Manual Compresor Infusor de Liquidos

l TM
OPERATOR’S MANUAL
P/N 4533708GB Rev. 008
s
ii | Operator’s Manual
C o p y r i g h t
Copyright
®
Level 1 H-1200 Fast Flow Fluid Warmer
Part Number: 4533708GB Rev. 008 (2010-02)
This revision supercedes all previous revisions.
Under copyright laws, this manual may not be reproduced in any form, in
whole, or in part, without prior written permission of Smiths Medical ASD,
Inc. (Smiths Medical).
Smiths Medical and Level 1 design marks and Level 1 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 tradenames,
trademarks, or service marks of their respective owners.
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
assumes no responsibility with regard to the performance or use of these
products.
For further information, please call your local Smiths Medical distributor or
Smiths Medical direct at 1-800-258-5361
or +1-781-878-8011.
©2010 Smiths Medical family of companies.

All rights reserved.
The products described are covered by one or more of the following U.S.
Patent Nos. 5,063,994; 5,097,898; 5,417,274; 5,512,043 and 6,575,935; and
counterpart foreign patent(s); other patent(s) pending.
Manufactured in the U.S.A.
| Operator’s Manual iii

Con te n ts
Contents
1 About this Manual 1
2 Description 3
3 Indications for Use 4
4 Important Safety Information 5

Contraindications 5
Warnings 5
Cautions 8
5 Out of the Box—Assembly 9
Step 1 Verify Components 10
Step 2 Assemble I.V. Pole to Warming Unit 11
Step 3 Install the Pressure Chambers 12
Step 4 Attach the I.V. Bag Hanger 13
Step 5 Disinfect the Recirculating Solution Reservoir 13
Step 6 Preliminary Preparation 14
Step 7 Connect the Pneumatic Tubing 14
®
Step 8 Install the Level 1 H-31, Version B, Air Detector/
Clamp 15
Step 9 Perform Electrical Safety Tests 17
6 Principle of Operation 19
Fluid Warming 19
Pressurized Fluid Delivery 19
Air Detection/Clamping 19
F-50 Gas Vent/Filter Assembly 20
7 Controls and Displays 21
Fluid Warmer Power and Alarm Test Panel 22
Fluid Warmer Display Panel 23
Air Detector/Clamp Control Panel and Alarms 24
Pressure Chamber Control Panel 25
Interlocks 26
8 Operation 29
Modes Of Operation 30
OFF Mode 30
ON/ Automatic Operation Mode for Fluid Warmer 30
Alarm Test Mode 31
Over Temperature Test Mode 31
Temperature Display 31
Check Disposables Mode 32
Add Recirculating Solution Mode 32
Over Temperature Alarm Mode 33
Power ON Test for the Air Detector/Clamp 33
Automatic Operation Air Detector/Clamp 34
Check Tubing Mode 34
Air Detected/Clamped Mode 35
Pressure Display 35
Pressurized Mode 35
Unpressurized Mode 36
iv | Operator’s Manual
C o nt en t s
9 Operating Instructions 37
Warnings 37
9.1 Set Up for Use 38
A Install Disposable Administration Set 38
B Prime the Disposable Administration Set 41
C Prime the Patient Line 42
D Test the Audible and Visual Alarms 43
E Test the Air Detector/Clamp 44
9.2 Use of the Fluid Warmer 46
Step 1 Load the Pressure Chambers 46
Step 2 Pressurize the Pressure Chambers 47
Step 3 Make Patient Connection 48
Step 4 Replace the Gas Vent/Filter Assembly 48
Step 5 Change the Fluid Bag 48
9.3 Replace the Gas Vent/Filter Assembly 48
9.4 Activated Alarms 49
9.5 After Use 51
10 Troubleshooting 52
General Troubleshooting Guide 52
Slow Flow Rate Troubleshooting Guide 53
11 Testing 54
Add Recirculating Solution Alarm 54
Check Disposables Alarm 54
Over Temperature Test 55
Fluid Warmer Alarm Signal Test 55
Performance Testing 56
Cold Start Test 56
Calibration Test 56
Alternative Calibration Test 56
Calibration Test with DSTA 40 56
Proper Calibration of Recirculating Solution Temperature 57
Periodic Electrical Testing 58
Earth Leakage 58
Ground Continuity 58
12 Maintenance 59
Maintenance Performed Prior to Every Use 59
Clean the Exterior 59
General Inspection 60
Maintenance Performed Every 30 Days 61
Lubricate O Ring Seals 61
Change Recirculating Solution with Distilled Water 61
Maintenance Performed Every 12 Months 61
Disinfect the Reservoir 61
Change Recirculating Solution with 0.3% Hydrogen
Peroxide/Distilled Water Solution 62
Change O Rings 62
Clean Fan Filter 62
Inspect Air Detector/Clamp 63
Testing Fluid Warmer Operation 63
Maintenance and Calibration Log 64
Scheduled Maintenance and Calibration Checklist 64
| Operator’s Manual v
Con te n ts
13 Limited Warranty 65
14 Service 67
Warranty Service 67
Non-Warranty Work 67
Additional Documentation 67
Disposal Information 68
Service Contacts 68
15 Specifications 69
System Specifications 69
Physical 69
Environmental 69
Thermal 69
Electrical 69
Electromagnetic Environment Recommendations 70
Disposable Administration Set Specifications 70
DI 50 70
D/DI 60HL and D/DI 65HL 70
D/DI 70 and D/DI 75 71
D/DI 100 and D/DI 150 71
D/DI 300 and D/DI 350 71
16 Symbols 72
Index 75
vi | Operator’s Manual
S EC T I O N 1 • A b o ut t his Ma n u a l
SE CTION 1
About this Manual

WARNING: These instructions contain important information
for safe use of the product. Read the entire 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.
This Operator’s Manual describes the set-up, use, and maintenance of:
• Level 1® H-1200 Fast Flow Fluid Warmer
• Level 1® H-1000 Fast Flow Fluid Warmer with H-2 Pressure
Chambers (H-1025)
• Level 1® H-1000 Fast Flow Fluid Warmer with H-2 Pressure
Chambers and H-31, Version B, Air Detector/Clamp
The manual is intended for use by individuals trained in the

healthcare and biomedical professions.
This operator’s manual is also for users of the H-1000 Fast Flow
Fluid Warmer. All references to the “Level 1® H-1200 Fast Flow Fluid
Warmer” apply to the H-1000 Fast Flow Fluid Warmer except where
indicated by the symbols defined in the following table.
Symbol Description
Appears in the margin to identify information
that only applies to the H-1200 Fluid Warmer
and the H-1000 Fluid Warmer equipped with the
H-31, Version B, Air Detector/Clamp
Appears in the margin to identify information
that only applies to the H-1000 Fluid Warmer
(not equipped with the H-31, Version B, Air
Detector/Clamp)
| Operator’s Manual 1
SECTIO N 1 • About this Manu a l
This manual is organized into the following sections:
2 and 3 Description and Indications for Use

These sections provide the purpose and indications for use of the
Level 1® H-1200 Fast Flow Fluid Warmer.
4 Important Safety Information
Lists the Contraindications, Warnings, and Cautions associated with the
use of the Level 1® H-1200 Fast Flow Fluid Warmer.
5 Out of the Box—Assembly
Guides the user through the installation of the Level 1® H-1200 Fast Flow
Fluid Warmer and the Level 1® H-31, Version B, Air Detector/Clamp.
6 Principle of Operation
Provides a functional description of the Level 1® H-1200 Fast Flow Fluid
Warmer.
7 Controls and Displays
Provides a description of the function and purpose of the controls,
displays, and indicators for the Level 1® H-1200 Fast Flow Fluid Warmer.
8 Operation
Describes Operation, Indicator, and Alarm modes of the Level 1® H-1200
Fast Flow Fluid Warmer.
9 Operating Instructions
Describes the Set Up, Use, and Alarm modes of the Level 1® H-1200
10 Troubleshooting
Contains information on troubleshooting the Level 1® H-1200
Fast Flow Fluid Warmer. This section also details troubleshooting
slow fluid flow rates.
11 Testing
Describes Operational, Performance, and Electrical Tests that are used to
verify the proper operation of the Level 1® H-1200 Fast Flow Fluid
Warmer.
12 Maintenance
Regular maintenance procedures for every use, 30-day, and 12-month
intervals are covered in this section.
13 Limited Warranty
Describes the Limited Warranty and its provisions.
14 Service
Explains Warranty Service and Non-Warranty Work as well as listing
Service Contacts.
15 Specifications
Provides physical, environmental, and electrical specifications of the
16 Symbols
Lists the symbols and their definitions used with the Level 1® H-1200 Fast
Flow Fluid Warmer.
2 | Operator’s Manual
S EC T I O N 2 • D e s crip t i o n
SE CTION 2
Description
The Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) is an I.V. fluid
warmer with pressure chambers, air detection, and automatic clamping
capability. I.V. fluid and/or blood products are warmed through the use of a
sealed heat exchanger through which a recirculating solution flows. Pressure
Chambers apply pressurization and deliver the fluids at a fast flow rate. This
non-invasive method employs single-use, disposable administration sets that
include a Gas Vent/Filter Assembly and Heat Exchanger.
The Air Detector/Clamp monitors for the presence of air in the disposable
Gas Vent/Filter Assembly. When air is detected in the Gas Vent/Filter
Assembly, the Air Detector/Clamp closes off the patient line and alerts
operators to the presence of air with audible and visual alarms. An ultrasonic
signal continually passes through the fluid filled Gas Vent/Filter Assembly. As
a bolus of air displaces the fluid in the Gas Vent/Filter Assembly, the
ultrasonic signal is broken and the clamp closes, stopping the air before it
enters the patient line. Audible and visual alarms are activated, notifying the
user that the fluid flow has stopped. Clearing the bolus of air and restoring
the fluid flow are quickly accomplished without disconnecting from the
patient.
Disposable Administration Sets
The installation, set up, and replacement of Level 1® Fast Flow I.V. Disposable
Administration Sets (Disposable Sets) follows a four-step sequence that
corresponds to numbered blocks on the device. Disposable Sets available for
use on the Level 1® H-1200 Fast Flow Fluid Warmer are listed below.
• DI-50
• D-60 / DI-60HL • D-65 / DI-65HL
• D-70 / DI-70 • D-75 / DI-75
• D-100 / DI-100 • D-150 / DI-150
• D-300 / DI-300 • D-350 / DI-350
D-series Disposable Sets are for use in the U.S.A. DI-series Disposable Sets
are for use in markets outside of the U.S.A.
SECTIO N 3 • Indic ations f or U s e
SECTIO N 3
Indications for Use

The Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) provides a
rapid flow of warmed fluids, such as crystalloid or blood product, including
red blood cells, as volume replacement for patients suffering from blood loss
due to trauma or surgery.
The Fluid Warmer provides fast flow of warmed fluid to re-warm patients
during surgery by trained medical personnel.
S EC T I O N 4 • I m p o rt a nt S a f e t y I nf o rm a t i o n
SE CTION 4
Important Safety Information

This section covers information for prescribers and guidelines for safe use of
the Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer).
CONTRAINDICATIONS
• Not for use in warming platelets, cryo-precipitates, or

granulocyte suspensions.
WARNINGS
Death or serious injury may occur to the patient or user if

these warnings are not followed:
• These instructions contain important information for safe use of

the product. Read the entire 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.
• Remove all air from the fluid bags before spiking and the fluid
lines before connecting to the patient. Failure to do so can result
in infusion of air into the patient.
• Replace Gas Vent/Filter Assembly every three hours, or when

the filter becomes clogged, or when air is slowly vented.
Failure to do so will result in a reduction of flow rate. This
may result in inadequate patient treatment.
• The replacement Gas Vent/Filter Assembly must be fully

primed before continuing infusion. Failure to do so may
allow air to be infused into the patient.
• Do not use the Fluid Warmer in high-energy fields such as:

