Smiths Level 1 H-1000 Manual de funcionamiento
Made in U.S. A.
P/N 4533801 Rev. 001
Level 1 H-1000
Fluid Warmer
-
H-1000 100V
OPERATOR’S AND SERVICE MANUAL
Manufacturer:
Smiths Medical ASD, Inc.
160 Weymouth Street
Rockland, MA 02370, USA
USA/Canada: 1-800-258-5361
International: +1-781-878-8011
www.smiths-medical.com
®
Level 1®H-1000 Operator's & Service Manual
About This Manual 2
Purpose 2
Concept 2
System Features 3
Filter with Gas Vent 3
Temperature Control 4
Flanking I.V. Pole Brackets 4
Unpacking and Set up 4
System 1000 Hardware 6
Power and Alarm Test Panel 6
Display Panel 7
Interlocks 8
Accessories: System 1025 Pressure Infusers 9
Set-up and Use 9
Disposables: Set up and Performance 12
Setting Up Disposable Sets 12
Priming Disposable Sets 13
Filter with Gas Vent Replacement in IV Disposable Sets 13
Trouble Shooting 15
Trouble Shooting Slow Flow Rates 16
Testing 17
Add Water Alarm 17
Check Disposables Alarm 17
Water Over Temperature Alarm 18
Alarm Testing 18
Performance Testing 18
Earth Leakage 19
Ground Continuity 19
Dialectric Strength 20
Maintenance 20
Maintenance and Testing Log 22
Service 22
Warranty Service 22
Non-Warranty Service 24
Specifications 24
Physical Specifications 24
Electrical and Environmental Specifications 24
Accessory, Maintenance and Calibration Part Numbers 25
Parts and Electrical Schematics 25
International Symbols 28
No part of this manual may be reproduced in any form without prior written permission from Smiths Medical ASD, Inc.
(Smiths Medical)
Level 1 and Smiths design mark are trademarks of the Smiths Medical family of companies. The symbol ® indicates the
trademark is registered in the U.S. Patent and Trademark office and certain other countries.
*Cover pictures the H-1025, a combination of the H-1000 Fluid Warmer and two accessory H-2 Pressure Infusion Chambers.
The products described are covered by one or more of the following U.S. Patent Nos. 4,759,749; 4,878,537; 4,900,308;
5,063,994; 5,097,898; and 4,678,460; other patent(s) pending.
© 2006 Smiths Medical family of companies. All rights reserved.
Operator’s Manual Part #4533801 (Rev 001) 2006/08
About This Manual
These instructions contain important information for safe use of the product. Read the
entire operator's manual, including Warnings and Cautions, before using the
Level 1®H-1000 Fluid Warmer. Failure to properly follow warnings, cautions, and
instructions could result in death or serious injury to the patient.
! WARNING !
Messages that are headed by "! WARNING !" indicate information or procedures that if not
followed correctly can cause improper results, damage to the equipment, injury to
personnel, or patient death.
Messages that are headed by "CAUTION:" indicate information or procedures that if not
followed correctly can cause improper results and damage to the equipment.
Messages that are headed by "NOTE:" indicate information or procedures that if not
followed correctly can cause improper results.
Purpose
The Level 1®H-1000 fluid warmer has been designed for safe, rapid in-line warming of I.V.
fluids as they are administered to patients. Disposable sets designed for warming at
various infusion rates are available. Blood and I.V. solutions may be infused through the
Level 1®I.V. Sets, and will be delivered near 40 °C.
High flow capacity, warm fluid delivery, simple operation, and continuous on-board safety
systems make the H-1000 the ideal choice for all procedures requiring routine to rapid
infusion of normothermic fluids. Typical uses of the system include blood and solution
warming during elective surgery, in the I.C.U., the Emergency Room and in Trauma.
Concept
The H-1000 fluid warmer consists of a reusable hardware device and a single-use
disposable set. Similar to extracorporeal warming technology found in the heart room,
warmed water is rapidly circulated through a disposable anodized aluminum tube to warm
fluids as they are delivered to the patient. The use of a thermal conductor, rapid warm
water circulation, and counter-current flow all contribute to the high warming capacity of
the H-1000.
2
3
System features
Filter with Gas Vent
Level 1®D-Series Disposable Sets employ a unique "hands-off" Gas Vent which vents
micro-bubbles of gas that are always released from fluids as they are warmed. In many
other warming systems, these micro-bubbles are actually delivered to the patient along
with the warmed fluids.
The Filter with Gas Vent assembly in the I.V. Sets contains a 170-micron screen filter to
trap macro-aggregates found in blood products. This filter has luer-lock connections and
Figure 1. Block diagram of Level 1®fluid warmers.
Circulating
water bath
flow
Heat
Exchanger
Heater
Pump
Figure 1 diagrams the H-1000 and its operation.
An onboard pump circulates warm water through
the aluminum heat exchanger in the disposable
set. Note that the circulating water bath and the
infusate flow against each other, or counter-
current, which maximizes heat transfer. This
diagram describes the essence of all Level 1®fluid
warmers.
can be easily changed without patient disconnection or repriming of the entire disposable
set. The Filter with Gas Vent should be changed every three hours or when the filter
becomes clogged, whichever comes first.
