Mistral-Air Technical Manual

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 INT-R298-EN-PM/5-10-14

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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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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.

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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. INT-R298-EN-PM/5-10-14

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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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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.

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 INT-R298-EN-PM/5-10-14

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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

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 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.

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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.

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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.

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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.

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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 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. 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. Fan only / ambient air indicator

Stand-by button / On

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Audible alarm suppression button

Temperature selection indicator

Temperature selection button

Service Under temp Over temp indicator alarm alarm

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Preparing the Mistral-Air® Plus 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 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.

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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.

Do not place the unit in or on the bed with the patient

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Mistral-Air® Curved Pole incl. Base MA5115A-PM Mistral-Air® Basket MA5120-PM

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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.

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.

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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-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.

8.2

Switching the Unit On

a

b

c

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. 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. INT-R298-EN-PM/5-10-14

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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  32 ºC (89.6ºF)  38 ºC (100.4ºF)  43 ºC (109.4ºF) 8.4.2

- Ambient air - Low temperature - Medium temperature - High temperature

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 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

b

c

a. Press the Stand-by button b. Disconnect the hose from the blanket c. If desired, leave the blanket on/under the patient

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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/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.

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9.1

General Alarms

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: 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: > 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 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

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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 Service indicator Under temperature alarm Over temperature alarm (primary and secondary)

9.3

Alarm priorities Low priority Low Priority Medium priority

The Blankets Do not use the Mistral-Air® Plus warming unit with any forced air disposables other than Mistral-Air® blankets. Thermal injury may result.

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 INT-R298-EN-PM/5-10-14

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