Operation, Maintenance and Service Manual
72 Pages
![O P E R AT I O N , M A I N T E N A N C E , A N D SERVICE MANUAL Pump MAX™ R Device Description Dimensions Width 15.5 in (39.37cm) 15.5 in (39.37cm) Depth 11.2 in (28.45cm) 11.2 in (28.45cm) Height 13.2 in (with handle) (33.53cm) 13.2 in (with handle) (33.53cm) Weight 22.3 lb (10.1kg) 21.0 lb (9.5kg) Sound <60 dBa <60 dBa Duty Cycle Non-continuous duty [45 min (97.8%) ON / 1 min (2.2%) OFF] Non-continuous duty [45 min (97.8%) ON / 1 min (2.2%) OFF] Operating Principle The negative and positive pressures of a rotary pump are developed by mounting the rotor off center in relation to the inside diameter of the pump housing. In reciprocating motion, a flexible cup mounted on top of the connecting rod creates vacuum or pressure as the cup maintains a seal against the cylinder walls in a rocking motion. Date of Manufacture The date of manufacture can be identified in the unit Serial Number where the first two digits refer to the year of manufacture, the second two the month of manufacture. Compatible Accessories Indication for Use The Aspiration Pump is compatible with a 1,000 ml disposable canister. Additional canisters are available by contacting your Penumbra sales representative. The Penumbra Pump MAX™ is intended for general suction use in hospitals or clinics. Contraindications Note: Plastic canisters, caps and tubes are Single Use Only and CANNOT be reused. There are no contraindications. Warnings / Precautions The canister comes pre-assembled with a removable lid, Pump Canister Tubing and filter. The filter is included to prevent fluid and aerosol contamination of the aspiration pump. This filter features a hydrophobic microporous membrane that filters air with maximum efficiency of 99.99% (particles in air, the mass median diameter is approximately 0.33μm), while blocking the flow of aqueous fluids and aerosol contaminants. The filter protects against suction pump contamination in the case of canister overflow because it prevents the overflow from reaching the pump. • The canister / tubing is intended for single use only. Do not reuse. Reuse may result in canister cracking or tubing blockages, which may result in the inability to aspirate. • Do not block bottom or back air vents. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. • To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Do not position the pump so that it is difficult to operate the power cord disconnection device • Remove and service the pump if liquids or solids have been drawn into the vacuum pump. • Do not use in the presence of a flammable anaesthetic mixture with air or nitrous oxide. • Do not use in oxygen rich environment. • To prevent fire or shock hazard, use replacement fuses of equal size and rating. • To prevent fire or shock hazard, use a replacement power cord of equal rating. • Do not re-infuse blood or fluid from the canister back into the patient. • Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. It will reduce the service life of the pump. Use only water-base solvents for cleaning. • Federal law (USA) restricts this device to sale by or on the order of a physician. • No modification of this equipment is allowed. The Aspiration Pump is supplied with standard equipment and accessories used as follows: Table 2 – Standard Compatible Equipment and Accessories Aspiration Pump Specification Model PMX110 PMX220 Voltage 100-115 Vac 230 Vac Vacuum Range 0-29 inHg (0-98.2 kPa) 0-29 inHg (0‑98.2 kPa) Vacuum Gauge Accuracy ± 2 inHg (± 7 kPa) ± 2 inHg (± 7 kPa) Flow Rate 0-0.8 SCFM (0-23 LPM) 0-0.8 SCFM (0‑23 LPM) Electrical Requirements Voltage 100 V AC; 100‑115 Vac 230 Vac Frequency 50 Hz; 60 Hz 50 Hz Fuses Two 5A 5 X 20 mm Fast acting fuse Operating Speed 0.05 sec Breaking Capacity 100A @ 250Vac Two 5A 5 X 20 mm Fast acting fuse Operating Speed 0.05 sec Breaking Capacity 100A @ 250Vac Motor and Pump Description Oil-less, rotating pump Oil-less, rotating pump 1. One 1,000 ml disposable canister with lid 2. Pre-assembled Pump Canister Tubing and filter. Description The canister has a self-sealing material that acts as an overflow protection device. When the filter comes in contact with moisture, the self-sealing material stops vacuum and prevents fluids from entering the pump and damaging the system. Set-Up 1. Place the canister on a flat surface and check that the lid is snapped on firmly. 