Kimberly-Clark M1000 User manual

Kimberly-ClarK*
Patient Warming System .
M1000 Control Unit
Operator’s Manual: U.S.

1
Preface
Customer Information & Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
chaPter One
1.1 Introduction........................................................ 4
1.2 SymbolsandStandards.............................................. 4
1.3 EnvironmentalConditions............................................ 6
1.4 IndicationsforUse.................................................. 6
1.5 ContraindicationsforUse............................................ 6
1.6 GeneralWarnings................................................... 6
1.7 Cautions........................................................... 7
chaPter twO
2.1 KIMBERLY-CLARK*
Patient Warming System M1000 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2 System Diagram of the Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.3 KIMBERLY-CLARK* Patient Warming System M1000
Control Unit User InterfacesControl Unit User Interfaces . . . . . . . . . . . . . . . 11
2.4 ModesofOperation................................................ 11
2.5 CustomMenuKeys ................................................ 12
2.6 Patient Temperature Trend Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.7 Patient Temperature Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.8 FluidDeliveryLines ................................................ 13
2.9 PatientTemperatureProbes......................................... 14
2.10 Patient Temperature Output (Echo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
chaPter three
3.1 OperatingInstructions.............................................. 15
3.2 StartUp........................................................... 15
3.3 Filling the KIMBERLY-CLARK*
Patient Warming System M1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.4 Placement of the KIMBERLY-CLARK*
Patient Warming System M1000 Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.5 SettingCustomParametres......................................... 17
3.6 Pre-warming of the KIMBERLY-CLARK*
Patient Warming System M1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.7 Connecting the Thermal Pads to the Fluid Delivery Lines. . . . . . . . . . . . . . . . 20
3.8 ThermalPadSelection ............................................. 20
3.9 ThermalPadPlacement ............................................ 21
3.10 Treating a Patient in Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.11 Treating a Patient in Manual Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.12 CompletingaProcedure............................................ 26
Table of Contents
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.

2
3.13 Interrupting Treatment for Patient Transport or Relocation . . . . . . . . . . . . . . 26
3.14 Collecting Data from the RS232 Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
chaPter fOur
4.1 Maintenance and Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.2 Draining the KIMBERLY-CLARK*
Patient Warming System M1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.3 Cleaning the KIMBERLY-CLARK*
Patient Warming System M1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.4 Cleaning/Replacing Fluid Delivery Line Filter . . . . . . . . . . . . . . . . . . . . . . . . . . 29
chaPter five
5.1 AlarmsandAlerts.................................................. 30
5.2 Troubleshooting ................................................... 32
aPPendices
A. Installation&TestProcedure........................................ 35
B. Alarms/Alert: Descriptions and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 38
C. Alarm/AlertTable.................................................. 39
D. SpecificationTable................................................. 47
E. ProductList....................................................... 48
F. DataOutput....................................................... 49
Table of Contents
(continued)
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.

3
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
This Operator’s Manual provides a detailed discussion of the KIMBERLY-CLARK*
Patient Warming System M1000 Control Unit, its components, and relevant acces-
sories. The Patient Warming System provides a safe and effective way of modifying
patient temperature, providing precise temperature control using a novel approach.
The Patient Warming System M1000 Control Unit is equipped with numerous safety
features, such as temperature and system alarms and alerts, and programming of
maximum or minimum water temperatures. Reading and understanding
this Operator’s Manual will help to guide the user to providing the maximum
performance of the Patient Warming System in a safe manner.
CAUTION: This product is to be used by or under the supervision of trained,
qualified medical personnel.
custOmer infOrmatiOn and technical suPPOrt
Kimberly-Clark hours of operation are 8 am to 5 pm Eastern Standard
Time. For service please call your sales representative or 1-800-KC-HELPS.
Educational materials, such as training programmes for in-house staff, operator
manuals, quick reference guides, and a bibliography of relevant materials are
available to all Kimberly-Clark customers through your Kimberly-Clark sales
representative.
Prior to using the KIMBERLY-CLARK* Patient Warming System M1000, a
Kimberly-Clark representative will provide on-site in-services to ensure adequate
training has occurred. Additional requests for technical support, information or
orders may be placed by mail, fax, or by calling Kimberly-Clark customer service.
Model No. KIMBERLY-CLARK* Patient Warming System M1000
Phone: [phone]
Fax: [phone]
Address: 1400 Holcomb Bridge Road
Roswell, GA 30076
Internet: www.kchealthcare.com
Preface

