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OPERATOR’S MANUAL

P/N 4533708GB Rev. 006  

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Summary of Contents for H-1200 115V

Page 1: ...OPERATOR S MANUAL P N 4533708GB Rev 006 lTM s...

Page 2: ...ii Operator s Manual...

Page 3: ...ensure that the information in this manual is accurate and details provided are correct at the time of printing The company however reserves the right to improve the equipment shown Mention of third...

Page 4: ...Operation 19 Fluid Warming 19 Pressurized Fluid Delivery 19 Air Detection Clamping 19 F 50 Gas Vent Filter Assembly 20 7 Controls and Displays 21 Fluid Warmer Power and Alarm Test Panel 22 Fluid Warme...

Page 5: ...heck Disposables Alarm 54 Over Temperature Test 55 Fluid Warmer Alarm Signal Test 55 Performance Testing 56 Cold Start Test 56 Calibration Test 56 Alternative Calibration Test 56 Calibration Test with...

Page 6: ...on 68 Service Contacts 68 15 Specifications 69 System Specifications 69 Physical 69 Environmental 69 Thermal 69 Electrical 69 Electromagnetic Environment Recommendations 70 Disposable Administration S...

Page 7: ...Fluid Warmer except where indicated by the symbols defined in the following table Symbol Description Appears in the margin to identify information that only applies to the H 1200 Fluid Warmer and the...

Page 8: ...Operation Describes Operation Indicator and Alarm modes of the Level 1 H 1200 Fast Flow Fluid Warmer 9 Operating Instructions Describes the Set Up Use and Alarm modes of the Level 1 H 1200 Fast Flow...

Page 9: ...nd visual alarms An ultrasonic signal continually passes through the fluid filled Gas Vent Filter Assembly As a bolus of air displaces the fluid in the Gas Vent Filter Assembly the ultrasonic signal i...

Page 10: ...f warmed fluids such as crystalloid or blood product including red blood cells as volume replacement for patients suffering from blood loss due to trauma or surgery The Fluid Warmer provides fast flow...

Page 11: ...air from the fluid bags before spiking and the fluid lines before connecting to the patient Failure to do so can result in infusion of air into the patient Replace Gas Vent Filter Assembly every thre...

Page 12: ...talled may contain air which if used can result in infusion of air into the patient Use only new fluid bags from which the air has been removed Activation of the Over Temperature warning signal indica...

Page 13: ...d may cause death or serious injury to the patient Disposable Sets are for single use only To reduce the risk of cross contamination do not reuse Disposable Sets If fluid exits in the Patient Line or...

Page 14: ...r does not illuminate or the audible signal does not sound do not use the Fluid Warmer Remove the device from service immediately Fully functional visual and audible alarm systems are essential for th...

Page 15: ...to install the Level 1 H 31 Version B Air Detector Clamp to the Level 1 H 1000 Fast Flow Fluid Warmer Step 1 Verify components of the Fluid Warmer Step 2 Assemble I V Pole to Warming Unit Step 3 Insta...

Page 16: ...g of the component parts for the Level 1 H 1200 Fast Flow Fluid Warmer Components Checklist Qty Component in order of appearance in illustration 2 Pressure Chambers Contents 2 U brackets 4 Thumbscrews...

Page 17: ...with Flanking Brackets 3 Place the I V Pole Base upright on its wheels c and lock the wheels to prevent movement during set up 4 Locate three bolts d and washers for the pole base 5 Align the three h...

Page 18: ...ence Guide over one of the poles on the Flanking Bracket Step 3 Install the Pressure Chambers 1 Locate the two Pressure Chambers 2 Locate the U brackets and thumbscrews supplied with the Pressure Cham...

Page 19: ...l of 3 hydrogen peroxide solution and 1 260 ml of distilled water 3 Fill the reservoir with 1 4 liters of 0 3 hydrogen peroxide distilled water solution 4 Replace the fill port plug 5 Insert a Disposa...

Page 20: ...ance requirement to change the recirculating solution is once every 30 days 2 Replace the fill port plug 3 Lubricate O Rings in 1 Block b and 2 Block c Place a small amount of silicone lubricant provi...

Page 21: ...id Warmer was manufactured before 2004 If it is inspect the F1 fuse to confirm that it is the correct value and type The year of manufacture can be determined by the serial number label which is locat...