MRI, X-RAY, portable and mobile RF communications equipment,
and other such devices. The Fluid Warmer may act as a
projectile in a strong magnetic field, cause image artifacts, or
not function as intended.
SECTIO N 4 • Important Saf ety I nf o rm a t io n
WARNINGS [continued]
• Do not bend the heat exchanger. Bending may damage the

heat exchanger allowing communication between the
recirculating solution and I.V. fluid path, resulting in the I.V.
delivery of inappropriate fluids.
• 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.
• When injecting medications into the fluid path, do not inject

through the triple lumen tubing of the D/DI-60HL and
D/DI-65HL Disposable Set. This may allow communication
between the recirculating solution and I.V. fluid path.
• Exposed conductor on MAINS power cord can cause an

electrocution hazard. Remove device from service if MAINS
power cord has exposed wires.
• Do not re-use partially full fluid bags. Fluid bags that have
been partially drained, un-spiked, and then reinstalled may
contain air, which if used can result in infusion of air into the
patient. Use only new fluid bags from which the air has been
removed.
• Activation of the Over Temperature warning signal indicates

that warming has stopped and immediate operator
intervention is required. Failure to clear the over temperature
condition or to take the device out of service may result in death
or serious injury to the patient.
• The Fluid Warmer is not for use with irrigating tubing, which
may not fit into the clamp slot of the Air Detector/Clamp
causing diminished flow or a failure to stop flow.
• The Fluid Warmer is for use only with Smiths Medical

supplied or approved parts, accessories, and D or DI series
Disposable Sets. The device may not function as intended with
the use of unapproved parts, accessories, or Disposable Sets.
• 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.
S EC T I O N 4 • I m p o rt a nt S a f e t y I nf o rm a t i o n
WARNINGS [continued]
• Use of a bedside leukocyte reduction filter may cause a

sudden precipitous drop in blood pressure resulting in
respiratory distress, facial flushing, abdominal pain and
nausea, and loss of consciousness. Immediately stop
transfusion, and follow institution’s protocol for treatment of
transfusion reactions.
• Do not operate the Fluid Warmer in the presence of a

flammable anesthetic mixture with air, oxygen, or nitrous oxide.
The risk of explosion exists if the Fluid Warmer is operated in
a potentially explosive environment.
• No user-serviceable parts. All service must be performed by

Smiths Medical or competent personnel.
• Disposable Sets are supplied with a sterile fluid path which may
be compromised if the caps are not in place. Do not use
Disposable Set if Luer and spike caps are not securely in place,
or if Luer connections are not secure as the fluid path may not
be sterile and may cause death or serious injury to the patient.
• Disposable Sets are for single use only. To reduce the risk of
cross contamination, do not reuse Disposable Sets.
• If fluid exits in the Patient Line or the D/DI-60HL and D/DI-65HL

Disposable Set, replace the Disposable Set.
• Do not use auto-transfusion bags. Auto-transfusion bags

may contain air that can result in infusion of air into the patient.
• Set-up, priming, and use require aseptic technique. Failure to

use aseptic technique may result in death or serious injury to
the patient.
• Do not use the Fluid Warmer if equipment or Disposable
Set malfunction is evident.
WARNINGS for the Air Detector/Clamp
• The tubing must be properly placed in the Clamp Slot of the

Air Detector/Clamp. Failure to ensure that the tubing is
correctly positioned in the Clamp Slot may result in failure to
stop air infusion.
SECTIO N 4 • Important Saf ety I nf o rm a t io n
WARNINGS for the Air Detector/Clamp [continued]
• Activation of the Air Detector/Clamp alarm during infusion

indicates that fluid flow has stopped and that immediate
operator intervention is required to restore fluid flow.
Failure to reinstate flow (after purging any air or foam) may
result in death or serious injury to the patient.
• Do not turn OFF the Fluid Warmer when the Air Detector alarm
is active. If the Fluid Warmer is powered OFF in an active alarm
state, the Air Detector/Clamp will open and the Air Detector
will become disabled. This could allow any air within the patient
line to be delivered to the patient resulting in serious injury or
death.
• The functional test for the Air Detector/Clamp accessory

must be performed before each use. 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. Fully functional visual and audible alarm systems
are essential for the safe use of the Air Detector/Clamp.
CAUTIONS
Malfunction, failure, or damage to the device may occur if

these cautions are not followed:
• Never use organic solvents (e.g., acetone), strong acids, or

bases to clean any portion of the Fluid Warmer.
• Do not place the Fluid Warmer directly under a faucet or use a

faucet sprayer to rinse. Never spray cleaning or other fluids into
openings on the Fluid Warmer or into the external connectors.
• When loading fluid bags into Pressure Chambers, choose a

hanging hook that allows the bag port to hang freely in the
indented slot at the bottom of the chamber door. If bag ports
are positioned above this slot, diminished flow could occur.
• 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.
S EC T I O N 5 • O ut o f t he B o x A s s e m b l y
SE CTION 5
Out of the Box—Assembly

This device must be assembled and tested by authorized Smiths Medical
personnel, an authorized distributor of Smiths Medical, or competent
personnel prior to placing the device into service.
The following steps describe how to assemble and do preliminary set up of the
Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer).
Refer to Step 8 if you need to install the Level 1® H-31, Version B, Air
Detector/Clamp to the Level 1® H-1000 Fast Flow Fluid Warmer.
Step 1 Verify components of the Fluid Warmer
Step 2 Assemble I.V. Pole to Warming Unit
Step 3 Install Pressure Chambers
Step 4 Attach the I.V. Bag Hanger
Step 5 Disinfect the Recirculating Solution Reservoir
Step 6 Preliminary Preparation
Step 7 Connect the Pneumatic Tubing
Step 8 Install the Level 1® H-31, Version B, Air Detector/Clamp
Step 9 Perform Electrical Safety Tests
Read through the instructions completely prior to setting up the device.
Note: After unpacking the system, recycle packaging material according to

hospital policy for recyclable materials.
SECTIO N 5 • Out of the Box A s s e m b ly
Step 1
®
Verify Components of the Level 1 H-1200 Fast Flow Fluid Warmer
Note: The Level 1® H-31, Version B, Air Detector/Clamp is shipped as a separate accessory only for
installation on an existing Level 1® H-1000 Fast Flow Fluid Warmer.
Check the contents of all packaging to verify that the following components are present. If any parts are
missing or damaged, do not use the Fluid Warmer. Do not substitute parts not supplied by Smiths
Medical. Contact Smiths Medical for replacement parts. Below is a listing of the component parts for the
Components Checklist
Qty Component
in order of appearance in illustration
2 Pressure Chambers / Contents:
(2) “U” brackets
(4) Thumbscrews
1 I.V. Bag Hanger
1 Fluid Warming Unit
1 H-31, Version B, Air

Detector/Clamp
1 Accessory Pack
(3) Pan-head screws
(3) Power Cord Clips
(3) Flat-head screws
1 Operator's Manual
1 Quick Reference Guide
1 I.V. Pole with Flanking Brackets
1 Accessory Pack / Contents:

(2) Plastic “J” Clamps
(1) Y Connector
(1) Black Tubing
(1) Hex Wrench
1 O Ring Kit / Contents:

(1) Silicone
(2) O Rings
(1) Hex Wrench
(1) Instructions for Use
3 Bolts
3 Washers
1 I.V. Pole Base
Step 2
Assemble I.V. Pole to the Warming Unit
There are three steps involved in assembling the I.V. Pole to the
Warming Unit. The steps are: 1. Assemble the I.V. Pole to the Base,
2. Close the Drain Valve, and 3. Attach the Warming Unit to the
Flanking Brackets. Each step is detailed in a short procedure.
2.1 Assemble the I.V. Pole to the Base
1 Locate the I.V. Pole Base (a).
2 Locate the dark-gray extruded I.V. Pole (b) with Flanking

b Brackets.
3 Place the I.V. Pole Base upright on its wheels, (c) and lock the
wheels to prevent movement during set up.
d
e 4 Locate three bolts (d) and washers for the pole base.
5 Align the three holes (e) in the I.V. Pole with the three screw
f
holes on the pole base.
g 6 Slide the I.V. Pole down over the pole base, (f) keeping holes
a
aligned.
7 Guide three bolts and washers through the holes (g) at the base
of the pole and tighten.
2.2 Close the Drain Valve
Turn valve, located on the bottom of the device, perpendicular to

stem (h) of the Warming Unit as shown.
2.3 Attach the Warming Unit to the Flanking Brackets
1 Align the eight hex screws on the back of the Warming Unit
with the eight keyhole notches on the flanking bracket.
2 Slide screw heads down into keyhole notches.
3 Tighten all eight hex screws with the supplied hex

wrench and secure in place.
2.4 Attach the Quick Reference Guide to the

Fluid Warmer by sliding the ring on the
Quick Reference Guide over one of the
poles on the Flanking Bracket.
Step 3
Install the Pressure Chambers
1 Locate the two Pressure Chambers.
2 Locate the U-brackets and thumbscrews supplied with the

Pressure Chambers.
3 Attach the U-brackets with thumbscrews to the back of the Pressure

Chambers, as shown. Keep thumbscrews and brackets loose.
4 Slide one Pressure Chamber with attached U-bracket over the top
of each flanking pole.
5 Align the U-bracket slightly below the top of the flanking pole.
Tighten the thumbscrews securely.
Step 4
Attach the I.V. Bag Hanger
1 Slide the I.V. Bag Hanger on top of the I.V. Pole.
2 Align with tabs.
3 Press down and snap into place.
Step 5
Disinfect the Recirculating Solution Reservoir

2
c 1 Remove the fill-port plug (a) on the reservoir.
2 Prepare a 0.3% hydrogen peroxide/distilled water solution for

the reservoir. Mix 140 ml of 3% hydrogen peroxide solution and
1,260 ml of distilled water.
3 Fill the reservoir with 1.4 liters of 0.3% hydrogen peroxide/

VE
LE EM
L
10
00 distilled water solution.
ST
SY
4 Replace the fill-port plug.

b
5 Insert a Disposable Set into the Fluid Warmer.
1
a AX
6 Insert the power cord into a properly grounded receptacle.
7 Turn the Fluid Warmer ON. Let the solution circulate for a 30-
minute disinfection period.
8 Turn the Fluid Warmer OFF.
9 Empty the reservoir.
10 Remove the Disposable Set and discard according to established

hospital procedures.
Step 6
Preliminary Preparation
1 Remove the fill-port plug (a) on the front of the warming unit and 2 c
fill the reservoir to the maximum level with 1.4 liters of one of the
following solutions:
• 0.3% Hydrogen Peroxide/Distilled Water Solution

Mix 140 ml of 3% hydrogen peroxide and 1,260 ml of distilled
water.
Note: If this option is selected, the maintenance requirement VE
L
10
00
LE TEM
S
to change the recirculating solution is once every 12 months. SY
b
Always use a 0.3% hydrogen peroxide/distilled water solution
when refilling the reservoir. a
• Distilled Water 1
Note: If this option is selected, the maintenance requirement AX
to change the recirculating solution is once every 30 days.

a
2 Replace the fill port plug.
b
3 Lubricate O-Rings in #1 Block (b) and #2 Block (c). Place a small
amount of silicone lubricant, provided in the supplied O-Ring Kit,
on a cotton swab and apply all around the inside of each O-Ring.
c
Step 7
Connect the Pneumatic Tubing
1 Locate the Accessory Pack with the black pneumatic tubing (a),
two “J” clamps (b), and one “Y” Connector (c).
2 Locate the orange protective plug in the red ring connector (d)
located on the back of the device. Remove the plug by depressing
the red plastic ring as you pull the plug out of the connector.
3 Take the pneumatic tubing and press one end of the tubing firmly
into the ring connector (d) until it can go no further.
4 Take the “Y” connector and press the other end of the pneumatic
tubing into the bottom of the “Y” connector, as shown (e), until it
can go no further.
5 Press the pneumatic tubing from the Pressure Chamber

into place (f) on the top of the “Y” connector until it can
go no further. Repeat this procedure with the pneumatic
tubing from the other Pressure Chamber.
f 6 Remove the protective backing sheet on one “J” clamp,

exposing the adhesive side.
e
g 7 Carefully position the “J” clamp and press the
adhesive side against the gray I.V. Pole in the
approximate locations (g)(h) shown.
Press down firmly to secure in place.
Repeat this procedure for the other “J” clamp.
8 Press the pneumatic tubing into place on the “J” clamps.

h
Step 8
Install the Level 1® H-31, Version B, Air

Detector/Clamp
d
Before installing the Air detector, determine if the
the Fluid Warmer was manufactured before 2004.
If it is, inspect the "F1" fuse to confirm that it is the
correct value and type. The year of manufacture
can be determined by the serial number label
which is located on the bottom right side of
the unit, or for older units on the inside.
If the first four characters of the serial number
are numbers, then the numbers represent
the year of manufacture (e.g. 20040100 would be
manufactured in 2004). If the first character of the
serial number is the letter "J", then the year of
manufacture is prior to 2004 (the letter “S”
indicates the year 2007 or later). For units
manufactured prior to 2004, perform the following.
1 Disconnect the power.

