enFlow System Manual Rev A

About this manual This manual has been developed to provide the user with the information necessary to operate and maintain the enFlow IV fluid/blood warming system. It is important that all medical personnel that operate this device read and understand all the information contained within this System Manual. This material is not meant as a substitute for formal training in the use of intravenous delivery systems, which may be required by local, regional or state protocol. As with any medical device, please consult your local medical director or governing agency for further information and requirements. If you have questions or concerns regarding this manual or product, please contact Customer Service or Technical Support for assistance:

Customer Service

Technical Support

E-mail: [email protected] Phone: 1.800.323.9088, option 1

Phone: 1.973.956.5431

Manufactured for Vital Signs, Inc. a GE Healthcare Company 20 Campus Road Totowa, New Jersey 07512, USA EC

RE P

GE Medical Systems SCS 283 rue de la Miniere, 78530 Buc, France

© 2015 General Electric Company – All rights reserved. All specifications subject to change without notice. GE, GE Monogram, and Vital Signs are trademarks of General Electric Company. * enFlow is a trademark of General Electric Company Enginivity, LLC., a subsidiary of Vital Signs, Inc. Vital Signs, Inc., a General Electric company, doing business as GE Healthcare.

4400-0024-EN Rev A

Symbols used on the equipment The following symbols may be viewed on any of the products or accessories that comprise the enFlow IV fluid/blood warming system.

Symbol

Symbol description

Symbol

Symbol description

LO T

Batch Code

On

RE F

Catalog Number

Off

SN

Serial Number

NS N

National Stock No. (US Military)

Expiration Date

2

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

Caution

Fuse

STERILE R

2

STERILIZ E

LATEX

Temperature; Thermometer

Not made with natural rubber latex

NON-PYROGENIC

Note

Danger High Voltage

4400-0024-EN Rev A

- 3 of 40 -

Not Made With Natural Rubber Latex

Non-Pyrogenic

This symbol indicates that additional information is being provided.

70˚C

Electric Energy

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

Temperature Range

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

Not made with Di(2-ethylhexyl) phthalate

In transport applications it is advised to cushion and insulate the Warmer from the patient’s skin and apply the Warmer as loosely as acceptable checking regularly for signs of potential pressure-related injury

-30˚C

DEHP

Manufacturer

IP67

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

IP31

Degree of protection provided by enclosure, no ingress of object > 2.5 mm diameter, protected against dripping water

IP68

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

Rx ONLY

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician

Surface may be hot

Consult Instructions for Use

Do not encase the Warmer with any external coverings like: towels, sheets, blankets or drapes. Covering the Warmer restricts the natural convection of heat.

System Fault XX

Low Battery

Lock or Password Required

Unlock

Do Not Throw in Trash

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).

Intertek 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 CAN/CSA-C22.2 No. 606011:2008 Ed 03, AAMI ES60601-1:2005, IEC 60601-1:2005 Ed 03, IEC 60601-1 -6:2010 Ed 3 and IEC 60601-1-8: 2006 Ed 2.

Mute the Audible ‘High Priority Alarm’ For 1 Minute

xx

CM

C

US

4005716

4400-0024-EN Rev A

- 4 of 40 -

Table of contents Warnings... 6 Cautions... 6 enFlow IV fluid/blood warming system description... 8 Indications for use... 8 Clinical and training information... 8 Unpacking the enFlow IV fluid/blood warming system... 9 To begin operation of the enFlow IV fluid/blood warming system... 9 enFlow Controller (Model 121 series) indicators and operation...12 Controller (Model 121 series)-Setup Instructions...12 Controller Display...12 enFlow Warmer (Model 100 series) indicators and operation...13 Cleaning the enFlow IV fluid/blood warming system components...14 Caution...14 Cleaning the Warmer...15 Cleaning the Controller...15 Storing the enFlow IV fluid/blood warming system components...15 Servicing the enFlow IV fluid/blood warming system components...16 Instructions for replacing the Controller clock battery...16 Instructions for changing the Controller fuse...18 enFlow fluid warming system temperature controls and alarms...19 Temperature control...19 Audible/Visual alarm...19 enFlow troubleshooting...19 Electromagnetic interference...19 Interference confirmation...19 Interference reduction steps...19 enCheck® (Model 400) user guide...20 Cleaning the enCheck...21 Appendix A: Technical specifications...22 Appendix B: Warmer fault code table...25 Appendix C: Warming system response by temperature...26 Appendix D: Parts list...27 Appendix E: Preventative maintenance procedure...28 Appendix F: enFlow IV fluid/blood warming system operational checklist-alternative method...38 Appendix G: enFlow IV fluid/blood warming system operational checklist-enCheck Model 400 method...39 Appendix H: Glossary...40

