Mistral-Air R780-PM User Manual May 2018

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Contents 1 General information... 5 1.1 About this manual... 5 1.2 Indications for use... 5 1.3 Contact... 5 1.4 FAQ and training... 5 1.5 Warranty... 6 1.6 Authorization of personnel... 6 1.7 Warning, caution and note...6 1.8 Disclaimer... 6 2 Contra-indications, warnings, cautions, notes and symbols... 7 2.1 Contra-indications...7 2.2 Warnings...7 2.3 Cautions...9 2.4 Notes... 9 2.5 Device safety symbols...10 2.6 Blanket safety symbols... 13 3 Description...16 3.1 Overview of the Mistral-Air® Warming Unit (MA1200‑PM)... 16 3.2 Overview of the control panel... 16 3.3 Visual and audible warning systems...17 3.3.1 Technical alarm... 18 3.3.2 Overtemperature alarm... 19 3.3.3 Microcontroller watchdog alarm... 19 3.3.4 Filter replacement indicator... 19 3.3.5 Temporarily audible alarm suppression...19 4 Accessories and disposables...20 4.1 Mistral-Air® Adjustable Pole (MA5200-PM)... 22 4.2 MA1200-PM mounting parts (MA5002-PM)... 23 4.3 Mistral-Air® blankets...24 5 Set up... 26 5.1 Transport and storage... 26 5.2 Connecting the power supply cord... 26 5.3 Attaching the mounting parts... 26 6 Operation...30 6.1 Safety instructions before operation...30 6.2 Connecting the power supply...30 6.3 Connecting the blanket... 30 6.4 Turning on the device...30 6.5 Selecting the temperature... 31

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6.6 Stopping warming...31 7 Maintenance... 32 7.1 Cleaning...33 7.2 Corrective maintenance...33 7.2.1 Replacing the filter (MA1200-1001-PM)... 33 7.2.2 Replacing the hose (MA1100-1018-PM & MA1100-1018XL-PM)... 35 7.2.3 Replacing the power cord... 37 8 Troubleshooting... 38 9 Specifications... 39 9.1 Specifications of the device... 39 10 Electromagnetic compatibility... 41 10.1 Electromagnetic immunity... 41 10.2 Electromagnetic emissions...42 10.3 Recommended separation distances... 43

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1

General information

1.1

About this manual

In this manual, you can find important information about how to operate the Mistral-Air® Warming Unit - SYK (MA1200-PM) (hereafter referred to as ‘the device’). The manual helps you with the operation and the maintenance of the device, in a safe and responsible manner. Read this manual carefully. Complete all the procedures. Do the procedures in the given sequence. Always keep the manual near the device. Please refer to the Mistral-Air® technical manual for maintenance, repair and calibration instructions. The Mistral-Air® technical manual is available for download at the business partner menu of the 37Company website.

1.2

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.

1.3

Contact

Stryker Medical 3800 E. Centre Avenue Portage, MI 49002 USA E-mail: [email protected] Website: www.stryker.com

1.4

FAQ and training

Please refer to our website (www.the37company.com) for an up-to-date overview of the frequently asked questions of the Mistral-Air® products: home / mistral-air | frequently asked questions. Warning! The device may only be operated by trained clinicians and maintenance may only be performed by trained biomedical technicians or engineers. Both user groups must be trained by certified trainers from Stryker.

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1.5

Warranty

For the warranty provisions, ask your local Stryker representative.

1.6

Authorization of personnel

Make sure that only authorized personnel use the device.

1.7

Warning, caution and note Warning! A "warning" tells you that there is a risk of personal injury or death.

Caution! A "caution" tells you that: • there is a risk of damage to the device, and/or • there is a risk of damage to other equipment.

A "note" gives more information.

1.8

Disclaimer

The manufacturer 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 manufacturer reserves the right to make alterations and improvements to the device. These may not yet have been described in the instructions. The manufacturer 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 manufacturer. These instructions are intended for personnel authorized to work with and/or service the medical device described in this manual.

