Smiths Medical HOTLINE HL-90 Operator's Manual
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Smiths Medical HOTLINE HL-90 Operator's Manual

Smiths Medical HOTLINE HL-90 Operator's Manual

Blood and fluid warmer
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OPERATOR'S MANUAL
®
HOTLINE
Blood and Fluid Warmer
<
HL-90
s
®

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Summary of Contents for Smiths Medical HOTLINE HL-90

  • Page 1 ® OPERATOR’S MANUAL ® HOTLINE Blood and Fluid Warmer < HL-90...
  • Page 2 Page intentionally blank...
  • Page 3 ® HOTLINE® Blood and Fluid Warmer < HL-90` OPERATOR’S MANUAL PN 10011022-003...

  • Page 4: General Information

    Smiths Medical and Level 1 design marks and Level 1 and HOTLINE are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark office and certain other countries.

  • Page 5: Table Of Contents

    C o n t e n t s Contents 1 About this Manual Indications for Use Conventions Used in this Manual 2 Description Components HOTLINE® Fluid Warming Set 3 Important Safety Information Additional WARNINGS and CAUTIONS for Accessories 4 Assembly Instructions Step 1 - Unpack the HOTLINE®...
  • Page 6 C o n t e n t s 10 Maintenance Maintenance Performed with Every Use Clean the Exterior General Inspection Disinfect the Reservoir and Change the Recirculating Solution Disinfect the Reservoir Add Recirculating Solution Maintenance Performed Every 30 Days Disinfect the Reservoir and Change Recirculating Solution for Distilled Water and 35% Isopropyl Alcohol Solution Lubricate O-Ring Seals Maintenance Performed Every 12 Months...

  • Page 7: About This Manual

    S E C T I O N • A b o u t t h i s M a n u a l S E C T I O N 1 About this Manual About this Manual This operator’s manual describes the assembly, use, and maintenance of the HOTLINE®...

  • Page 8: Description

    S E C T I O N • D e s c r i p t i o n 2 Description S E C T I O N Description The HOTLINE® Warmer delivers blood and intravenous fluid at normothermic temperatures by surrounding the sterile intravenous line with a layer of warmed recirculating solution.

  • Page 9: Power Cord

    S E C T I O N • D e s c r i p t i o n Right Side View 1 Socket with the reflux plug removed 2 Clamp for I.V. pole 3 Drain tube in tube holder 4 Reflux plug 5 Power cord Rear View...

  • Page 10: Hotline® Fluid Warming Set

    S E C T I O N • D e s c r i p t i o n HOTLINE® Fluid Warming Set HOTLINE® Fluid Warming Sets (L-70, L-70NI, L-80) are individually packed, single-use disposables with a Sterile Fluid Path. The priming volume is 20 ml for the L-70 and L-70NI, and 21 ml for the L-80.

  • Page 11: Important Safety Information

    I.V. flow path may not be sterile. • The HOTLINE® Warmer is for use only with Smiths Medical supplied or approved parts, accessories, and Disposable Sets. The device may not function as intended with the use of unapproved parts, accessories, or Disposable Sets.
  • Page 12 S E C T I O N • I m p o r t a n t S a f e t y I n f o r m a t i o n WARNINGS [continued] • Prime the recirculating solution path before connecting to the intravenous extension set.
  • Page 13 S E C T I O N • I m p o r t a n t S a f e t y I n f o r m a t i o n WARNINGS [continued] • Do not use the HOTLINE® Warmer in high-energy fields such as: MRI, X-RAY, portable and mobile RF communications equipment, and other such devices.
  • Page 14 S E C T I O N • I m p o r t a n t S a f e t y I n f o r m a t i o n CAUTIONS Malfunction, failure, or damage to the device may occur if these cautions are not followed.

  • Page 15: Additional Warnings And Cautions For Accessories

    S E C T I O N • I m p o r t a n t S a f e t y I n f o r m a t i o n Additional WARNINGS and CAUTIONS for Accessories WARNINGS for the L-10 Gas Vent and L-80 Fluid Warming Set •...

