Technical Manual
Mistral-Air® Warming Unit -SYK
MA1100-PM (110-120V~, 60 Hz)
Distributed by:
2
Foreword ...................................................................................................... 4
Disclaimer .................................................................................................... 4
1 Contra-indications, Safety Precautions, Symbols and Graphics .... 5
1.1 Contra-indications ....................................................................... 5
1.2 Safety Precautions...................................................................... 5
1.3 Symbols ...................................................................................... 8
1.4 Mistral-Air® Graphics ................................................................ 11
2 Indications For Use ............................................................................ 12
3 Temperature Management ................................................................ 12
4 Forced Air Warming ........................................................................... 12
5 Description of Mistral-Air® Plus Warming Unit ............................... 12
5.1 The Appliance ........................................................................... 13
5.2 The Control Panel ..................................................................... 13
6 Preparing the Mistral-Air® Plus Warming Unit For Use .................. 14
7 Mounting the Mistral-Air® Plus Warming Unit ................................. 14
8 User Instructions ................................................................................ 15
8.1 Connection to Power Supply .................................................... 16
8.2 Switching the Unit On ............................................................... 16
8.3 Connecting the Blanket ............................................................ 17
8.4 Warming Up With the Mistral-Air Plus Warming Unit ............. 17
8.4.1 Temperature Settings ........................................................ 17
8.4.2 Temperature Selection ...................................................... 17
8.5 Stop Warming ........................................................................... 18
9 Safety Systems and Alarms .............................................................. 18
9.1 General Alarms ......................................................................... 19
9.2 Other Safety Features .............................................................. 20
9.3 The Blankets ............................................................................. 20
10 Maintenance ........................................................................................ 21
11 Storage and Cleaning ........................................................................ 21
12 General Description of Hardware ..................................................... 22
12.1 Housing ................................................................................. 22
12.2 Top Plate ............................................................................... 22
12.3 Heating System ..................................................................... 22
12.4 Blower Motor ......................................................................... 22
12.5 Power Supply & Electronic Hardware ................................... 22
13 Replacing the Filter ............................................................................ 23
14 Reset the Hour Meter ......................................................................... 23
15 Repair Procedures ............................................................................. 24
15.1 Routine Maintenance ............................................................ 24
16 Trouble Shooting ................................................................................ 24
17 Parts Replacement ............................................................................. 26
17.1 Replacing the Hose ............................................................... 26
17.2 Replacing the Fuses ............................................................. 27
17.3 Replacing the Fan ................................................................. 27
17.4 Replacing the Power Cord .................................................... 27
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17.5 Replacing the Temperature Sensors .................................... 28
17.6 Replacing the Heater ............................................................ 28
17.7 After Service Test and Preventive Maintenance Protocols .. 29
17.8 Test set-up Mistral-Air® Plus Warming Unit .......................... 30
17.9 Control Board Test ................................................................ 30
17.10 Set Point Temperature Test .................................................. 31
17.11 Alarm Tests ........................................................................... 31
17.12 Electrical Safety Test ............................................................ 33
18 After Service Test and Preventive Maintenance Form ................... 33
18.1 Test Conditions Check .......................................................... 33
18.2 Control Board Test ................................................................ 33
18.3 Set Point Temperature Check ............................................... 33
18.4 Alarm Tests ........................................................................... 34
18.5 Electrical Safety .................................................................... 34
19 Electromagnetic Compatibility ......................................................... 35
19.1 Electromagnetic Immunity ..................................................... 35
19.2 Electromagnetic Emissions ................................................... 38
19.3 Recommended Separations Distances................................. 39
20 Illustrations ......................................................................................... 40
20.1 Disassembly of the Mistral-Air® Plus warming unit ............... 40
20.2 Assembly of the Mistral-Air® Plus warming unit .................... 43
20.3 The Power Controller Board (PCB) ....................................... 45
20.4 Block Diagram ....................................................................... 46
21 Spare Parts and Order List ................................................................ 47
22 Warranty .............................................................................................. 48
23 Specifications ..................................................................................... 49
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Foreword
Congratulations on your purchase of the Mistral-Air® Plus Forced Air
Warming Unit.
This device was developed with and for users and is built in accordance to
the latest safety standards.
We wish you every success in preventing and controlling hypothermia and
we are sure that the Mistral-Air Plus warming unit can help you to do so.
Please read this manual carefully before using the Mistral-Air® Plus warming
unit.
The 37Company
Disclaimer
The 37Company reserves all rights. No part of this document may be
reproduced or published, electronically, mechanically, in print, photographic
print, on microfilm or by any other means whatsoever, without the explicit
consent of The 37Company.
The content of this document has been compiled with the greatest possible
care and this information can be regarded as reliable. Nevertheless,
The 37Company is not liable for any consequences arising from the use of
the manual.
The 37Company reserves the right to make alterations and improvements to
the device.
The 37Company cannot be held liable for the final outcome of the patients’
treatment.
This document contains proprietary information that may not be disclosed to
third parties. This document may not be used without the explicit written
consent of The 37Company.
These instructions are intended for personnel authorised to work with and/or
service the medical device mentioned in this manual.
Contact Stryker Medical for detailed technical information for this device.
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Do not apply heat directly to open wounds.
Do not apply the warming system to ischemic limbs.
a. Use caution and consider discontinuing use on patients during
vascular surgery when an artery is clamped to an extremity (i.e.
aortic cross-clamping)
b. Use caution and monitor closely if used on patients with severe
peripheral vascular disease
Adequate grounding reliability can only be achieved when the
equipment is connected to an equivalent receptacle marked ‘hospital
grade’.
Prevent the blanket material from coming into direct contact with a
laser or an electrosurgical active electrode, rapid combustion could
result.
Using power cords or spare parts for internal components other than
specified by The 37Company may result in increased emission or
decreased immunity of the Mistral-Air® Plus warming unit.
When replacing the hose, do not touch the temperature sensors. If
these sensors are touched in any way, the unit must be recalibrated.
Portable and mobile RF (Radio Frequency) communication
equipment, and HF (High Frequency) surgical instruments or
endocardial catheters can affect the correct functioning of the
Mistral-Air® Plus warming unit.
1 Contra-indications, Safety Precautions, Symbols and
Graphics
Your Mistral-Air® Plus warming unit was designed and built with safety in
mind. The unit should provide reliable service and high quality patient care.
However, there is no replacement for care providers being attentive to their
patients’ needs and equipment operation. Read and understand all warnings
and precautions before using or prescribing the Mistral-Air® Plus warming
unit.
