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S E C T I O N 1 5 • S p e c i f i c a t i o n s

Operator’s Manual

S E C T I O N 1 5

Specifications

System Specifications

Physical

Measurement

Height, Overall

67 inches

(1.7 m)

Width, Overall

20 inches

(51 cm)

Depth, Overall

20 inches

(51 cm)

Weight Assembled; Dry

63 pounds

(28.5 kg)

Recirculating Solution Capacity

0.37 gallons

(1.4 L)

Air Source Pressure

300 (294 ± 6) mm/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 Point

43.9°C ± 0.1°C

Electrical

Type

Protection Against Electrical Shock

Class I Equipment
Type BF Equipment

Mode of Operation

Continuous

Type of Current

Alternating

Ingress Protection Rating

IPX1

MAINS Power Input

115 VAC, 60 Hz, 12 Amps

MAINS Power Input

230 VAC, 50 Hz, 6.3 Amps

Auxiliary MAINS Outlet

115 VAC, 1.5 Amps

Auxiliary MAINS Outlet

230 VAC, 0.75 Amps

Содержание H-1200 115V

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

Страница 2: ...ii Operator s Manual...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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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