SECTION IO + Meintenence 6 Remove the fill-port plug (¢), fill the reservoir with the hydrogen, peroxide solution, and replace the fil: port plug, 7 Remove the reflux plug from the socket if required, and insert a HOTLINE® Fluid Warming Set (d) (L-70, L-70NI, L-80) into the socket. 8 Tum the HOTLINE® Warmer ON, and let the recirculating solution circulate for a 30-minute disinfection period. 9 Tum the HOTLINE® Warmer OFF and unplug the power cord. 10 Empty the reservoir. 11 Remove the HOTLINE® Fluid Warming Set and discard according to established hospital procedures ‘These suggested instructions are designed to be used in conjunction. with established hospital procedures, ‘Add Recirculating Solution CAUTIONS + Do not fill the HOTLINE® Warmer reservoir with a HOTLINE” Fluid Warming Set or a TEMP CHECK in place. Failure to remove the HOTLINE” Fluid Warming Set before the fill procedure may result in an air lock in the HOTLINE® Warmer. 1 Prepare the recirculating solution. 2 Remove the fill-port plug. 3 Fill the reservoir with 14 liters of recirculating solution. 4 Replace the fill-port plug. Maintenance Performed Every 30 Days Disinfect the Reservoir and Change Recirculating Solution for Distilled Water and 35% Isopropyl Alcohol Solution Refer to Disinfect the Reservoir and Change the Recirculating Solution procedure in this section, aSECTION IO Lubricate ©. ing Seals 1 Place a small amount of silicone lubricant on a cotton swab. 2 Apply silicone lubricant 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 80-04-02). Maintenance Performed Every 12 Months infect the Reservoir and Change Recirculating Solution for 0.3% Hydrogen Peroxide Solution Refer to Disinfect the Reservoir and Change the Recirculating Solution procedure in this section. Replace O-Rings (O-Ring Kit: P/N 80-04-01) 1 Unplug the HOTLINE® Warmer before servicing. 2 Remove the socket head serews (b) with a 0.31em (1/8") hex wrench. foray 3. Remove the face plate, being careful not to damage the micro- Ting switch lever 4 Remove the old O-rings and clean the sockets with a cotton swab. 5 Apply silicone lubricant to two new O-rings and install into the sockets. 6 Reassemble in reverse order, being careful not to damage the micro- switeh lever 7 Insert HOTLINE” Fluid Warming Set and power on HOTLINE Warmer to verify that there are no leaks around the face plate. Testing HOTLINE” Warmer Operation Perform all the tests described in the testing section of this manual. See Section 9, Testing. The Scheduled Maintenance Checklist below also lists the tests. 2 jod and Fluid Warmer | Operator's Manual + WeintenenceMaintenance Log All maintenance and testing should be done by competent personns SECTION TO + Weintenonce Regularly scheduled maintenance ensures proper functioning of the equipment. Refer to the table below for required tasks and frequency of routine maintenance. Maintenance Checklist Task Every Use | Every 30 Days | Every 12 Months (Cleon the Exterior o ‘General Inspection o Disinfect the Reservoir and Change Distllac Water or isopropyl Alcohol solution Lube ie the O-Rings Disinfoc! the Reservoir ond CChonge the Hydrogen Peroxide Solution Replace the O-Rings ‘Alarm Signal Tes ‘Add Recirculating Soluton Test ‘Check Disposables Tes (Over Temperature Alarm Test Verily Temperature Electrical Safety Tests HOTLINE® Blood and Fluid Warmer | Operator's Manual aSECTION 11 + Limited Warrenty SECTION 11 Limited Warranty Smiths Medical ASD, Ine. (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 the Original Purchaser. THERE ARE NO OTHER WARRANTIES. ‘This warranty does not cover normal wear and tear and maintenance items, and excludes any accessory items or equipment used with the HOTLINE® Warmer. Suibject to the conditions of and upon compliance with this Limited ‘Warranty, the Manufacturer will repair or replace at its option without charge (except for a minimal charge for postage and handling) any HOTLINE® Warmer (not including accessories) which is defective if claim 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 extends only to the Original Purchaser of the HOTLINE® Warmer. This warranty does not extend to subsequent purchasers. The Original Purchaser may be medical personnel, a hospital, or institution which purchases HOTLINE® Warmers for treatment of patients. The Original Purchaser should retain the invoice or sales receipt as proof as co the actual date of purchase. 