level 1 System 1000 Operating manual

m
SMITHS INDUSTRIES
Medical Systems | Systems
System 1000
“Fluid Warmer
Τ1ον
Operator's
and
service Manual
SIMS Level 1, Inc.
160 Weymouth St.
Rockland, MA 02370 USA
ge USA/Canada: 1-800-SLEVEL1
a [phone]
Fax [phone]
Made in U.S.A.
"SIMS'- SIMS Registered Trademark
U.S. Patent Nos: 4,759,749; 4,878,537; 4,900,308;
5,063,994; 5,097,898; 4,678,460. Other Patents Pending
P/N: 4533700 | Rev:F

System 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 1.V. Disposable Sets 14
Trouble Shooting Hardware 15
Trouble Shooting Slow Flow Rates 16
Testing 17
Add Water Alarm 17
Disposable Alarm 17
Water Over Temperature Alarm 18
Alarm Testing 18
Performance Testing 18
Maintenance 20
Maintenance and Testing Log 22
Service 22
Warranty Service 22
Non-Warranty Service 23
Specifications 24
Physical Specifications 24
Electrical Specifications 24
Environmental Specifications 24
Accessory, Maintenance and Calibration Part Numbers 24
Parts and Electrical Schematics 25
35
Symbol Glossary for Hardware and Disposables
No part of this manual may be reproduced in any form without prior written permission from SIMS
Level 1, Inc.
*Cover pictures the System 1025, a combination of the System 1000 Fluid Warmer and two accessory
H-2 Pressure Infusion Chambers.
Part # 45-33-700
Rev F
March 12, 1998
SIMS Level 1. Inc.

About This Manual
This manual contains important information about the safe assembly, use and
service of the System 1000 fluid warmer. SIMS Level 1, Inc. urges you to read
this manual carefully and follow its recommendations to assure successful use of
the System 1000.
! WARNING !
Messages that are headed by “! WARNING F 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 SIMS Level 1 System 1000 fluid warmer has been designed for safe, rapid
in-line warming of |.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 SIMS Level 1 1.V. Sets, and will be
delivered at temperatures near 40°C.
High flow capacity, warm fluid delivery, simple operation, and continuous on-
board safety systems make the System 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 System 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 System 1000.

Circulating 1
water bath |
=
Heat
Pump
Figure 1. Block diagram of SIMS Level 1 fluid warmers.
Figure 1 diagrams the System 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 SIMS Level 1 fluid warmers.
System Features
Filter with Gas Vent
SIMS Level 1 D-series Disposable Sets employ a unique “hands-off” Gas Vent which
vents micro-bubbles of gas that are 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 each I.V. Set contains a 170-micron screen filter
to trap macro-aggregates found in blood products. This filter assembly has luer-lock

connections and can be easily changed out 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, which ever
comes first. | | |
Temperature Control
The System 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 System 1000 offers a compact, custom I.V. pole
mount set up. This versatile workstation features flanking side poles for
SIMS Level 1 pressure infusers, syringe pumps or infusion pumps.
Unpacking and Set Up
The System 1000 packaging should contain the following items:
Contents Quantity
H-1000 Warming Unit 1
H-1000 1.V. Pole Base 1
H-1000 1.V. Bag Hanger 1
H-1000 1.V. Pole with
Flanking Brackets
—h
Accessory Pack:
H-1000 Manual
D-series Instruction Card
Y-Connector
Black Pneumatic Tubing
Hex Wrench
=>
=>
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må
--
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
UV. 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. Noite: the flanking brackets shouid 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 System 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 |.V. pole and flanking brackets.
o. Lock I.V. bag hanger into place on the top of the I.V. pole.

6. Close the drain valve (seen in Figure 6) 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.
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Figure 2. System 1000 assembly.
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.) |

CAUTION: This device must be assembled and tested by SIMS Level 1
technical personnel, an authorized distributor of SIMS Level 1 or a trained
biomedical engineer prior to placing the device into service. Refer to the
Testing section of this manual for complete system testing instructions.
System 1000 Hardware
The System 1000 has an onboard water supply heated to 42°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 water over temperature condition.
Power and Alarm Test Panel
The power and alarm test panel on the front of the System 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 System 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.
ZAN
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
ala sl へ ハハ ヘー キョロ ta emana Thie ie narmal rati |
alarm will continue to sound. This is normal operation. To clear the
alarm condition, turn the unit OFF and then back ON again.
4. OVER TEMPERATURE TEST
This alarm test button confirms proper operation of the OVER

