do not touch the battery pack contacts when the battery charger is plugged into an outlet.
  7.   Never operate the battery charger if it has a damaged power cord, plug or if it is not working 

properly. Do not use if it has been dropped and damaged, or immersed into water. Contact 
Zimmer Biomet for return instructions.

  8.   Do not attempt to charge any other type of battery pack in the Biomet

®

 OrthoPak

®

 Non-invasive 

Bone Growth Stimulator System battery charger.

  9.   Keep all cords away from heated surfaces.
10.    Never insert 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

®

 OrthoPak

®

 Non-invasive Bone Growth Stimulator System has no installation, 

periodic maintenance requirements or user serviceable parts. If any of the replacement parts are 
damaged they must be replaced by Zimmer Biomet in order to avoid a hazard.

14.   Do not short circuit, overcharge, crush, mutilate, nail penetrate, heat, reverse the + or - 

terminals or disassemble the battery pack. Do not allow metal objects to come into contact with 
the battery pack terminals. These and any other abuses of the battery pack may cause serious 
injury and/or burns. To ensure proper charging and safety, use only the charger supplied with 
your device. Keep battery pack dry. This battery pack must be disposed of properly. Disposal 
information can be obtained by contacting the Rechargeable Battery Recycling Corporation 
(RBRC) at 1-800-822-8837 in the US. 

NOTE: Inside the United States call Zimmer Biomet at 1-800-526-2579 or 1-973-299-9300  
if calling from outside the United States with any questions or problems. 

Содержание OrthoPak

Страница 1: ...Biomet OrthoPak Non invasive Bone Growth Stimulator System Complete Manual and Package Insert ...

Страница 2: ...ded 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...

Страница 3: ...rger Cradle Rechargeable Battery Packs 2 Electrode Cover Patches Stimulator Device Holster Lead Wires 20 Lead Wire and 48 Lead Wire Patient Manual Complete Manual and Package Insert A C Power Adapter Extremity Band Cast Windowing Kit ...

Страница 4: ...r insert 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 OrthoPak Non invasive Bone Grow...

Страница 5: ...ing 3 7 VDC 800 mAh Do not use the rechargeable battery pack supplied with this system in any other device Use of Biomet OrthoPak Non invasive Bone Growth Stimulator System battery pack in any other device may cause damage or malfunction to the battery pack and or devices System Components STIMULATOR The Biomet OrthoPak Non invasive Bone Growth Stimulator System operates on a rechargeable battery ...

Страница 6: ... state Solid green Solid orange Fully charged battery pack Solid green Solid green A C power deficiency Off Off Error Solid green Off FOLLOWING ARE POSSIBLE ERROR CONDITIONS AND POSSIBLE RESOLUTIONS Error Conditions flashes orange Possible Resolutions Battery pack not properly connected to the charger Remove and re install the battery pack to ensure complete connection to the charger Battery tempe...

Страница 7: ...d and should not be permitted as this may compromise the effectiveness of the treatment The safety and effectiveness of the use of the device on individuals lacking skeletal maturity has not been established In the presence of a maligned nonunion careful consideration on the use of this device must be undertaken on an individual basis as treatment with this device is not yet intended to alter or a...

Страница 8: ... or a combination of both Such a reaction generally may be resolved spontaneously following diagnosis and correction of the underlying cause Operating Instructions RECOMMENDED USAGE The Biomet OrthoPak Non invasive Bone Growth 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 h...

Страница 9: ...to the stimulator Remove the current battery pack from the stimulator and place that battery pack in the charger cradle for recharging 3 Following arrows install the battery pack into the battery charger cradle as illustrated 1 Lightly press down on battery pack to ensure contact 2 A solid orange light on the charger cradle will illuminate indicating battery is installed and charging properly 5 Wh...

