3M Ranger Irrigation Fluid Warming System Model 247 Operators Manual

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Ranger™ Irrigation Fluid Warming System Model 247

Ranger™ Irrigation Fluid Warming System Model 247

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:... 5 Product Description ... 6 Ranger Irrigation Fluid Warming Unit ... 6 Ranger Irrigation Fluid Warming Disposable Set ... 7 Model 247 Product Safety Features ... 7 Instructions for Use ... 8 Preparation and Setup of the Ranger Irrigation Fluid Warming Unit ... 8 Removing the Irrigation Fluid Warming Set from the Ranger Irrigation Fluid Warming Unit ... 8 Troubleshooting ... 9 Maintenance and Storage...11 Cleaning the Ranger Irrigation Fluid Warming Unit ...11 Specifications ...12 Physical Characteristics ...14

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Ranger™ Irrigation Fluid Warming System Model 247

Ranger™ Irrigation Fluid Warming System Model 247

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:... 5 Product Description ... 6 Ranger Irrigation Fluid Warming Unit ... 6 Ranger Irrigation Fluid Warming Disposable Set ... 7 Model 247 Product Safety Features ... 7 Instructions for Use ... 8 Preparation and Setup of the Ranger Irrigation Fluid Warming Unit ... 8 Removing the Irrigation Fluid Warming Set from the Ranger Irrigation Fluid Warming Unit ... 8 Troubleshooting ... 9 Maintenance and Storage...11 Cleaning the Ranger Irrigation Fluid Warming Unit ...11 Specifications ...12 Physical Characteristics ...14

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Ranger™ Irrigation Fluid Warming System Model 247

Technical Service and Order Placement TECHNICAL SERVICE 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 a loaner device 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™ Irrigation Fluid Warming System Model 247

English

Introduction The 3M™ Ranger™ irrigation fluid warming system is designed to warm irrigation fluids and deliver these at flow rates under gravity up to 870 mL/min when the bag is hung 100 cm above the scope. At these flow rates, the device maintains fluid output temperatures ranging from 33°C to 41°C (Note: This is for room temperature fluids only). It takes less than 2 minutes to warm up to the 41°C set point temperature. The alert points on the Model 247 are 48°C and 50°C. The fluid warming disposable set is sterile, not made with natural rubber latex, single-use-only and is designed to be used with the reusable Model 247 warming unit. The Ranger irrigation 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 Ranger disposable sets visit us online at rangerfluidwarming.com. This manual includes operating instructions and unit specifications for the Model 247 irrigation fluid warming system. For information about using Ranger irrigation fluid warming disposable sets with the Model 247 irrigation fluid warming unit, refer to the “Instructions for Use” included with each disposable component. The Ranger irrigation fluid warming system should only be used in healthcare facilities by trained medical professionals.

Indications for Use The Ranger irrigation fluid warming system is intended to warm irrigation fluids.

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

Consult instructions for use

Follow instructions for use

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Ranger™ Irrigation Fluid Warming System Model 247

Technical Service and Order Placement TECHNICAL SERVICE 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 a loaner device 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™ Irrigation Fluid Warming System Model 247

English

Introduction The 3M™ Ranger™ irrigation fluid warming system is designed to warm irrigation fluids and deliver these at flow rates under gravity up to 870 mL/min when the bag is hung 100 cm above the scope. At these flow rates, the device maintains fluid output temperatures ranging from 33°C to 41°C (Note: This is for room temperature fluids only). It takes less than 2 minutes to warm up to the 41°C set point temperature. The alert points on the Model 247 are 48°C and 50°C. The fluid warming disposable set is sterile, not made with natural rubber latex, single-use-only and is designed to be used with the reusable Model 247 warming unit. The Ranger irrigation 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 Ranger disposable sets visit us online at rangerfluidwarming.com. This manual includes operating instructions and unit specifications for the Model 247 irrigation fluid warming system. For information about using Ranger irrigation fluid warming disposable sets with the Model 247 irrigation fluid warming unit, refer to the “Instructions for Use” included with each disposable component. The Ranger irrigation fluid warming system should only be used in healthcare facilities by trained medical professionals.

