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Level 1, HOTLINE, and Smiths design mark are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark office and certain other countries.
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 ®...
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C o n t e n t s 9 Testing Alarm Signal Test Over Temperature Test Add Recirculating Solution Test Check Disposables Test Temperature Verification of the Recirculating Solution Periodic Electrical Testing Leakage Current Ground Bond Test 10 Maintenance Maintenance Performed with Every Use Clean the Exterior General Inspection Disinfect the Reservoir and Change the Recirculating Solution...
S E C T I O N 1 • A b o u t t h i s M a n u a l SECTION About this Manual This operator’s manual describes the assembly, use, and maintenance of ® the HOTLINE Blood and Fluid Warmer.
S E C T I O N 2 • D e s c r i p t i o n SECTION 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.
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S E C T I O N 2 • D e s c r i p t i o n Right Side View Socket with the reflux plug removed Clamp for I.V. pole Drain tube in tube holder Reflux plug Power cord Rear View Fill-port plug...
S E C T I O N 2 • 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.
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.
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S E C T I O N 3 • 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 Continued from previous page WARNINGS WARNINGS •...
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Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle. • No user-serviceable parts. All service must be performed by Smiths Medical or an authorized representative. CAUTIONS • Federal Law (USA) restricts this device to sale by or on the order of a physician.
S E C T I O N 3 • 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 •...
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.
S E C T I O N 4 • A s s e m b l y I n s t r u c t i o n s Step 5 - Perform the Electrical Safety Tests Perform all applicable electrical safety tests as required per institutional Testing procedure.
S E C T I O N 5 • P r i n c i p l e o f O p e r a t i o n SECTION Principle of Operation ® HOTLINE Warmer delivers blood and intravenous fluid at normothermic temperatures under routine, gravity flow rates.
S E C T I O N 6 • O p e r a t i o n SECTION Operation This section describes the controls and displays that monitor and control ® the HOTLINE Warmer, and the modes of operation. Controls and Displays •...
S E C T I O N 6 • O p e r a t i o n Power and Alarm Test Panel 1.4 LITERS The Power and Alarm Test Panel is located on the left side of the ® HOTLINE Warmer next to the reservoir.
S E C T I O N 6 • 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 •...
S E C T I O N 6 • O p e r a t i o n To clear this mode, check that the Twin-Tube Connector on the ® HOTLINE Fluid Warming Set is firmly inserted in the socket. Add Recirculating Solution Mode The Add Recirculating Solution mode indicates that the solution level in the reservoir is below its minimum level.
S E C T I O N 7 • O p e r a t i n g I n s t r u c t i o n s SECTION Operating Instructions The Operating Instructions are grouped into five segments. Read through each segment BEFORE performing a procedure.
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S E C T I O N 7 • O p e r a t i n g I n s t r u c t i o n s Continued form previous page WARNINGS WARNINGS • Prime the recirculating solution path before connecting to the intravenous extension set.
S E C T I O N 7 • O p e r a t i n g I n s t r u c t i o n s Step 5 - After Use WARNINGS WARNINGS • Blood and blood products could contain pathogenic organisms. Failure to follow institutional policy and procedures for biomedical-hazardous materials could lead to exposure to harmful pathogens.
S E C T I O N 8 • T r o u b l e s h o o t i n g SECTION Troubleshooting Only authorized personnel should perform any routine maintenance and ® repairs to the HOTLINE Warmer.
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- question. receiving or 2 Plug the HOTLINE ® Warmer into a separate electrical transmitting circuit. • If the problem continues, notify Smiths Medical or an authorized representative for assistance. ® HOTLINE Blood and Fluid Warmer | Operator’s Manual...
Warmer and any installed accessories do not pass any of ® the listed tests, discontinue use of the HOTLINE Warmer and remove from service. Contact Smiths Medical or an authorized representative for service. WARNINGS WARNINGS • If any visual indicator does not illuminate or the audible signal does not sound, do not use the Fluid Warmer.
S E C T I O N 9 • T e s t i n g Over Temperature 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 button ( a ). 2 Observe the following: •...
S E C T I O N 9 • 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 ®...
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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.
S E C T I O N 9 • T e s t i n g Periodic Electrical Testing Electrical Safety Tests must be performed by qualified 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.
S E C T I O N 1 0 • M a i n t e n a n c e SECTION Maintenance Only authorized personnel should perform any routine maintenance and ® repairs to the HOTLINE Warmer. Maintenance is scheduled with each use, every 30 days, and every 12 months.
S E C T I O N 1 0 • M a i n t e n a n c e 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 recirculating solution used for the ®...
S E C T I O N 1 0 • M a i n t e n a n c e 7 Remove the reflux plug from the socket if required, and insert a ® HOTLINE Fluid Warming Set ( a ) (L-70, L-70NI, L-80) into the socket.
2 Apply silicone grease along the O-Rings inside the socket ( a ) ® located on the right side of the HOTLINE Warmer. 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...
S E C T I O N 1 0 • M a i n t e n a n c e Maintenance Log All maintenance and testing should be done by qualified personnel. Regularly scheduled maintenance ensures proper functioning of the equipment.
• L i m i t e d W a r r a n t y SECTION Limited Warranty Smiths Medical ASD, Inc. (the “Manufacturer”) warrants to the Original ® Purchaser that the HOTLINE Blood and Fluid Warmer (the ®...
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S E C T I O N 1 1 • L i m i t e d W a r r a n t y packaged and returned to the Manufacturer, postage prepaid. Any loss or damage during shipment is at the risk of the sender. ®...
S e r v i c e SECTION Service All service must be performed by Smiths Medical or an authorized service representative. Service by any other person or organization voids the warranty and transfers liability for malfunctions of the device to the servicing organization.
S E C T I O N 1 3 • 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 SECTION Specifications and Accessories System Specifications Standard Compliance Guidelines...
S E C T I O N 1 3 • 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 Protection Against Electrical Class 1 Equipment, Type BF Shock...
S E C T I O N 1 3 • 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 ®...
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S E C T I O N 1 4 • S y m b o l s SECTION Symbols 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...
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S E C T I O N 1 4 • S y m b o l s Symbols Definitions Protected Against Dripping Water Catalog Number Serial Number Part Number Batch Code Authorized Representative in the European Community Manufacturer Date of Manufacture Quantity Protective Earth [Ground] Alternating Current...
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S E C T I O N 1 4 • S y m b o l s Symbols Definitions Latex Free 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 CLASS 1 Protective earth terminal Do not use if package is damaged.
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I n d e x Numerics 0.3% Hydrogen peroxide solution Description maintenance schedule 30 components 2 preparation 11 HOTLINE Fluid Warming Sets 4 35% Isopropyl alcohol solution HOTLINE Warmer 2 maintenance schedule 30 Disinfect the reservoir 10 preparation 11 Display Panel 2 description 14 Disposal information 37 biohazardous materials 21...
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I n d e x Intravenous administration set priming volume connect 20 HOTLINE Fluid Warming Sets 4 Isopropyl alcohol solution 11 Principle of operation 13 L-10 Gas Vent Recirculating solution warnings and cautions 8 change 30 LCD 14 maintenance schedule 11 LEDs 14 preparation 11 Light-emitting diodes (LEDs) 14...
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I n d e x Troubleshooting 22 Add Recirculating Solution alarm 22 Check Disposables alarm 22 electrical interference 23 hot cabinet 22 install HOTLINE Fluid Warming Set 22 no power 22 Over Temperature alarm 22 recirculating solution leaks 23 USA service contact 37 Using the HOTLINE Warmer 20 Warnings 5 L-10 Gas Vent 8...
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