Instructions for Use
20 Pages
Preview
Page 1
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
Instruction For Use
PMH7000
Version 2
Table of Contents 1.
INTRODUCTION ----------------------------------------------------------------------------4
1.1
Intended Use ------------------------------------------------------------------------------------------------------------- 4
1.2
Features of the device------------------------------------------------------------------------------------------------- 4
2.
SAFETY PRECAUTIONS ----------------------------------------------------------------4
2.1
Warnings, Cautions and Notes ------------------------------------------------------------------------------------- 4
2.2
Symbols -------------------------------------------------------------------------------------------------------------------- 6
3.
SPECIFICATIONS --------------------------------------------------------------------------6
3.1 Power Requirements -------------------------------------------------------------------------------------------------- 6 3.1.1 Operating Voltage ------------------------------------------------------------------------------------------------- 6 3.1.2 Line Frequency ----------------------------------------------------------------------------------------------------- 6 3.1.3 Power Consumption----------------------------------------------------------------------------------------------- 6 3.1.4 Current Rating ------------------------------------------------------------------------------------------------------ 6 3.1.5 Heater Plate Power------------------------------------------------------------------------------------------------ 6 3.1.6 Heater Wire Power ------------------------------------------------------------------------------------------------ 7 3.1.7 Heater Plate 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 Storage Temperature --------------------------------------------------------------------------------------------- 7 3.3.3 Operating Relative Humidity ------------------------------------------------------------------------------------ 7 3.3.4 Storage Relative Humidity --------------------------------------------------------------------------------------- 7 3.3.5 Atmospheric Pressure -------------------------------------------------------------------------------------------- 7 3.4
Electromagnetic Interference --------------------------------------------------------------------------------------- 7
3.5
Compliant Accessories --------------------------------------------------------------------------------------------- 10
3.6
Settings for Ventilated Patients ---------------------------------------------------------------------------------- 10
3.7
Capacity of Humidifying Chamber ------------------------------------------------------------------------------ 10
4.
TEMPERATURE -------------------------------------------------------------------------- 10
4.1
Set Temperature Range--------------------------------------------------------------------------------------------- 10
4.2
Temperature Display------------------------------------------------------------------------------------------------- 10
5.
FRONT PANEL ---------------------------------------------------------------------------- 11
5.1
Front Panel View ------------------------------------------------------------------------------------------------------ 11
5.2
Front Panel -------------------------------------------------------------------------------------------------------------- 11
5.3
Front Panel Functional Description ---------------------------------------------------------------------------- 11
Revision 03
23 July 2019
Page 2 of 20
Instruction For Use
5.4
6.
PMH7000
Version 2
Other Functions ------------------------------------------------------------------------------------------------------- 13
SIDE PANEL ------------------------------------------------------------------------------- 14
6.1
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 Temperature Probe Check---------------------------------------------------------------------------------- 17
10.
REPROCESSING ------------------------------------------------------------------------- 18
11.
REPAIR -------------------------------------------------------------------------------------- 18
12.
DISPOSAL ---------------------------------------------------------------------------------- 18
13.
TROUBLE SHOOTING ------------------------------------------------------------------ 18
14.
COMPLIANT ACCESSORIES -------------------------------------------------------- 20
Revision 03
23 July 2019
Page 3 of 20
Instruction For Use
PMH7000
Version 2
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 30C. 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 43C. 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. Revision 03
23 July 2019
Page 4 of 20
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. 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 85C 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 patient 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. Revision 03
23 July 2019
Page 5 of 20
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 Applied Part
Consult instruction for use
Authorized Representative In The European Community
IPX1 Drip Proof
Serial Number
Alternating Current
Date of manufacture
CAUTION Electrical Shock Hazard Refer to qualified service personnel
Nonionizing Radiation
Power On/Off
WARNING Hot surfaces may exceed 85°C
IPPV Mode
Protective Earth (Ground)
NPPV Mode
Manufacturer
Alarm Silencer Button
Do not discard
3. Specifications WARNING! EXPLOSIVE HAZARD: Do not use this equipment in the presence of flammable gases or anaesthetic gases. Electric Shock Classification: Class I, type BF Applied Part Protection against Water Classification: IPX1 Mode of Operation Classification: Continuous Operation
3.1 Power Requirements The Humidifier base is set for the correct voltage at the factory prior to shipment, but before connecting to AC power, ensure that the voltage label shows the correct setting.
