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Level 1®

 CONVECTIVE WARMER

  |  Operator’s Manual

35

S E C T I O N   9     •     S y m b o l s

S E C T I O N   9

Symbols

Symbols

Definitions

<

Catalog Number

Indicates the manufacturer’s catalogue number so that the medical device can 

be identified. 

ISO-15223-1 Symbols - Used with Medical Device Labelling. ISO 7000: 2493

>

Serial Number

Indicates the manufacturer’s serial number so that a specific medical device can be 

identified. 

ISO-15223-1 Symbols - Used with Medical Device Labelling. ISO 7000: 2493

Batch Code

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

ISO-15223-1 Symbols - Used with Medical Device Labelling. ISO 7000: 2492

Non-sterile

Indicates a medical device that has not been subjected to a sterilization process.

ISO-15223-1 Symbols - Used with Medical Device Labelling. ISO 7000: 2609

J

Date of Manufacture

Indicates when the medical device was manufactured YYYY-MM-DD. 

ISO-15223-1 Symbols - Used with Medical Device Labelling. ISO 7000: 2497 

H

Manufacturer

Indicates the medical device manufacturer.

ISO-15223-1 Symbols - Used with Medical Device Labelling. ISO 7000: 3082

Quantity

Indicates the number of pieces in package
Symbol created by Smiths Medical

~

Not made with natural rubber latex

Large X indicates natural rubber latex (NRL) is not used as a material in the medical 

product or product container.

ISO-15223-1 Symbols - Used with Medical Device Labelling Annex B.2. ISO 7000: None

6

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a 

physician.

CFR 21 801.109

Protective Earth ; protective ground

Identifies any terminal which is intended for connection to an external conductor for 

protection against electric shock in case of a fault, or the terminal of a protective earth 

(ground) electrode.

ISO 7000: 5019

Follow Instructions for Use

Refer to the instruction manual/booklet 

ISO 7010-M002, IEC 60601-1

Содержание L1-CW-100V

Страница 1: ...a Konvekcinis šildytuvas Конвекторен нагревател Dispozitiv de încălzire prin convecție Konvekcijski grelnik Operator s Manual Manuel d utilisation Bedienungsanleitung 0 Manuale dell operatore 1 Manual del operador 2 Manual do operador 3 Gebruikershandleiding 4 Bruksanvisning 5 Brugervejledning 6 Operatørhåndbok 7 Käyttöohjekirja 8 Εγχειρίδιο χειριστή Uživatelská příručka Príručka operátora Kezelői...

Страница 2: ...Italiano 116 Español 153 Português 190 Nederlands 227 Svenska 264 Dansk 301 Norsk 338 Suomi 375 Eλληνικά 412 Česky 449 Slovenčina 486 Magyar 523 Polski 560 Eesti keel 597 Latviešu valoda 634 Lietuvių 671 Български 708 Română 745 Slovenščina 782 ...

Страница 3: ...Convective Warmer TO OBTAIN A PAPER COPY contact Smiths Medical customer service at 1 800 258 5361 ...

Страница 4: ...nal purposes only and constitutes neither an endorsement nor a recommendation Smiths Medical ASD Inc Smiths Medical assumes no responsibility with regard to the performance or use of these products The Smiths Medical and Level 1 design marks are trademarks of Smiths Medical The symbol indicates the trademark is registered in the U S Patent and Trademark office and certain other countries All other...

Страница 5: ...8 Step 2 Attach the Hose to the Convective Warmer 19 Step 3 Install the Convective Warmer 20 Step 4 Perform Electrical Functional and Safety Tests 20 Daily Use Step 1 Plug into Mains Power 21 Step 2 Select Convective Warming Blanket 21 Step 3 Attach the Hose to Convective Warming Blanket 22 Step 4 Attach the Sheet Clip to the Sheet Under the Patient 22 Step 5 Using the Convective Warmer 22 Step 6 ...

Страница 6: ...Level 1 CONVECTIVE WARMER Operator s Manual 8 This page intentionally left blank ...

Страница 7: ...or Use The Level 1 Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold The Level 1 Convective Warmer can be used with adult or pediatric patients and is intended for use by healthcare professionals in clinica...

Страница 8: ...ibility in patient treatment 37 C 40 C and 43 C These three temperature settings are controlled by thermistors placed at the end of the hose where the hose connects to the convective warming blanket A fourth temperature setting delivers ambient temperature air The temperature at the end of the hose is stable at the set point indicated on the control panel when the selected set point LED stops blin...

Страница 9: ...ective warmer 5 Thermistor Receptacle connection for the thermistor cable 6 Power Cord Receptacle connector for the power cord MAINS connect disconnect Rear View with Hose Attached 7 Hose transports air to the convective warming blanket 8 Hose Nozzle and Elbow hose end that attaches to the convective warming blanket 9 Air Intake air enters the convective warmer through the vents located under the ...