'B. Warranty Performance Procedure: Notice of the claimed defect must bbe made in writing or by telephone to the Manufacturer as follows: Customer Service Department, Smiths Medical ASD, Ine., 160 Weymouth Street, Rockland, MA 02370, (800) 258-536. Notice to the Manufacturer must include date of purchase, model and serial ‘number, and a description of the claimed defect in sufficient detail to allow the Manufacturer to determine and facilitate any repairs which may be necessary. AUTHORIZATION MUST BE OBTAINED PRIOR TO RETURNING THE HOTLINE® WARMER. If authorized, the HOTLINE® Warmer must be property and carefully jod and Fluid Warmer | Operator's ManualSECTION 11 + Limited Warrenty packaged and returned to the Manufacturer, postage prepaid. Any loss or damage during shipment is at the risk of the sender. 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; 2) altered so that its stability or reliability is affected; 3) misused; or 4) damaged by negligence or accident. Misuse includes, but is not limited to, use not in compliance with the Operator's Manual or use with non-approved accessories, Removal or damage to the HOTLINE® Warmer’s serial ‘number will invalidate this warranty. D, Limitations and Exclusions: Repair or replacement of the HOTLINE® Warmer or any component part thereof is the EXCLUSIVE remedy offered by the Manufacturer. The following exclusions and limitations shall apply: L. No agent, representative, or employee of the Manufacturer has authority to bind the Manufacturer to any representation of warranty, expressed or implied. 2. THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE HOTLINE® WARMER FOR ANY PARTICULAR PURPOSE. 3. The HOTLINE® Warmer can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the HOTLINE® Warmer for any particular medical 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 HOTLINE® Warmer for any particular medical treatment or for any ‘medical complications resulting from the use of the HOTLINE® Warmer. ‘The Manufacturer shall not be responsible for any incidental damages or consequential damages to property; loss of profits, or loss of use caused by any defect or malfunction of the HOTLINE® Warmer, This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may have other legal rights which may vary from state to state.SECTIONI2 © Service SeION 12 Service WARNINGS + No user-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, Non-Warranty Work ‘Devices received that are no longer under warranty can be returned for repair ata cost. The device will he 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 estimate. A written estimate will be provided upon request. Before returning the HOTLINE® Warmer for service, contact Smiths Medical for Returned Goods Authorization, Be sure that ALL recirculating. solution is drained from the device before packing the HOTLINE® Warmer for shipment. Note: The HOTLIN shipment or it will be immediately returned as received. {® Warmer must be cleaned and disinfected for repair Additional Documentation Upon request Smiths Medical will provide the following documentation: + Circuit diagrams + Components parts list(s) + Description of function + Service and calibration instructions 6 jod and Fluid Warmer | Operator's ManualSECTIONI2 © Service 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. 