1.1 Contra-indications
1.2 Safety Precautions
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The Mistral-Air® Plus warming unit is fitted with an air filter; however
airborne contamination shall be taken into consideration when using
the warming system.
In order to prevent the patient from becoming hypothermic due to
unanticipated loss of power, connect the unit to the emergency
mains power.
When the unit is switched off, use of good thermal conductivity
materials on the patient could decrease the patient temperature.
The heating device does not contain an alarm system with an
interruption of power supply/supply mains alarm condition. This
means that in case of a power failure, there will be no alarm.
The unit is not equipped with an isolating switch. Temporary
interruption of the supply mains will render the device in Stand-by
Mode.
The Mistral-Air® Plus warming unit is certified according to IEC
60601-1-2 for electromagnetic interference. However, if
electromagnetic interference with nearby devices is experienced, the
user is encouraged to correct the interference by one or more of the
following measures:
•Isolate the offending device.
•Reorient or relocate the Mistral-Air® Plus warming unit.
•Increase the distance between the interfering device and the
Mistral-Air® Plus warming unit, use another electrical outlet.
•If assistance is required, please contact your local dealer.
•The Mistral-Air® Plus warming unit shall not be used adjacent to or
stacked with other equipment.
Do not use the Mistral-Air® Plus warming unit with any forced air
disposables other than Mistral-Air® blankets. Thermal injury may
result.
Do not place the unit in or on the bed with the patient.
Monitor patient skin routinely.
Monitor patient temperature routinely.
A physician order is required for setting temperature and for
continued use.
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Neonates and pediatric patients of low weight will have a tendency to
overheat more readily than adults. Failure to monitor core
temperature could result in abnormal elevation of body temperature
resulting in serious injury or death.
If patient temperature is not responding or does not reach prescribed
temperature in prescribed time notify physician.
Place the unit in such way that the mains plug could be disconnected
easily in case of emergency.
Warming transdermal medications (patches) can increase drug
delivery, resulting in possible harm to the patient
To remove all power from the Mistral-Air® Plus warming unit, the
mains power cord must be removed from the electrical receptacle.
Stay in viewpoint of the user interface when performing the self-test,
and selecting the set-point.
In case of temperature alarm, check for free airflow. Ensure blanket
is not folded and do not place tools/equipment on the blanket which
could result in a blocked air flow. Be sure the air inlet is free. If the
unit continues to alarm, take the unit out of use and contact the
hospital service department or the local supplier.
Mistral-Air® blankets need to be used with the soft blue material
towards the patient’s skin and the white or reflective layer away from
the patient’s skin. The blue side provides the air distribution towards
the patient.
Never fold the blankets during use.
Do not obstruct blanket channels by e.g. instruments/tape/clamps.
Do not return the unit from service without the filter present.
Do not apply the lock screw into the sensor!
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IP21
Protected against solid foreign objects of 12 mm Ø and greater.
Protected against vertically falling water drops (according to IEC
60529).
Rx only
Caution: Federal US law restricts this device to sale by or on
order of a physician.
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI
ES60601-1 (2005) , CAN/CSA-C22.2 No. 60601-1 (2008),
IEC80601-2-35, IEC60601-1-8
Connect the Mistral-Air® Plus warming unit to an earthed socket
only. Risk of electrical shock exists if the equipment is not
connected to a properly grounded receptacle.
No free hosing. CAUTION! Hose nozzle MUST be connected to a
compatible forced air blanket or thermal injury may occur.
Check patient’s temperature and skin condition at least every 15
minutes.
Do not apply to patients with ischemic limbs.
Do not use Mistral-Air® Plus warming unit and blankets near
flammable anaesthetics, to avoid the risk of explosion.
Serial number
Catalogue / article number
Sterile, method of sterilisation ethylene oxide
Batch code / lot number
Manufacturer
1.3 Symbols
This paragraph contains a list of official symbols.
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Transport and storage ambient temperature range
Transport and storage relative humidity range
Transport and storage atmospheric pressure range
AC voltage
Electrical shock hazard. Do not disassemble the Mistral-Air® Plus
Warming Unit unless you are a qualified service technician. There
are electrically live parts within the unit when it is connected to a
power supply.
Type BF applied parts (according to IEC 60601-1)
Equipotentiality
Expiry date, year/month
For single patient use only. Do not re-use.
Does not contain natural latex components
Transformer fuses (250V 800 mA Fast Acting)
Refer to instruction manual/ booklet
Consult user manual; operating instructions
Alarm indication on control equipment.
Urgent alarm indication on control equipment
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Caution
Not for use in MRI
Bell, cancel temporary
Service indicator
Upper limit of temperature
Lower limit of temperature
Non-ionizing electromagnetic radiation
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1.4 Mistral-Air® Graphics
Prior to use, the user needs to check that the Mistral-Air® Plus
warming unit (including the power cord and the hose) is
undamaged. In the event of damage do not use the Mistral-Air®
Plus warming unit.
Do not use the Mistral-Air® blankets when damaged.
Maintenance and repairs shall be performed by qualified medical
instrument technicians only.
To keep the Mistral-Air® Plus warming unit stable, the wheelbase
of the stand must be in a particular ratio to the clamp height. See
chapter 7 .
Do not immerse the Mistral-Air® Plus warming unit in fluid. Clean
the appliance with standard cleaning agents. See chapter 11.
S = Small, M = Medium, L = Large, XL = Extra large
All steps are followed according to the manufacturer’s instructions
Make sure the power cord is secured by the cord anchor
Plug the unit into an earthed mains socket
Before using the Mistral-Air® Plus warming unit, it should be
attached to a pole or placed on a table.
This paragraph contains a list of Mistral-Air® graphics.
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2 Indications For Use
The Mistral-Air® Warming System is a forced air warming device and
comprises of a warming unit and a variety of blankets. It is intended to raise
and maintain patient temperature by means of surface warming.
3 Temperature Management
Hypothermia, an abnormal drop in body temperature, is a threat to human
life. Hospital patients in particular run serious risks if their body temperature
falls below 36 ºC. The risk of hypothermia is particularly high at moments
when they are vulnerable, such as pre-, per-, and post-surgical interventions.
Factors that can contribute to hypothermia include the duration of the
surgical intervention, the location of the wound, the amount of blood loss, the
surface area of the wound, the environmental temperature and the
anaesthetic technique.
