Smiths Medical HL-90-38_4534012EN_Rev-004_Print Infant Flow Advance System Operator’s Manual

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OPERATOR’S MANUAL

HOTLINE® Blood and Fluid Warmer

< HL-90-38

38°C Set Point

4524104 Rev. 000 (3/07)

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HOTLINE®

Blood and Fluid Warmer

< HL-90-38

OPERATOR’S MANUAL

PN 4534012EN Rev. 004

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General Information

HOTLINE® Blood and Fluid Warmer Part Number: 4534012EN Rev. 004 (2013-04)

This revision supersedes 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.

ii HOTLINE

Blood and Fluid Warmer | Operator’s Manual

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Contents

1 About this Manual 1

Indications for Use 1 Conventions Used in this Manual 1

2 Description 2

Components 2 HOTLINE® Fluid Warming Set 4

3 Important Safety Information 5

Additional WARNINGS and CAUTIONS for Accessories 8

4 Assembly Instructions 9

Step 1 - Unpack the HOTLINE Warmer 9 Step 2 - Clamp the HOTLINEWarmer to the I.V. Pole 9 Step 3 - Disinfect the Reservoir 10 Step 4 - Fill the Reservoir With Recirculating Solution 11 Step 5 - Perform the Electrical Safety Tests 11

5 Principle of Operation 12

Infusate Delivery Temperatures 12

6Operation 13

Controls and Displays 13

Display Panel 13 Power and Alarm Test Panel 14 Reservoir Level Display 14

Modes of Operation 15

OFF Mode 15 ON/Operating Mode 15 Check Disposables Mode 15 Add Recirculating Solution Mode 16 Over Temperature Alarm Mode 16

7 Operating Instructions 17

Step 1 - Set Up the HOTLINE Step 2 - Set Up the HOTLINE Step 3 - Connect the Intravenous Administration Set 19 Step 4 - Using the HOTLINE Step 5 - After Use 20

Storage 20

8Troubleshooting 21



Warmer 17



Fluid Warming Set 17



Warmer 19

Contents

9 Testing 23

Alarm Signal Test 23 Over Temperature Alarm Test 24 Add Recirculating Solution Test 24 Check Disposables Test 25 Temperature Verification of the Recirculating Solution 25 Periodic Electrical Testing 27

Leakage Current 27

HOTLINE

Blood and Fluid Warmer | Operator’s Manual iii

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Contents

Ground Bond Test 27

10 Maintenance 28

Maintenance Performed with Every Use 28

Clean the Exterior 28 General Inspection 30

Disinfect the Reservoir and Change the Recirculating Solution 30

Disinfect the Reservoir 30 Add Recirculating Solution 31

Maintenance Performed Every 30 Days 31

Disinfect the Reservoir and Change Recirculating Solution for Distilled Water and 35% Isopropyl Alcohol Solution 31 Lubricate O-Ring Seals 32

Maintenance Performed Every 12 Months 32

Disinfect the Reservoir and Change Recirculating Solution for

0.3% Hydrogen Peroxide Solution 32 Replace O-Rings 32

Testing HOTLINE

Maintenance Log 33



Warmer Operation 32

11 Limited Warranty 34 12 Service 36

Non-Warranty Work 36 Additional Documentation 36 Disposal Information 37 Service Contacts 37

USA/Canada 37

13 Specifications and Accessories 38

System Specifications 38 Electromagnetic Compliance 39 Electromagnetic Environmental Recommendations 40 Accessories 40

14 Symbols 41

iv HOTLINE

Blood and Fluid Warmer | Operator’s Manual

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SECTION 1 • About this Manual

SECTION 1

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 fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions. The HOTLINE provide routine flow of warmed I.V. fluid.

Fluid Warming Set to warm blood and intravenous (I.V.)

Warmer is intended for use by trained medical personnel to

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

Convention Description

CONTRAINDICATION A Contraindication statement alerts the user to

CAUTION A Caution statement alerts the user to conditions

WARNING A Warning statement alerts the user to conditions

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 1



Fluid Warming Set or Disposable Set.

conditions when the device should not be used.

that may cause malfunction, failure, or damage to the device.

that may cause death or serious injury to the patient or user.

Page 8

SECTION 2 • Description

SECTION 2

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 37.5°C ± 0.5 and circulated through the outer lumen of the HOTLINE intravenous line.



Fluid Warming Set, which surrounds the

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 38°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 39.2°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 Operating light illuminates on this panel when the HOTLINE



Warmer. A green



Warmer is

set up and operating correctly.

Components

The HOTLINE components are called-out in the following series of figures.

Front View

1 Socket for HOTLINE

place



Fluid Warming Set with the reflux plug in

HOTLINE

Fluid Warmer

2 Display Panel

2 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

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SECTION 2 • Description

o o

C C

HOTLINE

Fluid Warmer

1.4 LITERS

Right Side View

1 Socket with the reflux plug removed

2 Clamp for I.V. pole

3 Drain tube in tube holder

4 Reflux plug

5 Power cord

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)

Left Side View

1 Power and Alarm Test Panel

2 Fill-port plug

3 Reservoir, contains recirculating solution

4 Float switch (inside reservoir)

HOTLINE

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SECTION 2 • Description

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 into the socket on the right side of the HOTLINE only connection necessary to provide the warming function. The HOTLINE Warmer and discarded.



Fluid Warming Set has a Twin-Tube Connector that plugs



Fluid Warming Set is easily unplugged from the HOTLINE



Warmer. This is the

4 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

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SECTION 3 • Important Safety Information

CONTRAINDICATIONS

WARNINGS

SECTION 3

Important Safety Information

This section covers information for prescribers and guidelines for safe use of the HOTLINE



Warmer.

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

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

HOTLINE

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SECTION 3 • Important Safety Information

WARNINGS

Continued from previous page

• 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

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.

Continued

6 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

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SECTION 3 • Important Safety Information

WARNINGS

CAUTIONS

Continued from previous page

• 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 the HOTLINE

Warmer power cord by a black mark. Mounting

Warmer above 107cm (42") may result in

instability of the pole and tipping.

• Ensure that the HOTLINE onto the I.V. pole. Failure to securely mount the HOTLINE Warmer onto the I.V. pole may cause the HOTLINE

Warmer clamp is screwed tightly

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.