2. Check that the Pump Canister Tubing with the filter is attached firmly onto the canister lid. 3. Insert the Canister into the canister well. 4. Connect the free end of the Pump Canister Tubing to the Suction Inlet. Canister (1,000 ml Disposable) Specifications Table 1 – Pump Specifications Parameter Accessories 1 (72) English The Pump MAX™ is an oil-less rotary pump capable of delivering 29 inHg (98.2 kPa) of vacuum to draw fluid and small particles. The Pump MAX™ is fitted with an on-off button, vacuum regulator and analog gauge. The Pump’s accessory components are 1,000 ml disposable canister with a lid for fluid containment, filter and Pump Canister Tubing that connects the pump to the canister, and an aspiration tubing that connects the canister to the sterile field (see Pump MAX™ Component Diagram below).](https://images.bioclinicalservices.com.au/cfbiZiqmZpcVZfGVNEa3uyMA/320w/Penumbra%2C%20Inc%20-%20Pump%20MAX%20Operation%2C%20Maintenance%20and%20Service%20Manual%20Rev%20C%20June%202016%20-%202016-06.png)
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O P E R AT I O N , M A I N T E N A N C E , A N D SERVICE MANUAL
Pump MAX™
R
Device Description
Dimensions Width
15.5 in (39.37cm)
15.5 in (39.37cm)
Depth
11.2 in (28.45cm)
11.2 in (28.45cm)
Height
13.2 in (with handle) (33.53cm)
13.2 in (with handle) (33.53cm)
Weight
22.3 lb (10.1kg)
21.0 lb (9.5kg)
Sound
<60 dBa
<60 dBa
Duty Cycle
Non-continuous duty [45 min (97.8%) ON / 1 min (2.2%) OFF]
Non-continuous duty [45 min (97.8%) ON / 1 min (2.2%) OFF]
Operating Principle
The negative and positive pressures of a rotary pump are developed by mounting the rotor off center in relation to the inside diameter of the pump housing. In reciprocating motion, a flexible cup mounted on top of the connecting rod creates vacuum or pressure as the cup maintains a seal against the cylinder walls in a rocking motion.
Date of Manufacture The date of manufacture can be identified in the unit Serial Number where the first two digits refer to the year of manufacture, the second two the month of manufacture.
Compatible Accessories
Indication for Use
The Aspiration Pump is compatible with a 1,000 ml disposable canister. Additional canisters are available by contacting your Penumbra sales representative.
The Penumbra Pump MAX™ is intended for general suction use in hospitals or clinics.
Contraindications
Note: Plastic canisters, caps and tubes are Single Use Only and CANNOT be reused.
There are no contraindications.
Warnings / Precautions
The canister comes pre-assembled with a removable lid, Pump Canister Tubing and filter. The filter is included to prevent fluid and aerosol contamination of the aspiration pump. This filter features a hydrophobic microporous membrane that filters air with maximum efficiency of 99.99% (particles in air, the mass median diameter is approximately 0.33μm), while blocking the flow of aqueous fluids and aerosol contaminants. The filter protects against suction pump contamination in the case of canister overflow because it prevents the overflow from reaching the pump.
• The canister / tubing is intended for single use only. Do not reuse. Reuse may result in canister cracking or tubing blockages, which may result in the inability to aspirate. • Do not block bottom or back air vents. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. • To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Do not position the pump so that it is difficult to operate the power cord disconnection device • Remove and service the pump if liquids or solids have been drawn into the vacuum pump. • Do not use in the presence of a flammable anaesthetic mixture with air or nitrous oxide. • Do not use in oxygen rich environment. • To prevent fire or shock hazard, use replacement fuses of equal size and rating. • To prevent fire or shock hazard, use a replacement power cord of equal rating. • Do not re-infuse blood or fluid from the canister back into the patient. • Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. It will reduce the service life of the pump. Use only water-base solvents for cleaning. • Federal law (USA) restricts this device to sale by or on the order of a physician. • No modification of this equipment is allowed.
