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       Technical Features


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Technical Data


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One Patient-Warming Solution for the Entire Perioperative Journey


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Key Information
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Discover the Nova™ system firsthand, at your facility.
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Find out what makes the Nova™ system your best alternative to forced-air warming.
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Find out what the science says about the Nova™ system and patient warming.
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The Nova system comes with everything your patient needs to prevent hypothermia:

 

Upper body blanket
Lower body blanket
Smart cable
Control unit
Power cable

 

Upper body blanket
Lower body blanket
Smart cable
Control unit
Power cable

 

See the entire Nova™ system in action.

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Nova: Frequently Asked Questions

Will I be electrocuted if I disconnect the blanket while the unit is still on?
NO. The NOVA system is certified and meets all the required standards for safety in a medical electrical device.  For a patient warming system these are: 
  • ANSI/AAMI ES60601-1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
  • IEC 60601-1-2 3rd Ed (2007) Medical Electrical Equipment – Part 1-2: General requirements for safety –Part 1-2: Collateral Standard: Electromagnetic disturbances - Requirements and tests for General Medical Equipment.
  • IEC 80601-2-35 Edition 2.1 2016-04 Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use.
  • To further assure the safe use of the NOVA Patient Warming System, Arc Potential testing in accordance with NFPA 70E and IEEE 1584 was conducted by a 3rd Party on the system, the Flash Hazard Safety rating of -0- is acceptable for use in the blankets
Can I place the NOVA blanket directly on the patient’s skin?

The inner face (blue side) of the blanket can come into contact with the patient’s skin.  The blankets meet the required standards for surface contact of a device, these are: 

  • IOS10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
  • ISO10993-10 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization.
What happens if the blanket gets wet or cut? Is there a risk for electrocution?

No risk for electrocution. 

  • If the blanket gets wet -Turn off controller unit, wipe off wet area on blanket.  If moisture is observed on or near the cable connection to the controller, remove the blanket from use and replace. 
  • If the blanket gets cut - The side rails of the blanket provide a connection for powering the blanket.  If the side rails are cut there is no electrical risk however, the product performance will be compromised.  Turn off the controller unit and remove from use and replace.  
What will happen if the connector plate gets saturated with fluid?

This may cause the product performance to be compromised. Turn off control unit, wipe off wet area on blanket, remove blanket from use and replace.

What will happen if the control unit gets saturated with fluid (ex. 1 liter IV bag pouring on unit)?

Turn off control unit, wipe off wet area.  If moisture is observed on or near any cable connection to the controller, remove the controller from use to avoid any damage to the unit and return to Encompass Group LLC. for inspection and assessment.

Note: The control unit meets the electrical safety requirements for a medical device, but ingress is rated as IPXO – Wipe down only. 

What will happen if the control unit gets dropped from a carrying height or if the IV clamp was not tightened all the way on the IV pole?

It may crack or malfunction.  It would be wise to replace the controller in the environment of use.  

  • At the healthcare facility potential damage can be assessed with BioMed away from use or proximity to the patient. 
  • An assessment routine appears on pages 17-19 of the NOVA IFU.  Follow the sequence to determine if the control unit is working properly.  If there is any unresolved questions or concern, return the control unit to Encompass Group LLC. for inspection and assessment. IMPORTANT: There are no serviceable parts in the control unit or blanket(s).
Is the unit safe to use with equipment that requires grounding (ex. Bovie)?
YES.  The control unit system is grounded with an internal equipotential ground.
What is the voltage of the box and connector?

The control unit is rated at 110-120 VAC, 50-60Hz, 350 VAC Peak.

Can I strap the patient’s arms down over the blanket?

Strapping the arm down may be similar to folding. We have not tested for this and would not recommend it be done while the blanket is turned on and active.

Always strap the patient’s arm under the product not on top of the product.

Why is the connector plates located where they are?

Close proximity to the edge of the blanket facilitates easy access and connection/disconnection of the SMART Cable connector. This positioning also eliminates any cable to be extended across the patient.  

Is there any risk in disrupting or interfering with Evoked Potential testing or any electrical interference with pace maker etc.?

NO. The system is grounded with an internal equipotential ground.

The system meets the requirement under IEC-60601-1-2 3rd Ed (2007) Medical Electrical Equipment – Part 1-2: General requirements for safety –Part 1-2: Collateral Standard: Electromagnetic disturbances - Requirements and tests for General Medical Equipment.

Can this be used as an underbody blanket?
NO. The NOVA blankets are not intended for use for under the body.
  • The thermistor located in the approximate center of either blanket is sensitive.  The incremental weight of a person on a blanket may trigger false readings subsequent to poor system performance. 
  • The NOVA blankets have not been tested for pooling of fluids which can result when an underbody blanket is used. 
  • Refer to section 2.4 and 2.5 of the IFU on pages 7 & 8 for a complete listing of warnings and precautions.
Can I tie the arms of the upper body blanket down over the patient to hold in place?

NO.  The blanket can be fastened under the arm boards by connecting the edges in the passive section together.

Can the product be folded distally to access IV lines or line placement while the unit is on? This would require folding the product on to itself distally for an extended period of time. Are there any risk/concerns?

NO. The control unit should always be turned off prior to any folding scenario.  It should never be active with a fold back as false readings and subsequent patient warming could be adversely affected.  If folding is necessary, turn control unit off or place in standby mode.

  • Refer to section 2.4 and 2.5 of the IFU on pages 7 & 8 for a complete listing of warnings and precautions.
If the unit alarms/shuts off due to over temp will it turn back on once an acceptable temp is reached?

NO.  Alarm conditions and troubleshooting are found on page 17 of the IFU.  

Can I use the upper body blanket if the patient’s arms are at their side (the blanket would be hanging over the edges of the table and not touching the patient)?
YES.