HOTLINE HL-90 Operators Manual Rev 010 April 2013

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l HOTLINE® Blood and Fluid Warmer

< HL-90

OPERATOR’S MANUAL PN 4534005-GB Rev. 010

s

G e n e r a l I n f o r m a t i o n

HOTLINE® Blood and Fluid Warmer Part Number: 4534005-GB Rev. 010 (2013-04) This revision supercedes all previous revisions. Every effort has been made to ensure that the information in this manual is accurate and details provided are correct at the time of printing. The company, however, reserves the right to improve the equipment shown. Mention of third-party products is for informational purposes only and constitutes neither an endorsement nor a recommendation. Smiths Medical ASD, Inc. (“Smiths Medical”) assumes no responsibility with regard to the performance or use of these products. Smiths Medical and Level 1 design marks and Level 1 and HOTLINE are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark office and certain other countries. All other names and marks mentioned are the trade names, trademarks, or service marks of the respective owners. For further information, please call your local Smiths Medical distributor or Smiths Medical direct at 1 800 258 5361 or +1 614 210 7300. ©2013 Smiths Medical. All rights reserved.

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HOTLINE® Blood and Fluid Warmer | Operator’s Manual

C o n t e n t s

Contents 1

About this Manual

1

Indications for Use Conventions Used in this Manual

1 1

2 Description

Components HOTLINE® Fluid Warming Set

3 Important Safety Information

2 2 4 5

Additional WARNINGS and CAUTIONS for Accessories

8

Step 1 - Unpack the HOTLINE Warmer Step 2 - Clamp the HOTLINEWarmer to the I.V. Pole Step 3 - Disinfect the Reservoir Step 4 - Fill the Reservoir With Recirculating Solution Step 5 - Perform the Electrical Safety Tests

9 9 10 11 11

4 Assembly Instructions

5 Principle of Operation Infusate Delivery Temperatures

6 Operation

Controls and Displays Display Panel Power and Alarm Test Panel Reservoir Level Display Modes of Operation OFF Mode ON/Operating Mode Check Disposables Mode Add Recirculating Solution Mode Over Temperature Alarm Mode

7 Operating Instructions

Step 1 - Set Up the HOTLINE Warmer Step 2 - Set Up the HOTLINE Fluid Warming Set

Step 3 - Connect the Intravenous Administration Set Step 4 - Using the HOTLINE Warmer Step 5 - After Use Storage

8 Troubleshooting 9 Testing

Alarm Signal Test Over Temperature Alarm Test Add Recirculating Solution Test Check Disposables Test Temperature Verification of the Recirculating Solution Periodic Electrical Testing Leakage Current

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12 12 13 13 13 14 14 15 15 15 15 16 16 17 17 17 19 19 20 20 21 23 23 24 24 25 25 27 27

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Ground Bond Test

10 Maintenance

Maintenance Performed with Every Use Clean the Exterior General Inspection Disinfect the Reservoir and Change the Recirculating Solution Disinfect the Reservoir Add Recirculating Solution Maintenance Performed Every 30 Days Disinfect the Reservoir and Change Recirculating Solution for Distilled Water and 35% Isopropyl Alcohol Solution Lubricate O-Ring Seals Maintenance Performed Every 12 Months Disinfect the Reservoir and Change Recirculating Solution for 0.3% Hydrogen Peroxide Solution Replace O-Rings (O-Ring Kit: P/N 80-04-001) Testing HOTLINE Warmer Operation Maintenance Log

11 Limited Warranty 12 Service Non-Warranty Work Additional Documentation Disposal Information Service Contacts USA/Canada European Representative Australian Representative

13 Specifications and Accessories System Specifications Electromagnetic Compliance Electromagnetic Environmental Recommendations Accessories

14 Symbols

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27 28 28 28 30 30 30 31 31 31 32 32 32 32 32 33 34 36 36 36 37 37 37 37 37 38 38 39 40 40 41

HOTLINE® Blood and Fluid Warmer | Operator’s Manual

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SECTION

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t h i s

M a n u a l

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About this Manual This operator’s manual describes the assembly, use, and maintenance of the HOTLINE Blood and Fluid Warmer. This manual is intended for use by individuals trained in the healthcare and biomedical professions. WARNING: These instructions contain important information for safe use of the product. Read the entire contents of this operator’s manual, including Warnings and Cautions, before using this product. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient.

