3M Ranger Blood-Fluid Warming System Model 245 Operators Manual

Ranger™ Blood/Fluid Warming System Model 245

English

TABLE OF CONTENTS Technical Service and Order Placement ... 2 Introduction ... 3 Indications for use ... 3 Definition of Symbols ... 3 Explanation of Signal Word Consequences ... 4 WARNING: ... 5 CAUTION: ... 5 NOTICE:... 6 Product Description ... 6 The Ranger blood/fluid warming unit... 6 Ranger blood/fluid warming set ... 6 Product safety features ... 6 Instructions for Use ... 8 Preparation and setup of the Ranger blood/fluid warming unit ... 8 Removing the warming set from the Ranger blood/fluid warming unit ... 8 Transferring the warming set from one Ranger warming unit to another ... 8 Troubleshooting ... 9 Maintenance and Storage...11 Cleaning the Ranger blood/fluid warming unit ...11 Specifications ...12 Physical Characteristics ...14

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Ranger™ Blood/Fluid Warming System Model 245

Technical Service and Order Placement USA TEL: 1-800-228-3957

Outside of the USA Contact your local 3M representative.

In-warranty repair and exchange 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.

When you call for technical support Remember, we will need to know the serial number of your unit when you call us. The serial number label is located on the bottom of the warming unit.

Ranger™ Blood/Fluid Warming System Model 245

English

Introduction The 3M™ Ranger™ blood/fluid warming system includes a warming unit and a disposable warming set. The Ranger blood/fluid warming system is designed to warm blood, blood products, and liquids and deliver these at flow rates from KVO to 500 mL/min. At these flow rates, the device maintains fluid output temperatures ranging from 33°C to 41°C (Note: Output temperatures are dependent on input fluid temperatures and flow rate). It takes less than 2 minutes to warm up to the 41°C set point temperature. The alert points on the Model 245 are 43° and 44° C. Disposable blood/fluid warming sets are available in: pediatric flow, standard flow, and high flow applications. Warming sets are sterile, not made with natural rubber latex, single-use-only items and are designed to be used with the warming unit. The Ranger blood/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. For additional information on the Ranger blood/fluid warming sets visit us online at rangerfluidwarming.com. This manual includes operating instructions and unit specifications for the Ranger blood/fluid warming system. For information about using Ranger blood/fluid warming sets with the Ranger blood/fluid warming unit, Model 245, refer to the “Instructions for Use” included with each warming set. The Ranger blood/fluid warming system should only be used in healthcare facilities by trained medical professionals.

Indications for use The Ranger blood/fluid warming system is intended to warm blood, blood products, and liquids.

Definition of Symbols ON

OFF

Fuse

CAUTION

Type BF Applied Part

Voltage, Alternating Current (AC)

An equipotentiality plug (grounded) conductor other than a protective earth conductor or a neutral conductor, providing a direct connection between electrical equipment and the potential equalization busbar of the electrical installation. Please consult IEC 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

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Ranger™ Blood/Fluid Warming System Model 245

Technical Service and Order Placement USA TEL: 1-800-228-3957

Outside of the USA Contact your local 3M representative.

In-warranty repair and exchange 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.

When you call for technical support Remember, we will need to know the serial number of your unit when you call us. The serial number label is located on the bottom of the warming unit.

Ranger™ Blood/Fluid Warming System Model 245

English

Introduction The 3M™ Ranger™ blood/fluid warming system includes a warming unit and a disposable warming set. The Ranger blood/fluid warming system is designed to warm blood, blood products, and liquids and deliver these at flow rates from KVO to 500 mL/min. At these flow rates, the device maintains fluid output temperatures ranging from 33°C to 41°C (Note: Output temperatures are dependent on input fluid temperatures and flow rate). It takes less than 2 minutes to warm up to the 41°C set point temperature. The alert points on the Model 245 are 43° and 44° C. Disposable blood/fluid warming sets are available in: pediatric flow, standard flow, and high flow applications. Warming sets are sterile, not made with natural rubber latex, single-use-only items and are designed to be used with the warming unit. The Ranger blood/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. For additional information on the Ranger blood/fluid warming sets visit us online at rangerfluidwarming.com. This manual includes operating instructions and unit specifications for the Ranger blood/fluid warming system. For information about using Ranger blood/fluid warming sets with the Ranger blood/fluid warming unit, Model 245, refer to the “Instructions for Use” included with each warming set. The Ranger blood/fluid warming system should only be used in healthcare facilities by trained medical professionals.

