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.

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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.

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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

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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