3M Ranger 245 User manual

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of Minneso- КОПИЯ
SECRETARY OF STATE
1. Country:
APOSTILLE
(Convention de La Haye du 5 octobre 1961)
United States of America
This Public Document: Ranger BIood/FIuid Warming Unit Model 245 Operator’s
Manual
2. has been signed by Alison Leigh Chulla
3. acting in the capacity of Notary Public, State of Minnesota
4. bears the seal/stamp of Alison Leigh Chulla, Notary Public, State of Minnesota
CERTIFIED
5. at: St. Paul, Minnesota 6, Date: August 24, 2017
7. by: Secretary of State, State of Minnesota 8. File No: 9623765-5
9. Seal/Stamp: 10. Signature:
Steve Simon
Secretary of State
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ЗМ Health Care Business 3M Center
2510 Conway Ave., Bldg. 275-5W-06
St. Paul, MN 55I44U.S.A.
651 733 1110
To whom it may concern
In my capacity as International Regulatory Affairs Associate, 3M Health Care Business,
St.Paul, MN, USA, 1 certify that the attached Instruction for Use (IFU) for 3M™ Ranger
Irrigation Blood/Fluid Warming Unit model 245 and disposable warming sets in English is
truthful and accurate.
Regina Feferman
International Regulatory Affairs Associate
3M Health Care
Date
State of Minnesota )
County of Dakota) ss
Subscribed and sworn to before me this of August, 2017.
Alison Leigh Chulla, Notary Signature
My Commission Expires: January 31, 2021
ALISON LEIGH CHULLA
Notary Public
State of Minnesota
My Commission Expires
January 31,2021
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зм
Ranger
Blood/Fluid Warming Unit
Model 245
Operator’s Manual
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TEL: [phone]
OUTSIDE OF THE USA
Contact Technical Support Service of local authorized representative of the manufacturer.
When contacting Technical Support Service, please, provide serial number of your device. Marking with
serial number is located in the lower side of the warming device.
In-warranty repair and exchange (USA)
If your RANGER Infusion Fluid Warming System 245 requires factory servicing, call 3M Customer
Support Service. To return a device to 3M for service, first obtain a Return Authorization (RA) number
from a customer service representative. Please use the (RA) number on all correspondence when returning
a device for service. A shipping carton will be delivered to you at no charge, if needed. Call your local
supplier or sales representative to inquire about loaner devices while your device is being serviced.
Disposable wanning sets are single use and are not object of maintenance and repair.
OUTSIDE USA
For in-warranty repair and replacement, please contact your local authorized representative.
Technical Service and Order Placement (USA)
INTRODUCTION
The Ranger fluid warming system includes a warming unit. Model 245, and a disposable warming sets.
The Ranger infusion fluid warming system. Model 245, is designed to warm blood, blood products, and
liquids and deliver these at flow rates from KVO (regime for "open vein maintenance" - from 8 to 15 drops
per minute) to 500 mL/min (30,000 ml/hour). At these flow rates, the device maintains fluid output
temperatures ranging from 33°C to 41 °C (Note: Output temperatures are dependant on input fluid
temperatures and flow rate). It takes less than 2 minutes to warm up to the 41 °C set point temperature.
Disposable warming sets are sterile, latex-free, single-use-only items and are designed to be used with the
reusable warming unit. Model 245. For information about using Ranger fluid wanning sets with the Ranger
infusion fluid warming unit. Model 245, refer to the "Instructions for Use" attached to each disposable set.
^The Ranger fluid warming system should only be used in healthcare facilities by trained medical
professionals.
The Ranger fluid warming unit is designed to be mounted to an I.V. pole. A handle located on the top of the
unit makes transport easy. When mounted to the I.V. pole, the unit fits easily above the 3M Bair Hugger
warming unit.
This manual includes operating instructions and unit specifications for the Ranger infusion fluid wanning
system.
Indications for use
Indication:
The RANGER fluid w^arming system is intended to warm blood, blood products, and irrigation and infusion
solutions.
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Indication for use:
- the RANGER infusion fluid warming system is intended to warm blood, blood products, and infusion
solutions.
Contraindications
Not known
Definition of Symbols
ON
ОOFF
Fuse
ACAUTION
Type BF Applied Part
х/ 's .
©
Voltage, Alternating Current (AC)
An equipotentiality plug (grounded) conduetor other than a proteetive earth eonductor or a
neutral conductor, providing a direct connection between electrical equipment and the potential
equalization busbar of the electrical installation. Please consult lEC 60601-1; 2005 for
requirements.
This system is subject to European WEEE Directive 2002/96/EC. This product contains
electrical and electronic components and must not be disposed of using standard refuse
collection. Please consult local directives for disposal of electrical and electronic equipment.
Protective earth ground
Consult instructions for use
Follow instructions for use
рллГ|
Id
Recycle to avoid environmental contamination. This product contains recyclable
parts. For information on recycling - please contact your nearest 3M Service Center for advice.
