Kanmed BABYWARMER BW3 User Manual

User Manual
Kanmed BABYWARMER BW3™
User manual, art no BW3-070/4
2018-01-17
0413
Caution
Incorrect use of patient heating equipment may cause serious injury. Therefore, please study this manual thoroughly.
Manufactured by:
Kanmed AB Gårdsfogdevägen 18B SE-16867 BROMMA SWEDEN
www.kanmed.se
This manual is valid for Kanmed BabyWarmer BW3 system serial
number 0026-11 and above, with Software version 1.0 or higher.
Subject to changes.
User Manual BW3-070/4
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Contents
1 Kanmed BabyWarmer BW3 - Quick instruction ............................................................... 3
2 Safety Instructions ...................................................................................................... 4
3 General description ..................................................................................................... 5
4 Description of functions ............................................................................................. 11
5 Preparing the Kanmed BabyWarmer ............................................................................ 15
6 Mattress selction, Adjustments and Areas of use ........................................................... 15
7 Cleaning and maintenance ......................................................................................... 17
8 Alarm functions, indication and actions ........................................................................ 18
9 Control of Safety functions ......................................................................................... 21
10 Accessories, Spare parts and Technical documentation ................................................ 22
11 Technical data ........................................................................................................ 23
12 Warranty ............................................................................................................... 25
13 Disposal ................................................................................................................. 25
14 EMC COMPATIBILITY STATEMENT ............................................................................. 26
NOTE: This user manual contains important safety information and must be read thoroughly before use,
and must be saved for future reference.
Kanmed BabyWarmer BW3 and the Kanmed Baby Bed The perfect combination
BB101Standard without rails BB100 Standard with rails BB400 Twin Version with rails
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1 Kanmed BabyWarmer BW3 - Quick instruction
Leave the system constantly switched on - to be ready for instant use!
Refer to the Users manual whenever in doubt.
Filling the Water Mattress
Fill the Water Mattress with warm water (about 350C). Fill to the Max H2O level mark +1- 2 cm. Check by holding
the Water Mattress upright. Add Kanmed Clean Water Tablets.
Write the expiry date on the Water Mattress. (one year forward)
There must be no air in the Water Mattress. Place the Water Mattress on a flat surface. Grip the open mattress hole
to lift the mattress and press all air bubbles out. Lower the hole and close it properly.
Check the Water Mattress daily for leaks.
Using the Kanmed Gel Mattress
If the Gel Mattress mode is selected, note that the heat transfer is less than that of water. Also note that the actual
Gel surface temperature may vary from the displayed temperature setting.
Inserting the Heating Pad and selected mattress into the Kanmed Baby Nest
Place the selected mattress upside down on a flat surface. Insert the Heating Pad in the pocket with its printed text
towards the mattress. Turn the mattress over again.
Insert the mattress with Heating Pad into the Nest pocket. Use the opening in the head end of the Nest to assist in
fitting the Nest to the mattress.
You can use the BW3 without the Kanmed Baby Nest but it simplifies the positioning of the baby.
Preparing the bed
Ensure that the bed has drain-holes in the bottom (when the Water Mattress is used).
Place the BabyWarmer nest package on the bed mattress.
Protect the Nest with a sheet that is soft but not thick.
Connecting the Control Unit
Connect the mains power cable at the bottom of the Control Unit and hang it over the small hook.
Connect the Heating Pad at the back of the Control Unit. Be gentle, and fit the connector the correct way. Tighten
the connector screws gently.
Place and secure the Control Unit in a safe place where the display can be clearly seen.
Press the start button on the front panel and observe that the self test performs correctly.
During the self test, check that the correct mattress mode (H2O or GEL) is set. Change mode if required.
Placing the baby
Only when the desired temperature is reached (green smiley-indication), should you place the baby on the
mattress.
Position the lightly dressed baby (nappy, long arm T-shirt, bare legs (and a cap on very small ones)) on its back in
the Nest. Other positions are subject to approval from authorised staff and local protocols.
Adjust the Nest size by pulling the string. Hide the string under the mattress.
Cover the baby with suitable cover, such as 1-3 layers of soft cotton blankets.
Temperature setting
All babies are individuals and their temperature must be controlled frequently until you are familiar with the baby’s
reaction to the set temperature. Overheating is often caused by covering the baby too much.
When the Water Mattress is used, 370C- 37,50C is a good starting temperature for slightly hypothermic babies and
for babies weighing about 1000g.
36.50C - 370C is the most common temperature for babies weighing more than 1200g
As the baby’s weight increases, the temperature is primarily controlled by changing the number of blankets that
cover the baby and secondly by changing the set temperature.
When the lightly dressed and covered baby is maintaining body temperature with a Water Mattress temperature of
about 35.5 - 360C, then the baby is probably ready for a standard cot that has no additional warming.