The Aspiration Pump is supplied with standard equipment and accessories used as follows: Table 2 – Standard Compatible Equipment and Accessories Aspiration Pump
Specification Model
PMX110
PMX220
Voltage
100-115 Vac
230 Vac
Vacuum Range
0-29 inHg (0-98.2 kPa)
0-29 inHg (0‑98.2 kPa)
Vacuum Gauge Accuracy
± 2 inHg (± 7 kPa)
± 2 inHg (± 7 kPa)
Flow Rate
0-0.8 SCFM (0-23 LPM)
0-0.8 SCFM (0‑23 LPM)
Electrical Requirements Voltage
100 V AC; 100‑115 Vac
230 Vac
Frequency
50 Hz; 60 Hz
50 Hz
Fuses
Two 5A 5 X 20 mm Fast acting fuse Operating Speed 0.05 sec Breaking Capacity 100A @ 250Vac
Two 5A 5 X 20 mm Fast acting fuse Operating Speed 0.05 sec Breaking Capacity 100A @ 250Vac
Motor and Pump Description
Oil-less, rotating pump
Oil-less, rotating pump
1. One 1,000 ml disposable canister with lid 2. Pre-assembled Pump Canister Tubing and filter.
Description
The canister has a self-sealing material that acts as an overflow protection device. When the filter comes in contact with moisture, the self-sealing material stops vacuum and prevents fluids from entering the pump and damaging the system.
Set-Up
1. Place the canister on a flat surface and check that the lid is snapped on firmly. 2. Check that the Pump Canister Tubing with the filter is attached firmly onto the canister lid. 3. Insert the Canister into the canister well. 4. Connect the free end of the Pump Canister Tubing to the Suction Inlet.
Canister (1,000 ml Disposable)
Specifications Table 1 – Pump Specifications Parameter
Accessories
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English
The Pump MAX™ is an oil-less rotary pump capable of delivering 29 inHg (98.2 kPa) of vacuum to draw fluid and small particles. The Pump MAX™ is fitted with an on-off button, vacuum regulator and analog gauge. The Pump’s accessory components are 1,000 ml disposable canister with a lid for fluid containment, filter and Pump Canister Tubing that connects the pump to the canister, and an aspiration tubing that connects the canister to the sterile field (see Pump MAX™ Component Diagram below).
O P E R AT I O N , M A I N T E N A N C E , A N D SERVICE MANUAL
VACUUM REGULATOR DIAL
ON/OFF SWITCH
Pump MAX™
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Maintenance Frequency and Procedures
PUMP CANISTER TUBING
VACUUM GAUGE
The pump fuses are located next to the power receptacle on the rear of the pump. Replace the pump fuses by releasing the fuse holder with a small flat-head screwdriver. Do not touch the patient and the fuse contacts concurrently. The pump has no other user serviceable parts. For repair or replacement, contact your local Penumbra distributor (operating life of 500 hours).
FILTER
CANISTER LID
Cleaning Procedure
Wipe down the exterior of the pump using a soft cloth and a 70% isopropyl alcohol solution or mild detergent.
POWER CORD
Disposal Procedures
ASPIRATION PUMP
Used canisters and tubing sets should be disposed of using standard hospital biohazard procedures. Non-functioning pumps should be disposed of in accordance with standard hospital procedures for electro-medical equipment.
CANISTER
Trouble Shooting Table 3 – Troubleshooting
TO PATIENT ASPIRATION TUBING
PROBLEM*
PROBABLE CAUSE
REMEDY
Pump will not run when switch is pushed “ON”
Power source is bad or incorrect voltage Overheat due to vacuum flow occluded for an extended period Fuse blown
Check power outlet
Filter is clogged
Replace canister/tubing/filter set
Motor burned out
Contact Distributor
Loose canister lid or tubing connection Pump performance is low
Check all tubing connections
Aspiration Pump System Component Diagram Operator Profile
Operators of the Penumbra Aspiration Pump MAX™ should be experienced in performing the associated interventional procedure. No specific training is required to operate the pump other than reading and understanding this manual. Installation (set-up) of the Penumbra Pump MAX™ can be found below.
