enFlow Operator’s Manual EN Rev. L

Symbols Used on the Equipment The following symbols may be viewed on the any of the products or accessories that comprise the enFlow IV Fluid/Blood Warming System.

Symbol

Symbol Description

Symbol Description

Batch Code

On

Catalog Number

Off

Serial Number

Latex Free

National Stock No. (US Military)

Expiration Date

Single Use Only; Do Not Re-Use

Direct Current

Sterilized Using Irradiation

Alternating Current

Keep Dry

Type BF applied part, defibrillation-proof

Do Not Re-Sterilize

Do Not Use if Package is Damaged.

ATTENTION: Consult Instructions for Use

Fuse

Temperature; Thermometer

Non-Pyrogenic

Danger High Voltage

IP21

Symbol

Note

This symbol indicates that additional information is being provided.

Electric Energy

Effect or action in both directions away from reference point. (Open)

Operating Range

Effect or action in both directions towards a reference point. (Close)

Di(2-ethylhexyl) phthalate Free

Do not throw in trash.

TUV Rheinland of North America, Inc. is accredited by OSHA as a NRTL, as well as by the Standards Council of Canada. This mark indicates that the product has been tested to UL 60601-1:2003 R6.03, CAN/CSA-C22.2 No. 601.1M90, IEC 60601-1-1:2000, and IEC 60601-1-4:2000. The CE Mark is the manufacturer’s or importer’s mark of conformity declaring compliance with all applicable directives (Safety, EMC, Machinery, Medical and others). Degree of protection provided by enclosure, no ingress of object > 12.5 mm diameter, protected against dripping water

IP67

Degree of protection provided by enclosure, dust tight, temporary water immersion

IP68

Degree of protection provided by enclosure, dust tight, continuous water immersion Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Authorized Representative in the European Community

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TABLE OF CONTENTS ENFLOW® IV FLUID/BLOOD WARMING SYSTEM DESCRIPTION... 5 INDICATION FOR USE ... 5 CLINICAL AND TRAINING INFORMATION ... 5 WARNINGS ... 6 CAUTIONS... 6 UNPACKING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM... 8 TO BEGIN OPERATION OF THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM ... 8 ENFLOW CONTROLLER (PRODUCT NO. 980121) INDICATORS AND OPERATION ... 9 ENFLOW WARMER (PRODUCT NO. 980100) INDICATORS AND OPERATION ... 11 CLEANING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ... 13 STORING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ... 14 ENFLOW IV FLUID/BLOOD WARMING SYSTEM OPERATIONAL CHECKLIST ... 15 SERVICING THE ENFLOW IV FLUID/BLOOD WARMING SYSTEM COMPONENTS ... 16 APPENDIX A: TECHNICAL SPECIFICATIONS ... 17 APPENDIX B: GLOSSARY... 19 APPENDIX C: WARMING SYSTEM RESPONSE BY TEMPERATURE ... 20

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enFlow® IV Fluid/Blood Warming System Description The enFlow IV Fluid/Blood Warming System consists of the enFlow Warmer (Product No. 980100), the enFlow Controller (Product No. 980121), the enFlow Disposable Cartridge (Product No. 980200), and the enFlow Disposable Cartridge with IV Extension Set (Product No. 980202). Within seconds, this Warming System delivers normothermic infusate to the patient at flow rates of Keep Vein Open (KVO) to 200 mL/min when input fluid temperature is 20 °C. The Warmer is the reusable heating unit designed to work in conjunction with the Disposable Cartridge. Two multicolored light emitting diode (LED) indicators on the Warmer indicate its power status and the fluid/blood infusate temperature. The infusate within the Disposable Cartridge is warmed when in contact with the heating surface of the Warmer. This surface is heated by means of electrical resistance. The Warmer contains redundant temperature sensors ensuring fluid temperature accuracy and reliability. It also includes two independent over-heating protectors. Continuous internal diagnostics monitor essential components and system parameters when heating fluid/blood. The Controller serves as a power supply for the Warmer unit. The Controller is designed to mount on an IV pole or sit on a table top. The front panel includes a Controller reading in degrees Celsius, as well as a keypad, which controls the clock and the mute feature. The Controller display is always shown “right-side-up”. Each Disposable Cartridge and the Disposable Cartridge with IV extension set are radiation sterilized and non-pyrogenic as well as latex and DEHP free. The Disposable Cartridge connects to the IV Extension Set or any infusion set employing standard luer connectors. Once primed, the Disposable Cartridge in conjunction with the Warmer and the Controller combine to complete the enFlow IV Fluid/Blood Warming System.