Indications for Use The Ranger irrigation fluid warming system is intended to warm irrigation fluids.

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

Consult instructions for use

Follow instructions for use

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Ranger™ Irrigation Fluid Warming System Model 247

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

Ranger™ Irrigation Fluid Warming System Model 247

WARNING: 1.

Date of manufacture

Manufacturer

2.

Sterile, ethylene oxide

Store at room temperature

Quantity

Do not reuse

Not made with natural rubber latex

Keep dry

Temperature limits

3.

1. 2.

3.

4.

Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION:

5.

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.

To reduce the risks associated with hazardous voltage and fire and thermal energy hazards: • Do not substitute other devices (i.e. Model 245) for the Ranger irrigation fluid warming unit or Ranger irrigation disposable 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 disposable set. Have the warming unit tested by a biomedical technician or call 3M 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 Ranger warming 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 warming system when it appears the warming 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.

CAUTION:

Explanation of Signal Word Consequences WARNING:

English

Not for I.V. use. 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 irrigation 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. The 3M Ranger irrigation 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 irrigation 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.

NOTICE: 1. 2.

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 warming unit with solvents. Damage to the case, label, and internal components may result. • Do not immerse the warming unit in cleaning or sterilizing solutions. The unit is not liquid proof. • 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.

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Ranger™ Irrigation Fluid Warming System Model 247

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

Ranger™ Irrigation Fluid Warming System Model 247

WARNING: 1.

Date of manufacture

Manufacturer

2.

Sterile, ethylene oxide

Store at room temperature

Quantity

Do not reuse

Not made with natural rubber latex

Keep dry

Temperature limits

3.

1. 2.

3.

4.

Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION:

5.

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.

To reduce the risks associated with hazardous voltage and fire and thermal energy hazards: • Do not substitute other devices (i.e. Model 245) for the Ranger irrigation fluid warming unit or Ranger irrigation disposable 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 disposable set. Have the warming unit tested by a biomedical technician or call 3M 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 Ranger warming 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 warming system when it appears the warming 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.

CAUTION:

Explanation of Signal Word Consequences WARNING:

English

Not for I.V. use. 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 irrigation 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. The 3M Ranger irrigation 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 irrigation 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.

NOTICE: 1. 2.

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 warming unit with solvents. Damage to the case, label, and internal components may result. • Do not immerse the warming unit in cleaning or sterilizing solutions. The unit is not liquid proof. • 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.

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Ranger™ Irrigation Fluid Warming System Model 247

The Ranger irrigation 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.

Ranger™ Irrigation Fluid Warming System Model 247

English

RANGER IRRIGATION FLUID WARMING DISPOSABLE SET Irrigation fluid warming sets1 include a cassette, tubing, connectors, flow chamber and clamps (see Figure 2).

Product Description The Ranger irrigation fluid warming system consists of a Model 247 warming unit and a sterile disposable fluid warming set.

CASSETTE

ALERT INDICATOR LIGHT SLOT FOR WARMING CASSETTE

FLUID SOURCE

WHITE CLAMP

I.V. POLE CLAMP

INLET TUBE

ALPHANUMERIC DISPLAY OUTLET TUBE

POWER SWITCH FIGURE 1

BLUE CLAMP

RANGER IRRIGATION FLUID WARMING UNIT The 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. Located on the front panel you will find: • Alphanumeric display that indicates the heater temperature during normal operation. In an over temperature condition, the display alternately flashes a temperature of 48°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.

EXIT FIGURE 2

Irrigation set

FLOW RATE

PRIMING VOLUME

PATIENT LINE LENGTH

0-870 mL/min2

308 mL

213 cm

1

Refer to the instructions provided with each disposable set for information on use. 2 With the bag hung 100 cm above the scope under gravity flow.

