Cincinnati Sub Zero Blanketrol Iii User Manual

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Cincinnati Sub-Zero - Blanketrol II The Blanketrol II offers the largest heater and highest flow rates of any hyper-hypothermia system providing a fast respon. OPERATION AND TECHNICAL MANUAL. BLANKETROL III MODEL 233 FEATURES. Cincinnati Sub-Zero Products, Inc.

Class 2 Device Recall 115 V Blanketrol II, Model 222S HyperHypothermia System Date Initiated by Firm January 08, 2014 Date Posted June 10, 2014 Recall Status Terminated on June 06, 2014 Recall Number Z-1679-2014 Recall Event ID 510(K)Number Product Classification - Product Code Product 115 V Blanketrol II, Model 222S Hyper-Hypothermia System. Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer.

Part number 86165. Code Information Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703.Part # 86165 Recalling Firm/ Manufacturer Cincinnati Sub-Zero Products Inc 12011 Mosteller Rd Cincinnati OH For Additional Information Contact Mrs. Tener 513-772-8810 Ext.

5295 Manufacturer Reason for Recall The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode.

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The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but FDA Determined Cause Mixed-up of materials/components Action The firm initiated a telephone notification on, followed by a written notification which was sent to the customers via letter or email on. URGENT Medical Device Field Action (January 31, 2014) REF: 115V Blanketrol II Model 22S Hyper-Hypothermia System (1) Discontinue Use and contact CSZ (2)Upon receipt of new 115V (p/n 91113) solenoid coil(s), immediately remove and destroy/discard all the affected 220V (p/n 3600) solenoid coil(s) (3)After the affected 220V (p/n 36007) solenoid coil(s) have been removed, discard and replaced, please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to imform CSZ that you have performed and completed the requested actions. Return the form by fax Quantity in Commerce 7 units Distribution The product was distributed to one customer in MI, and internationally (Taiwan) Total Product Life Cycle 1 A record in this database is created when a firm initiates a correction or removal action.

The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see.

User

510(K) Database.

FEATURES. Preset-Variable and Programmable Variable Gradient temperature selection is available in both heating and cooling mode which allows for rapid or gradual patient temperature management control. A new feature, SMART mode, associated with the term gradient setting is to have the ability for the BIII to adjust the gradient temperature settings of 5°C should you not reach your desired patient temperature within 30 minutes.

Blanketrol Iii User Manual

The Blanketrol III continues to monitor and adjust temperature every 30 minutes until your desired patient temperature is reached. SPECIFICATIONS Height 37.5 in Length 17 in Weight 122 lbs Width 17 in Additional Specifications Fluid Temperature Range: 4°C to 42°C (39.2°F to 107.6°F) Patient Temperature Set Point Range: 30°C to 40°C (86°-104°F) Flow Rate 32 gph (121.1 lph) with blanket, approx.