LABCOLD
Blood Bank Refrigerators
Model RSBG2xxxMD Blood Bank Refrigerator Instruction Manual Rev 4 March 2018
Instruction Manual
51 Pages
Preview
Page 1
IMPORTANT INFORMATION COMMISSIONING CHECKLIST FOR CUSTOMER TO COMPLETE THIS IS IMPORTANT INFORMATION REGARDING THE VISIT THAT WILL BE BOOKED ONCE THE FOLLOWING ACTIONS HAVE BEEN COMPLETED.
If the following is not adhered to and a repeat visit is required you will be charged.
Please tick the box to confirm that all the actions below are complete. 1) Ensure the unit is unpacked and in it’s final destination. 2) The electrical supply to the cabinet has been provided within 2 metres. If the unit needs to be hard wired into a fused spur this would need to be done before our engineer arrives on site. If you require the unit to be connected to your alarm system please provide a suitable connection adjacent to the cabinet. 3) Item to be commissioned needs to be switched on and running to ensure that our engineer can carry out the required checks. Note: It can take several hours for the unit to achieve its final temperature. 4) Once the unit is switched on and the temperature starts to drop, the alarm may sound, if this occurs press the display screen alarm icon showing at the top GENTLY. Pressing forcibly may crack the screen. Note: Pressing the bell symbol will not silence the alarm.
Damage caused by not following the above instruction will be chargeable. PLEASE Tick and Sign this form to confirm all parts have been completed. The date for the visit will not be confirmed until this checklist has been received back by Labcold. Your Signature…………………………
Date………………………………..
End User Information: ESTABLISHMENT NAME, (Please Print)………………………………………………….. CONTACT NAME (Please Print)……………………………………………………………. TELEPHONE NUMBER……………………………………………………….……………... DEPARTMENT………………………………………………………………………………... MODEL……………….………………….SERIAL NUMBER……………………………….
FAX BACK TO: 01256 705575 G:SERVICECommissioning checklistsCOMMISSIONING IMPORTANT INFORMATION
JAN 2014
Thank you for choosing Labcold Your unit has been manufactured to ISO 13485 quality standards but in the unlikely event that you notice any defect on delivery, please contact your retailer immediately
Please read these instructions carefully and retain for future reference Useful Information Serial Number Date Purchased
Failure to operate your unit in accordance with these instructions may invalidate your warranty
www.labcold.com Labcold Limited Cherrywood, Chineham Park, Basingstoke, RG24 8WF, United Kingdom Blood Bank Refrigerator Instruction Manual: version 03, December 2017
Pharmacy I Blood I Laboratory I Technical Service
BLOOD BANK REFRIGERATOR
TABLE OF CONTENTS
1.
Limitations of Use and Model Overview
2.
Commissioning Instructions
3.
User Instructions
4.
Connection to external alarms
5.
Refrigeration controls
6.
Keypad instructions
7.
Chart recorder instructions
8.
Alarm module and symbol list
9.
Cleaning and maintenance
10.
Technical specification, Standards & Declaration of Conformity
11.
Calibration information
12.
Contact us
Blood Bank Refrigerator Instructions Medical Device
Sept 2015, Rev 3
Purpose and Limitations of Use. The product to which this manual relates is an independently certified Medical Device manufactured in accordance with Directive 93/42/EEC and our EN ISO13485:2012 Quality System. This is a complex and sophisticated piece of medical equipment that differs significantly from conventional refrigeration products both in its design, performance and in its Medical Device status. It is strongly recommended that only suitably qualified and trained personnel are permitted to maintain, repair or in any other way perform work on it. This Blood Bank Refrigerator is designed and certified for the storage of already chilled blood and blood products when contained in blood packs of a standard size and design. It is not suitable for the cooling down of materials that are not already at refrigeration temperature. The designed blood storage temperature range is between +20C and +60C however in normal operation the air temperature within the chamber may stray outside this range from time to time. Storage of anything other than as described above, and any modification to or adaption of the product in any way may have an adverse effect on its performance, and may invalidate its Medical Device status and the manufacturer’s warranty. Customers wishing to store other items or materials, or to make physical or setting changes to the product do so at their own risk. When loading, care should be taken to ensure a good airflow around the stored contents throughout the chamber, and in particular nothing should be placed within the chamber in such a way that it obstructs free circulation of air. The expectation designed into this product is that the load will be fairly uniformly distributed. Having the load concentrated in one or two areas of the chamber may adversely impact performance. The bag capacity quoted is the maximum the blood bank will hold and to be used for emergency purposes only. Prolonged operation with this loading is not recommended due to the potential restriction of airflow and consequential impact on performance. The recommended loading for normal usage is no more that 70% of the maximum capacity. This Blood Bank Refrigerator MUST NOT be used in an oxygen rich environment i.e. one that contains more than 22% oxygen e.g. hyperbaric chamber.