Indications for Use The HOTLINE Blood and Fluid Warmer is designed for use with the HOTLINE® Fluid Warming Set to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions. The HOTLINE® Warmer is intended for use by trained medical personnel to provide routine flow of warmed I.V. fluid.

Conventions Used in this Manual • The HOTLINE Blood and Fluid Warmer will be referred to as the HOTLINE Warmer. • The L Series Fluid Warming Sets (L-70, L-70NI, L-80) will be referred to as the HOTLINE Fluid Warming Set or Disposable Set. Convention

Description

CONTRAINDICATION

A Contraindication statement alerts the user to conditions when the device should not be used.

CAUTION

A Caution statement alerts the user to conditions that may cause malfunction, failure, or damage to the device.

WARNING

A Warning statement alerts the user to conditions that may cause death or serious injury to the patient or user.

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S E C T I O N 2

SECTION

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D e s c r i p t i o n

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Description The HOTLINE Warmer delivers blood and intravenous fluid at normothermic temperatures by surrounding the sterile intravenous line with a layer of warmed recirculating solution. An onboard recirculating solution supply is heated to 41.5°C ± 0.5 and circulated through the outer lumen of the HOTLINE Fluid Warming Set, which surrounds the intravenous line. The HOTLINE Warmer employs a safe, recirculating solution heating system, inherently free of “hot spots,” to actively warm the patient line. Electronic circuitry continuously monitors the recirculating solution temperature. The primary temperature control circuit limits the recirculating solution to 42°C maximum. In the unlikely event of a malfunction of this circuit, a second “watchdog” circuit will visually and audibly alarm and stop the recirculating solution pump if the temperature reaches 43.1°C. Fluid in the HOTLINE Fluid Warming Set is never exposed to any damaging or dangerous temperatures while the HOTLINE Warmer is operating. The recirculating solution temperature and visual alarms are indicated on the Display Panel on the front of the HOTLINE Warmer. A green Operating light illuminates on this panel when the HOTLINE Warmer is set up and operating correctly.

Components

1

The HOTLINE components are called-out in the following series of figures. Front View 1 Socket for HOTLINE Fluid Warming Set with the reflux plug in place

2

2

Display Panel

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2

HOTLINE Fluid Warmer

S E C T I O N 2

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D e s c r i p t i o n

Right Side View 1 Socket with the reflux plug removed 1

2

Clamp for I.V. pole

2

3

Drain tube in tube holder

3

4

Reflux plug

4

5

Power cord

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5

1 1 2 3 4 5

Rear View 1 Fill-port plug

2

Drain tube in tube holder

3

Clamp for I.V. pole

4

Protective earth terminal

5

Auxiliary electrical outlet (uncovered)

1

2

3

4

1.4 LITERS

Left Side View 1 Power and Alarm Test Panel

2

Fill-port plug

3

Reservoir, contains recirculating solution

4

Float switch (inside reservoir)

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S E C T I O N 2

HOTLINE® Fluid Warming Set HOTLINE Fluid Warming Sets (L-70, L-70NI, L-80) are individually packed, single-use disposables with a Sterile Fluid Path. The priming volume is 20 ml for the L-70 and L-70NI, and 21 ml for the L-80. The HOTLINE Fluid Warming Set has a Twin-Tube Connector that plugs into the socket on the right side of the HOTLINE Warmer. This is the only connection necessary to provide the warming function. The HOTLINE Fluid Warming Set is easily unplugged from the HOTLINE Warmer and discarded.

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D e s c r i p t i o n

S E C T I O N

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I m p o r t a n t

S a f e t y

I n f o r m a t i o n

3

Important Safety Information This section covers information for prescribers and guidelines for safe use of the HOTLINE Warmer.

CONTRAINDICATIONS • Not for use in warming platelets, cryo-precipitates, or granulocyte suspensions.

WARNINGS WARNINGS Death or serious injury may occur to the patient or user if these warnings are not followed. • These instructions contain important information for safe use of the product. Read the entire contents of this operator’s manual, including Warnings and Cautions, before using this product. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. • The HOTLINE® Fluid Warming Set, L-10, PC-8, and YC-8 are single-use devices and are not intended for re-sterilization. • Do not use HOTLINE® Fluid Warming Set, L-10, PC-8, and YC-8 if the caps are not securely in place, else the I.V. flow path may not be sterile. • The HOTLINE® Warmer is for use only with Smiths Medical supplied or approved parts, accessories, and Disposable Sets. The device may not function as intended with the use of unapproved parts, accessories, or Disposable Sets. • Blood and blood products could contain pathogenic organisms. Failure to follow institutional policy and procedures for biomedical-hazardous materials could lead to exposure to harmful pathogens. • Set-up, priming, and use require aseptic technique as per applicable institutional policies and procedures.