3.1.1 Operating Voltage 230V
3.1.2 Line Frequency 230V - 50Hz
3.1.3 Power Consumption 250 VA Maximum
3.1.4 Current Rating 230V - 1.1A
3.1.5 Heater Plate Power 150 Watts
3.1.6 Heater Wire Power Inspiratory 44 Watts (Max. DC24V, 1.8A), regulated Revision 03
23 July 2019
Page 6 of 20
Instruction For Use
PMH7000
Version 2
Expiratory 44 Watts (Max. DC24V, 1.8A), regulated
3.1.7 Heater Plate Temperature 115C Thermostat regulated (normal operation) 130C Thermostat limited (AC power disabled)
3.1.8 Heater Wire Resistance 11 to 50 Ω (ohms)
3.2 Physical Dimensions 3.2.1 Size (Without Humidification Chamber Installed) Height - 145mm / Width - 140mm / Depth - 180mm
3.2.2 Weight 1.7 kg. (approx.)
3.3 Environmental For stand and pole use, the PMH 7000 is designed to be fixed with a bracket, and should be used in the upright position. Do not use the complete system in a location with high temperature or high humidity. If the Humidifier base is reclined more than the tolerance of 20 degree in any direction, the Humidifier base must not be used. Do not close or obstruct any of the air venting on the base unit as this may cause overheating. It is recommended to keep the gas inlet temperature in a range of ± 1C of the room temperature.
3.3.1 Operating Temperature 20C to 26C
(68F to 79F)
3.3.2 Storage Temperature -20C to 60C
(-4F to 140F)
3.3.3 Operating Relative Humidity 30 to 75%
Non-condensing
3.3.4 Storage Relative Humidity 10 to 95%
Non-condensing. That includes the transportation time.
3.3.5 Atmospheric Pressure 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. ■ About EMC (Electromagnetic Compatibility) EMC means that the subjective devices shall comply with the following Requirements. ・ There should be no noise disturbances over the tolerance emitted from the device, which affect the function of neighbouring equipment. (Emission) ・ The device shall be made durable with the electromagnetic environment such as against the noise emitted from neighbouring equipment and shall be operated in normal function. (Immunity) EMC standards representing IEC 60601-1-2 specifies the following. 1) To keep the level of affection under the tolerated level to other equipments by the noise emitted from the device itself. 2) To keep the level of affection to the device itself by electromagnetic frequency of other equipments (like mobile phone) under tolerated level.
Revision 03
23 July 2019
Page 7 of 20
Instruction For Use
PMH7000
Version 2
As there is requirement under IEC 60601-1-2: 2007 that the detailed information on EMC environmental conditions shall be provided to the user so as to make the device being operated safely, the technical explanation relating EMC standards are described below. (For further details, please refer to IEC 60601-1-2: 2007). ■ Technical Information on EMC (Electromagnetic Compatibility) Electro-medical equipment requires an adequate attention to EMC standard and specifications, and shall be used under the following instructions.