Indications for use The Ranger blood/fluid warming system is intended to warm blood, blood products, and liquids.

Definition of Symbols ON

OFF

Fuse

CAUTION

Type BF Applied Part

Voltage, Alternating Current (AC)

An equipotentiality plug (grounded) conductor other than a protective earth conductor or a neutral conductor, providing a direct connection between electrical equipment and the potential equalization busbar of the electrical installation. Please consult IEC 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

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Ranger™ Blood/Fluid Warming System Model 245

Consult instructions for use

Ranger™ Blood/Fluid Warming System Model 245

WARNING: 1.

Follow instructions for use

Recycle to avoid environmental contamination. This product contains recyclable parts. For information on recycling - please contact your nearest 3M Service Center for advice.

English

2.

Date of manufacture

Manufacturer

Sterile, ethylene oxide

Store at room temperature

Container quantity

3.

Do not reuse

4. 5.

Not made with natural rubber latex

To reduce the risks associated with hazardous voltage and fire and thermal energy hazards: • Do not substitute other devices (i.e. Model 247) for the Ranger blood/fluid warming unit or Ranger blood/fluid 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 blood/fluid warming unit tested by a biomedical technician or call 3M Patient Warming technical service. To reduce the risks associated with hazardous voltage and fire: • 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. • 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/fluid 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. • Do not use with a multiple socket outlet or extension cord. • Do not use this equipment adjacent to, stacked with or in combination with other equipment without verifying that the total leakage current from the combined equipment does not exceed the safety limits for Type BF equipment and to assure normal operation in the configuration in which it will be used. 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 blood fluid warming system higher than patient level during infusion, as air embolism may result. To reduce the risks associated with potential blood loss, do not use in combination with an extracorporeal circuit.

CAUTION: Keep dry

1.

2. Temperature limits 3.

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: Indicates a situation which, if not avoided, could result in property damage only.

CONTRAINDICATIONS: None.

4. 5.

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. To reduce the risks associated with impact and facility medical device damage: • Clamp the Ranger blood/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). To reduce the risks associated with environmental contamination: • Follow applicable regulations when disposing of this device or any of its electronic components. • Do not use for direct cardiac application. When using the Ranger blood/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 blood/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. Follow the AABB Guidelines for the use of blood warming devices which caution against warming when administering platelets, cryoprecipitate, or granulocyte suspensions. The 3M Ranger blood/fluid warming system has been tested to be resistant to both electromagnetic fields (EMI) and electrostatic discharge (ESD). To reduce the risk associated with EMI due to portable and mobile RF communications equipment: • Install and put into service the 3M Ranger blood/fluid warming system according to the EMC information provided in the Guidance and Manufacturer's Declaration. • Should interference occur move away from the portable or mobile RF communications equipment.

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Ranger™ Blood/Fluid Warming System Model 245

Consult instructions for use

Ranger™ Blood/Fluid Warming System Model 245

WARNING: 1.

Follow instructions for use

Recycle to avoid environmental contamination. This product contains recyclable parts. For information on recycling - please contact your nearest 3M Service Center for advice.

English

2.

Date of manufacture

Manufacturer

Sterile, ethylene oxide

Store at room temperature

Container quantity

3.

Do not reuse

4. 5.