Page 22: ...the Fluid Warmer off and the Air Detector Clamp does not turn off contact Smiths Medical or your local Smiths Medical distributor 3 Loosen the three screws holding the mounting bracket to the rear of...

Page 23: ...Ground bond test WARNING Grounding reliability can only be achieved when MAINS power cords are connected to a properly grounded receptacle Risk of electrical shock exists if the equipment is not conn...

Page 24: ...S E C T I O N 6 P r i n c i p l e o f O p e r a t i o n Operator s Manual H 1200 H 1200 18...

Page 25: ...over temperature condition Pressurized Fluid Delivery The Fluid Warmer provides pressurized fluid delivery through the use of an on board compressor and two Pressure Chambers The Pressure Chambers pr...

Page 26: ...ny air in the line during priming is vented through a hydrophobic filter membrane During normal operation fluid passes through a particle filter into the fluid chamber and to the patient line When air...

Page 27: ...ction indicators are displayed They are called out in the figure and are defined in the list below 1 Fluid Warmer Display Panel 2 Power and Alarm Test Panel 3 Reservoir Level Display 4 Air Detector Cl...

Page 28: ...off to the unit The green Automatic Operation LED on the Display Panel will turn off when this button is pressed 3 Over Temperature Test Button The Over Temperature Test is used to confirm the proper...

Page 29: ...ndicator illuminates and an audible attention signal beeps when the Disposable Set is not properly installed See the Interlocks description in this section for directions on clearing the Check Disposa...

Page 30: ...med the patient line from the Gas Vent Filter Assembly is correctly placed in the 3 Clamp Slot and the Clamp Slot door is closed 2 Check Tubing LED The yellow Check Tubing LED illuminates and an audib...

Page 31: ...ion This applies 300 mmHg pressure in the Pressure Chamber when the Fluid Warmer is turned ON b To Unpressurize the Pressure Chamber To remove pressure from the Pressure Chamber slide the lever to the...

Page 32: ...cks 2 4 and 5 prevent the Fluid Warmer s pump from circulating reservoir solution if the Disposable Set s Heat Exchanger and Gas Vent Filter Assembly are not installed properly If Check Disposable Ala...

Page 33: ...Operator s Manual S E C T I O N 7 C o n t r o l s a n d D i s p l a y s 27...

Page 34: ...Operator s Manual 28 S E C T I O N 8 O p e r a t i o n...

Page 35: ...aces that control specific device functions The numbers call out individual Modes of Operation activated or indicated on the interface Functions Fluid Warming Air Detection Clamping Pressurized Fluid...

Page 36: ...OFF button a on the Power and Control Panel to turn the device off ON Automatic Operation Mode for Fluid Warmer The Fluid Warmer enters Automatic Operating mode when a Disposable Set is properly insta...

Page 37: ...id Warmer OFF and then back ON Over Temperature Test Mode The Over Temperature Test mode is used to test the operation of the Fluid Warmer s Over Temperature Circuitry This mode is entered by pressing...

Page 38: ...the heat exchanger is seated in the heat exchanger guide Press down firmly on the 2 Block Check the position of the Gas Vent Filter Assembly in the 4 Interlock Add Recirculating Solution Mode The Add...

Page 39: ...flow to the patient continues To Clear Over Temperature Alarm mode Do the following If connected to a patient close all clamps Turn OFF the Fluid Warmer to clear the alarm Turn the power back ON Powe...

Page 40: ...nated Monitoring for air in the Gas Vent Filter Assembly is active Fluid is ready to be delivered to the patient when in Automatic Operating mode Check Tubing Mode The Air Detector Clamp s Check Tubin...

Page 41: ...ssure applied to the fluid bags Pressure should be in the range of 280 300 mmHg pressure Pressurized Mode The H 2 Pressure Chambers deliver fluids at an increased flow rate with the application of 300...

Page 42: ...us unpressurized position c Unpressurized Mode Disable pressurization by moving the lever on the Pressure Chamber to the minus unpressurized position c Mode characteristics Pressure is released from t...

Page 43: ...result in a reduction of flow rate This may result in inadequate patient treatment resulting in death or serious injury to the patient The replacement Gas Vent Filter Assembly must be fully primed be...