NOTE: ・ The device requires an adequate attention to EMC standards and specifications, and shall be used under the EMC information described in this section. ・ 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. Emission test Compliance Electromagnetic environment - guidance RF emissions Group 1 The PMH7000 uses RF energy only for its internal function. Therefore, its RF emission are very low and are not likely to cause CISPR 11 any interference in nearby electronic equipment. RF emissions Class B The PMH7000 is suitable for use in all establishments, including domestic establishments and those directly connected to the public CISPR 11 low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/ flicker emissions
Complies
IEC 61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity 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. IEC 60601-1 test Compliance Immunity test Electromagnetic environment - guidance level level Electrostatic Floor should be wood, concrete or ceramic tile. ±6kV contact ±6kV contact discharge(ESD) If floors are covered with synthetic material, ±8kV air ±8kV air the relative humidity should be at least 30%. IEC 61000-4-2 Electrical fast transient / Mains power quality should be that of a typical ±2kV for power ±2kV for power burst commercial or hospital environment. supply lines supply lines IEC 61000-4-4 Surge
±1kV for input/output lines ±1kV line(s) to line(s)
N/A*
±2kV line(s) to earth <5% UT (>95 % dip in UT) for 0.5 cycle
±2kV line(s) to earth <5% UT (>95 % dip in UT) for 0.5 cycle
40% UT (60 % dip in UT) for 5 cycle
40% UT (60 % dip in UT) for 5 cycle
70% UT (30 % dip in UT) for 25 cycle
70% UT (30 % dip in UT) for 25 cycle
<5% UT (>95 % dip in UT) for 5s
<5% UT (>95 % dip in UT) for 5s
±1kV line(s) to line(s)
Mains power quality should be that of a typical commercial or hospital environment.
IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Revision 03
23 July 2019
Mains power quality should be that of a typical commercial or hospital environment. If the user of the PMH7000 requires continued operation during power mains interruptions, it is recommended that the PMH7000 be powered from an uninterruptible power supply or battery.
Page 8 of 20
Instruction For Use
Power frequency (50/60Hz) magnetic field
PMH7000
3A/m
3A/m
Version 2
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
IEC 61000-4-8 Portable and mobile RF communications equipment should be used no closer to any part of the PMH7000 including cables, than the recommended separation distance calculated from the question applicable to the frequency of the transmitter. Recommended separation distance
Conducted RF
3Vrms
IEC 61000-4-6
150kHz to 80 MHz
Radiated RF
3V/m
IEC 61000-4-3
80MHz to 2.5GHz
3V
d =1.2√P
3V/m
d =1.2√P d =2.3√P
80MHz to 800MHz 800MHz to 2.5GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) 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 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. b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
N/A: not applicable, this test item does not have to be performed. *The test on signal ports is not applicable since the signal cables are not longer than 3m according to the manufacturer’s specification. Recommended separation distances between portable and mobile RF communications equipment and the PMH7000 The PMH7000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PMH7000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PMH7000 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output m power of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz W d = 1.2√P d = 1.2√P d = 2.3√P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 Revision 03
23 July 2019
Page 9 of 20
Instruction For Use
PMH7000
Version 2
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
3.5 Compliant Accessories Dual temperature probe (REF 7700000) and single heated wire adaptor lead (REF 5600000) or dual heated wire adaptor lead (5601000). 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.
3.6 Settings for Ventilated Patients IPPV mode: When the gas flow is in the range of 10L/min to 60L/min, an absolute humidity of at least 33mg/L is delivered. NPPV mode: When the gas flow is in the range of 10L/min to 60L/min, an absolute humidity of at least 10mg/L is delivered.
3.7 Capacity of Humidifying Chamber Effective capacity of humidifying chamber is less than 500mL.
4. Temperature The airway temperature and chamber temperature are servo controlled by the Humidifier base.
4.1 Set Temperature Range Patient Side Chamber Side
30°C to 40°C 26°C to 43°C
(increments 1°C) (increments 1°C) Temperature setting of patient side vs. chamber side temperature is in relationship within the range of -4°C to +3°C.