4
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
The KIMBERLY-CLARK* Patient Warming System has been designed to monitor and
control patient temperature. The indications for use of the device include any con-
dition where patient temperature control within the range covering mild hypother-
mia to normothermia is required. The system consists of M1000 Control Unit, Fluid
Delivery Line, Thermal Pads and other associated accessories. Using a novel direct
heat conduction approach, the Patient Warming System aids in the elimination of
unplanned hypothermia.
Unplanned hypothermia may occur for a variety of reasons, including exposure to
cold environments, brain injury, or complex surgical procedures. During surgery, a
patient typically experiences mild hypothermia due to the effect of general
anaesthesia on the body’s thermoregulatory system and prolonged exposure of
internal organs. Mild hypothermia in the medical or surgical patient has been proven
to prolong the time to extubation, contribute to coagulopathies, increase the chance
of infection, and increase cardiac demand as a result of shivering.1
The use of the Patient Warming System is designed to be an effective means of
counteracting this drop in patient temperature by applying heat to the patient
through a set of patented thermally conductive foam pads.
The KIMBERLY-CLARK* Patient Warming System meets the electrical safety require-
ments of IEC 60601 and UL 2601, the relevant safety standard for electrical medical
devices. The control unit has also been tested to meet both the electromagnetic
interference and susceptibility requirements of IEC 60601-1, and is compatible with
other equipment that also currently conforms to that standard. There is no known
failure mode in the Patient Warming System M1000 Control Unit associated
with electromagnetic interference from other devices.
The Patient Warming System M1000 Control Unit bears the following symbols affixed
to the system. (see Table 1)
1Schwab S. Schwart S. Spranger M, et al. Moderate Hypothermia in theTreatment of
Patients with Severe Middle Cerebral Artery Infarction. Stroke 1998;29 (12): 2461-6
1.1 Introduction
1.2 Symbols and
Standards

For the safe and effective use of this device, the operator
must consult the accompanying documents prior to use.
This symbol adjacent to the patient connections means that
the thermal probe connection is a “Defibrillator-Proof, Type
BF Applied Part,” per standard IEC 60601-1 and affords the
degree of patient protection defined in that standard for this
type of applied part.
The Entela Monogram means that the control unit has
been Certified for Safety by Entela, Inc. against standard IEC
60601 and UL 2601.
Identifies the equipotential terminal on the equipment, which
is intended to be connected with the equipotential terminal(s)
on one or more other types of equipment in close proximity, in
order to bring all pieces of equipment
to the same potential for safety purposes.
Indicates high temperature part or component.
Indicates that only sterile or distilled water should be used
when filling the Patient Warming System M1000 Control Unit.
Identifies Patient Temperature 1, the primary patient
temperature probe input.
Identifies Patient Temperature 2, the secondary patient
temperature probe input.
Identifies the drain port.
Identifies the heater fuse.
Identifies the storage relative humidity range.
Indicates electrical hazard.
Indicates Earth Ground.
Indicates sharp object.
Manufactured Date
5
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
Table 1
1.2 Symbols and
Standards
(continued)
2005-01

6
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit should be
stored and used within the following specific operating conditions:
Ambient temperAture rAnge:
Operating Temperatures: 10ºC to 27ºC (50º to 80ºF)
Storage Temperatures: -30ºC to 50ºC (-20º to -120ºF)
NOTE: At higher room operating temperatures, the cooling capability is
compromised and the ability to cool a patient may be compromised. Therefore,
the unit’s cooling capacity is de-rated at an ambient temperature above 27ºC (80ºF).
Ambient Humidity rAnge:
Operating: 5% to 70% relative humidity, non-condensing
Storage: 5% to 95% relative humidity, non-condensing
The Patient Warming System is intended for monitoring and controlling
patient temperature. The indications for use of the device include any condition
where patient temperature control within a range covering mild hypothermia to
normothermia is required.
There are no known contraindications for the use of a thermoregulatory system.
The KIMBERLY-CLARK* Thermal Pads should not be placed on skin that is ulcerated,
burned, is poorly perfused or non-perfused, or has the appearance of rash. While
there are no known allergies to the hydrogel materials used in this product, caution
should be exercised with any patient who has a history of skin allergies or sensitivities.
CAUTION: This product is to be used by or under the supervision of trained,
qualified medical personnel.
❚ Do not use the KIMBERLY-CLARK* Control Unit in the presence of flammable
agents because an explosion and/or fire may result.
❚ Kimberly-Clark will not be responsible for patient safety or equipment
performance if the procedure to operate, maintain, modify or service the
Control Unit is other than those specified by Kimberly-Clark. Anyone
performing the procedures must be appropriately trained and qualified.
❚ There is a risk of electrical shock and hazardous moving parts. Refer servicing
to qualified personnel.
❚Power cable has a hospital grade plug. Grounding reliability can only be achieved
when connected to an equivalent receptacle marked “hospital use”
or “hospital grade.”
❚ When using the Patient Warming System, note that any other thermal conductive
systems, such as water blankets and water gels, in use while warming or cooling with
the Patient Warming System may alter or interfere with patient temperature control.
1.3 Environmental
Conditions
1.4 Indications
for Use
1.5 Contraindications
for Use
1.6 General Warnings