4 Forced Air Warming
Forced air warming is a widely used and clinically accepted intervention for
the prevention of hypothermia and/or re-warming of the postoperative
surgical patient. The principle of operation for forced air warming systems is
an electrically powered unit consisting of a fan and heating element that
propels warmed air via a flexible hose to a blanket draped over the patient.
Some configurations allow for the patient to be placed on top of the blanket
or surrounded by a warming tube.
All of these forced air warming systems are intended to distribute warmed air
to the patient in a manner that is safe and effective.
5 Description of Mistral-Air® Plus Warming Unit
The Mistral-Air® Plus warming unit is a system which is intended for use in
preventing patients from becoming hypothermic.
The Mistral-Air® Plus warming unit shall only be used with disposable
Mistral-Air® blankets that are single patient use only.
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5.1 The Appliance
Stand-by
button / On
Audible
alarm
suppression
button
Temperature
selection button
Service
indicator
Under temp
alarm
Over temp
alarm
Temperature selection
indicator
Fan only /
ambient air
indicator
Control panel
Hose towards
patient/blanket
Handle, at top side
The Mistral-Air® Plus warming unit can be controlled by using the control
panel at the front top of the unit. The clamp to fix the Mistral-Air® Plus
warming unit to a pole is positioned at the back of the unit.
Article Number: MA1100-PM (110-120 V~, 60 Hz)
5.2 The Control Panel
The control panel is located at the front top of the unit and may be operated
by pressure sensitive buttons.
The Mistral-Air® Plus warming unit is very easy to use. All settings are visible
on the control panel and you can select the preferred temperature by
pressing the Temperature Selection button.
In emergencies, an audible alarm will be activated and an LED will flash
yellow.
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6 Preparing the Mistral-Air® Plus Warming Unit For
Before using the Mistral-Air® Plus warming unit, it should be
attached to a pole or placed on a table.
Prior to use, the user needs to check that the Mistral-Air® Plus
warming unit, the power cord and the hose are undamaged. In the
event of damage do not use the Mistral-Air® Plus warming unit.
Plug the Mistral-Air® Plus warming unit into an earthed socket.
Place the unit in such way that the mains plug can be
disconnected easily in case of emergency.
The potential equalization plug at the rear of the device can be
connected to the hospital grounding system.
Do not place the unit in or on the bed with the patient
Use
7 Mounting the Mistral-Air® Plus Warming Unit
The Mistral-Air® Plus warming unit must be mounted securely before use.
The Mistral-Air® Plus warming unit can be mounted onto the Mistral-Air®
curved pole MA5115A-PM with optional basket MA5120-PM.
The unit should be clamped onto the pole at the indentation.
Avoid blocking the air inlet (bottom of unit).
It is also possible to place the Mistral-Air® Plus warming unit on a table.
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Check patient’s temperature and skin condition at least every 15
minutes.
Monitor patient skin routinely
Warming transdermal medications (patches) can increase drug
delivery, resulting in possible harm to the patient
Do not apply to patients with ischemic limbs.
Mistral-Air® Curved Pole incl. Base
MA5115A-PM
Mistral-Air® Basket MA5120-PM
8 User Instructions
When using the Mistral-Air® Plus warming unit, please follow the
instructions below. In each blanket box an instruction for use is added.
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8.1 Connection to Power Supply
a b c
d
To remove all power from the Mistral-Air® Plus warming unit, the
mains power cord must be removed from the electrical receptacle.
a b c
Stay in viewpoint of the user interface when performing the self-test,
and selecting the set-point.
Do not use the Mistral-Air® Plus warming unit without a
Mistral-Air® blanket connected to it. Thermal injury may
result.
a. Make sure the power cord is secured by the cord anchor.
b. Plug the unit into an earthed mains socket.
c. The unit automatically switches to Stand-by mode, which is indicated by
the amber Stand-by LED located on the left side of the control panel.
d. The Mistral-Air® Plus warming unit is now in Stand-by mode.
8.2 Switching the Unit On
a. Activate the Mistral-Air® Plus warming unit by pressing the Stand-by
button. The LED now turns green.
b. The Mistral-Air® Plus warming unit will now perform a self-test, which
includes a flash of all the LED’s and a short audible alarm. When a LED
or the audible beep fails, take the unit out of use for repair.
c. After passing the self-test The Mistral-Air® Plus warming unit will start
blowing air at the default temperature setting of 38 ˚C.
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8.3 Connecting the Blanket
Take the selected Mistral-Air® blanket out of the package and follow the
instructions on the insert provided with the blanket box.
Place the unit near the hose inlet of the blanket. Insert the end of the
flexible hose into the air inlet port of the Mistral-Air® blanket. Make sure the
hose is fully pushed in.
8.4 Warming Up With the Mistral-Air Plus Warming Unit
8.4.1 Temperature Settings
The four settings are:
Fan only - Ambient air
32 ºC (89.6ºF) - Low temperature
38 ºC (100.4ºF) - Medium temperature
43 ºC (109.4ºF) - High temperature
8.4.2 Temperature Selection
The Mistral-Air® Plus warming unit will start up with the default temperature
setting of 38 ºC.
By pressing the “–” temperature selection button twice (2x) (fan is selected
and the fan indicator turns green), the Mistral-Air® Plus will activate the unit
to draw in room temperature air and deliver it to the patient via the blanket.
The heater will not be activated.
The air temperature to the patient will depend on ambient conditions and
possible heat from the blower motor.
By pressing the “+” of the temperature selection button the Mistral-Air® Plus
will activate the heater to deliver the set temperature: 32 ºC, 38 ºC or 43 ºC
at the end of the hose.
By pressing the “+” of the temperature selecting button, the temperature
setting increases. This is indicated by a green LED:
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By pressing the “-” of the Temperature Selecting Button, the temperature
a b c
In case of temperature alarm, check for free airflow. Ensure
blanket is not folded and do not place tools/equipment on
the blanket which could result in a blocked air flow. Be sure
the air inlet is free. If the unit continues to alarm, take the
unit out of use and contact the hospital service department
or the local supplier.
setting decreases. This is indicated by a green LED:
After selecting the desired temperature, the LED below the Temperature
Indicator will flash green. After reaching the set temperature (+ 2 ˚C) the
green flashing LED will light up permanently.
8.5 Stop Warming
a. Press the Stand-by button
b. Disconnect the hose from the blanket
c. If desired, leave the blanket on/under the patient
9 Safety Systems and Alarms
The Mistral-Air® Plus warming unit is equipped with visual and audible
safety systems to protect against over temperature and under temperature
conditions as well as to indicate that filter change is required.