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2 Contra-indications, warnings, cautions, notes and symbols Your device was designed and built with safety in mind. The device 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 the contra-indications, warnings, cautions and notes before using or prescribing the device.

2.1

Contra-indications

• Only apply heat to intact skin and do not apply heat directly to open wounds. • Do not apply the warming system to ischemic limbs. 1. 2.

2.2

Use caution and consider discontinuing use on patients during vascular surgery when an artery is clamped to an extremity (i.e. aortic cross-clamping). Use caution and monitor closely if used on patients with severe peripheral vascular disease.

Warnings Warning! • Do not use the device when it is damaged or when the Mistral-Air® Blanket is damaged. Thermal injury may result. • Do not allow the patient to lie on or contact the hose with the skin when the device is active. Thermal injury may result. • Do not use the Mistral-Air® Blanket to transfer or move the patient. Injury to the patient may result. • To prevent tipping when mounting to an IV-pole, mount the device at a height at which the IV-pole is stable. Injury may occur. Before usage, assess the stability by placing the IV-pole on a surface at an angle of 10° from the horizontal plane with brakes activated. The IV-pole may not overbalance, or move. Also passing over a 10 mm threshold may not result in overbalancing. Mass and position of center of gravity are provided in this IFU for theoretical analysis. Stryker cannot provide maximum mounting height prescriptions for different wheel base diameters, numbers of castors (either with brakes or not) and configurations of other equipment mounted to the IV pole. • Do not use the device without a Mistral-Air® Blanket connected to it (no free hosing). Thermal injury may result. • Do not use the device and blankets near flammable anesthetics and/or in oxygenenriched environment, to avoid the risk of explosion or fire. • Check patient’s temperature and skin condition at least every 15 minutes, or according to institutional protocol. • Do not cover the patient’s thorax with our Mistral-Air® Blankets during cardioversion or defibrillation therapy.

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• Applying air with a temperature above the normothermic core body temperature range (36 – 37.5°C) incorporates the risk of hyperthermia. Depending on the selected set point, heating time, additional heat sources and insulation, the patient’s body core temperature can rise above 37.5°C. Thermal injury may result. • Pediatric patients of low weight will have a tendency to overheat more rapidly than adults. Failure to monitor core temperature could result in abnormal elevation of body temperature resulting in serious injury or death. • A physician order is required for setting temperature and for continued use. • If patient temperature is not responding to treatment or does not reach the desired temperature, notify a physician. • Warming transdermal medications (patches) can increase drug delivery, resulting in possible harm to the patient. • Do not use the device with any forced air disposables other than Mistral-Air® Blankets. Thermal injury may result. • 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 resistance) is not demonstrated. • Never fold the blankets during use. This could lead to insufficient treatment. • Do not obstruct blanket channels by e.g. instruments/tape/clamps. This could lead to insufficient treatment. • The device is fitted with a HEPA H13 class air filter (EN1822-1:2009, GROUP H). However airborne contamination should be taken into consideration when using the warming system to minimize the risk of infection for the patient. • Before you clean the device, disconnect the power supply cord to eliminate the risk of electrocution. • Clean the hose after each use to reduce the risk of infection. • When replacing the hose, do not touch the temperature sensors. If these sensors are touched in any way, they can be damaged and out of calibration. This could cause burns to the patient. If the temperature sensors are touched or damaged, contact your local Stryker representative. • Use of accessories, transducers and cables other than those specified or provided by Stryker of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. • Do not disassemble the device unless you are a qualified service technician. Injury may occur. • Before performing corrective maintenance (see Corrective maintenance on page 33), disconnect the power supply cord to eliminate the risk of electrocution. There are electrically live parts within the device when it is connected to a power supply. • Mistral-Air® blankets need to be used with the soft blue material towards the patient’s skin. When used oppositely the treatment will be ineffective. The blue side provides the air distribution towards the patient. • When placing the device on a surface, make sure the surface is horizontal, solid and clean. Do not place the device on a carpet because it could block the air inlet and reduce the performance.

