Operators Manual
76 Pages
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COVIDIEN, COVIDIEN with logo, and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2013 Covidien.
Table of Contents 1 Introduction... 1 Overview... 1 Safety Information... 1 Safety Symbol Definitions... 1 Warnings... 2 Cautions... 4 Labeling Symbols... 6 Obtaining Technical Assistance... 8 Related Documents ... 11 Warranty Information... 11 2 Product Overview... 13 Overview... 13 Product Description... 13 Features... 13 Indications for Use... 14 Contraindications... 14 Components and Accessories... 14 Covidien WarmTouch™ Warming Blankets... 15 Product Views ... 16 Front View... 16 Rear View ... 17 Operator’s Panel... 18 Requirements for Use... 20 Clinician Prerequisites... 20 Treatment Environment... 20 Warming Blanket Use... 21 Patient Considerations... 22 3 Installation... 23 Overview... 23 Safety Reminders... 23 Attaching the Power Cord... 24 Installing the Warming Unit... 26 IV Pole Installation... 26 Bed Installation ... 29 Cart Installation... 30
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4 Operation... 33 Overview... 33 Safety Reminders... 33 Positioning the Warming Unit... 34 Applying Power... 36 Overview of Warming Unit Operating Modes... 37 Beginning Treatment... 38 Controlling the Temperature ... 40 Using Boost Mode... 42 Using the Heat Off Setting... 42 Returning to Ready Mode ... 43 Returning to Standby Mode... 43 If Power is Interrupted... 44 Powering Off the Warming Unit... 44 Cleaning the Warming Unit after Operation... 44 5 Maintenance ... 45 Overview... 45 Cleaning the Warming Unit... 45 Safety Checks... 46 Physical Inspection... 46 Alarm and Temperature Verification... 46 Electrical Safety Tests... 46 Filter Replacement... 47 Monitoring the Filter Status... 48 Component Disposal... 50 6 Troubleshooting ... 51 Overview... 51 Safety Reminders... 51 Problems and Resolutions... 52 If an Alarm Condition Occurs... 53 Serial Number and System Information... 54 Serial Number... 54 System Information... 55 7 Product Specifications... 57 Overview... 57 Physical Characteristics... 57 Warming Unit... 57 Transport Cart (Optional)... 57
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Electrical Requirements... 58 Environmental Specifications ... 58 Operating ... 58 Shipping and Storage... 58 Performance Specifications... 59 Product Compliance... 59 Electromagnetic Compatibility (EMC)... 60 Manufacturer’s Declaration... 60 Electromagnetic Emissions... 60 Electromagnetic Immunity... 61 Ground Integrity Test... 64 Earth Leakage Current Test... 64 Enclosure Leakage Current Test... 64 Index... 65
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1 Introduction Overview This manual contains information for operating the Covidien WarmTouch™ Convective Warming System, which consists of the Covidien WarmTouch™ Convective Warming Unit and associated WarmTouch blankets. Before operating the warming system, thoroughly read this Operator’s Manual. The latest version of this manual is available at: www.covidien.com
Safety Information This section lists all safety information associated with the warming unit. Where appropriate in the manual, individual Warnings and Cautions are repeated as reminders. Please familiarize yourself with this safety information before operating the warming unit.
Safety Symbol Definitions Table 1. Safety Symbol Definitions Symbol
Definition WARNING Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment. Caution Cautions alert users to exercise appropriate care for safe and effective use of the product. Note Notes provide additional guidelines or information.
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Introduction
Warnings
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WARNING: Possible explosion hazard. Do not use the device in the presence of flammable anesthetics or in an oxygen-rich environment. WARNING: Possible electric shock hazard. Grounding reliability can be achieved only when the warming unit is connected to a suitable mains outlet with protective earth grounding. WARNING: No free-hosing. Keep hose nozzle connected to a WarmTouch™ blanket at all times or thermal injury may occur. WARNING: Possible burn or infection hazard. Do not allow warming blanket to come in contact with open wounds. All patients’ wounds should be covered while using the warming system. WARNING: Possible patient burns. Use caution and consider discontinuing use on patients during vascular surgery when an artery to an extremity is clamped. Do not apply the warming system to ischemic limbs. WARNING: Thermal injury may occur if the warming unit hose comes into contact with the patient. WARNING: Possible fire hazard. Prevent the blanket material from coming into contact with a laser or an electrosurgical active electrode. WARNING: Continuously monitor the patient's temperature during treatment with the warming system. Use good clinical judgment in selecting and adjusting temperature settings based on the patient's warming needs and response to treatment.