Not made with natural rubber latex

To reduce the risks associated with hazardous voltage and fire and thermal energy hazards: • Do not substitute other devices (i.e. Model 247) for the Ranger blood/fluid warming unit or Ranger blood/fluid 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 blood/fluid warming unit tested by a biomedical technician or call 3M Patient Warming technical service. To reduce the risks associated with hazardous voltage and fire: • 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. • 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/fluid 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. • Do not use with a multiple socket outlet or extension cord. • Do not use this equipment adjacent to, stacked with or in combination with other equipment without verifying that the total leakage current from the combined equipment does not exceed the safety limits for Type BF equipment and to assure normal operation in the configuration in which it will be used. 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 blood fluid warming system higher than patient level during infusion, as air embolism may result. To reduce the risks associated with potential blood loss, do not use in combination with an extracorporeal circuit.

CAUTION: Keep dry

1.

2. Temperature limits 3.

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: Indicates a situation which, if not avoided, could result in property damage only.

CONTRAINDICATIONS: None.

4. 5.

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. To reduce the risks associated with impact and facility medical device damage: • Clamp the Ranger blood/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). To reduce the risks associated with environmental contamination: • Follow applicable regulations when disposing of this device or any of its electronic components. • Do not use for direct cardiac application. When using the Ranger blood/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 blood/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. Follow the AABB Guidelines for the use of blood warming devices which caution against warming when administering platelets, cryoprecipitate, or granulocyte suspensions. The 3M Ranger blood/fluid warming system has been tested to be resistant to both electromagnetic fields (EMI) and electrostatic discharge (ESD). To reduce the risk associated with EMI due to portable and mobile RF communications equipment: • Install and put into service the 3M Ranger blood/fluid warming system according to the EMC information provided in the Guidance and Manufacturer's Declaration. • Should interference occur move away from the portable or mobile RF communications equipment.

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Ranger™ Blood/Fluid Warming System Model 245

Ranger™ Blood/Fluid Warming System Model 245

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NOTICE:

Product safety features

1.

The following chart describes the safety alert features of the Ranger blood/fluid warming unit.

1.

Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional. To avoid device damage: • Do not clean the blood/fluid warming unit with solvents. Damage to the case, label, and internal components may result. • Do not immerse the blood/fluid warming unit in cleaning or sterilizing solutions. The unit is not liquid proof. • Do not insert metallic instruments in the blood/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. • The Ranger blood/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.

ALERT TYPE

The Ranger blood/fluid warming unit

Alert indicator light Slot for cassette

The blood/fluid warming unit is a compact, lightweight, liquid-resistant device with a clamp located on the side for attachment to an I.V. pole (see Figure 1). A carrying handle on the top of the unit makes it easy to transport. I.V. pole Located on the front panel you will find: clamp • Alphanumeric display that Alphanumeric indicates the heater temperature Power switch display Bubble trap holder during normal operation. In an Figure 1 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 under-temperature 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 under-temperature condition occurs.

Ranger blood/fluid warming set

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.*

Observe alphanumeric display. If temperature does not drop to 41°C (may take a few minutes), discontinue use of unit. Call 3M customer service.

Undertemperature alert - 33°C

Alert indicator light illuminates and alert sounds, alphanumeric display alternately flashes a temperature of 33°C or lower and the word “LO.”

Heater temperature has fallen to 33°C.

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 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 TYPE

FLOW RATE

PRIMING VOLUME

PATIENT LINE LENGTH

150 mL/min

39-44 mL

76 cm 152 cm (76 cm patient line plus 76 cm extension)

High Flow Set

100-500 mL/min

65-150 mL

152 cm (76 cm patient line plus 76 cm extension)

WHAT TO LOOK FOR

DESCRIPTION/

ACTION

CAUSE

Independent back-up safety alert - 44°C

Warming Set

Standard Flow Set

ACTION

Overtemperature alert - 43°C

Figure 2

Blood/fluid warming sets include a cassette, tubing and connectors compatible with hospital standard I.V. blood/fluid administration sets and a bubble trap.