F1 2 Remove the 18 screws from the rear of the Fluid
Warmer and remove the back panel.
F1
3 Locate the “F1” fuse on the electronic assembly.
Two Fuse Configuration Four Fuse Configuration See figures to locate the “F1” fuse for either a two
fuse configuration or a four fuse configuration.
• For 100 - 120V Fluid Warmers,

Remove the fuse and verify that T6.3AL250V (time lag,
6.3 amp, 250V fuse), is printed on one of the silver end a
caps, if not replace the fuse with a new fuse marked d
T6.3AL250V.
• For 220 - 240V Fluid Warmers, a
Remove the fuse and verify that T3.15AL250V (time lag,
3.15 amp, 250V fuse), is printed on one of the silver end
caps, if not replace the fuse with a new fuse marked a
T3.15AL250V.
4 Replace the back panel and insert all but 6 of the screws (a) e
as indicated in Step 1 below. Then proceed to install the a
Air Detector/Clamp.
e
To install the Air Detector/Clamp,
a
1 Remove 6 screws (a) from the rear of the Fluid Warmer,
lower left side, from locations shown in figure.
e
a
2 Plug in the power cord (b) of the Level 1® H-31, Version B,
Air Detector/Clamp into the auxiliary MAINS outlet located
on the bottom of the Fluid Warmer.
Note: If you turn the Fluid Warmer off and the Air
Detector/Clamp does not turn off, contact Smiths Medical b
or your local Smiths Medical distributor.
3 Loosen the three screws holding the mounting bracket to the

rear of the Air Detector/Clamp (do not remove).
4 Align the slot on the Air Detector/Clamp with #3 Block on

the Fluid Warmer (c). Fit in place over the block.
Note: Do not bend the mounting bracket while holding the

Air Detector/Clamp against the fluid Warmer.
5 Carefully align the mounting bracket on the rear of the Air c

Detector/Clamp with three screw holes, shown (d). Ensure
that the gasket seal on the Air Detector/Clamp is flush with
the Fluid Warmer. Insert three flat-head screws and tighten,
securing the Air Detector/Clamp to the Fluid Warmer.
Tighten the three screws on the mounting bracket on the
Air Detector/Clamp.
6 Locate three power cord clips (e) included with the Air
Detector/Clamp and snap onto power cord. Align clips with
the three screw holes as shown, insert screws, and tighten.
7 Install and prime a Level 1® Fast Flow I.V. Disposable

Administration Set, and test the audible and visual alarms
and Air Detection/Clamp as described in Section 9
Operating Instructions.
Step 9
Perform Electrical Safety Tests
Perform all applicable electrical safety tests as required per

institutional procedure. These include but are not limited to:
• Leakage current • Hypot • Ground bond test
WARNING!
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 resulting in death or serious
injury to the patient or user.
The Electrical Safety Check must be performed by competent personnel

authorized by the institution to perform such testing. The Safety Check
must be performed and documented at least once per year, or according
to institutional policy.
SECTIO N 6 • Princ iple of Opera t io n
H-1200
S EC T I O N 6 • Princip le o f O p e ra t i o n
SE CTION 6
Principle of Operation
The schematic illustration on the facing page depicts the Level 1® H-1200 Fast
Flow Fluid Warmer’s (Fluid Warmer) operations. The primary operations are
described below.
Fluid Warming
The Fluid Warmer utilizes a solution reservoir housed in a controller

unit. Recirculating solution is warmed and pumped through a heat
exchanger (a part of the Disposable Set). The solution is returned to
the reservoir for continuous recirculation and remains isolated from the
patient and from the I.V. fluid path. The on-board recirculating solution
is heated to a pre-set manufacturer’s temperature set-point. The system
continuously monitors and controls the recirculating solution
temperature. The Fluid Warmer is designed to shut down and provide
audible and visual alarms in the event of an over-temperature condition.
Pressurized Fluid Delivery
The Fluid Warmer provides pressurized fluid delivery through the use of
an on-board compressor and two Pressure Chambers. The Pressure
Chambers pressurize the fluid bags for fast fluid delivery.
Air Detection/Clamping
The Air Detector/Clamp detects the presence of air in the Gas

Vent/Filter Assembly—a part of the Level 1® D/DI series Disposable
Administration Sets (Disposable Sets)—and clamps the patient line. An
ultrasonic signal continually passes through the fluid-filled Gas
Vent/Filter Assembly. As a bolus of air displaces the fluid in the Gas
Vent/Filter Assembly, the ultrasonic signal is broken and the clamp
closes, stopping the air before it enters the patient line. Audible and
visual alarms are activated, notifying the user that air has been detected
and fluid flow has been clamped off. Clearing the bolus of air and
restoring the fluid flow are quickly accomplished without disconnecting
from the patient.
SECTIO N X • Title
F-50 Gas Vent/Filter Assembly
The D/DI-65HL, D/DI-75, D/DI-150, and D/DI-350 Disposable

Administration Sets contain the F-50 Gas Vent/Filter Assembly.
The F-50 GasVent/Filter Assembly utilizes a float assembly contained in
a fluid chamber to prevent air from entering the patient line. As the
Disposable Set primes, fluid fills the fluid chamber raising the float
assembly to allow fluid to flow to the patient. Any air in the line during
priming is vented through a hydrophobic filter membrane. During
normal operation, fluid passes through a particle filter, into the fluid
chamber and to the patient line. When air enters the F-50 Gas
Vent/Filter Assembly, the volume of fluid in the fluid chamber decreases
causing the float assembly to drop down and close the fluid path, which
stops flow to the patient. Air in the fluid chamber is vented through the
hydrophobic membrane (gas vent) located under the vent cap. After air
has vented out and fluid re-enters the fluid chamber, the float assembly
rises to open the fluid path and resume flow to the patient.
F-50
Gas Vent/Filter Assembly
SE CTION 7
Controls and Displays

Five locations on the Level 1® H-1200 Fast Flow Fluid Warmer (Fluid
Warmer) govern how the device is controlled and where function
indicators are displayed. They are called-out in the figure and are
defined in the list below.
1 Fluid Warmer Display Panel
2 Power and Alarm Test Panel
3 Reservoir Level Display
4 Air Detector/Clamp Control Panel
5 Pressure Chamber Control Panel
The Fluid Warmer has five Interlocks, which detect for correct
installation of a Disposable Set, that are also defined this section.
SECTIO N 7 • Controls and Disp la y s
Fluid Warmer Power and Alarm Test Panel
The Power and Alarm Test Panel is located on the front of the Fluid
Warmer directly above the reservoir fill-cap. This panel contains four
pressure-sensitive buttons that are activated when pressed. Refer to the
Power Alarm Test Panel (figure on right) whose numbered call outs
correspond to a description of the button and the function it performs.
Button/Function
1 Power ON Button
The green button on the top-left of the Power and Alarm Test
Panel powers on the device. Power is applied to the on-board
compressor for the pressure chambers and the Air
Detector/Clamp. The green Automatic Operation LED on the
Fluid Warmer Display Panel illuminates when the Power ON
button is activated, with a Disposable Set in place.
2 Power OFF Button

The Power OFF is the orange button to the right of the Power
ON button on the Power and Alarm Test Panel. This button
turns power off to the unit. The green Automatic Operation
LED on the Display Panel will turn off when this button is
pressed.
3 Over Temperature Test Button

The Over Temperature Test is used to confirm the proper
operation of the Over Temperature circuitry. Testing the circuitry
requires that the Fluid Warmer is at operating temperature
(41°C). Once this is established, press and hold the button.
Then, release the button. The Over Temperature alarm
continues to function. Clear the alarm mode by turning the
device off, then back on. See Section 11, Testing, for instruction
on performing an Over Temperature Test.
4 Fluid Warmer Alarm Signal Test Button

The Fluid Warmer Alarm Signal Test is used to confirm proper
operation of the visual and audible alarm indicators. Press and
hold this button to test circuitry. Then, release the button. The
Over Temperature alarm continues to function. Clear the alarm
mode by turning the device off, then back on.
5 Reservoir Capacity
Capacity for recirculating solution reservoir is 1.4 liters. Use
recirculating solution. Do not exceed maximum capacity.
S EC T I O N 7 • C o nt ro ls a nd D is p l a y s
Fluid Warmer Display Panel

The Fluid Warmer Display Panel provides continuous information
about the operation of the Fluid Warmer. A liquid crystal display (LCD)
indicates recirculating solution temperature. Just below the LCD, four
light-emitting diodes (LEDs) indicate operation modes for the device.
For identification purposes, the diodes are shown illuminated.
1 Recirculating Solution Temperature
The temperature of the recirculating solution is displayed in the
LCD panel. The temperature is displayed in degrees celsius.
Note: This is NOT the temperature of fluid delivered to the

patient—the display reflects the temperature of the recirculating
solution.
2 Automatic Operation LED

The green LED indicator illuminates when the power is ON and
the Disposable Set has been properly installed. When lit, this
indicates the Fluid Warmer is operating.
3 Check Disposables LED

The yellow LED indicator illuminates and an audible attention
signal beeps when the Disposable Set is not properly installed.
See the Interlocks description in this section for directions on
clearing the Check Disposables alarm.
4 Add Recirculating Solution LED

The yellow LED indicator illuminates and an audible attention
signal beeps when reservoir is low. Additional recirculating
solution must be added to the reservoir. Maximum capacity for
the reservoir is 1.4 liters of recirculating solution.
5 Over Temperature LED

The red LED indicator illuminates and an audible warning signal
beeps when the recirculating solution is over the acceptable
temperature for safe use.
a
Reservoir Level Display
The Reservoir Level Display has a clear window for viewing the amount
of recirculating solution present in the reservoir. Check the reservoir to
ensure the solution level is near the maximum level indicator (a). If the
recirculating solution level is too low, the Add Recirculating Solution
LED on the Display Panel illuminates and an audible attention signal
beeps.
Air Detector/Clamp Control Panel and Alarms

The Air Detector/Clamp Control Panel has three LED indicators that
display the operational state of the Air Detector/Clamp. Refer to figure
on right.
1 Automatic Operation LED

The green Automatic Operation LED illuminates when the
following conditions are present: The Fluid Warmer power is
ON, a Disposable Set is properly installed in the Fluid Warmer
and primed, the patient line from the Gas Vent/Filter Assembly
is correctly placed in the #3 Clamp Slot, and the Clamp Slot
door is closed.
2 Check Tubing LED

The yellow Check Tubing LED illuminates and an audible
attention signal beeps when the patient line tubing from the Gas
Vent/Filter Assembly is not correctly placed in the #3 Clamp
slot, and when the Clamp Slot door is not closed correctly.
3 Clamped LED
The red Clamped LED illuminates and an audible warning signal
beeps when air is detected in the Gas Vent/Filter Assembly. The
patient line is automatically clamped.
Pressure Chamber Control Panel

The Pressure Chamber Control Panel uses a control lever to switch
from pressurized to unpressurized mode. A gauge displays pressure
levels in the Pressure Chamber.
1 Pressurize / Unpressurize Lever

This lever is used to control the pressure mode in the
Pressure Chamber.
a To Pressurize the Pressure Chamber

With Pressure Chamber door closed and latched, slide lever
to the left, all the way to the plus (+) pressurized position.
a This applies 300 mmHg pressure in the Pressure
Chamber when the Fluid Warmer is turned ON.
b To Unpressurize the Pressure Chamber

To remove pressure from the Pressure Chamber, slide the
lever to the right, all the way over to the minus (–)
b
unpressurized position. Pressure is released on the fluid bag
in the Pressure Chamber.
2 Pressure Gauge
This gauge indicates the pressure present in the Pressure
Chamber. When the Pressurize lever is in the plus (+)
pressurized position and the Fluid Warmer is ON, this gauge
displays the operating pressure in the Pressure Chamber. The
operating pressure should be 300 mmHg.
Interlocks
The Fluid Warmer has five Interlocks that detect for proper installation
of a Disposable Set’s components. Refer to the figure on the facing page
to identify the positions of interlocks.
Note: Block 1 is not an Interlock. It cannot detect if a Disposable Set

is not correctly installed. It is identified here because it is an essential
step for proper installation of the Disposable Set components.
Three Interlocks are located on the Fluid Warmer and check for proper
installation of:
2 Heat Exchanger, top end
4 Gas Vent/Filter Assembly
5 Heat Exchanger (guide)
Two Interlocks are located in the Air Detector/Clamp 3 and check for
the proper installation of:
Patient I.V. Line in the Clamp Slot
Door for the Clamp Slot
Interlocks 2, 4, and 5 prevent the Fluid Warmer’s pump from

circulating reservoir solution if the Disposable Set’s Heat Exchanger and
Gas Vent/Filter Assembly are not installed properly.
If Check Disposable Alarm is Activated on the Fluid Warmer
a Check Heat Exchanger for proper installation in Block 1, and