www.labcold.com Cherrywood, Chineham Park, Basingstoke, RG24 8WF, United Kingdom Blood Bank Refrigerator Instruction Manual: version 03, March 2018
Pharmacy I Blood I Laboratory I Technical Service
BLOOD BANK REFRIGERATOR
Reverse of Model: RSBG1030MD
Remote lock interface
Remote alarm contacts and battery pack
REVERSE VIEW Reverse of Models: RSBT1056MD RSBG1056MD RSBT1068MD RDBG1068MD RSBT2056MD RSBG2056MD RDBT2068MD RDBG2068MD
Danger warning: ·Disconnect from mains before removing cover ·Fridge MUST be earthed
Remote alarm contacts Remote lock interface
Alarm battery pack Blood Bank Refrigerator Instruction Manual: version 03, July 2017
Reverse of Models: RDBB2180MD RDBG2180MD RSBB2270MD RSBG2270MD RSBG2320MD RDBG2320MD Battery pack
Remote lock interface
Remote alarm contacts
Condensate removal tray WARNING! Can be hot
Reverse of Models: RSBB2540MD RDBB2640MD RSBG2540MD RSBG2640MD
Remote alarm contacts and battery pack Remote lock interface Condensate removal trays WARNING! Can be hot
Blood Bank Refrigerator Instruction Manual: version 03, July 2017
MODEL OVERVIEW Touch screen interface displaying: • Air temperature • Load temperature • Alarm status
Battery powered 7 day chart recorder recording load temperature Internal LED light
Digital keypad lock
Self closing door
Serial number plate (position varies depending on model)
Magnetic lock WARNING this can be hot in normal operation
Cold retaining drawer fronts.
Internal simulated load bottle (exact position depends on model)
Inner doors fitted on shelf models
Castors for easy manoeuvrability lockable on larger models
Blood Bank Refrigerator Instruction Manual: version 02, July 2017
www.labcold.com
COMMISSIONING INSTRUCTIONS IT IS IMPORTANT THAT THE BLOOD BANK REFRIGERATOR IS COMMISSIONED AND THAT THE USERS ARE TRAINED IN ITS OPERATION BY A COMPETENT PERSON. FUNCTION The Blood Bank Refrigerator is designed to store already refrigerated Whole Blood and Red Cell components at a storage temperature of between +2 and +6C. The Blood Bank Refrigerator is not designed to cool Blood to that temperature.
POSITION The Blood Bank Refrigerator should be stood on a firm level surface away from direct heat sources such as steam pipes, autoclaves or ovens. It is better to avoid direct sunlight if possible. The refrigerators should be used in an ambient of +16C to +32C. Operating Conditions Ambient temperature range: +16°C to +32°C Humidity Range: 80% RH @32°C Maximum Altitude: 2000M Pressure Range: 70 to 106 KPa Transit and storage conditions Temperature range: +5°C to 32°C Humidity non-condensing Pressure Range: 70 to 106 KPa POWER REQUIREMENTS The power cable with moulded on plug supplied with this Blood Bank Refrigerator is coded as follows: Brown - Live Blue - Neutral Green and Yellow - Earth It is rated for 230 volts 50Hz. It is essential that the Blood Bank Refrigerator is earthed. The supply must be fused at 13 amps. It is preferable that the blood bank refrigerator is connected to a secure electrical supply. Before connecting the device to the mains supply check that the appliance does not obscure the mains supply connection. The appliance does not have a main switch and the switching off or removal of the plug is the only way to disconnect the unit from the mains supply.
Warning: To avoid risk of electric shock, this equipment must only be connected to a mains supply with a protective earth. SET UP INSTRUCTIONS On receipt of the Blood Bank Refrigerator, remove all the packing from the outside and also check for visible damage which should be reported to the carriers or Labcold Ltd.