Indication for Use The enFlow IV Fluid/Blood Warming System’s intended use is for warming blood, blood products and intravenous solutions prior to administration. It is designed to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

Clinical and Training Information Operators must be trained to set up and deliver blood/ IV solutions in a medically approved manner, including aseptic techniques and standard hospital procedures. Use of the enFlow IV Fluid/Blood Warming System, properly administered, will help prevent hypothermia and the complications arising there of. This device will also help make the patient more comfortable during IV infusions, reducing shivering.

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WARNINGS 



       

All IV fluid bags must be vented of air per IV fluid manufacturers’ directions prior to connecting to the infusion set. Standard IV line protocols for priming the complete infusion set, the enFlow Disposable Cartridge, and the extension set must be followed before connecting to a patient. Care must be taken to ensure there is not sufficient air in the fluid bag and lines to cause an air embolism. A flashing RED LED, a flashing RED Controller display, and an audible alarm, indicate that the infusate is over temperature. Stop the fluid flow, and slide the Warmer covers open to stop warming. This condition is not standard and should not be experienced. If it occurs, replace the Warmer and contact Technical Support. The Warmer contains magnets; do not operate within 15 cm (6 in.) of a pacemaker or other devices that may be sensitive to strong magnetic fields. The Disposable Cartridge may be a potential biohazard during or after use. Handle and dispose of in accordance with acceptable medical practice and applicable regulations. Do not use in the presence of flammable anesthetics. Replace the fuses with only Bussmann part # GDB 5A or equivalent. The Disposable Cartridge should not be used for greater than 24 hours. Ensure that the Disposable Cartridge expiration date has not passed. If the IV line runs dry, disconnect the Disposable Cartridge from the Warmer. Re-prime the entire IV system using aseptic techniques. Ensure all the air is removed from both the line and the Disposable Cartridge. Replace the Disposable Cartridge in the Warmer. The enFlow Warmer is to be used only with approved enFlow power sources and the enFlow Disposable Cartridge.

Cautions            

Follow the AABB "Guidelines for the Use of Blood Warming Devices" (© 2006) which caution against warming when administering platelets, cryoprecipitate, or granulocyte suspensions. Some drugs or drug preparations may be sensitive to warming. As with any fluid or blood warming system, carefully review the drug manufacturer's literature for information about thermal sensitivity. The Warmer heating surface and Disposable Cartridge can get quite warm when heating cold IV fluids/blood at high flow rates. Wait a few seconds after stopping the IV fluid/blood flow before removing the Disposable Cartridge. The Controller should only be plugged into a hospital grade outlet. Do not block the fan in the Controller as this may cause overheating. Although the Warmer has been tested to insure it will survive a drop of 1 m (3.28 ft.), care should be taken that the device is not dropped to reduce the potential of damage. Do not clean with: o ketones (MEK, acetone, etc.) or o abrasive cleaners. Do not sterilize the Warmer with: o steam sterilization (autoclave) or o dry heat. Do not disinfect or sterilize the Controller. Do not spray or pour cleaning solutions directly on the Controller. Do not allow cleaning solutions to accumulate on the Controller. When using the Controller mounted to an IV pole, it must be tightly secured on the pole no higher than 122 cm (48 in.) from the ground. The pole should have a base diameter of no less

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    

Normal wear and tear during use of the Warmer may cause the device to be susceptible to fluid ingress. Carefully inspect the heating surface of the Warmer for tears or foreign matter before each use and take out of service if necessary. Always secure the infusion set with the clip provided on the Warmer power cable to prevent kinking in the line. Do not use a stiff bristle brush or sharp probe to remove foreign material. Do not use compressed air to dry. Avoid puncturing the heating surface. If damaged, remove the Warmer from service and replace immediately.

