CSZ Hemotherm 400CE User manual

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OPERATION MANUAL

MODEL 400CE DUAL RESERVOIR COOLER/HEATER

Cincinnati Sub-Zero Products, LLC. • 12011 Mosteller Road • Cincinnati, Ohio 45241, U.S.A.

www.cszmedical.com

©

Copyright 2017, Cincinnati Sub-Zero Products, LLC. All rights reserved.

Manual 56075 Rev. G

ECN# M1707-5344

Page 2 of 46

OPERATION MANUAL HEMOTHERM MODEL 400CE

SYMBOLS

Consult instructions for use
and/or manual before operating

Pump

Cool

Heat

Compressor

Water Temp – Heat

Water Temp – Cool

Temperature Set

Low Water

Test Indicators

~

Water Temperature

AC Voltage

Outlet

Return

Drain

Power Cord Holder

Change Water Monthly

Clean Condenser Monthly

Clean Water Filter Quarterly

Equipotentiality

Silence Alarm

High Limit

Low Limit

High Heater

Low Heater

Temperature Limit
Operating Instructions or

“Important/Caution Information”
Decreasing Temperature

Increasing Temperature

Protective Earth

Danger; Risk of Electric Shock

Power Fail

Disconnect Power Before Servicing

Earth (Ground)
Risk of Explosion: Do not use in the

Presence of Flammable Anesthetics
Type BF Equipment

Fill to Screen

Separate collection for electrical and
electronic

Page 3 of 46

OPERATION MANUAL HEMOTHERM MODEL 400CE

HEMOTHERM®

MODEL 400CE

OPERATION MANUAL

Cincinnati Sub-Zero Products, LLC, reserves the right to make equipment changes and
improvements which may not be reflected in this manual.

This document may not be reproduced in whole or in part without written permission from
Cincinnati Sub-Zero Products, LLC.

HEMOTHERM®, GELLI-ROLL®, MAXI-THERM®, MAXI-THERM® LITE, TEMP-PAD® and
PLASTIPAD® are registered trademarks of Cincinnati Sub Zero Products, LLC, Cincinnati,
Ohio USA.

©Copyright 2017, Cincinnati Sub-Zero Products, LLC. All rights reserved.

Page 4 of 46

OPERATION MANUAL HEMOTHERM MODEL 400CE

WARNING

Thermal injury may occur

Frequent observation

Skin damage

may

Proper sanitation procedures must be practiced and hygienic safety must be

Risk of

FILL MODE

A physician's order is required for use and the setting of equipment and blanket
temperature. Check patient's temperature and skin condition of areas in contact with
blanket; also, check blanket water temperature at least every 20 minutes, or as directed by
physician. Pediatric patients, temperature-sensitive patients with vascular disease, surgical
patients, diabetics and Raynaud’s disease patients should be checked more frequently.

Notify the physician promptly of any change in patient status in order to avoid
serious injury or death.

The HEMOTHERM is to be operated by a professionally trained perfusionist – with a
physician’s order for use and the setting of equipment and blanket temperature.
Do not use the HEMOTHERM MODEL 400CE Blankets distal to arterial cross clamping.
Non-observance can lead to thermal injury.

if heating/cooling blankets are used with a patient with an
ischemic limb.
Perfusionist must operate the HEMOTHERM when connected to extracorporeal circuit heat
exchanger. Lack of proper monitoring may result in serious injury or death.
The operator of the unit regulates the desired fluid temperature.
of the actual blood temperature and body temperature is required.
Perfusionist must monitor equipment continually during machine operation to ensure there
are no “alarms or intervention” required. Lack of proper monitoring may result in
serious injury or death.
No modification of this equipment is allowed without prior, written authorization from CSZ.

Failure to do so may result in damage to the HEMOTHERM system and/or patient
injury.

The method of temperature control provided by all cooler/heater units presents the danger
of heating or cooling body tissues, particularly the skin and or blood, to a point where they
are injured, i.e., burns or frostbite, respectively. Depending on the extent and severity of
a burn, very serious and even fatal complications may arise.
Prevent excessive and/or prolonged tissue pressure and shearing forces, especially over
bony prominences. Failure to do so may result in tissue injury.
Do not place additional heat sources between the patient and blanket.
result.
Prep solutions have been reported to injure the skin when allowed to remain between
patients and a water-circulating heating blanket during prolonged procedures. The area

between the patient and the blanket should be kept dry to avoid injury to patient.
maintained, to prevent contamination. Contamination can affect patient’s health, i.e. skin

irritation/rash or sepsis and infection may result.
Upon receipt of the HEMOTHERM, the unit should be disinfected per the WATER
SYSTEM CLEANING & DISINFECTION PROCEDURE. Additionally, any unit removed
from storage should be disinfected. Failure to do so could result in patient and/or

caregiver infection.

