User Manual
108 Pages
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USER’S MANUAL HEART-LUNG MACHINE HL 20
| Table of contents |
TABLE OF CONTENTS
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HL 20, User's Manual US version 1.1
General Console Pump modules Console modules System control panel Cardioplegia monitor unit Accessories
| 5 | 11 | 27 | 65 | 93 | 99 | 103
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| Table of contents |
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HL 20, User's Manual US version 1.1
| General | 1 |
1 GENERAL The MAQUET heart-lung machine HL 20 regulates and monitors the extracorporeal circulation during arterial perfusion, local perfusion or cardiopulmonary bypass procedures of six hours or less.
CONSOLE MODULES Air bubbles in a tube can be detected and prevented from entering the patient. A too low liquid (blood) level in a reservoir can be detected and regulated.
These are some of the features of the MAQUET heart-lung machine HL 20:
Four temperature channels can be monitored. Note: This manual covers different models and configurations of the HL 20. Availability of models and configurations may differ from country to country.
Four pressure channels can be monitored and regulated. Suction can be controlled. Digital and analog communication with external devices is possible.
CONSOLE The complete system can run up to 1.5 hours on the battery backup. PUMP MODULES
SYSTEM CONTROL PANEL Most functions needed during an operation can be controlled from the system control panel.
Master-slave operation is possible. 1
A more physiologically optimized pulsatile pumping is possible, internally triggered or controlled by the patient’s own ECG.
There are special functions for cardioplegia control and for blood cardioplegia.
1. The use of the term “pulsatile mode” refers to a variable pressure and flow waveform that results from cyclic operation of a blood pump. Replication of a physical pulse from the natural heart is not obtained from a pump with a variable speed control. No claim of clinical benefit from use of a pulsatile mode of a blood pump has been cleared by the FDA. HL 20, User's Manual US version 1.1
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1.1 COLD-START AND WARM-START A “cold-start” is a complete auto-test carried out when a pump or the system control panel is switched on, using the switch, after being switched off for more than five seconds. A “warm-start” without the complete auto-test is carried out if the part has been switched off for less than five seconds.
1.2 CLEANING AND DISINFECTION AFTER EVERY USE
Cautions: Do not flush the system with excessive water, as this could damage the electronics. Do not use chemical solvents (such as alcohol, ether and acetone) and do not spill anesthetics (such as Foram (Isofluoran)) as this could damage the machine.
1.3 MAINTENANCE AND REPAIR Service and repair should be performed by MAQUET authorized personnel only.
Clean the surface of the whole system including pump heads, tube occlusion rollers and tube guide rolls to remove any spilt blood.
For battery replacement, see page 22.
If necessary use an abrasive sponge for the stainless steel and aluminium surfaces.
IMPORTANT: The device must be serviced at least every 1000 hours of operation or every 12 months by MAQUET or MAQUET authorized personnel.
Generally a normal household washing-up liquid can be used to clean the front panel foils. If there is any doubt what to use, check with a MAQUET representative.
WARNINGS! During daily maintenance, always make sure that the tube guide rollers are fixed in position. If not, contact your local service technician. During daily maintenance, always make sure that the tube guide rollers turn freely. If not, lubricate the inside of the rollers (see page 27 for recommended lubricate) or contact your local service technician. If there are any problems with the tube guide roller, do not use the machine. This will avoid damage to the tube.
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Ensure that a machine to be returned is suitably packaged to protect it from damage during transportation. Enclose a description of the problem and name, address and phone number of the person concerned.
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1.4 SAFETY 1.4.1 EXPLANATIONS OF SYMBOLS ON THE HL 20 Important! Observe the warnings and safety precautions given in the accompanying documents
1.4.2 SPECIAL INSTRUCTIONS These special instructions are contained in the User’s Manual. Please bear them in mind. Risk of serious personal injury!
Observe the instructions in the User’s Manual
This is an instruction or procedure which must be observed to avoid injury to the user, patient or other persons.
IEC 60601-1 classification: Type B applied part
Risk of damage to device!
Alternating current.