Interlocks 2 and 5.
b Press Heat Exchanger down firmly in Block 1 to secure in O-Ring.
c Press Interlock 2 tab down firmly to engage the Interlock switch.
d Press Heat Exchanger firmly into Interlock 5.
e Check Gas Vent/Filter Assembly installation in Interlock 4.
If Check Tubing Alarm is Activated on the Air Detector/Clamp
a Open the door and check the Patient Line for proper installation in
the Clamp Slot at interlock 3.
b Close the door and check that the tab on the top edge of the door is
fully inserted into the Air Detector/Clamp at interlock 3 before
pushing the door down to close it.
SECTIO N 8 • Operation
S EC T I O N 8 • O p e ra t i o n
SE CTION 8
Operation
The Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) performs three
primary functions; Fluid Warming, Air Detection/Clamping, and Pressurized
Fluid Delivery. Functions are monitored and controlled by four
interfaces/control panels located on the Fluid Warmer.
The four interfaces are:
• Fluid Warmer Power and Alarm Test Panel

• Fluid Warmer Display Panel
• Air Detector/Clamp Alarm and Control Panel
• Pressure Chamber Control Panel
In the table on the facing page, operation of the device is represented in terms
of the four interfaces that control specific device functions. The numbers call-
out individual Modes of Operation activated or indicated on the interface.
Functions
• Fluid Warming
• Air Detection/Clamping
• Pressurized Fluid Delivery
Operational modes
• OFF Mode
• ON/Automatic Operation for Fluid Warmer
• Alarm Test Mode
• Over Temperature Test Mode
• Check Disposables Mode
• Add Recirculating Solution Mode
• Over Temperature Alarm Mode
• Power ON Test for Air Detector/Clamp
• Automatic Operation Air Detector/Clamp
• Check Tubing Mode
• Air Detected/Clamped Mode
• Pressurized Mode
• Unpressurized Mode
The modes of operation are individually defined in the following section. This
includes a description of each mode, activation and/or monitoring of the
mode, mode characteristics, and clearing of the mode state.
Modes of Operation
WARNING!
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.
OFF Mode
Power is off only for a part of the equipment. The MAINS are still a
connected. Press the OFF button (a) on the Power and Control Panel to
turn the device off.
ON/Automatic Operation Mode for Fluid Warmer
The Fluid Warmer enters Automatic Operating mode when a

Disposable Set is properly installed and the device is turned ON. This is b
done by pressing the ON button (b).
Mode characteristics
• The green Automatic Operating LED on the Display Panel
c
illuminates (c).
• Fluid warming begins.
• Pressure infusion is provided by activating the Pressure Chambers.
• Air Detector/Clamp enters the Power ON Test, then enters default
Automatic Operation mode.
Alarm Test Mode

The Alarm Test mode is used to test the visual and audible indicators of
the Level 1® H-1200 Fast Flow Fluid Warmer. This mode is entered by
d
pressing and holding the Alarm Test button (d) on the Fluid Warmer’s
Control Panel.
• All visual indicators on the Fluid Warmer’s Display Panel (e)
illuminate.
• The Fluid Warmer’s audible alarm beeps.
• When the Alarm Test button is released, the Over Temperature
e
LED and an audible alarm remains active.
• To clear the Over Temperature alarm, turn the Fluid Warmer OFF
and then back ON.
Over Temperature Test Mode
The Over Temperature Test mode is used to test the operation of the
Fluid Warmer’s Over Temperature Circuitry. This mode is entered by
pressing and holding the Over Temperature Test button (f) on the Fluid
f
Warmer Control Panel with the Fluid Warmer at operating temperature
(41°C).
g • The red Over Temperature LED (g) on the Display Panel
illuminates.
• An audible warning signal beeps.
To Clear this mode

• Turn Fluid Warmer OFF.
• Turn Fluid Warmer back ON.
Temperature Display
The Temperature Display functions when the Fluid Warmer is powered

ON. Temperature is displayed in degrees Celsius.
Check Disposables Mode

The Check Disposables mode of the Fluid Warmer indicates a missing
or improperly installed Disposable Set.
• The Check Disposables yellow LED (a) on the Fluid Warmer’s a
Display Panel is illuminated.
• An audible attention signal beeps.
• Reservoir solution circulation is stopped; fluid warming stops.
• Pressure Chambers continue to operate.
To Clear this mode

Install a disposable or check the disposable installation as follows:
• Check the position of the disposable in the #1 Block.
• Make sure the heat exchanger is seated in the heat exchanger guide.
• Press down firmly on the #2 Block.
• Check the position of the Gas Vent/Filter Assembly in the #4
Interlock.
Add Recirculating Solution Mode
The Add Recirculating Solution mode of the Fluid Warmer indicates

that the solution level in the recirculating solution reservoir is below its
minimum level.
Mode characteristics b
• The yellow Add Recirculating Solution LED (b), on the Fluid
Warmer’s Display Panel, is illuminated
• Solution circulation stops, fluid warming stops.
• Fluid flow to the patient continues.
To Clear this mode

Add recirculating solution to the Fluid Warmer’s reservoir.
Over Temperature Alarm Mode

The Over Temperature Alarm mode is entered when the temperature of
the recirculating solution reservoir is at or above 43.9°C
WARNING!
Activation of the Over Temperature warning signal indicates that

warming has stopped and immediate operator intervention is
required. Failure to clear the over temperature condition or to
take the device out of service may result in patient death or
serious injury.
• The Over-Temperature LED warning light illuminates (c).
c • Solution circulation is stopped; fluid warming stops.
• Fluid flow to the patient continues.
To Clear Over Temperature Alarm mode

Do the following:
• If connected to a patient, close all clamps.
• Turn OFF the Fluid Warmer to clear the alarm.
• Turn the power back ON.
Power ON Test for Air Detector/Clamp
The Power ON Test for the Air Detector/Clamp is activated when the
the Fluid Warmer is turned ON. This test activates the Air
Detector/Clamp’s visual and audible indicators.
• Audible alarm indicator beeps.
• All LED indicators on the Air Detector/ Clamp Control Panel
illuminate:
1 Automatic Operation LED indicator - Green
2 Check Tubing LED indicator - Yellow
3 Clamped LED indicator - Red
At the end of the Power ON Test the Air Detector/Clamp enters

Automatic Operation mode. This is the default mode for the Air
Detector/Clamp.
Automatic Operation Air Detector/Clamp

In Automatic Operating mode, the Air Detector/Clamp monitors for
the presence of air in the Disposable Set’s Gas Vent/Filter Assembly. If
air is detected the patient line is clamped off and an audible alarm
beeps. The Air Detector/Clamp goes into Automatic Operation mode
when the Fluid Warmer is turned ON and Disposable Set is properly
installed and primed—no air is present in the Gas Vent/Filter Assembly.
• The green Automatic Operation LED (1) is illuminated.
• Monitoring for air in the Gas Vent/Filter Assembly is active.
• Fluid is ready to be delivered to the patient when in Automatic
Operating mode.
Check Tubing Mode
The Air Detector/Clamp’s Check Tubing mode is entered when the

patient line from the the Gas Vent/Filter Assembly is not properly
installed in the Air Detector/Clamp Slot and when the Clamp Slot door
is not closed correctly.
• The yellow Check Tubing LED (b) on the Air Detector/Clamp
Control Panel is illuminated.
• An audible low-priority warning signal beeps. b
To Clear this mode
• Place the patient line from the Gas Vent/Filter Assembly in the
#3 Clamp Slot of the Air Detector/Clamp and close the Clamp Slot
door.
Air Detected/Clamped Mode

In this mode the Air Detector/Clamp is activated when the ultrasonic
sensor detects the presence of air in the Gas Vent/Filter Assembly.
Auditory and visual warnings are activated and the clamp is closed,
preventing passage of fluid through the patient line.
• The patient line is clamped until alarm condition is removed.
• The red Clamped warning indicator LED (c) illuminates.
• The Air Detector/Clamp warning signal beeps.
c To Clear this mode

Perform the steps in Section 9, Operating Instructions, under the
heading: Clear the “Air Detected” Alarm mode.
Pressure Display
The Pressure Display gauge (a) functions when the device is ON. The
graduated indicator represents the level of pressure applied to the fluid
a bags. Pressure should be in the range of 280-300 mmHg pressure.
Pressurized Mode
The H-2 Pressure Chambers deliver fluids at an increased flow rate

with the application of 300 mmHg pressure upon the fluid bags. Flow
rate varies according to fluid type and viscosity, temperature, Disposable
Set used, and the amount of clamping applied to the roller clamps.
Pressurized infusion is enabled when:

• A fluid bag is installed in the Pressure Chamber.
• The Fluid Warmer is turned ON.
• The Pressure Chamber lever is placed in the plus (+)
b
pressurized position (b).
• The Fluid Warmer must be ON for the Pressure Chamber to work.
• Operating pressure should be between 280-300 mmHg.
• Pressure is not adjustable on the Pressure Chamber.
• Pressure is applied to the fluid bag in the Pressure Chamber.
• Pressure is indicated on the pressure gauge.
To Exit this mode

• Place the Pressure Chamber lever in the minus (–) unpressurized
position (c).
Unpressurized Mode
Disable pressurization by moving the lever on the Pressure Chamber to

the minus (–) unpressurized position (c).
Mode characteristics c
• Pressure is released from the Pressure Chamber.
• A fluid bag can be removed or loaded into the Pressure Chamber.
S EC T I O N 9 • O p e ra t ing I ns t ruct i o n s
SE CTION 9
Operating Instructions
The Operating Instructions are grouped into five segments. Read through
each section BEFORE performing a procedure.
WARNINGS
• The Fluid Warmer is for use only with Smiths Medical

supplied or approved parts, accessories, and D or DI series
Disposable Sets. The device may not function as intended with
the use of unapproved parts, accessories, or Disposable Sets
resulting in death or serious injury to the patient or user.
• When injecting medications into the fluid path, do not inject
through the triple-lumen tubing of the Level 1® D/DI-60HL and
D/DI-65HL Disposable Set. This may allow communication
between the recirculating solution path and I.V. fluid path, which
could result in death or serious injury to the patient.
• Replace Gas Vent/Filter Assembly every three hours,
or when the filter becomes clogged, or when air is slowly vented.
Failure to do so will result in a reduction of flow rate. This may result
in inadequate patient treatment resulting in death or serious
injury to the patient.
• The replacement Gas Vent/Filter Assembly must be fully primed
before continuing infusion. Failure to do so may allow air to be
infused into the patient resulting in death or serious injury
to the patient.
• 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 resulting in death or serious injury to the patient or
user.
• Do not bend the heat exchanger. Bending may damage the heat
exchanger allowing communication between the recirculating
solution path and I.V. fluid path, resulting in the I.V. delivery of
inappropriate fluids which could result in death or serious injury to
the patient.
• The tubing must be properly placed in the Clamp Slot of the Air
Detector/Clamp. Failure to ensure that the tubing is correctly
positioned in the Clamp Slot may result in failure to stop air
infusion which may result in patient death or serious injury.
SECTIO N 9 • Operating Instruct io ns
9.1 Set Up for Use
WARNINGS
• Read and follow all instructions, labeling, and accompanying documents

supplied with this medical device. Failure to follow instructions, including all
warnings and cautions, could result in death or serious injury to the patient
or user.
• Disposable Sets are supplied with a sterile fluid path which may be
compromised if the caps are not in place. Do not use Disposable Set if Luer
and spike caps are not securely in place, or if Luer connections are not secure
as the fluid path may not be sterile and may cause death or serious injury to
the patient.
• Disposable Sets are for single use only. To reduce the risk of cross contamination,
do not reuse Disposable Sets, which could result in death or serious injury to
the patient.
A—Install the Disposable Administration Set
The installation sequence for the Disposable Administration Set corresponds to the
numbered Blocks marked 1-2-3-4 on the H-1200 Fast Flow Fluid Warmer (Fluid
Warmer) and 1-2-3 on the H-1000 Fluid Warmer.
Remove the Disposable Set from its packaging and review the Instructions for Use
provided. Do not remove spike caps or Luer caps at this time.
Note: Inspect the Disposable Set prior to use and confirm Luer connections are secure.
1 Push the bottom end of the Heat Exchanger (a) [the end near the Gas Vent/Filter
Assembly] into #1 Block (b). Press the Heat Exchanger down firmly to properly seat
in the block.
Note: D/DI-60HL and D/DI-65HL Disposable Sets require the Heat Exchanger to be
placed with the Patient Line extending to the left.
2 Slide #2 Block up (c). Snap Heat Exchanger into guide (d). Press firmly into place to
ensure it is properly seated. Slide #2 Block down (e), push down firmly to secure.
a e
c
a
d
b
3 Move the pinch clamp on the Patient Line of the Gas Vent/Filter
Assembly next to the Luer connector. Close the pinch clamp.
Note: Disposable Sets use two types of Gas Vent/Filter Assemblies as
shown in the following table. Step 4, which describes how to install the
Gas Vent/Filter Assembly, is different for each type of Disposable Set
and for the H-1200 and H-1000 Fluid Warmers. Continue with the
appropriate step 4 that applies for your specific Disposable Set and
Fluid Warmer.
Types of Gas Vent/Filter Assemblies
Disposable Set Gas Vent/Filter Assembly Type
D/DI 65HL, D/DI 75, F 50
D/DI 150, and D/DI 350
DI 50, D/DI 60 HL, D/DI 70, F 10/F 30

