BIOMET SpinalPak Complete Manual And Package Insert - Page 7

Browse online or download pdf Complete Manual And Package Insert for Fitness Equipment BIOMET SpinalPak. BIOMET SpinalPak 10 pages. Non-invasive spine fusion stimulator system
Also for BIOMET SpinalPak: Patient Manual (12 pages)

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Treatment Completion

Therapeutic treatment should not be suspended until fusion occurs or until

such time as a determination is made by the prescribing physician that no

progression to fusion is occurring. The device is programmed to deliver 270

continuous days of therapeutic treatment and automatically discontinues

operation after the 270 days.

Patient Compliance Monitoring

The Biomet

SpinalPak

Stimulator contains embedded software which allows the display of patient

specific history 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 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.)

Symbol Description

Attention see instructions

Alternating Current

Direct Current

Type B

Storage/Transport

temperature limits

Class II

Non Sterile

NON

STERILE

Manufacturer

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

cleaning products or detergents.

WEEE

Single Patient Use/

Prescription Only

Rx only

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.

SpinalPak

Stimulator System. Do not use