Date of manufacture
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Manufacturer
I sTEMLE|EO I Sterile, ethylene oxide
Store at room temperature
DEHP-free
Container quantity
Single use
Latex free
Keep dry
n^45-c
J Temperature limits
-20‘С-^Л
Explanation of Signal Word Consequences
/\ WARNING.
Indicates a hazardous situation, which, if not avoided, could result in death or serious injury.
/\ CAUTION.
Indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury.
NOTICE.
I Indicates a situation, which, if not avoided, could result in property damage only.
A WARNING.
1. To reduce the risks associated with hazardous voltage and fire and thermal energy hazards follow
requirements below.
• Do not substitute other devices (i.e. Model 247) for the Ranger infusion fluid warming unit or Ranger
disposable warming sets.
• Do not continue use of the unit if the over-temperature alert continues to sound and the temperature does
not return to the set point temperature. Immediately stop fluid flow and discard the warming set. Have the
fluid warming unit tested by a biomedical technician or call 3M Patient Warming technical service.
2. To reduce the risks associated with hazardous voltage and fire follow requirements below.
• Do not modify or service this device, and do not open the warming unit case as there are no user-
serviceable parts in the unit.
• Connect power cord to receptacles marked “Hospital Only,” “Hospital Grade,” or a reliably grounded
outlet.
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• Use only the power cord specified for this product and certified for the country of use.
• Do not allow the power cord to get wet.
• Do not use the Ranger blood/lluid warming system when it appears the unit power cord, or warming set
is damaged. Use only 3M specified replacement parts.
• Keep power cord visible and accessible at all times. The plug on the power cord serves as the disconnect
device. The wall socket outlet shall be as close as practical and shall be easily accessible.
3. To reduce the risks associated with air embolism follow requirements below.
• Never infuse fluids if air bubbles are present in the fluid line.
CAUTION.
1. To reduce the risks associated with cross-contamination perfonn the follow.
• The cleaning tool provides only superficial cleaning, it does not disinfect or sterilize the interior of the
unit.
2. To reduce the risks associated with impact and facility medical device damage follow recommendations
below.
• Clamp the Ranger infusion fluid wanning unit to an I.V. pole with a minimum 14” (35.6 cm) radius
^ wheelbase and at a height no higher than 44” (112 cm).
3. To reduce the risks associated with environmental contamination perform the follow.
• Follow applicable regulations when disposing of this device or any of its electronic components.
4. Do not use for direct cardiac application. When using the Ranger infusion fluid warming system with a
central venous catheter (CVC), ensure that the catheter tip does not have direct contact with the heart and
ensure that all electrical devices connected to or near the patient have an appropriate leakage current rating
for the application. If a CVC tip is found to be in direct contact with a patient’s heart, the infusion fluid
warming unit. Model 245 should be immediately disconnected from the CVC until the CVC is safely
repositioned. Failure to follow these precautions may cause cardiac disturbance and/or patient injury.
5. Follow the AABB Guidelines for the use of blood warming device which caution against warming when
administering platelets, cryoprecipitates, or granulocyte suspensions.
NOTICE.
1. Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional.
2. To avoid device damage follow the indications below:
• Do not clean the infusion fluid warming unit with solvents. Damage to the case, label, and internal
components may result.
I* Do not immerse the infusion fluid warming unit in cleaning or sterilizing solutions. The unit is not liquid
"proof.
• Do not insert metallic instruments in the infusion fluid warming unit.
• Do not use abrasive materials or solutions to clean the heater plates.
• Do not allow spills to dry inside the unit, as this may make it more difficult to clean the unit.
3. The Ranger infusion fluid warming unit meets medical electronic interference requirements. If radio
frequency interference with other equipment should occur, connect the unit to a different power source.
Product Description
The Ranger infusion fluid warming system consists of a Model 245 warming unit and a sterile disposable
warming set.
The Ranger infusion fluid warming system
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The infusion fluid wamiing unit is a compact, lightweight,
liquid-resistant device with a clamp located on the side for
attacliment to an I.V. pole. A carrying handle on the top of the
unit makes it easy to transport. Located on the front panel you
will find:
• Alphanumeric display that indicates the heater temperature
during normal operation.
kmi шсш
In an over-temperature condition, the display alternately
flashes a temperature of 43°C or higher and the word “HI.”
An audible alert also sounds. In an undertemperature condition, the display alternately flashes a
temperature of 33°C or lower and the word “LO.”
Alert indicator light that comes on when either an over- or undertemperature condition occurs.
Ranger infusion fluid warming disposable sets
ilnfusion fluid warming sets include a cassette, tubing and connectors
'compatible with hospital standard I.V. infusion fluid administration
sets, bubble trap, and injection port. The high flow set also includes 2
infusion fluid bag spikes and a 150 micron filter located in a central drip
chamber.
