Smiths Medical level 1 HOTLINE HL-90 User manual

OPERATOR’S MANUAL
PN 4534005-GB Rev D
HOTLINE
Blood and Fluid Warmer
HL-90
®

General Information
ii HOTLINE®Blood and Fluid Warmer | Operator’s Manual
HOTLINE®Blood and Fluid Warmer
Part Number: 4534005-GB Rev. D (2005-07)
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 responsi-
bility with regard to the performance or use of these products.
Level 1, HOTLINE, and Smiths design mark are trademarks of the Smiths Medical family of companies.
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.
The products described are covered by one or more of the following U.S. Patent Nos., 5,063,994;
5,097,898; other patent(s) pending; foreign patent(s) pending.
For further information, please call the local Smiths Medical representative or Smiths Medical direct at
1-800-258-5361 or [phone].
©2005 Smiths Medical family of companies. All rights reserved.

Contents
HOTLINE®Blood and Fluid Warmer | Operator’s Manual iii
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 12
5 Principle of Operation 13
Infusate Delivery Temperatures 13
6Operation 14
Controls and Displays 14
Display Panel 14
Power and Alarm Test Panel 15
Reservoir Level Display 15
Modes of Operation 16
OFF Mode 16
ON/Operating Mode 16
Check Disposables Mode 16
Add Recirculating Solution Mode 17
Over Temperature Alarm Mode 17
7 Operating Instructions 18
Step 1 - Set Up the HOTLINE®Warmer 18
Step 2 - Set Up the HOTLINE®Fluid Warming Set 18
Step 3 - Connect the Intravenous Administration Set 20
Step 4 - Using the HOTLINE®Warmer 20
Step 5 - After Use 21
Storage 21
8Troubleshooting 22

Contents
iv HOTLINE®Blood and Fluid Warmer | Operator’s Manual
9 Testing 24
Alarm Signal Test 24
Over Temperature Test 25
Add Recirculating Solution Test 25
Check Disposables Test 26
Temperature Verification of the Recirculating Solution 26
Periodic Electrical Testing 28
Leakage Current 28
Ground Bond Test 28
10 Maintenance 29
Maintenance Performed with Every Use 29
Clean the Exterior 29
General Inspection 29
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 Sterile
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®Warmer Operation 32
Maintenance Log 33
11 Limited Warranty 34
12 Service 36
Warranty Service 36
Non-Warranty Work 36
Additional Documentation 36
Disposal Information 37
Service Contacts 37
USA/Canada 37
European Representative 37
Australian Representative 37
13 Specifications and Accessories 38
System Specifications 38
Electromagnetic Compliance 39
Electromagnetic Environmental Recommendations 40
Accessories 40
14 Symbols 41

SECTION 1 • About this Manual
HOTLINE®Blood and Fluid Warmer | Operator’s Manual 1
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.
These instructions contain important information for safe use of the
product. Read the entire operator’s manual, including Warnings and
Cautions, before using the HOTLINE®Warmer. 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®Wa rmer.
• The L Series Fluid Warming Sets (L-70, L-70NI, L-80) will be
referred to as the HOTLINE®Fluid Warming 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 physical injury and/or an adverse
effect on the device or its performance.
WARNING A Warning statement alerts the user to conditions
that may cause serious personal injury or death
to the user or patient.

SECTION 2 • Description
2HOTLINE®Blood and Fluid Warmer | Operator’s Manual
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 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
The HOTLINE®components are called-out in the following series of
figures.
Front View
1Socket for HOTLINE®Fluid Warming Set with the reflux plug in
place
2Display Panel
o
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HOTLINE
Fluid Warmer
1
2

SECTION 2 • Description
HOTLINE®Blood and Fluid Warmer | Operator’s Manual 3
Right Side View
1Socket with the reflux plug removed
2Clamp for I.V. pole
3Drain tube in tube holder
4Reflux plug
5Power cord
Rear View
1Fill-port plug
2Drain tube in tube holder
3Clamp for I.V. pole
4Protective earth terminal
5Auxiliary electrical outlet
Left Side View
1Power and Alarm Test Panel
2Fill-port plug
3Reservoir, contains recirculating solution
4Float switch (inside reservoir)
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HOTLINE
Fluid Warmer
2
1
3
4
5
1
2
1
3
4
5
1.4 LITERS
2
1
3
4

SECTION 2 • Description
4HOTLINE®Blood and Fluid Warmer | Operator’s Manual
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.