Blood Bank Refrigerator Instructions Medical Device
Rev 4 Mar 2018
Page 1 of 5
Remove the instruction manual, pack of charts, pen and keys, the calibration certificate and certificate of conformity and place somewhere safe, as is your statutory requirement. Assemble the shelves and runners (if applicable) and position in the correct location. Remove all protective film from the exterior and the inner doors. (Caution static) Check that the electrical rating on the serial plate matches your electrical supply. The serial plate is located just inside the refrigerator door on right hand side. Connect up any external wiring, i.e. to the switchboard, making sure that the external voltage is less than 30V and less than 200mA. For more details see Section 4 Connection to external alarms. Open the pack of charts and using the appropriate key, open the chart recorder door and fit a new chart and pen. (See separate instructions) close and lock the recorder door. BEFORE START UP If the Blood Bank Refrigerator has been tilted during its transit or positioning it is important that it is left to stand for 12 hours before connecting the power. (This procedure allows compressor oil to return to the sump and prolongs compressor life expectancy). OPERATION PRIOR TO COMMISSIONING Plug the Blood Bank Refrigerator into the mains supply or switch on the fused spur if wired into a secure supply. It is recommended that a secure emergency supply be used wherever possible. The operating temperature and alarm thresholds are factory set and should require no adjustment. The Blood Bank Refrigerator will pull down to operating temperature, which can be confirmed by the indicating and recording thermometer. This Blood Bank Refrigerator has been set as shown on the enclosed certificate and should not require further adjustment. Connect up the external battery connection at the rear of the cabinet. This can only be connected in one way as the connection is asymmetrical. IMPORTANT: DISCONNECT THE BATTERY IF THE CABINET IS NOT IN USE. Allow the Blood Bank Refrigerator to cool down to the set point. Once down to temperature the Blood Bank Refrigerator can be tested and then loaded to the Department’s written protocol.
Blood Bank Refrigerator Instructions Medical Device
Rev 4 Mar 2018
Page 2 of 5
INSTALLATION OF THE CONDENSATE TRAY The following assembly should only be performed by a qualified technician: 1. Remove the rear channel (Fig 3.1) by unscrewing the 6 screws (Fig 3.2) and keeping the screws and channel in a safe place.
Rear Channel Fig 3.2
Fig 3.1
2. Locate the condensate tray and position it under the rear of the Blood Bank Refrigerator (Fig 3.3), making sure that the front edge is located in the clip (Fig 3.4) under the Blood Bank Refrigerator.
Fig 3.3
Fig 3.4
Blood Bank Refrigerator Instructions Medical Device
Rev 4 Mar 2018
Page 3 of 5
3. Attach the tray using the screw and spacers provided (Fig 3.5)
Spacers
Fig 3.5
4. Making sure that the power is disconnected from the Blood Bank Refrigerator, plug in the heater cable (Fig 3.6) to the rear of the control box.
Heater cable
Fig 3.6
5. Lay the cable down the back of the Blood Bank Refrigerator (Fig 3.7) and reattach the channel. Take care not to pinch the wires when tightening the channel.
Fig 3.7
6.
Repeat if required for multiple trays.
Blood Bank Refrigerator Instructions Medical Device
Rev 4 Mar 2018
Page 4 of 5
7.
Remove bung from interior drip tray to allow drainage. (Fig 3.8) Discard the bung.
Bung to remove
Fig 3.8
8.
Switch the Blood Bank Refrigerator back on.
DO NOT TOUCH the heated tray under the cabinet as it gets very hot. COMMISSIONING Once down to temperature the Blood Bank Refrigerator can be commissioned by the Labcold engineer or their approved service engineer. IMPORTANT THE ALARM HAS BEEN DISABLED AND WILL BE SWITCHED ON BY THE COMMISSIONING ENGINEER. DO NOT PLACE PRODUCT IN THE BLOOD BANK UNTIL IT IS SWITCHED ON. If the Blood Bank Refrigerator is not being commissioned by Labcold please contact the Labcold Service Department (Contact details in “Contact us” section)
Blood Bank Refrigerator Instructions Medical Device
Rev 4 Mar 2018
Page 5 of 5
USER INSTRUCTIONS ALARM SYSTEM NOTE:
The touch screen has a built in delay to stop casual cancelling of alarm states.
