IFU (User Manual) - HotDog Patient Warming
Contents
1. Patient Warming Mattress Model U10X User Manual Manufactured by Augustine Temperature Management 6581 City West Parkway Eden Prairie MN 55344 USA TEL 952 465 3500 FAX 952 465 3501 www hotdogwarming com EU Authoriz Repr Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 0 70 345 8570 Fax 31 0 70 346 7299 ntative 0086 User Manual Hot Dog Patient Warming Mattress DEVICE DESCRIPTION The Hot Dog Patient Warming Mattress is a component of the Hot Dog Patient Warming System and should only be used with Hot Dog Controller Model WCS5X These instructions apply to Warming Mattress Model U10X The Warming Mattress provides a surface area for under body patient warming at a specified and uniform temperature An internal temperature sensor provides output to the Hot Dog Controller to maintain the set temperature The Warming Mattress has a built in pressure relief pad and is water and solvent resistant All seams are fully sealed to allow for easy cleaning and disinfection INDICATIONS FOR USE The Hot Dog Patient Warming Mattress is intended to prevent or treat hypothermia and to provide warmth to patients The Hot Dog Patient Warming Mattress should be used in circumstances in which patients could become cold In addition the mattress is designed to provide pressure relief The Hot Dog Patient Warming System is intended primarily for use in hospitals and surgical centers includi2. a disinfectant Scrub the affected area with detergent using a soft brush or sponge to remove organic matter Rinse the surface of the mattress using a dampened cloth Do not immerse the mattress in liquids 3 Apply a low or intermediate level disinfectant to the entire mattress by spraying or wiping Follow the disinfectant manufacturer s application instructions to ensure disinfection 4 Dry thoroughly before use ALARMS If the Warming Mattress temperature exceeds one degree above set point or other fault conditions exist an audible alarm sounds and the Controller Alarm Light illuminates red for the port that is alarming The Controller will automatically discontinue power to the Warming Mattress When the operating temperature is regained the alarm will shut off and normal function will be restored If the Alarm Light illuminates steadily and the alarm continues to sound turn the Controller Mains Power Switch to the OFF position and disconnect the Warming Mattress from the Controller If the Controller senses an over current the audible alarm will sound and all alarm lights will illuminate Power will be lifted from all ports and the Controller will need to be turned off to reset If all Alarm Lights illuminate after resetting the Controller discontinue use of the Warming Mattress DEFINITION OF SYMBOLS Attention consult BF Patient Applied Part accompanying documents fre AL according to IEC60601 1 Serial Number Reference Nu
3. or connectors may result in damage to the wires or the connector pins User Manual Hot Dog Patient Warming Figure 2 Cable Disconnect m Grip ppi j dn ENT ya bbm rehas 1 Fal beri m Fa marre Dera i boy shig iry B Prej De ee Ee Boel m ala heil k ee h Sates 1 bs CARE AND MAINTENANCE e DO NOT launder or sterilize as this may damage the Warming Mattress e DO NOT immerse the Warming Mattress in liquids e DO NOT use high level disinfectants e g gluteraldehyde peracetic acid to clean the Warming Mattress e DO NOT spray cleaning solutions into the electrical connector e DO NOT use cleaning or disinfection methods different from those recommended in the User Manual without first checking with an authorized service representative to ensure that the proposed methods will not damage the equipment e DO NOT use the Warming Mattress if it shows signs of damage or excessive wear such as cuts holes or loose electrical connectors Technical staff should inspect the Warming Mattress to determine if it is safe for use e DO NOT disassemble the Warming Mattress the product contains no user serviceable parts If service inrequircd callan authorized service representative g Mattress in a dry place and in ents the product from being cut e Warming Mattress store at Note If the Warming Mattress has been exposed to freezing temperatures do not bend or roll the product as this may result in cracks to th
4. Federal law USA restricts this device to sale by or on the order of a licensed healthcare professional PRECAUTIONS Use under the direct supervision of a clinician Monitor the patient s vital signs regularly during warming according to institutional protocol If vital sign instability occurs notify the clinician Care should be taken when using multiple warming methods Ensure that the Warming Mattress is securely fastened to the table The risk of skin irritation caused by pooling of surgical prep solutions under the patient may increase with warming ensure that surgical prep solution instructions for use are followed The use of gel pads between the Warming Mattress and the patient is not recommended gel pads may cause a loss of warming performance Always use a patient barrier between the patient and the Warming Mattress Position the patient on flat Warming Mattress Care should be taken to alleviate or remove the risk of heating skin under pressurized bony prominences Care should be taken to place the patient s body in contact with the labeled sensor on the Warming Mattress DO NOT use operating table clamps or similar devices on the Warming Mattress as they may cause damage to the product and result in loss of the heating function and or localized heat build up in the damaged area DO NOT place the Warming Mattress over a table joint that will move during surgery DO NOT use on OR tables wider than 20 inche