Ranger infusion fluid warming set specification
г
Standard Flow Fluid Warming Set High Flow Fluid Warming
Set Pediatric Fluid Warming Set
Model 24200 24250 24355 24450
Flow rate KVO-
9,000 ml/h KVO-
9,000 ml/h KVO- 3,0000 ml/h KVO- 6,000 ml/h
Priming
volume 39 ml 44 ml 150 ml 20 ml
Spike None None 2 spikes None
Heat
l^hanger,
^lensions
Length 12.662 inches
Width 5.825 mm Length 12.662 inches Width 5.825 mm Length 12.662 inches
Width 5.825 mm Length 12.662 inches Width 5.825 mm
Length of
patient line 76 cm 145 cm 152 cm 60 cm
Inner diameter
of patient line 0.118±0.003 inches 0.118±0.003 inches 0.189±0.004 inches 0.098±0.003 inches
Outer diameter
of patient line 0.161±0.003 inches 0.161±0.003 inches 0.268±0.005 inches 0.161±0.003 inches
Drip chamber None None Yes None
Bubble trap None None Yes None
Filter (Model
90029) None None Yes None
Pressure
infusion Up to 300 mm Hg Jp to 300 mm Hg Jp to
300 mm Hg N/A
Sterile EtO EtO EtO EtO
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Sterilization
validity 3 years 3 years 3 years 3 years
Use Single use Single use Single use Single use
Standard Flow Fluid Warming Set (Model 24200)
Standard Flow Fluid Warming Set are designed for cases where a moderate flow of fluid is required
• For flow rates up to 150 ml/min (9000 ml/hour)
• Priming volume: 39 ml
• Patient line: 76 cm
• STERILE and nonpyrogenic fluid pathway. Do not use if sterile barrier system has been breached
• For use with Range infusion fluids warming unit
• Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional
• Not made with natural rubber latex
Instructions For Use
Do not use if package has been previously opened or is damaged. Refer to the Range infusion fluid warming
unit Operator’s Manual for set up and use of the warming system.
^WARNING
• To reduce the risks associated with air embolism and incorrect routing of fluids follow recommendations
below:
• Never infuse fluids if air bubbles are present in the fluid line.
• Ensure all luer connections are tightened.
• Do not mount the Ranger blood fluid warming system higher than patient level, as air embolism may
result.
• This product is designed for single patient use only. 1 о reduce the risk of cross contamination or infection
do not reuse.
• To reduce the risk associated with patient exposure to leakage current that exceeds Type BF equipment
limits, do not use in combination with other medical equipment without verifying that the total leakage
current from the combined equipment does not exceed the safety limits for Type BF equipment.
• To reduce the risks associated with potential blood loss, do not use in combination w'ith an extracorporeal
circuit.
CAUTION
• Do not exceed 300 mmHg pressure.
• Follow the AABB Guidelines for the use of blood warming devices which caution against warming when
Administering platelets, cryoprecipitate, or granulocyte suspensions.
• To reduce the risks associated with potential material toxicity, do not use in combination with an
extracorporeal circuit as the Ranger infusion fluid warming system is not designed for use with a circulating
blood system; therefore, biocompatibility testing has not been completed to assess genotoxicity.
Illustration of Disposable Set A) Inlet line
B) B, E, H) Clamps
C) Fluid warming cassette D) Bubble trap
F) Patient line
G) Injection port
I) Patient connection.
e g fiG
Instructions
Remove excess air from I.V. solution containers before spiking bags.
7
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Before priming, slide the fluid warming cassette into the slot in the warming unit.
2. Connect the short inlet line (A) on the Ranger warming set to the fluid source.
3. Prime all tubing to purge air from the line. Invert the bubble trap (D) while priming and fill.
4. Turn the bubble trap right side up and prime the patient line (F).
5. Place the bubble trap into the holder on the warming unit.
6. Close all clamps.
7. Turn the warming unit on.
The fluid warming set is now ready for use.
Removing Air from the Disposable Set
1. Close the clamp (H) between the injection port (G) and the patient connection (I).
2. Invert the bubble trap.
3. Insert a syringe in the injection port and aspirate air until the bubble trap and I.V. line are free of air.
4. Place the bubble trap right side up in the holder.
5. Open the clamp and continue the infusion.
I Removing the Disposable Set
’ 1. Close the inlet clamp (B) and open the patient line clamps (E, H).
2. Disconnect the warming set from the fluid source (if applicable).
3. Allow fluid to flow into the patient (this may take 2-3 seconds).
4. Remove the fluid warming cassette from the warming unit and discard according to institutional protocol.
5. Reconnect the patient I.V. line to the fluid source to continue the infusion without warming.
Standard Flow Fluid Warming Set with Extension (Model 24250)
Standard Flow Fluid Warming Set with Extension is designed for RANGER infusion fluid warming device
application in those cases where a moderate flow of fluid is required.
