Level 1 H-1200 with H-31 ver B Air Detector Clamp Operators Manual Rev 002

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Copyright Level 1 H-1200 Fast Flow Fluid Warmer ®

Part Number: 4533708GB Rev. 002 (2006-07) This revision supercedes all previous revisions. Under copyright laws, this manual may not be reproduced in any form, in whole, or in part, without prior written permission of Smiths Medical ASD, Inc. (Smiths Medical). The Level 1, and Smiths design mark 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. Every effort has been made to 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. Other company and product names mentioned herein are trademarks of their respective companies. Mention of third-party products is for informational purposes only and constitutes neither an endorsement nor a recommendation. Smiths Medical assumes no responsibility with regard to the performance or use of these products. For further information, please call your local Smiths Medical representative or Smiths Medical direct at 1-800-258-5361 or +1-781-878-8011. ©2006 Smiths Medical family of companies. All rights reserved. The products described are covered by one or more of the following U.S. Patent Nos. 4,759,749; 4,878,537; 4,900,308; 5,063,994; 5,097,898; 5,417,274 and 5,512,043. Manufactured in the U.S.A.

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Contents 1 2 3 4

About this Manual Description Indications for Use Important Safety Information Contraindications Warnings Cautions

5 Out of the Box-Assembly Step 1 Verify Components Step 2 Assemble I.V. Pole to Warming Unit Step 3 Install the Pressure Chambers Step 4 Attach the I.V. Bag Hanger Step 5 Disinfect the Recirculating Solution Reservoir Step 6 Preliminary Preparation Step 7 Connect the Pneumatic Tubing Step 8 Install the Level 1® H-31, Version B, Air Detector/ Clamp Step 9 Perform Electrical Safety Tests

6 Principle of Operation

3 4 5 5 5 8 9 10 11 12 13 13 14 14 16 17

Fluid Warming Pressurized Fluid Delivery Air Detector/Clamping

19 19 19 19

Fluid Warmer Power and Alarm Test Panel Fluid Warmer Display Panel Air Detector/Clamp Control Panel and Alarms Pressure Chamber Control Panel Interlocks

21 22 23 24 25 26

Modes Of Operation OFF Mode ON/ Automatic Operation Mode for Fluid Warmer Alarm Test Mode Over Temperature Test Mode Temperature Display Check Disposables Mode Add Recirculating Solution Mode Over Temperature Alarm Mode Power ON Test for the Air Detector/Clamp Automatic Operation Air Detector/Clamp Check Tubing Mode Air Detected/Clamped Mode Pressurized Display Pressurized Mode Unpressurized Mode

29 30 30 30 31 31 31 32 32 33 33 34 34 35 35 35 36

7 Controls and Displays

8 Operation

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9 Operating Instructions Warnings 9.1 Set Up for Use A-Install Disposable Administration Set B-Prime the Disposable Administration Set C-Prime the Patient Line D-Test the Audible and Visual Alarms E-Test the Air Detector/Clamp 9.2 Use of the Fluid Warmer Step 1-Load the Pressure Chambers Step 2-Pressurize the Pressure Chambers Step 3-Make Patient Connection Step 4-Replace the Gas Vent/Filter Assembly Step 5-Change the Fluid Bag 9.3 Replace the Gas Vent/Filter Assembly 9.4 Activated Alarms 9.5 After Use

37 37 38 38 39 41 41 42 44 44 44 45 45 45 46 47 49

General Troubleshooting Guide Slow Flow Rate Troubleshooting Guide

50 50 51

Add Recirculating Solution Alarm Check Disposables Alarm Over Temperature Test Fluid Warmer Alarm Signal Test Performance Testing Cold Start Test Calibration Test Alternative Calibration Test Calibration Test with DSTA-40 Proper Calibration of Recirculating Solution Temperature Periodic Electrical Testing Earth Leakage Ground Continuity

52 52 52 53 53 54 54 54 54 54 55 56 56 56

10 Troubleshooting 11 Testing

12 Maintenance

Maintenance Performed Prior to Every Use Clean the Exterior General Inspection Maintenance Performed Every 30 Days Lubricate O-Ring Seals Change Recirculating Solution with Distilled Water Maintenance Performed Every 12 Months Disinfect the Recirculating Solution Reservoir Change Recirculating Solution with 0.3% Hydrogen Peroxide/Distilled Water Solution Change O-Rings Clean Fan Filter Inspect Air Detector/Clamp Testing Fluid Warmer Operation Maintenance and Calibration Log Scheduled Maintenance and Calibration Checklist

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13 Limited Warranty 14 Service Warranty Service Non-Warranty Work Additional Documentation Disposal Information Service Contacts