7
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
❚This product is to be used by or under the supervision of trained, qualified medical
personnel.
❚The operator is responsible for determining the appropriateness of user-settable
parameters.
❚The KIMBERLY-CLARK*Patient Warming System M1000 Control Unit must be used
only with the KIMBERLY-CLARK* Thermal Pads.
❚The Thermal Pads are non-sterile. If used in a sterile environment, pads should
be placed according to the physician’s request, prior to the sterile preparation or
sterile draping. Thermal Pads should not be placed in a sterile field.
❚The Control Unit will control and monitor core temperature using an indwelling
temperature probe attached to the system – Kimberly-Clark recommends
the use of a second site to verify core temperature while controlling and
monitoring patient temperature.
❚It is the sole responsibility of the clinician operator to monitor patient
temperature when in Manual Mode and to adjust the water temperature
target appropriately.
❚Federal law (USA) restricts this device to sale by or on the order of a physician.
❚The Control Unit will not control the patient’s temperature in Manual
Mode (Water Temperature Control). Ensure that the selected target water
temperature is appropriate for the patient’s temperature. Since patient
temperature is not controlled in Manual Mode, patient temperature should be
monitored at regular intervals during prolonged warm water or cold water treat-
ment to minimise over-warming or over-cooling the patient.
❚Any device connected to the RS232 data port must comply with the applicable
standards for that device.
❚Patient temperature will not be controlled and alarms are disabled in Stop Mode.
Patient temperature may increase or decrease with the KIMBERLY-CLARK*
Patient Warming System M1000 Control Unit in Stop Mode.
❚Do not place Thermal Pads over an electrosurgical grounding pad. The
combination of heat sources may result in skin injury.
❚The Thermal Pads must be changed after 24 hours of use. If thermal treatment is
to continue, a new set of pads should replace the old pads.
❚Do not allow circulating water to contaminate the sterile field if pad lines are
disconnected. The circulating water is non-sterile.
❚The pads are non-sterile for single patient use. Do not reprocess or sterilize.
❚Do not puncture the pads with sharp objects. Punctures will result in air
entering the fluid pathway and may reduce performance.
1.7 Cautions

8
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
❚Use only distilled or sterile water. The use of other fluids may damage the Patient
Warming System M1000 Control Unit.
❚Skin injury may occur as a cumulative result of pressure, time and temperature.
Do not place a bean bag or other firm positioning devices under the pads.
Do not place positioning devices under the pad manifolds or patient lines.
❚Due to underlying medical or physiological conditions, some patients are more
susceptible to skin damage from pressure and heat or cold. Patients at risk
include those with poor tissue perfusion or poor skin integrity due to diabetes,
peripheral vascular disease, poor nutritional status, steroid use or high dose
vasopressor therapy.
❚If accessible, examine the patient's skin under the pads often, especially those at
higher risk of skin injury.
❚If warranted, use pressure relieving or pressure reducing devices under the
patient to protect from skin injury.
❚Do not allow antibacterial agents to pool underneath the pads. Excess
antibacterial agents can absorb into the pad adhesive and cause chemical
burns and loss of pad adhesion.
❚Carefully remove pads from the patient's skin at the completion of use.
❚Carefully observe the system for air leaks in the system before and during use.
If the pads fail to prime or a significant continuous air leak is observed in the pad
return line, check connections. If needed, replace the leaking pad. Leakage may
result in lower flow rates and potentially decrease the performance of
the system.
❚The top of the controller must be placed at a level15 cm to 90 cm (6 in. to 36 in.)
below the patient to ensure proper fluid flow.
❚Users should not use cleaning or decontamination methods different from those
recommended by the manufacturer without first checking with the
manufacturer that the proposed methods will not damage the equipment.
❚It is advisable not to cancel the alarm or alert until the situation is resolved. If an
alarm is cancelled and the condition has not been cleared, the alarm will recur.
If an alert is cancelled and the alert condition has not been cleared, the alert will
not recur unless the Stop Mode is activated.
1.7 Cautions (continued)

