Smiths Medical Level 1 NORMOFLO H-1129, Operator'S Manual

Page 1: ...rer Smiths Medical ASD Inc 160 Weymouth Street Rockland MA 02370 USA USA Canada 1 800 258 5361 International 1 781 878 8011 www smiths medical com Made in USA s s Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer H 1129 115V lTM lTM ...

Page 2: ...Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer H 1129 115V OPERATOR S MANUAL P N 4533800 EN Rev 004 lTM ...

Page 3: ... Inc Smiths Medical assumes no responsibility with regard to the performance or use of these products Level 1 NORMOFLO and Level 1 and Smiths Medical design marks 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 All other names and marks mentioned are the trade names trademar...

Page 4: ...Hanger 10 Step 5 To Set Up the 3 Liter 3L Pressure Accessory 11 Step 6 Disinfect the Recirculating Solution Reservoir 11 Step 7 Preparation for Use 12 Step 8 Perform Electrical Safety Tests 12 6 Principle of Operation 13 Fluid Warming 13 Pressurized Fluid Delivery 13 7 Controls and Displays 15 Fluid Warmer Power and Alarm Test Panel 16 Fluid Warmer Display Panel 17 Reservoir Level Display 18 Press...

Page 5: ...Alarm 37 Over Temperature Test 38 Fluid Warmer Alarm Signal Test 38 Performance Testing 39 Periodic Electrical Testing 41 12 Maintenance 42 Maintenance Performed with Every Use 42 Maintenance Performed Every 30 Days 42 Maintenance Performed Every 12 Months 43 Maintenance and Calibration Log 45 13 Limited Warranty 46 14 Service 48 Warranty Service 48 Non Warranty Work 48 Additional Documentation 48...

Page 6: ...in death or serious injury to the patient or user Conventions Used in this Manual These instructions contain important information for safe use of the product Read the entire operator s manual including Warnings and Cautions before using the product Failure to properly follow warnings cautions and instructions could result in death or serious injury to the patient Convention Description Note A Not...

Page 7: ...ses micro bubbles of gas from fluids as they are warmed Temperature Control The Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer employs a safe recirculating solution heating system inherently free of any hot spots The primary temperature control circuit sets the recirculating solution to a temperature of approximately 41 7 C for efficient heat exchange and maximum fluid warming Automatically Opera...

Page 8: ...Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer Operator s Manual 3 SECTION 3 Indications for Use The Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer Fluid Warmer is designed for use by trained medical personnel for in line warming of irrigating fluids ...

Page 9: ...use the Fluid Warmer in high energy fields such as MRI X RAY portable and mobile RF communications equipment and other such devices The Fluid Warmer may act as a projectile in a strong magnetic field cause image artifacts or not function as intended Do not bend the heat exchanger Bending may damage the heat exchanger allowing communication between the recirculating solution and irrigation fluid pa...

Page 10: ...o not operate the Fluid Warmer in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide The risk of explosion exists if the Fluid Warmer is operated in a potentially explosive environment No user serviceable parts All service must be performed by Smiths Medical or an authorized representative Disposable Sets are supplied with a sterile fluid path which may be compromised ...

Page 11: ...ansport Load 12 liters at maximum height of 2 25 meters 7 ft 4 inch 6 liters at maximum height of 2 54 meters 8 ft 4 inch from floor to bag hanger Federal law U S A restricts this device to sale by or on the order of a physician The 3L Pressure Cuff accessory should not be pressurized above 300 mmHg Pressure greater than 300 mmHg may compromise the integrity of some Disposable Sets or the cuff its...

Page 12: ...assemble and do preliminary setup of the Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer Fluid Warmer Step 1 Verify Components of the Fluid Warmer Step 2 Assemble Fluid Warmer to Base Step 3 Install the Pressure Chambers Step 4 Attach the Fluid Bag Hanger Step 5 To Set Up the 3 Liter 3L Pressure Accessory Step 6 Disinfect the Recirculating Solution Reservoir Step 7 Preparation for Use Step 8 Perfo...

Page 13: ...nts Checklist Qty Component 1 Fluid Warmer and Automatic Pole Assembly a 1 Base Assembly b 3 Pole to Base Assembly screws c 10 32x1 2 inch long button head 1 Fluid Bag Hanger d 4 Casters 2 locking e and 2 non locking 1 HI 2 Bracket f 2 HI 2 Pressure Chambers g 1 Operator s Manual not shown 1 O Ring Kit not shown 1 Assembly Wrench 1 8 inch Allen not shown 1 Assembly Wrench 5 64 inch Allen not shown...

