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S E C T I O N 1 4

•

S y m b o l s

HOTLINE

3 Blood and Fluid Warmer | Operator’s Manual

€

Caution: This product contains natural rubber
latex which may cause allergic reactions.

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

Device is class type 1 equipment

Protective earth terminal

Do not use if package is damaged.

Sterile fluid path, ethylene oxide gas sterilized

Temperature Limitation

Humidity Limitation

Use by

Keep away from sunlight

Keep dry

Recyclable Product

Device has been tested by TÜV SÜD America, a
nationally recognized technical laboratory, to
meet all requirements for safety.

Device has been tested by National Technical
Systems, a nationally recognized technical
laboratory, to meet U.S. requirements for safety.

Collect separately for electrical and electronic
equipment.

‚

Contains or Presence of Phthalate:
bis(2-ethylhexyl) phthalate (DEHP)

Symbols

Definitions

CLASS 1

Содержание LEVEL 1 HOTLINE 3 HL-390-38

Страница 1: ...s l OPERATOR S MANUAL HOTLINE 3 Blood and Fluid Warmer HL 390 38 6...

Страница 2: ...HOTLINE 3 Blood and Fluid Warmer HL 390 38 OPERATOR S MANUAL PN 4534013EN Rev 002 s l...

Страница 3: ...poses only and constitutes neither an endorsement nor a recommendation Smiths Medical ASD Inc Smiths Medical assumes no responsi bility with regard to the performance or use of these products Smiths M...

Страница 4: ...fusate Delivery Temperatures 12 6 Operation 13 Controls and Displays 13 Display Panel 13 Power and Alarm Test Panel 14 Reservoir Level Display 14 Modes of Operation 15 OFF Mode 15 ON Operating Mode 15...

Страница 5: ...isinfect the Reservoir and Change Recirculating Solution for 0 3 Hydrogen Peroxide Solution 31 Disinfect the Reservoir and Change the Recirculating Solution 31 Disinfect the Reservoir 32 Add Recircula...

Страница 6: ...as the HOTLINE 3 Warmer The HOTLINE 3 L 370 Fluid Warming Set will be referred to as the HOTLINE 3 Fluid Warming Set or Disposable Set Note Some HOTLINE 3 Warmers may have a Converted from HL 90 to HL...

Страница 7: ...ture The primary temperature control circuit limits the recirculating solution to 38 C maximum In the unlikely event of a malfunction of this circuit a second watchdog circuit will visually and audibl...

Страница 8: ...ube in tube holder 4 Reflux plug 5 Power cord Rear View 1 Fill port plug 2 Drain tube in tube holder 3 Clamp for I V pole 4 Protective earth terminal 5 Auxiliary electrical outlet uncovered Left Side...

Страница 9: ...ly 20 ml The HOTLINE 3 Fluid Warming Set has a connector that plugs into the socket on the right side of the HOTLINE 3 Warmer The connector is designed with a support guide to facilitate installation...

Страница 10: ...low warnings cautions and instructions could result in death or serious injury to the patient The HOTLINE 3 Fluid Warming Set L 10 PC 8 and YC 8 are single use devices and are not intended for re ster...

Страница 11: ...e HOTLINE 3 Fluid Warming Set with needles as this will breach the I V path and compromise the integrity of the patient intravenous line If a Disposable Set with a breached recirculating solution path...

Страница 12: ...er above 107cm 42 may result in instability of the pole and tipping Ensure that the HOTLINE 3 Warmer clamp is screwed tightly onto the I V pole Failure to securely mount the HOTLINE 3 Warmer onto the...

Страница 13: ...acteristics to perform as intended These characteristics have been verified for single use only Any attempt to re process the device for subsequent re use may adversely affect the integrity of the dev...

Страница 14: ...unpacking the HOTLINE 3 Warmer recycle packaging material according to hospital policy for recyclable materials Step 2 Clamp the HOTLINE 3 Warmer to the I V Pole WARNINGS WARNINGS Ensure that the HOTL...

Страница 15: ...ogen peroxide solution 3 Replace the fill port plug d 4 Insert a HOTLINE 3 Fluid Warming Set e into the socket 5 Plug the HOTLINE 3 Warmer into properly grounded power outlet 6 Turn the HOTLINE 3 Warm...