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9.1 General Alarms
A. Primary Over Temperature Alarm
This flashing yellow LED indicates an over temperature
condition of ≥ 45.5 ºC. The flashing LED will be accompanied by
a triple beep with an interval of 12.5 seconds. These alarms will
remain activated until the temperature falls below 45.5 ºC.
The heater shuts down; the unit tries to control the output
temperature to the set point. If this fails three times in a row, the
heater and blower will shut down completely.
B. Secondary Over Temperature Alarm
This flashing yellow LED indicates an over temperature
condition:
Lower limit: > T
primary
Upper limit: ≤ 56.4 ºC
The flashing LED will be accompanied by a triple beep with an
interval of 12.5 seconds. If this occurs, the heater and blower
will shut down and control of the unit will not be restored until
the unit is powered off by disconnecting the mains plug and the
internal temperature sensor has been cooled down.
In case of a secondary over temperature alarm, check for hose
blockage.
In case of a repeated secondary over temperature alarm,
after resetting the unit, take the unit out of service and
contact Stryker Medical for technical support.
C. Under Temperature.
This yellow LED indicates an under temperature condition. It is
set to activate at 6 ºC under the set temperature. One single
beep is produced
If equipment emergencies occur, an audible alarm sounds and the relevant
LED(s) on the control panel will turn yellow. These safety systems are
described as follows:
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NOTE:
A broken temperature sensor or bad connection to the sensor
will result in an over temperature alarm. This applies for two
situations:
A defective sensor of the temperature controlling circuit
results in a primary over temperature alarm condition.
A defective sensor of the safety circuit results in a
secondary over temperature alarm condition.
9.2 Other Safety Features
D. Audible Alarm Suppression
The audible alarm may be suppressed for a short period by
pressing the Audible Alarm Suppression button. Audible alarm
suppression is indicated by a solid amber led. After the interval
of 2 or 3 minutes, or after pushing the button once again, the
audible alarm will automatically be activated again.
E. Service Indicator
When the yellow LED under the wrench turns on, accompanied
by a single beep, the Mistral-Air® Plus warming unit has been
used for ≥ 2000 hours. This service indicator means that the
filter must be replaced. Reference Chapter 13 for filter
replacement instructions.
Alarm type
Alarm priorities
Service indicator
Low priority
Under temperature alarm
Low Priority
Over temperature alarm (primary and
secondary)
Medium priority
Do not use the Mistral-Air® Plus warming unit with any forced air
disposables other than Mistral-Air® blankets. Thermal injury may
result.
9.3 The Blankets
The Mistral-Air® Warming System is a forced air warming device and is
comprised of a warming unit and a variety of blankets. It is intended to raise
and maintain patient temperature by means of surface warming.
All Mistral-Air® blankets do not contain latex components and are:
Made from non-woven polypropylene and polyethylene
Manufactured to meet flammability standards
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MR (Magnetic Resonance) Conditional Conditional (MA02XX-PM series,
Mistral-Air® blankets need to be used with the soft blue material
towards the patient’s skin and the white or reflective layer away from
the patient’s skin. The blue side provides the air distribution towards
the patient.
Never fold the blankets during use.
Thermal injury may occur if heat is applied to ischemic limbs.
Do not obstruct blanket channels by e.g. instruments/tape/clamps.
MA2XXX-PM series and MA05XX-PM series only)
Non-conductive (electrical and thermal)
Non-sterile, except for several dedicated blankets (ask your distributor)
Blanket box including an instruction insert in the main world languages
Single-patient use only
Made from lightweight, soft materials that have been approved for skin
contact
10 Maintenance
It is recommended that Routine Maintenance be performed on an annual
basis for The Mistral-Air
Plus warming unit. Routine Maintenance or other
service shall only be performed by trained clinical or biomedical technicians
or engineers. Clinical users shall not repair or open the Mistral-Air
warming unit in the event of a malfunction. This can damage the appliance
and will invalidate the warranty. When the service indicator is activated, the
filter must be replaced.
Have the Mistral-Air
Plus warming unit serial number ready when you
contact the hospital service department or Stryker Medical for technical
support. The serial number is located on the side of the unit.
11 Storage and Cleaning
Store the Mistral-Air
place when not in use.
Disconnect from power when cleaning the Mistral-Air® Plus warming unit. Do
not use dripping wet cloths and do not allow water to seep into electrical
areas of the Mistral-Air
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Plus warming unit and its accessories in a cool and dry
Plus warming unit.
Plus
22
Clean the unit by wiping the outer surface (including the hose) with a soft
cloth lightly dampened with a solution of water and mild detergent or a nonstaining hospital disinfectant.
Wipe all excess detergent or disinfectant from the unit and allow to air dry.
Do not use alcohol or acid based cleaners on the control panel.
12 General Description of Hardware
The Mistral-Air® Plus warming unit comprises of plastic enclosure parts, a
control panel, an internal heating element, a fan and electrical components.
The unit may be mounted to an IV pole.
12.1 Housing
The Mistral-Air® Plus warming unit housing consists of 5 plastics enclosure
parts and an internal steel top plate. To disassemble the unit, see
paragraph 20.1.
12.2 Top Plate
The Mistral-Air® Plus warming unit top plate frame is made of stainless
steel.
The top plate is used to mount the fan blower motor and to create an
airtight fan space. A U-shaped, silicone profile is used to support this
function.
12.3 Heating System
The Mistral-Air® Plus warming unit uses a 1000 Watt coiled electric heating
element to heat the air that it delivers to a blanket.
12.4 Blower Motor
After assembly, the flow rate with a blanket attached is
approximately 1.4 m3/min (49 CFM).
12.5 Power Supply & Electronic Hardware
It is fixed at the rear of the Mistral-Air® Plus warming unit.
A Block Diagram of the Mistral-Air® Plus warming unit is shown in
paragraph 20.4 “Block Diagram”.
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On the printed circuit board two processors are used. Both use software to
Do not return the unit from service without the filter present.
+
a b c d e
work. When the unit serial number is known, the original revision number of
the software can be identified by The 37Company.
13 Replacing the Filter
The accumulation of dust in the air filter will reduce the efficiency of the
Mistral-Air® Plus warming unit. The filter shall be replaced as alerted by the
service indicator or when indicated by visual inspection. Only use parts
provided by Stryker Medical.