Do not use the HEMOTHERM system in the presence of flammable anesthetics.
explosion can result.
Power interruption will cause the HEMOTHERM to revert to
therapy to the patient. Follow instructions for desired mode to resume operation. Failure to

resume therapy could result in serious injury or death.

Page 5 of 46

resulting in no

OPERATION MANUAL HEMOTHERM MODEL 400CE

WARNING

Failure to

Before

after

Any time water is found leaking into or around the unit, connecting hose, and/or blanket,
turn the unit off, disconnect the power cord from its power source, and correct the
problem before proceeding. Water leaks could lead to electric shock. Water leaks
could present a slip and/or fall hazard.
Proper sanitation procedures should be followed including, but not limited to, the
preventative maintenance described in this manual. Leaky blankets or hoses, as well as
unapproved blankets or hoses should never be used. Water leaks present a risk of

infection and should be handled accordingly.

Contaminated blankets or hoses could contaminate the unit. Reusable accessories
should be disinfected on a quarterly basis. Failure to do so could result in patient
and/or caregiver infection.
Exercise extreme caution if the unit is used for patients who are electrically susceptible
(probe, catheter, or electrodes connected to the heart).
Materials of good thermal conductivity, such as water, gel and similar substances on the
blanket, with the HEMOTHERM not switched on may decrease the temperature of the

patient.

Do not position unit near any objects that can generate a strong electrical/magnetic field.
Unit has been investigated to be in compliance with IEC 60601-1-2. Potential
electromagnetic interference may result.
The repair, calibration, and servicing of the HEMOTHERM should be performed by qualified
Medical Equipment Service Technicians, Certified Biomedical Electronics Technicians, or
Certified Clinical Engineers familiar with good repair practices for servicing medical devices,
and in accordance with instructions contained in this manual. Improper repair can result
in damage to the HEMOTHERM system and patient injury.
The HEMOTHERM must be serviced and/or preventive maintenance must be performed at
specific intervals as outlined in the manual. Improper repair and inadequate maintenance
can result in damage to the HEMOTHERM system and patient injury.
Always unplug the unit before accessing internal components during service.
unplug the unit could result in electric shock.

returning the HEMOTHERM to patient use

UP/SYSTEM TEST ROUTINE must always be performed. Improper repair and

inadequate maintenance can result in damage to the HEMOTHERM system and/or
patient injury.

Remove the HEMOTHERM from service if the outer casing or key pad is cracked or internal
components are exposed. Contact with internal components could result in electric

shock or thermal injury to the patient or operator. Additionally, the patient or operator
could be exposed sharp edges.

Before performing any disassembly procedure, be sure the power switch is in the
OFF/”O” position and the power cord is unplugged from the receptacle. Electrical
Hazards may result.
Keep HEMOTHERM grille and condenser clean and free of debris and obstruction. Cool air
is taken in through the grille and warm air is evenly expelled through the bottom of the
unit. Both the air intake and outlet must be kept clear when the machine is in operation.

Blockage of the grille and condenser could result in the unit overheating which could
render the unit unable to provide adequate therapy and excessive surface
temperatures could cause injury to patient or operator. Keep unit, specifically the
grille away from curtains or other obstructions.

Electrical Hazards may result.

repairs, the FIRST TIME SET-

Page 6 of 46

OPERATION MANUAL HEMOTHERM MODEL 400CE

WARNING

Electrical Hazards may

Use only 20 Amp hospital grade receptacles or electric shock may result. (US only)

UL/IEC 60601

-

1 Class I, type BF applied parts

To avoid the risk of electric shock

can increase drug delivery, resulting

Do not use an adapter plug to by-pass the plug ground lug.

result.