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Unpacking the enFlow IV Fluid/Blood Warming System Upon receipt of the enFlow IV Fluid/Blood Warming System components, visually inspect the shipping containers and internal contents for damage that may have occurred during shipment. If there is any visible or mechanical damage to the contents, or if the order is incomplete, please contact Customer Service immediately. The parts list for each model is reflected below:  Model 100 o Warmer (Product No. 980100) o Operator’s Manual  Model 121 o Controller (Product No. 980121) o Power Cord o Warmer Mount o Warmer Mount Instructions o Operator’s Manual  Model 200 o Disposable Cartridge (Product No. 980200) o IFU  Model 202 o Disposable Cartridge with IV Extension Set (Product No. 980202) o IFU

To Begin Operation of the enFlow IV Fluid/Blood Warming System a) Place the Controller on a firm, level surface or on an IV pole with an outside dimension of no greater than 3.0 cm (1.25 in.) Two Controllers may also be mounted next to each other on an IV pole as shown below. The Controller’s display will have a “right-side-up” orientation regardless of its position.

b) Plug the Controller into a hospital grade outlet. c) Setting the clock to the local time is optional, but usually done on initial use. No changes in performance are affected by the clock’s setting. d) Connect the enFlow IV Fluid/Blood Warmer cable to the Controller. This action is accomplished in three steps: 1. Insert the male plug end of the Warmer into the female receptacle on the front face of the Controller. Push it in so that the plug cover is tight against the receptacle. 2. The plug and receptacle are “keyed” in both orientation and configuration. This feature ensures that the Warmer can only be plugged in properly. Additionally, it prevents other plug devices from fitting into this receptacle. 4400-0024 enFlow Operator’s Manual EN Rev. L 07/09

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3. Turn right to lock. (See arrows on label.) e) The rear mounted I/0 (ON/OFF) switch on the Controller turns the power on and off. Switch the Controller to ON. Upon startup, the Controller conducts a self-test. The power indicator illuminates green, the Controller display flashes “enFlow”, a short audible “Beep” occurs, and the LED’s light up for about one (1) second. Note The Controller automatically switches for operation at either 115 VAC or 230 VAC f)

Open the covers on the Warmer by sliding them apart.

g) Connect the infusion set and or extension set to the Disposable Cartridge; then prime with fluid using standard medically approved protocols. Next, connect the infusion set to the patient and place the Disposable Cartridge into the Warmer. h) Completely close the covers on the Warmer by sliding them inward toward each other until the covers meet. Upon closing the covers, a short audible “Beep” occurs indicating that the Warmer self-test is being performed that confirms operation of temperature sensors and alarm indicators. After this process is complete, regulated power is delivered to the Warmer’s heating surface, which then begins heating the infusate through the Disposable Cartridge. Adjust the fluid flow to the desired rate. i)

Place the IV line in the IV Line clip in order to prevent it from kinking.

IV Line Clip

j)

Opening the Warmer covers immediately stops the heating but not the flow.

enFlow Controller (Product No. 980121) Indicators and Operation Keypad Controller Display

Power

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Female Receptacle for Warmer Connector Page 9 of 20

Controller Display The Controller display continuously reflects the specific infusate temperature that the Warmer monitors and maintains. The various readouts that may be depicted on the Controller display are described in the following tabulation: TABLE 1: Controller Display: Normal Operating Mode

Activity

Display Reads

Display Color and Function

Temperature and Clock 40 °C 9:00 A Not Heating

Identical to Warmer Temp LED

Warmer is connected, but covers are open on Warmer.

Not Heating

Yellow

Warmer is connected, and covers are either open or closed on Warmer; however, disposable is not in Warmer.

Not Heating

Yellow

Display Reads

Display Color and Function

Display alternates between Over Temp and Press Key to Mute

Identical to Warmer Temp LED

Over Temp Muted System Fault XX

Identical to Warmer Temp LED Red

Warmer is connected and power is engaged. Warmer is not connected, but Controller is powered on.

Yellow

TABLE 2: Controller Display: Alarm Mode

Activity Warmer Over Temperature

Mute button activated. Fault detected

If a system fault message is on the Controller display, contact Technical Support. TABLE 3: Controller Display: Setup Mode

Activity While powering up the Controller, hold the center button down until the clock screen is displayed. Then, use the buttons to set the clock.

Display Reads

Display Color and Function Blue

09:00 A

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enFlow Warmer (Product No. 980100) Indicators and Operation The Warmer monitors and maintains the infusate temperature at 40 °C ± 2 °C . On the top of the Warmer, there are two status indicator lights (multicolored LEDs), which reflect the following: Power - indicates the power and operational status of the Warmer. Temperature - indicates that the infusate temperature is within an acceptable operating range (35 °C to 42 °C). Temperature Status LED Sliding Covers

(Indicated by Symbol

)

Power LED Power Cable

Heating Surface

(Indicated by Symbol

)

Table 4: Description of Warmer LED indicator lights without a Disposable Cartridge and covers in either open or closed position

Power LED Status Indicator

Illuminates

Description

Warmer covers are in either the open or closed position.