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

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 7

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SECTION 3 • Important Safety Information

CAUTIONS

Continued from previous page

• Never use organic solvents (e.g., acetone), strong acids, or

bases to clean any portion of the HOTLINE

• Do not place the HOTLINE

Warmer directly under a faucet or

Warmer.

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 Fluid Warming Set in place. Failure to remove the HOTLINE

Warmer reservoir with a 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.

8 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

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SECTION 4 • Assembly Instructions

WARNINGS

CAUTIONS

SECTION 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

• 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 HOTLINE

Warmer line cord by a black mark. Mounting the

Warmer above 107cm (42”) may result in instability of the pole and tipping that may injure the patient or user.

• This device is cooled by convection. Be sure the air vents on the bottom and the back of the device are kept clear.

HOTLINE

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SECTION 4 • Assembly Instructions

1.4 LITERS

o o

C C

HOTLINE

Fluid Warmer

1 Slide the clamp (a) on the HOTLINE Warmer over the I.V. pole

(b) and tighten the clamp screw (c) firmly.

2 Check the tightness of the HOTLINE



Warmer to ensure it is

securely clamped to the pole.

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.

2 Remove the reflux plug from the socket if required, and then

remove the fill-port plug (

0.3% hydrogen peroxide solution.

3 Replace the fill-port plug (

4 Insert a HOTLINE

into the socket.

5 Plug the HOTLINE

6 Tu r n t h e H O TL I NE

a 30-minute disinfection period.

d) and fill the reservoir with 1.4 liters of

d).



Fluid Warming Set (e) (L-70, L-70 NI, L-80)



Warmer into properly grounded power outlet.



Warmer ON and let the solution circulate for

7 Tu r n t h e H O TL I N E

8 Invert the drain tube (

tube. Remove the end cap ( 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

according to established hospital procedures.

10 HOTLINE



Warmer OFF.

f) and place a container under the end of the

g) and drain the recirculating solution



Fluid Warming Set and discard

Blood and Fluid Warmer | Operator’s Manual

Page 17

SECTION 4 • Assembly Instructions

WARNINGS

Step 4 - Fill the Reservoir With Recirculating Solution

• 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

Recirculating Solution Protocols



Warmer.



Use one of the following solutions for the reservoir.

Recirculating Solution Preparation Maintenance

0.3% Hydrogen Peroxide Solution

Distilled Water Use distilled water. Replace solution and

35% Isopropyl Alcohol Solution

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.

Mix 140 ml of 3% hydrogen peroxide with 1,260 ml of distilled water.

Mix 700 ml of 70% isopropyl alcohol with 700 ml of distilled water.

Replace solution and disinfect reservoir every 12 months.

disinfect reservoir every 30 days.

Replace solution and disinfect reservoir every 30 days.

1 Prepare the recirculating solution.

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,

Te s t i n g

, for more information about

electrical safety testing.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 11

Page 18

SECTION 5 • Principle of Operation

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

Flow Rate (ml / hr)

20° C Saline 10° C Saline

Temperature ° C

40.0

36.0

32.0

28.0

24.0

20.0

22.0

42.0

38.0

34.0

30.0

26.0

Ambient Temperature Range: 20° C ± 2° C Source data on file

SECTION 5

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 problem by providing active warming of the patient line all the way to the patient connection.

Active warming is achieved by surrounding the sterile intravenous line with a layer of precisely controlled warm recirculating solution ( protecting the patient line against exposure to cold and eliminating patient line cool-down.



Warmer overcomes this

a), thereby

Infusate Delivery Temperatures

The following table shows the typical infusate delivery temperatures at the patient end of an L-70 HOTLINE

Note: The setpoint temperature of the recirculating solution is

38.0C.

12 HOTLINE

Blood and Fluid Warmer | Operator’s Manual



Fluid Warming Set.

Page 19

SECTION 6

Operation

SECTION 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 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 Wa rm e r.

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.

Warmer



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.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 13

Page 20

Power and Alarm Test Panel

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.

SECTION 6 • Operation

1.4 LITERS

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.

14 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 21

SECTION 6 • Operation

Modes of Operation

The HOTLINE Warmer operation is defined in the following modes:

• OFF Mode

•ON/Operating Mode

• Check Disposables Mode

• Add Recirculating Solution Mode

• Over Temperature Alarm Mode

The description of each mode includes a definition of the mode, activation and/or monitoring of the mode, mode characteristics, and method to clear the mode state.

OFF Mode

The power switch is in the OFF position (

a) and the HOTLINE

Warmer is turned off.

ON/Operating Mode

The power switch is in the ON position (

b) and the HOTLINE

Warming Set has been properly installed.

Mode Characteristics

• The green Operating LED (c) illuminates.

• The reservoir temperature display will begin to increase.

• The recirculating solution path in the HOTLINE



Fluid

Warming Set will automatically prime.

Check Disposables Mode

The Check Disposables mode indicates a missing or improperly



installed HOTLINE

Mode characteristics

Fluid Warming Set.

• The green Operating LED on the Display Panel turns off.

• he red Check Disposables LED (

d) on the Display Panel

illuminates.



Fluid

• The audible alarm sounds and repeats approximately every two seconds.

• The recirculating solution stops circulating.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 15

Page 22

SECTION 6 • Operation

To clear this mode, check that the Twin-Tube Connector on the HOTLINE



Fluid Warming Set is firmly inserted in the socket.

Add Recirculating Solution Mode

The Add Recirculating Solution mode indicates that the solution level in the reservoir is below its minimum level.

Mode characteristics

• The green Operating LED on the Display Panel turns off.

• The red Add Solution LED (

a) on the Display Panel illuminates.

• The audible alarm sounds and repeats approximately every two seconds.

• The recirculating solution stops circulating.

To clear this mode, add recirculating solution to the reservoir.

Over Temperature Alarm Mode

The Over Temperature Alarm mode indicates that the temperature of the recirculating solution is at or above 39.2°C.

Mode characteristics

• The green Operating LED on the Display Panel turns off.

• The red Over Temperature LED (

b) on the Display Panel

illuminates.

• The audible alarm sounds and repeats approximately every two seconds.

• The recirculating solution stops circulating.

For instructions to clear this mode, see Section 8,

16 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Troubleshooting

Page 23

SECTION 7 • Operating Instructions

WARNINGS

SECTION 7

Operating Instructions

The Operating Instructions are grouped into five segments. Read through each segment BEFORE performing a procedure.