SECTION 3 • Important Safety Information
HOTLINE®Blood and Fluid Warmer | Operator’s Manual 5
SECTION 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.
• Read and follow all instructions, labeling, and accompanying
documents supplied with this medical device. Failure to follow
instructions, including all warnings and cautions, could lead to
misuse of the device or device malfunction.
•TheHOTLINE
®Fluid Warming Set is a single-use device and is
not intended for re-sterilization.
• Do not use HOTLINE®Fluid Warming Set if the caps are not
securely in place, else the I.V. flow path may not be sterile.
•TheHOTLINE
®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.
• Do not fill the HOTLINE®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.
• 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.
Continued

SECTION 3 • Important Safety Information
6HOTLINE®Blood and Fluid Warmer | Operator’s Manual
Continued from previous page
WARNINGS
WARNINGS
• Set-up, priming, and use require aseptic technique as per
applicable institutional policies and procedures.
• 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 intravenous fluid lines before
connecting to the patient. Failure to do so may result in
introduction of air to the patient.
• 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.
• 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.
Continued

SECTION 3 • Important Safety Information
HOTLINE®Blood and Fluid Warmer | Operator’s Manual 7
Continued from previous page
WARNINGS
WARNINGS
• 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.
• No user-serviceable parts. All service must be performed by
Smiths Medical or an authorized representative.
CAUTIONS
• Federal Law (USA) restricts this device to sale by or on the order
of a physician.
• 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.
• Do not autoclave or immerse any part of the HOTLINE®Warmer
in liquids, which may cause damage and improper functioning.
• 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®to slide
down the I.V. pole.
• Do not use the HOTLINE®Warmer if equipment or Disposable
Set malfunction is evident.
• 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.
• This device is cooled by convection. Be sure the air vents on the
bottom and the back of the device are kept clear.

SECTION 3 • Important Safety Information
8HOTLINE®Blood and Fluid Warmer | Operator’s Manual
Additional WARNINGS and CAUTIONS for Accessories
WARNINGS for the L-10 Gas Vent
• 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
• Contains natural rubber latex, which may cause allergic
reactions.

SECTION 4 • Assembly Instructions
HOTLINE®Blood and Fluid Warmer | Operator’s Manual 9
SECTION 4
Assembly Instructions
Read through the instructions completely prior to setting up the
HOTLINE®Warmer.
Step 1 - Unpack the HOTLINE®Warmer
1Open the shipping carton and remove the HOTLINE®Wa rme r.
2Check the contents of the package to verify the following
components are present:
•HOTLINE
®Warmer
• Operator’s Manual
3Examine the HOTLINE®Warmer for damage. If any components
appear damaged, do not use the HOTLINE®Warmer. Co nt act
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
CAUTIONS
• Insure 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.
• 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.
• This device is cooled by convection. Be sure the air vents on the
bottom and the back of the device are kept clear.