4400-0024-EN Rev A

- 5 of 40 -

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. The ‘High Priority Alarm’ is a flashing RED LED, a flashing RED controller display, and an audible alarm, indicating that the infusate is over temperature. Stop the fluid flow, and slide the Warmer covers open to stop warming. If the above occurs, then replace the Warmer and contact Technical Support. The attending practitioner should remain within 4 m of the patient when the device is in use to enable visualization of the enFlow display and hear the audible high priority alarm. 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 Bussmann® part #S500-5-R or equivalent. The Disposable Cartridge should not be used for more 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. To avoid risk of electric shock, this equipment must only be connected to a supply main that is grounded. Should the need arise the device may be disconnected by the appliance coupler. Do not connect the enCheck® to an enFlow system while it is in any way connected to a patient.

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 Disposable Cartridge contains aluminum. Review the preparation or solution manufacturer’s instructions for use about chemical sensitivity. Do not affix, place or bind the Warmer directly to a patient during general use. Do not wrap the Warmer in towels, sheets, blankets or drapes. Warmer Strap (980304VS30) may be used with the Warmer for transport purposes only, such as field use (for the military) and inter-hospital transport and ambulatory circumstances. Do not strap for non-transport scenarios. 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:  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. 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 than 61 cm (24 in). A Controller mounted too high on the IV pole may cause instability. IV pole accessories or the attachment of fluid bags may also cause instability. 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 provided IV Line Clip 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.

4400-0024-EN Rev A

- 6 of 40 -

• • • • • • • • •

Avoid puncturing the heating surface. If damaged, remove the Warmer from service and replace immediately. This equipment is not intended for use in an oxygen rich environment (defined as >22% O2). No modification of this equipment is allowed. Do not position the device in a way that makes it difficult to disconnect the device. 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 (Appendix F) should be performed at least once a year, or as required by your accrediting body. The enCheck is to be used only with the enFlow Warmer and Controller. Do not touch the enCheck contact plate surface during or immediately after use since it may be very hot. The warmer and controller may be a potential biohazard during or after use. Handle and dispose of in accordance with acceptable medical practice and applicable regulations at the end of their life.

4400-0024-EN Rev A

- 7 of 40 -

enFlow IV fluid/blood warming system description The enFlow IV fluid/blood warming system consists of the enFlow Warmer (Model 100 series), the enFlow Controller (Model 121 series), the enFlow Disposable Cartridge with IV extension set (Model 202) or without IV extension set (Model 200). Within seconds, this warming system delivers normothermic infusate to the patient at flow rates of Keep Vein Open (KVO defined as 2 mL/min) 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 to help ensure 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.

ON TEMP EMP

POWER PO OWER

OFFF

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.

POWER UNLO

CK

40°C 2:20 P

Controller Model 121

LOCK

Each Disposable Cartridge and the Disposable Cartridge with IV extension set are radiation sterilized and non-pyrogenic, not made with natural rubber latex or DEHP. 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.

Indications 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, when properly administered, will help to prevent hypothermia and the complications arising therefrom.

4400-0024-EN Rev A

- 8 of 40 -

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 components for each model are reflected below: •

•

•

Model 100  Warmer  Warmer Cord Clip  IV Line Clip  USB Manual  Patient Leakage Report  Certificate of Conformance Model 121  Controller  Patient Leakage Report  Warmer Mount (Warmer Mount Instructions)  USB Manual Model 200  Disposable Cartridge  IFU

Model 202  Disposable Cartridge with IV extension set  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.

4400-0024-EN Rev A

- 9 of 40 -

Controller Model 121

POWER CK

40°C 2:20 P

Controller Model 121

40°C 2:20 P

40°C 2:20 P

Controller Model 121

LOCK

Controller Model 121

UNLO

40°C 2:20 P

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. (Please refer to the “enFlow Controller (Model 121 series) indicators and operations” section for directions to set the clock). d. Connect the 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.

enFlo

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. 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 100, 115, or 240 VAC (100-240 VAC).