• Set-up, priming, and use require aseptic technique as per applicable institutional policies and procedures. Death or serious injury may occur to the patient or user if this warning is not followed.

• Grounding reliability can only be achieved when MAINS power cords are connected to a properly grounded receptacle. Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle.

• Do not fill the 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 reservoir with a HOTLINE®

Warmer.

Step 1 - Set Up the HOTLINE Warmer

1 Check that the level is above the minimum level mark (a) on the

reservoir. Add recirculating solution to the reservoir through the fill-port if required.



2 Check the condition of the HOTLINE

inspection before using. Remove from service any HOTLINE

Warmer with a visual



Warmer that shows physical damage.

3 Plug the

HOTLINE



Warmer into properly grounded power outlet.

Step 2 - Set Up the HOTLINE Fluid Warming Set

•The HOTLINE Fluid Warming Set is a single-use device and is not intended for re-sterilization. Death or serious injury may occur to the patient or user if this warning is not followed.

Continued

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 17

Page 24

SECTION 7 • Operating Instructions

WARNINGS

o o

C C

HOTLINE

Fluid Warmer

Continued form previous page

• Do not use HOTLINE Fluid Warming Set, L-10, PC-8, and YC-8 if the caps are not securely in place, else flow path may not be sterile and may cause death or serious injury.

• 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 extension



set, remove and replace HOTLINE

Fluid Warming Set. Death or serious injury may occur to the patient or user if this warning is not followed.

To set up the HOTLINE Fluid Warming Set, you will need the following:

•HOTLINE



Warmer

• Intravenous administration set

• Intravenous fluid or blood

• Extension Set, 20cm (8") or less in length (optional)

1 Remove the reflux plug (if present) from the socket on the right

side of the HOTLINE Warmer.

2 Plug the Twin-Tube Connector on the

HOTLINE



Fluid Warming

Set (a) into the socket.

3 Turn ON the power switch.

• The green Operating LED on the Display Panel illuminates.

• The recirculating solution temperature display will begin to increase.

• The recirculating solution path in the HOTLINE



Fluid

Warming Set will automatically prime.

4 Remove the end cap and inspect the patient end of the HOTLINE

Fluid Warming Set for leaks to confirm the integrity of the intravenous pathway.

18 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 25

SECTION 7 • Operating Instructions

WARNINGS

Step 3 - Connect the Intravenous Administration 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, which may contribute to serious patient injury or death.

• 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 recirculating solution entering the patient's blood stream.

Warmer's

1 Connect the I.V. fluid and the intravenous administration set to the

HOTLINE

2 Fully prime the intravenous administration set, the



Fluid Warming Set.

HOTLINE



Fluid Warming Set, and patient extension set (if used).

3 Connect the distal end of the

HOTLINE



Fluid Warming Set to

the patient's intravenous access site without entrapping air.

Step 4 - Using the HOTLINE Warmer

• If any visual indicator does not illuminate or the audible signal does not sound, do not use the HOTLINE device from service immediately. Death or serious injury may occur to the patient or user if this warning is not followed.

Warmer. Remove the

Continued

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 19

Page 26

SECTION 7 • Operating Instructions

WARNINGS

o o

C C

HOTLINE

Fluid Warmer

Continued from previous page

• 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.

1 Wait until the recirculating solution temperature display reaches

°C, which indicates the HOTLINE



Warmer is ready for use.

2 Adjust the rate of I.V. flow using the clamp on the intravenous

administration set.

Note: Do not kink the Disposable Set. Do not restrict the circulation of the solution through the tubing.

Step 5 - After Use

• 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.

1 Turn OFF the power switch.

2 Remove the

plug (

HOTLINE

a) into the socket.

3 After use, handle and dispose of the

Set in a safe manner according to local guidelines for disposal of contaminated medical waste.



Fluid Warming Set, and insert the reflux

HOTLINE



Fluid Warming

4 Wipe down the external surfaces of the HOTLINE



mild liquid detergent soap and warm tap water mixture and a soft cloth or sponge. See Section 10,

Maintenance,

for more details

about cleaning and external disinfection.

Storage

Store the HOTLINE extreme temperatures. See Section 13,

20 HOTLINE



Warmer in a cool, dry place. Do not expose to

Specifications

Blood and Fluid Warmer | Operator’s Manual

, for more details.

Warmer with

Page 27

SECTION 8 • Troubleshooting

SECTION 8

Troubleshooting

Only competent personnel should perform any routine maintenance and repairs to the HOTLINE

Problem Check the following

No power

Check Disposables alarm

Add Recirculating Solution alarm

Over Temperature alarm



Warmer.



1 Confirm that the HOTLINE

Warmer is plugged in

properly.

2 Confirm that the power switch is in the ON position.



Note: If the HOTLINE

Warmer is plugged in and the power switch is turned ON, the green or red LED will illuminate.



Confirm that the HOTLINE

Fluid Warming Set is properly installed. 1 Push the Twin-Tube Connector firmly into the socket



on the right side of the HOTLINE

Warmer.

Note: Turn OFF the power switch before replacing the



HOTLINE

2 If the alarm is not cleared, replace the HOTLINE

Fluid Warming Set.



Fluid Warming Set. Turn ON the power switch and verify that the alarm has cleared.



3 If the alarm is not cleared, remove the HOTLINE

Warmer from service.

Check the level in the reservoir

• Turn OFF the power switch, remove the HOTLINE

Fluid Warming Set if installed, and add recirculating solution to the maximum level.

1 Check the HOTLINE



Fluid Warming Set for kinks or

other restrictions.

2 Check for air lock:

a Turn the power switch OFF, remove the HOTLINE

Fluid Warming Set, and gently shake HOTLINE



Warmer to dislodge air.



b Plug in the HOTLINE

Fluid Warming Set and turn

power switch ON.

c If the alarm is not cleared, remove the HOTLINE

Warmer from service and return it for repair or replacement.



HOTLINE

Blood and Fluid Warmer | Operator’s Manual 21

Page 28

SECTION 8 • Troubleshooting

Problem Check the following

Hot cabinet Check for blocked air vents on the bottom or the back of

the HOTLINE Warmer.

Note: Room temperature above 38

°C may cause the

HOTLINE Warmer to shut down and the Over Temperature alarm to activate. In this situation, turn



the power switch OFF and allow the HOTLINE Warmer to cool down before returning it to service.

