Intersurgical PMH7000 Скачать руководство пользователя страница 4

Instruction For Use                                                           PMH7000                                                         

       

Version 2

   

 
 

Revision 03                                                                  23 July 2019    

 

                                                   Page 4 of 20 

1.   Introduction 

1.1 Intended Use 

The Humidifier Heater Base PMH7000 is intended to add moisture and to warm the breathing gasses through ET tubes, 
Tracheostomy tubes or any NIV interface for any patient adult, paediatric or neonate who needs mechanical or positive 
pressure ventilation. 
 

1.2 Features of the device 

PMH7000 Humidifier base features a dual temperature servo control system, which regulates the temperature of the gas 
delivered to the patient and the gas at the outlet of the humidifying chamber. It continuously monitors temperatures using a 
platinum dual temperature probe.  The Humidifier base warms and humidifies the gas through the humidifier chamber and 
in addition a heated wire in the patient breathing circuit further controls and keeps the same gas warm.  The operator is 
allowed to set the temperature of the chamber outlet gas, which controls the gas humidity just before it is delivered to the 
patient.  Temperature is displayed on the front panel. 
 
A dual heated wire adaptor lead (REF 5601000)

 

is separately available for the PMH7000 Humidifier base, for use with a 

dual heated wire system, a single adaptor lead (REF 5600000) is available when using a single heated wire system.  
PMH7000 Humidifier base is equipped with alarms, which activate audible and visual indicators to alert the operator of 
adverse conditions.  Alarms are provided for high and low airway temperature, high and low chamber outlet temperature, 
dual temperature probe disconnect or fault condition, heated wire fault connection,

 

a light on the front panel identifies the 

area of alarm. 
 
Various safety monitoring functions are incorporated to detect and prevent the over-heated conditions which may affect the 
patient conditions or damage the unit itself.  For patient safety, alarm conditions continue for 10 minutes and the Humidifier 
base turns off unless set levels are achieved or adjusted by the operator.

 

2.  Safety Precautions 

The information provided in this manual should be read and fully understood before using the PMH7000 Humidifier base.  
The information applies to the Humidifier base as well as any optional equipment and accessories used with the device. 

 

 

2.1 Warnings, Cautions and Notes 

In this manual, a 

WARNING

 describes the actions necessary to prevent injury or loss of life.  A 

CAUTION

 describes the 

actions to be taken to protect the equipment from being damaged.  A 

NOTE

 contains precautions, procedures and actions. 

 

The principal WARNING and CAUTION notices to be observed during use of the PMH7000 are included in this 
section for emphasis. 

 

 

WARNING !  

FOR USE BY TRAINED PERSONNEL ONLY: The PMH7000 Humidifier base and accessories are 

designed for use by trained medical personnel acting under physician’s orders.  It is prohibited that anyone other than 
qualified medical personnel use these Humidifier bases. 

 

 

WARNING !  

OBSERVE BEST PRACTICE:  The instructions in this manual do not supersede established medical 

procedures or staff preferences concerning patient care.  “Best Practice” as determined by the medical community and/or 
individual institutions is always to be observed. 

 

 

WARNING !  

SETTING-UP:  Do not place the Humidifier base and the humidifying chamber higher than patient, 

otherwise, condensed water droplets may enter the patient airway. 

 

 

WARNING !  

SETTING-UP:  Do not fill the humidifying chamber above the maximum fill level.  Droplets of water may 

enter into the patient breathing system if the chamber is overfilled. 

 

 

WARNING !  

SETTING-UP:  Do not fill the chamber with distilled

 

water in excess of 30

C. 

 

 

WARNING !  

SETTING-UP:  Ensure that the water level in the chamber is correct before use. Failure to ensure correct 

water level in the chamber at start-up could result in the under humidification of the patient (see chamber IFU for details). 

 

 

WARNING !  

SETTING-UP:  Ensure that the dual temperature probes are inserted correctly into the breathing system 

ports as shown in diagrams on pages 17.  Failure to do so may result in gas delivery to the patient above 43

C.  Before 

connecting 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: Prior to the use of this Humidifier base, the user must be totally familiar with the use, 

application and safety procedures associated with this device. 

