Smiths Medical LEVEL 1 HOTLINE HL-90-40 Скачать руководство пользователя

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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

HOTLINE

Blood and Fluid Warmer | Operator’s Manual

SECTION 13

Specifications and Accessories

System Specifications

Standard Compliance

Guidelines

Product Safety

IEC 60601-1:2005

EMC

EN 60601-1-2, FCC 47 CFR Part 15,
Class B

Enclosure Protection

IEC 60529 IP Code: IPX1

Fluid Warmers

ASTM F2172-02

Physical

Dimensions

Height, Overall

24.1 cm

(9.5 inches)

Width, Overall

21.0 cm

(8.3 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
Capacity

1.4 L

(0.37 gallons)

Maximum Height on I.V. Pole

107 cm

(42 inches)

Environmental

Temperature

Humidity [%]

Operation

C to 45

10 to 95

Transportation

-18

C to 60

5 to 90

Storage

-18

C to 60

5 to 90

Thermal

Temperature

Temperature Set Point

40.0

C ± 0.1

Over Temperature Set Point

41.2

Electrical

Type

MAINS Power Input: 115V

115VAC, 50/60 H

, 3.0 Amps

MAINS Auxiliary Supply Power
Output: 115V

115VAC, 50/60 H

, 1.0 Amps

Содержание LEVEL 1 HOTLINE HL-90-40

Страница 1: ...OPERATOR S MANUAL l s HOTLINE Blood and Fluid Warmer HL 90 40 6 4524104 Rev 000 3 07 40 C Set Point ...

Страница 2: ...Page intentionally blank ...

Страница 3: ...HOTLINE Blood and Fluid Warmer HL 90 40 OPERATOR S MANUAL PN 4534010EN Rev 004 s l ...

Страница 4: ...nly 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 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 Al...

Страница 5: ...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 Check Disposables Mode 15 Add Recirculating Solution Mode 16 Over Temperature Alarm Mode 16 7 Operating Instructions 17 Step 1 Set Up the HOTLINE Warmer 17 Step 2 Set Up the HOTLINE Fluid Warming Set...

Страница 6: ...ed Water and 35 Isopropyl Alcohol Solution 31 Lubricate O Ring Seals 32 Maintenance Performed Every 12 Months 32 Disinfect the Reservoir and Change Recirculating Solution for 0 3 Hydrogen Peroxide Solution 32 Replace O Rings O Ring Kit P N 80 04 001 32 Testing HOTLINE Warmer Operation 32 Maintenance Log 33 11 Limited Warranty 34 12 Service 36 Non Warranty Work 36 Additional Documentation 36 Dispos...

Страница 7: ...Conventions Used in this Manual The HOTLINE Blood and Fluid Warmer will be referred to as the HOTLINE Warmer The L Series Fluid Warming Sets L 70 L 70NI L 80 will be referred to as the HOTLINE Fluid Warming Set or Disposable Set WARNING These instructions contain important information for safe use of the product Read the entire contents of this operator s manual including Warnings and Cautions bef...

Страница 8: ...perature The primary temperature control circuit limits the recirculating solution to 40 C maximum In the unlikely event of a malfunction of this circuit a second watchdog circuit will visually and audibly alarm and stop the recirculating solution pump if the temperature reaches 41 2 C Fluid in the HOTLINE Fluid Warming Set is never exposed to any damaging or dangerous temperatures while the HOTLI...

Страница 9: ...e 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 View 1 Power and Alarm Test Panel 2 Fill port plug 3 Reservoir contains recirculating solution 4 Float switch inside reservoir o o C C HOTLINE FluidWarmer 2 1 3 4 5 1 2 1 3 4 5 1 4 LITERS 2 1 3 4 ...

Страница 10: ... 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 The HOTLINE Fluid Warming Set has a Twin Tube Connector that plugs into the socket on the right side of the HOTLINE Warmer This is the only connection necessary to provide the warming function The HOTLINE Fluid Warming Set is easily unplugged from the HOTLINE Warmer and discarded ...