62 62 62 62 63 63

System Specifications Physical Environmental Thermal Electrical Electromagnetic Environment Recommendations Disposable Administration Set Specifications D-50 / DI-50 D-60 / DI-60HL D-70 / DI-70 D-100 / DI-100 D-300 / DI-300

64 64 64 64 64 64 65 65 65 65 66 66 66

15 Specifications

16 Symbols Index

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About 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 Level 1® H-1200 Fast Flow Fluid Warmer. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. This Operator’s Manual describes the set-up, use, and maintenance of: • Level 1® H-1200 Fast Flow Fluid Warmer • Level 1® H-1000 Fast Flow Fluid Warmer with the Level 1® H-31, Version B, Air Detector/Clamp Descriptions about the use and functionality of the Level 1® H-1200 Fast Flow Fluid Warmer in this manual are also applicable to the Level 1® H-1000 Fast Flow Fluid Warmer when equipped with the H-2 Pressure Chambers and Level 1® H-31, Version B, Air Detector/Clamp. The manual is intended for use by individuals trained in the healthcare and biomedical professions. WARNING! Read the entire operator’s manual before using the Level 1® H-1200 Fast Flow Fluid Warmer. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient.

This manual is organized into the following sections: 2 and 3 Description and Indications for Use

These sections provide the purpose and indications for use of the Level 1® H-1200 Fast Flow Fluid Warmer.

4 Important Safety Information

Lists the Contraindications, Warnings, and Cautions associated with the use of the Level 1® H-1200 Fast Flow Fluid Warmer.

5 Out of the Box-Assembly

Guides the user through the installation of the Level 1® H-1200 Fast Flow Fluid Warmer and the Level 1® H-31, Version B, Air Detector/Clamp.

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6 Principle of Operation

Provides a functional description of the Level 1® H-1200 Fast Flow Fluid Warmer. 7 Controls and Displays

Provides a description of the function and purpose of the controls, displays, and indicators for the Level 1® H-1200 Fast Flow Fluid Warmer. 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 Fluid Warmer. 10 Troubleshooting

Contains information on troubleshooting the Level 1® H-1200 Fast Flow Fluid Warmer. This section also details troubleshooting slow fluid flow rates. 11 Testing

Describes Operational, Performance, and Electrical Tests that are used to verify the proper operation of the Level 1® H-1200 Fast Flow Fluid Warmer. 12 Maintenance

Regular maintenance procedures for every use, 30-day, and 12-month intervals are covered in this section. 13 Limited Warranty

Describes the Limited Warranty and its provisions. 14 Service

Explains Warranty Service and Non-Warranty Work as well as listing Service Contacts. 15 Specifications

Provides physical, environmental, and electrical specifications of the device. 16 Symbols

Lists the symbols and their definitions used with the Fluid Warmer.

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Description The Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) is an I.V. fluid warmer with pressure chambers, air detection, and automatic clamping capability. I.V. fluid and/or blood products are warmed through the use of a sealed heat exchanger through which a recirculating solution flows. Pressure Chambers apply pressurization and deliver the fluids at a fast flow rate. The Air Detector/Clamp monitors for the presence of air in the disposable Gas Vent/Filter Assembly. This non-invasive method employs single-use, disposable administration sets that include a Gas Vent/Filter Assembly and Heat Exchanger. When air is detected in the Gas Vent/Filter Assembly, the Air Detector/Clamp closes off the patient line and alerts operators to the presence of air with audible and visual alarms. An ultrasonic signal continually passes through the fluid filled Gas Vent/Filter Assembly (GV/FA). As a bolus of air displaces the fluid in the GV/FA, the ultrasonic signal is broken and the clamp closes, stopping the air before it enters the patient line. Audible and visual alarms are activated, notifying the user that the fluid flow has stopped. Clearing the bolus of air and restoring the fluid flow are quickly accomplished without disconnecting from the patient. Disposable Administration Sets

The installation, set up, and replacement of Level 1® Fast Flow I.V. Disposable Administration Sets (Disposable Sets) follows a four-step sequence that corresponds to numbered blocks on the device. Disposable Sets available for use on the Level 1® H-1200 Fast Flow Fluid Warmer are listed below. • D-50 / DI-50 • D-60 / DI-60HL • D-70 / DI-70 • D-100 / DI-100 • D-300 / DI-300 D-series Disposable Sets are for use in the U.S.A. DI-series Disposable Sets are for use in markets outside of the U.S.A.

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Indications for Use The Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) provides a rapid flow of 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 of warmed fluid to re-warm patients during surgery by trained medical personnel.

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Important Safety Information This section covers information for prescribers and guidelines for safe use of the Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer).

CONTRAINDICATIONS • Not for use in warming platelets, cryo-precipitates, or

granulocyte suspensions.

