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INT-R295-EN-10-11-17

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

Содержание Mistral-Air MA1100-EU

Страница 1: ...Original Instructions Version INT R295 EN 10 11 17 ...

Страница 2: ......

Страница 3: ...User Manual Mistral Air Plus Warming Unit MA1100 EU 220 240V 50 60 Hz MA1100 US 110 120V 60 Hz MA1100 JP 100 110V 50 60 Hz ...

Страница 4: ......

Страница 5: ...ion to Power Supply 15 8 2 Switching the Unit On 16 8 3 Connecting the Blanket 16 8 4 Warming Up With the Mistral AirÒ 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 21 10 Maintenance 21 11 Storage and Cleaning 22 12 Replacing the Filter 22 13 Re...

Страница 6: ...ns 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 li...

Страница 7: ...disease 1 2 Safety Precautions Adequate grounding reliability can only be achieved when the device is connected to an equivalent receptacle marked hospital grade Avoid direct contact between a blanket and a laser Although the blankets are flame retardant per 16 CFR Part 1610 Standard for the flammability of clothing textiles class 1 compliance with ISO 11810 2015 classification for the laser resis...

Страница 8: ...he Mistral Air Plus warming unit is certified according to IEC 60601 1 2 2014 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 inte...

Страница 9: ... 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 th...

Страница 10: ...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 or according to institutional protocol Do not apply to patients with ischemic limbs Do n...

Страница 11: ... 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 ...

Страница 12: ...INT R295 EN 10 11 17 9 Not for use in MRI Bell cancel temporary Service indicator Upper limit of temperature Lower limit of temperature Non ionizing electromagnetic radiation ...

Страница 13: ... 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 instr...

Страница 14: ...ally 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 bla...

Страница 15: ... 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 EU 220 240 V 50 60 Hz MA1100 US 110 120 V 60 Hz MA1100 JP 100 110 V 50 60 Hz Control panel Hose towards patient blanket Handle at top side side ...

Страница 16: ...Warming Unit For Use 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...

Страница 17: ...e mounted securely before use The Mistral Air Plus warming unit can be mounted onto the Mistral Air curved pole with basket art MA5100 C 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 Do not place the unit in or on the bed with the patient Mistral Air curved pole with ...

Страница 18: ...se drug delivery resulting in possible harm to the patient Do not apply to patients with ischemic limbs 8 1 Connection to Power Supply a b c d 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...

Страница 19: ...ng unit will start blowing air at the default temperature setting of 38 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 8 3 Connecting the Blanket Take the selected Mistral Air blanket out of the package and follow the instructions...

Страница 20: ...ice 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 a...

Страница 21: ...nket 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 In case of temperature alarm check for free airflow Ensure blanket is not folded and do not place tools equ...

Страница 22: ...mpletely B Secondary Over Temperature Alarm This flashing yellow LED indicates an over temperature condition Lower limit Tprimary 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 ...

Страница 23: ...sion 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 Unit type 50 Hz 60 Hz MA1100 EU 3 min 2 min MA1100 US 2 min MA1100 JP 3 min 3 min E Service Indicator When the yellow LED under the wrench turns on accompanied by a single beep the Mistral Air Plu...

Страница 24: ...only 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 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 ...

Страница 25: ...ot allow water to seep into electrical areas of the Mistral AirÒ Plus warming unit 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 non staining 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 pa...

Страница 26: ...e clockwise 5 Remove screws 3x of filter screen 6 Remove filter screen 7 Remove filter 1 For disassembly follow steps 1 2 and 5 7 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 ...

Страница 27: ...ator 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 b c d e a Switch unit in Stand by mode b Press and hold the buttons and the Audible Alarm Suppression button simultaneously c While holding down the buttons press the Stand by button d Now an audible alarm is produced and the unit retu...

Страница 28: ...o 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 15 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 Sensor Temperature se...

Страница 29: ...engineers to repair the Mistral Air Plus warming unit Be sure to contact your local dealer or The 37Company for all your replacement part needs before servicing the unit Service is available for this Mistral Air Plus warming unit contact your local dealer or The 37Company High risk of accessible electrically live parts when removing the hose ...

Страница 30: ...u shape profile MA1100 1020 EU Capacitor EU MA1100 1021 PE connector MA1100 1022 IV pole knob MA1100 1024 Screw assy set MA1100 1025 Wiring set MA1100 1026D Handle with keyboard pins MA1100 1027A Packaging MA1100 1028 Cord Anchor MA1100 1031 Mistral Air Front Cover Pin 10 pcs MA5001 Hoseclamp box of 20 R295 EN User Manual printed1 R298 EN Technical Manual printed1 MA0100 PC XX2 Standard power cord...

Страница 31: ...th 1 8 m Power cord length 4 0 m Filtration HEPA 0 3 µm 99 99 H13 conform EN 1822 1 Current leakage 50 µA Classification 93 42 EEC Class IIb 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 43 ºC ambient temperature Accuracy of temperature 2 5 ºC Set point reached after Maximum 2 minutes Low tempera...

Страница 32: ...INT R295 EN 10 11 17 29 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 ...

Страница 33: ...and external antennas should be used no closer than 30 cm 12 inches to any part of the Mistral Air Plus warming unit including cables specified by The 37Company Otherwise degradation of the performance of Mistral Air Plus warming unit could result The Emissions characteristics of Mistral Air Plus warming unit make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used...

Страница 34: ...s Distances Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip...

Страница 35: ...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 ...

Страница 36: ...INT R295 EN 10 11 17 33 20 Warranty For the general The 37Company warranty statement please visit our website www the37company com Contact information is located on the last page of this manual ...

Страница 37: ...ropean 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 ...

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