Operation Maintenance and Service Manual
4 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 P e n u m b r a EN G I NE ™ R Device Description Specifications The Penumbra ENGINE is an electromechanical device designed to create vacuum pressure for use with Penumbra Aspiration Systems. The Penumbra ENGINE’s accessory component is a 1,000 mL disposable ENGINE canister with a vacuum filter for fluid containment. The Penumbra Aspiration Systems include an aspiration tubing that connects the canister to the sterile field. Table 1 – Penumbra ENGINE Specifications 100-240 VAC Frequency 50 Hz; 60 Hz Current 2.0 A Fuse Two 2A, 5 X 20 mm Operating Speed Type T (Time lag fuse) Breaking Capacity 1500A at 250VAC (T2A H 250VAC) Port Output 5-20VDC, 3.0A Motor and Pump Description Oil-less, diaphragm pump Maximum Vacuum ≤10% of Ambient Pressure ≥26.9 inHg (91.1 kPa) at sea level Flow Rate 0-0.8 SCFM (0-23 LPM) Width 13 in (33 cm) Depth 11 in (28 cm) Height 10 in (25 cm) Weight 15 lbs max (6.8 kg) Sound <60 dBa Duty Cycle Non-continuous duty [45 min (97.8%) ON / 1 min (2.2%) OFF] Date of Manufacture The date of manufacture can be identified in the unit label where the first four digits refer to the year of manufacture, the following two digits refer to the month of manufacture, and the last two digits refer to the day of manufacture. Operating Principle The Penumbra ENGINE is intended to generate vacuum pressure for use with Penumbra Aspiration Systems. Indication for Use The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Contraindications There are no contraindications. Warnings / Precautions • The canister is intended for single use only. Do not reuse. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. • Do not block bottom air vents. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. • To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. • Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. The means of mains disconnect is to remove the power cord. • Only use replacement fuse with correct rating (see Table 1 for fuse rating). • Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. • Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. • Do not use in an oxygen rich environment. • 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 based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. It will reduce the service life of the Penumbra ENGINE. Use only water-based solvents for cleaning. • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of the Penumbra ENGINE. Otherwise, this could result in degradation of the performance of this equipment. • Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. • Equipment is not safe for MR use. • No modification of this equipment is allowed. Compatible Accessories The Penumbra ENGINE is compatible with the 1,000 ml disposable ENGINE canister. Note: Plastic canisters, canister lids, and vacuum filters are Single Use Only and CANNOT be reused. The canister comes pre-assembled with a removable lid and vacuum filter. The vacuum filter is included to prevent fluid and aerosol contamination of the pump. The vacuum filter protects against pump contamination in the case of canister overflow because it prevents the overflow from reaching the pump. Table 2 – Standard Compatible Equipment and Accessories Accessories One 1,000 ml disposable ENGINE canister with lid Description The ENGINE canister has a self-sealing material that acts as an overflow protection device. When the vacuum 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 ENGINE canister on a flat surface and check that the lid is securely attached. 2. Insert the ENGINE canister into the canister receptacle. Operator Profile Operators of the Penumbra ENGINE should be experienced in performing the associated surgical or interventional procedure. No specific training is required to operate the Penumbra ENGINE other than reading and understanding this manual. Installation (set-up) of the Penumbra ENGINE and Canister can be found below. Use Environment The Penumbra ENGINE is intended for use in operating rooms or interventional catheterization laboratories. 1 (4) English Voltage](https://images.bioclinicalservices.com.au/cq6o0fdu2y6i8ykm9k8ukjn644xh/320w/Penumbra%2C%20Inc%20-%20Penumbra%20ENGINE%20Pump%20Operation%20Maintenance%20and%20Service%20Manual%20Sept%202019%20-%202019-09.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
P e n u m b r a EN G I NE ™
R
Device Description
Specifications
The Penumbra ENGINE is an electromechanical device designed to create vacuum pressure for use with Penumbra Aspiration Systems. The Penumbra ENGINE’s accessory component is a 1,000 mL disposable ENGINE canister with a vacuum filter for fluid containment. The Penumbra Aspiration Systems include an aspiration tubing that connects the canister to the sterile field.