4.2 Temperature Display Patient side temperature or chamber side temperature is displayed by switching using , which is displayed in Chapter 5.1 while operated in manual mode. Patient Side Temperature Display Range 10°C to 47°C increments 0.1°C Chamber Side Temperature Display Range 10°C to 45°C increments 0.1°C
Revision 03
23 July 2019
Page 10 of 20
Instruction For Use
PMH7000
Version 2
5. Front Panel 5.1 Front Panel View
a
b c
d e
5.2 Front Panel 1 2 3 4 5 6 7 8
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 ⓑ Chamber Outlet Side LED ⓒ Heater Wire LED ⓓ Temp. Probe ⓔ (Unit Fault ) LED Alarm Silencer Button
9
5.3 Front Panel Functional Description 1
Power Button: Power can be turned on/off by pressing this button for more than 1 second. While it is turned on, it activates all the initial check-up which include CPU and temperature displays, all the LED test, 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 on self-test, the operator should check that all LED lights, and that the buzzer sounds.
2
Temperature Display: 2-1
The display normally shows either chamber outlet temperature or patient temperature whichever is selected. Opposite selection can be made by holding ▲ (Up) button when turning ON the device. LED ⓐ lights in green: indicating patient side temperature. LED ⓑ lights in green: indicating chamber side temperature. To briefly display the opposite temperature, hold button ⑨ (ALM) for 2 seconds, the display indicates the opposite side temperature and then the display returns to the original display conditions automatically after 10 seconds.
Revision 03
23 July 2019
Page 11 of 20
Instruction For Use
3
4
5
6
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. Mode Display LED: IPPV→NPPV→MANUAL IPPV Mode: This mode is for patients with a tracheal tube. The preset for the patient side is 40C and chamber side is 37C automatically. NPPV Mode: This mode is for patients with NIV (Non Invasive Ventilation) masks. The preset for the patient side is 34C and chamber side is 31C automatically. MANUAL mode: This mode allows the selection of optional temperature of both patient side and chamber side. (Refer to 5 for the details.) On selecting MANUAL mode, a sound confirmation will be activated and the display will show the set patient temperature and then the currently set chamber side temperature for approximately 2 seconds each as confirmation of the initial setting. After 2 seconds, LEDⓐ, ⑧ status indication, blinks in green, and the patient side temperature can be set. Temperature setting can be changed by ⑤ scroll button. While pressing ⑥ “Set” button, operate ⑤ scroll button to set the chamber side temperature. If you do not make changes for 10 seconds, the unit will return to the normal state, and display will be as selected. *Patient side: 30°C to 40°C (increments 1°C) *Chamber side: 26°C to 43°C (increments 1°C) *Temperature setting of patient side vs. chamber side temperature is in relationship within the range of 4°C to +3°C. *The pre-set temperatures are 37C at chamber side and 37°C at patient side when the unit is shipped out from the factory. Refer to ⑤ section for how to change pre-set value. Scroll Button: ▲up ▼down In “MANUAL” mode, these buttons allow the user to change the temperature setting of both patient side and chamber side. Press either ▲up or ▼down button for more than 2 seconds, patient icon will blink 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 1°C. Holding the button will not change the temperature value continuously. Warning ! Rain out in the patient circuit will increase when room temperature is lower than patient side set temperature. Status Indication LED: There are 5 LED indicators showing position around the heater base and breathing system on a diagram on the front panel. 1. In normal operation the temperature shown in main display (2) is measured from the point indicated by LED ⓐ (patient temperature) or LED ⓑ (chamber temperature) whichever is illuminated in green. 2. On entering manual mode the temperature shown in display (2) will be the patient temperature when LED ⓐ is blinking green and chamber temperature when LED ⓑ is blinking. To change temp see section 5 3. Illuminated LED shows location of the fault, as detailed below. LED ⓐ Patient Temperature Flashes red - the measured temperature has exceeded the set temperature by 2C, or exceeded a maximum temperature of 43C (in this case there is a high priority audible alarm and the heated wire is turned off). Flashes red - Patient Probe temperature has not increased by >2C in 2 minutes after Power-on (in this case there is a high priority audible alarm). Flashes yellow – the measured temperature is 4C below the set temperature (in this case a medium priority audible alarm sounds intermittently). Note: this alarm is disabled while the Humidifier base warms up