Page 14: ...hree screws c and tighten using the 1 8 inch Allen wrench supplied Note Take care not to strip the screw threads 4 Plug the power cord from the Base Assembly into the Auxiliary Outlet f on the bottom of the Fluid Warmer Pole Assembly a 5 Turn valve located on the bottom of the device perpendicular to stem g of the Fluid Warmer as shown 6 Remove 61 cm 24 black tubing from its package Push one end o...

Page 15: ...and tighten with the 5 64 wrench supplied Note Make sure the two slanted ends of the HI 2 Bracket face towards the front of the Fluid Warmer 2 Feed the thumb screws through the back of the HI 2 Bracket and into the HI 2 Pressure Chamber hand tighten 3 Connect the two ends of the 1 4 black pneumatic tubing from the Pressure Gauge Box and the Pressure Chamber to the In Line Pneumatic Fittings by pre...

Page 16: ... connectors e securely 6 Slide the 3L Fluid Bag into the Pressure Cuff and hang them from the Fluid Bag Hanger 7 Repeat steps 3 6 if you are using a second 3L Pressure Cuff Step 6 Disinfect the Recirculating Solution Reservoir 1 Remove the fill port plug a on the reservoir 2 Prepare a 0 3 hydrogen peroxide sterile water solution for the reservoir Mix 140 ml of 3 hydrogen peroxide solution and 1 26...

Page 17: ...nd 2 Block c Place a small amount of silicone lubricant provided in the supplied O Ring Kit on a cotton swab and apply all around the inside of each O Ring Step 8 Perform Electrical Safety Tests Perform all applicable electrical safety tests as required per institutional procedure These include but are not limited to Leakage current Hypot Ground bond test WARNING Grounding reliability can only be ...

Page 18: ...irculation and remains isolated from the patient and from the irrigating fluid path The recirculating solution is heated to a pre set temperature The system continuously monitors and controls the recirculating solution temperature The Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer is designed to stop fluid warming and provide audible and visual alarms in the event of an over temperature condition...

Page 19: ...id Return Solution Pump Float Switch Pressure Chambers Solution Heaters NOT FOR USE WITH ANY I V SOLUTION NOT FOR USE WITH ANY I V SOLUTION NOT FOR USE WITH ANY I V SOLUTION To Air Compressor in Base Heat Exchanger Irrigating Fluid Bag Sterile Patient Line Pressure Gauge H 1129 H 1129 NORMOFLOW Irrigating Fluid Warmer Gas Vent Pressure Gauge Box ...

Page 20: ...ow the device is controlled and where function indicators are displayed They are called out in the figure on the facing page and defined in the list below 1 Fluid Warmer Display Panel 2 Power and Alarm Test Panel 3 Reservoir Level Display 4 Pressure Chamber Control Panel 5 Pressure Gauge Box The Fluid Warmer has three Interlocks which are defined in this section The Interlocks detect for correct i...

Page 21: ...n the Power and Alarm Test Panel This button turns off power 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 operation of the Over Temperature circuitry Testing the circuitry requires that the Fluid Warmer is at operating temperature 41 C Once this is ...

Page 22: ...display reflects the temperature of the recirculating solution 2 Automatic Operation LED This green LED indicator illuminates when the power is ON and the Disposable Set has been properly installed When lit this indicates the Fluid Warmer is operating 3 Check Disposables LED This yellow LED indicator illuminates and an audible attention signal activates when the Disposable Set is not properly inst...

Page 23: ...ber Control Panel 1 Pressurize Unpressurize Toggle Switch This switch is used to pressurize the Pressure Chamber a To Pressurize the Pressure Chamber With Pressure Chamber door closed and latched push Toggle Switch all the way to the plus pressurized position This applies pressure in the Pressure Chamber when the Fluid Warmer is turned ON b To Unpressurize the Pressure Chamber To release pressure ...

Page 24: ...erlocks Note Block 1 is not an Interlock It cannot detect if a Disposable Set is not correctly installed It is identified here because it is an essential step for proper installation of the Disposable Set components The three Interlocks are located on the Fluid Warmer and check for proper installation of 2 Heat Exchanger top end 3 Gas Vent 4 Heat Exchanger guide Interlocks 2 3 and 4 prevent the Fl...

Page 25: ... following page operation of the device is represented in terms of the two interfaces that control specific device functions The numbers call out individual Modes of Operation activated or indicated on the interface Operational modes OFF Mode ON Automatic Operation for Fluid Warmer Alarm Test Mode Over Temperature Test Mode Check Disposables Mode Add Recirculating Solution Mode Over Temperature Al...