TEMPERATURE circuitry. 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 the alarm condition, turn the unit OFF and then
back ON again.
Figure 3. Power and Alarm Test Panel Figure 4. Display Panel
C x | C y
|
(une
=
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o
ON POWER OFF
mı @PERATING
| O BISPOSABLE
ALARM TEST OVERTEMP — ABB WATER
DI @VERTEMP
1.4 Liters
Distilled Water Only
q | q | y
Display Panel
The display panel shown in Figure 4 contains visual information that continuously
indicates the status of the System 1000 during operation. Five displays provide
information for safe, convenient use of the device.
AAA
1. CIRCULATING WATER BATH TEMPERATURE
Displays temperature of the circulating water in °C. Note that this is not the
temperatu! ire of the fluid delivered to the natient, but the temperature of the heat
SOUTCE.
2. OPERATING
This GREEN indicator illuminates when the power switch is ON and the heat exchanger
has been properly installed.

3. DISPOSABLE
This RED indicator and pulsing AUDIBLE ALARM indicate the disposable set is
NOT properly installed. There is also a RED indicator next to the top socket that
illuminates if the #2 socket is NOT seated properly.
4. ADD WATER
This RED indicator and pulsing AUDIBLE ALARM indicate additional distilled
water must be added to the water reservoir.
5. OVERTEMP |
This RED indicator and AUDIBLE ALARM indicate a water over temperature
condition.
NOTE: When any one or more of the alarms are activated, and the red
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 disposable heat exchanger and filter with gas vent. These
interlocks prevent the pump from circulating water when there is no disposable
in place. If the “DISPOSABLE” alarm is activated and the light next to the #2
interlock socket is illuminated, press the #2 socket down firmly to engage
the interlock switch.
The System 1000 display panel provides information for safe, convenient set-up
and use of the device.

Accessories: System 1025 Pressure Infusers
The System 1000 is equipped with an onboard compressor that is used to operate
two SIMS Level 1 pressure infusion chambers (H-2’s). Pressure infusion chambers
are sold separately as an accessory to the System 1000. The System 1000 combined
with two H-2 pressure infusion chambers is referred to as the System 1025. Pressure
infusers are not required to operate the System 1000, but are a valuable accessory to
complete this total fluid management system.
System 1025 pressure infusers provide controlled, convenient pressurization of blood
and |.V. solution bags for rapid administration of 1.V. fluids. These automated pressure
chambers quickly reach and hold a preset pressure of 300 mmHg for high speed fluid
delivery not possible with manually pumped pressure cuffs. The factory set 300 mmHg
pressure is constant and not adjustable. At 300 mmHg pressure, flow rates may be
altered by adjusting the roller clamp on the Level 1 D-series disposable I.V. fluid
warming set.
With the System 1025 infusion chambers, pressure can be applied or released with the
throw of a switch. Empty I.V. fluid bags can be de-pressurized, replaced and re-
| pressurized in seconds. Each pressure infuser contains an expansion bladder to
squeeze the bag contained in the chamber. Each H-2 chamber can accommodate
either a 500 ml bag or a 1000 ml bag. And a safety relief valve is also contained in
-each chamber to help prevent over-pressurization of fluid bags.
_ If you have purchased a pair of pressure infusion chambers, please refer to the
| following pressure infuser set up instructions for proper installation.
Packaging for each pair of System 1025 pressure infusers should contain the following
items:
Contents Quantity
H-2 Pressure Infuser 2
Y-Connector 1
Black Pneumatic Tubing 1
Set Up and Use
CAUTION: This device must be assembled and tested by SIMS Level 1
technical personnel, an authorized distributor of SIMS Level 1 or a trained
biomedical engineer prior to placing the device into service.
! WARNING !: Level 1 pressure chambers are to be used only as an accessory to
Level 1 fluid warmers. Do not connect to compressed gas bottles, O.R. Air, or any
other pneumatic pressure source.
1. Loosen the two pole mounting thumb screws on the back of one H-2 pressure
chamber as seen in Figure 5. Slide the H-2 over the top of a flanking bracket.