WER

PO

MP

TE OFF ON

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.

WER

PO

MP

TE OFF ON

4400-0024-EN Rev A

- 10 of 40 -

h. Completely close the covers on the Warmer by pressing down on the cartridge and sliding the covers inward toward each other until they meet. Upon closing the covers, a short audible beep occurs indicating that the Warmer self-test is being performed and 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.

WER

PO

MP

TE

OFF ON

i.

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

ON

IV Line Clip

j.

The Warmer is designed to be placed on the bed and/or attached to patient coverings in close proximity to the site of infusion using the cord clip P/N 980309VS-20. Cushion the patient from the Warmer to aid in the prevention of perioperative peripheral neuropathies or heat-related dermal injury.

k. Do not wrap the Warmer in towels, sheets, blankets or drapes.

l.

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

m. To turn off the device, use the switch located at the rear of the Controller.

4400-0024-EN Rev A

- 11 of 40 -

Controller Model 121

enFlow Controller (Model 121 series) indicators and operation

Controller Display

Keypad

40°C 2:20 P Female Receptacle for Warmer Connector

Power Indicator

Controller (Model 121 series)-setup instructions 1. Set the clock a. To modify the initial default mode of the Controller, press the center button of the front keys of the display window prior to pushing the power switch that is located in the back of the unit. The key must be held down continuously until the clock is displayed. b. Once the clock appears, toggle the center button to move through the fields. To change a field, press the right or left arrow keys. 2. Set the Controller display default mode to symbols (International Mode) a. Continue to toggle through to the set zone field. Press either the right or left arrow key to access the padlock symbol to enter the password screen. b. The password is 781. c. An underscore will display under the first digit field. Press the arrow key to set the appropriate digit. d. Next, press the center key again to toggle to the next place. e. Repeat steps three and four for the second and third digits. If an incorrect password is entered, the system reverts to the set zone screen. f. After the third digit is set, press the center key again. First a green padlock and then the zone USA will appear. Press the right arrow to change to INTL. g. Press the center key again to set. The system begins to operate. h. After the initial setup, whenever the Controller is powered on, the display screen defaults to the last mode entered.

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 tables:

4400-0024-EN Rev A

- 12 of 40 -

Table 1-Controller Display: Normal Operating Model Activity

Display reads

Display color and function

Temperature and Clock 40 °C 9:00 A

Identical to Warmer temperature LED

Warmer is not connected, but Controller is powered on.

Not Heating

Yellow

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, Cartridge is not in Warmer.

Not Heating

Yellow

Warmer is connected and power is engaged.

Table 2-Controller Display: Alarm Mode Activity

Display reads

Display color and function

Display alternates between Over Temp and Press Key to Mute

Identical to Warmer temperature LED

Over Temp Muted

Identical to Warmer temperature LED

System Fault XX If a system fault message is on the Controller display, refer to the system fault section Appendix B or contact Technical Support.

Red High priority alarm

Display reads

Display color and function

09:00 A

Blue

Warmer over temperature Mute button activated Fault detected

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.

enFlow Warmer (Model 100 series) 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).

Sliding covers

Temperature Status LED (Indicated by symbol )

ON TEMP

POWER

OFF

Power cable

4400-0024-EN Rev A

Heating surface

- 13 of 40 -

Power LED (Indicated by symbol

)

Table 4: Warmer indicator status Status

Warmer covers

Disposable cartridge

Power LED indicator

Temperature LED indicator

Audible indicator

Description

Action required

Ready

Open or closed

None

Flashing Green every 3 seconds

Unlit

None

Warmer unit has power, but is not heating

None

Device power up

Closed

In place

Red ½ second duration

Red ½ second duration

½ second beep

Successful device power up and over temperature circuit test

Observe. If the LED does not flash red, replace the Warmer; and contact Technical Support.