1. For disassembly follow steps 1-2 and 5-7 of paragraph 20.1
2. Insert the new filter with the black seal towards the fan
3. For assembly follow steps 1-2 and 5-7 of paragraph 20.1 in reverse order
4. Reset the Hour Meter (see chapter 14)
The filter is the only part, which is allowed to be replaced without the need
of a bio medical engineer.
14 Reset the Hour Meter
The Mistral-Air® Plus warming unit is equipped with a built-in timer (hour
meter) that will activate the “service indicator” after ≥ 2000 hours of use.
This is an indication that replacement of the filter, is required. After
replacing the filter, follow the steps below to reset the timer.
a) Switch unit in Stand-by mode.
b) Press and hold the “-”, “+” buttons and the Audible Alarm
Suppression button simultaneously.
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c) While holding down the buttons, press the Stand-by button.
If this equipment is modified, appropriate inspections and testing
must be conducted to ensure continued safe use of the
equipment.
a) Reset the hour meter if filter is replaced
See chapter 14
b) Perform After Service Test Protocols
See chapter 18
c) Clean the unit if needed
See chapter 11
Problem
Possible Cause
Action
The unit does
not switch on
Unplugged or
damaged power
cord.
Make sure power cord is plugged in and is
undamaged. Replace cord if necessary.
No power to outlet
Confirm power to outlet.
Poor or loose wire
connections.
Ensure all connectors and terminals are
secure.
Blown fuses at
PCB
Replace fuse(s)
Over
temperature
alarm and
warming unit
stopped
Poor or loose wire
connections.
Verify connections to PCB of the heater,
the temperature sensors (2x) and the
inductor.
Faulty heater
Check resistance of the heater connection
to the PCB.
Cold element resistance should be:
MA1100-PM 13.1 Ω ± 10%
Replace heater if necessary.
d) Now an audible alarm is produced and the unit returns to Stand-by
mode.
e) The hour meter has been reset successfully.
15 Repair Procedures
Contact Stryker Medical for spare parts. If you wish to return the unit for
examination and repair, please refer to the following section.
15.1 Routine Maintenance
Routine Maintenance shall be performed on an annual base. At every
service interval, please follow the next steps.
16 Trouble Shooting
INT-R298-EN-PM/5-10-14
25
Problem
Possible Cause
Action
Faulty temperature
sensors
Check resistance of the temperature
sensors connection to the PCB.
Resistance must be 2.4 – 2.6 KΩ
Consult Stryker Medical Technical
Services.
Faulty inductor
Replace Inductor
The unit
delivers warm
air but
switches off
before
reaching the
set
temperature
Temperature
(heater/blower
housing) may be
out of calibration.
Allow unit to cool from possible over-heat
condition. If condition persists, check
continuity of each temperature sensor.
Consult Stryker Medical Technical
Services.
Faulty PCB
Consult Stryker Medical Technical
Services.
Faulty temperature
sensors
Check resistance of the temperature
sensors connection to the PCB.
Resistance must be 2.4 – 2.6 KΩ
Stryker Medical Technical Services.
Obstructed Filter
or Blower fan.
Verify unit has adequate airflow (with new
filter and blanket attached: 0,021 – 0,030
m³/s. Replace filter if necessary and verify
that blower fan spins freely.
The unit
alarms at too
low or too
high
temperature
Temperature
(heater/blower
housing) maybe
out of calibration.
Adjust the temperature and recalibrate the
unit.Consult Stryker Medical Technical
Services.
Faulty temperature
sensors
Check resistance of the temperature
sensors connection to the PCB.
Resistance must be 2 – 3 KΩ (room
temperature must be between 18-27 °C).
Consult Stryker Medical Technical
Services.
Faulty PCB
Confirm unit is being used in ambient
temperatures (see paragraph 20.1).
Consult Stryker Medical Technical
Services.
The unit
turns on but
does not
blow air
Air inlet obstructed
or dirty filter
Remove filter and inspect for obstructions.
Clean out debris and replace filter if
necessary.
Blower fan is
obstructed.
Remove covers and verify that blower fan
spins freely.
Poor or loose wire
connections
Ensure all connectors and terminals are
secure. Ensure power cord and the base
wire harnesses are properly attached to
terminal block
INT-R298-EN-PM/5-10-14
26
Problem
Possible Cause
Action
The unit
turns on but
temperature
settings
cannot be
selected.
Faulty PCB
Consult Stryker Medical Technical
Services.
Faulty or loose
membrane switch
(switch contacts or
header).
Remove covers and inspect the membrane
connection to the control board. Ensure
red/white wire is located at the top.
Faulty control
board.
Consult Stryker Medical Technical
Services.
High risk of accessible electrically live parts when removing the
hose!
Do not apply the lock screw into the sensor!
17 Parts Replacement
The replacement procedures contained herein allow trained clinical or
biomedical technicians or engineers to repair the Mistral-Air® Plus warming
unit. Contact Stryker Medical for replacement parts or when service may be
required.
17.1 Replacing the Hose
a) For disassembly follow steps 1-4 of paragraph 20.1
b) Apply the new hose by twisting it firmly counter clockwise into place
and apply the lock screw to secure the hose.
Note: When replacing the hose, do not touch the temperature sensor (see
image). If these sensors are touched in any way, the unit must be
recalibrated. Contact Stryker Medical for calibration service.
INT-R298-EN-PM/5-10-14
27
Sensor
Temperature sensor plate
17.2 Replacing the Fuses
a) For disassembly follow steps 1-11 of paragraph 20.1
Replace fuses; make sure that the replacements fuses have the correct
rating refer to “Specifications”.
b) For assembly follow step 1-11 of paragraph 20.1 in reverse order. Follow
paragraph 20.2 for placing back the front cover.
c) Execute “After service test protocols” (chapter 18)
17.3 Replacing the Fan
a) For disassembly follow steps 1-18 of paragraph 20.1
b) Replace the fan
c) For assembly follow step 1-18 of paragraph 20.1 in reverse order
d) Execute “After service test protocols” (see chapter 18)
17.4 Replacing the Power Cord
a) Unplug the unit
b) Remove power cord from back of unit by unlocking the cord anchor:
c) Insert the new power cord and press it firmly into place.
d) Lock cord anchor:
INT-R298-EN-PM/5-10-14
28
17.5 Replacing the Temperature Sensors
Due to the technical complexity associated with replacing the sensors, the
unit must be returned to Stryker Medical for service according to Stryker
Medical instructions.