If the Gel Mattress is being used, try setting the temperature to 37-380C in order to compensate for the heat loss in
the Gel Mattress. Otherwise the same operating instructions apply, but beware of the reduced warming efficiency of the Gel Mattress. Connecting a skin type temp sensor to the unit may be helpful in obtaining the right temperature.
Maintenance
Wash the re-usable Kanmed Nest at maximum 900C. Preferably 600C. Tumble dry it. Kanmed recommends changing
the Baby Nest once a year.
Disinfect the surface of the Mattress, the Control Unit, Gel Mattress and the Heating Pad.
Check the water level in the Water Mattress frequently and remove any air. Replace the Water Mattress once a
year.
See the user’s manual for further maintenance instructions and periodical safety checks.
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2 Safety Instructions
Please study this manual thoroughly and you will find the Kanmed BabyWarmer BW3 to be both safe and easy to use.
Intended use
The intended use of the Kanmed BabyWarmer BW3 is to keep newborn and premature babies normo­thermic. Kanmed BabyWarmer BW3 is designed for hospital use only. It must be used according to the instructions in the manual and according to established clinical routines and by qualified personnel.
Essential Performance
The automatic system supervision will safeguard any malfunction that may have influence on the performance of the system. If used according to this instruction manual, and if the warning information is considered, no unacceptable patient risks should occur. However, always monitor the patient's vital signs and adapt the use after the patient's actual requirements.
Warning
Proper Use. To ensure optimal performance and to prevent incorrect use, the user manual must be
read completely before the system is being used. Only use genuine Kanmed BabyWarmer parts together with the BW3 control unit.
System Malfunction. If the BabyWarmer BW3 self test does not perform correctly or the system
displays an alarm or error message, or the Control Unit has been dropped, received mechanical damage etc., it must be examined by a qualified technician before being used. If it is suspected that the BabyWarmer BW3 is not operating properly, immediately consult a qualified technician for advice and do not use it.
Never use the BabyWarmer BW3 without a Kanmed Water or Gel Mattress!
Electrical Hazard The system must always be connected to a mains power outlet with proper
protective grounding. Always remove the mains power cable before cleaning the Control Unit.
Body temperature. The temperature monitor is intended for added safety purposes only, please use
a dedicated hospital grade precision thermometer, and a method in accordance to hospital procedures for precise measurements of the patient’s actual body temperature.
Never place a baby face down on the Kanmed Mattresses or in the BabyWarmer Nest unless this is
ordered by responsible staff.
A cold mattress, or a mattress which is cooling down due to the heating being switched off, will
decrease the body temperature of the baby. Likewise, a too warm mattress can induce fever.
Trans dermal medications (patches) can increase drug delivery, resulting in possible harm to patient
when used with warming devices.
Caution
Check the Water Mattress daily for leaks.
Be aware that the acoustic alarm has a reduced sound level of 55dBA (adapted for use in silent
environments, e.g. a neonatal ward).
Always fill the Water Mattress to the required level before the unit is brought into use. Preferably fill
with lukewarm water at around 350C.
Replace the Water Mattress periodically as indicated on the Water Mattress (after about 12 months of
use).
Don't fold or bend the Heating Pad sharply, don't pull the Heating Pad cable or use it for carrying the
Heating Pad.
Make sure that the text side of the Heating Pad is facing the Mattress.
Make sure that there are at least 2 drain holes in the bottom of the bed if using the Water Mattress.
Make sure that the adjusting string is placed outside the Baby Nest to prevent it from interfering with
the baby.
Check the temperature of the baby regularly. Check the mattress temperature regularly.
Continue to use appropriate monitoring of vital signs.
Before first use, please clean everything according to your standard hospital routines and to
instructions in the user manual. Always wash a new re-usable Baby Nest before first use.
Please note that the control unit BW3 shall be placed standing on a flat surface, or mounted with the
front end up, having the display clearly visible.
The BW3 may not be interfaced with any other electrical system. If this is done a new “system” is
created per definition, and the safety classification of the BW3 may be effected. Please be aware that use of HF surgical instruments or similar devices may interfere with the BW3 and may require special precautions regarding potential equalization etc.
The Kanmed Gel Mattress may not be used without its integrated aluminium-plate.
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3 General description
Symbols
Display the graph screen during operation. Move highlighted selection in MENU.
Display the status screen during operation. Move highlighted selection in MENU. Also part of the keyboard lock.
Decrease temperature, or change highlighted selection in MENU
Increase temperature, or change highlighted selection in MENU.
OK, ENTER, select highlighted item in MENU.
High Temperature Alarm Limit for the temperature monitor. When pushed, the display changes to "adjust high alarm level screen" (Note: This function is only selectable when an external temperature sensor is connected).
Low Temperature Alarm Limit for the temperature monitor. When pushed, the display changes to "adjust low alarm level screen". (Note: This function is only selectable when an external temperature sensor is connected).