Страница 11: ...ollow warnings cautions and instructions could result in death or serious injury to the patient The HOTLINE Fluid Warming Set L 10 PC 8 and YC 8 are single use devices and are not intended for re sterilization Do not use HOTLINE Fluid Warming Set L 10 PC 8 and YC 8 if the caps are not securely in place else the I V flow path may not be sterile The HOTLINE Warmer is for use only with Smiths Medical...

Страница 12: ...ntravenous path do not use needles greater than 38 mm 1 5 in length when accessing the injection port If there is a breach between the recirculating solution path and intravenous path patient illness may occur because of the HOTLINE Warmer s recirculating solution entering the patient s bloodstream Do not stick the HOTLINE Fluid Warming Set with needles as this will breach the I V path and comprom...

Страница 13: ...tacle Do not mount the HOTLINE Warmer more than 107cm 42 above the floor For convenience 107cm 42 is indicated on the HOTLINE Warmer power cord by a black mark Mounting the HOTLINE Warmer above 107cm 42 may result in instability of the pole and tipping Ensure that the HOTLINE Warmer clamp is screwed tightly onto the I V pole Failure to securely mount the HOTLINE Warmer onto the I V pole may cause ...

Страница 14: ...ecific material characteristics 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 device or lead to deterioration in performance Additional WARNINGS and CAUTIONS for Accessories WARNINGS for the L 10 Gas Vent and L 80 Fluid Warming Set Do not tape over vents else a...

Страница 15: ... unpacking the HOTLINE Warmer recycle packaging material according to hospital policy for recyclable materials Step 2 Clamp the HOTLINE Warmer to the I V Pole WARNINGS WARNINGS Ensure that the HOTLINE Warmer pole clamp is screwed tightly onto the I V pole Failure to securely mount the HOTLINE Warmer onto the I V pole may cause the HOTLINE Warmer to slide down the pole and may injure the patient or...

Страница 16: ...1 4 liters of 0 3 hydrogen peroxide solution 3 Replace the fill port plug d 4 Insert a HOTLINE Fluid Warming Set e L 70 L 70 NI L 80 into the socket 5 Plug the HOTLINE Warmer into properly grounded power outlet 6 Turn the HOTLINE Warmer ON and let the solution circulate for a 30 minute disinfection period 7 Turn the HOTLINE Warmer OFF 8 Invert the drain tube f and place a container under the end o...

Страница 17: ...p 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 safety testing Recirculating Solution Preparation Maintenance 0 3 Hydrogen Peroxide Solution Mix 140 ml of 3 hydrogen peroxide with 1 260 ml of distilled water Replace solution and disinfect reservoir every 1...

Страница 18: ...ly controlled warm recirculating solution a thereby protecting the patient line against exposure to cold and eliminating patient line cool down The unique design of the HOTLINE Fluid Warming Set allows blood and intravenous fluid to be delivered to the patient at normothermic temperature at gravity flow rates to 50 5 000 ml hr Infusate Delivery Temperatures The following table shows the typical in...

Страница 19: ...t emitting diodes LEDs indicate operation modes for the HOTLINE Warmer 1 Recirculating Solution Temperature The temperature is displayed in degrees Celsius 2 ON Operation The green LED illuminates when the power is turned on and the HOTLINE Fluid Warming set is properly installed 3 Check Disposables The red LED illuminates and an audible attention signal beeps when the HOTLINE Fluid Warming Set is...

Страница 20: ...arm Test is used to confirm the proper operation of the Over Temperature circuitry 2 Alarm Test Button The Alarm Signal Test is used to confirm proper operation of the visual and audible alarms 3 Power ON OFF Switch The black switch toggles to turn power ON and OFF Reservoir Level Display The reservoir for the recirculating solution is located on the left side of the HOTLINE Warmer next to the Pow...