17.6 Replacing the Heater
Due to the technical complexity associated with replacing the motor or the
heater, the unit must be returned to Stryker Medical for service according to
Stryker Medical instructions.
INT-R298-EN-PM/5-10-14
29
Zone 3
Zone 2
Zone 1 + 2: No air obstructions or heat sources
Zone 3: No airconditioning units
17.7 After Service Test and Preventive Maintenance Protocols
Test conditions:
1 Tests shall be executed at an ambient temperature of 22 ±1.5 ˚C.
2 The unit shall be acclimated to the ambient temperature.
3 Tests shall be executed in a draft free room.
4 No air obstructions within one meter of the air outlet of the Mistral-Air®
Plus test equipment (zone 1).
5 Free air inlet, no air obstructions within one meter (zone 2).
6 There shall be no air conditioning or climate control air outlet within 2
metres (zone 3).
Refer to image below “Air Obstruction Zones”.
Record findings at paragraph 18.1.
Image: Air Obstruction Zones
INT-R298-EN-PM/5-10-14
30
17.8 Test set-up Mistral-Air® Plus Warming Unit
All tests shall be executed by using the Mistral-Air® test equipment
(MA2100-B-PM). The test tube is representing a MA0220-PM / MA2220PM Adult blanket.
The Mistral-Air® Test Equipment has an own thermometer (check
calibration due date).
17.9 Control Board Test
1 Switch unit from Stand-by mode to on.
2 Check that all LED’S blink once and the audible alarm sounds
once.
3 Check that after this self-check procedure the blower is in the 38 ˚C
heating mode, indicated by the blinking 38 ˚C LED at the control
panel.
4 Select the following different settings: FAN ONLY, 32, 38 and 43
°C using the control board buttons (5 seconds per temperature set
point). Check that the buttons react within 0.5 seconds.
Record findings at paragraph 18.2.
INT-R298-EN-PM/5-10-14
31
17.10 Set Point Temperature Test
1 Switch unit from Stand-by mode in active mode.
2 Select 43 °C and wait for at least 3 minutes for the temperature to
stabilize. After the set point is reached the 43 °C LED stops
flashing and turns solid green.
3 Check that no low temperature alarm or primary over temperature
alarm is enabled (alarm LED and buzzer) due to possible
temperature overshoots.
4 Measure the temperature in the test tube (must be between 40.5
and 45.5°C).
5 Repeat steps 2, 3 and 4 for 38 °C and 32 °C (35.5 – 40.5
respectively 29.5 - 34.5 °C in test tube).
Record findings at paragraph 18.3.
17.11 Alarm Tests
Low temperature alarm test
Switch unit in Stand-by mode.
1 Press and hold the audible alarm button and press the Stand-by
button once.
2 The ventilator now starts and the set point 32 °C and service
indicator LED starts blinking.
3 Press the audible alarm suppression button to confirm. The heater
starts to control the temperature till the 43 °C set point is reached.
Both the 43 °C and the Service Indicator LED’s are blinking. Then
heating is stopped.
4 After 20 seconds: check if the low temperature alarm is also
visually and audibly enabled. The tube temperature must be lower
than 37.5 °C.
5 Exit this test mode by switching the blower OFF by pressing the
stand-by button.
Record findings at paragraph 18.4.
Primary over temperature test
Switch unit in Stand-by mode.
1 Press and hold the audible alarm button and press the Stand-by
button once.
2 The ventilator now starts and the set point 32 °C and service
indicator LED starts blinking.
3 Scroll via the “-” or “+” buttons to 38 °C.
INT-R298-EN-PM/5-10-14
32
4 Press the audible alarm suppression button to confirm. The heater
will control the temperature till the primary over temperature set
point is reached. Both the 43 °C and the Service Indicator LED’s
are blinking.
5 Check if the primary over temperature alarm is also visually and
audibly enabled (blinking over temperature LED).
6 Check if the primary temperature alarm is enabled ≥ 45.5 °C.
7 Then, heating is stopped automatically till the temperature has
dropped to the under temperature alarm value, followed by a
second and third heating/cooling cycle. Check if the heater and
ventilator switches OFF after the third cycle.
Note: The secondary over temperature alarm shall not be enabled!
Record findings at paragraph 18.4.
Secondary over temperature test
Switch the unit in Stand-by mode.
1 Press and hold the audible alarm button and press the Stand-by
button once.
2 The ventilator starts and you are able to select between the set
points 32, 38 and 43 °C.
3 Scroll via the “-” or “+” buttons to 43 °C.
4 Press the audible alarm suppression button to confirm. The heater
will control the temperature till the primary over temperature set
point is reached; the primary alarm will be enabled and the unit will
keep on heating.
5 Check if the secondary over temperature alarm is enabled
between:
Lower limit: > T
primary
Upper limit: ≤ 56.4 °C (triple beep, over temperature LED on).
6 The ventilator and heater are switched off by the alarm circuit.
7 After the test: press at the ON/Stand-by button. Check if the
audible alarm is disabled. Switch the power on by pressing the
Stand-by button to check if the alarm is still on (triple beep).
8 Switch the power OFF by disconnecting the mains plug.
9 Switch the power ON to check restarting without an alarm.
Record findings at paragraph 18.4.
INT-R298-EN-PM/5-10-14
33
17.12 Electrical Safety Test
Hospital
Location
Serial Number
Date
Test Engineer
Signature
Ambient temperature (°C)
°C
20.5 – 23.5°C
Draft free room
Pass Fail
No air outlet obstructions
Pass Fail
Free air inlet
Pass Fail
No air conditioner / climate control
Pass Fail
Pass Fail
Comment …
LED’S blinking
Pass Fail
Audible alarm
Pass Fail
Switch on at set point 38 °C
Pass Fail
Button check
Pass Fail
Selected set point temperature (°C)
Temperature
Range (°C)
43
°C
40.5 – 45.5
38
°C
35.5 – 40.5
32
°C
29.5 – 34.5
Pass Fail
Comment …
Execute an electrical safety test conform IEC 60601-1, for a class I, BF
device.
Record findings at paragraph 18.5.