WARNINGS Death or serious injury may occur to the patient or user if these warnings are not followed: • Read and follow all instructions, labeling, and accompanying documents supplied with this medical device. Failure to follow instructions, including all warnings and cautions, could lead to misuse of the device or device malfunction. • Remove all air from fluid lines before connecting to patient. Failure to do so can result in infusion of air into the patient. • 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 flow rate. This may result in inadequate patient treatment. • The replacement Gas Vent/Filter Assembly must be fully primed before continuing infusion. Failure to do so may allow air to be infused into the patient. • Do not 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.

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WARNINGS [continued] • Do not bend the heat exchanger. Bending may damage the heat exchanger allowing communication between the recirculating solution and I.V. fluid path, resulting in the I.V. delivery of inappropriate fluids. • 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. • When injecting medications into the fluid path, do not inject through the triple lumen tubing of the D/DI-60HL Disposable Set. This may allow communication between the recirculating solution and I.V. fluid path. • Exposed conductor on MAINS power cord can cause an electrocution hazard. Remove device from service if MAINS power cord has exposed wires. • Do not re-use partially full fluid bags. Fluid bags that have been partially drained, un-spiked, and then reinstalled 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. • The tubing must be properly placed in the Clamp Slot of the Air Detector/Clamp. Failure to ensure that the tubing is correctly positioned in the Clamp Slot may result in failure to stop air infusion. • Activation of the Air Detector/Clamp alarm during infusion indicates that fluid flow has stopped and that immediate operator intervention is required to restore fluid flow. • Activation of the Over Temperature warning signal indicates that warming has stopped and immediate operator intervention is required to clear the over temperature condition or to take the device out of service. • The Fluid Warmer is not for use with irrigating tubing, which may not fit into the clamp slot of the Air Detector/Clamp causing diminished flow or a failure to stop flow.

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WARNINGS [continued] • The Fluid Warmer is for use only with Smiths Medical supplied or approved parts, accessories, and D or DI series Disposable Sets. The device may not function as intended with the use of unapproved parts, accessories, or Disposable Sets. • 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 connected to a properly grounded receptacle. • The functional test for the Air Detector/Clamp accessory must be performed before each use. If the device does not function correctly, air in the I.V. line may not be detected, and the patient line may not be clamped. Remove the device from service immediately. • Use of a bedside leukocyte reduction filter may cause a sudden precipitous drop in blood pressure resulting in respiratory distress, facial flushing, abdominal pain and nausea, and loss of consciousness. Immediately stop transfusion, and follow institution’s protocol for treatment of transfusion reactions. • 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. • Do 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. • Do not use Disposable Set if luer caps are not securely in place, else I.V. flow path may not be sterile and may cause death or serious injury.

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CAUTIONS Physical injury to the patient, user, and/or an adverse effect on the device or its performance may occur if these cautions are not followed: • Do not use the Fluid Warmer if equipment or Disposable Set malfunction is evident. • To reduce the risk of cross contamination, do not reuse Disposable Sets. Disposable Sets are for single use only. • When loading fluid bags into Pressure Chambers, choose a hanging hook that allows the bag port to hang freely in the indented slot at the bottom of the chamber door. If bag ports are positioned above this slot, diminished flow could occur. • Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

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Out of the Box-Assembly This device must be assembled and tested by authorized Smiths Medical personnel, an authorized distributor of Smiths Medical, or a qualified person prior to placing the device into service. The following steps describe how to assemble and do preliminary set up of the Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer). Refer to Step 8 if you need 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

Install Pressure Chambers

Step 4

Attach the I.V. Bag Hanger

Step 5

Disinfect the Recirculating Solution Reservoir

Step 6

Preliminary Preparation

Step 7

Connect the Pneumatic Tubing

Step 8

Install the Level 1® H-31, Version B, Air Detector/Clamp

Step 9

Perform Electrical Safety Tests

Read through the instructions completely prior to setting up the device. Note: After unpacking the system, recycle packaging material according to hospital policy for recyclable materials.

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Step 1 Verify Components of the Level 1® H-1200 Fast Flow Fluid Warmer Note: The Level 1® H-31, Version B, Air Detector/Clamp is shipped as a separate accessory only for

installation on an existing Level 1® H-1000 Fast Flow Fluid Warmer. Check the contents of all packaging to verify that the following components are present. If any parts are missing or damaged, do not use the Fluid Warmer. Do not substitute parts not supplied by Smiths Medical. Contact Smiths Medical for replacement parts. Below is a listing of the component parts for the Level 1® H-1200 Fast Flow Fluid Warmer. Components Checklist Qty Component

in order of appearance in illustration N OT F N OT F N OT F

2

Pressure Chambers / Contents: (2) “U” brackets (4) Thumbscrews

1

I.V. Bag Hanger

1

Fluid Warming Unit

1

H-31, Version B, Air Detector/Clamp Accessory Pack (2) Pan-head screws (2) Power Cord Clips (2) Flat-head screws