LED ⓑ Chamber temperature Flashes red - The measured temperature exceeds the set temperature by 4C for more than 20 minutes, or the measured temperature exceeds the set level by 10C (in this case there is a high priority audible alarm and the heated wire is turned off). Flashes yellow – the measured temperature is 4C below the set temperature for more than 20 minutes, or the measured temperature is below the set temperature by 10C (in this case a medium priority audible alarm sounds intermittently). Note: this alarm is disabled while the Humidifier base warms up. Revision 03
23 July 2019
Page 12 of 20
Instruction For Use
PMH7000
Version 2
LED ⓒ Heated wire Flashes red – The heated wire is disconnected or faulty (in this case a high priority audible alarm sounds intermittently). 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 red - The measured chamber temperature does not rise more than 2C in 20 minutes from start up (in this case a high priority audible alarm sounds intermittently). Note: If an alarm state is left unresolved for 10 minutes, then the device displays “000”, and stops operating. The Humidifier base requires turning off and on again to resume operation. Note: To check the alarm status, operator should be located in the same room with the patient. Alarm Silence Button “ALM”: It mutes all audible alarms for 2 minutes. Mute will end after 2 minutes. If the alarm situation continues, the alarm will again sound intermittently after 2 minutes. If any new alarm condition occurs under the mute mode other than original alarm condition, the original mute mode will be invalid and the alarm will activate against the new alarm condition. Note: Pressing the “ALM” button for more than 2 seconds will switch the display After 10 seconds it will revert back and display airway temperature.
5.4 Other Functions Prevention of abnormal temperature rise. To prevent abnormal temperature rise, a thermal fuse is used for the safety of the power circuit. Should there be a shortcircuit due to some damage, the power will cease automatically. When the patient side temperature exceeds +43C, the patient icon LED (A) lights up in red and the alarm sounds intermittently. Then, a solid state relay (ssr) is activated and stops the temperature rise. 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 !
Revision 03
Under such condition, stop using the PMH7000 Humidifier base and contact your sales provider immediately for assistance.
23 July 2019
Page 13 of 20
Instruction For Use
PMH7000
Version 2
6. Side Panel 6.1 Left Side View
6.2 Left Side Panel Description 1 2 3
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. The power cord should only be replaced by an approved engineer at the facility where such engineer is stationed. Warning !
Revision 03
The Humidifier base cable should not be twisted during either connection or disconnection.
23 July 2019
Page 14 of 20
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. * Patient side temperature sensor: Connect to the patient side temperature sensor connecting port on the breathing circuit. ③ Heater wire connection * Inspiratory side: Connect the connector of inspiratory heater wire extension cord or inspiratory/expiratory heater wire extension cord to the inspiratory breathing circuit. * Expiratory side: When the dual heater wire breathing circuit is used, use the inspiratory/expiratory heater wire extension cord (optional item). Connect the connector to expiratory breathing circuit.
“Disposable Breathing Circuit Set-Up”
With Single Heater Wire
“Disposable Breathing Circuit Set-Up” With Dual Heater Wire
Revision 03
23 July 2019
Page 15 of 20
Instruction For Use
PMH7000
Version 2
8. Set up and Operation of the Humidifier base (1)
Position the Humidifier base Mount the heater base using appropriate bracket and make sure the heater base is placed lower than patient position.
(2)
Placing Chamber Before placing the chamber onto the heater base, check the base unit and the chamber for damage. a) Verify the heater base is clean and dry. Then, place the chamber on the heater base and make sure it sits properly on the housing as illustrated. b) Ensure the water feed is correctly assembled and positioned.
Note: When using auto fill chamber, first place the chamber and then connect sterile water pack. Warning! ◇ Do not fill with water hotter than 30C ◇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). ◇ Do not exceed maximum water level.