In operation

Closed

In place

Solid Green

Flashing Blue

None

Infusate temperature is < 33 °C

None

In operation

Closed

In place

Solid Green

Solid Blue

None

Infusate temperature is ≥ 33 °C and < 35 °C

None

In operation

Closed

In place

Solid Green

Solid or Flashing Blue >30 seconds

None

Warmer is unable to heat the infusate within operational range. Infusate temperature is < 20 °C and/or the flow rate is > 200 mL/min.

Reduce the flow rate if possible. If there is no change in operational temperature, consider replacing the Warmer and contact Technical Support.

In operation

Closed

In place

Solid Green

Solid Green

None

Infusate temperature is ≥ 35 °C and ≤ 42 °C

None

In operation

Closed

In place

Solid Green

Solid Yellow

None

Infusate (and/or ambient temperature) is > 42 °C but less than an Over Temp condition

Observe. This state whereby the infusate is > 42 ºC should only be entered periodically during changes in flow rate or infusate temperature.

In operation

Closed

In place

Flashing Red

N/A-Varies

Continuous audible bursts

Internal failure in the Warmer

Replace the Warmer if this occurs, and contact Technical Support.

Continuous operation

Closed

In place

Solid Green

Flashing Red

Continuous audible bursts

Infusate (and/or ambient temperature) is > 45 °C signifying an Over Temp condition

Stop the fluid flow, and slide the Warmer covers open to stop warming. Replace the Warmer if this occurs, and contact Technical Support.

High priority alarm

Refer to Appendix C for the chart on “Warming system response by 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.)  Abrasive cleaners

•

Do not sterilize the Warmer with:  Steam sterilization (autoclave)  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.

4400-0024-EN Rev A

- 14 of 40 -

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: • • • • • • • • •

40% bleach sodium hypochlorite and 60% water solution Isopropyl alcohol Clorox® Bleach Germicidal Wipe Cidex® OPA CIDEX® Glut CaviWipes® Super Sani-Cloth® Sani-Cloth® HB Sani-Cloth® AF

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. Be sure to wipe clean the orange heating surface regularly. If the heating surface starts to grey or if the controller displays a system fault 50, thoroughly clean with isopropyl alcohol and inspect for damage to the heating surface. 4. 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 manufacturer’s recommendations. (Refer to list in Cleaning Section, above.) 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. 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)

4400-0024-EN Rev A

- 15 of 40 -

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. The system uses current Surface Mount Technology (SMT) and materials. If a System Fault error occurs, then remove the device from service and refer to the table in Appendix B for proper evaluation and handling. Do not return the device or place it back into service unless it has been cleaned per the instructions above and evaluated by a trained technician using the instructions in Appendix E and Appendix F. If the unit stops working properly, contact Customer Service to obtain an Return Goods Authorization (RGA) number prior to returning the unit to Vital Signs. If damage has occurred to the heating surface, immediately remove it from service.

RGA number The Technical Support Representative will troubleshoot your product issue with you on the phone. If it is necessary to return a product under warranty, a replacement unit will be shipped to you within 48 hours. (If the product is no longer under warranty, the Customer Advocacy Representative will discuss replacement options.) You will be issued a RGA number. You will be instructed to return the product in sufficient packaging to prevent damage in transit, clearly marking the RGA number on the outside of the box. The return address will be provided to you. Warmer (Model 100 series) The Warmer is permanently sealed against fluid ingress and has no user serviceable parts inside. Controller (Model 121 series) See “Servicing the enFlow IV fluid/blood warming system components” below for information on user serviceable parts inside the Controller. Check the fuses located in the outside power entry module if the Controller fails to function. The power cord must be removed to do this. Replaceable parts for the Controller: • Clock battery (See below for replacement instructions) • Fuse – Bussmann #S500-5-R or equivalent (See below for replacement instructions) • Cover • Screws • Pole clamp screw • Power cord • Warmer mount The Controller should be subjected to routine safety checks as required by local regulations, (i.e., Earthing Impedance, Leakage Current).