DESCRIPTION/ CAUSE

Product Description The Ranger blood/fluid warming system consists of a Model 245 warming unit and a sterile warming set.

WHAT TO LOOK FOR

Pediatric/Neonate 100 mL/min 20 mL 46 cm Refer to the instructions provided with each warming set for information on use.

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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.

TURN OFF THE UNIT AND UNPLUG IT. Do not use the blood/fluid warming unit. Discard the disposable set. Call 3M customer service.

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Ranger™ Blood/Fluid Warming System Model 245

Ranger™ Blood/Fluid Warming System Model 245

English

NOTICE:

Product safety features

1.

The following chart describes the safety alert features of the Ranger blood/fluid warming unit.

1.

Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional. To avoid device damage: • Do not clean the blood/fluid warming unit with solvents. Damage to the case, label, and internal components may result. • Do not immerse the blood/fluid warming unit in cleaning or sterilizing solutions. The unit is not liquid proof. • Do not insert metallic instruments in the blood/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. • The Ranger blood/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.

ALERT TYPE

The Ranger blood/fluid warming unit

Alert indicator light Slot for cassette

The blood/fluid warming unit is a compact, lightweight, liquid-resistant device with a clamp located on the side for attachment to an I.V. pole (see Figure 1). A carrying handle on the top of the unit makes it easy to transport. I.V. pole Located on the front panel you will find: clamp • Alphanumeric display that Alphanumeric indicates the heater temperature Power switch display Bubble trap holder during normal operation. In an Figure 1 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 under-temperature 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 under-temperature condition occurs.

Ranger blood/fluid warming set

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.*

Observe alphanumeric display. If temperature does not drop to 41°C (may take a few minutes), discontinue use of unit. Call 3M customer service.

Undertemperature alert - 33°C

Alert indicator light illuminates and alert sounds, alphanumeric display alternately flashes a temperature of 33°C or lower and the word “LO.”

Heater temperature has fallen to 33°C.

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 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 TYPE

FLOW RATE

PRIMING VOLUME

PATIENT LINE LENGTH

150 mL/min

39-44 mL

76 cm 152 cm (76 cm patient line plus 76 cm extension)

High Flow Set

100-500 mL/min

65-150 mL

152 cm (76 cm patient line plus 76 cm extension)

WHAT TO LOOK FOR

DESCRIPTION/

ACTION

CAUSE

Independent back-up safety alert - 44°C

Warming Set

Standard Flow Set

ACTION

Overtemperature alert - 43°C

Figure 2

Blood/fluid warming sets include a cassette, tubing and connectors compatible with hospital standard I.V. blood/fluid administration sets and a bubble trap.

DESCRIPTION/ CAUSE

Product Description The Ranger blood/fluid warming system consists of a Model 245 warming unit and a sterile warming set.

WHAT TO LOOK FOR

Pediatric/Neonate 100 mL/min 20 mL 46 cm Refer to the instructions provided with each warming set for information on use.

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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.

TURN OFF THE UNIT AND UNPLUG IT. Do not use the blood/fluid warming unit. Discard the disposable set. Call 3M customer service.

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Ranger™ Blood/Fluid Warming System Model 245

Ranger™ Blood/Fluid Warming System Model 245

English

Instructions for Use

Troubleshooting

Preparation and setup of the Ranger blood/fluid warming unit

CONDITION

CAUSE

SOLUTION

Nothing illuminates on the warming unit panel.

•

Unit is not turned on, plugged in, or power cord is not plugged into an appropriate outlet.

•

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.

•

Unit failure.

• •

Check panel fuses Call 3M technical service.

1.

Attach the Ranger blood/fluid warming unit to the I.V. pole. Tighten the pole clamp securely (see Figure 3).

CAUTION: To reduce the risks associated with impact and facility medical device damage: • Clamp the Ranger blood/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 (see Figure 4). 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.

44" (112 cm)

14" (35.6 cm)

Figure 3

CONDITION

CAUSE

SOLUTION

Alert indicator illuminates and alert sounds, alpha-numeric display alternately flashes a temperature of 43°C or higher and the word “ HI.”