D/DI 100, and D/DI 300
Step 4 — H-1200 Fluid Warmer with D/DI-65HL, D/DI-75,

D/DI-150, and D/DI-350.
4 Install the Gas Vent/Filter Assembly. Refer to the series of figures
on the left.
F-50 a Open the #3 Clamp Slot door—push down on the
tab (a).
b Lift up the front of the door (b).
b
c Pull the door down (c) and away from the Clamp Slot.
a d Align the Gas Vent/Filter Assembly to the #4 Block, (d)
and press it into place.
e Press the clip at the top of the Gas Vent Vent/Filter
Assembly (e) to the bottom of the Heat Exchanger.
f Insert the Patient Line in the Clamp Slot (f) and push it
back into the slot.
c
g Hold the Patient Line in the Clamp Slot and push the
door up (g) to engage the top hinge.
h Push the front of the door down (h) to close it.
e
d
h
g
f
Step 4 — H-1200 Fluid Warmer with DI-50, D/DI-60HL, D/DI-70,

D/DI-100, and D/DI-300.
4 Install the Gas Vent/Filter Assembly. Refer to the series of figures
on the left.
a Open the #3 Clamp Slot door—push down on the tab (a).
b Lift up the front of the door (b).
c Pull the door down (c) and away from the Clamp Slot. F-10/30
b d Insert the Patient Line in the Clamp Slot (d) and push it
back into the slot.
a
e Hold the Patient Line in the Clamp Slot and push the
door up (e) to engage the top hinge. Then push the front
of the door down to close it.
f Pull the Patient Line to the right (f) to align it in the
Clamp Slot without kinking.
g Align the Gas Vent/Filter Assembly to the #4 Block, (g)
c
d f g
e
Step 4 — H-1000 Fluid Warmer with D/DI-65HL, D/DI-75,

D/DI-150, and D/DI-350.
4 Install the Gas Vent/Filter Assembly.
a Align the Gas Vent/Filter Assembly to the #3 Block,
b Press the clip at the top of the Gas Vent Vent/Filter
Assembly to the bottom of the Heat Exchanger. F-50
c Press the green Power ON button, located on the Power
and Alarm Test Panel, to turn ON the Fluid Warmer.
Step 4 — H-1000 Fluid Warmer with DI-50, D/DI-60HL, D/DI-70,

D/DI-100, and D/DI-300.
4 Install the Gas Vent/Filter Assembly.
a Align the Gas Vent/Filter Assembly to the #3 Block,
b Press the green Power ON button, located on the Power
and Alarm Test Panel, to turn ON the Fluid Warmer.
F-10/30
B—Prime the Disposable Administration Set

1 Close the Disposable Set clamps above the Heat Exchanger.
• For DI-50, D/DI-60HL, D/DI-65HL, D/DI-70, and
D/DI-75 Disposable Sets,
– close pinch clamps below the bag spikes, and
– close roller clamp below the drip chamber (a).
• For D/DI-100, D/DI-150, D/DI-300, and D/DI-350
Disposable Sets
– close pinch clamps below the drip chambers.
a
2 Remove all air from the fluid bag:
a Invert solution bag.
b Use aseptic technique. Pierce membrane of bag port
with spike of Disposable Set. Then withdraw spike.
c Squeeze bag to exhaust ALL air.
d Place spike in bag port. Do not allow air to re-enter bag.
e Repeat this step for each fluid line to be used.
3 Slide lever on H-2 Pressure Chamber to the minus (–)
unpressurized position.
4 Hang spiked fluid bag/s in Pressure Chamber:
a Release hinged latch, open door and hang fluid bag inside
on tab appropriate for bag size.
b Close the door and secure latch.
c Injection and Spike ports on the fluid bag should extend
from opening at the bottom of the Pressure Chambers
without being obstructed.
Note: When installing Level 1® D/DI-300 and D/DI-350 series
Disposable Sets, hang the third fluid bag from the I.V. pole.
CAUTION
• When loading fluid bags into H-2 Pressure Chambers,

choose a hanging hook that allows the bag port to hang
freely in the indented slot at the bottom of the chamber
door. If bag ports are positioned above this slot, diminished
flow could occur resulting in physical injury to the patient, user,
and/or an adverse effect on the device or its performance.
5 Open clamp above Drip Chamber on Level 1® DI-50,

D/DI-60HL, D/DI-65HL, D/DI-70, and D/DI-75 Disposable
Administration Sets for each I.V. fluid bag being used to prime
the drip chamber.
6 Prime Drip Chamber by squeezing drip chamber until one-half

to three-quarters full of fluid.
Note: • DI-50, D/DI-60HL, D/DI-65HL, D/DI-70, and

D/DI-75 series use a single drip chamber.
• D/DI-100, D/DI-150, D/DI-300, and D/DI-350 series
use a separate drip chamber for each spiked bag.
The clamp is below the drip chamber.
7 Open remaining clamps above the Heat Exchanger. Fluid flows into
the Gas Vent/Filter Assembly.
8 For DI-50, D/DI 60HL, D/DI-70, D/DI 100, and D/DI 300
vigorously tap the Gas Vent/Filter Assembly to dislodge air bubbles
from filter screen.
9 Press the green Power ON button, located on the Power and Alarm
Test Panel, to turn ON the Fluid Warmer.
• The Air Detector/Clamp runs a Power ON Test.

• All Air Detector/Clamp indicator LEDs illuminate.
• The audible warning beeps.
– If the above does not occur, remove the device from service.
• Upon completion of the Power On Test the Air Detector/Clamp
enters Operation mode with the Automatic Operation LED
illuminated.
• If the Disposable Set is incorrectly installed, the Fluid Warmer’s
Check Disposables attention indicator illuminates and the
audible attention signal beeps. Check the installation of the
Disposable Set following the directions provided in Section 6
Controls and Displays, on Interlocks.
C—Prime the Patient Line
1 Remove the male Luer cap from the distal end of the Patient Line.
Note: On Level 1® D/DI-60HL and D/DI-65HL Disposable

Administration Sets verify that no recirculating solution
comes out of the distal end of the Patient Line.
WARNING!
If fluid exits in the Patient Line or the D/DI-60HL and D/DI-65HL

Disposable Set, replace the Disposable Set.
2 Open the pinch clamp below the Gas Vent/Filter Assembly.
3 Allow fluid to flow until no air is observed in the Patient Line and
the line is primed with fluid. Then, close the roller clamp on the
Patient Line.
Note: On D/DI-60HL and D/DI-65HL Disposable Sets close roller
clamp below Drip Chamber.
D—Test the Audible and Visual Alarms
Test the visual and audible alarm signals by performing the

following steps.
1 Press and hold the Alarm Test button on the Fluid Warmer’s
Power and Alarm Test Panel.
• All Fluid Warmer visual alarm LEDs illuminate
and the audible alarm signal beeps.
2 Release the Alarm Test button; the Over Temperature alarm
continues.
3 Clear the Over Temperature alarm condition.
• Turn the Fluid Warmer OFF, then ON.
• The Air Detector/Clamp runs a Power On Test.
• The Air Detector/Clamp goes into Automatic operation.
E—Test the Air Detector/Clamp
WARNING!
The functional test for the Air Detector/Clamp accessory must be

performed before each use. 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. Fully
functional visual and audible alarm systems are essential for the
safe use of the Air Detector/Clamp.
1 Slide the lever on the Pressure Chambers to the plus (+)

pressurized position to pressurize fluid delivery.
2 Move the Gas Vent/Filter Assembly away from the Air
Detector sensor as shown.
3 The following occurs:
• The Air Detector clamp closes.
• The red Clamped indicator LED illuminates.
• The audible warning signal beeps.
• Fluid Warmer disposable alarm activates.
If any of the above does not occur, remove the device from service.
4 Open roller clamp on the Patient Line to verify that fluid
does not flow.
After verifying that no fluid is flowing, close the roller clamp
completly. If fluid flow is observed, remove the device from service.
5 Return to normal operation by placing the Gas Vent/Filter Assembly
back into the #4 Block as shown.
6 The Air Detector/Clamp resumes Automatic Operation mode.
• The green Automatic Operation LED on the
Air Detector/Clamp Control Panel illuminates.
7 The Fluid Warmer is now ready for patient connection. Unclamp

Patient Line to begin infusion.
Note: On D/DI-60HL and D/DI-65HL Disposable Sets open roller
clamp below drip chamber.
Conclusion
This concludes Section 9.1, Set Up for Use. Operators can proceed to
the next Section 9.2, Use of the Fluid Warmer.
WARNINGS
• Remove all air from the fluid bags before spiking and the fluid
lines before connecting to the patient. Failure to do so can result
in infusion of air into the patient resulting in death or serious
injury to the patient.
• Do not reuse partially full fluid bags. Fluid bags that have
been partially drained, un-spiked, and then reinstalled may
contain air, which if used can result in infusion of air into the
patient resulting in death or serious injury to the patient. Use
only new fluid bags from which the air has been removed.
• Replace Gas Vent/Filter Assembly every three hours, or when

the filter becomes clogged, or when air is slowly vented.
Failure to do so will result in a reduction of flow rate. This
may result in inadequate patient treatment resulting in death
or serious injury to the patient.
• The Replacement Gas Vent/Filter Assembly must be fully

primed before continuing infusion. Failure to do so may
allow air to be infused into the patient which could result in
patient death or serious injury.
CAUTION
• When loading fluid bags into Pressure Chambers, choose a

hanging hook that allows the bag port to hang freely in the
indented slot at the bottom of the chamber door. If bag ports
are positioned above this slot, diminished flow could occur
resulting in physical injury to the patient, user, and/or an
adverse effect on the device or its performance.
9.2 Use of the Fluid Warmer

Use of the Fluid Warmer requires that the steps in Section 9.1, Set Up
for Use have been completed.
Overview
Use of the Fluid Warmer involves the following steps:
1—Load the Pressure Chambers
2—Pressurize the Pressure Chambers
3—Make patient connection, begin infusion
4—Replace Gas Vent/Filter Assembly
5—Change fluid bag
Step 1—Load the Pressure Chambers
a Turn the hinged latch on the right side of the Pressure Chamber
outward. Open the door.
b Hang a solution bag on the appropriate hanging hook inside the
door. The Pressure Chamber can hold bags of varying sizes.
• On the inside of the Pressure Chamber door are hooks for
bags smaller than 1000ml.
• On the top of the Pressure Chamber door are hooks
appropriate for 1000ml bags.
• Bags from different fluid manufacturers vary somewhat in
their dimensions.
• Choose a hanging hook that allows the bag drain port to
hang freely in the indented slot at the bottom of the
Pressure Chamber door.
c Close the door and secure side latch.
Step 2—Pressurize the Pressure Chambers
a Turn ON the Pressure Chamber by moving the lever

located at the top of the Pressure Chambers over to the plus (+)
pressurized position.
b Check gauge to ensure pressure of 280-300 mmHg is achieved.