• For flow rates up to 150 ml/min (9000 ml/hour).
• Priming volume: 44 ml.
• Patient line: 76 cm + plus 76 cm extension.
• STERILE and nonpyrogenic fluid pathway. Do not use if sterile barrier system has been breached.
• For use with Range infusion fluids warming unit.
• Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional,
h* Not made with natural rubber latex.
Instructions For Use
Do not use if package has been previously opened or is damaged. Refer to the Range infusion fluid warming
unit Operator’s Manual for set up and use of the wanning system.
WARNING
• To reduce the risks associated with air embolism and incorrect routing of fluids follow recommendations
listed below:
- Never infuse fluids if air bubbles are present in the fluid line.
- Ensure all luer connections are tightened.
• Do not mount the Ranger infusion fluid wanning system higher than patient level, as air embolism may
result.
• This product is designed for single patient use only. To reduce the risk of cross contamination or infection
do not reuse.
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• То reduce the risk associated with patient exposure to leakage current that exceeds Type BF equipment
limits, do not use in combination with other medical equipment without verifying that the total leakage
current from the combined equipment does not exceed the safety limits for Type BF equipment.
• To reduce the risks associated with potential blood loss, do not use in combination with an extracorporeal
circuit.
CAUTION
• Do not exceed 300 mm Hg pressure.
• Follow the AABB Guidelines for the use of blood warming devices which caution against wanning
when administering platelets, cryoprecipitate, or granulocyte suspensions.
• To reduce the risks associated with potential material toxicity, do not use in combination with an
extracorporeal circuit as the Ranger blood/fluid warming system is not designed for use with a circulating
_ __ _ blood system; therefore, biocompatibility testing has not been
^ completed to assess genotoxicity.
Illustration of Disposable Set
A) Inlet line.
B) B, E, H) Clamps.
C) Fluid warming cassette.
D) Bubble trap.
F) Patient line.
■ I G) Needleless injection port.
^ ' * 1) Patient connection.
H
0L
Instructions
Remove excess air from l.V. solution containers before spiking bags.
1. Before priming, slide the fluid warming cassette into the slot in the warming unit.
2. Connect the short inlet line (A) to the fluid source.
3. Prime all tubing to purge air from the line. Invert the bubble trap (D) while priming and fill.
4. Turn the bubble trap right side up and prime the patient line (F).
5. Place the bubble trap into the holder on the warming unit.
6. Close all clamps.
7. Turn the warming unit on.
The fluid warming set is now ready for use.
emoving Air from the Disposable Set
1. Close the clamp (H) between the injection port (G) and the patient connection (I).
2. Invert the bubble trap.
3. Insert a syringe in the injection port and aspirate air until the bubble trap and l.V. line are free of air.
4. Place the bubble trap right side up in the holder.
5. Open the clamp and continue the infusion.
Removing the Disposable Set
1. Close the inlet clamp (B) and open the patient line clamps (E, H).
2. Disconnect the warming set from the fluid source (if applicable).
3. Allow fluid to flow into the patient (this may take 2-3 seconds).
4. Remove the fluid warming cassette from the warming unit and discard according to institutional
protocol.
5. Reconnect the patient l.V. line to the fluid source to continue the infusion without warming.
Pediatric Fluid Warming Set with Fluid Aspiration Port (Model 24450)
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Pediatric Fluid Wanning Set with Fluid Aspiration Port is intended for use with RANGER Infusion Fluids
Warming Unit in the patients who require less infusion volumes, in particular, a group of pediatric / neonatal
patients.
• For flow rates up to 100 mL/min (6000 ml/hour)
• Priming volume: 20 mL
• Patient Line: 60 cm
• STERILE and nonpyrogenic fluid pathway. Do not use if sterile barrier system has been breached.
• For use with the Ranger Infusion Fluid Warming System
• Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional
• Not made with natural rubber latex
Instructions for Use
Do not use if package has been previously opened or is damaged.
Refer to Ranger Infusion Fluid Warming Unit Operator’s Manual for set up and use of the warming system.
WARNING:
• To reduce the risks associated with contamination, biohazard exposure and delay of therapy, do not use
if caps are not in place and ensure that all luer connections are securely tightened prior to priming set.
• To reduce the risks associated with air embolism and incorrect routing of fluids:
- Never infuse fluids if air bubbles are present in the fluid line.
- Ensure all luer connections are tightened.
• Do not mount the Ranger infusion fluid warming system higher than patient level, as air embolism may
result.
• This product is designed for single patient use only.
• To reduce the risk of cross contamination or infection do not reuse.
• To reduce the risk associated with patient exposure to leakage current that exceeds Type BF equipment
limits, do not use in combination with other medical equipment without verifying that the total leakage
cuiTent from the combined equipment does not exceed the safety limits for Type BF equipment.