9
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit is a CLASS I
(Type BF, IPX0 and Mode of Operation - Continuous) portable device per classifica-
tion scheme of IEC 60601 (UL 2601).
The Patient Warming System is a thermoregulatory device that monitors and
controls patient temperature within a range of 33°C to 37°C (91.4ºF to 98.6ºF). The
control unit pulls temperature-controlled water ranging between ambient tempera-
ture to 42°C (68ºF to 107.6ºF) through the Thermal Pads at approximately one liter
per minute per pad. This results in heat exchange from the water to the patient.
The system functions in either Automatic Mode or Manual Mode. In Automatic Mode,
a patient temperature probe is connected to the Patient Warming System M1000
Control Unit and provides feedback to an internal control algorithm. This control
algorithm then modifies the water temperature (thus pad temperature) to reach a
pre-set patient temperature target determined by the clinician. In Manual Mode, the
feedback control algorithm is not activated. The operator adjusts the temperature of
the water delivered to the pads to achieve the appropriate patient temperature.
The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit must
be used only with the KIMBERLY-CLARK* Thermal Pads. The pads are thin, con-
formable, and anatomically shaped to cover areas of the patient's skin. They come
in non-sterile kits in sizes to cover a broad range of patients, fit both males and
females, and are for single patient use only. Each pad has an inlet and an outlet
connection that attaches to a fluid delivery line. The pads allow water to flow
within an internal pathway across its surface to provide even, efficient heat transfer
between the skin and water. The pads adhere to the patient by the use of a skin
compatible hydrogel adhesive which maintains its adhesion level over extended
periods. The biocompatible hydrogel material consists of approximately 50% water
and is a good thermal conductor. The pads can be removed and replaced on the
patient's skin if repositioning is needed. The back of each pad is insulated to
minimise heat loss to the environment and condensation when cooling.
The Thermal Pads contain no natural rubber latex.
The Patient Warming System M1000 Control Unit (Figure 1) can be placed
in various locations while being controlled from a remote display panel.
The Control Unit is mounted on a four-wheel independent locking action
cart with an adjustable height stand.
2.1 Kimberly-ClArK*
Patient Warming
System M1000
Description
Figure 1
When in use, the display
module can be separated
from the control module
and placed in a convenient
position. The display
module can also be
attached to the handle for
easy visibility.

10
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
Below is a diagram (Figure 2) of the KIMBERLY-CLARK* Patient Warming System
M1000 Control Unit showing the connection ports for the associated accesso-
ries. The Fluid Delivery Line, Primary and Secondary Patient Temperature Cables,
Temperature Output Cable, Remote Display Cable, and the Power Cable are all
connected to the rear of the control unit. The lengths of these accessories are
found in Table 2.
1 Power Switch
2 RS232 Data Port
3 Latch Handle
4 Fluid Delivery Line Port (Manifold)
5 Fill Port
6 Reserved for future use
7 Patient Temperature 1 Input
8 Patient Temperature 2 Input
9 Patient Temperature Output (Echo)
10 Fill Tube Clip
11 Drain
12 Power Cable Storage
13 Heater Fuse
14 Equipotential Terminal
15 Power Cable Connection
Figure 2
2.2 System Diagram
of the Controller
2
13
14
15
1
12
11
10
9
8
7
6
4
5
3
Accessories Metres Feet
Remote Display Cable (standard) 1.1 metres 42 feet
Remote Display Cable (optional) 4.6 metres 15 feet
Power Cable 4.6 metres 15 feet
Water Supply Lines 3.0 metres 10 feet
Temperature Input Cables 3.0 metres 10 feet
Temperature Output Cable (pigtail) 13 centimetres 5 inches
Fill Tube 0.6 metres 24 inches
Table 2