Page 44: ...osable Administration Set The installation sequence for the Disposable Administration Set corresponds to the numbered Blocks marked 1 2 3 4 on the H 1200 Fast Flow Fluid Warmer Fluid Warmer and 1 2 3...

Page 45: ...I 70 F 10 F 30 D DI 100 and D DI 300 Step 4 H 1200 Fluid Warmer with DI 55 D DI 65HL D DI 75 D DI 150 and D DI 350 4 Install the Gas Vent Filter Assembly Refer to the series of figures on the left a O...

Page 46: ...without kinking g Align the Gas Vent Filter Assembly to the 4 Block g and press it into place Step 4 H 1000 Fluid Warmer with DI 55 D DI 65HL D DI 75 D DI 150 and D DI 350 4 Install the Gas Vent Filt...

Page 47: ...inus unpressurized position 4 Hang spiked fluid bag s in Pressure Chamber a Release hinged latch open door and hang fluid bag inside on tab appropriate for bag size b Close the door and secure latch c...

Page 48: ...tor Clamp runs a Power ON Test All Air Detector Clamp indicator LEDs illuminate The audible warning beeps If the above does not occur remove the device from service Upon completion of the Power On Tes...

Page 49: ...p on the Patient Line Note On D DI 60HL and D DI 65HL Disposable Sets close roller clamp below Drip Chamber D Test the Audible and Visual Alarms Test the visual and audible alarm signals by performing...

Page 50: ...Vent Filter Assembly away from the Air Detector sensor as shown 3 The following occurs The Air Detector clamp closes The red Clamped indicator LED illuminates The audible warning signal beeps Fluid Wa...

Page 51: ...rom which the air has been removed Replace Gas Vent Filter Assembly every three hours or when the filter becomes clogged or when air is slowly vented Failure to do so will result in a reduction of flo...

Page 52: ...of the Pressure Chamber door are hooks for bags smaller than 1000ml On the top of the Pressure Chamber door are hooks appropriate for 1000ml bags Bags from different fluid manufacturers vary somewhat...

Page 53: ...the filter becomes clogged or if air is venting slowly Refer to Section 9 3 Replace the Gas Vent Filter Assembly Step 5 Change the Fluid Bag a Move the lever on the Pressure Chamber over to the minus...

Page 54: ...lock For DI 55 D DI 65HL D DI 75 D DI 150 and D DI 350 disconnect the clip from the bottom of the Heat Exchanger b Open the 3 Clamp Slot door and remove the patient line from the Clamp Slot 4 Install...

Page 55: ...l self prime 7 Turn the power ON 8 Remove the end cap on the lower patient line of the new Gas Vent Filter Assembly Slowly release the lower clamp and allow the lower patient line to fill completely 9...

Page 56: ...Set 2 Remove pressure from the Pressure Chambers by moving the lever to the minus unpressurized position 3 Inspect the entire Disposable Set for the presence of air locate the source of the air and re...

Page 57: ...heck Tubing Alarm Add Recirculating Solution Alarm 9 5 After Use 1 Discontinue infusion 2 Turn the Fluid Warmer OFF 3 Release chamber pressure before opening the Pressure Chamber door a Move the lever...

Page 58: ...erature Press OFF button to clear alarm Then press ON button to Alarm beeps power on If the Fluid Warmer continues to alarm discontinue use of the medical device and remove from service Contact Smiths...

Page 59: ...et may restrict flow Consider using Level 1 PF 1 pre filters 340 micron Clamps partly Verify all clamps are fully open engaged Clamps left in the Leaving clamps fully clamped for long periods will cau...

Page 60: ...culating Solution Alarm mode the circulating pump is not running With a Disposable Set in place and the unit turned on test the Add Recirculating Solution Alarm by draining the solution until the leve...

Page 61: ...ture Test Do the following 1 Insure that the Fluid Warmer is at operating temperature 41 C 2 Press and hold the Over Temperature Test button a 3 The Over Temperature LEDs illuminate and an audible ala...

Page 62: ...s to use the Level 1 Thermal Calibration Well TCW Part Number 80 03 002 A replacement filter F 10 30 or F 50 must be in place to utilize the TCW Note Use of the TCW requires a digital thermometer NIST...

