Stryker Mistral-Air Plus MA1100-PM User Manual

User Manual

Mistral-Air® Warming Unit - SYK

MA1100-PM (110-120V~, 60 Hz)

Distributed by:

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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 .................................................... 15

8.2 Switching the Unit On ............................................................... 16

8.3 Connecting the Blanket ............................................................ 16

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 ......................................................................... 18

9.2 Other Safety Features .............................................................. 19

9.3 The Blankets ............................................................................. 20

10 Maintenance ........................................................................................ 21

11 Storage and Cleaning ........................................................................ 21

12 Replacing the Filter ............................................................................ 22

13 Reset the Hour Meter ......................................................................... 24

14 Replacing the Hose ............................................................................ 25

15 Replacing the Power Cord ................................................................ 25

16 Parts Replacement ............................................................................. 26

17 Spare Parts and Order List ................................................................ 26

18 Specifications ..................................................................................... 27

19 Electromagnetic Compatibility ......................................................... 28

19.1 Electromagnetic immunity ........................................................... 28

19.2 Electromagnetic Emissions ................................................... 31

19.3 Recommended Separations Distances................................. 32

20 Warranty .............................................................................................. 33

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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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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

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

1.2 Safety Precautions

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.

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.

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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.

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1.3 Symbols

This paragraph contains a list of official symbols.

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.

With respect to electric shock, fire and mechanical hazards only.

In accordance with IEC 60601-1, UL 60601-1, CAN/CSA C22.2

No. 601.1 and ASTM F2196-02 45YV.

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

Transport and storage ambient temperature range

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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

Caution

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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

This paragraph contains a list of 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 paragraph 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.