Flashing Green

Flashes green every 3 seconds to show that the Warmer unit has power but is not heating.

Temp LED Status Indicator

Illuminates

Description

Warmer covers are in the open or closed position.

Unlit

Indicates that no power is being delivered to the Warmer’s heating surface.

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Table 5: Description of LED indicator lights with a Disposable Cartridge (covers in closed position)

Power LED Status Indicator

Illuminates

Description

Immediate Power up of device

Red ½ second

Continuous Operation

Solid Green

Indicates the power up of the device. (If the LED does not flash red, replace the Warmer; and contact Technical Support). Indicates power is on.

Continuous Operation:

Solid Yellow

Continuous Operation:

Flashing Red

Temp LED Status Indicator

Illuminates

Description

Immediate Power up of device

Red ½ second

Indicates the power up of the device. (If the LED does not flash red, replace the Warmer; and contact Technical Support).

Initial Warming

Flashing Blue

Indicates that the infusate in the Disposable Cartridge is < 33 °C.

Initial Warming

Solid Blue

Indicates that the infusate in the Disposable Cartridge is > 33 °C and < 35 °C.

Continuous Operation

Solid Green

Indicates that the infusate temperature is within an acceptable operating range (35 °C to 42 °C).

Continuous Operation

Flashing Blue

Warning - Indicates that the infusate in the Disposable Cartridge is < 33 °C.

Continuous Operation

Solid Blue

Warning - Indicates that the infusate in the Disposable Cartridge is > 33 °C and < 35 °C.

Continuous Operation:

Solid or Flashing Blue >30 seconds

Warning - Warmer is unable to heat the infusate and one or more of the following conditions may exist: The infusate temperature is < 20 °C and/or the flow rate is > 200 mL/min. Reduce the flow rate if possible.

Continuous Operation:

Solid Yellow

Warning - Indicates that the supply voltage is below the amount required by the Warmer; the Warmer will illuminate yellow, and sound a single audible note every minute. Warning - There is an internal failure in the Warmer; the Warmer will flash the power LED red and sound a three note audible burst. If this sequence occurs, replace the Warmer, and contact Technical Support.

The Warmer may not be working properly. Replace the Warmer if this is the suspected condition, and contact Technical Support. Warning - Indicates that the infusate (and/or ambient temperature) is > 42 °C but less than an “Over Temp” condition. This state whereby the infusate is over 42 ºC should only be entered periodically during changes in flow rate or infusate temperature.

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Refer to Appendix C for the chart on “Warming System Response versus Fluid Temperature”. Refer to Warnings for additional information.

Cleaning the enFlow IV Fluid/Blood Warming System Components Caution Do not clean with:  ketones (MEK, acetone, etc.) or  abrasive cleaners. Do not sterilize the Warmer with:  steam sterilization (autoclave) or  dry heat. Do not disinfect or sterilize the Controller. Do not spray or pour cleaning solutions directly on the Controller. Do not allow cleaning solutions to accumulate on the Controller. The Warmer and Controller are chemically resistant to most common hospital grade instrument cleaning solutions and non-caustic detergents. The following list of approved cleaning solutions may be used to clean the Warmer and Controller:  Isopropyl alcohol  Mild detergent solution  Diluted chlorine bleach (30 mL/L water)  Ammonia based cleaners  Glutaraldehyde-based cleaners  Hydrogen peroxide  Chlorhexidine

Cleaning the Warmer Wipe down and or wash 1. After each use, clean the Warmer only as required. In many instances, it may only need to be wiped clean. 2. If the warmer needs to be cleaned more intensively, use a cleaning solution and a soft bristle brush to gently scrub the Warmer to remove any foreign material. 3. Rinse thoroughly with distilled water. Do not immerse the Warmer’s electrical plug connector. Drying 1. After cleaning, dry completely before placing back into use. 2. If disinfecting is required, dry completely before disinfecting so that the disinfecting solution will not be diluted. Disinfecting 1. The enFlow Warmer may be disinfected using commercially available solutions with no greater than 2.4 % glutaraldehyde and by following the solution manufacturers’ recommendations. 2. Soak the Warmer in the disinfectant solution according to the manufacturer’s application time guidelines. Do not immerse the Warmer’s electrical plug connector in the solution. 3. Thoroughly rinse the Warmer of all solution using distilled water. 4400-0024 enFlow Operator’s Manual EN Rev. L 07/09

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4. Completely dry the Warmer before placing into service. 5. Confirm operation. Connect the Warmer to a Controller. Insert a Disposable Cartridge into the Warmer and close the covers. Turn the Controller to the ON position, and allow the start up procedure to run until complete.

