Nellcor WarmCloud User manual

User Manual
KANMED WarmCloud™
Art no OT-600-070/6
2008-03-27
0413
Incorrect use of heating equipment can cause serious injury. Read this manual carefully.
Manufactured by: KANMED AB
www.kanmed.se
This manual is valid for KANMED WarmCloud system serial number 200 and above, with main program version 99 1.5 or higher and hand control program version 99 1.4 or higher. Subject to changes.
CONTENTS
KANMED WARMCLOUD USER GUIDE – QUICK INSTRUCTION…………………..……………………….3
USER MANUAL ....................................................................................................... 4
1. INTENDED USE...............................................................................................................4
2. EXPLANATION OF SYMBOLS USED ...........................................................................................4
3. SAFETY INFORMATION .......................................................................................................4
4. USING THE KANMED WARMCLOUD.......................................................................................6
5. PRACTICAL ADVICE...........................................................................................................9
6. CLEANING, CHECKS BEFORE USE AND MAINTENANCE...................................................................10
7. ACCESSORIES AND SPARE PARTS .........................................................................................10
8. TECHNICAL INFORMATION ................................................................................................. 10
9. TECHNICAL DATA ..........................................................................................................10
10. TROUBLE SHOOTING AND ERROR CODES...............................................................................10
11. ANNUAL CHECK OF THE SYSTEM.........................................................................................10
12. WARRANTY CONDITIONS.................................................................................................10
13. DISPOSAL.................................................................................................................10
User manual
Unpacking the system
Is the transport box intact? If not make sure that the transport company notes this on the delivery receipt. If any damage is found on the equipment then this must be reported immediately to your supplier. Check against your order that everything has been delivered.
Note that KANMED WarmCloud is delivered from KANMED AB without the power cable. Save the transport
material. Be careful not to damage the air hoses when removing the unit from the box.
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KANMED WarmCloud User Guide - Quick instruction
Caution! Incorrect use of heating equipment can cause serious injury. The user manual must be
read completely before use.
Preparation Place the Warm Air Mattress on the operating table. If the mattress has fixating straps then tie them to the side rail with a reliable knot. Do not tighten down the mattress too hard. The air hoses are connected to the air inlets and the Velcro straps are tightened securely. Connect the Hand Controller to the Main Unit. Connect the power cable to an outlet with protective grounding. Switch on the mains power switch, located at the power intake on the Main Unit. Observe that a self test is performed.
Note: Alarm code PO LOS will be received after mains power has been reconnected. This is normal!
Press the Alarm button to reset the alarm. The system is now ready for operation.
Start Press the button on the Hand Controller to start. Always attend the patient when inflating the
mattress.
Correct STOP procedure for the Control Unit
User manual
Reduce the pressure to 0 alternatively press the start/standby button Switch of the Control Unit before you pull out the power cable.
Adjusting the temperature Preset temperature is 37°C. The average air temperature can be set between 20°C (no warming) and 42°C by pressing the [+] or [-] buttons until desired temperature is displayed. 42°C is the recommended start temperature and should be adjusted according to the patient’s needs.
Note: When temperatures above 38°C or below 35°C are selected, the unit will alert the operator
by an audio signal and flashing digits as a reminder that settings that deviate from body temperature are being selected.
Caution! It is highly recommended to monitor the patient’s actual core temperature with a reliable method.
Adjusting the pressure Increase after start to about 45 mb. Then reduce to about 30 mb. Make sure that the patient is not “bottoming out”. This will block the airflow and reduce the warming efficiency. Check by inserting your hand between the Mattress and the operating table under the heaviest part of the patient. Very important with heavy patients. If required, increase the pressure by 5 or 10 mb. Ensure that there are no wrinkled materials under the patient.
Important Safety information
General
Skin Protection
Patient Stability
Weight limits
Reduced Blood Flow
Error Codes Mattress
Types
Please read the user manual carefully and pay special attention to Section “Warnings and Cautions”
Always place a cushion under the part of the body located at the air inlets to prevent possible local overheating and skin damage. This is especially important when selecting the highest temperature and when using the short mattress. Always use some kind of protection for the heels, especially if they are close to the air inlets.
The Mattress may fill or empty unevenly, therefore you must observe the patient carefully when you are inflating or deflating the Mattress. Be extra careful patient is adequately fixated whenever tilting the operating table out of horizontal position. If the mattress is rolled in under the patient after the patient has been put on the operating table, be extra cautious during inflation!
Please see section 5 for information and advice about patient weight limits.
Parts of the body that have reduced or no blood flow should not be warmed. Reduce the temperature setting to lowest value well ahead of a blood vessel shut off.
Error codes are displayed on the hand controller. Full information is found in the user manual.
Please see section 4 for specific information about mattress types.
for 2 seconds.
, and always make sure the
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USER MANUAL
1 Intended Use
The KANMED WarmCloud, a pressure relieving warm air Mattress, is designed to be used pre, per and post operatively. It must be used according to this manual. The system is intended to reduce the risk of hypothermia and pressure sores. It is not intended for home use. It may only be used by qualified medical staff that has undergone proper product training according to the hospital routine.
Only KANMED Warm-Air Mattresses can be used with the system. All other uses will risk the function of the system and patient safety.