Instructions for replacing the Controller clock battery

Clock Battery Specifications Cell #

CR2032

Classification

Lithium Coin

Chemical System

Lithium / Manganese Dioxide (Li/MnO2)

Designation

ANSI / NEDA-5004LC, IEC-CR2032

Nominal Voltage

3.0 Volts

Typical Capacity

220 mAh

4400-0024-EN Rev A

- 16 of 40 -

1. Turn Controller over.

Diagram 1

Diagram 2

LOCK

UNLO CK

Controller Model 121 Controller Model 121 LOCK

UNLO CK

2. To remove the bottom, unscrew pole clamp screw; unscrew six (6) screws shown below. Next, lift the cover.

Diagram 3

Diagram 4

Screw_1 Screw_2 Pole Clamp Screw

Screw_4

Screw_3

Screw_5

Screw_6

3. Remove power supply assembly a. On the power supply assembly, unscrew two (2) screws shown below (see Diagram 5). Also remove the screws holding the zip ties to the post for the ferrite bead securement. b. Gently lift assembly by holding pole clamp, and prop up with a small block or box (see Diagram 6).

Diagram 5

Pole Clamp

Diagram 6 Fan Assembly

Screw_1 Display Board

Pole Clamp

Block

Display Board

Battery Post_1

White Posts Post_2

Screw_2 Zip ties

4400-0024-EN Rev A

- 17 of 40 -

4. Remove display panel a. On the display panel, remove the four (4) screws at the end of the panel next to the display screen (see Diagram 7). b. Pull the display panel away from the fan assembly. c. With pliers, gently pull out battery. d. Insert new battery in the same direction as the old battery. Push firmly into place. e. Reinsert and tighten all screws on the display board.

Diagram 7 Display

Remove Screw_3 Battery

Remove Screw_1

Remove Screw_2

Remove Screw_4 Cont rolle r Mod el 12 1

CK LO

CK LO

enF low

Block or Box

UN

R

WE

PO

5. Reassembly a. Reseat fan assembly and display board (see Diagram 5). b. When reseating display board, make sure that all wires are between the two white posts (see Diagram 6). c. When reseating the fan assembly on the display board end, make sure that the wires are inside the corner post_1 (See Diagram 5) and wrap around the edge of the fan assembly. d. On the opposite end from the display board, make sure the wires go around the outside of the corner post_2. e. Reinsert and tighten the two (2) screws for the power assembly (see Diagram 5). f. Reinstall the two screws for the zip ties that were taken apart in step 3a. g. Attach bottom cover; reinsert and tighten the six (6) related cover screws (see Diagram 3). h. Reinsert pole clamp screw. i. Dispose of the old battery in accordance with any government regulations in effect in your area.

Instructions for changing the Controller fuse Note

: Remove power cord before inserting screwdriver.

1. Insert a screwdriver on either side of the fuse box and push gently to pop the fuse case out of its socket.

Fuses

Fuse Case

Keyed

2. Pull the fuse out of the case. 3. Replace the fuse with (Bussmann #S500-5-R or equivalent). The socket in the Controller is keyed so that the fuse case can only be inserted in the correct orientation. Push the case in gently, but firmly, until it snaps into place. At this point, it will be flush with the surrounding surface.

4400-0024-EN Rev A

- 18 of 40 -

enFlow fluid warming system temperature control and alarms Temperature control The enFlow IV fluid/blood warming system includes multiple safety features to prevent overheating of infusion fluids. There are built-in redundancies and back-up safety systems as means for protection in the event of a failure in the primary control mechanism. Several aspects of the system work together to accomplish desired and appropriate safety: 1. 2. 3. 4.

Closed-loop temperature control software Audible and visual alarms Software system monitor Independent heater temperature monitoring circuit

Audible/Visual alarms The enFlow system incorporates an audible/visual alarm system. This system monitors the fluid temperature for an over-temperature condition and system faults. The alarm function is tested each time a Cartridge is inserted. The audible alarm is briefly sounded, and the red light emitting diode indicator is also briefly illuminated. If a dangerous condition occurs, a continuous audible and visual alarm is activated. Over-temperature conditions are calculated according to ASTM Standard F2172-02 (an FDA recognized standard for fluid warmers). This standard allows for spikes in the fluid temperature without activating an alarm. The alarm has a linear time-temperature relationship; therefore, the hotter the fluid the less time it will take for the alarm to be activated. At 45 ºC the alarm will sound after about 20 seconds while at 50 ºC it will be essentially instantaneous. The alarm will be activated by either the Warmer over-heating the fluid or if the fluid entering the Warmer is too hot. The audible aspect of the alarm can be muted for 1 minute by pressing any key on the Controller. The alarm can also be ended completely by sliding open the covers on the Warmer. (For further information, please reference test for Over-temperature Alarm located in Appendix E: Preventive Maintenance Procedure.)

enFlow troubleshooting Electromagnetic interference • • •

ECG, EEG or EMG (cardiac or neuro monitoring) artifact or other interference caused by the enFlow is an uncommon event. Cardiac or neuro monitoring interference is common and well-documented in medical literature. There are published suggestions to reduce or eliminate the interference that should be employed.