Страница 16: ...Step 5 Perform the Electrical Safety Tests Perform all applicable electrical safety tests as required per institutional procedure Refer to Section 9 Testing for more information about electrical safe...

Страница 17: ...ctive warming is achieved by surrounding the sterile intravenous line with a layer of precisely controlled warm recirculating solution a thereby protecting the patient line against exposure to cold an...

Страница 18: ...t emitting diodes LEDs indicate operation modes for the HOTLINE 3 Warmer 1 Recirculating Solution Temperature The temperature is displayed in degrees Celsius 2 ON Operation The green LED illuminates w...

Страница 19: ...Test is used to confirm the proper operation of the Over Temperature circuitry 2 Alarm Signal Test Button The Alarm Signal Test is used to confirm proper operation of the visual and audible alarms 3 P...

Страница 20: ...E 3 Warmer is turned off ON Operating Mode The power switch is in the ON position b and the HOTLINE 3 Fluid Warming Set has been properly installed Mode Characteristics The green Operating LED c illum...

Страница 21: ...on LED a on the Display Panel illuminates The audible alarm sounds and repeats approximately every two seconds The recirculating solution stops circulating To clear this mode add recirculating solutio...

Страница 22: ...ed to a properly grounded receptacle Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle Do not fill the HOTLINE 3 reservoir with a HOTLINE 3 Fluid Warm...

Страница 23: ...ere is not a breach between the recirculating solution path and intravenous path If fluid exits the patient end of the HOTLINE 3 Fluid Warming Set before connecting to the intravenous extension set re...

Страница 24: ...WARNINGS Remove all air from the HOTLINE 3 Fluid Warming Set L 10 PC 8 and YC 8 before connecting to the patient Failure to do so may result in introduction of air to the patient which may contribute...

Страница 25: ...Death or serious injury may occur to the patient or user if this warning is not followed Not for use with pressure devices generating over 300 mmHg Pressure greater than 300 mmHg may compromise the in...

Страница 26: ...ng to local guidelines for disposal of contaminated medical waste 5 Wipe down the external surfaces of the HOTLINE 3 Warmer with mild liquid detergent soap and warm tap water mixture and a soft cloth...

Страница 27: ...FF the power switch before replacing the HOTLINE 3 Fluid Warming Set 2 If the alarm is not cleared replace the HOTLINE 3 Fluid Warming Set Turn ON the power switch and verify that the alarm has cleare...

Страница 28: ...power switch OFF and allow the HOTLINE 3 Warmer to cool down before returning it to service Recirculating solution leaks at the socket where the HOTLINE 3 Fluid Warming Set plugs into the HOTLINE 3 W...

Страница 29: ...al distributor WARNINGS WARNINGS If any visual indicator does not illuminate or the audible signal does not sound do not use the Fluid Warmer Remove the device from service immediately Death or seriou...

Страница 30: ...the Over Temperature Alarm Test button to stop the test Add Recirculating Solution Test The HOTLINE 3 Warmer is equipped with a float switch which senses the recirculating solution level in the reserv...

Страница 31: ...g Solution Use the Level 1 TEMP CHECK Thermometer HLTA 390 to verify the displayed recirculating solution temperature Other methods of temperature verification may be inaccurate TEMP CHECK provides an...

Страница 32: ...k label from the auxiliary outlet on the back of the HOTLINE 3 Warmer and plug in the TEMP CHECK power cord Note The auxiliary outlet is for use only with Smiths Medical accessories 4 Turn ON the HOTL...

Страница 33: ...Leakage current must be performed with the heater circuit in the full ON condition To achieve this condition perform the test when the reservoir is at room temperature When the HOTLINE 3 Warmer is fir...

Страница 34: ...INE 3 Warmer Clean the Exterior Clean the entire HOTLINE 3 Warmer after every use CAUTIONS Never use organic solvents e g acetone strong acids or bases to clean any portion of the HOTLINE 3 Warmer Do...

Страница 35: ...components to insure that they have been thoroughly cleaned Repeat cleaning procedure if necessary 7 After thoroughly cleaning the HOTLINE 3 Warmer perform disinfection if required 8 If it is hospita...