Difficult to install the HOTLINE



Fluid

Warming Set

Recirculating solution leaks at the socket where the HOTLINE Fluid Warming Set plugs into the HOTLINE Warmer

Electrical interference receiving or transmitting

Lubricate O-rings in the socket. Refer to Section 10, Maintenance, for the procedure.

Replace O-rings. Use the O-ring Replacement Kit: P/N 80-04-001. Refer to Section 10, Maintenance, for the procedure.



1 Move the HOTLINE

Warmer away from the device in

question.



2Plug the HOTLINE

Warmer into a separate electrical

circuit.

• If the problem continues, notify Smiths Medical or your local Smiths Medical distributor.

22 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 29

SECTION 9 • Testing

WARNINGS

SECTION 9

Te s t i n g

The HOTLINE Warmer should be tested by hospital biomedical personnel prior to placing it in service. All testing and maintenance should be performed by competent personnel. If competent personnel are not available, contact Smiths Medical or your local Smiths Medical distributor.

If the HOTLINE the listed tests, discontinue use of the HOTLINE



Warmer and any installed accessories do not pass any of



Warmer and remove from service. Contact Smiths Medical or your local Smiths Medical distributor.

• If any visual indicator does not illuminate or the audible signal

does not sound, do not use the Fluid Warmer. Remove the device from service immediately. Death or serious injury may occur to the patient or user if this warning is not followed.

Note: Alarm testing requires a HOTLINE Fluid Warming Set to be installed and that the HOTLINE Operating mode.



Warmer be turned ON and in the

Alarm Signal Test

The Alarm Signal Test is used to confirm proper operation of the visual and audible alarm indicators.

1 Press and hold the Alarm Test button (a).

2 Observe the following:

• The green Operating LED turns off.

• Three red LEDs (Check Disposables, Add Solution, and Over Temperature) illuminate.

• The audible alarm sounds and repeats approximately every two seconds.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 23

Page 30

Over Temperature Alarm Test

The HOTLINE Warmer should be running at an operating temperature of approximately 37°C to 38°C.

1 Press and hold the Over Temperature Alarm Test button (a).

2 Observe the following:

• The recirculating solution Over Temperature Alarm activates at 40°C.

• The green Operating LED turns off.

SECTION 9 • Testing

• The red Over Temperature LED (

b) illuminates.

• The audible alarm sounds and repeats approximately every two seconds.

3 Stop pressing the Over Temperature Alarm Test button to stop the

test.

Add Recirculating Solution Test

The HOTLINE Warmer is equipped with a float switch, which senses the

recirculating solution level in the reservoir. When the recirculating

solution is too low, the Add Recirculating Solution Alarm will activate.

1 Remove the fill-port plug (c) on the reservoir.

2 Gently depress the float switch (

low solution condition.)

Note: Use a non-metal tool to depress the float switch because the float switch contains a magnet.

3 Observe the following:

• The green Operating LED turns off.

d). (This action will simulate the

• The red Add

Recirculating Solution LED (e) illuminates.

• The audible alarm sounds and repeats approximately every two seconds.

24 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 31

Check Disposables Test

o o

C C

HOTLINE

Fluid Warmer

SECTION 9 • Testing

Level 1® TEMP CHECK

Thermometer

An interlock switch/sensor, located in the socket on the right side of the HOTLINE Warming Set. When the switch does not sense a HOTLINE



Warmer, senses a properly installed HOTLINE Fluid



Fluid

Warming Set, the Check Disposables alarm activates.

1 Slowly remove the HOTLINE Fluid Warming Set (a) from the

HOTLINE



Warmer socket.

2 Observe the following actions:

• The green Operating LED turns off.

• The red Check Disposables LED (

b) illuminates.

• The audible alarm sounds and repeats approximately every two seconds.

Note: In any alarm condition, the pump should not be running. A small amount of solution dripping from the disconnection is normal and should stop in a few seconds.

Temperature Verification of the Recirculating Solution

Use the Level 1 TEMP CHECK Thermometer (HLTA-40) to verify the displayed recirculating solution temperature. Other methods of temperature verification may be inaccurate.

TEMP CHECK provides an accurate reading of the highest temperature of the recirculating solution. Because the temperature of the reservoir is typically 0.5°C to 2.0°C lower than the temperature from the heater, and the temperature of the recirculating solution begins to drop due to the effect of ambient temperature on the HOTLINE



Fluid Warming Set, the highest temperature of the solution is just after it leaves the heater. During the temperature verification test, the TEMP CHECK is positioned on the right side of the HOTLINE solution just after it leaves the heater and before it enters the HOTLINE



Warmer attached to the socket and senses the



Fluid Warming Set.

Refer to the TEMP CHECK HLTA-40 Thermometer Operator's Manual for complete Temperature Verification and Calibration Instructions.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 25

Page 32

To verify the recirculating solution temperature, you will need the following:

• TEMP CHECK (HLTA-40)

•HOTLINE



Warmer



Fluid Warming Set

To Verify the Recirculating Solution Temperature:

1 Plug the HOTLINE Warmer into a power outlet.

SECTION 9 • Testing

2 Place the TEMP CHECK on the top right corner of the

HOTLINE

the HOTLINE

3 Plug the Twin-Tube Connector on the



Warmer and plug it into the socket on the right side of



Warmer.

HOTLINE



Fluid Warming

Set into the socket on the right side of the TEMP CHECK.

4 Remove the black label from the auxiliary outlet on the back of the

HOTLINE



and plug in the TEMP CHECK power cord.

Note: The auxiliary outlet is for use only with Smiths Medical accessories.

5 Tu r n O N t he HOTLINE Warmer. Allow 15 minutes for the

temperature to stabilize.

6 If the TEMP CHECK display indicates a temperature between

°C and 38°C, and the HOTLINE



Warmer display equals the TEMP CHECK display, recirculating solution verification is complete. Refer to the TEMP CHECK Manual for OVERTEMP ALARM verification.

7 If the TEMP CHECK display does not indicate a temperature

between 37

°C and 38°C, refer to the TEMP CHECK Manual for

calibration instructions.