Mounting Sorews |
Chrome pole
Remove Plug
and insert biack tubing
—
Figure 5. Installing
Pressure Infusers
2. Secure the H-2 in
place by
tightening
the two pole
mounting screws.
. Repeat steps 1
and 2 for the
second H-2
pressure chamber.
. Remove the
orange plug from
the red ring
connector located
on the back of
the H-1000. This
is done by
depressing the red
plastic ring and
pulling the
plug out.
. Press the piece of
black pneumatic
tubing firmly into
the connector on
the back of the H-
1000 until it
bottoms out.
Press the other
end of the tubing
into the bottom of
the Y-Connector.
6. Press the black tube from one of the H-2s into the Y-connector. Press the
black tube from the other H-2 into the Y-connector.
Once the System 1000 is turned on, 300 mmHg pressure can be automatically
applied by pushing the toggle switch on the top front of the H-2 chamber all the
way over to the “+” or ON position. Always make sure that the chamber door is
closed and latched when pressure is activated.
With Level 1 pressure infusion chambers properly installed, the H-1000 fluid
warmer becomes the System 1025, a complete fluid management system.
10

To Load
In order to help avoid inadvertent infusion of air to the patient, the following warnings
should be observed:
| WARNING !:
Remove all air from solution bags.
| WARNING |:
Not for use with commercial I.V. solution bags less than 1 liter with air.
| WARNING |:
Not for use with autotransfusion bags.
1. Set up and prime Level 1 D-series disposable |.V. fluid warming set following the
instructions on disposable package.
2. Flip toggle switch on the top front of the H-2 chamber all the way over to the “-
OFF position.
3. Open chamber door by swinging out hinged latch on right side. —
4. Hang air-free solution bag on door post.
NOTE: Each pressure chamber can hold either a 500 ml bag or a 1000 ml bag. Fora
500 ml bag, the hanging post is located on the inside of the door. For a 1000 ml bag
the post is located on the top of the door. For optimum drainage of 1liter bags, the
upper molded post is for longer style bags. The lower molded post is used for standard
size bags.
5. Close door and secure side latch.
To Pressurize
CAUTION: Be certain latch is secure before chamber is pressurized. Never pressurize
with door open.
CAUTION: Do not exceed 300 mmHg.
1. Push toggle switch all the way over to the “+” or ON position. Observe pressure
gauge to ensure 300 mmHg (approx.) is achieved.
NOTE: The pressure is not adjustable on this device. The fluid warmer power switch
must be ON for pressure chambers to operate.
To Unload | |
1. Push toggle switch all the way over to the “-“ or OFF position. This will release
pressure in the chamber and deflate the bladder.
2. Open door and remove the fluid bag.
11

NOTE: Chamber pressure must be released before the pressure chamber door
can be opened.
To Clean
Please refer to the maintenance section of this manual for complete cleaning
and disinfecting procedures for the System 1025 pressure infusers.
Disposables: Set Up and Performance
| WARNING!
Refer to D-series disposable packaging for complete set up and priming
instructions, indications and contraindications warnings, and cautions, and
additional product information.
Setting Up Disposable Sets
SIMS Level 1 D-series disposable sets have been designed to be highly
effective and easy to use in combination with the System 1000 fluid warming
hardware. By following the simple 1-2-3 blocks found on the System 1000 fluid
warmer, properly trained users can confidently have the system safely set-up
and operating within seconds.
Following the numbers found on the System 1000:
1. Push the bottom end of the heat exchanger into the bottom heat exchanger
#1 socket. Be sure the heat exchanger is fully seated.
! WARNING !:
t Do not bend heat exchanger tube. Bending the heat exchanger
tube may damage the inner aluminum tube. If the tube is bent,
serious patient injury or death could result.
2. Slide the top +2 socket up. Snap the heat exchanger into the heat exchanger
guide. Be sure it is fully seated. Slide the top heat exchanger socket down over
the heat exchanger tube.
If the top socket is not pressed down correctly, a red indicator next to the top
socket will illuminate. When the top socket is properly seated the red indicator
will go out.
3. Snap the Filter with Gas Vent into the #3 holder on the front of the cabinet.
4. Press the green power switch on the front of the cabinet to turn ON the unit
12

and allow it to reach operating temperature while the disposable set is being primed. It
takes between 3 and 7 minutes for the water in the System 1000 to reach operating
temperature.
When the System 1000 is plugged in and turned ON and the disposable set is correctly
installed, the green "OPERATING" light will illuminate and the water temperature will
begin to increase on the display panel. If the disposable set is incorrectly installed and
the unit is turned ON, the red “DISPOSABLE" light will illuminate and an intermittent
alarm will sound. |
Priming Disposable Sets
! WARNING !:
Set up, priming and use require aseptic technique. Follow applicable hospital policy
and procedures.
! WARNING !:
Remove all air from fluid bags before spiking with D-series disposable set.
| WARNING !:
All air must be removed from fluid lines prior to patient connection. Failure to do so
could result in the introduction of air to the patient.
| WARNING !:
Monitor fluid lines to ensure they are air-free. Never infuse fluids if there are bubbles in
the line between the filter chamber and patient connection.
1. Close the Y-set clamps.
2. Remove one bag spike cap and spike it into an air-free fluid bag with a twisting
motion. |
3. Hang the fluid bag from the adjustable 1.\. pole and open the lead clamp to the I.V.
bag.
4. Squeeze the drip chamber to the I.V. bag so it is 1/3 to 1/2 full.
5. Remove the male luer cap on the patient line and open the Y-set clamp to the I.V.
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7. Gently tap the filter with gas vent against the cabinet to release all trapped air.
Priming is complete. Make patient connection without entrapping air.
8. Adjust the flow rate using the roller clamp.
13

