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Fax: 732-605-1631

General Warning

  • Physician and health care personnel must be trained, Read and understand the GSV200.DBL manual before using the device to ensure patient and operator safety.
  • Do not attempt to service any part of this product except by specialist and no modification of this equipment is allowed.
  • Check the GSV200.DBL for any rough or sharp edges and any fatigue crack in the ratchet spring beforeusing and verify its proper functional condition.
  • Make sure GSV200.DBL is in correct position providing space for front incisors.
  • GSV200.DBL is provided with safety pin to prevent uninstall of ratchet spring lock.
  • Uninstalling ratchet spring lock can lead to breakage with partial loss of function however, operator can continue intubation procedure and return the device tospecialist for repair.
  • Cleaning, disinfecting and sterilization instructions are provided in this manual.
  • The operator is responsible to make sure that any connection to externalelectric operated devicesthat may connect to theGSV200.DBL follows electric isolation and groundingrequirement of IEC60601-1 to prevent Leakage currentwhich can be additive.
  • Do not recharge DVR battery during device use. This may lead to hazardousdischarge causing decrease in safety to patient or operator.
  • The handle battery MC2 Charger is not to be used by individuals (including children) with reduced physical, sensory or mental capabilities, or lack of experience and knowledge, unless they have been given supervision or instruction.
  • MC2 is compatible with two Sanyo UR14650P 3.7 V 940 mAh rechargeable lithium-ion handle batteries. Do not Attempt to charge other battery types, which may be hazardous and can damage the battery and charger.
  • Do not leave handle battery MC2 charger unattended andmust only be powered from an external device that provides a SELV output. A SELV output is a Safety Extra-Low Voltage output that provides the enough isolation and a low enough voltage that it does not represent a shock hazard.
  • Do not disassemble MC2 charger, keep MC2 charger away from water and excessive heat.
  • If battery runs out of power or software freezes during intubation, the individual performing the intubation should immediately focus on completing with direct visual intubation and follow difficult airway intubation algorithm.
  • There is a reset capability to refresh device OS and return to service if the device is not charging or not functioning.
  • Replacement ofDVR battery by inadequately trained personnel could result in a hazardous(excessive temperatures, fire or explosion) and the device must be return for battery replacement by trained specialist.
  • The GSV200.DBL is not defibrillator proof and is not intended to use in conjunction with cardiacdefibrillator.
  • USA federal law restricts the use of this device to saleby or in order of physicians.