Intersurgical PMH7000, Instructions For Use Manual

Page: 5 / 20

Instruction For Use PMH7000 Version 2
Revision 03 23 July 2019 Page 5 of 20

WARNING ! OPERATION: Before connecting the breathing system to the patient, ensure the ventilator or gas delivery
device is operating properly and check the flow rate and pressure levels are functioning correctly.

WARNING ! OPERATION: If the room temperature is lower than the Humidifier base patient set temperature, there may
be an increase in condensation in the patient breathing system. A build up of excess fluid in the system should be
monitoring carefully at all times.

WARNING ! OPERATION: Please keep watching and checking the water level in the humidification chamber.

WARNING ! OPERATION: Do not use Humidifier base without gas flow. If gas flow is interrupted or significantly
decreased, turn off the Humidifier base until the gas flow has resumed and stabilised.

WARNING ! EXPLOSIVE HAZARD: Do not use this equipment in the presence of flammable gases or anaesthetic
gases.

WARNING ! EXPLOSIVE HAZARD: Do not use this equipment in an OXYGEN RICH ENVIRONMENT; for example
during hyperbaric oxygen therapy. It could lead to an explosion.

WARNING ! BURN HAZARD: Do not touch the heater plate of the humidifier base and metal edge of the chamber until
it has been given sufficient time to cool. The heater plate and metal edge of the chamber can achieve temperatures
above 85

C immediately after use.

WARNING ! BURN HAZARD: Do not cover patient circuit with insulated materials, such as sheets, towels or blankets,
as it may cause the circuit to be overheated. Patient or operator contact with the circuit may result in burns. To protect the
patient from burns, the p
atient circuit should not be in contact with the patient’s skin. Also, a distorted circuit could cause
flow disruption.

WARNING ! ALARMS: If an alarm condition cannot be identified the humidifier base should be turned off immediately
and the humidifying chamber should be removed from the patient system. Some alarm conditions can cause patient
injury if not acted upon.

WARNING ! ALARMS: No alarms sound or alarm location lights on the front panel can be activated while the system is
shut down or while the protective thermostat is activated.

WARNING ! RECOMMENDED ACCESSORIES: Use accessories (humidifying chambers, patient systems, heater wire
and other accessories) recommended by the manufacturer. Patient systems, chambers and adaptor leads commercially
available from other manufacturers have not been fully validated.

WARNING ! SHOCK HAZARD: A shock hazard may exist if this system is not properly grounded. The system is
designed to operate with a 3-wire AC power source containing a separate ground wire. The grounding wire must not be
removed or cut off. Grounding reliability can be assured only if connected correctly to the receptacle [hospital
specification] with proper grounding.

WARNING ! CLEANING AND CARE: As a general safety precaution, the unit must turn off and AC power must
disconnect before performing any cleaning or maintenance procedures.

WARNING! SERVICE AND/OR MAINTENANCE: Service and/or maintenance should be performed by an authorized
and fully trained technician familiar with the device, please contact your sales provider

WARNING ! Never use this device with an HME (Heat and Moisture Exchanger) or HMEF (Heat and Moisture Filter).

WARNING ! Humidifier bases and dual temperature probes must be cleaned before use in line with this manual
’s
section 10. Reprocessing. Dual temperature probes are not clinically clean when shipped.

WARNING ! DO NOT IMMERSE, STERILIZE or AUTOCLAVE the humidifier base.

WARNING ! Refer to the specifications of humidifying chamber and patient breathing circuits concerning the maximum
operating pressure.

WARNING ! If this Humidifier base is used outside the specified operating temperature, it may lead to an inadequate
warming/humidifying capability. Contact your sales provider for advice.

WARNING ! The operator, should not touch the temperature probe connector and the patient simultaneously.

WARNING ! No modification of this equipment is allowed.

CAUTION ! U.S. Federal Law restricts the sale of this device to or on the order of a licensed physician.