Operator’s Manual
Safety Information
WARNING: Using the warming system on patients with transdermal medication patches may increase the rate of drug delivery, potentially causing harm to the patient. WARNING: Thermally conductive materials, such as water, gel, and similar substances, can decrease the patient's body temperature when the warming unit is switched off. WARNING: Do not use the warming system during magnetic resonance imaging (MRI) scanning. WARNING: The use of accessories or cables with the warming system other than those indicated in this manual may result in non-compliance with the specifications listed in Electromagnetic Compatibility (EMC) on page 60. WARNING: Do not operate the warming system in a stacked configuration with other equipment. WARNING: Do not operate the warming system adjacent to other equipment. If such a configuration cannot be avoided, first test the warming system in the intended configuration to verify normal operation. WARNING: Use WarmTouch™ blankets only as directed. Carefully follow the Instructions for Use provided with the blankets regarding proper handling and positioning. WARNING: WarmTouch™ blankets are for single patient use only. WARNING: Clean the warming unit after each use, as described in this manual.
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Introduction
WARNING: If a fault or sudden change in performance occurs in the warming system, discontinue use. Notify your sales/service center. The unit must be serviced by qualified personnel using procedures provided in the Service Manual. WARNING: Possible electrical shock hazard. To reduce the risk of electrical shock, do not remove the back case. Servicing is only to be done by qualified personnel. WARNING: No modification of this equipment is allowed.
Cautions
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Caution: Federal (U.S.A.) law restricts the use of the warming system to sale by or on the order of a physician. Caution: Only use WarmTouch™ blankets with the WarmTouch warming unit. Do not attempt to use other types of blankets with the warming unit. Similarly, do not attempt to use WarmTouch blankets with other types of warming units. Caution: Do not spray, pour, or spill any liquid on the warming unit, its accessories, connectors, switches, or openings in the case. Caution: The HEPA filter must be replaced every 2,000 hours of operation or 365 days, whichever comes first. Filter replacement must be performed by qualified personnel. Refer to the Service Manual for replacement instructions.
Operator’s Manual
Safety Information
Caution: Operation of the warming system may affect or be affected by other devices in the vicinity due to electromagnetic interference (EMI). If interference occurs, try increasing the distance between devices, repositioning the cabling, or plugging the devices into separate outlet circuit branches. Reference Electromagnetic Compatibility (EMC) on page 60 for additional guidance. Caution: The USB port on the warming unit is for service use by qualified personnel only. During patient treatment, a USB cable must not be connected to the warming unit. Caution: The institution should follow local governing ordinances and recycling instructions regarding disposal or recycling of filter and device components or end of life of the product.
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Introduction
Labeling Symbols Table 2 defines the symbols that appear on the warming unit or its shipping label. Table 2. Symbols on the Warming Unit and Shipping Label Symbol
Description
Appears On... Warming Shipping Unit Label
By prescription only
X
No Free Hosing: Hose nozzle must be connected to a WarmTouch™ blanket or thermal injury may occur.
X
Do not use during magnetic resonance imaging (MRI).