Latest version of the user manual and information about accessories can be found on
User manual
www.KANMED.se
2 Explanation of symbols used
Start/stop button on Hand Controller
I ON (Main Unit power on switch)
O OFF (Main Unit power off switch)
ALARM
2
Alarm Silence
Please read the instruction manual
Risk of explosion in the presence of inflammable gases.
Safety class BF, Defibrillator safe
Disposable (single patient use), shall not be reused.
0413
Fulfils MDD93/42 ECC and EMC directive 89/336/EEC
+
-
Increase temperature / Increase pressure
Decrease temperature/ Decrease pressure
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3 Safety information
Warnings
To ensure optimal performance and to prevent accidental misuse the user manual must be read completely.
If you feel that the KANMED WarmCloud is not operating properly, then you must ask a qualified technician for advice.
Single Patient Use Mattress: Reuse will cause leakage because of weakening of the plastic material and increase infection risk and void product liability.
Mattress Fixation straps. If the mattress has fixation straps then they must be tightened to the side rails of the OR table with a reliable knot.
Operating table Safety Straps: When the patient is fixated by the safety straps (recommended standard procedure), first inflate Mattress to ensure proper tension.
Patient Stability: The Mattress may fill or empty unevenly, therefore you must observe the
patient carefully when you are inflating or deflating the Mattress. Be extra careful, and always make sure the patient is adequately fixated whenever tilting the operating table out of horizontal position. If the mattress is rolled in under the patient after the patient has been
User manual
placed on the operating table, be extra cautious during inflation!
Skin Protection. Always place a cushion under the part of the body located at the air inlets to prevent possible local overheating and skin damage. This is especially important when selecting the highest temperature and when using the short mattress. Always use some kind if protection for the heels, especially if they are close to the air inlets.
Compatibility: Only use KANMED air Mattress with KANMED Main Unit to assure performance and safety.
Reduced Blood Flow: Parts of the body having reduced or no blood flow must not be warmed. Reduce the temperature setting to lowest value well ahead of a blood vessel shut off.
Risk of Fire. Protect the Mattress from laser, electrosurgical active knives and naked flame. Be particularly cautious after use of flammable disinfectants (e.g. alcohol).
Skin damage. Ensure that there are no wrinkled materials under the patient.
MRI cameras: The system is not designed or tested for use with MRI cameras.
The system must always be connected to a mains outlet with proper protective grounding.
Patient weight
Recommended lower weight limit 10 kg Recommended upper weight limit 150 kg Read section 5 for more information
Cautions
Be careful not to puncture the Mattress.
If for instance the patients head is mechanically fixated to the operating table then extra
attention must be paid. The patient’s body will drop about 5 cm if the mattress is deflated.
If patient stability is vital for the operation, carefully evaluate the risk/benefit involved in using the system, with respect to the risk of involuntary deflation of the mattress.
Remember to adjust the height of the arm supports after inflating the mattress.
If the unit alarms or it has received mechanical damage, it should be examined by a technician.
See section Trouble Shooting and Error Codes for advice.
The KANMED WarmCloud is a powerful heating device! Always monitor the patient’s actual body temperature with a reliable method. Be particularly observant on patients with low body mass (small children, elderly etc.), and use lower temperature settings on this patient category.
Observe that the set temperature is an average air-temperature value and may differ somewhat from the actual mattress temperature, especially if the patient is covered with blankets.
EMC. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC, and needs to be installed and put into service according to the EMC information which is provided on the KANMED home page under downloads.
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4 Using the KANMED WARMCLOUD
Description of system
KANMED WarmCloud, a pressure relieving closed warm air patient warming system, is designed to be used pre, per and post operatively. It is a highly efficient patient warming system and is particularly suitable for long surgical cases where the risk of hypothermia and pressure sores is high.
KANMED WarmCloud is an under body warming system and thereby provides full access to the patient. It looses very little heat to the surroundings which increases the comfort of the staff working close to the patient.
The risk of pressure sores is very low because of the softness of the Mattress which creates an even pressure distribution under the patient.
Mattress types
Other mattresses may be available. Please contact your local supplier or check on internet
User manual
www.kanmed.se
Full length mattress OT-600-222
Length 200 cm. Width about 55cm Suitable for most patients in supine position but may also be used in lateral or prone position. Always fixate the mattress to the OR table with the fixating straps. See section about weight limits.
Short Mattress OT-600-211
Length 110 cm. Width about 50 cm Suitable for patients in lithotomic type position ( legs supported in the air) or for small children. Heavy patients and patients where the legs are not fully supported may block the air circulation. This is solved by increasing the mattress pressure. Always fixate the mattress to the OR table with the fixating straps See section about weight limits.
Standard Mattress OT-600-220
Length 200 cm. Width about 50 cm This mattress is 5 cm narrower than OT-600-222. It has raised sides in the middle section. It has currently no fixating straps. Therefore it can only be used if no or very little table tilt will take place. Suitable for most patients in supine position but may also be used in lateral or prone position. See section about weight limits
The system consists of a soft warm air under body Mattress, Hand Controller and a Main Unit. The Main Unit can be placed at the head or foot end of the Operating table. The Main Unit’s air hoses are connected to the disposable Mattress on which the patient is placed. Once the Mattress is pressurised, warm air will circulate under the patient in a closed system.
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