11
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
The Patient Warming System M1000 Control Unit can be operated from remote loca-
tions by attaching the User Interface (Figure 3) to an IV pole or other suitable holder.
The User Interface is connected to the Patient Warming System M1000 by a 1.1
metre (42 inch) cable. A 4.6 metre (15 foot) cable is also available.
Figure 3
Kimberly Clark
*
There are four principle modes of operation. These can be accessed by
pressing any of the four keys on the lower right side of the display: Automatic,
Manual, Purge, and Stop. Each key represents a unique function of the
KIMBERLY-CLARK* Patient Warming System M1000 Control Unit.
autOmatic mOde:
The Automatic Mode monitors and controls the patient’s temperature to a set target
temperature. Water will be cooled or warmed as needed and pulled through the
Thermal Pads to achieve the pre-set patient target temperature. Patient temperature
can be controlled and monitored between 33°C and 37°C (91.4ºF and 98.6ºF).
NOTE: The system will not go into Automatic Mode unless a patient’s temperature
probe is inserted into a patient and attached to the control unit.
CAUTION: The Control Unit will control and monitor core temperature using an
indwelling temperature probe attached to the system. Kimberly-Clark
recommends the use of a second site to verify core temperature while
controlling and monitoring temperature.
manual mOde:
The Manual Mode is functional with or without a patient temperature probe placed.
Water temperature is established and managed by the operator. Patient tempera-
ture is not controlled in Manual mode. The operator must monitor patient tempera-
ture when Manual Mode is active. Water temperature can be modified during the
Manual Mode Operation.
NOTE: Manual Mode can be used prior to placement of a temperature probe or
transition to Automatic Mode.
2.3 KIMBERLY-CLARK*
Patient Warming
System M1000
Control Unit User
Interfaces
2.4 Modes of
Operation

12
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
The KIMBERLY-CLARK* Patient Warming
System M1000 Control Unit control
settings can be adjusted through a
series of menu options displayed
on the LCD screen at the top of the
user interface.
The Menu Control Keys are used to scroll through the various menu options and
adjust settings.
dOwn Or uParrOw
When in Stop Mode, these keys allow the operator to review custom menu options
and display screens. The arrows are also used for adjusting settings for the custom
options. During Manual Mode, these arrows provide access to the Water Target
Temperature Modification Screen.
enter Key
The Enter Key is used to accept modifications or enter changes to a custom
parameter.
hOme Key
Pressing the Home Key returns the screen to the Main Menu when in any
custom display screen. This key does not accept modifications or changes.
alarm Key
The Alarm Key is illuminated when situations arise that may pose a safety issue for
the patient or if the system is not performing to its proper specification. To silence
or acknowledge an alarm or alert, press the Alarm Key.
Kimberly Clark
*
Purge mOde:
The Purge Key removes water from the Thermal Pads. Water flows from the Thermal
Pads back to the reservoir prior to disconnection, which minimizes
leakage and reduces the amount of water remaining in the pads.
NOTE: Pads should be emptied prior to a Fill Cycle. Failure to empty pads before
filling may result in inadequate emptying of the pads, or overfilling the device.
stOP mOde:
The Stop Key halts all modes of operation. During power up and alarm states,
the system defaults to a Stop Mode. While in Stop Mode, all of the customisable
machine settings can be adjusted.
CAUTION: Patient temperature will not be controlled in Stop Mode. Patient
temperature may increase or decrease with the Patient Warming
System M1000 in Stop Mode. Alarms are not enabled in the Stop Mode.
2.4 Modes of
Operation
(continued)
2.5 Custom
Menu Keys

13
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
The Patient Temperature Trend Indicator reflects the change in the patient’s temper-
ature over the previous five minutes. Flashing Up arrows indicate patient tempera-
ture is increasing. Flashing Down arrows indicate patient temperature is decreasing.
The Patient Temperature Display indicates temperature from Patient Temperature
1 in degrees Centigrade (C) or degress Fahrenheit (F). The display units can be
changed in the custom parameter menu found under Setup when in Stop Mode. The
temperature range that can be displayed is between 10°C and 42°C (50ºF to 108ºF).
Water flows from the KIMBERLY-CLARK* Patient Warming System M1000 Control
Unit to the thermal pads through the Fluid Delivery Line that connects to the back
of the control unit. The Fluid Delivery Line is reusable and should only be replaced
if defective (see Section 5.2 Troubleshooting). The Fluid Delivery Line comes in two
configurations accepting either 2 pads (Part # 00834-04) or 4 pads (Part # 00834-05).
• Center circle no change or less than 0.25ºC (0.45ºF)
change per hour
• One arrow (up or down) – 0.25ºC to 0.5C (0.45ºF to 0.96ºF)
change per hour
• Two arrows (up or down) – 0.5ºC to 0.75ºC (0.96ºF to 1.35ºF)
change per hour
• Three arrows (up or down) – 0.75ºC to 2.0ºC (1.35ºF to 3.6ºF)
change per hour
• Three arrows flashing simultaneously – > 2.0ºC (> 3.6ºF)
change per hour
2.6 Patient
Temperature
Trend Indicator
2.7 Patient
Temperature
Display
2.8 Fluid Delivery
Lines
Figure 4 Patient Temperature Trend Indicator
Fluid Delivery Line Port