160 Weymouth Street Rockland, MA 02370 USA Tel: 1 800 258 5361 swwwssmiths-medical.com arSECTION 13, SECTION 13 + Spocificotions and Recesserios Specifications and Accessories System Specifications Standard Compliance Product Safely mc. Enclosure Protection Fluid Warmers Physical “Feah, Oval SY Wid, Overall Depth, Overall Weight, Dry Weight, Wet wih recirculating soltion} Weight, Shipping Recirculating Solution Copecily Maximum Height on IV. Pole Environmental ‘Operation Tronsporation Storoge Thermal Temperature Sel Point Over Tempercture SetPoint Electrical TAINS Power Inout V15V MAINS Auxiliary Supaly Power Output: 115 28 Guidelines TEC 60601-1:2005 EN 6060)-1.2, FCC A7 CFR Pon 15, loss 8 EC 60529 IP Code: Ix’ ASTM F2172.02 Dimensions Alem (7 aches) 21.0em (8.3 inches} 7.8m (7.0 inches) 35 Ke (7.6 los) 5.0 Kg (17.0 lbs} 3.6 Ke 7.95 Ibs) 14 (0.37 gollons) 107 em (42 inches) Temperature Humidity [6] TOC 45°C 101095 “18°C 10 60°C 51090 “18°C 10 60°C 51090 Temperature orc = 01°C ac Type TISVAC, 0/60 Hz, 3.0 Amps TISVAC, $0/60 Hz, 1.0 AmpsSECTION 15. + Electrical Protection Agains Elecvical Shock Mode of Operation Type of Cunent ingress Protection Rating Performance Recireulatng Solaion Tomperciure Normothermic Flow Roles Specifications ané Accasseries Type Coss T Equipment, ype BF Continuous Alternating Px! [Recirculating soliion Temperature reaches 37°C from ambient in about 4 minutes As grow low rates to 8,000 ml per hour Electromagnetic Compliance HOTLINE® Warmer is certified o be in compliance with the European Communities Couneil Directi c relating to Electromagnetic Compatibility (EMC): (89/336/EEC). Test methods and acceptance criteria as specified in EN 60601-1-2 demonstrate conformance. HOTLINE® Blood and Fluid Warmer | Operator's Manual a»SECTION 13 + Spocificotions and Recesserios Electromagnetic Environmental Recommendations Recommended separation distances between portable and mel equipment and the HOTLINE® Warmer The HOTINE® Warmers irlended for use in an eledromagnelic environment in which radioed RF disturbances are controlled. The customer of he user of the HOTLINE® Warmer con help prevent eledromegnetc interarence by mantaring @ minimum distance belween portable and mobile RF communication eqvipment nd the HOTLINE® Warmer as recommended below, according to the masimum output power of ne communications aquipmen Rated maximum ‘Separation distance according to frequency of transmitter m output power of [7150 kHz to 80 MHz | 80 MHz to 800 MHz ‘800 MHz to 2.5 GHz ‘ronsmitter d=13.5/V1INP d=13.5/E1NP d={7/E1/NP w oor one oe 0233 oT O68 368 OaT T 1S 16 238 a ae 3 738 00 11.86 1.86 23.33 For ransmitiers rated ata maximam ouipvt power not Isied above, he recommended separation dstonce din motras (m) can be estimated using the equation applicable tothe frequency of the transmitter, where P is the maximum output power raling of fhe transmitter in waits (W) according fo the transmitter menufacturer. NOTE ! A 80 Me ond 800 He, he seperation distance rhe higher kequany orgs alien NOTE 2 These guidlines mayo opin suolons Eachoagnat propagation #ecos by aberption ad elon hor sive, objects and people Accessories Product Description 70 TOTLINE® Fid Warming Set wih Injection Por L70NI HOTLINE® Fluid Warming Set without Injaction Port L-80 HOTLINE? Warming Set wih L-10 Gos Vent Lio Gos Vent PCB T-Connector, 20.3 cm 8" Patient Lead with Injection Port Yes Y.Connector, 20.3 em (8" Potent Lead with Injection PortSECTION 14 Symbols Symbols SECTIONI4 © Symbole nitions Power switch in the ON position Power switch in the OFF aostion ON/Operation Reservoir Temperature Disploy Add Recirculating Solution Check Disposobles Over Temperature Maximum Reservoir Level Minimum Reservoir Level ‘Avorm Test Type BF Equipment Waring: Do not stick HOTLINE? tubing with needles. Patent injury or death could result HOTLINE® Blood and Fluid Warmer | Operator's Manval 41SECTIONI4 © Symbole Symbols Definitions IPX1 Protected Against Oripoing Water REF Catalog Number SN Serial Number PN Lor Botch Code REP Authorized Representative in the European m ° Manufacturer Date of Manufacture Quantity Protective Earth [Ground] Alternating Current Do Not Reuse Consult insiructions for use {ihe symbol egpears an he device wih blue background Consult instructions for use Caution Electric Shock Hazai > |ple\olel2 @ICIE/E HOTLINE® Blood and Fluid Warmer | Operator's ManualSymbols Qa x iy 20 CLASS 1 SECTIONI4 © Symbole Definitions Not made wih notural eubber latex ‘Caution: This product contains na la ‘which may cause allergic reactions. ‘Caution: Federal (U.S.A, law restricts this jevice to sole by or on the order of a physician Device is closs type 1 equi Pr ive