• To reduce the risks associated with potential blood loss, do not use in combination with an extracorporeal
circuit.
CAUTION:
• Do not use with pressure, use only gravity.
• Do not inject fluids or medication through aspiration ports.
• Follow the AABB Guidelines for the use of blood warming devices which caution against warming when
administering platelets, cryoprecipitate, or granulocyte suspensions.
To reduce the risks associated with potential material toxicity, do not use in combination with an
extracorporeal circuit as the Ranger blood/fluid warming system is not designed for use with a circulating
blood system; therefore, biocompatibility testing has not been completed to assess genotoxicity.
Illustration of Disposable Set
A. Fluid warming cassette
B. Inlet clamp
C. Inlet line
D. Patient line
E. Fluid aspiration port
F. Air aspiration port
G. Bubble trap
H. Outlet clamp
10
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Instructions: See corresponding illustrations at left
Remove excess air from I.V. solution containers before spiking bags.
1. Before priming, slide the fluid warming cassette (A) into the slot in
the warming unit.
2. Connect the inlet line (B) on the Ranger warming set to the fluid
source. 3. Prime all tubing to purge air from the line. Invert the bubble trap (G)
while priming and fill. Turn the bubble trap right side up and prime the patient
line (D).
4. Place the bubble trap into the holder on the warming unit.
5. Close the outlet line clamp and turn the warming unit on. The pediatric
infusion disposable cassettes with Aspiration Port is now ready for use.
Removing the Disposable Set
1. Close the inlet clamp proximal to the fluid warming cassette and open
the outlet clamp distal to the cassette.
2. Allow fluid to flow into the patient (this may take 2-3 seconds).
3. Remove the fluid warming cassette from the wanning unit and discard
according to institutional protocol.
High Flow Fluid Warming Set (Model 24355)
High Flow Fluid Warming Set is designed for use with RANGER infusion fluids warming device for those
cases when intensive fluid flow is required.
• For flow rates up to 500 mL/min (30000 ml/h)
у Priming volume: 150 mL
• Patient line; 76 cm and 76 cm extension
• Drip rate: 20 drips per mL
• STERILE and nonpyrogenic fluid pathway. Do not use if sterile barrier system has been breached.
• For use with a Ranger Infusion Fluid Warming System.
• Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional.
• Not made with natural rubber latex
Instructions for Use
Do not use if package has been previously opened or damaged. Refer to the Ranger Infusion Fluid Warming
System Operator’s Manual for set up and use of the warming system.
WARNING
• To reduce the risks associated with contamination, biohazard exposure and delay of therapy, do not use if
caps are not in place and ensure that all luer connections are securely tightened prior to priming set.
• To reduce the risks associated with air embolism and incorrect routing of fluids:
- Never infuse fluids if air bubbles are present in the fluid line.
11
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- Ensure all luer connections are tightened.
• Do not mount the Ranger infusion fluid wanning system higher than patient level, as air embolism may
result.
• This product is designed for single patient use only. To reduce the risk of cross contamination or infection
do not reuse.
• To reduce the risk associated with patient exposure to leakage current that exceeds Type BF equipment
limits, do not use in combination with other medical equipment without verifying that the total leakage
current from the combined equipment does not exceed the safety limits for Type BF equipment.
• To reduce the risks associated with potential blood loss, do not use in combination with an extracorporeal
circuit.
CAUTION
• Do not exceed 300 mmHg pressure.
• Follow the AABB Guidelines for the use of blood warming devices which caution against warming when
administering platelets, cryoprecipitate, or granulocyte suspensions.
• To reduce the risks associated with potential material toxicity, do not use in combination with an
extracorporeal circuit as the Ranger blood/fluid warming system is not designed for use with a circulating
(blood system; therefore, biocompatibility testing has not been completed to assess gcnotoxicity.
Illustration of Disposable Set
/
В
/ „ в
В
F / ' н
A) Bag spikes
C) Drip chamber with filter
D) Inlet clamp
F) Bubble trap
H) Outlet clamp
NOTE: Change the filter when it becomes clogged or according to
institutional protocol. Additional filters may be obtained from 3M
Patient Warming.
Instructions
Remove excess air from I.V. solution containers before
spiking bags.
1. Tighten luer connections (B).
2. Before priming, slide the fluid warming cassette (E)
into the slot in the warming unit.
3. Adjust warming unit height to patient level or lower.
4. Insert the Ranger set spikes (A) into the I.V. bag ports.
5. Invert the drip chamber (C) and fill 2/3 full. Turn
upright.
6. Close the clamp below the bubble trap (F) and allow
the bubble trap to fill. Flow will stop when it is properly
filled. Gently tap the bubble trap against the warming unit
to expel any trapped air, if necessary.
7. Place the bubble trap into the holder (I) on the warming
unit.
8. Open the clamp and continue to prime the patient line.
9. Close any clamp to stop flow.
10. Turn the warming unit on.
The fluid warming set is now ready for use.