18 After Service Test and Preventive Maintenance Form
18.1 Test Conditions Check
18.2 Control Board Test
18.3 Set Point Temperature Check
INT-R298-EN-PM/5-10-14
34
18.4 Alarm Tests
Selected alarm
Temperature
Range (°C)
Low temperature
°C
< 37.5
Primary over temperature
°C
≥ 45.5
Secondary over temperature
°C
Lower limit: > T
primary
Upper limit: ≤ 56.4 °C
Alarm suppression button
Pass
Current
Type Body Floating (BF)
Maximum values [A]
Measured
[A]
Normal
Condition (NC)
Single Fault
Condition (SFC)
Earth leakage
current general
500
1000
Pass Fail
Cabinet
leakage
100
500
Pass Fail
18.5 Electrical Safety
During the electrical safety test, maximum values of continuous leakage
and patient auxiliary currents shall be measured, according the following
table:
INT-R298-EN-PM/5-10-14
35
19 Electromagnetic Compatibility
Guidance and manufacture’s declaration - electromagnetic immunity
The Mistral-Air® Plus warming unit is intended for use in an electromagnetic
environment specified below. The customer or the user of the Mistral-Air® Plus
warming unit should assure that it is used in such an environment.
Immunity test
IEC60601 test
level
Compliance
level
Electromagnetic
environment
guidance
Electromagnetic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%
Electrical fast
transient / burst
IEC 61000-4-4
±2 kV for power
supply lines
±1kV for
input/output
lines
±2 kV for power
supply lines
±1kV for
input/output
lines
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
IEC61000-4-5
±1 kV
differential
mode
±2 kV common
mode
±1 kV
differential
mode
±2 kV common
mode
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT
)
for 0.5 cycle
40 % UT
(60 % dip in UT )
for 5 cycles
70 % UT
(30 % dip in UT )
for 25 cycles
<5 % UT
<5 % UT
(>95 % dip in UT
)
for 0.5 cycle
40 % UT
(60 % dip in UT )
for 5 cycles
70 % UT
(30 % dip in UT )
for 25 cycles
<5 % UT
Mains power quality
should be that of a
typical commercial
or hospital
environment. If the
user of the MistralAir® Plus warming
unit requires
continued operations
during power mains
interruptions, it is
recommended that
the Mistral-Air® Plus
warming unit be
powered from an
19.1 Electromagnetic Immunity
INT-R298-EN-PM/5-10-14
36
(>95 % dip in UT
)
for 5 sec
(>95 % dip in UT
)
for 5 sec
uninterruptible power
supply or a backup
battery system.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile
RF communications
equipment should
not be used any
closer to any part of
the Mistral-Air® Plus
warming unit,
including cables,
than the
recommended
separation distance
calculated from the
equation applicable
to the frequency of
the transmitter.
Recommended
separation distance
d = 1.2 √ P
d = 1.2 √ P 80 MHz
to 800 MHz
d = 2.3 √ P 800 MHz
to 2.5 GHz
where P is the
maximum output
power rating of the
transmitter in watts
(W) according to the
transmitter
manufacturer and d
INT-R298-EN-PM/5-10-14
37
is the recommended
separation distance
in meters (m).
Field strengths from
fixed RF
transmitters, as
determined by an
electromagnetic site
surveya, should be
less than the
compliance level in
each frequency
rangeb.
Interference may
occur in the vicinity
of equipment
marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
a
Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured filed strength in the location in which the Mistral-Air® Plus warming unit
is used exceeds the applicable RF compliance level above, the Mistral-Air® Plus
warming unit should be observed to verify normal operations. If abnormal
performance is observed, additional measures may be necessary, such as
reorienting or relocating the Mistral-Air® Plus warming unit.
b
Over the frequency range 150 kHz to 80 MHz, filed strengths should be less
than 3 V/m
INT-R298-EN-PM/5-10-14
38
19.2 Electromagnetic Emissions
Guidance and manufacture’s declaration – electromagnetic emissions
The Mistral-Air® Plus warming unit is intended for use in an electromagnetic
environment specified below. The customer or the user of the Mistral-Air® Plus
warming unit should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
The Mistral-Air® Plus uses RF
energy only for its internal
function. Therefore, its RF
emissions are very low and are
not likely to cause any
interference in nearby electronic
equipment
RF emissions
CISPR 11
Class B
The Mistral-Air® Plus is suitable
for use in all establishments,
including domestic
establishments and those directly
connected to the public lowvoltage power supply network
that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC61000-3-3
Complies
INT-R298-EN-PM/5-10-14
39
19.3 Recommended Separations Distances
Recommended separation distances between portable and mobile RF
communications equipment and the Mistral-Air® Plus warming unit
The Mistral-Air® Plus warming unit is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or
the user of the Mistral-Air® Plus warming unit can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Mistral-Air® Plus warming
unit as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output power
of transmitter
W
150 kHz to 80
MHz
80 MHz to 800
MHz
800 MHz to 2,5
GHz
Rated maximum
output power
of transmitter
W
150 kHz to 80
MHz
80 MHz to 800
MHz
800 MHz to 2,5
GHz
0.01
0.12
0.12
0.24
0.1
0.37
0.37
0.74
1
1.17
1.17
2.34
10
3.69
3.69
7.38
100
11.67
11.67
23.34
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
INT-R298-EN-PM/5-10-14
40
20 Illustrations
Step
Description
Image
1
Disconnect the unit from the power outlet
n.a.
2
Place the unit upside down
(be careful not to scratch the top cover)
3
Remove hose screw
4
Twist off hose clockwise
5
Remove screws (3x) of filter screen
20.1 Disassembly of the Mistral-Air® Plus warming unit
INT-R298-EN-PM/5-10-14
41
6
Remove filter screen
7
Remove filter
8
Remove screws (6x) of bottom housing
9
Remove both front cover pins by using a
Phillips screwdriver. Prevent the screw
sleeve from rotating by pressing with your
finger or a knife.
10
Take out the screw sleeve and remove
the front cover in the directions as
indicated below by (1) and (2)
11
Place the unit upright
n.a
INT-R298-EN-PM/5-10-14
42
12
Remove screw from PCB
13
Disconnect the wiring of the user interface
(keyboard)
See paragraph 20.3
14
Disconnect the wiring of the inductor
See paragraph 20.3
15
Disconnect the wiring of the start
capacitor
Disconnect the wiring of the fan.
See paragraph 20.3
16
Lift upper housing and place beside the
unit
17
Remove screws (6x) of spiral casing cover
18
Remove screws (4x) to release fan.
During re-assembly, apply droplets of
Loctite to secure screws into rubber struts
19
Remove screws (7x) to access user
interface
For maintenance to the fan and user interface please follow the next few
steps.
INT-R298-EN-PM/5-10-14
43
20.2 Assembly of the Mistral-Air® Plus warming unit
20
Remove silicone residues. Use a knife if
needed.