Страница 10: ...ttery compartment an LED light will blink and sound a beep indicating power and closing the battery door 1 2 3 Insert the uncharged battery pack into the battery charger cradle by pushing it onto the charger cradle 1 Lightly press down on the battery pack to ensure contact 2 1 Depress the battery door latch 1 and slide down the battery door on the back of the stimulator 2 and remove the depleted b...

Страница 11: ...LARM ON OFF BUTTON The Biomet OrthoPak Non invasive Bone Growth 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 quickly 0 5 seconds will temporarily disable the audible alarm Depressing the button for a longer period of time 3 seconds will togg...

Страница 12: ...aphic assessment select the axis around the fracture nonunion for the placement of electrodes Placement of the electrodes in the anteroposterior mediolateral or any axis around the area of the fracture nonunion is at the discretion of the physician Electrodes should be placed so that they transmit minimal stimulation through scar tissue are convenient to access for replacement and are least likely...

Страница 13: ...o the lead wire Insert the lead wire plug into the jack at the top of the stimulator shown in Figure 6 If the stimulator is functioning properly the stimulator display will indicate Figure 7 This means that the electrodes are properly applied the battery is functioning and the device is delivering therapeutic current If the device is not functioning properly an audible alarm and LED light will app...

Страница 14: ...lected fracture site Templates are labeled TEMPLATE FOR WINDOWING CAST CUT ALONG OUTSIDE EDGE WITH CAST CUTTING TOOL Figure 9 Utilizing standard cast cutting tool cut out window along edges of the template guide This will assure proper sizing of cast window Figure 10 Trim cast padding and stocking material to provide direct skin access for the electrodes Following directions on electrode package p...

Страница 15: ...ulator Mounting Options Patients have several options for mounting the stimulator at the waist Figure 17 1 The stimulator can be kept in a shirt or pants pocket 2 The stimulator can also be placed in the holster The holster has a clip on the back of it which allows the patient to wear it on their waistband or belt The holster also allows the patient to clip the stimulator to the extremity band The...

Страница 16: ...story data including usage and therapeutic treatment times This data may be downloaded to a personal computer for viewing storage and or print out via the use of Biomet Compliance Data Download Software Please call your local Zimmer Biomet representative to obtain more information Symbol Condition Instructions Treating Continue use Audible alarm If beeping depress the button briefly to silence the...

Страница 17: ...has not been established Symbol Description 2 Rx only Ordering Information To order supplies contact Zimmer 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 items patient home MD office etc Equipment Classification Stimulator Internally powered by rechargeable batter...

Страница 18: ...nce and manufacturer s declaration electromagnetic emissions The Biomet OrthoPak Non invasive Bone Growth Stimulator System is intended for use in the electromagnetic environment specified below The customer or the user of the Biomet OrthoPak Non invasive Bone Growth Stimulator System should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidanc...

Страница 19: ...dance Electrostatic discharge ESD IEC 610004 2 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 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4...

Страница 20: ...c site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field streng...

Страница 21: ... 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 separation...

Страница 22: ... 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 14 The patient should be instructed to keep the audible alarm system engaged as often as practical and to reset the alarm system if it has been toggled to the disengaged position as soon as practical Bathing The patient should be i...

Страница 23: ... clear plastic backing liner 3 Wet finger with tap water and moisten entire gel area 4 Place electrode on skin 5 Connect electrode to electrode lead Renewal 1 With continuous use electrodes may dry out 2 To renew wet finger with tap water and moisten entire gel area 3 Reapply electrode to skin Store in a cool place Notes ...

Страница 24: ...helped over one million people To learn more about this product contact your local Zimmer Biomet Sales Representative today PN 1067799 00 Rev F Biomet OrthoPak Non invasive Bone Growth Stimulator System Complete Manual and Package Insert 399 Jefferson Road Parsippany NJ 07054 800 526 2579 zimmerbiomet com bonehealing BNS231000L 11 19 2019 Zimmer Biomet All rights reserved All trademarks are the pr...

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