Temporary overtemperature 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.

•

CONDITION

CAUSE

SOLUTION

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 (warming 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 technical service.

Figure 4

Removing the warming set from the Ranger blood/fluid warming unit 1. 2. 3. 4. 5.

Close the inlet clamp proximal to the cassette and open all clamps distal to the cassette. Disconnect the warming set from the fluid source, if applicable. Allow fluid to flow to the patient (this may take 2-3 seconds). Close a distal clamp. Remove the cassette from the warming unit and discard according to institutional protocol. Reconnect the patient I.V. line to the fluid source to continue the infusion without warming.

Transferring the warming set from one Ranger warming unit to another 1. 2. 3. 4. 5.

Follow steps 1-3 above, then remove the warming set from the first warming unit. During transport, keep the clamps closed and do not infuse fluids while the cassette is outside of the warming unit. Slide the cassette into the second warming unit. Ensure that air is removed from the tubing. Open the clamps and continue the infusion.

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•

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.

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Ranger™ Blood/Fluid Warming System Model 245

Ranger™ Blood/Fluid Warming System Model 245

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Instructions for Use

Troubleshooting

Preparation and setup of the Ranger blood/fluid warming unit

CONDITION

CAUSE

SOLUTION

Nothing illuminates on the warming unit panel.

•

Unit is not turned on, plugged in, or power cord is not plugged into an appropriate outlet.

•

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.

•

Unit failure.

• •

Check panel fuses Call 3M technical service.

1.

Attach the Ranger blood/fluid warming unit to the I.V. pole. Tighten the pole clamp securely (see Figure 3).

CAUTION: To reduce the risks associated with impact and facility medical device damage: • Clamp the Ranger blood/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 (see Figure 4). 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.

44" (112 cm)

14" (35.6 cm)

Figure 3

CONDITION

CAUSE

SOLUTION

Alert indicator illuminates and alert sounds, alpha-numeric display alternately flashes a temperature of 43°C or higher and the word “ HI.”

Temporary overtemperature 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.

•

CONDITION

CAUSE

SOLUTION

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 (warming 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 technical service.

Figure 4

Removing the warming set from the Ranger blood/fluid warming unit 1. 2. 3. 4. 5.

Close the inlet clamp proximal to the cassette and open all clamps distal to the cassette. Disconnect the warming set from the fluid source, if applicable. Allow fluid to flow to the patient (this may take 2-3 seconds). Close a distal clamp. Remove the cassette from the warming unit and discard according to institutional protocol. Reconnect the patient I.V. line to the fluid source to continue the infusion without warming.

Transferring the warming set from one Ranger warming unit to another 1. 2. 3. 4. 5.

Follow steps 1-3 above, then remove the warming set from the first warming unit. During transport, keep the clamps closed and do not infuse fluids while the cassette is outside of the warming unit. Slide the cassette into the second warming unit. Ensure that air is removed from the tubing. Open the clamps and continue the infusion.

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•

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.

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Ranger™ Blood/Fluid Warming System Model 245

CONDITION

CAUSE

SOLUTION

Unit alerts soon after plugging it in (unit does not have to be turned on for this condition to occur). Heater temperature rises to 44°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 technical service.

Ranger™ Blood/Fluid Warming System Model 245

English

MAINTENANCE AND STORAGE CLEANING THE RANGER BLOOD/FLUID WARMING UNIT Clean the Ranger warming unit on an as-needed basis.

CAUTION 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

CONDITION

CAUSE

SOLUTION

Alert sounds but unit has been turned off.

Independent backup safety system has been activated.

Unplug unit. Call 3M technical service.

CONDITION

CAUSE

SOLUTION

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 excessive back pressure.

•

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. Raise unit above patient level.

CONDITION

CAUSE

SOLUTION

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 technical service.

CONDITION

CAUSE

SOLUTION

Alphanumeric display reads “Er 4” or “Open.”