(3)
Attaching heater wire and dual temperature probe (a) Heater Wire When using dual heated wire systems connect electrical adaptor 5601000 to the electrical adaptor power outlet on heater base then 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 electrical power adaptor outlet on heater base then connect cloverleaf connection to the inspiratory heated wire limb. (b) Dual Temperature Probe Connect the dual temperature probe to the heater base unit and insert the temperature sensors in to the inspiratory limb ports as shown in diagram on page 15. Warning ! ◇ Ensure the dual temperature probe is fully inserted into the port. Otherwise it could cause an abnormal temperature reading. ◇ Prevent sensor portion of the dual temperature probe from being in contact with the heater wire. ◇ Do not place dual temperature probe into the incubator or in any other heated place. It may affect the temperature control.
(4)
Connect patient circuit to chamber Set up for single and dual heated wire systems shown on page 15.
(5)
Connect power cord to AC wall socket NOTE: Do not place the heater base on such a place where pushing in/out of the power cord plug is disturbed.
(6)
Turn on gas supply equipment (Ventilator) Connect the ventilator to the gas supply and turn on and carry out pressure testing applicable to the ventilator protocol. Warning ! Conduct pressure test of breathing circuit including chamber, before connecting the device to the patient.
Revision 03
23 July 2019
Page 16 of 20
Instruction For Use
(7)
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. A short alarm sound will be activated when Humidifier base is turned off. Warning ! ◇ Do not use a heater base that does not properly function until probable causes are resolved. ◇ Do not use device without gas flow. If gas flow is interrupted or significantly decreased, turn off the device until the gas flow has resumed and stabilised.
(8)
Select desired mode When “MANUAL” mode is selected, the factory setting is 37C at both patient side and chamber side. This value can be changed by following instructions, please refer to Section 5.3.3 for how to change the setting.
(9)
Connect to patient once the temperature has stabilized. Humidification will start approx. 10 minutes later with the entire warm up period taking 30 minutes to reach the setting temperature. The portion physically touching to the patient (applied part) is a breathing circuit. Remove chamber Chamber can be easily removed by pressing the lock bar as illustrated.
(10)
(11)
(12)
Exchange or replace the dual temperature probe When 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. Safe Process to stop operation Please follow below process for the operator to stop operation safety. 1) Remove the breathing circuit from the patient. 2) Press the power switch of the heater base for more than one (1) second to turn off the power. 3) Remove the power plug of the heater base from AC power supply. 4) Turn off the power switch of the gas supplying unit.
9. Maintenance & Repair 9.1 Basic Checks Visual inspection of the heater base and accessories should be performed monthly. Check the temperature probe sensors, temperature sensor cables, all unit cables and connectors, and the power cord. Damaged items should be replaced if necessary. For complete maintenance information, contact your sales provider.
9.2 Dual Temperature Probe Check It is recommended that the dual temperature probe be functionally tested on a routine basis (every 6 months) to ensure that it is operating properly. The following method is recommended: 1 2 3
Obtain a precision thermometer or other temperature measuring device accurate to within +/-0.5°C. Place the thermometer (or equivalent device) and both of the temperature sensors into a container of warm water (between 25°C and 45°C). Allow time for equilibration of the thermometer and the dual temperature probe. Connect the dual temperature probe to the heater base as recommended and turn the unit on. Compare temperature readings. The display should be within +/-1.5°C of the thermometer. If not, probe should be replaced.
Revision 03
23 July 2019
Page 17 of 20
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 Material Parts Sterilization Solution Dual Temperature Housing: Polycarbonate No Yes Probe Base Unit Housing: Polycarbonate No Yes ※ETO Gas Sterilization: Sterilization Time: 4 hours at 55°C, Aeration Time: min. 15 hours
ETO Gas @ 55°C Yes No
Note: CaviWipeTM (or equivalent) Disinfecting Towelettes to clean and disinfect all surfaces of the Humidifier base and Dual Temperature probe. Note: Ensure that the heater plate surface is clean and free from excessive abrasions. Warning ! DO NOT IMMERSE or STERILIZE main unit of PMH7000 Humidifier heater base. Warning ! DO NOT STERILIZE or AUTOCLAVE the heater base unit.