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• When using bed hooks, only mount the device to a horizontal secured surface. Do not mount the device to a tilting non-secured surface. The device may fall and pull the blanket from the patient. • Do not place the device above, or in the bed with the patient. Thermal injury may occur. • Place the device in such a way that the mains plug can be disconnected easily in case of emergency. Operator injury may occur. • Connect the device to an adequate reliable grounded receptacle. Operator injury may result. • When mounted to the Mistral-Air® Adjustable Pole, make sure that the hose does not extend beyond the wheelbase of the Mistral-Air® Adjustable Pole so that it is protected by the wheelbase. Otherwise damage to the hose may occur. • Clean the hose at ambient temperature and make sure the hose is dry before use. Damage to the hose or device may occur. • When the device has suffered impact, disconnect the power plug and contact your local Stryker representative.

2.3

Cautions Caution! • Do not use a sharp object to press the buttons on the control panel. • The device must be mounted securely, or placed on a stable flat surface before use to prevent the device from falling. • To ensure stability when mounted to a trolley the device may only be mounted to a Mistral-Air® Adjustable Pole (MA5200-PM). • Do not immerse the device in liquids. Otherwise, the device can be damaged. • Stay in viewpoint of the control panel when the device is performing the self-test and selecting the set-point. See Turning on the device on page 30. • In case of an alarm, check for any obstruction of the air flow; ensure that the blanket and the hose are not folded, the inlet is free (not blocked) and no tools/equipment are placed on the blanket. If the device continues to alarm, take the device out of use and contact the hospital service department or the local supplier. • Do not place the device on a carpet because it could block the air inlet and reduce the performance.

2.4

Notes • 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 device is not equipped with an isolating switch. Temporary interruption of the supply mains will render the device in standby mode and discontinue treatment.

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2.5

Device safety symbols

This section contains a list of symbols used for the Mistral-Air® Forced Air Warming Unit. Protected against ingress of solid objects larger than 12.5 mm and water falling as a spray at an angle up to 60° from the vertical axis (according to IEC 60429).

Caution: Federal US law restricts this device to sale by or on order of a physician.

Connect the device to an earthed socket only. Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle.

No free hosing. Warning! 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.

Warning! Do not use the device distal to arterial cross clamping or with a patient with an ischemic limb.

Serial number

Catalogue / article number

Manufacturer

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Transport and storage ambient temperature limits

Transport and storage relative humidity limits

Transport and storage atmospheric pressure limits

AC voltage

Type BF applied parts (according to IEC 60601-1:2005+A1:2012)

Equipotentiality

Read the user manual

Consult the instructions for use

Caution

Low priority alarm indication on control equipment

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Medium priority alarm indication on control equipment

Temporarily audible alarm suppression

Repair is required

Upper limit of temperature, overtemperature alarm

Replace filter

Air flow at ambient temperature (not heated)

32°C

Air flow setpoint at a temperature of 32°C (heated)

38°C

Air flow setpoint at a temperature of 38°C (heated)

43°C

Air flow setpoint at a temperature of 43°C (heated)

Prior to use, the user needs to check that the device (including the power cord and the hose) is undamaged. In the event of damage do not use the device.

Maintenance may only be performed by trained biomedical technicians or engineers. Both user groups must be trained by certified trainers from Stryker.

Warning! Plug the device into an earthed mains socket.

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Before using the device, it should be attached to a pole, Mistral-Air® Adjustable Pole (MA5200-PM), bed rail/end, ISO rail, wall, or placed on a table.

2.6

Blanket safety symbols

This section contains a list of symbols used for the Mistral-Air® Blankets.