Page 26: ...ables Add Recirculating Solution Over Temperature None LEDs display LEDs display LEDs display LCD Readout Green LED Yellow LED Yellow LED Red LED None None 1 second 1 second None None 1 5 seconds 1 5 seconds 1 second 1 2 3 4 5 6 7 8 9 Operation Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer Pressurized Fluid Delivery Pressure Chamber Control Panel Pressure Gauge Pressurized Unpressurized Numbered...

Page 27: ...s not followed OFF Mode Power is off only for a part of the equipment The MAINS are still connected Press the 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 installed and the device is turned ON This is done by pressing the ON button b Mode characteris...

Page 28: ...ature LED and audible alarm remain active To clear this mode Turn the Fluid 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 To enter this mode press and hold the Over Temperature Test button f on the Fluid Warmer Control Panel with the Fluid Warmer at operating temperature 41 C Mode...

Page 29: ...changer for proper installation in Block 1 and in Interlocks 2 and 4 Press Heat Exchanger down firmly in Block 1 to secure in O Ring Press Interlock 2 tab down firmly to engage the Interlock switch Check Gas Vent installation in Interlock 3 Add Recirculating Solution Mode The Add Recirculating Solution mode of the Fluid Warmer indicates that the solution level in the recirculating solution reservo...

Page 30: ...ristics The Over Temperature LED warning light illuminates c An audible warning signal beeps Solution circulation is stopped fluid warming stops Pressure Chambers continue to operate Fluid flow to the patient continues To Clear Over Temperature Alarm mode Do the following Turn the Fluid Warmer OFF and then back ON Pressurized Mode The HI 2 Pressure Chambers deliver fluids at an increased flow rate...

Page 31: ...he minus unpressurized position Mode Characteristics Pressure is released from the Pressure Chamber A fluid bag can be removed or loaded into the Pressure Chamber Pressure Regulation Mode Pressure Regulator Knob The Pressure Regulator Knob d functions when the device is ON and the Pressure Chamber Toggle Switch b is in the plus position The knob lets you adjust the pressure in the Pressure Chamber...

Page 32: ...roperly grounded receptacle resulting in death or serious injury to the patient or user Do not bend the heat exchanger Bending may damage the heat exchanger allowing communication between the recirculating solution and irrigation fluid path resulting in the delivery of inappropriate fluids which could result in death or serious injury to the patient Do not use the Fluid Warmer in high energy field...

Page 33: ...of the chamber door If bag ports are positioned above this slot diminished flow could occur 9 1 Set Up for Use WARNINGS WARNINGS Read and follow all instructions labeling and accompanying documents supplied with this medical device Failure to follow instructions including all warnings and cautions could result in death or serious injury to the patient or user Disposable Sets are supplied with a st...

Page 34: ...he Fluid Warmer Remove the Disposable Set from its packaging and review the Instructions for Use provided Do not remove spike caps at this time 1 Push the bottom end of the Heat Exchanger a the end near the Gas Vent into 1 Block b Press the Heat Exchanger down firmly to properly seat in the block 2 Slide 2 Block up c Snap Heat Exchanger into guide d Press firmly into place to ensure it is properly...

Page 35: ...erent Disposable Sets have different configurations Refer to the applicable Irrigating Disposable Set Instructions for Use for details The following steps use the IR 500 Disposable Set 1 Aseptically deliver the Patient Line g into the sterile field 2 Close clamps a b and c 3 Make sure Pressure Chamber Toggle Switch is at the minus unpressurized position 4 Open the Pressure Chamber doors and hang f...

Page 36: ...e a standard bag spike on the fluid supply tubing 1 Complete steps 2 8 in B Priming Irrigating Disposable Sets on page 30 2 Remove orange cap from the Gas Vent and the Spike Cap from the hand piece or specialized irrigation disposable 3 Firmly insert the Bag Spike a into the connector on the Gas Vent b 4 Complete setup and priming of the hand piece or specialized irrigation disposable as per the i...

Page 37: ...ressurized position Observe Pressure Gauge d to make sure that required pressure is achieved Note A pressure relief valve automatically activates if pressure goes above 550 mmHg B Prepare the 3 Liter 3L Pressure Cuff Accessory for Use CAUTION The 3L Pressure Cuff accessory should not be pressurized above 300 mmHg Pressure greater than 300 mmHg may compromise the integrity of some Disposable Sets o...