Continued

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I m p o r t a n t

Continued from previous page WARNINGS WARNINGS • Prime the recirculating solution path before connecting to the intravenous extension set. This is to confirm that there is not a breach between the recirculating solution path and intravenous path. If fluid exits the patient end of the HOTLINE® Fluid Warming Set before connecting to the intravenous administration set, remove and replace HOTLINE® Fluid Warming Set. • Remove all air from the HOTLINE® Fluid Warming Set, L-10, PC-8, and YC-8 before connecting to the patient. Failure to do so may result in introduction of air to the patient. • To reduce the risk of outgassed microbubbles entering patient vasculature, an L-10 Gas Vent may be used with the HOTLINE® Fluid Warming Set. • Not for use with pressure devices generating over 300 mmHg. Pressure greater than 300 mmHg may compromise the integrity of the HOTLINE® Fluid Warming Set. • To prevent a breach between the recirculating solution path and intravenous path, do not use needles greater than 38 mm (1.5") in length when accessing the injection port. If there is a breach between the recirculating solution path and intravenous path, patient illness may occur because of the HOTLINE® Warmer's recirculating solution entering the patient's bloodstream. • Do not stick the HOTLINE® Fluid Warming Set with needles, as this will breach the I.V. path and compromise the integrity of the patient intravenous line. If a Disposable Set with a breached recirculating solution path/intravenous path is used, then patient illness may occur because of the HOTLINE® Warmer's recirculating solution entering the patient's bloodstream. • Activation of the Over Temperature warning signal indicates that warming has stopped and immediate operator intervention is required to clear the over temperature condition or to remove the device from service. • If any visual indicator does not illuminate or the audible signal does not sound, do not use the HOTLINE® Warmer. Remove the device from service immediately. • Do not operate the HOTLINE® Warmer in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The risk of explosion exists if the HOTLINE® Warmer is operated in a potentially explosive environment.

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Continued from previous page WARNINGS WARNINGS • Do not use the HOTLINE® Warmer in high-energy fields such as: MRI, X-RAY, portable and mobile RF communications equipment, and other such devices. The HOTLINE® Warmer may act as a projectile in a strong magnetic field, cause image artifacts, or not function as intended. • Exposed conductor on MAINS power cord can cause an electrocution hazard. Remove device from service if the MAINS power cord has exposed wires. • Grounding reliability can only be achieved when the MAINS power cord is connected to a properly grounded receptacle. Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle. • Do not mount the HOTLINE® Warmer more than 107cm (42") above the floor. For convenience, 107cm (42") is indicated on the HOTLINE® Warmer power cord by a black mark. Mounting the HOTLINE® Warmer above 107cm (42") may result in instability of the pole and tipping. • Ensure that the HOTLINE® Warmer clamp is screwed tightly onto the I.V. pole. Failure to securely mount the HOTLINE® Warmer onto the I.V. pole may cause the HOTLINE® Warmer to slide down the I.V. pole. • Do not use the HOTLINE® Warmer if equipment or Disposable Set malfunction is evident. • No user-serviceable parts. All service must be performed by Smiths Medical or competent personnel. • No modification of this equipment is allowed. CAUTIONS Malfunction, failure, or damage to the device may occur if these cautions are not followed. • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. • Do not autoclave or immerse any part of the HOTLINE® Warmer in liquids, which may cause damage and improper functioning.

Continued

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Continued from previous page CAUTIONS • Never use organic solvents (e.g., acetone), strong acids, or bases to clean any portion of the HOTLINE® Warmer. • Do not place the HOTLINE® Warmer directly under a faucet or use a faucet sprayer to rinse. Never spray cleaning or other fluids into openings on the HOTLINE® Warmer or into the external connectors. • This device is cooled by convection. Be sure the air vents on the bottom and the back of the device are kept clear. • Do not fill the HOTLINE® Warmer reservoir with a HOTLINE® Fluid Warming Set in place. Failure to remove the HOTLINE® Fluid Warming Set before the fill procedure may result in an air lock in the HOTLINE® Warmer. • Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.

