BIOMET SpinalPak 전체 설명서 및 패키지 삽입물 - 페이지 3
{카테고리_이름} BIOMET SpinalPak에 대한 전체 설명서 및 패키지 삽입물을 온라인으로 검색하거나 PDF를 다운로드하세요. BIOMET SpinalPak 10 페이지. Non-invasive spine fusion stimulator system
BIOMET SpinalPak에 대해서도 마찬가지입니다: 환자 설명서 (12 페이지)
페이지 인쇄Important 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 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 the battery in water.
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 when wet.
6.
Do not touch the battery 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
Biomet for return instructions.
8.
Do not attempt to charge any other type of batteries in the Biomet
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
SpinalPak
®
Stimulator System has no installation, periodic maintainance
requirements or user serviceable parts. If any of the replacement parts are damaged they must
be replaced by 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. Do not allow metal objects to come into contact with the
battery terminals. These and any other abuses of the battery may cause serious injury and/or
burns. To ensure proper charging and safety, use only the charger supplied with your device.
Keep battery 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.
NOTE: Inside the United States call Biomet at 1-800-526-2579 or 1-973-299-9300 if calling from
outside the United States with any questions or problems.
®
SpinalPak
®
Stimulator
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Biomet
®
SpinalPak
®
Stimulator
Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order of a
physician. Rx Only.
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This device is not intended for re-sale or re-distribution.
DESCRIPTION
®
The Biomet
SpinalPak
®
Stimulator (Figure 1) promotes healing by inducing a low electrical current
at the fusion site. The therapeutic signal generates a low energy electrical field by passing a specific
current between the electrodes.
ELECTRICAL REQUIREMENTS FOR BATTERY AND CHARGER
Charger
Input: 88-240 VAC 50/60 Hz 6 W
Output: 12V DC 500mA
For use with the Biomet
®
SpinalPak
®
Stimulator battery only (PN 1067720).
Battery rating: 3.7 VDC > 600 mAh
Do not use the batteries supplied with this unit in any other device.
®
Use of the Biomet
SpinalPak
®
batteries in any other device may cause damage or malfunction to the
batteries and/or device.
System Components
STIMULATOR
Biomet
®
SpinalPak
®
The
Stimulator operates on a rechargeable battery, which allows for ambulatory use. It includes an
audible and visible self-checking alarm mechanism to alert the patient if it is not functioning properly. The
SpinalPak
®
Stimulator is designed to store the patient's daily therapeutic treatment data which may be downloaded and
read with the patient compliance software (See Patient Compliance Monitoring pg. 9). Patients are encouraged to bring
the stimulator to each follow-up visit with the prescribing physician to review how they are using their stimulator.
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Figure 1
Biomet
®