Open wire on temperature sensor.

Do not use unit. Call 3M technical service.

CONDITION

CAUSE

SOLUTION

Alphanumeric display reads “Er 5” or “Open.”

Electrical interference.

Remove the unit. Refer to biomedical technician or call 3M technical service.

To avoid device damage: • 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: 1. 2. 3.

Disconnect the Ranger warming unit from the power source. Wipe the outside of the unit with warm, soapy water, nonabrasive cleaning solutions, dilute bleach, or cold sterilants. Do not use abrasive materials. Wipe with a dry, soft cloth.

To clean the heating plates: 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 1. 2. 3. 4. 5.

Unplug the warming unit. Unfold the cleaning tool. Wet the foam pads with a nonabrasive solution, such as Alconox™* brand detergent. Insert the tool from the back of the unit and pull the tool all the way out from the front (see Figure 5). Rinse the tool with water and repeat 3 times. Wipe off the unit to remove excess fluid.

To clean resistant, dried-on fluids: 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 biomedical technician.

Storage Store all components in a cool, dry place when not in use.

Figure 5

Servicing There are no user-serviceable parts in the Ranger blood/fluid warming unit. All service must be performed by 3M or an authorized service technician. Call 3M Technical Service at 1-800-228-3957 for service information. Outside of the USA contact your local 3M Patient Warming representative. *Alconox is a trademark of Alconox, Inc.

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Ranger™ Blood/Fluid Warming System Model 245

CONDITION

CAUSE

SOLUTION

Unit alerts soon after plugging it in (unit does not have to be turned on for this condition to occur). Heater temperature rises to 44°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 technical service.

Ranger™ Blood/Fluid Warming System Model 245

English

MAINTENANCE AND STORAGE CLEANING THE RANGER BLOOD/FLUID WARMING UNIT Clean the Ranger warming unit on an as-needed basis.

CAUTION 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

CONDITION

CAUSE

SOLUTION

Alert sounds but unit has been turned off.

Independent backup safety system has been activated.

Unplug unit. Call 3M technical service.

CONDITION

CAUSE

SOLUTION

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 excessive back pressure.

•

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. Raise unit above patient level.

CONDITION

CAUSE

SOLUTION

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 technical service.

CONDITION

CAUSE

SOLUTION

Alphanumeric display reads “Er 4” or “Open.”

Open wire on temperature sensor.

Do not use unit. Call 3M technical service.

CONDITION

CAUSE

SOLUTION

Alphanumeric display reads “Er 5” or “Open.”

Electrical interference.

Remove the unit. Refer to biomedical technician or call 3M technical service.

To avoid device damage: • 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: 1. 2. 3.

Disconnect the Ranger warming unit from the power source. Wipe the outside of the unit with warm, soapy water, nonabrasive cleaning solutions, dilute bleach, or cold sterilants. Do not use abrasive materials. Wipe with a dry, soft cloth.

To clean the heating plates: 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 1. 2. 3. 4. 5.

Unplug the warming unit. Unfold the cleaning tool. Wet the foam pads with a nonabrasive solution, such as Alconox™* brand detergent. Insert the tool from the back of the unit and pull the tool all the way out from the front (see Figure 5). Rinse the tool with water and repeat 3 times. Wipe off the unit to remove excess fluid.

To clean resistant, dried-on fluids: 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 biomedical technician.

Storage Store all components in a cool, dry place when not in use.

Figure 5

Servicing There are no user-serviceable parts in the Ranger blood/fluid warming unit. All service must be performed by 3M or an authorized service technician. Call 3M Technical Service at 1-800-228-3957 for service information. Outside of the USA contact your local 3M Patient Warming representative. *Alconox is a trademark of Alconox, Inc.

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Ranger™ Blood/Fluid Warming System Model 245

Ranger™ Blood/Fluid Warming System Model 245

English

SPECIFICATIONS

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The model 245 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 245 should assure that it is used in such an environment.