26 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 33

SECTION 9 • Testing

Periodic Electrical Testing

Electrical Safety Tests must be performed by competent personnel authorized by the institution to perform such testing. The Safety Tests must be performed and documented at least once per year, or according to institutional policy. These tests include but are not limited to:

• Leakage current

•Ground bond test

Leakage Current

Leakage current must be tested according to methods and pass/fail criteria described in IEC 60601-1:2005. Leakage current must be performed with the heater circuit in the full ON condition. To achieve this condition, perform the test when the reservoir is at room temperature. When the HOTLINE temperature is rapidly rising, but still below 37°C, the heater circuit is in a full ON condition.



Warmer is first turned on and the

Note: The HOTLINE Warmer is equipped with sensing interlocks. A HOTLINE HOTLINE the sensing interlocks or try to operate the HOTLINE HOTLINE



Fluid Warming Set is required to correctly operate the



Warmer and perform leakage current testing. Do not defeat



Fluid Warming Set in place.



without a

Ground Bond Test

Ground bond test must be tested according to methods and pass/fail criteria described in IEC 60601-1:2005.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 27

Page 34

SECTION 10

CAUTIONS

Maintenance

SECTION 10 • Maintenance

Only competent personnel should perform any routine maintenance and repairs to the HOTLINE



Warmer. Maintenance is scheduled with each

use, every 30 days, and every 12 months. The tasks are described below.

Maintenance Performed with Every Use

• Do not autoclave or immerse any part of the HOTLINE Warmer in liquids, which may cause damage and improper functioning.

Clean and inspect the HOTLINE Warmer.

Clean the Exterior

Clean the entire HOTLINE

• Never use organic solvents (e.g., acetone), strong acids, or bases to clean any portion of the HOTLINE



Warmer after every use.

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.

1 Unplug the HOTLINE Warmer before servicing.

2 Visually inspect the HOTLINE



Warmer to ensure there is no visible damage or deterioration of the enclosure such as cracks, or deterioration of the labels and power cord. Do not clean if there is a defect. Contact Smiths Medical or your local Smiths Medical distributor.

3 Immerse a soft cloth or sponge as an applicator into the cleaning

solution consisting of mild liquid detergent soap and warm tap water mixture. Squeeze out excess solution so that the applicator is not dripping. Wipe or scrub the entire surface of the enclosure and

28 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 35

SECTION 10 • Maintenance

control panels. Use a soft brush to clean the power cord if necessary.

4 Rinse a separate soft cloth or sponge in room temperature running

potable water. Squeeze out excess water so that the applicator is not dripping. Wipe all of the aforementioned surfaces. Repeat rinsing the cloth or sponge several times with fresh running water during this process to insure all visible residue is removed.

5 Dry the item with a hand towel or soft cloth.

6 Visually inspect the HOTLINE



Warmer and its components to insure that they have been thoroughly cleaned. Repeat cleaning procedure if necessary.

7 After thoroughly cleaning the HOTLINE



Warmer, perform

disinfection if required.

8 If it is hospital policy to perform disinfection as part of

reprocessing, then follow your institution's guidelines for disinfecting of the surfaces of non-critical medical devices. The list below includes low-level disinfectants that are commonly used in the medical community and high-level disinfectants that are claimed by the manufacturer. The effectiveness of these listed disinfectants should be validated using the hospital procedures.

The following disinfectant agents can be used without causing damage to the enclosure:

Low Level Disinfectants:



•fantastik

All Purpose Cleaner

High Level Disinfectants:



• 1.56% Phenol (e.g., Sporicidin

• 3.4% Glutaraldehyde (e.g., CIDEX

)



Plus)

•10% Bleach solution

• 1% Ammonia solution

•Surface disinfectants compatible with plastic materials.

9 Rinsing of the disinfectant residue should be done using a soft cloth

or sponge as the applicator.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 29

Page 36

SECTION 10 • Maintenance

General Inspection



• Check the condition of the HOTLINE inspection before using. Remove from service any HOTLINE

Warmer with a visual



Warmer that shows physical damage.

•If the HOTLINE



Fluid Warming Set does not install easily,

lubricate the O-Rings as directed in the following section.

Disinfect the Reservoir and Change the Recirculating Solution

Disinfect the reservoir and change the recirculating solution every 30 days or every 12 months based on the recirculating solution used for the

HOTLINE Warmer. Refer to the following table for the maintenance schedule

Recirculating Solution Preparation Maintenance

0.3% Hydrogen Peroxide Solution

Distilled Water Use distilled water. Replace solution and

35% Isopropyl Alcohol Solution

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.

Mix 140 ml of 3% hydrogen peroxide with 1,260 ml of distilled water.

Mix 700 ml of 70% isopropyl alcohol with 700 ml of distilled water.

Replace solution and disinfect reservoir every 12 months.

disinfect reservoir every 30 days.

Replace solution and disinfect reservoir every 30 days.

Disinfect the Reservoir

1 Unplug the HOTLINE Warmer before servicing.

2 Remove the drain tube from the holder on the rear of the

HOTLINE

3 In

vert the drain tube (a) and place a container under the end of the

tube



Warmer.

. Remove the end cap (b) and drain the recirculating solution

into the container.

4 When all the recirculating solution has drained from the reservoir,

replace the end cap and insert the drain tube back in the holder.

5 Prepare a 0.3% hydrogen peroxide solution by mixing 140 ml of 3%

hydrogen peroxide solution and 1,260 ml of distilled water.

30 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 37

SECTION 10 • Maintenance

CAUTIONS

o o

C C

HOTLINE

Fluid Warmer

6 Remove the fill-port plug (c), fill the reservoir with the hydrogen

peroxide solution, and replace the fill-port plug.

7 Remove the reflux plug from the socket if required, and insert a

HOTLINE



Fluid Warming Set (d) (L-70, L-70NI, L-80) into the

socket.

8 Tu r n t h e H O T L I N E



Warmer ON, and let the recirculating

solution circulate for a 30-minute disinfection period.

9 Tu r n t h e H O T L I N E



Warmer OFF and unplug the power cord.

10 Empty the reservoir.

11 Remove the HOTLINE



Fluid Warming Set and discard

according to established hospital procedures.

These suggested instructions are designed to be used in conjunction with established hospital procedures.

Add Recirculating Solution

• Do not fill the HOTLINE Warmer reservoir with a HOTLINE Fluid Warming Set or a TEMP CHECK in place. Failure to



remove the HOTLINE procedure may result in an air lock in the HOTLINE

Fluid Warming Set before the fill



Warmer.