X
Degree of protection from electric shock:
X
X
X
Protection Class I, Type BF applied part Recommendation to consult accompanying documents
X
X
Requirement to consult accompanying documents
X
X
Nature of power supply: Alternating Current (AC)
X
Potential equalization conductor terminal
X
Used to access the warming unit’s electrical ground for electrical safety testing Universal Serial Bus (USB) port
X
(For service use by qualified personnel only) Keep dry
Temperature limitations (shipping/storage): -40°C to +70°C
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X
X
X
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Labeling Symbols
Table 2. Symbols on the Warming Unit and Shipping Label (Continued) Symbol
Description
Appears On... Warming Shipping Unit Label
Temperature limitations (operating): +18°C to +28°C
X
Relative humidity limitations (shipping/storage): 10% to 95% (non-condensing)
Relative humidity limitations (operating): 15% to 85% (noncondensing)
X
X
Atmospheric pressure limitations (shipping/storage): 12 kPa to 106 kPa
X
Atmospheric pressure limitations (operating): 70 kPa to 106 kPa
X
CE – Conformité Européene authorization mark
X
X
0123 – TÜV SÜD Product Service GmbH (notified body) Signifies compliance with Medical Device Directive 93/42/EEC
Operator’s Manual
CSA – Canadian Standards Association certification mark
X
European Community (EC) authorized representative
X
X
Serial number
X
X
Catalog number
X
X
Manufacturer
X
X
Date of manufacture
X
X
Proper waste disposal for electrical and electronic equipment (WEEE)
X
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Introduction
Obtaining Technical Assistance For technical assistance or to order parts and additional manuals, contact Covidien Technical Services or a local Covidien representative. When contacting Covidien for troubleshooting or service issues, please provide the information described in Serial Number and System Information on page 54.
Covidien Technical Services
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Covidien Argentina
Covidien Asia
Covidien Australia
Aguero 351 Capital Federal - 1171 ABC Argentina Tel: (5411) 4863-5300 Fax: (5411) 4863-4142
Singapore Regional Service Centre 15 Pioneer Hub, #06-04 Singapore 627753 Tel (65) 6578 5288 Fax (65) 6515 5260
52A Huntingwood Drive Huntingwood, NSW 2148 Australia Tel: (+61) 1800 - 350702 Fax: (+61) 2967 - 18118
Covidien Austria GmbH
Covidien Belgie S.A.-N.V.
Covidien Brazil
Campus21 Europaring F09402 Brunn am Gebrige A-2345 Österreich Tel: (+43) 2236 - 3788 39 Fax: (+43) 2236 - 3788 3940
Generaal De Wittelaan 9/5 Mechelen 2800 België Tel +32 152 981 37 Fax +32 152 167 83
Av. Das Nações Undias 12995 Andar 23 - Brooklin São Paulo, SP Brasil 04578-000 Tel: (5511) 2187-6200 Fax: (5511) 2187-6380
Covidien Canada
Covidien Chile
Covidien China
19600 Clark Graham Baie d'Urfe, QC, H9X 3R8 Canada Tel:1-514-695-1220, Ext.4004 Fax: 1-514-695-4965
Camino lo Boza (Ex 8395) Pudehuel Santiago Chile Tel: (562) 739 - 3000 Fax: (562) 783 - 3149
2F, Tyco Plaza 99 Tian Zhou Rd Shang Hai 200233 P.R. China Tel: (+86) 4008 1886 86 Fax: (+86) 2154 4511 18
Covidien Colombia
Covidien Costa Rica
Covidien ECE
Edificio Prados de la Morea Carretera Central Del Norte (Cra 7a) Kilometro 18, Chia-Cundinamarca Bogota, Colombia Tel: (571) 619-5469 Fax: (571) 619-5425
Global Park, Parkway 50 La Auroa de Heredia Costa Rica Tel: (506) 2239 - 5386 Fax: (506) 2239 - 5319
Prosecká 851/64 190 00 Praha 9 Česká republika Tel: +420 239 000 711 Fax: +420 239 000 437
Operator’s Manual
Obtaining Technical Assistance
Covidien Technical Services (Continued) Covidien Danmark A/S Langebrogade 6E, 4. sal 1411 København K Danmark Tel +45 702 753 50 Fax:+45 702 756 50
Covidien Deutschland GmbH Technisches Service Center Raffineriestr. 18 93333 Neustadt / Donau Germany Tel + 49 944 595 93 80 Fax + 49 944 595 93 65
Covidien ECE Galvaniho 7/a 821 04 Bratislava Slovakia Tel.: +421 248 214 573 Fax: +421 248 214 501
Covidien Finland Oy
Covidien France SA
Covidien Hong Kong
Läkkisepäntie 23 00620 Helsinki Finland Te. +35 896 226 84 10 Fax +35 896 226 84 11
Parc d'affaires Technopolis Bat. Sigma, 3 Avenue du Canada LP 851 Les Ulis 91975 Courtaboeuf Cedex France Tel +33 169 821 416 Fax +33 169 821 532
Unit 12 - 16, 18/F BEA Tower Millennium City 5 4187 Kwun Tong Road Kwum Tong, Kowloon, Hong Kong Tel + 852 3157 7299 Fax + 852 2838 0749
Covidien India
Covidien Hungary
Covidien Ireland
10th Floor Building No 9B DLF Cyber City Phase III Gurgaon Haryana - 122002 India Tel + 91 1244 709800 Fax + 91 1244 206850
1095 Budapest Mariassy u. 7 Magyarorszag Hungary Tel + 36 1880 7975 Fax + 36 1777 4932
Block G, Ground Floor, Cherrywood Technology Park, Loughlinstown County Dublin, Ireland Tel +353 1 4381613 Fax 353 1 439 3039
Covidien Israel
Covidien Italia S.p.A.