ear terminal Do no! use if package is damaged Storie fuid path, ethylene oxide gas sterlized Temperature Limitation Humiclty Limitation Use by Keep awoy from sunlight Keop dry Recyclable Product Device hos been tested by TUV SUD Americe, @ nationally recognized technical laboratory, to maet al raquiremen's for sofey. Device has beer tested by National Technical Systems, nationclly recognized toch laboratory, to meet US. requirements fr safely Cal equipment seperately for electrical and electronic Contains or Presence of Phialote: bis(2-ethylhexy} phthalate (DEH?) HOTLINE® Blood and Fluid Warmer | Operator's Manval aNumerics 0.3% Hydrogen peroxide solution ‘maintenance schedule 30 preparation II, 30 35% Isopropyl alcohol solution ‘maintenance schedule 30 preparation II, 30 A Accessories list 40 ‘Add Recirculating Solution mode 16 ‘Add Recirculating Solution test 24 ‘Add Solution LED 16 ‘Additional documentation 36 After Use 20 Alarm signal text 23, Alarm Test button 14 ‘Aleohol (isopropyl) solution 11, 30 Anesthetic use warning 7 ‘Assembly instructions 9 Auniliary electrical outlet 3 Biohazardous materi disposal information 20 c Canada service contact 37 Cautions 8 L-10 Gas Vent 8 Change the recirculating solution 30 Cheek Disposables LED 15 Cheek Disposables mode 15, Cheek Disposables Test 25 Clamp for LV. pole 3 Clean exterior surfaces 28 Components 2 description 2 Connect the intravenous administration set 19 Contents list 9 Contraindications 5 Controls 13 Conventions used in manual 1 D Description components 2 HOTLINE Fluid Warming Sets 4 HOTLINE Warmer 2 Disinfect the reservoir 10, 30 Display Panel 2, 13 description 13 Disposal information 37 biohazardous materials 20 maintenance schedule 30 Drain tube 3 Electrical safety tests II, 27 Electrical specifications 38 Electromagnetic compliance 39 Electromagnetic environmental recommendations 40 Environmental specifications 38 F Fill-port plug 3 Float switch 3 G Grounding reliability 7, 17 Guidelines for safe use 5 H HOTLINE Fluid Warming Sets description 4 priming volume 4 Hydrogen peroxide solution preparation 10, 11, 30 LY. pole mounting height restrictions 9 Important safety information 5 Indications for use 1 Infusate delivery temperatures 12 HOTLINE® Blood and Fluid Warmer | Operator's ManvalIntravenous administration set connect 19 Isopropyl alcohol solution 11, 30 L L-10 Gas Vent warnings and cautions 8 LeD 13 LEDs 13 Light-emitting diodes (LEDs) 13 Liquid crystal display (LCD) 13 M Maintenance 28 performed every 12 months 32 performed every 30 days 32 performed with every use 28 Maintenance schedule recirculating solution 11, 30 Modes of operation 15 Mounting to LV. pole 9 N Non-Warranty work 36 ° OFF mode 15 ON/Operating mode 15, Operating LED 15 Operation modes 13, 15 O-Rings lubricate seals 32 replace 32 Over Temperature Alarm mode 16 Over Temperature LED 16 Over Temperature test 24 (Over Temperature Test button 14 Pp Performance specifications 39 Physical specifications 38 Power and Alarm Test Panel 14 Power cord 3 Power ON/OFF switch 14 priming volume HOTLINE Fluid Warming Sets 4 HOTLINE® Blood and Fluid Warmer | Operator's Manual Principle of operation 12 R Recirculating solution change 30 ‘maintenance schedule II, 30 preparation 11, 30 protocols Il Reflux plug 3 Replace O-Rings 32 Reservoir 3 fill with recirculating solution 11 Reservoir level display 14 s Service 36 Service contacts 37 Sct 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 T ‘Temperature display 13 Over Temperature Alarm 16 Temperature verification of the recitculating solution 25 Testing 23 ‘Thermal specifications 38 Troubleshooting 21 ‘Add Recirculating Solution alarm 21 Check Disposables alarm 21 electrical interference 22 hot cabinet 22 install HOTLINE Fluid Warming Set 22 45no power 21 Over Temperature alarm 21 recirculating solution leaks 22 u USA service contact 37 ‘Using the HOTLINE Warmer 19 w Warnings 5 L-10 Gas Vent 8 ‘Warranty 34 HOTLINE® Blood and Fluid Warmer | Operator's ManvalPage intentionally blank@ LEVEL tail Manufacturer: ‘Smiths Medical ASD, Inc. 160 Weymouth Street Rockland, MA 02370, USA “Tel: 1800258 5361 smiths medical