12
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Removing Air from the Bubble Trap
1. The bubble trap is designed to continuously vent air from the patient line. Monitor fluid lines to ensure
that they are air-free.
2. Gently tap the bubble trap against the wanning unit to expel any trapped air.
Removing the Disposable Set
1. Close the inlet clamp (D) proximal to the fluid warming cassette and open all clamps distal to the cassette.
2. Disconnect the Ranger set from the fluid source (if applicable).
3. Allow fluid to flow into the patient (this may take 2 to 3 seconds) and close outlet clamp (H).
4. Remove the fluid warming cassette from the warming unit and discard according to institutional protocol.
5. Reconnect the patient I.V. line to the fluid source to continue the infusion without warming.
Product safety features, Model 245
The following chart describes the safety alert features of the Ranger infusion fluid warming unit.
ALERT TYPEWHAT TO LOOK FOR DESCRIPTION/CA ACTION
Over
temperature
I alert - 43°C
Alert indicator light illuminates
and alert sounds, alphanumeric
display alternately
flashes a temperature of 43 °C or
higher and the word “HI.”
Heater temperature
rose to 43 °C
because of
transient
conditions.*
Under
temperature
alert - 33°C
Heater temperature
has fallen to 33°C.
Observe alphanumeric
display. If temperature does
not drop to 41 °C (may take a
few minutes), discontinue
use of unit. Call 3M Patient
Warming Customer Service.
Alerts stop when
temperature rises above
33°C. Continue use of unit.
If the temperature does not
rise above 33°C, unplug the
unit and call 3M Patient
Warming Customer Service.
• Transient conditions may cause an over-temperature alert condition. These conditions include:
• There was an extreme change in flow rates (e.g., from 500 mL/min to stop flow).
• The unit was turned on and reached the set point temperature of 41 °C before the warming cassette
was inserted in the device.
• Fluids were prewarmed to above 42°C before being infused.
Alert indicator light illuminates
and alert sounds, alphanumeric
display alternately
flashes a temperature of 33°C or
lower and the word “LO.”
^Warming units Rev A to M
LERT TYPE/HAT TO LOOK FOR ESCRIPTION/CAUSE CTION
СТЮ
Independent
back-up safety
alert - 46°C
• Alert indicator light illuminates
and alert sounds, alphanumeric
display alternately flashes a
temperature of 43°C or higher and
the word “HI.”
• Alphanumeric display is dark,
alert sounds (backup safety alert
still works even if display is dark).
Heater temperature rose to
46°C. Safety backup system
is activated at 46°C and unit
shuts off power to the heating
plates.
TURN OFF THE
UNIT AND
UNPLUG IT. Do not
use the unit. Discard
the disposable set.
Call 3M Patient
Warming Customer
Service.
Warming units Rev N and newer
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ALERT TYPEWHAT TO LOOK FOR
Independent
back-up safety
alert - 44°C
• Alert indicator light illuminates
and alert sounds, alphanumeric
display alternately flashes a
temperature of 43 °C or higher
and the word “HI.”
• Alphanumeric display is dark,
alert sounds (backup safety alert
still works even if display is
dark).
Heater temperature rose to
44°C. Safety backup system is
activated at 44°C and unit
shuts off power to the heating
plates.
DESCRIPTION/CAUSE TURN OFF THE
UNIT AND
UNPLUG IT. Do not
use the blood/fluid
warming unit.
Discard the set. Call
3M Patient Warming
Customer Service.
ACTION
T
41- 14-p i t OH',
Instructions for Use
Preparation and setup of the Ranger infusion fluid warming unit
1. Attach the Ranger infusion fluid wanning unit to the I.V. pole. Tighten the
pole clamp securely.
•A CAUTION. To reduce the risks associated with impact and facility medical
device damage comply with the following recommendations.
• Clamp the Ranger infusion fluid warming unit to an I.V. pole with a minimum
14” (35.6 cm) radius wheelbase and at a height no higher than 44”
(112 cm).
2. Slide the cassette into the slot in the warming unit. The cassette can only fit
into the device one way.
3. Prime the warming set. For more information about priming the set, refer to
instructions provided with the warming sets.
4. Place the bubble trap in the holder.
5. Plug the power cord into an appropriate outlet. Turn the unit ON. In a few seconds, the alphanumeric
display will illuminate. It takes less than two minutes to warm up to the 41 °C set point temperature.
6. Begin infusion. When infusion is completed, remove the warming set and discard according to
institutional protocol.
Removing the warming set from the Ranger infusion fluid warming unit
1. Close the inlet clamp proximal to the cassette and open all clamps distal to the cassette.
^1^2. Disconnect the warming set from the fluid source, if applicable.