1 Prepare the recirculating solution.

2 Remove the fill-port plug.

Fill the reservoir with 1.4 liters of recirculating solution.

4 Replace the fill-port plug.

Maintenance Performed Every 30 Days

Disinfect the Reservoir and Change Recirculating Solution for Distilled Water and 35% Isopropyl Alcohol Solution

Refer to

Disinfect the Reservoir and Change the Recirculating Solution

procedure in this section.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 31

Page 38

Lubricate O-Ring Seals

o o

C C

HOTLINE

Fluid Warmer

o o

C C

HOTLINE

Fluid Warmer

1 Place a small amount of silicone lubricant on a cotton swab.

SECTION 10 • Maintenance

2 Apply silicone lubricant along the O-Rings inside the socket (

located on the right side of the HOTLINE Warmer.

Silicone lubricant is available from Smiths Medical, (Silicone lubricant P/N 80-04-002).

Maintenance Performed Every 12 Months

Disinfect the Reservoir and Change Recirculating Solution for

0.3% Hydrogen Peroxide Solution

Refer to procedure in this section.

Replace O-Rings

1 Unplug the

2 Remove the socket head screws (

3 Remove the face plate, being careful not to damage the micro-

Disinfect the Reservoir and Change the Recirculating Solution

(O-Ring Kit: P/N 80-04-001)

HOTLINE



Warmer before servicing.

b) with a 0.31cm (1/8") hex

wrench.

switch lever.

4 Remove the old O-rings and clean the sockets with a cotton swab.

5 Apply silicone lubricant to two new O-rings and install into the

sockets.

6 Reassemble in reverse order, being careful not to damage the micro-

switch lever.

7 Insert

HOTLINE



Fluid Warming Set and power on HOTLINE

Warmer to verify that there are no leaks around the face plate.

Testin g H O T L INE Warmer Operation

Perform all the tests described in the testing section of this manual. See Section 9, the tests.

32 HOTLINE

Te s t i n g

. The Scheduled Maintenance Checklist below also lists

Blood and Fluid Warmer | Operator’s Manual

Page 39

SECTION 10 • Maintenance

Maintenance Log

All maintenance and testing should be done by competent personnel. Regularly scheduled maintenance ensures proper functioning of the equipment. Refer to the table below for required tasks and frequency of routine maintenance.

Maintenance Checklist

Task Every Use Every 30 Days Every 12 Months

Clean the Exterior

General Inspection

Disinfect the Reservoir and Change Distilled Water or Isopropyl Alcohol solution

Lubricate the O-Rings

Disinfect the Reservoir and Change the Hydrogen Peroxide Solution

Replace the O-Rings

Alarm Signal Test

Add Recirculating Solution Te st

Check Disposables Test

Over Temperature Alarm Te st

Verify Temperature Calibration



Electrical Safety Tests

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 33



Page 40

SECTION 11

Limited Warranty

SECTION 11 • Limited Warranty

Smiths Medical ASD, Inc. (the “Manufacturer”) warrants to the Original Purchaser that the HOTLINE “HOTLINE

Warmer”), not including accessories, shall be free from

Blood and Fluid Warmer (the

defects in materials and workmanship under normal use, if used in accordance with this Operator’s Manual, for a period of one year from the actual date of sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES.

This warranty does not cover normal wear and tear and maintenance items, and excludes any accessory items or equipment used with the HOTLINE

Warmer.

Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or replace at its option without charge (except for a minimal charge for postage and handling) any HOTLINE

Warmer (not including accessories) which is defective if a

claim is made during such one-year period.

The following conditions, procedures, and limitations apply to the Manufacturer's obligation under this warranty:

A. Parties Covered by this Warranty: This warranty extends only to the

Original Purchaser of the HOTLINE

Warmer. This warranty does not extend to subsequent purchasers. The Original Purchaser may be medical personnel, a hospital, or institution which purchases HOTLINE

Warmers for treatment of patients. The Original Purchaser should retain the invoice or sales receipt as proof as to the actual date of purchase.

B. Warranty Performance Procedure: Notice of the claimed defect must

be made in writing or by telephone to the Manufacturer as follows: Customer Service Department, Smiths Medical ASD, Inc., 160 Weymouth Street, Rockland, MA 02370, (800) 258-5361. Notice to the Manufacturer must include date of purchase, model and serial number, and a description of the claimed defect in sufficient detail to allow the Manufacturer to determine and facilitate any repairs which may be necessary. AUTHORIZATION MUST BE OBTAINED PRIOR TO RETURNING THE HOTLINE authorized, the HOTLINE

34 HOTLINE

Warmer must be properly and carefully

Blood and Fluid Warmer | Operator’s Manual

WARMER . If

Page 41

SECTION 11 • Limited Warranty

packaged and returned to the Manufacturer, postage prepaid. Any loss or damage during shipment is at the risk of the sender.

C. Conditions of Warranty: The warranty is void if the HOTLINE

Warmer has been 1) repaired by someone other than the Manufacturer or its authorized agent; 2) altered so that its stability or reliability is affected; 3) misused; or 4) damaged by negligence or accident. Misuse includes, but is not limited to, use not in compliance with the Operator's Manual or use with non-approved accessories. Removal or damage to the HOTLINE

Warmer’s serial

number will invalidate this warranty.

D. Limitations and Exclusions: Repair or replacement of the

HOTLINE

Warmer or any component part thereof is the EXCLUSIVE remedy offered by the Manufacturer. The following exclusions and limitations shall apply:

1. No agent, representative, or employee of the Manufacturer has

authority to bind the Manufacturer to any representation or warranty, expressed or implied.

2. THERE IS NO WARRANTY OF MERCHANTABILITY OR

FITNESS OR USE OF THE HOTLINE

WARMER FOR ANY

PARTICULAR PURPOSE.

3. The HOTLINE

Warmer can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the HOTLINE

Warmer for any particular medical

treatment.

4. All recommendations, information, and descriptive literature supplied by the Manufacturer or its agents are believed to be accurate and reliable, but do not constitute warranties.

The Manufacturer disclaims responsibility for the suitability of the HOTLINE medical complications resulting from the use of the HOTLINE

Warmer for any particular medical treatment or for any

Warmer. The Manufacturer shall not be responsible for any incidental damages or consequential damages to property, loss of profits, or loss of use caused by any defect or malfunction of the HOTLINE

Warmer.