Separate collection of electric and electronic devices in accordance with Directive 2002/96/EC: Do not dispose of the device with normal domestic waste. Keep separate from domestic waste and dispose of in an environmentally safe way in compliance with local regulations.
This is an instruction or procedure which must be observed to avoid the device being damaged. Notice This is important or explanatory information.
The device meets the requirements of Council Directive 93/42/EEC concerning medical devices. The device conforms to Canadian and American electrical safety standards CSA C22.2 No. 601.1 and UL 60601-1. Protection type in accordance with IEC 60529: Protection against vertically dripping water Equipotential bonding
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1.4.3 PRECAUTIONS
WARNINGS! Use the system and the accessories according to the user's manual and proven medical practices. It is the responsibility of a qualified perfusionist to ensure that the system is used, tested and maintained according to all updates of the product description and the user's manual. Use only fully functioning machines and equipment during an operation. Set up the extracorporeal circulation properly and check it before operation. The system may only be used by a qualified operator who has experience in operating the MAQUET heart-lung machine or similar systems. Use the system under supervision. The safety of the patient requires that the system is continuously monitored by a qualified operator. Clinical processes and methods are the responsibility of the physician. The system must not be used in the presence of leaking combustible or inflammable gases. Attach equipment, devices and modules firmly to the HL 20. Check the mechanical stability. For disposal of parts, check with MAQUET what is currently the most environment friendly way. The optional side guard must be mounted by MAQUET authorized personnel only. The same applies for changing its position (left or right). Do not sit on the side guard. Do not operate more than one of the optional LED lamps at the same time. Do not use any other lamp than the LED lamp which is available as an accessory. The optional extended mast must be evenly loaded. Before using or after adjusting the mast, make sure that the mast clamps are tightened. 8
Cautions: Federal law restricts this device to sale by or on the order of a physician. Switch off the main switch before maintenance, cleaning, preparation for operation, storage or replacement of a module. Do not touch the plugs of the modules or the pumps as static electricity and dampness could cause damage. Keep the rear flap of the console (or the module box) closed whenever possible to protect the electronics.
Note: Before use read the user's manual thoroughly!
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1.4.4 EXTERNAL DEVICES
1.4.6 LEVEL AND BUBBLE DETECTOR
WARNINGS! When the HL 20 is used together with other medical devices the total of the leakage currents must be checked. Ensure conformity to IEC 60601-1 for all devices. Ensure conformity to IEC specifications for devices connected to the analog or digital interface of the HL 20 (IEC 60950 for data processing devices more than 1.5 meters from the operation table and IEC 60601 for data processing devices within 1.5 meters and other medical devices).
WARNINGS! Gas emboli could cause death or severe injury to the patient. Install and use the bubble and level monitoring system according to the instructions. Test with liquid the function of the bubble and level monitoring system together with the oxygenator and the reservoir. Bubble and level monitoring do not replace the function of the arterial filter. Several systems must be used and the user is still responsible for precautions. If the HL 20 is used without bubble or level monitoring the safety of the patient must be guaranteed by other satisfactory systems and methods.
1.4.5 MEMBRANE OXYGENATOR Pressure fluctuations (caused by an abrupt fall in the arterial flow) in a microporous membrane oxygenator might cause gas microemboli (if the blood pressure gets lower than the gas pressure).
WARNING! The pressure in the arterial tubing must be monitored and the pump adjusted so that the pressure in the blood flow through the oxygenator is always higher than the gas pressure.
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1.5 TECHNICAL DATA See also the technical data for each separate section.
POWER SUPPLY Mains
230 V~/50 Hz; 230V~/60 Hz; 220 V~/50 Hz; 115 V~/60 Hz; 100 V~/50 Hz
Power consumption
1000 VA
Batteries
2 × Sonnenschein A512/30G6 (30 Ah)
SAFETY Certificate Standard
IEC 60601-1, IEC 60601-1-1
Electromagnetic compatibility
IEC 60601-1-2
Electrical safety
Class 1
Protection type in accordance with IEC 60529 IPX1 Classification (MDD, Annex IX)
IIb
ENVIRONMENTAL CONDITIONS
Temperature
Operation
Storage and transportation
10°C to 35°C
–20°C to 60°C
Relative humidity
30 % to 85 %
10 % to 96 %
Air pressure
87 to 106 kPa
70 to 106 kPa
Notes: Use an independent power supply, protected by a 16 A fuse. If storage and transportation is for longer than 15 weeks, follow the operation environmental conditions.
