Monitored Therapeutics GoSpiro Spirometer - Unapproved Accessory Warning; Unsafe Interconnection Warning; Turbine Handling Caution; Charging Alignment Caution

Monitored Therapeutics, Inc. © Copyright 2020 7 P/N 45-50035 Rev. K, 2020-10-21
WARNING: Do not use accessories not described in this manual.
WARNING: It is unsafe to interconnect this GoSpiro device to other equipment not
described in this manual.
CAUTION: Do not force the turbine beyond the 90 degree position when inserting or
removing the turbine from the GoSpiro housing as it can break the locking tabs. Note
the direction of insertion and removal for left or right hand use. See Section 8
Getting Started for more information.
CAUTION: The charging station is keyed to assure alignment of the GoSpiro with its
charging connection. Do not force the GoSpiro into the charging station.
WARNING: Avoid exposing the GoSpiro to direct sunlight, dusty conditions, damp
environments, heating appliances or radiators as these conditions can affect the
performance or the life expectancy of the GoSpiro.
WARNING: Do not use the GoSpiro in a moving vehicle. Use in a moving vehicle
may result in inaccurate results.
WARNING: Only IEC 60601-1 or IEC 60950-1 certified products should be used with
the GoSpiro charging station or for data collection.
CAUTION: Keep the GoSpiro dry. The limited Ingress Protection (IP22) rating of the
GoSpiro case will not prevent damage from water making contact with case, leaking
into the case and damaging the electronics.
CAUTION: Children under the age of 10 may require parental assistance to perform
tests or operate a tablet or smartphone application.
PLEASE NOTE: The product you have purchased should not be disposed of as
unsorted waste. Please utilize your local EPA or WEEE collection facilities for the
disposal of this product.
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
WARNING: If the GoSpiro is used for more than one patient without a mouthport
filter, the turbine assembly should be replaced or undergo high level disinfection before
use on another patient to prevent infection.
WARNING: Medication decisions should be only under the direction of a physician.
WARNING: The GoSpiro should not be used for more than an accumulated use of 24
hours (approximately 1400 testing sessions) on a single patient. It is expected that the
GoSpiro will typically be used about 1 time per week for 1 minute per testing session.