Not for use in magnetic resonance imaging (MRI)

Caution: Federal US law restricts this device to sale by or on order of a physician.

Do not use the device if the package is damaged.

Catalogue / article number

Sterile, method of sterilisation ethylene oxide

Batch code / lot number

S = Small, M = Medium, L = Large, XL = Extra large

Manufacturer

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Check patient’s temperature and skin condition at least every 15 minutes, or according to institutional protocol.

Warning! Do not use the device distal to arterial cross clamping or with a patient with an ischemic limb.

Transport and storage ambient temperature limits

Transport and storage relative humidity limits

Transport and storage atmospheric pressure limits

Use-by-date

For single patient use only

Not made with natural rubber latex.

Read the user manual

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Consult the instructions for use

Caution

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3

Description

3.1

Overview of the Mistral-Air® Warming Unit (MA1200‑PM)

The device is a Forced Air Warming Unit which consists of a fan, heater, electronics and a filter to propel filtered and heated air to a blanket. The device may only be used with disposable MistralAir® blankets that are single use only. 1. 2. 3. 4. 5. 6. 7. 8. 9.

Control panel Mounting clamp Mounting options (accessory) Appliance inlet Equipotential pin Data connection Cord anchor Filter (air inlet) Hose

The device can be controlled by using the control panel at the front top of the device. The back of the device is equipped with a universal mounting clamp, a sealed data connector, an appliance inlet and an equipotential pin. It can be expanded with a mounting accessory set as shown in the image above to offer various mounting options, see Accessories and disposables on page 20. For more device specifications, see Specifications on page 39.

3.2

Overview of the control panel

The control panel is located at the front top of the device and can be operated by pressure sensitive buttons. The device is easy to use. All settings are visible on the control panel and you can select the preferred temperature by pressing the temperature selection buttons. When an alarm condition is detected, an audible alarm will be activated and an alarm LED will flash yellow.

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1

2

3

1. 2. 3.

Standby button Temperature selection indicators Overtemperature alarm LED

4. 5. 6.

Technical alarm LED Filter replacement indicator LED Temperature selection + and – buttons Fan only/ambient air indicator Temporarily audible alarm suppression button

7. 8. 8

3.3

7

6

5

4

Visual and audible warning systems

The device is equipped with visual and audible warning systems to protect against excessive temperatures, to warn for a technical malfunction, and to indicate that filter change is required. If equipment errors occur, an audible alarm sounds and the relevant LED indicator(s) on the control panel will flash or light up continuously. There are four different alarms/indicators: • • • •

Technical alarm Overtemperature alarm Microcontroller watchdog alarm Filter replacement indicator

These alarms/indicators are described in the sections below. It is also possible to temporarily suppress the audible alarm.

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Alarm/indicator summary Alarm/indicator

Priority

Behavior

Technical alarm

Medium

Technical alarm LED: Yellow flashing Audible alarm: 3 beeps repeated every 6 seconds

Overtemperature alarm

Medium

Technical alarm LED: Yellow flashing Overtemperature alarm LED: Yellow flashing Audible alarm: 3 beeps repeated every 6 seconds

Microcontroller watchdog alarm

Medium

Technical alarm LED: Yellow continuous Overtemperature alarm LED: Yellow flashing Audible alarm: continuous beep

Filter replacement indicator

Low

Filter replacement indicator LED: Yellow continuous Audible alarm: 1 single beep

3.3.1

Technical alarm

A flashing yellow technical alarm LED indicates that a technical error has occurred and the air temperature cannot be accurately controlled. The visual alarm is accompanied by an audible alarm, which consists of three pulses of 200 ms duration, with 200 ms spacing between each pulse. This pattern is repeated every 6 seconds. Some possible causes of this alarm: • The leads to the temperature sensors are damaged, or disconnected. • The fan is blocked, or damaged and cannot reach its desired speed. • The heater is damaged and the desired air temperature is not reached. • A mains power dip (≥ 30%) occurred for more than 1/60 seconds. If this alarm occurs, the heater and fan are turned off and the device enters standby mode. It is impossible to start the device by pushing the standby button. Control of the device can only be recovered through resetting the device. To do this, disconnect the mains plug and reconnect it. Caution! If this alarm occurs, check for anything blocking the air flow path. If the technical alarm continues, take the device out of use and contact the hospital service department or Stryker.