Cleaning the Controller 1. Use only approved cleaning solutions. 2. Moisten a clean cloth with the cleaning solution; do not spray or pour cleaning solutions directly on to the Controller. 3. Wipe the surface of the Controller, taking care not to leave excess residual cleaner on the Controller. If fluid ingress is detected, set the Controller aside for an extended period of time to allow it to dry.

Storing the enFlow IV Fluid/Blood Warming System Components The Warmer and Controller should be stored in a clean, dust free environment. (See Appendix A)

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enFlow IV Fluid/Blood Warming System Operational Checklist Warmer Serial No_________ Controller Serial No_________ Warming System Location/Identifier__________ Date: Procedure Instructions

Pass Fail

Input Temp

Output Temp

Inspection Ensure that all cords and connectors are in good condition and void of any cuts, cracks, or frays.

Ensure that the units are clean and void of any cracks or other signs of damage. Performance Test Setup Set up the system for normal operation. Provide a 0.5 liter source of fluid at 20 °C ± 2 °C. Measure the temperature within 22.9 cm (9 in.) of both the input and output connections of the Disposable Cartridge by inserting a T connector in the direct fluid path which will accommodate a temperature probe. Connect the temperature probes to a meter capable of measuring between 10 °C and 60 °C with 0.1 °C accuracy. Prime the IV line setup according to standard IV protocols. Turn the enFlow system on and establish a fluid flow of 100 ± 20 mL/min. Wait for the temperature probes to stabilize.

Record the input fluid temperature. Input fluid temperature 20 °C ± 2 °C. Record the output fluid temperature. Output fluid temperature 40 °C ± 2 °C. Over-Temperature Alarm Check Use performance testing setup. Change the source of fluid’s temperature to 50 °C ± 2 °C. Turn the enFlow system on and establish a fluid flow of 100 ± 20 mL/min. Wait for the temperature at the probes to stabilize. Record the input and output fluid temperatures. Over Temp alarm occurs within less than 20 seconds of reaching input temperature. (See Appendix C) Audible beep and Over-Temp message in Red appears on the Controller. Red Temperature LED flashes on the Warmer. Electrical Safety Follow safety analyzer manufacturer’s instructions Test leakage current at the AC power cord using a safety analyzer. Test leakage current of the Warmer to the saline in the IV line using a safety analyzer.

Inspected By Enter initials and confirm date.

Comments, Observations or Corrective Actions

Note Please reference the Service Manual for the specific procedures in order to perform the tests listed

above.

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Servicing the enFlow IV Fluid/Blood Warming System Components The enFlow IV Fluid/Blood Warming System components have been designed to be durable and long lasting. They comprise the latest in Surface Mount Technology (SMT) and materials. If service is required, it must be performed by Vital Signs – A GE Healthcare Company or one of its authorized agents. Service by others voids the warranty and transfers the liability for malfunctions of the device to the servicer. If the unit stops working properly, contact Customer Service to obtain an RGA number prior to returning the unit to the enFlow Service Center. If damage has occurred to the heating surface, immediately remove it from service. RGA Number Prior to returning any Product, Original Purchaser must receive prior consent and must receive a Return Goods Authorization (RGA) number from Vital Signs, Inc. No Product may be returned without an RGA number. Our Customer Service Representatives can be reached by phone at 800-932-0760 or by e-mail at [email protected]. The Service Representative will troubleshoot your Product issue with you on the phone. If it is necessary to return a Product under warranty, a replacement loaner will be shipped to you within 48 hours. (If the Product is no longer under warranty, the Service Representative will discuss repair/replacement options.) You will be issued a Return Goods Authorization (RGA) number. You will be instructed to return the Product in packaging sufficient to prevent damage in transit, clearly marking the RGA number on the outside of the box. The return address will be provided to you. Note Federal (U.S.A.) Law requires contaminated Medical Equipment to be cleaned and disinfected before shipment. If this is not done, your unit will be immediately returned as it is received.

