Intended Use - Thermo Scientific Isotemp -86 C Freezers Assembly, Installation And Operation

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The contacts will trip in the event of a power outage, high
temperature alarm, low temperature alarm or door ajar alarm.

Intended Use

The –86°C Freezers (refer to Models for the specific model
series) described in this manual are intended for the storage
of Frozen Red Blood Cells in 40% Glycerol at –65°C for up to
10 years; Frozen Rejuvenated Red Blood Cells at –65°C for
up to 10 years; Fresh Frozen Plasma at –65°C for up to 10
years.
These products are suitable for Vaccine and Pharmaceutical
Storage when –50°C to –86°C is determined as an
acceptable storage condition.
These products should only be used by an authorized and
adequately trained personnel. It is considered a medical
device and has therefore been listed with medical device
regulatory body FDA and is considered a Class II Medical
Device by the FDA. This product is listed under product code
KSE, Regulation Number 864.9700 and is considered 510(K)
exempt. This unit is not intended for use in classified
hazardous locations, nor to be used for the storage of
flammable inventory.
Reference: AABB - Technical Manual 17th Ed., page
273,274.
8 |
Installation
Isotemp -86°C Freezers

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