3. Allow fluid to flow to the patient (this may take 2-3 seconds). Close a distal clamp.
4. Remove the cassette from the warming unit and discard according to institutional protocol.
5. Reconnect the patient I.V. line to the fluid source to continue the infusion without wanning.
Transferring the warming set from one Ranger warming unit to another
1. Follow steps 1-3 above, then remove the warming set from the first warming unit.
2. During transport, keep the clamps closed and do not infuse fluids while the cassette is outside of the
warming unit.
3. Slide the cassette into the second warming unit.
4. Ensure that air is removed from the tubing.
5. Open the clamps and continue the infusion.
Troubleshooting
CONDITION CAUSE SOLUTION
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Nothing illuminates on the
warming unit panel. • Unit is not turned on, plugged
in, or power cord is not plugged
into an appropriate outlet.
• Unit failure.
• Turn unit on. Make sure the power
cord is plugged into the power entry
module of the warming unit. Make
sure the warming unit is plugged into
a properly grounded outlet.
• Call 3M Patient Wanning Customer
Service.
Alert indicator illuminates and
alert sounds, alphanumeric
display alternately flashes a
temperature of 43°C or higher
and the word “HI.”
Temporary over-temperature
condition because.
• An extreme change in flow
rates occurred (e.g., from 500
mL/min to stop flow).
• Unit was turned on and
reached set point temperature
before cassette was inserted.
• Fluids were prewarmed to
above 42°C before being run
through the warming unit.
• Open flow to reduce temperature.
Alerts will stop when the display
reads 41 °C. The unit is ready to use.
• Alerts will stop when the display
reads 41°C. The unit is ready to use.
• Turn off unit and unplug it.
Discontinue infusion of fluids. Do
not warm fluids before infusing them
through the Ranger warming unit.
Alert sounds, alphanumeric
display and alert indicator light
go dark.
Primary controller failure. Unit
will no longer operate. Power to heating plates will shut off
if temperature rises to 44°C
(warming unit Rev N and newer) or
46°C (wanning units Rev A to M).
Turn unit off and unplug it.
Discontinue use of unit. Discard
disposable set. Alert will continue to
sound if you do not unplug unit. Call
3M Patient Warming Customer
Service.
• Unit alerts soon after plugging
it in (unit does not have to be
turned on for this condition to
occur).
• Heater temperature rises to
k44°C (warming units Rev N
and newer) or 46°C (warming
units Rev A to M) and unit
shuts down soon after plugging
it in (unit does not have to be
turned on for this condition to
occur).
Test screw on bottom of unit is
loose or missing. Make sure test screw is completely
tightened. If it is missing, turn unit
off and unplug it. Call 3M Patient
Warming Customer Service.
Alert sounds but unit has been
turned off. Independent backup safety system has been activated. Unplug unit. Call 3M Patient Warming Customer
Service.
Cannot remove cassette from
unit. • Cassette is too full, fluids are
still being infused, or clamp is
open proximal to the cassette.
• Warming unit is below
patient level, creating
• Make sure fluid is drained from
cassette before sliding out the
cassette, that fluids are no longer
infusing, and that clamp is closed
proximal to the warming cassette.
15
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excessive back pressure. • Raise unit above patient level.
Alert indicator light
illuminates and alert
sounds, alphanumeric display
alternately flashes a
temperature of 33°C or below
and the word “LO.”
Under temperature condition
caused by very high flow using
very cold fluid, or defective
heater/relay.
Alert should stop when temperature
rises above 33°C. If alert continues,
turn unit off unplug unit and
discontinue use. Call 3M Patient
Warming Customer Service
Alphanumeric display reads
“Er 4” or “Open.” Open wire on temperature
sensor. Do not use unit. Call 3M Patient
Warming Customer Service.
Alphanumeric display reads
“Er 5” or “Open.” Electrical interference. Remove the unit. Refer to biomedical
technician or call 3M Patient
Warming Customer Service.
CLEANING
. Cleaning the Ranger infusion fluid warming unit
w Clean the Ranger warming unit on an as-needed basis.
A CAUTION
1. To reduce the risks associated with cross-contamination:
• The cleaning tool provides only superficial cleaning, it does not disinfect or sterilize the interior of the
unit.
NOTICE
1. To avoid device damage follow the instructions below.
» Do not immerse the warming unit in cleaning or sterilizing solutions. The unit is not liquid proof
• Do not clean the warming unit with solvents. Damage to the case, label, and internal components may
result.
• Do not insert metallic instruments in the warming unit.
• Do not use abrasive materials or solutions to clean the heater plates.
• Do not allow spills to dry inside the unit, as this may make it more difficult to clean the unit.
TO CLEAN THE EXTERIOR OF THE WARMING UNIT FOLLOW THE INSTRUCTIONS
BELOW.
^ 1. Disconnect the Ranger warming unit from the power source.
2. Wipe the outside of the unit with warm, soapy water, nonabrasive cleaning solutions, dilute bleach, or
cold sterilants. Do not use abrasive materials.