Warmer (Product No. 980100) The Warmer is permanently sealed against fluid ingress and has no user serviceable parts inside. Caution Normal wear and tear during use of the Warmer may cause the device to be susceptible to fluid ingress. Carefully inspect the heating surface of the Warmer for tears or foreign matter before each use and take out of service if necessary. Due to highly stable components, microprocessor control, and built-in self-tests, an annual performance check is sufficient. The steps listed in the enFlow IV Fluid/Blood Warming System Operational checklist should be performed at least once a year, or as required by your accrediting body.

Controller (Product No. 980121) The Controller (Product No. 980121) contains no user serviceable parts inside. Check the fuses located in the power entry module if the Controller fails to function. The AC line power cord must be removed to do this. The Controller should be subjected to routine safety checks as required by local regulations, (i.e. Earthing Impedance, Leakage Current).

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Appendix A: Technical Specifications Size...Warmer: 12.7 cm L x 6.6 cm W x 3.0 cm H, (5.0 in. L x 2.6 in. W x 1.2 in. H) Controller: 23.6 cm L x 16.8 cm W x 9.7 cm H, (9.3 in. L x 6.6 in. W x 3.8 in. H) Disposable Cartridge: 11.4 cm L x 3.8 cm W x 1.0 cm H, (4.5 in. L x 1.5 in. W x 0.4 in. H) Extension Set: 120 mm L x 10.6 mm W, (4.7 in. L x 0.4 in. W) Weight...Warmer: (w/o Disposable): 279 g, (9.8 oz.) Controller: 1.8 kg, (3.9 lb.) Disposable Cartridge: 33 g (1.2 oz.) Extension Set: 2 g (0.07 oz.) Disposable Cartridge and (optional IV Extension Set): Priming Volume ...Disposable Cartridge: 4 mL (optional IV Extension Set): 0.5 mL Sterility ...Gamma Sterilized Biocompatibility...ISO 10993 Infusion Set Compatible ...ISO 8536-4 Performance Fluid Temperature Output...40 °C ± 2 °C Flow Rate Range ...KVO to 200 mL/min Input Voltage ...Warmer: 28 VDC at a maximum of 300 Watts Controller: 110-120 or 220-240 VAC Temperature Set Point ...40 ºC Over Temperature Set Point ASTM F-2172-02 Alarms ...IEC60601-1-8 Input Current...5 A Input Frequency Range ...Warmer: DC Controller: 47-63 Hz Environmental/ Physical Requirements Temperature, Operating... -5 °C to 50 °C Temperature, Storage ... -30 °C to 70 °C Water Resistance...Warmer: IEC 529 IPX7 30 minutes immersion at a depth of 91.4 cm (36 in.) Controller: IEC 529 IPX1 dripping water Disposable Cartridge and (optional IV Extension Set): IEC 529 IPX8 continuous immersion Penetration ...Warmer: IEC 529 IP6X dust tight Controller: IEC 529 IP2X ≥ 12.5 diameter against ingress of solid foreign bodies Disposable Cartridge and (optional IV Extension Set): IEC 529 IP6X dust tight 4400-0024 enFlow Operator’s Manual EN Rev. L 07/09

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Electrical Safety ... UL 60601-1:2003 R6.03, CAN/CSA-C22.2 No. 601.1-M90, IEC 60601-1-1:2000, IEC 60601-1-4:2000 (Canada) Relative Humidity, Operating and Storage ...Warmer: 10 % to 90 % Controller: 10 % to 100 % Disposable Cartridge and (optional IV Extension Set): 10 % to 90 % Altitude, Operating and Storage...up to 15,000 ft Air Pressure, Operating and Storage...570 hPa, (17 inHg) to 1060 hPa (31 inHg) Shock/Drop Abuse Tolerance ...MIL-STD-810F Vibration...MIL-STD-810F Electromagnetic Emissions...CISPR11 Group 1 Class A (Ref 60601-1-2) Electromagnetic Immunity...IEC61000-4-3 Level 3, 10 V/M (Ref 606011-2) Magnetic Field Immunity...IEC61000-4-8 Level 2, 3 A/M (Ref 60601-1-2) Electrostatic Discharge...IEC61000-4-2 Level 4, 8KV Contact, 15 KV Air (Ref 60601-1-2) Note Electromagnetic Compatibility (EMC) The enFlow IV Fluid / Blood Warmer System has been tested and found to comply with the limits for medical devices as set forth in IEC 60601-1-2: (2001) and related standards. These limits are designed to provide reasonable protection against electromagnetic interference (EMI) in a typical medical installation. The enFlow System generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If the enFlow System does cause interference to other devices, which can be determined by turning the Controller off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reposition the Warmer and any intertwined cables. - Check ECG monitoring electrode contact and impedance. - Confirm monitoring lead wires are functioning properly and shielding is intact. - Connect the Controller into an outlet on a circuit different from that to which the other device(s) are connected. - Consult the manufacturer for help. Safety Classifications Type of protection against electrical shock...Class I, or Internally Powered Degree of protection against electric shock ...Type BF, Defibrillation-Proof Mode of operation...Continuous