Additional WARNINGS and CAUTIONS for Accessories WARNINGS for the L-10 Gas Vent and L-80 Fluid Warming Set

• Do not tape over vents, else air will not be vented. • Not for use with volumetric infusion pumps, hand pumps, or syringes. These may compromise the integrity of the L-10 Gas Vent or HOTLINE® Fluid Warming Set. • When the L-10 Gas Vent is in use, it should be placed at or below the heart level. Do not raise the gas vent above the patient’s heart level. If the gas vent is raised above heart level, air may be entrained into the infusion line, possibly causing air embolism, resulting in serious injury or death. CAUTIONS for the L-10 Gas Vent and L-80 Fluid Warming Set

• This product contains natural rubber latex, which may cause allergic reactions.

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S E C T I O N 4

SECTION

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A s s e m b l y I n s t r u c t i o n s

4

Assembly Instructions Read through the instructions completely prior to setting up the HOTLINE Warmer.

Step 1 - Unpack the HOTLINE Warmer 1 Open the shipping carton and remove the HOTLINE Warmer. 2 Check the contents of the package to verify the following components are present: • HOTLINE Warmer • Operator’s Manual • HOTLINE Inspection/Test Form

3 Examine the HOTLINE Warmer for damage. If any components appear damaged, do not use the HOTLINE Warmer. Contact Smiths Medical for a replacement. Note: After unpacking the HOTLINE Warmer, recycle packaging material according to hospital policy for recyclable materials.

Step 2 - Clamp the HOTLINEWarmer to the I.V. Pole WARNINGS WARNINGS • Ensure that the HOTLINE® Warmer pole clamp is screwed tightly onto the I.V. pole. Failure to securely mount the HOTLINE® Warmer onto the I.V. pole may cause the HOTLINE® Warmer to slide down the pole and may injure the patient or user. • Do not mount the HOTLINE® Warmer more than 107cm (42”) above the floor. For convenience, 107cm (42") is indicated on the HOTLINE® Warmer line cord by a black mark. Mounting the HOTLINE® Warmer above 107cm (42”) may result in instability of the pole and tipping that may injure the patient or user. CAUTIONS • This device is cooled by convection. Be sure the air vents on the bottom and the back of the device are kept clear.

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S E C T I O N 4

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A s s e m b l y I n s t r u c t i o n s

1 Slide the clamp (a) on the HOTLINE Warmer over the I.V. pole (b) and tighten the clamp screw (c) firmly. a

2 Check the tightness of the HOTLINE Warmer to ensure it is securely clamped to the pole.

b c

Step 3 - Disinfect the Reservoir 1 Prepare a 0.3% hydrogen peroxide solution by mixing 140 ml of 3% hydrogen peroxide solution and 1,260 ml of distilled water.

d

1.4 LITERS

2 Remove the reflux plug from the socket if required, and then remove the fill-port plug (d) and fill the reservoir with 1.4 liters of 0.3% hydrogen peroxide solution. 3 Replace the fill-port plug (d). 4 Insert a HOTLINE Fluid Warming Set (e) (L-70, L-70 NI, L-80) into the socket. 5 Plug the HOTLINE Warmer into properly grounded power outlet. 6 Turn the HOTLINE Warmer ON and let the solution circulate for a 30-minute disinfection period. 7 Turn the HOTLINE Warmer OFF.

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8 Invert the drain tube (f) and place a container under the end of the tube. Remove the end cap (g) and drain the recirculating solution into the container. 9 When all the recirculating solution has drained from the reservoir, replace the end cap and insert the drain tube back in the holder. 10 Remove the HOTLINE Fluid Warming Set and discard according to established hospital procedures.

f g

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A s s e m b l y I n s t r u c t i o n s

Step 4 - Fill the Reservoir With Recirculating Solution WARNINGS WARNINGS • Do not fill the HOTLINE Warmer reservoir with a HOTLINE Fluid Warming Set in place. Failure to remove the HOTLINE Fluid Warming Set before the fill procedure may result in an air lock in the HOTLINE Warmer.

Recirculating Solution Protocols

Use one of the following solutions for the reservoir. Recirculating Solution

Preparation

Maintenance

0.3% Hydrogen Peroxide Mix 140 ml of 3% hydrogen Solution peroxide with 1,260 ml of distilled water.