14
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
To run the Patient Warming System M1000 Control Unit in Automatic Mode, an
indwelling temperature probe must be placed into the patient and connected to the
control unit. The control unit comes with an adapter cable to connect to the patient
temperature probe. This temperature probe cable adapter is inserted in the Patient
Temperature 1 Input port in the rear of the machine (Figure 2). Two types of adapter
cables are available: one for 2-pin connections (Nellcor/SIMS) and one for a single
jack connector (Bard).
The control unit only works with Yellow Springs Instrument 400 Series (YSI 400)
thermistor compatible patient temperature probes. These probes include
nasopharyngeal, esophageal, tympanic, rectal, or bladder probes. Refer
to the temperature probes’ Manufacturer’s Instructions for Use for the specific
indications and placement of these probes.
A second patient temperature probe, identified as Patient Temperature 2, may be
connected to the Patient Warming System M1000 Control Unit to provide patient
temperature monitoring from a second patient site. The adapter is similar to Patient
Temperature 1 and is inserted into the appropriately labelled connector directly
below the Patient Temperature 1 port.
NOTE: Patient temperature is not controlled from the secondary patient temperature
probe. The secondary patient temperature probe is a backup patient temperature
monitor for increased patient safety in those instances when patient temperature is
not constantly monitored by the clinician. The secondary probe will alarm and
shut down the control unit if the primary probe is dislodged or fails.
The Patient Warming System M1000 will output Patient Temperature 1 (the
primary patient temperature) input reading to a YSI 400 compatible hospital monitor
using the Patient Temperature Output (Echo). An adapter for use with various
temperature probe cables (similar to the patient temperature adapter cables)
included with the installation kit, can be inserted into the Patient Temperature
Output (Echo) port in the rear of the machine. The temperature displayed on the
Patient Warming System M1000 Control Unit and monitor represents the same
temperature but may not be identical due to calibration differences between the
control unit and the monitor.
2.9 Patient Temperature
Probes
2.10 Patient
Temperature
Output (Echo)

The KIMBERLY-CLARK* Patient Warming System offers an easy efficient way of
managing patient temperature. The sophisticated control algorithm works to modify
patient temperature precisely and accurately. It is essential that the clinician review
the patient's medical history, inspect the skin integrity, and determine the adequacy of
tissue perfusion prior to treating with the Patient Warming System. The clinician can
then adjust the specific parameters prior to cooling or warming the patient.
To begin using the Patient Warming System M1000 Control Unit, press the ON/OFF
Switch to the ON position. The system will go through a brief self-diagnostic system
check and check the water level in the reservoir. When finished, the display will read
“Kimberly-Clark Patient Warming System.” This is the Main Menu or “Home” Screen.
When the Patient Warming System M1000 Control Unit is turned to the ON position,
a power up test for the independent safety alarm is automatically run. The audio
alarm will sound and the alarm indicator will illuminate during setup. The operator
must verify that both are operational before operating the system. For additional
information on alarms, see Appendices B and C.
WARNING: Do not use the Patient Warming System M1000 in the presence of
flammable agents because an explosion and/or fire may result.
WARNING: Power cable has a hospital grade plug. Cable grounding reliability can
only be achieved when connected to an equivalent receptacle marked
"hospital use" or "hospital grade."
The water level is displayed at a variety of times: when the system is powered on;
after completion of a fill; after the pads are emptied or purged; and, when accessing
the Fill Screen from the custom menu. The levels displayed are as follow:
The KIMBERLY-CLARK* Patient Warming System M1000 Control Unit can be
operated at any level except when reading Water Level Empty.
CAUTION: Use only distilled or sterile water. The use of other fluids may damage
the Patient Warming System M1000.
NOTE: If Alarm 4 or 5 is activated when the unit is turned on, silence the alarm by
pressing the flashing alarm button. Perform the following procedure to fill the unit
before operating. Additionally, if Alert 3 (Low Fluid Level) sounds, Kimberly-Clark
recommends filling the unit as well.
3.2 Start Up
3.3 Filling the
Kimberly-ClArK*
Patient Warming
System M1000 Water Level Action
Full Do not add water
3/4 Full Add approximately 0.5 liters
1/2 Full Add approximately 1.0 liters
Water Level Low Add approximately 1.5 liters
Water Level Empty Add approximately 2.0 liters
Initial Installation & refill after cleaning Use approximately 3 liters
Table 3
3.1 Operating
Instructions
15
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.

Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
To fill the KIMBERLY-CLARK* Patient Warming System M1000, take the
following steps:
1. Obtain approximately 2.0 liters of distilled or sterile water.
2. Locate the Fill Tube on the back of the controller and to the lower left
of the Fluid Delivery Line (see Appendix E Parts Table for part number for
reordering). NOTE: Fluid Delivery Line Port (Figure 2) must have either a fluid
delivery line without pads or manifold plug attached in order to properly fill
the tank.
3. Press the Home Key. Then press the down arrow until the fill screen appears:
“Water Level Empty. Enter to Fill.” Press Enter to proceed.
4. The display screen will read: “Place the Fill Tube in the container of water.
Press Enter to fill.” Place the end of the fill tube in the container of water.
5. Press Enter again and the Patient Warming System M1000 will automatically
fill until the reservoir is full. The fill tube may have to be held in the container
to ensure adequate suction.
6. The screen will read “Fill Complete.” Press Enter and remove the Fill Tube
from the container. Keep the fill tube connected to the Control Unit.
7. Press Home to return to Main Menu.
NOTE: Pads must not be connected to the fluid delivery line while filling the unit.
The filling cycle can be terminated at any point during the filling process by pressing
Stop. If the filling cycle is stopped prior to completion, the reservoir will have a
volume less than full and may require more frequent filling. The number of proce-
dures that can be conducted prior to filling depends on the number of pads used
and the amount of water remaining in the pads after a Purge cycle is completed.
To avoid overfilling, do not fill the KIMBERLY-CLARK* Patient Warming System
M1000 Control Unit unless pads have been emptied by pressing the Purge Key.
If the reservoir is filled prior to emptying the pads, the reservoir may be full and
may not allow a full Purge to occur. An incomplete Purge may result in excess
water remaining in the pads.
In the event of a power failure or shutdown of the system, the reservoir may read
EMPTY if the pads are filled with water. Press Purge to refill the reservoir and then
resume treatment.
The control unit has been designed to take up a minimal amount of space and to
be easily moved to an appropriate location in the Operating Suite. To ensure proper
operation, the top of the unit should be located 15 cm to 90 cm (6 in. to 36 in.) below
the patient to ensure proper flow. Maintaining the reservoir lower than the patient
also minimises accidental leakage in the event of puncture or disconnection of the
fluid delivery lines.
CAUTION: The top of the controller must be placed at a level 15 cm to 90 cm below
the patient to ensure proper flow.
3.3 Filling the
Kimberly-ClArK*
Patient Warming
System M1000
(continued)
3.4 Placement of the
Kimberly-ClArK*
Patient Warming
System M1000
Control Unit
Fill Tube
Fluid Delivery
Line Port
16

17
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
The Patient Warming System M1000 Control Unit is shipped with default settings
(see Tables 4-6 below), which may be modified as needed. Settings can be changed
for individual patients or procedures, or permanently changed to create new
default settings.
Prior to using the Patient Warming System on a patient, it is important to verify that
all parameters are appropriately set for the particular patient or procedure, including
maximum water temperature in Automatic Mode.
Table 4 indicates the parameters, the default settings, the available ranges of settings,
and incremental changes. When pressing the Down arrow, the parameters that are
displayed are shown in order of their appearance.
3.5 Setting Custom
Parameters
Patient Target XX°C
Automatic Mode/
(Default-37°C) (98.6ºF)
Water Target XX°C
Manual Mode/
(Default-37°C) (98.6ºF)
Water Level
Maximum Water XX°C
Automatic Mode
(Default-42°C) (107.6ºF)
Minimum Water XX°C
Automatic Mode
(Default-4°C) (39.3ºF)
Set desired target
patient temperature in
Automatic Mode.
Set desired water
temperature in Manual
Mode.
Shows the level of
the water in the
reservoir at any given
time. This reading is
updated during purge,
fill cycle & power on.
Set the maximum
water temperature
the system will use
to control patient
temperature in
Automatic Mode.
Set the minimum
water temperature
the system will use
to control patient
temperature in
Automatic Mode.
33°C-37°C
(91.4ºF to 98.6ºF)
20°C-42°C
(68ºF to 105.8ºF)
Empty to Full
32°C-42°C
(89.6ºF to 107.6ºF)
20°C-32°C
(68ºF to 89.6ºF)
0.1°C (0.1ºF)
increments
1.0°C (1.0ºF)
increments
Empty, Low, Full
1.0°C (1.0ºF)
increments
1.0°C (1.0ºF)
increments
Parameter–Default Explanation Range Resolution
Table 4
Setup provides a second tier of user-defined options that pertain to equipment
settings that may require less frequent changes. (See Tables 5 and 6)
Patient High Alert XX°C
Automatic Mode
(Default 42°C) (107.6ºF)
Patient Low Alert XXºC
Automatic Mode
(Default 10°C) (50ºF)
Defines the tempera-
ture limit at which the
system should issue
an alert if the patient
temperature exceeds
that limit.
Defines the tempera-
ture limit at which the
system should issue
an alert if the patient
temperature falls
below that limit.
10.1°C- 42.0°C
(50.1ºF to 107.6ºF)
10.0°C- 41.9°C
(50ºF to 107.5ºF)
0.1°C (0.1ºF)
0.1°C (0.1ºF)
Incremental
Parameter–Default Explanation Range Changes
Table 5

