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General Information
Cautions
Inspect the circuit every day to ensure that there is no damage or wear that could affect its
•
performance. Remove fluid or other biological material from the circuit or replace the
circuit following the local standard of care.
Federal law restricts this device to sale by or on the order of a physician.
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Only qualified biomedical equipment technicians should service the device.
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Internal components are susceptible to damage from static discharge. Do not remove device
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covers.
Possession or purchase of this device does not convey any expressed or implied license to
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use the device with unauthorized sensors or cables which would, alone, or in combination
with this device fall within the scope of one or more of the patients related to this device.
ZOLL cannot ensure the proper functioning of this device if it is used with unauthorized
sensors, cables, or patient circuits.
FDA Tracking Requirements
U.S. Federal Law (21 CFR 821) requires the tracking of ventilators. Under this law, owners
of this ventilator must notify ZOLL Medical Corporation if this product is
Received
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Lost, stolen, or destroyed
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Donated, resold, or otherwise distributed to a different organization
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If any such event occurs, contact ZOLL Medical Corporation in writing with the following
information:
Originator's organization – Company name, address, contact name, and contact phone
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number
Model number, and serial number of the ventilator
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Disposition of the ventilator (for example, received, lost, stolen, destroyed, distributed to
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another organization), new location and/or organization (if known and different from
originator's organization) – company name, address, contact name, and contact phone
number
Date when the change took effect
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Please address the information to:
ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-04105
Fax: (978) 421-0007
Telephone: (978) 421-9655
1-14
www.zoll.com
9650-002360-01 Rev. A
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