Warmflo Fluid Warming System FW 538 Operators Manual Rev A Oct 2003

Contents Contents... i Figures... iii Table... iv Safety Information... 1 Warnings and Cautions ... 1 Warnings ... 1 Cautions ... 2 Notes ... 2 Disposable Fluid Warming Set Warnings & Cautions ... 2

Introduction... 5 Indications for Use ...5 Contra-Indications ... 5 Description ... 5 System Symbols ... 7

Setting Up Fluid Warming System... 9 Procedure ...9

Fluid Warmer Operation...11 Instructions For Operation ... 11 Alarms ... 13 Alarm Test Procedure ... 14

FW-538 Internal Tests... 15 Introduction ... 15 Tests ... 15 Test #1: Zone Heating Monitoring ... 15 Test #2: Individual Thermistor Monitoring ... 15 Test #3: Automatic Thermistor Zone Monitoring ... 16

Troubleshooting... 17 Problems ... 17 Electromagnetic Interference ... 20

Preventive Maintenance... 23 Specifications... 25 Dimensions ... 25 Weight ... 25 Technical Specifications ... 25 Transportation and Storage ... 26 Performance Requirements ... 26

Accessories... 27 Introduction ... 27 Disposable Fluid Warming Sets ... 27 Infusors and Irrigators ... 27 Disposal of Fluid Sets ... 28 Disposal Of Fluid Warming System ... 28

Warmflo Model FW-538

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Contents

Theory of Operation... 29 Introduction ... 29 Temperature Adjustment ... 30 Alarm Control Buttons ... 30

Index... 31

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Contents

Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7:

Warmflo Model FW-538

Filter and Filter Mount ... 3 WF-250 Heat Exchanger Cassette ... 4 Warmflo FW-538 ... 5 Warmflo Model FW-538 with WF-250 Surgery Set ... 6 Mounting on IV Pole ... 9 Accessing Heater Plates ...23 Increasing/Decreasing Temperature ... 30

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Contents

Ta b l e Table 1: Table 2: Table 3: Table 4:

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Audible and Visual Alarms ...13 System Problems and Solutions ... 17 System Fault Codes ... 18 System Preventative Maintenance ...23

Safety Information

Warnings and Cautions

Warnings in this manual are identified by the WARNING symbol shown above. A warning alerts you to potentially serious outcomes (death, injury, or adverse events) to the user or the patient.

Warnings WARNING: Possible electrical shock hazard. The warming unit should only by serviced by a qualified technician. If a qualified technician is not available, please notify your sales/service center.

WARNING: The fluid warmer must be plugged into a properly grounded 115 volt AC power source.

WARNING: Grounding reliability can only be achieved when the fluid warmer is connected to an equivalent receptacle marked “HOSPITAL ONLY” or “HOSPITAL GRADE.”

WARNING: If a malfunction occurs in the fluid warmer, discontinue use. Notify your sales/service center of the malfunction. The unit must be serviced by an authorized service technician.

WARNING: Cassette pressures above 300 mmHg may cause hemolysis. Excessive pressures will burst the cassette.

Warmflo Model FW-538

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Safety Information

Cautions

Cautions are identified by the CAUTION symbol shown above. A caution alerts you to exercise care necessary for the safe and effective use of the FW-538. Caution: Do not store liquids on top of the fluid warmer.

Caution: Use only Warmflo® disposable fluid warming sets with the fluid warmer. Caution: Do not use the fluid warmer with preheated fluids. Fluids preheated above 44ºC may activate the heater safety mechanism, causing the high temperature alarm to activate.

Notes

Notes are identified by the Note symbol shown above. Notes provide additional helpful information.

Disposable Fluid Warming Set Warnings & Cautions WARNING: Refer to the instructions for use provided with all disposable fluid warming sets prior to use.