Covidien Japan Inc.
5 Shacham St. North Industrial Park Caesarea 38900 Israel Tel +97 246 277 388 Fax+97 266 277 688
Via Rivoltana 2/D 20090 Segrate Italy Tel +39 027 030 81 31 Fax +39 027 031 72 84
Technical Support Center 83-1, Takashimadaira 1-Chome Itabashi-ku, Tokyo 175-0082 Japan Tel: +81 (0) 3 6859 0120 Fax: +81 (0) 3 6859 0142
Covidien Korea
Covidien Mexico
Covidien Nederland BV
5F, Hibrand Living Gwan, #215, Yangjae-Dong, Seocho-Gu Seoul, Korea Tel: +822 570 5459 Fax: +822 570 5499
Insurgentes Sur # 863, Piso 16 Col. Nápoles Del. Benito Juarez Mexico, D.F. 03810 Mexico Tel: (5255) 5804-1524 Fax: (5255) 5536-1326
Hogeweg 105 5301 LL Zaltbommel Nederland Tel +31 41 857 66 00
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Introduction
Covidien Technical Services (Continued)
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Covidien Norge AS
Covidien Panama
Covidien Polska
Postboks 343 1372 Asker. Norway Tel +47 668 522 22 Fax +47 668 522 23
Parque Industrial Costa del Esta Calle Primera, Edifio # 109 Panama City, Panama Tel: (507) 264-7337 Fax: (507) 236-7408
Al. Jerozolimskie 162 Warszawa. 02-342 Polska Tel +48 223 122 130 Fax +48 223 122 020
Covidien Portugal Lda.
Covidien Puerto Rico
Covidien Russia
Estrada do Outeiro de Polima, Lote 10-1° Abóboda 2785-521 S.Domingos de Rana Portugal Tel +35 121 448 10 36 /30 Fax +35 121 445 1082
Palmas Industrial Park Road 869 Km 2.0 Bdlg. #1 Cataño, PR 00962 Tel. 787-993-7250 Ext. 7222 & 7221 Fax 787-993-7234
53 bld. 5 Dubininskaya Street Moscow RUSSIA. 119054 Tel +70 495 933 64 69 Fax +70 495 933 64 68
Covidien Saglik A.S.
Covidien South Africa
Covidien Spain S.L.
Maslak Mahallesi Bilim Sokak No: 5, Sun Plaza Kat: 2-3 Sisli, Istanbul 34398 Turkey Tel +90 212 366 20 00 Fax +90 212 276 35 25
Corporate Park North 379 Roan Crescent Randjespark Midrand, South Africa Tel +27 115 429 500 Fax +27 115 429 624
Business Park World Trade Center Almeda Park Edificio 7 - 3ª planta Plaça de la Pau s/n Cornellà de Llobregat
Covidien Sverige AB
Covidien Switzerland
Covidien Thailand
Box 54 171 74 Solna Sweden Tel +46 858 56 05 00 Fax + 46 858 56 05 29
Roosstrasse 53 8832 Wollerau Schweiz Tel +41 44786 5050 Fax +41 44786 5010
99 Soi Rubia, Sukhumvit 42 Road 13 - 14 Fl., Berli Jucker Building Prakanong, Klongtoey Bangkok 10110, Thailand Tel +662 2073 - 100 Fax +662 657 - 6325
Covidien UK
Covidien US
Unit 2, Talisman Business Park London Road, Bicester OX26 6HR, United Kingdom Tel +44(0)1869 328092 Fax +44(0)1869 327585
15 Hampshire Street Mansfield, MA 02048 USA Tel 1.800.635.5267 Tel 1.925.463.4635 (toll)
Operator’s Manual
Related Documents
Related Documents •
Instructions for Use - Covidien WarmTouch™ Warming Blanket - This document, provided with WarmTouch warming blankets, contains important information regarding intended use, handling, connection, and positioning of the blanket.