  • Page 16: Assembly Instructions

    3 Examine the HOTLINE® Warmer for damage. If any components appear damaged, do not use the HOTLINE® Warmer. Contact Smiths Medical for a replacement. Note: After unpacking the HOTLINE® Warmer, recycle packaging material according to hospital policy for recyclable materials.

  • Page 17: Step 3 - Disinfect The Reservoir

    S E C T I O N • A s s e m b l y I n s t r u c t i o n s 1 Slide the clamp (a) on the HOTLINE® Warmer over the I.V. pole (b) and tighten the clamp screw (c) firmly.

  • Page 18: Step 4 - Fill The Reservoir With Recirculating Solution

    S E C T I O N • A s s e m b l y I n s t r u c t i o n s Step 4 - Fill the Reservoir With Recirculating Solution WARNING Do not fill the HOTLINE® Warmer reservoir with a HOTLINE® Fluid Warming Set in place.

  • Page 19: Principle Of Operation

    S E C T I O N • P r i n c i p l e o f O p e r a t i o n S E C T I O N Principle of Operation HOTLINE® Warmer delivers blood and intravenous fluid at normothermic temperatures under routine, gravity flow rates.

  • Page 20: Operation

    S E C T I O N • O p e r a t i o n S E C T I O N Operation This section describes the controls and displays that monitor and control the HOTLINE® Warmer, and the modes of operation. Controls and Displays •...

  • Page 21: Power And Alarm Test Panel

    S E C T I O N • O p e r a t i o n Power and Alarm Test Panel The Power and Alarm Test Panel is located on the left side of the HOTLINE® Warmer next to the reservoir. This panel contains two pressure-sensitive buttons that are activated when pressed, and the ON/OFF switch.

  • Page 22: Modes Of Operation

    S E C T I O N • O p e r a t i o n Modes of Operation The HOTLINE® Warmer operation is defined in the following modes: • OFF Mode • ON/Operating Mode • Check Disposables Mode •...

  • Page 23: Add Recirculating Solution Mode

    S E C T I O N • O p e r a t i o n Add Recirculating Solution Mode The Add Recirculating Solution mode indicates that the solution level in the reservoir is below its minimum level. Mode characteristics •...

  • Page 24: Operating Instructions

    S E C T I O N • O p e r a t i n g I n s t r u c t i o n s S E C T I O N Operating Instructions The Operating Instructions are grouped into five segments. Read through each segment BEFORE performing a procedure.

  • Page 25: Step 2 - Set Up The Hotline® Fluid Warming Set

    S E C T I O N • O p e r a t i n g I n s t r u c t i o n s Step 2 - Set Up the HOTLINE® Fluid Warming Set WARNINGS •...

  • Page 26: Step 3 - Connect The Intravenous Administration Set

    S E C T I O N • O p e r a t i n g I n s t r u c t i o n s Step 3 - Connect the Intravenous Administration Set WARNINGS • Remove all air from the HOTLINE® Fluid Warming Set, L-10, PC-8, and YC-8 before connecting to the patient.

  • Page 27: Step 5 - After Use

    S E C T I O N • O p e r a t i n g I n s t r u c t i o n s WARNINGS [continued] • Not for use with pressure devices generating over 300 mmHg. Pressure greater than 300 mmHg may compromise the integrity of the HOTLINE®...

  • Page 28: Troubleshooting

    S E C T I O N • T r o u b l e s h o o t i n g S E C T I O N Troubleshooting Only competent personnel should perform any routine maintenance and repairs to the HOTLINE®...
  • Page 29 1 Move the HOTLINE® Warmer away from the device in interference - question. receiving or 2 Plug the HOTLINE® Warmer into a separate electrical transmitting circuit. • If the problem continues, notify Smiths Medical or your local Smiths Medical distributor. HOTLINE® Operator’s Manual BLOOD AND FLUID WARMER...