Temperature control
The H-1000 employs a safe circulating water heating system, inherently free of any "hot
spots." The primary temperature control circuit sets the circulating water bath to a
temperature of approximately 42 °C for efficient heat exchange and maximum fluid
warming.
Flanking I.V. Pole Brackets
The sturdy design of the H-1000 offers a compact, custom I.V. pole mount set up. This
versatile workstation features flanking side poles for Level 1®pressure infusers, syringe
pumps or infusion pumps.
Unpacking and Set up
The H-1000 packaging should contain the following items:
Contents Quantity
H-1000 Warming Unit 1
H-1000 I.V. Pole Base 1
H-1000 I.V. Bag Hanger 1
H-1000 I.V. Pole with Flanking Brackets 1
Accessory Pack:
H-1000 Manual 1
D-Series Instruction Card 1
Y-Connector 1
Black Pneumatic Tubing 1
Hex Wrench 1
1. Place the base upright on its wheels. Lock casters to prevent pole movement during
set up.
2. Remove the three threaded pole screws on the vertical base tube. Slide the I.V. pole
with flanking brackets down over the vertical base tube lining up the three screw holes in
the pole with the three screw holes in the base as shown in Figure 2. Note: the flanking
brackets should face the longer side of the base.
3. Thread the three pole screws back through the holes at the base of the pole and
tighten.
4. Attach the H-1000 warming unit to the flanking brackets by sliding the eight threaded
screws on the back of the unit into the eight keyhole notches on the flanking I.V. pole
brackets. (Refer to Figure 2.) Tighten all eight screws to secure warmer to I.V. pole and
flanking brackets.
5. Lock I.V. bag hanger into place on the top of the I.V. pole.
4
5
6. Close the drain valve (seen in Figure 7) on the bottom of the unit. Remove the fill port
plug on the front of the unit and fill the tank with 1.4 liters of distilled water. Replace the fill
port plug.
CAUTION: Tap water will increase earth leakage current. For proper system operation and
component life, use only DISTILLED WATER in the water reservoir.
7. Plug the unit into the appropriate electrical outlet. (See specifications for details. )
Figure 2. H-1000 assembly
6
CAUTION: This device must be assembled and tested by Smiths Medical technical
personnel, an authorized distributor of Smiths Medical or a trained biomedical engineer
prior to placing the device into service. Refer to the Testing section of this manual for
complete system testing instruction.
H-1000 Hardware
The H-1000 has an onboard water supply heated to 41.7 °C. This temperature controlled
water supply is rapidly circulated through the heat exchanger of the disposable set. Two
independent circuits continuously control and monitor water temperature, and will shut the
system down and alarm in the event of an over temperature condition.
Power and Alarm Testing
The power and alarm test panel on the front of the H-1000 cabinet is shown in Figure 3
below. It contains four membrane switches. Only a gentle press is required to activate
each switch.
1. POWER ON
The green switch on the left powers ON the H-1000 warming unit including the onboard
compressor for the pressure infuser accessory system.
2. POWER OFF
The orange switch on the right powers OFF the unit.
3. ALARM TEST
This alarm test button confirms proper operation of visual and audible alarm systems.
Press and hold this button to test alarm systems. When the switch is released the WATER
OVER TEMPERATURE alarm will continue to sound. This is normal operation. To clear
the alarm condition, turn the unit OFF and then back ON.
4. OVER TEMPERATURE TEST
This alarm test button confirms proper operation of the OVER TEMPERATURE circuitry.
7
Press and hold this button to test this alarm circuitry. When the switch is released the
WATER OVER TEMPERATURE alarm will continue to sound. This is normal operation.
To clear this alarm condition, turn the unit OFF and then back ON.
Display Panel
The display panel shown in Figure 4 contains visual information that continuously
indicates the status of the H-1000 during operation. Five displays provide information for
safe, convenient use of the device.
1. CIRCULATING WATER BATH TEMPERATURE
Displays temperature of the circulating water bath in °C. This is not the temperature of the
fluid delivered to the patient.
2. SYSTEM OPERATIONAL
This GREEN indicator illuminates when the power switch is ON and the heat exchanger
has been properly installed.
1.4 Liters
H2O
Figure 3. Power and Alarm Panel Figure 4. Display Panel
41
8
3. CHECK DISPOSABLES
This Yellow indicator and pulsing AUDIBLE ALARM indicate the heat exchanger is NOT
properly installed.
4. ADD WATER
This Yellow indicator and pulsing AUDIBLE ALARM indicate additional distilled water must
be added to the water reservoir.
5. WATER OVER TEMPERATURE
This RED indicator and AUDIBLE ALARM indicate an over temperature condition. Press
and hold this switch to confirm proper operation of the OVER TEMP circuitry.
NOTE: When any one or more of the alarms are activated, and the red and/or yellow
indicators are illuminated, and the audible alarm is sounding, no water is circulating and
no fluid warming is taking place.
Interlocks
Three low voltage interlocks are located in the cabinet. They sense the presence of a
properly installed heat exchanger and filter with gas vent. These interlocks prevent the
pump from pumping water when there is no disposable in place to complete the circulation
loop. If the "CHECK DISPOSABLE" alarm is activated and the light next to the "2" socket
is illuminated, press the #2 socket down firmly to engage the interlock switch.
The H-1000 display panel provides information for safe, convenient set up and use of the
device.
Este manual sirve para los siguientes modelos
1
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