18
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
3.5 Setting Custom
Parameters
(continued) Patient Temperature
2(Default-Disabled)
Control Strategy
(Default: Surgical)
Temperature Mode
(Default -°C)
Language
(Default-English)
Data Output Interval
(Default-1 minute)
Reset Calibration
Alert Timer
Save Current Settings
as Defaults
Allows user to enable the system for
a second patient temperature probe
if a probe is connected to the control
module from a secondary site on
the patient. The second site is for
monitoring, not controlling patient
temperature.
Determines the response of the
internal algorithm to anaesthetised
patients.
Select temperature units of measure.
Note: All custom settings should be
verified if changing between °C and °F.
Data outlet intervals 2000 systems
house a 250 power speed when sending
real time system information through the
RS232 port for data collection.
Alert will notify user at defined
intervals to contact Kimberly-Clark
or authorised biomedical engineer
to verify system calibration and
operation.
Press Enter to save all current
settings as defaults.
Enabled Disabled
Surgical Reserved
ºC (Centigrade)
ºF (Fahrenheit)
English
Off, Between 5 and
60 seconds: 5 second
increments; Between
1 and 10 minutes:
1 minute increments
Do not reset until
calibration is
completed.
Press Return to
Main Menu Key to
return to the main
screen.
Parameter–Default Explanation Options
Table 6
CAUTION: The operator is responsible to determine the appropriateness of custom
parameters for each patient.
With the Stop Key lit, press the Down or Up Arrow to access the custom
settings menu to verify or modify default parameters. To modify a setting, scroll
to the appropriate parameter shown on the display screen. Press the Enter
Key. The setting will flash indicating that the setting can be changed. Using the
Down or Up Arrows, change the setting. Press Enter to accept the new setting.
(See Figure 5 for an overview of the settings.)
Note:When the system is powered off, all changes will revert to the default unless
the new settings have been established as new defaults.

19
Kimberly-clarK* Patient Warming Systems M1000 Control Unit Operator’s Manual: U.S.
Figure 5
Patient High Alert-XX-Automatic Mode
Patient Low Alert-XX-Automatic Mode
PatientTemperature 2 (Enabled/Disabled)
Control Strategy (Surgical/Reserved)
Temperature Mode (C/F)
Language (English)
Data Output Interval (Off, 5-55 seconds,
1-10 Minutes)
Reset Calibration Alert Timer
Save Current Settings as Default
STOP
Patient Target - Automatic Mode
Water Target - Manual Mode
Water Level (Empty, Full)
Maximum Water - Automatic Mode
Minimum Water - Automatic Mode
SETUP
3.5 Setting Custom
Parametres
(continued)
3.6 Pre-warming the
KIMBERLY-CLARK*
Patient Warming
System M1000
Pre-warming of the Patient Warming System can be accomplished prior to
connecting the pads to facilitate efficient operating theatre setup. To pre-warm the
control unit, turn the power on by pressing the On/Off switch to the “On” position.
The control unit then performs the startup self-diagnostic check and will eventually
show the Main Menu or “Home” Screen. Press the “Manual” Key to begin warming
the water in the unit.
The control unit will then begin heating the water to the previously saved default
water target temperature. To change this temperature, press the Down Arrow Key
once until the screen reads “Water Target Temperature XX, Press Enter to Change.”
Press “Enter” and adjust the temperature using the Up and Down Arrow Keys.
From room temperature (20ºC/68ºF) the control unit will warm the water to the target
temperature in approximately 5 to 10 minutes.
CAUTION: The surface of the heating device should be checked for mechanical
damage prior to use.