Страница 10: ...r serviceable parts inside the enclosure Only competent personnel knowledgeable in the safety procedures required for servicing live primary MAINS parts shall be allowed to open the enclosure Grounding reliability can only be achieved when the MAINS power cord is connected to a properly grounded receptacle Risk of electrical shock exists if the equipment is not connected to a properly grounded rec...

Страница 11: ...pped ensure that the convective warmer IV pole mounting clamp is properly tightened before each use Failure to securely mount the convective warmer onto the IV pole may cause it to slide down the IV pole and injure the patient or user Do not perform maintenance while the convective warmer is operating Risk of thermal injury exists if the device is operating This device can only be used in conjunct...

Страница 12: ...your local Smiths Medical distributor The convective warmer must be serviced by competent personnel authorized by Smiths Medical Failure to service the device correctly may result in thermal injury to the patient To prevent insufficient or excessive heat therapy the convective warmer should only be used in operating temperatures of 10 C 40 C The use of materials of good thermal conductivity such a...

Страница 13: ...se of the convective warmer to prevent thermal injury to the patient Remove the device from service Contact Smiths Medical or your local Smiths Medical distributor Do not use strong solvents to clean the hose or exterior surfaces These solutions may damage labels and other parts Never use organic solvents e g acetone strong acids or bases to clean any portion of the convective warmer Do not place ...

Страница 14: ...nvective Warmer is monitored and controlled by the control panel User Interface This section describes the control panel and the modes of operation Control Panel The Control Panel provides the controls indicators and displays used during operation of the convective warmer 1 Standby Button 2 Temperature Setting Buttons 3 Operation Indicators 2 3 1 ...

Страница 15: ...ting Button When selected the air temperature is set to 40 C at the hose end A blinking LED indicates that the system has not yet reached the selected temperature Green LED None 43 C Temperature Setting Button When selected the air temperature is set to 43 C at the hose end A blinking LED indicates that the system has not yet reached the selected temperature Green LED None Over Temperature indicat...

Страница 16: ...ng steps describe how to assemble and do preliminary set up of the convective warmer Step 1 Unpack the Convective Warmer 1 Check the contents and verify that all components are present If any parts are missing or damaged do not use the convective warmer Contact Smiths Medical for replacement parts Refer to the following list of components that are part of the convective warmer Level 1 Convective W...

Страница 17: ...mistor cable a from the hose to the thermistor receptacle b mounted inside the air outlet c To connect align the three prongs in the thermistor with the three holes in the receptacle then gently push the thermistor inward to secure it in the receptacle 2 Attach the hose d to the air outlet Push the hose firmly into the outlet a b c d shown with optional pole clamp installed ...

Страница 18: ...receptacle The indicated lock feature is spring loaded and self locking The lock must be intentionally pulled back to release the power cord Step 4 Perform Electrical Functional and Safety Tests Perform all applicable electrical functional and safety tests as required per institutional procedure Electrical safety check must be performed by competent personnel authorized by the institution to perfo...

Страница 19: ...emperature Maintenance and Occlusion c all light in turn during the automatic selftest When the self test is complete the Standby LED lights green 3 Ensure hose connection to back of warmer is firmly seated 4 Ensure the standby indicator is lit signifying electrical power is applied Step 2 Select the Convective Warming Blanket Warning Refer to the Warnings and Precautions in the Instructions for U...

Страница 20: ... under the patient is essential to the proper function of the sheet clip assembly Step 5 Using the Convective Warmer 1 Press the desired Temperature setting to begin the delivery of therapy The standby LED indicator will turn off and the selected temperature LED will blink green until the temperature setting is reached Once the set temperature has been achieved the temperature LED indicator will b...

Страница 21: ...e convective warming blanket Note Dispose of the convective warming blankets in a safe manner according to local guidelines for disposal of contaminated medical waste 3 Perform routine cleaning after each use Refer to Section 6 Cleaning Maintenance for more details Step 7 Storage Store the convective warmer in a cool dry place away from temperature extremes Refer to Section 8 Specifications for mo...

Страница 22: ... soft cloth or sponge as an applicator into the cleaning solution consisting of mild liquid detergent soap and warm tap water mixture Squeeze out excess solution so that the applicator is not dripping Wipe or scrub the entire surface of the enclosure and control panel Use a soft brush to clean the power cord if necessary 4 Rinse a separate soft cloth or sponge in room temperature running potable w...

Страница 23: ...he manufacturer The effectiveness of these listed disinfectants should be validated using the hospital procedures The following disinfectant agents can be used without causing damage to the enclosure Isopropyl Alcohol Water mix 70 30 Chlorine and Chlorine products Cidex Hydrogen Peroxide Quaternary Ammonium compounds Phenolic Disinfectants Replace Air Filter The air filter in the convective warmer...

Страница 24: ...hing slowly and an alarm is sounding 1 The warmer has not come up to temperature in the anticipated time frame Continue to wait for the temperature to be reached No air flow 1 The hose and or the thermistor cable may not be properly connected Check the hose and thermistor cable connections Reference Indicator lights for troubleshooting Weak air flow 1 Clogged air filter or obstructed air filter in...