Page 38: ... may become unstable CAUTION Avoid contact with surgical lights or other overhead fixtures Maximum Transport Load 12 liters at maximum height of 2 25 meters 7 ft 4 inch 6 liters at maximum height of 2 54 meters 8 ft 4 inch from floor to bag hanger To raise the pole push and hold the Membrane Switch Up Arrow located on the left side of the Automatic Pole until the pole reaches the desired height or...

Page 39: ... kinked 7 Close and latch Pressure Chamber doors 8 Push the Pressure Chamber Toggle Switch to the plus pressurized position 9 3 After Use 1 Close all clamps 2 Push the Pressure Chamber Toggle Switch to the minus unpressurized position to release pressure in the pressure chambers 3 Turn the Fluid Warmer OFF 4 Open the Pressure Chamber door and remove the fluid bag 5 Properly discard the Disposable ...

Page 40: ...alled Add Recirculating Solution Alarm activates Fill reservoir to the maximum reservoir level with recirculating solution Over Temperature Alarm activates Press OFF button to clear alarm Then press ON button to power on If the Fluid Warmer continues to alarm discontinue use of the medical device and remove from service Contact Smiths Medical or an authorized representative for service Hot Cabinet...

Page 41: ... onto the Base Assembly Check to see if the unit is plugged into a working MAINS receptacle and power is turned ON Make sure the valve handle on Adapter Assembly is in the plus pressurized position not the minus vent position Problem Check the following Fluid bag not fully spiked or bag port twisted Make sure the membrane of the fluid bag port is fully pierced by the bag spike and that the neck of...

Page 42: ...es and an audible alarm beeps In the Add Recirculating 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 level has dropped below the minimum reservoir level The Add Recirculating Solution Alarm should activate To drain recirculating solution from the Fluid Warmer...

Page 43: ...larm beeps 4 Release the Over Temperature Test button 5 Over Temperature LED and audible alarm signal remains active Clear the Alarm mode Turn the Fluid Warmer OFF and then back ON Fluid Warmer Alarm Signal Test The Alarm Test button is used to confirm proper operation of the visual and audible alarm indicators Do the following 1 Press and hold the Alarm Test button b 2 The Check Disposables Add R...

Page 44: ...7 C 0 3 C Note If the Fluid Warmer does not pass the Cold Start Test it should be removed from use and returned to Smiths Medical or an authorized representative for service Calibration Test One approved way to confirm proper calibration of the recirculating solution temperature is to use the Level 1 Thermal Calibration Well TCW Part Number 80 03 002 A replacement filter F 10 or F 30 must be in pl...

Page 45: ...ly from the auxiliary outlet on the bottom of the Fluid Warmer 2 Plug the DSTA 40 TEMP CHECK into the auxiliary outlet 3 Install the DSTA 40 TEMP CHECK in the heat exchanger position 1 Block and 2 Block 4 Install a test filter in the 3 Block 5 Turn the Fluid Warmer ON Allow to warm up until the DSTA 40 temperature display stabilizes 6 Compare the DSTA 40 TEMP CHECK temperature display with the tem...

Page 46: ...be performed on units which have room temperature recirculating solution in the reservoir Units not meeting this standard should be returned to Smiths Medical or an authorized representative for service Ground Continuity The Fluid Warmer must be tested in accordance with EN 60601 1 WARNING Grounding reliability can only be achieved when MAINS power cords are connected to a properly grounded recept...

Page 47: ... Check the condition of the Fluid Warmer with a visual inspection Remove from service any unit that shows physical damage If the Disposable Set does not install easily lubricate the O Rings as directed in the following section Maintenance Performed Every 30 Days Lubricate O Ring Seals It is not necessary to disassemble the blocks to lubricate the O Rings 1 Place a small amount of silicone grease o...

Page 48: ...n peroxide sterile water solution Mix 140 ml of 3 hydrogen peroxide solution and 1 260 ml of sterile water 6 Fill the reservoir with 1 4 liters of 0 3 hydrogen peroxide sterile water solution 7 Replace the fill port plug 8 Insert a Disposable Set into the Fluid Warmer 9 Turn the Fluid Warmer ON Let the solution circulate for a 30 minute disinfection period 10 Turn the Fluid Warmer OFF 11 Empty the...

Page 49: ... 3 Press each O Ring into its socket Clean Fan Filter The Fan Filter a is located on the bottom of the Fluid Warmer The fan guard snaps in place 1 Unsnap and remove the fan guard from the bottom of the unit 2 Remove the filter and clean it with warm soapy water 3 When the filter is fairly dry replace the fan guard and filter Testing Fluid Warmer Operation Perform all the tests described in the tes...