Replace solution and disinfect reservoir every 12 months.

Distilled Water

Use distilled water.

Replace solution and disinfect reservoir every 30 days.

35% Isopropyl Alcohol Solution

Mix 700 ml of 70% isopropyl Replace solution and alcohol with 700 ml of distilled disinfect reservoir every water. 30 days.

Note: Use distilled water only, not tap water. Failure to do so may cause build-up of mineral deposits in the recirculating solution path, which may impair heater performance.

1 Prepare the recirculating solution. a 1.4 LITERS

2 Remove the fill-port plug (a). 3 Fill the reservoir with 1.4 liters of recirculating solution. 4 Replace the fill-port plug.

Step 5 - Perform the Electrical Safety Tests Perform all applicable electrical safety tests as required per institutional procedure. Refer to Section 9, Testing, for more information about electrical safety testing.

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P r i n c i p l e

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Principle of Operation HOTLINE Warmer delivers blood and intravenous fluid at normothermic temperatures under routine, gravity flow rates. Conventional fluid warming systems suffer from cool-down between the warmer and the patient connection. HOTLINE Warmer overcomes this problem by providing active warming of the patient line all the way to the patient connection.

a a

Active warming is achieved by surrounding the sterile intravenous line with a layer of precisely controlled warm recirculating solution (a), thereby protecting the patient line against exposure to cold and eliminating patient line cool-down. The unique design of the HOTLINE Fluid Warming Set allows blood and intravenous fluid to be delivered to the patient at normothermic temperature at gravity flow rates to 50-5,000 ml/hr.

Infusate Delivery Temperatures The following table shows the typical infusate delivery temperatures at the patient end of an L-70 HOTLINE Fluid Warming Set.

Temperature ° C

Note: The setpoint temperature of the recirculating solution is 41.9C. 44.0 42.0 40.0 38.0 36.0 34.0 32.0 30.0 28.0 26.0 24.0 22.0 20.0 50

250

500

750

1000

1250

1500

2000

2500

3000

3500

Flow Rate (ml / hr) Ambient Temperature Range: 20°C ± 2°C

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HOTLINE® Blood and Fluid Warmer | Operator’s Manual

4000

4500

5000

20° C Infusate 10° C Infusate

S E C T I O N 6

SECTION

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O p e r a t i o n

6

Operation This section describes the controls and displays that monitor and control the HOTLINE Warmer, and the modes of operation.

Controls and Displays • Display Panel • Power and Alarm Test Buttons • Reservoir Level Display Display Panel The Display Panel is located on the front of the HOTLINE Warmer and provides continuous information about the operation of the HOTLINE Warmer. A liquid crystal display (LCD) indicates recirculating solution temperature. Just below the LCD, four lightemitting diodes (LEDs) indicate operation modes for the HOTLINE Warmer.

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1

Recirculating Solution Temperature - The temperature is displayed in degrees Celsius.

2

ON/Operation - The green LED illuminates when the power is turned on and the HOTLINE Fluid Warming set is properly installed.

3

Check Disposables - The red LED illuminates and an audible attention signal beeps when the HOTLINE Fluid Warming Set is not properly installed.

4

Add Recirculating Solution - The red LED illuminates and an audible attention signal beeps when the level in the reservoir is low and additional recirculating solution must be added.

5

Over Temperature - The red LED illuminates and an audible warning signal beeps when the recirculating solution is over the acceptable temperature for safe use.

1

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S E C T I O N 6

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O p e r a t i o n

Power and Alarm Test Panel 1.4 LITERS

The Power and Alarm Test Panel is located on the left side of the HOTLINE Warmer next to the reservoir. This panel contains two pressure-sensitive buttons that are activated when pressed, and the ON/OFF switch. 1

Over Temperature Alarm Test Button - The Over Temperature Alarm Test is used to confirm the proper operation of the Over Temperature circuitry.

2

Alarm Test Button - The Alarm Signal Test is used to confirm proper operation of the visual and audible alarms.

3

Power ON/OFF Switch - The black switch toggles to turn power ON and OFF.

Reservoir Level Display The reservoir for the recirculating solution is located on the left side of the HOTLINE Warmer, next to the Power and Alarm Test Panel. The level of the recirculating solution is visible in the reservoir. Two symbols indicate the maximum (a) and minimum (b) solution level requirements.

a

b

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HOTLINE® Blood and Fluid Warmer | Operator’s Manual