Table 1 – Penumbra ENGINE Specifications 100-240 VAC
Frequency
50 Hz; 60 Hz
Current
2.0 A
Fuse
Two 2A, 5 X 20 mm Operating Speed Type T (Time lag fuse) Breaking Capacity 1500A at 250VAC (T2A H 250VAC)
Port Output
5-20VDC, 3.0A
Motor and Pump Description
Oil-less, diaphragm pump
Maximum Vacuum
≤10% of Ambient Pressure ≥26.9 inHg (91.1 kPa) at sea level
Flow Rate
0-0.8 SCFM (0-23 LPM)
Width
13 in (33 cm)
Depth
11 in (28 cm)
Height
10 in (25 cm)
Weight
15 lbs max (6.8 kg)
Sound
<60 dBa
Duty Cycle
Non-continuous duty [45 min (97.8%) ON / 1 min (2.2%) OFF]
Date of Manufacture
The date of manufacture can be identified in the unit label where the first four digits refer to the year of manufacture, the following two digits refer to the month of manufacture, and the last two digits refer to the day of manufacture.
Operating Principle
The Penumbra ENGINE is intended to generate vacuum pressure for use with Penumbra Aspiration Systems.
Indication for Use
The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems.
Contraindications
There are no contraindications.
Warnings / Precautions
• The canister is intended for single use only. Do not reuse. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. • Do not block bottom air vents. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. • To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. • Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. The means of mains disconnect is to remove the power cord. • Only use replacement fuse with correct rating (see Table 1 for fuse rating). • Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. • Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. • Do not use in an oxygen rich environment. • 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 based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. It will reduce the service life of the Penumbra ENGINE. Use only water-based solvents for cleaning. • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of the Penumbra ENGINE. Otherwise, this could result in degradation of the performance of this equipment. • Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. • Equipment is not safe for MR use. • No modification of this equipment is allowed.
Compatible Accessories
The Penumbra ENGINE is compatible with the 1,000 ml disposable ENGINE canister. Note: Plastic canisters, canister lids, and vacuum filters are Single Use Only and CANNOT be reused. The canister comes pre-assembled with a removable lid and vacuum filter. The vacuum filter is included to prevent fluid and aerosol contamination of the pump. The vacuum filter protects against pump contamination in the case of canister overflow because it prevents the overflow from reaching the pump. Table 2 – Standard Compatible Equipment and Accessories Accessories
One 1,000 ml disposable ENGINE canister with lid
Description
The ENGINE canister has a self-sealing material that acts as an overflow protection device. When the vacuum 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 ENGINE canister on a flat surface and check that the lid is securely attached. 2. Insert the ENGINE canister into the canister receptacle.
Operator Profile
Operators of the Penumbra ENGINE should be experienced in performing the associated surgical or interventional procedure. No specific training is required to operate the Penumbra ENGINE other than reading and understanding this manual. Installation (set-up) of the Penumbra ENGINE and Canister can be found below.
Use Environment
The Penumbra ENGINE is intended for use in operating rooms or interventional catheterization laboratories.
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Voltage
O P E R AT I O N , M A I N T E N A N C E , A N D SERVICE MANUAL Operating Procedure
Cleaning Procedure
1. Place the Penumbra ENGINE 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. 2. Plug the power cord into a grounded electrical outlet, making sure that it is the same voltage as indicated on the unit label. Ensure the power receptacle is connected to a supply mains with protective earth. 3. Check that the ENGINE canister lid is attached securely. Place the ENGINE canister into the canister receptacle of the Penumbra ENGINE (Refer to the Penumbra ENGINE Canister Instructions for Use). Attach the Penumbra Aspiration System aspiration tubing to the ENGINE canister lid port. 4. Push the power switch to the “ON” position. The switch should become brightly illuminated. Warning: Do not touch the power switch and the patient at the same time. 5. The indicator lights (4 lights encircling the power button) will illuminate to indicate suction is activated (see Figure 1).
Turn off power to the unit and remove the power cord before cleaning. Wipe down the exterior of the Penumbra ENGINE using a soft cloth and a 70% isopropyl alcohol solution or mild detergent.
Disposal Procedures
Used canisters should be disposed of using standard hospital biohazard procedures. Non-functioning Penumbra ENGINE should be disposed of in accordance with Waste Electrical and Electronic Equipment Directive (WEEE).