  • Page 30: Testing

    All testing and maintenance should be performed by competent personnel. If competent personnel are not available, contact Smiths Medical or your local Smiths Medical distributor. If the HOTLINE® Warmer and any installed accessories do not pass any of the listed tests, discontinue use of the HOTLINE®...

  • Page 31: Over Temperature Alarm Test

    S E C T I O N • T e s t i n g Over Temperature Alarm Test The HOTLINE® Warmer should be running at an operating temperature of approximately 41°C to 42°C. 1 Press and hold the Over Temperature Alarm Test button (a). 2 Observe the following: •...

  • Page 32: Check Disposables Test

    S E C T I O N • T e s t i n g Check Disposables Test An interlock switch/sensor, located in the socket on the right side of the HOTLINE® Warmer, senses a properly installed HOTLINE® Fluid Warming Set.
  • Page 33 4 Remove the black label from the auxiliary outlet on the back of the HOTLINE® and plug in the TEMP CHECK power cord. Note: The auxiliary outlet is for use only with Smiths Medical accessories. 5 Turn ON the HOTLINE® Warmer. Allow 15 minutes for the temperature to stabilize.

  • Page 34: Periodic Electrical Testing

    S E C T I O N • T e s t i n g Periodic Electrical Testing Electrical Safety Tests must be performed by competent personnel authorized by the institution to perform such testing. The Safety Tests must be performed and documented at least once per year, or according to institutional policy.

  • Page 35: Maintenance

    Do not clean if there is a defect. Contact Smiths Medical or your local Smiths Medical distributor. 3 Immerse a soft cloth or sponge as an applicator into the cleaning solution consisting of mild liquid detergent soap and warm tap water mixture.
  • Page 36 S E C T I O N • M a i n t e n a n c e 4 Rinse a separate soft cloth or sponge in room temperature running potable water. Squeeze out excess water so that the applicator is not dripping.

  • Page 37: General Inspection

    S E C T I O N • M a i n t e n a n c e General Inspection • Check the condition of the HOTLINE® Warmer with a visual inspection before using. Remove from service any HOTLINE® Warmer that shows physical damage.

  • Page 38: Add Recirculating Solution

    S E C T I O N • M a i n t e n a n c e 3% hydrogen peroxide solution and 1,260 ml of distilled water. 6 Remove the fill-port plug (c), fill the reservoir with the hydrogen peroxide solution, and replace the fill-port plug.

  • Page 39: Maintenance Performed Every 12 Months

    S E C T I O N • M a i n t e n a n c e Silicone lubricant is available from Smiths Medical, (Silicone lubricant P/N 80-04-002). Maintenance Performed Every 12 Months Disinfect the Reservoir and Change Recirculating Solution for 0.3% Hydrogen Peroxide Solution...

  • Page 40: Maintenance Log

    S E C T I O N • M a i n t e n a n c e Maintenance Log All maintenance and testing should be done by competent personnel. Regularly scheduled maintenance ensures proper functioning of the equipment. Refer to the table below for required tasks and frequency of routine maintenance.

  • Page 41: Limited Warranty

    S E C T I O N Limited Warranty Smiths Medical ASD, Inc. (the “Manufacturer”) warrants to the Original Purchaser that the HOTLINE® Blood and Fluid Warmer (the “HOTLINE® Warmer”), not including accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with this Operator’s Manual, for a period of one year from the actual date of sale to...
  • Page 42 S E C T I O N • L i m i t e d W a r r a n t y C. Conditions of Warranty: The warranty is void if the HOTLINE® Warmer has been 1) repaired by someone other than the Manufacturer or its authorized agent;...

  • Page 43: Service

    Service WARNING No operator-serviceable parts. All service must be performed by Smiths Medical or competent personnel. Death or serious injury may occur if this warning is not followed. All service must be performed by Smiths Medical or competent personnel. Service by any other person or organization voids the warranty and transfers liability for malfunctions of the device to the servicing organization.