Low suction or low pressure
Operating Procedure
Filter is clogged
1. Place the power button in the “OFF” position. The green button is not illuminated in the “OFF” position. 2. Place the pump on a flat, stable surface capable of bearing its weight and in a position where the controls and power cord are easily accessible to the operator and the aspiration tubing can access the sterile field. 3. Plug the power cord into a grounded electrical outlet, making sure that it is the same voltage as indicated on the unit nameplate. Ensure the power receptacle is connected to a supply mains with protective earth. The receptacle should be marked “Hospital Grade”. 4. Verify that Pump Canister Tubing attached to the canister is dry. 5. Push the power switch to the “ON” position. The green switch should be illuminated. • Warning: Do not touch the power switch and the patient at the same time. 6. Set the vacuum by rotating the Vacuum Regulator Dial until the Vacuum Gauge reads the desired vacuum level. • Note: Do not exceed 20 inHg vacuum. 7. Verify the degree of vacuum by pinching off the Pump Canister tubing or the Aspiration tubing. Release after verification. 8. The pump is now ready for patient use. The level of vacuum will register on the vacuum gauge. To increase the vacuum, turn the regulator dial clockwise. To decrease the vacuum, turn the regulator dial counter-clockwise. 9. During use, monitor the canister fluid level and replace the canister / tubing if the fill level reaches 75% of the volume. 10. To turn the pump off, push the green power button and ensure that the button is not illuminated.
Pump runs, but no suction or pressure
Turn off pump and allow to cool Replace fuse
See specification and maintenance and service sections Replace canister/tubing/filter set
Vacuum regulator or pressure regulator is leaking Vacuum regulator improperly adjusted Disconnect vacuum or pressure line Filter is clogged
Contact Distributor
Canister unit full
Empty or replace canister
Adjust Vacuum regulator needle valve. Check all tubing connections Replace canister/tubing/filter set
* Refer all service and maintenance to qualified personnel. For service or service questions on your Aspiration Pump please call Penumbra Customer Service.
Approvals
The Penumbra Aspiration Pump MAX™ complies with the following international safety and EMC requirements for medical electrical equipment: • IEC 60601-1:2007 • EN 60601-1:2011 • JIS T0601-1:1999 • IEC 60601-1-2:2007 (EN 60601-1-2:2010 & CSA C22.2.60601.1.2:2008) including: • CISPR 11 Class B • EN 61000-4-2 • EN 61000-4-3 • EN 61000-4-4 • EN 61000-4-5 • EN 61000-4-6 • EN 61000-4-8 • EN 61000-3-2 • EN 61000-3-3 • EN 61000-4-11 • CAN/CSA C22.2 No. 601.1-M90: 2008
Operating Conditions
• Temp: 65°F - 75°F (18°C - 24°C) • Humidity: <75% RH • Pressure: Sea Level – 6000 ft
Transportation / Storage Conditions • Temp: -20°F - 120°F (-29°C - 49°C) • Humidity: <95% RH
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O P E R AT I O N , M A I N T E N A N C E , A N D SERVICE MANUAL Electro-Magnetic Compatibility
Guidance and manufacturer’s declaration – electromagnetic immunity The Pump MAX™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump MAX™ should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic emissions The Pump MAX™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump MAX™ should assure that it is used in such an environment. Emissions test
Compliance
RF emissions CISPR 11
IMMUNITY test
IEC 60601 TEST LEVEL
Compliance level
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Complies Complies
The Pump MAX™ uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Recommended separation distance
The Pump MAX™ is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Conducted RF
3 Vrms
3 VRMS
Radiated RF
3 V/m
3 V/m
IEC 61000-4-6
IEC 61000-4-3
150 kHz to 80 MHz
80 MHz to 2.5 GHz
IEC 61000-4-2 Electrostatic Discharge
IEC 61000-4-4 Electrical Fast Transient/Burst
IEC 61000-4-5 Surge Immunity
IEC 61000-4-8 Power Frequency Magnetic Field Immunity
IEC 61000-4-11 Voltage Dips and Short Interruptions Immunity
Compliance level
Electromagnetic environment – guidance
±6 kV contact discharge ±8 kV air discharge
Complies
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
AC power ports, ±2 kV
Complies
Input/output lines, ±1.0 kV
Not Applicable1
AC power ports, ±1 and ±2 kV
Complies
3 Arms/m
AC power lines Reduction 30%, 25 periods Reduction 60%, 5 periods Reduction 100%, 0.5 period Reduction 100%, 250 periods
Not Applicable1
Complies
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 80 MHz and 800 MHz, 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.