The HEMOTHERM unit has
be noted that internal and external electrically isolated components must remain isolated
before, during and after any maintenance or repair. Improper maintenance or repair can
result in patient injury or damage to the HEMOTHERM unit.

mains with protective earth.
Inspect all blankets for mechanical damage before use. Do not use in proximity to sharp
objects. Blanket punctures can result in an increased risk of infection or electrical
shock.
The warming of transdermal medications (patches)
in possible injury to the patient.
If a means is needed in restraining a patient either on or under a CSZ Hyper-Hypothermia
Blanket or the Connecting Hose, the means should not block the fluid pathways of the
HEMOTHERM unit. Failure to do so may result in inadequate treatment.

Immediately remove from service and clean & disinfect devices that show discoloration or
cloudiness in the fluid lines/circuits. Failure to do so could result in patient and/or

caregiver infection.

and it should

, this equipment must only be connected to a supply

Page 7 of 46

OPERATION MANUAL HEMOTHERM MODEL 400CE

CAUTION

•

•

•

•

•

•

•

•

Caution: Federal law restricts this device to sale by or on the order of a physician.
Use only sterile water or water that has been passed through a filter of less than or

equal to 0.22 microns. Do not use deionized water. Do not use alcohol. Alcohol may
cause heat exchanger, blanket, and/or unit deterioration. Do not use tap water to
rinse, fill, refill or top-off water tanks.

Do not operate without water, to avoid damage to internal components.
Do not overfill. Overfilling may result in overflow when the water in the blanket drains

back into the system when the system is turned off.

Be careful to not put any strain on any of the electrical cables connected to the circuit

boards.

Working with electronic boards, plugs, and cables requires delicate handling. Proper

Electrostatic Discharge procedure should be followed during replacement of any
electronic board.

For safe handling and use of chemicals follow manufacturer guidelines.

Page 8 of 46

OPERATION MANUAL HEMOTHERM MODEL 400CE

TABLE OF CONTENTS

Page No.

TECHNICAL HELP ........................................................................................................... 11

AUTHORIZED EUROPEAN REPRESENTATIVE: ........................................................... 11

BEFORE YOU CALL FOR SERVICE... ............................................................................ 11

IN-WARRANTY REPAIR AND PARTS ............................................................................. 11

RECEIVING INSPECTION ............................................................................................... 11

IMPORTANT SAFETY INFORMATION ........................................................................... 11

SHIPPING PARTS ........................................................................................................... 12

WORLDWIDE ORDER PLACEMENT ............................................................................. 12

SECTION 1. INTRODUCTION ........................................................................................ 13

1.1

GENERAL SAFETY PRECAUTIONS ................................................................... 13

1.2

INTENDED USE ................................................................................................... 14

1.3

DESCRIPTION, EXTERNAL FEATURES AND PRODUCT PARTS ..................... 14

1.4

FUNCTION OF HEMOTHERM MODEL 400CE COOLER/HEATER .................... 20

1.5

COOLING SYSTEM ............................................................................................. 21

1.6

HEATING SYSTEM .............................................................................................. 21

1.7

WATER CIRCULATION SYSTEM ........................................................................ 22

1.8

GENERAL OPERATION ...................................................................................... 23

1.9

REMOTE CONTROL OPTION ............................................................................. 27

1.10 HEMOTHERM SYSTEM EQUIPMENT & ACCESSORIES .................................. 27

1.11 HEMOTHERM SYSTEM EQUIPMENT SPECIFICATIONS .................................. 29

1.12 ESSENTIAL PERFORMANCE TABLE ................................................................. 31

1.13 HEMOTHERM CLASSIFICATION AND CERTIFICATIONS ................................. 31

SECTION 2. OPERATING INSTRUCTIONS .................................................................. 35

2.1

INITIAL SET-UP ................................................................................................... 35

2.2

CONNECTION PROCEDURE ............................................................................. 36

2.3

DISPOSAL OF WASTE PRODUCTS ................................................................... 36

2.4

SAFETY CONTROLS .......................................................................................... 37

SECTION 3. MAINTENANCE AND REPAIR .................................................................. 38

3.1

GENERAL ............................................................................................................ 38

3.2

EXTERNAL CLEANING INSTRUCTIONS ............................................................ 38

3.3

TEMPERATURE ACCURACY CHECK ................................................................ 38

3.4

MAINTENANCE OF THE WATER RESERVOIRS ............................................... 39

3.6

MAINTENANCE OF THE WATER FILTER ........................................................... 42

44

3.7

3.8

3.9

MAINTENANCE OF THE CONDENSER GRILLE ................................................ 44

MAINTENANCE OF THE HYPER-HYPOTHERMIA BLANKETS ......................... 44

REMOVE FROM SERVICE ALARM (RFS) .......................................................... 45

3.10 REQUIRED QUARTERLY PREVENTIVE MAINTENANCE CHECKLIST ............ 47

3.11 REQUIRED MONTHLY PREVENTIVE MAINTENANCE CHECKLIST ................. 48

Page 9 of 46

OPERATION MANUAL HEMOTHERM MODEL 400CE

LIST OF ILLUSTRATIONS

Page No.