Filter with Gas Vent Replacement in I.V. Disposable Sets
Replace the filter with gas vent every THREE HOURS or when the filter
becomes clogged or air is slowly vented. Replace with Level 1 product number
F-10 or F-30. Refer to the disposable packaging for appropriate filter
replacement product number.
| WARNING !:
Replacement filter with gas vent must be fully primed before continuing infusion.
Thoroughly check patient line for air bubbles before opening roller clamp. If air
‘bubbles are present, disconnect from the patient and re-prime before continuing
infusion. ーー |
1. Close all clamps on the D-series disposable set and on new filter with gas
vent. | |
2. Remove the used filter with gas vent from the holder while still connected to
the disposable set. |
3. Install the new filter assembly into the #3 holder.
4. Using aseptic technique, disconnect upper luer-lock fitting, and after
removing upper male luer end cap from the new filter, connect the set to new
filter inlet.
5. Holding the used filter horizontally, disconnect the lower patient line luer-
lock. Connect the used filter luer-lock fittings together and discard.
6. With the filter outlet tube clamped, open the clamps above the filter. The
filter with gas vent will self prime.
7. Slowly release the outlet tube clamp and allow the outlet tube to fill
completely.
8. Remove the second luer-lock end cap and connect outlet tube luer-lock to
patient line.
9. Remove the filter with gas its from its holder and tap it against the cabinet
several times until all trapped air bubbles have been vented out. Return
the filter to its holder.
Note: The “‘DISPOSABLE” alarm will be activated whenever the filter with gas
vent assembly is removed from its #3 holder.
14

rouble Shooting Hardware
o Power
Make sure that the unit is plugged in and the
power switch is ON.
Make sure that the water tank is filled above
the minimum mark level. Fill or top off the
tank with DISTILLED water only.
Make sure that the air inlet on the bottom of
e unit is not blocked or clogged with dust.

Trouble Shooting Slow Flow Rates
Many factors which are insignificant in low fluid administration are
restrictors of higher flow infusion. If you encounter flow restriction with
any Level 1 Fluid warmer, CHECK EACH OF THESE POSSIBLE
CAUSES.
OLD BLOOD
Stored blood begins to develop particulate within 5 to 7 days. This may
partially block fluid pathways, impeding flow.
FULLY SPIKED BAG |
Bag port membranes may only be split, not compleatiy pierced.
BAG PORT FILTER(if used)
40 micron to 80 micron filters used between the blood bag and the bag
spike of the Disposable set may restrict flow because:
1. Cold, viscous blood does not flow well through small pore filters.
2. As they are directly connected to the source of particulate with no
pre-filtering, they clog quickly.
3. They may trap air which can block filter media surface area.
CLAMPS PARTLY ENGAGED
Check to be sure all clamps are FULLY open.
TUBE SET
Leaving clamps engaged for extended periods of time when the
Disposable Set is not in use (such as pre-set-up) will cause the tubing to
take a SET in the clamped position.
TUBE KINK |
Be sure no tube kinks are present anywhere in the set, especially in the
Y-set when a pressure cuff is employed and the I.V. Pole is used in a
lowered position.
TRAPPED AIR IN FILTER
As noted in the Priming Instructions, remove the Filter from the holder
and tap against the Cabinet to dislodge air bubbles and allow them to
vent out. |
CLOGGED FILTER
If good quality blood is used, this filter should never cause flow
restriction. In the event of a clogged filter, this component may be
changed. See REPLACING FILTERS section of this manual. If frequent
clogging is encountered, discuss the QUALITY of the blood being used
with you Blood Bank.
EXTENSION LINES
Use only extension lines with a bore of .130" (3.3 mm) or larger,
equipped with large bore fittings, such as Level 1 Part No's. X-36 or
Y-30.
STOPCOCK or Y ADAPTER
Any fittings attached to the male luer-lock at the end of the Patient Line
should have large bores. If their bores are smaller than the male
luer-lock bore, they are restrictors.
NEEDLE or CATHETER
if possible, use a minimum 18 Gauge needle or
Smaller sizes will reduce flow.
16