DISPLAY IN NORMAL OPERATION
Chamber Temperature
External alarm indicator and alarm Test Button
Refrigeration Mode and System
Door Status Chamber temperature shows the current air temperature for a single sensor system. Refrigeration mode and system shows the system status (E.g. Automatic mode on system 1) Door Status indicates whether the doors are open or closed. Test Button when pressed will show all the alarm symbols, sound the local alarm and close the remote contacts. This will be activated for the duration of the pressing of the button.
DISPLAY IN ALARM
Air Temperature High
Temperature High icon indicates that the temperature has exceeded the trigger point (8C) and that the local alarm is sounding. Pressing gently for 2 secs the alarm icon will mute the local alarm.
Blood Bank Refrigerator Instructions Medical Device
Rev 3 Mar 2018
Page 1 of 4
! WARNING ! IMPORTANT! THE MUTING OF THE ALARM WILL STOP ANY FURTHER ACTION. THE RESPONSIBILITY FOR RECTIFYING THE FAULT LIES WITH THE PERSON THAT ACCEPTED AND MUTED THE ALARM.
ALARM MUTED
Alarm Icon changes to clear
Recall The cause of the alarm, if not rectified, will mean that the alarm will return after the predetermined period set in the menu.
ALARM NOT MUTED
Auxiliary connections changed
If the alarm is not muted within the preset time scale then the auxiliary (remote) contacts close and the Telephone icon is illuminated. The Auxiliary connections have to be cancelled separately by pressing the Telephone icon.
Blood Bank Refrigerator Instructions Medical Device
Rev 3 Mar 2018
Page 2 of 4
ALARM TEST
Pressing the Telephone icon, when in non-alarm mode, will cause all the alarm indicators, the local sounder and the external connections to activate while the icon is pressed and held.
DOOR ALARM
If the door is left open for longer than the permitted time the local alarm will sound and the door alarm icon will appear. The sounder can be muted by pressing the icon.
ADDITIONAL ALARMS Mains supply
Battery charge low
The two icons show the mains electrical supply has failed and the battery is getting low. The battery icon is advisory only, whilst the failure of the power supply needs to be rectified immediately.
Blood Bank Refrigerator Instructions Medical Device
Rev 3 Mar 2018
Page 3 of 4
LOAD PROBE
When enabled the display will show two temperatures labelled “AIR” and “LOAD” The air is monitored by fixed air sensor, and an additional sensor is placed in a load container of 200ml of water. The “LOAD” sensor will have a high temperature alarm of 6C with no delay. The alarm indications for the additional probe are labelled “Lo 2” or “Hi 2”.
! IMPORTANT ! DO NOT USE ANY POINTED OR SHARP IMPLEMENTS TO PRESS THE TOUCH PANEL. IT IS DESIGNED FOR FINGER PRESSURE ONLY. MECHANICAL DAMAGE TO THE DISPLAY AND ITS TOUCH MEMBRANE IS NOT COVERED BY WARRANTY
Blood Bank Refrigerator Instructions Medical Device
Rev 3 Mar 2018
Page 4 of 4
CONNECTION OF EXTERNAL ALARMS REMOTE CONTACTS The contacts mounted on the rear of the Blood Bank Refrigerator (See Fig. 4.1) are connected to the Alarm module, and will change state to alarm once the set time for the Remote alarm trigger on the Alarm module has elapsed. The contacts are volt free switches and require the application of a voltage to be used. The contacts are designed to integrate with an alarm system BMS or paging system and are not designed to switch any load. The contacts are rated at 200mA only and are fitted with a 200mA fast blow fuse. A spare fuse is provided in the holder, only replace with a fuse of the correct rating. The use of filament bulbs, relays, buzzers or bells will damage the contacts and will not be covered by warranty. If the system you wish to connect to only has switchboard connections of a higher loading than allowed by the Alarm module, contact the Labcold service department for advice. N.B. In the event of a communications failure the remote alarm system shall not be relied upon for the receipt of alarm signals. TESTING To test the contacts for correct operation, press gently the telephone symbol on the Alarm module and all the alarm icons will illuminate, the sounder will operate and the contacts will change state.