Страница 25: ...eck that room temperature is not below 15 C 20 C for L1 CW 100V Warmer is running the selected Temperature Setting Indicator is on solid or is blinking the Over Temperature Error Indicator is on solid or is blinking and an alarm may be sounding 1 The temperature at the hose end is above the temperature selected on the control panel Continue use and wait for the temperature to reduce Warmer stops t...

Страница 26: ...lled and used in accordance with the instructions it may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to other devices which can be determined by removing power unplug power cord and then reapplying power the user is encouraged to try to corre...

Страница 27: ...greater for 0 2 mm size particles BFE VFE efficiency 99 999 tested per ASTM F2101 Meets IEC 60601 1 and EN 60601 1 Meets ASTM D4169 Dist Cycle 12 Assurance Level I Vehicle stack height meets Assurance Level II Environmental Operation Operation Altitude Transportation Storage Transportation Storage Pressure Temperature Humidity 10 C to 40 C 15 to 95 noncondensing 400 to 3000 meters 40 C to 60 C 15 ...

Страница 28: ...fore stopping the warmer lockout and logging the error Temperature Set LED Off Over Temp LED Fast Flash Standby LED On Maintenance LED Fast Flash Medium Off Over Temp Limit Above Temperature Limit of 45 C for more than 5 seconds Total Over Temp Limit Time before stopping the warmer lockout and logging the error Temperature Set LED Off Over Temp LED Fast Flash Maintenance LED Fast Flash Standby LED...

Страница 29: ...ke mitigation measures such as relocating or re orienting the equipment Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Note Compliance using 100 240V 50 60Hz with AC power cord of 3 m 5 m with hose thermistor cable of 2 m WARNING The use of power cord and hose other than those listed in the electromagnetic emissions declaration may result in ...

Страница 30: ...5 kV 1 kV for line to line 0 5 kV 1 kV 2 kV for line to ground 1 kV line to line 2 kV line to ground Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 100 drop 0 5 periods 0 45 90 135 180 225 270 315 100 dip 250 300 period 30 dip 25 30 periods 100 drop 0 5 periods 0 4...

Страница 31: ...r manufacturer and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guideli...

Страница 32: ... 69 3 69 7 38 100 11 66 11 66 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where power 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 ...

Страница 33: ...cture Indicates when the medical device was manufactured YYYY MM DD ISO 15223 1 Symbols Used with Medical Device Labelling ISO 7000 2497 H Manufacturer Indicates the medical device manufacturer ISO 15223 1 Symbols Used with Medical Device Labelling ISO 7000 3082 Quantity Indicates the number of pieces in package Symbol created by Smiths Medical Not made with natural rubber latex Large X indicates ...

Страница 34: ...lling ISO 7000 2621 _ Humidity Limitation Indicates the range of humidity to which the medical device can be safely exposed ISO 15223 1 Symbols Used with Medical Device Labelling ISO 7000 2620 Collect separately Indicates that when the end user wishes to discard this product it must be sent to separate collection facilities for recovery and recycling By separating this product from other household...

Страница 35: ...haser may be medical personnel a hospital or institution which purchases Convective Warmers for treatment of patients The Original Purchaser should retain the invoice or sales receipt as proof as to the actual date of purchase The Original Purchaser may have other legal rights which may vary from state to state province or country B Warranty Performance Procedure Notice of the claimed defect must ...

Страница 36: ... Warmer for any particular medical treatment 4 All recommendations information and descriptive literature supplied by the Manufacturer or its agents are believed to be accurate and reliable but do not constitute warranties The Manufacturer disclaims responsibility for the suitability of the Convective Warmer for any particular medical treatment or for any medical complications resulting from the u...

Страница 37: ...ices received that are no longer under warranty can be returned for repair at a cost The device will be serviced for a flat fee Contact Smiths Medical for pricing Before returning the Level 1 Convective Warmer for service contact Smiths Medical for a Returned Goods Authorization Note The convective warmer must be cleaned and disinfected for repair shipment or it will be immediately returned as rec...

Страница 38: ...er of the convective warmer when you contact the service department The serial number is located on the rear of the convective warmer Contact your Smiths Medical Technical Service Department or Smiths Medical distributor at USA Canada Smiths Medical ASD Inc 6000 Nathan Lane Minneapolis MN 55442 USA Tel 1 800 258 5361 US CA Tel 1 614 210 7300 European Representative Smiths Medical Czech Republic a ...

Страница 39: ...apolis MN 55442 USA Tlf 1 800 258 5361 USA CA Tlf 1 614 210 7300 Europeisk representant Smiths Medical Czech Republic a s Olomoucká 306 Hranice 1 Město 75 3 01 Hranice Czech Republic Tlf 44 0 1233722100 www smiths medical com ML 0001 558 Rev 303 04 19 2797 ...

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