Page 63: ...and 2 Block 3 Install a test filter in the 4 Block 4 Turn the Fluid Warmer ON Allow to warm up until the DSTA 40 temperature display stabilizes 5 Compare the DSTA 40 temperature display with the temp...

Page 64: ...ating solution in the reservoir Units not meeting this standard should be returned to Smiths Medical or your local Smiths Medical distributor Ground Continuity The Fluid Warmer must be tested in accor...

Page 65: ...fter every use Note Never use organic solvents e g acetone strong acids or bases to clean any portion of the Fluid Warmer Note Do not place the Fluid Warmer directly under a faucet or use a faucet spr...

Page 66: ...evices 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 effectiveness of these list...

Page 67: ...close the drain valve 4 Refill the reservoir with distilled water The reservoir holds 1 4 liters Maintenance Performed Every 12 Months Disinfect the Reservoir 1 Place a container under the drain valve...

Page 68: ...lution Mix 140 ml of 3 hydrogen peroxide solution and 1 260 ml of distilled water 5 Fill the reservoir with 0 3 hydrogen peroxide distilled water solution The reservoir holds 1 4 liters Change O Rings...

Page 69: ...lamp Slot and Detector Head for structural integrity Testing Fluid Warmer Operation Perform all the tests described in the testing section of this manual See Section 11 Testing Add Recirculating Solut...

Page 70: ...st Task Every Use Every 30 Days Every 12 Months Clean Exterior 9 General 9 Inspection Change Distilled 9 Water Lubricate O Rings 9 Disinfect 9 Recirculating Solution Reservoir Change 0 3 9 Hydrogen Pe...

Page 71: ...acturer s obligation under this warranty A Parties Covered by this Warranty This warranty extends only to the Original Purchaser of the Level 1 H 1200 Fast Flow Fluid Warmer This warranty does not ext...

Page 72: ...RANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE LEVEL 1 H 1200 FAST FLOW FLUID WARMER FOR ANY PARTICULAR PURPOSE 3 The Level 1 H 1200 Fast Flow Fluid Warmer can only be used under the supervision of...

Page 73: ...ger under warranty can be returned for repair for a cost The unit will be promptly inspected and a verbal estimate of the repair cost will be provided A purchase order will be required from the origin...

Page 74: ...dical distributor at USA Canada Smiths Medical ASD Inc 160 Weymouth Street Rockland MA 02370 USA USA Canada 1 800 258 5361 International 1 781 878 8011 European Representative Smiths Medical Internati...

Page 75: ...Hg Environmental Temperature Humidity Operation 10 C to 40 C 10 to 95 Transportation 18 C to 60 C 5 to 95 Storage 5 C to 40 C 5 to 95 Thermal Temperature Set Point 41 7 C 0 3 C Over Temperature Set P...

Page 76: ...d Delivery Range 10 C Input 40 ml min to 300 ml min 20 C Input 40 ml min to 400 ml min Maximum Flow Rate 500 ml min crystalloid 300 mmHg 14g catheter D DI 60HL and D DI 65HL Filter Size 170 Micron Pri...

Page 77: ...ing Volume D DI 100 65 ml D DI 150 155 ml System 1200 Normothermic 35 41 C Fluid Delivery Range 10 C Input 30 ml min to 650 ml min 20 C Input 30 ml min to 950 ml min Maximum Flow Rate 950 ml min cryst...

Page 78: ...Operator s Manual S E C T I O N 1 6 Symbols S E C T I O N 1 6 S y m b o l s 72...

Page 79: ...S E C T I O N 1 6 S y m b o l s Operator s Manual 73...

Page 80: ...circulating Solution Check Disposables Check Tubing Clamped Maximum Reservoir Level Minimum Reservoir Level Device has been tested by National Technical Systems a nationally recognized technical lab t...

Page 81: ...lectrical testing 58 Electromagnetic Environment Recommendations 70 F F 50 Gas Vent Filter Assembly 20 Flanking brackets 12 Fluid Bag Change 47 Fluid Warmer Description 3 Principles of operation 19 Us...

Page 82: ...23 S Safety information 5 Service information 67 contacts 68 Set Up for use 38 Specifications 69 Disposable Set 70 system 69 Symbols 72 T TEMPCHECK calibration test 56 Temperature Display 23 31 Test A...

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