The model 245 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 245 should assure that it is used in such an environment. EMISSIONS TEST

COMPLIANCE

RF emissions CISPR 11

Group 1

The model 245 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.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

The model 245 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.

Voltage fluctuations/ Flicker emissions IEC 61000-3-3

Complies

IMMUNITY TEST

IEC 60601

COMPLIANCE

TEST LEVEL

LEVEL

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

The model 245 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 245 should assure that it is used in such an environment. IMMUNITY TEST

IEC 60601

COMPLIANCE

TEST LEVEL

LEVEL

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±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%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV power lines

±2 kV power lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV line to line ±2 kV line to gnd

±1 kV line to line ±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 IEC 61000-4-11

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 6 cycles 70% UT (30% dip in UT) for 30 cycles <5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 6 cycles 70% UT (30% dip in UT) for 30 cycles <5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the model 245 requires continued operation during power mains interruptions, it is recommended that the model 245 be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

3 Vrms 3 V/m

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the model 245, 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. a

b

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 245 is used exceeds the applicable RF compliance level above, the model 245 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 245. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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Ranger™ Blood/Fluid Warming System Model 245

Ranger™ Blood/Fluid Warming System Model 245

English

SPECIFICATIONS

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The model 245 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 245 should assure that it is used in such an environment.

The model 245 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 245 should assure that it is used in such an environment. EMISSIONS TEST

COMPLIANCE

RF emissions CISPR 11

Group 1

The model 245 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.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

The model 245 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.

Voltage fluctuations/ Flicker emissions IEC 61000-3-3

Complies

IMMUNITY TEST

IEC 60601

COMPLIANCE

TEST LEVEL

LEVEL

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

The model 245 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 245 should assure that it is used in such an environment. IMMUNITY TEST

IEC 60601

COMPLIANCE

TEST LEVEL

LEVEL

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±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%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV power lines

±2 kV power lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV line to line ±2 kV line to gnd

±1 kV line to line ±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 IEC 61000-4-11

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 6 cycles 70% UT (30% dip in UT) for 30 cycles <5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 6 cycles 70% UT (30% dip in UT) for 30 cycles <5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the model 245 requires continued operation during power mains interruptions, it is recommended that the model 245 be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

3 Vrms 3 V/m

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the model 245, 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. a

b

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 245 is used exceeds the applicable RF compliance level above, the model 245 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 245. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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Ranger™ Blood/Fluid Warming System Model 245

Ranger™ Blood/Fluid Warming System Model 245

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE MODEL 245

Electrical characteristics

The model 245 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model 245 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model 245 as recommended below, according to the maximum output power of the communications equipment.

Temperature and accuracy characteristics

DEVICE RATING 100-120 VAC, 50/60 Hz 220-240 VAC, 50/60 Hz

SET POINT TEMPERATURE 41° ± 1° C

MAXIMUM HEATING POWER 900 W

OVER-TEMPERATURE ALERT 43° +3/-2° C

FUSE 2 x T10A-H (250V) for 100-120 VAC 2 x T6.3A-H (250V) for 220-240 VAC

UNDER-TEMPERATURE ALERT 33° ± 2° C

FUSE TYPE Time delay, high breaking

OVER-TEMPERATURE CUTOFF 44° ± 2° C (warming units Rev N and newer) 46° ± 2° C (warming units Rev A to M)

SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER m

RATED MAXIMUM OUTPUT POWER OF

W

150 KHZ TO 80 MHZ d = 1.2 √P

80 MHZ TO 800 MHZ 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

TRANSMITTER

10

3.69

3.69

7.37

LEAKAGE CURRENT

100

11.67

11.67

23.30

Meets leakage current requirements in accordance with UL/IEC 60601-1.

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.