ON/OFF
Information symbol (Read the Manual) The push button is part of the keyboard lock.
Alarm Silence
Menu. (Note: This function is only selectable the unit is in stand by!)
Marking under the buttons related to the keyboard lock.
Alarm LED Colour: Red/Yellow
Red flash = High Priority Alarms Yellow flash = Medium Priority Alerts Yellow constant light = A medium alarm has been silenced
Power LED
Colour: Green
Off = No power connected Slow flash = Stand by mode Constant light = Active mode
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Risk of explosion in the presence of inflammable gases.
Earth potential equalisation connection point.
Safety class BF, Defibrillator safe.
IPX7 Water proof Heating Pad.
Machine washable at max. 60 0C
Can be centrifuged at low speed.
No dry cleaning.
Tumble-dry
Fulfils MDD93/42/ECC. (Notified Body 0413 = Intertek AB, Sweden).
Disposable (single patient use only), shall not be reused.
H2O
Water (Heating Pad)
///////
GEL (Heating Pad)
System Description
The Kanmed Baby Warmer BW3 standard kit consists of 4 major components:
Control Unit
Heating Pad
Water or Gel Mattress
Kanmed Baby Nest
Control Unit, BW3-020
The Control Unit can be connected to any mains AC power supply voltage between 100 - 240 V AC at 50 or 60 Hz frequency, or can be powered from a 12 Volts battery. See the technical section for details.
60
o
2
60
o
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Top Panel Layout
1. Display
2. Keyboard lock button
3. Menu button
4. Power indication, LED
5. ON/OFF button
6. Navigation Pad, with second keyboard lock button
7. Alarm silence button
8. Alarm indication LED
9. Temperature monitor Low alarm limit button
10. Temperature monitor High alarm limit button
Front panel
The YSI400 compatible temperature sensor (T) and optional earth potential equalisation grounding is connected here.
Bottom Panel
The Bottom Panel contains information about manufacturer, part number, serial number, voltage, etc.
The mains power connector is located in the deep bottom of the unit. The Heating Pad connector and the battery power input are also accessible here
Back Panel with pole clamp
Standard since March 2017. Easy to upgrade older units.
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The Heating Pad, BW3-003
The Heating Pad consists of an electric element with four integrated temperature sensors. The design and construction of the Heating Pad has reduced the magnetic and electrical fields to normal background levels and thereby making them harmless. The Heating Pad voltage is 24V DC. See technical data for information about warming up times.
Location of the integrated temperature sensors.
T1 and T3: temperature of the Mattress
T2 and T4: temperature of the Heating element
Explanation of the markings on the Heating Pad
1. Read the manual!
2. Always use a Kanmed Water (H2O)
or Gel (//////) Mattress.
Never place a baby directly on the Heating Pad!
3. The Heating Pad must be inserted in the pocket under the Mattress. (This is best done if the Mattress is placed upside down on a flat surface).
The Water Mattress
When filled to the level mark a standard Water Mattress contains about 4.5 litres of water. Always add Kanmed Clean Water Tablets when the Water Mattress is filled. One Tablet per litre of water. The water level should be checked frequently and water must be added if required. Big air bubbles must be removed. When used for the first time, please write the date of expiry in the box (one year into the future).
Explanation of the markings on the Water Mattress
1. Instructions for Kanmed Water Mattresses
Fill with tap water up to the MAX indication line + 1-2cm. Maximum water temperature 40. Add Kanmed clean water tablets when the water mattress is filled. One tablet per litre. Change water when the water is below the MIN level line and add Kanmed Clean Water Tablets.
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2. Remove air bubbles, very important! Place the Water Mattress on a flat surface and lift the filling hole properly upwards. (20cm.) Press the air bubbles towards the filling hole repeatedly until all major air bubbles are expelled while at she same time lowering the filling hole. Fit the screw cork firmly. Check for major air bubbles on a regular basis.
3. Turn the Water Mattress upside down and insert the Heating Pad in the pocket with the markings facing the Water Mattress. The Water Mattress and the Heating Pad is inserted into the Kanmed Baby Nest.
4. Check the Water Mattress daily for leaks
The Gel Mattress
A Kanmed Gel Mattress may be used as an alternative to the standard Water Mattress. Please observe that when a Gel Mattress is used, the heating capacity of the Kanmed BabyWarmer system is reduced (compared to water). The indicated temperature is an estimated temperature value and may differ from actual spot temperature readings on the Gel Mattress surface. In GEL-mode there is a 2,0° C offset added to the Heating Pad temperature (compared to the set temperature) to compensate for the lesser heat conductivity of the Gel Mattress.
Kanmed (extra soft pebble surfaced) Gel Mattress
NOTE: The Gel Mattress may never be used without it's integrated aluminium-plate which must be
situated under the Heating Pad
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