Model 247 Product Safety Features The following chart describes the safety alarm features of the Ranger irrigation fluid warming unit. ALERT TYPE

SET-POINT

INDICATION

DESCRIPTION

Primary overtemperature alert system

48°C

LED alternately displays “HI” and temperature, alert sounds, alert light flashes.

Primary Alert: Alert sounds, controller cuts power to the heaters until temperature falls below 48°C. When heater temperature drops below 48°C, audible and visual alerts stop.

Independent back-up over-temperature alert system (cut-off).

50°C

LED displays the temperature or has gone dark, alert sounds.

Primary failure. Temperature will rise to 50°C within a few seconds. The safety backup system is activated at 50°C and power is immediately shut off to the heating plates.

Under-temperature alert

33°C

LED displays “LO” and temperature, alert sounds, alert light flashes.

Heater temperature has fallen to 33°C. Alerts will stop when temperature rises above 33°C. Continue use of unit.

NOTE: The difference in over-temperature alert system cut-off points does not indicate any difference in safety and is simply a result of tighter controller tolerances. The Ranger irrigation fluid warming system is designed with very tight controls to regulate its temperature to the 41°C set-point. The microprocessor controller measures the temperature at the fluid pathway inside the warming plate four times every second, making it very responsive to changes in flow rate.

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3.

Ranger™ Irrigation Fluid Warming System Model 247

The Ranger irrigation 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.

Ranger™ Irrigation Fluid Warming System Model 247

English

RANGER IRRIGATION FLUID WARMING DISPOSABLE SET Irrigation fluid warming sets1 include a cassette, tubing, connectors, flow chamber and clamps (see Figure 2).

Product Description The Ranger irrigation fluid warming system consists of a Model 247 warming unit and a sterile disposable fluid warming set.

CASSETTE

ALERT INDICATOR LIGHT SLOT FOR WARMING CASSETTE

FLUID SOURCE

WHITE CLAMP

I.V. POLE CLAMP

INLET TUBE

ALPHANUMERIC DISPLAY OUTLET TUBE

POWER SWITCH FIGURE 1

BLUE CLAMP

RANGER IRRIGATION FLUID WARMING UNIT The 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. Located on the front panel you will find: • Alphanumeric display that indicates the heater temperature during normal operation. In an over temperature condition, the display alternately flashes a temperature of 48°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.

EXIT FIGURE 2

Irrigation set

FLOW RATE

PRIMING VOLUME

PATIENT LINE LENGTH

0-870 mL/min2

308 mL

213 cm

1

Refer to the instructions provided with each disposable set for information on use. 2 With the bag hung 100 cm above the scope under gravity flow.

Model 247 Product Safety Features The following chart describes the safety alarm features of the Ranger irrigation fluid warming unit. ALERT TYPE

SET-POINT

INDICATION

DESCRIPTION

Primary overtemperature alert system

48°C

LED alternately displays “HI” and temperature, alert sounds, alert light flashes.

Primary Alert: Alert sounds, controller cuts power to the heaters until temperature falls below 48°C. When heater temperature drops below 48°C, audible and visual alerts stop.

Independent back-up over-temperature alert system (cut-off).

50°C

LED displays the temperature or has gone dark, alert sounds.

Primary failure. Temperature will rise to 50°C within a few seconds. The safety backup system is activated at 50°C and power is immediately shut off to the heating plates.

Under-temperature alert

33°C

LED displays “LO” and temperature, alert sounds, alert light flashes.

Heater temperature has fallen to 33°C. Alerts will stop when temperature rises above 33°C. Continue use of unit.

NOTE: The difference in over-temperature alert system cut-off points does not indicate any difference in safety and is simply a result of tighter controller tolerances. The Ranger irrigation fluid warming system is designed with very tight controls to regulate its temperature to the 41°C set-point. The microprocessor controller measures the temperature at the fluid pathway inside the warming plate four times every second, making it very responsive to changes in flow rate.

