Updates
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T34 Syringe Pump TM
3rd Edition updates
This document describes the updates incorporated in the release of the BD/CME T34 Syringe Pump that guarantee compliance with the latest standard. TM
T34 key changes include: TM
• Compliance with standard IEC 60601-1 Edition 3.1 • IP22 • Software updates • PCBA update to alarms • Update to DFU, QRG & Patient guide • Bolus function default off from new - configurable enable/disable in change settings Alarms Product changes T34 Syringe - alarm tones and priorities TM
Description
Alarm Type
Audio Signal as per 60601-1-8
Visual Signal as per 60601-1-8
High Priority Alarm Requires immediate user response
High Priority Volume = ~ 58 dBA
RED flashing visual Operation LED flashes RED
Medium Priority Alarm Requires prompt user response
3 tones Volume = ~ 58 dBA
YELLOW flashing visual Operation LED flashes YELLOW
Low Priority Alarm Requires user awareness
Low Priority 2 or 3 pulses Volume = ~ 54 dBA
YELLOW solid visual Operation LED solid YELLOW
Information Signal Provides information that may or may not require actions from clinicians
1 or 2 pulses
No visual
Down occlusion End battery End of infusion Syringe displaced during infusion Restart pump Switch off and on ERROR XX End of infusion (keep vein open) Pump paused too long Low battery Near end Bolus started/completed Keypad lock/unlock Syringe plunger hit the limit Syringe loaded Purge started/end Power on/off Infusion started/resumed/ stopped by user KVO stopped by user Service interval alert
Visual changes
2nd Edition International
3rd Edition UK
T34
TM
Text
IEC Symbols
3rd Edition Syringes It is recommended that all but the brand of syringe in regular use are disabled via the BodyComm * communication software to prevent accidental selection of the incorrect brand during set up. Should the need arise to program the T34 syringe pump to operate with a manufacturer and/or brand other than one of those listed above, you should consult either your local medical engineering department or BD/CME Technical Services. TM
TM
Default Syringe Brands Configured for Use Manufacturer
Syringe Sizes (ml) 2nd Edition
Syringe Sizes (ml) 3rd Edition
BD Plastipak
-
3
5
10
20
30
50
-
3
5
10
20
30
50
Braun Omnifix
2
-
5
10
20
30
50
2
-
5
10
20
30
50
Monoject
-
-
6
12
20
35
50
-
3
6
12
20
35
50
Codan/Once
2.5
-
5
10
20
30
50
-
-
-
10
20
30
50
Terumo
-
3
5
10
20
30
50
-
-
5
10
20
30
50
Nipro
-
-
-
-
-
-
-
-
-
5
10
20
30
50
It is possible to disable default syringes from memory or replace them with one not listed above. This procedure is not detailed in the DFU as it should only be undertaken by trained, certified service centres or biomedical engineers. Please consult a biomed engineer or your local T34 syringe pump supplier should this need arise.
Clinical updates
TM
Category
3rd Edition
Battery life
Battery life update: 25h @ 1ml/h 20h @ 5ml/h Always check battery power prior to each infusion
Time to alarm before end of infusion
Fixed to 3 min before end of infusion
Epidural indication - intended use
Intended use removed
Immunoglobulins, biosimilar - intended use
Intended use updated to include
Minimum flow rate
Range updated to 0.1-650ml/h
Flow rate increments
Range updated to 0.1–10 ml/h in 0.01 ml/h increments; 10–29.9 ml/h in 0.1 ml/h increments; 30–49.5 ml/h in 0.5 ml/h increments; 50–299 ml/h in 1 ml/h increments; 300–650 ml/h in 5 ml/h increments.
Bolus function
Updated to include new function
Minimum occlusion pressure
Updated from 100mmHg to 200mmHg
Fluid ingress - classification
IP22
Weight
Updated from 210g to 230g
New connectors - battery
Update to rear assembly
Cover labels and branding
Update to CME labels
Rear label
Updated to comply with standard
KVO Rate Operation
Update to range from 2.0 ml/h to 5.0 ml/h
Rear drainage
New design feature to avoid fluid accumulation
GTIN barcode labels
Updated to comply to GTIN standard
Continues overleaf
Technical updates
Category
3rd Edition
Software
Update to software
Add primary sound self-test into boot-up process
Update to software
Update BodyComm software for 3rd edition pump software
BodyComm v3.0 (and next) compatible (n.b. not compatible with 2nd edition pumps)
Service interval alert added (1-year period)
New default at 12 months - can be switched off in Tech. mode
Reduce safe stop current threshold and use this threshold during travel calibration ("Pinch Hazard")
New limits
Date input order changed
Updated to date: year, month, day
RTC battery changed
Updated from disposable battery to rechargeable 3V battery
Add microphone test and threshold
New alarm test during startup
Add backup alarm test into Tech. mode
New test function in 3rd edition
Add LEDs test into Tech. mode
New test function in 3rd edition
Add microphone level calibration into Tech. mode
New feature in 3rd edition
Keypad LED yellow colour
LED colour update from red and green to red, yellow and green
Part differences - hardware
Update included in TSM
Battery indication (vs voltage) was changed
Changes to battery measurement method in 3rd Edition
Pressing on/off or stop key disabled the alarm
Update 3rd edition pump alarms if 9v battery is removed
* BodyComm is intended to permit qualified and trained personnel only to configure BD BodyGuard infusion and syringe pumps TM
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