This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may have other legal rights which may vary from state to state.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 35

Page 42

SECTION 12

WARNINGS

Service

• No user-serviceable parts. All service must be performed by Smiths Medical or competent personnel. Death or serious injury may occur if this warning is not followed.

All service must be performed by Smiths Medical or competent personnel. Service by any other person or organization voids the warranty and transfers liability for malfunctions of the device to the servicing organization.

Non-Warranty Work

SECTION 12 • Service

Devices received that are no longer under warranty can be returned for repair at a cost. The device will be promptly inspected and a verbal estimate of the repair cost will be provided. A purchase order will be required from the original purchaser consistent with the verbal estimate. A written estimate will be provided upon request.

Before returning the HOTLINE Medical for Returned Goods Authorization. Be sure that ALL recirculating solution is drained from the device before packing the HOTLINE Warmer for shipment.

Note: The HOTLINE shipment or it will be immediately returned as received.

Warmer must be cleaned and disinfected for repair

Warmer for service, contact Smiths

Additional Documentation

Upon request Smiths Medical will provide the following documentation:

• Circuit diagrams

• Components parts list(s)

• Description of function

• Service and calibration instructions

36 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 43

SECTION 12 • Service

Disposal Information

Observe national and local codes or requirements for disposal of contaminated materials and for recycling of solid waste materials that may impact the environment.

Service Contacts

Contact your Smiths Medical Technical Service Department or Smiths Medical distributor at:

USA/Canada

Smiths Medical ASD, Inc. 160 Weymouth Street Rockland, MA 02370 USA Tel: 1 800 258 5361

www.smiths-medical.com

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 37

Page 44

SECTION 13 • Specifications and Accessories

SECTION 13

Specifications and Accessories

System Specifications

Standard Compliance Guidelines

Product Safety IEC 60601-1:2005 EMC EN 60601-1-2, FCC 47 CFR Part 15,

Class B Enclosure Protection IEC 60529 IP Code: IPX1 Fluid Warmers ASTM F2172-02

Physical Dimensions

Height, Overall 24.1 cm (9.5 inches) Width, Overall 21.0 cm (8.3 inches) Depth, Overall 17.8 cm (7.0 inches) Weight, Dry 3.5 Kg (7.6 lbs) Weight, Wet (with recirculating

solution) Weight, Shipping 3.6 Kg (7.95 lbs) Recirculating Solution

Capacity Maximum Height on I.V. Pole 107 cm (42 inches)

Environmental Temperature Humidity [%] Operation

Transportation Storage

Thermal Temperature

Temperature Set Point

Over Temperature Set Point

Electrical Type

MAINS Power Input: 115V 115VAC, 50/60 HZ, 3.0 Amps MAINS Auxiliary Supply Power

Output: 115V 115VAC, 50/60 HZ, 1.0 Amps

5.0 Kg (11.0 lbs)

1.4 L (0.37 gallons)

C to 45oC 10 to 95

C to 60oC 5 to 90

-18

-18oC to 60oC 5 to 90

C ± 0.1oC

38.0

39.2

38 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 45

SECTION 13 • Specifications and Accessories

Electrical Type

Protection Against Electrical Shock

Mode of Operation Continuous Type of Current Alternating Ingress Protection Rating IPX1

Performance

Recirculating Solution Te mperatu r e

Normothermic Flow Rates At gravity flow rates to 5,000 ml per hour

Class 1 Equipment, Type BF

Recirculating solution temperature reaches 37oC from ambient in about 4 minutes

Electromagnetic Compliance

HOTLINE Warmer is certified to be in compliance with the European Communities Council Directive relating to Electromagnetic Compatibility (EMC): (89/336/EEC). Test methods and acceptance criteria as specified in EN 60601-1-2 demonstrate conformance.

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 39

Page 46

SECTION 13 • Specifications and Accessories

Electromagnetic Environmental Recommendations

Recommended separation distances between portable and mobile RF communications

equipment and the HOTLINE

Warmer

The HOTLINE® Warmer is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the HOTLINE

Warmer can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and the HOTLINE

Warmer as recommended below, according

to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

d=[3.5/V1]P

80 MHz to 800 MHz

d=[3.5/E1]P

800 MHz to 2.5 GHz

d=[7/E1]P

0.01 0.116 0.116 0.233

0.1 0.368 0.368 0.737 1 1.16 1.16 2.33

10 3.69 3.69 7.38

100 11.66 11.66 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from

structures, objects and people

Accessories

Product Description

L-70 L-70NI L-80

HOTLINE HOTLINE

HOTLINE L-10 Gas Vent PC-8 T-Connector, 20.3 cm (8”) Patient Lead with Injection Port YC-8 Y-Connector, 20.3 cm (8”) Patient Lead with Injection Port

40 HOTLINE



Fluid Warming Set with Injection Port



Fluid Warming Set without Injection Port



Warming Set with L-10 Gas Vent

Blood and Fluid Warmer | Operator’s Manual

Page 47

SECTION 14

Symbols

Symbols Definitions

Power switch in the ON position

Power switch in the OFF position.

ON/Operation

Reservoir Temperature Display

SECTION 14 • Symbols

Add Recirculating Solution

Check Disposables

Over Temperature

Maximum Reservoir Level

Minimum Reservoir Level

Alarm Test

Type BF Equipment



Warning: Do not stick HOTLINE needles. Patient injury or death could result.

tubing with

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 41

Page 48

Symbols Definitions

Protected Against Dripping Water

Catalog Number

SECTION 14 • Symbols

? = @ H J G

Serial Number

Part Number

Batch Code

Authorized Representative in the European Community

Manufacturer

Date of Manufacture

Quantity

Protective Earth [Ground]

Alternating Current

42 HOTLINE

Do Not Reuse

Consult instructions for use (The symbol appears on the device with a blue background.)

Consult instructions for use

Caution

Electric Shock Hazard

Blood and Fluid Warmer | Operator’s Manual

Page 49

Symbols Definitions

Not made with natural rubber latex

SECTION 14 • Symbols

€

CLASS 1

P _ 8 M

Caution: This product contains natural rubber latex which may cause allergic reactions.

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

Device is class type 1 equipment

Protective earth terminal

Do not use if package is damaged.