•
Service Manual - Covidien WarmTouch™ Convective Warming Unit - This document, for use by qualified personnel only, contains instructions for servicing, testing, updating, and maintaining the warming unit. The Service Manual also includes schematics, a parts list, and shipping instructions for factory service.
Warranty Information To obtain warranty information, contact Covidien Technical Services or a local Covidien representative. Reference Obtaining Technical Assistance on page 8.
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Introduction
Page Left Intentionally Blank
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Operator’s Manual
2 Product Overview Overview This chapter provides an introduction to the Covidien WarmTouch™ Convective Warming System, including information about its features, accessories, controls, and requirements for use.
Product Description The warming system provides a means for treating or preventing hypothermia in adult and pediatric patients in clinical settings. The warming system consists of an electronic blower (warming unit) that delivers heated air through a flexible hose to a lightweight blanket placed on the patient. The blanket distributes the heated air through numerous small perforations that allow the air to reach the targeted areas of the patient’s body.
Features •
Multiple Temperature Settings - A range of temperature settings allows the clinician to customize and adjust treatment based on the patient’s needs.
•
Boost Mode - For rapid warming, air is generated at 47°C for 45 minutes, after which the temperature automatically drops to the 45°C (High) temperature setting.
•
HEPA Filter - A High Efficiency Particulate Air (HEPA) filter removes at least 99.97% of particles 0.3 micrometers or larger from the air delivered to the warming blanket. The warming unit monitors the amount of time the filter is in use and indicates when the filter needs to be replaced.
•
Automatic Over- and Under-Temperature Protection - At any of the heated air settings, if the temperature of the generated air is out of range for a specific amount of time, the heater and fan automatically shut off and an alarm is issued.
•
Optional Cart with Wheel Locks - An optional transport cart, equipped with wheel locks, is available for the warming unit. The wheel locks reduce cart movement while the system is in use.
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Product Overview
Indications for Use The WarmTouch Convective Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia.
Contraindications None known.
Components and Accessories To order components and accessories, contact Covidien Technical Services or a local Covidien representative. Reference Obtaining Technical Assistance on page 8. Table 3. Warming System Components and Accessories
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Item
Description
Covidien WarmTouch™ Convective Warming Unit
Electronic blower that delivers heated air to the warming blanket.
Covidien WarmTouch™ warming blankets
Warming blankets designed for exclusive use with the warming unit. Available for a variety of treatment applications.
HEPA filter
Replaceable air filter for the warming unit.
Power cord
Detachable power cord for the warming unit. Type depends on country of use.
Transport cart (optional)
Optional wheeled cart for mounting the warming unit.
Operator’s Manual
Product Description
Covidien WarmTouch™ Warming Blankets The Covidien WarmTouch™ Convective Warming Unit is designed for use with WarmTouch™ blankets only. WarmTouch blankets are designed to attach securely to the warming unit’s hose nozzle. The nozzle features guides and a clip to ensure correct orientation. Do not attempt to use other types of blankets with the warming unit; the performance of the warming system has not been evaluated with other blankets and cannot be predicted. The warming unit is compatible with all WarmTouch blankets. Consult the Instructions for Use provided with the warming blankets for important information regarding proper handling and application.
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Product Overview
Product Views Front View Figure 1. Front View
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1
Operator’s Panel
4
Hose
2
Handle
5
Nozzle Strap with Clip
3
No Free-Hosing Label
6
Nozzle
Operator’s Manual