11. Repair Repair of the unit should be done only by a qualified technician. Please contact your sales provider if there are any problems.
12. Disposal Some authorities consider these materials are subject to special disposal. Contact your local authority for the detailed information.
13. Trouble Shooting The device has an alarm function, which shows any 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 minutes, but the LED will keep flashing until the alarm condition itself is removed. LED Indicator Alarm Possible Cause User Action Sound Patient Icon Yes 1) Patient temperature≧set value Confirm first that there is no problem (Abnormal high on setting and breathing circuit. If the +2°C temperature: Flashes alarm conditions are not restored, stop red) using the unit and contact your sales 2) No increase over +2°C in two provider minutes after power on Patient Icon (Abnormal low temperature :Flashes yellow)
Yes
1) Patient temperature≦set value -4C
Chamber Outlet Icon (Abnormal high Temperature: Flashes red)
Yes
1)
2)
Chamber Outlet Icon (Abnormal low Temperature: Flashes yellow)
Revision 03
Yes
1)
2)
Check dual temperature probe, and restore the alarm condition.
Chamber outlet temperature≧set value+ 4°C lasting for more than 20 minutes. Chamber outlet temperature reaches 10°C higher than set temperature.
Confirm that there is no problem with the setting. Review alarm conditions and restore. If the alarm conditions are not restored, stop using the unit and contact your sales provider for repair.
Chamber temperature≦set value -4°C lasting for more than 20 minutes. Chamber temperature reaches 10°C lower than the set temperature.
Confirm the conditions of dual temperature probe, and restore the alarm condition.
23 July 2019
Page 18 of 20
Instruction For Use
PMH7000
Version 2
Heater Wire Connection Icon (Heater wire abnormal: Flashes red)
Yes
1) Heater Wire is not connected. 2) Heater Wire has come-off or short-circuited.
1) Connect the heater wire firmly. 2) Replace the heater wire.
Temp Probe Connection Icon (Fault: Flashes red)
Yes
1) Dual Temp Probe is not connected. 2) Dual Temp Probe has disconnected or short-circuited 1) Chamber Temp doesn’t rise more than 2°C for 30 minutes after power-on. 2) Heater plate fault 3) Software memory error. Over heat protector is activated.
1) Connect the dual temp probe firmly. 2) Replace the dual temp probe.
Remove the device from the breathing system, and contact your sales provider for repair.
Icon (Unit Fault: Flashes red)
Yes
All LED suddenly turn off.
No
The device is not activated even though the alarm condition is restored. The device is not powered on.
Yes
Alarm state inter-lock is activated (It is locked when alarm state continues for > 10 minutes)
Turn off the device and restart it.
No
1) 2) 3)
Device fused. Heater base fault. Overheat protector is activated.
Temp panel is blank or displaying “8.8.8.” or other. (Display is different according to the state when the power is on)
Yes
1)
Failure of self-check
1) Change the fuse. 2) Remove the device from the breathing circuit, and contact your sales provider for repair. Remove the device from the breathing circuit, and contact your sales provider for repair.
Remove the device from the breathing circuit, and contact your sales provider for repair.
* If an alarm state is left unresolved for 10 minutes, then the device displays “ ” and stops operating. The alarm continues to sound intermittently. The Humidifier base requires turning off and on again to resume operation. *The priority of each alarm condition is represented by the colour of the LED. Yellow indicates medium priority, RED is high priority.
14. Compliant Accessories The following accessories are available to order. Part Number
Accessory Name
5600000
Electrical adaptor lead (Single heated wire system)
5601000
Electrical adaptor lead (Dual heated wire system)
7700000
Dual temperature probe assembly
Revision 03
23 July 2019
Page 19 of 20
Instruction For Use
Revision 03
PMH7000
23 July 2019
Version 2
Page 20 of 20