Summary of Contents for Stryker Mistral-Air Plus MA1100-PM
- Page 1 User Manual ® Mistral-Air Warming Unit - SYK MA1100-PM (110-120V~, 60 Hz) Distributed by:...
- Page 2 INT/R295-EN-PM/4-09/14...
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Page 3: Table Of Contents
Foreword ...................... 4 Disclaimer ....................4 Contra-indications, Safety Precautions, Symbols and Graphics ..5 Contra-indications ............... 5 Safety Precautions..............5 Symbols ..................8 ® Mistral- Air Graphics ............... 11 Indications For Use ................12 Temperature Management ..............12 Forced Air Warming ................12 ®... -
Page 4: Foreword
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. INT/R295-EN-PM/4-09/14... -
Page 5: Contra-Indications, Safety Precautions, Symbols And Graphics
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’... - Page 6 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.
- Page 7 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.
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Page 8: Symbols
1.3 Symbols This paragraph contains a list of official symbols. Protected against solid foreign objects of 12 mm Ø and greater. IP21 Protected against vertically falling water drops (according to IEC 60529). Caution: Federal US law restricts this device to sale by or on Rx only order of a physician. - Page 9 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.
- Page 10 Not for use in MRI Bell, cancel temporary Service indicator Upper limit of temperature Lower limit of temperature Non-ionizing electromagnetic radiation INT/R295-EN-PM/4-09/14...
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Page 11: Mistral- Air Graphics
® 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. -
Page 12: Indications For Use
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. -
Page 13: The Appliance
5.1 The Appliance Handle, at top side side Control panel Hose towards patient/blanket ® 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. -
Page 14: Preparing The Mistral-Air Plus Warming Unit For Use
® 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. -
Page 15: User Instructions
® 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. Check patient’s temperature and skin condition at least every 15 minutes. -
Page 16: Switching The Unit On
c. The unit automatically switches to Stand-by mode, which is indicated by the orange 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. ® To remove all power from the Mistral-Air Plus warming unit, the mains power cord must be removed from the electrical receptacle. -
Page 17: Warming Up With The Mistral-Air Plus Warming Unit
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... -
Page 18: Stop Warming
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. -
Page 19: Other Safety Features
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. -
Page 20: The Blankets
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 12 for filter replacement instructions. -
Page 21: Maintenance
Thermal injury may occur if heat is applied to ischemic limbs. Do not obstruct blanket channels by e.g. instruments/tape/clamps. 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 ... -
Page 22: 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. Step Description Image Disconnect the unit from the power outlet n.a. - Page 23 Remove screws (3x) of filter screen Remove filter screen Remove filter 1. For disassembly follow steps 1-2 and 5-7 of this paragraph 2. Insert the new filter with the black seal towards the fan 3. For assembly follow steps 1-2 and 5-7 in reverse order 4.
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Page 24: Reset The Hour Meter
13 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. -
Page 25: Replacing The Hose
Do not apply the lock screw into the sensor. 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. Sensor Temperature sensor plate... -
Page 26: Parts Replacement
The replacement procedures contained herein allow qualified medical ® equipment persons to repair the Mistral-Air Plus warming unit. Be sure to contact Stryker Medical for all your replacement part needs before ® servicing the unit. Service is available for this Mistral-Air Plus warming unit by contacting Stryker Medical. -
Page 27: Specifications
18 Specifications Article number MA1100-PM Voltage 110-120V~ Frequency 60 Hz Current Peak current 8.7 A Peak power 925 W Average power 550 W Fuses 10AT/125V~/250V~ P 36954 (Heating pad control unit, air) GMDN-code and term 47681 (Air heating/cooling pad, single-use, non-sterile) 47682 (Air heating/cooling pad, single-use, sterile) 10 7 8 ⁄... -
Page 28: Electromagnetic Compatibility
19 Electromagnetic Compatibility 19.1 Electromagnetic immunity 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 Compliance... - Page 29 (>95 % dip in U (>95 % dip in U powered from an uninterruptible power for 5 sec for 5 sec supply or a backup battery system. Power frequency 3 A/m 3 A/m Power frequency (50/60 Hz) magnetic fields magnetic field should be at levels characteristic of a IEC 61000-4-8...
- Page 30 manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol:...
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Page 31: Electromagnetic Emissions
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. Electromagnetic environment –... -
Page 32: Recommended Separations Distances
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 ®... -
Page 33: Warranty
20 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/R295-EN-PM/4-09/14... - Page 34 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 (800) 327-0770 INT/R295-EN-PM/4-09/14...