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Instruction For Use
PMH7000
Version 2
Intersurgical
Humidifier Heater Base PMH7000
Instructions for Use
Distributed by:
Intersurgical Ltd, Crane House, Molly Millars Lane, Wokingham,
Berkshire, RG41 2RZ, UNITED KINGDOM
T: +44 (0) 118 9656 300
www.intersurgical.com
Revision 03
23 July 2019
Page 1 of 20
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Summary of Contents for Intersurgical PMH7000
- Page 1 PMH7000 Version 2 Intersurgical Humidifier Heater Base PMH7000 Instructions for Use Distributed by: Intersurgical Ltd, Crane House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UNITED KINGDOM T: +44 (0) 118 9656 300 www.intersurgical.com Revision 03 23 July 2019 Page 1 of 20...
- Page 2 Instruction For Use PMH7000 Version 2 Table of Contents INTRODUCTION ---------------------------------------------------------------------------- 4 Intended Use ------------------------------------------------------------------------------------------------------------- 4 Features of the device------------------------------------------------------------------------------------------------- 4 SAFETY PRECAUTIONS ---------------------------------------------------------------- 4 Warnings, Cautions and Notes ------------------------------------------------------------------------------------- 4 Symbols -------------------------------------------------------------------------------------------------------------------- 6 SPECIFICATIONS -------------------------------------------------------------------------- 6 Power Requirements -------------------------------------------------------------------------------------------------- 6 3.1.1...
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Page 3: Table Of Contents
Instruction For Use PMH7000 Version 2 Other Functions ------------------------------------------------------------------------------------------------------- 13 SIDE PANEL ------------------------------------------------------------------------------- 14 Left Side View ---------------------------------------------------------------------------------------------------------- 14 Left Side Panel Description --------------------------------------------------------------------------------------- 14 ASSEMBLY WITH BREATHING CIRCUIT ---------------------------------------- 15 SET UP AND OPERATION OF THE HUMIDIFIER BASE-------------------- 16 MAINTENANCE &... - Page 4 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.
- Page 5 Instruction For Use PMH7000 Version 2 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.
- Page 6 Instruction For Use PMH7000 Version 2 CAUTION ! Contact your sales provider for all technical support and services. 2.2 Symbols The labels or labelling for this product have the following symbols. Please read description below Symbols: Type BF IPX1...
- Page 7 700 to 1060 hPa 3.4 Electromagnetic Interference PMH7000 complies with limitations as specified in IEC 60601-1-2 for Medical Products. The function of this machine may be adversely affected by the operation of other equipment, such as high frequency surgical diathermy equipment, short wave therapy equipment, defibrillators or MRI equipment, if located nearby. Place the Humidifier base away from the above devices which may give adverse affect to the function of the Humidifier base.
- Page 8 ・ The device may be affected by other portable and mobile RF communication equipments. Guidance and manufacturer’s declaration – electromagnetic emissions The PMH7000 is intended for use in the electromagnetic environment specified below. The customer or the user of the PMH7000 should assure that it is used in such an environment.
- Page 9 To assess electromagnetic environment due to fixed RF transmitters, an electromagnetic sites survey should be considered. If the measured field strength in the location in which the PMH7000 is used exceeds the applicable RF compliance level above, the PMH7000 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PMH7000.
- Page 10 Patient systems, chambers, adaptor leads and dual temperature codes commercially available from other manufacturers have not been fully validated. As the PMH7000 Humidifier base incorporates a shunt fuse, the PMH7000 is not compatible for use with electrical adaptors containing a shunt fuse.
- Page 11 Instruction For Use PMH7000 Version 2 5. Front Panel 5.1 Front Panel View 5.2 Front Panel Power Button Temperature Display Mode Change Mode Display LED Scroll Button Set (temperature in manual mode) Button “°C” Display Status Indication LED ⓐ Patient Side LED ⓑ...
- Page 12 Instruction For Use PMH7000 Version 2 Mode Change: “IPPV” mode is set as a default when the unit is delivered out from factory. Keep pressing the “MODE” button for 2 seconds, it changes with following order: IPPV→NPPV→MANUAL, so select necessary mode.
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Page 13: Other Functions
If the heater plate temperature exceeds +130C, a thermostat will cease the power supply to the circuit, and stop operation. At that time, all displays are cleared, and the unit is not active. Warning ! Under such condition, stop using the PMH7000 Humidifier base and contact your sales provider immediately for assistance. Revision 03... -
Page 14: Side Panel
Instruction For Use PMH7000 Version 2 6. Side Panel 6.1 Left Side View 6.2 Left Side Panel Description Power Cord Plug: to be connected AC power supply Probe Connector : Temperature probe connecting port Inspiratory / Expiratory Heater Wire Connector: Heated wire adaptor connecting port NOTE: The power cord cannot be detached from the heater base. -
Page 15: Assembly With Breathing Circuit
Instruction For Use PMH7000 Version 2 7. Assembly with Breathing Circuit As the preparation before use, the assembly process of breathing circuits is explained. ① Refer to the breathing circuits assembling illustration, assemble breathing circuits. ② Temperature probe or temperature probe connection * Chamber outlet side temperature sensor: Connect to the chamber outlet side temperature probe connecting port. -
Page 16: Set Up And Operation Of The Humidifier Base
Instruction For Use PMH7000 Version 2 8. Set up and Operation of the Humidifier base Position the Humidifier base Mount the heater base using appropriate bracket and make sure the heater base is placed lower than patient position. Placing Chamber Before placing the chamber onto the heater base, check the base unit and the chamber for damage. -
Page 17: Maintenance & Repair
PMH7000 Version 2 Turn on PMH7000 power button. Heater base displays “88.8” and all LED’s are activated, alarm sounds for 2 seconds then will revert to display the previous setting for temperature (patient side and chamber side). When it does not function as described, turn off the power and remove heater base from breathing circuit and contact your Sales provider for assistance. -
Page 18: Reprocessing
Instruction For Use PMH7000 Version 2 10. Reprocessing PMH7000 humidifier bases and accessories should be cleaned, disinfected and sterilized according to the instructions in the Cleaning, Disinfection and Sterilization Manual before use. Components and Autoclave Cleaning and Disinfectant ETO Gas Material @ 55°C... -
Page 19: Compliant Accessories
Instruction For Use PMH7000 Version 2 Heater Wire Connection 1) Heater Wire is not connected. 1) Connect the heater wire firmly. Icon 2) Heater Wire has come-off or 2) Replace the heater wire. (Heater wire abnormal: short-circuited. Flashes red) Temp Probe Connection 1) Dual Temp Probe is not 1) Connect the dual temp probe firmly. - Page 20 Instruction For Use PMH7000 Version 2 Revision 03 23 July 2019 Page 20 of 20...
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