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Ranger™ Irrigation Fluid Warming System Model 247

Ranger™ Irrigation Fluid Warming System Model 247

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Instructions for Use

Troubleshooting

PREPARATION AND SETUP OF THE RANGER IRRIGATION 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 irrigation fluid warming unit to the I.V. pole. Tighten the pole clamp securely.

CAUTION: To prevent tipping, clamp the Ranger irrigation 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). Failure to do so may result in damage to the product (see Figure 3). 2. Slide the irrigation 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. Plug the power cord into an appropriate outlet. Turn the unit ON. In a few seconds the alpha-numeric display will illuminate. It takes less than 2 minutes to warm up to the 41°C set point temperature. 5. Begin flow. When flow 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 48°C or higher and the word “HI.”

Temporary over-temperature condition because: • An extreme change in flow rates occurred (e.g., from 870 ml/min to stop flow). • Unit was turned on and reached set point temperature before warming cassette was inserted. • Fluids were prewarmed to above 42°C before being run through the warming unit.

•

FIGURE 4

REMOVING THE IRRIGATION FLUID WARMING SET FROM THE RANGER IRRIGATION FLUID WARMING UNIT 1. 2. 3. 4.

Close the inlet clamp proximal to the fluid warming cassette and open all clamps distal to the cassette. Disconnect the warming set from the fluid source, if applicable. Allow a small amount of fluid to drain from the end of the patient line to reduce pressure in the cassette. Remove the warming set from the warming unit and discard according to institutional protocol.

•

•

Open flow to reduce temperature. Alerts will stop when the temperature drops below 48°C. The unit is ready to use. Alerts will stop when the temperature drops below 48°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 irrigation fluid warming unit.

CONDITION

CAUSE

SOLUTION

Alert sounds, alpha-numeric 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 50°C. 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.

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Ranger™ Irrigation Fluid Warming System Model 247

Ranger™ Irrigation Fluid Warming System Model 247

English

Instructions for Use

Troubleshooting

PREPARATION AND SETUP OF THE RANGER IRRIGATION 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 irrigation fluid warming unit to the I.V. pole. Tighten the pole clamp securely.

CAUTION: To prevent tipping, clamp the Ranger irrigation 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). Failure to do so may result in damage to the product (see Figure 3). 2. Slide the irrigation 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. Plug the power cord into an appropriate outlet. Turn the unit ON. In a few seconds the alpha-numeric display will illuminate. It takes less than 2 minutes to warm up to the 41°C set point temperature. 5. Begin flow. When flow 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 48°C or higher and the word “HI.”

Temporary over-temperature condition because: • An extreme change in flow rates occurred (e.g., from 870 ml/min to stop flow). • Unit was turned on and reached set point temperature before warming cassette was inserted. • Fluids were prewarmed to above 42°C before being run through the warming unit.

•

FIGURE 4

REMOVING THE IRRIGATION FLUID WARMING SET FROM THE RANGER IRRIGATION FLUID WARMING UNIT 1. 2. 3. 4.

Close the inlet clamp proximal to the fluid warming cassette and open all clamps distal to the cassette. Disconnect the warming set from the fluid source, if applicable. Allow a small amount of fluid to drain from the end of the patient line to reduce pressure in the cassette. Remove the warming set from the warming unit and discard according to institutional protocol.

•

•

Open flow to reduce temperature. Alerts will stop when the temperature drops below 48°C. The unit is ready to use. Alerts will stop when the temperature drops below 48°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 irrigation fluid warming unit.

CONDITION

CAUSE

SOLUTION

Alert sounds, alpha-numeric 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 50°C. 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.

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Ranger™ Irrigation Fluid Warming System Model 247

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 50°C 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.