N O TI LU N SO TIO .V. N LU YI AN SO TIO U ITH .V. OR USE W OL YI AN .V. S ITH YI OR USE W AN ITH OR USE W

N O TI LU N SO TIO .V. N LU YI AN SO TIO U ITH .V. N OT F OR USE W OL YI AN .V. S ITH N OT F YI OR USE W AN ITH N OT F OR USE W

2

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H-31B

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H-31B

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I.V. Pole with Flanking Brackets

1

Accessory Pack / Contents: (2) Plastic “J” Clamps (1) Y Connector (1) Black Tubing (1) Hex Wrench

1

O-Ring Kit / Contents: (1) Silicone (2) O-Rings (1) Hex Wrench (1) Instructions for Use

3 3

Bolts Washers

1

I.V. Pole Base

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Step 2 Assemble I.V. Pole to the Warming Unit

There are three steps involved in assembling the I.V. Pole to the Warming Unit. The steps are: 1. Assemble the I.V. Pole to the Base, 2. Close the Drain Valve, and 3. Attach the Warming Unit to the Flanking Brackets. Each step is detailed in a short procedure. 2.1 Assemble the I.V. Pole to the Base 1 Locate the I.V. Pole Base (a). 2 Locate the dark-gray extruded I.V. Pole (b) with Flanking Brackets.

b

3 Place the I.V. Pole Base upright on its wheels, (c) and lock the wheels to prevent movement during set up. d

4 Locate three bolts (d) and washers for the pole base. e

5 Align the three holes (e) in the I.V. Pole with the three screw holes on the pole base.

f

6 Slide the I.V. Pole down over the pole base, (f) keeping holes aligned.

g

a

7 Guide three bolts and washers through the holes (g) at the base of the pole and tighten.

c

h

2.2 Close the Drain Valve Turn valve, located on the bottom of the device, perpendicular to stem (h) of the Warming Unit as shown.

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2.3 Attach the Warming Unit to the Flanking Brackets 1 Align the eight hex screws on the back of the Warming Unit with the eight keyhole notches on the flanking bracket. 2 Slide screw heads down into keyhole notches.

2

3 Tighten all eight hex screws with the supplied hex wrench and secure in place.

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Step 3 Install the Pressure Chambers

1 Locate the two Pressure Chambers. 2 Locate the U-brackets and thumbscrews supplied with the Pressure Chambers. 3 Attach the U-brackets with thumbscrews to the back of the Pressure Chambers, as shown. Keep thumbscrews and brackets loose. 4 Slide one Pressure Chamber with attached U-bracket over the top of each flanking pole. 5 Align the U-bracket slightly below the top of the flanking pole. Tighten the thumbscrews securely.

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Step 4 Attach the I.V. Bag Hanger

1 Slide the I.V. Bag Hanger on top of the I.V. Pole. 2 Align with tabs. 3 Press down and snap into place.

2

Step 5 Disinfect the Recirculating Solution Reservoir 2

c

1 Remove the fill-port plug (a) on the reservoir. 2 Prepare a 0.3% hydrogen peroxide/distilled water solution for the reservoir. Mix 140 ml of 3% hydrogen peroxide solution and 1,260 ml of distilled water.

R

3 Fill the reservoir with 1.4 liters of 0.3% hydrogen peroxide/ distilled water solution.

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5 Insert a Disposable Set into the Fluid Warmer. 6 Insert the power cord into a properly grounded receptacle. 7 Turn the Fluid Warmer ON. Let the solution circulate for a 30minute disinfection period. 8 Turn the Fluid Warmer OFF. 9 Empty the reservoir. 10 Remove the Disposable Set and discard according to established hospital procedures.

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Step 6 Preliminary Preparation 2

1 Remove the fill-port plug (a) on the front of the warming unit and

c

fill the reservoir to the maximum level with 1.4 liters of one of the following solutions: R

• 0.3% Hydrogen Peroxide/Distilled Water Solution Mix 140 ml of 3% hydrogen peroxide and 1,260 ml of distilled water. Note: If this option is selected, the maintenance requirement to change the recirculating solution is once every 12 months. Always use a 0.3% hydrogen peroxide/distilled water solution when refilling the reservoir.

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• Distilled Water Note: If this option is selected, the maintenance requirement to change the recirculating solution is once every 30 days.

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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, provided in the supplied O-Ring Kit, on a cotton swab and apply all around the inside of each O-Ring.

Step 7

a

Connect the Pneumatic Tubing 1 Locate the Accessory Pack with the black pneumatic tubing (a),

b

two “J” clamps (b), and one “Y” Connector (c).

c

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