Smith Medical LEVEL 1 HOTLINE 3 HL-390-38 Operator'S Manual Download

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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

SECTION 14

Symbols

Definitions

Power 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 Reservoir Level

Alarm Test

Type BF Equipment

Warning: Do not stick HOTLINE



3 tubing with

needles. Patient injury or death could result.

Summary of Contents for LEVEL 1 HOTLINE 3 HL-390-38

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

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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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