Страница 21: ...urned off ON Operating Mode The power switch is in the ON position b and the HOTLINE Fluid Warming Set has been properly installed Mode Characteristics The green Operating LED c illuminates The reservoir temperature display will begin to increase The recirculating solution path in the HOTLINE Fluid Warming Set will automatically prime Check Disposables Mode The Check Disposables mode indicates a m...

Страница 22: ...play Panel illuminates The audible alarm sounds and repeats approximately every two seconds The recirculating solution stops circulating To clear this mode add recirculating solution to the reservoir Over Temperature Alarm Mode The Over Temperature Alarm mode indicates that the temperature of the recirculating solution is at or above 41 2 C Mode characteristics The green Operating LED on the Displ...

Страница 23: ...ounded receptacle Do not fill the HOTLINE reservoir with a HOTLINE Fluid Warming Set in place Failure to remove the HOTLINE Fluid Warming Set before the fill procedure may result in an air lock in the HOTLINE Warmer Step 1 Set Up the HOTLINE Warmer 1 Check that the level is above the minimum level mark a on the reservoir Add recirculating solution to the reservoir through the fill port if required...

Страница 24: ...g Set Death or serious injury may occur to the patient or user if this warning is not followed To set up the HOTLINE Fluid Warming Set you will need the following HOTLINE Warmer Intravenous administration set Intravenous fluid or blood Extension Set 20cm 8 or less in length optional 1 Remove the reflux plug if present from the socket on the right side of the HOTLINE Warmer 2 Plug the Twin Tube Con...

Страница 25: ...ble Set with a breached recirculating solution path intravenous path is used then patient illness may occur because of the HOTLINE Warmer s recirculating solution entering the patient s blood stream 1 Connect the I V fluid and the intravenous administration set to the HOTLINE Fluid Warming Set 2 Fully prime the intravenous administration set the HOTLINE Fluid Warming Set and patient extension set ...

Страница 26: ...S 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 1 Turn OFF the power switch 2 Remove the HOTLINE Fluid Warming Set and insert the reflux plug a into the socket 3 After use handle and dispose of the HOTLINE Fluid Warming Set in a safe manner according to...

Страница 27: ...e Turn OFF the power switch before replacing the HOTLINE Fluid Warming Set 2 If the alarm is not cleared replace the HOTLINE Fluid Warming Set Turn ON the power switch and verify that the alarm has cleared 3 If the alarm is not cleared remove the HOTLINE Warmer from service Add Recirculating Solution alarm Check the level in the reservoir Turn OFF the power switch remove the HOTLINE Fluid Warming ...

Страница 28: ...t to install the HOTLINE Fluid Warming Set Lubricate O rings in the socket Refer to Section 10 Maintenance for the procedure Recirculating solution leaks at the socket where the HOTLINE Fluid Warming Set plugs into the HOTLINE Warmer Replace O rings Use the O ring Replacement Kit P N 80 04 001 Refer to Section 10 Maintenance for the procedure Electrical interference receiving or transmitting 1 Mov...

Страница 29: ...l 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 serious injury may occur to the patient or user if this warning is not followed Note Alarm testing requires a HOTLINE Fluid Warming Set to be installed and that the HOTLINE Warmer be turned ON and in the Ope...

Страница 30: ...the Over Temperature Alarm Test button to stop the test Add Recirculating Solution Test The HOTLINE Warmer is equipped with a float switch which senses the recirculating solution level in the reservoir When the recirculating solution is too low the Add Recirculating Solution Alarm will activate 1 Remove the fill port plug c on the reservoir 2 Gently depress the float switch d This action will simu...

Страница 31: ...Use the Level 1 TEMP CHECK Thermometer HLTA 40 to verify the displayed recirculating solution temperature Other methods of temperature verification may be inaccurate TEMP CHECK provides an accurate reading of the highest temperature of the recirculating solution Because the temperature of the reservoir is typically 0 5 C to 2 0 C lower than the temperature from the heater and the temperature of th...

Страница 32: ...Set into the socket on the right side of the TEMP CHECK 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 6 If the TEMP CHECK display indicates a temperature between 39 C and 40 C a...