FIGURE 1-1, UNIT FRONT PARTS VIEW .......................................................................... 15

FIGURE 1-2, KEYPAD – 115V UNIT................................................................................... 17

FIGURE 1-3, KEYPAD – 115V REMOTE ............................................................................ 17

FIGURE 1-4, KEYPAD – 230V UNIT................................................................................... 18

FIGURE 1-5, KEYPAD – 230V REMOTE ............................................................................ 18

Page 10 of 46

OPERATION MANUAL HEMOTHERM MODEL 400CE

TECHNICAL HELP

United States and Canada Telephone ............ 1-513-772-8810

Cincinnati Sub-Zero Products, LLC Toll Free 1-800-989-7373
12011 Mosteller Road Fax [phone]
Cincinnati, OH 45241 Technical Support

Clinical Support 513-460-2038

1-888-437-5608

AUTHORIZED EUROPEAN REPRESENTATIVE:

CEpartner4U, BV
Esdoornlaan 13
3951 DB Maarn
The Netherlands
www.CEpartner4U.com

BEFORE YOU CALL FOR SERVICE...

To help us better serve you, please have the serial number of your HEMOTHERM unit
ready when you call for parts or service. The serial number is located on the side panel
of the unit along with the part number.

IN-WARRANTY REPAIR AND PARTS

All parts on your Hemotherm unit are covered by a one-year warranty. To return defective
parts or units, first obtain a Returned Materials Authorization (RMA) number from our
Medical Technical Service department. A Hemotherm shipping carton will be sent to you,
if needed.

NOTE: There is a service charge for a replacement shipping carton

.

RECEIVING INSPECTION

After unpacking the HEMOTHERM System, be sure to inspect the system for concealed
damage. Retain all packing material and carefully describe or photograph any damage.
Notify the carrier at once and ask for an inspection (in writing). Failure to do this within 15
days may result in loss of claim. Do not return the equipment to Cincinnati Sub-Zero. Call
our Medical Technical Service department for further instructions. Refer to the section
TECHNICAL HELP for phone numbers.

IMPORTANT SAFETY INFORMATION

Refer to this manual for instructions and caregiver information. Read and understand all
precautionary information before using, prescribing, or servicing the HEMOTHERM unit.

In order to minimize risk of contamination and/or infection, the unit should be disinfected
per the WATER SYSTEM CLEANING & DISINFECTION PROCEDURE prior to its first
use and at a minimum on a quarterly basis.

Page 11 of 47

OPERATION MANUAL HEMOTHERM MODEL 400CE

SHIPPING PARTS

Parts to be returned to the factory must be carefully packaged, especially the circuit boards.
These boards should be cushioned in static safe packaging material to prevent damage
from Electro Static Discharge (ESD).

NOTE: SHIPPING DAMAGE WILL BE THE RESPONSIBILITY OF THE SHIPPER. INSURE IF

NECESSARY.

NOTE: IF CIRCUIT BOARDS ARE NOT SHIPPED IN STATIC SAFE PACKAGING, WARRANTY

WILL BE VOID.

If shipping complete unit, to avoid freezing or damage to packaging, the entire system

must be drained before shipping.

Worldwide Order Placement

United States and Canada Telephone ........ [phone]

(U.S.) Toll Free ........ 1-800-989-7373

Fax ................. 1-513-772-9119

Healthlink Europe
Burgemeester Burgerlaan 40
5245 NH Rosmalen (Den Bosch)
The Netherlands

Page 12 of 47

OPERATION MANUAL HEMOTHERM MODEL 400CE

SECTION 1. INTRODUCTION

To provide the maximum patient safety during the use of the HEMOTHERM Model 400CE
Dual Reservoir Cooler/Heater system, a thorough knowledge and understanding of the
system, and its correct application and operating use are required. Each person who is
responsible for use or direction of use of the system, such as physicians, perfusionists,
technicians and operators must read and understand this operating manual and all
precautions and warnings prior to use. It is recommended that this manual be reviewed at
least semi-annually as a refresher for safe operation and application. For proper knowledge
and understanding, in-service is available upon request.

