Maintenance Guide
10 Pages
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™ Ranger™ Pressure Infusor Model 145 Maintenance Guide Preventative Maintenance... 1 Inspection Checklist ... 4 Replacement Instructions... 5 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ... 7
About this Maintenance Guide
This maintenance guide describes the maintenance of the 3M™ Ranger™ pressure infusor. This maintenance guide and the Ranger pressure infusor are to be used only by individuals trained in the healthcare and biomedical professions. Read and follow all instructions, labeling, and accompanying documents supplied with this medical device. Failure to follow instructions could lead to misuse of the device or device malfunction.
Preventative Maintenance 1
Visual inspection
Carefully inspect the Ranger pressure infusor for signs of damage. For a list of recommended inspections and instructions see the “Inspection Checklist” on page 4.
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Cleaning the Ranger pressure infusor
Service frequency
Clean the Ranger pressure infusor unit on an as-needed basis or according to institutional protocol. NOTICE: • Do not immerse the pressure infusor or use a dripping wet cloth for cleaning. Moisture may seep inside the device and damage the electrical components. Clean the pressure infusor exterior with a soft cloth using plain water or a mild, all-purpose or nonabrasive cleaner. • Do not spray cleaning solutions on to the pressure infusor. Damage to the pressure infusor may occur.
Cleaning the Ranger pressure infusor and cord
Clean the Ranger pressure infusor on an as-needed basis or per facility policies and procedures for cleaning electronic equipment. 1. Disconnect power supply from power outlet. 2. Use a slightly damp soft cloth moistened with a mild, nonabrasive cleaning solution or disinfectant to clean the device surfaces and cord. Avoid getting liquid into electronic ports. 3. Dry with a separate soft cloth.
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MAGENTA
YELLOW
BLACK
34-8715-3543-0
SILVER
PMS 5265 C
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CYAN
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Indicator inspection
1. Plug the Ranger pressure infusor into an appropriate outlet. 2. Turn the main power switch located underneath the pressure infusor ON. Verify all the Ranger pressure infusor status indicators and power button indicators illuminate for approximately two seconds (see Figure 1). 3. Repeat as necessary to verify the indicators.
Figure 1: Illuminated indicators
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Testing the pressure infusors
Tools and equipment • •
mmHg pressure gauge Saline/fluid bag (6” x 10” [152.4 x 254 mm]), 1000 mL, unpurged
Method 1. Insert the saline bag into an infusor. Note: For the following instructions, observed output pressure of the Ranger pressure infusor is dependent on surface area and volume of the fluid bag. To verify the output pressure, use an independent, calibrated pressure gauge and a new, unpurged 1000 mL (6” x 10” [152.4 x 254 mm]) fluid bag. 2. Prime the entire fluid outlet tube and attach to an independent calibrated pressure gauge. The inlet of the calibrated pressure gauge should sit at the same height as the fluid output (see Figure 2).
Figure 2: Pressure gauge 3. Zero the pressure gauge and confirm the unit of measure on the pressure gauge is “mmHg”. 4. Turn ON the pressure infusor by pressing the pressure infusor power button on the pressure infusor control panel. 5. Wait three minutes for pressure infusor to stabilize pressure. 6. Verify calibrated pressure gauge reading is within 250-340 mmHg with no flow. Note: The reading on the calibrated pressure gauge will vary with the surface area and volume of the fluid bag. 7. If the pressure infusor is outside of the calibration range please call 3M Customer Service at 1-800-228-3957. 8. Turn OFF the pressure infusor. 9. Repeat in second chamber if calibration is within specification.
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Inspection Checklist Maintenance Action Performed Model ____________ sn______________ Item
Instructions
Pressure infusor bladder
If damaged or missing, replace. See “Bladder replacement” on page 5 for instructions.
Completed
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Pressure infusor door latch If damaged, replace. See “Pressure infusor door latch replacement” on page 6 for instructions.
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Pressure infusor door
If cracked, replace. See “Pressure infusor door replacement” on page 7 for instructions.
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Pressure infusor fingers
Verify that there are no sharp edges that could potentially puncture a fluid bag.
□
Power cord
Confirm there are no cracks in the power cord. Confirm the cord retainer is present and held by two screws. Replace if necessary.
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Replacement Instructions Bladder replacement Method 1. Remove the pressure infusor bladder by lifting and pulling the bladder away from the nut.