• Pressure in the chambers is not adjustable.
Note: Power must be ON for the Pressure Chambers to operate.
WARNING!
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 which could result in user death or serious
injury.
Step 3—Make Patient Connection
Make patient connection and begin infusion.
Step 4—Replace the Gas Vent/Filter Assembly
Replace the Gas Vent /Filter Assembly every 3 hours, when the
filter becomes clogged, or if air is venting slowly. Refer to Section
9.3, Replace the Gas Vent/Filter Assembly.
Step 5—Change the Fluid Bag
a Move the lever on the Pressure Chamber over to the

minus (–) unpressurized position. This will release the pressure in
the Pressure Chamber and deflate the bladder.
Close pinch clamp under empty bag.
b Open door and remove the fluid bag from the Pressure Chamber.
c Remove the spike from the used fluid bag.
d Remove any air from the new fluid bag and spike the fluid bag.
e Hang the new fluid bag in the Pressure Chamber. Close and latch
the door.
f Move the lever on the Pressure Chamber over to the

plus (+) pressurized position to pressurize the chamber.
g Open pinch clamp.
9.3 Replace the Gas Vent/Filter Assembly

Use one of the following Gas Vent/Filters Assemblies:
• F-10 Gas Vent / Filter Assembly for DI-50, D/DI-60HL, D/DI-70,

and D/DI-100 Disposable Sets
• F-30 Gas Vent / Filter Assembly for D/DI-300 Disposable Sets
• F-50 Gas Vent / Filter Assembly for D/DI-65HL, D/DI-75,
D/DI-150, and D/DI-350 Disposable Sets
1 Close all clamps above and below the Gas Vent/Filter Assembly on
D/DI-series Disposable Set and on new Gas Vent/Filter Assembly.
Note: Steps 3 and 4 are different for the H-1200 and H-1000 Fluid
Warmers. Continue with the appropriate steps 3 and 4 that apply for
your specific Fluid Warmer.
3 Remove the used Gas Vent/Filter Assembly while still connected to
the Disposable Set:
a Remove the Gas Vent/Filter Assembly from the #4 Block.
For D/DI-65HL, D/DI-75, D/DI-150, and D/DI-350
disconnect the clip from the bottom of the Heat Exchanger.
b Open the #3 Clamp Slot door and remove the patient line from
the Clamp Slot.
4 Install the new Gas Vent/Filter Assembly:

Note: The steps to install the Gas Vent/Filter Assembly differ
depending on the Disposable Set. Continue with the appropriate
steps that apply for your Disposable Set.
Use the following steps for D/DI-65HL, D/DI-75,

D/DI-150, and D/DI-350.
a Press the new Gas Vent/Filter Assembly into the #4 Block and
press the clip to the bottom of the Heat Exchanger.
b Insert patient line in the Clamp Slot.
c Align the patient line in the Clamp Slot without kinking.
d Close the Clamp Slot door.
F-50
e Go to step 5 to continue.
Use the following steps for DI-50, D/DI-60HL, D/DI-70,

D/DI-100, and D/DI-300.
a Insert patient line in the Clamp Slot.
b Close the Clamp Slot door.
c Align the patient line in the Clamp Slot without kinking.
d Press the Gas Vent/Filter Assembly into the #4 Block.
e Go to step 5 to continue.
F-10/30
3 Remove the used Gas Vent/Filter Assembly from the #3 Block

while still connected to the Disposable Set.
disconnect the clip from the bottom of the Heat Exchanger.
4 Press the new Gas Vent/Filter Assembly into the #3 Block.

press the clip to the bottom of the Heat Exchanger.
F-50 F-10/30
5 Using aseptic technique:
a Disconnect the upper Luer fitting on the used Gas Vent/Filter
Assembly.
b Remove the upper Luer end cap on the new Gas Vent/Filter
Assembly.
c Connect the Disposable Set to the new Gas Vent/Filter Assembly
inlet.
6 With the lower clamp on the new Gas Vent/Filter Assembly closed,
open all clamps above Gas Vent/Filter Assembly.
The Gas Vent/Filter Assembly will self prime.
7 Turn the power ON.
8 Remove the end cap on the lower patient line of the new Gas
Vent/Filter Assembly. Slowly release the lower clamp and allow the
lower patient line to fill completely.
9 Close the clamp after the line is full.
10 Holding the used Gas Vent/Filter Assembly horizontally, disconnect

the Luer lock on the lower patient line. Connect the Luer-lock
fittings on the used Gas Vent/Filter Assembly together and discard.
11 Connect the Luer lock on the lower patient line of the Gas
Vent/Filter Assembly to the Patient Line.
12 Open clamps below the Gas Vent/Filter Assembly and resume

infusion.
9.4 Activated Alarms

Refer to Section 8, Operation for information on identifying Alarm states,
conditions that activate them, and methods for clearing Alarm states.
A. “Air Detected” Alarm mode
Detection of air in the Gas Vent/Filter Assembly results in the

following:
• The patient line is clamped off

• The red Clamped LED warning signal illuminates
• The audible warning signal beeps
WARNING!
• Activation of the Air Detector/Clamp Alarm during infusion

indicates that fluid flow has stopped and that immediate
operator intervention is required to restore fluid flow. Failure to
reinstate flow (after purging any air or foam) may result in
patient death or serious injury.
• Do not turn OFF the Fluid Warmer when the Air Detector alarm
is active. If the Fluid Warmer is powered OFF in an active alarm
state, the Air Detector/Clamp will open and the Air Detector
will become disabled. This could allow any air within the patient
line to be delivered to the patient resulting in serious injury or
death.
B. Clear the “Air Detected” Alarm mode:
1 Immediately close all clamps on the Disposable Set

2 Remove pressure from the Pressure Chambers by moving the
lever to the minus (–) unpressurized position.
3 Inspect the entire Disposable Set for the presence of air, locate the
source of the air, and remove it.
Note: Air or foam may have been vented through the Gas
Vent/Filter Assembly.
4 Remove any remaining air from the Disposable Set:

a Insert spike into an air-free bag/s of I.V. solution.
b Place the I.V. bag/s in the Pressure Chamber/s; close and secure
the door.
c Move the lever to the plus (+) pressurized position to
pressurize the Chamber/s.
d Prime the drip chamber/s and open the Disposable Set clamps
above the Gas Vent/Filter Assembly.
e Fluid flows freely through the tubing. Air in the I.V. line is
vented out through the Gas Vent/Filter Assembly. When air is
no longer present in the Gas Vent/Filter Assembly, the
Clamp opens and resumes automatic operation mode.
Note: If air is not freely vented, replace the Gas Vent/Filter

Assembly.
Refer to Section 9.3, Replace the Gas Vent/Filter Assembly.
5 If no warning signals are active, the Fluid Warmer with Air

Detection and Pressure Chambers is ready for use.
6 Open the remaining Disposable Set clamps, slowly open the

roller clamp, and reestablish fluid flow to the patient.
For more information on the following alarm conditions, refer to Section 8,

Operation:
• Over Temperature Alarm

• Check Disposables Alarm
• Check Tubing Alarm
• Add Recirculating Solution Alarm
9.5 After Use

1 Discontinue infusion.
3 Release chamber pressure before opening the Pressure Chamber

door:
a Move the lever to the minus (–) unpressurized position.
This will release the pressure in the chamber and
deflate the bladder.
b Open door and remove the fluid bag.
4 Remove the Disposable Set from the Fluid Warmer.
5 Dispose of the Disposable Set in a safe manner according to local

guidelines for disposal of contaminated medical waste.
6 Visually check the condition of the device. Remove from service

any unit that shows physical damage.
7 Clean the device with warm soapy water.
SECTIO N 10 • Troubleshooting
SECTIO N 10
Troubleshooting
Only competent personnel should perform any routine maintenance and
repairs to the Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer).
The following two tables feature general troubleshooting information along

with slow flow rate troubleshooting.
General Troubleshooting Guide
Problem Check the following:
No Power Check to see if unit is plugged in and power is turned ON.

Be sure the unit is plugged into a working MAINS receptacle.
Disposables Check to see that the Heat Exchanger and Gas Vent/Filter
Alarm beeps Assembly are properly installed.
Add Recirculating Fill reservoir to the maximum reservoir level with recirculating
Solution Alarm solution.
Over - If connected to a patient, close all clamps.

Temperature Press OFF button to clear alarm. Then, press ON button to
Alarm beeps power on. If the Fluid Warmer continues to alarm, discontinue
use of the medical device and remove from service. Contact
Smiths Medical or your local Smiths Medical distributor.
Hot Cabinet Check the air inlet on the bottom of the unit. Remove any
blockage or dust to insure adequate air flow.
Heat Exchanger Lubricate O-Rings in #1 and #2 block heat exchanger sockets

hard to install with silicone lubricant. Silicone lubricant part # 80-04-002.
Loud Compressor Verify pneumatic tubing is fully seated into fittings.
LED doesn’t 1. Verify unit is plugged into MAINS.

light up during 2. If still no LED illumination, discontinue use of the medical
set up (on Fluid device and remove from service.
Warmer or Air
Detector/Clamp)
Tubing doesn’t fit Verify tubing is Level 1® D/DI series tubing.

in Air Detector/
Clamp
S EC T I O N 1 0 • Tro ub le s ho o t i n g
Slow Flow Rate Troubleshooting Guide
Problem Check the following:
Pressure Chambers Verify the Fluid Warmer is ON.

not activated Verify the Pressure Chamber levers are fully in the plus (+),
pressurized position.
Verify pneumatic tubing is fully seated into fittings on the
Pressure Chambers and Fluid Warmer.
Blood develops Stored blood develops particulate. If blood is older

particulate than 5-7 days, consider using Level 1® PF-1 pre-filters.
Clogged filter Change Gas Vent/Filter Assembly if filter becomes

clogged.
Fluid bag not fully Make sure the membrane of the fluid bag port is fully
spiked or bag port pierced by the bag spike and that the neck of the bag port
twisted is not twisted.
Non-Level 1® bag 40 to 80 micron filters used between the bag port and
port filters the spikes of the Disposable Set may restrict flow. Consider
using Level 1® PF-1 pre-filters (340 micron).
Clamps partly Verify all clamps are fully open.

engaged
Clamps left in the Leaving clamps fully clamped for long periods will cause
clamped position the tubing to become deformed. Do not leave clamps
for long periods closed for extended periods of time.
Kinked tubing Verify that no tubing kinks are present.
Air trapped on filter Remove Gas Vent/Filter Assembly and tap against the
screen of Gas Vent/ cabinet of the Fluid Warmer to dislodge air bubbles,
Filter Assembly allowing them to vent. If this fails to correct problem, replace
with new Gas Vent/ Filter Assembly.
Non-high flow Use only extension lines with an inner diameter of

extension lines 0.13" (3.3mm) or larger, such as Level 1® X-36 or Y-30
extension sets.
Stopcock Use only Level 1® SC-3 (9 french inner diameter).
Small gauge needle Use large bore needles or catheters to maximize flow
or catheter rates.
SECTIO N 11 • Testing
SECTIO N 11
Testing
This unit 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.
If the Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) and installed
accessories do not pass the tests, discontinue use of the medical device and
remove from service. Contact Smiths Medical or your local Smiths Medical
distributor. Testing requires a Level 1® Disposable Administration Set
(Disposable Set) to be installed in the Fluid Warmer.
Add Recirculating Solution Alarm
The Fluid Warmer is equipped with a float switch that senses the level
of the recirculating solution in the reservoir. When the solution level is
too low, an LED on the Display Panel illuminates and an audible alarm
beeps. In the Add Recirculating Solution Alarm mode, the circulating
pump is not running. With a Disposable Set in place and the unit
turned on, test the Add Recirculating Solution Alarm by draining the
solution until the level has dropped below the minimum reservoir level.
The Add Recirculating Solution Alarm should activate. To drain
recirculating solution from the Fluid Warmer, turn the drain valve, on
the bottom of the unit 90 degrees clockwise and allow some of the
recirculating solution to drain into a container.
Check Disposables Alarm
Five Interlocks detect the proper installation of an Disposable Set in the

Fluid Warmer. If a Disposable Set is not properly installed and the
power is ON, an indicator will illuminate and an audible alarm beeps.
With the Fluid Warmer ON, the Interlocks should be tested one at a
time by performing the following steps.
1 Top Heat Exchanger Socket – Slide the #2 Block up slowly. The

Check Disposables indicator will illuminate and the audible alarm
beeps.
2 Heat Exchanger Interlock – Gently pull on the middle of the heat
exchanger. The Check Disposables indicator will illuminate and the
audible alarm beeps.
S EC T I O N 1 1 • Te s t i n g
3 Gas Vent/Filter Assembly Interlock – Pull the top of the Gas

Vent/Filter Assembly from the Block. The Check Disposables
indicator will illuminate and the audible alarm beeps.
4 #3 Check Tubing Interlock on the Air Detector/Clamp – Remove

the tubing from the Clamp Slot and close the door. The Check
Tubing alarm signal on the Air Detector/Clamp is activated and the
5 #3 Check Door Closed Interlock on the Air Detector/Clamp – With

tubing installed in the Clamp Slot, open the door. The Check
Tubing alarm signal on the Air Detector/Clamp is activated and the
a Over Temperature Test
Do the following
1 Insure that the Fluid Warmer is at operating temperature
(41°C).
2 Press and hold the Over Temperature Test button (a).
3 The Over Temperature LEDs illuminate, and an audible alarm
beeps.
4 Release the Over Temperature Test button.
5 Over Temperature LED and audible alarm signal remains active.
Clear the Alarm mode

2 Turn the Fluid Warmer back ON.
Fluid Warmer Alarm Signal Test

b
The Alarm Test button is used to confirm proper operation of the visual
and audible alarm indicators.
Do the following
1 Press and hold the Alarm Test button (b).
2 The LED illuminates, and an audible alarm beeps.
3 Release the Alarm Test button.
4 Over Temperature LED remains lit, and the audible alarm
continues to beep.
Clear the Alarm mode

2 Turn the Fluid Warmer back ON.
Performance Testing
Cold Start Test
Store the Fluid Warmer unit in a room where the room temperature is
approximately 21°C (70°F).
1 Put a Disposable Set in place.