CONDITION

CAUSE

SOLUTION

Alert sounds but warming 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.

•

•

Ranger™ Irrigation Fluid Warming System Model 247

English

Maintenance and Storage CLEANING THE RANGER IRRIGATION FLUID WARMING UNIT Clean the Ranger irrigation fluid 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

•

Cassette is too full, fluids are still being infused, or clamp is open proximal to the warming cassette.

Warming unit is below patient level, creating excessive back pressure.

•

Make sure fluid is drained from warming 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.

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 irrigation fluid 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.

CONDITION

CAUSE

SOLUTION

Alerts indicator light illuminates and alert sounds, alpha-numeric 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.

Alerts should stop when temperature rises above 33°C. If alerts continue, turn off unit, unplug unit, and discontinue use. Call 3M technical service.

CONDITION

CAUSE

SOLUTION

5.

Alpha-numeric display reads “Er 4” or “Open.”

Open wire on temperature sensor.

Do not use unit. Call 3M technical service.

TO CLEAN RESISTANT, DRIED-ON FLUIDS:

METHOD 1. 2. 3. 4.

Unplug the irrigation fluid 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. Discard the tool according to institutional protocol. Wipe off the unit to remove excess fluid.

1. CONDITION

CAUSE

SOLUTION

Alpha-numeric display reads “Er 5” or “Open.”

Electrical interference.

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

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: You may use a nonmetal instrument, such as a cotton swab, to clean the upper channels. If you are unable to adequately clean the unit, call 3M technical service.

STORAGE

FIGURE 5

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

SERVICING There are no user-serviceable parts in the Ranger irrigation 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. *Alconox is a trademark of Alconox, Inc.

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Ranger™ Irrigation Fluid Warming System Model 247

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 50°C 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.

CONDITION

CAUSE

SOLUTION

Alert sounds but warming 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.

•

•

Ranger™ Irrigation Fluid Warming System Model 247

English

Maintenance and Storage CLEANING THE RANGER IRRIGATION FLUID WARMING UNIT Clean the Ranger irrigation fluid 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

•

Cassette is too full, fluids are still being infused, or clamp is open proximal to the warming cassette.

Warming unit is below patient level, creating excessive back pressure.

•

Make sure fluid is drained from warming 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.

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 irrigation fluid 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.

CONDITION

CAUSE

SOLUTION

Alerts indicator light illuminates and alert sounds, alpha-numeric 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.

Alerts should stop when temperature rises above 33°C. If alerts continue, turn off unit, unplug unit, and discontinue use. Call 3M technical service.

CONDITION

CAUSE

SOLUTION

5.

Alpha-numeric display reads “Er 4” or “Open.”

Open wire on temperature sensor.

Do not use unit. Call 3M technical service.

TO CLEAN RESISTANT, DRIED-ON FLUIDS:

METHOD 1. 2. 3. 4.

Unplug the irrigation fluid 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. Discard the tool according to institutional protocol. Wipe off the unit to remove excess fluid.

1. CONDITION

CAUSE

SOLUTION

Alpha-numeric display reads “Er 5” or “Open.”

Electrical interference.

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

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: You may use a nonmetal instrument, such as a cotton swab, to clean the upper channels. If you are unable to adequately clean the unit, call 3M technical service.

STORAGE

FIGURE 5

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

SERVICING There are no user-serviceable parts in the Ranger irrigation 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. *Alconox is a trademark of Alconox, Inc.

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Ranger™ Irrigation Fluid Warming System Model 247

Ranger™ Irrigation Fluid Warming System Model 247

English

Specifications

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The model 247 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 247 should assure that it is used in such an environment.

The model 247 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 247 should assure that it is used in such an environment.

IMMUNITY TEST

EMISSIONS TEST

COMPLIANCE

RF emissions CISPR 11

Group 1

The model 247 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 247 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

IEC 60601

COMPLIANCE LEVEL

TEST LEVEL

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

Portable and mobile RF communications equipment should be used no closer to any part of the model 247, 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

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The model 247 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 247 should assure that it is used in such an environment. IMMUNITY TEST

IEC 60601

COMPLIANCE LEVEL

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

±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%.