PHYSICAL CHARACTERISTICS WARMING UNIT

ENVIRONMENTAL CONDITIONS OPERATING TEMPERATURE RANGE 15° to 40°C (59° to 104°F)

STORAGE AND TRANSPORT TEMPERATURE RANGE -20° to 45°C (-4° to 113°F)

OPERATING HUMIDITY 10 to 85% RH, noncondensing

4.5 in. (11 cm) high x 7.5 in. (19 cm) wide x 10 in. (25 cm) long; wt.: 7 lb. 7 oz. (3.4 kg)

ATMOSPHERIC PRESSURE RANGE

CERTIFICATIONS

50 kPa to 106 kPa

IEC/EN 60601-1; IEC/EN 60601-1-2; CAN/CSA-C22.2, No.601.1

CLASSIFICATION MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1; CAN/ CSA-C22.2, No.601.1; ANSI/AAMI ES60601-1:2005 CSA-C22.2 No. 60601-1:08; Control No.4HZ8 Classified under IEC 60601-1 Guidelines (and other national versions of the guidelines) as Class I, Type BF, Ordinary equipment, Continuous operation. Not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. Classified by Underwriters Laboratories Inc. with respect to electrical shock, fire and mechanical hazards only, in accordance with IEC/EN 60601-1 and Canadian/CSA C22.2, No. 601.1 Classified under the Medical Device Directive as a Class IIb device.

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Ranger™ Blood/Fluid Warming System Model 245

Ranger™ Blood/Fluid Warming System Model 245

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE MODEL 245

Electrical characteristics

The model 245 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model 245 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model 245 as recommended below, according to the maximum output power of the communications equipment.

Temperature and accuracy characteristics

DEVICE RATING 100-120 VAC, 50/60 Hz 220-240 VAC, 50/60 Hz

SET POINT TEMPERATURE 41° ± 1° C

MAXIMUM HEATING POWER 900 W

OVER-TEMPERATURE ALERT 43° +3/-2° C

FUSE 2 x T10A-H (250V) for 100-120 VAC 2 x T6.3A-H (250V) for 220-240 VAC

UNDER-TEMPERATURE ALERT 33° ± 2° C

FUSE TYPE Time delay, high breaking

OVER-TEMPERATURE CUTOFF 44° ± 2° C (warming units Rev N and newer) 46° ± 2° C (warming units Rev A to M)

SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER m

RATED MAXIMUM OUTPUT POWER OF

W

150 KHZ TO 80 MHZ d = 1.2 √P

80 MHZ TO 800 MHZ 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

TRANSMITTER

10

3.69

3.69

7.37

LEAKAGE CURRENT

100

11.67

11.67

23.30

Meets leakage current requirements in accordance with UL/IEC 60601-1.

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.

PHYSICAL CHARACTERISTICS WARMING UNIT

ENVIRONMENTAL CONDITIONS OPERATING TEMPERATURE RANGE 15° to 40°C (59° to 104°F)

STORAGE AND TRANSPORT TEMPERATURE RANGE -20° to 45°C (-4° to 113°F)

OPERATING HUMIDITY 10 to 85% RH, noncondensing

4.5 in. (11 cm) high x 7.5 in. (19 cm) wide x 10 in. (25 cm) long; wt.: 7 lb. 7 oz. (3.4 kg)

ATMOSPHERIC PRESSURE RANGE

CERTIFICATIONS

50 kPa to 106 kPa

IEC/EN 60601-1; IEC/EN 60601-1-2; CAN/CSA-C22.2, No.601.1

CLASSIFICATION MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1; CAN/ CSA-C22.2, No.601.1; ANSI/AAMI ES60601-1:2005 CSA-C22.2 No. 60601-1:08; Control No.4HZ8 Classified under IEC 60601-1 Guidelines (and other national versions of the guidelines) as Class I, Type BF, Ordinary equipment, Continuous operation. Not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. Classified by Underwriters Laboratories Inc. with respect to electrical shock, fire and mechanical hazards only, in accordance with IEC/EN 60601-1 and Canadian/CSA C22.2, No. 601.1 Classified under the Medical Device Directive as a Class IIb device.

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