2 Record the start time.
3 Turn the Power button ON.
• The green system operational indicator illuminates.
• The Air Detector/Clamp goes through the Power ON Test.
• Rapidly rising numbers will appear on the recirculating solution
temperature display.
• Within 60 seconds (±) the display should read at least 30°C.
• In 3 to 10 minutes the display should read 41°C.
The Temperature Set Point is 41.7°C (+/– 0.3°C).
Note: If the Fluid Warmer does not pass the Cold Start Test, it should
be removed from use and returned to Smiths Medical or your local
Smiths Medical distributor.
Calibration Test
One approved way to confirm proper calibration of the recirculating
solution temperature is to use the Level 1® Thermal Calibration Well
(TCW) (Part Number 80-03-002). A replacement filter (F-10/30 or
F-50) must be in place to utilize the TCW.
Note: Use of the TCW requires a digital thermometer NIST traceable
and accurate within 0.1°C. Required probe size: 0.099" OD (Outside
Diameter) maximum (0.25 cm) 0.50" — 1.50" long (1.27—3.81cm).
Alternative Calibration Test

Another approved way to confirm proper calibration of the recirculating
solution temperature is to use the Level 1® DSTA-40 TEMPCHECK
(Part Number 80-01-040).
Calibration Test with DSTA-40

The DSTA-40 TEMPCHECK (DSTA-40) is an electronic thermometer
used to verify the recirculating solution operating temperature of the
Fluid Warmer. The DSTA-40 uses thermistor technology to sense the
temperature of the recirculating solution temperature for the Fluid
Warmer. The recirculating solution temperature is displayed by a liquid
crystal display (LCD). The DSTA-40 is powered from the auxiliary
outlet of the Fluid Warmer. No batteries are required.
Note: The Level 1 ® DSTA-40 TEMPCHECK is available for purchase
from Smiths Medical.
S EC T I O N 1 1 • Te s t i n g
Proper Calibration of Recirculating Solution Temperature

Confirm proper calibration of recirculating solution temperature by
performing the following steps:
1 Plug the DSTA-40 into the auxiliary outlet located on the

bottom of the Fluid Warmer.
2 Install the DSTA-40 in the heat exchanger position (#1 Block

and #2 Block).
3 Install a test filter in the #4 Block.
4 Turn the Fluid Warmer ON. Allow to warm up until the

DSTA-40 temperature display stabilizes.
5 Compare the DSTA-40 temperature display with the

temperature display on the Fluid Warmer’s Display Panel.
Note: The Fluid Warmer’s temperature display must read within

0.3°C of the Level 1 ® DSTA-40 TEMPCHECK display on a properly
calibrated unit.
If the DSTA-40 reads 41.7°C and the Fluid Warmer’s

temperature display is within the range of 41.4°C-42.0°C, the
calibration is OK.
Periodic Electrical Testing

Earth Leakage
The Fluid Warmer must be tested in accordance with EN 60601-1.

The earth leakage current test should be performed with the immersion
heater circuit in the full ON condition; for this reason the leakage
current test should be performed on units which have room
temperature recirculating solution in the reservoir. Units not meeting
this standard should be returned to Smiths Medical or your local Smiths
Medical distributor.
Ground Continuity
The Fluid Warmer must be tested in accordance with EN 60601-1.
WARNING!
Grounding reliability can be achieved only 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 resulting in death or serious
injury to the patient or user.
S EC T I O N 1 2 • Ma int e n a n c e
SE CTION 1 2
Maintenance
Only competent personnel should perform any routine maintenance and
repairs to the Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer).
Maintenance is scheduled prior to each use, every 30 days, and annually. The
tasks are detailed below.
Note: If distilled water is used as the recirculating solution, change the

solution every 30 days. If a 0.3% hydrogen peroxide/distilled water
solution is used as the recirculating solution, change the solution
every 12 months, and during the 12 month period, always refill the
reservoir with a 0.3% hydrogen peroxide/distilled water solution.
Maintenance Performed Prior to Every Use

Clean and inspect the Fluid Warmer with Air Detector/Clamp and
Pressure Chambers after each use.
Clean the Exterior

Clean the entire Fluid Warmer after every use.
CAUTIONS
• Never use organic solvents (e.g., acetone), strong acids, or bases

to clean any portion of the Fluid Warmer.
• Do not place the Fluid Warmer directly under a faucet or use a
faucet sprayer to rinse. Never spray cleaning or other fluids into
openings on the Fluid Warmer or into the external connectors.
1 Unplug the Fluid Warmer before servicing.

2 Visually inspect the Fluid 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 control panels. Use a soft brush to clean the
power cord if necessary.
SECTIO N 12 • Maintenanc e
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 Fluid Warmer and its components to insure
that they have been thoroughly cleaned. Repeat cleaning
procedure if necessary.
7 After thoroughly cleaning the Fluid 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:
• 1.59% Phenol (e.g., Sporicidin®)
• 3.4% Glutaraldehyde (e.g., CIDEX® Plus)
• 10% Bleach solution
• 1% Ammonia solution
• Surface disinfectants compatible with plastic or metal materials
9 Rinsing of the disinfectant residue should be done using a
soft cloth or sponge as the applicator.
General Inspection
• Check the condition of the Fluid Warmer with a visual inspection.

Remove from service any unit that shows physical damage.
• If the Disposable Set does not install easily, lubricate the O-Rings
as directed in the following section.
Maintenance Performed Every 30 Days
Lubricate O-Ring Seals
It is not necessary to disassemble the blocks to lubricate the O-Rings.

1 Place a small amount of silicone grease on a cotton swab.
2 Apply the silicone grease along the O-Rings in the bottom

#1 Block, and top #2 Block Heat Exchanger sockets.
Change Recirculating Solution with Distilled Water
1 Place a container under the drain valve of the Fluid Warmer.
2 Drain the recirculating solution by turning the drain valve

clockwise 90 degrees.
3 When all solution has drained from the reservoir, close

the drain valve.
4 Refill the reservoir with distilled water. The reservoir

holds 1.4 liters.
Maintenance Performed Every 12 Months
Disinfect the Reservoir

3 When all solution has drained from the reservoir,

close the drain valve.
4 Remove the fill-port plug on the reservoir.
5 Prepare a 0.3% hydrogen peroxide/distilled water solution. Mix

140 ml of 3% hydrogen peroxide solution and 1,260 ml of
distilled water.
6 Fill the reservoir with 1.4 liters of 0.3% hydrogen

peroxide/distilled water solution.
7 Replace the fill-port plug.
8 Insert a Disposable Set into the Fluid Warmer.
9 Turn the Fluid Warmer ON. Let the solution circulate

for a 30-minute disinfection period.
11 Empty the reservoir.
12 Remove the Disposable Set and discard according to established

hospital procedures
Change Recirculating Solution with a 0.3% Hydrogen

Peroxide/Distilled Water Solution

3 When all the solution has drained from the reservoir, close the
drain valve.
4 Prepare a 0.3% hydrogen peroxide/distilled water solution. Mix
140 ml of 3% hydrogen peroxide solution and 1,260 ml of
distilled water.
5 Fill the reservoir with 0.3% hydrogen peroxide/distilled water
solution. The reservoir holds 1.4 liters.
Change O-Rings
Change the O-Rings in the #1 Block and #2 Block.

1 Remove each O-Ring from its socket by pulling it out
with a pair of needle-nose pliers or by prying it out with
a small screwdriver.
2 Lubricate the new O-Rings from the O-Ring Kit.
3 Press each O-Ring into its socket.
Clean Fan Filter
The Fan Filter (a) is located on the bottom of the Fluid Warmer.
The fan guard snaps in place. a
1 Remove four screws and unsnap the fan guard from the bottom
of the unit.
2 Clean the filter with warm soapy water.
3 Replace the fan guard and filter.
Inspect Air Detector/Clamp
1 Check Clamp Cover Door for proper closure.

2 Check the Clamp Cover Door, Clamp Slot and Detector
Head for structural integrity.
Testing Fluid Warmer Operation
Perform all the tests described in the testing section of this manual.
See Section 11, Testing.
• Add Recirculating Solution Alarm
• Check Disposables Alarm
• Over Temperature Alarm
• Performance Testing
Maintenance and Calibration 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.
Scheduled Maintenance and Calibration Checklist
Task Every Use Every 30 Days Every 12 Months
Clean Exterior 9
General 9
Inspection
Change Distilled 9
Water
Lubricate O Rings 9
Disinfect 9
Recirculating
Solution Reservoir
Change 0.3% 9
Hydrogen
Peroxide Solution
Replace O Rings 9
Clean Fan Filter 9
Test Over 9
Temperature Alarm
Test Add 9
Recirculating
Solution Alarm
Test Disposable 9
Alarm
Test Fluid Warmer 9

Alarm Signal
Verify Temperature 9
Calibration
Electrical Safety 9
Tests
S EC T I O N 1 3 • L im it e d Wa rr a n t y
SE CTION 1 3
Limited Warranty
Smiths Medical ASD, Inc. (the “Manufacturer”) warrants to the Original
Purchaser that the Level 1® H-1200 Fast Flow Fluid Warmer, not including
accessories, shall be free from 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 Level 1® H-1200
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 Level 1® H-1200 Fast Flow
Fluid 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 Level 1® H-1200 Fast Flow Fluid Warmer. This
warranty does not extend to subsequent purchasers. The Original
Purchaser may be medical personnel, a hospital, or institution which
purchases Level 1® H-1200 Fast Flow Fluid Warmer 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 LEVEL 1® H-1200 FAST FLOW FLUID
WARMER. If authorized, the Level 1® H-1200 Fast Flow Fluid Warmer
must be properly and carefully packaged and returned to the
Manufacturer, postage prepaid. Any loss or damage during shipment is at
the risk of the sender.
SECTIO N 13 • Limited Warrant y
C. Conditions of Warranty: The warranty is void if the Level 1® H-1200

Fast Flow Fluid 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 Level 1® H-1200 Fast Flow Fluid Warmer
serial numbers will invalidate this warranty.
D. Limitations and Exclusions: Repair or replacement of the Level 1®

H-1200 Fast Flow Fluid 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 LEVEL 1® H-1200 FAST FLOW
FLUID WARMER FOR ANY PARTICULAR PURPOSE.
3. The Level 1® H-1200 Fast Flow Fluid Warmer can only be used
under the supervision of medical personnel whose skill and
judgment determine the suitability of the Level 1® H-1200 Fast Flow
Fluid 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 Level 1®

H-1200 Fast Flow Fluid Warmer for any particular medical treatment or for
any medical complications resulting from the use of the Level 1® H-1200 Fast
Flow Fluid 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 Level 1® H-1200 Fast
Flow Fluid 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.
S EC T I O N 1 4 • S e r v i c e
SE CTION 1 4
Service
WARNING!
• No user-serviceable parts. All service must be performed by

Smiths Medical or competent personnel.
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.
Warranty Service
Units received for repair which have not been obviously abused or
impact damaged and are still under warranty will be promptly repaired
and returned at no charge. See the limited warranty section of this
manual. A no-charge purchase order is requested for tracking.
Non-Warranty Work
Units received that are no longer under warranty can be returned for
repair for a cost. The unit 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 your Level 1® H-1200 Fast Flow Fluid Warmer (Fluid
Warmer) or Level 1® H-31, Version B, Air Detector/Clamp for service,
contact Smiths Medical for Returned Goods Authorization. Be sure that
ALL recirculating solution is drained from the unit before packing the
Fluid Warmer for shipment.
Note: The Fluid Warmer must be cleaned and disinfected for

repair shipment or it will be immediately returned as received.
Additional Documentation
Upon request Smiths Medical will provide the following documentation:

• Circuit diagrams
SECTIO N 14 • Servic e
• Components parts list(s)

• Description of function
• Service and calibration instructions
Disposal Information
Observe national and local codes or requirements for disposal of

contaminated materials and for recycling 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
USA/Canada 1-800-258-5361
International +1-781-878-8011
European Representative
Smiths Medical International Ltd

Colonial Way, Watford,
Herts, WD24 4LG, UK
Tel +44 (0) 1923 246434
Fax +44 (0) 1923 240273
Australian Representative
Smiths Medical Australasia Pty. Ltd.