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Appendix B: Glossary enFlow IV Fluid/Blood Warming System

The enFlow IV Fluid/Blood Warming System consists of three products: the Warmer (No. 980100), the Controller (No. 980121), and the Disposable Cartridge (No. 980200), which together form a system designed to warm intravenous fluids and blood products helping in the reduction of hypothermic effects.

Warmer

The Warmer is a small, lightweight, rugged fluid warmer that heats blood, blood plasma, and intravenous fluids being delivered to the patient’s body within seconds from 20 ºC to 40 ºC through a flow rate range of KVO to 200 mL/min.

(Product No. 980100) Controller (Product No. 980121) Disposable Cartridge (Product No. 980200) Disposable

The Controller displays a temperature readout in degrees C, as well as containing a keypad, which controls the clock and the mute feature. Additionally, it converts AC line power to 28 Volts DC, and is used as a power source for the Warmer. The Disposable Cartridge uses a sterile, single use component to be used as an in-line component of an IV infusion set for the heating of the fluids/blood being infused into the patient’s body.

Cartridge with IV Extension Set (Product No. 980202)

The Disposable Cartridge with IV Extension Set product contains the same Disposable Cartridge described above. In addition, it includes a sterile, single use IV extension set.

Intravenous Fluids

Fluids such as Normal Saline, Dextrose, Dextron, Packed RBC’s

KVO

“Keep Vein Open” refers to an intravenous infusion rate defined as approximately 2 mL/min (120 mL/hr).

LED

Light Emitting Diode

mL/min

Milliliters per minute

RBC’s

Packed Red Blood Cells

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Appendix C: Warming System Response by Temperature

Fluid Temp 30 °C 31 °C 32 °C 33 °C 34 °C 35 °C 36 °C 37 °C 38 °C 39 °C 40 °C 41 °C 42 °C 43 °C 44 °C 45 °C

Heater

Temperature LED on Warmer Blue Flashing Blue Flashing Blue Flashing Blue Blue Green Green Green Green Green Green Green Green Yellow Yellow Yellow (Red Flashing after 20 seconds)

Active Active Active Active Active Active Active Active Active Active Active Off Off Off Off Off

46 °C

Off

Yellow (Red Flashing after 16 seconds)

47 °C

Off

Yellow (Red Flashing after 12 seconds)

48 °C

Off

Yellow (Red Flashing after 8 seconds)

49 °C

Off

Yellow (Red Flashing after 4 seconds)

50 °C

Off

Red Flashing (immediately)

Display on Controller 30°C Blue Flashing 31°C Blue Flashing 32°C Blue Flashing 33°C Blue 34°C Blue 35°C Green 36°C Green 37°C Green 38°C Green 39°C Green 40°C Green 41°C Green 42°C Green 43°C Yellow 44°C Yellow 45°C Yellow & then after 20 seconds Red Flashing "Over Temp" message 46°C Yellow & then after 16 seconds Red Flashing "Over Temp" message 47°C Yellow & then after 12 seconds Red Flashing "Over Temp" message 48°C Yellow & then after 8 seconds Red Flashing "Over Temp" message 49°C Yellow & then after 8 seconds Red Flashing "Over Temp" message Red Flashing "Over Temp" message (immediately)

4400-0024 enFlow Operator’s Manual EN Rev. L 07/09

Audible alarm No No No No No No No No No No No No No No No After 20 seconds After 16 seconds After 12 seconds After 8 seconds After 4 seconds Immediately

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