 

 

WARNING !

  OPERATION: Periodic checks of the temperature must be made to ensure that the temperature of the gas 

delivered to the patient is as set by trained medical personnel. Excessive heat delivered to the patient may cause harm to 
the airways and/or other hazards to the patient. 

Содержание PMH7000

Страница 1: ...03 23 July 2019 Page 1 of 20 Intersurgical Humidifier Heater Base PMH7000 Instructions for Use Distributed by Intersurgical Ltd Crane House Molly Millars Lane Wokingham Berkshire RG41 2RZ UNITED KING...

Страница 2: ...late Temperature 7 3 1 8 Heater Wire Resistance 7 3 2 Physical Dimensions 7 3 2 1 Size Without Humidification Chamber Installed 7 3 2 2 Weight 7 3 3 Environmental 7 3 3 1 Operating Temperature 7 3 3 2...

Страница 3: ...Left Side View 14 6 2 Left Side Panel Description 14 7 ASSEMBLY WITH BREATHING CIRCUIT 15 8 SET UP AND OPERATION OF THE HUMIDIFIER BASE 16 9 MAINTENANCE REPAIR 17 9 1 Basic Checks 17 9 2 Dual Tempera...

Страница 4: ...vice 2 1 Warnings Cautions and Notes In this manual a WARNING describes the actions necessary to prevent injury or loss of life A CAUTION describes the actions to be taken to protect the equipment fro...

Страница 5: ...n 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...

Страница 6: ...ing Radiation Power On Off IPPV Mode NPPV Mode Alarm Silencer Button Do not discard 3 Specifications WARNING EXPLOSIVE HAZARD Do not use this equipment in the presence of flammable gases or anaestheti...

Страница 7: ...10 to 95 Non condensing That includes the transportation time 3 3 5Atmospheric Pressure 700 to 1060 hPa 3 4 Electromagnetic Interference PMH7000 complies with limitations as specified in IEC 60601 1 2...

Страница 8: ...y network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declarat...

Страница 9: ...ordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess electromagnetic environment due to fixed RF...

Страница 10: ...0 Humidifier base incorporates a shunt fuse the PMH7000 is not compatible for use with electrical adaptors containing a shunt fuse 3 6 Settings for Ventilated Patients IPPV mode When the gas flow is i...

Страница 11: ...est and alarm sound test as well When it is turned off alarm sound verification will be activated only once in short time Note In order to verify the functionality of the alarm system during the power...

Страница 12: ...nk quickly in green and display patient temperature setting At this time temperature setting changes can be made by pressing up and down button Press the button once and the temperature value changes...

Страница 13: ...rmittently LED Dual temperature probe Flashes red The dual temperature probe 7700000 is disconnected or faulty in this case a high priority audible alarm sounds intermittently LED Heater plate Flashes...

Страница 14: ...Connector Temperature probe connecting port 3 Inspiratory Expiratory Heater Wire Connector Heated wire adaptor connecting port NOTE The power cord cannot be detached from the heater base The power co...

Страница 15: ...g port Patient side temperature sensor Connect to the patient side temperature sensor connecting port on the breathing circuit Heater wire connection Inspiratory side Connect the connector of inspirat...

Страница 16: ...connect the cloverleaf connector to inspiratory heated wire limb and oval connector to the expiratory heated limb When using a single heated wire systems connect the electrical adaptor 5600000 to the...

Страница 17: ...n the dual temperature probe is exchanged or replaced be sure to turn off the power of the Humidifier base After exchange or replacement re activate the Humidifier base 12 Safe Process to stop operati...

Страница 18: ...abnormal conditions during operation Each alarm shows the abnormal conditions by illuminating an LED on the front panel and sounding the alarm Alarm sound can be muted by the mute button for 2 minute...

Страница 19: ...e inter lock is activated It is locked when alarm state continues for 10 minutes Turn off the device and restart it The device is not powered on No 1 Device fused 2 Heater base fault 3 Overheat protec...

Страница 20: ...Instruction For Use PMH7000 Version 2 Revision 03 23 July 2019 Page 20 of 20...

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