Страница 33: ... 2005 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 Warmer is first turned on and the temperature is rapidly rising but still below 39 C the heater circuit is in a full ON condition Note The HOTLINE Warmer is equipped with sensing interlocks A HOTLINE Fluid War...

Страница 34: ...rong acids or bases to clean any portion of the HOTLINE Warmer Do not place the HOTLINE Warmer directly under a faucet or use a faucet sprayer to rinse Never spray cleaning or other fluids into openings on the HOTLINE Warmer or into the external connectors 1 Unplug the HOTLINE Warmer before servicing 2 Visually inspect the HOTLINE Warmer to ensure there is no visible damage or deterioration of the...

Страница 35: ...OTLINE Warmer perform disinfection if required 8 If it is hospital policy to perform disinfection as part of reprocessing then follow your institution s guidelines for disinfecting of the surfaces of non critical medical devices The list below includes low level disinfectants that are commonly used in the medical community and high level disinfectants that are claimed by the manufacturer The effec...

Страница 36: ...in tube a and place a container under the end of the tube Remove the end cap b and drain the recirculating solution into the container 4 When all the recirculating solution has drained from the reservoir replace the end cap and insert the drain tube back in the holder 5 Prepare a 0 3 hydrogen peroxide solution by mixing 140 ml of 3 hydrogen peroxide solution and 1 260 ml of distilled water Recircu...

Страница 37: ...tal 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 recircula...

Страница 38: ...ace O Rings O Ring Kit P N 80 04 001 1 Unplug the HOTLINE Warmer before servicing 2 Remove the socket head screws b with a 0 31cm 1 8 hex wrench 3 Remove the face plate being careful not to damage the micro 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 car...

Страница 39: ...asks 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 Change Distilled Water or Isopropyl Alcohol solution Lubricate the O Rings Disinfect the Reservoir and Change the Hydrogen Peroxide Solution Replace the O Rings Alarm Signal Test Add Recirculating Solution Test Check Disposab...

Страница 40: ...ade 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 HO...

Страница 41: ...f 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 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 medic...

Страница 42: ...epair 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 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 soluti...

Страница 43: ...irements 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 www smiths medical com ...

Страница 44: ...th Overall 21 0 cm 8 3 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 Capacity 1 4 L 0 37 gallons Maximum Height on I V Pole 107 cm 42 inches Environmental Temperature Humidity Operation 10o C to 45o C 10 to 95 Transportation 18o C to 60o C 5 to 90 Storage 18o C to 60o C...

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 Continuous Type of Current Alternating Ingress Protection Rating IPX1 Performance Recirculating Solution Temperature Recirculating solution temperature reaches 37o C from ambient in about 4 minutes Nor...

Страница 46: ...0 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 3 69 3 69 7 38 100 11 66 11 66 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum ou...

Страница 47: ...r 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 tubing with needles Patient injury or death could result ...

Страница 48: ...Part Number Batch 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 symbol appears on the device with a blue background Consult instructions for use f Caution Electric Shock Hazard Symbols Definitions ...

Страница 49: ... damaged Sterile 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 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...

Страница 50: ...or I V 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 electrical device 37 D...

Страница 51: ...pecifications 38 Power and Alarm Test Panel 14 Power cord 3 Power ON OFF switch 14 priming volume HOTLINE Fluid Warming Sets 4 Principle of operation 12 R Recirculating solution change 30 maintenance schedule 11 30 preparation 11 30 protocols 11 Reflux plug 3 Replace O Rings 32 Reservoir 3 fill with recirculating solution 11 Reservoir level display 14 S Service 36 Service contacts 37 Set Up the HO...

Страница 52: ... HOTLINE Blood and Fluid Warmer Operator s Manual 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 ...

Страница 53: ...Page intentionally blank ...

Страница 54: ...s l H Manufacturer Smiths Medical ASD Inc 160 Weymouth Street Rockland MA 02370 USA Tel 1 800 258 5361 ...

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