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3.3.2

Overtemperature alarm

The overtemperature alarm is triggered with a maximum air temperature of 56°C. When the overtemperature alarm occurs, the technical and overtemperature LED's flash yellow. These indicate that the air temperature is too high. The visual alarms are accompanied by an audible alarm, which consists of three pulses of 200 ms duration, with 200 ms spacing between each pulse. This pattern is repeated every 6 seconds. If this alarm occurs, the heater and fan are turned off and the device enters standby mode. It is impossible to start the device by pushing the standby button. Control of the device can only be recovered through resetting the device. To do this, disconnect the mains plug and reconnect it. Caution! If this alarm occurs, check for anything blocking the air flow path. Ensure that the blanket is not folded and do not place tools/equipment on the blanket which could result in a blocked air flow. Ensure that the air inlet is free. If the overtemperature alarm continues, take the device out of use and contact the hospital service department or the local supplier.

3.3.3

Microcontroller watchdog alarm

The microcontroller watchdog alarm is visually indicated by a continuous yellow technical alarm LED and a flashing yellow overtemperature LED. The visual alarms are accompanied by a continuous single tone audible alarm. The microcontroller watchdog alarm indicates a technical malfunction and is triggered when the microcontroller is not functioning properly. If this alarm occurs, the heater and fan are turned off and the device enters standby mode. It is impossible to start the device by pushing the standby button. Control of the device can only be recovered through resetting the device. To do this, disconnect the mains plug and reconnect it. Caution! If this alarm occurs, send the device to a certified service department for technical support.

3.3.4

Filter replacement indicator

When the yellow filter replacement LED lights up, the filter needs to be replaced. This LED is activated when the device has been used for more than 2000 hours. When it is activated, it is accompanied by a single beep. Refer to Replacing the filter (MA1200-1001-PM) on page 33 for the filter replacement procedure.

3.3.5

Temporarily audible alarm suppression

The audible alarm may be suppressed for up to 2 minutes by pressing the temporarily audible alarm suppression button. When the audible alarm is suppressed, the orange LED lights up. After 2 minutes or after pushing the button once again, the audible alarm will automatically be restored.

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4

Accessories and disposables

The device can be used with the following accessories and disposables: • Mistral-Air® Adjustable Pole (MA5200-PM) • MA1200-PM mounting parts (MA5002-PM) • Mistral-Air® blankets Warning! • Do not place the device above, or in the bed with the patient. Thermal injury may occur. • When placing the device on a surface, make sure the surface is horizontal, solid and clean. Do not place the device on a carpet because it could block the air inlet and reduce the performance. • When mounted, the device must be mounted securely before use to prevent the device from falling. • To prevent tipping when mounting to an IV-pole, mount the device at a height at which the IV-pole is stable. Injury may occur. Before usage, assess the stability by placing the IV-pole on a surface at an angle of 10° from the horizontal plane with brakes activated. The IV-pole may not overbalance, or move. Also passing over a 10 mm threshold may not result in overbalancing. Mass and position of center of gravity are provided in this IFU for theoretical analysis. Stryker cannot provide maximum mounting height prescriptions for different wheel base diameters, numbers of castors (either with brakes or not) and configurations of other equipment mounted to the IV pole. The image below shows the position of the center of gravity in relation to the center of the pole clamp.

35 mm 105 mm

In the standard configuration, the device can be mounted to an IV pole or ISO rail using the universal clamp on the back of the device (see figures below). It is also possible to place the device on a table without reducing the air flow rate.

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