Page 50: ...quipment Refer to the table below for required tasks and frequency of routine maintenance Scheduled Maintenance and Calibration Checklist Task Every Use Every 30 Days Every 12 Months Clean the Exterior General Inspection Change Recirculating Solution Lubricate O Rings Disinfect Recirculating Solution Reservoir Replace O Rings Clean Fan Filter Perform Over Temperature Alarm Test Test Add Recirculat...

Page 51: ...ply to the Manufacturer s obligation under this warranty A Parties Covered by this Warranty This warranty extends only to the Original Purchaser of the Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer This warranty does not extend to subsequent purchasers The Original Purchaser may be medical personnel a hospital or institution which purchases Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer for tre...

Page 52: ...or implied 2 THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE LEVEL 1 NORMOFLO H 1129 IRRIGATION FLUID WARMER FOR ANY PARTICULAR PURPOSE 3 The Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the Level 1 NORMOFLO H 1129 Irrigation Fluid Warmer for any particular medical ...

Page 53: ...d for tracking Non Warranty Work Units received which have suffered obvious abuse or impact damage and units no longer under warranty will be promptly inspected and a verbal estimate of repair cost will be supplied A purchase order will be required from the hospital consistent with the verbal estimate A written estimate will be provided upon request Before returning your Level 1 NORMOFLO H 1129 Ir...

Page 54: ...bly When you are ready to dispose of the device observe federal state and local codes or requirements for disposal of hazardous 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 Smiths Medical ASD Inc 160 Weymouth Street Rockland MA 02370 USA USA Canada 1 80...

Page 55: ... 3 cm 19 inches Weight Assembled Dry 38 1 kg 84 pounds Recirculating Solution Capacity 1 4 L 0 37 gallons Air Source Pressure 0 500 mmHg Environmental Temperature Humidity Operation 10o C to 45o C 30 to 75 Transportation 0oC to 70oC 30 to 75 Storage 0o C to 70o C 30 to 75 Thermal Temperature Temperature Set Point 41 7o C 0 3o C Over Temperature Set Point 43 9o C 0 1o C Electrical Type Protection A...

Page 56: ... 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 output po...

Page 57: ...TION 16 Symbols Symbols Definitions Type BF Equipment Protected Against Dripping Water Catalog Number Serial Number Part Number Batch Code Manufacturer Date of Manufacture Quantity Protective Earth Ground Alternating Current Do Not Reuse Attention see instructions for use Electric Shock Hazard Latex Free ...

Page 58: ... device to sale by or on the order of a physician Device is class type 1 equipment Protective earth terminal Consult instructions for use Do not use if package is damaged Temperature Limitation Humidity Limitation Use by Recyclable Product Do not bend heat exchanger Alarm Test ON Only for a part of the equipment MAINS are connected OFF Only for a part of the equipment The MAINS are still connected...

Page 59: ...circulating Solution Over Temperature Add Recirculating Solution Check Disposables Check Tubing Maximum Reservoir Level Minimum Reservoir Level Device has been tested by National Technical Systems a nationally recognized technical laboratory to meet U S requirements for safety Collect separately for electrical and electronic equipment Pressurized Unpressurized Symbols Definitions ...

Page 60: ...6 Changing Fluid bag 34 O Rings 44 Check Disposables indicator 17 Check Disposables Mode 24 Cleaning Exterior 42 Fan filter 44 Components list 8 Controls and displays 15 D Description Fluid Warmer 2 Dial Gauge 19 Disinfecting recirculating solution During assembly 11 Reservoir 43 Disposable Hand Piece Attach 31 Disposable Sets Installing 29 Priming 30 Used with 1129 Fluid Warmer 2 51 Disposal Info...

Page 61: ...le Raising and lowering 33 Power and Alarm Test Panel 16 Power OFF button 16 Power ON button 16 Preparing the Fluid Warmer for use 12 Pressure Activating and adjusting 32 Deflating 3L Pressure Cuff 33 Turning off 34 Pressure Chambers Control Panel 18 Depressurizing 34 Dial Gauge 19 Installing 10 Pressure Gauge 18 Pressure Regulator Knob 19 Toggle Switch 18 Troubleshooting 36 Pressure Cuff Accessor...

Page 62: ...n Alarm 37 Calibration 40 Check Disposables Alarm 37 Electrical 41 Fluid Warmer Alarms 38 Ground continuity 41 Maintenance requirements 44 Over Temperature test 38 Performance 39 Thermal specifications 50 Toggle Switch on Pressure Chamber 18 Troubleshooting Slow flow rate 36 U Unpressurized Mode 26 W Warming Sets See Irrigation Warming Sets Warnings Conventions 1 List of 4 Warranty information 46 ...