Clean edges of front cover with alcohol
(defatting).
n.a.
21
Add silicone on top, left, and right side
of front cover (indicted by the red lines)
22
First place the front cover in the upper
housing and then the bottom housing
(from right to left (1, 2, 3 and then 4).
23
Secure the front cover with new front
cover pins to be inserted through the
bottom housing openings and gently hit
it with a hammer.
Follow the disassembly steps of paragraph 20.1 in reverse order.
When placing back the front cover, below steps must be followed.
INT-R298-EN-PM/5-10-14
44
24
25
Remove any surplus of silicone with an
alcohol swab.
n.a
After assembling, a functional check, temperature safety check, and
electrical safety check must be performed according to the Technical
Manual Mistral-Air® Plus.
INT-R298-EN-PM/5-10-14
45
20.3 The Power Controller Board (PCB)
Legend:
1. Keyboard connector
2. RS232 connector
3. Programmer connector main controller processor
4. Temperature sensor main controller
5. Programmer connector safety processor
6. Not connected (used for production testing)
7. Temperature sensor safety controller connector
8. Mains connector
9. Heater connector
10. Inductor connector
11. Start capacitor connector
12. Fan connector
INT-R298-EN-PM/5-10-14
46
20.4 Block Diagram
7,1
INT-R298-EN-PM/5-10-14
47
21 Spare Parts and Order List
Part Number
Description
Parts available for local repair
MA1100-1001-PM
Filter - SYK
MA1100-1002A-PM
Upperhousing + pins - SYK
MA1100-1004A-PM
Front cover + pins - SYK For units with serial >
130715001
MA1100-1004R-PM
Front cover replacement Kit- SYK For units with serial
<130715001
MA1100-1006-PM
Filterscreen - SYK
MA1100-1007-PM
Fan US - SYK
MA1100-1009-PM
Fuse US - SYK
MA1100-1012-PM
Pole cent.plate - SYK
MA1100-1014-PM
Bracket - SYK
MA1100-1015-PM
Mains entrance - SYK
MA1100-1016-PM
Spiralcasing cover - SYK
MA1100-1017-PM
Coil - SYK
MA1100-1018-PM
Hose - SYK
MA1100-1019-PM
u-shape profile - SYK
MA1100-1020-PM
Capacitor US - SYK
MA1100-1021-PM
PE connector - SYK
MA1100-1022-PM
IV pole knob - SYK
MA1100-1024-PM
Screw/assy set - SYK
MA1100-1025-PM
Wiring set - SYK
MA1100-1026D-PM
Handle with keyboard + pins - SYK
MA1100-1027A-PM
Packaging - SYK
MA1100-1028-PM
Cord Anchor - SYK
MA1100-1031-PM
Front Cover Pin - SYK
MA5001-PM
Hoseclamp - SYK
R295-EN-PM
User Manual printed - SYK1
R298-EN-PM
Technical Manual printed - SYK1
MA0115-PC-US-PM
Standard power cord US Type - SYK
Spare parts NOT for local repair, only for authorized calibration center
MA1100-1003-PM
Bottom housing - SYK (provide serial number)
MA1100-1008-PM
Heater - SYK
MA1100-1010-PM
Outletplate - SYK
MA1100-1011-PM
Print circuit board - SYK
MA1100-1013-PM
Temp. Sensor - SYK
MA1100-1023-PM
Printed typelabel - SYK (provide serial number)
MA1100-1030-PM
Sensor Plate - SYK
1
= Free of charge download at www.the37company.com distributor menu
INT-R298-EN-PM/5-10-14
48
22 Warranty
Please contact Stryker Medical Customer Service or your Stryker Medical
Sales Representative for warranty related questions. Contact information is
located on the last page of this manual.
INT-R298-EN-PM/5-10-14
49
23 Specifications
Article number
MA1100-PM
Voltage
110-120V~
Frequency
60 Hz
Current
6 A
Peak current
8.7 A
Peak power
925 W
Average power
550 W
Fuses
10AT/125V~/250V~
GMDN-code and term
P 36954 (Heating pad control unit, air)
47681 (Air heating/cooling pad, single-use, non-sterile)
47682 (Air heating/cooling pad, single-use, sterile)
Dimensions
10
7
8
⁄
inch x 15
1
4
⁄ inch x 9
3
8
⁄ inch (l x w x h)
Weight
+/- 13 lbs
Hose length
6 ft
Power cord length
13 ft
Filtration
HEPA, 0.3 µm, 99.99%, H13 conform EN 1822
Current leakage
< 50 µA
Classification IEC
60601-1
Class I, Body Floating (BF)
Classification IEC 60529
IP21
Protective earth
impedance
≤ 0.1 Ω
Set point temperature
32 ºC, 38 ºC or 43 ºC & ambient temperature
Accuracy of temperature
± 2.5 ºC
Set point reached after
Maximum 2 minutes
Low temperature limit
6 ºC below set point
Maximum contact surface
temperature:
45.5 °C
Primary high temperature
Limit
≥ 45.5 ºC
Secondary high
temperature Limit
Lower limit: > T
primary
Upper limit: ≤ 56.4 ºC
Auditory alarm signal
sound pressure
54 dBA
Expected product life
time
7 year (Mistral-Air® Warming Unit)
Environmental conditions
Ambient temperature
10 ºC to 40 ºC
Relative humidity
30 % to 75 %
Atmospheric pressure
70 kPa to 106 kPa
Transport and storage conditions
Ambient temperature
- 40 ºC to 70 ºC
Relative humidity
10 % to 90 % (non-condensing)
Atmospheric pressure
50 kPa to 106 kPa
INT-R298-EN-PM/5-10-14
50
Tools needed for repair:
Phillips PH2 screwdriver
Pozidriv PZD2 screwdriver
Allen key HOP2.5 (2.5mm)
Torx key T20
Wrench 10 (Metric)
Pincers (to cut cable ties)
Disposable syringes 60 cc, to apply silicone glue
A hot-melt gun
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Partner in Patient Temperature Management
The 37Company is a leading European company in the field of hypothermia
and offers a complete range of innovative solutions for patient temperature
management.
The Surgical Company International B.V.
Beeldschermweg 6F
3821 AH Amersfoort
The Netherlands
www.the37company.com
The 37Company is member of The Surgical Company Group
Distributed by:
Stryker Medical
3800 E. Centre Ave.
Portage, Michigan 49002
USA
(800) 327-0770
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INT-R298-EN-PM/5-10-14
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