5. HIS SIDE UP labeling faces up 3 Attach the Warming Mattress straps to the operating table Warning Ensure that the straps on each side of the Warming Mattress are firmly secure If the straps are not secure the mattress can slide off the table resulting in patient injury 4 Place a patient barrier over the entire surface of the Warming Mattress 5 Insert the female end of the blue Mattress Cable into the Mattress Connector Figure 1 Note Do not force the connector into the socket Align the red dots on each connector and gently push the connectors together You will feel a click when the connectors engage Figure 1 Cable Connection 6 Insert the male end of the blue Mattress Cable into the blue port on the Hot Dog Controller 7 Turn the Hot Dog Controller on and select the desired temperature setting to begin warming Allow 5 minutes for the Warming Mattress to reach set point Refer to the Hot Dog Controller User Manual 8 Ifthe Hot Dog Controller alarm sounds when the Warming Mattress is connected do not use the Warming Mattress Refer to the Alarms section 9 When use of the Warming Mattress is complete clean as necessary Refer to the Care and Maintenance section 10 To disconnect the Mattress Cable grip the connector bodies and pull them apart Figure 2 Note Do not pull on the cables or attempt to rotate or unscrew the connectors Bending or twisting the cables
6. e pressure relief pad Allow the product to reach room temperature prior to handling e DO NOT store any other objects on top of the Warming Mattress e DO NOT fold or sharply bend the Warming Mattress the recommended storage configuration is flat preferred or rolled User Manual Hot Dog Patient Warming Mattress Page 4 Cleaning General Clean the Warming Mattress between each patient use and anytime it appears soiled Wipe the mattress with a damp soapy cloth and disinfect following standard hospital protocol In general alcohol based disinfectants are easiest to use since they are fast acting and can be either sprayed or wiped on the mattress Other cleaners that are compatible with the outer surface of the mattress include sodium hypochlorite diluted bleach phenolic germicidal detergent and quaternary ammonium detergent Iodine containing cleaners may cause discoloration of the surface material and are therefore NOT recommended for routine cleaning Dry thoroughly before use Caution DO NOT place the Warming Mattress in an autoclave sterilizer automatic washer disinfector or any other high temperature system as this may damage the product Cleaning amp Disinfection Steps The cleaning steps below are general recommendations and are not meant to replace hospital specific cleaning protocols 1 DONOT allow cleaning fluids to get into the electrical connector 2 If visible soiling is present remove before applying
7. mber FN Not Sterile i Use only with Hot Dog Patient Store as directed in mara O a E Protect from sharp objects aaa Conforms to European Discontinue use if product is 1 Keep Dry M edical Device Directive cut or damaged 0086 93 42 EEC Transport and Storage Transport and Storage te Return to Authorized Humidity Range Temperature Range alse Representative Temperature Sensor This Side Up pC HotDog is a trademark of Augustine Temperature Management registered in the U S Patent amp Trademark Office Patents Pending 2010 Augustine Temperature Management All rights reserved P N 2064EN Rev C 01 2011
8. ng without limitation operating recovery and emergency rooms and on medical surgical floors CONTRAINDICATIONS e DO NOT warm patients during aortic cross clamping thermal injury may result e DO NOT warm patients with ischemic or non perfused limbs thermal injury may result e DONOT warm patients receiving transdermal medication increased drug delivery may occur e DO NOT use the Warming Mattress on patients weighing over 300 Ibs 136 kg e DO NOT use the Warming Mattress with other under patient thermal management systems WARNINGS e EXPLOSION HAZARD DO NOT use the Warming Mattress in the presence of flammable anesthetics or highly oxygen enriched environments such as hyperbaric chambers oxygen tents etc e Caution should be taken when using electric warming devices with HF surgical instruments or endocardial catheters in respect to potential equalization e Inspect the Warming Mattress prior to use for signs of damage or excessive wear such as cuts holes or loose electrical connections If signs of wear are evident do not use the Warming Mattress until it is inspected by technical staff e DONOT continue to use the Warming Mattress if the Hot Dog Controller over temperature indicator and or alarm continues to sound after reset e The Warming Mattress is not sterile Take appropriate precautions as necessary to protect the sterile field e Use only with Hot Dog Controller Model WC5X CAUTION Page 2
9. s 50 8 cm DO NOT use the Warming Mattress as a stand alone patient pressure relief system DO NOT place any hard objects e g mattress cables EKG cables hard cautery return pads patient fluid lines etc between the Warming Mattress and the patient s body DO NOT fold or wrinkle the Warming Mattress during use as localized heat build up may occur in the overlapped area DO NOT use the Warming Mattress when pressure injury is a concern DO NOT X ray or MRI through the white labeling or edges of the Warming Mattress DO NOT allow patient fluid lines to be placed between the Warming Mattress and Warming Blanket or other warming equipment DO NOT position the patient s head directly on the Warming Mattress DO NOT allow the heated side of a Hot Dog Warming Blanket to come in continuous contact with the Warming Mattress when both devices are on INSTRUCTIONS FOR USE Contents Page 3 Mattress The following components are included in the Hot Dog Patient Warming Mattress package 1 Warming Mattress 1 Mattress Cable P N A112 The following supplies are not provided but are required for use with the Warming Mattress Patient barrier e g thin cotton sheet General I nstructions 1 Inspect the surface of the Warming Mattress for damage e g cuts tears creases Do not use the Warming Mattress if it is damaged 2 Place the Warming Mattress on the padded operating table Note Ensure T
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