TEST LEVEL

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

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 247 requires continued operation during power mains interruptions, it is recommended that the model 247 be powered from an uninterruptible power supply or a battery.

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.

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

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

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 247 is used exceeds the applicable RF compliance level above, the model 247 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 247. 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™ Irrigation Fluid Warming System Model 247

Ranger™ Irrigation Fluid Warming System Model 247

English

Specifications

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The model 247 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 247 should assure that it is used in such an environment.

The model 247 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 247 should assure that it is used in such an environment.

IMMUNITY TEST

EMISSIONS TEST

COMPLIANCE

RF emissions CISPR 11

Group 1

The model 247 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 247 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

IEC 60601

COMPLIANCE LEVEL

TEST LEVEL

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

Portable and mobile RF communications equipment should be used no closer to any part of the model 247, 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

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The model 247 is intended for use in the electromagnetic environment specified below. The customer or the user of the model 247 should assure that it is used in such an environment. IMMUNITY TEST

IEC 60601

COMPLIANCE LEVEL

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

±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%.

TEST LEVEL

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

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 247 requires continued operation during power mains interruptions, it is recommended that the model 247 be powered from an uninterruptible power supply or a battery.

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.

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

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

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 247 is used exceeds the applicable RF compliance level above, the model 247 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 247. 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™ Irrigation Fluid Warming System Model 247

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE MODEL 247 The model 247 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model 247 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model 247 as recommended below, according to the maximum output power of the communications equipment. 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

10

3.69

3.69

7.37

100

11.67

11.67

23.30

TRANSMITTER

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 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)

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

Ranger™ Irrigation Fluid Warming System Model 247

ELECTRICAL CHARACTERISTICS

TEMPERATURE CHARACTERISTICS AND ACCURACY

INPUT VOLTAGE 100-120 or 220-240 VAC

SET POINT TEMPERATURE 41 ± 1 °C

OPERATING FREQUENCY 100-120 or 220-240 VAC 220-240 VAC, 50/60 Hz

OVER-TEMPERATURE ALERT 48 + 3/- 2°C

MAXIMUM HEATING POWER 900 W

UNDER-TEMPERATURE ALERT 33 ± 2°C

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

OVER-TEMPERATURE CUTOFF 50 ± 2°C

FUSE TYPE Time delay, high breaking

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

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

ATMOSPHERIC PRESSURE RANGE 50 kPa to 106 kPa

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. 606.1. Classified under the Medical Device Directive as a Class IIa device.

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Ranger™ Irrigation Fluid Warming System Model 247

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE MODEL 247 The model 247 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model 247 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model 247 as recommended below, according to the maximum output power of the communications equipment. 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

10

3.69

3.69

7.37

100

11.67

11.67

23.30

TRANSMITTER

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 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)

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

Ranger™ Irrigation Fluid Warming System Model 247

ELECTRICAL CHARACTERISTICS

TEMPERATURE CHARACTERISTICS AND ACCURACY

INPUT VOLTAGE 100-120 or 220-240 VAC

SET POINT TEMPERATURE 41 ± 1 °C

OPERATING FREQUENCY 100-120 or 220-240 VAC 220-240 VAC, 50/60 Hz

OVER-TEMPERATURE ALERT 48 + 3/- 2°C

MAXIMUM HEATING POWER 900 W

UNDER-TEMPERATURE ALERT 33 ± 2°C

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

OVER-TEMPERATURE CUTOFF 50 ± 2°C

FUSE TYPE Time delay, high breaking

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

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

ATMOSPHERIC PRESSURE RANGE 50 kPa to 106 kPa

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. 606.1. Classified under the Medical Device Directive as a Class IIa device.

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