Fig 4.1
Blood Bank Refrigerator Instructions Medical Device
Rev 5 Mar 2018
Page 1 of 1
REFRIGERATION CONTROLS TEMPERATURE ADJUSTMENT – SINGLE SYSTEM
Temperature Display. To deter unauthorised tampering the controller is placed on the top of the Blood Bank Refrigerator behind the blue panel or on the rear of the unit, depending on model. To raise or lower the operating temperature of the Blood Bank Refrigerator press and hold the button down, then use the left or right arrows until the required value is shown.
Temperature adjustment should only be carried out be carried by Labcold engineers or an approved service agent. DUAL SYSTEM CYCLING (WHERE FITTED) This unit is provided with two independent refrigeration systems to give complete product security. To maintain the system in good condition the workload is shared between the systems on a time basis. This time is set in the Alarm module and indicated on the front of the panel. The displays can be found on the top of the control box behind the blue fascia.
To deter unauthorised tampering the controller is placed on the top of the Blood Bank Refrigerator behind the blue panel or on the rear of the unit, depending on model. To raise or lower the operating temperature of the Blood Bank Refrigerator press and hold the button down, then use the up or down arrows until the required value is shown.
Blood Bank Refrigerator Instructions Medical Device
Rev 5 Mar 2018
Page 1 of 1
Keypad Instructions LED Light
q
When the cabinet is locked the light will flash red intermittently to show it is working. In programming mode, the light is red continuously. Once you start inputting the numbers it changes to orange continuously and when you confirm the number, it will briefly turn green before reverting to red continuously and then intermittently flashing red. The light will turn green to show the cabinet is unlocked.
This blood bank refrigerator/platelet incubator is fitted with a keypad operated magnetic lock which automatically locks when the door is closed keeping the contents secure. It can be programmed to accept new PIN access numbers and you can delete PIN numbers to restrict access when people leave. WARNING - The magnet can get hot under normal operation, do NOT touch It also features an anti tamper alarm, this is currently switched off but you can activate it should you wish. To access programming mode you need to enter the master code which is Ü0291# you may also need to use your personal PIN which is factory set at 1111# Adding a PIN code You can program the keypad to accept up to 1000 users. The PIN can be 4 to 6 digits long but can’t be 1234. To allocate a PIN number you need to: 1. 2. 3. 4. 5.
Enter the master code Ü0291# Enter 1 then any 2 numbers (your personal number) followed by # Enter new 4-6 digit PIN number followed by # to confirm Enter ÜÜ to exit Test the new PIN code works All PIN numbers must end in # as this confirms to the lock that you want to enter the digits
To delete a PIN code To delete a PIN number you need to: 1. 2. 3. 4. 5.
Enter the master code Ü0291# Press 2 and enter your user ID followed by # Enter the PIN you wish to delete followed by # Enter ÜÜ to exit Test the PIN code has been deleted
To change a PIN code To change a PIN number you need to: 1. 2. 3. 4. 5.
Enter Ü and your user ID followed by # Enter the PIN you wish to change followed by # Enter the new PIN followed by # Re Enter the new PIN followed by # Press Ü to exit
Blood Bank Refrigerator and Platelet Incubator Instruction Manual: version 07, November 2017
Keypad Instructions Setting the anti-tamper alarm The alarm is designed to engage after 5 failed PIN attempts. It is currently turned off. There are two options for the alarm. You can set it to lock for 10 minutes after engaging or you can set it to alarm, up to 30 minutes or until a valid PIN or master code is entered. To set the anti-tamper alarm you need to: 1. 2. 3. 4. 5.
Enter the master code Ü0291# To deny access for 10 minutes enter 6 1 # To get the buzzer to sound enter 6 2 # To set the term enter 5 (and any number between 0 and 30 depending on how many minutes you want it to alarm) # Press Ü to exit WARNING - If there is a power failure the lock will unlock. It is recommended that your blood bank refrigerator/incubator is connected to a secure source of power.
Lock interface
The control of the lock can be integrated into an electronic issue or blood tracking system. The connections are at the rear of the blood bank refrigerator/platelet incubator and wires can be inserted to connect to the electronic issue system. When connected together the main control will be passed to the electronic issue system. The keypad will then be inactive. The keypad password should be changed to a different code to avoid accidental bypassing of the electronic issue system. Removal of either wire from the interface socket takes back total control to the keypad. The lock is de-energised when the two wires are connected. No voltage should be applied to these contacts.
Blood Bank Refrigerator and Platelet Incubator Instruction Manual: version 07, November 2017