Figure 3: Remove pressure infusor bladder 2. To reattach, use your thumbs to fit one side of the bladder port on the nut and stretch circumference of hole into place.
Figure 4: Attach pressure infusor bladder
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Removing the back of the pressure infusor Tools and equipment •
Medium Phillips™ screwdriver.
Method 1. Remove the Ranger pressure infusor from the I.V. pole. 2. Loosen (do not remove) the vent cover screw on the top of the pressure infusor. 3. Remove the eight pressure infusor case screws and four I.V. pole mount bracket screws, set aside.
Screws
Screws
Figure 5: Remove pressure infusor screws
Pressure infusor door latch replacement Tools and equipment •
Medium Phillips screwdriver.
Method 1. Remove the pressure infusor back. See above for instructions. 2. Remove the two latch screws from the back of the pressure infusor door latch that needs to be replaced (see Figure 6). Latch screws Pin heads
Figure 6: Pressure infusor door latch replacement
Figure 7: Head of latch pin
3. Replace the pressure infusor door latch. Verify the finger lip of the latch faces towards infusor chamber so that it can retain the pressure infusor door. Confirm the head of the latch pin faces up (see Figure 7). 4. Replace the pressure infusor case back.
Phillips is a trademark of Phillips Screw Company.
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Pressure infusor door replacement Tools and Equipment •
Medium Phillips screwdriver.
Method 1. 2. 3. 4.
Remove pressure infusor back. See “Removing the back of the pressure infusor” on page 6 for instructions. Remove two screws that hold the hinge rod and hinge in place. Remove and replace the pressure infusor door. Confirm the hinge retainer washers are placed securely on each end of the hinge rod before tightening the screws.
Correctly placed hinge washers
Figure 8: Attach pressure infusor door 5. Replace the pressure infusor housing back.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The model 145 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 145 should assure that it is used in such an environment. Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
The model 145 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.
Class B
The model 145 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
CISPR 11 RF emissions CISPR 11 Harmonic emissions
Class A
IEC 61000-3-2 Voltage fluctuations/ Flicker emissions
Complies
IEC 61000-3-3
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The model 145 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 145 should assure that it is used in such an environment. Immunity Test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge (ESD)
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
±2 kV power lines
±2 kV power lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge
±1 kV line to line
±1 kV line to line
IEC 61000-4-5
±2 kV line to gnd
±2 kV line to gnd
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
<5% UT (>95% dip in UT) for 0,5 cycle
<5% UT (>95% dip in UT) for 0,5 cycle
40% UT (60% dip in UT) for 5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 sec
<5% UT (>95% dip in UT) for 5 sec
3 A/m
3 A/m
IEC 61000-4-2
Electrical fast transient/ burst IEC 61000-4-4
IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
NOTE
Mains power quality should be that of a typical commercial or hospital environment. If the user of the model 145 requires continued operation during power mains interruptions, it is recommended that the model 145 be powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
UT is the a.c. mains voltage prior to application of the test level.
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The model 145 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 145 should assure that it is used in such an environment. Immunity Test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3V
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2,5 GHz
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the model 145, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2,5 GHz 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 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. 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 model 145 is used exceeds the applicable RF compliance level above, the model 145 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the model 145. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. a
Recommended separation distances between portable and mobile RF communications equipment and the model 145. The model 145 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model 145 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model 145 as recommended below, according to the maximum output power of the communications equipment.
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Rated maximum output power of transmitter W
Separation distance according to frequency of transmitter 150 kHz to 80 MHz d = 1.2√P
80 MHz to 800MHz d = 1.2√P
800 MHz to 2,5 GHz d = 2.3√P
0,01
0.12
0.12
0.23
0,1
0.37
0.37
0.74
1
1.17
1.17
2.30
10
3.69
3.69
7.37
100
11.67
11.67
23.30
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. 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. NOTE 3 V1 is the value from the conducted RF immunity test and E1 is the value from the radiated RF immunity test.
Made in the USA of globally sourced material by 3M Health Care. 3M, RANGER and the BAIR HUGGER logo are trademarks of 3M. Used under license in Canada. ©2014, 3M. All rights reserved. Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional. 3M Deutschland GmbH, Health Care Business Carl-Schurz-Str. 1, 41453 Neuss, Germany 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144 USA TEL 800-228-3957 • www.rangerfluidwarming.com Issue Date: 2014-09 34-8715-3543-0
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