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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