Trouble Shooting Table 3 – Troubleshooting
Figure 1: Indicator Lights
6. Verify the degree of vacuum by confirming all 4 lights encircling the power button are illuminated. When the 4th indicator light illuminates, the Penumbra ENGINE is at maximum vacuum and vacuum pressure is between -20 inHg and -29 inHg [-67.7 kPa and -98.2 kPa]. 7. The Penumbra ENGINE is now ready for patient use. 8. During use, monitor the canister fluid level and replace the canister if the fill level reaches its maximum fill level. 9. To turn the Penumbra ENGINE off, push the power button and ensure that the button is dimly illuminated.
25.0
Vacuum (kPA)
Vacuum (inHg)
20.0
0.0
0.2
0.4
0.6
0.8
Power source is bad or incorrect voltage Overheat due to vacuum flow occluded for an extended period Fuse blown
Check power outlet
Vacuum filter is clogged
Replace canister
Motor burned out
Contact Distributor
Low suction or low pressure
Loose canister lid or tubing connection Penumbra ENGINE performance is low Vacuum filter is clogged
Check tubing connection or canister lid connection See specification and maintenance and service sections Replace canister
Penumbra ENGINE runs, but no suction or pressure
Vacuum filter is clogged
Replace canister
Canister unit full
Empty or replace canister
Canister disconnected from Penumbra ENGINE
Check canister placement in receptacle
Turn off Penumbra ENGINE and allow to cool Replace fuse
The Penumbra ENGINE complies with all current international safety and EMC requirements for medical electrical equipment as follows: • IEC 60601-1 • CAN/CSA-C22.2 60601-1 • EN-60601-1 • CENELEC EN 60601-1 • SN EN 60601-1 • JIS T0601-1 • KS C IEC 60601-1 • IEC 60601-1-2 including: • CISPR 11 • IEC 61000-4-2 • IEC 61000-4-3 • IEC 61000-4-4 • IEC 61000-4-5 • IEC 61000-4-6 • IEC 61000-4-8 • IEC 61000-4-11 • IEC 61000-3-2 • IEC 61000-3-3
Flow Rate (L/Min) 15.0
REMEDY
Penumbra ENGINE will not run when switch is pushed “ON”
Conforms to • AAMI STD ES60601-1 • IEC STD 60601-1-6 • IEC STD 62366 • ISO STD 10079-1 • Certified to CSA STD C22.2#60601-1
ENGINE Pressure-Flow Performance 10.0
PROBABLE CAUSE
Approvals
• Temperature: 65°F - 75°F (18°C - 24°C) • Humidity: <75% RH • Pressure: at Sea Level – 6000 ft (1829 m)
5.0
PROBLEM*
* Refer all service and maintenance to qualified personnel. For service or service questions on your Penumbra ENGINE please call Penumbra Customer Service.
Operating and Storage Conditions
0.0
P e n u m b r a EN G I NE ™
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1.0
Flow Rate (SCFM)
Transportation Conditions
• Temperature: 14°F - 131°F (-10°C - 55°C) • Humidity: <85% RH
Maintenance Frequency and Procedures
Prior to performing any maintenance ensure that the Penumbra ENGINE is unplugged. The Penumbra ENGINE fuses are located below the power receptacle on the rear of the Penumbra ENGINE. Replace the fuses by releasing the fuse holder with a small flat-head screwdriver. Do not touch the patient and the fuse contacts concurrently. The Penumbra ENGINE has no other serviceable parts. For repair or replacement, contact your local Penumbra distributor (the Penumbra ENGINE can be run for 3 hours of continuous use and has an overall operating life of 500 hours). 2 (4)
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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 - Immunity The Penumbra ENGINE is intended for use in the electromagnetic environment specified below. The customer or the user of the Penumbra ENGINE should ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration – Emissions The Penumbra ENGINE is intended for use in the electromagnetic environment specified below. The customer or the user of the Penumbra ENGINE should ensure that it is used in such an environment. Emissions Test
P e n u m b r a EN G I NE ™
R
Compliance
RF emissions CISPR 11
Group 1
RF Emissions CISPR 11
Class A
Harmonics IEC 61000-3-2
Class A
Flicker EN 61000-3-3
Complies
Electromagnetic Environment - Guidance The Penumbra ENGINE 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. The Penumbra ENGINE 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.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment Guidance
Conducted RF IEC 61000-4-6
3V 0.15 MHz – 80 MHz 6 V in ISM between 0.15 MHz and 80 MHz 80% AM at 1 kHz
3V 0.15 MHz – 80 MHz 6 V in ISM between 0.15 MHz and 80 MHz 80% AM at 1 kHz
Professional Healthcare Facility Environment
Radiated RF IEC 61000-4-3
3V/m 80 MHz – 2.7 GHz 80% AM at 1 kHz
3V/m 80 MHz – 2.7 GHz 80% AM at 1 kHz
Professional Healthcare Facility Environment
Guidance and Manufacturer’s Declaration – Immunity to RF Wireless Communications Equipment The Penumbra ENGINE is intended for use in the electromagnetic environment specified below. The customer or the user of the Penumbra ENGINE should ensure that it is used in such an environment.
Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
Guidance and Manufacturer’s Declaration – Immunity The Penumbra ENGINE is intended for use in the electromagnetic environment specified below. The customer or the user of the Penumbra ENGINE should ensure that it is used in such an environment.
Test Frequency
Band
Service
Modulation
Maximum Power
Distance
Immunity Test Level
MHz
MHz
385
W
Meters
(V/m)
380390
TETRA 400
Pulse modulation 18 Hz
1.8
0.3
27
450
430470
GMRS 460, FRS 460
FM ±5 kHz deviation 1 kHz sine
2
0.3
28
710 745 780
704787
LTE Band 13, 17
Pulse modulation 217 Hz
0.2
0.3
9
810 870 930
800960
GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5
Pulse modulation 18 Hz
2
0.3
28
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment Guidance
17001900
GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS
Pulse modulation 217 Hz
28
±8kV Contact ±15kV Air
1720 1845 1970
0.3
±8 kV Contact ±15 kV Air
Floors should be wood, concrete, or ceramic tile. If floors are synthetic, the r/h should be at least 30%.
2
ESD IEC 61000-4-2
EFT IEC 61000-4-4
±2 kV Mains ±1 kV I/Os
±2kV Mains ±1kV I/Os
Mains power quality should be that of a typical commercial or hospital environment.
2450
24002570
Pulse modulation 217 Hz
2
0.3
28
Surge IEC 61000-4-5
±1 kV Differential ±2 kV Common
±1kV Differential ±2kV Common
Mains power quality should be that of a typical commercial or hospital environment.
Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7
5240 5500 5785
51005800
WLAN 802.11a/n
Pulse modulation 217 Hz
0.2
0.3
9
>95% Dip for 0.5 Cycle >95% Dip for 1 Cycle 30% Dip for 25/30 Cycles >95% Dip for 250/300 Cycles
Mains power quality should be that of a typical commercial or hospital environment. If the user of the Penumbra ENGINE requires continued operation during power mains interruptions, it is recommended that the Penumbra ENGINE be powered from an uninterruptible power supply or battery.
30 A/m
Power frequency magnetic fields should be that of a typical commercial or hospital environment.
Immunity Test
Voltage Dips/ Dropout IEC 61000-4-11
Power Frequency 50/60 Hz Magnetic Field IEC 61000-4-8
>95% Dip for 0.5 Cycle >95% Dip for 1 Cycle 30% Dip for 25/30 Cycles >95% Dip for 250/300 Cycles
30 A/m
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
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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 Symbol Definitions
R
P e n u m b r a EN G I NE ™
Limited Warranty Refer to Instruction Manual / Booklet Transport Temperature Range 14°F (-10°C) to 131°F (55°C) Transportation Relative Humidity <85%
US and Canada Certification
European Union Authorized Representative Prescription Only – US Federal Law restricts this device to use by or on the order of a physician
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.
Medical Device
Manufacturer
MR Unsafe
Serial Number
On/Off
Catalogue Number
Maximum Vacuum Level
Lot Number
1000
Maximum Fill Level
Date of Manufacture
Suction Equipment (High Vacuum/High Flow Device)
Attention, see instructions for use
Type CF Applied Part
Do not re-use
Fuse
This Side Up
Alternating Current
Dispose of Properly
Frequency
Fragile
Current
Manufacturer:
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA Tel: 1-888-272-4606 1-510-748-3200 Fax: 1-510-748-3232
12028.B 4 (4) 2019-09