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Safety Information

Caution: To avoid potential kinks in the fluid line at point 1 (Figure 1 below), route the fluid line through the channel in the filter mounting bracket as shown:

1 - Potential kinks

2 - Filter mount bracket

3 - Filter

4 - Slide tubing through channel

Figure 1: Filter and Filter Mount Caution: Do not attempt to prime the disposable fluid set while the heat exchanger cassette is outside the fluid warmer or while the door is not latched. Caution: If the fluid set has primed before the heat exchanger cassette is inserted into the fluid warmer, open all clamps distal to the heat exchanger cassette and allow the cassette to relax before attempting to insert the cassette. Caution: After use, turn off the automated pressure infusor or release pressure cuffs, if used. Always close the red pinch clamp (Figure 2) prior to removing the heat exchanger cassette from the fluid

Warmflo Model FW-538

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Safety Information

warmer. Failure to do so could result in rupturing the heat exchanger cassette.

1 - Red clamp

Heat exchanger cassette

Figure 2: WF-250 Heat Exchanger Cassette

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Introduction

Indications for Use The FW-538 fluid warming system is used to provide safe and effective warming of fluids, such as blood, blood products, physiologic fluids, and irrigation fluids. The FW-538 can be used for all types of surgical procedures and operations that require warmed fluids administered to patients.

Contra-Indications There are no known contra-indications for use of this device.

Description

Figure 3: Warmflo FW-538 The FW-538 fluid warming system is designed for use in medical environments under the direction of a physician to warm blood, intravenous (IV), and irrigation fluids. The FW-538 fluid warming system uses a heat exchanger cassette that is inserted between microprocessor-controlled heater plates located within the warmer housing. The dry heat process is safe, reliable, and requires little warm up time. There are a variety of disposable blood and fluid administration sets available for use in routine surgery, standard intravenous warming, and irrigation applications.

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Introduction

The FW-538 fluid warming system may be used as a gravity flow device or in conjunction with automatic and manual pressure infusors and irrigation pumps to deliver fluids.

Figure 4: Warmflo Model FW-538 with WF-250 Surgery Set A B C

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Warmflo® pressure infusor or irrigation pump (optional) Warmflo® model FW-538 Air eliminator chamber with filter

D

WF-250 heat exchanger cassette

E

Roller clamp

F

Dual injection port

Introduction

System Symbols The following symbols are used on the FW-538 unit.

On

Off

Alarm Test

Alarm Silence

Underwriters Laboratories Inc.

Canadian Standards Association

Shock Hazard BF Classification

Drip Proof

Refer to Instructions for Use

Equipotential Terminal (ground)

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S e t t i n g U p F l u i d Wa r m i n g S y s t e m

Procedure 1. Using the IV pole bracket located on the left side of the unit, attach the fluid warmer to a stable IV pole. Mount the unit no higher than patient level and check that the pole and unit are stable and not easily tipped. 2. Attach the power cord to the back of the unit and into a 115 volt hospital grade AC outlet. 3. Turn the power switch, located at the rear of the unit, to the ON (I) position.

Figure 5: Mounting on IV Pole 4. Perform the alarm test procedure. See Alarm Test Procedure on page 14.

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F l u i d Wa r m e r O p e r a t i o n

Instructions For Operation Caution: The use of preheated fluids above 44ºC may activate the high temperature alarm. 1. Turn the FW-538 on using power switch (I/O) located on the rear panel. The control panel will display the start-up test mode, followed by the software revision number. During the start-up routine, a continuous beep will sound to test the over-temperature safety system. When the default temperature set point is displayed (38ºC) and three beeps are heard, the unit is ready for operation.

Start-up test mode

Software revision number

Fault code number

Note: Listen for three beeps, indicating that the unit is ready for operation before inserting cassette. Note: If fault code numbers are displayed during the start-up test mode (i.e., F_XX), turn the unit off and then on again to attempt to clear the fault. See Troubleshooting on page 17. 2. Adjust the temperature set point as desired using arrow buttons. The temperature display will flash for 5 seconds to indicate the new temperature setting. (The temperature range is 28ºC to 42ºC.)

Warmflo Model FW-538

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Fluid Warmer Operation

3. Push the door latch button to open the cassette door. The door will open downward approximately 1/2 inch (1.27 cm).

Note: Observe the orientation label on the cassette for proper insertion of the cassette into the FW-538. 4. Slide the Warmflo disposable heat exchanger cassette into the door opening until fully inserted.