“Interference of the monitored or recorded electrocardiogram is common within operating room and intensive care unit environments.”1 The enFlow IV fluid/blood warming system, as with all electrical devices, can be associated with some electromagnetic interference (EMI); however, it has been uncommon and inconsistently experienced. Below are troubleshooting suggestions for situations where interference is observed:

Interference confirmation Turn the unit off. Turn the power supply on the back of the Controller to the OFF position. Reassess the interference. Knowing that cardiac or neuro monitoring is being affected, determine if the interference adversely affects your ability to care for the patient. Consider attempting to reduce the level of interference by employing some simple and readily available solutions.

Interference reduction steps Check the monitoring pads All monitoring pads should be fully adhered to the patient’s properly prepared skin. Confirm that the pad’s foam insulator is not curled up, peeled back or otherwise exposing the conductive gel layer. Confirm that the leadwires’ connectors are properly and fully attached. Consider reapplying monitoring electrodes if there is any suspicion they have dried out. Confirm the patient is properly grounded In many cases, and in all cases using mono-polar or bi-phase cautery, a grounding pad should be present and applied according to the manufacturer’s instructions. As previously suggested, confirm the ground pad is fully adhered to a properly prepared skin surface.

Patel, Santosh I., M.D., F.R.C.A. and Souter, Michael J, M.B., Ch.B., F.R.C.A.; Equipment-related Electrocardiographic Artifacts, Causes, Characteristics, Consequences, and Correction; Anesthesiology 2008; 108:138–48.

1

4400-0024-EN Rev A

- 19 of 40 -

Confirm the enFlow and the ECG monitor are plugged into different outlets There are two reasons for this action. It is possible that the two systems are in an electrical phase related conflict, which is being expressed on the monitor. Secondly, it is possible that the outlets are not properly grounded or grounded in different locations. While rare, it can be the case and outwardly there would be no way to tell. Confirm the Warmer cord is not entwined or near the ECG lead cable Separating the two cords will allow each cable’s shielding to work to its full potential. Confirm the monitoring cables and lead wires are in proper working order The insulating layer on lead wires and cables degrades over time and with use. Confirm the insulation is intact and operates at its stated specifications. Review the monitor’s notch filter Check to ensure that the monitoring system’s frequency filter is set appropriately. Determine the monitor’s sensitivity setting Many physiological monitors have the ability to interpret electrical signals in two distinct modes: a highly sensitive “Diagnostic” mode or a more filtered “Monitoring” mode. Determine the current mode of operation. If the current mode is set on “Diagnostic” consider adjusting it to “Monitoring.” Check the ECG pads impedance Contact your current supplier of monitoring pads or your local Vital Signs representative to determine if a lower impedance version is available. High impedance monitoring pads are less sensitive to the very low signal strength from the heart beat and appear to be more prone to pronounced interference.

enCheck (Model 400) user guide

Intended use Use this product only for the purpose for which it was designed; refer to product description below.

Purpose The enCheck tester was developed to quickly and reliably trigger the over-temperature alarm condition on the enFlow Warmer. Within seconds, the enCheck unit will heat the Warmer to an over- temperature scenario causing the alarm to sound. Additionally, the enCheck is designed to verify the Warmer operation at enFlow’s installation site.

Procedure When the enCheck is connected and running in the normal mode, the heat is generated from the Warmer unit using the same technology as when a cartridge is installed. This mode allows for confirmation of the temperature output of the Warmer. (See Appendix E, section on “Simulated Use Performance Testing.”)

enCheck system description The enCheck is designed to verify the Warmer operation at enFlow’s installation site. In the Normal Mode, it allows for confirmation of the temperature output of the Warmer. In the Overheat Mode, it heats the Warmer to an over-temperature scenario causing the alarm to sound.

4400-0024-EN Rev A

- 20 of 40 -