Mains power quality should be that of a typical commercial or hospital environment.
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 the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Pump MAX™ is used exceeds the applicable RF compliance level above, the Pump MAX™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM].
a
Mains power quality should be that of a typical commercial or hospital environment.
b
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Recommended separation distances between portable and mobile RF communications equipment and the Pump MAX™ The Pump MAX™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pump MAX™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pump MAX™ as recommended below, according to the maximum output power of the communications equipment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the Pump MAX™ requires continued operation during power mains interruptions, it is recommended that the Pump MAX™ be powered from an uninterruptible power supply or a battery.
Rated maximum output power of transmitter W
NOTE UT is the a.c. mains voltage prior to application of the test level. 1
d=1.2√P 80 MHz to 800 MHz
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).
Guidance and manufacturer’s declaration – electromagnetic immunity
IEC 60601 test level
d=1.2√P
d=2.3√P 800 MHz to 2.5 GHz
The Pump MAX™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump MAX™ should assure that it is used in such an environment. IMMUNITY test
Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the Pump MAX™, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Electromagnetic environment – guidance
Group 1
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Pump MAX™
R
Separation distance according to frequency of transmitter m 150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d=1.2√P
d=1.2√P
d=2.3√P
0.01
.12
.12
.23
0.1
.38
.38
.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
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 of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
The EUT does not contain signal, control, or telecom lines.
NOTE 1 At 80 MHz and 800 MHz, 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.
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O P E R AT I O N , M A I N T E N A N C E , A N D SERVICE MANUAL
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Equipment Classifications Protection from electric shock... Class I and externally powered Degree of protection against electric shock. .Type CF Applied Part Degree of protection against ingress of liquids or particles... IP21 Mode of Operation... Non-continuous Operation
ISO Classification
Electrically powered medical suction equipment for non-transport use according to ISO 10079 1: 2009
Symbol Definitions Responsible Manufacturer
European Union Authorized Representative
Serial Number
Catalogue Number
On / Off
Caution Dangerous Voltage
Refer to Instruction Manual / Booklet
Type CF Applied Part
Vacuum Increase / Decrease
Transport and Storage Temperature Range -20°F (-29°C) - 120°F (49°C). Relative Humidity <95%
Interference may occur in the vicinity of equipment marked with this symbol
Limited Warranty
Penumbra warrants for a period of three years from date of shipment that the Aspiration Pump is free from defects in material and workmanship. In the event of breach of this warranty, Penumbra’s sole and exclusive liability shall be, at its option, either (i) to repair or replace the Aspiration Pump, or (ii) to accept return of the Aspiration Pump and refund the purchase price; in either case provided that written notice of any defect is given to Penumbra within the warranty period, the Aspiration Pump is found by Penumbra to have been defective, the Aspiration Pump has been installed and/or operated in accordance with Penumbra’s instructions, no repairs, alterations or replacements have been made without Penumbra’s written approval, and owner notifies Penumbra in writing within sixty (60) days after the defect becomes apparent. In no event shall the aggregate liability of Penumbra in connection with breach of any warranty or warranties exceed the purchase price paid for the Aspiration Pump. Penumbra may, at its option, require the return of the Aspiration Pump to establish any claim of defect. EXCEPT AS EXPRESSLY STATED HEREIN, PENUMBRA MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, AND DOES NOT WARRANT THAT THE ASPIRATON PUMP IS MERCHANTABLE OR FIT FOR ANY PARTICULAR PURPOSE. Penumbra shall not, except as set forth above, be otherwise liable to any owner or user of the Aspiration Pump or any component thereof or accessory thereto for damages of any kind, including, but not limited to direct, indirect, special or consequential damages or loss of profits resulting from any cause whatsoever, including, but not limited to, any delay, act, error or omission of Penumbra.
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Pump MAX™
O P E R AT I O N , M A I N T E N A N C E , A N D SERVICE MANUAL
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Pump MAX™
O P E R AT I O N , M A I N T E N A N C E , A N D SERVICE MANUAL
Manufacturer:
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA Tel: 1-888-272-4606 1-510-748-3200 Fax: 1-510-748-3232
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Pump MAX™
EU Representative:
MedPass International Ltd. Windsor House, Bretforton Evesham, Worcestershire WR11 7JJ, UK
5796.C 2016-06