  • Page 44: Disposal Information

    Observe national and local codes or requirements for disposal of contaminated materials and for recycling of solid waste materials that may impact the environment. Service Contacts Contact your Smiths Medical Technical Service Department or Smiths Medical distributor at: USA/Canada Smiths Medical ASD, Inc.

  • Page 45: Specifications And Accessories

    S E C T I O N • S p e c i f i c a t i o n s a n d A c c e s s o r i e s S E C T I O N Specifications and Accessories System Specifications...
  • Page 46 S E C T I O N • S p e c i f i c a t i o n s a n d A c c e s s o r i e s Electrical Type MAINS Auxiliary Supply Power Output: 100V 100VAC, 50/60 Hz, 1.0 Amps...

  • Page 47: Electromagnetic Compliance

    S E C T I O N • S p e c i f i c a t i o n s a n d A c c e s s o r i e s Electromagnetic Compliance HOTLINE® Warmer is certified to be in compliance with the European Communities Council Directive relating to Electromagnetic Compatibility (EMC): (89/336/EEC).

  • Page 48: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    S E C T I O N • S p e c i f i c a t i o n s a n d A c c e s s o r i e s Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity test IEC 60601 test level Compliance level...
  • Page 49 S E C T I O N • S p e c i f i c a t i o n s a n d A c c e s s o r i e s Guidance and Manufacturer’s Declaration – Radiofrequency Electromagnetic Immunity Immunity test IEC 60601 test level...

  • Page 50: Electromagnetic Environmental Recommendations

    S E C T I O N • S p e c i f i c a t i o n s a n d A c c e s s o r i e s Electromagnetic Environmental Recommendations Recommended separation distances between portable and mobile RF communications equipment and the HOTLINE®...

  • Page 51: Symbols

    S E C T I O N • S y m b o l s S E C T I O N Symbols Symbol Meaning Caution Follow Instructions for Use Do not re-use Catalog Number Serial Number Batch Code Part Number Date of Manufacture Use by Manufacturer...
  • Page 52 S E C T I O N • S y m b o l s Symbol Meaning Humidity Limitiation Atmospheric pressure limitation Quantity Do not use if package is damaged Keep dry Keep away from sunlight Collect separately Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician Electrical Shock Hazard...
  • Page 53 S E C T I O N • S y m b o l s Symbol Meaning Over Temperature Test (Recirculating Solution Over Temperature) Add Recirculating Solution Check Disposables, Check Tubing Maximum Reservoir Level Minimum Reservoir Level Device has been tested by TÜV SÜD America, a nationally recognized technical laboratory, to meet all requirements for safety.

  • Page 54: Index

    I n d e x Index Numerics biohazardous materials 20 electrical device 37 0.3% Hydrogen peroxide solution Maintenance 28 Distilled water maintenance schedule 30 performed every 12 months 32 maintenance schedule 30 preparation 11, 30 performed every 30 days 31 Drain tube 3 35% Isopropyl alcohol solution performed with every use 28...
  • Page 55 I n d e x Service 36 Service contacts 37 Set Up the HOTLINE Fluid Warming Set 17 Set Up the HOTLINE Warmer 17 Socket 2 Specifications 38 electrical 38 environmental 38 performance 39 physical 38 thermal 38 Standard compliance guidelines 38 Storage 20 Symbols 41 System specifications 38...
  • Page 56 I n d e x Page intentionally blank HOTLINE® Operator’s Manual BLOOD AND FLUID WARMER...
  • Page 57 ® Manufacturer: European Representative: Smiths Medical ASD, Inc. Smiths Medical Czech Republic a. s. 6000 Nathan Lane North Olomoucká 306, Hranice 1 - Město, Minneapolis, MN 55442 USA 75 3 01 Hranice, Czech Republic Tel: 1 800 258 5361 (USA/CA)

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