Caution: Do not prime the cassette with fluid prior to closing the door, as rupture of the cassette and fluid leakage may occur. 5. Close the door by lifting up firmly until the door is latched into position as indicated by the appearance of the green band on the top edge of the door latch button.

Note: To be sure that the door is closed, pull out on the door latch button until the green band is visible. Caution: The door must be firmly latched prior to use to avoid potential rupture of the cassette.

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Fluid Warmer Operation

6. Prime the heat exchanger cassette according to the instructions for use provided with each disposable warming set. 7. After use, turn off the automatic pressure infusors or release pressure cuffs if used. Close the red clamp on the disposable warming set. Reduce the pressure on the heat exchanger cassette by releasing fluid downstream. Push the door release button to open the door and remove the cassette. Discard the warming set in accordance with your medical facility procedures.

Alarms The alarm test button can be used at any time to check the proper operation of the high and low temperature alarms. See Alarm Test Procedure on page 14. Normal operation automatically resumes after the test, which takes less than 15 seconds. The alarm silence button causes any audible alarm to be silenced momentarily while visual alarm messages are maintained. The audible alarm is automatically restored after 2 minutes if the alarm conditions persist. The FW-538 has multiple, independent temperature control and alarm systems to help assure patient safety. The following alarms are intended to alert users to faulty operation or out-of-range performance.

Table 1: Audible and Visual Alarms Alarm

Cause

Internal Malfunction

Detected component malfunction

None

Flashing display of fault code

Refer to Troubleshooting on page 17, for a list of the fault codes and the appropriate response.

First High Temperature

When output temperature is detected to be above 44.5° C for greater than 2 seconds

Repetitive tone at one-second intervals

Flashing display of output temperature

Heater plates are disabled when the high temperature is detected.

Second High Temperature

When output temperature is detected to be above 44.5° C for greater than 2 seconds

Continuious tone

Flashing display of output temperature and fault code

FW-538 shuts down.

Low Temperature

When output temperature is detected to be 3° C below set point for 10 seconds

Short beep every five seconds

Flashing display of output temperature

Warmer continues to operate.

Warmflo Model FW-538

Audible

Visual

Note

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Fluid Warmer Operation

Alarm Test Procedure When performing the alarm test, the FW-538 provides a visual temperature display. The low alarm will display a reading that is three degrees below the set point temperature. For example, with a set point of 38.0 degrees, L35.0 is displayed. The high temperature alarm display will vary depending on the version of software used on your system. One of the following displays will be seen during the alarm test: • Software version 2.19 flashes H42.0 during the high alarm test. • Software version 2.24 flashes H44.5 during the high alarm test. A secondary over temperature shutdown occurs if the temperature exceeds 45º C. A continuous tone audible alarm and alternating flashing display of the temperature and fault code (if applicable) indicate this condition. The secondary over temperature alarm cannot be silenced without turning the unit off. If the fault code is flashing, turn off the unit and wait until the fluid temperature cools down before restarting.

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F W - 5 3 8 I n t e r n a l Te s t s

Introduction The Warmflo FW-538 software provides three internal test modes. After pressing the Increase and Decrease temperature buttons simultaneously for five seconds, the unit enters the internal test mode. A series of test modes are accessible in a round-robin fashion by pressing the increase button. When a test is initially entered, its test number is displayed in the first LED, while the other LEDs are blank. The test number is displayed for one second. Pressing the alarm silence button during any test will cause the program to return to normal operating mode.

Tests All temperatures displayed in the internal test modes are actual temperatures without rounding.

Test #1: Zone Heating Monitoring The first LED indicates which zones are heating. The remaining three LEDs display the output temperature.

Test #2: Individual Thermistor Monitoring The first LED indicates the currently selected zone (1, 2, 3, lower plate). The selected zone is displayed as an illuminated segment in the first LED. These segments are mapped in the following way:

1- Zone 2 2 - Zone 3 3 - Lower plate 4 - Zone 1

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