Страница 36: ...re in this section Disinfect the Reservoir and Change the Recirculating Solution Disinfect the reservoir and change the recirculating solution every 30 days or every 12 months based on the recirculati...

Страница 37: ...c fill the reservoir with the hydrogen peroxide solution and replace the fill port plug 7 Remove the reflux plug from the socket if required and insert a HOTLINE 3 Fluid Warming Set d into the socket...

Страница 38: ...g solution 2 Remove the fill port plug 3 Fill the reservoir with 1 4 liters of recirculating solution 4 Replace the fill port plug Testing HOTLINE 3 Warmer Operation Perform all the tests described in...

Страница 39: ...below for required tasks and frequency of routine maintenance Maintenance Checklist Task Every Use Every 30 Days Every 12 Months Clean the Exterior General Inspection Disinfect the Reservoir and Chan...

Страница 40: ...is made during such one year period The following conditions procedures and limitations apply to the Manufacturer s obligation under this warranty A Parties Covered by this Warranty This warranty ext...

Страница 41: ...of the Manufacturer has authority to bind the Manufacturer to any representation or warranty expressed or implied 2 THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE HOTLINE 3 WARMER F...

Страница 42: ...ir at a cost The device will be promptly inspected and a verbal estimate of the repair cost will be provided A purchase order will be required from the original purchaser consistent with the verbal es...

Страница 43: ...r disposal of contaminated materials and for recycling solid waste materials that may impact the environment Service Contacts Contact your Smiths Medical Technical Service Department or Smiths Medical...

Страница 44: ...th Overall 23 1 cm 9 11 inches Depth Overall 17 8 cm 7 0 inches Weight Dry 3 5 Kg 7 6 lbs Weight Wet with recirculating solution 5 0 Kg 11 0 lbs Weight Shipping 3 6 Kg 7 95 lbs Recirculating Solution...

Страница 45: ...Compatibility EMC 89 336 EEC Test methods and acceptance criteria as specified in EN 60601 1 2 demonstrate conformance Protection Against Electrical Shock Class 1 Equipment Type BF Mode of Operation...

Страница 46: ...distance according to frequency of transmitter m 150 kHz to 80 MHz d 3 5 V1 P 80 MHz to 800 MHz d 3 5 E1 P 800 MHz to 2 5 GHz d 7 E1 P 0 01 0 116 0 116 0 233 0 1 0 368 0 368 0 737 1 1 16 1 16 2 33 10...

Страница 47: ...switch in the ON position Power switch in the OFF position ON Operation Reservoir Temperature Display Add Recirculating Solution Check Disposables Over Temperature Maximum Reservoir Level Minimum Res...

Страница 48: ...Code Authorized Representative in the European Community H Manufacturer J Date of Manufacture G Quantity Protective Earth Ground Alternating Current 7 Do Not Reuse Consult instructions for use The sy...

Страница 49: ...fluid path ethylene oxide gas sterilized P Temperature Limitation _ Humidity Limitation 8 Use by M Keep away from sunlight L Keep dry Recyclable Product Device has been tested by T V S D America a nat...

Страница 50: ...2 Connect the intravenous administration set 19 Contaminated medical waste disposal information 21 Contents list 9 Contraindications 5 Controls 13 Conventions used in manual 1 D Description components...

Страница 51: ...er cord 3 Power ON OFF switch 14 priming volume HOTLINE 3 Fluid Warming Set 4 Principle of operation 12 R Recirculating solution change 31 maintenance schedule 11 31 preparation 11 31 protocols 11 Ref...

Страница 52: ...I n d e x HOTLINE 3 Blood and Fluid Warmer Operator s Manual 47 U USA service contact 38 Using the HOTLINE 3 Warmer 20 W Warnings 5 L 10 Gas Vent 8 Warranty 35...

Страница 53: ...I n d e x 48 HOTLINE 3 Blood and Fluid Warmer Operator s Manual...

Страница 54: ...s l H Manufacturer Smiths Medical ASD Inc 160 Weymouth Street Rockland MA 02370 USA Tel 1 800 258 5361 US CA Tel 1 781 878 8011 Made in USA...

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