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HL 20, User’s Manual US version 1.22
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2 CONSOLE Note: This manual covers different models and configurations of the HL 20. Availability of models and configurations may differ from country to country.
WARNINGS! Switch off the main switch when not using the HL 20. Unplugging from the mains only activates battery operation. Unplug the mains plug before opening the console.
The system control panel can be moved, turned and rotated to meet your individual requirements. By default, it is mounted right-oriented.
WARNINGS! The orientation (right or left) must be changed by MAQUET authorized personnel only. Before using or after adjusting the system control panel, make sure that: - the mast clamps are tightened - the cable is not stretched tight.
System control panel and infusion masts are included in the console. The console contains the battery backup system and the power supply for the other parts of the HL 20. For the different modules contained in the console, see Chapter 4.
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| 2 | Console |
2-PUMP CONSOLE
Left-oriented System control panel
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Right-oriented System control panel
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4-PUMP CONSOLE
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5-PUMP CONSOLE
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2.1 FRONT VIEW OF THE CONSOLE
1.
2. 3. 4.
5.
Main switch of the whole system Lit during mains operation. Switch off when not using the HL 20. Unplugging from the mains only activates battery operation. System control panel switch Lit when the system control panel is on. Battery operation light Lit during battery operation. Battery charging light Lit when the batteries are being charged. Not lit when the batteries are fully charged. Pump switches Lit when the corresponding pump is on.
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2.2 REAR VIEW OF THE CONSOLE
1.
2.
3.
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Infusion masts Maximum extension height: 110 cm. Maximum load on each mast: 5 kg. Quadruple distributor socket Connect the mains plug (IEC cable) of the external device. See page 9. Wheels The wheels are conductive to prevent electrostatic charging. Lock the total lock of the front wheels before operation and the directional lock of the back wheels in a transverse position during transportation (the 2-pump console has total lock on all wheels).
HL 20, User's Manual US version 1.1
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2.3 REAR PANELS OF THE CONSOLE 2.3.1 OPENING THE COVERS 2-PUMP CONSOLE
Module box
Transparent flap at the console base
4-PUMP AND 5-PUMP CONSOLE
Rear flap
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2.4 REAR PANELS 2-PUMP CONSOLE
Inside the module box
Under the transparent flap
4-PUMP CONSOLE
MIM
Under the rear flap
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Circuit breaker for the distributor socket Circuit breakers for the pumps Circuit breaker for the system control panel 4. Main circuit breaker 5. Connection for potential equalization 6. Circuit breaker for the 24 V socket 7. Additional socket (24 V) for an external device. 8. Power supply module 9. Air emboli protection module (or Air protection module, for bubble sensor only or for level sensor only) 10. Blank 11. Quad temperature module 12. Blank 13. Dual pressure module, channel 1+2 14. Dual pressure module, channel 3+4 15. Console control module and battery charger module: Monitors different console functions, e.g. the battery charge, the pump fuses and the supply voltages. 16. Blank 17. Blank 18. Digital I/O module (DIO) 19. Not used in the US. 1. 2. 3.
For a detailed description of individual modules, see Chapter 4.
Note: Do not use the circuit breakers as on/off switches. They break the circuit in case of error.
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| 2 | Console |
2.5 2-PUMP CONSOLE WORKING POSITION
1.
Loosen the locking screws for the System control panel.
2.
Turn it to the desired working position and tighten the locking screws.
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2.6 2-PUMP CONSOLE PARKING POSITION To park the machine: 1. Loosen the locking screws for the System control panel.
2.
Turn it to a suitable position for parking, and tighten the locking screws.
2.7 MOVING THE MACHINE 1. 2. 3.
Switch off the machine, unplug the mains plug and roll up the mains cable. Put it into a parking position. Attach all sensors and cables, which are to be transported, firmly to the machine.
WARNING! Only lift the machine at the short sides. Be careful.
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