SECTION 4 • Assembly Instructions
10 HOTLINE®Blood and Fluid Warmer | Operator’s Manual
1Slide the clamp (a) on the HOTLINE®Warmer over the I.V. pole
(b) and tighten the clamp screw (c) firmly.
2Check the tightness of the HOTLINE®Warmer to ensure it is
securely clamped to the pole.
Step 3 - Disinfect the Reservoir
1Prepare a 0.3% hydrogen peroxide solution by mixing 140 ml of 3%
hydrogen peroxide solution and 1,260 ml of sterile distilled water.
2Remove 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.
3Replace the fill-port plug.
4Insert a HOTLINE®Fluid Warming Set (e) (L-70, L-70 NI, L-80)
into the socket.
5Tu r n t h e H O T L I N E ®Warmer ON and let the solution circulate for
a 30-minute disinfection period.
6Tu r n t h e H O T L I N E ®Warm e r OF F.
7Invert the drain tube (e) and place a container under the end of the
tube. Remove the end cap (f) and drain the recirculating solution
into the container.
8When all the recirculating solution has drained from the reservoir,
replace the end cap and insert the drain tube back in the holder.
9Remove the HOTLINE®Fluid Warming Set and discard according
to established hospital procedures.
b
c
a
1.4 LITERS
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HOTLINE
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SECTION 4 • Assembly Instructions
HOTLINE®Blood and Fluid Warmer | Operator’s Manual 11
Step 4 - Fill the Reservoir With Recirculating Solution
WARNINGS
WARNINGS
• Set-up, priming, and use require aseptic technique. Follow
applicable institutional policies and procedures.
• 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.
1Prepare the recirculating solution.
2Remove the fill-port plug (a).
3Fill the reservoir with 1.4 liters of recirculating solution.
4Replace the fill-port plug.
Recirculating Solution Preparation Maintenance
0.3% Hydrogen Peroxide
Solution
Mix 140 ml of 3% hydrogen
peroxide with 1,260 ml of
sterile distilled water.
Replace solution and
disinfect reservoir every
12 months.
Sterile Distilled
Water
Use sterile distilled water. Replace solution and
disinfect reservoir every
30 days.
35% Isopropyl Alcohol
Solution
Mix 700 ml of 70% isopropyl
alcohol with 700 ml of sterile
distilled water.
Replace solution and
disinfect reservoir every
30 days.
Note: Use sterile 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.
1.4 LITERS
a

SECTION 4 • Assembly Instructions
12 HOTLINE®Blood and Fluid Warmer | Operator’s Manual
Step 5 - Perform the Electrical Safety Tests
Perform all applicable electrical safety tests as required per institutional
procedure. Refer to Section 10,
Te s t i n g , for more information about
electrical safety testing.

SECTION 5 • Principle of Operation
HOTLINE®Blood and Fluid Warmer | Operator’s Manual 13
SECTION 5
Principle of Operation
HOTLINE®Warmer delivers blood and intravenous fluid at
normothermic temperatures under routine, gravity flow rates. All other
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.
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.
Note: The setpoint temperature of the recirculating solution is
41.9°C.
a
a
50 250 500 750 1000 1250 1500 2000 2500 3000 3500 4000 4500 5000
Flow Rate (ml / hr) 20° C Infusate
10° C Infusate
Temperature ° C
44.0
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: 19.5° C - 20.5° C

SECTION 6 • Operation
14 HOTLINE®Blood and Fluid Warmer | Operator’s Manual
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®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 light-
emitting diodes (LEDs) indicate operation modes for the HOTLINE®
War mer.
1Recirculating Solution Temperature - The temperature is displayed
in degrees Celsius.
2Operating - The green LED illuminates when the power is turned
on and the HOTLINE®Fluid Warming set is properly installed.
3Check Disposables - The red LED illuminates and an audible
attention signal beeps when the HOTLINE®Fluid Warming Set is
not properly installed.
4Add Solution - The red LED illuminates and an audible attention
signal beeps when the level in the reservoir is low and additional
solution must be added.
5Over Temperature - The red LED illuminates and an audible
warning signal beeps when the recirculating solution is over the
acceptable temperature for safe use.
o
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2
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4
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SECTION 6 • Operation
HOTLINE®Blood and Fluid Warmer | Operator’s Manual 15
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.
1Over Temperature Test Button - The Over Temperature Test is
used to confirm the proper operation of the Over Temperature
circuitry.
2Alarm Test Button - The Alarm Signal Test is used to confirm
proper operation of the visual and audible alarms.
3Power 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.
1.4 LITERS
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b

SECTION 6 • Operation
16 HOTLINE®Blood and Fluid Warmer | Operator’s Manual
Modes of Operation
The HOTLINE®Warmer operation is defined in the following modes:
• OFF Mode
•ON/OperatingMode
•CheckDisposablesMode
• 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®Fluid
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®Fluid Warming Set.
Mode characteristics
• The green Operating LED on the Display Panel turns off.
•Τhe red Check Disposables LED (d) on the Display Panel
illuminates.
• The audible alarm sounds and repeats approximately every two
seconds.
• The recirculating solution stops circulating.
a
b
c
d