All service associates, who interface with this equipment, must read and understand this

Operation Manual in its entirety prior to maintaining or operating the equipment.

1.1 GENERAL SAFETY PRECAUTIONS

The HEMOTHERM has internal self-diagnostics that could prevent the equipment from
operating improperly. The most serious of these are the Remove from Service (RFS)
alarms. The RFS alarms will require the equipment to be repaired immediately. They are
indicated by an “EE” on the Heat side temperature display and a number on the Cool side
temperature display. Too high of a temperature in the heat reservoir is also an RFS alarm
and will be indicated by the appropriate red LED indicator. All RFS alarms will be
announced by an audible alarm that cannot be muted.

High and low temperature limiting thermostats are preset at the factory and should
perform satisfactorily for the life of the HEMOTHERM unit. Except for refrigeration
component repairs, the repair and servicing of the HEMOTHERM unit requires no special
tools. However, no attempt should be made to perform any of the repairs or service
procedures outlined in this manual unless the proper skills and knowledge are
possessed.

If water is found leaking into or around the HEMOTHERM unit prior to or during the
operating procedure discussed here, immediately disconnect power to the unit and
correct the malfunction before proceeding.

Before performing any disassembly procedure, press the power switch to the OFF/“O”
position and unplug power cord from receptacle.

Exercise extreme caution if this equipment is used on electrically susceptible patients
(probe, catheter or electrodes directly connected to the heart). Always test for current
leakage before returning unit to service. Additional warnings are expressed at
appropriate points in the manual.

See the Warnings and Cautions in the front of this manual.

Page 13 of 47

OPERATION MANUAL HEMOTHERM MODEL 400CE

1.2 INTENDED USE

The HEMOTHERM® Model 400CE Dual Reservoir Cooler/Heater is used to lower,
maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat
Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures
lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be
used with a hyper / hypothermia blanket under the patient to provide warming through
conductive heat transfer.

The HEMOTHERM is capable of delivering temperature controlled water to blood heat
exchanger(s) and one (1) blanket in the full range of controllability between 3°C - 42°C.

There are many variables that affect the heating or cooling of the patient in the
extracorporeal circuit. Some of these include the patient's weight, blood flow, gas flow
and oxygenator/heat exchangers. The HEMOTHERM has been designed to provide high
water flow rates at low pressure for safe and highly efficient operation with a blood
oxygenator/heat exchanger.

The HEMOTHERM can help maintain normal body temperature (normothermia)
particularly during lengthy surgical procedures or where the ambient (room) temperature
is set low. This can be done with the use of a Hyper-Hypothermia blanket underneath the
patient.

1.3 DESCRIPTION, EXTERNAL FEATURES AND PRODUCT PARTS

The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater consists of a primary unit
that has a water cooling system and a water heating system. These share a common
pump, filter and distribution outlet connections. Each water cooling/heating system has
its own reservoir, cooler/heater hardware, water level switch, temperature sensor and
associated plumbing.

Page 14 of 47

OPERATION MANUAL HEMOTHERM MODEL 400CE

FIGURE 1-1, UNIT FRONT PARTS VIEW

Reference Figure 1-1, Unit Front Parts View

1. HANDLES - The handles permit the operator to grip the unit when moving.

2. CONTINUOUS HINGE – Provides durable smooth lid operation.

3. RESERVOIR LID – Covers the reservoir area.

4. LID HANDLE – Allows the user to easily grip the lid for opening.

5. 1/2 INCH QUICK-CONNECT PLUG OUTLET – This fitting is for the connection of the

tubing that is connected to the user provided heat exchanger.

6. 1/8 INCH QUICK-CONNECT PLUG OUTLET – This fitting is for the connection of the

tubing that is connected to the user provided optional blanket.

7. 1/2 INCH QUICK-CONNECT SOCKET INLET – This fitting is for the connection of the

tubing that is returned from the user provided heat exchanger.

8. 1/8 INCH QUICK-CONNECT SOCKET INLET – This fitting is for the connection of the

tubing that is returned from the user provided optional blanket.

9. MAINS POWER CORD – For connection to the mains power receptacle.

Page 15 of 47