Sterile fluid path, ethylene oxide gas sterilized

Temperature Limitation

Humidity Limitation

Use by

Keep away from sunlight

‚

HOTLINE

Keep dry

Recyclable Product

Device has been tested by TÜV SÜD America, a nationally recognized technical laboratory, to meet all requirements for safety.

Device has been tested by National Technical Systems, a nationally recognized technical laboratory, to meet U.S. requirements for safety.

Collect separately for electrical and electronic equipment.

Contains or Presence of Phthalate: bis(2-ethylhexyl) phthalate (DEHP)

Blood and Fluid Warmer | Operator’s Manual 43

Page 50

Index

Numerics

0.3% Hydrogen peroxide solution maintenance schedule preparation

35% Isopropyl alcohol solution

maintenance schedule preparation

11, 30

Accessories list 40 Add Recirculating Solution mode Add Recirculating Solution test Add Solution LED Additional documentation After Use Alarm signal test Alarm Test button Alcohol (isopropyl) solution Anesthetic use warning Assembly instructions Auxiliary electrical outlet

11, 30

Biohazardous material

disposal information

Canada service contact 37 Cautions

Change the recirculating solution Check Disposables LED Check Disposables mode Check Disposables Test Clamp for I.V. pole Clean exterior surfaces Components

Connect the intravenous administration set Contents

Contraindications Controls Conventions used in manual

L-10 Gas Vent

description

list

Description

components HOTLINE Fluid Warming Sets

HOTLINE Warmer Disinfect the reservoir Display Panel

description Disposal information

biohazardous materials

electrical device Distilled water

maintenance schedule Drain tube

10, 30

2, 13

Electrical safety tests 11, 27 Electrical specifications Electromagnetic compliance Electromagnetic environmental recommendations Environmental specifications

Fill-port plug 3 Float switch

Grounding reliability 7, 17 Guidelines for safe use

HOTLINE Fluid Warming Sets

description

priming volume Hydrogen peroxide solution

preparation

10, 11, 30

I.V. pole mounting height restrictions 9 Important safety information Indications for use Infusate delivery temperatures

44 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 51

Index

Intravenous administration set

connect

Isopropyl alcohol solution

11, 30

L-10 Gas Vent

warnings and cautions

LCD

LEDs Light-emitting diodes (LEDs) Liquid crystal display (LCD)

Maintenance 28

performed every 12 months performed every 30 days performed with every use

Maintenance schedule

recirculating solution Modes of operation Mounting to I.V. pole

11, 30

Non-Warranty work 36

OFF mode 15 ON/Operating mode Operating LED Operation modes O-Rings

lubricate seals

replace Over Temperature Alarm mode Over Temperature LED Over Temperature test Over Temperature Test button

13, 15

Performance specifications 39 Physical specifications Power and Alarm Test Panel Power cord Power ON/OFF switch priming volume

HOTLINE Fluid Warming Sets

Principle of operation

Recirculating solution

change maintenance schedule preparation

protocols Reflux plug Replace

O-Rings Reservoir

fill with recirculating solution Reservoir level display

11, 30

Service 36 Service contacts Set Up the HOTLINE Fluid Warming Set Set Up the HOTLINE Warmer

Socket Specifications

electrical

environmental

performance

physical

thermal Standard compliance guidelines Storage Symbols System specifications

Temperature

display

Over Temperature Alarm Temperature verification of the recirculating solution Testing Thermal specifications Troubleshooting

Add Recirculating Solution alarm

Check Disposables alarm

electrical interference

hot cabinet

install HOTLINE Fluid Warming Set

HOTLINE

Blood and Fluid Warmer | Operator’s Manual 45

Page 52

no power 21 Over Temperature alarm recirculating solution leaks

USA service contact 37 Using the HOTLINE Warmer

Warnings 5

L-10 Gas Vent

Warranty

Index

46 HOTLINE

Blood and Fluid Warmer | Operator’s Manual

Page 53

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Page 54

Manufacturer:

Smiths Medical ASD, Inc.

160 Weymouth Street Rockland, MA 02370, USA Tel: 1 800 258 5361

Smiths Medical HL-90-38_4534012EN_Rev-004_Print Infant Flow Advance System Operator’s Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

SECTION 1

About this Manual

Indications for Use

Conventions Used in this Manual

SECTION 2

Description

Components

2 Display Panel

1 Socket with the reflux plug removed

2 Clamp for I.V. pole

3 Drain tube in tube holder

4 Reflux plug

5 Power cord

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 Power and Alarm Test Panel

2 Fill-port plug

3 Reservoir, contains recirculating solution

4 Float switch (inside reservoir)

HOTLINE® Fluid Warming Set

SECTION 3

Important Safety Information

SECTION 4

Assembly Instructions

Step 3 - Disinfect the Reservoir

Step 4 - Fill the Reservoir With Recirculating Solution

1 Prepare the recirculating solution.

3 Fill the reservoir with 1.4 liters of recirculating solution.

4 Replace the fill-port plug.

Step 5 - Perform the Electrical Safety Tests

SECTION 5

Principle of Operation

Infusate Delivery Temperatures

SECTION 6

Operation

Controls and Displays

Power and Alarm Test Panel

Modes of Operation

SECTION 7

Operating Instructions

3 Turn ON the power switch.

Step 3 - Connect the Intravenous Administration Set

Step 5 - After Use

1 Turn OFF the power switch.

SECTION 8

Troubleshooting

2 Confirm that the power switch is in the ON position.

2 Check for air lock:

SECTION 9

Te s t i n g

Alarm Signal Test

1 Press and hold the Alarm Test button (a).

2 Observe the following:

Over Temperature Alarm Test

1 Press and hold the Over Temperature Alarm Test button (a).

2 Observe the following:

Add Recirculating Solution Test

1 Remove the fill-port plug (c) on the reservoir.

3 Observe the following:

Check Disposables Test

2 Observe the following actions:

Temperature Verification of the Recirculating Solution

Periodic Electrical Testing

SECTION 10

Maintenance

Maintenance Performed with Every Use

5 Dry the item with a hand towel or soft cloth.

Disinfect the Reservoir and Change the Recirculating Solution

1 Prepare the recirculating solution.

2 Remove the fill-port plug.

Fill the reservoir with 1.4 liters of recirculating solution.

4 Replace the fill-port plug.

Maintenance Performed Every 30 Days