3. Wipe with a dry, soft cloth.
CLEAN THE HEATING PLATES FOLLOW THE INSTRUCTIONS BELOW.
The Ranger hardware cleaning tool is intended to clean both heating plates of the warming unit. It is not
necessary to disassemble the warming unit to use the tool.
METHOD OF CLEANING
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1. Unplug the warming unit.
2. Unfold the cleaning tool. Wet the foam pads with a nonabrasive solution,
such as Alconox™ brand detergent.
3. Insert the tool from the back of the unit and pull the tool all the way out
from the front.
4. Rinse the tool with water and repeat 3 times. Dispose cassette in
accordance with the rules of the medical protocol.
5. Wipe off the unit to remove excess fluid.
TO CLEAN RESISTANT, DRIED-ON FLUIDS FOLLOW THE INSTRUCTIONS BELOW.
1. Spray a nonabrasive solution inside the slot of the warming unit and let sit for 15-20 minutes.
2. Clean the unit by using the cleaning tool.
^^Note: If the cleaning tool cannot be inserted through the slot of the warming unit because of excess dried-
on fluids, send the unit to a 3M biomedical technician.
Storage
Store all components in a cool, dry place when not in use.
Servicing
There are no user-serviceable parts in the Ranger infusion fluid warming unit. All service must be performed
by 3M Patient Warming or an authorized service technician.
Call 3M Patient Warming Technical Service at 800-228-3957 for service information. Outside of the
USA contact your local 3M representative.
SPECIFICATIONS
Recommendations and statement of the equipment manufacturer: electromagnetic radiation
Device, Model 245, is
user of the Device, Mocdesigned for use in electromagnetic environment described below. The buyer or
el 245, should ensure the device use in this environment.
Radiation test Compliance Electromagnetic environment: recommendations
Radiation test
' CISPR 11 Group 1 Device, Model 245, uses radio frequency energy only to
perform its internal functions. In this regard, the level of radio
frequency radiation is extremely low and, most likely, will not
affect the operation of nearby electronic equipment.
Radio radiation
CISPR 11 Class В Device, Model 245, is suitable for use in any premises,
including residential and directly connected to low-voltage
public utility networks, which provide electricity to
residential buildings.
Emission of harmonic
current components
lEC 61000-3-2
Class A
Voltage fluctuations
and flicker
lEC 61000-3-3
Requirements
are met
Recommendations and statement of the equipment manufacturer; electromagnetic stability
17
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Device, Model 245, is designed for use in electromagnetic environment described below. The buyer or
user of the Device, Model 245, should ensure the device use in this environment.
Electromagnetic
stability test Test level
according to
lEC 60601
Level of
compliance Electromagnetic environment:
recommendations
Electrostatic
discharges
lEC 61000-4-2
contact ±6 kV
air ±8 kV contact ±6 kV air ±8 kV Floors should be wooden, cement or
covered with ceramic tiles. If the floors are
covered with synthetic material, the relative
humidity should be at least 30%.
Fast electrical
transients or bursts
of pulses
lEC 61000-4-4
power lines ± 2
kV power lines ± 2
kV The quality of the electricity supply
network should meet the standard
requirements for commercial or medical
institutions.
Dynamic changes in
supply voltage
lEC 61000-4-5
interphase
voltage ± 1 kV
phase voltage ±
2kV
interphase
voltage ± 1 kV
phase voltage ±
2kV
The quality of the electricity supply
network should meet the standard
requirements for commercial or medical
institutions.
Voltage dips, short
term faults and
voltage fluctuations
lEC 61000-4-11
< 5 % Ut
(dip > 95 %
from Uy)
for 0.5 period
40 % Uy
(dip 60 %
from Uy)
for 6 periods
70 % Uy
(dip 30 %
from Uy)
for 30 periods
< 5 % Uy
(dip > 95 %
from Uy)
for 5 seconds
< 5 % Uy
(dip > 95 %
from Uy)
for 0.5 period
40 % Uy
(dip 60 %
from Uy)
for 6 periods
70 % Uy
(dip 30 %
from Uy)
for 30 periods
< 5 % Uy
(dip > 95 %
from Uy)
for 5 seconds
The quality of the electricity supply
network should meet the standard
requirements for commercial or medical
institutions. If user of the Device, Model
245, should continuously operate the device
during power failure, it is recommended to
use an uninterruptible power supply or
battery as a power source of the device.
Magnetic field of
industrial frequency
(50-60 Hz)
lEC 61000-4-8
3 A/m 3 A/m Characteristics of magnetic fields of
industrial frequency should be at the level
characteristic for the typical room in a
typical commercial or medical institution.
NOTE, f/т - АС voltage before test level application.
Recommendations and statement of the equipment manufacturer: electromagnetic stability _______
Device, Model 245, is designed for use in electromagnetic environment described below. The buyer or
user of the Device, Model 245, should ensure the device use in this environment.
18
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