61 Brandl Street
Eight Mile Plains, QLD 4113, Australia
Tel +61 (0) 7 3340 1300
Fax +61 (0) 7 3340 1399
New Zealand
Tel 0 800 444 200
www.smiths-medical.com
S EC T I O N 1 5 • S p e cif ica t i o n s
SE CTION 1 5
Specifications
System Specifications
Physical Measurement
Height, Overall 67 inches (1.7 m)

Width, Overall 20 inches (51 cm)
Depth, Overall 20 inches (51 cm)
Weight Assembled; Dry 63 pounds (28.5 kg)
Recirculating Solution Capacity 0.37 gallons (1.4 L)
Air Source Pressure 300 (294 ± 6) mm/Hg
Environmental Temperature Humidity [%]
Operation 10°C to 40°C 10 to 95

Transportation 18°C to 60°C 5 to 95
Storage 5°C to 40°C 5 to 95
Thermal
Temperature Set Point 41.7°C ± 0.3°C
Over Temperature Set Point 43.9°C ± 0.1°C
Electrical Type
Protection Against Electrical Shock Class I Equipment

Type BF Equipment
Mode of Operation Continuous
Type of Current Alternating
Ingress Protection Rating IPX1
MAINS Power Input 115 VAC, 60 Hz, 12 Amps

MAINS Power Input 230 VAC, 50 Hz, 6.3 Amps
Auxiliary MAINS Outlet 115 VAC, 1.5 Amps

Auxiliary MAINS Outlet 230 VAC, 0.75 Amps
SECTIO N 15 • Spec if ic ations
Electromagnetic Environment Recommendations
Disposable Administration Set Specifications
DI-50
Filter Size 170 Micron
Priming Volume
DI 50 56 ml
System 1200 Normothermic (35 41°C)
Fluid Delivery Range
10°C Input: 40 ml/min. to 300 ml/min.
Maximum Flow Rate 500 ml/min.
(crystalloid, 300 mmHg, 14g catheter)
D/DI-60HL and D/DI-65HL

Priming Volume
D/DI 60HL 74 ml
D/DI 65HL 164 ml
10°C Input: 75 ml/hour to 530 ml/min.
20°C Input: 75 ml/hour to 530 ml/min.
(crystalloid, 300 mmHg, 8.5 F catheter)
S EC T I O N 1 5 • S p e cif ica t i o n s
Disposable Administration Set Specifications (continued)
D/DI-70 and D/DI-75

Priming Volume
D/DI 70 70 ml
D/DI 75 160 ml
D/DI-100 and D/DI-150

Priming Volume
D/DI 100 65 ml
D/DI 150 155 ml
D/DI-300 and D/DI-350

Priming Volume
D/DI 300 90 ml
D/DI 350 180 ml
SECTIO N 16 • Symbols
SECTIO N 16
Symbols
S EC T I O N 1 6 • S y m b o l s
SECTIO N 16 • Symbols
Symbol Meaning
Alarm Test
ON Only for a part of the equipment.

MAINS are connected
OFF Only for a part of the equipment.

The MAINS are still connected
Automatic Operation
Recirculating Solution Temperature
Over Temperature Test

(Recirculating Solution Over Temperature)
Add Recirculating Solution
Check Disposables, Check Tubing
Clamped
Maximum Reservoir Level
Minimum Reservoir Level
Device has been tested by National Technical

Systems, a nationally recognized technical lab, to
meet U.S. requirements for safety.
CE Mark and Notified Body number

(0473 indicates AMTAC)
0473
95%
% Humidity Limitation
5%
Collect separately for electrical and electronic

equipment.
‚
Contains or Presence of Phthalate:
bis(2 ethylhexyl) phthalate (DEHP)
In d ex
A D M
Add Recirculating Solution indicator 23 Description 3 Maintenance 59
Add Recirculating Solution Mode 32 Air Detector/Clamp 3 Every 12 months 61
After Use 51 Disposable Administration Set 3 Every 30 days 61
Air Detected Alarm mode Fluid Warmer 3 Log/Schedule 64
Clear 50 Pressure Chambers 3 Prior to every use 59
Detected 49 Disinfect recirculating solution Modes of Operation 30
Air Detected/Clamped Mode 35 reservoir 61 Add Recirculating Solution Mode 32
Air Detection /Clamp During assembly 13 Air Detected/Clamped Mode 35
Description 3 Disposable Administration Set Alarm Test Mode 31
Principles of operation 19 Description 3 Automatic Operation Air
Air Detector/Clamp Control Panel 24 Install 38 Detector/Clamp 34
Alarm Test Mode 31 Prime 41 Check Disposables Mode 32
Alarms Disposal information 68 Check Tubing Mode 34
Add Recirculating Solution 32 Drain valve 11 OFF Mode 30
Air Detected 49 DSTA-40 calibration test 56 ON/Automatic Operation for Fluid
Air detected/Clamped 35 Warmer 30
Check Disposables 32 E Over Temperature Alarm Mode 33
Check Tubing 34 Electrical safety tests 17 Over Temperature Test Mode 31
Over Temperature 33 Electrical testing 58 Power ON Test for Air
Summary table 28 Electromagnetic Environment Detector/Clamp 33
Assembly instructions 9 Recommendations 70 Pressurized Mode 35
Disinfect recirculating solution Unpressurized Mode 36
reservoir 13 F
Fluid Warmer 9 F-50 Gas Vent/Filter Assembly 20 O
H-31, B Air Detector/Clamp 15 Flanking brackets 12 OFF Mode 30
Automatic Operation Air Detector/ Fluid Bag ON/Automatic Operation for Fluid
Clamp 34 Change 47 Warmer 30
Automatic Operation indicator Fluid Warmer Operating Instructions 37
Air Detector/Clamp 23 Description 3 Operation Display/Panel summary 28
Fluid Warmer 24 Principles of operation 19 O-Rings
Use of 46 Lubricate 61
B Fluid Warmer Alarm Signal Test Over Temperature Alarm Mode 33
Button functions 22 button 22 Over Temperature indicator 23
Fluid Warmer Display Panel 23 Over Temperature Test button 22
C Over Temperature Test Mode 31
Calibration of recirculating solution G
temperature 57 Ground continuity 58 P
Change O-Rings 62 Panels
Change recirculating solution H Air Detector/Clamp Control 24
Distilled water 61 H-31, B Air Detector/Clamp Fluid Warmer Display 23
0.3% hydrogen peroxide/distilled Assembly instructions 15 Power and Alarm Test 22
water solution 62 Pressure Chamber control 25
Check Disposables indicator 23 Performance testing 56
I
Check Disposables Mode 32 Pneumatic tubing 14
Indications for use 4
Check Tubing indicator 24 Power and Alarm Test Panel 22
Interlocks for Disposable Set
Check Tubing Mode 34 Power OFF button 22
installation 26
Clamped indicator 24 Power ON button 22
Clean fan filter 62 Power ON Test for Air Detector/Clamp 33
Clean the exterior 59
L Pressure Chamber Control Panel 25
Log
Components list 10 Pressure Chambers
Maintenance and calibration 64
Contraindications 5 Description 3
Lubricate O-Ring seals 61
Controls and displays 21 Install 12
Load for use 46
Pressurize for use 46
Principles of operation 19
In de x
Pressure gauge 25 S Over Temperature test 55

Pressurize Pressure Chambers 46 Safety information 5 Performance 56
Pressurize/Unpressurize lever 25 Service information 67 Troubleshooting
Pressurized Mode 35 contacts 68 General 52
Prime Set Up for use 38 Slow flow rate 53
Disposable Administration Set 41 Specifications 69
Patient Line 42 Disposable Set 70 U
Principles of operation 19 system 69 Unpressurized Mode 36
Symbols 72
Q W
Quick Reference Guide 10, 12 T Warranty information 65
TEMPCHECK calibration test 56
R Temperature Display 23, 31
Recirculating solution temperature Test Air Detector/Clamp 44
calibration 57 Test Fluid Warmer Alarms 43
Recirculating Solution Temperature Testing 54
display 23 Add Recirculating Solution Alarm 54
Replace Gas Vent/Filter Assembly 48 Air Detector/Clamp 44
Reservoir Capacity 22 Check Disposables Alarm 54
Reservoir level display 23 Electrical 58
Fluid Warmer Alarm 55
Ground continuity 58
Maintenance requirement 59
TM
Manufacturer: Australian Representative: European Representative:

Smiths Medical ASD, Inc. Smiths Medical Australasia Pty. Ltd. Smiths Medical International Ltd.
160 Weymouth Street 61 Brandl Street Colonial Way
Rockland, MA 02370, USA Eight Mile Plains, QLD 4113, Australia Watford, Herts, WD24 4LG, UK
USA/Canada: 1-800-258-5361 Tel AU: +61 (0) 7 3340 1300 Tel: +44 (0) 1923 246434
International: +1-781-878-8011 Tel NZ: 0 800 444 200
www.smiths-medical.com
Made in USA

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©2010 Smiths Medical family of companies.

Manufactured in the U.S.A.

| Operator’s Manual iii

3 Indications for Use 4

4 Important Safety Information 5

About this Manual

The manual is intended for use by individuals trained in the

This manual is organized into the following sections:

2 and 3 Description and Indications for Use

Disposable Administration Sets

Indications for Use

Important Safety Information

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

Death or serious injury may occur to the patient or user if

• These instructions contain important information for safe use of

• Replace Gas Vent/Filter Assembly every three hours, or when

• The replacement Gas Vent/Filter Assembly must be fully

• Do not use the Fluid Warmer in high-energy fields such as:

• Do not bend the heat exchanger. Bending may damage the

• Blood and blood products could contain pathogenic

• When injecting medications into the fluid path, do not inject

• Exposed conductor on MAINS power cord can cause an

• Activation of the Over Temperature warning signal indicates

• The Fluid Warmer is for use only with Smiths Medical

• Grounding reliability can only be achieved when MAINS

• Use of a bedside leukocyte reduction filter may cause a

• Do not operate the Fluid Warmer in the presence of a

• No user-serviceable parts. All service must be performed by

• If fluid exits in the Patient Line or the D/DI-60HL and D/DI-65HL

• Do not use auto-transfusion bags. Auto-transfusion bags

• Set-up, priming, and use require aseptic technique. Failure to

WARNINGS for the Air Detector/Clamp

• The tubing must be properly placed in the Clamp Slot of the

WARNINGS for the Air Detector/Clamp [continued]

• Activation of the Air Detector/Clamp alarm during infusion

• The functional test for the Air Detector/Clamp accessory

Malfunction, failure, or damage to the device may occur if

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

• Do not place the Fluid Warmer directly under a faucet or use a

• When loading fluid bags into Pressure Chambers, choose a

• Medical devices require specific material characteristics to

Out of the Box—Assembly

Step 1 Verify components of the Fluid Warmer

Step 2 Assemble I.V. Pole to Warming Unit

Step 3 Install Pressure Chambers

Step 4 Attach the I.V. Bag Hanger

Step 5 Disinfect the Recirculating Solution Reservoir

Step 6 Preliminary Preparation

Step 7 Connect the Pneumatic Tubing

Step 8 Install the Level 1® H-31, Version B, Air Detector/Clamp

Step 9 Perform Electrical Safety Tests

Read through the instructions completely prior to setting up the device.

Note: After unpacking the system, recycle packaging material according to

1 I.V. Bag Hanger

1 Fluid Warming Unit

1 H-31, Version B, Air